Now it’s time for a silver bullet of sorts, or a wooden stake, to put that tired quote to rest at last.

The quote was from Ronald McKay, a stem cell researcher at the National Institutes of Health, and the topic was human embryonic stem cells. In an interview I did for The Washington Post in 2004, I asked McKay why so many people kept talking about the possibility that injections of stem cells into the brains of people with Alzheimer’s disease might someday cure these people when, in fact, the scientific consensus at the time (and still today) was that such injections were unlikely to benefit such patients.

Alzheimer’s, after all, affects such a large part of the brain that treating it with injections of cells would almost certainly be futile. (Parkinson’s disease, by contrast, involves a very small area in the brain so has real of hope of being helped by injections of replacement cells there.) So why did people keep saying that stem cell injections might someday cure the disease?

“To start with, people need a fairy tale,” McKay told me. “Maybe that’s unfair, but they need a story line that’s relatively simple to understand.”

I had a feeling that quote would come back to haunt McKay, but as a journalist, that was not really my problem. He said it on the record and it struck me as true; people often do want to believe there is hope, even where there is little.

What I didn’t know was that conservative opponents of embryonic stem cell research would take that comment and repeat it over and over—increasingly out of context—until it had taken on a meaning that McKay never intended and that no scientist believes is true. Specifically, these opponents have used the quote to argue that embryonic stem cells have no potential role to play whatsoever in the search for treatments for Alzheimer’s. So let’s just set the record straight: That is simply not the case, and I will explain why.

I bring this up now because last week, yet again, McKay’s quote was resurrected, this time by conservative blogger Ed Morrissey. He used it to chide President Obama, who said during his news conference last week that stem cells could prove valuable “to find cures for Parkinson’s or for Alzheimer’s….”

“Alzheimer’s?” Morrissey wrote in response. “Would embryonic stem cells hold promise for Alzheimer’s?” That’s when he dredged up my old article—the one with the fairy tale quote from McKay—in which I wrote about a scientific consensus that “of all the diseases that may someday be cured by embryonic stem cell treatments, Alzheimer’s is among the least likely.…”

Here is what Morrissey and his ilk keep ignoring: Just because injections of stem cells into the brain are not likely to cure Alzheimer’s does not mean the cells are not uniquely able to help scientists find a cure for this devastating disease.

Recall that the whole beauty of embryonic stem cells is that they can develop into any cell type. Among the cell types they can become are brain cells, including the kinds of neurons that go bad in Alzheimer’s.

Exactly why these cells lose function in some people as they age remains a mystery. Scientists know that the problem seems related to the buildup of proteins around these neurons, but they know little about the genetic or other underpinnings of the problem. And there are obviously very few things a researcher can do to observe this process up close as it happens, since it is happening inside people’s skulls.

Imagine, though, being able to watch a neuron undergo its natural development and aging process in a laboratory dish. And imagine being able to compare this process in normal brain cells and in brain cells bearing the subtle molecular differences that scientists have so far found to be characteristic of at least some varieties of Alzheimer’s disease. In fact, you don’t need to imagine this because it is already being done, thanks to embryonic stem cells.

Scientists are using these cells to create normal neurons and abnormal neurons with many of the characteristics of Alzheimer’s. They are using them not only to compare them, but to be able to test various chemical compounds and potential medicines to see which of these compounds might have salutary effects on the ailing neurons. They are using them, in short, to do studies that could never be done in patients and that, in fact, could never be done in laboratory dishes were it not for the newfound ability to grow them from embryonic stem cells.

“We’re in the process of building a large program in San Diego with industry to use human neurons generated from human embryonic stem cells lines … to test and search for new drugs for Alzheimer’s,” Larry Goldstein told me just last week. Goldstein is a leading stem cell scientist at the UCSD School of Medicine, and one of many in the field tired of the bogus use of McKay’s fairy-tale quote by people with political or religious reasons to oppose embryonic stem cell research generally. “We are introducing by molecular means the genetic changes that cause hereditary Alzheimer’s disease into existing stem cell lines …for drug discovery.”

The approach has every chance of identifying targets in Alzheimer’s neurons that new drugs might attack to slow the disease, stop it, or perhaps someday even to reverse it. And that is extremely important for a disease such as Alzheimer’s, not only because it takes such an awful toll on patients and their families but because the cupboard of potential therapies, at this point, is nearly bare.

“We’ve got almost nothing,” Goldstein said, noting that the few FDA-approved Alzheimer’s medicines have modest beneficial effects at best. “And we’ve got very little in the pipeline, so radical new approaches really are needed.”

Will it work? Goldstein’s answer is optimistic but sensible—not so much a fairy tale as a fable from Aesop: “Any new approach might fail,” he said. “But it absolutely will fail if you don’t try.”

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

In one of the videos, the camera zooms in on a personnel manager at the Bronx Zoo delivering bad news to an off-camera character. “I’m sure you’ve heard that Governor Paterson’s proposed budget will mean severe cuts here at the Bronx Zoo and the New York Aquarium,” the somber official says. “So … even though you bring record numbers of people to New York and help the economy, we’re going to have to let you go.”

Only then does the camera pan to the dejected victim of this lay-off—a porcupine from one of the exhibits. A damn cute one at that.

A second video (both were made at virtually no cost by zoo staffers) features the jobless porcupine—whose real-life name, it turns out, is “Wednesday”—visiting the unemployment office as part of her sorry search for work. “Alright,” the case worker asks, looking up from Wednesday’s resume, “how are you with PowerPoint?”

Maybe I wouldn’t have been so touched by the plights of these institutions and their resident menageries had I not just spent the breakfast hour reading newspaper articles about the way the federal bailout’s been going. Those bonuses going to fat-cats was galling, of course. But also the news that AIG is suing the U.S. government (that’s right, suing its majority owner) because—catch this—it is peeved that the IRS did not give it a big enough tax break for its offshore tax havens. What sheer testicular chutzpah, using bailout money to pay lawyers to sue the government that saved you!

Even an unemployed porcupine knows better than to bite the hand that bailed it.

It was while I was mulling the unfairness of it all—the squandering of wealth on the one hand and, on the other hand, the squeeze being put on New York’s living museums of nature—that I learned a final detail about the bailout that really sent me, lemming-like, over the psychological edge:

Section 1604 of the American Recovery and Reinvestment Act of 2009 makes it explicitly illegal to appropriate even a dollar of bailout money to aquariums or zoos (or any “gambling establishment,” either, though I don’t get the connection. Maybe they meant “gamboling,” which some zoo animals do).

That is when it really sunk in for me that human beings are the problem, and that the way to make the most of this bailout is to earmark it exclusively for non-human species.

Consider that the Bronx zoo, which is the largest single employer of youth in the Bronx and brings in millions of dollars every year to one of the most underserved neighborhoods in the country. Consider, too, that taken together, the 76 New York zoos, botanical gardens and aquariums sponsoring Wednesday-the-Porcupine’s viral video debut attract more than 12 million visitors each year—people who spend large sums in surrounding enterprises during their visits. Under the 2008-2009 budget, the state will contribute a mere 35 cents or so per visitor in support of these institutions—surely a tiny investment relative to the economic payoff, not to mention the educational and entertainment value of these venues.

Nationally, according to the Association of Zoos and Aquariums, the group’s 200 member institutions generate a whopping $7.6 billion in economic activity every year, while employing 100,000 people (not to mention a small army of porcupines and other critters). As for the ancillary benefits, the prestigious National Research Council concluded in January that informal science education venues such as zoos and aquariums are “integral” elements of the nation’s science education system. “We’re actually out there informing people about science,” said John Calvelli, a vice president with the Wildlife Conservation Society, which runs the zoo and the New York Aquarium. “We help people understand complex science issues.”

It isn’t cheap to run these joints, either. It costs real money, for example, to remove the 500 pounds of elephant waste produced per pachyderm per day. Talk about shovel ready…

Of course, zoos and the like should not be the only beneficiaries of my Biodiversity Bailout. Arguably, far more should go to non-human species living in the wild. Heaven knows—as does a growing cadre of environmental economists—that Mother Nature is on the verge of planetary homelessness and could use a handout. At $780 billion, the bailout pales in comparison to, say, the $2 trillion to $5 trillion dollars that, according to a European Union analysis, is the value of annual forest loss around the world.

Or look at it the way Jaboury Ghazoul does. In an article in the January 23 issue of Science (subscription required), Jaboury, of the Institute of Terrestrial Ecosystems in Zurich, calculated the benefits of distributing a $700 billion bailout evenly among Earth’s estimated 10 million species. The resulting $7,000 per species could easily make the difference between survival and extinction for some.

“Consider the jellyfish tree Medusagyne oppositifolia from the Seychelles,” Jaboury wrote. “Even $70,000 should be enough to save its few remaining individuals … by investing in simple nursery facilities and a modest propagation and planting program.”

And what a bonanza for communities of multiple species. “The intertidal bryozoans of Scotland’s West Coast would alone receive more than $3 million,” Jaboury concluded. “The 43 species of ants from E. O. Wilson’s single leguminous tree at the Tambopata Reserve in Peru could pool their resources to buy about 150,000 hectares of Amazonian forest (at $20 per hectare).”

Well, maybe and maybe not. But one thing’s for sure: These animals are not going to use the money to sue you.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Salmonella bacteria was the weapon of choice. Colorless. Odorless. Invisible. “They think they are such royalty, those Americans,” the terrorists laughed. “Well they can spend all day and all night on their porcelain thrones!”

Okay. It didn’t happen that way. It was just a shoddy American peanut-processing company trying to maximize its profits from lousy legumes, filthy with fecal bacteria. But there is something distressing about the U.S. response to this home-grown catastrophe, which has now sickened 683 people in 46 states and forced the recall of about 3,500 food products.

More than two years after the Peanut Corporation of American began seeding Salmonella through the U.S. food supply—and more than two months after federal investigators proved consumers were getting ill from peanut products made in the the company’s Blakely, Georgia, processing plant—the number of cases continues to grow.

In addition to the more than 100 victims who were made so seriously ill that they had to be hospitalized, at least eight people have died from Peanutgate, according to figures from the Centers for Disease Control and Prevention. That’s more than the five who died as a result of the anthrax bioterror attacks of 2001. And yet, says a recent CDC posting: “The outbreak is continuing….”

Nowhere is the nation’s inability to rein in this epidemic more obvious than in the steady flow of alerts from the Food and Drug Administration that, day after day, comes into my e-mail box, announcing foods newly added to the list of recalled products. In the last three days of last week alone, I received notices about 11 companies recalling more than 17 different products because of the peanut recall (just see the sidebar to get an idea).

Shouldn’t we pretty much know by now which products are affected? What if this was a terror attack? Can’t we do better than this?

Granted, part of the problem is that earlier this year the FDA concluded that a second processing plant owned by the same company also sent out contaminated peanut products. So the list of affected distributors, retailers, and products grew, and a new wave of notifications got underway. Still, it’s been more than a month since that source was documented. And at least some of the most recent recalls relate to products produced back in Georgia, which—let’s face it—really should have been tracked and pulled from the market by now.

It hasn’t helped that the owners of Peanut Corp., consummate businessmen that they are, saw which side of their peanut-butter-smeared bread was going to fall face down, so promptly declared bankruptcy and bailed. They are legally responsible for contacting their various distributors. However, the company announced last month, “The firm’s assets are currently under the control of a bankruptcy trustee, which impacts the company’s ability to take any actions regarding recalled products ….” As though it was such a responsible company before it went into bankruptcy, but anyway.

These particulars notwithstanding (and as I have complained about before) the nation’s system for getting a handle on these kinds of outbreaks is clearly in need of a major overhaul. Thanks to bioterror legislation passed in 2002, food suppliers must have records showing from whom they got products and to whom they sold products—one step in each direction. But food supply chains often contain several middleman-distributors, so the notification process slowly bumps along, one link at a time.

I called several retailers last week who had become caught up in the recall. One told me that she got a call from her distributor asking to whom he should send an important letter about an issue he didn’t want to mention on the phone. She said, “It’s me. Just tell me what’s up.” But he insisted on sending a letter, which arrived three days later, telling her that some of the food he had shipped previously needed to be recalled.

“I called back, furious,” she told me. “I told him, ‘I’ve been selling this for three days when I could have pulled it!’”

As I learned from my calls, many of these operations are small; although they have computers, their shipping records are often paper invoices, stored in boxes; they have neither legal staffs to interpret their responsibilities nor spare workers to thumb through stacks of invoices to compare lot numbers and production codes and to figure out which batches have sold and which may still be in their storerooms or warehouses.

“It’s ludicrous to trace back through paper records,” Mike Taylor, a former FDA deputy commissioner, told me last week. Yet that is what stitches the U.S. food sales network together. And though several bills recently introduced into Congress make tippy-toe steps toward insisting upon better, computerized tracking systems, none really takes the tiger by the tail (to mix a few anatomical metaphors).

Most of these companies also have no idea how to handle a recall, which under federal law is their responsibility, not the FDA’s. And guess what? There is no time limit under the law stipulating the number of days a company can take to alert consumers about contaminated products. So most of those I spoke to just waited until an FDA employee could find the time to get to their doorstep and, in person, walk them through the process.

Meanwhile the stuff keeps getting sold, and more people get sick.

The real kicker here is that, by the time any of this happens, most of this food is long gone and long eaten. Many of the notices last week were for trail mix and other snacks sold last fall. Some of the recalled foods were distributed as far back as 2007. It’s enough to make you wonder whether this whole, hugely expensive recall process is more a federally sponsored ass-covering process than an actual strategy for promoting the public health.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Welcome to Science Next, a collection of some of the most exciting and far-reaching ideas about innovation for a new American century.

The writings in this volume emerged from a literary experiment that has been evolving during the past year on the virtual and paper pages of Science Progress (www.scienceprogress.org), which is a project of the Center for American Progress, a Washington, D.C.–based policy-research institute. The mission of Science Progress is to provide an opportunity for scientists and non-scientists to share ideas about ways that scientific and technological innovation can contribute to human flourishing.

Given its genesis in a Washington think tank, the Science Progress conversation focused first on “inside the beltway” policymakers—a much-maligned but invaluable American species. Derided in the vernacular of Capitol Hill as “wonks,” these public servants and their minions are burdened with the enormous responsibility of translating the nation’s collective knowledge and wisdom into practical, political, and economic action.

We at Science Progress have grown increasingly inspired, though, by the range of smart ideas outside those conventional circles and by the public hunger to become more a part of the process of bringing the art of science to good governance. With Science Next we take the conversation to a new level, and invite you to be part of it. After all, “wonk” spelled backwards is “know.” And it is knowledge—including public knowledge and understanding of science as an engine of progress—that will reveal solutions to today’s most pressing problems, including climate change, energy independence, and national security.

The phrase “science progress” is, arguably, a bit awkward. Some would say it is redundant; others, less sanguine about where science is going, might call it contentious. But we who have been cultivating the pages of Science Progress find the construction provocative in the best sense of the word. It reminds us that we are the inheritors of the Enlightenment’s confidence in the possibility of improving the human condition—a possibility predicated on values of individual freedom, social equality, and democratic solidarity, and one that values reason as superior to dogma or blindly “received wisdom.” From this standpoint, scientific inquiry is the paradigmatic exercise of Enlightenment values.

You got a problem with that? Well let’s go at it, because one of the things we love about science is that it is nothing if not argumentative. Both as a way of thinking and as a wellspring of novel ideas and products, science is a tumultuous truth-seeking process and even further, we contend, a revolutionary force for human liberation. This understanding of science as progressive does not deny that the power of science may be misused. Nor does it exclude the importance of other sources of inspiration or belittle the need for guidance and even regulation to ensure that the products of our progress are distributed fairly. But it does assert that the core values of science are democratic and antiauthoritarian. And it reflects a philosophical commitment to perpetual change and improvement over certainty and stasis.

The very words “science” and “progress” took on their modern meanings in the nineteenth century, and it should not be surprising that they came of age around the same time. It was an era in which microscopes and telescopes were drilling down and up into nature, while stethoscopes were revealing the body’s mysterious inner space. Systematic investigation involving the careful manipulation of isolated variables was beginning to prove itself superior to mere observation, speeding the shift from mere anecdote to real evidence. The possibilities that could emerge from human insight were beginning to seem endless.

Science as progressive, however, boasts philosophical and political skeins stretching much further back into the American historical experience. Francis Bacon’s utopian New Atlantis is often credited as being the first literary work to express the modern idea of progress in terms of advancing science and technology. It was a vision that was to have a profound effect on later seventeenth-century thinkers, including those who provided the intellectual justification for the American Revolution. For all the founders’ disagreements, they shared the conviction that the new nation’s promise was necessarily bound up with its innovative genius. Even those bitter rivals Jefferson and Hamilton were of one mind as they made their synergistic contributions to America’s identity as a nation dedicated to modernity: Jefferson through the patent statute and Hamilton by laying the foundations for history’s most successful capitalist economy, which together have so rewarded and nourished inventiveness.

It is no coincidence that so many of the concepts at the very heart of how America has come to understand itself—ideas such as the frontier and the West—demand an experimental attitude in grappling with novel challenges. The optimistic “can do” spirit; the approval of bigness, boldness, and adventure; the lure of “the road”—all are associated with this sensibility and are at the heart of our veneration of this country’s great inventors, people like Benjamin Franklin, Thomas Edison, Jonas Salk, and Bill Gates. We hold these truths of perseverance and perspicacity to be, if not self-evident, at least within our grasp.

Even as America’s western frontier has vanished, the pioneer spirit and the virtues and values associated with it have maintained their powerful hold over the American psyche. Inspired by that vision, Americans have repeatedly heeded the call to cross new and ever more challenging frontiers—including those well beyond the comforts of our cozy planet. Indeed, few government initiatives have been so wildly successful in capturing the public imagination as the space program of the 1960s, which explicitly drew upon the American frontier spirit. “[W]e stand today on the edge of a New Frontier,” John F. Kennedy exhorted in 1960 as he clinched the Democratic nomination for president. “Beyond that frontier are the uncharted areas of science and space, unsolved problems of peace and war, unconquered pockets of ignorance and prejudice, unanswered questions of poverty and surplus.”

Generations of Americans have come to characterize the United States itself as an experiment, a romantic and visionary theme compatible in orientation with pragmatist philosophers and early progressives. In this view, the only sure path to social and scientific advancement is as an iterative process of hypothesis, systematic experimentation, and data-gathering, followed by reform in light of experience. That the human condition can and should be improved by any means necessary—whether through government or private enterprise or some combination of the two, but with government as the ultimate guarantor of the public interest—has come to be the essence of progressivism, ever grounding those alleged improvements in the best possible evidence.

America’s emergence as a nation of perpetual progress is all the more impressive given that this historical theme is not an inherent element of Western culture. The Greeks tended to think of their own time either as inferior to the mythical Golden Age or as part of a cycle of advance and decline. Imperial Romans saw themselves as in stasis since the establishment of the empire. Medieval Roman Catholic thinkers largely gave up on worldly progress in favor of spiritual improvement while awaiting Armageddon.

And perhaps reflecting these cautious and frankly depressing roots, the conjunction of science and progress in the modern era has not always been welcomed as an unalloyed good. Just as the words’ modern meanings were coming into consciousness there were also the first signs of alarm, in a tradition that began famously with Mary Shelley’s Frankenstein and continues to exert a powerful hold on popular culture today. Taken to an extreme, this view holds that far from being a guarantor of progress (a promise that even progressives could not reasonably make), the potentially inhumane and even dehumanizing drift of science threatens the furtherance of progress itself.

One common criticism of progressive science policy is that it naively adopts an instrumental view of science without reflection on the goals of innovation. At Science Progress, we appreciate that progressives have too often appeared to worship at the altar of change, and we reject the notion that a philosophy of innovation must be dumb to moral values. As you will see, Science Next considers ends as well as means, moral values as well as instrumentalities, as it explores the places where new ways of thinking can inform good governance.

Similarly, at the risk of invoking a hackneyed reference to spirituality, we also believe that science occupies an exalted dimension, that the growth of reliable knowledge is in effect an expansion of consciousness. Science may not be the only path to a greater grasp of reality, but it makes a unique contribution to enhanced understanding of the cosmos and our place within it. To be sure, science is a social enterprise, conducted in the service of the metaorganism—We the People—that is funding the work, and it bears a profound responsibility to respect its roots. But to distort the process of inquiry through the imposition of political or religious filters amounts to a narrowing of vision, a corruption of imagination, and a threat to our freedom as beings endowed with intellect.

One need not hark back to Copernicus or Galileo to see how such distortions can affect the arc of progressive science. It seems to many Americans that in recent years the respect for evidence and the spirit of open inquiry has been undermined and even sabotaged for the sake of short-term political advantage. The complex machinations of the American electoral system have recently placed the United States under new management, and there is reason to hope that science may once again find a more respected place at the policymaking table. It should be obvious to all that it is in the nation’s long-term interest to have the best evidence available—evidence that in many cases only science can provide—to foster commercial innovation, economic growth, energy efficiency and environmental stewardship, educational advancement, military defense, and the best possible array of intelligence options.

In the twenty-first century, more than ever, it is no exaggeration to assert that only free and rigorous inquiry, and not authoritarian dicta, can provide the reliable information required for our physical survival. Open inquiry is also the best ticket to developing the tools that will allow us to fulfill our moral obligations to others in need, and to the planet itself. Perhaps most important, progress in science is essential for a continued sense of our national purpose as participants in a historic experiment in freedom and self-governance, as one people joined by a common future rather than a common past, a future we cherish not only for ourselves but for the sake of the generations of Americans to come.

Now we invite you to dip into Science Next, where our future may be written.

—Jonathan D. Moreno and Rick Weiss

The greatest potential for making advances in regenerative medicine lies in the ability of scientists to tap into the process of cell differentiation and development. This requires studying the development of a wide variety of human cells from their very beginnings—something U.S. scientists have been hard-pressed to do under the Bush policy, which made fewer than two dozen cell lines available out of the hundreds that have been cultivated worldwide.

Although details have yet to be released, the next steps are likely to involve a formal promulgation of guidelines for ethical research. And happily, Congress also appears to be moving apace to codify the essential elements of ethical embryonic stem cell research—something legislators did twice during the Bush administration, only to see the President veto the law twice—which will prevent future presidents from obstructing this important work.

Basic research in stem cell science promises to offer revolutionary new ways of treating diseases, but the process of getting these technologies out of the labs and into clinical trials is sure to be slow. Only recently, after more than a decade of basic research, did the FDA approve the first clinical trial for a stem-cell based therapy. The new U.S. policy will let more scientists get to work on the basic studies that will serve as the foundation for tomorrow’s new medical treatments.

Jonathan Moreno is the David and Lyn Silfen University Professor and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania. He is a Senior Fellow at the Center for American Progress and Editor-in-chief of Science Progress.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Read the latest from the Center for American Progress and Science Progress in stem cell research policy:

Report: A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically (CAP)

News: Stem Cell Science Takes and Ambitious Step Forward (CAP)

Timeline: A Brief History of Stem Cell Research (SP)

Top Eight: Eight Reasons to Applaud Action on Stem Cells (CAP)

In part, at least, this process is moving apace. Today, the U.S. Equal Employment Opportunity Commission released a Proposed Rule that describes how that agency intends to implement GINA’s so-called Title II provisions, which deal with genetic discrimination in the workplace. (Title I of the Act deals with the insurance provisions—more about that in a moment.) The public will now have 60 days to offer comments on the employment rules, which EEOC will then consider before crafting final language. By statute, the process must be completed by May 21 and the law will go into effect in November.

You don’t have to be a total wonk to appreciate the groundbreaking nature of this accomplishment: We’re talking about the first significant expansion of workplace discrimination protections since 1990, when the Americans with Disabilities Act added “disability” to the list of factors—age, race, religion, and sex—that cannot be considered in hiring decisions.

Gratifyingly, not only is the EEOC’s work on track to be completed on time but the content appears to reflect virtually all of the elements that progressives had called for in their decade-long battle to get GINA passed. A major goal of the legislation was to ensure that people can take full advantage of the ever-growing power of genetic testing for predictive, diagnostic, and genealogical purposes without having to worry that the information revealed would jeopardize their ability to get or keep a job. Another incentive was that without such protections, people were likely to balk at requests to participate in genetic research, which depends on large-scale participation by diverse populations to make new biomedical discoveries about propensities to diseases and other aspects of inheritance.

“We know that in the past, patients have passed up genetic testing that could benefit their health, and have gone to great lengths to keep genetic information secret—even from their own doctors,” said Susannah Baruch, who directs the law and policy program of the Genetics and Public Policy Center at Johns Hopkins University, speaking last week at an EEOC meeting. “There are many factors an individual may consider in deciding whether to take a genetic test, but the fear of discrimination must not be one of them.”

Under the language proposed by EEOC (shorter summary here), GINA would absolutely, and with no exceptions, prohibit the use of genetic information—including family medical history—in employment decisions. It would create protections for people whose genetic information falls into an employer’s hands by accident. And it would make victims of discrimination by private or government employers eligible for potentially robust remedies, including reinstatement, promotion, back pay, injunctive relief, compensatory damages and, in some cases, additional punitive damages.

Unfortunately, progress toward implementing regulatory language is not as far along for Title I of GINA—the part that aims to prevent gene-based discrimination by health insurance companies. That reflects in part the fact that oversight of this provision cuts across agency lines, so language must be agreed upon by a coalition of regulators representing the departments of Health and Human Services, Labor, and Treasury. It also reflects the reality that anything having to do with the lucrative health insurance industry—which for more than a decade argued that GINA was not needed and should not pass—is politically treacherous. And honestly, there are some tricky issues in this part of the Act.

Consider, for example, that the law generally prohibits insurers from even asking a person to reveal genetic information, including whether any diseases run in a person’s family. But what to do about the growing number of employer-sponsored “wellness programs” that try to prevent the onset of diseases by using health risk assessments? These programs typically include questions about family history and other genetic information to help design personalized plans for staying healthy. Indeed, that is pretty much the basis of how they work. It will take some elegant crafting to implement GINA without undercutting the potential value of wellness programs and other emerging aspects of personalized medicine.

The agencies working on language for Title I need to wrap up their work soon if they are going to make the May 21 deadline. They must resist the temptation to punt—by, say, implementing an interim or temporary rule, as some have quietly begun to talk about. That would only delay final implementation of GINA’s valuable protections.

GINA is an unusually forward-looking package of protections in that it prohibits a class of discrimination that has not yet become widespread. But hundreds of gene tests are now widely available for various purposes and more are being developed every month—including some that are being marketed directly to consumers with only vaguely defined firewalls to keep insurers and other interlopers at bay. If we wait much longer, GINA could go down in history not as a pioneering piece of legislation but as an important but embarrassingly late corrective akin to the Civil Rights Act, righting a wrong that was allowed to go on for too long.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Opponents of human embryonic stem cell research are sure to jump on the findings as an excuse to argue that President Obama need not keep his campaign promise to loosen the federal funding restrictions on human embryonic stem cells imposed by George W. Bush in 2001. Why continue using embryos in research, they will ask, when you can get similar cells in a less ethically contentious way? But the administration would be foolish to follow this line, which would continue the unethical strangling of a potentially lifesaving research avenue in favor of a new and unproven alternative.

Consider:

• This is the first paper to show this technique. The findings have yet to be verified by others and the genetic manipulations involved remain only poorly understood.
• The method starts with human fetal skin cells, not adult skin cells. Experience from animal studies suggests it will be more difficult to convert adult cells—from patients—into embryonic stem cells (which is, after all, the ultimate goal) than to convert fetal cells, which are more genetically pliable.
• It will take years to thoroughly compare these cells to “gold standard” human embryonic stem cells to see if they are biologically and medically equivalent. Meanwhile research on bona fide human embryonic stem cells has made great strides in the past decade. And the first human clinical study of such cells recently got green-lighted by the Food and Drug Administration.

Virtually all scientists agree that the smart way to unleash the promise of embryonic stem cells and regenerative medicine is to pursue multiple lines of work using cells produced by a variety of techniques under strict ethics guidelines, and see which ones prove most valuable in the end for various purposes. The Obama administration must not waver in its commitment to this sensible approach.

Image: Jeff Miller/University of Wisconsin-Madison

This fascinating conference, sponsored by the Food and Drug Law Institute and aimed largely at company officials, offered panel after panel of lawyers telling nanotech execs how to avoid getting sued by…other lawyers.

Whether it’s about suing or being sued, it seems that nanotechnology—and every other new technology with a still-uncertain benefit-to-risk ratio—is a 21^st century Full Employment Act for attorneys.

“‘Sophisticated user’ is a great defense….That’s how we’ve escaped liability for lots of clients.”

“If you think nanotech liability claims are never going to be a problem, you’re dreaming,” said Lynn L. Bergeson, a partner at Bergeson & Campbell P.C. in Washington, noting that even a “fear of disease” is sufficient basis these days for filing a lawsuit. That’s a standard that may not be difficult to meet today given the array of worrisome, if inconclusive, studies about the possible health risks posed by nanotech’s microscopic fibers and engineered particles, which, depending on who you ask, are either the key to future techno-prosperity or the harbingers of environmental and medical Armageddon. It’s even possible, Bergeson said, that a court might consider it a violation of current worker safety laws if a company is not maintaining detailed records of each employee’s exposure to nanomaterials, for reference years later should certain cancers or other ailments come to be associated with the high-tech materials.

In short, if you are a nanotech company you need to start developing a legal strategy for “how to protect yourself,” summarized Henry Chajet, an attorney with Patton Boggs. Listening, I felt sheepish for thinking it was about how to protect your employees and customers.

Truth be told, such defensiveness is understandable. Some critics have exaggerated the negative health implications of preliminary animal studies involving nanomaterials and have unfairly ignored the technology’s real promise. And plaintiffs’ attorneys already are boldly trolling the Internet for potential clients who believe they may have been harmed by nanotechnology.

“They are actively hunting for that next [equivalent to an] asbestos case, which, by the way, made them billions,” said James Chen of Crowell & Moring LLP, a DC-based food and drug law firm.

One of the best ways to stay clear of such lawsuits is to post adequate safety warnings for workers and consumers, Chajet advised, so that any user who eventually claims to have been harmed by the stuff can be argued in court to have been a “sophisticated user”—someone who was aware of the risks and took them anyway.

“‘Sophisticated user’ is a great defense,” Chajet said. “That’s how we’ve escaped liability for lots of clients.”

“Don’t test yourself out of a product.”

Nowhere is the nanotech industry’s nervousness about its own potential liability more apparent than in its relationship with regulators, several of whom also made presentations at the FDLI conference. Agencies such as the Environmental Protection Agency and the Food and Drug Administration are still trying to work out how nanotech fits into existing regulations, and whether new guidances or rules may be required to protect the public. That means that for now, at least, regulators are largely relying on their sparkling personalities and cajoling invitations to “come talk to us” just to find out what nano-companies are up to.

Not that any lawyer would encourage a company to participate.

“You can be the government’s guinea pig if you turn in a lot of data,” warned George Burdock, president of the Burdock Group, an Orlando-based consulting firm. While companies should do enough safety tests of their products to show they were reasonably diligent, Burdock added, they should not overdo it. “Don’t test yourself out of a product,” he advised.

Given warnings like that one, it should not be surprising that companies have hardly been lining up at regulator’s doors. Fewer than 30 companies have offered information under a one-year-old EPA program that asks nanocompanies to volunteer information. In the words of Jesse Barkas, a program attorney in EPA’s chemical control division, that’s “really pretty low participation.” What’s more, participating companies have ultimately provided “little actual data,” Barkas lamented. And for those of you who might want to know more, don’t come to the EPA. Much of what the companies provided is classified as “confidential business information” so is unavailable for public review.

Participation has been even lower for the agency’s voluntary “in-depth” program, in which companies are asked to divulge even more details about their products. Only four companies have volunteered, Barkas said. And although they have been generally forthcoming about the physical characteristics of their products, they have provided “very little data on eco-toxicity.”

All told, Barkas said, there is a “pretty big gap” between what the agency knows about nanoproducts and what is out there on the marketplace. The agency needs a lot more information, she said, “so we can get our arms around what it is we are regulating.”

In a few cases, nonetheless, the EPA has begun to use sticks as well as carrots. In March it will begin enforcing a decree that requires all manufacturers and importers of carbon nanotubes—some types of which have been shown to cause tissue damage similar to that caused by asbestos fibers—to notify the agency before releasing their products onto the market. Federal regulators also recently declared that they will demand tighter controls on nanoscale particles of titanium dioxide (used in paints and pigments) and alumina/silica, in recognition of the added health risks these ultrafine powders appear to pose compared to their larger particulate cousins.

Some states are also getting tougher. In January, California’s Department of Toxic Substances Control sent letters to the 27 companies and universities that it believes are manufacturing or importing carbon nanotubes, and asked a series of tricky legal questions such as: “When released, does your material constitute a hazardous waste under California Health & Safety Code provisions?”

“I’m not here to give legal advice,” said John Monica, of Porter Wright Morris & Arthur LLP, a Washington law firm, “but…God help you if you say ‘yes’ to that.”

Jim O’Reilly, of Baker & Daniels in Cincinnati, encouraged nanotech execs to hire a few experts to do enough basic studies so they can at least argue that they made a good effort to determine employee risks. The expense will pale in comparison to the cost of defending yourself in a tort case, he said, noting that “for one lawyer’s time you can hire four industrial hygienists.”

Given all the money being spent and made in the field of nano-liability, some are wondering aloud what they will do for a living if this self-sustaining element of the U.S. economy ever peters out. In the words of Donald Ewert, an environmental health and safety manager at Oso BioPharmaceuticals Manufacturing LLC in Albuquerque: “I’m wondering…what we’re all going to do when we find out that nanotechnology is not dangerous?”

But lawyers are nothing if not good at spotting the next income stream. “Synthetic biology!” one quickly shouted, referring to the controversial new science of making artificial bacteria and viruses from scratch.

