I say this because I was a little surprised to recently find myself the object of an Internet tempest for a few days over an interview I did with my friend, conservative political theorist Robert George of Princeton University. Robbie, with whom I disagree about many things but deeply respect for his willingness to engage in honest debate, understood what I had to say and knew I said so prior to this interview. Apparently, other critics of stem cell research had chosen to ignore my caustic comments about some proponents overpromising cures over the years.

In the interview I said many scientists and their supporters favoring public funding of embryonic stem cell research had gone too far in hyping the prospects of rapid cures following right on the heels of generous government funding. They did. My saying so, however, was hardly the news The American Spectator, First Things, and other electronic conservative outlets made it out to be.

Anyone who has followed my advocacy for embryonic stem cell research would know I have long been critical of claims that funding today means people tomorrow will leap from their wheelchairs and walk. This is me in 2006 describing overpromising of embryonic stem cell research in Wired: “There’s big expectations, a lot of hype.” And saying the same thing at greater length two years ago: “There has been hype and overpromising. … I don’t know if stem cell research will work, I think it’s very interesting, I support doing it, but I think you have to be honest and say there’s a small chance nothing will work.”

I then explained why the hype had grown so loud:

There was such a bitter battle over funding, so one side was screaming that you can’t kill embryos to try and save people and in response, the defenders of stem cell research began to say, ‘look, if you would let us do this research we can save lives. … it was in the heat of that political battle to score points that they [proponents] overstated the case.”

Having lived during the 1990s when the hype machine was spinning full throttle about the curative powers of gene therapy, the clinical wonders that would quickly follow from mapping the human genome, and the frothy promise that genetically engineering plants would quickly cash out in the form of fortified foods such as golden rice that would rapidly solve the nutritional deficiencies of the world’s poor, I am keenly sensitive to the kind of overpromising that occurs when a novel form of science is in search of public funding. The fact that the fight over public funding of embryonic stem cell research had the critics screaming “murder” regarding the destruction of human embryos evoked even more overwrought language from proponents about the speedy cures lying right around the corner.

Since everyone for some reason now seems very interested in coming clean about hype in the embryonic stem cell debate, I thought I might take a quick tour of five of the most outrageous, overhyped claims by critics that have characterized what has passed for debate during the years since George W. Bush addressed the nation from the Rose Garden in 2001 to offer his “compromise” position over public funding of embryonic stem cell research.

Hyped claim #5: The Bush “compromise”

The president tried to offer a “compromise” about government funding of embryonic stem cell research. Government funds could be spent on stem cell lines made from human embryos prior to August 9, 2001, but nothing else. The president said there were cell lines available from 64 embryos for which consent had been obtained to use them in research.

Except there were not. Some of the cell lines were owned by non-U.S. companies who would not share them. Some of the cell lines did not grow well. Some of the cell lines had been generated without informed consent from anyone. What was touted as a brilliant “solution” by many conservatives and not a few middle-of-the-road commentators was nothing more than a ban dressed up as a compromise.

Hyped claim #4: Adult stem cells can do it all

The number of antiembryonic stem cell researchers offering up this bit of hype are legion. The argument goes that since adult stem cells have been used to cure many people while embryonic stem cells have not, there is no need to pursue embryonic stem cell research. Father Thad Pacholczyk, often quoted in right-wing circles, who is a staunch critic of embryonic stem cell research, offered one of a zillion such examples in 2006 of why there is no need to pursue embryonic stem cell research, because there are “dozens of diseases currently treatable using these [adult] stem cells, including sickle-cell anemia, leukemia, spinal cord injury, and heart disease.”

I am not sure what he was talking about regarding spinal cord injuries, which as far as I know remain completely incurable, but it is true that bone marrow transplants have cured a lot of children and adults. And bone marrow is a type of adult stem cell. That is where the truth of this claim ends and the hype begins.

The research behind bone marrow transplantation began in the 1950s. It received generous government grant support for the next 50 years. It still does. Embryonic stem cells were first discovered in 1998. Research involving those cells has received minimal funding from any source since then. As Robert George forthrightly said in our discussion, it is just dishonest not to concede that you are giving up a key line of research if you don’t fund embryonic stem cell work by pretending you know that it can be completely replaced by adult stem cell research.

Hyped claim #3: If embryonic stem cell research is so promising, then why isn’t private research behind it?

A typical example of this absurd claim appeared in The Wall Street Journal where Richard Miniter opined in 2001:

Of the 15 US biotech companies solely devoted to developing cures using stem cells, only two focus on embryos. Embryo stem cell research is at the drawing-board stage – not for lack of funds but for lack of promising research to finance. Venture capitalists have no agenda beyond making money; if they see embryo projects that are likely to bear fruit over the next five to seven years – the usual VC time horizon – they will fund them. That the market is speaking so loudly against embryo stem cell research probably explains why embryo researchers are so eager to reverse the ban on government funding.

It has been echoed in the conservative right-wing blogsphere ever since.

This is hype in a very pure form. No venture capitalist or firm is going to back research in a big way that (a) is just starting out, (b) does not yet understand the basic science involved, and (c) has elicited huge opposition from the then-president of the United States and his supporters in Congress. Governments fund basic, early-stage research. The U.S. government has long been the 100-pound gorilla of such funding. It is only later, as commercial possibilities emerge, that the private sector gets really interested. Keep the NIH out of funding basic stem cell research and few private dollars will flow no matter how promising that line of research might be.

Hyped claim #2: IPS cells are the magical solution to the embryonic stem cell quandary

Conservative columnist Charles Krauthammer led the hype machine on this subject. Back in 2007 an announcement was made that researchers in Japan had discovered how to reprogram adult skin cells to resemble embryonic stem cells. Krauthammer immediately declared Bush had been right to ban public funds for embryonic stem cell research (I thought that had been a “compromise”) since there was now a way to create “a magical stem cell that can become bone or brain or heart or liver” without using human embryos. Magical—really? Could there be any claim more fraught with hype then declaring that any biomedical discovery is ready to go right out of the lab to your doctor’s office?

Making adult cells into embryo-like cells remains the current darling of critics of research involving embryos. But the technique is barely understood and its safety is a huge concern to those working in the area. Not only was it hype to declare in 2007 that the game was over for embryonic stem cells or even to continue to say in 2011 that there is no need to pursue embryonic stem cell research (note, by the way, no cures from IPS—five years and counting) is nothing less than unadulterated hype driven by an agenda utterly disconnected from the nascent state of the science.

Hyped claim #1: Frozen embryos should be put up for adoption rather than used as sources of stem cell lines

The meshugana lawsuit that Dr. James Sherley, a biological engineer at Boston Biomedical Research Institute who works on adult stem cells, has brought is currently holding up NIH funding of expanded embryonic stem cell research. Sherley implausibly argues that permitting more funding for research on stem cells derived from human embryos would harm his work by increasing competition for federal funding.

What has been forgotten about this suit is that it was originally joined by an adoption agency called Nightlight Christian Adoptions, which argued that expanding funding for research on embryos obtained from fertility clinics reduces the number available for use in adoption.

Now the Nightlight folks got the axe from a federal judge and were kicked out of the lawsuit. What needs to be remembered, though, is that far too many critics of embryonic stem cell research, including President Bush, advance adoption and continue to do so as if it were an alternative to either the destruction of embryos at fertility clinics or the use of abandoned frozen ones in research.

This is Bush in 2005: “There’s an alternative to the destruction of life, with little babies being born as a result of the embryos that had been frozen.”

Now I am very sensitive on the matter of unwanted embryos left behind at fertility clinics. In 1999 I published a paper with George Annas and Sherman Elias, “Stem Cell Politics, Ethics and Medical Progress,” in which we first outlined the ethical case for using unwanted frozen embryos at infertility clinics as the true compromise position about where to obtain embryos for stem cell research. It was a good idea then and remains so now.

There have been about 50 reported adoptions of frozen embryos from infertility clinics in the past five years. Few will have any interest in using embryos from couples having infertility problems to try and have a child. And the whole point of using infertility treatment in the first place is to create a genetic tie between the child and one or both parents. Knowing there are hundreds of thousands of unwanted frozen embryos in clinics today means pointing to adoption as an “alternative” to their use in research is utter hype.

While I am on this particular bit of hype, I should add that those who do not favor the use of unwanted and certain-to-be-destroyed frozen embryos languishing in clinics worldwide never ever say what they propose be done with them. Conservatives say destruction is unthinkable, however, since it is inevitable then what are they talking about? ( I suppose this constitutes hypocrisy and not hype.)

There is plenty more hype to be had from what has passed as debate over the past decade or so since human embryonic stem cells were first isolated. I don’t mean to suggest that most of the hype has come from critics rather than proponents. I do mean to suggest, however, that those who live in very fragile houses often constructed of hype ought not be quick to cast stones.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania.

Lots of folks seem to think we have too much regulation of drugs and devices already—among them Paul Howard at the Manhattan Institute and Scott Gottlieb at the American Enterprise Institute—so much so that it is choking innovation to death. But, if that is so, then why are there so many scandals?

One possible answer is that the companies know they have problems but sit on that knowledge. If that’s sometimes (or oftentimes) the case, then we need a regulatory system that can get around that kind of immoral behavior. We don’t have that system.

What we have is a regulatory system that is too skewed toward looking at the earliest stages of research. Moreover, the way it is designed makes recalls almost inevitable. The diabetes drug Avandia is the latest in a long parade of failures of our current post-clinical trial drug approval process.

Avandia went through the usual approval process with the U.S. Food and Drug Administration. The drug was a blockbuster. But sales began to fall after a 2007 study of people taking the drug suggested that Avandia could cause heart attacks and strokes. I first learned about this while serving on a bioethics advisory board for GlaxoSmithKline, the developer of the drug—a panel that was looking at research ethics issues in poor nations. The panel, on which Science Progress Editor-in-chief Jonathan Moreno also served, came to an abrupt halt.

In response, the FDA put a black-box warning on the drug telling doctors of the heart attack risk. GlaxoSmithKline was not happy. There was a lot of back and forth about the safety of the drug. Over the past few months more evidence become public that shed doubt on Avandia’s safety. Worse, it appears the company withheld data about serious side-effects. The FDA appointed an advisory panel this July to consider these allegations, but the panel itself quickly got caught up in charges of conflict of interest among its members. It is likely that more black-box warnings to doctors will follow, should GlaxoSmithKline choose to keep Avandia on the market.

Avandia is not alone. The drug’s problems in the marketplace follow hard on the heels of Prempro, a hormone replacement therapy made by Wyeth Pharmaceuticals, now part of Pfizer Inc., which became caught up in lawsuits alleging it caused breast cancer. More recently, the FDA released a warning about the Afluria flu vaccine, made by CSL Ltd. of Australia, concerning high fever and seizures. Prior to that was Merck & Co.’s widely publicized recall of Vioxx, which came after problems with Astra Zeneca’s Seroquel, Abbott Laboratory’s Meridia, Pfizer’s Rezulin, C.R. Bard Inc.’s G2 filter, Bayer’s Baycoll, Boston Scientific Inc.’s Express Stent, and on and on.

So is there a real phenomenon here or just more PR associated with recalls? And if there are more recalls going on then what is wrong with the oversight of new drugs and devices?  It is not clear from the literature whether there are more recalls taking place in recent years—there is no real database that would show such a trend. There are certainly more stories about recalls and more people studying the objectivity of the marketplace surveillance being done by pharmaceutical, biotech, and device companies.

No one seems to have reliable numbers on recall trends, yet the Institute of Medicine and other groups still warn that the existing system of drug protections after the FDA approval process is complete does not seem adequate to handle the products that are reaching the market. Fortunately, there is a way to fix the system.

The major problem today is that too many lousy or dangerous drugs and devices get to you without adequate safety review because drug and device regulation is heavily weighted in the United States toward early stages of research. Every drug has to be tried in animals to roughly determine safety. Then drugs are introduced into a small number of humans to further check safety—so-called phase one trials. Then dose and mode of administration are checked for safety, biological activity, and signs of effectiveness—phase two. Only after all this safety testing is a drug or device ready to go to phase three clinical trials. In these studies hundreds or sometimes thousands of subjects are recruited to receive the drug or product for periods of time that range in nearly every case from a few months to a year.  Phase three trials are almost always placebo controlled randomized, blinded studies.

So there is a lot of effort to try and make sure that subjects are not hurt in phase three trials. The deaths of subjects in phase one clinical trials, among them Ellen Roche and Jesse Gelsinger in early stage studies over a decade ago seem to have reinforced regulatory anxiety about the risk of deaths in first in-human studies.

Meanwhile, the weakest link is the fourth and final step in the research process—phase four—in which drugs are to be monitored when out in actual use in the world for adverse events and problems. Drug companies sometimes promise to do these trials to get final product approval but don’t. These studies are heavily weighted to support the funders of these studies, Big Pharma, which results in much more rosy reporting then studies done by independent groups.

Reporting of problems in phase four is left to doctors and patients who rarely do so.  And there is no systematic tracking of a subpopulation taking new drugs or other medical products to see what is going on with real patients in real world conditions. Deaths have to mount rapidly and obviously to get regulatory or physician attention before phase four studies are ever seriously undertaken.

But a lack of independent, well designed phase four trials is not the only problem.  Approving drugs based on current standards for phase three testing has its own built-in limits. Testing drugs and devices in randomized, blinded, placebo control trials is great, but it means that approval is given on the basis of highly controlled studies on highly selective populations—often subjects who are not that old, not that sick and are highly compliant. That’s not the real world, where patients take lots of drugs, some legal some not, are poorly compliant, have multiple diseases, and can be very old or very young.

So what looks safe in a phase two or phase three study can prove lethal when given to real people in uncontrolled, unsupervised environments. What’s more, phase three studies are also relatively short. What looks safe after three months exposure or six may not be after three or six years.

The seemingly endless parade of horrors of FDA approved drugs gone bad merits a reexamination of a regulatory system that is not keeping us safe.  The issue is not too much bureaucracy and too much red tape, but a strategy of safety that puts the emphasis in the wrong place—early not late—and then uses techniques that by themselves cannot ensure safety for real people in the long run.

Update August 17 2010: CNN Money reported that the number of drug recalls in the U.S. surged to 1,742 in 2009, up 309 percent from the 2008 level. Recalls so far in 2010 are also on pace greatly exceed previous levels. However, not all of these recent recalls were due to the drugs themselves being unsafe—some were due to problems with the manufacturing process of generic, over-the-counter drugs.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania

Last week the Food and Drug Administration gave its first approval for a clinical trial of an embryonic stem cell treatment. Embryonic stem cells are special because they can grow, or differentiate, into any kind of human tissue. Many believe they hold great promise for treating a wide range of diseases and disorders, from Alzheimer’s to cancer to spinal cord injuries to blindness.

The FDA had put the application from biopharmaceuticals company Geron Corp, which produced the cells, on clinical hold after some mice given the treatment developed tiny spinal cysts. But another animal study found no cysts. The testing will involve patients with recent spinal cord injuries, who will receive infusions of embryonic stem cells that have been differentiated into cells that can produce myelin, the coating that conducts electrical impulses in the spine.

There is no expectation that this cell treatment would magically regenerate spinal cords, though much could be learned from a greater understanding of how new cells integrate into damaged tissue. Rather, the goal is to facilitate some improved potential for movement along with strenuous physical rehabilitation. It is thought that recently injured patients might be more susceptible to improvement.

The company is reported to have spent $150 million to get the trial approved.

The stem cells developed by the company are derived from an embryo that was left over following fertility treatment. It had to be donated with full informed consent by the couple. Geron was able to proceed with the lab work to develop the treatment in spite of the Bush administration policy that severely limited federally funded embryonic stem cell research.  Several years ago the company produced dramatic footage of injured rats that had been treated with the cells and were able to regain movement.

The greatest concern that experts have about the trial is that potent cells injected into the spine might develop into tumors called teratomas. This worry explains the FDA’s cautious approach.  Although there are nonembryonic stem cell treatments for spinal cord injury that have been tried, they have been criticized for inadequate safety data from animals and unclear explanations of surgical procedures. By contrast, owing to the potential harm, novelty, and public controversy, the Geron trial is surely among the most intensively reviewed proposed clinical trials in history.

All this does not guarantee success, of course, nor does it guarantee that no harms will result.  This is biology in the real world, not a computer simulation. But it does establish a reasonable regulatory pathway for human embryonic stem cell treatments for serious diseases that currently have only very inadequate therapies, a milestone that would have been all but political science fiction just a few years ago.

Meanwhile, thanks to the Obama administration’s responsible stem cell policies, dozens of new embryonic stem cell lines are being approved for federally funded research under grants from the National Institutes of Health. This should lead to more academic centers engaging in targeted research with these and other stem cells sources.

While the FDA’s approval of the Geron trial is just a small incremental step forward for potentially lifesaving research, it represents a significant break from past bickering, and raises the inkling of hope that someday we may wonder what all the shouting was about.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

According to FDA, Pathway Genomics is in fact selling what appears to be a medical device under section 201(h) of the Federal Food Drug and Cosmetic Act, which defines a medical device as an instrument that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” As the Washington Post reported, the tests would scan consumers’ genes “for a propensity for Alzheimer’s disease, breast cancer, diabetes and other ailments.” Up until this point the FDA has exercised its enforcement discretion to refrain from regulating direct-to-consumer genetic tests as medical devices.

Other companies offering these types of tests by mail have maintained that the products they sell are for informational purposes only. Despite repeated calls for FDA to set rules for genetic tests during the Bush administration, the lack of federal attention came into sharp focus in 2008, when California and New York sent “cease and desist” letters to several companies offering direct-to-consumer tests through the mail, including 23andMe and Navigenics. Along with a few others, these companies won approval from the state of California by demonstrating that they used up-to-date genetic research to back up their claims, had physicians and genetic counselors on staff to help customers, and contracted their genetic sequencing out to labs that were state-licensed and certified according to federal standards under the Clinical Laboratory Improvement Act, known as CLIA. Navigenics successfully applied for approval under New York’s licensing board and now markets mostly to physicians, but 23andMe and Pathway are not approved and their test cannot be ordered in New York. In fact, Walgreens did not plan to sell the Pathway test kit in any of its New York stores.

