Amid the bitter and protracted negotiations over this fiscal year’s federal budget, U.S. investments in science and innovation were largely spared from the deepest cuts some federal programs faced. But they may not be safe for long as Congress considers making further spending cuts in the fiscal year 2012 budget beginning in October against the backdrop of debate this summer over raising the national debt ceiling.

That’s why it is critically important that members of Congress on both sides of the aisle distinguish between federal “spending” and “investments.” What many fiscally conservative lawmakers omit in their zeal to slash spending is that many federal programs actually have positive rates of return, meaning they bring in more revenue—to the government, economy, or both—than they cost the taxpayer. To put it another way, some federal investments are profitable to the public balance sheet and save the taxpayers money in the long run.

Need proof? Look no farther than two reports released last week, which looked at the economic benefits and return on investment in the Human Genome Project, and the National Institutes of Health, respectively, and showed that both federal programs have had a tremendously positive economic impact. Let’s examine each in turn.

The National Institutes of Health and economic growth

The first report “An Economic Engine: NIH Research, Employment, and the Future of the Medical Innovation Sector,” published last week by a consortium of science and research medical organizations, looked at the consequences of the public investment in the NIH on employment and economic output. The study, authored by Dr. Everett Ehrlich, a leading business economist and former Clinton-era undersecretary of commerce, found that the NIH directly and indirectly supported nearly 488,000 public and private sector jobs, and generated $68 billion in new economic activity in 2010 alone. Meanwhile, NIH research grants in FY 2010 cost the taxpayers only $26.6 billion. This would represent a 150 percent single-year return on public investment, counting total economic output from the research as revenue.

The economic activity and jobs supported by the NIH are not limited just to the NIH’s Bethesda campus outside Washington, D.C. They are spread across every state and territory in the country. In 2010 NIH research awards supported 12,000 public and private sector jobs in Georgia, 5,300 in Iowa, 1,300 in Alaska, and 31,000 in Texas, just to name a few.

In California, a company called Syntouch LLC is developing synthetic tactile sensors for prosthetics thanks to NIH-funded research. In Alabama, a company called DiscoveryBioMed, Inc. is using principles discovered by NIH-funded research to identify new therapeutic compounds for respiratory, metabolic, inflammatory, and hyperinflammatory diseases. West Virginia-based Protea Bioscience, Inc. is developing technology based on NIH research that improves the quality, reproducibility, and speed of processing protein samples, a technique that will aide with drug development across the board. See the map below for the number of jobs supported in each state by NIH federal research awards.

Source: Map by Science Progress with data from United for Medical Research

Critics of federal investment in R&D programs often argue that public programs like the NIH crowd out private investment. But a recent study conducted by the National Bureau of Economic Research found that the opposite is in fact true for the NIH. Each dollar of federal investment leads to a 32-cent increase in private medical research investment as discoveries diffuse out of academia and filter into the market. Another study found that NIH-sponsored research was more likely to be considered “advanced,” “novel,” or be related to “orphan diseases” than entirely privately funded drug research. This means that the NIH not only supports an ecosystem of business and innovative companies, but the innovation that comes out of this research is more likely to be novel and substantial.

The evidence in this report contradicts an oft-repeated fiscal conservative argument that public investments cannot create jobs. To quote the report, “simply put, NIH—and the research, jobs, technology, and businesses surrounding it—is nothing less than…an economic engine.”

The Human Genome Projects’ incredible return on investment

The second report, published by the Battelle Memorial Institute, is even more stunning. The report looked specifically at the economic impact and return on the federal investment of the Human Genome Project, an iconic federal science research program begun in the late 1980s.

The findings of the study speak for themselves: the public investment of $3.8 billion spread between1988 and 2003 yielded $796 billion (three-quarters of a trillion dollars), in economic output, and created nearly 4 million job-years over the 23-year period between 1988 and 2010. In 2010 alone, while it costing the government nothing, this farsighted, bipartisan investment in genomics research added $67 billion to U.S. gross domestic product, created $20 billion in personal income for American families, and sustained 310,000 public and private sector jobs.

If looking at these public investments from the point of view of a business, these numbers would represent phenomenal growth and profitability. If the total public investment in the Human Genome Project were a private investment fund, and the total public benefits thought of as revenue, the investments made in it would be said to have a return on investment, or ROI, of 14,000 percent over the 23-year period. A return like that would be enough to make any investor drool. Or, to look at it another way, imagine a family that put just $1,000 of their savings into the Human Genome Project in 1988. Today, they would have $140,000.

These figures are remarkable in and of themselves, but they don’t even take into account the intangible fact that these investments lead to innovation in medical treatments, medicines, and technologies that save lives and improve our public health. NIH research made possible the implementation of the Human Genome Project and genetic sequencing. It has also led to new cardiovascular treatments, neurotransmitters, and monoclonal antibodies, which were a component in 5 of the top 20 best selling drugs in 2010, generating worldwide revenue of $35 billion.

The project also had a tremendous impact not just on economic growth and job creation, but on innovation that is helping save lives. This research has helped launch an entirely new industry around personalized medicine and direct-to-consumer genetic testing, both making it easier to target specific medicines and treatments to patients’ needs. A 2009 study showed that 15 percent of healthcare providers reported at least one patient brought them results from a direct-to-consumer genetic test in the previous year, and 75 percent said they changed some aspect of the patient’s care based on the information. This new technology and the fast-growing industry around it were made possible entirely thanks to the research directly funded and indirectly catalyzed by the federal investment in the Human Genome Project.

The takeaway is that while these public investments have led to jobs, growth, and new technologies, more important is that the product of all this is new medical knowledge that benefits the public good. In the words of Greg Lucier, the chief executive officer of Life Technologies, whose foundation sponsored the Battelle analysis:

“From a simple return on investment, the financial stake made in mapping the entire human genome is clearly one of the best uses of taxpayer dollars the U.S. government has ever made. This project has been, and will continue to be, the kind of investment the government should foster…one with tangible returns.

“The initial dollar investment has already been returned [12 times over] to the government via $49 billion paid in taxes. Now we sit at the dawn of the ‘Genomics Revolution’ and all humankind will reap the benefits as we transfer what we now know about the human genome into major breakthroughs including: new forms of ‘personalized medicine’ and genetics therapy better suited to solving the problems we all care so much about, such as cures for cancer, cardiovascular diseases, Alzheimer’s, HIV/AIDS, and many more terrifying diseases. These major advancements are rapidly creating multiple new industries and companies and those companies are creating quality jobs for thousands of people. Life will be even better for all of us thanks to the HGP.”

Conclusion

When times are tough and budgets are tight, everyone—families, businesses, and yes, even the government—must make difficult choices and prioritize the things they really need while giving up some of the things they don’t. This process of economic recalibration, while painful, is a necessary and healthy step in making our economy more efficient in the long run.

But advocating cuts to government investments that bring in more revenue throughout the economy than they cost to run is self-defeating in terms of both deficit reduction and job creation. Cuts to these high-performing programs would be like a business cutting its best-selling product lines in the name of cost reduction. McDonalds doesn’t cut french fries from its menu just to save a buck. They know their french fries are profitable and draw customers to their restaurants. Such cuts would make McDonalds’ balance sheet worse—not better.

Similarly, cutting programs such as the NIH that demonstrably create jobs, catalyze private investment, and drive economic growth in excess of their public cost is misguided. As we proceed in the discussion of how best to make our government more efficient, and reduce our mounting foreign debt, our lawmakers need to adopt the same mentality. Investments in innovation—fundamental science and the research, development, and commercialization of new technology—have long been shown to have not only a positive return on investment for the government, but also great spillover benefits for private enterprise, small businesses, consumers, and ultimately for American families. Congress can’t forget this as it debates government investment targets for FY 2012 this fall.

Sean Pool is the Assistant Editor for Science Progress.

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Cody Unser is a normal 23-year old woman. A graduate of the University of Redlands in California, she now pursues her master’s in public health at the George Washington University School of Public Health. In her spare time she loves exploring marine ecosystems as a certified scuba diver. But there is more to Cody than meets the eye: paralyzed from the chest down by a rare auto-immune disorder at the age of 12, she now leads a double life as one of the most effective crusaders for stem cell research funding our nation has seen.

Cody hails from a family with a special status in American life:  Her father is two-time Indianapolis-500 winner Al Unser Jr. and her grandfather, Al Unser Sr., is also a repeat winner of the iconic American race, as is her uncle, Bobby Unser. The Unser’s are a veritable racing dynasty, with a total of 9 Indy-500 titles between them. Coming from a family that is considered American royalty by some has certainly helped Cody to tell convey her message. But Cody knows she cannot rely on her family’s notoriety alone.

“As an advocate, I’m trying to understand more about how to use my personal story and bring it together in a more powerful way,” she says. “I don’t want to just use my story, I want to back it with facts and the truth. And what these [embryonic stem cells] are and what the science is.”

With the help of the First Step Foundation, which she runs with the help of her family, Cody travels the country to raise awareness for spinal injuries, paralysis, and research funding for potentially life-changing therapies such as embryonic stem cells that could one day allow her to regain the use of her legs. She was even asked to testify before the Senate Appropriations Committee in September (you can watch the video here). Last Friday, Science Progress’s Jonathan Moreno had a chance to catch up with Cody to talk to her about biopolitics, her future, and educating congress and the public about the importance of science and technology in medicine and society.

“People who walk don’t necessarily think of their shoes as technology as much as I do my wheelchair. There’s a difference there that is interesting,” says Cody. “I rely on [technology] just to get around, from point A to point B. So I’ve learned so much about how technology influences science and health… there are two different avenues it seems… to think of the body not only as biology but also as engineering.”

Cody’s life is intrinsically connected to technology. “I think for a lot of people with paralysis or spinal cord injury, rehab and maintaining their body is a daily struggle—our bodies are deteriorating at a faster rate than most people.” Besides her wheelchair she uses a mechanical standing frame to help keep her bones strong, special scuba gear to allow her pursue her passion of diving, and special electrodes which stimulate her nervous system, allowing her to help maintain leg muscle by peddling on a special bike. From everyday use of technology that young people in her generation have become accustomed to—like Facebook—to the devices that she relies on to live a normal life and maintain her body, to her activism on behalf of millions whose futures literally depend on the rate of advancement of new technologies, Cody knows that she has a special relationship with science and technology.

“I think science gets at the core of our human vulnerability. Both in a negative and a positive [way]. Science has evolved so fast and it freaks people out because we don’t want to lose what makes us human. Science brings about cures in the medical world, stem cell research one day will be able to treat disease and disability. But I don’t think that we will ever lose what makes us human. Science will never be able to push us back that far.”

Science and health policy have a profound impact on Cody’s life, a fact which she thinks has shaped her decision to pursue a career educating Congress and the public about the importance of science and health policy. As an advocate for paralysis victims, Cody represents a population of as many as 6 million Americans living without the use of some part of their body. Of her testimony before the Senate Appropriations Committee on the promise of human embryonic stem cell research, Cody recalls:

“Basically you are the voice of a population whom science can influence and benefit. I was so humbled to be given the opportunity to speak on behalf of a huge community. I represent the spinal chord injury community, but I don’t know what it’s like to have diabetes, Parkinsons… [other diseases that could be cured by stem cell research]. To try to bring everyone together in the same world [to advocate for human embryonic stem cell research] was really cool. To be able to speak on behalf [of that] was something I’ll never forget.”

Ultimately, Cody is humble about the advantages she has had which enable her to pursue her passion for sound science-based healthcare and research policy, and as an advocate for spinal cord injury victims.

“I didn’t have to fight for my right to work or to enjoy my life like anybody else. To be able to now represent that population and not think about those things and move forward…I think the fight is out there. And the fight is different this time.”

Listening to Cody, it’s clear she’s more than up to the fight.

]]> http://scienceprogress.org/2010/11/interview-with-youth-crusader-for-stem-cell-research/feed/ 0 http://scienceprogress.org/2010/08/thrown-back-to-the-90%e2%80%99s/ http://scienceprogress.org/2010/08/thrown-back-to-the-90%e2%80%99s/#comments Mon, 30 Aug 2010 18:07:11 +0000 Jeanne F. Loring, Ph.D. http://www.scienceprogress.org/?p=6773 In 1998, a handful of laboratories around the world were trying to generate human embryonic stem cells from five-day old embryos that had been discarded by in vitro fertilization clinics. The feat had been accomplished for mouse embryos 17 years earlier, and mouse embryonic stem cells had a tremendous, Nobel Prize-winning impact on basic and translational medical research. Unlike the mouse ES cell research, the human embryonic stem cell efforts were funded exclusively by private funds from companies.  Because of the so called Dickey-Wicker amendment, the National Institutes of Health was prohibited from providing support for the use of human embryos to make these cells.

Scientists are good at overcoming barriers, and the first human embryonic stem cell (or, hESC) lines were made in 1998 in the United States and Australia. Three years later, there were around 20 documented hESC lines in countries around the world, and on August 9, 2001, President George W. Bush decreed that federal funding would be allowed for this small number of existing lines; he recognized that hESCs were key to launching a new era in medicine—regenerative medicine.

Progress since 2001 has been nothing short of astonishing. Research using these 20 hESC lines created a foundation that led to remarkable breakthroughs that are already improving medicine. From this hESC research we learned how to turn skin cells into hESC-like cells, and how we may be able to treat diseases that are currently incurable. Knowledge about hESCs is the basis for all of regenerative medicine, including ideas about how to improve the limited abilities of adult stem cells.

Then, on August 23, 2010, after millions of dollars in NIH investment in hESC research, a pair of disgruntled scientists convinced a U.S. District Court judge to issue a preliminary injunction barring federal funding of work involving hESCs. So, a dozen years after hESC research was launched, and well into the development of therapies using these remarkable cells to improve human health, it is possible that this judgment will send us back right back to the stem cell dark age, 1998.

Why?  It’s about money. These two researchers working on adult stem cells were afraid that if the NIH continued to fund hESC research then it was going to make it harder for them to get money for themselves. This argument is ridiculous to anyone who knows anything about how the NIH works, and we fervently hope that this foolishness is resolved quickly.

But let’s look at the damage that will be done if this injunction holds. The meeting of the International Society for Stem Cell Research, held in San Francisco this June, drew a crowd of more than 3,000 scientists from the United States and many other countries.  The society was formed in 2002 to bring together the ever-growing group of scientists whose work was sparked, directly or indirectly, by Bush’s policy. Among the scientists were the next generation, 20- and 30-somethings, who were going to lead the charge for development of hESC therapies in the future.

What will become of these scientists if the injunction stops their research? The first effect will be that some will almost immediately lose their jobs when their NIH funding is stopped. Many graduate students and postdoctoral researchers are supported by the NIH; those working with hESCs will have to find other jobs. This is terrible for the individuals, but it may be worse for the millions of people who will acquire Type I diabetes, Parkinson’s disease, heart disease, and suffer from strokes in the next 20 years. Without this generation of stem cell scientists, the chances of regenerative therapies for these disorders will be miniscule.

The NIH has invested money, and thousands of scientists have invested years of their lives in order to make hESC-based therapies possible. To stop now will mean that all of those dollars and all of that sacrifice will be wasted. Other countries who continue to fund hESC research will rapidly surpass our nation. China, for example, has invested greatly in hESC research. The end of U.S.-based hESC research will mean that the benefits, both medical and financial, will go elsewhere.

We can’t afford the loss of intellectual power that this injunction will bring. In 2010 it would be a tragedy to set hESC research back to 1998 in the United States while scientists in other countries (and perhaps many now working and living here who will soon alight to Asia) forge ahead.

Jeanne F. Loring is a professor and the director of the Scripps Research Institute Center for Regenerative Medicine in La Jolla, CA.

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.

In a press release, AUTM recognized that the institutions “have relatively little influence over companies’ decisions about the pricing and distribution of drugs, vaccines, devices, and other medical technologies in developing countries. However, they are committed to make every effort to ensure that their intellectual property does not become a barrier to access.”

The statement of principles commits the signatories to “make vigorous efforts to develop creative and effective licensing strategies that help to promote global access to health-related technologies,” affirming that “intellectual property should not become a barrier to essential health-related technologies needed by patients in developing countries.” It goes on to say that the institutions should negotiate agreements that promote access through, for instance, non-exclusive licensing or tiered pricing. It also outlines a commitment to investing in research and development on diseases that affect poor countries.

The document also contains a commitment to developing metrics on the impact of the policies and to revisiting the statement biennially.

Universities Allied for Essential Medicines, a student group backed by the Ford Foundation, has been pressuring the schools to change their technology transfer rules since 2001. In its press release, the group heralded the victory, but said it “sees this document as a floor for future policies rather than a ceiling and we hope that other universities will go further still.”

Since Monday, the National Institutes of Health, the University of Illinois Chicago, the University of Illinois Urbana-Champaign, and the Centers for Disease Control and Prevention have also endorsed the principles.