Well, I’m not here to give legal advice. But if you think you’ve been harmed by a synthetic life form, there is definitely an attorney out there who wants to talk to you.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Senate-House conferences are closed door affairs, and a clear picture of the horse-trading that went on in that room (with record-breaking speed, we might add; amazing what Congress can do when a holiday week is nigh) may not leak out for some time. Moreover, not every segment of the U.S. scientific enterprise came out ahead. The Centers for Disease Control, a perennial Congressional stepchild (when it’s not a full-blown whipping boy) got largely stiffed, despite a frightening array of looming public health issues on the horizon. And NASA is going to have to trim a few celestial sails.

But the end-product of this harrowing political process—$ 21.5 billion, or the equivalent of about a 15 percent “tip” on top of conventional, government-wide, annual science appropriations—reflects with gratifying fidelity President Obama’s oft-repeated commitment to get science and technology back on track after eight years of government-inflicted starvation and abuse.

Things were looking grim a few days ago. The National Science Foundation, for example, which is the major government funder of physical sciences and science education-related research in this country, had been in line to get $3 billion under the House plan, until the Senate trimmed that figure to $1.2 billion. But when conferees came out of their huddle, squinting in the limelight like a gaggle of groundhogs in Punxsutawney, Pennsylvania, funding had been restored—not to some compromise level but to the full $3 billion.

That bolus of money represents about half again what the NSF typically gets appropriated per year, and it is in line to be spent immediately—to fund grants that have already passed peer-review, to support science, technology, engineering, and mathematics education programs, and to purchase equipment and finance building construction.

The Department of Energy enjoyed a similar reprieve. After the House voted to authorize $1.6 billion for that department’s Office of Science and an additional $400 million for the new Advanced Research Projects Agency for Energy, or ARPA-E, the Senate reduced the science office allocation by about four-fifths to a mere $330 million and totally zeroed out the ARPA-E budget. At the end of the conference, however, both were fully funded again.

“I’m especially glad to see funding that will establish ARPA-E eighteen months after it was signed into law,” Rep. Bart Gordon (D-TN), chairman of the House Committee on Science and Technology, said in a news release suffused with an almost palpable sense of relief. ARPA is designed to mimic the renowned Defense Advanced Research Projects Agency, or DARPA, which has successfully pursued especially creative, blue-skies initiatives for the defense community. “Besides pursuing the high-risk, high-reward research, I believe ARPA-E is uniquely positioned to be the bridge to the new energy economy—and, with it, the ‘green’ jobs we need, the same way DARPA formed the underpinnings of the multi-billion dollar defense industry,” Gordon said.

The National Institutes of Health also pulled a rabbit out of its hat—though in this case it was the Senate language that saved the day. The House had promised $3.9 billion, and the Senate had upped that ante to $10.4 billion—a one-time boost amounting to more than a third of that agency’s standard operating budget. In the end, the Senate language carried the day, providing a long-needed cash infusion for the nation’s premier biomedical research agency, which has been flat-funded for the past five years.

These are important victories and, we can hope, down-payments on a debt to science that America is at last poised to repay. But the work of rebuilding the nation’s scientific infrastructure is far from complete.

NASA, for example, did not fare as well. The embattled agency, which faces tough decisions in the next few years as the shuttle program winds down and as other priorities—including climate-change-related earth observation research—orbit aimlessly as though weightless in limbo, was in line to get $600 million from the House while the Senate had pushed for fully $1.3 billion. In the end, it was told to settle for a compromise of $1 billion.

Worse, the National Oceanic and Atmospheric Administration, which has important responsibilities in the arena of climate research and monitoring and whose leader, the widely renowned marine scientist Jane Lubchenco, is poised to be confirmed by the Senate any day now, had been in line to get $1 billion under the House plan and a tad more under the Senate plan but came out of conference with just $833 million.

Similarly, the ever-inadequately funded U.S. Geological Survey—the only science office within the Interior Department, responsible for earth science, as well as research on earthquakes and other natural disasters—had hopes of getting $200 million under the House plan but is now in line to get just $140 million, just a hair above the penurious $135 million recommended by the Senate.

And the Centers for Disease Control and Prevention, which has long had a deserving hand extended for physical plant improvements, and was at last in line to get either $462 million (House) or $412 million (Senate) for buildings, ended up with not a penny from the conferees.

Finally, in an especially worrisomely short-sighted decision, House-Senate conferees zeroed out the $420 million that the House had recommended for pandemic flu preparations under the Department of Health and Human Services, despite accumulating evidence that a terrible emergency is brewing in Asian chicken farms. They also offered no funding at all for HHS biodefense countermeasures.

When it comes to bird flu, it seems, Congress has its head in the sand, hoping to get by on two wings and a prayer.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Map: Confirmed Human Cases of Avian Influenza

Explore WHO data on human avian influenza infections in the countries where they have been reported since 2003.

The media have moved on from the avian influenza scare. Editors got bored when, after bird flu first jumped to humans a few years ago, a feared global pandemic did not swallow humanity. But the risk has not diminished. Indeed, scientists agree that it is inevitable that the avian influenza virus will at some point gain the lucky mutation or two that will allow it to spread not just from chickens to people but also quickly and easily from person to person. Such a strain could quickly kill two million Americans and incapacitate tens of millions more, according to government estimates. The global toll would be orders of magnitude higher, wreaking economic and social havoc and perhaps political instability.

A meeting in Washington last week sponsored by the Infectious Diseases Society of America offered a sobering update of what the disease is up to and the level of preparedness here at home and around the world. The facts are scary. But a lot more is known today than in 1918-1919, when the last massive flu pandemic swept around the globe, sickening one-third of all humanity and killing 50 to 100 million people. And it is inspiring to see how much scientific and logistical work is underway to help humanity survive the next pandemic relatively intact.

To speak of humanity being at risk may sound overly dire considering that the so-called H5N1 avian flu is still almost entirely a disease of birds. But the virulent virus is clearly developing an appetite for people. Since 2003, there have been 404 confirmed human cases of avian flu in 15 countries, most of them in Indonesia, Vietnam, and Egypt but with a recent serious uptick in China, which has reported seven cases and four deaths already this year.

Any single case could become the epicenter of a global epidemic in the event of a lucky mutation. And trust me, you don’t want to get infected with this bug. Two out of three people who fall ill from it die. “The potential to kill so many so quickly makes this the number one infectious threat” worldwide, said Keiji Fukuda, coordinator of the World Health Organization’s Global Influenza Program.

The good news is that the global stockpile of antiviral medicines, which will hopefully be at least somewhat effective against pandemic flu, is growing every year. Also growing is the world’s capacity to produce and stockpile large amounts of vaccine, including the 150 million doses that WHO is committed to distributing to low- and middle-income countries if needed.

But let’s not lose perspective on what this “good news” means. We’re talking here about a goal of being able to vaccinate perhaps two percent of the population of these countries—mostly healthcare workers and essential emergency and government personnel. And that is assuming that global distribution goes well. WHO is still considering which countries should serve as storage and distribution hubs, with one consideration being the likelihood that a given government might just grab what’s there for itself in a pinch. “It’s obviously a very political” issue, said Douglas Holtzman of the Bill and Melinda Gates Foundation, which is bankrolling a lot of the nuts–and-bolts planning for a global pandemic response.

Speaking of every man for himself, how are we doing in this country? Until recently Congress has generally been good about keeping the money flowing for federal pandemic preparedness. The nation is on track to accumulate enough vaccine to inoculate every American within 6 months of the first signs of an outbreak, for example. Shortsightedly, however, Senate negotiators last week agreed to remove a crucial $870 million allocation for further preparations to be coordinated by the Biomedical Advanced Research and Development Authority. (A look at what BARDA is up to says a lot about the government’s entirely appropriate worries in anticipation of flu-based “mass casualties.” In addition to speeding the commercialization of emergency medicines and vaccines, for example, there is an effort to mass-produce ventilators for rapid deployment to the countless Americans who would die from pandemic flu without respiratory assistance.) That money needs to be reinserted in conference with the House.

Equally worrisome, pandemic preparedness funding for states and localities—those crucial first responders—has been cut by 25 percent since 2005. It’s crucial that this funding be restored in the 2010 budget, said Jeffrey Levi, a public health policy specialist at George Washington University and executive director of Trust for America’s Health. Levi also worries about the longstanding expectation that private companies will purchase drug stockpiles for their employees. “In a recession this is the first thing to go,” Levi said.

In general, the U.S. preparedness plan needs a thorough freshening up to reflect current scientific and political realities and to highlight unmet priorities. Among them: Hospitals still have virtually no “surge capacity”—the ability to absorb added patients in the event of a pandemic. And only a few states (notably New York and California) have done the tough work of mapping out pandemic rules for hospitals and healthcare workers. Those rules reflect the cold realities of a pandemic, including orders to take older patients off their life-saving ventilators if younger flu victims show up and are deemed to have better odds of long-term survival with the help of that equipment.

Vaccine and drug makers are cranking hard, and should be applauded for their commitments to help prepare the nation for a pandemic. But check out what is behind them: Big federal grants for research and development, and government commitments to pay for about half the cost of new production facilities, which the companies can use to make other profitable pharmaceuticals during non-emergency years.

In short, no entity other than the federal government is going to make sure we are prepared for a pandemic (or bioterror or dirty bomb attacks, requiring similar preparations). There is no better example of your tax dollars at work. So if the sheer embarrassment of recent nomination withdrawals isn’t incentive enough, think about all that is being done on your behalf as you consider cutting corners on your Form 1040 this year.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

If that seems quick to you (how could a company pass muster just a few weeks after the ground rules were released?) you are right. In fact, by approving the drug without having at least one public meeting devoted to important environmental, animal welfare, and other issues, the agency broke its own promises of how such approvals will be handled. Word on the street was that Atryn’s maker was in need of a positive nod from the FDA to help it get some investor dollars. Well, we wish the company well. But we also hope that the agency gets back on its own track with future applications, which are anticipated to encompass not only medicines made in animals but also gene-altered animals that themselves will be marketed for human consumption.

Image: flickr.com/jb1

Among the cuts to the recovery and reinvestment package that the Senate is considering today:

• $6.6 billion in energy expenditures, including $1 billion from the Department of Energy’s energy efficiency and renewable energy programs
• $5.2 billion for prevention and wellness programs, which would save money by catching health problems early or keeping them from happening in the first place
• $1.4 billion in funds that were slated for the beleaguered National Science Foundation

Let’s just consider the NSF, which is a marvel of funding efficiency (it invests 94 percent of its budget directly into supporting research in colleges and universities in all 50 states), but which today can afford to fund only 25 percent of the proposals that pass scientific review. At the funding level proposed by the House stimulus bill, that percentage could rise to 32 percent, about the same as it was back in 2000. But the Senate seems to want to kill that goose.

What difference would it make? One way to think about it is that each NSF grant directly creates 4 to 5 good jobs, according to government statistics. So as initially proposed by the House, NSF stimulus funding would have created nearly 13,000 jobs directly. Affiliated construction and facilities stimulus money stood to create another 12,000 jobs, for a total of 25,000 additional Americans employed.

But that is just the tip of the science-jobs multiplier-effect iceberg. Consider the $4.5 million NSF grant that went to Stanford University in 2004. Four years later, that program had morphed into Google Inc. ‘Nuff said.

Economists understand the value of investment in the physical sciences, which are the cornerstone of nuts-and-bolts technology that we all use everyday. Consider an analysis done by the Council for Chemical Research, which found that a $1 billion federal investment in chemical sciences research and development gets amplified into a $40 billion boost to the nation’s gross national product and can create or maintain 600,000 jobs. Which federal agency hands out those kinds of grants? The NSF, above all others.

Compare that kind of payoff to the proven poor track record of tax cuts as job creators. There is no contest here.

Congress knows—or at least, once knew—that science and engineering are the nation’s principal drivers of innovation and economic growth. In a nearly unanimous vote a few years ago, it passed the America COMPETES Act, which promised to double NSF’s budget over seven years. Yet year after year, appropriations have not been forthcoming. Now is the time to correct, not exacerbate, that wrong.

The committee was created in reaction to the Soviet Union’s surprise launch of Sputnik, the first manmade satellite, which threatened U.S. preeminence in science generally and aeronautics in particular. Today, again, there is substantial concern that U.S. science is losing its competitive edge. Not least of those concerns is that Russia and China are cultivating robust space programs at a time when the United States is about to retire its shuttle fleet while being years away from having a next-generation means of getting into space.

Fifty years ago, the committee also wrung its hands about the state of science education in this country. Indeed, a first order of business in 1959 was the creation of a provision for granting scholarships and graduate fellowships in math, physics and engineering, among other topics in the sciences. Today, the need to better support so-called STEM (Science, Technology, Engineering, and Mathematics) education is still a top issue for legislators, and promises to be high on the science committee’s list of priorities for the new session.

“Science does not have a left or a right. It only knows a right and a wrong.”

Of course, not everything from 50 years ago remains a high profile today. For better or worse (C-SPAN ratings would certainly go up), the 1959 subcommittee assigned to study Unidentified Flying Objects—and specifically to investigate what the Air Force knew about them and was not telling the public—does not exist today (though the related topic of extraterrestrial life has been on the committee’s agenda on and off for decades).

Last week’s initial gathering for 2009 was largely spent on routine business, confirming chairmen and members of subcommittees and so on. It was also a chance for committee members to congratulate themselves on how well they all get along and how bipartisan a gang the science committee is. “Science does not have a left or a right. It only knows a right and a wrong,” intoned Rep. Brian Bilbray (R-CA), in a no-doubt overstated proclamation of committee-wide unity, but one arguably closer to the truth than for many other committees on Capitol Hill.

So what’s on the agenda?

One leading priority is expected to be electronic waste-a topic close to the heart of the committee’s chairman, Bart Gordon (D-TN). Gordon has railed against this nation’s failure to recycle more than a small percentage of the 2 millions pounds of e-waste it produces every year, from which toxins leach liberally into soil and groundwater. And the problem does not stop at our borders. A Government Accountability Office report released in September was highly critical of the Environmental Protection Agency for doing little to curb the export of hazardous waste from discarded electronics, which pose long-term threats to public health and the environment abroad. Current regulations are under-enforced, and the committee is likely to relaunch legislative efforts to restrict current practices.

The committee will also be one of several looking for ways to accelerate the introduction of new energy technologies (with some emphasis on how to get the most promising ones commercialized quickly). Climate change (including a piece of the cap-and-trade debate); water conservation (a growing concern as climate change wreaks increasing havoc with the nation’s limited fresh water reserves); disaster response; STEM education; and transportation (the highway bill, a predictable political pileup, is coming up for reauthorization) will all be on the agenda—along with one of the most difficult of science topics for the coming year: a multi-year reauthorization of NASA, which will raise all kinds of questions about that beleaguered agency’s capacities and priorities.

“NASA is at a very critical stage,” said Vernon Ehlers (R-MI), one of three physicists in Congress. Added Baron Hill (D-IN): “For too long, NASA’s been asked to do too much with too little funds.”

Among the considerations expected to come up is whether to extend the shuttle program to shrink the gap between its planned retirement next year and the launch of the next-generation space vehicles that will be part of the Constellation program, which is not expected to be ready to transport astronauts to the International Space Station until around 2015. Also open for discussion will be how realistic current plans are to revisit the moon by 2020, and to go on from there to Mars in the relatively near future.

Me, I’m all for exploration, and I’ve been thrilled with the footage from our various Mars rovers. But in these days of budget crises and other problems here at home, the idea of sending people off to the chilly deserts of Mars falls squarely in the category of extraordinary rendition—truly, for now, a bridge too far.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Yesterday, officials from the FDA and the Centers for Disease Control and Prevention announced an expanded nationwide recall of products made from peanuts processed at the Georgia plant to include ingredients released as far back as January 2007. That expansion-which makes this recall one of the biggest in U.S. history-made sense, they said, as it has become clear that the company repeatedly failed to keep products off the market despite their having tested positive on several occasions for Salmonella, a bacteria that can cause food poisoning.

The toll to date: 501 people known to have been sickened in 43 states and in Canada. Of those, 108 hospitalized. And eight people so far believed to have died from having eaten the tainted products. All of the deaths have been people 59 years old or older. But fully half of the known cases of illness have been in children 16 years old or younger-a reflection of the prevalence of peanut butter and concentrated peanut paste in snack foods.

FDA and CDC are asking the right questions of the folks at Peanut Corp. And before long, so will lawyers for the victims. But there are equally important questions that independent investigators need to ask FDA and CDC, among them:

• How is it that a company’s internal testing can repeatedly come up positive for a disease-causing microbe and yet that company can have no obligation to report those findings to anyone, ever-not even the FDA or state health officials when they come around periodically to see how things are going?
• When the FDA subcontracts to state health departments its responsibility to inspect food processing plants, as it often does because of federal manpower shortages, how does the agency validate the professionalism and accuracy of those contracting departments?
• Might there be a need to clarify, either in the regs or through legislation, a company’s responsibility to act on initial test results that indicate contamination-that is, to keep those products off the market-as opposed to retesting (as Peanut Corp. repeatedly did) until a negative result is obtained?
• At what point are current FDA requirements that the agency keep sensitive information about companies confidential counterproductive to good manufacturing practices and to the public’s legitimate right to know?

As PeanutGate and the financial meltdown both exemplify, the regulatory philosophy in this country has historically been one that relies on the foxes to out themselves when they’ve indulged in malfeasance. Sure, everyone knows that too much oversight can stifle the flexibility that is key to ingenuity and innovation. But the pendulum has swung awfully far. Do we really have to wait until the fox gets caught with blood on its claws-and tainted peanut butter in its teeth-before we consumers get to find out what’s going on behind closed doors?

Image: flickr.com/dberlind

As of last week, about 500 people were known to have been seriously sickened by eating Salmonella-tainted peanut paste (and in some cases, peanut butter), all of it produced during the past few months at a single Peanut Corporation of America plant in Blakely, Georgia. What’s impressive about this outbreak is that those victims are dispersed among 43 states, and they collectively got their illnesses from having eaten one or more of 135 or so different products, all of which contained peanut paste or peanut butter from the same Peanut Corp. plant.

What a vivid example of our intensively centralized food production and distribution system! A small-town Georgia processing plant, soiled with fecal bacteria from an unknown source, sickens hundreds of consumers across the country-and probably thousands more who wrote off their bouts of diarrhea and vomiting as one of those “facts of life” and so went untallied by health authorities.

The most mundane truth behind these events is that the agencies we depend on to oversee food safety in this country are underfinanced and understaffed.

This is but the latest in a string of tainted food scandals that have gripped the nation in the past couple of years, including ones involving toxic melamine in pet food and baby formula and Salmonella in peanut butter and on sprouts, spinach, tomatoes, and peppers. What to make of it all?

The most mundane truth behind these events is that the agencies we depend on to oversee food safety in this country are underfinanced and understaffed. As documented in Change for America, the progressive blueprint recently released by the Center for American Progress Action Fund, those responsibilities fall mostly on the Agriculture Department and the Food and Drug Administration-but primarily the FDA, even though it enjoys a far smaller food-related budget than does USDA.

Years of stale budgets for the chronically cash-strapped agency have led to the departure of about 1,000 FDA scientists in the past few years, even as Congress enacted about 125 statutes that demand additional agency resources. Nearly half of the FDA’s managers and supervisors are old enough to retire within the next five years. And staffing at the agency’s Center for Food Safety has declined 20 percent over the past three years. A new food protection plan, released more than a year ago, remains unfunded.

It would be naive to believe that these realities did not contribute to the fact that, either unnoticed or undaunted by federal or state overseers, Peanut Corp. has apparently been producing Salmonella-tainted products since July 2008, according to a Centers for Disease Control and Prevention retrospective, still being constructed by government epidemiologists. It’s still not clear who, if anyone, was aware of that problem back then. The FDA inspected the plant last year and found failings, but details have not been disclosed. Months later Georgia state authorities inspected it again at FDA’s request. What triggered that request, and exactly what was found, is still a secret.

Beyond the fact that the nation’s food-plant inspection and follow-up process is not sufficiently aggressive, the peanut-paste outbreak has brought other shortcomings into focus.

For one, the FDA still lacks the legal authority to recall tainted foods, despite repeated calls for Congress to grant this important power. Instead FDA must cajole offending companies, and allow them to arrange such actions on their own terms, which often means slowly and one product at a time even as overwhelming evidence of trouble accumulates. Delays can matter: at least six people are so far suspected of having been killed by the bacteria in this outbreak.

Equally troubling is what the FDA and CDC have had to go through to figure out where tainted paste may have been shipped and which products it ended up in. I am on an FDA listserve that alerts subscribers every time a food is recalled, and the pace of Peanut Paste-gate has been enlightening.

On January 17th, for example, it was Kellogg recalling its peanut butter sandwich crackers and Famous Amos and Keebler Soft Batch Peanut Butter Cookies; Hy-Vee Inc. recalling its Monster and Reese’s Pieces cookies and its People Chow Party Mix and Assorted Truffle Fudge; and Perry’s Ice Cream Co. recalling its Select Peanut Butter Ice Cream. On January 18th McKee Foods recalled its Little Debbie Peanut Butter Toasty and Peanut Butter Cheese Sandwich Crackers, and South Bend Chocolate Co. recalled some of its candies. On the 19th it was Kroger Select Ice Cream Products; various ZonePerfect health and energy bars; and cookies made under the Wal-Mart, Food Lion, Lofthouse, Chuck’s, Meijer’s and Pastries Plus brands (not to mention a recall of “uneviscerated mackerel fish,” apparently unrelated, though who knows what was going on in the back rooms of that Blakely peanut processing facility?).

Day after day the news has continued to trickle out, like a bad case of the runs (egads, not the PetSmart “Great Choice” Dog Biscuits too!). The problem is that Peanut Corp. and federal and state regulators have had to shuffle through countless invoices going back many months, and each suspect company has had to confirm that information using its own (often incompatible) computer and bookkeeping system. Isn’t it time for a unified, interoperable software program for use by all FDA-regulated entities that would allow this kind of information to be called up quickly by health authorities in situations such as this? Wouldn’t that be useful if some bioterrorist were to slip a nasty bug into a distribution hub for baby carrots or hamburger patties or bottled water?

While we’re at it, might it be time to take seriously what so many expert groups (and some in Congress) have been saying for a long time, namely that food safety is too important to be a stepchild of an agency that is primarily concerned with the pharmaceutical industry? Let’s face it: The current system is nuts.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Good riddance to the lies, the deception, the White House-edited pseudoscience reports. Good riddance to the stacked science advisory committees, the faux peer-review of proposed regulations, the junkyard claims of “junk science.”

Good riddance to the scientist manqué at the top of the Environmental Protection Agency who big-footed actual evidence for political convenience. Good riddance to the leadership at the Office of Science and Technology Policy that supported President Bush’s skepticism about the need to address climate change aggressively.

Good riddance to the vice-president who thought the telecom revolution was about better bugging of innocent citizens’ phone calls. Good riddance to the president who cared more about human embryos than he did about children living in the lower Ninth Ward.

Now, however, comes the difficult task of looking forward—of finding the place for progressive voices in an administration refreshingly committed to treating science fairly, but burdened by an inheritance of underfunded agencies and dispirited federal scientists. And all this comes in the midst of an economic crisis that precludes the cash infusion that our emaciated science agencies and their surviving public servants need and so richly deserve.

But there are two aspects of the current predicament that give me hope. First, of course, is that when it comes to science, Obama really does get it. Back in October 2008, he sent via the government employees union several letters to federal workers in the science-based agencies, stating in no uncertain terms his commitment to evidence. “In an Obama administration, the principle of scientific integrity will be an absolute, and I will never sanction any attempt to subvert the work of scientists,” he wrote.

By my reading, those missives could be reduced to about seven words—two-sevenths exhortation—“Hang on!”—and five-sevenths supplication—“I’m going to need you!”

The supplication gets me to my second reason for hope, which is that despite all the failings at

• the Food and Drug Administration: the Plan B debacle, the parade of contaminated foods, and the failure to follow up on serious side effects of drugs
• the EPA, with its repeated overruling of science on pesticide approvals, chemical contamination standards, air and water pollution
• the Interior Department, which, according to The New York Times, is “riddled with incompetence and corruption, captive to industries it is supposed to regulate and far more interested in exploiting public resources than conserving them.”
• the Department of Agriculture, which has been repeatedly scolded by federal courts for its failed science policies and which, according to a just-released Inspector General report, “does not have a strategy for monitoring new transgenic plants and animals that may be developed and imported into the United States”
• the National Institutes of Health, which has not paid sufficient attention to conflicts of interest among its grantees and provided too much cover for the morally corrupt Bush stem cell plan
• the National Aeronautics and Space Administration—consider the Columbia disaster and the pending loss of the shuttle fleet with no other means of reaching the space station
• the Centers for Disease Control and Prevention, which failed in “almost every respect” to protect Hurricane Katrina victims from the well-understood risks of formaldehyde fumes, according to a congressional investigation, and which has alienated scientists around the world for failing to share important public health data

…Despite all these failings and more, the amazing thing is that every time I talk to the men and women who are actually doing the science in these agencies, I find them almost without exception to be hugely talented and dedicated professionals. Most of them are working on shoestrings but virtually all of them are squeezing all the integrity they can into the process, wanting nothing more (and nothing less) than to get the best answers to the smartest questions so the United States can be a leader among nations and help save the world. Who can’t relate to that?

In short, I am heartened that the nation is endowed with a huge corps of public-servant scientists devoted to going where the evidence takes them and who, as of Wednesday, will for the first time in years be respected by the highest officials in the land for what they do. What’s more, one of the silver linings of our recent eight-year nightmare is that scientists have awakened to the political context within which they work, and more of them than ever seem willing to speak their minds when it comes to how their studies are to be integrated into the world of public policy.

Now is the time for progressives inside and outside of science to solidify these gains for the common good—to avoid overreaching in these days of our political ascendance and instead prove that science can bring economic as well as environmental benefit, prove that scientists can be responsive to social, ethical, and cultural concerns, and prove that evidence is a better source of ideas than ideology.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Such is the case with the Food and Drug Administration’s handling last week of the nation’s first formal application by a company to market a human medicine produced by genetically engineered farm animals—specifically, a medicine made in the udders of goats.

The medicine is antithrombin III (brand name ATryn), a protein that aims to prevent blood clots in people with a rare but dangerous hereditary propensity to clot when they should not, manufactured by GTC Biotherapeutics of Massachusetts. More to the point, it is manufactured by the company’s transgenic goats, which contain a human gene that directs production of the anti-clotting protein in their milk.

It’s a cool approach. The only antithrombin III approved in the United States today is purified from donated human plasma, an unpredictable source that periodically dries up, leaving American patients scrambling. And compared to conventional means of producing biological drugs, such as gene-altered bacteria grown in vats, goats are stalwart and generous, churning out massive quantities in every glass of the white stuff. “Got Antithrombin III? You betcha!”

GTC’s application is the first of its kind, but others are on deck. The company, along with more than 20 other research teams around the country, anticipates a not-too-distant future in which transgenic farm animals will make many human medicines. Endowed with the right genes, a small herd of lactating goats could squirt out enough malaria medicine for all of Africa faster than you could sing a few verses of “Old MerckDonald had a Pharm.”

Problem is, federal regulators were not fully prepared when the folks at GTC anted up for a fast-track review. As I’ve written, it was not until September that the FDA released a draft version of its Guidance for Industry #187, which would codify how the agency will review applications to approve food or drugs from gene-altered farm animals. The agency accepted public comments through December and has yet to release any final guidance.

That made for an awkward situation on Friday, when an FDA advisory committee was asked to rule on whether the medicine made by GTC’s goats was safe and effective and therefore suitable for sale—without the agency’s veterinary center having even finished writing the rules on what constitutes an acceptable production process in animals.

Also embarrassing, if not plainly disingenuous: Agency officials had promised that its reviews of the first foods and drugs made in gene-altered animals would include public meetings at which they would discuss animal welfare, environmental, and public health issues openly. Yet Friday’s meeting had jurisdiction only over the safety and efficacy of the drug itself. After some hemming and hawing, FDA veterinary officials conceded that no public meeting dedicated to those other important issues was likely to happen for this first approval, in part because of statutory requirements that demand the agency move quickly on applications, such as this one, that have won fast-track designation. (The company’s hurry was not explained. In similar cases the problem has often been a shortage of funds and the need to achieve a key regulatory success in order to attract fresh venture capital.)

Friday’s presenters did divulge a few details about ATryn pharming. Company officials and FDA scientists (who have repeatedly inspected GTC’s operations), described all seven generations of the clot-busting goats as hale and healthy (indeed, the founder goat—the grand patriarch of this valuable line—was repeatedly described using the scientific term “handsome fella”). To prevent escape and ensure that their meat and medicinal milk never find their way onto grocery shelves, the goats are double-fenced and under constant video surveillance. They even have electronic transponders implanted under their skin so scientists can track them, if necessary, through the Massachusetts woods. A shockingly thin (read: single sheet of paper) agency-led “Environmental Assessment” concludes that the herd “is unlikely to result in significant effects on the environment.”

Several observers, including Greg Jaffe, director of biotechnology at the Center for Science in the Public Interest, were rightly unimpressed.

“More information about the risk analysis surrounding the genetically engineered goats needs to be made public and scrutinized by independent experts before any product approvals,” Jaffe told me, calling the FDA’s work to date “a good first step.”

Nina Mak, a research analyst with the American Anti-Vivisection Society, raised animal welfare issues. Typically, she said, hundreds to thousands of animals are engineered before an acceptable founder is created. “Unintended and unexpected problems are frequent, greatly increasing animal suffering.”

Mak said it was “astounding” that the FDA would consider approving a drug from a genetically engineered animal when it has not even decided what the rules for such approvals should be. She is right. The only tempering factor is that a number of FDA officials all but conceded that they, too, were chagrined. “Ordinarily,” said the FDA’s Eric Flamm, “we may want to coordinate the two reviews” of the drug itself and of the engineered animals and their various impacts.

After the advisory committee was told, to some members’ open dismay, that it could consider only whether goat-derived ATryn is safe and effective in patients, it voted yes. A final FDA decision is expected by next month. By then the FDA will presumably have released a more finished document describing the rules for approving drugs from gene-altered animals (I predict a release on Jan. 16, the last government workday of the Bush administration), and agency officials will have declared that GTC’s goats passed muster, though it will be too late for the public to weigh in.

A lot of eyes ought to be watching to see if the agency keeps its promise to do better next time.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

The nation’s provisions for assigning and protecting intellectual property rights, and the U.S. patent system in particular, are at the very core of the American model of scientific, technical, and economic advancement. Patents assure an inventor a period of time, generally 20 years, to exclude others from using the invention, in return for a full explication of that invention by the patent holder. The assurance that competitors can be blocked from freely copying inventions during this period of exclusivity is a powerful stimulus to capital investment, which is a key enabler of the inventive process.

At the same time, the policy of requiring that inventors provide a full and public description of their invention as part of the patent process ensures there will be a well-described platform upon which others can quickly build. This provision supports the progressive principle that open access to information is a common good. As a practical matter, it also fuels a faster pace of innovation than would occur through other means of market exclusivity, such as trade secrets, which in turn boosts broad-based economic growth and prosperity.

The patent system has been the subject of legislative, administrative, and judicial modernization, and many experts in law, industry, and economics agree that the system is past due for another tune-up. Congress spent much of 2007 and 2008 debating legislation that would have amounted to the most significant changes of U.S. patent law in decades. The Senate was unable to reach consensus and the Patent Reform Act of 2008 was not enacted, but a fresh push is expected in 2009. Still, it remains uncertain whether legislators will be able to bridge the few remaining deep divisions among stakeholders.

In an attempt to explore patent reform options that could bolster innovation and economic recovery and have a reasonable chance of garnering the support of a range of patent players, the Center for American Progress and its sister organization Science Progress in October 2008 convened a roundtable of expert stakeholders from a wide array of business, legal, and academic disciplines, including many with competing intellectual property interests. This report provides a summary of our perspective and recommendations, taking into account ideas and opinions discussed at the roundtable and prefaced by a brief history of the U.S. patent system to help put the newly proposed changes in context.

Roots of the current patent system

The general principle of intellectual property predates by centuries the founding of the United States and was codified in Article 1, section 8 of the U.S. Constitution: “Congress shall have the power…to promote the progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Importantly, and pertinent to America’s current economic predicament, the U.S. patent system was inspired not so much by a desire to protect individual rights but to spur economic growth and inspire technological advancement. The best way to catalyze investment in ingenuity, the founders believed, was to enhance the prospect of a return on that investment while simultaneously fostering the public release of information to seed future innovations.

The patent system has periodically been the subject of legislative, administrative, and judicial modernization, and many experts in law, industry, and economics agree that the system is past due for another tune-up.

Thomas Jefferson penned the first patent act, which gave the patent holder an exclusive right to make, use, and sell his or her invention in the United States or import the invention from abroad. The act, signed by President George Washington on April 10, 1790, declared as eligible for a patent “any useful art, manufacture, engine, machine, or device, or any improvement thereon not before known or used.” This definition has been reinterpreted over more than 200 years to include, among the many inventions that Jefferson could not have anticipated, genes and genetically altered plants and animals; the invisible etchings of integrated circuits; and algorithms for predicting the kinds of financial risk a credit card holder might take.

Not surprisingly, the process for reviewing and granting patents has changed over the years. In the 18th century, applicants were asked to provide a description and drawing of their invention and, when practical, a model, along with their $4 filing fee. A federal Patent Board, which included Jefferson, Henry Knox (then secretary of war), and Edmund Randolph (then attorney general), reviewed applications and issued rulings, yea or nay, on the basis of whether the invention was “sufficiently useful and important.”

At most, patents were allowed for 14 years. There was no right of appeal. And there were no lines to wait on. The first patent was issued to Samuel Hopkins of Philadelphia for his improved method for making “Pot ash and Pearl ash,” useful for the production of soap. By the end of the year, a grand total of three patents had been issued, the latter two for novel improvements in candle-making and flour-milling.