For years, public and food industry officials have maintained that the American food supply is one of the safest in the world. Yet in 1999, the Centers for Disease Control and Prevention  estimated that food borne pathogens caused 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths annually in the United States. Now, more than ten years later, American families still face the same meaningful risks of illness or death from their food. While incidents involving some foodborne microbes have declined significantly, others have not abated in years. While incidents involving some foodborne microbes have declined significantly, according to the CDC, others have not abated in years.

These everyday dangers are evident from periodic, dramatic nationwide outbreaks of foodborne illness. These range from the infamous 1993 Jack-in-the-Box hamburger E. coli outbreak that struck hundreds, including many children, to the recent 2008 salmonella outbreak—the largest ever—that federal officials mistakenly attributed to tomatoes, before belatedly identifying the Mexican jalapeno peppers that sickened over 1,200 Americans.

Federal food safety officials openly acknowledge the persistence of this public health threat. Last October, Commissioner of Food and Drugs Peggy Hamburg echoed the CDC’s 1999 statistics in Senate testimony, acknowledging that every year “millions of people in the United States suffer from food borne illness, hundreds of thousands are hospitalized, and thousands die.” This staggering toll in health is matched by a tremendous economic impact. Last month, the Pew Charitable Trusts and Georgetown University concluded that the American economy incurs annual economic losses of $152 billion from medical costs, disability, and losses to quality of life attributable to food borne illnesses.

Deficiencies in the regulation of the American food supply constitute the most serious and persistent gap in American consumer protection. But solving the problem requires a combination of legislation to strengthen oversight authority, resources necessary to implement reforms, and an administration with the courage to take on difficult political choices. Thus far, that elixir has proven as elusive as health insurance reform. Sporadic congressional interest, historic infighting between the two principal agencies responsible for food safety, the Food and Drug Administration and the U.S. Department of Agriculture, and effective opposition from food producers and agricultural interests, have all but assured for many years that meaningful food safety reforms did not occur. But the chances of real reform are looking healthy.

This year, the possibility of action is significant. In the House of Representatives, Congressman John Dingell’s (D-MI) H.R. 2749, the Food Safety Enhancement Act of 2009, moved quickly last summer through committee markup and passed the House by a commanding 280-150 vote. The legislation would provide FDA with stronger authority to conduct inspections, mandate performance standards and preventive controls, and review records in order to trace outbreaks and unsafe food imports. The FDA would also strengthen nationwide laboratory capacity to test food samples and gain clear authority to mandate recalls of contaminated food. While the agency can mandate recalls for medical devices, it currently lacks the authority to do the same for contaminated food products. According to a 2010 Government Accountability Office report, “Limitations in FDA’s food recall authorities heighten the risk that unsafe food will remain in the food supply.” Under the proposed legislation, the agency would even have the power to quarantine regions where it suspects outbreaks originate. An effective combination of regulatory reforms and legislative compromises, the bill has broad bipartisan support, as well as the support, or absence of opposition, from regulated food industries and agricultural interests.

As Republican Congressman Shimkus (R-IL), a leading member of the House Energy and Commerce Committee, said, “We just couldn’t sit on the sidelines anymore as we saw case after case of food-borne illnesses. We had to come together in a way to address this.”

In the Senate, Richard Durbin’s (D-IL) S. 519, the FDA Food Safety Modernization Act, moved swiftly by voice vote through committee and is expected to reach the floor this month. The legislation has been amended to reflect reasonable compromises that have the bipartisan support of key senators, including Senate Health, Education, Labor, and Pensions Committee Chairman Tom Harkin (D-IA), fellow Democratic Senator Chris Dodd (CT), and Republican Senators Mike Enzi (WY) and Judd Gregg (NH). Like H.R. 2749, the Senate legislation strengthens FDA authority to regulate food, increase inspections, establish science-based standards, and better cope with the ever-expanding volume of imported foods.

Just as important, the Obama administration has heightened enforcement of consumer protections, selecting new, like-minded leadership at FDA and USDA committed to better coordinating their work and improving federal oversight of food safety. Commissioner Hamburg is a physician and public health leader who considers food safety “a core public health issue.” Deputy Commissioner for Foods Mike Taylor is a widely respected leader in food safety, having served as USDA undersecretary for food safety, as well as an FDA deputy commissioner under former commissioner David Kessler. At USDA, deputy undersecretary for food safety Jerry Mande worked with Taylor at FDA and Dr. Elisabeth Hagen, the department’s chief medical officer, has been nominated as the new undersecretary for food safety. Finally, the administration has matched its rhetoric and appointments with funding: the FDA’s Fiscal Year 2011 budget calls for a $326 million increase to “transform” food safety through $88 million in appropriations and $239 million in industry-funded user fees.

If the Senate successfully completes ongoing negotiations on a managers’ amendment and can bring S. 519 to a floor vote, the remaining steps to enacting comprehensive food safety reforms will be few. With few major substantive differences between the House and Senate bills, a bipartisan Congress would have to stumble badly to fail to deliver a law to President Obama for his signature before it adjourns this year. Provided enactment of these new authorities can be matched with equal commitments in funding, the federal government will have secured and begun implementing landmark reforms that will improve the safety of the food supply and better protect the health of all Americans.

Paul Kim is a partner at Foley Hoag LLP, and former deputy staff director for health under Senator Edward M. Kennedy and counsel to Congressman Henry Waxman.

The coordination is an important move that will ideally shape a faster approval process for certain life-saving treatments, while also ensuring that therapies are safe and effective when they reach the marketplace. Moreover, this sort of tighter coordination is necessary for integrating personalized medicine into the health care system, as Michael Rugnetta and Whitney Kramer explained in a report last year.

The collaboration consists of three components:

• NIH and FDA will form a Joint Leadership Council, chaired by NIH Director Francis Collins and FDA Commissioner Margaret Hamburg. Six additional members drawn from senior leadership at each agency will complete the membership. The council will share information in order to promote “the translation of basic and clinical research findings into medical products and therapies,” according to the council charter.

• The two agencies will make available $6.75 million over three years to fund projects that advance regulatory science—$2 million per year from NIH and $250,000 from FDA. The notice of the funding opportunity was issued today and is likely to support from two to four projects. Example projects mentioned in the announcement include: development of new methods for identifying adverse effects from drugs and devices; crafting new clinical trial designs, particularly for rare diseases that affect small populations; building new assessment tools for emerging fields, including RNAi therapy, nanomedicine, and personalized medicine.

• NIH and FDA will hold a public meeting this spring to solicit additional input on how to improve regulatory science and translational research. Results from that event may point the way to further public outreach.

“The need for such collaboration has never been more pressing,” said Collins, acknowledging that in the past, NIH may not have always brought FDA into the research process early enough, as well as that FDA may have lacked sufficient scientific knowledge of certain emerging technologies.

Back here on the ground, though, it’s still 1958.

As things stand in the United States, food producers do very little to keep bacteria, as well as other common food contaminants such as viruses and chemicals, in check. Dr. Marion Nestle is a New York University food specialist who has worked with the Food and Drug Administration to create food policy. “Right now, we don’t have a food safety system,” she tells Science Progress. But that is poised to change. This spring, the House of Representatives passed a plan to finally apply the same sort of risk-based strategy to our food supply as NASA uses for astronauts. (The legislative vehicle in the House is H.R. 2749, the Food Safety Enhancement Act.) The Senate is set to take up the debate in the next few weeks.

The fact is, there’s a crying need for some sort of strategic intervention. Odds are that you have a few unpleasant memories of eating something that made you sick—according to the Centers for Disease Control, 76 million Americas get sick from food each year, some 325,000 of whom end up in the hospital. “These are way more than tummy aches,” says Bill Marler, a Seattle attorney who specializes in food outbreak cases. During the infamous 1993 Jack in the Box outbreak, Marler represented a seven-year-old girl who spent 42 days in a coma. Once she came out of it, she had to learn to walk again. Then there are the 5,000 or so Americans who actually die each year from something they ate. People like Kyle Allgood, a two-year-old Utah boy whose mother fed him shakes blended with spinach in a bid to slip something healthy into his diet. The spinach, alas, was infected with a mutant strain of E. Coli known as 0157:H7. Kyle’s kidneys were under attack, and proved outmatched.

Safe food for the rest of us

The genius of the Hazard Analysis and Critical Control Points system, as NASA’s approach is known, is that it forgoes the myth that all foods are created equal and all food processing is equally risky. Vegetables often eaten raw, like the spinach Kyle Allgood ate, deserve to be tracked with a closer eye than produce that is, in common practice, heated to a kill point before it gets to the table. Fruits that producers cut into on the farm are also a risk—for instance in operations where harvesting and processing happen in the same space. The HACCP plan takes what science knows about what makes certain foods and certain processes a risk and uses our limited food safety resources to zero in on those weak points in the system. With those points identified, the Food and Drug Administration can, finally, come up with a plan that directs its attention where it is most needed The mind-blowing truth is that the FDA today inspects food facilities somewhere on the order of once a decade. Under the bill currently up for debate in Congress, low-risk facilities would see that rate increase to one visit every year and a half to three years. Higher-risk facilities would be inspected every six to twelve months.

There are a number of other provisions in the plan that aim to do one simple thing: give us more knowledge about where what we eat is coming from. As things stand, our dinner plates are really black holes of information. Where did that tomato come from? That avocado? That grated cheddar cheese? The truth is that that information is so scattered, so hard to find, that it very nearly doesn’t exist. No more, should advocates in Congress get their way. If the plan does pass, food will have a history. Under new traceability provisions, anyone who produces food in the United States will have to keep records of where the food came from before it got to them, and where it went when it left their shop. (There are exemptions for small farmers and direct-to-consumer operations like farm stands. More on that below.) Big operations will have to keep those records electronically, which is enormously helpful as public health officials start to look for patterns when outbreaks occur. And food facilities will—amazingly, for the first time—get unique identification numbers, so we know who’s who.

Fairly simple changes, but a significant enough shift from the current state-of-play to be revolutionary.

Because the fact of the matter is that not knowing where what we eat comes from causes all sorts of problems, particularly in a day and age where we might be eating a West Coast cucumber, East Coast corn, and soybeans from China all in the same meal. (Food importers will have to abide by many of the same requirements as domestic food operations.) To be fair, part of the challenge is that nature makes it tough to track exactly what of what we’ve eaten is making us ill. Common food-borne bacteria—E. Coli, Listeria, Salmonella—incubate for up to a few days. Donna Rosenbaum started Safe Tables Our Priority, or S.T.O.P., after her seven year-old daughter’s best friend was the first life claimed during the ’93 Jack in the Box outbreak. “What you’re throwing up today isn’t what made you sick,” she explains. But the bigger problem is that knowing so little about where and how our food was made means that, when coupled with a distributed food supply, what could be limited eruptions of food poisoning turn into full-blown outbreaks and public health debacles. In one 2007 case, more than 1,300 people in 43 U.S. states got sick from a strain of Salmonella. Researchers soon found that all had eaten fresh salsa. Beyond that, though, mystery and confusion reigned. First jalapeño peppers became the scapegoat. Then tomatoes.

Said Colorado Democrat Rep. Dianna DeGette during one congressional hearing, in a statement that would be comic if not for the thousand-plus people who suffered from the outbreak, “We could never really figure out what’s wrong with the salsa.”

“If you had better data,” says Bill Marler, “you could say ‘It’s from this lot from this day and this facility,’ rather than, ‘We’re recalling all the tomatoes.” That confusion brings tragedy. In Kyle Allgood’s sad case, the FDA knew for days that something was making people sick, but lacked enough information to pinpoint the particular cause and ask producers to pull their spinach from the market. Under current law, food recalls are all voluntary. Under the new plan, the FDA would be newly empowered to order a recall when conditions warrant.

Better data, especially in electronic form, would give public health officials a fighting chance at detecting and stopping outbreaks at their front end, rather than resort to simply cleaning up a mess once it has gotten out of hand. The plan before Congress would direct the CDC to develop a new epidemiological surveillance system that scours the data for signs of troubles in the food supply. What’s more, the public would be given access to generalized sets of that data. The Reverend Henry Whitehead, a medical amateur, played a role in determining how cholera works when he used publicly available data to track it back to its source during London’s late-19^th century cholera outbreak. Who’s to say that, with food data posted online, one of us might not help to spot and stop an outbreak before it spirals out of control?

Seasoning a plan for the national appetite

By anyone’s measure, government officials, especially those in the FDA and CDC, would be given considerable new power. When it comes to food safety, there will be more officials with more fingers in more pies, and that has some people worried. When Congress was considering H.R. 2749, there was an explosion of interest in the bill in the sustainable food movement, with a particular worry over how it would impact small farmers and farmers markets—exactly the sort of personal, people-centered food production and distribution many of us would like to see flourish.

And then there was the response on the political right, where the bill was read as an attempt by the federal government to wrap its hands around the American food supply, a particular sensitivity for those who prefer small government. (References to H.R. 2749 as the “Hitler Act” aren’t even the most heated thing you’ll read about it if you spend time on conservative blogs.) On the political right, what causes the most ire was the ID numbers for food facilities and the bill’s “traceability” requirements—which shares many of the same outlines as the National Animal Identification System, now voluntary, which some worry might shift into a mandatory livestock tracking program.

But for food safety advocates, the concerns with the new plan, and the Internet clamor that accompanied them, are misguided and overblown. Negotiations in the House dropped the annual per-facility registration fee from $1,000 down to $500 in deference to representatives from coastal farm states worried that the cost—an attempt to provide FDA with a steady pool of funding to pay for increased inspections—would simply be too burdensome for the small local cheese maker or family farm. Some small producers, particularly those who deal directly with consumers, are exempt from many of the plan’s more demanding requirements.

That said, those who have been tracking and bemoaning the rate at which American foods make Americans sick don’t see small size as a justification for not producing safe food. “Whether or not Kraft should meet the same standard as somebody who produces 20 pounds of cheese for their neighbors is one question,” says Rosenbaum, “but if you’re capable of producing a product that can kill someone, then you have to be on the lookout for that.” She cites so-called “bathtub cheese.” A delicacy in Latino communities in the United States, the homemade cheese also has a history of carrying dangerous levels of Listeria, and has been known to cause spontaneous abortions in pregnant women. When it comes to focusing on risky ingredients and risky ways of making food, “I can’t think of any reason why small farmers should be exempt from doing this,” says Nestle.

As for fears from the right that a risk-based food safety plan is Congress’s back door into a mandatory animal-tracking future, the truth is that thanks to the might of the agriculture industry and Congress’ weakness in the face of it, the plan stops well short of keeping tabs on every cow in America. In the United States, meat is the purview of U.S. Department of Agriculture, and the plan now before Congress limits itself to the Food and Drug Administration’s areas of oversight.

Concerns from the right, left, and middle need to take into account the fact that our current reactionary food system hurts farmers, big and small alike, and has a demonstrably negative impact on the ability of those who make food to live off their labors. When we can’t manage to figure out, as DeGette put it, “what’s wrong with the salsa,” everyone who grows or produces something that goes into the salsa suffers. When peanuts are making people sick, as we saw in this spring’s Salmonella bacteria outbreak that was eventually traced back to two peanut processing plants in Georgia and Texas, wary consumers swear off all peanuts, not just those that are actually no good. Produce rots in the fields. Good producers suffer. In the ’07 salsa outbreak, tomatoes were ultimately cleared, within the margin of reasonable doubt, with having anything to do with the Salmonella contamination. That was little consolation for the U.S. tomato industry, which lost an estimated $100 million as the situation dragged out for six long and destructive weeks.

With better data, government health officials are given better odds at detecting an outbreak early, isolating the cause, and issuing warnings that actually eliminate the threat without causing collateral damage on innocent producers. And what has happened in the past is that government safety officials, burned by having reacted slowly to outbreaks in the absence of solid information, drag their feet on lifting warnings once the actual health threat has passed—meaning that our reactions to dangerous foods in the United States now carry the double-whammy of both being too late for consumers and going on too long for producers. When bad food is making people sick, the goal, says Bill Marler, “is to hold the people responsible who are actually responsible”—both perfectly sensible and a sea change from how we currently do things.

A fresh start for FDA

Whether the plan, if it indeed passes the Senate as expected, manages to target food safety risks while allowing small producers to flourish and food producers of all sizes to thrive free from too much government involvement depends in large part on the Food and Drug Administration. The FDA’s track record when it comes to being smart about making food safe is, by general consensus in and out of the agency, decidedly mixed. But there are hopeful signs. Just last week, the agency opened the doors on a new online Reportable Food Registry where producers can quickly inform FDA when a case of food contamination crops up. And new administrators appointed by the Obama administration are pushing to make the agency more transparent and engage the public in its work. During this spring’s Salmonella peanut outbreak, for example, the FDA reaction reflected a more aggressive and considered approach, using its website to post as much as it knew about what was making people sick, in as timely a way as possible, including pointing out what outside scientific experts had to say.

The hope is that by calling on the FDA to use what NASA and others have figured out about managing food risks, and by providing them with the resources necessary to actually put that knowledge to use, we can shrink the number of outbreaks that occur, spot them when they happen, limit the damage they do, and return business back to normal as quickly as possible. It’s too late for Kyle Allgood and the many thousands of other Americans killed or seriously injured by what they ate. But we owe it to them to use the best of what science knows to give the rest of us a fighting chance.

Nancy Scola is a writer in Brooklyn, NY.