With a bold investment of federal resources into clinician education during their academic training years and throughout their careers, we can improve reproductive health care—including family planning—and contribute significantly to the reduction of unintended pregnancy rates in the United States.

At the moment we lack a full picture of what students preparing for health professions are or are not learning about family planning. Understanding and improving education on reproductive health for clinicians-in-training will improve the care they can offer patients. Students have been strong advocates for these changes and are asking for more reproductive health training. For example, a 2006 study published in Contraception reported that “students requested that more time be devoted to teaching contraception.”^[2] This education should include the linked issues of contraception, sexuality, abortion, HIV and sexually transmitted infections, pregnancy, and maternal and child health, among others.

The time is right to transform provider education in reproductive health and family planning. The president has challenged all Americans to work together to help reduce the need for abortion by, among other complementary goals, reducing unintended pregnancies in the country.

This idea is not new to the core reproductive health community. In a 1999 lecture at the annual clinical conference of the Association of Reproductive Health Professionals, Dr. Daniel Mishell focused on the pressing need to expand family planning curricula at U.S. medical schools. More recently, the National Campaign to Prevent Teen and Unintended Pregnancy and ARHP jointly convened a panel of experts to review and discuss barriers to effective contraception among young adults.

After a thorough literature review and two intensive meetings, the panel concluded that there is not a clear picture in the United State of the amount of contraceptive education health care providers receive at all levels of their training. Worse, it appears that much education is minimal or nonexistent, in spite of family planning training requirements in various specialties and disciplines.^[3] The panel recommended expanding “broadly based, well-balanced and unbiased continuing education activities where practitioners could be exposed to evidence-based information in addition to practical hands-on experiences.”^[4] Other research supports this conclusion:

• A 2007 editorial published in Contraception reports that lack of training is the number one reason cited by health care practitioners for not taking a sexual health history from patients on a routine basis, followed by clinician embarrassment and a belief that sexual health is not relevant to the patient’s visit.^[5] Reasons for the small amount of time spent on contraceptive counseling, abortion care, and sexuality during training are listed as lack of time, competing curricular priorities, lack of trained faculty or appropriate training sites, and the belief that these issues are less important than training in other areas.
• A review published in the Journal of Sexual Medicine reinforces these conclusions, stating that “in all countries, medical students, house staff, and practicing physicians currently receive variable, nonstandardized, or inadequate training in sexual history taking and sexual medicine assessment and treatment. There remain significant physician–patient barriers to discussing sexual issues; and patients feel that their physicians are reluctant, disinterested, or unskilled in sexual problem management. There is a knowledge gap between developments in sexual medicine and the clinical skills of practicing physicians.”^[6]
• A study of contraceptive knowledge and attitudes among residents confirms that physician knowledge about contraceptives may not be optimal and is inconsistent across primary care specialties.^[7] The authors recommend that “health care providers need ongoing education about new and effective methods of contraception, including long-acting methods. Support should be given to higher education institutions to provide students in the health and medical field with evidence-based information on the latest contraceptive methods. Grants should be available so that health care providers can pursue ongoing continuing medical education on the latest contraceptive methods.”

Our priority should be to expand research and invest heavily into its translation into academic and continuing education for all health care providers. For the reproductive health and family planning field, this means increasing provider knowledge, skills and understanding of contraception, family planning, abortion, sexuality, prepregnancy health, HIV and sexually transmitted infections, maternal and child health, and other issues associated with reproductive health. But it also means incorporating key research about human behavior to improve patient consultation skills, develop cultural competence, and increase awareness of and sensitivity to the potential impacts of provider and patient biases on reproductive health care.

In addition to learning about family planning essentials, clinicians need to improve their communication skills with their patients. Discomfort about discussing sexuality can interfere with effective reproductive health care. A 2003 ARHP survey of women and primary care providers in the United States concludes that providers can be as uncomfortable as patients when discussing specific issues such as sexuality, vaginal health, sexually transmitted infections, and other related issues. Sex and sexuality must be addressed in any discussion about pregnancy prevention.^[8] An analysis published in the Journal of the National Medical Association in 2006 on sexually transmitted disease prevention programs also addresses this point, concluding that “it is essential to train all healthcare providers to lead discussions, educate patients and provide treatment in hopes that sexual health promotion will become as important as other socially accepted healthcare concerns.”^[9]

But reproductive health care, including patient counseling, can be time intensive. A 2000 report focusing on contraceptive counseling for teens concludes that “prescribing and reviewing contraceptive methods with adolescents involves a significant amount of time and resources. Health care providers need to be familiar with how teens think about sex and birth control, what their beliefs are, and how individual teens may make different choices based on their lifestyles.”^[10] An investment in provider education on family planning and reproductive health is in order to meet these needs.

From the patient’s perspective, an untrained or unavailable health care provider can negatively impact contraceptive care. In an analysis of contraceptive use and nonuse published in Perspectives in Sexual and Reproductive Health, the authors found that many women experiencing problems with their contraceptive methods believe that contraceptive service providers are not readily available to answer method-related questions.^[11] Another study completed by Motivational Educational Entertainment Corporation in 2004 found that among a group of urban, African-American teens in the United States, experiences with the health system (including family planning services) were among the most distressing encounters they experienced with any human services system at all.^[12]

Of course, this work will not exist in a vacuum. The investment in provider education will only work in concert with an equivalent surge in new research, health care reform, patient education and advocacy, and a healthier economy. The concept of ramping up family planning education is only one of a handful of linked efforts that, when combined, can help reduce U.S. unintended pregnancy rates.

In a 2007 article on the state of U.S. family planning published in Obstetrics and Gynecology, the authors conclude that “a comprehensive approach requires policy change to improve funding for and access to family planning.”^[13] To accomplish this goal, the time is right for significant federal investment in provider training and continuing education on reproductive health and family planning.

Wayne C. Shields is president and CEO of the Association of Reproductive Health Professionals. This article is adapted from an editorial in the journal Contraception: An International Reproductive Health Journal.

Notes

^[1] Association of American Medical Colleges. AAMC Curriculum Management & Information Tool. http://www.aamc.org/currmit 2009.

^[2] Cwiak CA, Emmons SL, Khan IM, Edelman AB. A comparison of different contraceptive curriculums and their impact on knowledge retention and learning skills of medical students. Contraception. 2006; 73: 609–612.

^[3] Providers’ perspectives: perceived barriers to contraceptive use in youth and young adults, Final report, March 17, 2008. http://www.arhp.org/.

^[4] Brown S, Burdette L, Rodriguez P. Looking inward: provider-based barriers to contraception among teens and young adults. Contraception. 2008; 78: 355–357.

^[5] Lazarus C, Brown S, Doyle LL. Securing the future: a case for improving clinical education in reproductive health. Contraception. 2007; 75: 81–83

^[6] Parish SJ, Clayton AH. Sexual medicine education: review and commentary. J Sex Med. 2007; 4: 259–267.

^[7] Schreiber CA, Harwood BJ, Switzer GE, et al. Training and attitudes about contraceptive management across primary care specialties: a survey of graduating residents. Contraception. 2006; 73: 618–622.

^[8] Association of Reproductive Health Professionals. Vagina dialogues survey, August 8, 2003. /Publications-and-Resources/Studies-and-Surveys/Vagina-Dialogues. Accessed May 26, 2009.

^[9] Williams C, Wimberly Y. Sexually transmitted disease prevention in adolescents and young adults. J Natl Med Assoc. 2006; 98: 275–276.

^[10] Brill SR, Rosenfeld WD. Contraception. Med Clin North Am. 2000; 84: 907–925.

^[11] Frost JL, Singh S, Finer LB. Factors associated with contraceptive use and nonuse, United States, 2004. Perspect Sex Reprod Health. 2007; 39: 90–99.

^[12] In: Motivational Educational Entertainment, National Campaign to Prevent Teen and Unplanned Pregnancy. Key findings: this is my reality: the price of sex, an inside look at black urban youth sexuality and the role of media. 2004; p. 1–8.

^[13] Espey E, Cosgrove E, Ogburn T. Family planning American style: why it’s so hard to control birth in the US. Obstet Gynecol Clin North Am. 2007; 34: 1–17 vii.

But today the Associated Press has a story on the newly digitized Children’s Hospital of Pittsburgh that presents a clear narrative of how computer-powered records work in real life, speeding diagnoses, preventing costly and dangerous errors, and helping administrators track effective techniques.

The boon to patient care and hospital bottom lines are compelling reasons to move to EHRs. The power to keep young children healthy is a good one too.

See also: Data Bank: Health Information Technology

More from CAP: “A Historic Opportunity: Wedding Health Information Technology to Care Delivery Innovation and Provider Payment Reform”

(HT: Kaiser Health News)

The stimulus package President Obama will sign into law today contains $1.1 billion for comparative effectiveness research. The money will support work to determine what treatments are effective for various conditions and which are boondoggles that unnecessarily increase healthcare costs.

Over at Gooznews.com, Merrill Goozner calls the provision “half a loaf,” lauding its inclusion, but expressing dismay at the fact that the conference report reads: “The conferees do not intend for the comparative effectiveness research funding included in the conference agreement to be used to mandate coverage, reimbursement, or other policies for any public or private payer.”

Donald Light explained the benefits of comparative effectiveness in his Science Progress article, “How Reducing Negligible Risks Drives Up Health Costs.” In it, he took a close look at the clinical trials for Crestor, a statin, and the subsequent media frenzy that followed the publication of results that it “slashed nearly in half” the risk of cardiovascular trauma for people taking it. In this case, “slashed in half” meant reducing risk from 1.36 percent to 0.77 percent, while offsetting the cardiovascular benefits with an increased risk of diabetes. Light goes on to explain that the current FDA new drug approval process more or less requires that new drugs “just have to be better than nothing.”

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.

Several weeks ago, fifteen of my primary care-internist colleagues and I sat in a midtown skyscraper in a classroom fitted with a laptop computer for each of us. Coffee cups in hand, we embarked upon a two-hour class—the first installment of a ten-hour course—to learn to use a multispecialty electronic medical record (EMR).

The EMR our medical center has decided to launch is elegant, with lots of pop-ups, color-coding, and an amazing ability to collect and generate data. Our instructors pointed out that the new system was more than just a computer to write notes or order prescriptions. Our practice has had that capability for years.

The beautifully scribed notes of the past, sequestered in a doctor’s office or lost in transition in Medical Records, did little to disseminate knowledge or share the insights essential for patient care.

No, this new system was different. It was a medical information superhighway. It connected you with colleagues throughout the medical center by means of a shared medical record. Between sips of coffee, we were told of the new system’s capabilities: If you want to know about your patient’s last visit to the urologist or send a pre-op clearance note to his cardiac surgeon, your colleague is but a click away. Order a drug that is incompatible with the patient’s medication list, and the EMR will warn you away from your choice and steer you clear of a pharmacologic mismatch. Beyond its capability to promote safety, it also can facilitate outcomes research.

Although I was none too thrilled to trudge downtown for training, I must admit that typing up a mock patient visit on the computer was fun. Since it is not altogether different from ordering a book on Amazon or searching UpToDate for medical information, it was not entirely unfamiliar, but it was still novel for a middle-aged doc whose career in medicine began before computers, much less the advent of information systems.

You see, I am part of that cusp boomer generation that came of age before the Internet. Although I am now wedded to a PDA at all hours of the day, night, and weekends, my worldview was shaped in an analog time right before the digital onslaught—now an almost premodern experience.

In high school, my chemistry class was the last to use the slide rule. We thought they were cool and a marker of scientific sophistication, at least until the first hand-held calculators displaced them. By our senior year, physics was made simpler by my little Casio computer, but I’ll always be glad to have experienced the seventeenth-century charm of a slide rule. It might have been centuries old, but it taught you to appreciate logarithms in a way the Casio did not.

In medical school, my class was the last to do pathology solely with glass slides and microscopes. The following year, an innovative pathology professor started to use primitive Apple computers to display some images. No longer were students wedded to one hundred prized slides that they lugged around in old wooden cases. The possibilities were limitless.

Because I am of a certain age, the age of informatics has been trailing me and will chase my generation forever. This is especially true when it comes to the galloping arrival of the EMR. When we were residents in the late 1980s, we would pride ourselves on how our charts read and looked. The chart was a place to tell a patient’s story from our point of view. Although we had all been trained in the architecture of the medical note and the progression from Chief Complaint (CC) to History of Present Illness (HPI) on down to Assessment and Plan (A/P), each of us did it a bit differently. Each of us had our own voice. I recall marveling at the charting styles of my colleagues and professors: the long, obsessively complete note of the intern versus the almost aphoristic musings of the attending—the former chock full of unorganized information, and the latter synthetic in its encapsulation of the problem and plan of action. And in that transition, through our writings in the medical record, we all learned how to think as doctors.

The notes were also often handsome. Although the rule was that all were to be written in black ink, some engaged in a degree of civil disobedience by expressing themselves in another color (myself included). I recall a pioneering female doctor-professor who used a fountain pen and wrote in a turquoise hue. Each of these notes was reflective of a grand personality and as recognizable as the author’s signature.

As a resident, I used to “specialize” in notes depicting occurrences of angina. In the premodern age of fancy twelve-lead cardiograms that would print out the whole thing out on a single sheet, we would run long strips one lead at a time. Later we would collect the strips and label them carefully. As an intern I learned from a resident how to cut the strips into usable samples using a credit card as a template for gauging the width. Once placed in the chart, these notes were a thing of beauty and a testament to our earnest efforts.

But as beautiful as my EKGs were, they were of limited utility. In retrospect, they are now reminiscent of the quaint temperature charts of the late nineteenth century, so carefully drawn by our predecessors. Because they were unofficial EKGs, unread by cardiology, they did not always make their way into the permanent medical record. If they did creep through, they—along with the entire chart—were often “lost to follow-up” in Medical Records until the chart had been “broken down” for billing purposes. That would work out fine if the patient spaced his admissions for angina to the hospital to once every three or four weeks, but not if there was a rapid readmission. In that case, the chart was often unavailable, with no one having access to a current cardiogram or list of meds.

It is for these reasons that my rational self applauds the new electronic medical record. The beautifully scribed notes of the past, sequestered in a doctor’s office or lost in transition in Medical Records, did little to disseminate knowledge or share the insights essential for patient care. With the EMR, data is always available in the service of patients. Our ability to communicate findings has no hiatus.

But still, my romantic self worried that something has been lost with the homogenization of the medical record. Our instructors told us that we could write whatever we wanted in a particular box as “free text.” In the past, we were free to write and construct the medical narrative as we saw fit. Today, it seems we need to be liberated from a grid that has the potential to depersonalize the medical record by squelching creativity and silencing helpful narratives.

The creation of this virtual yet patient-specific social network will force us to create a new balance between privacy and information exchange, both as individual physicians and as members of practice communities.

While the medical record could never be equated with the doctor-patient encounter itself, it was the narrative reflection of that dyad by one of its participants. As we think about pop-ups and automated prompts, will our engagement with patients become similarly muted of affect? Will it deprive us of an empathic response? This concern is more than the well-rehearsed literature, dating back to the 1990s, about having a computer in the exam room. It is about the sentience of an information system, a sentience with which physicians might engage at the expense of engagement with patients. Will the EMR turn the doctor-patient relationship into a new sort of triad, with the EMR itself now acting as proxy for all who care for the patient? If the EMR is the vector of information out to colleagues and the recipient of data from medical cyberspace, what does that mean for the privacy, indeed the intimacy, of our relationship with patients?

In our class, we learned that we would have the option of making some notes “sensitive” and off-limits to other readers unless they are specifically authorized. We heard that the psychiatrists and obstetrician-gynecologists are availing themselves of this option. If it now takes a medical village—and a shared medical record to provide care—are we therefore also responsible for each other’s work? And if so, are we obliged to collectively share information, sensitive or not, with each other?

My psychiatrist and obstetrician-gynecologist colleagues’ urge to demarcate special sections of the EMR speaks to some of these issues. But it also betrays a deeper concern about how the EMR might transform the doctor-patient relationship. Its ability to morph the medical record from a practice-based document into a communal one will move patient care into a social network, beyond any exam room and outside the scope of any single provider or solitary doctor-patient relationship. The creation of this virtual yet patient-specific social network will force us to create a new balance between privacy and information exchange, both as individual physicians and as members of practice communities.

My first morning in clinic with the new system put some of these speculative concerns about the EMR to the test. As a primary care doc, one of my biggest challenges is coordinating patient care and keeping abreast of all the other doctors my patients may be seeing. The EMR solved this problem. With a simple click on “chart review” I could see which physicians my patients had consulted and get accurate, up-to-date information. This was far better than relying solely on incomplete or poorly recalled patient histories about what happened between visits or being at the mercy of specialty consultants who sometimes send a note outlining their findings. Now I had access to their medical records and their thoughts in real time.