The situation today

Today the United States Patent and Trademark Office has 6,000 employees to handle the more than 460,000 patent applications that are filed each year. There is a backlog of about a million unexamined patent applications and it takes, on average, two years to get a first action from the PTO and three years to get a patent issued (or rejected). In some fast-changing fields, including computer architecture, IT security, and software- and communications-related technologies, average wait times are even longer.

While the widespread characterization of the PTO as “broken” is an overstatement, there is no disagreement that improvements are needed. Most obvious among the current failings, examiners are overwhelmed by the sheer volume of applications and the lack of time and resources to perform their jobs at the level of excellence demanded of them. As a result, too many patents are issued that, but for the scarcity of time and resources, would almost surely have either been honed to greater quality through the examination process or not issued at all. There is broad consensus today that the U.S. system for protecting intellectual property is burdened with too many patents of questionable quality and validity.

Underlying these and other problems, the Patent and Trademark Office is underfunded and undermanaged. Although Congress converted the office to a “fee-based organization” in 1991, which means it is self-supported through fees paid by applicants, Congress has also repeatedly raided that fund, diverting more than $750 million into the general treasury over the past decade. Although this practice has been quelled over the last three years, prior diversions so eroded the PTO’s infrastructure and resources that rebuilding is now urgently required.

Meanwhile the patent challenge, appeals, and enforcement processes are cumbersome and have bogged down the PTO and the courts—a problem exacerbated by the emergence of so-called non-practicing entities, or NPEs, sometimes called patent “trolls.” Unlike operating companies that produce products and services, and universities that generate most of their revenue from tuition and grants and generate intellectual property through their academic investigations, patent-holding entities typically do not produce any products or offer any service beyond patent licensing and enforcement. Their primary revenue sources are royalties obtained from asserting patents against successful product and service companies.

These challenges and others faced by PTO have been analyzed repeatedly in an array of independent reports in recent years, all of which have ended with calls for substantive degrees of patent reform. Among the organizations compiling such reports have been the Federal Trade Commission in a 2003 report, the Commerce Department’s Office of Inspector General in 2004, the National Academy of Sciences (2004), the Government Accountability Office (2007), the PTO itself (most recently in its 2007–2012 Strategic Plan), and the U.S. Patent Policy Advisory Committee (2008). Although a number of reform initiatives have been implemented over the years, they have progressed too slowly—in some instances because of resistance by groups of applicants that have learned to use the system’s shortcomings to their own advantage.

Informed by previous reports, recent incomplete efforts at reform, and the patent stakeholders’ roundtable discussion sponsored by the Center for American Progress and Science Progress in October, we conclude that the patent system can be immediately improved through a range of practical administrative changes within the Patent and Trademark Office. Those changes, outlined below, can and should be implemented early in the new administration, though some may require supportive legislative action.

Even if supportive legislative action is not required to implement near-term reforms within the PTO, other legislative reform is critical, as outlined in this report. The Constitution directs Congress to make the patent system work effectively in the public interest. But it has been more than 50 years since Congress took a hard look at patent law and made needed changes. In that time the pace of invention and the complexity of science have both increased enormously. The PTO and the courts have tried to fill the resulting legislative gaps through jurisprudence, sometimes with strained results. This imperfect approach has created a system with too much emphasis on the mere granting and enforcing of patents, many of them of poor quality, and inadequate attention to the promotion of useful inventions and investment.

Beyond the PTO and Congress, patent applicants also bear duties and responsibilities to keep the system working well. In recent years, however, applicants have aggressively sought, and in too many cases obtained, patents containing overly broad claims—that is, claims to subject matter broader than is justified by the actual invention. In a third group of recommendations, this essay suggests how applicants could, with proper incentives, cooperatively adjust their behaviors to facilitate the kinds of improvements we seek through administrative and legislative changes.

Finally, we take note of some areas of controversy in which it is possible—even likely—that the Court of Appeals for the Federal Circuit or the Supreme Court may institute clarifying reforms through court decisions, as they have already done in the recent eBay decision (made by the Supreme Court in 2006 regarding the near automatic grant of injunctions),^[1] the MedImmune decision (made by the Supreme Court in 2007 regarding the ability of a licensee to challenge patent validity while still making royalty payments),^[2] Sandisk (made by the Court of Appeals for the Federal Circuit in 2007) regarding standards required to file a declaratory judgment),^[3] KSR (made by the Supreme Court in 2007 regarding the obviousness standard),^[4] Quanta Computer (made by the Supreme Court in 2008 regarding patent exhaustion),^[5] Bilski (made by the Federal Circuit in 2008, regarding business method patents)^[6] and other important decisions.

Historically, the courts have struggled with patent law. Judges and juries are asked to decide difficult cases involving complex applications of science, technology, and law. Recognizing these realities, Congress established a specialized court to hear all patent appeals, the Court of Appeals for the Federal Circuit, which in its 20 years has contributed substantially to creating consistency in patent law. While the judicial approach to resolving patent issues is inherently reactive, episodic, and slow, there is reason to hope that to the extent the PTO and Congress fall short of the goal of comprehensive patent reform, the courts will fill some of the key gaps (see judicial section below).

Recommendations

Whether by administrative changes, legislated reforms, applicants’ stricter adherence to high standards, or judicial review, the overarching goals must be to increase patent quality and reduce uncertainty about the limits of intellectual property protection. The following recommendations are presented with these goals in mind and with confidence that with a just and robust patent system in place the United States will strengthen its position as a global center of innovation and, in so doing, benefit economically.

U.S. Patent and Trademark Office

The PTO needs to embark on a series of changes that will make it more fiscally secure, more organizationally efficient, and more operationally poised to accomplish its goals and those of the inventors it serves. To accomplish these changes it will be necessary, through one mechanism or another, for the PTO to operate much more like a smart and progressive business.

The PTO’s primary responsibility is to determine whether patent and trademark applications meet the legal requirements for issuance, and to issue patents and trademarks as a means to help stimulate innovation and economic growth. In an effort to facilitate those important functions, Congress converted the PTO to a fee-based operation in 1991 (under the Omnibus Budget Reconciliation Act of 1990), though because of congressional diversions, those fees were not fully available to fund PTO operations. Eight years later Congress made the PTO into a so-called performance-based organization, which granted the PTO certain limited managerial flexibilities in return for adopting specific measurable goals and customer service standards.

Today, however, the PTO is still hobbled by bureaucratic barriers and inadequate control over its resources, undermining its ability to perform effectively. There are four overarching changes that the PTO must immediately embrace, none of which are likely to be implemented unless the office—through either administrative or legislative changes discussed below—is granted an added measure of economic and administrative autonomy and flexibility.

Solidify the budget, and control revenue and expenses

No organization can be effective if it lacks the ability to balance its income and expenses. The PTO has the responsibility of supporting itself entirely by fees, but without having effective control over those fees or its expenses. The office must gain this authority (subject, of course, to government oversight) and use it to further its mission, keeping in mind that any changes it makes to its fee structure should not have an undue negative impact on individuals and small- or medium-sized businesses, which provide the majority of new patentable inventions in the United States.

Among the ideas to consider are the creation of a fee-based fast-track system; demanding that a greater share of patent-processing fees be paid earlier in the examination process, since that is the time that some of the most labor-intensive aspects of the PTO’s work is done; and increasing those fees that the PTO is authorized to set. The office must have full control over its budget and retention of funds carried over from prior years. And there must be a total and permanent halt to diversion of PTO funds to other government purposes.

Hire and retain the best patent staff

The hiring of additional staff will not by itself resolve the problems of increasing patent pendency (the amount of time it takes for a decision to be rendered on a patent application) and decreasing patent quality (one result of a rushed examination process), but progress cannot be expected in these areas without first bolstering the examining staff. Examiners today are simply asked to do too much with too few resources and too little time. Two-thirds of departing examiners cite unrealistically high production goals as a primary reason for leaving. Those goals (the number of applications to handle per week) have not changed since 1976, despite the ever-increasing complexity of inventions and patent applications. Some 70 percent of examiners told the GAO they had worked unpaid overtime in the past year to meet goals.

The pay of PTO professional staff, relative to compensation available in the private sector, is not competitive. When the undersecretary of commerce and director of the PTO is paid the equivalent of a mid-level manager in the private sector, and all other positions within the PTO are scaled accordingly, it should not be surprising that the best talent will first seek employment in the private sector or migrate there when possible. Indeed, the average examiner is employed by the PTO for approximately three years, which is just the amount of time required to become a proficient examiner. It is essential that the abysmal examiner attrition rate be lowered.

Adding to job dissatisfaction is the fact that too little time is allowed for examination, particularly given the deficient information infrastructure available. Moreover, rules make access to outside experts and even applicants difficult, leaving examiners largely isolated as they work. Substantially improving the work environment, pay, and information resources, and establishing a clear and attractive career path for examiners could have a dramatic impact on attracting the very best talent.

At the same time, the metrics of examiner success need to be updated. For instance, the quality of the examination process is conventionally assessed by reviewing a sampling of issued patents to see how many should not have been issued. But rejected applications should also be reviewed, to see how many should in fact have issued. Additional objective measures should be developed that are verifiable by independent, third parties.

Improve communication with applicants and stakeholders

No corporation is effective without dynamic and frequent communication with its clients and customers. In similar fashion, it is essential that the PTO maintain clear channels of communication with all the stakeholders it serves so it can respond quickly and effectively to the ever-changing global marketplace.

PTO outreach and consultations have been in very short supply during the Bush administration, bringing PTO-stakeholder relations to what are widely considered to be an historic low. So strained are relations that last year, for the first time, the PTO was sued by a stakeholder over a rules package the office released without initial consultation. In the Obama administration, the office should seek early and extensive public input on rules packages; offer better access to PTO economic and other data, including first action and appeals statistics; and provide guidance based on relevant judicial decisions. The PTO’s Public Policy Advisory Committee should open its meetings to the public and webcast them to the maximum extent practicable. Meeting minutes and transcripts should be posted, and advisory committee membership should be broadened.

Some of these goals may require judicial or legislative changes to the so-called inequitable conduct defense (see below), to facilitate greater communication and exchange between the applicant, the patent examiner, and third-party experts. But there is no reason why the director of the office, through the power of the bully pulpit, cannot initiate significant changes from day one.

Improve information available to the PTO staff

Electronic information systems at the PTO are woefully inadequate. While those systems can perform the core task of searching for patent prior art, they fall far short in their ability to search global products that may practice inventions, as well as non-patent prior art (through, for example, industry trade publications, R&D publications, and academic research journals). The technology exists to remedy this situation, but it is lacking at the PTO, as are staffers with the technical expertise to implement it.

At the same time, the office should better avail itself of third-party experts. Experiments that have enabled interested third parties to comment and provide input to examiners, such as pilot projects using “peer-to-patent” reviews, have been promising, but have not been scaled up. As with other proposed changes, it will be important to ensure that any new duties, costs, or other burdens relating to a shared examination process do not disadvantage independent inventors and small enterprises.

The GOC question

Some argue that the four changes outlined above can be accomplished only by congressional conversion of the PTO into a so-called government-owned corporation, or GOC, and perhaps this is the case. The conversion of the PTO from its current status as a federal performance-based organization to a GOC would give the office greater flexibility than agencies have in terms of hiring, firing, salary ranges, and full-time employee staffing-level caps, effectively allowing the PTO to manage itself more competitively and attract and retain highly skilled employees. As a government-owned corporation, the PTO could compete more effectively with the private sector to attract and retain the talent required to improve quality and efficiency. And it would have firewall protection against fee diversions to the U.S. treasury.

Nonetheless, we believe that the PTO can accomplish its objectives within the framework of responsive government and that keeping the PTO wholly within the government could have real advantages. It would reflect the reality that, no matter how much administrative independence the office may earn, it is the federal government that promulgates the nation’s patent policies. Moreover, to maintain the PTO’s current status within the executive branch would appropriately place the office near the center of the Obama administration’s efforts to use progressive and enlightened federal policies to take on the economic and financial crises facing our country.

Finally, it should also be noted that there is no inherent reason that a government office cannot be granted many of the administrative and material resources the PTO needs in order to be successful—nor are those resources necessarily assured through the simple conversion to a GOC. Thus it should be a high priority of the new administration to give the PTO the tools it needs to achieve its goals without separating it from the government family. If organizational and administrative constraints prove to be too high a hurdle to overcome with reasonable rapidity, however, then a GOC should be considered.

Whether or not the PTO becomes a GOC, none of the important changes outlined here are likely to be achieved unless the Obama administration appoints a highly skilled director with professional managerial experience in a large, mission-driven organization, empowered with a clear mandate to apply best business practices to every aspect of the PTO. In selecting a new director, skills in executive management and business operations should be paramount, with less attention directed to whether the individual is an attorney. In fact, many corporations now select non-attorneys to lead their intellectual property organizations, recognizing that what is lacking are business skills to manage those organizations, rather than legal skills, which are already abundant.

Additional improvements within PTO

As part of a renewed commitment to the quality and consistency of patent application review, the office should, in addition to achieving the above goals, craft and release new examination guidelines clarifying the PTO’s insistence on high standards of disclosure and the need for strict compliance with written description and enablement provisions. While hardly a panacea for the recent, widely perceived decline in examining standards and concomitant drop in patent quality, a strong restatement of high expectations through the issuance of PTO guidelines would be an important start.

In addition, given the significant threat posed by patent trolls to the integrity and stability of the patent system (discussed in more detail in the accompanying article by Dan McCurdy), and notwithstanding the possibility of legislative actions and court decisions to deal with this threat, the PTO should initiate a study assessing various approaches to understanding and resolving the patent troll issue. Among the policies that have been proffered and are deserving of study are the awarding of legal fees to successful defendants (a “losers pay” rule); more strict adherence to Rule 11 requirements (which set the bar height for the filing of patent infringement suits) by the courts; and a requirement that all patent assignments and licenses be registered with the PTO, including ongoing declaration of assignments and licenses to and by the patent-holder’s upward and downward affiliates.

Yet another way the PTO could simplify operations and help prosecutors would be to revamp its current interpretation of restriction requirements and unity-of-invention standards. Under current standards, inventions that require the integrated use of many independent pieces of, say, genetic material or gene products—such as those used on analytic “gene chips”—have been ruled by PTO to be multiple inventions, slowing issuance and adding significantly to cost. Those standards are taking a toll particularly on the emerging bioinformatics field and should be reassessed.

Reducing the time to get a patent decision

A number of initiatives could help reduce the problem of prolonged pendency times, including, as briefly alluded to above, an increase in regional and international work sharing and better synchronization among various patent offices worldwide. Huge amounts of duplicative work are carried out in patent offices around the world. Various forms of work sharing among patent offices are allowed under the terms of the Patent Cooperation Treaty and the Patent Prosecution Highway, but for the most part they remain untapped.

Similarly, programs that enable interested third parties to comment and provide input to examiners, such as pilot projects using peer-to-patent, have been promising, but have not been scaled up. As these and other changes in the examination process are implemented, it will be important to ensure that any new duties, costs, or other burdens do not disadvantage independent inventors and small enterprises.

A second possible means of reducing pendency would be to remove some of the current incentives for continuations. The ability of a patent holder to continue to tailor claims of a related patent provided the claimed invention in that continuation application is deemed within the scope of the original patent—and to claim the original filing date of the parent patent even though the continuation patent may be altered many years following the initial patent filing—has created mischief and reduced the predictability surrounding patented inventions. The PTO should initiate a study of whether continuations as practiced today are in keeping with the public policy principles underpinning the patent system and make recommendations, if necessary, to amend the law.

A third approach to reducing pendency is to identify and implement incentives to defer examination. Japan has a robust system of voluntary patent deferrals, which has helped to reduce pendency there (as counted from the date of examination request)—and has resulted in shifting some of the burden of primary examination to the United States. Deferral is not currently an option in the United States but should be, both to allow the PTO to focus on applicants’ most important applications and to bypass applications that all parties agree are by this time stale. New legislation may be required to implement such a change

Finally, the PTO should conduct or share responsibility for a study that would examine the feasibility of launching a multinational patent examination office to conduct patent examinations on behalf of member states (discussed in more detail in the accompanying article by Bruce Lehman). The findings of such a world-class patent examination entity would be shared across all member states, but with each member state maintaining its own patent office for issuance, appeal, and other non-examination activities. Given the realities of multinational negotiations, this new office is an ambitious plan, but one that deserves energy and emphasis from the Obama administration.

Separately from the issue of patent pendency, the PTO must devise a plan for streamlining existing post-grant and ex parte proceedings, which result when third parties ask the office to re-examine the validity of an issued patent. In particular, inter partes re-examination, which allows third parties to play an expanded role in the re-examination process, is seldom used and therefore ineffective, and thus has not contributed to providing more IP certainty, as originally intended.

Congress

The Patent and Trademark Office has been reincarnated repeatedly in various forms over the centuries (it first became a distinct bureau in 1802, under the State Department; was transferred to Interior in 1849; and in 1925 moved to Commerce, its current home). If the administrative changes outlined above—along with some of the legislative changes noted below—cannot be mustered to achieve the major goals outlined in this report, it may be that a new reincarnation will be needed, in this case to a government-owned corporation. For both the philosophical and practical reasons outlined above—and given the reality that more political capital would likely be spent arguing over the implication of the PTO as a GOC than would be required to implement many of the changes called for in this report—we recommend the GOC as a mechanism of last resort, rather than the preferred path forward.

Notwithstanding how the GOC question is handled, Congress should pass legislation that would at last change the U.S. patent system to a “first-inventor-to-file” system—that is, a system that rewards the first person to file a claim for an invention rather than a person who, after a claim has been filed by another, provides evidence for having created that invention earlier. The United States is the last major economy in the world that grants patents on the basis of “first to invent,” rather than “first to file.” Without question, the American tradition has proven resilient and there remains a lack of consensus among U.S. stakeholders about aligning the United States with international practice. Some individual inventors and small companies have voiced concerns that a “first-inventor-to-file” system could place them at a disadvantage relative to larger companies, which they perceive may be better able to file patent applications rapidly. Some also fear that, since patents can take years to issue, a policy of making applications public 18 months after filing might help unscrupulous competitors who are willing to flirt with infringement. But there are strong arguments to be made for such a change. Among them, moving to a first-inventor-to file system would improve predictability and reduce controversy surrounding patents issued around the world. Also, many of the recommendations in this report are predicted to reduce pendency, making 18-month publication less of an issue.

To facilitate greater communication between examiners and applicants, Congress should also pass legislation updating the law governing inequitable conduct—the legal term describing a patent applicant’s failure to disclose faithfully to the PTO all information required during the patent application process. The doctrine serves an important public policy purpose, namely to help ensure that applicants tell the PTO the truth about their inventions and claims. But it is often abused. Parties accused of infringing a patent almost always assert—albeit rarely with success—the inequitable conduct defense, which claims that the patent holder was less than appropriately forthcoming about knowledge he or she had about relevant prior art.

The issue of inequitable conduct is ripe for reform because it may be an obstacle to other changes that could improve patent quality. Specifically, one way to lessen the overwhelming burdens already borne by the PTO is to shift more responsibility to applicants to supply information to the patent examiner, such as through more diligent searches of prior art. Such a shift could both speed the examination process and improve patent quality. But it is important that any policy encouraging that diligence not make an applicant more susceptible to charges of inequitable conduct that, if successful, would render the patent unenforceable.

To this end, if PTO rules are enhanced to require applicants to more diligently search for invalidating prior art, then it should be made clear that mere failure to cite a specific relevant prior art reference would not, by itself, constitute inequitable conduct. Rather, intentional failure to disclose art that was known by the applicant to be material and that resulted in an asserted claim being found invalid would constitute inequitable conduct.

Moreover, to curtail abuse and reduce the enormous burden on the courts and discovery costs associated with defending against a claim of inequitable conduct, the inequitable conduct defense should be limited to cases in which at least one claim of the patent has been found invalid. And to gain the benefits of broadened prior-art searches and submissions central to the peer-to-patent initiative, Congress should enact reform legislation that explicitly allows the public to submit prior art to the PTO with commentary.

As described in the PTO section above, Congress should also consider crafting legislation that would create a new post-grant opposition system and reform inter partes re-examination, as well as legislation revamping the laws on apportionment of damages (though this is also likely to be a subject of review by the courts, as noted below). Instituting a post-grant review proceeding was recommended by both the FTC and National Academies reports.

Further, Congress should consider legislation to curtail “venue shopping,” the practice of plaintiffs launching lawsuits in jurisdictions with histories of rulings favorable to them even if the jurisdiction has little or no connection to the parties or the events involved in the litigation. Venue shopping has already been the focus of an important Fifth Circuit case and, like the issue of proportional damages, is likely to attract further court review in the near term, as discussed below. Congress should also consider legislation that would provide alternatives to a broad right to interlocutory appeal of trial court decisions.

Applicants

Many business leaders decry the recent perceived decline in patent quality. But a significant part of the problem plainly rests on the shoulders of overreaching applicants themselves and their outside prosecution counsel, who are measured primarily by metrics of patent quantity rather quality.

First, applicants need to be more proactive, collaborative, and thorough with regard to disclosure. Although pre-exam meetings are not always efficient or worthwhile (or always welcomed by examiners), the prosecution process would generally benefit from more open communication in the early stages. As mentioned earlier, changes to the inequitable conduct doctrine would likely be required to facilitate such changes in approach.

A second way applicants can step up to the plate is to ensure that their claims are closely aligned to specifications in their applications. Many experts have noted a disturbing trend in recent years toward exaggerated claims that rest on little or no basis in fact, or evidence of the claimed invention or its practical usefulness. These claims slow the approval process and add to pendency problems. They can also encourage cases of adventurous enforcement, in which a claimed infringement is of a product or service that has virtually no resemblance to the product or service that was envisioned in the issued patent. Product-producing companies can hardly hazard a guess—let alone know—what blocking patent may lay in their path given sufficient creativity in claim interpretation. Time-consuming and expensive legal challenges are the only sure products of overly broad and low-quality patents.

Third, applicants should consider working with the PTO and with Congress to design and implement a process of deferred examinations, taking into account the need for a mechanism to mitigate the additional uncertainty that would necessarily result from additional unexamined patent applications. In conjunction with implementation of a first-to-file system, discussed above, applicants could preserve the priority of their patent application while deferring examination of inventions that are unlikely to have near-term commercial importance.

The impact of the current application backlog could be significantly reduced if applicants were able and willing to rank the importance of their pending applications and agree to defer some in order to get the most valuable and more urgently required pending patents issued. Incentives may be needed, including some already in widespread use in Japan where deferrals are commonplace.

The courts

Among the most vexing issues in patent law is that of selection of venue, or where lawsuits can be filed. Currently, plaintiffs have wide discretion in selecting the court in which they file a patent case. Patent owners seeking to enforce their patents generally prefer venues that have a promising record with respect to finding in favor of patent holders; producing significant damages; and hearing and deciding cases with relative haste. For these reasons a few jurisdictions—including the Eastern District of Virginia, the Western District of Wisconsin, and the most-favored venue, the Eastern District of Texas—have become popular in recent years. Critics have countered that venue should have a tangible relationship to the parties in the suit. This was a sticking point in the recent attempt at legislative reform.

Recently, in an en banc decision of the Fifth Circuit (in re Volkswagen AG, No. 07-40058, October 10, 2008), the court held that Eastern District of Texas Judge John Ward had erred in his decision to reject a motion to transfer a product liability case from the Eastern District of Texas to Dallas, where an automobile accident at the core of the case had occurred. Specifically, the court rejected the judge’s argument that the residents of the Eastern District had an interest in the product liability case because the product (a Volkswagen Golf) was available there as well. “Indeed they [the residents of the Eastern District] do not,” the Court ruled, “as they are not in any relevant way connected to the events that gave rise to the suit …In contrast, the residents of the Dallas Division have extensive connections with the events that gave rise to the suit.” Though the venue-shopping elements of the recent congressional patent reform effort failed, in re Volkswagen likely indicates a new willingness on the part of the courts to further tackle this contentious issue.

Another hotly debated issue in patent law that may move toward resolution in the courts involves royalty damages awards. At issue is how to fairly value the essential elements of the invention and assess reasonable damages for infringement. Central to the debate is whether damages awards are too often based on the total value of the product that wrongly incorporated a patented invention, rather than being based on the value attributable to the infringing element that contributes to the product’s total value.

Consider, for example, a case in which a semiconductor component that controls a laptop’s ability to connect to a wireless network is found to infringe a patent. Should damages (for example, an assigned royalty rate) be based on the value of the semiconductor component alone? Or (as has been the case in some high-tech cases) should damages be based on the total value of the laptop?

That question was a major point of contention among different stakeholders in the 2008 congressional patent reform efforts. Today the issue remains stalemated, and unless or until industry finds a compromise position it is unlikely to gain sufficient congressional support for passage. That said, there are signs of a potential willingness by the Federal Circuit or the Supreme Court to take up this issue if presented the opportunity, and it appears likely that proponents of reform may attempt to provide such an opportunity. The Supreme Court has signaled that it is dissatisfied with the way patents are now valued for purposes of assessing damages. In its recent Quanta opinion, a contributory infringement case, the Court said valuation should be based on the “essential elements” of the invention and not the claimed product that incorporates the invention. This admonition of the Supreme Court provides good guidance for resolving the legislative and court impasse.

A third arena that is inviting legal attention encompasses issues of inequitable conduct, willful infringement, and enforcement. High among the questions here is whether a patent holder found to have intentionally withheld material information resulting in the issuance of patents should be punished by having all claims of the patents ruled unenforceable, or only the claim granted by virtue of the conduct ruled unenforceable, or some other approach that leaves valid claims of the patent intact or enforceable. Although much of this legal terrain is still virgin, the courts have begun to address the issue, for example in the recent (Aug. 2008) case, Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.

Finally, the courts also have recently shown a willingness to deal with longstanding issues relating to standards of obviousness, novelty, and ordinary skill in the art. Specifically, there is widespread agreement that in recent years the PTO has been granting too many patents for products or processes of questionable novelty or that were obvious. This can be addressed in part administratively, as mentioned above. But the courts can also help set the standards through rulings on challenges, as recently demonstrated by the KSR decision, referenced above.

Conclusions

The time is ripe for positive change in the U.S. patent system. The Obama administration clearly understands the important role that investment in science and technology must play in America’s economic recovery. A wide array of patent-system stakeholders agrees not only on the need for change but also on many of the most immediate fixes that need to be made. And after a year of struggle over the remaining differences among stakeholders and constituents, Congress is deeply informed and motivated to improve the system.

The first opportunity to make a difference will come very soon, with the all-important selection of a new PTO director—one committed to instituting much-needed administrative reforms, including greater transparency and communication with applicants and others, and examination-process reforms to increase patent quality and reduce pendency.

Sobered by the economic challenges now facing the nation and the world, and cognizant of the tolls that deficient quality patents impose on enforcement costs, investment, and innovation, patent applicants can and should do their share by recommitting themselves to the highest and fairest standards as they craft their claims and defend their intellectual property. It is to be hoped as well that the courts will tread fairly but assertively into the legal frontier that remains unaddressed by the PTO and Congress.

All the pieces of the puzzle are aligned for a renewed flowering of American investment in ingenuity. A modernized patent system promises to improve patent quality, reduce uncertainty about the boundaries of intellectual property, and spur the kind of confidence in the future that in the years to come will be at the heart of American scientific, technological, and economic advancement.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Notes

[1] Prior to eBay, the standard applied by the Federal Circuit resulted in permanent injunctions virtually always being granted after a patent holder won at trial, and the status of the patent holder (e.g., whether it was a product-producing company or NPE) did not matter. In its eBay decision, the Supreme Court rejected the automatic entry of injunction and instead ruled that the traditional four-factor test must be applied to determine if an injunction is warranted: (i) Is there irreparable injury (ii) are there inadequate remedies at law; (iii) is there a balance of hardships; and (iv) is the injunction in the public interest. In the case of certain NPEs (such as patent holding companies), it is difficult to imagine how these tests will be met in favor of the NPE and thus, post eBay, district courts have refused to grant injunctions to such NPEs.

[2] Prior to MedImmune, the CAFC routinely held that a licensee in good standing could not sue for declaratory judgment of patent invalidity because there was no immediate threat of being sued for patent infringement. Thus, in order to bring a declaratory judgment action a licensee had to first stop making royalty payments, thereby rendering itself vulnerable to a lawsuit for willful infringement. The Supreme Court rejected this approach, and held that a licensee in good standing is not required to “bet the farm” or risk treble damages for willful infringement and possible loss of business before seeking a declaration of its legal rights. Thus, licensees can now continue to make royalty payments while simultaneously challenging the validity of the patent in court.

[3] Prior to the Sandisk case, a potential licensee must have had a reasonable apprehension of litigation to file for a declaratory judgment (an important right, since it enabled the potential defendant to select the forum in which the case would be heard). In Sandisk, the Court threw out the reasonable apprehension test and ruled that the new standard only requires a prospective licensee to contend that it does not need a license after a patent holder contends that it does in order to create a controversy that is sufficient to support declaratory judgment jurisdiction.

[4] In KSR, the Court rejected the Federal Circuit’s rigid application of the “teaching-suggestion-motivation,” or TSM, test, holding that the determination of obviousness must allow the use of “common sense” by one skilled in the art. A key ingredient of KSR was the elimination of the requirement of foreshadowing in the prior art, which precluded a finding of obviousness with respect to “innovations” that were so obvious that no one even bothered to write about them.

[5] Because the doctrine of patent exhaustion applies to method patents, and because the License Agreement authorizes the sale of components that substantially embody the patents in suit, the exhaustion doctrine prevents LGE from further asserting its patent rights with respect to the patents substantially embodied by those products.

[6] The Bilski decision significantly narrowed the 1998 State Street ruling by the CAFC that spurred a decade-long flurry of business method patents. In Bilski, the CAFC held that the sole analysis to determine if a process qualifies for a patent should be the “machine-or-transformation” test, which requires a showing that the claimed invention was tied to a particular apparatus or operated to change materials to a “different state or thing.”

But if we are truly committed to evidence, we should push ourselves to take one last glance backward and review some of the biggest science policy-related lessons that 2008 had to teach. Here, then, is a Science Progress thumbnail of eight advances in science that will have long-lasting impacts on science policy—or advances in science policy that we predict will have long-lasting impacts on science. Counting down from 8 to 1, in no particular order:

8: Strong evidence that making biofuels such as ethanol from food crops is not going to save the world

Detailed global modeling by Timothy Searchinger of Princeton and colleagues showed that production of corn-based ethanol would double the amount of greenhouse gas emissions over a 30-year period instead of reducing those emissions by 20 percent, as previous calculations had suggested. Biofuels from switchgrass grown on U.S. corn lands would increase emissions by fully 50 percent, the study also found. Older research had not properly taken into account the impacts of land-use changes, such as converting carbon-sequestering rainforests to farmland. Thanks to the new understanding, many are now calling for changes in fledgling U.S. economic incentives that had aimed to boost biofuel production on domestic farms.

7: Growing evidence that we are going to have to get CO2 levels down even more than we thought if we don’t want to live in an ice-free world

Record-breaking glacial melts and improvements in climate models have led a growing number of scientists to agree that the world needs to get CO2 levels down to 350 parts per million, and avoid hitting the cap of 450 ppm that many had previously accepted as a goal. While the details are still in dispute, the need to change our behavior with regard to CO2 emissions is now beyond doubt, with real concern that even a very concerted effort at this point will barely be able to save the planet from radical mean temperature changes and greater rises in sea-level than had previously been expected. As NASA climate scientist James Hansen put it earlier this year: “Present policies, with continued construction of coal-fired power plants without CO2 capture, suggest that decision-makers do not appreciate the gravity of the situation. Continued growth of greenhouse gas emissions, for just another decade, practically eliminates the possibility of near-term return of atmospheric composition beneath the tipping level for catastrophic effects.”

6: Overwhelming evidence that in this age of global trade, the Food and Drug Administration is not anywhere near able to protect us from imported contaminants and toxins in our food, toys, drugs and other commodities

Phony heparin in blood thinners from China. Toxic melamine not just in pet food but also in baby formula. Leaded paint on toddler’s toys. Potentially dangerous phthalates such as BPA in baby bottles and intravenous tubing. E. coli in spinach. Salmonella on cantaloupes. The list goes on. It’s not that the agency is inherently inept or its employees unqualified. Quite the contrary, it is bustling with dedicated scientists and public health expertise. But short on resources, struggling with a bureaucratic structure that no longer makes sense, hobbled by a lack of needed legal authorities, the agency is today destined to fail repeatedly. Happily, the string of problems that the FDA battled in 2008 seemed at last to reach the degree of critical mass needed to get the attention of the public and Congress. Expect real action next year, both in terms of budget growth and a push for organizational reform.

5: Passage of legislation requiring “open access” publishing for all research reports resulting from work funded by the National Institutes of Health

After years of heated debate inside and outside of Congress, the NIH implemented the nation’s first open access law in April. As a result, all 80,000 or so research papers published each year that describe the results of NIH-funded studies must now be made available on a free, publicly accessible database within 12 months after publication in a journal. No longer will people who want to read the results of NIH research—paid for with their tax dollars—have to subscribe to expensive scientific journals or pay page charges to the publishers, as has long been the case. The advance will also make it easier for scientists to access each other’s work and for researchers to combine data sets from multiple published reports to perform meta-analyses—a cost-saving means of leveraging scientific data that has been difficult to implement until now.

4: The official opening of the Svalbard seed vault in Norway

This high-security, deep-freeze storage locker, nicknamed by some “the doomsday vault,” is poised to become the seed bank of last resort—the go-to place after a nuclear holocaust or other disaster. After more than a year of construction in the side of a permafrost-bound mountain, it began accepting its first deposits in 2008. The governments responsible for many of the world’s smaller, regional seed banks are not maintaining them, it turns out, or natural disasters or war have damaged or destroyed the banks. The opening of the new vault helped bring food security to the fore, reminding nations that today’s agricultural seeds are the product of ten millennia of slow, scientific work on genetic improvement, and that this legacy deserves both protection and responsible extension.