A public registry would give patients, their doctors, and their parents access to information essential to making informed decisions about genetic testing, Zonno said. It should include the name of the laboratory performing tests, the name of the test developer, and facts about the test’s ability to enhance existing care.

Genetic Alliance suggested that the National Center for Biotechnology Information maintain the registry and that the FDA oversee it so information could be combined with other genetic resources. One such resource already available from the NCBI, GeneTests, provides “current, authoritative information on genetic testing and its use in diagnosis, management, and genetic counseling.” A public registry with the characteristics Zonno recommended would be more comprehensive than the current GeneTests system.

When FDA sends warning letters to pharmaceutical companies, only some are made public. After FDA released a group of these letters last year, former CAP senior fellow Rick Weiss wrote that although the “rare bit of transparency” was good news, the delay in disclosure leaves time for patients and physicians to be affected by the companies’ “bold twists of truth.” In a warning letter to Novartis Pharmaceuticals concerning the ADHD drug Focalin XR, FDA warned Novartis to remove the claim that the drug’s benefits are sustained for over six months since the effectiveness of Focalin XR had never been studied beyond seven weeks. Over at TechPresident, Nancy Scola considers a new open document management project, DocumentCloud, that could support this sort of transparency.

The Transparency Task Force, formed in January to address the Obama Administration’s Transparency and Open Government agenda, is led by FDA deputy commissioner Joshua Sharfstein. The task force is considering all views including supporters of strong trade secret protection and a comprehensive report will be submitted to FDA commissioner Margaret A. Hamburg in five months.

The FDA defines counterfeit medicines as “fake or copycat medicines” that may be contaminated, contain the wrong active ingredients, or contain the wrong amount of ingredients. The FDA Counterfeit Drug Task Force is currently improving their ability to track and trace medications in a manner similar to tracking systems proposed to speed contaminated food recalls. Ilisa Bernstein, director of pharmacy affairs in the Office of the Commissioner at the FDA, explained the new efforts at the American Enterprise Institute’s “The Global Impact of Fake Medicine” event yesterday.

The Prescription Drug Marketing Act of 1987 requires drug distributors to record the chain of custody, or pedigree, of drugs to increase accountability and transparency, but its implementation is challenging, Bernstein said. Radio-frequency Identification tags, small bar codes, and other electronic technologies are currently used to track drug products, but some companies are slow to adopt them. In addition to boosting traceability, the United States can toughen penalties for counterfeit drug manufacturers to discourage the practice, Bernstein said.

Image: NSF

Paul Blumental explains the importance of the task force over at the Sunlight Foundation Blog:

This transparency effort may be one of the more important ones for the administration, as most Americans rely on the FDA to provide accurate information as to whether a drug or device is not to be used, or what dangers may exist. An FDA that does not have the trust of consumers would assuredly cause increased risks in health decisions and lead to profit loses for companies manufacturing drugs and devices. Transparency is essential to instill trust in this area.

For the moment, posts on the blog indicate that the first order of discussion will be the questions posed in the Federal Reister notice of last week requesting comment on the agency’s operations. First up, “How can the agency better explain its operations, activities, processes and decision making?”

In effect, the blog functions much like the Office of Science and Technology Policy blog did when collecting information on the president’s scientific integrity memo. It puts the contents of the official Register notice online and grafts comment functionality onto the content—offering a method for simple feedback that should have been available on Regulations.gov long ago. The advantage here is that the conversation happens on the agency site, where it can include ideas presented in the voice of key policymakers, be surrounded by information and branding specific to the agency, and attract input from those already paying attention to agency efforts. Feedback is still welcome in the official online docket system, but the discussion in the comments is, at the moment, far more lively.

(HT: GenomeWeb)

Rep. John Dingell (D-MI), who co-sponsors the “Food Safety Enhancement Act of 2009″ with Rep. Henry Waxman (D-CA), noted on the committee site that “Consumer confidence in the nation’s food supply is low.”

The legislation would further give the FDA greater power to prevent problems through heightened inspection regiments, as well as the authority to initiate mandatory recalls in the event of a contamination or outbreak.

Waxman notes as well on the committee site that the poor state of the food safety system is a threat not just to public health, but to food companies themselves. Hence, Layton reports that “the proposal would put greater responsibility on growers, manufacturers and food handlers by requiring them to identify contamination risks, document the steps they take to prevent them and provide those records to federal regulators.”

Such a system would also present an opportunity for the FDA to provide relevant portions of those records to the public in an accessible format—and the bill summary indicates that the registry would require unique identification numbers for food facilities and importers. This information could make a welcome future addition to Data.gov, so that third parties and citizen groups can keep up with the safety of what’s in the their shopping cart.

Image: AP/John Bazemore

However, a budget increase of 5.7 percent, to $2.4 billion, along with Commissioner Hamburg and deputy Sharfstein’s plan for improving food safety through partnerships with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, the National Institutes of Health, the pharmaceutical and biotechnology industries, individual states, and various academics should bring hope for the safety of the U.S. food supply yet. The FDA and USDA will continue to follow the salmonella outbreak from contaminated peanut butter earlier this year that sickened hundreds of Americans and is responsible for several deaths.

Referring to the outbreak, Hamburg and Sharfstein write: “It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls.” With this recognition, Hamburg and Sharfstein intend to work with Congress to update food safety laws that will hopefully prevent future “Peanutgates.”

In the spirit of public health, Hamburg and Sharfstein acknowledge “the urgent need to develop and produce a vaccine against H1N1 influenza virus,” which is currently being studied at the FDA. “The agency’s success will be determined by the nation’s access to a safe and effective vaccine,” said Hamburg and Sharfstein.

Image: flickr.com/Robert Couse-Baker

“Who is best equipped to protect the consumer from dangerous drugs and medical devices: regulatory agencies or the courts?” Mark Agrast, Senior Fellow at the Center for American Progress, asked a panel of experts during his introductory remarks at the CAP-hosted event “Protecting America from Unsafe Drugs and Medical Devices: Federal Preemption or Consumer Protection?” on Wednesday. The panel included Georgetown Law Professor David Vladeck, Director of Federal Relations for American Association for Justice John Bowman, Arnold and Porter LLP Partner Robert Weiner, and Alliance for Justice President Nan Aron.

Last year’s Supreme Court case Riegel v. Medtronic held that a 1976 federal law that regulates medical devices expressly preempts common law claims challenging the safety or efficacy of FDA-approved medical devices. The decision “turned established law on its head in courts around the country,” Aron said as she introduced “Hit and Run,” a short documentary about the case. She posed a question to the audience on the issue of preemption, asking: “ Should the FDA’s approval of medical devices, such as a defibrillator, preclude individuals from getting access to the courts if they are harmed?”

The Medtronic ruling stands in contrast to the Court’s decision this March in Wyeth v. Levine that federal law did not preempt state tort suits about drug warning labels. “Wyeth was an enormous victory for consumers,” said Vladeck. “The ruling drives a stake through the heart of Bush’s “preemption by preamble” program … I think that Wyeth is a signal that this very ambitious program by the Bush administration to reshape American tort law through regulatory preamble is probably doomed to judicial invalidation.”

The panelists discussed legislation introduced by Reps. Frank Pallone, Jr. (D-NJ) and Henry A. Waxman (D-CA) and Sen. Edward M. Kennedy (D-MA), known as the Medical Device Safety Act, which would reverse Riegel and permit consumers to sue manufacturers of faulty devices in state court. Vladeck and Bowman, who favor the bill, argued that tort cases are an important “backstop” for federal regulation which not only deter manufactures from knowingly selling flawed devices and provide injured consumers with compensation, but also bring information to light of which may not have been available to the FDA.

In contrast, Weiner said, “I believe in regulation, but regulation by litigation is inefficient and inappropriate,” calling juries in tort cases “less democratic than the regulatory process.” In addition, Weiner asked whether it was fair to ask a device manufacturer to compensate injured parties when the company acted in accordance with the FDA’s instructions, and argued that the fear of civil liability can deter manufacturers from bringing new and innovative devices to the marketplace.

As an alterative to litigation, Weiner suggested an industry-wide, no-fault insurance-style system. But Bowman argued that such a system would not provide adequate compensation or take proper account of the circumstances of specific cases.

Ultimately, the panelists agreed that more effective regulation would help reduce the need for lawsuits but differed over whether, given the limited ability of the FDA to protect consumers from harm, the tort system is a help or a hindrance.

Drug industry advocates are quietly allying with some of their longtime critics pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.

President Barack Obama bolstered hopes for a breakup last Saturday when he named two public health specialists to the agency’s top positions and appointed an advisory group to reassess the nation’s decades-old food safety laws.

Drug executives see a chance to speed up drug approvals that have lagged amid a drought of new products, provided their regulator is no longer distracted by high-profile food-safety breakdowns.

Other ideas have also been floated in the past for the creation of an over-arching food safety agency. But if a split is in the works, there have to be sufficient resources ready to tackle the problems FDA will still face, which include missing review deadlines on 20 percent of 2008 drug applications (according to the AP), a problem that could be compounded by workforce issues. As Virginia Cox points out in her chapter on FDA in Change for America: “Almost 50 percent of [FDA] managers and supervisors are eligible for retirement in the next five years.”

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.

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.

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

Already, the FDA runs the Critical Path Initiative, which aims to enhance the product development process by incorporating new tools for product evaluation. These include biomarker assessments, which aim to correlate the presence of certain genes or proteins to the likelihood that a patient will respond to a new medical product. And just a few months ago, the FDA entered into a partnership with Medco, a pharmaceutical benefits manager for more than one fifth of the American population, which can give the FDA access to a plethora of de-identified patient information on tests, prescriptions, and clinical outcomes. The partnership provides an economical alternative to clinical trials, as Medco can data mine reimbursement claims from very large, diverse, real-world cohorts. From this data, Medco and the FDA can then infer the predictive power of genetic tests and identify dosing trends—knowledge extremely valuable to personalized medicine as a whole, because the FDA can then issue more clinically effective guidelines for drug administration.

Unfortunately, dramatic changes will be necessary before the U.S. healthcare system can fully incorporate personalized medicine into everyday clinical practice. Two major priorities include: adoption of digital health records and a reformed reimbursement process that rewards positive clinical outcomes instead of just additional procedures and tests. Last year the Department of Health and Human Services put together a small group called the Personalized Healthcare Initiative which issued a 300-page report on personalized medicine. Additionally, the Secretary’s Advisory Committee on Genetics, Health, and Society, or SACGHS, at HHS also released a behemoth report on pharmacogenomics. It is time for HHS to start taking comprehensive action and coordinate across relevant agencies: from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, to the NIH and the Agency for Healthcare Research and Quality.

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

Okay, so according to the Lyndsey Layton in today’s Washington Post, the FDA has issued clear information that major brands of jarred peanut butter on grocery shelves are not subject to the recall. But there are hundreds of products affected–so many that the FDA has set up a database to track them all. If you want to stay on top of future recalls, the agency actually has a dedicated Twitter feed. (Science Progress is following.)

This is all the result of Salmonella in one Georgia plant. As Rick Weiss pointed out in his Monday column, it’s “a vivid example of our intensively centralized food production and distribution system.”

Cartoon: Mike Luckovich, Atlanta Journal-Constitution. From the Cartoonist Group.

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.

Geron’s trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site 7 to 14 days after the injury occurs, because there is evidence the therapy will not work for much older injuries. …Geron’s therapy involves using various growth factors to turn embryonic stem cells into precursors of neural support cells called oligodendrocytes, which are then injected into the spinal cord at the site of the injury.

He is careful to note that this is still a very early stage in the process, and that it could be years before the therapy, if successful, could be widely available. Geron officials quoted express tempered expectations, emphasizing that the trial will focus on safety.

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.

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.

Basic Books

Change for America: A Progressive Blueprint for the 44th President

Change for America is a joint project between CAP’s sister organization, the Center for American Progress Action Fund, and the New Democracy Project, and offers recommendations for the next president and administration on priorities for a broad swath of executive branch departments and offices. Cox spent nearly a decade at FDA and the Department of Health and Human Services, and is now senior vice president at the Consumer Healthcare Products Association. Her recommendations focus on restoring the reputation of this embattled office, which has lost more than 1,000 scientists over the past few years in the face of insufficient funding and a mushrooming workload. Here’s a look at some of the key guidance she offers:

Increase Funding and Recruit and Retain a Workforce That Can Keep Pace With New Technological Demands

“Less than 4 percent of [the FDA's] workforce is under 30 years of age, and 44 percent are over 50,” she explains. “Almost 50 percent of its managers and supervisors are eligible for retirement in the next five years.”

Protect the Food Supply

The agency released a comprehensive Food Protection Plan in November 2007, but in the intervening year, the Bush administration declined to request funding for implementation. Cox recommends that the president-elect and his transition team work with Congress to appropriate the necessary funding and give FDA the necessary authority to implement the plan. Moreover, FDA should implement science-based controls for food safety monitoring and require that manufacturers can regularly assure the FDA that they are producing safe products. Food safety is important to avert contamination like the salmonella outbreak of this year, and the potential for a bioterrorism attack on the food supply is all the more reason to act.

Improve Drug Safety

The new administration must, within its first year in office, make sure that the FDA implements plans to conduct more thorough postmarket monitoring to ensure that drugs are still safe after they’ve gone on sale to the public.

Reduce Risk From Abroad

“A recent GAO report showed that 80 percent of all drugs sold in the United States are made, in whole or in part, overseas,” Cox writes, and FDA needs to make sure that those pharmaceuticals and other products are safe before they enter the United States. “The new administration will need to develop and implement a comprehensive risk-based approach to overseeing foreign inspections.”

Long-Term

Beyond the first year in office, Cox argues that FDA must set up protocols to ensure the safety of products made from cloned or genetically engineered animals (an issue Rick Weiss has covered here and here). As well, the agency must adapt to assure the safe and environmentally-friendly use of nanotechnology (see Weiss’s coverage here and here) and monitor the judicious application of genomic research for personalized medicine (Weiss, again).

Finally, FDA has an important role to play in addressing the deceleration of drug development through its Critical Path Initiative, which is designed “to help modernize the drug-development system by creating a process to identify new critical therapies, to prioritize innovation, to work with the nongovernmental scientific community, and to streamline processes,” but requires administration support to move forward with a more detailed plan.

For full listing of chapters in the book, including several that are available for download now, in advance of the January 5 release, visit the CAPAF project page.

In January 2008, scientists at the J. Craig Venter Institute announced that they had created the first complete synthetic genome, setting the stage for the complete “reprogramming” of an organism with synthetic DNA. While the ramifications of this accomplishment are stunning, the news itself was not a surprise to those who have followed the progress of biotechnology research.

Technologies that can “read,” map, and manipulate the genetic code of living organisms have escalated in power and capabilities over the past 30 years, yielding an unprecedented amount of data and a more sophisticated understanding of how genetic materials give form and function to living cells. This new knowledge has, in turn, given rise to a new engineering discipline for living organisms—a discipline that has become known as “synthetic biology.”

As evidenced by the Venter Institute announcement, synthetic biology seems to be on the brink of two noteworthy accomplishments: to be able to “streamline” and redesign the genetic material of living organisms to make them operate more efficiently; and to design and assemble entirely new, artificial life forms from scratch.

How Synthetic Biology Works

According to the tenets of synthetic biology, living organisms are made up of discrete components that perform in distinctive ways, much in the same way as the functions of transistors and other electronic components can be assembled first into circuits, and then into systems designed to accomplish specific tasks. In synthetic biology, “bioengineers” are developing an inventory of biological parts, which they sometimes refer to as “biobricks,” using chemical ingredients and equipment that are common to any modern biology lab. Like electronic components, the researchers claim, these biobricks—which include genes and chromosomes, as well as proteins that can sense and report activities within a cell—can be assembled and programmed to compel organisms to operate in specific ways, or to produce custom chemicals that can later be “harvested” from cells and sold.

Both the discipline and the budding industry of synthetic biology are made possible by two concurrent technological trends. One trend is the increased power, sophistication and availability of technologies for sequencing genomes and for synthesizing and assembling DNA molecules into long strings of functional genes and genomes. The second trend is the rapidly decreasing cost of these powerful technologies. The productivity of sequencing technologies has increased 500-fold over the past 10 years, and is doubling every 24 months. At the same time, costs have declined from $1 to less than $.001 for each base pair sequenced.[1] Similarly, the productivity of DNA synthesis technologies has increased by a factor of 700 over 20 years, doubling every 12 months. The accuracy of the synthesis process has increased as well, while costs have dropped from $30 per base pair to less than $1 over the same period.[2]

These advances in automated processes and improved chemistry have made it possible to make large quantities of a wide range of moderate-length DNA sequences. The process is now so easy to do that many suppliers accept orders for custom DNA sequences over the Internet and deliver them by mail. These advances have catalyzed an industry of low-cost DNA suppliers around the globe.

Unknowns and Uncertainties

Synthetic biology represents an amalgam of scientific disciplines and sub-disciplines, public and private funding, public and private institutions, complex cross-sector collaborations and, in some cases, new approaches to intellectual property protection. Not surprisingly, most of the significant synthetic biology research and development is taking place in the United States, where most of the world’s biotechnology R&D activities are also centered. But other countries, most notably those in Europe, are also investing heavily in synthetic biology development.

Proponents of this new engineering discipline claim that the ability to create, manipulate and cheaply manufacture customized or unique life forms will produce many benefits across a wide range of applications, from medicine to energy generation and environmental remediation. In the near term, their vision of the future includes designer microorganisms and other engineered life forms that can be deployed as “devices” to stimulate tissue repair and cell regeneration and sense changes in body chemistry that might be precursors to disease. They also say synthetic organisms will be able to produce new kinds of pharmaceutical compounds and plastics, as well as detect toxins, break down air and water pollutants, destroy cancer cells, and generate hydrogen and other substances for new energy technologies.