I felt empowered by this wealth of information and my newfound ability to share recommendations with colleagues. This became immediately clear when I “signed” a note for a patient needing pre-op clearance for a gynecological procedure. My electronic signature turned the medical record into a virtual e-mail. The gynecologist had immediate access to my suggestions and a way to get back to me.

But it was more than medical e-mail. I also had the sense that a window on my practice was now opened. I am now writing for a wider audience than before. My charts are now public documents in the context of the local medical community where one’s local reputation as a clinician is forged. All care is now witnessed, open to local peer review: others can read what I write and assess its content, clinical judgment, and quality.

The EMR will never compare with the aesthetics of the old paper chart, but it has a functional capacity that the conventional medical record will never have. Like the paperback, which supplanted the medieval illuminated manuscript, the EMR has a mass appeal; within medical communities, it will distribute information beyond a sequestered few to those who actually need to be informed.

I still lament the passing of the beautifully scribed medical record—and remain concerned about confidentiality and the doctor-patient relationship—but I also welcome what information technology can do to minimize discontinuities of care and the medical errors that stem from miscommunication. Most of all, I welcome what the EMR has done to reestablish relationships with colleagues. As dispersed as we are in our separate clinics across the medical center, we are actually talking to each other and sharing our charts. This web of care is already appreciated as an operational improvement over the status quo. I suspect it will also become a way to collectively reaffirm and redefine our values as a healing community. Linked through technology, we can now articulate what constitutes scientifically sound and humanistically informed medical practice in the information age.

Joseph J. Fins, M.D., F.A.C.P. is Chief of the Division of Medical Ethics at Weill Medical College of Cornell University where he serves as Professor of Medicine, Professor of Public Health and Professor of Medicine in Psychiatry.

© The Hastings Center. Reprinted by permission. This article originally appeared in the Hastings Center Report, vol. 38, no. 5 (2008), available at: http://www.thehastingscenter.org/Publications/HCR/Detail.aspx?id=2216&page=1

As the new Obama administration develops its innovation, economic development, and workforce policies, it should look to build and sustain regional and networked efforts, rather than only crafting broad national policies. The work of innovation can be inspired or stymied by the regulatory, operational, and funding mechanisms adopted by the federal government and Congress. What has limited prior administrations is the failure to leverage federal investments and initiatives conducted throughout the country—often based on the aspirations of local business, civic, academic, and entrepreneurial interests—and align them around a highest common denominator for transforming the economy and society. We live in a networked economy that is not reflected in federal grants and initiatives that are distributed across the country into silos of community needs, and therefore fail to leverage knowledge, experience, and accelerated sources of innovation.

This view of the primacy of federal-regional innovation partnerships stems from more than 20 years of work in assisting local, regional, state, and federal governments in building strong technology-driven economies. Over this period, there has been a shift in the thinking about the development and support of local industry clusters. As originally articulated by Harvard University’s Michael Porter in the late 1980s, traditional cluster theory argued that all assets, companies, and business- and financial-related value chains must be located in a contained regional area. In our observation, however, industry clusters no longer require the presence of all facets of research, operations, management, and distribution in order to contribute to the strength of a regional economy.

In today’s global and domestic hubs-and-nodes clusters, research and discovery is based on a specific institution or industry campus in one location, manufacturing in a second node, and distribution hubs in other places. Rather than focusing on specific physical assets, the most important element for successful regional, innovation-led economic development is the leveraging and networking of regional assets to best deploy the human talent—the “know-what and the know-how”—that is central to competitiveness and wealth creation. Our national economic strategy has been based for far too long on individualized responses to individualized communities, never considering the linkages of knowledge or competency in contributing expertise that must be networked to hasten competitiveness and innovation in and among “communities of practice.”

In the three case studies that follow, we highlight examples of the federal government catalyzing regional or networked innovation through the development of new models of collaboration. Some of these, such as the U.S. Department of Labor’s pioneering Workforce Innovation in Regional Economic Development, or WIRED, initiative, are focused on workforce strategies in specific regions across the United States. Others, such as the Central Intelligence Agency’s In-Q-Tel venture capital program and the National Cancer Institute’s advancement of cancer cure initiatives, are focused on addressing longstanding national security/intelligence and medical Grand Challenges.

All three initiatives, however, share the same goals of building innovative partnerships in order to effect a transformation in the delivery and impact of federal services. The Grand Challenges confronting America demand new frameworks for engagement—not from a command-and-control central system but through a networking of networks across the spectrum of U.S. ingenuity, creativeness and entrepreneurial spirit. In an uncertain economy undergoing sometimes agonizing restructuring of business and government operating models, these networked partnerships and frameworks should suggest best practices for the Obama administration, Congress, governors, and mayors—and above all for the citizens who will benefit from these transformative systems of collaboration, innovation, and delivery.

Central Intelligence Agency: In-Q-Tel

The Central Intelligence Agency in the late 1990s needed to develop innovative technologies to meet the demands and needs of the post Cold-War era but faced the challenge of how to do so in a rapidly changing marketplace. Ruth David, then head of the science and technology directorate, understood that commercial and consumer markets were so highly active in both discovery and the attraction of the best product development minds that the U.S. intelligence community could no longer rely on being the first-in-line for obtaining consistently innovative tools, nor recruiting the workforce and skills required to keep pace.

Tasked with identifying and accelerating a new framework—one that would be highly transparent and significantly more public than ever before—David determined the agency should effectively partner with the private sector, including research universities, angel and venture capital investors, and emerging technology companies. In this way, the CIA could leverage government, academic, entrepreneurial, and private sector resources toward novel products, services, and even skilled workforce development objectives.

Based on a request from the Science and Technology Directorate to “consider all options—even those that have not been on our list of models in the past so that we can signal our seriousness and commitment to attract innovators and their innovations,” a small expert team benchmarked all previous federal models, among them laboratories, federal-funded R&D centers, outsourced programs, and initiatives such as the Defense department’s Defense Advanced Research Projects Agency, or DARPA. The team then assessed the return-on-investment as well as the risk-mitigation scenarios of each of these concepts.

The outcome: an operational plan for the Central Intelligence Agency’s In-Q-Tel project—a first-ever collaboration among the U.S. intelligence community, academic research, and the entrepreneurial community. The In-Q-Tel framework identified approaches for the selection of key technologies, risk management in an environment that sought to harness both the intelligence community’s culture of secrecy and the entrepreneurial focus on openness and transparency, along with the criteria for investing the $50 million per year in dual-use products and services.

In-Q-Tel now makes investments in technologies to create sustainable solutions for the national intelligence community. In-Q-Tel measures impact through the value of investments to deploy technologies, ability to strengthen nascent companies, and long-term financial returns on such partnerships versus attempting to only value in-house resources and capabilities.

The lesson for the Obama administration: Not all capital and research capacities rely solely on the lead by the federal government. If federal funds are harnessed toward a focused but characteristically venture capital-style investment model, then the results are new resources (talent, knowledge, dollars) deployed in strategies that mitigate conflicts of interest while accelerating solutions. These results are not just useful for the CIA’s spycraft needs, but also for alternative energy, information-based government services, and water-environmental challenges.

National Cancer Institute: Accelerating advancements in cancer cures

Since the 1960s’ endeavor to wage a “war on cancer,” NCI has dedicated significant resources to support an increasing number of Comprehensive Cancer Centers across the United States. There are now some 64 centers across the country that are designated on the depth of research and capacity to engage the public in education and training, with an annual budget of more than $4 billion distributed to these centers, other designated programs, and the research community.

In 2003, however, then-NCI Director Andrew von Eschenbach decided to try something different. He tasked the entire NCI community (public, private, philanthropic, entrepreneurial, and venture capital-based) to “eradicate cancer by 2012,” a moon-shot commitment for ending a disease costing Americans, employers, and the federal budget a minimum of $500 million per year in health insurance payments, treatments, and lost productivity, as well as the loss of lives that could be prevented through a number of new discoveries.

Despite significant successes over the 40-year history of the centers, von Eschenbach convened a roundtable in 2004 to examine the “scientific, societal, cultural and economic barriers to the success of fighting cancer in order to get a head start on his 2012 goal. This forum, titled “Leveraging Multi-Sector Technology Development Resources and Capabilities to Accelerate Progress Against Cancer,” brought together a wide variety of leaders from government, the academic-medical community, and the private sector, including representatives from biotechnology, pharmaceutical, information technology, and investment companies.

In addition, the forum included state and regional economic and innovation-based development entities and organizations, each bringing its perspective on networking relationships and teams for immediate results in applied-translational research and commercialization. There were four primary challenges that roundtable members were asked to address:

• Identify key barriers that stand in the way of optimizing the timely transfer, development, and commercialization of advanced biomedical technologies, including incremental and disruptive technologies, to accelerate progress against cancer
• Explore key regional, national, and other models whereby advanced biomedical technologies are successfully identified, transferred, and ultimately commercialized for broad patient benefit
• Brainstorm and evaluate novel concepts to facilitate the strategic alignment of resources and capabilities from all sectors to remove mission-critical barriers and design novel, innovative approaches to speed the development and delivery of new diagnostics, preventatives, and treatments for cancer
• Suggest actions that can be undertaken by the appropriate sectors in alignment and coordination through networked, shared knowledge system investments

After a series of panels outlining some of the challenges in matters such as drug development, funding gaps, effective multidisciplinary collaboration, regulatory requirements, technology, and other matters, the group identified four primary obstacles to developing effective and innovative cancer technologies: The need to build effective cross-disciplinary collaboration; the need to bridge the gap between late discovery and early development of diagnostics and therapeutics; the need to develop new data standards and information sharing; and the requirement to build effective cross-cutting technology platforms.

Just as the NCI Roundtable was driven by the need for new and effective public-private partnerships that could apply a focused and highly leveraged solution to a specific task, the suggested outcomes put a high priority on the need for a new governance structure that could effectively address funding, technology, and multi-use efforts across a wide geography. Two proposed solutions emerged from the NCI analysis and gathering.

First was the recommendation that the Department of Health and Human Services, NCI, the White House, and 10 major philanthropic and venture investment leaders combine resources to create a $3 billion Advancement Accelerator for Cancer Cures, which would work much like the In-Q-Tel model but focus on networking solutions in an open-source teaming setting. Second was the decision by General Electric Co. and IBM Corp. to act on that decision by committing to invest adjacent to several of the comprehensive cancer centers and regional innovation “eco-systems” in areas of bioinformatics, biomarkers, and bio-imaging. These three sub-technology challenges were declared critical not only to cancer, but also to research and discovery of other diseases.

Therefore, with a proposed $3 billion venture fund and new networks of collaborative commercialization, the opportunity to eradicate cancer by 2012 became perhaps more achievable than in prior strategies and initiatives. Although the venture fund was not approved by the Bush White House for further exploration, the venture and philanthropic communities began to link their interests and to drive new investments in market-ready solutions.

Lessons for the Obama administration: Bringing together all the interested parties to define the innovations necessary for addressing a core challenge or targeting a specific opportunity, and then in turn putting the correct level of resources and governance together for implementation, can enable the federal government to be a true catalyst for demonstrative transformation of a long-standing costly issue to American society and the economy. In turn, by first examining the value chain of the current delivery system, then tweaking or wholesale revamping the system through new technologies, partnerships and collaborations, federal intent and goals can meet with accelerated timelines and responses beyond the traditional yearly budget objectives or even four-year political cycles.

Department of Labor: The Workforce Innovations in Regional Economic Development program

Every year, the U.S. Department of Labor distributes nearly $18 billion through formula grants and contracts to train, retrain, and otherwise assist employees and employers in developing new skills to meet the demands of the marketplace, or worse, to respond to major dislocations, offshoring, and negative trade scenarios. And every year, through a program under the Workforce Investment Act, governors and, in turn, state employment and labor agencies acting in concert with local workforce investment boards allocate these federal funds intended to ensure the nation’s competitiveness and skills capabilities of all citizens.

Problem is, this established public workforce system is increasingly misaligned to the needs of industry, job creation, sustainable skills certification, and a host of other challenges confronting our nation’s economy, which is more attuned to new global business models than the traditional manufacturing, smokestack days when most of the federal programs were designed. Simply put, ensuring at one and the same time a safety net for those most vulnerable to the ill consequences of globalization and focusing on the transformative employment, career, and certification of competencies required a different set of tactics and mechanisms.

A new approach was required to build upon congressional mandates given to the Department of Labor. These included the Workforce Act of 1998, which required a role for the private sector in the operation of regional workforce efforts, and Community-Based Job Training Grants, which sought to create partnerships between community and technical colleges and the public workforce system.

Despite these recent efforts at labor market reform—supported by both Democratic and Republican administrations—there remained the clear recognition that the workforce system, broadly defined to include public- and private-sector and academic programs, was not sufficiently and quickly responsive to address the needs of both businesses, industry clusters and individual workers in the global economy. New partnerships had to be created to support, at the regional level, the successful development and deployment of human talent that would drive innovation and support the competitiveness of American companies.

In 2005, the Department of Labor Employment and Training Administration launched the WIRED initiative, which is designed to better align efforts in workforce and economic development with regional innovation capacity building. In addition, WIRED’s unique request for proposals suggested that regions should broaden their own workforce perspective to include high schools, four-year and graduate-degree universities, community colleges, philanthropic and faith-based organizations, and most important, the emerging technology and entrepreneurial sectors fostering and catalyzing innovations and new industries.

Over an 18-month period, 40 regions throughout the country have been awarded WIRED grants totaling $350 million, and a new national pilot project commenced to determine how best to realign and transform the structures, relationships, networks, and delivery systems for addressing global challenges and innovation-based opportunities. The new program at a stroke reframed how policymakers approached the public workforce system and renewed their commitment to seek transformations at both the regional and the federal levels of government.

For too long there has been a disconnect between federal workforce training efforts, led by the Employment and Training Administration, and federal economic development efforts, led by agencies such as the Economic Development Administration and the Department of Commerce’s National Institutes of Standards and Technology programs, as well as other federal interests at the departments of Energy, Defense, Transportation, and the Small Business Administration. WIRED sought to address this challenge by creating replicable structures and incentives that rewarded joint funding by multiple local, state and federal agencies, thereby breaking down traditional barriers of separate financial mechanisms and evolving the partnerships between federal and regional delivery systems for improved, real-time solution identification and response.

Other relevant efforts at building innovative local and regional workforce and economic development partnerships included several WIRED institutes, which have been held throughout the country. In April 2007, for example, the Institute on Alternative Energies, held at the National Renewable Energy Laboratory in Golden, Colo., brought together 100 regional stakeholders from industry, academia, and government, with federal officials from the departments of Energy, Labor, Defense, Agriculture, and Transportation, and the Environmental Protection Agency, to discuss best practices and new developments in renewable fuels—the science, technology, commercialization, business development, and ultimately the human capital and skills. The impact from the two-day WIRED Institute was the formation of a multi-agency response on Green Technologies, Green Jobs, and the enhancement of some 68 agencies focused on enterprise and entrepreneurial development forming a more coordinated response in WIRED regions as a further test-bed for collaboration on resource allocation and performance.

Finally, WIRED sparked the need for increased access to real-time data and knowledge sharing, opportunities to network the best minds across the country within and beyond WIRED communities and institutions, and to inspire new innovations in economic-workforce products and services. Through two tools—the Workforce and Innovation Technical Solution Toolkit and the Innovating Nation Internet-based social collaborative network—the WIRED regions and some 1,500 individuals now have access to more robust data and information on the economy, demographics, economic and innovation investments—a whole host of resources never assembled in this manner to assist decision-making, cooperation, and allocation of time and money toward achieving the mission of WIRED nationally and the aspirations and performance metrics locally.

Lessons for the Obama administration: When given the platform, rules of engagement, metrics, and the latitude to “own their destiny,” Americans will identify the collaborations and pathways needed to resolve Grand Challenges and day-to-day operational issues plaguing governance by a Beltway mindset. These new innovative frameworks for coordination and partnerships at the local and regional level often are not measured as quickly in Washington as in states and communities, especially in areas of job creation, employment, and business decision-making, which means these WIRED programs are likely to boost U.S. economic competitiveness more creatively and more decisively than the plethora of outdated 20th-century workforce development programs.

Further, by coordinating workforce and economic development at the federal level, governors and mayors can be free to explore and implement new operational plans within their respective geographic domains. Indeed, precisely because WIRED encourages crossing boundaries—including several state lines—the program allows policymakers to explore the demand-side of the equation over the supply-oriented mechanisms that historically have been limited by Washington federalism. In short, WIRED increases collaboration among elected and appointed officials and their common constituencies of employees and employers, enhancing the forces of economic growth by sharing a common accessibility to talent, skills, and know-how.