3: Congressional passage of the Genetic Information Non-discrimination Act

It took about a dozen years of lobbying by scientists, ethicists, healthcare advocates, and others, but Congress at last passed GINA, a watershed civil rights bill that prevents employers and health insurers from discriminating on the basis of individuals’ inherited genetic material. The law protects patients and genetic study participants from having their genomes used against them and, by minimizing the threat of genetic mischief, should facilitate the launch of personalized medicine, in which diagnoses and treatments will be tailored to individuals’ genetic codes. It may also boost direct-to-consumer advertising of genetic tests, some of which have proven in the past year to be of questionable medical value. Watch for an escalating debate in 2009 over how best to oversee this nascent-but-growing blend of medicine, marketing, and DNA-based narcissism.

2: The first construction on an entire bacterial genome from scratch

Scientists at the J. Craig Venter Institute in Rockville, Maryland, reported they had synthesized the complete genome of a bacterium, Mycoplasma genitalium. Previous experiments suggest that if the stitched-together DNA were inserted into a cell, it would automatically “boot up” and turn that cell into what would be the world’s first synthetic life form. Venter’s primary goal is to design, from scratch, artificial cells able to break down pollutants or produce novel biofuels. At the same time, some experts are now wringing their hands over the fact that the same technology could be used to create highly customized biological weapons. This “dual-use” aspect of synthetic biology is sure to be a major focus of scientific societies, regulators, and ethicists in 2009.

1: The appointment of a new team of scientific advisers for the next administration

What can we say? President-elect Barack Obama has created nothing less than a dream team when it comes to putting people with real scientific expertise in all the key slots that will need to make evidence-based decisions over the next four years—including his decision, released over the weekend, to post Nobel-prize-winning cancer researcher Harold Varmus and genomics whiz kid Eric Lander to the President’s Council of Advisers on Science and Technology.

The actual evidence that all these Obama-appointed scientists are going to hew to, of course, is largely dispiriting. Climate change, energy needs, food insecurity, and economic chaos—all are threatening global peace and undermining the human quest for justice. But progress is not possible without a square look at the facts. I for one am ready to swallow hard, face the unalloyed truth, and support the plans that have the best hope of getting this listing ship of state on an even keel again.

Here’s to a happy, healthy and evidence-based 2009.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

At the time, Michael Crichton had recently come out with his terror novel, Prey, which is about self-organizing nanoparticles running amok and unleashing coordinated attacks against humanity. There was talk about the book being made into a major motion picture. “All I can say is we better get our messaging out about nano before the movie comes out,” an NSF official said to me during a break. “Otherwise the battle is lost.”

As it turns out, the movie did not get made. But two new studies published last week suggest that it may not matter much whether the NSF gets around to educating the public about this new technology, at least not in the conventional sense of education. Despite the common conception that a better-educated public is more likely to appreciate and support scientific and technological advances, the new study found that deeply ingrained psychological and cultural factors drive individuals’ acceptance or rejection of new and potentially frightening technologies—much more so than factual information.

For people whose cultural views leave them disinclined to trust new technologies, the act of getting more information—even very balanced information—can harden rather than soften attitudes of opposition.

“Our study reinforces the conclusions of other researchers who have cautioned against assuming that enlightened public opinion will spontaneously emerge from accumulating scientific information on the risks and benefits of nanotechnology,” write Dan M. Kahan, of the Yale Law School, and his colleagues in the December 7 online edition of Nature Nanotechnology.

Indeed, the team found, for people whose cultural views leave them disinclined to trust new technologies, the act of getting more information—even very balanced information—can harden rather than soften attitudes of opposition. That finding, along with the conclusions from an accompanying study that finds a strong link between religiosity and rejection of nanotechnology, suggest that proponents of the technology—along with federal regulators—have some serious work to do beyond public education if the field is to break through safely to commercial success.

A 20-second refresher: Nano has to do with engineered particles, fibers, and devices between 1 and 100 billionths of a meter in diameter—a scale so small that it involves in some cases the manipulation of individual atoms. Ordinary materials behave in extraordinary ways at that size scale, offering materials scientists a new palette of chemical, electrical, and optical properties to work with, but also posing potential threats because of these substances’ ability to get into the body or contaminate the environment.

Many studies have shown that, in general, Americans have vaguely positive feelings about nanotechnology but also that they know very little about it. To see what underpins those feelings and what impact more information might have, Kahan and his colleagues surveyed 1,862 adults. The goal was to see which of two models best described how people come to perceive nano’s risks and benefits: the “familiarity hypothesis,” which posits that the more people know about nano the more they will appreciate and trust it, or the “cultural cognition” hypothesis, which predicts that preexisting worldviews (in particular, whether one is in essence “individualistic” or “communitarian”) will largely determine people’s attitudes toward the science, irrespective of how much they actually know about it. (The individualists tend to be supportive, while communitarians worry about negative impacts on others and on the world.)

Among those in the study who knew relatively little about nano and were not told anything new in the survey, people of both worldviews were equally likely to be supportive of the technology—about 61 percent of them. But that changed when people of each worldview were given identical, balanced fact sheets that offered equal amounts of detail on both benefits and risks. Their knowledge-bases thusly enriched, people with individualistic worldviews became 25 percent more likely to support the science than they were before. By contrast, communitarians responded to the same information by becoming 38 percent less likely to be supportive than they had been.

After reading the same information, that is, two groups of people who once felt the same about the technology suddenly were split, 86 percent to 23 percent—scientific proof, of a sort, that some people really do see the glass as half empty while others see it as half full.

In the second study, led by Dietram A. Scheufele of the University of Wisconsin, Madison, researchers compared Americans’ attitudes about whether nanotechnology “is morally acceptable” against measures of their religiosity, and found the two to be inversely correlated. (Surveys have found similar trends for other areas of science, perhaps because of a sense among some religious people that scientists are meddling with aspects of nature that are properly God’s domain.) Then, going further, they surveyed people in several European countries. They found a clear continuum in which people in countries with the lowest levels of religiosity had the highest odds of finding nanotech to be morally acceptable, while those living in countries with high measures of religiosity (the United States being higher than even the highest in Europe, namely Ireland and Italy) had the lowest odds of finding nanotech to be morally acceptable.

Those relationships held true even when the researchers applied correction factors to account for differences in the countries’ general alignment with science, as measured by national research productivity and high-school science scores.

One way to gain public confidence and acceptance, of course, is to reassure consumers that the government has assessed the science and implemented responsible oversight policies. As I’ve written here and here, and as confirmed last week in a new report from the National Research Council, the feds still have a lot of work to do in this regard.

But if the new studies are right about the importance of pre-existing worldviews and religiosity, then it will take more than government pronouncements to gain widespread public support for nano, which the Commerce Department has hailed as nothing less than “the next industrial revolution.”

Worldviews and religiosity are not easily changed or overcome. So is the prospect for a positive consensus on nano altogether out of reach?

“Nothing in our study suggests that cultural polarization over nanotechnology is inevitable,” Kahan and his colleagues write. “Social psychology is making important advances in identifying techniques for framing information on controversial policy issues in a manner that makes it possible for people of diverse values to derive the same factual information from it.”

To which I can only say: Really? That sounds awfully close to the line between education and brainwashing, doesn’t it?

Come to think of it, compared to being subjected to educational materials engineered by social psychologists that are guaranteed to convince me that everything is okay, I wonder if I might just rather live in an intellectually stunted, religiously suffused, and hopelessly divided country where there is at least a free and full, if largely fruitless, debate still going on.

That’s my (very small) worldview. And I’m sticking to it.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Mona Younis directs the Science and Human Rights Program at the American Association for the Advancement of Science, which recently convened a panel of scientists and advocates to highlight successful collaborations that stemmed rights abuses in the D.C. prison system, recruited forensic experts to exhume mass graves in Bosnia, and focused international attention of vulnerable villages in Darfur. Her program just launched a matching service that will pair more researchers and advocates around the world. In her vision for the future, scientists will work with advocates with the same frequency—and with the same impact—as lawyers do today.

The text of this interview has been edited and condensed. For the full conversation, check out the audio available in the sidebar.

Rick Weiss, Science Progress: When people think of human rights, they think of wars, dictators and suffering, and when they think of science and technology they think of laboratories and computers—maybe nerds. To the extent that there’s any overlap at all, I can imagine people think maybe only about negative things like the wiring of prisoners at Abu Ghraib, the science of torture. What are the positive connections between science and human rights that your group is trying to foster?

Mona Younis: Well, there are many. Scientists have a history of being very concerned about freedoms of all kinds: freedom to practice science, freedom of expression, freedom of scientific inquiry. And they’ve also had a history of being very actively involved in defending the human rights of individual scientists who’ve been oppressed or under threat around the world. So there’s been a natural affinity between scientists and human rights, but what’s interesting is that increasingly, we’re finding scientists are open to considering additional ways in which they can be engaged in human rights. And that’s what the Science and Human Rights Program at AAAS is about: exploring those openings and interests, and figuring out what else can they do. We are discovering a number of different things.

Weiss: So there are specific science technologies or techniques that can be brought to bear? I think that many people are aware of the fact that in the situations involving genocide or mass graves, conventional forensic medicine can help identify bodies and how they were killed. Does it go beyond that? Do we get into fancier science—genetics or other fields?

Mona: Oh yes—that and much more. In fact, the Science and Human Rights program pioneered in the 1980s the application of forensic and genetic sciences to the exhumation of mass graves in Argentina. In the 1990s the program addressed a large-scale violation of human rights via statistical information management techniques. That was the first time that had been done and the program staffer at the time gave evidence at international tribunal in the former Yugoslavia in the case against Milošević.

Weiss: So this was a matter of having to develop new computer technology just to organize all the information from these bodies?

Younis: It wasn’t so much the technology, but it was organizing the information—how to collect and organize and capture the patterns and predictions of activity. That was unique.

Weiss: Because patterns of abuse are crucial to a conviction of genocide?

Younis: Absolutely, because it’s hard to capture intent. You’re not easily going to get the papers and documents giving the orders. If you are able to identify the pattern, and compare the evidence, then it’s possible.

Weiss: It’s great to see science in the service of bringing perpetrators to justice. It would be great if it could get further upstream. Are there ways science can be brought to bear with the idea of preventing human rights abuses?

Younis: We certainly hope so. In fact we say is, “Imagine what scientists have been able to accomplish with better documenting and reporting of violations.” The Science and Human Rights Program has been engaged in developing geospatial technology applications for human rights. We’ve done work in Darfur and Burma and Zimbabwe. We say “imagine”—and in this case it was a geographer who brought this technology and this tool to human rights—so imagine if scientists in every discipline considered what they might be able to contribute, what tools and expertise might be brought to bear to human rights challenges. Who knows what might be possible in terms of prevention and early warning?

Weiss: How could satellite imagery give an early warning of a problem as opposed to identifying something afterwards, like seeing evidence of mass graves?

Younis: The program worked last year with Amnesty International USA on Darfur and produced the Eyes on Darfur website, which was remarkable. It’s tracking the situation through images of 12 villages in Darfur—the idea is that we have “eyes in the sky,” and it is a signal to the potential perpetrators of further human rights violations that we are watching these 12 villages. We are keeping an eye on what is happening there, and so far, thank goodness, they have been fine. We would like to hope that it was helpful in prevention.

Weiss: Scientists wouldn’t necessarily bump into human rights activists at their usual dinner parties and find out that they have something to share with each other. How can we help people in need find people with the skills that can help human rights work?

Younis: Scientists have so much to contribute to human rights groups, and human rights groups have such a need for science and scientific expertise. The problem is how do they meet? To address that we recently launched a new project we’re calling On-Call Scientists. It’s a project aimed at cultivating the tradition of pro bono science and pro bono scientists, just as are is pro bono lawyers and lawyering for human rights groups. We’re determined to set up the same thing, establish the same tradition of science and scientific expertise for human rights organizations.

This is an online system where scientists can go to volunteer to be available to provide their time and expertise and answer questions in the service of human rights organizations or UN field offices that are engaged in human rights work and national human rights institutions. Similarly, we have a database that receives requests from these organizations for scientific expertise. As these fill up we have a committee that will work on the optimal partnerships between them. We are very excited because we just launched this in October, and we already have over 90 scientists who have signed up to volunteer.

Weiss: This is the ultimate online dating service.

Younis: Exactly. What could be better?

Weiss: How did you get into the business of science of human rights? Are you a scientist or a human rights advocate, or have you become both?

Younis: My training is as a sociologist, and I feel that my turning to sociology has something to do with human rights—in the sense that sociologists want to figure out how to fix things. And what’s better to fix than the situation of the human condition?

My first encounter with human rights was in the 70s, working on the Palestine human rights campaign. From then on my passion for human rights grew, and I was very fortunate to find an opportunity where I could combine my scientific training as a sociologist with my passion for human rights.

Weiss: I can see how the science of sociology might reasonably blend with the human rights issues. Have you found some cultural gaps that you’ve had to bridge? How do scientists generally get along as they try to get into the human rights business?

Younis: Well, there are, of course, issues on both sides. One of the things we are working on is looking at the language: developing translation documents for what scientists need to know about human rights, and what human rights practitioners need to know about scientists. There are, of course, issues there. But they’re not anything that can’t be overcome.

In fact working with one another enriches both communities. For some sciences it seems inconceivable that they can contribute to human rights, but then you discover that it is actually possible.

Last year we were contacted by a human rights organization that was working to set up a small human rights group in southern Sudan. They wanted to look at water contamination that they suspected was the result of oil drilling. So we worked to try to find a hydrologist to work with them.

It was fascinating because as I was reaching out to find hydrologists, and one responded with curiosity at first. After several communications, he emailed back and said, “You know what? I feel that water should be a human right.” And I was delighted to respond with several URLs—places where he could learn that water is indeed a human right.

Weiss: A newly radicalized hydrologist.

Younis: And he will not look at human rights in the same way ever again.

Weiss: Scientists are so used to sticking to the evidence, they sort of pride themselves sometimes on not adding interpretation. I can imagine it can be difficult for some of them to make the leap into advocacy. It sounds like from the experience with this hydrologist, something sometimes clicks.

Younis: Yes, you’re right. And there are different comfort levels, and we have to be patient. At the Science and Human Rights Program projects that apply science and technology to human rights problems, those projects are not involved in human rights advocacy directly. We are focused very much on the science piece. But we realize that with human rights work, it’s not gonna happen on its own. You cannot just do the science piece and expect it on it’s own to advance into human rights advances, so all those projects are conducted in partnerships with human rights groups. They do the advocacy directly.

But we are also creating other opportunities where scientists can become advocates for human rights. Since we are celebrating the 60^th anniversary of the Universal Declaration of Human Rights, there is an article—few people know this—number 27, devoted to the human right to the enjoyment of the advancement of science and scientific progress. That is something that scientists very naturally want to advocate for, or do now indirectly, but once they learn that it’s a human right, we hope that they become human rights advocates.

Weiss: I think there are few scientists out there who know that the work they are doing is actually embodied or described as a human right in a universal declaration created 60 years ago. Let’s just talk for just a minute about how to put some of these things into action in terms of public policy. I imagine at this point in our nation’s history, the U.S. government is not seen around the world as the savior of human rights. There’s been a lot of discussion about that in the course of the last administration. Is there though a role for the federal government, as we have a new administration coming in?

Younis: We certainly hope so. As human rights advocates, our role is to make sure that the governments including—or I should say especially—our own, given we are U.S. citizens, meet their human rights obligations. Our government has obligations to respect, protect and fulfill these various human rights. That is their goal; that is what they should be doing. The question is not, “Is there a role to play?”—it’s their responsibility. So in that sense there is a role for them to play.

Weiss: This year and this week is the 60^th anniversary of the Universal Declaration of Human Rights. No better time to reaffirm our commitment to those rights as a nation. You’ve got an interesting conference coming up on this don’t you?

Younis: On January 14 through the 16, we are launching the AAAS Science and Human Rights Collation. This is a network of scientific associations, societies, and science academies that believe that scientists and science are vital to the realization of human rights. Over 20 associations have been working together over the past year to lay the foundations for this collation. We are looking forward to January for launching it publicly. We’re very honored to have Mary Robinson, the former UN high commissioner for human rights and the former president of Ireland, one of the plenary speakers. Her joining us attests to the importance of the human rights community is placing on the engagement of as many segments as possible in the realization of human rights. It’s very clear that they are welcoming this initiative by scientists.

Edited from the full-length audio interview by Andrew Plemmons Pratt and transcribed by Tristan Fowler.

That at least was my initial stance as I started to read the latest report from President George W. Bush’s President’s Council on Bioethics. “The Changing Moral Focus of Newborn Screening” focuses on something that happens to virtually every newborn in this country, typically with little or no knowledge of the exhausted and usually delighted parents—the quick prick of the baby’s heel with a lancet and the collection of a few drops of blood to screen for hidden genetic defects.

Such tests have saved countless children from awful outcomes by, for example, informing parents that their child has a rare, invisible, metabolic glitch that, if left unaddressed, would result in mental retardation or other serious problems but that can be completely averted with proper dietary adjustment. The Council’s report offers a solemn warning, however, that this practice has quietly expanded in recent years to include dozens of inherited ailments, including some for which no treatment yet exists and others that may occur later in life and cannot be prevented. This expanded testing is done on the same tiny sample of blood with no added medical risk to the child. Yet the report concludes that many of these tests should probably not be done because they offer no direct benefit to the child. Rather, the potential benefits accrue to society in general, in the form of new knowledge about health, disease, and genetics.

Broad genetic testing could cause real harm, the Council warns. Parents might worry unnecessarily if a test comes up positive. Gene testing could even speed the arrival of a new era of eugenics in which people are discriminated against, or fetuses aborted, just because of the patterns in their genes.

“Who is to say at what point an uncovered defect becomes serious enough to warrant preventing the birth of other children who might carry it? At what point have we crossed the line from legitimate family planning to capricious and morally dubious eugenics?”

As I said, I am more than a little sensitized to science-bashing these days, so my first reaction upon reading this was to ridicule the writers as overwrought hand-wringers. And, it turns out, some members of the President’s Council had the same reaction. The report ends with an appendix of “personal statements” written by various Council members, and one such statement makes for a particularly remarkable read. It was jointly penned by Michael Gazzaniga, a professor of psychology at the University of California, Santa Barbara, and Floyd Bloom, a neuropharmacologist at the Scripps Research Institute in La Jolla, California.

Gazzaniga and Bloom decry the report’s heavy focus on the potential negative outcomes of broadened genetic screening, including the report’s pedestrian declaration that “there is…the possibility that such knowledge will be misused or misinterpreted.” Isn’t that true of all new science, they ask?

Is it always anti-intellectual to want “not to know”?

They also find some language in the report to be “anti-intellectual.” For example: “The presumption of modern science, including medical genetics, has always been that knowledge is fundamentally good for human beings, and that the more we know about ourselves the better we will be able to live the kind of lives we want to live. The truth of this supposition remains in doubt as we lift the lid of the Pandora’s box of our genomic inheritance.” To the report’s similarly ostrich-like warning that U.S. newborn screening “seems to be heading into uncharted territory,” Gazzaniga and Bloom rhetorically respond: “Should Lewis and Clark have stayed home?”

Yet even I have to wonder if Gazzaniga and Bloom are perhaps going too far in their argument. I wonder if by defending current newborn testing trends in the name of intellectual freedom they may be saving the bath water along with the baby.

Of course we don’t want fear of possible negative consequences to keep us from pursuing the unknown. But is it always anti-intellectual to want “not to know”? Some people may want to know everything there is to be known about their medical future, including what will kill them and when. Others may prefer a few surprises, for any number of reasons—especially when that information is uncertain. I am concerned about a presumption that people should want to know such stuff, and the corollary presumption that anyone who does not pursue such knowledge is either a Luddite or, worse, a burden on society.

Now, it is difficult to argue against routine testing for the genetic underpinnings of diseases that can be prevented or that will take less of a toll when treated early. A few decades ago those were the only diseases anyone tested for. But as the Council report documents, the rules have stretched considerably, sometimes with the dubious rationale of gaining generalized knowledge for society.

“We as a nation have not been in the habit of subjecting individuals to compulsory screening merely for research purposes,” the report says. It’s an idea that Gazzaniga and Bloom belittle as “anti-scientific thinking,” saying in their personal statement that the phrase “‘compulsory screening’ depicts a far more invasive procedure than the sampling of heel stick … while ‘merely for research purposes’ greatly diminishes the fundamental quest for self-knowledge.”

Yet as they well know, even low-risk research cannot ethically be done on people—especially children—without informed consent (by the parents in the case of minors), and there are real questions about whether whatever consent is being collected from labor-stressed mothers can rightly be counted as informed at all. At the heart of the issue: even if states have technical avenues by which parents can opt out of certain newborn tests—the ones for genes or diseases that nothing can be done about anyway—are there practical means for those parents to learn of this right and take advantage of it?

Finally there is the issue of false positives, which are common in most screening programs since screening tests are designed to err on the side of catching every case. In 2007, the Council report notes, some 3.4 million U.S. infants were tested for maple syrup urine disease, a metabolic disorder. Of those, 1,249 were positive. But upon further testing, just 18 were confirmed; the other 1,231 were false positives.

Ultimately, the parents of those children got the right answers. But speaking as one who has lived (second-hand) through a pregnancy in which the developing child, my daughter, was wrongly identified by a prenatal test as having severe abnormalities, only to learn at birth that the “diagnosis” was a false positive, I can say with some authority that although such outcomes are happy, false positives can be emotionally and financially costly errors and not just the minor accounting hiccups with which they are sometimes equated.

Ultimately, whether widespread genetic screening’s costs to parents and children are justified by the benefits of new, generalized knowledge for society is a question that different cultures answer differently. When British and American medical experts looked at the same data a few years ago, the Brits decided there was justification to routinely screen newborns for two inborn metabolic disorders, while the American panel decided to recommend 20 and encouraged states to seriously consider an additional 22.

The President’s Council recommends that newborns be screened only for diseases for which there are effective treatments. Beyond that, it says, states should implement pilot studies aimed at assessing the real costs and benefits of screening for other conditions—participation in which should be voluntary, with informed consent.

It seems to me there is room for some leeway in the middle—for the routine inclusion of at least some diseases for which the benefits of early diagnosis are not in hand but are under development, and may come to fruition faster with better data. And I cannot at all abide by the Garden-of-Eden idea that knowledge is something humanity should fear. But while society deserves a big menu of knowledge, individuals should have the right to decide what they want to know about themselves. In that respect the Council is right to raise the question of whether newborn screening is suffering from mission creep.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

As my brother-in-law and I gazed upon the enormous, picture-perfect turkey glistening golden-brown on his cutting board last Thursday, we had the same thought—and blurted it out in near-unison: It looks just like the fake turkey that President George Bush delivered to the troops during that photo-op in Baghdad a few years ago!

Indeed, the big-breasted bird on his kitchen counter was too plump, too perfectly muscled, too marvelous to be true. And as I recalled some of what I’d learned over the years about how the once-wild American turkey came to be the magnificently mutated mass of meat that it is today, I couldn’t help but also think again about the Food and Drug Administration’s pending decision on whether to allow the marketing of foods from gene-altered farm animals.

Turkeys are not made by genetic engineering—not yet, at least. But no one can look at the modern Butterball (or, for that matter, the Amish-market free-range Amazon that my brother-in-law broasted) without facing the fact that the animals we eat today have little in common with their wild predecessors. It’s an argument that proponents of gene-altered food have made repeatedly, and one that is especially difficult to ignore on Thanksgiving: Whether by DNA manipulation or old-fashioned selective breeding, we engineer our food. Get over it.

As I’ve written before, I don’t fully buy it. But to be fair, let’s consider the turkey’s trajectory from sinewy forest fowl to succulent urban uber-bird.
The turkeys of Pilgrim’s pride were bigger than the average avian entrée of the day and so popular for special occasions, but they were small and scrawny by today’s standards. The modern turkey was not born until the 1940s, when scientists in Beltsville, Maryland, used conventional breeding to begat a definitively better bird—one whose feathers were white instead of the traditional camouflage green and brown. That took care of a longstanding aesthetic issue. When turkeys with colored feathers got processed, it turns out, the leftover roots and pigments from those feathers gave the meat a five-o’clock shadow. Understandably, that didn’t sit well with consumers.

The advent of the Beltsville White helped launch a major market for turkey meat, which in turn led to a big push for faster growth and bigger birds. Through a series of intensive breeding efforts that began in earnest in the 1980s, turkeys in the 1990s were achieving weights of about 35 pounds in as little as 20 weeks—a 40 percent improvement in heft compared to a decade earlier. Of course, that’s a trend we’ve seen in humans, too. But in this case we’re not talking about an obesity epidemic. The new birds have extremely efficient metabolisms that quickly convert feed into meat and not fat.

Today, more than a quarter of a turkey’s body weight is muscle, and most of that is breast, to satisfy U.S. consumers’ preference for white meat. The bones are oriented and muscled in ways that allow the birds to remain upright despite their teetering, cantilevered, Dolly Parton-ish proportions.

There was a price to pay, of course—for the turkey, that is. The birds’ internal organs are crammed together in what little space remains in the body cavity, which may help explain why the lifespan of a modern turkey is a fraction of what it used to be, even if it is lucky enough to get a Sarah Palin pardon. And sex is all but physically impossible, which is why virtually every turkey raised in this country today is conceived by means of artificial insemination. (I once met, in Beltsville, the guy whose job it was to get many of the semen samples used in this process. He did so by hand, using a technique that he referred to as “abdominal massage.” Suffice it to say that he did not have to call to the turkeys when he walked into a pen.)

My point is that this massive reengineering of the turkey by old-fashioned breeding is clearly more substantive than any of the changes that we might expect to occur through the insertion of a mere gene or two into a few members of the modern barnyard menagerie, such as the Aqua Bounty farmed salmon (gene-altered to make them grow faster) or the Canadian Enviropigs (gene-altered to make their manure more environmental friendly). So it is understandable, perhaps, that the FDA has taken a stance favoring the marketing of milk and meat from gene-altered animals, at least once they have passed some basic tests for safety.

The agency accepted public comments on the issue until just before Thanksgiving (virtually all of which, visible here, were negative, though for the most part not carefully reasoned), and a final decision is expected soon.

As the agency digests consumer sentiments and weighs them against the economic interests anxious to get their altered animals to market, let me just remind regulators and other readers of a few facts that should temper any decision to commercialize these critters too quickly.

1. Breeding happens slowly. Genetic combinations that result from sexual recombination and that don’t work well tend to get weeded out over time and are unlikely to get to a consumer’s mouth. That safety margin can be compromised when genes are crammed into massive numbers of creatures that are then sent on the fast-track to grocery shelves.
2. Genes can behave differently in foreign species than they do in their home turf. An experiment a few years ago involved the transfer of an ordinary gene from a bean into a pea plant. In the bean, the gene coded for the production of an ordinary, non-allergenic protein. In the foreign genomic environment of the pea plant, however, the innocuous bean protein attracted a coating of other molecules that made the protein potentially dangerous to people with certain food allergies. Such unexpected results in cross-species recombinant DNA experiments undermine the idea that genetic engineering is just like regular breeding but more precise.
3. Eating is intimate. People have emotional relationships to food. Even if the health risks to consumers and the animals themselves are low, producers and regulators would be wise to open the new agricultural approach to some degree of public inspection as a way of fostering all-important consumer trust. In other words, make the approval process more transparent than what the FDA has proposed so far.
4. Remember our far-flung food importers. Even if we in the United States decide we are okay with food from engineered animals, our trading partners around the world may not be. In fact, history has shown many of them to be more than a little queasy on this topic. Whatever cost savings may be had from a faster-growing salmon must be weighed against the potential losses in confidence and, ultimately, sales, caused by our move into what others might see as the realm of phony food.

There is an important future for engineered animals as sources of food, medicines, plastics, high-tech fibers and perhaps even organs for transplantation into people—all applications researchers are now pursuing in an array of U.S. labs. But if companies insist on working through an FDA approval process that, as currently proposed, would allow essential details to be kept under wraps forever as “confidential business information,” then they shouldn’t be surprised if they are lambasted as, well, turkeys.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

Ten years to the month after James Thomson at the University of Wisconsin announced in the journal Science his discovery of human embryonic stem cells, scientists and officials from the Food and Drug Administration gathered in Washington last week to talk about the prospects of starting the first human clinical trials of the high-profile cells.

At a public meeting hosted by the National Academies, scientists discussed results from the latest animal studies suggesting that the cells, after proper treatments in laboratory dishes, show promise for their ability to rebuild scarred cardiac muscle after a heart attack, replace lost brain cells in Parkinson’s disease, and regenerate the parts of the pancreas that go awry in diabetes. In response, an FDA official urged them to move the research onward but also noted, as gently as she could, that they could still expect to face some significant hurdles before getting a green light to try their fledgling therapies in patients.

The scientists were not taken completely by surprise about the regulatory labyrinth ahead. Most were already well aware of Geron Corp.’s repeated announcements that it was on the verge of starting the world’s first human embryonic stem cell-based clinical trial—announcements that in every case have been followed by less-loudly-trumpeted updates noting that FDA-related delays had set those start dates back. The Menlo Park, Calif.-based company, which wants to inject partially matured embryonic stem cells into the spinal cords of paralyzed people, has conducted tests on nearly 1,000 rodents, filed some 21,000 pages of data to the regulatory agency, and distributed a compelling video showing partially paralyzed mice walking again after getting the cells. But the nearly decade-long road to approval wends onward still.

It may be, one official said, that despite the promise shown in animal studies, patients with partial paralysis or Parkinson’s disease are not the ideal first subjects for embryonic stem cell experiments.

Some of the issues that stand between ongoing laboratory experimentation and eventual hospital studies are common to cell therapies of all kinds: How do you know where the cells will go once they are injected? Will they change in some way once they are in the body? How long will the cells live and what happens when they die? Will they stir up a dangerous immune response?

Other concerns are more specific to cells with embryonic origins: Are you sure they will mature into the right kinds of cells once they settle in the body? What are the odds that a few will fail to mature but rather will grow and multiply like tumors? And if there is a chance of that happening—and since tumors often take a decade or more to form—are you prepared to follow the patients for the rest of their lives, to watch for cancers or other long-term side effects?

Animal studies to date mostly suggest that cells derived from embryonic stem cells pose very small health risks if cultivated and purified appropriately before injection or infusion into the body. And the evidence for potential benefits continues to grow—albeit slowly, in part because of constraints on the funding of stem cell experiments (even in animals) under the policy promulgated by President Bush in 2001.

But despite the encouraging evidence to date, the cells are new and different enough that the FDA is opting to play it conservatively. It may be, one official said, that despite the promise shown in animal studies, patients with partial paralysis or Parkinson’s disease are not the ideal first subjects for embryonic stem cell experiments. That’s because despite their compromised condition, they can in most cases expect to live long and relatively satisfying lives. Instead, suggested FDA investigator Deborah Hursh, researchers may want to choose patients whose ailments portend “very limited life-spans.”

“We’ll let you be pretty experimental with that population,” Hursh said.

One futuristic approach under consideration by some researchers: Instead of injecting the millions of cells that are probably going to be needed to have a clinically significant effect on patients, cultivate those cells on a three-dimensional matrix to grow a solid organ or part of an organ—say the left ventricle for a human heart. Such “heart parts” would be ready to use as a unit, would stay in place once patched into the patient’s own organ, and—unlike millions of freely circulating individual cells—could be removed if need be, thus solving what Lawrence Goldstein, a stem cell researcher at the University of California, San Diego, called “the exit strategy problem” of cell-based therapies.

A number of researchers noted that there is great enthusiasm for a new kind of cell created in the past year that seems to have most of the characteristics of human embryonic stem cells but can be derived without the destruction of human embryos. But they also warned that, so far, at least, these so-called iPS cells have their own drawbacks, including genetic alterations that can trigger tumor growth and uncertainties about whether they could escape attack by a patient’s immune system, even if they were grown from that patient’s own skin cells.

“I don’t think it has been unequivocally shown” that iPS cells won’t be rejected, said Kenneth Chien, of the Massachusetts General Hospital and the Harvard Stem Cell Institute. iPS cells represent an “amazing technology,” he said. But embryonic stem cells “are the gold standard.”

One element of the stem cell research field was universally apparent at the meeting: An irrepressible sense of relief that the Bush administration, reviled by so many in the stem cell field because of its 2001 research restrictions, will soon be over. And a palpable anticipatory enthusiasm about statements by the Obama-Biden camp that it intends to lift those restrictions early in the new administration. Although the details of how that policy transition will occur remain under wraps, virtually everyone in the field expects it to result in a scientific Renaissance.

“In the end we will end up with a much better policy,” a government-funded scientist said in an interview, preferring to remain anonymous for now. “I think it will be a wonderful new era.”

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

“Personalized medicine” is the hot new buzz phrase in medicine. Why settle for diagnostic tests or therapies that were designed for the average patient, the thinking goes, when doctors can use new technology to pinpoint the specific details of your bodily biology and tailor tests and treatments to your exact medical situation?

The idea has potential and may gradually catch on as gene tests and other new technologies become more accurate and affordable. But a candid new report from the Department of Health and Human Services balances those lofty promises with a tally of the daunting challenges that scientists, doctors, patients, and insurers will face as the American healthcare behemoth tries to make the leap to the personalized medicine paradigm.

The issue is gaining importance because healthcare reform is high on the agendas of both Congress and the new president in the coming year. Proponents of personalized medicine want to make sure that whatever reforms are instituted do not undercut progress toward a more personalized future. At the same time, one can’t help but conclude, on the basis of the HHS report, that it is going to be an uphill battle to justify some of the upfront costs of the personalized medicine revolution, given the many technical, political, and educational hurdles that stand between where we are and where we want to get.