But that vision does not adequately acknowledge an equally lengthy list of potential risks, as well as broad scientific and social concerns, that as yet are largely unaddressed.

The most obvious risk, which has caused the most concern to date, is the ability bestowed by synthetic biology to design and manufacture biological weapons in the form of virulent pathogens, most notably microbes such as bacteria and viruses. Other risks come under the heading of “bioerror,” rather than bioterror: namely, the consequences of accidental release of engineered organisms that were not intended to come into contact with the open environment; the mutation of “harmless” man-made organisms into ones that are harmful to people and/or the environment; or the effects of alien organisms that invade and destroy native populations and become impossible to eliminate, in much the same way as non-native, “invasive” species of plants, animals and microbes do today.

Many other critical questions have to do with broader, unacknowledged issues about scientific uncertainty. In 2007, a global consortium organized by the U.S. National Human Genome Research Institute, or NHGRI, published the results of a four-year study to identify and analyze the functional elements of the human genome—the “biobricks” upon which the discipline and industry of synthetic biology (and the entire biotechnology industry, for that matter) are built.[3] To the researchers’ surprise, according to the NHGRI announcement, they found that the genome is not a “tidy collection of independent genes.” Instead, it appears to operate as a “complex, interwoven network,” where components interact and overlap with one another and with other components in ways that are not yet fully understood.

The study, called the Encyclopedia of DNA Elements, or ENCODE, raises serious questions for synthetic biologists about the limitations of the “engineering” paradigm that they are applying to living systems. While there may be encyclopedic knowledge of the mechanics of electronic components and their interactions, clearly there remain far more questions than answers about the biological mechanisms that govern living organisms.

In fact, in many respects scientists know less today about these mechanisms than they did even just five years ago. As the NHGRI said at the release of the ENCODE report, scientists are now challenged “to rethink some long-held views” about genetic components and what they do. Given this scarcity of knowledge, can synthetic biologists truly claim to know enough about living, reproducing biological systems to design artificial organisms—and, more important, to reliably predict their behavior and effects once they have been released? Are the parallels they draw between electronic components and biological parts accurate, or even relevant?

More specifically, synthetic biologists have left unaddressed several critical mechanisms that limit their ability to predict the long-term consequences of synthetic organisms. One is the effects of horizontal gene transfer—the natural mechanism that moves genetic material between species and even kingdoms and facilitates, for example, the transmission of avian influenza to other animals, including mammals—when artificial genes make their inexorable move across species to indigenous organisms, or vice versa. Also unaddressed are issues about mutation and evolution; that is, how synthetic organisms will adapt to their environment once they are released. Likewise, synthetic biologists do not know how effective are the methods (such as sterilization of engineered organisms) that they say they will use to prevent synthetic life forms from reproducing. In fact, a 2004 National Academies study addressing the “bioconfinement” of genetically engineered organisms stated flatly that no single method could be considered effective.[4]

Under normal circumstances, these kinds of issues might best be considered as part of a scientific research agenda, and not as topics that should fall within the purview of governance and regulatory oversight. But the circumstances surrounding synthetic biology’s development are anything but normal. Rarely, if ever, has scientific discovery been so tightly coupled with proprietary commercial development, with so little time set aside for reflection and testing, so little consideration of results in the context of broader understanding, and so little independent review of research findings in anticipation of commercial release.

In fact, the technologies and products for creating synthetic components are already affordable and widely available to virtually anyone with access to the Internet, a credit card and a shipping address—or to any clever biology student, for that matter. When Eckard Wimmer, professor at the State University of New York, Stony Brook, who first synthesized the poliovirus from single nucleotides, was interviewed for a 2006 journal article on synthetic biology, he said, “With this technology you can make poliovirus for 50 cents. [I]n five years you [could] have this synthesis facility in every university lab. … You cannot stop this technology because there is a great hunger for it from many biologists.”[5]

Wimmer’s “five years” could conceivably come much sooner. For two years before the Venter Institute’s January 2008 announcement, for example, hundreds of undergraduates from around the world had spent their summer holidays making biological parts and building systems with them. In 2006 alone, 32 teams that participated in the International Genetically Engineered Machines, or iGEM, competition, hosted by the Massachusetts Institute of Technology, added 724 new biobricks to MIT’s Registry of Standard Biological Parts. In 2008, 84 teams and more than 1,000 undergraduate participants from 21 countries across Asia, Europe, Latin America, and the U.S. participated. Biotech companies and venture funds from around the world sponsor teams in the competition.

The iGEM competition is only one example of the investment money and taxpayer-funded research dollars that are flooding the nascent field of synthetic biology. The potential payoff for the ability to build and sell novel living organisms is considered to be so great that venture capitalists, government agencies and multinational corporations, including BP (formerly British Petroleum), Shell, Cargill, and Dupont, are already investing in research and partnerships with startup companies to drive synthetic biology products to market as quickly as possible.

Synthetic biology products may eventually comprise a significant portion of what analysts at Morgan Stanley estimate will be a trillion-dollar market for alternative fuels by 2030. Several companies, including Dupont, already produce commercial “bioplastics” that are manufactured by semi-synthetic bacteria. The synthetic biology company Solazyme recently announced that it would partner with Chevron, the world’s seventh-largest corporation, to develop biodiesel from synthetically redesigned algae. BP is an equity investor in Craig Venter’s company, Synthetic Genomics, Inc. (Financial terms for the latter two deals were not disclosed by the companies.)

In addition, several U.S. government agencies, including the Departments of Defense and Energy, the National Institutes of Health, and the National Science Foundation, have already made investments of millions of dollars in synthetic biology centers and projects, and published NSF research priorities for the 2009 fiscal year indicate synthetic biology funding may increase.[6] A handful of science-minded foundations, most notably the Bill and Melinda Gates Foundation, are investing in synthetic biology projects. Not wanting to be left behind, the European Union is funding the development of a European strategy for synthetic biology, including “stimulation activities” for the mobilization of public and private resources to fuel the nascent industry. Researchers in Africa, Canada, India, Israel, Japan, Korea, Latin America, Slovenia, Turkey, and many other countries are said to be actively pursuing synthetic biology projects as well.

A Profound Challenge for Governance

Synthetic biology poses what may be the most profound challenge to government oversight of technology in human history, carrying with it significant economic, legal, security and ethical implications that extend far beyond the safety and capabilities of the technologies themselves. Yet by dint of economic imperative, as well as the sheer volume of scientific and commercial activity underway around the world, it is already functionally unstoppable. With hundreds of millions of dollars worldwide already spent or committed to synthetic biology R&D across several sectors, and what is almost certainly millions more in undisclosed venture financing and corporate partnerships, companies are driving hard to deliver products for commercial release. This drive to market, coupled with no substantive expert, stakeholder or public policy discussion regarding the balance of risk and benefit for its products, has led many observers to declare that synthetic biology is a juggernaut already beyond the reach of governance.

Proponents are quick to point out that synthetic biology research and its products are not entirely unregulated. In the United States, the NIH still requires laboratories receiving NIH funds to comply with laboratory procedures as outlined in their Recombinant DNA Guidelines. A drug produced by a synthetic organism would be evaluated like any other by the Food and Drug Administration. Also, depending on the application, the Environmental Protection Agency or the U.S. Department of Agriculture would oversee the potential release of synthetic organisms into the environment.

This argument, however, presumes that present regulations are appropriate for evaluating the products of synthetic biology. The critical question that has not been explored is whether synthetic biology poses unique risks that are unconsidered by present health and safety regulations (and regulatory approaches), as well as by financial regulations that govern intellectual property rights and trade.[7]

Some of synthetic biology’s researchers, investors and funders acknowledge the possibility of unintended consequences, but for the most part they minimize the risk, openly acknowledging that they want to avoid synthetic biology becoming the new target for the negative perceptions that many people around the world continue to hold for biotech crops and other biotech products. As a group, they overwhelmingly insist that if synthetic biology is to fulfill its promise, scientists must be trusted to do the right thing, and that existing regulations are sufficient to shield the public from any hazards that might result from the products of synthetic biology. This perspective is best expressed by a recent statement made by Victor de Lorenzo, vice director of the National Centre of Biotechnology in Madrid, Spain. In a 2006 article in the journal of the European Molecular Biology Organization, he said, “I think the question of regulation should not be the first question. … Let’s first see what [the technology] is good for. If you first ask the question about risk, then you kill the whole field.”[8]

The main argument used in favor of self-regulation of synthetic biology’s processes is that they are simply the result of a more sophisticated application of the aforementioned laboratory techniques developed for working with recombinant DNA. As for the products of synthetic biology, practitioners argue that they already fall within the purview of existing regulations that govern genetically engineered organisms and the substances that these organisms may produce. But these characterizations sell short several fundamental, related differences between the two practices, and ignore the history of how genetically engineered organisms came to be as lightly regulated as they are today.

The Difference Between Synthetic Biology and Genetic Engineering

These differences and regulatory history are worth reviewing before turning our attention to recommendations for improving the governance of synthetic biology’s products and processes.

1. Synthetic biology is based on the intentional design of artificial biological systems, rather than on an understanding of natural biology.

Like traditional genetic engineering, synthetic biology uses recombinant DNA techniques to manipulate and construct various kinds of DNA molecules. The goal of a synthetic biology engineering project, like that of traditional genetic engineering, is to create an organism that does what its engineer has designed it to do. But as one report notes, “genetic engineering [is] a cut and paste affair,” shuttling traits from one naturally existing organism to another. “By contrast,” the report continues, “today’s synthetic biologists are armed with the biological equivalent of word processors.”[9] That is, rather than simply being able to splice DNA “words” into or out of existing organisms, synthetic biologists are now in the early stages of learning to write and assemble from scratch the entire paragraphs of code needed to make an entire organism.

Creating unprecedented life forms that can grow, reproduce, mutate, evolve and transfer their genes to other, naturally occurring organisms will yield consequences that are impossible to anticipate with today’s knowledge. The process is dramatically different from modifying the function of an existing organism using the techniques of traditional genetic engineering.

For example, part of the early sales pitch for genetic engineering was that it is more precise and predictable than traditional cross-breeding. But in reality, genetic engineering often triggers unpredictable mutations in an organism’s genome. While most of these mutations are screened out of commercial transgenic products before they reach the market, they do occur. And when they do, they can cause unexpected and sometimes harmful changes in a living organism. (Witness the foreshortened life span and health problems that have plagued genetically engineered and cloned animals.)

While synthetic biologists use the tools of traditional genetic engineering, they aim to eliminate such random events by designing, writing, or rewriting an organism’s genetic code, then synthesizing the sequence of molecules themselves, using the aforementioned “standardized” parts and DNA synthesis equipment. They say such stripped-down, intentional design, coupled with directly synthesizing the genome themselves, will eliminate much of the expensive trial and error that typifies traditional genetic engineering. They believe that they will be able to far more quickly and cheaply fabricate new or more “efficient” life forms of their own design that predictably and precisely display the desired traits.

But as mentioned earlier, there remain many unanswered questions about synthetic biology that bear only a partial resemblance to those asked about traditional genetic engineering. Among them is what effects artificial life forms may have on natural organisms, and vice versa. The larger, more important point is the presupposition by synthetic biologists that their existing understanding about DNA and the processes of heredity is sufficient to enable them to safely and predictably eliminate what they believe to be “inefficiencies” in natural organisms.

As evidenced by the ENCODE study, this is not specious questioning by fearful people who do not understand the science. To wit: researchers are only now beginning to discover that the so-called junk DNA that is present in all organisms (it comprises between 80 and 90 percent of the human genome, for example) serves a critical function in organisms, even though it does not contain instructions for making proteins or other cell products. What is the meaning of “efficiency” when researchers understand only a fraction of how basic biological systems function and how organisms interact with each other and their environments? What is the long-term effect of willful action in the context of so much scientific ignorance and uncertainty?

Finally, the fact that synthetic biology technology can be used to design and synthesize dangerous pathogens not found in nature also challenges existing laws regarding what are known as “select agents”—the toxins and pathogens that can pose a severe threat to human, plant or animal health that are regulated by the Centers for Disease Control and Prevention. Traditional recombinant DNA technology has raised similar or related concerns, but the de novo products that synthetic biology promises will eliminate the need for those with ill intent to gain access to known, naturally occurring agents or naturally occurring genetic material from these agents. This not only greatly expands the potential availability of select agents but also circumvents the CDC regulatory framework that presently governs their possession and use.[10]

2. Synthetic biology’s practitioners are not, as a rule, biologists or even molecular biologists. Many are computer scientists or come from disciplines that do not study or work with whole organisms, but instead apply an even more mechanistic, reductionist perspective to living systems than do traditional genetic engineers.

Synthetic biology’s design and construction of simplified biological systems are, at the very least, supposed to provide scientists with a useful way to test their understanding of the complex functional networks that mediate life processes. However, this understanding is still extremely limited, and extends only to the cell and to a few very small, very simple organisms. As a rule, synthetic biologists do not concern themselves with the relationship between the genetics of organisms and their environment; that is, with how whole organisms mutate and evolve, or how disparate species exchange genetic material in nature, outside of the laboratory.

Traditional genetic engineers generally hold this reductionist perspective as well, but even if they tend to ignore the long-term evolutionary or network effects of their creations, at least they have had to learn how to make alien DNA behave properly within the genomes of natural plants and animals. Synthetic biologists, having no such restrictions, can ignore even this relatively low level of complexity.

But at whose peril? If the goal is a regulatory environment that intelligently anticipates the unintended consequences of a new technology, these distinctions and relationships—between molecules, cells, organisms, and ecosystems—are critical. Biologists who study organisms and ecosystems are steeped in the complexity of biological systems, and understand the limitations of their knowledge about how organisms behave and interact in the real world. The plants, animals, and microbes they study demonstrate to them on a daily basis that the cell and its molecular components are not, in fact, wholly analogous to electronic circuitry. DNA and other components of heredity do not always behave in nature in the same way as they do under the controlled laboratory conditions of synthetic, or even traditional molecular biology. Without this understanding, synthetic biologists cannot reliably predict how their inventions will behave in the natural world.

3. If the goal for synthetic biologists is both public acceptance and credible risk assessment of their products and processes, genetic engineering should not be considered a model for best practices in the context of proper governance and regulation of biological innovations.

A thorough examination of the historical record shows that politics and industrial interests, at least as much as scientific evidence, drove the regulatory process for genetically engineered products from its genesis in the White House Office of Science and Technology Policy in 1986. The same is true today of synthetic biology.

OSTP’s starting assumption for biotech regulation, made at the behest of industry, was that only the products of genetic engineering, and not the radical new process (recombinant DNA) that was used to create them, should be considered in a safety evaluation. This assumption was noted as scientifically questionable by several administrators and scientists inside the FDA itself at the time the first regulation for a genetically engineered organism was being developed. Among other things, they noted, the product category was brand-new, thus literally no evidence or historical data, other than that provided by industry applicants, existed upon which to base such a statement. What’s more, they said, while various experts in molecular biology, chemistry, toxicology, and related fields were asked to provide input to the FDA regarding risk, not one risk analyst was invited to do so—despite the fact that the entire purpose of risk analysis is to scientifically assess the potential effects of taking action in the presence of uncertainty. By selectively narrowing the scope of their concerns and a priori not considering the process of genetic engineering itself as part of their risk evaluations, regulators were able to speed the products of genetic engineering to market.[11]

When confronted with the historical record on biotech regulation, proponents often say that there have been no known health or environmental effects as a result of genetically engineered organisms, so the approach was the right one. However, in the United States at least, there is no objective way of knowing whether that statement is true. Existing regulations contain no requirements for monitoring the movement of genetically engineered organisms in the field once they have been approved, or for labeling products with genetically engineered ingredients in the marketplace. There is no tracking or monitoring of the potential effects that engineered organisms may be producing in other living things. As a result, both the organisms and their effects are literally untraceable, should a health or safety issue arise.

Nonetheless, synthetic biologists today are arguing that existing laws and policies are sufficient for their products in the presence of even more scientific uncertainty and less historical data than are available for transgenic organisms. It is an easy argument to make, and one that is not likely to be refuted by the regulators themselves, since both U.S. law and regulatory philosophy tends to place the burden of proof regarding risk or hazard on those who oppose a new technology. If new regulations cannot be avoided, agencies often work closely with regulated industries to develop the rules and select the methods that will inform the assessment process. As a result, safety determinations about a technological innovation are almost always based on evidence that regulators know the scientists can provide—a situation that inevitably leaves unasked many of the larger, more complex questions about potential hazards that scientists cannot easily answer.

Self-regulation is already running into snags in the context of intellectual property; that is, who owns and controls the discoveries upon which the nascent industry of synthetic biology is based.

Many academic scientists who are at the forefront of developing the technology publicly support the development of a synthetic biology “commons”—a legal framework for public access to common resources and goods (such as water) for a given community. In the context of synthetic biology, an intellectual property commons would ensure that standard biological parts remain freely available and unfettered by patent thickets that have been known to slow or halt academic research, stifle innovation and keep the fruits of discovery out of economic reach for those who might need them most. At the same time they are encouraging the development of this bioparts “commons,” and in seemingly contradictory fashion, many of these same academics serve on the scientific advisory boards of synthetic biology companies that are working to develop the proprietary patent portfolios that are required to attract investors.

This paradox spotlights another critical issue regarding the credibility and objectivity of the evidence that scientists provide regulators regarding the risks of synthetic biology’s products and processes. Most synthetic biology researchers, even more than traditional biotechnologists, operate simultaneously in several spheres: as academic researchers receiving government funding for research and product development, as inventors seeking patentable discoveries, as company founders receiving investment capital from the private sector to finance product development based on those patents, and as members of scientific advisory boards for groups that are engaged in similar activities.

How these conflicts affect synthetic biologists’ attitudes and perspectives on risk, and their impact on both the quality of research and the long-term viability of the nascent synthetic biology industry, has not been addressed in proponents’ reports or studies on the topic.