Conclusion and Recommendations

In this period of economic meltdown and uncertainty, it is imperative that the government create a framework to unleash the competitiveness and entrepreneurial spirit of community and regional ideas and solutions. This calls for new federal-regional Innovation Collaboratories—intermediaries that connect the reach and depth of the federal mission with the goals and opportunities of local institutions, organizations, and individuals inclined to work as a team in new ways and on new outcomes measured by whether we resolved problems better and faster and less by whether the money was spent according to the demands of the bureaucracy.

The Obama administration, in partnership with the Office of Management and Budget, key congressional committees and staff, federal agencies, and state and local governments, should review all rules, regulations, and barriers that limit the ability to construct new frameworks for action and implementation as well as to create these federal-regional Innovation Collaboratories. This will enable the leveraging of government resources and co-investment opportunities with academia and the private sector.

To focus this transformation, we suggest choosing two or three Grand Challenges—competitive skills, alternative energy, water and the environment, or health care—to target the best private sector/academic/entrepreneurial/philanthropic localized expertise and creative thinking in partnership with White House policymakers, federal department leadership and program staff. All three of our case studies suggest that no matter the setting, there is a willingness among government policymakers at all levels to engage in out-of-the-box design and implementation of structures and governance in order to address 21st-century challenges that no longer can be effectively resolved without new paradigms.

This leads us to our final recommendation: The Obama administration should swiftly embrace an open-source innovation model for innovation-based economic development that establishes pathways for any person, in any institution or garage, with the interest of the country and its future, to become a member of a national and regional team set to expedite and accelerate these new Collaboratories around Grand Challenges. In tandem with new investments in ubiquitous broadband, new emerging wireless communications technologies and collaborative online tools for research and innovation, a national Open Source Innovation Initiative should become the platform for testing ideas with pilot resources.

The Obama administration will have a unique opportunity to break from the stale research, development, and commercialization model of long-term planning and tardy approvals by responding to a crying need to “launch a new moon shot.” Our nation has neither the time nor the full financial capital to rely on the traditional ways of encouraging innovation, as is so clearly evident today in national security, health care, and workforce development.

Fortunately, we have at hand new, 21st-century pathways to leverage and exploit—based on existing success through proof of previous pilots. If we are to both manage ourselves through an economic crisis and at the same time leap forward to help the current and next generation of Americans thrive and prosper, then it is time to unleash innovation in the public sector from within federal agencies already prone to be more innovative if not for constraints placed on them by old models and old metrics.

Richard Seline is chief executive and principal at New Economy Strategies LLC. Steven Miller is a consultant for New Economy Strategies.

Bloomberg News announced, “AstraZeneca’s Crestor slashed the risk of heart attack, stroke and death by nearly half in people with normal or low cholesterol in a study, potentially opening a way to save the lives of thousands seemingly healthy people.” MSNBC News made the same announcement and then quoted the president of the American College of Cardiology: “This takes prevention to a whole new level.” Ron Winslow of The Wall Street Journal added, “The findings could substantially broaden the market for statins, the world’s best-selling class of medicines.” Except for USA Today, which worried about the high cost to patients, health plans, and the public, most announcements read like infomercials, excited about a major new market.

In short, this “pathbreaking” study that “takes prevention to a whole new level” actually offers little benefit and offsets it with a costly side effect.

These news headlines referred to a large clinical trial published on November 20^th in the New England Journal of Medicine that purported to demonstrate the effectiveness of Crestor—even on older patients with low cholesterol who scored high on a test for CRP, or C-reactive protein. CRP levels are used as an imprecise indicator of heart disease, though the molecule is “a nonspecific marker for low-grade inflammation,” according to Dr. Bernadine Healy, an adviser to U.S. News and World Report.

Almost no one learned that the “slashed nearly in half” reduction in cardiovascular trauma was tiny, from 1.36 percent to 0.77 percent, a difference of just 0.59 percent.

And almost none of the stories reported that the people taking Crestor had a comparable increased risk (0.60 percent) of getting diabetes. Those that did said the increase was “small,” but then so was the reduction in cardiovascular events. Suppose newscasters announced, “Major study finds patients taking Crestor for systemic inflammation experience less than 1 percent reduction in cardiovascular events and an equal increase in diabetes”? In short, this “pathbreaking” study that “takes prevention to a whole new level” actually offers little benefit and offsets it with a costly side effect.

American medicine is rife with such commercial bandwagon tests, procedures, and drugs. An effective policy solution would involve the creation of a comparative effectiveness institute that offered independent evaluations and subjected treatments to head-to-head trials in order to make recommendations about which ones are actually worth the money. President-elect Barack Obama’s health care platform calls for such an entity, and in August, Senate Finance Committee Chair Max Baucus (D-MT) and Senate Budget Committee Chair Kent Conrad (D-ND) introduced the “Comparative Effectiveness Research Act,” legislation that would create a nonprofit institute.

The closer you look, the less beneficial this breakthrough looks. For example, the investigators had screened out 80 percent of their sample so that the trial included only patients with a high CRP but without 13 other prevalent health risks. Those 13 risks include a history of cardiovascular disease, diabetes, arthritis, high blood pressure, cancer, hypothyroidism, or substance abuse. Also excluded were people taking hormone replacement therapy or lipid-lowering therapy.

Put another way, the vast majority of older women and men with low cholesterol and high CRP were excluded because they had conditions that might weaken the results. The trial aimed to select just those people who were most likely to produce a dramatic result but establish the basis for everyone to take the test to see if they have high CRP. If they do, they probably have other risks or behaviors like those people screened out of the trial, so taking Crestor (the most expensive statin) might or might not increase their risk for diabetes and reduce their risk for cardiovascular trauma.

Only a few news stories noted vaguely that Crestor itself has serious side effects. Reports to the FDA of kidney problems from patients taking Crestor exceeded reports for all other statins combined and led The Health Research Group in Washington, D.C. to recommend it be taken off the market. Crestor also lowers levels of CoQ10, a compound that helps generate energy and maintain muscle (including the heart muscle). Fatigue and weakness can result.

Moreover, the trial was stopped with 3.1 years remaining, and it is during this later period of testing when adverse side effects are most likely to surface. Running trials long enough to record benefits but too short to record adverse effects is a common practice in company-sponsored trials. It is one reason why adverse side effects are now epidemic, the 4^th leading cause of death, according to the Food and Drug Administration. As Professor Mark Hlatky at Stanford Medical School wrote in a cautious editorial, “Long-term safety is clearly important in considering committing low-risk subjects without clinical disease to 20 years or more of drug treatment.”

Currently, new drugs “just have to be better than nothing.”

The results of this market-driven trial were reported to the press in a way to get the public as well as the medical profession mobilized to generate large new revenues, thus making the media an agent of commercial interests. No mention was made of the fact that doctors are already prescribing statins to millions of patients to lower their cholesterol when in fact doing so does not reduce cardiovascular risk for those who have no other specific risk. The over-prescription of statins is costing everyone billions. Instead, the news emphasized how statins would now benefit millions more with low cholesterol.

The additional cost to the nation’s insurers, employers, and taxpayers of prescribing Crestor to patients with CRP is estimated to be $9.0-9.7 billion. The reduction of an already small risk would cost about $557,000 per life saved, according to James Stein at the University of Wisconsin School of Medicine and Public Health. That does not include the $80 for the patented CRP test that a much larger population would first have to take, nor the costs of treating new cases of diabetes and other side effects. Yet official guidelines for doctors appear likely to change and recommend the CRP test, whose patent is held by the principal investigator of the trial and his employer, Brigham and Women’s Hospital in Boston.

The main beneficiaries will be the patent-holders and AstraZeneca, the sponsor of the trial. Industry-sponsored trials are nearly 4 times more likely to produce results favorable to the sponsor’s product than independently funded trials, and this one is no exception.

In order to avert future misleading claims about new drugs and to help lower the costs of health care, the country needs an organization like the Comparative Effectiveness Research Institute proposed by Senators Baucus and Conrad. Their bill, S.3408, cosponsored with Senators Jeff Bingaman (D-NM) and Sheldon Whitehouse (D-RI), aims to control costs by improving the effectiveness of treatments used. It would have independent funding to assess the additional clinical benefit of new tests and interventions against their costs in order to get good value for our money.

Currently, new drugs “just have to be better than nothing,” according to Dr. David Barbe, chair of the American Medical Association Council on Medical Service. As Gail Shearer, the director of Consumer Reports’ Best Buy Drugs website and service said, “People are ready to talk about value.” The CRP-Crestor trial and bandwagon illustrates why an institute like this is a vital part of any health care reform under the new administration.

Donald W. Light is a professor of comparative health care at the University of Medicine & Dentistry of New Jersey and a senior fellow at the Center for Bioethics, University of Pennsylvania. His forthcoming book, The Risks of Prescription Drugs, will appear in bookstores this winter.

Across the nation, in hospitals, clinics, and doctor’s offices both military and civilian, health care providers are facing unprecedented challenges in dealing with these weapons’ results. Among the most puzzling is a set of injuries widely considered a medical “signature” of this conflict, and one that raises clinical and scientific questions thus far unanswered.

This is the combination of traumatic brain injury and post-traumatic stress disorder. TBI is a force to the head that damages the brain and impairs its function, with the extent and kind of harm depending on the exact location and scope of the injury. PTSD is a terrifying and often disabling anxiety disorder caused by the experience of violent trauma.

Any blast powerful enough to cause TBI is also powerful enough to cause PTSD, so a high—though unknown—percentage of the many exposed to blasts suffer from both. The scientific literature finds that “anywhere form 20% to 60%” of blast victims have PTSD, says Maxine Krengel, PhD, clinical neuropsychologist at the Department of Veterans Affairs Poly Trauma Network Site in Boston. “It’s huge.” The circumstances of the “event itself” indicate TBI, Krengel says. For example, “did the somebody have a loss of consciousness? If so, for how long?” At least mild TBI is therefore also very common.

Many Questions

A major clinical challenge is that the symptoms of the two conditions overlap—although the conditions are very different in their natures—making diagnosis often “very, very tricky,” Krengel says. TBI causes physiological damage to brain tissue that can result in cognitive deficits and reduced emotional control, among many other problems. PTSD is a learned connection between a traumatic event and a set of responses, which can include nightmares, flashbacks, and constant anxiety and can lead sufferers to alcohol, drugs, and even suicide. But the two conditions share many markers, including sleep disruption, irritability, personality changes, difficulty concentrating and remembering, depression, and more.

To add to the complication, the presence of one condition can interfere with the treatment of the other. And to make things even more uncertain, the type and extent of the brain damage caused by the compression wave of a blast appears to differ considerably from the injuries that form the basis of current scientific understanding of TBI.

“Most of the TBI research has been done in survivors of either motor vehicle accidents or sports injuries—a quarterback [who] gets knocked unconscious” or a driver who hits his head against the steering wheel, says Matthew Friedman, MD, PhD, Executive Director of the National Center on PTSD and professor of psychiatry at Dartmouth medical school. “But the real question that a lot of people are raising is, given the tremendous impact of an explosion, can it really compare to the impact of even a 350 pound defensive end knocking you to the ground? Even though that’s pretty bad, is it anything to compare to a bomb blowing up your Humvee and killing the person sitting beside you?”

Beyond a difference in strength of the impact, Krengel adds, the percussive wave of an explosion acts differently on tissue than an ordinary blow. “The blast impacts the air-filled cavities in the body, every air-filled cavity,” she says. “It’s different in different areas and also depending on how close you are to the blast.”

What is known about the impact of blasts on the brain essentially comes from animal models. “But in the animal literature there is a difference in what the connectivity looks like”—in other words, how the brain’s parts work together—“in blast injury versus traumatic brain injury, that we are typically used to seeing,” Krengel says.

“And then the second piece is that so many of these people have had more than one blast injury,” Friedman continues. So the crucial but as yet unresolved scientific question, he says, is “How generalizable is the sports injury or motor vehicle accident to what is coming into Walter Reed or VA hospitals these days?”

Figuring Out How to Help

The point is not just to study the problems with more science, but to find the best ways of helping suffering human beings, Friedman and Krengel emphasize. “We have two fabulous treatments for PTSD,” says Friedman. “These are evidence-based treatments and…vigorous review recently by the Institute of Medicine has verified their effectiveness.” One treatment, cognitive behavioral therapy, uses systematic, Socratic challenges to thinking about the traumatic experience to help patients restructure their thinking. The other, exposure therapy, breaks the Pavlovian connection between the event and the response with guided confrontation with the troubling memories. Beyond that, several medications help control the symptoms, though they do not resolve the basic issues. If medication is used alone, the symptoms return when treatment ends. Successful psychotherapy, however, permanently frees people from the terrors of PTSD. Which type of psychotherapy works better in a given case depends on the individual, but, Friedman says, in tests of otherwise normal individuals, both overall “perform extremely well and equally well.”

There are no drugs approved for TBI, although some appear to provide some benefit. They are not, however, the same drugs useful for PTSD.

But blast victims very often also have some degree of TBI, and depending where and how it damaged the brain, TBI can reduce the effectiveness of either or both of the two best PTSD treatments. Cognitive damage can impair the intellectual resources needed for cognitive behavioral therapy. The loss of emotional inhibition caused by brain injury can make a person unable to tolerate the emotional stress involved in exposure therapy. Mild TBI very often resolves over time, potentially allowing psychotherapy to work, but clinicians do not consider waiting a sound option because, as Friedman says, “six months is a long time to suffer.”

An additional potential complication is that a damaged brain may not tolerate medications very well. There are no drugs approved for TBI, although some appear to provide some benefit. They are not, however, the same drugs useful for PTSD.

A number of studies and proposals are underway, many of them sponsored by the VA or the Department of Defense, Krengel says, noting that, “The VA system is developing treatment modules or manuals to treat the pain issues, the PTSD, the depression.” Whether sufficient resources have been devoted to studying these conditions is a matter of opinion. But, Friedman notes, “It’s probably going to be a few years until we have definitive data. What I can tell you is that we understand the challenge and research is ongoing.”

Until the big questions get answered, “the challenge is to figure out what to do for these folks. We have some good stuff on PTSD, other [work] on TBI. The question is how applicable, how useful is it going to be for this more complicated situation. Can we utilize what works in the less-complicated cases and how much are we going to have to improvise?” At present, clinicians are improvising ad hoc modifications to treatments to make them more usable by individuals with impairments, while waiting for research to provide more answers.

Is It Enough?

Beyond these questions of basic knowledge and treatment are large issues of access to appropriate care. Although the VA maintains a number of specialized polytrauma centers in various parts of the country for dealing with complicated cases, for an unknown but undoubtedly large number of veterans distances can be large and waiting times long. People with mild TBI and PTSD can be “quite ambulatory and they’re going to walk into primary care clinics, psychiatric clinics” throughout the nation, Friedman says. They often show up with vague symptoms such as headaches or sleep disturbances. Many providers lack even the understanding of the conditions found in more specialized facilities. That’s why, he says, primary care doctors and mental health providers across the country need to be educated about these conditions and told that “anyone who has been in uniform should be asked about the different kinds of exposures they’ve had.”

For now, though, untold numbers of service members and veterans who have experienced blasts are suffering, often without knowing why. And PTSD can strike months or years after a traumatic experience. “You might be in a blast and you have to immediately go back to your job,” Krengel says. “You can sort of keep it together while you’re busy, busy, busy, but after you’re home for a while, people say, ‘Wait, I’m not functioning the way I should be.’”

The experience of a blast may therefore be a time bomb that goes off long after the traumatic event. Unless and until researchers and clinicians answer the crucial questions and effective care is readily available from military, veteran, and civilian providers, it should surprise no one that many who served in today’s wars continue to feel their effects long after the conflicts end.

Washington, D.C. science journalist Beryl Lieff Benderly contributes the monthly “Taken for Granted” column on labor force and early career issues to the website of Science magazine and articles to other major magazines and websites.

To help you understand this psychological phenomenon, I want you to imagine that you have ten years left in your career, and can choose between the following two income streams over those ten years: In the rising salary stream, you would start at salary X, and then receive a steady raise in your salary over the next ten years till you finish at salary X+Y. In the falling salary stream, you’d start right now at an salary of X+Y, and your salary would steadily decline across the ten years to end at salary X. Both choices would leave you with the exact same amount of salary over these ten years, only differing on whether your salary grows over time or declines.

What would you choose?

When I was given this hypothetical choice, I chose the increasing salary stream. I wanted to see my earnings get bigger over time, not watch them fall. Behavioral economist George Loewenstein created this hypothetical choice to illustrate an irrational side of human nature. You see, if I had been rational, I would have chosen the falling salary stream, because in theory I could have invested some of that early money and watched the interest compound over the ten years, leaving me richer at the end of the day than with the strategy I chose. Reason, in my case, lost out to instinct.

Most people, when given this hypothetical choice, are like me and choose the increasing salary. Most of us feel that our incomes are supposed to rise from year to year. The thought of watching our paychecks shrink over time goes against our instincts.