Some kind of reform is clearly needed. As HHS Secretary Michael O. Leavitt notes in his introduction to the 299-page report (a follow-up to one published a year ago), U.S. healthcare expenditures amounted to just 4 percent of the nation’s gross domestic product when he was born in 1951 but are now 16 percent of GDP and are projected to hit 20 percent by 2016—a trend he calls “not sustainable.” All told, today’s health expenditures of about $2 trillion are expected to double within less than a decade.

The core of the problem, as described in the report, is that Medicare—by far the nation’s largest healthcare payer and the standard-bearer that other insurers use as a model—bases its payouts on volume rather than on value.

Under this system, there is a positive economic incentive to deliver more care rather than better care since Medicare makes payments made irrespective of quality. Indeed, there is little or no incentive to make a proper diagnosis or choose the best treatment the first time around.

Among the many efficiencies that could be brought to this system, one shines brightest among proponents of personalized medicine: customize treatments based on individuals’ particular situations and especially on the basis of their genetic makeup. By one estimate, simply customizing the doses people get of the blood-thinning drug warfarin could save as much as $1 billion a year. The medicine is one of the most heavily prescribed in the country and can cause serious side effects if not calibrated precisely to a patient’s needs.

But there are a number of difficult hurdles to clear before we can realize that dream.

First, we must create a universally usable electronic health records system capable of managing, in a standardized way, the new kinds of genetic information that will be at the core of personalized medicine.

“At a time when information technology has transformed most other sectors, with particular benefit to the consumer, the health care sector, with its paper files, often inaccessible records, and incomplete patient data, stands out as primitive indeed,” Leavitt laments in the HHS report.

There is, at least, progress on this count. The department proposed standards for embedding genetic data and other family history information into electronic health records in 2008 and is in line to finalize those guidelines in 2009. HHS also set a national goal of getting most Americans switched over to electronic health records within five years, an ambitious if probably unrealistic aim.

But we will need a lot more than electronic records. By one account in the HHS report, patients (who are known in the lingo of personalized medicine as “consumers,” a worrisome shift in nomenclature I will address in a moment) will have to take on more of the job of keeping those records accurate and up to date with the help of “new consumer-friendly tools.”

For the most part we still don’t know when, if ever, medical professionals will understand enough of this information in a way that can really have a positive impact on people’s health or the national health care budget.

Take, for example, the time you generally spend at the beginning of a doctor visit, describing how you’re doing and giving the clues that a trained physician might recognize as medically important. That conversation “unnecessarily consumes precious time from providers,” according to a chapter in the HHS report contributed by Geisinger Health Systems. The solution? Spell out your woes to a touch-screen computer before the doctor comes into the exam room.

As it turns out, this is just one of several ways in which personalized medicine will demand a new (and rather impersonal) level of personal responsibility when it comes to health care. In fact, the hidden bomb in the word “personalized” in this new medical context is that it is going to be very much up to the “person”—that “consumer” we were talking about a moment ago—to decide how to deal with all the incoming information, including how to understand what it means and how to balance it against the economic realities of limited health coverage.

As the group FasterCures notes in the HHS report, a major hurdle for personalized medicine “is a lack of ‘genetic literacy’ among members of the general public. Informed patients are critical to patient-centered care, but as personalized medicine techniques become more sophisticated and information more complex, caregivers will face steeper challenges in communicating effectively with patients of all education levels and backgrounds.”

This education process will get even more dicey as doctors and other caregivers try to convince patents—er, consumers—to upload their personal medical information to giant databases in order to help researchers figure out what all these genetic signals really mean. “Discovery will come more rapidly if large amounts of clinical information are made available to researchers,” the report says. “The largest source of such information is ourselves,” it goes on, noting that this is one of the great advantages of getting people’s information into uniform “interoperable electronic health records”: It’s easier to suck personal data up into a data-crunching combine to speed discovery.

I did find one clause buried in those 299 pages acknowledging that “many issues, including privacy protection,” still need to be addressed.

No kidding.

Patient-consumers (or perhaps impatient consumers, waiting for that automated touch-screen to ask them where it hurts) are not the only ones who may find it difficult to adjust to the brave new world of personalized medicine. There are questions about whether pharmaceutical companies will find any economic incentive to develop medicines that are useful for only small, genetically specialized portions of the population. And then there is the looming question of how many of the countless genetic tests now under development are really going to prove themselves to be valuable at all.

As noted at a Personalized Healthcare Summit held in October, “Genetic and genomic knowledge relating to clinical outcome is missing – does value exist when these markers are used in a real clinical setting? The data don’t exist yet to guide physician action.”

In other words, for the most part we still don’t know when, if ever, medical professionals will understand enough of this information in a way that can really have a positive impact on people’s health or the national healthcare budget.

It doesn’t help that the Food and Drug Administration has opted not to regulate most gene tests, citing a shortage of resources; that HHS has so far resisted calls to create a proficiency testing program that would help ensure that test results are accurate and meaningful; or that the Medicare program for the most part does not reimburse for tests considered “predictive,” which pretty much blows the incentive to create these kinds of tests in the first place.

Health officials can say all they want to convince us “consumers” that it is empowering to take the reins of our own healthcare, but the truth is most people feel totally overwhelmed as it is and will be feeling even more so as health technology advances further. No wonder the HHS report acknowledges that the public may not be ready for personalized medicine.

“Patient education will play a prominent role in the acceptance of personalized healthcare, given that patients will need to become more involved in managing their own health portfolios….”

There’s a lot of work to be done by those designing this revolution before I’ll be waving a red flag at the barricades.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

The presidential transition, begun quietly before the party conventions, now barrels ahead at full speed. And as soon as the transition team has completed its immediate work on the two most pressing issues of the day—national security and the economy—there is good reason to believe that the nation’s science agencies and offices will get fast and close attention.

It is a truism by now that the solutions to many of the major problems facing the United States—climate change, energy, the environment, health care, and food security, among others—have major scientific or technological components. It is also widely recognized that the Bush administration’s almost allergic rejection of scientific evidence and government oversight has badly stalled the development of new approaches to these problems, as well as others in the life sciences and public health. Transition officials clearly plan to act quickly to select new heads for the agencies responsible for these interlinked issues, with an eye toward enabling coordinated efforts.

Already, the Washington rumor mill is buzzing with names of possible science appointees. I have no inside information, but to satisfy the innate human urge to give and receive gossip, I’m happy to highlight some of what I’ve heard from others. For secretary of Health and Human Services, there is talk of former Majority Leader (and CAP senior fellow) Tom Daschle (D-S.D.), who released a book in February on the nation’s healthcare crisis; Nobel laureate and former National Institutes of Health Director Harold Varmus, currently president of Memorial Sloan-Kettering Cancer Center; Howard Dean, the Democratic National Committee chairman and a family physician; and Kathleen Sebelius (D), the governor of Kansas, who made a name for herself when she successfully fought a major battle against BlueCross-BlueShield’s plan to become a for-profit company.

For FDA Commissioner, some have floated the names of Mike Taylor, a former deputy FDA commissioner with particular expertise in food safety; Mary Pendergast, who had a top post in the FDA under President Clinton and has also consulted for the pharmaceutical industry; and even Steven Nissen, the Cleveland Clinic maverick M.D. who has become a chronic thorn in the side of big pharma by repeatedly challenging the data that drug companies have used to back up their claims of safety and efficacy.

It’s been easy for scientists to gripe about their mistreatment during the past eight years. But now is not the time to demand payback.

The parlor game could go on, and it will. But what is more interesting, really, is just how many high-level science openings there are to fill. There are the cabinet-level positions overseeing such science-heavy departments as Agriculture, Energy, and Commerce. There is the surgeon general, the directors of the Centers for Disease Control and Prevention, the National Institutes of Health, and the National Institute of Standards and Technology; the administrators of NASA and the National Oceanic and Atmospheric Administration; and the head of the United States Geological Survey, the all-important research arm of the Interior department.

Within the executive office of the president alone there is the director of the Office of Science and Technology Policy and science advisor to the president (a position that many in science hope will be elevated to a cabinet level “assistant to the president” post); four associate directors of the Office of Science and Technology Policy; a gaggle of presidentially appointed members of the President’s Council of Advisors on Science and Technology; the chairman of the Council on Environmental Quality; the director and three associate directors of the Office of Management and Budget; and the administrator of OMB’s Office of Information and Regulatory Affairs, which has in recent years become an increasingly important venue for scientific review and regulation.

Now feel free to skip this paragraph—and to seek help if in fact you make it to the end—but I would be remiss not to mention as well that within the Agriculture Department alone the president needs to appoint three science-based under secretaries—for research, education, and economics; food safety; and food, nutrition, and consumer services. In Commerce he must choose an under secretary for oceans and atmosphere. In Defense he must find a director of defense research and engineering; an under secretary for acquisition, technology and logistics; a director for the Defense Advanced Research Projects Agency; an assistant secretary for health affairs; an assistant secretary for networks and information integration; a chief information officer; and an assistant to the secretary for nuclear and chemical and biological defense programs. In Education he must pick a director of that department’s Institute of Education Sciences. In Energy there are slots that must be filled for an under secretary of science; an under secretary for energy and environment; an assistant secretary for energy efficiency and renewable energy; an assistant secretary for environmental management; an assistant secretary for fossil energy; an assistant secretary of nuclear energy; and an under secretary for nuclear security.

And remember, we’re just talking about the most science-y presidential appointments here. We’ll ignore the nearly 500 others for now (but see below for a more exhaustive list).

Of these myriad positions, the most important will be the director of the White House Office of Science and Technology Policy. This is a position that has traditionally been held by a physicist, a holdover from the days when the most important thing to think about in science was the risk of a nuclear attack. Today, as the nation faces a far broader array of scientific threats, including climate change and biological warfare, it will be interesting to see if the new president breaks with tradition and appoints an earth scientist or biologist to that central scientific coordinating position.

The fruits of all these transitional decisions will take time to ripen, but here are a few questions worth asking today:

Will HHS lead a quick and effective charge to focus more on prevention, reduce the cost of healthcare and insurance, and expand coverage to the un- and underinsured?

Will FDA work together with Agriculture to revamp the nation’s food safety system? Will it demand more of pharmaceutical companies, and will it regulate tobacco?

Will EPA get back to the job of using science to calculate honestly the effects of pesticides and other chemicals on the environment and human health? Will it lead the way to dealing with climate change and stand up for endangered species?

Will DOE jump-start the transition to a low-carbon economy by aggressively funding work on alternative energy sources and promulgating strict energy efficiency standards for homes and office buildings? Will it tackle the problem of nuclear waste?

And will Interior manage, in an integrated way, the nation’s precious fresh water resources and protect public lands for we the taxpayers who together own them?

To answer these questions in the affirmative will require a government commitment to data instead of ideology, which alone would constitute a real break from the Bush legacy. But it will also require a huge corps of scientists willing to speak up, and to provide and interpret those much-needed data for the good of the country.

The National Academies put it well in their 2008 report, “Science and Technology For America’s Progress: Ensuring the Best Presidential Appointments in the New Administration”:

The nature of our current national challenges, whether domestic or abroad, demands the best of science, engineering and technology to solve. “More of the same” will not work in the 21st century. Innovative thinking will be needed to a degree unprecedented in American history. Fortunately, large numbers of scientists, engineers, and health professionals have experienced positive change throughout their careers and have been enormously successful as a result. They have much to give back. Government service is an excellent means by which to repay that debt.

It’s been easy for scientists to gripe about their mistreatment during the past eight years. But now is not the time to demand payback. Now is the time for science to put its best foot forward and show the country what it’s been missing.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Key Science and Technology Positions

Adapted from the NAS report, “Science and Technology for America’s Progress: Ensuring the Best Presidential Appointments in the New Administration”

PAS = presidential appointment with Senate confirmation

PA = presidential appointment (without Senate confirmation)

NA = noncareer appointment

FT = fixed term appointment, with length of appointment indicated

Examples of Scientific and Technical Federal Advisory Commitees, by Origin and Purpose

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

Cleanliness is next to Godliness, it’s been said. And Godliness, like a Visa card, is arguably priceless. But that doesn’t mean you can’t put a price on cleanliness. And now someone has: $1.98.

That’s how much it costs a hospital every time a health care professional fails to wash his or her hands, according to a study released last week.

A doctor fails to wash her hands after examining a patient, spreading a few germs that could seed a new infection and perhaps necessitate a round of tests and antibiotics. Kaching! Ring up, on average, $1.98.

A nurse forgets to wash up after taking a patient’s blood pressure, then moves on to the next room. Kaching! Another $1.98.

An aide removes Patient A’s food tray and delivers a fresh one to Patient B without the benefit of a handwashing intermezzo. Kaching!

Two bucks may not seem like a lot of money, but it adds up fast when you consider the thousands of interactions that can occur in a hospital every day. To be precise, it adds up to a whopping $1.77 million a year at a typical 200-bed hospital, Duke University Medical School researchers reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy, held in Washington.

Indeed, as we prepare to welcome a new administration, handwashing, I would argue, is the metaphor of the day.

The key to stemming this health care expense is simple and uncontroversial. Handwashing is highly effective. It takes less than half a minute. And one can hardly turn around in a hospital without bumping into a sink or a hand sanitizer dispenser. Yet even highly trained professionals either forget or semiconsciously cut corners with some regularity. And so do we non-medical personnel as we go about our days holding handrails and subway straps in this season of sniffles.

All of which raises the question: Why aren’t all of us—doctors and nurses especially, but all of us really—more diligent about washing our hands? Or more to the point: What would it take to make handwashing a higher priority?

As it turns out, a large number of studies have addressed that simple question, and the answers have relevance far beyond the sink. Indeed, without a stretch, they get to the very heart of human nature and, in doing so, they say something important about smart governance and policymaking on a larger scale—something worth considering as the country closes the door on an era of regulatory slumber and unencumbered greed and considers anew how to get people and institutions to behave in more socially responsible ways.

Indeed, as we prepare to welcome a new administration, handwashing, I would argue, is the metaphor of the day.

To start, let’s consider last year’s survey sponsored by the American Society for Microbiology and the Soap and Detergent Association—one in which the famed polling company Harris Interactive won the questionably attractive contract to go undercover in restrooms and observe, firsthand, what 6,076 adults actually did. It found that while 92 percent of adults claim they always wash their hands after using a public restroom, only three-quarters truly do. Other studies have found considerably lower rates, in the 40 to 50 percent range.

So the first challenge is getting people to face the problem squarely.

Here’s one way: In a 2002 study, researchers clandestinely observed whether doctors washed their hands after having direct contact with patients and confronted those who didn’t. Each offending doctor was then enrolled in an “importance-of-handwashing” educational program. When asked in followup interviews which part of the educational program was, in the doctor’s opinion, most effective in getting him or her to recommit to regular handwashing, it turned out that no part of the program had made as big an impression as the mere act of getting busted in the first place.

In short, every doctor already knew that handwashing is important. But, well, laxness happens (or “hand washing apathy,” as a 2002 research report called it). And there is nothing like enforcement—and the shame that comes with being made an enforcee— to revitalize one’s commitment to doing the right thing.

Fortunately, there are similarly effective ways of getting people to change their handwashing habits that do not involve being pulled over, cited and sentenced to a remedial hygiene class. All of us, it turns out, have the power to bring handwash scofflaws to the sink. In one study of women using a public restroom, only 11 of 28 washed their hands when they thought no one was there to see them, but 24 of 31 did so when a another woman was plainly in the room. In other words, the simple knowledge that one is perhaps being watched can cause significant changes in behavior—a truth familiar to anyone who has considered quietly reaching for the cookie jar, whether in the kitchen or on Wall Street.

A second study compared handwashing rates among women using the restroom in a bar, under two kinds of situations: when another woman was present and made eye contact and initiated a conversation, and when another woman was present but talked on a cell phone the whole time and did not make eye contact. The results were robust: Women in the first situation were twice as likely to wash their hands compared to their counterparts who thought they were being ignored, 56 percent to 27 percent.

This is not to say that handwashing or any other single behavior can singlehandedly (as it were) eliminate hospital-acquired infections, which affect up to 2 million Americans each year and kill an estimated 100,000. And some parts of the solution may come from other, unexpected places.

A 2004 study at a teaching hospital in New York, for example, found that about half of all neckties worn by doctors harbored disease-causing bacteria—a prevalence five times greater than for ties worn by other hospital staffers who had no contact with patients. No one knows if neckties really contribute to the spread of disease inside hospitals, but statistics like those led the British Medical Association in 2006 to recommend that doctors “refrain from wearing functionless pieces of clothing, such as ties” (and has helped launch renewed interest in bowties, which give doctors the professional look they want without flopping from one germy patient to the next).

Financial incentives can obviously help, too. In October, the federal Medicaid and Medicare programs announced they would no longer reimburse hospitals for the treatment of infections caused by those hospitals. No more sugar daddy picking up that $1.77 million tab.

All told, however, the lesson for anyone trying to encourage best practices, whether they are hospital administrators or government regulators, is that at least as important as making smart policy changes—fixing the “neckties” in the system—is creating a system that is truly transparent and that includes a real threat of enforcement, something there has been precious little of during the Bush administration.

A few plain-clothed observers could go a long way toward cleaning up the worlds of government and finance. No doctor, no mortgage derivatives trader, no recipient of a big defense department contract wants to be seen doing the perp walk to handwashing class.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

In the political turmoil that devastated Latin America in the 1970s and 1980s, tens of thousands of adults were abducted and killed by paramilitary forces, and many of their children were “adopted” by wealthy adults affiliated with the government or the military. The task of reuniting these young victims with what remained of their families seemed impossible in the decades that followed. Impossible, that is, until scientists joined with human rights activists and developed sophisticated genetic tests that could link the youngsters with their surviving grandparents.

In a similar collaboration, experts with Physicians for Human Rights helped unearth hundreds of bodies from mass graves in the Srebrenica region of Bosnia and used their skills in pathology, radiology, and forensic anthropology and archaeology to document war crimes that had been committed there in 1995. The work built on the group’s earlier efforts in Croatia, where it collected scientific evidence that led the International Criminal Tribunal for the former Yugoslavia to indict Yugoslav Army officers for the mass killing of hundreds of hospital patients.

And in Darfur, where raping and pillaging janjaweed gunmen have repeatedly overrun villages, activists at Amnesty International last year arranged to have commercial satellites focus on a dozen villages deemed at high risk of attack. The organization invited people around the globe to keep an eye on the targeted areas, and informed Sudan’s president that the world would be watching for human rights abuses. Today those villages remain intact, perhaps the first ever to be protected by global, technology-enabled citizen policing.

These are among a growing number of cases in which technologies developed for routine scientific and medical uses are finding unexpected application in the shrouded world of genocide, torture, and political oppression. In addition to fostering the rule of law around the globe, the collaborative programs are reenergizing experts from both specialties—giving human rights activists the objective tools they’ve long needed to strengthen their cases against those who violate international law, and at the same time rewarding scientists and doctors with the knowledge that their skills are being used for a greater good.

“We can make it harder for people to get away with these crimes,” said Ariela Blätter of Amnesty International USA’s Center for Crisis Preparedness and Response.

Human rights work is inherently political, and scientists often chafe when it comes to adding layers of political interpretation to their basic objective findings.

Blätter was one of a half-dozen experts in science, medicine and human rights who told their stories at an event last week sponsored by the American Association for the Advancement of Science. The Washington-based general science organization has a Science and Human Rights Program that has long sought to foster synergy between the two fields. Last week it launched the latest of those efforts: an “on-call scientists” database to facilitate the matching of appropriately skilled scientists with human rights organizations that could use their help.

Sometimes all that is needed of scientists is a means of showing the world what has happened—through land- or satellite-based photographic images, for example. In a growing number of cases, commercial satellite images are not only providing important legal evidence but, equally important, they are evoking pangs of compassion from a world that at times seems all too willing to ignore rights abuses.

In one case, a simple pair of before-and-after pictures taken in Zimbabwe resulted in a huge outpouring of outrage and calls for justice, Blätter said. In the first picture, a village is intact. In the second, 850 homes have been destroyed in an apparent act of political punishment by an oppressive regime—an act that left thousands of residents homeless and violated international law.

“It’s the ‘seeing is believing’ concept on steroids,” Blätter said.

Scientists and human rights workers are products of very different kinds of training, and the gradual integration of the two communities—a delicate pas de deux that AAAS geographer Lars Bromley called “flirting, dating, and then marriage,” —has not been easy. For one thing, human rights work is inherently political, and scientists often chafe when it comes to adding layers of political interpretation to their basic objective findings.

Yet many are warming to the idea that they can have a role in advocacy. Chris Beyrer, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, said he has been working with the DC Prisoners’ Project to assure that prisoners’ healthcare rights are not violated while they are incarcerated—a commitment that he said has added a lot to the satisfaction he gets from his work.

Unfortunately, as a matter of public policy, there are few mechanisms in place to foster such collaboration between scientists and human rights workers, and there are a fair number of obstacles that need to be lowered, especially in the arena of federal rules and procedures. Indeed, given the current administration’s legacy with regard to secret extraditions, abridged rights of accused terrorists, and the rewriting of rules relating to torture, most human rights organizations at this point consider the U.S. government a less-than-welcome partner. But that does not mean there is no role for federal dollars or federal policy-making bodies in the fight for human rights at home and around the world.

Beyrer recounted the hassles he faced when he sought to initiate a study in which DC prisoners’ attorneys were to be recruited, without the jail’s knowledge, to gather information about how their clients’ healthcare needs were being met. Since the study would involve human beings, it had to pass muster with the Johns Hopkins institutional review board, which is charged with the protection of human subjects in research. Thinking conventionally, the board wanted evidence that the prison had signed off on the project.

It took some “educating” to convince the board that secrecy was the whole point, Beyrer said. In other human rights cases, IRB’s have had to adjust to the idea that anonymity is sometimes crucial to getting at the truth. As a matter of policy, it may be that the rules that typically govern federally funded research will need to be reinterpreted to more easily accommodate this important class of work.

Similarly, when U.S. government investigators do show up at scenes of suspected human rights abuses abroad—in many cases, it’s the military that arrives—they often dominate the crime scene and compete, rather than cooperate, with nongovernmental human rights groups that also are there, panelists said. And while the quality of the government’s science may be good, the military’s approach to such investigations tends undervalue the emotional context of the crimes being investigated, including the importance of helping families gain possession of their loved ones’ remains for proper burial, said Susannah Sirkin, deputy director of Physicians for Human Rights, adding that a little training in this regard could buy the government a lot of good will.

Finally, because research relating to human rights violations does not fit cleanly into the primary funding silos through which federal grant money flows, there is no obvious source of support for scientific studies of human rights issues. There is no institute within the National Institutes of Health that explicitly focuses on the topic, nor is there a branch of the National Science Foundation that is a natural fit with human rights concerns.

IRB policies, on-site investigator behaviors, and funding channel scopes are not written in federal stone. It would be a powerful first step down the road of global justice if, as the next administration’s new agency heads parse their 2009 policies and budgets, a few of these procedural wrongs could be righted.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

Looking for a scientific good time this weekend? Consider joining the festivities at Fusionopolis, the futuristic research complex that’s having a week-long grand opening celebration on the tropical island of Singapore.

Fusionopolis is more than a place to work. It is a planned community for scientists, complete with high-tech research labs, high-rise apartments, and high-end entertainment venues, including a rooftop swimming pool and fitness center, restaurants, experimental theater, and 13 elevated “sky gardens.” Visitors to the spanking new complex this weekend will find themselves entertained by dancing robots, wind-turbine displays and cool chemistry demonstrations—all honoring Singapore’s latest step toward fulfilling its ambition of becoming an economic powerhouse through science, technology and innovation.

Singapore, of course, is a very different place than the United States, with a much higher degree of central control over science priorities and economic strategy. Fusionopoli are not likely to sprout like ethanol refineries in the U.S. Midwest, even though they would look pretty cool there.

But the island nation’s development goals are actually very similar to those that scholars and domestic policy advisors around the United States are espousing here at home: to support the development of novel technologies that can solve our energy, environment, telecom, and infrastructure problems while simultaneously jumpstarting the economy with a new wave of “green collar” jobs.

So as different as the place may be from America politically and culturally, there is something about the way Singapore is tackling its economic challenges through big investments in science and technology that deserves attention from Washington insiders and the American public.

Crumbling are the walls between basic and applied research, public and private research, and even (for better or worse) recreation and work.

The science buildings at Fusionopolis house government-funded as well as corporate labs that focus on materials science, communications technologies, microelectronics, and high-performance computing and manufacturing. Architects designed the structures explicitly to facilitate interactions among the 800 researchers who will initially be working in them (a number that’s expected to grow to 2,400 by 2012, when additional construction is complete). Among the initial corporate tenants are Vestas, a leading wind turbine company; Ubisoft, one of Europe’s largest electronic game publishers; Linden Lab, the creator of the popular virtual universe Second Life; and Nitto Denko, the Japanese electronics and advanced materials company. Also among the tenants are two government-sponsored engineering research institutes and the “Advanced Digital Sciences Center,” the first overseas research center to be launched by the University of Illinois at Urbana-Champaign.

But the theme of advancement through collaboration goes well beyond the corridors and catwalks connecting those public, private and university labs. The community itself, including the living quarters and public spaces, were designed to be “test beds” for some of the new technologies being developed in those labs—all part of the “work-play-live-learn” environment that Fusionopolis strives to be.

The supermarket chain Cold Storage, for example, plans to test its “intelligent shopping cart” at its Fusionopolis outlet. Chips embedded in the carts can identify the shopper and his or her programmed preferences and, based on that shopper’s location in the store, will project targeted ads on a cart-mounted monitor and guide the shopper to desired products.

Even the homes are set to become research labs of sorts, where novel wireless security and entertainment systems will be installed for real-life beta testing.

Moreover, the complex is just half a mile from Singapore’s Biopolis, a similarly Flash Gordon-like complex of labs and living spaces focused on biomedical, rather than engineering, research. I had the opportunity to visit the Biopolis a few years ago, where hundreds of scientists in more than a dozen publicly and privately funded laboratories work and live an intellectually and entrepreneurially intense—if somewhat nerdy—existence. The idea, in part, is that if you concentrate enough of a nation’s greatest minds in a few rather sterile but well-funded acres, some of the best solutions to the next century’s problems may emerge from chance encounters at the local Starbucks or sandwich stand.

Late last week I got in touch with Charles Zukoski, a professor in the department of chemical and biomolecular engineering at the University of Illinois, who also chairs the Science and Engineering Research Council of Singapore’s Agency for Science, Technology and Research. I reached Zukoski in Singapore, where he was attending some of the celebratory events (which included, to the organizers’ great credit, fun science events for families and kids), and I asked him to describe the scene at Fusionopolis.

“There are a lot of people in the elevators and in the research facilities,” he said. “The computer facility is up and fully operational as are the visualization facilities of the institute of High Performance Computing.” All of the corporate spaces have been rented out, he said, and “you can hear the clank of construction” nearby, where the second phase of the complex is under construction.

“There is a lot of science going on,” Zukoski said. “My sense is one of great excitement and expectation.”

The Science and Engineering Research Council that Zukoski chairs oversees a number of government research institutes focusing on various areas of engineering and technology. Unlike the system in this country, in which most of the government’s research expenditures are funneled through academic centers, these major research initiatives are not related to that nation’s Ministry of Education. Rather they are explicitly geared toward growing the Singapore economy.

“We look at ourselves as being placed between universities and the private sector,” Zukoski said. “We harvest and develop ideas that will lead to commercial products and develop these ideas into commercializable units on our own, or in collaboration with the private sector.”

The approach goes far beyond the trend toward “multidisciplinary research” that has started to become popular in the United States. Not only are the old “silos” that once separated various research specialties being broken down. Also crumbling are the walls between basic and applied research, public and private research, and even (for better or worse) recreation and work.

“The opening of the Fusionopolis represents the physical embodiment of a new approach to doing research,” Zukoski said.

Again, it is not an approach appropriate for direct transplant to the United States. Compared to New York and Los Angeles, Washington’s suburbs are already a little short on culture and rife with people out of step with fashion. All Bethesda needs is to have its restaurants and concerts attended by people in lab coats and pocket protectors.

But how refreshing it would be if, in our own American way, we as a nation also focused on investment in technological innovation as a central strategy for reversing our economic decline. Consider this: Singapore’s $4.2 billion investment in research and development in 2007 was 26 percent higher than it was in 2006, and twice the amount invested in 2000. The nation is quickly approaching its goal of having R&D expenditures amount to fully 3 percent of it gross domestic product by 2011.

By contrast, R&D spending in the United States has been flat for years, at just 2.6 percent of GDP. That’s higher than the European Union (1.8 percent) and China (1.4 percent), but embarrassingly less than Japan (3.4 percent) and South Korea (3.3 percent) according to figures compiled by the American Association for the Advancement of Science.

In fact, as of this year, it appears that Singapore has surpassed the U.S. in R&D spending as a percentage of GDP. Singapore has said very plainly that it is betting its future on growing “a knowledge-based, innovation-driven economy.”

We in the United States could do worse.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

The top 10 pharmaceutical giants spent an average of $1.25 billion each on advertising alone last year—a huge tab that we consumers pick up every time we fill a prescription. But even more worrisome than the inflationary pressure those glossy ads are placing on America’s healthcare system are the misrepresentations and flat-out lies found in so many of them.

That’s a world of deception rarely glimpsed by the public, but one that occasionally comes to light when the Food and Drug Administration releases on its website copies of its latest warning letters sent to drug companies for false advertising. One such batch was released last week, and it offers an enlightening, if depressing, view of the game of cat-and-mouse constantly underway between Big Pharma and our underfunded federal watchdogs.

Consider the FDA letter sent to Forest Laboratories in New York, regarding a medical journal ad for that company’s blood pressure-lowering beta-blocker drug, Bystolic. There are many beta blockers on the market, but the ad calls Bystolic “a novel beta blocker” and a “next generation beta blocker” with a “unique mechanism of action.” In its letter, the FDA notes that anyone who reads such phrases would likely conclude that Bystolic is superior to other beta blockers. There is just one problem: That’s never been shown, or even tested, in a study.

“FDA is not aware of any substantial evidence or substantial clinical experience that demonstrates that Bystolic represents a ‘novel’ or ‘next generation’ beta blocker,” the agency letter states. “Indeed, we are not aware of any well-designed trials comparing Bystolic to other beta blockers. Furthermore, FDA is not aware of any data that would render Bystolic’s mechanism of action ‘unique.’”

In fact, the FDA notes, no one even knows yet how beta blockers really work.

Well, it turns out that one of Straterra’s risks—a risk that has earned it a “black box warning” on its package insert, the most serious warning a drug can be required to have—is that it can get children and adolescents to consider suicide.

The ad also “minimizes risks associated with the use of Bystolic,” the letter goes on. Specifically, the ad boasts a “favorable tolerability profile” (one wonders: Is this the best that Forest Labs can offer? A drug that is “tolerable”?), when in fact, according to the FDA, Bystolic “is associated with a number of serious risks,” including heart failure and liver damage, and there is no evidence that it is any less risky than competing beta blockers.

“If you have data to substantiate these claims, please submit them to the FDA for review,” the agency writes with pointed cordiality.

The last paragraphs, aimed at the company’s lawyers, don’t beat around the Bystolic bush. Your ad, they state plainly, violates 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(i); and e)(6)(ii). Stop running it. Now. And, because the violations are “serious,” submit to FDA an action plan “to disseminate truthful, non-misleading, and complete corrective messages … to the audience(s) that received the violative promotional materials.”

Another FDA letter made public last week, this one to Eli Lilly & Company in Indianapolis, takes that company to task for the “professional sales aid” it produced for its drug Strattera, which is for attention-deficit/hyperactivity disorder (ADHD)—a sales aid that, according to the agency, overstates the drug’s efficacy, minimizes its risks, and wrongly suggests it is useful against a broader range of ailments than the facts can support.

One of those lapses cited by the FDA is especially disturbing: The sales materials give “the overwhelmingly misleading impression … that Straterra has been proven safe and effective for the treatment of anxiety.” What’s the big deal about that? Well, it turns out that one of Straterra’s risks—a risk that has earned it a “black box warning” on its package insert, the most serious warning a drug can be required to have—is that it can get children and adolescents to consider suicide. And guess what? Anxiety, too, has been associated with a higher risk of suicidal thoughts. In other words, the FDA notes, the materials from Lily could lead a doctor to prescribe Strattera, a drug that increases the risk of suicidal thinking, to anxious children, who are already at heightened risk of heading down the path toward suicide.

The Lily sales aid also suggests that Strattera will help kids fall asleep better, without also noting that it can cause insomnia. And it says that the abdominal pain, stomach upset, nausea, and vomiting that affect many patients who take the drug are “commonly transient,” even though, in the words of the FDA, the agency “is not aware of any data supporting the claim that these adverse events are transient in nature.”

“If you have such data, please submit them to the FDA for review,” the letter goes on—a phrase one sees a lot, it turns out, in FDA letters to drug companies.

I could go on. And you know what? I think I will. Let’s look at the latest letter to our friends at Novartis Pharmaceuticals in East Hanover, N.J., about promotional materials developed for its ADHD drug Focalin XR. Here again is a drug with a black box warning, in this case because of the risk of addiction (not to mention a long list of other risks, including “sudden death”). The materials state that “improvements are sustained over 6 months.” But in fact, the FDA notes, the effectiveness of Focalin XR has never been systematically studied for any length of time beyond seven weeks.

So Novartis is pushing for long-term use of a drug whose proven benefits don’t go beyond a few weeks and whose major risk for patients is that it is very addictive.

Who cares if it works longer than seven weeks? Addiction means never having to stop renewing your prescription.

Then there is the letter to Mallinckrodt Inc. of St. Louis, Mo., regarding its patient brochure for Methylin, the company’s drug for attention deficit disorders. The agency notes a number of problems, including unsubstantiated claims of efficacy. But the easiest to appreciate is this one: “The patient brochure presents efficacy claims in consumer-friendly language using colorful, bolded headers and bulleting but presents risk information in medical terminology in paragraph form below the reference list … without any presentation elements that indicate to the reader that it is important risk information.”