Recommendations for Improved Governance (listed in terms of priority)

The wide variety of products, activities and players involved in synthetic biology research and development can be separated into some general categories (see Appendix). Hundreds of scientists, companies and organizations worldwide are associated with these categories.[12] Not all of them are key to emerging governance issues, but it is important to keep all of them in mind, because many of these categories include product offerings, methods, and practices that are shared with traditional biotechnology research and product development (such as DNA synthesis).

As a result, a very large “industry-in-waiting,” so to speak, is poised to take advantage of advancements in synthetic biology. Without regulatory acknowledgment of the differences between traditional genetic engineering and synthetic biology products, these players will not have to change their existing practices or offerings very much to “upgrade” into the synthetic biology category. This will quietly increase the sector’s activity, the potential volume of products and, subsequently, the risks it poses. It is also important to note that some categories of research and development in synthetic biology are closely related to nanotechnology, another area of scientific innovation that has proven to be challenging for proper regulatory oversight and governance.

Because of the untested nature of both the risks and the benefits of synthetic biology, and the tremendous financial impetus to bring commercial products based on the technology to market, it is important to take action as quickly as possible to improve the oversight and governance of synthetic biology. Four recommendations are given below. The goal is to get to Priority 3, the comprehensive risk assessment, as quickly as possible. Priorities 1 and 2 must be done first in order to best inform that assessment, and they, too, should be done without delay.

Priority 1. Research and report the current regulatory situation for synthetic biology across agencies and sectors. Because of the “déjà vu” argument being presented by proponents, this research should include a reassessment of the viability and utility of regulations for the products of traditional genetic engineering.

A detailed and comprehensive assessment of the regulatory environment for synthetic biology, both in the United States and abroad, is critical in order to provide a realistic foundation for future conversations about this technology. Because synthetic biologists are likely to use the official safety record of genetically engineered organisms as an argument for no additional regulations, it is important to reassess the shortcomings of these existing policies as well.

In addition to including the process as well as the products of synthetic biology, this assessment must include the current thinking about scientific uncertainties in genomics-related disciplines, starting with the ramifications of findings such as those produced by the ENCODE study.

In the context of the synthetic biology “commons” and other intellectual property issues, the assessment must also consider how synthetic biology is being considered within the World Trade Organization and in the context of its Trade-Related Aspects of Intellectual Property Rights agreement (commonly referred to as TRIPS), as well as within individual countries’ thinking and activities in the area.

A tremendous amount of synthetic biology activity, much of which is intended to eventually yield commercial products, is taking place around the world. It is critical to learn which way governments around the world are leaning in terms of synthetic biology regulation. If one of their scientists or companies were to announce that it was ready to ship a commercial synthetic organism in the next 12 months, what would be the policy response, if any?

Also critical to this assessment will be mapping where various agencies’ responsibilities and practices create gaps, conflicts or overlaps in regulatory coverage. For example, given our assessment that there are fundamental differences between synthetic biology and genetic engineering, under what circumstances will (and/or should) existing biosecurity regulations be applied?

As a starting point, it might be helpful to use the concept of “select agents” and the recent report from the National Science Advisory Board for Biosecurity on synthetic biology.[13] Select agents are pathogens or biological toxins that have been declared by the Department of Health and Human Services or by the USDA to have the “potential to pose a severe threat to public health and safety.” Possibly the most influential agency in the context of synthetic biology regulation, NSABB represents more than a dozen U.S. government offices and agencies, including EPA and USDA, which may be charged with regulating the products of synthetic biology.

In the summary of its findings, the report noted the need for additional clarity about existing regulations, because “responsible agencies, affected scientists, and commercial providers differ in their interpretation of the laws, regulation and policies” as they affect synthetic biology. Given the global ubiquity of synthetic biology research and the possibly imminent release of synthetic biology products, policymakers need to be able to gauge the effectiveness of the existing oversight system—including the consistency of coordination (or lack thereof) across agencies sharing the oversight responsibility and the realities of field practice.

Furthermore, the report stated that the speed of technological advances “will require governance options that are capable of keeping pace with rapidly evolving science.” One of the questions to be addressed, the answer to which would be of broad utility, is “How can possible risks associated with the generation of novel organisms be addressed?”

It might also be useful to investigate whether non-obvious policy alternatives exist that could be deployed if agencies cannot be compelled to take proper action.

Priority 2. Conduct a comprehensive critique of the synthetic biology reports that have been published so far, and assess their impact on decision makers.

Virtually all the reports on synthetic biology have come from the synthetic biology community or from a proponent’s or an opponent’s point of view. These reports have serious logical flaws and omissions of fact and critical perspective, and they should be countered by a more objective source as soon as possible.

Of the most concern in the context of risk and governance are the reports that uncritically support synthetic biology, as they encourage development and commercial release with little or no acknowledgment of the degree of scientific uncertainty that surrounds the endeavor. A 174-page report on synthetic biology published by Bio-Economic Research Associates in 2007 and funded by the Department of Energy (which itself has invested heavily in synthetic biology research), contained but a single, three-quarter-page discussion of the limitations of the engineering paradigm as applied to living systems. Giving such short shrift to a topic that is still under deep consideration in the broader scientific community lends an air of certainty to a highly uncertain endeavor. Such under-representation has real significance from the perspective of investment and economic risk, as well as from that of health and the environment.

Similarly, and perhaps most disappointingly, a $500,000 report funded by the Alfred P. Sloan Foundation on synthetic biology’s “Options for Governance” was co-authored by two of the pioneering institutions of synthetic biology, the J. Craig Venter Institute and MIT, along with the Center for Strategic and International Studies.[14] Promoted as a “stakeholder” study on the broader societal risks and implications of synthetic biology, the Sloan study instead focused mainly on the largely benign laboratory procedures for handling synthetic organisms in the context of biosafety. It did not substantively address the more significant issues of scientific uncertainties, intellectual property conflicts, or the social implications and the intended and unintended effects of synthetic biology’s products on human health or the natural environment. Not surprisingly, given its co-authors, the “options for governance” that were presented in the study’s conclusions weighed heavily in favor of self-regulation.

Discovering the degree to which such biased perspectives and recommendations have affected decision makers will be an important step in a more relevant and comprehensive approach to assessing synthetic biology’s risks. This knowledge will also be an important factor in deciding how quickly action must be taken to counter their biases, as legal judgments or official decisions on synthetic biology become imminent.

Priority 3. Using (and challenging the assumptions of) the data and scenarios in the above-mentioned reports, conduct a comprehensive risk characterization of synthetic biology.

Given the financial and intellectual momentum of the nascent industry, it is not surprising that there is a tremendous aversion in the synthetic biology community to speaking directly about the risks of unintended or unanticipated consequences, or to involving risk practitioners who are schooled in methods that are designed for highly uncertain issues or experts from other sectors in assessments of its future. It is very difficult to find a synthetic biology report that uses the word risk more than in passing, let alone directly addresses the subject at any depth.

One reason for this omission is that many scientists believe the word risk refers to a technical calculation of probability that is demonstrable only by way of “evidence” that a risk exists. Such calculations are near impossible, however, when analyzing technological innovations, where there are no historical precedents other than by analogy and sparse data to use in a probability calculation. Yet without data, these scientists say, there is no risk, only speculation. While technically “scientific” in its approach, this circular argument forces decision makers to consider only a very narrow, pre-determined and ultimately subjective view of the important issues they are being asked to address.

However, there is another approach to risk assessment that has proven very useful for decisions regarding scientific and technological innovations. This approach combines data analysis and extensive deliberation with a broader representation of relevant scientific expertise, as well as parties who are interested in the issue or who will be affected by the outcome of the analysis. This process of analysis and deliberation is described in the 1996 National Academy of Sciences study, Understanding Risk: Informing Decisions in a Democratic Society.[15]

Should this type of assessment be undertaken, the analytic deliberative approach could be augmented with a methodology that is under development by myself and Baruch Fischhoff at Carnegie Mellon University, designed to address unprecedented risks such as those presented by synthetic biology. It uses scenario narratives to develop comprehensive risk models that are computable over time, as research continues and data become available.[16] There are several credible scenarios available regarding synthetic biology that, taken together, could provide the foundation for characterizing and assessing synthetic biology’s risks and benefits.

Such an assessment would be designed to yield five important outcomes:

(a) A mutually agreed-upon risk/benefit model for lawmakers to use in regulatory decisions. This model would map critical scientific uncertainties associated with commercialization and/or release of synthetic organisms (e.g., the effects of evolution, environmental and health effects, assessment of product versus process, the significance of horizontal gene transfer, synergies between synthetic biology and nanotech), as well as economic, legal, biosecurity, social and ethical implications for the United States and its relationship to other countries;

(b) An understanding of the degree to which existing biotech regulations can usefully be applied to synthetic biology processes and products and, conversely, where they should not be used;

(c) A scientific research agenda for addressing knowledge gaps and known risks as revealed by the assessment process;

(d) A contingency/preparedness plan for unintended consequences, including potential legal strategies should rational approaches not prevail; and

(e) A public database/repository to collect information on synthetic biology so that risks (and regulations) can be reassessed as new data are added and uncertainties are reduced.

Priority 4. Convene cross-sector stakeholder working groups on elements in the assessment that were deemed most important to address.

After the risk characterization has been completed, stakeholder groups should develop policy recommendations for addressing the issues and elements of concern. At this point, these groups would likely be organized around at least the following three elements:

(a) Scientific uncertainties. How should the nature and extent of the scientific uncertainties in synthetic biology, discovered during the risk-characterization process, affect regulatory policies? Are there examples of more iterative (Bayesian) approaches to policy that can be deployed for issues such as these, where well-informed decision makers have determined there is a need to move forward with research and development despite scientific uncertainty? What is required in terms of research funding to better address these uncertainties in advance of commercial deployment?

(b) Patents and intellectual property. How do existing patent and intellectual property laws add to or lessen the broad risk profile for synthetic biology products? What would happen if a significant portion of the field’s intellectual property remained in the public domain or commons, as some synthetic biologists want? What would be the social and economic implications of various patent approaches to synthetic parts and organisms? Having this conversation soon, before too many synthetic biology patents are issued, could be tremendously useful.

(c) Human factors. What human factors affect the regulatory/policy profile for synthetic biology’s products and processes, and what kinds of interventions can best address them? Who are the equivalents of the nuclear plant operators in synthetic biology scenarios, i.e., what constitutes risky behavior for humans using synthetic biology in the field? This group would look at implications for deliberate misuse of the technology as well as for bioerror.

Conclusion: Opportunity Costs

If even a fraction of its proposed applications pan out over the long term, synthetic biology has the capacity to radically change our approach to some of the most pernicious problems of our time. That human beings may someday know enough to safely and predictably engineer life forms that can eliminate ocean pollution, generate sustainable energy sources, or help to eliminate infectious diseases will be nothing short of transformative. So it is no wonder, standing at what seems to be the very brink of such tremendous promise, that proponents of synthetic biology want to dismiss most conversations about risk as speculation.

But it is important to note that in its early stages, the promised benefits of any technological innovation are purely speculative as well. While there may not be historical precedent for synthetic biology, the history of science is replete with examples of the high price of biological interventions that were brought to market or released without sufficient consideration of consequences.

For example, the toads that were imported from Hawaii to rid Australia’s sugarcane plantations of beetles have instead eaten all the native amphibian and invertebrate species in their path—except the cane beetle. The morning-sickness drug DES, sold to millions of women between 1940 and 1971, was almost entirely ineffectual for its ostensible purpose, yet has passed along its carcinogenic mutations to children in every subsequent generation. The overuse of man-made antibiotics has created new strains of “superbugs” that are virtually unkillable and can make being admitted to a hospital more life-threatening than staying at home. And we have not yet begun to tally the costs of regulatory myopia about nanotechnology, where agencies remain loathe to step in despite the demonstrated health and environmental risks of some nanomaterials.

Synthetic biology stands to have a far greater impact than all of these—especially if its products are allowed to be released without pausing for thoughtful consideration of risk and benefit in the context of scientific uncertainty. Many of synthetic biology’s proponents see such consideration as an opportunity cost, maintaining that both money and benefit are lost each day their activities are questioned or delayed. But the role of government is to understand these developments in a broader context, properly oversee them, and ensure that society is not forced to bear the cost of that opportunity, should plans go awry. Today, with the benefit of hindsight, we have developed the methods to practice foresight in these matters. We have in hand the means to practically address scientific uncertainty and risk for the benefit of all stakeholders: the industry, the independent research community, and the public. The sooner and more willingly that we as a society embrace those means, the greater the opportunity will be for synthetic biology to fulfill its promise.

I am grateful to David Rejeski at the Woodrow Wilson International Center for Scholars for supporting the research and the writing of this report; and to the Center for American Progress and Rick Weiss for its final production and publication. All views expressed herein are my own, and do not necessarily reflect the positions of either organization.

Denise Caruso is executive director and co-founder of the Hybrid Vigor Institute, an independent, not-for-profit research organization and consultancy that is dedicated to interdisciplinary and collaborative problem solving. She is the author of Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet, which won a Silver Medal in the Science Category of the 2007 Independent Publisher Book Awards, and was listed as a “Best Business Book of 2007” by strategy+business magazine. She also edits and contributes to the Institute’s blog, at hybridvigor.org and, in 2008, was named a contributing editor for strategy+business, where she writes about risk, public policy, and innovation.

Caruso has developed and served as co-principal investigator on research projects that aim to improve upon traditional methods of risk and decision analysis for innovations in science and technology. Topics of case studies in which she has been involved, funded by the National Science Foundation, have included the risks of xenotransplantation using genetically modified pigs, and the risks of pandemic avian influenza. She is an affiliated researcher at the Center for Risk Perception and Communication at Carnegie Mellon University. Since 2003, she has been a member of Global Business Network, a worldwide organization that works to enhance competitive and adaptive capacities in organizations through collaboration, scenario development, and strategic planning.

Caruso is also a veteran journalist and analyst. In 2007, she wrote “Re:framing,” a column on innovation and creativity, for the Bright Ideas page in the Sunday Business section of The New York Times. She also chronicled the converging industries of digital technology and interactive media from the mid-1980s to 2000. For the five years prior to founding Hybrid Vigor in 2000, she wrote the Technology column for the Monday Information Industries section of The New York Times.

One of the first journalists to focus on the intersection of technology, commerce, and culture, Caruso is a director emerita of the Electronic Frontier Foundation. She was elected to the board of directors of the Independent Media Institute in January 1995, and continues to serve in that capacity. She is a trustee of the Molecular Sciences Institute, a non-profit laboratory conducting research into basic biological processes. She also serves on the advisory boards of several organizations, including Public Knowledge and London-based SustainAbility.com; she recently became an advisor to Echo & Shadow, an intelligent robot company.

Appendix: An Overview of the Synthetic Biology Landscape

Hundreds of scientists, companies, and organizations are already engaged in synthetic biology research and development. A comprehensive, albeit somewhat dated list, with an emphasis on research and researchers in North America and Europe, may be found in the European Union report “Synbiology: An Analysis of Synthetic Biology Research in Europe and North America,” published in October 2005.[17]

The general categories of key products, applications and players in the field of synthetic biology (listed alphabetically) are populated as follows.

• Funders and investors, including venture capital firms, U.S. government agencies and foundations, and corporations directly funding scientific research and/or development;
• Government agencies and regulators, including those governing trade and commerce as well as those responsible for risk regulation;
• Issues analysis and strategy, which includes media coverage; private and public studies and reports on the economic, ethical, and political impact of synthetic biology, including intellectual property protection; and risk analysis and decision-making/regulatory strategies by industry organizations, consulting firms, non-government organizations, and academic researchers;
• Laboratory-based molecular and nanotechnology development, which includes the development of molecular machines and strategies for machine evolution and the development of self-assembling biomaterials and bioelectronics, reporters, and sensors and artificial life;
• Products and applications of synthetic biology, including artificial genes and genomes; drugs, chemical agents, plastics, fuel, electricity, and other products manufactured by synthetic or semi-synthetic bacteria; tissues, organs and organisms generated by design; and biofuels and bioelectricity;
• (Practical) engineering in living organisms, which includes engineering of structural functions; artificial evolution and strategies for optimizing artificial evolution; design of semi-synthetic organisms; engineering of cell regulatory functions; the biobricks strategy of biological parts characterization, fabrication and assembly; and engineering of programmable systems of organisms;
• Related and enabling technologies, which include DNA sequencing, synthesis and design equipment; analytic devices such as diagnostics, microarrays, chromatography, and microfluidic chips; and cell technology, including cell cultures and stem cell technologies; and
• (Theoretical) computerized modeling, which includes computer analysis and modeling of natural systems, molecular networks, and synthetic biology systems.

Within these categories, the activities of a handful of key players are being closely watched. These are some of the best known:

1. George Church: professor of genetics, Harvard Medical School; director, Center for Computational Genetics, Harvard University; co-founder, Codon Devices; co-founder, LS9 Inc.

Considered one of the pre-eminent synthetic biology researchers, Church is also a well-known figure in the larger biology community. His 1984 Ph.D. dissertation included a description of the first direct genomic sequencing. He also co-initiated the Human Genome Project while serving as a postdoctoral fellow at Biogen and as a Monsanto fellow at the University of California, San Francisco. As director of the Center for Computational Genetics, he is developing broadly distributed, integrated models for biomedical, biofuel, and ecological systems. The Center’s research currently focuses on genome engineering and synthetic biology development to build “genetic circuits,” vaccines and optimal drug biosyntheses. Among many other active and advisory affiliations, Church also co-founded Codon Devices in Cambridge, the first venture-backed synthetic biology company that is focused on synthesizing very long pieces of custom DNA, and LS9, which is designing biofuels produced by microbes created via industrial synthetic biology.