Recent battles over President Bush’s proposal to reign in Medicare costs revealed the power of this instinct. The Bush administration wanted to control costs in part by reducing physician reimbursement. On one level, the political battle was straightforward: A powerful interest group (physicians) stirred up fears to enrich itself. But on another level, the battle was more subtle. Physicians in this case weren’t after more money. They were trying not to lose money.

Daniel Kahneman won the Nobel Prize in part for elucidating people’s powerful psychological desires to avoid losses. (He conducted much of this work with Amos Tversky, who unfortunately died before the Nobel was awarded.) Kahneman and Tversky showed that people feel much worse about a modest loss than they feel good about a similarly-sized gain. In fact, people look more favorably upon a surgical intervention with a 90 percent survival rate than on one with a 10 percent mortality rate, even though there is no difference between the interventions. The mere framing of a choice as potentially involving a loss (of money, of life) triggers strong negative emotions. Human beings are hardwired with an aversion to losses.

Here’s the challenge raised by this psychological phenomenon: If we as a society want to control healthcare costs, one of the things we need to do is control physician income, which in the United States dwarfs that of most other advanced countries. (The most egregious physician incomes are generally earned by procedural specialists, with other groups, such as primary care pediatricians, receiving much more modest incomes.) But if we threaten to reduce physicians’ incomes, we will face tremendous resistance. Psychological resistance. Physicians won’t want to see their incomes go down.

The only way to control physicians’ income is to allow their income to grow over time, while controlling the rate of growth so that physicians’ incomes fall in relation to inflation. An oncologist making $400,000 last year (yes, that’s a pretty common income for such physicians) will probably fight aggressively to keep someone from reducing his income to $395,000 this year. Now, if through a new Medicare plan his income grows 1 percent this year, a rate significantly less than inflation, he will make $404,000. Psychologically speaking, he will feel like his income is growing, and he will probably be less likely to become politically active fighting the plan.

There’s another reason people fight hard to keep their incomes from declining: they often buy homes based on their income expectations. I’m not asking anyone to feel sorry for an orthopedic surgeon who, due to a loss of income, is forced to downsize from his 6,000 square foot home. But I am asking you to imagine yourself in that person’s shoes: you’ve bought your dream house and now, because of a shift in Medicare policy, you may have to move to a smaller house. How hard will you work to maintain your income? Will you donate money to a lobbying organization that will fight the Medicare plan? Will you buy a radiology practice, so you can start making money on your patients’ x-rays? Will you start operating on patients more often, including on elderly people who, in the past, you would have referred to a physical therapist?

Any politician who wants to change the healthcare system should heed the psychological power of loss aversion. Not to do so is a recipe for failure.

Peter Ubel, MD is the director of the Center for Behavioral and Decision Sciences in Medicine at the Ann Arbor VA Medical Center and the University of Michigan. His book Free Market Madness: Why Human Nature is at Odds with Economics—And Why it Matters (Harvard Business Press) is being published in January 2009.

Weiss’s Notebook

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

No kidding.

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

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

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

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

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

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

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

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

AP/Petr David Josek

A U.S. soldier from the 3rd Brigade combat team, 101st Airborne Division, adjusts his colleague’s helmet. New research may lead to headgear that better protects against traumatic brain injuries.

According to Iraq and Afghanistan Veterans of America, from 10 to 20 percent of Iraq war vets, or between 150,000 and 300,000 soldiers, have suffered a traumatic brain injury. TBI does not necessarily leave a visible wound; rather, the force of an explosion can bruise the brain, causing a variety of symptoms than may be difficult to distinguish from other psychological injuries prevalent in combat zones. Developing better ways to diagnose and treat TBI is important, but preventing it in the first place would be even better.

Recent research from scientists at Lawrence Livermore National Laboratory investigates the mechanics of how blasts affect the brain and may provide an answer. Traditionally, armor design, including helmets, focused on minimizing the force of impacts–either from objects striking the soldier or from the soldier being thrown against hard surfaces. But the new study investigates how shock waves from explosions can flex and deform the skull itself, creating internal pressure on the soft brain tissue. Some current helmet designs that maintain a gap between the skull and the helmet wall actually amplify the pressure from blast waves. The research could lead to improved helmet design that protects from projectiles, impacts, and blast waves.

The abstract from “Skull Flexure from Blast Waves: A New Mechanism for Brain Injury with Implications for Helmet Design”:

Traumatic brain injury [TBI] has become the signature injury of current military conflicts. The debilitating effects of TBI on society are long-lasting and costly. Although the mechanisms by which impacts cause TBI have been well researched, the mechanisms by which blasts cause TBI are not understood. Various mechanisms, including impacts caused by the blast, have been investigated, but blast-induced deformation of the skull has been neglected. Through the use of hydrodynamical numerical simulations, we have discovered that non-lethal blasts can induce sufficient flexure of the skull to generate potentially damaging loads in the brain, even if no impact occurs. This mechanism has implications for the diagnosis of TBI in soldiers and the design of protective equipment such as helmets.

(Hat tip: VSL: Science)

This situation arises from a particular pharmaceutical landscape, and young medical professionals indicate future trends and current issues.

Consequently, medical neophytes may feel pressure from within and without to maintain their edge. Nine current and recent residents around the country and one medical student all spoke to me on condition of anonymity for themselves and their programs in order to recount their experiences without fear of embarrassing or implicating anyone. According to this group, they and their peers frequently imbibe alcohol to relax and caffeine to stay alert, and some legally get antidepressants. However, a minority turns illegally to ubiquitous medications. “You can’t just not show up for work one day,” an anesthesiology resident said, “no matter how crappy you feel—so you grab a Zofran out of the dispenser, or you get one of your friends to write you the antibiotic for an infection that you might not have but you’re afraid not to treat it. Being in office settings, you have easy access to all the meds the drug reps bring, so yeah, you’re inclined to grab a handful of Zoloft or whatever and see if it helps.”

Few medical professionals have quite this attitude or access. Nonetheless, the demand to be at one’s mental best is constant. One obstetrician/gynecologist “ate a lot of blueberries because I heard they improved memory.” Meanwhile, the above anesthesiologist’s roommate crushed and snorted “illegally obtained” Ritalin to study, and a neurologist knew four or five people “who’d taken other people’s Ritalin to stay up late to study for exams.” A third resident had once used her brother’s Ritalin in conjunction with caffeine to study in high school but decided not to do it again.

Because these students and residents are not using the drugs to make up for normal abilities they lack, but rather to enhance their performance, they effectively raise the standards for “normalcy,” and the ethical questions get complicated. But this situation arises from a particular pharmaceutical landscape, and young medical professionals indicate future trends and current issues.

By 1999, the United States was consuming 85 percent of the global supply of methylphenidate, a stimulant packaged as Ritalin and Concerta, to treat attention deficit hyperactivity disorder, commonly known as ADHD.[3] Methylphenidate and similar drugs can help healthy people—not by overcoming a deficit—but by allowing them to exceed their normal abilities. Ritalin, for instance, can improve spatial working memory, and Provigil (the marketing name for modafinil), designed to alleviate narcolepsy, can increase accuracy on mental tasks.[4] Since Ritalin, Provigil, and others are not prescribed for cognitive enhancement, it is illegal to use them thus. Yet over 20 studies in the last decade show people do.[5]

A review of those studies showed 5 to 9 percent of students through twelfth grade reported use of a “nonprescribed stimulant” in the last year, often Ritalin or Adderall (amphetamine and dextroamphetamine), as did 5 to 35 percent of college-aged respondents. Sixteen to 29 percent of people with prescriptions for stimulants had given away or sold the drug in their lifetime. Some people used these drugs to party, others to concentrate and elevate productivity.[6] Following a December 2007 commentary on neuroethics,[7] Nature asked its readers about their experiences with cognitive enhancement. Twenty percent of those who answered had used medication, mostly Ritalin or Provigil, without a diagnosed condition to enhance their concentration, memory, or problem-solving (another 14 percent used them with a prescription), and about three quarters of the respondents took such drugs once a month or more.[8]

The question of brain-boosting drugs has simmered in medical enclaves since at least 2004, when the American Medical Association’s ethics journal Virtual Mentor featured the topic. The British Medical Association followed suit with a conference and ensuing discussion paper, “Boosting your brainpower: ethical aspects of cognitive enhancements.”[9] The BMA went beyond questions of individual safety, agency, and social inequality to ask if we should invest in creating and testing drugs on healthy people to improve normal performance when illnesses and other disorders require therapy, and if we should encumber doctors with supervising enhancement and handling the fallout when things go wrong, whether from misuse or side-effects like hypertension and altered personalities.

The transformation from a paradigm that corrects impairment to one that enhances normalcy poses a complicated question for policy.

These discussions have remained largely hypothetical. However, some medical students and residents already boost their mental powers by taking drugs off label, which matters since doctors model behaviors for patients and provide legal access to medication. Moreover, the medical community largely polices itself. Thus, the norms of rising doctors will influence whatever regulation of cognitive enhancement, if any, occurs, and any successful regulation must in turn penetrate medical culture, which physicians and physicians-in-training collectively forge in the absence of some laws and in quiet deviation from others.

Almost all the recent or aspiring MDs quoted above agreed cognitive enhancement would spread assuming nothing else changed. A first-year student concluded, similarly to many, “If there’s money to be made, as long as people want that stuff, then there’ll be people interested in supplying it.” And demand exists. “If there’s a pill out there that can’t be abused,” explained the neurology resident, “but makes me more alert and a better doctor during the day and gives me energy to work out at the gym afterward, sure, I’d take it.” One MD-Ph.D. heard people contemplating nicotine patches or gum to study longer.

The potential for abuse, however, is key. Residents, like any doctor, can prescribe many if not all drugs, and they do so in what several called a “gray zone” between the letter of the law and tacit communal standards. Most states prohibit prescribing drugs outside a formal patient-physician relationship except in extreme cases. Yet at least three of the residents I spoke with bend that law and remain firmly within their group norms. According to the neurologist, “If I have a cold that I think needs an antibiotic, then I get a colleague to write the prescription. It’s not 100 percent right, but I do it out of convenience. But for narcotics or stimulants or anything that would raise eyebrows, I wouldn’t.” The MD-Ph.D. said, “There are some fairly benign medicines that most medical professionals would say writing an Rx for a friend wouldn’t be a big deal. And then there are the psych, pain, sleeping drugs that writing for anyone would raise eyebrows.” Another resident illustrated the gray zone: “All 3 of these [different prescriptions for family] would have flown under the radar and I used my clinical judgment to decide that they were or were not okay.”

If cognitive enhancement establishes itself among medical professionals, then “under the radar” and not yet “raising eyebrows” may annex stimulants like methylphenidate. An effective policy on cognitive enhancement, therefore, should reach this gray zone, which may require education and other ways to change medical culture, since medical cultural norms do not always coincide neatly with the law. Indeed, two studies indicate people who conduct themselves unprofessionally during medical training are significantly more likely to be disciplined by state medical boards later, but unprofessionalism is in the eye of beholding supervisors, deans, and board certification scores.[10] That discretion muddles whether discipline for inappropriate prescription and acquisition of drugs—which constitute 5 to 8 percent of violations in these studies—is uncommon because these incidents are rare or because only cases too far beyond the community’s pale are punished.

Dr. Gary Carr, president-elect of the Federation of State Physician Health Programs, believes “Education, education, education” can best translate any professional guidelines about cognitive enhancement into practice. Although he has yet to see data that demonstrate cognitive enhancement needs to be addressed among medical residents and students, he considers it “a slippery slope” from taking someone else’s Ritalin to trying amphetamines or cocaine. Furthermore, prescribing Ritalin or Provigil “without just cause” could incur “board action for practicing ‘outside the scope.’” Dr. Carr thinks physician health programs could address cognitive enhancement, if needed, since “most of us have some opportunity to lecture to the students/residents,” and the programs take referrals and provide treatment.

Yet physician health programs were created to prevent physician impairment, typically from alcohol and drug abuse, not physician enhancement. AMA ethics, too, emphasize physician impairment. Hence, just as a society’s shift from therapy to enhancement outstrips defined policy, detecting physician enhancement under the rubric of physician impairment appears difficult. Most medical students and residents are referred for poor performance to a physician health program. Improved performance would fly under the radar; only a secondary effect would register, such as the ethical impairment of forging a prescription or perhaps making a mistake in treatment when the cognitive enhancer wore off or misfired, such as increasing impulsive decision making.

The transformation from a paradigm that corrects impairment to one that enhances normalcy poses a complicated question for policy. In the interim, practices continue to develop. As one recent MD said, “My personal belief is, you can drink, smoke, medicate as much as you want as long as it does not impair your personal or professional life.” She may be right—for now.

Mark Meier is a freelance writer with a particular interest in ethics, identity, and social structure.

Notes

[1] Laura K. Barger, et al. 2006, “Impacts of Extended-Duration Shifts on Medical Errors, Adverse Events, and Attentional Failures,” PLoS Medicine 3 (12), e487 doi:10.1371/journal.pmed.0030487. Current ACGME regulations limit shifts to 30 consecutive hours, with 10 hours off in between, and no more than 80 hours average per week over any four-week period. Some exceptions are allowed, and violations do occur.

[2] Amy M. Fahrenkopf, et al., “Rates of medication errors among depressed and burnt out residents: prospective cohort study,” British Medical Journal (2008), doi: 10.1136/bmj.39469.763218.BE

[3] “International Narcotics Control Board 1999 Annual Report,” available at http://www.incb.org/incb/annual_report.html.

[4] The results of these and other small clinical trials are summarized in the British Medical Association’s discussion paper, “Boosting your brainpower: ethical aspects of cognitive enhancements” from November 2007, available at http://www.bma.org.uk/ap.nsf/content/CognitiveEnhancement2007.

[5] T.E. Wilens, et al, “Misuse and diversion of stimulants prescribed for ADHD: a systematic review of the literature,” Journal of the American Academy of Child and Adolescent Psychiatry 47 (1) (2008): 21-31.

[6] Ibid.

[7] Barbara Sahakian and Sharon Morein-Zamir, “Professor’s little helper,” Nature 450 (2007): 1157-59.

[8] The full survey results are available at http://network.nature.com/forums/naturenewsandopinion/1309.

[9] The August 2004 issue of Virtual Mentor (virtualmentor.ama-assn.org) included Martha Farrah’s “Neuroethics,” Abe Schwabe’s “Ethical Issues in the Application and Prescription of CNS Interventions,” and Anjan Chatterjee’s “Cosmetic Neurology: For Physicians the Future is Now”; the same journal in its February 2007 issue printed Steffen K. Rosahl’s “Neuroprosthetics and Neuroenhancement: Can We Draw a Line?” The New England Journal of Medicine in September 15, 2005, published an essay by Richard Kadison of Harvard’s Health Services, “Getting an Edge—Use of Stimulants and Antidepressants in College,” and in November 2007, the BMA released its discussion paper. A month later, Nature published the commentary which led to its informal survey of readers, a story The New York Times picked up in Benedict Carey’s “Brain Enhancement Is Wrong, Right?’ from March 9, 2008.

[10] Maxine Papadakis, et al., “Disciplinary Action by Medical Boards and Prior Behavior in Medical School,” New England Journal of Medicine 353 (25) (2005): 2673-83. Maxine Papadakis, et al., “Performance during Internal Medicine Residency Training and Subsequent Disciplinary Action by State Licensing Boards,” Annals of Internal Medicine 148 (11) (2008): 869-76.

The survey data landed just after a new study reinforcing the fact that the measles vaccine has no connection to autism. The research appeared in PLoS One, and as the Associated Press explained: “There is no evidence that MMR plays any role, the international team—which included researchers who first raised the issue—reported Wednesday.

AP

The AP and The Washington Post both referenced the discredited 1998 research that first suggested a link between the MMR shot and autism. Wariness over vaccine safety spurred by the faulty study first lead to measles outbreaks in Britain. Just last month, CDC released numbers indicating that vaccination exemptions drove measles cases in the United States this year to the highest level in a decade.

CDC quoted Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases in its press release:

Because our nation has been so successful in reducing and eliminating vaccine preventable diseases, it is easy to take the benefits of immunizations for granted…However, recent cases and outbreaks of measles in our country have been a sobering reminder that we must not let our guard down.

In an interview earlier this year on vaccine safety with Science Progress, Dr. Saad Omer, associate director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health discussed research indicating that some of the risks associated with rubella complications (one of the diseases the MMR vaccine prevents) are very similar to the autism vaccine-opposing parents fear.

Comprehensive vaccination not only protects children, it keeps individuals and communities healthy and saves billions in medical expenses. From CDC: “For each group of vaccinated children born during a given year, an estimated 14.3 million cases of vaccine-preventable diseases and 33,500 premature deaths are prevented over the course of a lifetime. In addition, vaccination results in a total savings of $43.3, billion, including $9.9 billion in direct medical costs.”