Here’s a great idea for some of you artists out there looking to make a statement: Design a full-color drug brochure using all those bold and colorful elements to describe the side effects, and then put all the purported benefits in fine print at the bottom.

And just to be fair (I don’t want you to feel left out, Johnson & Johnson!) a quick shout-out to the good people at J&J in Fort Washington, Pa. They, too, have an ADHD drug on the market, one called Concerta, which also carries a black box warning about addiction. The problem in this case: In a series of informational panels aimed at professionals at medical conventions, Johnson & Johnson suggests that the drug can help kids enjoy after-school activities including “sports, clubs, part-time jobs, socializing with friends, household chores, and, of course, homework.” Oops, the FDA letter notes: “This has not been demonstrated by substantial evidence.” In fact, the agency notes, Concerta has been shown to reduce only a limited array of symptoms, such as fidgeting and talking excessively, and has never been tested for its after-school activity benefits. Moreover, the letter says, the company’s educational panels omit important information about Concerta’s risk of causing long-term growth suppression.

So maybe your kid ends up a little shy of five feet tall. At least he’s not fidgeting anymore.

The good news, of course, is that these letters were written and sent. And that we get a chance to see them—a rare bit of transparency for an agency that is required by law to do much of its work in secrecy, to protect “confidential business information.”

The bad news is that one can only believe that these regulatory efforts are capturing but a tiny percentage of the total deception going on out there. And like a judge telling a jury to ignore evidence that it should not have heard, it all happens too late. How many patients and doctors have already been influenced by the bold twists of truth highlighted in the agency’s most recent batch of letters?

“By the time the FDA issues a warning letter,” complains John Mack on his Pharma Marketing blog, “the cow has long left the barn.”

And they just keep coming. Last Thursday, Ad Age reported that Bayer Healthcare Pharmaceuticals was told by FDA to pull a couple of 60-second ads for its birth-control pill Yaz, which the agency said misleadingly indicated that the drug was useful against premenstrual syndrome and acne. Well, at least one of those ads had already been pulled by then. But the airwaves can’t be recalled. And the checks to Bayer are already in the mail.

Obviously, the system for catching and punishing these crooks needs to be ramped up. The odds of getting caught, and the pain of occasionally getting nabbed, are not providing sufficient deterrence.

Is there a better way? Let me make a modest proposal: For each ad found by the FDA to be false or misleading, pharmaceutical companies must create and promulgate another, equally circulated ad, seriously badmouthing its own drug. As an example, I refer you to this side-splitting Saturday Night Live spoof on Seasonale, a birth control pill made by DuraMed Pharmaceuticals of Pomona, N.Y., which works by reducing the frequency of women’s menstrual periods. (Hat tip to Tara Parker-Pope.)

Maybe with a mix of humor and painful honesty, we can get back to a world in which taking your meds isn’t the same as drinking the Kool Aid.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Likewise for other agencies of the public health service and the many government entities in the business of making healthcare delivery more efficient and humane. All deserve a call-out, and it does not stop there. As long as we are looking at priorities, let’s not forget our non-biological brethren: Especially notable are the resource-strangled scientists affiliated with the National Science Foundation, the Department of Energy’s Office of Science, and the National Institute of Standards and Technology. All three were in line for a five-year doubling of budgets starting two years ago, but none has seen a penny of that promised increase because of repeated last-minute budget woes and delays. Scientists in these agencies are among those most likely to come up with solutions to many of our most pressing non-medical problems, in particular our need ramp up production of energy from renewable sources.

Of course, after a point, the call for more money starts to sound hollow. Who doesn’t need more of it? My own 401(k) could use a federal bailout this week. But the common thread here is that this administration and, alas, this Congress as well, have failed to appreciate that an investment in science is exactly that: an investment, and not a mere expenditure. How do we think we are going to deal with climate change, rising energy costs, environmental degradation, food security, and water shortages, not to mention the challenges of national security? I can tab through my daughter’s Middle School notebook for options: English? Hardly. Algebra? I doubt it. World Studies? Well maybe if it helps me pronounce “Ahmadinejad.” Band? Play on! But here’s something promising: Science!

For those wondering where we can find the necessary cuts to help fund this rejiggering of priorities, I promise you there are plenty of juicy offsets just waiting to be found by sensible budgeteers as we make the transition to a new administration—some of them even “sciencey” (can we talk missile defense?). But as every card player knows, never underbid your strong suit, and science is one thing that the United States knows how to do. There are times when you need to ante up despite feeling pinched. Now is one of those times.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

The housing market wasn’t the only bubble to get pricked of late. Consider the budget for the National Institutes of Health, the primary source of funding for U.S. biomedical researchers. It, too, has recently had the rug pulled out from under it. And while the negative impacts may not be as obvious or immediate as the fallout from the housing, credit and stock market crises, the repercussions of this pound-foolish parsimony promise to be massive.

Recall that between 1998 and 2003 the NIH budget underwent a long-overdue expansion. In a remarkable act of bipartisan solidarity—and reflecting a broad appreciation that biomedical research is both an economic pump-primer and the best first step to conquering diseases—Congress doubled the agency’s budget over those five fiscal years.

Even more important than bolstering the work of hotshot scientists across the country, the move opened the doors to a new generation of young researchers with fresh ideas and enthusiasm. Laboratories grew. Scientists launched ambitious projects. And American leadership in the biomedical sciences seemed assured well into the future.

Then, immediately following that enlightened surge, something strange happened. It all stopped. The money dried up. Through the fiscal 2004, 2005, 2006, and 2007 budgets—and again this year in 2008—the NIH was flat-funded. And despite a rising tide of concern, it looks like the same fate will recur in 2009.

A higher and higher percentage of grant proposals—more than 80 percent at last count—now go unfunded.

In fact, Congress last week passed a continuing resolution to keep the Department of Health and Human Services (of which NIH is part) operating for the first five months of fiscal 2009, which began October 1. Within that legislation is an NIH research budget that, once again, is flat-out flat.

But it is worse than that. Because as everyone who has tried to keep up with rising food prices knows, flat is not flat at all. Modest increases would be needed simply to keep up with inflation. And the inflation rate for research is higher than it is for the general economy. So for all its so-called flatness, the NIH research budget has actually now dipped to an inflation-adjusted level about 13 percent less than it was five years ago, according to the American Association for the Advancement of Science.

The impact has been insidious. For one thing, a higher and higher percentage of grant proposals—more than 80 percent at last count—now go unfunded. This in turn has a perverse effect not only on the research pipeline but also on the careers of countless scientists who, during those halcyon millennial years, were wooed into the fraternity of experimentation and discovery.

Like cars hitting their brake lights on the Washington beltway as they come upon a rush-hour traffic jam, scientists who have just gotten up to speed on projects taking aim at humankind’s greatest causes of suffering—diabetes, Alzheimer’s, cancer, and infectious diseases—have had to stop what they were doing, scramble for temporary funding from their universities or research institutes, and in many cases start looking for other work. For those who stick with it, as postdocs or other underlings laboring in the low-paid laboratorial labyrinth, the years tick by with little in the way of rewards.

The average scientist today does not win a first federal research grant until he or she is nearly 42 years old. In 1970, that age was 34.

The implications of this recession go deeper yet. Think about which grants are most likely to be funded in such a situation: The ones that are most likely to pay off. Meaning, the ones that are in many cases the least imaginative, and the most derivative.

“People don’t take as many risks,” says Jerry Chi-Ping Yin, a researcher at the University of Wisconsin-Madison, one of many scientists to decry the current situation in a report from earlier this year, “Within Our Grasp—Or Slipping Away?” compiled by a group of universities and research institutions. “You can’t afford to swing the bat and miss too many times.”

Meanwhile, that report notes, other countries are increasing their investment in science. Singapore recently announced it was doubling its national biomedical research budget, and has taken explicit aim at hiring U.S. scientists away.

The corridors of scientific institutions are rife with anecdotes of promising young researchers changing tracks and moving on to other careers. “She’s decided to go to law school!” is the common refrain, in semi-mock horror. But the downstream effects are no joke.

“You can lose a generation of researchers pretty fast—in five or ten years,” Joshua Boger, founder and chief executive of Vertex Pharmaceuticals and chairman of the Biotechnology Industry Organization, says in another report, also released earlier this year: “A Broken Pipeline? Flat Funding of the NIH Puts a Generation of Science at Risk.”

“You create such a discouraging atmosphere,” Boger says, “they just go somewhere else instead of academic research. We don’t have to lose 50,000 researchers, just 50 really good ones. Once it happens, we won’t get those people back.”

And of course, just as it is homeowners who will ultimately pay the price for the housing bubble, it will be the everyday owners of bodies—each and every one of us and our children—who will pay the price of the NIH funding deflation. Take it from Nancy Andrews, Dean of the Duke University Medical School, in the Pipeline report:

“People who have diseases that five or ten years from now should be curable are going to have to wait a lot longer,” Andrews says. “The knowledge is there, and we have the people who know exactly what to do to study the things that turn into cures. But they don’t have the funding to do it.”

On Friday Congress promised up to $700 billion for Wall Street. The entire NIH budget is (and for years has been) less than $30 billion. As our intrepid legislators scatter for their home states, perhaps some janitorial broom-jockey, sweeping up the Capitol building’s marble floors, will find a scattered two or three billion dollars on the floor and send it on to Bethesda, to buy the American people, and the world, a healthier future.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

I was in Madison, Wisconsin, last week at the 2008 “World Stem Cell Summit,” a gathering of hundreds of scientists, pharmaceutical company reps, patient advocates and policy folks united in their evidence-based faith that stem cells are going to revolutionize biology and medicine.

I’ve been to a fair number of stem cell meetings over the years, but this one was remarkable in several respects. For one, it was held in Madison, where Jamie Thomson and his colleagues first discovered and isolated human embryonic stem cells ten years ago this fall. So it was something of a decadal celebration and homecoming for the Wisconsin team. Go badgers!

For another, there was a palpable sense that the United States is fast approaching the end of the Bush administration, reviled by advocates for the restrictions it has maintained on embryonic stem cell research funding. In short, there was a lot of “good riddance” buzz in the air and equal measures of conjecture and concern about what stem cell policies will emerge in the next administration.

Third, I have never seen so many people in wheel chairs at a stem cell meeting, an indication, it seemed, that patients are getting more uppity about gaining access to the first experimental therapies that may soon be tested in clinical trials.

And finally, most striking and no doubt related to that third point, there was an extraordinary and, in my experience, unprecedented focus on the commercialization of stem cells for research and therapy—a sign that stem cell science has achieved a certain level of maturity despite the endless ethical and political debates that have hobbled progress since the field’s inception.

Jamie Thomson was the star attraction, closely watched not only because of his stature as the founder of the field but because his lab was one of two that recently transformed adult human skin cells directly into cells that seem virtually identical to human embryonic stem cells—so-called iPS cells. That has suggested the scientifically and politically tantalizing possibility that embryonic stem cells themselves—controversial in some circles because their derivation requires that five-day-old embryos be destroyed—may before long become irrelevant.

But Thomson said it makes no sense to drop studies on embryonic stem cells on the presumption that iPS cells will satisfy all of scientists’ and patients’ needs. For now, he said, both approaches deserve full-bore exploration.

Their “Where do I sign up?” spirit was reminiscent of the early days of the AIDS epidemic, when angry patients ultimately forced the FDA to give them access to AZT and other experimental drugs.

“I personally believe the future is in these iPS cells, but the future isn’t quite here today,” Thomson said. “If they’re identical to embryonic stem cells, then everything we’re doing with embryonic stem cells today will apply directly to these new stem cell lines. If they’re fatally flawed in some way, not clinically relevant, then everything we’re doing with embryonic stem cells will apply to embryonic stem cells and we won’t waste any time.”

His comments were in sync with the conclusions of a National Academy of Sciences panel that earlier this month declared: “It is far from clear at this point which types cell types will prove to be the most useful for regenerative medicine, and it is likely that each will have some utility.”

Former Wisconsin governor Tommy Thompson, who served as secretary of Health and Human Services in the early years of the Bush administration, was there as well, telling a never-told-before and perhaps only partially believable story that it was he who singlehandedly convinced Bush to allow at least some funding for the controversial work.

But to my ears, the most interesting talks—whether inside the meeting rooms or around the coffee urns and cupcakes during breaks—were about how and when the long-suffering research specialty will at last lose its virginity and get Food and Drug Administration approval for testing in people. And how and when, in the aftermath of those clinical trials, the field will graduate to a full-blown, commercially viable, and medically useful subspecialty of medicine.

None of this is going to happen tomorrow. But the seriousness of the prospect was ineluctable.

Among the strongest evidence for real pending change was a talk by John McNeish of Pfizer, the pharmaceutical giant, who revealed details about that company’s newly founded regenerative medicine unit, which will focus largely on stem cells. Although the company plans to use stem cells initially as laboratory tools to test the safety and efficacy of experimental drugs, it and a smattering of other big players, including GlaxoSmithKline, are starting to see an economic future in stem cell-based therapies. Many at the meeting spoke unabashedly about the need to move on to human testing.

“We’ve almost worn out what we can do with animals in disease biology such as fruit flies and mice,” said Lawrence Goldstein, a stem cell researcher at the University of California, San Diego. “The problem at the end of the day is that humans are not just big mice.”

Geron Corp. of Menlo Park, California, has been saying for years that it will soon start what would be the first human studies of an embryonic stem cell therapy—one for people partially paralyzed because of spinal cord injuries. Approval has been put off repeatedly by the FDA for reasons that have not been released. Several experts at the meeting said they suspect two main issues are in play: A desire by regulators to be as certain as possible that Geron’s cells will not, even in rare instances, cause tumor formation (a fear that can never be 100 percent allayed but which has led to demands that the company test the treatment in an ever-growing number of rodents); and perhaps a preference among regulators to launch the first stem cell clinical trial not in patients who, despite being paralyzed, can be expected to live long and reasonably productive lives, but in patients with terminal conditions—just in case the treatment proves worse than the disease.

Comments from some of the attendees in wheelchairs made plain that they had a different perspective. Their “Where do I sign up?” spirit was reminiscent of the early days of the AIDS epidemic, when angry patients ultimately forced the FDA to give them access to AZT and other experimental drugs. That chapter of medical history tested the U.S. regulatory system—and the nation’s conscience—as officials struggled to find a balance between their conventional, paternalistic protectionism and the patients’ hyper-libertarian view that people have the right to risk their lives as guinea pigs no matter how slim the chances of success or how high the chances they will be harmed.

Already, a growing number of patients suffering from a wide range of ailments are traveling to India, China and other less-regulated countries to throw the dice with experimental stem cell therapies. As evidence of potential efficacy amasses here at home, it will be a challenge to thread that therapeutic and regulatory needle and ethically speed access to those patients most likely to benefit—or at least to those most willing to take the gamble.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

All victories in Washington are temporary, the pundits say. And if the publishers of scientific journals have their way, then that truism will rise up and save them in the waning days of this Congress.

The publishers, you see, were the losers earlier this year in a long-running battle over what is known in the scientific publishing industry as “open access.” But they’ve been quietly building a legislative Phoenix that they hope to ride to victory this year.

Proponents of open access argue that the results of taxpayer-supported research should be made available on the Web for free within a year after those results are published in journals—sooner if possible. Federal tax dollars paid for the research, they argue, so why should taxpayers have to also buy expensive subscriptions to scientific journals to get the results of those studies—especially when those results from, say, scientists funded by the National Institutes of Health, might help them learn more about a disease they or a family member may have?

On the other side, publishers argue that a policy demanding that results be made widely available for free would undercut their subscription base and their economic viability. Such an approach, they say, fails to appreciate the “value added” they provide by financing the peer review and publishing processes. And they fear that it sends the wrong signal about the importance of copyright protection at a time when the nation should be strengthening, not weakening, the enforcement of intellectual property laws.

In April, building on supportive appropriations language passed by Congress, NIH implemented the policy that it and consumer representatives wanted. It demands that researchers getting NIH funds submit copies of their accepted-for-publication manuscripts to a website that will make those details publically accessible within 12 months after publication.

Game over.

But of course, not.

Proponents of the open access system are equally adamant—and furious that the publishers are trying a legislative end run.

In Terminator-like fashion, it turns out that the publishing industry has come back from the near-dead and helped get new legislation offered up in the House that would effectively undo the NIH policy. The “Fair Copyright in Research Works Act” (HR 6845) would change copyright law to make it illegal for a government agency to demand that grantees hand over their published results for free if either of the two following conditions were met: If anyone other than federally funded researchers was involved in the project (which means virtually all research, since it is rare for federally funded researchers to work alone in these days of multicenter and public-private collaborations) or if any third party added value to the published product—say, by putting the manuscript through an independent peer review process, as happens with virtually all published scientific papers.

The bill was introduced by Rep. John Conyers (D-MI), and by most accounts has no shot at passing in the final stretch of this congressional session. But its language could conceivably be covertly tacked onto other legislation in the term’s final rush.

It deserves to pass, according to Allan Adler of the Association of American Publishers. Among his arguments: The current policy never got a proper review before congressional passage he says. It ignores other working models of open access such as those used by the National Science Foundation that are more flexible and less onerous on the industry. And it forces publishers into an untenable business model. It is the journals, after all, that pay for the independent peer review process, Adler says, which helps everyone trust the results that eventually get published.

Proponents of the open access system are equally adamant—and furious that the publishers are trying a legislative end run. They note that publishers typically pay nothing to expert peer reviewers. Indeed they note, many, if not most, peer reviewers are academics who take time off to read and judge submitted manuscripts—and whose salaries are paid by federal grant money. More proof, they say, that the public is owed free access to the data.

Perhaps their strongest argument is that the system is working. Last year, when NIH had a voluntary policy in which funded researchers were encouraged but not required to submit their accepted manuscripts for pubic access, only about 4 percent of the 80,000 articles published annually in which at least one author was NIH-funded was submitted. Since April of this year, when the policy became a mandate, the numbers have soared to higher than 50 percent, and the rates are increasing every month as scientists get accustomed to the process (which NIH officials say takes about ten minutes of an author’s time). Hundreds of thousands of users are accessing the database every day, according to NIH director Elias Zerhouni, who recently testified to Congress on the matter.

“Publishers should be looking at changing their business models to adapt rather than trying to hold on to something that is slowly dying,” a blogger argued recently in a typical comment on one of the many web sites engaged in heated discussion on open access these days. “Especially if the research and publication costs are being borne by the public.”

One can’t help but feel a little sorry for some of these publishers. Many of the smaller ones are hard pressed for subscribers and funds, and some of them support laudable educational and training programs with the profits they make from their journals. Even the larger ones, which enjoy sinfully high profit margins without even having to take out risky loans against failing mortgages, are already facing a range of challenges in the Internet era, as information moves faster than they can print it and the expectation of free content suffuses the young, data-hungry public.

I also happen to agree with Adler, of the publishers group, that Congress did not handle this in the most upright fashion. The mandate was handled through the appropriations process rather than through conventional legislation, and hearings could have helped hammer out a more perfect and perhaps more flexible system. But for better or worse, a lot of federal policymaking is accomplished through the appropriations process. Potentially lifesaving research on human embryonic stem cells and other studies on early human development have been stalled for more than a decade in large part because of appropriations language. If Adler wants to reform that Congressional shortcoming, I am all for it. But I would start by going after approps language that is really harming society in a big way, not language that is leaning on scientific publishers to share their material more equitably.

In any case, I have not seen any evidence that any of these journals are at serious risk under the NIH plan. Most subscribers (scientists and academic libraries in particular) are not going to dump their subscriptions just because a fraction of each month’s contents will be available for free on the Web within a year. Indeed, the publishers should perhaps be counting their blessings that legislation proposed by Sen. John Cornyn (R-TX) and Joseph Lieberman (I-CT), which would expand the NIH rules to most other federal agencies that dole out research grants, is as stalled in Congress as the Conyers bill appears to be.

The open access system is in place, on a limited scale. I say, “Let the experiment go on.” It’s a great opportunity to see if it works. And it’s a great inspiration for ink-and-paper publishers to start thinking about more modern ways to continue to profit in the inevitably lucrative business of onpassing new scientific findings.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Today the FDA released its long-awaited—and in some quarters, long feared—proposed new rules for marketing foods from animals that have been genetically engineered to have particular traits.

Among the gene-altered animals that could come through the pipeline first are salmon endowed with extra growth hormone genes, to make them grow faster. Pigs with bacterial genes that make their manure less environmentally damaging. And cattle with genes that help them fight disease or, a little further down the road, genes for omega-3 fatty acids, which could make filet mignon as healthful as a fillet of trout.

AP/Will Kincaid

One possibility for engineered animals: pigs with bacterial genes that make their manure less environmentally damaging.

The FDA proposal, which is open for public comment for the next 60 days, is sure to raise lots of consumer interest. Thousands weighed in on the agency’s clone ruling, with many expressing disgust over the idea of scarfing down clone-burgers. So wary of clones are our foreign trading partners that the Agriculture Department has asked U.S. farmers to hold off sending their clonal critters to market until the rest of the world gets over its jitters, even though the FDA has declared them safe.

Back then, the FDA and the biotech industry made a big deal about the fact that clones were “just” clones and are not genetically manipulated per se. They are merely conceived in an unusual way that involves just one parent instead of two, we were reminded, which produces an individual genetically identical to that parent. If the government were ever to allow gene-altered animals into the food supply, officials reassured the public, the requirements for approval would be even more stringent than they were for clones.

Well, those rules are out today, with ancillary information from the FDA, and they make for an interesting read.

The good news is that the agency has decided to regulate gene-altered animals under the provisions of its “New Animal Drug” rules rather than through, say, its conventional food safety provisions. That’s good because novel foods for the most part can simply be introduced into the food supply without any restrictions, and enforcement by FDA does not kick in unless something goes wrong, like a lot of people dropping dead. By contrast, under the new animal drug provisions, each new kind of animal produced through genetic engineering will have to get approval from the FDA before it is commercialized. That’s the appropriate approach to something as biologically complex and emotionally charged as gene-altered animal products for the dinner table.

The bad news is that the process of getting such stuff approved is, as is the case with new drugs, extremely secretive. In fact, it would be against the law for the FDA (without permission from the affected company) to reveal that it has even received an application for a new gene-altered food animal until it approves that animal for sale in grocery stores. And once it has given its approval, there is virtually no recourse available to the public if people are not happy with that decision.

There are lots of reasons why the public may want to weigh in on these approvals. Concerns about the welfare of engineered animals. Environmental concerns (what happens when some of those genetically enhanced salmon escape their offshore cages and mate with wild salmon?). Concerns about subtle changes in nutritional values or even economic or ethical issues that the FDA is not really authorized to consider.

In interviews yesterday, FDA and biotech officials made a pretty convincing case that the agency is going to be looking very closely at these applications. The safety of consumers and the welfare of the animals themselves are their twin No. 1 priorities, they said. They also said they intend to make the process as public under the rules as possible, at least at first, to reassure consumers that their interests are being properly handled.

As always, the devils will be in the details: Just how much data the agency demands. How well it coordinates with the USDA and the Environmental Protection Agency, which will share responsibilities for many of the issues raised by engineered animals. But the first test will be how the agency responds to public comments over the next two months. Will it take the time to absorb them, respond to them thoughtfully in a public document, and integrate the best suggestions into a final version of the guidance? Or will it, as some agency-watchers suspect, finalize the proposed guidance very quickly after the 60 days are up, adding it to the bureaucratic bolus being force fed through the Washington policy machine in the waning days of the Bush administration?

Undue delay would be wrong. The nation and the world has been worse off, not better, for lack of guidance on how this next generation of animals is going to be regulated. And importantly, this is about more than just food. Engineered animals are also being made that produce important medicines in their blood, milk, and urine. Others may someday grow organs suitable for transplantation into people. Some animals being made or on various drawing boards are just capricious or quaint, such as the pet fish that glow in the dark and the cats that briefly were being produced under the (questionable) claim that they would not trigger allergies.

There is a world of biological manipulation to be had out there, and while some of it will be offensive a lot of it will be for the better. But the process is important. The FDA has to prove it is really listening, and show in its first few application reviews that it cares about the public interest and the animals themselves as much as it cares about the companies that hope to profit from these living and breathing products.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

No one expects the federal bureaucracy to move quickly. To paraphrase the old Willie Dixon song, the government is built for comfort, not for speed. And okay, the bureaucracy is bound to appear especially sluggish when compared to the speed of scientific progress.

But there was something especially stultifying last week about the Food and Drug Administration’s latest effort to figure out how to protect the public from foods, drugs, cosmetics, and other products spiked with nanotech ingredients. A sleepy fog suffused the Rockville, MD meeting rooms where agency officials listened all day to scientists, policy experts, and consumer advocates. One could not help but wonder how many new nano-laced products had made their way onto supermarket shelves that day while the grinding wheels of the federal oversight machine ground around in their grinding grindiness.

Nanotechnology, as the general public increasingly knows, refers to the science of the very small. It involves the engineering of materials on the order of a billionth of a meter, or a few ten-thousandths the diameter of a human hair. The cool thing about such minuscule materials is that they take on novel properties that the very same chemical substances do not exhibit when made in chunkier dimensions. Substances that normally don’t conduct electricity suddenly do when made on the nanoscale. Things that are normally opaque become transparent. Matter normally weak becomes strong.

The not-so-cool thing about nanoscale materials is that they can be far more toxic to cells and other biological systems than macro versions of the same stuff. When it comes to safety, size matters.

That’s relevant to the FDA because the products that it regulates are increasingly being made with nanoscale ingredients. Nanoparticulate medicines can be absorbed faster. Cosmetics with nanoparticles penetrate the skin’s outer layers better. Nanoscale food additives can improve flavor, texture, and “mouth feel.” The problem is, it is not at all clear that conventional testing methods long relied upon by the agency to assure that foods, drugs, and cosmetics are safe can discern the unique risks that may be posed by nanoingredients.

The number of consumer products on the market containing nanoparticles or nanofibers now exceeds 800 and is growing rapidly.

The FDA has been struggling for years to come up with an approach for figuring this out. It determined back in 2007 that it ought to release at least a general guidance for manufacturers—a far cry short of actual regulation, but at least a start—that would lay out the kinds of safety standards manufacturers ought to apply as they seek to market products with nanoscale ingredients. At a follow-up meeting earlier this summer, agency advisors hedged on that modest commitment, suggesting it may be premature to produce even a general guidance document.

At the latest meeting, agency officials at least appeared to recommit themselves to producing some kind of document that might assure consumers that someone is looking out for their safety. But at the risk of practicing medicine without a license, let me give you a bit of advice: Don’t … hold … your … breath.

Admittedly, the problem is complex. The science of nanotoxicology is still young. Definitive safety tests for nanoscale materials are far from perfect. And too heavy a regulatory hand could stifle innovation in a fast-paced and potentially revolutionary field of science. But entrepreneurs, who see big dollar signs in small stuff, are not showing restraint.

According to conservative estimates by the Washington-based Project on Emerging Nanotechnologies, the number of consumer products on the market containing nanoparticles or nanofibers now exceeds 800 and is growing rapidly. That includes 125 cosmetic products, which already as a class are barely regulated by the FDA, even though most of them are meant to be applied directly to the skin; and 44 dietary supplements, which, thanks to Congressional action back in 1994, can today be marketed to consumers not only without first having to prove they are safe or effective, but without even having to prove that they actually contain what they say they contain.

Unfortunately, FDA is still at Nano Square One, debating how to define the term “nanotechnology”—a question most expert groups got past several years ago.

“Nanotechnology has the potential to blur the boundary between cosmetics and drugs.”

At the Rockville meeting, manufacturers and their trade-group representatives leaned on FDA to let them self-regulate. Many of their nanoproducts, they said, are not really nano, because those nanoparticles tend to clump together into larger agglomerates. That raised a question: So why make those ingredients nanoscale to begin with? Because, it turns out, even after they clump together, they exhibit many of the properties conferred upon them by virtue of their essential nano-ness. Well, doesn’t that suggest that the peculiar toxicities of nanoscale materials might also persist, even after agglomeration?

There is “no evidence” of any unique toxicities associated with drugs made this way, said Daniel Caldwell of Johnson & Johnson. Of course, there is pretty much “no evidence” of anything, one way or the other, because there is virtually no research going into this question.

As I’ve written before, drugs, at least, do have to pass reasonably rigorous tests for overall safety and efficacy before being marketed. So although I worry that regulators might not be using the best tests to actually detect novel (and perhaps long-term) toxicities associated with nanotech, at least there is something of a safety net there. Not so for foods, food additives, cosmetics and dietary supplements, which effectively only get regulated after evidence arises that they are making people sick. That’s especially worrisome because one of the reasons nanotech is being increasingly incorporated into these kinds of products is to increase absorption into the body and boost their biological impacts.

“Nanotechnology has the potential to blur the boundary between cosmetics and drugs,” said Andrew Maynard of the Project on Emerging Nanotechnologies.

How can FDA reasonably protect public health in this interim period before researchers completely understand the science of nanotechnology?

In the food arena, one way would be for the agency to just agree up front that it will reject applications seeking to declare nanoingredients as “Generally Recognized as Safe,” or GRAS—the classification granted to some foods and food additives that have a long history of safe use. Specifically, while the macro form of an ingredient may indeed be GRAS, nano versions should not be presumed to have the same safety profile and instead should be declared as being subject to the same kind of oversight as other novel foods or food additives.

In the drug arena, the billion-dollar question is going to be whether drugs that are formulated with nanomaterials deserve to be treated as entirely new chemical entities or simply as innocuously modified versions of already approved drugs. That’s going to be a tough call, and will probably need to be decided on a case-by-case basis. But it may be that the default should be “new chemical entity,” unless the manufacturer can present compelling evidence that the safety and efficacy profile of the new product is not significantly more worrisome than the old.

“If you’re going to hype it as ‘all new,’ then you ought to be testing it as ‘all new,’” said Jaydee Hanson of the Washington-based International Center for Technology Assessment.

In the arena of dietary supplements, the FDA has very little flexibility and authority, but it does have at least one legal means of keeping a grip on the growing use of nanotechnology: declare that all nanomaterials in dietary supplements will be categorized by the agency as “new dietary ingredients,” or “NDI.” By doing so, said William B. Schultz, an attorney and former FDA deputy commissioner for policy, supplement makers would be required to notify the agency at least 75 days before starting to market a product with nanomaterials in it. It would also require that these companies show the FDA the safety data they have relied on, as marketers, to ensure that the nanoproducts they are about to sell are safe. That would at least give the FDA a fighting chance of looking into the product’s potential risks before the product hits the market.

The beauty and utility of the NDI designation, Schultz noted, is that FDA does not have to prove that the product is unsafe if it wants to keep the product off the market. It must simply declare that the company did not supply adequate information to convince the agency that it is safe. Of course, that can only happen if the agency has the staff it would take to review these applications before the 75-day period passes. And given current staffing and funding, which have left the agency unable to keep up even with more pressing reports of people becoming sick from supplements, there is not much chance of it getting sufficiently ahead of the curve to review applications before products get marketed.

Today, Schultz said, the dietary supplements office of the FDA is “barely alive.”

Hopefully the FDA will figure out a way to get a handle on nano before the same can be said for those of us eating the stuff, or getting it in our medicines.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

That is the question that scientists in Australia recently asked—and nicely answered—in a study that offers new and elegant support for the inexplicably maligned theory of evolution.

More than 40 percent of polled Americans agree with the statement: “Humans and other living things have existed in their present form since the beginning of time.”

The research, described in the September issue of the journal Animal Behaviour, is the latest in a seemingly endless stream of nails, screws, and spikes that scientists have driven into the coffin of creationism—albeit with shockingly little impact on Christian fundamentalists, many of whom remain committed to undermining evolution’s teachings in public schools. More generally, the research deserves celebration as a quintessential example of why the scientific method is the way to understand the world around us.

The findings are worth highlighting because the battle over evolution is still far from won in this country, despite the overwhelming mass of scientific evidence that supports this model of how the biological universe works. School districts are still having fights over how to address evolution in curricula. And astonishingly, more than 40 percent of polled Americans agree with the statement: “Humans and other living things have existed in their present form since the beginning of time,” while less than half agree that “humans and other living things have evolved over time.”

Which gets us to the chickens.

Chickens have long been popular subjects for studies of “sexual selection,” an aspect of evolutionary theory first proposed by Charles Darwin himself. The more widely taught evolutionary principles of “natural selection” and “survival of the fittest” speak to the importance of an individual’s ability to weather life’s challenges, occasionally with the help of new, advantageous mutations. Sexual selection refers to a particular component of that formula for success: Convincing a member of the opposite sex to mate with you, so you can have more offspring than your less-fit competitors before you die. And as anyone who has visited a bar knows full well, generally it’s the males that need to do the convincing.

Toward that end, the males of many species are heavily ornamented. The theory of sexual selection says that such visual extravagances can serve as a signal of an individual’s health. It takes energy, after all, to maintain colorful tufts of hair, brilliant waddles, or other seemingly goofy goo-gahs. Indeed, in many instances these accoutrements are barely manageable—think about the peacock’s tail—and are the first to go shabby when a male gets sick or is parasitized. Over generations, as females repeatedly choose the most flamboyant males as a surrogate means of picking the healthiest sperm on the block, these exotic traits become more prevalent.

Experiments have generally confirmed that females are suckers for male décor. When female ornamental chickens (Gallus gallus) are given a choice between two males, presented to them in separate cages simultaneously, they go for the one with the most brilliant orange feathers and the reddest, fleshiest comb. The new experiments sought to go further: Do a mate-choice experiment in a more natural setting, in which males could not just show off their colors but literally strut their stuff—that is, behave in ways that might contribute to their attractiveness.