2. Drew Endy: assistant professor in the Department of Bioengineering at Stanford University

The former assistant professor at the Massachusetts Institute of Technology moved to Stanford University in fall 2008 to become its first synthetic biology professor and is probably the best-known and most public face of synthetic biology. Widely acknowledged as a founder of the field, he is one of its most active participants in all aspects, from academic research to social implications and commercial development. At MIT, he co-founded the Registry of Standard Biological Parts as well as the annual iGEM international synthetic biology design competition, where teams of undergraduate students create novel biological parts and build them into working systems. He is a co-founder of Codon Devices.

He also started the non-profit BioBricks Foundation, whose mission is to ensure that standard biological parts remain freely available to the public and to encourage the development of codes of standard practice for the use of standard biological parts.

3. Foundations

a. The Bill & Melinda Gates Foundation

The Gates Foundation is helping drive synthetic biology research out of the lab and into applications by investing in health-related synthetic biology products. In addition to the $42.6 million it granted to three organizations for the development of a synthetic microbe to produce an anti-malarial compound, the Foundation has granted $19.4 million to a consortium, led by the Seattle Biomedical Research Institute’s Viral Vaccines Program, to create synthetic molecules to trigger antibodies against HIV.[18]

b. The Alfred P. Sloan Foundation

The Sloan Foundation is one of the few remaining private philanthropies that funds direct research in selected areas of scientific significance. In 2005, Sloan’s Bioterrorism Program awarded $500,000 to the J. Craig Venter Institute, in collaboration with the Center for Security and International Studies and the Synthetic Biology Group at MIT, to examine the risks and benefits of synthetic genomics in the context of regulations and governance.

Through its Bioterrorism Program, Sloan has also made several other grants aimed at addressing issues of potentially dangerous applications of synthetic biology. These include a feasibility study to develop a global network of bioscientists, support for a workshop on Genomics for Development, Bioterrorism, and Human Security, and an assessment of the World Health Organization’s oversight of smallpox virus research.

4. Jay Keasling: director, SynBERC, University of California, Berkeley; co-founder, Amyris Biotechnologies

Keasling is responsible for two of the field’s largest and most visible synthetic biology projects, spanning both academic research and commercial development. He is director of the Synthetic Biology Engineering and Research Center (SynBERC) at U.C. Berkeley, funded with $16 million from the National Science Foundation and $4 million from the biotech industry and participating universities.

Amyris, which he co-founded, is developing synthetic microbes capable of producing novel pharmaceuticals, renewable fuels and specialty chemicals. SynBERC and Amyris, along with OneWorld Health, were Gates Foundation grantees for the development of synthetic microbes to produce artemisinin, an anti-malarial compound.

5. U.S. Government

The U.S. government is a primary driver of the nascent industry of synthetic biology. Several agencies have each committed several millions in taxpayer dollars to synthetic biology researchers and organizations, most of which is directed toward specific applications. These include the NIH, including the National Cancer Institute, the National Institute for Allergy and Infectious Diseases, the National Institute of General and Medical Sciences, the National Institute of Biomedical Imaging and Bioengineering, the NIH Roadmap Program, the Nanomedicine Program, and the NIH Cancer Biology Training Grants Program.

The Department of Energy is funding research and development into synthetic organisms to produce biofuels and clean up pollution, as well as explorations into societal consequences such as the relationship of synthetic biology to intellectual property law. The Department of Commerce’s Advanced Technology Program has awarded a grant for the development of synthetic microbes to convert sugars into plastic. The NSF also has committed several millions of dollars to synthetic biology research, primarily to academic institutions.

6. J. Craig Venter: founder, Synthetic Genomics, Inc., and the J. Craig Venter Institute

Venter is still best known for his role in mapping the human genome, but his personal ambition, combined with his ability to draw worldwide media attention, has placed his organizations’ activities at the center of the synthetic biology field. He and Drew Endy are generally the scientists of record when questions about the risks of synthetic biology are raised by outsiders.

Venter’s activities are also the most visible example of the fluid financial arrangements that typify synthetic biology. His privately held company, Synthetic Genomics, is developing synthetic genomes and organisms for commercial applications in renewable energy and bioremediation—based on research done under the auspices of his own non-profit research institute, the J. Craig Venter Institute. The institute, which is funded by government grants as well as by Synthetic Genomics, is focused on trying to develop a minimal cell in order to build a new cell and organism with optimized functions. Synthetic Genomics’ president is Aristides Patrinos, former director of the Office of Biological and Environmental Research for the DOE, which made significant investments in synthetic biology and, more specifically, in Venter’s projects during the period when Patrinos was at the helm.

7. Venture Capital Firms

Venture capital may be more responsible for driving the creation of a synthetic biology industry than are the scientific discoveries coming from the research community. At the time Codon Devices received its first round of venture capital, for example, its co-founders and principals (named above) were basically the entire roster of synthetic biology researchers in the world. A handful of well-known venture capital firms, primarily those that have been involved in early-stage science and technology investments in Silicon Valley and in Cambridge-based startup companies, have already established a beachhead in the synthetic biology area. These firms include Alloy Ventures, Khosla Ventures, Kleiner Perkins Caufield & Byers, Mohr Davidow, and X/Seed Capital.

Notes

[1] A base pair refers to the two nucleotides that form a “rung” of the DNA ladder. The number of base pairs is used to describe the length of a DNA strand. DNA sequencing is the process of determining the exact order of the base pairs that comprise individual genes as well as whole genomes. DNA synthesis is a natural cellular process that replicates DNA, but as used here refers to artificial, chemical replication.

[2] James Newcomb, Robert Carlson, Steven Aldrich, Genome Synthesis and Design Futures: Implications for the U.S. Economy (Cambridge, MA: Bio Economic Research Associates, 2007).

[3] The ENCODE (ENCyclOpedia of DNA Elements) Project, available at http://www.genome.gov/10005107 (accessed August 18, 2008).

[4] Committee on Biological Confinement of Genetically Engineered Organisms, “Biological Confinement of Genetically Engineered Organisms” (National Research Council, 2004).

[5] Holger Breithaupt, “The engineer’s approach to biology,” EMBO Reports, 7(1)(2007): 21-24, available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1369239 (accessed August 8, 2008).

[6] Elizabeth Pain, “Getting Ready for Synthetic Biology,” Science Careers, October 17, 2008, 10.1126/science.caredit.a0800152, accessed at http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2008_10_17/caredit.a0800152.

[7] Arti Rai and James Boyle, “Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons,” PLoS Biology, March 13, 2007, available at: http://biology.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pbio.0050058&ct=1 (accessed August 8, 2008).

[8] Breithaupt, “The engineer’s approach to biology.”

[9] The ETC Group, “Extreme Genetic Engineering: An Introduction to Synthetic Biology” (Ontario, Canada, 2007), available at: http://www.etcgroup.org/en/materials/publications.html?pub_id=602 (accessed August 18, 2008).

[10] National Science Advisory Board for Biosecurity, “Addressing Biosecurity Concerns Related to the Synthesis of Select Agents” (Rockville, MD: National Institutes of Health, 2006).

[11] A lengthy discussion of this issue can be found in Intervention: Confronting the Real Risks of Genetic Engineering and Life on a Biotech Planet, Chapter 6, “Politics, Science and Substantial Equivalence” (Hybrid Vigor Press, San Francisco, 2006).

[12] European Commission, “Synbiology: An Analysis of Synthetic Biology Research in Europe and North America: Output D3: Literature and Statistical Review,” European Commission FP6 Reference: 15357 (2005), pp 28-40, available at: http://www2.spi.pt/synbiology/documents/SYNBIOLOGY_Literature_And_Statistical_Review.pdf (accessed August 18, 2008).

[13] National Science Advisory Board for Biosecurity, “Addressing Biosecurity Concerns Related To The Synthesis Of Select Agents.”

[14] Michelle S. Garfinkel, Drew Endy, Gerald L. Epstein, Robert M. Friedman, “Synthetic Genomics: Options for Governance,” (Rockville, MD, Washington, DC, Cambridge, MA: J. Craig Venter Institute, Center for Strategic and International Studies, Massachusetts Institute of Technology, 2007), available at: Available at http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-genomics-report/synthetic-genomics-report.pdf (accessed August 18, 2008).

[15] Paul C. Stern, Harvey V. Fineberg eds., Understanding Risk: Informing Decisions in a Democratic Society (Washington, DC: Committee on Risk Characterization, National Academy of Sciences: National Academy Press, 1996).

[16] Denise Caruso and Baruch Fischhoff, principal investigators, “Understanding Genomic Risks: An Integrated Scenario and Analytic Approach” (Washington, DC: National Science Foundation Award No. SES-0350493, 2006).

[17] European Commission, “Synbiology: An Analysis of Synthetic Biology Research in Europe and North America.”

[18] Seattle Biomedical Research Institute, press release: “Sbri Receives $19.4 Million HIV/AIDS Research Grant From Gates Foundation” (Seattle, WA: 2006), available at: http://www.sbri.org/news/2006/releases_06/SBRI-Receives-$19.4M-Gates-Grant-for-HIV-Vaccine-Research.pdf (accessed August 18, 2008).

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

Bisphenol A is an endocrine disruptor–its chemical behavior is similar to that of estrogen and can cause the normal functioning of hormones in a person’s body to go awry.

The crew over at Effect Measure provide a useful archive of their numerous previous posts on the matter and wonder why the agency is now “moving forward with planned research to address the potential low dose effects of bisphenol A” when they should have already done so.

But Sarah Vogel at The Pump Handle is not sure that the FDA is even up to the job of making an appropriate call on the issue:

[C]an the current FDA conduct a transparent, high quality scientific assessment of BPA?…Determining BPA’s safety is not a matter of needing more scientific research. There are already over 700 studies on this chemical. “Credible” minds at the NTP and a consensus of BPA researchers have determined that there are a number of serious risks of exposure to BPA at the levels of human exposure. The challenge to credible scientists and regulators now is to determine the level and magnitude of the risks presented by current BPA exposure at all developmental stages in life.

The tactics used by chemical industry corporations to delay regulation of harmful toxins are well documented–just see David Michaels’s Doubt Is Their Product. This is just another unfortunate example of why relying on industry-funded research to make regulatory decisions isn’t really regulation at all.

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.

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.

Christopher Doering of Reuters reported Tuesday that the “FDA and USDA have said it is impossible to differentiate between cloned animals, their offspring and conventionally bred animals, making it difficult to know if offspring are in the food supply.”

AP/Jason Turner

Offspring of cloned dairy cows.

In January, the FDA released a report giving two thumbs up on products from cloned cows, pigs and goats (the FDA didn’t make a recommendation on sheep because there wasn’t enough information), stating in a 968-page “final risk assessment” that food from cloned versions of these animals doesn’t pose any harmful health risks. The milk and meat from cattle was deemed safe, as well as meat from pigs and goats. The day after the FDA report was released, the USDA requested that U.S. farmers not sell food products from cloned animals, citing a need to first harmonize rules with trading partners and to build acceptance.

Consumers in many countries, including in the United States, have said they oppose food from clones or their offspring because of health and safety issues and because of concerns for the health of the clones themselves. Ethical issues are also being considered by the European Food Safety Authority, which is funded by the European Union to provide risk assessments on food. It’s their opinion that “considering the current level of suffering and health problems of surrogate dams and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified.”

Center for American Progress Senior Fellow Rick Weiss, who was then a staff writer at the The Washington Post, reported in January the FDA doesn’t require food companies to label products containing cloned livestock. But the agency may allow other companies to label products that do not contain cloned meat or milk.

In May, Nancy Scola reported in Science Progress on the disarray of the federal food safety system. With several recent food recalls and government agencies constantly placing blame on one another, Scola wrote that the food safety system is so complicated it “verges on the absurd.”

“When we had the spinach episode, everyone acted like it was a great surprise,” former FDA Commissioner Lester Crawford, a Bush-appointee and long-time federal food safety official, told Scola, “But the likelihood of something bad happening [with the food supply] is always quite high.”

The number of cloned animals in the country is low—only around 600, with cattle being the majority—but offspring are unaccounted for, and the size of the second generation is unknowable, especially since a single male clone can sire countless offspring through mail-order semen sales. Indeed, clones are too expensive to slaughter for the meat market, so for most farmers the business plan is to use them to breed high-quality offspring. Alex Seitz-Wald of NewsHour Extra says one breeder in Kansas has been selling his cloned cattle’s sperm for years. According to Seitz-Ward, cattle experts believe that food products from the offspring of clones already exist in the American food supply.

AP

Executives from Hormel Foods Corporation and Cargill, Inc. testify before Congress on food safety in November 2007.

Previously, “downer” cows were deemed fit or unfit for slaughter on a case-by-case basis. But concern over the safety of the beef supply peaked earlier this year when the USDA issued the largest meat recall in history of 143 million pounds. A congressional hearing following the recall raised serious questions about both the ability of the USDA to keep food-borne pathogens out of the food supply, and the problem of overlapping jurisdiction between the Food and Drug Administration, the Centers for Disease Control, and the USDA.

In this instance, oversight responsibility seems clear and it’s a good thing that the USDA is aiming to close this loophole through which E. coli, salmonella and other such nasties can slip (UPDATE: see testimony from the February hearing by Michael Greger, M.D.). But the proposed rule highlights the broader problem of trifurcated food regulation. Writing in Science Progress about “Our Fractured Food Safety System,” Nancy Scola reported recently that, “The GAO, which has long called for a single food agency, last year bumped the current system up to the level of ‘high-risk area.’” She goes on to describe internal conflicts at USDA:

Its primary role in Washington is to promote the food trade—to boost the amount of American pork the Chinese eat, not to worry over whether the pork Americans consume is safe to eat. GAO recently profiled seven countries (Canada, Denmark, Germany, Ireland, the Netherlands, New Zealand and the United Kingdom) that have consolidated food oversight under one roof. Most interesting is the holistic farm-to-fork approach of EU member countries. Ireland is a typical case, moving its food safety agency under the auspices of its existing public health authority—in recognition of the fact that the raison d’etre of their own Department of Agriculture is promotion, not policing.

Keeping sick cows out of the food supply is a good start, but rationalizing food safety will take more than just rulemaking. The comment period on the USDA rule extends until September 29. More info here.

Effect Measure goes where few other dare and questions the validity of the Ivins fiasco, not once but twice this week. The evidence is the same as what the mainstream media presents, but the authors arrive at a different conclusion from the FBI’s.

Joe Romm, writing at Science Blog’s Next Generation of Energy Ideas blog, explains that if we don’t stem the flood of carbon pouring out of coal-fired power plants, nothing else we do to stop climate change will matter.

Mira Kolodkin at SEA’s blog covers the FDA’s inability to adequately follow up on illegal uses of drugs and comments on the GAO’s suggestion of a tracking system to help the FDA respond to complaints of violations more efficiently.

Brandon Keim at Wired touches on the bioethical implications of cloning Booger and comments on misconceptions about personhood. He explains that Booger, like people, was more than his genes.

Rep. Dennis Cardoza (D-CA), Chairman of the House Agriculture Subcommittee on Horticulture and Organic Agriculture, called the Salmonella St. Paul outbreak the next saga of “outbreak roulette,” and asked “which industry will be next?” Rep. Diana DeGette (D-CO), sponsor of the TRACE Act, H.R. 3485, which would strengthen the food industry’s traceability system, did not hesitate to call the FDA and CDC out on their faults. She called the food safety system “agonizingly slow.” In her opening statement, she asked, “Why is it that the FDA has jurisdiction over cheese pizzas, but the CDC has jurisdiction over pepperoni pizzas?”

Yesterday Dr. David Acheson, assistant commissioner for food protection at the FDA, shocked the audience by admitting that only three FDA investigators were currently in Mexico, and that none were stationed there permanently to check the food supply that enters the United States. But he was able to escape the most severe questioning by breaking the news that the FDA had only hours before discovered Salmonella St. Paul in the groundwater of a farm in Mexico that produced serrano peppers.

That did not save Bill Hubbard, former senior associate commissioner for policy, planning and legislation at the FDA, this morning, as he testified in front of the House Energy and Commerce Committee. Hubbard was quick to discuss the flaws in his agency. He said that reduced funding has led to a reduced staff and a reduced ability to perform the agency’s essential duties. He also noted that while the Bioterrorism Act of 2002 requires that food industries be able to trace their food supply back one step and forward one step, the FDA receives only partial reports, if any, from many food producers.

DeGette came to his rescue by supporting his claim that not all of the FDA’s problems are their fault. The FDA had pushed for additions to the Bioterrorism Act that would have included electronic food tracing records, the identification of each box of tomatoes with individual farm lot numbers, and a consistent recording format, all of which were denied.

Ed Beckman of the California Tomato Cooperative argued today that his company could successfully trace back their tomatoes “in 35 minutes.” Parker Booth of Delta Prepack Company even brought physical evidence of how his company maintains efficient and reliable traceability. He held up a cardboard tomato box which had, printed on the side, the individual farm lot number that the tomatoes came from, along with other state identification codes. This code, provided by a commercial system called HarvestMark, labels all of his company’s tomato boxes, and costs about a penny per box. It could be a good idea to implement on a federal level.

flick.com/SuperFantastic

An estimated 20.8 percent of all adults (45.3 million people) smoke cigarettes in the United States.

With the support of cigarette manufacturer Phillip Morris USA, the House voted Wednesday to approve legislation that would give the Food and Drug Administration the power to regulate tobacco. According to The New York Times, the bill would give the FDA the authority to stipulate nicotine levels allowed in cigarettes sold to consumers, and the agency could mandate a nonaddictive threshold for the chemical.

Writing about the legislation in March, Michael Stebbins noted that without the ability to ban nicotine outright, the FDA would not have sufficient power:

A superficial glance at the bill reveals that it fails the logic test by requiring an agency charged with protecting the health of Americans with regulating a deadly product without the authority to ban it outright. But the alternative, of leaving Big Tobacco to freely manipulate their product to keep me and the rest of my stinky-fingered brethren addicted, is unacceptable.