But since 1971, U.S. citizens have had access to a highly effective vaccine that protects against measles, mumps, and rubella. It confers lifetime immunity to 95 percent of the children to whom it is administered. Most readers born after 1971 are probably too young to even remember getting the first preventative shot. And the evidence that high vaccination rates keep children and adults healthy is overwhelming: kids exempted are 33 times more likely to acquire measles than those who get inoculated.

But yesterday, the CDC announced that more cases of measles have been reported in the Unites States thus far this year than in any year since 1996. When rates hit a seven-year high earlier this year, the news grabbed headlines. From the full report:

No one has died this year from the reported infections, but there have been cases in 131 patients, 112 of whom were unvaccinated or whose vaccination status was unknown. Sixteen of those patients were infants too young to get the shot, but 63 of the 95 patients old enough were children whose parents, for philosophical or faith-based reasons, decided not to get them vaccinated.

Vaccine safety has sparked a series of heated debates this year, driven in part by advocates who cite discredited scientific research linking the MMR vaccine to autism. For an expert take on the issue, Science Progress spoke with Johns Hopkins professor Dr. Saad Omer, who talked about the importance of taking parental concerns seriously, but also ensuring that they make healthy decisions for their kids:

[E]ven those that are concerned about vaccine safety are coming from the right place. All of us want our children to be safe from any harm, including harm from any pharmaceutical interventions. So we shouldn’t be dismissive of that, but it’s our responsibility, for those of us in the public health community, to put out the right information so that people make a truly informed decision about the risks and benefits of vaccines and vaccine-preventable diseases.

Not only does the public health research demonstrate the immense benefits of vaccination—to individual children as well as to the communities in which they live—some of the risks associated with rubella complications (one of the other diseases the MMR vaccine prevents) are very similar to the autism vaccine-opposing parents fear. Dr. Omer explained in that same interview:

[W]e do know that congenital rubella syndrome is associated—and there are some studies showing an association—with autism-like symptoms. …MMR vaccine prevents against something that is associated with autism. So if you are thinking specifically in terms of autism, one should consider that we are talking about something that prevents autism. Congenital rubella syndrome is when mothers get rubella in pregnancies, and children develop certain abnormalities.

You can read the rest of Dr. Omer’s analysis here. It’s worth remembering that the CDC’s “Parent’s Guide to Childhood Immunizations” states in no uncertain terms: “Immunization has been called the most important public health intervention in history, after safe drinking water. It has saved millions of lives over the years and prevented hundreds of millions of cases of disease.” Armed with the best information, public health experts, doctors, and parents can help drive measles rates where they belong: down to zero.

The technology is undeniably impressive. For as little as $1,000, anybody who can drool into a mailing tube can now find out his or her genetic odds of getting any of 20 or more potentially debilitating diseases, including cancer, heart disease and diabetes. Most of these tests will not lead to a frank diagnosis, as happened with Gulcher. But discovering an inherited propensity toward a particular illness can motivate consumers — or, as they used to be known, patients — to get more frequent checkups, take preventive medicines or make lifestyle changes to try to ward off the specter of disease. At last, we seem to be on the cusp of the long-promised personalized-medicine revolution in which gene tests allow physicians to craft far more individualized and effective ways of keeping us well.

While the top officials from all of the major competing gene testing companies agreed that regulations over the industry must be standardized, Weiss does not believe this measure is enough. He calls upon the Department of Health and Human Services and the Food and Drug Administration take the lead on crafting smart policy. Genetic testing companies should also be more transparent about their technology, test results, privacy, and security systems, and the potential use of client specimens for experimental purposes, he argues.

Weiss will discuss the article online this morning on the Washington Post website at 11 a.m. EST.

UPDATE: Weiss discusses the challenges of direct-to-consumer genetic testing in CAP’s latest installment of the Ask the Expert videos.

According to the research, 90 percent of the African population express two copies of a mutation in DARC called DARC-negative. This mutation effectively removes the Duffy antigen from the surface of red blood cells, where it would normally bind to chemokines, small molecules that contribute to the immune response. Antigens like Duffy are large molecules that help generate antibodies and increase the response of the immune system.

However, the new study suggests that the mutated Duffy antigen that is so common in the African population actually helps the HIV virus attach to red blood cells, and more efficiently infect T cells. T cells are like the police chiefs of the immune system—they activate other cells and tell them to destroy various biological threats, such as cells that have been infected by viruses. Once T cells get infected by HIV, the body’s ability to destroy other cells infected by the virus is severely compromised.

But the DARC mutation is not completely devastating for those at risk of contracting HIV. The study indicates that “DARC-negative… is associated with slower disease progression.” In other words, HIV spreads slower when the body’s immune system is already slightly compromised by the mutation in DARC. So while individuals who are DARC negative are at a greater risk for contracting HIV, the same mutation may also slow the progression of the disease.

This research news comes just after the House and Senate passed bills allocating $50 billion for the global fight against AIDS and other diseases and lifting a travel ban for HIV-positive people that has been in place since 1987. However, this latest work on the mutation suggests that policymakers should also increase their commitment to funding HIV/AIDS research, especially because of further discouragement within the community about the possibilities for the development of a vaccine.

This week, the Howard Hughes Medical Institute stepped in with $600 million in grant funding to 56 biomedical researchers pursuing high-risk, high-return work.

In previous decades, the federal government was a significant supporter of bold R&D ideas that had the potential to fail. But as research agencies lose their ability to fund more than a small percentage of grant requests, the review process becomes more conservative. As Science Progress adviser Tom Kalil explains in his report on “A National Innovation Agenda“:

It may take only one reviewer on a peer review panel to block an innovative but risky research proposal. In this environment, researchers become cautious and conservative and propose incremental advances based on previous results. They do not “swing for the fences” by pursuing ideas that will lead to breakthrough technologies or open up new lines of scientific inquiry.

He also points out that the Rising Above the Gathering Storm report recommends allocating 8 percent of federal research to high-risk, high-return projects. Some of them will fail; some will succeed spectacularly. But all of them will help scientists learn more about their fields, and the support will foster a climate of innovative thinking—what the National Science Board calls “transformative research.”

So here’s to the bold women and men who now have the support of Howard Hughes to swing for the fences.

The sad news of Senator Kennedy’s brain cancer has made the general question of balancing politicians’ privacy and the public’s right relevant again, especially in a presidential election cycle. In 1992 Sen. Paul Tsongas, locked in a primary battle with Bill Clinton, claimed he had been cured of lymphoma, but he died a day before the end of what would have been his first term, had he accomplished his White House bid. Since then medicine’s ability to diagnose and prognosticate has only grown, but in general effective interventions lag behind.

Presidents and candidates for the office do release the results of their physical exams, but this is voluntary. The press and the public have no way of knowing what information is withheld, nor exactly when it is released. For example, some cancer patients may get checked for suspicious cells every three months, but politicians may not release medical records, and even if they do, they might hand them over to the press just months before election day.

Also challenging is the question of whether the explosion of new drugs now marketed for conditions like insomnia and erectile dysfunction should be part of a presidential medical report. I have often wondered how many highly stressed candidates used Ambien or some related sleep medication, which would likely disable them for that now-legendary “3 a.m. phone call.” Or, to stay awake on 4 hours of sleep amid half a dozen stump speeches, how many use Provigil? If Bob Dole had been elected, would we have been told that he used Viagra? Would we have needed to know?

The answer to the “need to know” question for many of these new drugs is obscure because we don’t know much about the long-term effects of their use. Not only is the system for our follow-up data poor (though perhaps improving with the FDA’s new “Sentinel” program), never before in human history have so many people been on so many drugs for so long. There is virtually no understanding about how these medications might affect an individual’s mood or judgment, especially over the long term.

The question will only become more pressing as genetic knowledge information explodes. The issue is not confined to risks for maladies like cancer, stroke, or heart disease. When more is known about what genes increase the risk of depression, for example, will that screening be reported? George Stephanopoulos revealed that he used an anti-depressant while working in the White House as the Communications Director for President Clinton. There has been much speculation about the effect of steroids on President Kennedy’s mood (though it was probably positive). It is not difficult to imagine that a future president would be prescribed a mood-lightener. What would this mean for his or her conduct in office?

Many will conclude that the imponderables implied by more medical information are so overwhelming that we should not even raise these questions, and that the practice of releasing presidential health records should remain voluntary and unregulated. But when there is one serious incident that could have been anticipated by the medicine of the day, whenever that day arrives, that judgment may change.

An alarming number of countries are failing to provide the most basic health services that would save lives, with 30 percent of children in developing countries not getting basic health intervention such as prenatal care, skilled assistance during birth, immunizations and treatment for diarrhea and pneumonia.

Wide disparities in health care for the poorest and best-off children are seen even in the highest-ranked countries, the report said.

…

Use of existing, low-cost tools and knowledge could save more than 6 million of the 9.7 million children who die yearly from easily preventable or curable causes, the report [by Save the Children] said.

They include antibiotics that cost less than $0.30 to treat pneumonia, the top killer of children under 5, and oral rehydration therapy—a simple solution of salt, sugar and potassium—for diarrhea, the second top killer.

This is as much a failure on the part of the rich developed world as it is one on the part of governments in the developing world. In addition to financial aid, there needs to be a focused effort to help developing countries set up sustainable primary care networks in socially and economically disadvantaged areas.

One wonders how much of a public health crisis we need before we rethink our vaccine exemption policies—particularly given that misconceptions floating around about a connection between vaccines and autism are driving more parents to opt against MMR.

When asked whether health insurance would pay for genetic testing and custom pharmaceuticals, Dr. Motulsky had this to say:

That’s a problem. On the hopeful side, people say it may soon be possible to sequence a person’s genome for $1,000. Once they figure out low-cost ways to sequence the genome, the price of personalized medicine will come down.

Still, one shouldn’t be misled. What we know about the genome today is not enough for all the miracles many expect from this field. There’s a lot about what regulates the genes and how they interact that we still need to understand. We won’t have the answers by tomorrow.

This hopeful but cautionary attitude seems to be widespread among genetics experts. For example, it is reflected in comments made by Nancy B. Spinner and Barbara Bernhardt in interviews with Science Progress.

Dr. Motulsky remains very active and is currently working on a project related to human color-blindness, which he thinks has useful implications for the study of higher brain functions: “It’s exciting to learn that because of heredity, different people can see the same thing differently. I think this may prove useful in studying more complex brain functions. If this were 20 years ago, I’d focus on neurogenetics. What’s going on in the brain, that’s the last frontier.”

Any eager young minds out there looking for a cutting-edge Ph.D. project?

But a British study published in 1998 drew a link between the measles-mumps-rubella vaccine and autism. While the study itself was flawed and discredited, and subsequent research has demonstrated no link between vaccines and autism, parents and advocacy groups are still wary.

To learn more about vaccine safety, Science Progress spoke with Dr. Saad Omer, the associate director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. Parents concerned about vaccine safety, he says, are coming from the right place in terms of their desire to protect their children, and that it is the responsibility of the public health community to broadcast the right information so that people can make informed decisions about the risks and benefits of vaccines and vaccine-preventable diseases. This interview has been edited.

Andrew Plemmons Pratt, Science Progress: Some recent media coverage has focused on the March ruling from the National Vaccine Injury Compensation Program to Terry and John Poling, who claim that a vaccine contributed to their daughter Hannah’s development of autism. In a New York Times editorial, Paul Offit of the Children’s Hospital of Philadelphia laments the fact that the program abandoned a previous standard for a “preponderance of evidence” for determining the link between vaccines and injuries and instead ruled that their claim was made on standards of “biological plausibility.” Is there a problem with the way that vaccine injury compensation program ruled on this issue, and what does it say about the way we are approaching vaccines in general?

Dr. Saad B. Omer: Let me start with the case, to briefly describe it for those who are not familiar with it. It was a case of a nineteen-month-old girl who received several vaccines together after a delay due to current bouts of otitis media, or an ear infection. And so those vaccines were administered together and she developed some symptoms after that, and at the twenty-three month assessment she was diagnosed with having mild symptoms of autism spectrum disorder, and during her evaluation she was diagnosed with a mitochondrial disorder. A claim was filed in a federal court, and the government settled, awarding them compensation for that.

So to put things in perspective for that case—and in terms of people drawing conclusions from it—I would caution that this is just a case and the question I often ask, even within the scientific community is “where are the controls?” Because when we assess scientific evidence, we need to keep in mind that we need to compare an association of an event with an outcome in both cases and controls, we haven’t had that kind of evaluation yet. And I can go into specific examples of what problems one can have. However, this is a “biologically plausible hypothesis.” What does that mean? That means we should explore this kind of hypothesis under a counterfactual model but should not draw conclusions from it at this point.

And just to clarify why we are on this topic: even if this link is established, and what it says is that mitochondrial disorders, which are a kind of disorder in the cell’s energy mechanism, is proven to be exacerbated by vaccines and result in autism spectrum disorders, metabolic disorders are very rare and it would explain a very small proportion of autism diseases—just to put that in perspective.

Now to the second part of your question, about the change in the standard in the vaccine court that resulted in the awarding of this compensation. First of all, it wasn’t the injury compensation program that changed it, it was the interpretation of a couple of circuit court decisions. These higher court decisions were the result of some cases from the compensation program that were appealed and there were a couple of decisions which the Special Masters of the compensation program, not the HHS, interpreted as having said that the evidence should be evaluated on a standard of “biologically plausible.” I think that’s dangerous, because I can sit here and come up with twenty or thirty different hypotheses which would be biologically plausible on several biological models. We are not talking about probable; we are talking about plausible. Even with probable models, we know the human body is complex, and if you test twenty different biological hypotheses, a majority of them won’t pan out in humans. So I think it’s not a very robust standard to go by because what we are saying is that we would have judgments on these cases based on something that could happen, not something that does happen.

SP: The government has programs that do vaccine surveillance and maintain safety. Could you talk a little bit about what those programs are and how effective they are?

Omer: One major program is the Vaccine Adverse Events Reporting system, which is jointly managed by the CDC and the FDA, and events that seem to be associated with vaccines are reported into that system. It’s a good system for generating signals but it has its limitations. The major limitation is that we don’t have a good denominator to calculate rates so we cannot assume all the vaccine doses that entered the market were administered, so we don’t know the rates.

But another interesting problem that has come up is due to the fact in the U.S. adverse event reporting system, anyone can report a case into the system. There was a recent analysis published in Pediatrics that showed that most of the rise in reports of autism-related symptoms associated with vaccines has been due to increased reporting of litigation-associated cases. So we have that kind of a problem with VAERS but it still has a lot of utility in terms of generating signals. For example, it generated a signal for the old rotavirus vaccine.

Then the CDC has the Vaccine Safety Datalink. They have put together a system by linking databases from several large HMOs, and it covers approximately two percent of the U.S. population of zero to six years. Fortunately because vaccine events are rare, you need large databases to get enough numbers and do a robust scientific study, so that’s a good system.

Then there is the Clinical Immunization Safety Assessment Network, which is a network of a few centers of excellence, mostly academic centers, coordinated by the CDC, to assess vaccine safety in a clinical setting.

So this is basically what the vaccine safety system is in the U.S. However I must say, I think vaccine safety needs a lot more resources than it is provided. Because as I said, vaccine events are rare so you need large numbers to study these phenomena and the resources that are available are very low.

SP: These are very personal choices that parents are making about whether or not to exempt their children from getting vaccinations. What do you say to parents who might be thinking of exempting their children from getting vaccines because of what they might have heard about these possible links to autism?

Omer: There have been several studies—both in the U.S. and outside, in Denmark and other parts of Europe—that have looked at the issue of vaccines and autism and we haven’t found any credible association between vaccines—either thimerosol, which is a mercury preservative that was of concern a few years ago—and MMR, the measles mumps and rubella vaccine and autism. So there have been several studies, and our website, vaccinesafety.edu, discusses some of these issues so people can go and look up specific evidence related to that.

On the other hand, we know that there is risk of—even an individual level risk—of acquiring vaccine-preventable diseases in the United States if your child is not vaccinated. For example, in a national-level study it was found that kids who are exempt from vaccination requirements had thirty-three times—not percent, it’s times—higher risk of acquiring measles with those who are vaccinated, who do not seek exemptions, and [in a Colorado study] six times higher risk of acquiring pertussis than those who are vaccinated. So there are real risks involved in terms of acquiring vaccine-preventable diseases

One last point in this regard: we do know that congenital rubella syndrome is associated—and there are some studies showing an association—with autism-like symptoms. So we know that part of that syndrome is explained by a congenital rubella syndrome which used to occur when the population-level immunity in the U.S was relatively low. So actually, MMR vaccine prevents against something that is associated with autism. So if you are thinking specifically in terms of autism, one should consider that we are talking about something that prevents autism. Congenital rubella syndrome is when mothers get rubella in pregnancies, and children develop certain abnormalities.