Here is where the Australian research team helped resolve a longstanding quandary in evolutionary biology. Chickens, it has long been known, are among a number of species in which individuals—generally males—will let out warning calls of various sorts when a predator is near. These calls are extremely valuable to the group as a whole. When, for example, a male chicken lets out the call that means “aerial predator approaching!” other chickens in the vicinity crouch low and look upwards, as though watching for a hawk. When a male gives the signal indicating an approaching land-based predator, the others stand erect and look toward the horizon, as though searching for a fox.

But what’s in it for the one doing the signaling? Under the strict rules of natural selection, an animal ought to do whatever it can to boost its own odds of survival—like hiding as soon as trouble appears and leaving others to fend for themselves. Running around making a lot of noise (okay, not necessarily crossing the road while at it) is surely not the best way to avoid being noticed by a predator. It just didn’t sit well in evolutionary theory, though possible explanations have been proffered.

Beyond the specifics of evolution itself, the new research on poultry paramours is also worth highlighting because it is such a fine example of the simple power of the scientific method.

Some scientists have suggested that even if the signaling individual sacrifices himself, he may at least end up saving some close relatives, a perhaps reasonable, though imperfect, substitute for saving his own DNA for posterity. Others have suggested that the chaos that often ensues after raising a predator alarm may confuse the would-be attacker and help protect the whole group.

But for chickens, at least, the real advantage did not become clear until David R. Wilson, Christopher S. Evans and their colleagues at Macquarie University in Sydney did their unprecedented mate-choice experiments, which involved small groups of male and female chickens in natural, open spaces—places where females could base their choices not just on the degree of decoration among a few caged males but on the actual behavior of those males.

To their surprise, the team members found that in naturalistic conditions, feather brightness and comb color were not the best predictors of which male a female would swoon for. Outside of caged conditions, behavior, it turned out, was more important than sartorial style. And specifically, “the best predictor of mating and reproductive success was the rate at which males produced anti-predator alarm calls.”

No one knows, of course, what is running through those little female bird brains. Perhaps the gals are attracted to the selfless heroism of those who shout warnings. Or perhaps, as Animal Behaviour’s editor Daniel T. Blumstein opined in an accompanying commentary, female chickens “are attracted to honestly scared males.”

These are, after all, chickens.

Whatever is going on, the males willing to squawk when danger looms are the ones who get the girls. And the math suggests that even if, now and then, this bold behavior does prove fatal, the overall odds are that, by then, those pluckily clucking pieces of prey will have sired more offspring than their quieter cousins. And thus, gratifyingly, another puzzle piece that seemed not to fit into Darwin’s theory—a behavior that had been presumed to decrease a male chicken’s chances of evolutionary enlightenment but which, in fact, now appears to increases those odds—clicks into place after all, like so many before it. Darwin’s rules keep proving true.

The fact that nearly half of Americans refuse to acknowledge this could be tolerated if these very same people were not tirelessly foisting their beliefs upon others—and not just upon their own children, who are arguably victims of child abuse for being taught such a warped picture of reality, but upon school districts across the country. Once again, for example, the Kansas board of education is poised for an electoral war over the teaching of evolution in that state’s classrooms. The Louisiana legislature also recently passed the Louisiana Science Education Act, which calls upon the state’s Board of Elementary and Secondary Education to “create and foster” a school environment that promotes “objective discussion of scientific theories being studied, including, but not limited to, evolution, the origins of life,” and a other indisputable elements of the scientific canon.

Beyond the specifics of evolution itself, the new research on poultry paramours is also worth highlighting because it is such a fine example of the simple power of the scientific method. There was a presumption: a male chicken that clucks when a predator is present is essentially a dead duck, one that female chicks would hardly consider dating. And there was a hypothesis: Maybe there is more to clucking than meets the eye. There was an experiment: Let’s see how these blustering boys really do. Then there was a result, and a revamping of scientists’ thinking—a revamping that if anything only bolsters the overarching framework of evolutionary theory.

So here’s to the scientists who, while school boards and others wave the flag for creationism and “Intelligent Design,” just keep on following their beaks, and sticking to the facts. Perhaps someday a majority of Americans will believe the evidence these researchers have repeatedly confirmed. Perhaps someday we, like the proverbial road-crossing chickens, will get to the other side.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

That scientists have gained the almost alchemical ability to conjure such transformations is a remarkable sign of their deepening understanding of how genes work.

Now three scientific papers, all published within the past few weeks, offer tantalizing evidence that a human regenerative revolution may be on the horizon. One study showed that red blood cells can be mass-produced from simple starter cells in the lab, an advance that some experts predict could make the Red Cross blood donor program obsolete. Another showed that conventional cells living humdrum lives in the pancreas can be prodded to become specialized, insulin-secreting “beta cells”—the kind that aren’t working or are missing in people with diabetes. A third study showed that muscle precursor cells can be nudged within the body to become brown fat cells. Unlike ordinary fat cells, which contribute to obesity and gave rise to today’s robust liposuction industry, brown fat cells actually burn calories. By boosting one’s supply of them, scientists suggested, a person might be able to get in shape without ever setting foot in a gym.

That scientists have gained the almost alchemical ability to conjure such transformations—changing one kind of cell into another—is a remarkable sign of their deepening understanding of how genes work. Virtually all human cells have the same 25,000 or so genes inside of them; a cell’s identity as muscle or fat or any of the other approximately 200 tissue types comes down to which of those genes are turned on or off—a status once believed to be set in cellular stone. Now it is clear that many cells can be cajoled to change their occupations, though the process requires that countless genetic switches get flipped to precisely the appropriate settings.

The challenge of cellular reprogramming is daunting. Think about that gray, metal electrical box in your basement, but with 25,000 circuit breakers inside instead of 10 or 20, all of them having to be flipped to the proper position to make just one cell behave as the kind of cell you want it to be. How on Earth are scientists figuring out those proper patterns?

One of the best ways, it turns out, has been to watch the Master at work. Master cell, that is, namely the human embryonic stem cell. Embryonic stem cells are the blank-slate cells that are tucked inside microscopic embryos during the first days after an egg cell has been fertilized. They divide—and thus multiply—and over a period of months those millions of offspring cells flip their genes to the proper settings to become all the kinds of tissues needed to make a fully formed person.

In the decade since human embryonic stem cells were discovered, scientists have learned a lot about which gene-activity profiles correlate with various kinds of cell specialization. They have also learned how to culture embryonic stem cells under just the right conditions so those cells and their offspring set their own switches in desired ways, allowing the cultivation of muscle cells, nerve cells, blood cells, and others. In two out of the three recent studies, scientists went a big step further: They turned cells that had already taken on a specialty into cells with a brand new specialty—muscle cells into brown fat cells and ordinary pancreatic “exocrine” cells into beta cells—without any involvement of stem cells at all. Predictably, some conservative commentators who oppose research on embryo cells took the news as evidence that embryonic stem cell research no longer needs to be supported.

There will come a day when embryonic stem cells will seem crude and extraneous for the kinds of work that needs to be done. But that time is not here yet.

But a close look at the research papers reveals that embryonic cells still have a lot to teach before scientists will have gained clinically useful control over human cell fates. In the first study, by scientists at Advanced Cell Technology in Worcestor, Massachusetts, human embryonic stem cells in laboratory dishes were coaxed to multiply en masse and mature into red blood cells, the oxygen-carrying corpuscles that circulate by the trillions in everybody’s body. Celebrating the feat, researchers spoke of a future in which people in need of transfusions might get the life-saving crimson freshly made to order, instead of from donors who might carry viruses or other infectious agents. And indeed, the transformation was impressive: Just as happens naturally in the bone marrow, cultivated stem cells were made to mature into full-blown red blood cells. Those red cells produced the oxygen-ferrying protein hemoglobin and even ejected their own DNA once they fully matured, a neat trick that is unique to red blood cells.

There is a catch, though. Lanza’s cells produce mostly fetal hemoglobin, a variant that is useful to fetuses, which get their oxygen from the placenta, but less than ideal for the already born, who get their oxygen by breathing. In short, these are the wrong kind of red cells for transfusion. And little is known at this point about how to flip the right switches to get these cells to make adult hemoglobin. Clearly, this is a technology that is promising but far from ready for Red Cross approval.

The other two studies are more attractive and scientifically elegant because no stem cells were involved and because they involved the direct transformation of one kind of cell into another while those cells were living inside the body (mouse bodies, by the way, so keep in mind that this work may or may not pan out in people). The potential benefits are obvious: an injection of the right genes into a patient and Presto, those deadbeat pancreas cells are transformed into super beta cells, and that clunker of a pancreas is regulating your blood sugar again! None of the fuss or muss of laboratory dishes. No need for pesky embryonic stem cells. But also, it turns out, no proper regulation of those cells after they’ve made their miraculous transition. For example, in the experiments, led by Douglas Melton at Harvard, in which ordinary pancreas cells were made to morph into insulin-secreting cells, those cells just kept churning out insulin, endlessly. That’s a far cry from what beta cells are supposed to do, which is to increase insulin production after meals, when needed, and decrease it when blood sugar levels go down. A person would be better off with old-fashioned periodic injections of insulin than with these newfangled insulin-churning pancreatic cells.

Similarly, while it’s attractive to think of the weight-loss benefits of a simple DNA-based injection that converts some of your lumbering muscle precursor cells into white-hot, energy-burning brown fat cells, the system as tested in mice so far—by researchers at the Dana Farber Cancer Center—is less than reassuring in terms of having some control over the process. Among the unanswered questions: Might muscle mass decrease as cells once destined to become bicep or tricep changed jobs and became part of the body’s brown fat farm? Would appetites simply increase as we sizzled through calories? Would there be any way to undo the cellular shift, or tweak the newly retuned system, to assure some kind of biological balance?

In nature and in our bodies, as we develop from embryos to babies and as we live out our lives, cellular processes are kept in underappreciated balance all the time by regulatory processes in our DNA—processes that scientists have barely begun to plumb. And there is no better venue for studying these crucial processes than embryonic stem cells—both because that is where they naturally occur, in sequence, as development progresses, and because stem cells can multiply endlessly in the lab, making them the perfect platform for cell biology and genetic studies.

No doubt there will come a day when embryonic stem cells will seem crude and extraneous for the kinds of work that needs to be done. But that time is not here yet. If we want to learn how to gain control over our bodies, how to rejuvenate aging tissues and regenerate ailing organs, we should sit with the masters. Study the salamanders. And stand by our stem cells.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

“Pssst,” he says. “You want to win gold? Guaranteed to help. And perfectly legal.”

“What is it?” you ask, as he shows you a mysterious device, smaller than a credit card and with wires dangling from it.

“Intracranial transducers,’” he says in practiced English, pointing to the ends of the wires. “Stick them in your ears and they focus the brain, increase blood oxygen, prepare muscles for action. Made here in China.”

“So it’s a doping device!” you say with disgust.

“No, no,” the man exclaims in a hoarse whisper, looking around to make sure no one else has heard your incriminating comment. “Like I said, totally legal.”

“So what is it called?” you ask.

He looks askance again, then leans over and whispers in your ear: “‘iPod,’” he says. “We call it ‘iPod.’ It worked for Phelps. It can work for you.”

***

It is now a widely known fact that Michael Phelps, winner of a record-breaking eight gold medals in this year’s Olympics, is an iPod fanatic. In the minutes before diving into the pool, those trademark white wires were almost invariably hanging from his ears. He has confessed at various times to using tunes by Eminem, Young Jeezy, Lil’ Wayne and Jay-Z to motivate him and enhance his concentration.

When broken down to its mechanical elements, an iPod is nothing more, and nothing less, than what my hypothetical Chinese huckster was pitching—a device that transduces electrical energy into acoustical energy, namely music.

You see where I am going with this. And before I go any further, why don’t you get it out of your system? Let me have it. I know what’s coming because soon after I began to wonder about the parallels between iPoding and doping, an Israel-based medical doctor and scientist with whom I have communicated occasionally in the past—Alexei Koudinov, who among other things edits an online scientific publication called The Doping Journal—sent me a blog in which he raised the same issue. And that blog, I saw, had led to instant and effusive derision by his online readers.

“Who pays this guy to think up things like this?” one respondent wrote, after Koudinov argued the undoubtedly extreme case that Phelps should give up his medals. Others called the idea that music should be classified as a performance enhancer “asinine,” “silliness,” “a crock,” “ridiculous,” and “mean-spirited.”

One clever commentator claimed that “The writer of the article is qualified
to write for that [Doping] Journal: He is a Dope!” Another, less clever, called Koudinov’s posting “a waste of ink.” In fact, as with most online postings, no ink was involved.

But let’s pursue the idea a bit further. When broken down to its mechanical elements, an iPod is nothing more, and nothing less, than what my hypothetical Chinese huckster was pitching—a device that transduces electrical energy into acoustical energy, namely music. And as everyone knows, music can have profound psychological and physiological effects. It can relax a listener. It can anger or enthrall. It can excavate deep emotions and energy.

If that is not specific enough, consider research published in the Journal of Nursing Research in 2003, which showed that hospitalized infants who had music played for them had significantly higher oxygen levels in their blood than other babies . Now consider that the 2008 World Anti-Doping Code of the World Anti-Doping Agency, in Article M1 under the category of “Prohibited Methods,” bans methods of “artificially enhancing the uptake, transport or delivery of oxygen….”

I suppose this raises the interesting legal and philosophical question of what is “artificial.” In the words of one especially cynical blogger: “As just about everyone knows, breathing increases blood oxygenation. Should this also be considered illegal?” I won’t go that far. But even if normal breathing is acceptable, what about the arguably less-natural activities known as deep breathing or stretching or limbering up?

Moreover, music can affect more than mere oxygen levels. Koudinov cites research by Stefan Koelsch of the Max Planck Institute for Human Cognitive and Brain Sciences in Leipzig, Germany, who has published research on biological responses to music. According to Koelsch, music can induce biochemical “relaxing effects.” Given all the talk during this year’s Olympics about the risks and downsides of “having the jitters,” which can throw even the best of gymnasts off their balance beams, relaxation is clearly a big potential benefit.

Yet anti-jitter drugs, such as beta blockers, are expressly prohibited in many Olympic sports (including marksmanship, as evidenced last week when the North Korean Olympic shooter Kim Jong Su was stripped of his silver and bronze medals after blood tests came up positive for propranolol, which can slow a heart that is racing from nervousness and, in so doing, reduce anxiety and enhance concentration).

Phelps may even have received a double benefit by yanking out his ear buds in the last minute or two before competing. Research published in 2005 suggests that intense music followed by a sudden silent pause may be just the ticket for someone poised at the edge of an Olympic pool, since the music itself can boost arousal and the sudden silence that follows can induce, in handy sequence, a wave of relaxation.

“Music, especially in trained subjects, may first concentrate attention during faster rhythms, then induce relaxation during pauses,” that study concluded.

Now that the tomatoes are well on their way to my e-podium, let me tell you that I raise these points not to call for an end to music at the Olympics, much less for an end to respiration, oxygenating though both may be. Rather my goal here is to make a distinction between the rationales that many in the anti-doping community use to justify their anti-doping efforts and the single rationale that, in my opinion, is the only one that stands up to real scrutiny.

The arguments against doping come down to two major moralistic themes:

1) Doping is not fair because it rewards those who artificially augment their abilities instead of rewarding what sports are supposed to be about, namely hard work and perseverance.

2) Doping often carries health risks and we should not encourage or inspire people to put their health at risk, and we should especially not inspire children—who are known to worship sports heroes—to take such risks.

By my analysis, No. 1 falls apart because, the Declaration of Independence notwithstanding, all men and women are not created equal. No amount of training is going to make me a gold medal sprinter or swimmer. Some folks have extraordinary genetic potential (indeed, the Chinese seem very good at picking them out early and incarcerating them in training camps). Others are born into environmental privilege, including access to coaches or high-tech running shoes (which are legal, while artificial spring-loaded prosthetic feet are not, of course). The Olympics do not exclude the genetic and environmental Haves out of a concern for fairness to the Have-nots like me. All are invited to compete as though equal, even though we know which group is going to win. So what is so morally obvious about the need to exclude the Have-drugs out of fairness to the Have-no- or Use-no-drugs?

No. 2 falls apart because society already allows adults to take risks as long as they understand them. (Or purport to understand them. Consider the case of Fort Lauderdale kite-boarder Kevin Kearney, whose decision to make sport of Tropical Storm Faye’s recent winds resulted in his getting tossed hundreds of yards through the air before being slammed against a building and hospitalized in critical condition. Arguably stupid, but not illegal.) As for influencing kids, well, the law allows adults to do all kinds of stuff that’s a bad influence on kids—smoke cigarettes, drink alcohol, engage in unprotected intercourse. Allowing adult athletes to dope does not mean that kids must ethically be allowed to do the same.

No, there are no moral reasons to oppose music, meditation, or methamphetamine in sports. But there is one water-tight reason, and it is a reason that will resonate with every kid who grew up with a parent. The reason, in short, is, “Because I said so.” Not because an individual “I” said so, of course, but because those who have been elevated to the status of rulemakers have agreed on the rule. And that is that.

As Gary Wadler, chairman of the World Anti-Doping Agency’s Prohibited List and Methods Committee explained at a recent Center for American Progress event on athletic enhancement and reiterated in a later interview: “These things are arbitrary. But people settle on a set of rules.”

There is no moral reason why the distance from home plate to first base must be 90 feet, Wadler said, but people have agreed on that distance. And unless and until the rules get changed, that’s the way it’s going to be. If you don’t like it, you don’t have to play. But if you do play, that’s a rule you’ll have to follow.

It may sound shallow and less convincing than relying on some grand ethical theory of fair play and the quest for human excellence. And let’s face it: nothing was more irritating than hearing one’s parent fall back on the seemingly lame comeback of “Because I said so.” Surely our “Whys?” deserved better than that.

But it is good to remember—especially in these times of great religious and moral fervor, when presidential candidates feel oppressively obliged to affirm their belief in Christ as their personal savior and presidents invoke disproportionately righteous reasons for going to war—that not every decision is, in fact, a big fat moral decision. Sometimes we should just do things because those are the rules we have agreed upon. Because, for example, the Constitution says so, or the laws passed by our representatives in Congress say so. Removing the fatty cover of moral certitude when morality is not, in fact, the best argument for action would simplify life, make us more honest and, perhaps most important, put us more in the habit of acting on the basis of evidence rather than on received wisdom and protestations of personal piety.

You question that? Well too bad. When you’re in my column space, you play by my rules.

Now go to bed.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

It’s been a marathon year for media coverage of athletic doping. Everybody, it seems, is upset about the ever-growing use of interventions to build muscle mass, quicken reaction times, and boost oxygen levels in the body. So much chatter! It’s like steroids on steroids.

Suddenly, the idea of winning the enemy’s hearts and minds becomes weirdly biochemical.

But let me draw your attention to a new event in the Handwringing Olympics, described in a remarkable report released this week by the National Research Council. It focuses in part on the flip side of the enhancement market, namely the military and intelligence communities’ interest in drugs and other methods for degrading performance—of enemy soldiers and terrorists, of course—and perhaps reading their intentions and even controlling their minds. Cognitive war is hell, sure, but at least it’s all in your head.

And you thought a shot of growth hormone in a baseball player’s butt was the biggest doping crisis facing the nation.

The 151-page NRC report was commissioned by the Defense Intelligence Agency. It was released with spy-like discretion on Wednesday (no press conference or major media blast), bearing a title too bland to be bland by accident: “Emerging Cognitive Neuroscience and Related Technologies.” (Inexplicably, the folks running the National Academies web site blew the report’s undercover cover, giving it the somewhat more telling online title “Cognitive Neuroscience Research and National Security”)

The report argues that the U.S. intelligence community must do a better job of keeping up with advances in the neurosciences. It’s not for nothing, it notes, that the brain is associated with intelligence. And echoing today’s Beijing blogosphere, it focuses a fair amount on enhancement, noting that there is a large and quickly growing market in drugs and other products that can boost physical strength and cognitive performance, which can benefit not just bicyclists and weightlifters but also U.S. forces in battle.

“In the future,” the report notes, “as soldiers prepare for conflict, [the Department of Defense] may call on the neurophysiology community to assist in maintaining the warfighting superiority of the United States. Commanders will ask how they can make their troops learn faster. How can they increase the speed with which their soldiers process large amounts of information quickly and accurately? How can the neurosciences help soldiers to make the correct decision in the difficult environment of wartime operations?”

Let’s ignore for now how this message contradicts what is perhaps the biggest antidoping argument tossed around by Olympic commentators, namely that a focus on enhancement “sends the wrong message” about drugs to our nation’s kids. Suffice it to say that the link between warfare and sports runs deep, and it is hard to imagine a society that honors enhancement on the battlefield but truly shuns it in the sports arena.

But even more interesting to me is the report’s discussion of the emerging market in brain-targeted, performance-degrading techniques. Some experiments, it turns out, suggest that magnetic beams can be used to induce seizures in people, a tempting addition to the military’s armamentarium. More conventionally, as scientists discover new chemicals that can blur thinking or undermine an enemy’s willpower, and as engineers design aerosolized delivery systems that can deliver these chemicals directly to the lungs (and from there, the brains) of large groups of people, the prospect of influencing the behavior of entire enemy regiments becomes real.

Indeed, in a crude way, that is exactly what Russian troops did in 2002 during the Moscow theater crisis, when they incapacitated rebels with a narcotic gas, fentanyl. But in a perfect war, the attack would be more subtle and perhaps even covert.

“Although conflict has many aspects, one that warfighters and policy makers often talk about is the motivation to fight, which undoubtedly has its origins in the brain and is reflected in peripheral neurophysiological processes,” the NRC report notes. “So one question would be, ‘How can we disrupt the enemy’s motivation to fight?’ Other questions raised by controlling the mind: ‘How can we make people trust us more?’ ‘What if we could help the brain to remove fear or pain?’ ‘Is there a way to make the enemy obey our commands?’…As cognitive neuroscience and related technologies become more pervasive, using technology for nefarious purposes becomes easier.”

Suddenly, the idea of winning the enemy’s hearts and minds becomes weirdly biochemical.

The report acknowledges that this approach to dealing with international squabbles is likely to stir some controversy.

“The brain is viewed as the organ most associated with personal identity,” it says, so “there is sure to be enormous societal interest in any prospective manipulation of neural processes.”

But cognitive warfare is potentially “more humane” than old-fashioned warfare—“pills instead of bullets,” in the report’s words—making this a likely growth industry, the NRC concludes. And if nothing else, it suggests, the United States should be a leader in the field so that if our enemies develop such weapons then American soldiers can have the best defenses available.

“The fear that this approach to fighting war might be developed will be justification for developing countermeasures to possible cognitive weapons. This escalation might lead to innovations that could cause this market area to expand rapidly. Tests would need to be developed to determine if a soldier had been harmed by a cognitive weapon. And there would be a need for a prophylactic of some sort.”

Moreover, the report says, with perhaps a subliminal nod to Abu Ghraib, “The concept of torture could also be altered by products in this market. It is possible that someday there could be a technique developed to extract information from a prisoner that does not have any lasting side effects.”

This is important not only because photos of hooded prisoners with wires attached to them are embarrassing, but also because, as noted in the report, one of the real drivers of torture today is scientists’ ongoing failure to develop reliable means of determining whether someone is lying or telling the truth. Of course, neuroscience can cut both ways, helping torturers extract information but also helping captives resist. In what the NRC report acknowledges may be a “far-fetched” but not necessarily crazy example, one can imagine soldiers getting Botox injections before a mission to prevent their facial expressions from giving away information if they get captured and interrogated.

Botox. The ultimate in cosmetic counterterrorist tactics.

The NRC is probably correct that these and similar avenues of scientific inquiry deserve better monitoring than is now underway in the secretive hallways of American intelligence agencies. No nation wants to get caught by surprise by a fancy new cognitive weapon that makes its soldiers suddenly willing to settle for a bronze medal in World War III.

But where and when will the discussions of human rights, privacy, and sovereignty come in? How do these nascent technologies fit into existing international conventions on warfare, on the treatment of prisoners, on civil and political rights and on medical experimentation and informed consent? Surely Congress deserves to know what methods are to be used when it makes the precipitous decision to go to war.

Perhaps Olympic doping is a big problem. Perhaps it is right that so much attention is being paid to athletes and their coaches who are tinkering with the limits of human capacity. Me, I am much more worried about the Big Boys with their brainy neurological toys. It’s bad when players break the rules, but games that have none are scarier.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

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Rick Weiss and Jonathan Moreno on stem cells in the San Francisco Chronicle:
New possibilities for stem cell research

Americans don’t want Uncle Sam slithering between their bed sheets. But recent events in the field of human embryonic stem cell research suggest we’d do well to let the bearded geezer’s foot into the bedroom door a tad.

To quote Tom Friedman, “Let me explain.”

A few decades ago, the U.S. government was in a position to keep a close eye on, and perhaps even regulate, the fledgling fertility clinic business. Doctors were learning, pretty much by the seat of their pants, how to mix sperm and eggs in laboratory dishes to make human embryos that could then be transferred to the wombs of women who were having trouble getting pregnant.

President Bush’s approach to stem cell oversight has been worse in some ways than none at all, as it purports to spell out ethics guidelines without actually doing so.

The technology was a real medical and societal breakthrough. But the decision of how to deal with the newly emerging business of assisted reproductive technology was complicated because the field resided—and still resides—in a peculiar regulatory space. To the extent that it constitutes the practice of medicine, it is not subject to federal oversight. But to the extent it constitutes experimentation, it would be subject to a wide array of federal and international rules relating to research on human subjects.

As it turned out, the U.S. government did not want to go there. For one thing, baby-making seemed a very private matter. More importantly, the field was and remains a political hot potato, irrevocably related to the abortion debate and subject to endless sparring among those who do and do not think that microscopic human embryos have the same moral standing as late-stage fetuses or adults. That’s relevant because far more embryos are thrown away (or frozen indefinitely in liquid nitrogen) than are turned into babies at in vitro fertilization clinics.

Well, it was one thing for federal overseers to ignore plain vanilla IVF. But of course, things expanded. Today, the number of procedures performed on fertility clinic clients without any good experimental proof of their safety is rather amazing. Over the years, clinics have increasingly turned to intracytoplasmic sperm injection (in which sperm are jammed into an egg, rather than being allowed to fertilize under their own tadpole-like power), with uncertain effects on the recipient egg’s chromosomes. Women’s eggs have been frozen, then thawed months or years later for fertilization, with virtually no data from animal or human studies to assure that those eggs are not genetically damaged by the process. And increasingly, cells are being plucked for analysis from early embryos before those embryos are transferred to a womb, to test for the presence of various genetic traits. The practice can prevent the birth of children harboring damaging mutations, but could also be used to select embryos with preferred genders or traits. That practice raises ethical concerns about what traits, if any, are appropriate to select for in a child, along with medical concerns about possible developmental effects of the cell-biopsy procedure itself—none of which, because of the federal government’s queasiness, are being adequately addressed.

Finally there are important ethical, economic, and other societal questions that emerge from the related market in sperm and egg “donation,” a word that rightly belongs in quotes in this context since altruism is but a small part of the motivation that drives this lucrative industry. Just yesterday, CNN reported disturbing evidence that as a result of the declining economy, a growing number of young women are turning to egg donation as a means of making ends meet—disturbing not because this is an inherently bad practice but because it is one with real medical and psychological risks and should arguably be played by rules more sensitive than those of unfettered capitalism.

Which gets us to the issue of stem cells, where history is at risk of repeating itself.

President Bush’s approach to stem cell oversight has been worse in some ways than none at all, as it purports to spell out ethics guidelines without actually doing so, while largely keeping the cells off limits from the federally funded scientists who could make the most of them. Bush claims to have put great thought into his policy’s creation, though so profound a solution to such a complex problem surely deserved to be promulgated in a fashion more formal than the September 9, 2001, television address in which he laid out his basic ideas, or the “Fact Sheet” that was later distributed to the media that spelled out precious few additional details. Bush offered no legislation. No Executive Order. And, as was recently made clear, no real ethics requirements beyond a vague insistence on “informed consent”—a rule that was clearly broken almost as soon as the ink was dry on the White House news release.

The Bush system of stem cell oversight is falling apart and is sure to dissolve along with his presidency at the end of this year. Now is the time for smart people in science, government and ethics to start crafting practical and morally defensible rules for embryonic stem cell research that will foster scientific and medical progress while assuring that the couples who donate these cells for research do so with a full understanding of their options and the potential implications of their decision.

This fall marks the tenth anniversary of the first isolation of human embryonic stem cells. The hype that accompanied their discovery was, in retrospect, extreme, and the cells will undoubtedly fall short of the dramatic promises made by scientists and others at the time. But neither have they had a real chance to prove themselves. The trick moving forward will be to release these promising cells from the political confines that have stunted their practical potential, without leaving them wholly unattended by federal overseers.

That’s going to require Uncle Sam to quit being so squeamish about embryos—and it will require that stem cell scientists and the fertility clinics that provide embryonic cells for research open their doors a bit further to Sam’s prying eyes. The alternative is an expansion of today’s lawless frontier. And one thing this country does not need is a new Wild West on the outer borders of today’s reprotech badlands.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

As recounted at a National Academies meeting this past week by Lawrence Kazmerski of the Department of Energy’s National Renewable Energy Laboratory, there was some debate among the engineers designing that satellite. Some just wanted to rely on a battery. As it worked out, both technologies were incorporated. The battery worked fine…for less than three weeks. After it died the solar cells kicked in, and the satellite kept beeping and beeping—for so long, in fact, that the satellite became something of a pest, tying up that Naval Research Laboratory radio frequency for nearly seven years before finally petering out in 1964.

Lesson learned: Next time, include an on-off switch.

With those robust beginnings one might expect, or at least hope, that by now solar energy would be everywhere. But of course it is not (though it is in every one of the many satellites now circling the globe). Solar power today accounts for just a fraction of one percent of U.S. electricity generation, despite our early venture into the technology and despite the Manhattan Project-like call by President Jimmy Carter to get at least 20 percent of our electricity from solar way back in the 1980s.

In the years that Congress passed tax incentive legislation, investment in renewable energy sources skyrocketed.

The reasons for this failure are many. Financial incentives promulgated by President Carter were dismantled by his successor, President Ronald Reagan, who also gutted Carter’s clean energy program. The technology has, until recently, remained frustratingly expensive. And shortages of silicon, a key ingredient for most photovoltaic systems, put a crimp on emerging businesses in the early part of the new millennium.

Now a perfect storm of the best kind appears to be gathering. New technologies are increasing efficiencies and lowerering costs. Fossil fuel prices are skyrocketing—oil imports last year accounted for almost half of the nation’s total trade deficit—making it easier for alternative energies such as solar to prove their cost effectiveness. Climate change adds new incentives for the nation (and indeed, the world) to shift away from carbon-emitting power sources. And here in the United States, at least, huge expanses of territory are constantly awash with sunlight. Indeed, the American Southwest is a veritable Saudi Arabia of sun.

And yet it is not out of the question that the United States may squander this opportunity, according to scientists, investors and politicians who spoke at the National Academies on Tuesday. And as with so many issues in these treacherous times, the factor that stands to make all the difference one way or the other is “political will.”

That’s a general term, of course, and one that is thrown around a lot in Washington. But happily, there seems to be a growing consensus as to what “political will” really means in the realm of renewable and sustainable energy, and in particular for solar energy. Here is what I keep hearing from a wide range of stakeholders:

Institute a cap and trade system that places a price on carbon emissions commensurate with their damage. Everything else follows from this. Until carbon is accurately valued—or devalued—the energy playing field will remain too crooked to stand on.

Create a National Renewable Production Standard. Many states set enforceable goals for themselves for what percentage of their energy production should come from renewable sources. But unless the nation does the same across the board, it will be impossible to have coordinated transmission among regions that are rich in different resources (most notably, sun in the Southwest and wind in the Midwest). In a Novemeber 2007 report from the Center for American Progress, “Capturing the Energy Opportunity,” the Center called for 25 percent of the energy produced in the United States to come from renewable sources by 2025.

Provide long term assurances of investment and production tax credits. Depending on how you calculate things, solar power and wind power are still years or even a decade from being fully cost competitive, but we don’t have that kind of time to kill. The evidence is overwhelming: In the years that Congress passed tax incentive legislation, investment in renewable energy sources skyrocketed. In years when those incentives failed on Capitol Hill, those investments took a nosedive. Pay-as-you-go conservatives should not be allowed to block these incentives with their false economic analyses that ignore the long-term savings to be gained by earlier adoption of renewable technologies. Moreover, these incentives should be designed to last at least a decade, to provide the kind of stability and assurance that will prove truly inviting to investors.

Revive federal investment in renewable energy research and development. Time was, a few decades ago, that the Department of Energy invested billions annually in renewable energy R&D. Indeed, the federal government accounted for 98 percent of solar research in the country. Today, DoE’s renewable energy budget is a mere $250 million or so—most of it in photovoltaics even though the other major method of capturing solar energy, thermal capture, which grabs heat from the sun and uses it to power steam turbines, is equally deserving. Today DoE’s funding of solar energy R&D is just 2 percent of the national total, a pittance given the importance of government investment at this crucial stage of technology development.

Of course, making the transition to renewable energy will not be simple. Environmental issues must be addressed, including the effects of large-array solar facilities on endangered species such as the desert tortoise. Companies also complain, with some legitimacy, that as empty as the southwest deserts seem, the patchwork of federal and private land ownership in that region complicates the resolution of land-use issues. “There’s a challenging permitting process” in the California desert, said Steve Kline, a vice president at Pacific Gas & Electric Co., deftly sidestepping the public relations hurdles that even a solar-centric PG&E will still have to face in the aftermath of the Erin Brockovich debacle.