Stebbins notes as well that “In the United States, cigarette smoking is responsible for about one in five deaths annually, or about 438,000 deaths per year; on average, these people die 13 years younger than non-smokers.” Moreover, “Annually, cigarette smoking costs more than $167 billion, based on lost productivity ($92 billion) and health care expenditures ($75.5 billion).” “Cigarettes,” he points out, “are unregulated drug delivery systems.”

With the ability to regulate tobacco, FDA could better protect the health of Americans and prevent young people from becoming early smokers. But if the lessons from past battles with the tobacco industry are any lesson, there may be fights on the horizon to defend the science that will put teeth in FDA’s authority. As David Michaels, author of Doubt Is Their Product, noted in an interview earlier this year, there are many industry tricks of the trade that “turn positive studies into negative ones or take one positive study and do a literature review which buries the positive study in what is essentially a whole mass of garbage so it looks like there is nothing there.” Let’s hope that legal arguments over the precise levels levels of nicotine allowed in cigarettes do not obscure the fact that the product kills.

The Washington Post reports that phthalates are so ubiquitous today that in one study, the Food and Drug Administration found traces of the chemicals in every one of its 1,000 subjects. Despite strong lobbying from the chemical industry, especially Exxon Mobil, Congress moved to outlaw the chemicals from commercial products, pending further research. The Post indicates that a White House spokesman stated that President Bush opposes the legislation. Sarah Vogel explained the scientific maneuvering that led to this much-needed oversight earlier this year at The Pump Handle. Describing a Senate hearing on bisphenol A and phthalates oversight, she wrote: “At stake is the means by which society determines chemical risks and benefit.”

Hopefully the most recent budget increase will alleviate some of the FDA’s shortcomings. According to a statement made by the FDA commissioner, “[t]he funds requested yesterday include $125 million to protect the food supply, $100 million for the safety of drugs and medical devices and $50 million to prepare the FDA’s workforce and laboratories for ‘areas of emerging science’ such as nanotechnology and gene therapies.”

Interview with David Michaels on Doubt Is Their Product

Tobacco companies perfected the manufacture of scientific uncertainty, setting the example for numerous U.S. industries to follow. Realizing that studies demonstrating the fact that cigarettes cause cancer posed an immanent threat to their business model, tobacco executives hired public relations experts to attack the science behind the research. Their basic tactic, according to David Michaels, was to argue that the studies “weren’t correct enough.” Despite the wide acceptance of the link between smoking and cancer in the scientific community and the public at large, the strategy worked, and the controversy over the carcinogens in cigarette smoke bought the industry decades of time to continue profiting off a deadly product.

Michaels, an epidemiologist and the director of the Project on Scientific Knowledge and Public Policy at the George Washington School of Public Health, is an expert on how U.S. industries have hired mercenary scientists to use the same tactics to create scientific controversy where it did not previously exist. He spoke yesterday at the Center for American Progress about his new book, Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health, which chronicles the “tricks of the trade” employed by scientists-for-hire to systematically delay government action to curb the health risks of asbestos, beryllium, pharmaceuticals, diacetyl (which causes “popcorn lung”), and man-made climate change.

Digging through the documents made public in the multistate settlements against the tobacco industry, Michaels noticed that Hill & Knowlton, the PR firm leading the charge against science on behalf of the cigarette makers, was not a single-issue uncertainty shop. Hill & Knowlton, Michaels discovered, reached out over the years to many industries that exposed workers or the public to dangerous chemicals. Among their clients was DuPont, and the firm boasted about their success fending off regulation long enough for the chemical giant to develop an alternative to the chlorofluorocarbons that were tearing a hole in the ozone layer.

“Most scientists who work for industry are honest,” Michaels points out. Companies interested in delaying regulation will therefore hire consultants Michaels calls “sleazy.” After the success of groups like Hill & Knowlton, these scientists got into the lucrative “product defense” industry (now referred to by the friendlier “product support” moniker). These firms, Michaels explains, use methods “similar to the accounting done by Arthur Anderson for Enron.” They conduct “literature reviews” that include studies of good and poor quality, diluting the results of research identifying hazards to public health. They also take advantage of the uneven playing field by accessing and reanalyzing raw data from government studies. Aside from the Food and Drug Administration, which has access to raw data from drug makers’ clinical trials, most regulatory industries do not have access to the raw data from industry-funded studies. When corporations fight regulation with the results of industry-funded research, as well as with jerry-rigged reanalysises of government data that make health risks evaporate in statistical smoke, the public loses and industry profits.

But Michaels proposes a slate of reforms that can curb the manufacture of uncertainty and protect citizens and workers. He is a strong advocate for strict rules barring scientists with financial conflicts of interest from participating in government advisory panels, as they cannot be expected to provide unbiased interpretations of research. “We need transparency and full disclosure,” he says, explaining that “the interpretation has to be done by scientists who don’t have a financial interest.” With multibillion dollar issues like drug regulation at stake, and with public health a central question in industry regulation, Michaels argues that the government can afford to hire scientists without conflicts.

He also proposes a “Sarbanes-Oxley” for science—a legal framework similar to the one enacted after the accounting scandals that led to the fall of Enron. It would hold corporate executives responsible for the nefarious accounting that goes into product defense research for products that harm the public.

In addition, Michaels proposes equal treatment of public and private science: a level playing field that allows for bi-directional access to raw data. “Industry has the right to do its own studies,” he says, “That’s important.” But if the research will have an effect on public policy, data and methods have to be public information.

Ultimately, the key step to defending public health from underhanded industry tactics may be to follow the money. Prestigious medical journals, Michaels points out, require statements indicating who paid for a study, but smaller publications (sometimes set up by product defense firms themselves) and regulatory agencies don’t always have such rules. Scientists, journalists, and policy makers must always ask where the money comes from when there are controversies over research on public health. “Sunlight,” in the words of Justice Louis Brandeis, “is said to be the best of disinfectants.”

View full event video (CAP site)

Interview with David Michaels on Doubt Is Their Product

As a Government Accountability Office report dryly notes, an open-faced ham sandwich sold at a highway rest stop is the responsibility of the U.S. Department of Agriculture and subject to daily inspections. But add a second slice of bread and it becomes the Food and Drug Administration’s job to check in on the sandwich, which it does about once every five years.

And so it goes with just about every type of food Americans consume, resulting in a food safety system that verges on the absurd. The FDA regulates chicken broth, but beef broth is under the USDA’s watchful eye—except in the case of dried soups, in which case the agencies swap duties. Responsibility for packaged baked beans depends on whether the meat in the can is pork chunks (FDA) or bacon (USDA). And under which agency’s purview a pizza falls depends on whether it is of the cheese lover, meat lover, or seafood lover variety.

The American food supply chain’s remarkable ability to assemble a coherent meal independent of the season masks stunningly uneven oversight of the production and assembly process. A single cheeseburger purchased at the “to go” window of a fast food chain off any highway in America can contain a beef patty made from a hundred heads of cattle, cheese from the milk of a dozen dairy farms, lettuce from Arizona engineered to look fresh for days on end, and tomatoes “strip-mined in Texas,” as Garrison Keillor once joked. And yet the inspection of these ingredients rests with a bureaucratic alphabet soup of agencies. Take the 2004 case involving two USDA agencies, the Animal and Plant Health Inspection Service and the Food Safety and Inspection Service. At the very same time APHIS was testing the carcass of a cow infected with bovine spongiform encephalopathy, or “mad cow disease,” FSIS was clearing its beef to head out to market.

Food production today is a well-oiled system, as we saw in 2006 when spinach contaminated with E. coli spread quickly from California’s Salinas Valley out across the country, turning up from Oregon to West Virginia. But where the food supply is a symphony of cooperation, the federal oversight of that system is a nearly completely atonal chorus. More than a dozen different federal agencies share differing and overlapping areas of responsibilities and ways of doing business.

Plans for a single government public health body to take command have long foundered in Congress, but interest grows as the news today is filled with tales of outbreaks, from multi-million pound beef recalls to salmonella-tainted peanut butter and pot pies to melamine-laced imports from China. According to the CDC, each year in the United States an estimated 76 million illnesses and 5,000 deaths are tied to unsafe food.

Putting American eaters at risk is a fractured federal system overseeing what we put into our mouths—one crafted for days when Upton Sinclair’s 1906 book The Jungle turned Republican Theodore Roosevelt into the nation’s leading progressive food reformer. Since the days of The Jungle, the U.S. food safety system has evolved in fits and starts. When Franklin Roosevelt sponsored the creation of the FDA in the 1930s in response to food and drug scares, much responsibility was left behind at the USDA.

Visit the food section of Recalls.gov, a joint project of a collection of federal agencies, and the problem immediately becomes clear. To go any further on the website, you must opt to click the logo of either the FDA or USDA—leaving it to eaters to know which federal agency is responsible for overseeing the safety of which foods. What’s more, recall notices on a .gov website may be misleading, given that food recalls are nearly always voluntary.

The result is a system designed to put out fires, not for ensuring food safety in line with modern science. “When we had the spinach episode, everyone acted like it was a great surprise,” former FDA Commissioner Lester Crawford, a Bush-appointee and long-time federal food safety official, told Science Progress. “But the likelihood of something bad happening [with the food supply] is always quite high.”

The Wrong Recipe for Federal Food Oversight

Marion Nestle, New York University professor and the author of Safe Food who has served in a number of food positions on the federal level, describes “an overlapping system with huge gaps where everybody blames everybody else.” Indeed, asked about the working relationship between FDA and USDA officials, Crawford says, they “generally don’t bump into each other. I don’t know if I ever tried to make a phone call to the USDA. And if I did, I don’t know if it would have been returned.”

The GAO, which has long called for a single food agency, last year bumped the current system up to the level of “high-risk area.”

The GAO, which has long called for a single food agency, last year bumped the current system up to the level of “high-risk area.” When it comes to the FDA, part of the problem, says Lisa Shames, GAO’s Director of Food Safety and Agriculture Issues, is “a mismatch between funding and food oversight responsibility,” where the FDA oversees four-fifths of the food supply but receives just a fifth of the total federal budget for the effort. The FY2009 presidential budget calls for increasing the Food and Drug Administration’s funding level to $662 million, a meager 7 percent boost covering little more than inflation. The FDA itself says it needs an additional $275 million to beef up its overseas inspections.

Beyond FDA’s meager budget is the challenge of having an agency with so vast and diverse a mission, one responsible for the safety of America’s food and drug supply. Says former commissioner Crawford, “I just can’t recall an incident when I said, ‘My gosh, thank God we have the drug people with the food safety people.’” Crawford discounts the possibility of finding agency-level leadership equally skilled in food science and pharmaceuticals. “They just don’t make people like that,” he says.

USDA, home to the majority of agencies with food oversight duties, is an altogether different entity with its own special challenges. In 2003, then-Secretary Ann Veneman lamented that the department was bound by laws that pre-dated the Model T. Says Mike Doyle, director of the University of Georgia’s Center for Food Safety, “USDA is in the plant to look at gross morphology, basically looking for lesions. That was relevant back when the statutes were written,” in the turn-of-the-century days when Sinclair wrote of meat in Chicago’s packinghouses found to be “moldy and white, stinking and full of maggots.” But visible problems like rotting meat aren’t the modern concern, says Doyle. Today’s worry: bacterial pathogens such as E. coli and salmonella, both of which are invisible to the naked eye.

What’s more, USDA is a department internally conflicted. Its primary role in Washington is to promote the food trade—to boost the amount of American pork the Chinese eat, not to worry over whether the pork Americans consume is safe to eat. GAO recently profiled seven countries (Canada, Denmark, Germany, Ireland, the Netherlands, New Zealand and the United Kingdom) that have consolidated food oversight under one roof. Most interesting is the holistic farm-to-fork approach of EU member countries. Ireland is a typical case, moving its food safety agency under the auspices of its existing public health authority—in recognition of the fact that the raison d’etre of their own Department of Agriculture is promotion, not policing.

Added to those challenges is that we’re now pulling an enormous amount of food into our supply stream from overseas—up to 15 percent of what we eat, by volume—and inspecting a miniscule one percent of it at most. The current regime sends a message to food producers in the wake of the melamine scare, says NYU’s Nestle. “The Chinese were very frank about it,” she explains. “’You asked us to give it to you at the cheapest prices. You didn’t say anything about quality.’” Even occasional point-of-entry inspections can act as a deterrent. Nearly non-existent inspections simply set the expectation that the fractured U.S. food supply is willing to absorb foods of dubious quality.

Calls for a Single Federal Food Safety Agency

What’s the solution? For years now, diverse voices in Washington—from GAO to the National Academies’ Institute of Medicine and National Research Council to former Department of Homeland Security Secretary Tom Ridge—have been calling for the creation of a single food safety agency, a player in the federal bureaucracy with the necessary mission, might, and budget to ensure a safe food supply. On Capitol Hill, Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) routinely introduce the Safe Food Act, a legislative vehicle that not only creates a Food Safety Administration but establishes a firm schedule for inspections and gives the new body the power to invoke mandatory recalls.

Interestingly, given Ridge’s past support for the idea, GAO recently eased its strong call for single agency plans in response to the rocky process of getting the Department of Homeland Security up and running. A spokesperson for Rep. DeLauro counters GAO’s concerns by arguing that the creation of DHS was a different effort entirely—an attempt at unifying offices and agencies with unique aims and cultures. She argues that the creation of a Food Safety Administration would be more akin to federal reorganizations like the 1947 establishment of the Department of Defense, which united federal agencies and offices already committed to a common mission.

Even industry opponents of current single-agency proposals, such as the National Cattlemen’s Beef Association, are quick to say that they are united behind the common goal of ensuring a safe food supply. Reached via email, the Cattlemen’s Phyllis Marquitz objects to Durbin and DeLauro’s plans as “political solutions that rearrange agency structures but do little to show potential for real-world practical change.” But the beef industry spokesperson adds that she judges beef producers to be receptive to a convincing case that one unified federal food safety agency is indeed the best way to ensure safe food.

Former FDA Commissioner Crawford echoes the sentiment. In his experience, everyone involved in the food chain “agree[s] with the idea that we have to put safety first,” he says. “The question is how we get there.”

Of course, restructuring the way the federal government handles food safety is no easy task. Agency heads are generally loath to give up jurisdiction and budget. From deep-pocketed meat lobbyists to members of House and Senate agriculture committees, many in Washington with a role in the food supply chain have an interest in maintaining the idea that food safety is an industry issue, rather than a public health concern.

But perhaps most important is Congress’s limited supply of attention. It’s been nearly 70 years since the last time the public demand for safe food forced politicians to act. But given our globalized way of eating and the mounting reports of food-borne outbreaks, that time is likely coming again. The day has certainly arrived for Congress to consider the Safe Food Act with all the thoughtfulness that what we put in our mouths deserves.

Nancy Scola is a freelance writer in Brooklyn, NY.

The NYT reports:

David G. Strunce, chief executive of Scientific Protein Laboratories, the company that supplied contaminated heparin material to Baxter International, which manufactured and distributed the finished drug, described the contamination as “an insidious act” that “seems to us an intentional act upstream in the supply chain.”

The F.D.A. has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.

Mr. Strunce said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.

It is no longer realistic to expect the FDA to make informed decisions if it does not have the resources to undertake foreign inspections. Yet, despite what the NYT describes as “a growing bipartisan consensus on Capitol Hill that the F.D.A. needs a rapid increase in its budget to ensure the safety of the nation’s drugs, medical devices and food,” the Bush Administration’s proposed budget increase for next year is “not enough to cover even its expected cost increases.” (The Bush Administration is proposing a 3% increase.)

The FDA regulates products accounting for 25 cents of every dollar spent by consumers. It plays a hugely important role, and we are rightly outraged when contaminated blood thinner (or toxic plastic) is missed. We are also rightly outraged by reports of corruption and big pharma influence. But how much of this is an internal FDA problem, and how much is a larger symptom of the Bush Administration? How can the FDA do its job properly if it is laboring under an administration that encourages political interference in its affairs (remember the Plan B contraception debacle?) and does not give it the financial means to do its job?

Sirine Shebaya, Ph.D. is a Greenwall Fellow in Bioethics and Health Policy at the Johns Hopkins Berman Institute of Bioethics.

“Tobacco figured this out, and essentially it’s the same model,” said David Michaels, who was a federal regulator in the Clinton administration. “If you fight the science, you’re able to postpone regulation and victim compensation, as well. As in this case, eventually the science becomes overwhelming. But if you can get five or 10 years of avoiding pollution control or production of chemicals, you’ve greatly increased your product.”

Mitchell Cheeseman, deputy director of the FDA’s office of food additive safety, said the agency is not biased toward industry.

“The fact is, it’s industry’s responsibility to demonstrate the safety of their products,” he said. “The fact that industry generated data to support the safety I don’t think is an unusual thing.”

The FDA may be correct in assuming that it’s perfectly usual for industry groups to generate data that supports their claims. The positive correlation between funding source and desirable study outcomes is strong in other fields like nutritional research. But the simultaneous assumption that demonstrating safety is an industry responsibility and that industry groups will generate data that supports their assertions of product safety is a virtual abdication of regulatory responsibility.

Both the FDA and the Environmental Protection Agency regulate BPA. The Senate Committee on Environment and Public Works will hold a hearing tomorrow on the EPA’s oversight of toxic chemicals. Let’s hope they hold at least one agency charged with protecting public health accountable.

I didn’t start writing this column about my friend’s father’s cancer or my addiction. I set out to write about legislation that could finally bring parasitic tobacco companies under the control of the Food and Drug Administration and the astonishingly shortsighted opposition to placing basic health and safety regulations on products that have been proven dangerous.

Currently the FDA can regulate my mouthwash, but not the cigarettes that made my breath stink.