SP: So in your experience, where does this misinformation about the risks of vaccination come from? Is it usually generated through parents talking to parents? Is it the media? Is it doctors talking to parents?

Omer: It’s several sources. We found in our studies—looking at parents of children exempted from vaccination requirements, compared to those vaccinated—there was an association with types of provider, trust in government, the sources of information people tended to get, information from some of the advocacy sites tended to seek exemptions at a higher rate, etc. So yes. There are several sources of that, and there are passionate people who feel there is an association with vaccines and autism, and that includes some celebrities as well. So that gets people’s attention.

On the other hand I must say that most parents, even those that are concerned about vaccine safety, are coming from the right place. All of us want our children to be safe from any harm, including harm from any pharmaceutical interventions. So we shouldn’t be dismissive of that, but it’s our responsibility, for those of us in the public health community, to put out the right information so that people make a truly informed decision about the risks and benefits of vaccines and vaccine-preventable diseases.

SP: What do you think is most important for people who are both working in the public health community, people who are policymakers, people who might be hearing about this issue, and for parents to take away from this whole conversation in the public sphere at the moment?

Omer: One thing that people should realize is that we know that vaccines have some side effects. And we should acknowledge that, everyone who is involved. However, the risk and benefit calculus for all vaccines that are out there, based on our current knowledge, heavily favors not only getting your child vaccinated, but also getting them vaccinated according to the specified schedule. I have seen a new trend where people are splitting the difference and saying, “OK, I’m going to get my kid vaccinated, but I’m going to get them vaccinated late.” Well the risk of illness is not constant across childhood and so that’s why the Advisory Committee on Immunization Practices and the American Academy of Pediatrics come up with these recommendations to look at several factors, including the burden of disease. So it’s important to not only get your child vaccinated, but also to get them vaccinated per specified schedule.

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.

The Scientist NewsBlog reports on conflicts of interest within the HHS Stem Cell Council (free registration):

The Center for Science in the Public Interest polled the 25 voting members of HHS’s Advisory Council on Blood Stem Cell Transplantation (ACBSCT) and found that 11 reported having financial ties to stem cell and umbilical cord blood banking companies, drug makers, and the transplantation industry.

Apparently, none of the original applicants to the Council were screened for such conflicts.

Science Progress recently covered a report in The Chronicle on a study (subscription) from the Journal of the American Medical Association showing that many academic scientists are adding their names to reports and papers written by corporations.

In any other context, both of these revelations would have been shocking. But within the medical profession, this is apparently not unusual.

The Health Section of the NYT yesterday reported that the Association of American Medical Colleges is proposing a ban on medical giveaways:

Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.

The NYT also recently profiled a small group of scientists who decided to cease all paid services or consulting appointments with the food, drug, and medical device industries:

No longer will they be paid for speaking at meetings or for sitting on advisory boards. They may still work with companies. It is important, they say, for knowledgeable scientists to help companies draw up and interpret studies. But the work will be pro bono.

…

They are part of a group responding to accusations of ethical conflicts inherent in these arrangements, and their decisions repudiate decades of industry influence, says Dr. Jerome P. Kassirer, a professor at the Tufts School of Medicine, who has written a book on conflicts of interest.

Well it’s high time, too. Just because a practice is pervasive within a profession does not mean it passes ethical muster. And just because somebody is a well-intentioned doctor does not mean she’s immune to bias. That is why we institute ethical regulations. So far, the medical and scientific community has been surprisingly lax about conflicts of interest. One would hope that the personal decision of a few scientists and the ban by the Association of American Medical Colleges indicate the beginning of a trend in the opposite direction.

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

• 20 percent of respondents report using medications to increase memory retention, concentration or focus.
• 60 percent of those who admitted non-medical use of cognitive-enhancing drugs used Ritalin.
• 44 percent of the admitting respondents used Provigil, known generically as modafinil.
• 15 percent admitted use beta-blockers.
• 9 out 10 respondents said they used the drugs to improve concentration and attention.

Science Progress advisory board member Martha Farah expressed concern about the ethical use of brain-enhancing drugs during a Seed Magazine-sponsored briefing on the Hill last month:

If higher productivity can come in a harmless pill, Farah wondered if workers might find themselves saying one day, “I want this job, but I don’t want to have to take a drug to get it.”

If Wired’s coverage is any indication, her concerns may already be manifest in some workplaces. In a recent edition of the magazine’s Mr. Know-It-All column, a reader asks the following question:

One of my coworkers, a rising star at the firm, is using unprescribed modafinil to work crazy hours. Our boss has started getting on my case for not being as productive. Should I tell him about my coworker’s pharmaceutical enhancement? Or should I start taking modafinil, too?

The question of what sort of social or governmental rules will govern such ethical choices about brain enhancement remains unanswered, but it’s obvious that deliberations have already begun.

Jonah Lehrer at the Frontal Cortex argues that we need more science critics and an open public atmosphere for critiquing science. His suggestion to science bloggers: Don’t post anonymously.

Eric Berger over at SciGuy discovered that the Federal government spends 200 times more on bioterrorism preparedness than on hurricane research. This discrepancy is even more significant, he suggests, because bioterrorism might happen while hurricane disasters will happen.

Jacob Goldstein at the Wall Street Journal Health blog covers several stories on the growing number of parents refusing to vaccinate their children over fears that the injections may be linked to autism or neurological disorders, despite the fact that no solid evidence exists suggesting vaccines pose any such danger.

The Chronicle’s Wired Campus covered the news that Intel and Microsoft have teamed to open research centers at top universities to enlist them in a new initiative to harness the power of parallel computing for the next generation of computing systems. It’s worth noting the long-haul five-year commitment to the research.

After offering a scathing critique of federal science policy last Thursday, David Baltimore, AAAS president and Noble-prizing winning biologist, speaking to a packed room of scientists and journalists, said that “little hope” exists for a HIV vaccine after almost 20 years of research.

“We know that politically motivated stakeholders reject scientific analysis that challenges their policy positions,” said MIT professor Lawrence Susskind during a talk on science and policymaking. Introducing stakeholders to third-party “neutrals” while designing scientific studies could support a more fruitful “joint-fact finding” process, he suggested, and could facilitate science-based decisionmaking in the public sphere. MIT and the U.S. Geological Survey have a pilot program, the Science Impact Collaborative, that aims “to harmonize science and policy” by implementing such approaches.

Nicholas Negroponte, co-founder of the MIT Media Lab and the One Laptop Per Child organization, spoke on the current state of play at OLPC, the goal of which is to bring cheap laptops (currently $187) to children in the developing world. Using Moore’s law, Negroponte believes they can bring the laptop’s price down to $50 by 2011. The original cost target for the project was $100 per laptop.

The Knight Science Journalism Tracker, Wired, and the CJR Observatory all feature round-ups and analysis of the AAAS meeting.

Dr. Davis’ new book is an ambitious story of the search for the causes of cancer, extensively footnoted and supported by a website featuring links to scientific studies and corporate documents.

Her research reveals the extent to which official governmental anti-cancer efforts were spearheaded by leaders from the very industries producing cancer-causing materials and products. Her book is already generating considerable buzz, contributing to a lively debate about the nature of cancer risks, what can be done to avoid them, and who is responsible for keeping us safe from dangerous products.

Jeff Stryker’s interview with Dr. Davis for Science Progress has been edited and condensed for posting.

Science Progress: It has been more than 35 years since President Nixon declared “war” on cancer. How are we doing?

Devra Davis: For much of the enterprise we have been fighting the wrong war with the wrong weapons against the wrong enemies. The good news is we now in the United States have 10 million cancer survivors.

We have not dealt with the main causes of the disease. Think about it. In 1971, President Nixon officially declared war on cancer. But by 1936, the world’s leading cancer scientists understood that benzene caused cancer. It was known that diagnostic radiation, solar radiation, and hormones caused cancer in the 1930s. But the war on cancer started in 1971—leaving off the table tobacco, benzene, radiation, sunlight, hormones, mining, and other things then known to cause cancer.

SP: I suppose most casual observers would point to the 1964 U.S. Surgeon General’s report as the first major acknowledgement of the role of tobacco causing cancer, yet you identify the Nazi research as strong on this point.

Davis: The recognition of the dangers of tobacco goes back a hundred years and more. In the late 19th century, autopsies were reported in the literature showing the black lungs of people who smoked cigarettes. Yet individual clinical case reports such as these were basically ignored as the field of epidemiology grew as a science.

SP: How are we doing on some of the particular cancers? I mean, tobacco’s risks are now well known and we’re getting them under control.

Davis: Cancer deaths in the United States are dropping, because we have finally made some inroads against tobacco. If we had acted on tobacco when we first knew it was a hazard, we would never have addicted generations of GI’s in World War I and II to tobacco by giving them free cigarettes, which we did.

We are, in fact, seeing an increase in certain cancers not related to smoking and not as a result of improvements in screening.

SP: Your book left me a bit afraid to leave the house or stay in the house or eat or drink anything.

Davis: The point of the book is not to frighten, but to let people know what can be done to reduce the risk of cancer and its chance of recurrence. People also deserve to recognize that we have not been dealt fairly with by industries that make cancer-causing products.

We are doing amazing research at our Center for Environmental Oncology on the use of certain natural products that can basically extinguish cancer cells, things taken from broccoli or fish oil or yogurt or even sometimes dark chocolate.

SP: Epidemiologists face huge challenges in studying cancer. One hurdle is that they can’t study risky products without the help of the people and companies making and selling them.

Davis: It is hard to do epidemiology. It is expensive. It takes time. The early epidemiologists had to cooperate with industry or they would not have received any data whatsoever. Under our current system there are no incentives for companies to come forward with information about hazards relating to material that they produce.

I think we need a “truth and reconciliation commission” on toxic hazards. Companies could provide independent information with appropriate confidentiality protections concerning potential hazards. This would absolve them from punitive damages. They would still be responsible for paying medical costs for their own workers and to others that they may have injured.

As it stands now, there’s no reason for anyone to come forward with disclosures.

SP: Injured people can always sue. But you discuss the difficulties of doing this in your book—problems in forcing disclosure of trade secrets and with the Daubert rule (Daubert v. Merrell Pharmaceuticals, Inc., 509 U.S. 579 (1993)) if litigation gets underway.

Davis: One group of scholars called it, “The Most Influential Supreme Court Ruling You’ve Never Heard Of.”

The Daubert decision has had exactly the effect the defense bar intended. Namely, 90 percent of all judgments now are going against plaintiffs in tort cases. Daubert raised a very, very high bar of proof. It basically made the collecting of epidemiologic evidence in many cases a requirement before you could prove harm. But cancer is a disease that in humans can take 10, 20, 30, or 40 years to develop. Under Daubert, we have to wait until enough people have been harmed in order to prevent others from additional harm.

SP: What should be the standards of proof before products are deemed toxic or dangerous? Your book resurfaces some battles I thought had been fought and resolved, say, for example, Aspartame.

A recent Aspartame study should give us all cause for alarm. As you may be aware, the typical animal study takes two years, after which animals in both the experimental and control groups are sacrificed and examined for tumors.

SP: By animals you mean mice?

Davis: Rodents—rats or mice.

SP: How long do they usually live?

Davis: Their natural life is three years. But in most studies we sacrifice them at two years. Soffritti and his colleagues in the Ramazzini Foundation in Bologna, Italy exposed thousands of rodents to Aspartame prenatally and throughout their lifetime. He let them live to three years, which is equivalent to humans getting into our 70s, 80s, and 90s. Twice as many exposed animals developed tumors. Yet none of the tumors started to appear until that third year of animal life, corresponding to the last third of human life today. Two hundred million people in the United States today regularly consume Aspartame.

SP: So that horse is out the barn door and headed down the road a piece. How do you study something that’s so prevalent? Is it too late, for example, to be concerned about cell phone risks, now that everyone has one?

Davis: Cell phones are a great convenience and even save lives. It is also clear that the old cell phones, the clunky analog cell phones, were probably much more hazardous than the current generation of cell phones today. Even so, the British, Swedish, and German governments recommend that children not use cell phones. The cell microwave signal is known by industry to penetrate the skull and children’s heads have thinner skulls and are more vulnerable.

My advice is to use a cell phone with speaker phone whenever possible or with a hollow wired headpiece.

SP: Cell phones are changing rapidly. Isn’t the technology a moving target when it comes to pinning down risk?

Davis: Precisely. There’s also the problem that the epidemiology on cell phones, like the epidemiology on Aspartame, has involved studying limited exposures for short periods of time. In the case of cell phones, most studies absolving the technology of risk looked at people who used cell phones in the early 1990s and checked back five years later to see if they had brain cancer. Now, in both cases, that’s far too short a period of observation.

More troubling data has just emerged from a meta-analysis done by Leonard Hardell and his colleagues in Sweden. They found that people using cell phones for 10 years or more showed a doubled risk of certain brain cancers.

SP: Where are the regulators when it comes to toxic hazards? Lead paint in toys has been the scare du jour. Are regulatory agencies letting us down?

Davis: There has been a long-standing decline in the United States of funding for testing and monitoring and measurement. Enforcement on environmental issues is at an all-time low. We do not even have the in-house capacity of the Food and Drug Administration to evaluate toxicology information. We don’t have inspectors. By the way, the problem is not simply lead paint on wood or metal toys. Lead can be put into plastic, and plastics can also contain other toxic materials that can come out of them when children suck on them or when they are heated.

The government has really stopped doing its job. Our laws allow us to think we might be protected. But President Bush has shown a creative ability to ignore laws with his signing statements. Another way to undermine existing laws is to fail to fund the regulatory agencies established to implement them. In the case of the FDA and the Consumer Products Safety Commission, the problem is also their reach. It is clear that they do not have the authority to monitor, for example, contaminants in personal care products or a wide range of imported foods.

SP: Can you talk a bit about the difference between U.S. and European regulatory attitudes on personal care products? I was taken aback by your examples of the placenta-based beauty products.

Davis: It’s been a shock to a lot of us. Hospitals sold placentas to cosmetic companies. They were used in beauty products and marketed principally to the African-American community. These hormones do a good job of plumping up hair and skin all right, but they also penetrate into the body. One study you can find on our website found that black baby girls whose mothers applied skin creams to their scalps developed breasts between the ages of one and three. Dr. Chandra Tiwary, a pediatric endocrinologist treating these girls, asked the mothers what they were using. Dr. Tiwary found they were all applying these hormone creams. When they stopped, in every single case the baby girl’s breasts disappeared. If something can cause a baby girl to develop breasts, what might it do to older women? Could these products play a role in why young African-American women have more breast cancer than their white counterparts?

SP: Is this harder to find out because we don’t have the same kind of rules about ingredients in cosmetics as we do for drugs?

Davis: Absolutely. There are no requirements for approving the safety of the materials in cosmetics. The European Union, which covers a population larger than the United States, nearly half a billion people, has passed legislation requiring the evaluation and assessment of chemical hazards. So, in Europe, it is illegal to use many ingredients in personal care products that can still be used in the United States. For example, baby bubble bath and shampoo in the United States can contain a product known to cause cancer in male and female rats and mice, which is banned in Europe.

SP: Europe is generally ahead of us in warding off these risks?

Davis: Not only are they ahead of us, American business is losing its competitive edge because of this.

SP: You’re very critical of business and industries from many quarters, but also you point to them as the hope for change with the green movement.

Davis: The greening of business is one of the most positive developments we’ve seen. Our own hospital, the University of Pittsburgh Medical Center, is going green. UPMC covers more than 400 different buildings in five states and four countries. We’re saving water by changing the way we clean and mopping floors with removable micro-fiber mops. These mops help reduce infectious disease rates, use a third as much water and fewer toxic chemicals. Less run-off into our rivers and less damaging exposure to our workers will ultimately lead to less cancer.

SP: Beyond what companies are doing, what can we do as individuals to lessen our cancer risk from potentially hazardous products and chemicals?

Davis: We can look under our sinks and read labels. You can clean most things in your house with baking soda, vinegar, and toothpaste. You can get rid of roaches with boric acid powder. And smart companies are now marketing these things as pesticides. You can buy red pepper in a bottle that says, “repels ants.”

SP: So cleaning products that come with warnings about ventilation and fumes—maybe we shouldn’t be using them at all.

Davis: The world is not without risk. Nor am I advocating a return to the Stone Age. If we have outbreaks of potentially lethal infectious diseases, like dengue and yellow fever, which may come about as a result of the changing climate, we’re going to have to rely on pesticides on occasion. But we have to be smarter about what we use. And that’s the message of the book.

There is a lot of hope out there. As someone who has dealt with cancer in my own family, I know that for cancer patients, hope is the most powerful drug in the world. But meanwhile there’s a lot that you can do to reduce your risk of cancer for your families and yourself.