Finally there are lingering technological challenges. Solar thermal capture systems are virtually 100 percent efficient already, but construction costs need to be lowered considerably. Photovoltaics must become more efficient and cost effective—and are expected to do so in double-digit leaps over the next few years as better physics and chemistry are brought on line, especially through nanotechnology. Energy storage must be improved, since sunlight is obviously no way to power a city at night. But studies show that energy demand actually tracks peak sunlight times quite closely, so being able to store captured energy for just an hour or two would go most of the way to allowing full reliance on sunlight.

Finally, the nation’s infrastructure of transmission lines needs to be upgraded, through a creative pubic-private partnership, to carry energy cheaply and efficiently from the places where sun and wind are most prevalent to regions that are lacking. That is an interstate-highway-like project that the next president should immediately take on with Eisenhower-ish zeal.

By one estimate, the mere elimination of scattered, small but constantly occurring power interruptions caused by storms and other insults to our aging transmission lines would save something like $80 billion a year. Savings like those could offset upgrade expenses considerably. But for those looking for cold cash up front to prime the renewable energy research pump, there’s plenty of that to be had as well—in the suitcases of dough now being spent on federal tax beaks and subsidies for the oil and gas industries.

ExxonMobil Corp. on July 31 reported second quarter profits of $11.7 billion, the largest in history. Ongoing subsidies for a company as well heeled as that are about as anachronistic as a satellite that can do no more than beep.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

An expert panel at Stanford University has determined that nearly one quarter of the colonies of human embryonic stem cells that the Bush administration had approved as ethically derived and eligible for study with federal funds do not meet Stanford’s ethics standards and should no longer be available to researchers there.

The decision is the first of what is expected to become a string of such moves following the publication in May of a little-noticed report by a University of Wisconsin professor who found serious ethics lapses in the way some of the Bush-approved cells were obtained from embryo donors. Johns Hopkins University has quietly come to a decision similar to Stanford’s, and will undertake case-by-case assessments of the appropriateness of using various cell lines. And at least two University of California campuses, as well as the University of Wisconsin and California’s state-wide stem cell consortium are currently considering similar moves.

The revelations bolster a growing sense among researchers, the public, and representatives on Capitol Hill that the Bush stem cell policy is untenable and in need of a major overhaul. Bush’s policy, announced by the president on August 9, 2001, determines which colonies, or “lines,” of stem cells can be studied with taxpayer dollars—not on the basis of whether those cells were obtained by ethical means but simply on the basis of when they were derived. It says cells that were derived before August 9, 2001 can be studied with federal monies and those derived later cannot.

When Bush announced the policy in 2001, it was touted by administration officials as a moral triumph and a Solomonic compromise between those who flatly opposed the research and those who wanted unfettered funding for research on the cells. The Wisconsin investigation found otherwise.

The administration was adamant that as many cell lines as possible that were derived before the August 9, 2001 deadline be included on the approved list…in the hope that scientists would be mollified.

For some of the Bush-approved cell lines, the Wisconsin report found, consent forms that women signed as they donated their embryos for research promised that cells from the embryos would be used for a single, narrowly defined experiment and then destroyed. But stem cell research is not done this way. The whole point is to grow the cells into tissues for research and possible medical use. And in fact, the cells in question have been kept alive and reproduced repeatedly and distributed to scientists around the world for an apparently unlimited array of stem cell experiments.

For other Bush-approved lines, the informed consent form used by researchers to gain access to fertility patient’s embryos was not a consent form for research at all, but rather was a standard medical consent form to begin fertility treatments. Only one vague sentence toward the end of the several-page form mentions the possibility that cells from some of the women’s embryos might be used for research. By contrast, widely accepted standards of informed consent require a full accounting of what kind of experiments will be done and what the various risks and benefits of participation may be. The Bush policy ignored these standards.

The revelation that many of the Bush-approved cells were obtained without proper informed consent is but the latest evidence that there is less to the Bush plan than meets the eye. When the president announced his long-awaited policy on funding of human embryonic stem cell research on August 9, 2001—in his first televised address to the nation after being elected—he said there were more than 60 lines of cells that qualified under his plan, plenty for scientists to work with. As it turned out, the number was actually 21.

Then it came out that all those lines that were eligible and available had been cultivated with mouse cells and were potentially contaminated with mouse viruses, seriously diminishing their value as therapeutic tools. And more recently it has become clear that some of these older lines have begun to accumulate genetic mutations. Meanwhile, researchers around the world have developed hundreds of new embryonic stem cell lines using scientifically and ethically superior methods, but none of them are available to researchers using federal funds because the Bush plan is all about when instead of what.

Made aware of the informed consent lapses, a special stem cell ethics committee at Stanford recently concluded that all five human embryonic stem cell lines derived by two companies—Celartis of Sweden and BresaGen of Athens, Georgia—did not meet widely accepted ethics standards. That means the number of lines now available to federally funded scientists has shrunk at Stanford to just 16.

Stanford officials said they are discussing whether to implement the committee’s recommendations. Those recommendations came about as a result of research by Robert Streiffer, a professor of bioethics and philosophy at the University of Wisconsin at Madison. Streiffer used the Freedom of Information Act to examine the informed consent forms used by all the various research groups whose cells eventually passed muster with Bush. The Celartis and BresaGen forms were in gross violation of federal and international ethics standards, Streiffer said. The others, while imperfect, he deemed acceptable and he encouraged ongoing use of those cells in research.

The Celartis consent form told donors that the cells “will be destroyed” upon the conclusion of a single (undescribed) experiment, but no such restriction is actually in place for researchers who want to use those cells nor would such a restriction be practical, according to scientists. In the BresaGen forms, which women must sign if they want to get fertility treatments involving in vitro fertilization, the one sentence that mentions research says embryos created through the fertility treatments might be used for research if the embryos “are not developing or living.”

In addition to the form not going into any detail about what kind of research might be done, Streiffer said—a basic requirement of any consent form—the forms are deceptive because there are no accepted tests for whether an embryo in a lab dish is, in fact, developing or alive. “This probably does not count as informed consent for research at all,” Streiffer said of the BresaGen form in his published analysis, which appeared in the May/June issue of the Hastings Center Report, a journal of bioethics.

A representative of Celartis said he could not comment on the issue, and BresaGen did not respond to a query from Science Progress.

In an interview, Streiffer expressed surprise that the National Institutes of Health accepted the BresaGen and Celartis lines as eligible for federal funding, given the obvious lapses in the quality of their informed consent. But NIH insiders, speaking on condition of anonymity, said they had little choice at the time. The administration was adamant that as many cell lines as possible that were derived before the August 9, 2001 deadline be included on the approved list, NIH sources said, in the hope that scientists would be mollified. “We essentially had a gun held to our heads,” one insider said.

It is not clear how many experiments in the United States or abroad may be affected by the new restrictions. At least one experiment had been approved at Stanford using one of the lines, and will now be halted before it begins. Federal documents indicate that at least 90 shipments of cells from the two companies have been sent to researchers since they were first made available.

The new recognition that the Bush cells don’t really inhabit any particular moral high ground could change the dynamics of the stem cell debate going into the election. There has been growing suspense in scientific and political circles as to whether the Republican presidential contender, Sen. John McCain of Arizona, will maintain his support for legislation that would loosen the Bush restrictions. McCain twice voted for bills that would have done so, but has recently been rumored to be considering a reversal given a perceived need to solidify support from what remains of Bush’s conservative base.

Streiffer said it makes no ethical or scientific sense to base a policy on the timing of when cells were derived, as opposed to how they were derived. There have been many technical improvements, he noted, that make more recently derived cells more scientifically useful. In addition, newer lines have largely been derived with the benefit of new ethics guidelines that in recent years have been promulgated by the National Academies and other groups.

“Bush’s policy is getting in the way of us doing it better, scientifically, and ethically,” Streiffer said.

* Update, July 28, 2008: This article indicated that Johns Hopkins University has come to a similar decision to Stanford’s. It has been updated to indicate that Hopkins will undertake case-by-case assessments of the appropriateness of using various cell lines. Other changes reflect Stanford’s ongoing review of its committee’s recommendations.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Well, nanotechnology is indeed making its way into medicine. But as might have been expected, it is doing so in more modest, albeit impressive, ways, scientists told a panel of Food and Drug Administration advisers earlier this week. Therapeutic powders for use in pills and capsules are being ground into nanoscale motes of medicine that are orders of magnitude smaller than the “micronized” powders widely used today—an advance that promises to speed absorption, increase effectiveness and perhaps even improve safety, since less of the drug may be needed in this form. Cancer medicines are being made so small that they can wend their way through tightly layered body tissues, giving them unprecedented access to their tumor targets. Before long, doctors may even have access to their first “theragnostics”—engineered nanoscale molecules that are both diagnostic (by glomming onto tumors and making those cancers “light up” on an imaging device, for example) and therapeutic (by destroying those tumors once they attach to them, and allowing doctors to monitor their demise).

But even as the first wave of novel nanoproducts is washing up on the FDA’s shores in the hope of gaining marketing approval, the agency is still trying to figure out whether its age-old criteria for determining the safety and efficacy of new drugs need to be upgraded to deal with this new world of nanotech. After all, nanoscale materials, which are generally between 1 and 100 billionths of a meter in size, or a few ten-thousandths the width of a human hair, are in many cases far more toxic than the same materials in bulk form. Indeed, the blessings of nano are also its curses. Nanoparticles will get into those tumors, for example, but they will also get into places you don’t want them to get. And when they get there, they will do things you don’t want them to do, because particles that size tend to be far more chemically reactive than the same materials in larger form. So FDA officials, along with their counterparts in other agencies dealing with their own versions of the nanotech revolution, need to figure out how to judge these new materials, and pronto.

Yet most have barely taken a nanostep.

As a sign of how slowly the FDA is moving to address this issue, consider that the main question that advisors scratched their heads over at this week’s meeting was whether the agency ought to craft some helpful “guidance” for industry, to tell companies the kinds of things they ought to consider as they start pitching their new nanodrugs for approval. Sound familiar? It ought to. It was the same question asked—and answered—by the FDA’s own Nanotechnology Task Force last year. The answer, by the way, was “yes.”

“The guidances the Task Force is recommending would give affected manufacturers and other interested parties timely information about FDA’s expectations, so as to foster predictability in the agency’s regulatory processes, thereby enabling innovation and enhancing transparency, while protecting the public health,” that task force concluded exactly a year ago today.

At this week’s meeting, advisors split fifty-fifty on the question, though there was nothing reassuring in the reasoning behind several of those who voted against crafting that guidance. That “no,” several said, was not a reflection of their confidence that the current system was adequate. Rather it came from their realization that no one has much of a clue what to look out for and what to tell these companies. That is a disconcerting sentiment from the agency that regulates the nation’s medicines, medical devices, food additives, and cosmetics (and don’t get me started on those last two categories, which are already heavily laden with nanotech ingredients with absolutely no approval from the FDA because food additives and cosmetics are effectively not subject to FDA oversight until after they cause harm).

Of course, we can hope that there is no particular risk to these products. We can hope that the slides presented to FDA advisors by Darin Furgeson of the University of Wisconsin-Madison, who is doing research on nanotoxicity, were misleading as they showed little laboratory fish developing abnormally after being raised in water spiked with small amounts of nanoparticles. “Some changes begin to occur,” Furgeson told the FDA advisors with nonjudgmental equanimity. Among his observations: “Their eyes began to get different shapes.” “Excess fluid around the heart.” “Even the number of vertebrae changes,” as does the curvature of the spine.*

This was not true for all nanoparticles at all concentrations. But perhaps most worrisome, experiments described by Furgeson showed that extremely minor differences in the size or structure of various nanoparticles can make big differences in their apparent toxicity, suggesting that this is not going to be an easy field to get straight.

Later I spoke to Frank M. Torti, principal deputy commissioner and chief scientist at the FDA, and mentioned that if I were a little more jaded then I might conclude that the FDA is going to keep asking the question of whether guidance is needed until it gets the answer that it and the industry wants. After all, while guidance is technically just a recommendation, it can be time consuming to craft and is seen by companies as added regulation. Torti urged patience. While it may be helpful, he agreed, to provide industry with some general pointers about how to assure their nanoproducts are safe, based on what little is known to date, it would be more helpful to have guidance a little later that incorporates findings from the research now being conducted by FDA and others.

“There is ton of stuff going on with nano,” Torti said of the federal research agenda. Meanwhile, he added, the good thing about how the FDA regulates is that, in the end, whether a company knows everything about how its product works or not, it has to prove that the product is safe in animal tests and human studies before getting permission to market it. So bad medicines of any kind are likely to get screened out.

I think that an assignment to write guidance on nano would force the FDA to focus, and give the topic the aura of urgency it deserves. But truth be told, the safety of nano in medicine is but a minor worry of mine compared to the equivalent safety challenges posed by nano for other regulators such as the Environmental Protection Agency and the Occupational Safety and Health Administration. At the FDA, at least, the rules are plain, at least at high altitude: Before being approved, a company must show that its product is safe and effective. There are going to be some questions about how to prove these things for nano-based medicines, but in the end, even if very little is known about why nanomaterials behave as they do, dangerous ones will hopefully be identified during the standard safety testing in animals and early studies in people.

Source: J. Clarence Davies, “Nanotechnology Oversight,” (Woodrow Wilson International Center for Scholars, 2008).

By contrast, safety rules under the authority of EPA and OSHA are in many cases written differently. Pesticides, for example, are regulated by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, only if they are plainly advertised as pesticides. Thus the many products on the market that are loaded with nanoparticles of silver as a means of killing bacteria (thus preventing odors, for example, in the socks that are impregnated with that silver) today escape FIFRA regulation entirely by simply not claiming on their labels that the silver is there as a pesticide. “Big deal,” you may say. “Who wants to regulate a smidgeon of silver in socks, anyway?” Well, among others, engineers who run water treatment plants—who have complained that washing machine water laced with nanosilver threatens the survival of helpful bacteria that clean up the waste water flowing into their facilities.

Similarly, the Toxic Substances Control Act that the EPA uses to regulate various toxic chemicals typically allows companies to manufacture thousands of pounds of a chemical before that chemical is subject to regulation, on the assumption that such modest quantities can do only so much harm. But a mere pound of a chemical in nano form can be even more toxic than thousands of pounds of bulk material. Yet the law, as written, does not recognize this difference.

These and other glaring regulatory lacunae have been talked about for years, with nothing having come of it but a voluntary program, boldly promulgated by our protectors at the EPA, that asks companies to please, if they don’t mind, step forward and tell the agency what they are making. And don’t worry, dear companies, because we, the EPA, won’t tell the public what you tell us.

Surely we can do better than this. Nanotechnology is a radically promising new branch of engineering and ought to be given the best boost it can get. But just as a child does not benefit from free access to the cookie jar, the nano industry can only suffer in the end from a lack of reasonable oversight. As J. Clarence Davies, who served as an assistant EPA administrator under George H.W. Bush, said on Wednesday as he and the Project on Emerging Nanotechnologies launched their latest report on what is needed in the way of new nano oversight, “We’ve realized over recent years that if you’re going to have adequate markets, you’ve got to have adequate oversight.”

Davies’s excellent report spells out numerous nano-related regulatory lapses that the new administration should tackle ASAP. What good is it, he asks, to give workers OSHA-required Material Safety Data Sheets that spell out the toxicity of the nanomaterials they are working with, if the toxicity data contained in those sheets is based on studies of the materials in bulk form? We know that these substances have very different safety profiles on the nanoscale. Yet the law does not require the sheets to reflect this.

“That’s not okay,” Davies said. “It’s deceptive and misleading and does not give the necessary guidance to workers in terms of what kinds of precautions they should take.”

The United States should not blow its early lead in nanotechnology, a field that the Commerce Department has called “the next industrial revolution.” But to get it best, we’re going to have to get it right. The window of opportunity is still open. Now is the time to sweat the small stuff.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

* In response to comment #2, below, the text has been changed from “changing the curvature of the spine” to “as does the curvature of the spine.”

Life expectancy has grown by leaps and bounds in the past century. And to be sure, that success story has been written not by exotic anti-aging creams or wrinkle removers but by hard-won victories over infectious diseases, primarily through public health advances and antibiotics. A century ago, only about 40 percent of babies born in countries where births and deaths were reliably counted could be expected to live past the age of 65. Today, almost 90 percent do so. That’s one reason why in the United States alone, the number of people older than 85 is projected to quadruple by 2050, to 18 million from today’s 4 million.

But how do we keep that progress going in developed countries, now that infectious diseases have largely been tamed? The current approach to extending life, which has garnered some modest success in the past decade or so, has been to focus on curing those chronic diseases of aging that have become the modern era’s major killers, such as heart disease, stroke, cancer, diabetes, and Alzheimer’s disease.

Yet most of these diseases have proven remarkably resistant to treatment. More important, a number of research models have concluded that even if scientists were to score a complete home run by finding a “cure” for any single chronic disease such as cancer or stroke, life spans in developing countries would hardly grow longer. That’s because the other chronic diseases of old age are right there, waiting to kill us anyway at about the same age. You’d have to find cures for virtually all of them, these models suggest, to make any real progress at this point.

That’s where the anti-aging approach comes in. As it turns out, scientists studying the aging process in a wide variety of organisms—from worms to flies to fish to monkeys and people—have been finding that certain genes common to virtually all kinds of life play key roles in the metabolic and genetic processes that together underlie most diseases of aging. Some of these genes are important for repairing DNA damage caused by sunlight, chemicals, or other environmental insults. Others affect the levels of vital hormones. As scientists figure out what these key genes do, it becomes possible to envision developing medicines that mimic their activity, which typically wanes late in life.

Complementing that cross-species work, a number of ongoing research projects promise to clarify some of the most important anti-aging genes in people. In one project, described in this week’s issue of Technology Review, researchers are comparing DNA from two populations: people 80 or older who have never had serious illnesses and those who died of age-related ailments before they hit 80.

Two analyses to be published in the July 19 issue of the British medical journal, BMJ, make the case that such efforts could have big payoffs. Unlike conventional advances in lifespan, which in many cases have added years of disability and suffering to the end of life, the anti-aging approach would add healthy years, according to Colin Farrelly of the University of Waterloo in Canada. “There is a credible scientific basis for believing that we could slow aging in the foreseeable future,” he concludes. “And the amount of public funding we invest into such research will determine the likelihood and timescale of success for aging interventions.”

Others writing in that journal—including Robert Butler (a former head of the federal National Institute on Aging), S. Jay Olshansky (a leader in the field at the University of Chicago), and Daniel Perry (of the Alliance for Aging Research in Washington)—argue that $3 billion, or one percent of the Medicare budget, would be a “prudent” investment in anti-aging research. They make a convincing case that such an investment could pay for itself many times over by delaying not only the fatal diseases of old age but also the many debilitating conditions such as osteoporosis, arthritis, cataracts, and cognitive decline that typically take a big toll on quality of life in people’s final decade or two.

They call that benefit “a longevity dividend,” and it looks to me to have a much higher probable rate of return than most of the other dividends I’ve been counting on for my retirement. Meanwhile, hang in there, ol’ Ponce. Your reputation, if not your bod, may get rehabilitated yet.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

So it should come as no surprise that I was flabbergasted at first, and then practically apoplectic, when I saw recent news about the Louisiana legislature’s latest effort to undercut the teaching of evolution in that state’s schools. State Senate bill No. 733, purposively misnamed the “Louisiana Science Education Act,” calls upon the state’s Board of Elementary and Secondary Education to “create and foster” a school environment that promotes “objective discussion of scientific theories being studied including, but not limited to, evolution, the origins of life, global warming, and human cloning.”

How long does this fight need to go on? Do we need to teach the “strengths and weaknesses” of the theory of gravity?

Setting aside for now that global warming and human cloning are not “theories” at all—a concept that Louisiana’s legislators should have learned in school—the new state legislation has a familiar ring. It resonates with similar efforts now underway in Texas to have schools teach the “strengths and weaknesses” of the theory of evolution. Both are examples of the ongoing efforts by indefatigable religious fundamentalists to spike science classes with a dose of creationism, which relies on supernatural explanations for the origin of Earth and the life that lives on it.

If you thought that maybe this battle had already been won, you’d be wrong, though your error would be understandable. ‘Twas five days before Christmas, 2005, when the United States District Court for the Middle District of Pennsylvania delivered its highly anticipated decision in Kitzmiller vs. the Dover Area School District. At issue was the legality of a 2004 Dover Area School District decision to inform all students that they should “keep an open mind” about evolution and to encourage students to peruse Of Pandas and People, which the school district gamely referred to as “a reference book,” to gain an understanding of a competing view of how life came to be, known as intelligent design.

Judge John E. Jones III did not pull his punches. He found that the testimony of school board members who favored the teaching of intelligent design in the schools “was marked by selective memories and outright lies under oath.” He labeled intelligent design as “a religious alternative masquerading as a scientific theory.” And he stated plainly that intelligent design was “the progeny of creationism.” That’s important, because in a previous ruling the U.S. Supreme Court had banned the teaching of creationism from science classes.

Indeed, Jones highlighted a secret game plan written by leaders of the intelligent design movement that made clear the real goal of these various academic battles. The “Five Year Strategic Plan Summary,” known to fundamentalist insiders as the “Wedge Document,” states that the movement’s goal is to replace science as currently taught and practiced with “theistic and Christian science.” The group’s “governing goals,” according to this document, are to “defeat scientific materialism” and to “replace materialistic explanations with the theistic understanding that nature and human beings are created by God.”

In one of the more gratifying parts of the trial, Judge Jones dissected what he called the “historical pedigree” of the book Of Pandas and People. Not only is it published by a group registered with the Internal Revenue Service as a religious, Christian organization, he noted, but a look at the various versions it went through over years of editing reveals something rather amazing. Early versions of the manuscript, written before the Supreme Court’s creationism decision, refer throughout to creationism. Later edits, completed in 1987 after the Court’s ruling, are virtually identical but for the substitution of the words “intelligent design” wherever the word “creationism” had previously appeared. “This compelling evidence strongly supports Plaintiffs’ assertion that ID is creationism re-labeled,” Jones concluded.

Now America’s schools find themselves under assault by yet another relabeling of creationism, which this time is making its cowardly run for the academic goal line under the linguistic guises of “strengths and weaknesses” and “objective discussion of scientific theories.”

How long does this fight need to go on? Do we need to teach the “strengths and weaknesses” of the theory of gravity? That’s right. That’s all it is. A theory. But I don’t see any creationists defiantly jumping off cliffs.

Do we need more “objective discussions” of the atomic theory? C’mon, it’s only a theory. So why aren’t more of these activists moving next door to nuclear power plants?

I don’t see hordes of scientists beating down church doors to teach rationalism to parishioners in their pews. In a fair world, supernaturalists would similarly refrain from foisting their beliefs on kids in science classes.

But I have a theory that this is not about fairness. Of course, it’s just a theory.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

It sounds ridiculous, but this is the situation our nation is in for one of the hottest new tools in medicine, genetic tests. Gene tests conducted on a drop of blood can help predict what diseases a person is likely to get, fostering better preventive care and earlier diagnosis. For a growing number of diseases, gene tests can tell a patient which drug will work and which will not.

The moves by California and New York are the clearest evidence yet that a federal leadership gap now threatens to undermine the pending benefits of the genomics revolution.

But despite repeated calls by scientific and patient advocacy groups for the Bush administration to focus on this important emerging specialty, years have gone by without federal leadership. The Food and Drug Administration says it has the authority to regulate these tests—to make sure they give accurate results and provide meaningful information—but has largely steered clear of the complicated arena. The Federal Trade Commission, which has the responsibility for protecting Americans against false claims and consumer fraud, has effectively been AWOL on the gene test front, with the exception of a general “buyer beware” warning it put out in 2006. And despite repeated assurances that gene tests are a top priority, Health and Human Services Secretary Mike Leavitt has barely acknowledged receipt, back in April, of a long-awaited federal advisory report that called for HHS to take the reins on gene tests before this fast-moving specialty gets tainted by bad science and overzealous entrepreneurs.

Yesterday that lack of federal attention came sharply into focus with the revelation that California’s public health department had sent “cease and desist” letters to more than a dozen gene test companies, including several direct-to-consumer companies that have recently begun to offer DNA tests through the mail. Health officials told the ventures they have two weeks to prove that they are in compliance with applicable state rules relating to such things as laboratory licensure and the status of the doctors or other professionals who are ordering and interpreting these pricey tests for clients.

It’s tempting to see California’s move as simply a responsible act by state officials concerned that consumers not get taken for a ride. And to be sure, there is room for concern. The tests offered by these companies—most prominent among them are 23andMe, Inc. of Mountain View, California, and Navigenics, Inc. of Redwood Shores, California—provide predictive information about future disease risks that is, by nature, preliminary, approximate, and difficult to interpret. Since by law consumers in some states cannot order these tests themselves, they are ordered by doctors affiliated with the testing companies, who do not know the clients/patients personally. And test results can be easily misinterpreted by clients if not explained by a trained genetic counselor or other professionals. Moreover, since there are some diseases for which there are no good treatments or preventives, there are questions of medical ethics, such as whether people are being too glibly encouraged to get information they may wish they never got.

At the same time, the gene test industry is the leading edge of a pending revolution in which diagnoses and treatments will, in many cases, be personalized to individuals’ precise biological details. Already, the FDA has begun to approve drugs with gene test requirements or recommendations. In December, for example, the agency oversaw a label change for the drug carbamazepine—which is used to treat epilepsy, bipolar (“manic depressive”) disorder, and nerve pain—to inform people of Asian ancestry that they should get a genetic test before starting therapy with the drug. People with a certain version of a gene, it turns out—a gene that is particularly common in Asians—have a significantly higher risk of developing an otherwise rare, but serious, skin reaction to the drug.

Similarly, researchers reported last month that a lung cancer drug that has otherwise been disappointing appears to be very effective in the ten percent of patients who have a particular gene variant. Such discoveries can mean the difference between life and death for some patients, and can turn a drug that might have been thrown away by its developers into an overnight money-maker.

The problem is that state laws and regulations meant to protect patients and other users of gene tests vary considerably across the nation. Indeed, many of the same companies that got letters from California received similar letters not long ago from health authorities in New York State, which has perhaps the strictest medical test rules in the nation.

Now is the time for a clear guiding hand from the highest levels of the federal health bureaucracy.

The moves by California and New York are the clearest evidence yet that a federal leadership gap now threatens to undermine the pending benefits of the genomics revolution. “I can buy any number of medicines whose safety has been reviewed but I may not be able to get a test to say which drug is better for me,” Kathy Hudson explains with apparent frustration. Hudson is the director of the Genetics and Public Policy Center in Washington D.C., which has produced a chart that shows the wide variation in state laws and regulations regarding gene test oversight.

One thing that this latest twist shows is that it is not enough to assure patients that the information gleaned from gene tests will not be used to discriminate against them in health insurance or employment. Congress secured that important human right this spring when it passed the Genetic Information Non-discrimination Act. But it took a dozen or so years for the legislation to pass, and the pace needs to pick up.

Consider that back in 2005, Secretary Leavitt responded to concerns about oversight of direct-to-consumer gene tests, saying he would “carefully consider” looking into the issue. More than a year ago, Leavitt announced that HHS was reviewing “existing structures for ensuring that genetic tests are accurate, valid and useful.” Last September, he said, “work is moving ahead rapidly to support genomic medicine in particular and Personalized Health Care in general.”

Meanwhile, tired of waiting, a number of gene test companies did their due diligence and launched, hoping that regulators would either ignore them or ultimately agree that they were in compliance with relevant laws and regulations. Washington remained silent.

In April, the Secretary’s Advisory Committee on Genetics, Health and Society sent Leavitt a carefully researched report on oversight of genetic tests. Among other things, it recommended that the FDA use its authority to oversee the full range of genetic tests and that the Centers for Medicare & Medicaid Services, which oversees proficiency testing for various medical specialties, start a program of proficiency testing for gene test labs to make sure these fledgling enterprises really know what they are doing. It also recommended the launch of a variety of federal programs to help individuals know what they are getting into when they decide to get a genetic test.

To the great frustration of many, Leavitt has not even formally acknowledged receipt of the report, much less hinted at how he will respond.

The advisory committee’s recommendations echo a report released by the Center for American Progress in April, “Genetic Non-discrimination: Policy Considerations in the Age of Genetic Medicine.”

If HHS does not act, the CAP report says, then Congress should pass legislation requiring proficiency testing and FDA oversight. Two Senate bills already introduced, S. 976 and S. 736, could accomplish those goals. The CAP report also calls for a public registry of available gene tests to facilitate consumer education and government oversight. And it calls for the FTC and the FDA to collaborate toward creating advertising guidelines for gene testing companies, and for strict enforcement by the FTC of companies that violate those guidelines.

Without attention from the Bush administration, the fledgling field of genetic medicine could deteriorate into a war among companies and state governments, exacerbated by a turf war among doctors, medical geneticists and genetic counselors as they vie for control over this new and potentially profitable piece of the healthcare pie. Representatives of the major gene test companies quickly expressed a willingness yesterday to work with state government officials to draw up ground rules that can protect consumers and not stifle the nascent industry. Now is the time for a clear guiding hand from the highest levels of the federal health bureaucracy.

Rick Weiss is a Senior Fellow at the Center for American Progress.

Current estimates are that the number of Americans older than 85 will quadruple by 2050, to 18 million from today’s four million. A huge proportion of these people will require some kind of ongoing help with the tasks of daily living. Yet as spelled out last year in a Center for American Progress report by Lisa Eckenwiler, “Caring About Long-Term Care,” the vast majority of our elderly will not get the benefit of professional long-term caregivers because of the lack of resources or lack of available programs in their communities.

The worst thing that could happen is for people to gain extra years of life and wish, for lack of decent care, that they’d had an earlier exit.

In fact, 80 percent of the nation’s long-term care is provided by unpaid caregivers, mostly family and friends. There are many obvious benefits of keeping at least a portion of long-term care in the family, but it is not practical in many cases to expect family members to be able to carry the entire burden. At least 60 percent of those unpaid caregivers are already busy with their own jobs.

Meanwhile, few employers offer assurances of help for employees who need to care for aging relatives. And the Family and Medical Leave Act, which assures up to 12 weeks of unpaid leave for such purposes, still applies to only a fraction of employers and, if anything, has lately come under threat of being weakened by business lobbyists.

As yesterday’s report showed, the need is only going to grow. In 2006, the latest year for which data are available, U.S. life expectancy grew to a record high of 78.1 years, up from 77.8 a year earlier. Death rates from all the major killers dropped, including cancer, heart disease, stroke, high blood pressure and diabetes. In fact, diabetes dropped from the No. 6 leading killer to No. 7, overtaken by Alzheimer’s disease.

In large part this reflects a payoff of years of basic research by federally funded researchers, especially those supported by the National Institutes of Health, according to Robert Palazzo, president of the Federation of American Societies for Experimental Biology. “Thanks to NIH research, millions of deaths from heart disease have been averted, millions more people have survived cancer, and deaths from diabetes have decreased dramatically,” he said in a statement. Yet as Palazzo and others have noted with increasing alarm, the $27 billion agency—considered the crown jewel of U.S. biomedical research—has been flat-funded for five years now.

Clearly we need to renew our nation’s commitment to high-quality research aimed at understanding the mechanisms of the major diseases. But at the same time, we need to develop a comprehensive approach to caring for all the people who will benefit from those discoveries. Eckenwiler notes that among the problems contributing to the long-term care crisis is an overemphasis on research relating to acute medical problems, and an inadequate research focus on medical and social management of the chronic conditions that lower the quality of life for long-term survivors.

This fragmented approach to medicine, which emphasizes specialists focused on their part of a patient’s problems instead of taking a holistic approach to patients’ needs, is out of step with the rising longevity of the American people. And this fragmentation is mirrored in the conflicting payment structures for different kinds of care.

In the short term, it will be important to protect and even strengthen or broaden the protections of the Family and Medical Leave Act. The worst thing that could happen is for people to gain extra years of life and wish, for lack of decent care, that they’d had an earlier exit.

Rick Weiss is a Senior Fellow at the Center for American Progress.

Like a growing number of others, I can no longer pretend that this doesn’t matter.

The orderly and unbiased testing of reality to see how things actually work—the art and science of science—has ever been the engine of better health, higher productivity and greater economic power, not to mention enhanced entertainment and leisure-time options. So it is something of a wonder that so many today eschew it, and so openly.

But while incurious leaders and an undereducated public surely account for much of this disconnect, scientists and the marketers of science deserve blame too, having done so much to lose the public’s trust.

Unkeepable promises, exaggerated claims, financial conflicts of interest. It all starts to sound like the worst of politics and business. So why believe scientists when they tell you that the Earth is going to cook, or that vaccines don’t cause autism, or that life has been living for 4 billion years?

This is an excellent time for a Renaissance of reason. For one thing, the world is not waiting for us to put our lab coats back on. And while there is nothing that says the United States really has to be No. 1 in science, being on top is good for the competitive juices and can, if nothing else, bolster the gross national product. But more fundamental is the simple fact that facts work best. They are the raw materials on which ingenuity and innovation work their alchemy.

It’s not just the facts, Ma’am, of course. “Facts do not speak for themselves,” Stephen Jay Gould once wrote, “they are read in the light of theory.” And not just scientific theory, as Gould probably meant, but political theory too. So yes, when it comes to crafting policies, power and politics will have their say.

But first there has got to be an honest call for facts. And some assurance that the facts that do come in—the ones showing that new drug to be a winner, for example—are not just the ones that were left standing after the evidence for nasty side effects was buried.

The United States has lost a good deal of credibility in recent years, and has even been ridiculed, because of its careless blending of faith and fact. Faith, for example, that government and taxes are bad and that markets will bring us what we need, even as evidence has repeatedly shown that without blue-skies, taxpayer-funded basic research there would be no Internet, no biotechnology, no DNA databases to convict the criminal or exonerate the bystander—not to mention no science for science’s sake, the nonprofitable but hugely enriching enterprise of finding out what the heck we are and where we came from.

We Americans have been ridiculed, but we can fight cat calls with fact calls. My goal is to have history look back at the post-Bush era as the time when evidence was reintegrated into the business of government decision making.