In 1996, the FDA actually tried to assert regulatory power over tobacco products, but the tobacco companies fought back and ultimately the Supreme Court unanimously ruled in 2001 that Congress had not granted the FDA the power to do so. Enter the Family Smoking Prevention and Tobacco Control Act, introduced last year by Senators Edward Kennedy (D-MA) and John Cornyn (R-TX) in the Senate, and Congressmen Henry Waxman (D-CA) and Thomas Davis (R-VA) in the House. The bill would reinstate the 1996 rule and expand the FDA’s power to restrict the marketing of cigarettes, to children in particular.

A superficial glance at the bill reveals that it fails the logic test by requiring an agency charged with protecting the health of Americans with regulating a deadly product without the authority to ban it outright. But the alternative, of leaving Big Tobacco to freely manipulate their product to keep me and the rest of my stinky-fingered brethren addicted, is unacceptable.

Indeed, a 2007 study by the Harvard School of Public Health [1] confirmed a previous study by the Massachusetts Department of Public Health showing cigarette companies deliberately increased the amount of nicotine in the average cigarette by 11.6 percent between 1997 and 2005. So during the time period that I and many other Americans were trying to quit smoking, Big Tobacco was bumping up nicotine levels to make it even more challenging.

Since cigarette ingredients are unregulated, they were neither required to seek approval before increasing the amount of an addictive chemical nor to inform their customers. That’s the kind of regulatory oversight the FDA could bring to this drug-peddling industry.

Cigarettes are unregulated drug delivery systems.

It’s common knowledge that cigarettes are far more than dried tobacco leaves, and that the companies that produce them have misled the public for years. But somehow we don’t think of cigarettes as highly engineered nicotine delivery systems. It is the nicotine-induced blast of dopamine and other neurotransmitters that keeps me coming back for more, so, naturally, improving the drug delivery mechanism will increase addiction. And that is the key. Cigarettes are unregulated drug delivery systems.

A recent report by several respected health organizations, including the American Heart Association and the American Lung Association, details many of the clever advances that make the modern cigarette an engineering marvel. Case in point: Philip Morris, which manufactures my brand of cigarettes, discovered that adding ammonia-based compounds to cigarettes increased the absorption of nicotine. That’s the same principle as crack cocaine. Genius!

The addition of ventilation holes in the filter paper is another brilliant bit of engineering designed to dilute the smoke so the machines that test for tar levels register lower amounts, and the cigarettes can be marketed as “light.” The problem is, smokers functionally draw on cigarettes differently than the machines to maintain nicotine levels, and there is no net health benefit, just smooth smoky goodness [2]. The best part about these companies is that they continue to innovate. A recent Wall Street Journal article detailed the many wonderful products that Phillip Morris has developed, including a high-tar, high-nicotine cigarette and shorter cigarettes for those who just need a quick fix [3].

Fear Itself

Like cigarettes marketed to minorities and children, opposition to the FDA regulating tobacco comes in a variety of flavors. Dr. Andrew von Eschenbach, the Commissioner of the FDA, told the Associated Press last year that the FDA “approve(s) products that enhance health, not destroy it,” and that if regulated the FDA could unintentionally make a decision on cigarettes that could make “the public health radically worse.” In a Senate hearing last year, von Eschenbach also expressed concern that “the public will believe that products ‘approved’ by the Agency are safe and that this will actually encourage individuals to smoke more rather than less.”

Yet the bill now in Congress does not mean the FDA will be approving cigarettes. And the public, while foolish enough to start smoking, is not so foolish as to believe that smoking is okay because the FDA regulates it.

The fear that the FDA could make things worse scares the hell out of me. Are we to believe that the FDA is incapable of making rational decisions about cigarettes, but rational ones about all other consumer products they regulate? It is also irrational to think that forcing companies to lower the amount of nicotine in cigarettes or to remove the ammonia compounds that help deliver it to the brain faster could cause people to smoke more cigarettes, especially in light of a study by the National Cancer Institute that found that gradually lowering the level of nicotine in cigarettes does not cause smokers to smoke more or inhale more.

Senator Mike Enzi (R-WY) is perhaps the most outspoken opponent of the bill in Congress, and along with eight Republican colleagues on the Senate Health Education Labor and Pensions Committee, he voted against it. Enzi has referred to the bill as a “public health disaster” because it does not allow the FDA to kill the tobacco industry completely.

He also claims that the bill is a peace offering to Big Tobacco because Philip Morris has expressed support. But the support by one of the biggest offenders is not an indication that the bill is a public health disaster and does not preclude passing additional laws that aim directly at stopping people from smoking or putting Big Tobacco out of business.

To that end, Enzi introduced the Help End Addiction to Lethal Tobacco Habits Act, which he touts as an alternative to having the FDA regulate tobacco. At its heart, the bill is a kind of cap-and-trade program that allows companies to divest from the tobacco industry over a period of 20 years. Keep in mind that Enzi’s bill is not mutually exclusive from the Kennedy-Cornyn, Waxman-Davis Family Smoking Prevention and Tobacco Control Act, which has 55 cosponsors and has passed the Senate twice before—virtually guaranteeing that it will pass when brought to a vote.

This brings up the second and perhaps more important point regarding Enzi’s alternative bill; he has failed to convince a single Senator that it is worthwhile enough to co-sponsor.

The Family Smoking Prevention and Tobacco Control Act will be considered by the House Energy and Commerce Subcommittee on Health this week, and the full committee is likely to consider it in the next couple of weeks. But ranking subcommittee member Joe Barton (R-TX) now claims that part of the bill might be out of their jurisdiction because the user fees charged to tobacco companies are adjusted for inflation over time and thus, in his view, constitute a new tax. The House parliamentarian will surly resolve this minor jurisdictional issue before next week. Then we may hear much of the same hollow and often embarrassing opposition from many in Congress, including Rep. Steve Buyer (R-IN), who invoked the slippery slope argument at a House hearing on the bill last fall, stating “What are we going to do? Outlaw Halloween, Valentine’s Day, the Easter bunny?…That gets pretty ridiculous when you think about all that.” I have and it is.

What is clear is that this brand of specious opposition will be far less decisive than the over 600 public advocacy groups that support it. With over 430,000 Americans dying of tobacco-related deaths each year, one would suppose that in most districts, more constituents have died from cigarettes over the years than would oppose the bill today.

I hate the fact that I am at the mercy of a tobacco company that has engineered their product to keep me addicted. And I hate the fact that my friend has to bring his father to chemotherapy because of cigarettes. But the fact that cowardice has prevented our government from protecting us from such manipulation makes me physically queasy.

Sen. Enzi is correct—having the FDA regulate tobacco will not get rid of cigarettes. But it sure will make it a lot harder for more dangerous products in development and currently sold abroad to make it to the United States. And if Big Tobacco has to stop developing their products for and advertising them to children, then please explain to me again how this bill is worse for us than a pack of Luckys.

Michael Stebbins is the Director of Biology Policy for the Federation of American Scientists, President of the SEA Action Fund and author of Sex, Drugs and DNA: Science’s Taboos Confronted. He quit smoking as of the publication of this piece and will donate $1000 to the American Heart Association for every cigarette he smokes from now until the end of the year. You can track his progress at SexDrugsandDNA.com.

Notes

[1] Connolly, GN, et al., Trends in Smoke Nicotine Yield and Relationship to Design Characteristics Among Popular U.S. Cigarette Brands, 1997-2005, A Report of the Tobacco Research Program Division of Public Health Practice, Harvard School of Public Health, January 2007.

[2] National Institutes of Health, Risks Associated with Smoking Cigarettes with Low Machine-Yields of Tar and Nicotine; Report of the NCI Expert Committee, National Cancer Institute, Smoking and Tobacco Control Monograph 13, October 2001.

[3] “Philip Morris Readies Aggressive Global Push,” The Wall Street Journal, January 29, 2008.

According to the panelists, off-label can increase the risk of joint pain, carpal tunnel syndrome, and even cancer. Specifics about HGH’s athletic benefits are still unknown because little clinical data exists on the subject and the few related case studies involve athletes using HGH in conjunction with steroids, making it difficult to link performance enhancement to HGH alone. Committee Chairman Henry Waxman (D-CA) cited a 2007 Stanford study which concluded that “HGH could not be recommended as an anti-aging therapy.” Yet the market for HGH anti-aging therapies continues to grow, raking in two billion dollars in sales last year. Panelists also pointed out the lack of physician supervision for off-label users means they may not know the correct doses, leading to the risk of acromegaly–a serious condition resulting from too much HGH in the body.

Tackling the problem of HGH abuse is difficult in a sports culture fixated on shortcuts and competitive advantages. And reports of use among professional baseball players only compounds the struggle to end steroid use among young athletes. Dr. Alan Rogol, of the University of Virginia and Indiana University School of Medicine, emphasized the importance of raising public awareness about the abuse of performance-enhancing drugs with the results of a startling survey indicating that 3 out of 5 kids in grades 8 through 12 who were using steroids were willing to continue use even if they knew the drugs could shorten their lives.

In light of such statistics, HGH is a public health priority. Panelists suggested developing drug tests that can detect HGH use among professional athletes and further restricting access to the hormone. Today, the the Committee held a second round of testimony on illegal steroid use in Major League baseball.

The European Commission has filed two new inquires into complaints that Microsoft is unfairly preventing competition by withholding interoperability information from developers and by bundling Internet Explorer with its operating system. The European Committee for Interoperable Systems filed the complaints with the backing of IBM, Sun Microsystems, and Nokia. Opera, whose eponymous web browser competes with Microsoft’s Explorer, filed its complaint separately.

Japan has announced a new five-year plan to boost cutting edge physics research and reiterated its commitment to the International Linear Collider. The decrease in U.S. and UK funding for the collider may mean the ILC will end up being built in Japan. This rubs salt in the wounds of some in the U.S. scientific community who are already reeling from large budget cuts in particle-physics and fusion research in the new omnibus spending bill. Science Progress recently covered R&D funding in the 2008 budget.

Terminally ill patients do not have a constitutional right to developmental drugs that have not yet been approved by the FDA. The U.S. Supreme Court declined to hear an appeal on a DC Circuit court ruling in favor of the FDA’s restrictions on unproven drugs. The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, claiming that its policies moderating access to experimental drugs are unconstitutional.

The FCC’s wireless spectrum auction, scheduled for January 24, may be running into the ground before it even takes off. One of the wireless licenses available, the Block D license, would allow the highest bidder to build a network with national coverage. Because the license stipulates a public/private partnership granting the government access to the network for emergency responders, the Commission is offering the license with a discounted reserve bid. But Block D may have difficulty finding a buyer. The most likely bidder, Frontline Wireless, dropped out of the auction, and if the license for Block D does not sell, FCC officials may have to re-auction the license without the public safety conditions. It is hard to know what companies may bid for this license because the FCC has forbidden participants from discussing the auction and the deadline for joining the bidding has already passed.

At the moment, clones are rare animals. The Post indicates that there are 570 cloned cattle in the U.S., with 30 bovine offspring; there are 24 cloned dairy cows, and 5 pigs. It would be many years before farmers would consider slaughtering or milking clones themselves—their near-term value lies in cloning hearty animals for breeding purposes.

Some groups will argue that consumers might like to know if, in the future, they’re buying products derived from cloned animals. But Weiss reports that “FDA officials have said they do not expect to require food from clones to be labeled as such, but they may allow foods from ordinary animals to be labeled as not from clones.”

The strategy sounds counter-intuitive—labeling all livestock-derived products in a grocery store that are not made from cloned animals would presumably be more complicated and costly than just labeling everything that is derived from clones. But the proposal would serve the interest of producers because a “Made From Cloned Livestock” label could effectively serve as a black mark on food packaging. Organic food labeling provides an analogy. Producers are not required to indicate when they utilize environmentally hazardous chemical fertilizers and pesticides to produce food products. Rather, by following stringent regulations, they are allowed to label foods that are not produced with hazardous agents. Those products are “organic.”

UPDATE: The FDA has released the report: press release, full site; Weiss has more coverage of the negative reactions from consumer groups.

Image credit: flickr.com/sunfox

“If your project is disease-related, health-related, you should not submit a proposal to the National Science Foundation.”

At an Institute of Medicine panel on global health yesterday, an argument over the effect of climate change on the spread of infectious diseases (via the KSJ Tracker).

“We did not propose cutting out entire pages….after they [the Office of Management and Budget] received our comment, they sent back a recommendation to the CDC that they simply drop whole pages from the beginning of the testimony.” An interview with John Marburger (National Journal subscription), Director of the White House Office of Science and Technology Policy.

How hard is it to assemble an FDA advisory panel free of experts with conflicts of interest? Not as hard as the FDA makes it seem, reports the Center for Science in the Public Interest (via The Scientist Blog).

The NSF-funded Discovery Corps Fellowship grants scientists $200,000 for two years to run outside-the-box scientific outreach projects. But stigmas against outreach work, as opposed to dedicated research, may have kept applicants numbers so low that the program may dissolve (Science subscription).

Christopher Mims, of the new Scientific American site 60 Second Science explains Evolutionary Developmental Biology in 123 seconds.

The report highlights a number of severe problems plaguing the government agency, an organization that regulates over $1 trillion in consumer products annually. Among many others, the report highlights the following problems plaguing the FDA and hindering the fulfillment of its mission:

• A lack of a coherent vision and structure for the organization.
• A depleted staff, which despite a huge growth in agency responsibilities, is about the same size as it was 15 years ago.
• A workforce with far too few scientists who understand emerging biotechnology
• An “inadequate” and “obsolete” information-technology system.

The report found that most of the problems in the agency stemmed from the interplay of two main factors: the rapidly increasingly demand put on the FDA and the fact that the agency’s resources, financial and intellectual, have not risen to meet the increasing demand. If the discrepancy between the responsibilities placed on the FDA and the resources the FDA has to successfully uphold these responsibilities is not rectified, then the organization will stand in an increasingly precarious position that is dangerous for the American consumer and the American economy.

Fixing the problems afflicting the FDA is essential to the health of this country. As a nation, we must realize that if America is to continue to be a player on the world stage and an example for other countries, our important government agencies must be brought up to par. The experts that wrote this report should be commended for their effort, but their dedication will mean nothing if their recommendations are not taken seriously and if policy makers do not act on them. It is the right time for the FDA to catch up to the science that it purports to evaluate in a sophisticated and impartial fashion.

The report summarizes its plea to the FDA:

We recognize that adequate resources — human and financial — alone will not be sufficient to repair the deteriorating state of science at FDA, which is why we also recommend significant restructuring. But without a substantial increase in resources, the Agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public. This will damage not only the health of the population of the US, but also the health of our economy. Currently each American pays about a penny and a half a day for the FDA; an increase to three cents daily would not, in our view, be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world.

In its National Innovation Agenda, the Center for American Progress calls for increased funding for the FDA and other governmental scientific groups.

UPDATE: The Senate Health, Education, Labor and Pensions Committee will hold a hearing on food safety at 10:30 a.m. this morning. Webcast available here.

The University of Virginia is home to a Johnson & Johnson-funded study on Topamax’s ability to treat alcoholism. The Health Blog describes claims from the Public Citizen’s Health Research Group, which says that the University of Virginia, where the study took place with funding from J&J, put out a press packet that encouraged doctors to prescribe the medication off-label. Doctors can prescribe drugs off-label for uses not formally approved by the Food and Drug Administration, but drug makers cannot advertise or promote these alternative uses. The Health Blog also notes that the scientist who led the study at UVA, Bankole Johnson, chairman of UVA’s Department of Psychiatric Medicine, has financial ties to J&J.

In their main article on the study (subscription), The Wall Street Journal relays Dr. Johnson’s comments about how the current drugs used to treat alcoholism are only prescribed after a person stops drinking or goes through detox. According to Johnson, a drug like Topamax is a welcome development because it can be introduced while a person is still drinking.

The Wall Street Journal also reports that a spokeswoman for Ortho-McNeil Neurologics, the J&J subsidiary that produces Topamax, says they have no intention of submitting the drug for FDA approval as a treatment for alcoholism. And in an article by MedPage Today, they quote a UVA spokeswoman:

“We are not suggesting a go-ahead for doctors, but we are stating a fact,” said a spokesperson. “Doctors who are interested are allowed to prescribe it. No off-label use is being proposed, advocated, or promoted.”

Looking a bit deeper into the specifics of the scientific methodology, Mark Willenbring, doctor at the National Institute on Alcohol Abuse and Alcoholism, commented in an editorial in The Journal of the American Medical Association that accompanied Johnson & Johnson’s paper on Topamax that alcoholic subjects who volunteer for a study such as this one are self-selecting, whereas many alcoholics who undergo specialty treatment are coerced by judges or employers. This self-selecting group mostly closely resembles patients likely to be seen in primary care where pharmacotherapy would be most appropriate.

The New Scientist goes into some detail about how much the patients actually improved and how the drug works by blocking the brain-chemical (or neurotransmitter) dopamine; the piece is more optimistic than The Wall Street Journal.

A letter to Food and Drug Administration Director Andrew von Eschenbach from Sidney Wolfe, MD of the Public Citizen’s Health Research Group, emphasizes the current FDA warnings that caution against taking the drug with alcohol and calls attention to the statistically significant increase in side effects mentioned in the study such as dizziness and trouble concentrating.

Although the results of the study look promising, the side effects seem substantial and even the authors admit that there was no follow-up to determine whether the patients relapsed.

The findings aren’t necessarily hype, but Public Citizen is right to call attention to the fact that FDA approval is more than red tape. Large studies must be done on diverse populations in order to ensure safety and effectiveness and assess the overall risk-benefit relationship. That’s why Topamax remains off-label for alcoholism treatment and should remain so until the FDA approves it. Although it may be worth asking whether news coverage of the study and controversy itself may spur more patients or doctors to consider off-label use.