SP: This might be the place to reassure readers that The Secret History of the War on Cancer is more than an epidemiology textbook, given how the science in the book is interwoven with the stories of your relatives, friends, and colleagues who have battled cancer. Was it a hard book to write?

Davis: Yes. Parts of it were very difficult and even painful to write; other parts felt like they wrote themselves. Like when I was sitting talking to my good friend in Wyoming about discovering that the first organic gardens in the world were at Dachau. I was stunned to learn that the Nazis had an interest in organic farming and that my friend’s grandfather had run these gardens.

SP: There are many such stories in the book, and they help leaven the epidemiology.

Davis: Well, cancer epidemiology turns out to be hard work. There is a story from the Torah that I think is relevant. A group of workers are told they have a job to do and they say, “What are you talking about, this job is way too big. We don’t have the right tools. We’ll never ever be able to finish.” And the Rabbi replies, “It is not up to you to finish the job, but you must begin it.”

The Environmental Protection Agency pleaded the 5th on Friday, refusing to furnish an explanation for why it rejected California’s attempt to create stricter greenhouse gas laws. The EPA denied the state’s request for a federal waiver to enact its own stricter emissions rules, separate from those stipulated in the Clean Air Act. Documents provided as part of the congressional investigation into the EPA’s rejection had much of the information removed, and some pages were entirely blank. The EPA claimed that the omitted pages included details pertaining to internal debates and attorney-client discussions. The agency claimed its current litigation battle with California and 15 other states who sued the EPA in an effort to have the agency reassess its decision as another reason for withholding information.

The University of California at San Francisco issued an apology for controversial language in a recent research publication on drug-resistant staph infections, or MRSA. Last week, the university released a statement saying that gay men were more likely to become infected by a new strain of the staphylococcus bacteria. The study quickly gained media attention as gay rights groups criticized the report’s framing and as antigay groups used the results as fodder for their campaigns. The university apologized saying their press release “contained some information that could be interpreted as misleading.” The Center of Disease Control and Prevention, which financed the study, was quick to clarify that the disease is “not sexually transmitted or limited to a certain type of person” and is actually transmitted by skin-to-skin contact.

The most inexpensive way of reducing carbon emissions is to simply use less energy—or use it more efficiently. The Washington Post reports on efforts to use already-existing technologies to increase the efficiency of microelectronic devices. “We’re talking about the exact same principle as replacing incandescent light bulbs with compact fluorescent ones,” said Andy Williams, vice president of the company On Semiconductor. “If our products were built into all consumer electronics—computers, flat-screen TVs, cellphones—we could save 800 million pounds of carbon emissions”, he said. But vested corporate interests and the risks inherent in new technology investments can stand in the way, which means that governments have a role to play in setting progressive standards and rewarding financial risk-takers.

A recent $19 million gift from the Bill and Melinda Gates Foundation highlights some of the difficulties in garnering support for medical research on diseases affecting the world’s poorest and most neglected people. The donation to the Drugs for Neglected Diseases Initiative will support research on a new drug for African sleeping sickness, a disease contracted from tsetse flies that infects about a 150,000 people a year and causes vivid hallucinations and eventually death in its victims. The hope is to have a viable drug by the year 2020. Previous intravenous treatments either proved too difficult to administer in rural Africa or were discontinued by the producers for lack of profitability.

Take a look at the little number stamped on the the nearest plastic water bottle. Depending on the number you see, reusing that bottle may pose a health risk by leeching undesirable chemicals into your water as the plastic wears out. But researchers and industry representatives don’t agree on the risks, and manufacturers aren’t forthcoming about the toxic metals that may appear in the materials.

Image credit: NASA.

Pharmaceutical companies justify massive marketing budgets, which drive up drug costs, by citing large numbers of drug handouts. They claim that these free samples often go to the uninsured, who might not otherwise be able to afford these drugs. But according to the Chronicle, “More than four-fifths of the people receiving the freebies were covered by insurance all year…The groups that received a disproportionately high number of freebies were patients who were white… and had better access to medical care.” In addition to the disparity of access, there is also an increased likelihood that doctors will prescribe a drug that might not be right for the patient just because it is free.

The study demonstrates that pharmaceutical company marketing tactics that seem beneficent do not adequately compensate for a fundamentally flawed healthcare system that does not mandate a minimum level of care for all citizens regardless of income. Nevertheless, the Pharmaceutical Research and Manufacturers of America, a trade group, issued a statement saying that the studies, which use data from 2003, were “fatally flawed” since they do not take into account the outreach program that that the industry began in 2005. The statement goes on to point out that even though doctors are likely to consider patient income when giving free samples during an office visit, the uninsured often cannot make office visits in the first place.

But this is not the only recent news underscoring the threat an inequitable care system poses to public health. In an editorial published today, The New York Times argues for universal coverage and cites another study by Harvard Medical School finding that “uninsured near-elderly people got sicker at a faster rate than comparable people with insurance. Those disparities were sharply reduced when people turned 65 and became eligible for Medicare.” The NYT also pointed to a study from the American Cancer Society indicating that uninsured patients were less likely to receive cancer screenings, which means that cancers can go undetected until they progress and become more difficult to cure.

The inequities of the health industry present public health risks to an unacceptable number of Americans, and these recent studies provide more hard evidence of this unsustainable situation.

Image source: AP.

“Is the military bound by environmental laws, or does national security trump them?” A forthcoming court ruling will determine what the Navy must do to protect marine animals from loud bursts of sonar.

Your race may determine the painkillers you get in the emergency room. A new study appears today in the Journal of the American Medical Association indicating that ER doctors prescribe opioid narcotics like oxycodine and morphine for pain management less frequently to black patients than they prescribe them to whites. Better standards and protocols could close the gap (via Science in the News).

Ever Googled your Social Security Number? Despite ever-present concerns over identity theft, public documents containing the numbers are easily and freely accessible over the Internet.

The EU’s Galileo geopositioning system is behind schedule and over budget. The alternative to the United States’ GPS infrastructure will never be the competitive alternative it was conceived as.

Image credit: DOJ.

Last week, The Scientist reported on experiments at a Tufts lab involving a compound that can regulate the spread (free registration) of antibiotic-resitent strains like MRSA. Bacteria regularly targeted with antibiotics can mutate, evolving resistance to drugs, but “as opposed to antibiotics which target and kill bacteria, prompting them to thicken biofilm layers and devise other antibiotic-resistant measures,” the new therapy utilizes an RNAIII-inhibiting peptide, or RIP, which “makes the bacteria think they are alone in their microenvironment, and do not need to spread. Thus, in combination with antibiotic treatment, RIP may lessen bacteria defenses.”

The ability to treat drug-resistant infections could save thousands of lives each yeah, but the other facet of the problem involves preventing the development of these virulent strains where they evolve.

Michael Pollan follows one possible trail in his NYT Magazine article, “Our Decrepit Food Factories,” back to animal feedlots, where factory farms employ massive amounts of antibiotics to protect pigs, chickens, and cattle from various infections before they reach maturity. He reports that the Union of Concerned Scientists estimates that “at least 70 percent of the antibiotics used in America are fed to animals living on factory farms.” This means that feedlots may be a prime breeding ground not just for U.S. meat products, but also for resistant bacteria.

He points to recent research in Europe and Canada confirming that this is the case for pig-raising operations: “A European study found that 60 percent of pig farms that routinely used antibiotics had MRSA-positive pigs (compared with 5 percent of farms that did not feed pigs antibiotics).” MRSA moved from animal populations to humans in the Netherlands, as well as in Ontario.

Pollan is careful to indicate that there has not yet been any confirmation that MRSA infections in the U.S. originated from animal populations. But the FDA is moving sluggishly–if at all–to gather data on the issue, indicating earlier this month “that it may begin a pilot screening program with the C.D.C.”

With such strong indicators that feedlots may be a source of resistant staph strains, the Federal government should move quickly to investigate if the practices that produce cheap meat are not also producing deadly pathogens.

“Because the world now fights malaria—ineptly—with nets, insecticides and drugs, a vaccine is desperately needed.” Another inside-the-lab look at Sanaria Inc., which is working on a malaria vaccine made from whole irradiated parasites, rather than protein fragments. Founded with backing from the National Institute of Allergy and Infectious Diseases, the Army, and the Institute for One World Health, $29 million from the Gates Foundation ramped up research last year. Questions about the vaccine’s effectiveness, safety, and difficulty of storage and delivery remain.

Should states and cities distribute naloxone, which counteracts the effects of a heroin overdose, directly to addicts? Some public health officials point to existing programs that do so, citing drops in overdose death rates, and call the policy “a no-brainer”; the White House Office of National Drug Control Policy says there is insufficient data to support the conclusion.

“Peace can be defined as security and the secure access to resources that are essential for living,” said Rajendra K. Pachauri, chairman of the Intergovernmental Panel on Climate Change, accepting one-half of the Nobel Peace Prize on behalf of the organization, which shared the honor with former Vice President Al Gore.

American hospitals inject the radioisotope technetium-99 into 20 million patients annually as a radioactive tracer for imaging the brain, thyroid, lungs, liver, gallbladder, kidneys, skeleton, blood, and tumors. Those hospitals rely on the Canadian reactor for the production of molybdenum-99, which decays into technetium-99, to meet the needs of their patients. The majority of American hospitals purchase molybdenum-99 from U.S. corporations like Bristol-Myers Squibb, which in turn buy their supplies from Canadian distribution companies like MDS Nordion, which controls the distribution of the Chalk River isotopes.

The isotope crisis has revealed both the extent to which American medical care is dependent on international supplies and the companies and government entities that control the distribution of these supplies. With America so reliant on foreign imports of important radioisotopes, it is unacceptable that the time and money hasn’t been spent to develop sufficient radioisotope production facilities on U.S. soil. But medical centers around the globe are feeling the impact of the shutdown: the Chalk River reactor produces 50 to 80 percent of the world’s supply of molybdenum-99.

Advanced Medical Isotope Corporation Chief Science Officer Dr. Robert Schenter has recognized this fundamental problem and pledged to engage his company in developing a solution. The company is finalizing agreements with two universities to further production capabilities addressing the need for domestic production of isotopes. The corporation is also developing a linear accelerator in Washington that it expects will be fully operational and delivering isotopes by early 2008.

It is far more dangerous to rely on foreign imports for important medical supplies than to deal with the security and environmental concerns that attend the development of sufficient domestic nuclear facilities. The health of patients depends upon these supplies.

Introduction

I

Breast cancer is all around us: cutting down lives, causing fear, and presenting difficult, often impossible, dilemmas. In the week in which I first drafted this introduction, both my 80-year-old uncle and his 50-year-old daughter-in-law (my cousin’s wife) were diagnosed with invasive breast cancer. My then 12-year-old daughter did not think men had breasts; most adults similarly do not know that men get breast cancer. My cousin’s wife could have chosen a limited excision of her small cancer but instead decided to have both breasts as well as her ovaries removed. Her mother had died at about her age of ovarian cancer, and her younger sister had recently died of breast cancer. She was “taking no chances.” I understood her reasons for this decision and would not second-guess them. But I also knew that even such radical surgery would not entirely extirpate the danger or her fear of cancer.

American women fear breast cancer much more today than they did a hundred years ago when there seemed to be less of it, and it was not such a visible – and contested – public concern. In today’s way of talking about and experiencing the fear of breast cancer, we characteristically speak of the increased risk of the disease. The central development I analyze in An Unnatural History: Breast Cancer and American Society is the historical change over the last two centuries from isolated, private fears of breast cancer to immense individual and collective concern over the risk of breast cancer. I will detail how and why our biological understandings, epidemiological perceptions, clinical and public health interventions, and personal experience and fears of breast cancer have changed so radically.

The change from a disease that was hardly visible to anyone who was not directly affected by it to the highly publicized statistic that women in the United States have a lifetime risk of 1:8 of being afflicted with the disease is not simply a reflection of more and worse disease. Epidemiologists have observed that the age-specific mortality from breast cancer – the odds of women of a given age dying from breast cancer – in the United States remained essentially unchanged from the time minimally adequate aggregate data were first collected in the 1930s until around 1990 (see Figure 1.1), when it began to decline. Epidemiologists use age-specific mortality to make valid historical comparisons – in this case, to factor out the increase in breast cancer deaths due only to more people surviving into older ages (when breast cancer is more common). It is possible that efforts at early detection and progress in treatment had just kept up with an increasing tide of new breast cancer cases, resulting in a mortality standoff for most of the twentieth century. A more economical explanation is that we have detected a large amount of disease not destined to seriously harm or kill and – until quite recently – have not made significant progress in treating cancer.

Figure 1.1. Changing patterns for twelve major cancers in U.S. females 1950–91. Death rates for females, per 100,000, fortwelve sites, 1950–91, age-adjusted to1970. (Adapted from SEER Data, public use files).

Unnatural History‘s terrain is the chasm between our medical and cultural understandings of breast cancer and its direct biological impact. Starting with the experience of breast cancer in the early nineteenth century, I examine the social forces and developments that led to a radical transformation of breast cancer’s impact and meaning in American society. Some readers and medical colleagues will probably be surprised and challenged by my emphasis on underlying social rather than biological causes of the historical shift in both the perception and lived experience of breast cancer in the United States. For example, I will argue in Chapter 6 that the widely perceived improvements in breast cancer survival rates in the middle decades of the twentieth century largely resulted from changed health-seeking behavior and diagnostic practices rather than more effective means of prevention and treatment. I want to redress an imbalance that follows from the priority generally given to biological over social explanations in cancer and many other diseases. Pushing social explanations as far as they might plausibly go also has considerable heuristic value. Cancer and other diseases look different when social factors are in the foreground, rather than evoked only to explain what cannot be attributed to biologically mediated changes.

At the same time, I do not assume that breast cancer, as a purely biological process in the bodies of American women, has had an unchanging clinical expression or population impact. It is highly probable, for example, that the real incidence of breast cancer (number of new cases in a given time period) was rising during the nineteenth and early twentieth century America. This change most likely resulted from social and economic shifts that led to earlier onset of menstrual periods, older age of first childbirth, fewer children, and later menopause. Neither do I assume that our clinical and public efforts have had little or no impact on breast cancer as a biological process. The declining breast cancer mortality in the United States since 1990 has probably resulted from more use of effective treatment, especially hormonal therapy and chemotherapy given to women who do not have clinical evidence of cancer spread, and to a lesser extent, the identification of cancers through screening.

Unnatural History is not a polemic about medical and popular misunderstanding of breast or other cancers’ natural history and epidemiology, and the exaggerated claims of efficacy by supporters of current efforts at prevention and treatment. There already exists a sizeable literature that uses the tools of clinical epidemiology and “evidence-based medicine” to critically analyze current concepts and practices. While this literature often points out important limitations of many beliefs about cancer and treatment practices, it does not try to systematically account for how we arrived at our present situation. Unnatural History is a history of how we incrementally arrived at our present state of belief and practice. This narrative involves choice, change, and continuity in medical and lay beliefs about cancer and the body, the felt experience of cancer and fear of cancer, the nature of relations between patients and doctors, and the assumptions patients and doctors have used in making clinical decisions.

The narrative alternates between detailed “grain of sand” case studies of individual patients and overviews of important developments in medical thought and clinical and public health practice, from the early nineteenth century to the third quarter of the twentieth century. I do not consider in any detail case studies or medical developments after 1977. This is in part arbitrary, but also reflects my belief that the major elements of what I consider to be our current era of breast cancer risk (subject of the concluding chapter) were in place at that time. The detailed case studies give texture to the felt experience of affected women. I similarly use the writings and clinical records of selected doctors to provide a close up view of the often subtle continuities and changes in medical assumptions about breast cancer. The larger picture that emerges is thus potentially distorted by my selective sampling, but I hope that this limitation is balanced by the book’s wide historical sweep and the advantages of examining in detail how breast cancer was experienced and decisions were made in different eras.

In the many casual historical overviews of breast cancer, which have appeared in such diverse places as patient accounts, newspaper articles, medical review articles, and grand round talks, there are typically three recurring motifs: (1) the post-World War II movement away from radical mastectomies toward more localized surgery, led by a few researchers who tested their original ideas in robust clinical trials whose results then influenced practitioners to change their practice; (2) the important role women played in this and other changes in cancer treatment; and (3) the declining paternalism and increased honesty in doctor-patient interactions surrounding breast and other cancers. While these overviews capture some important developments, they are incomplete and partly reflect the problematic assumptions, priorities, and visions of their narrators. They assume a basic stability in what breast cancer is and means as well as that significant therapeutic progress has and is being made. They tend to ignore countervailing contemporary trends, such as the increased frequency of radical surgery for breast cancer risk, and deeper continuities, such as the desire of both physicians and patients to maintain hope and avoid stark confrontations with mortality.

Apart from a skeptical reading of epidemiological trends, there are reasons to believe that the many historical changes in the magnitude, meaning, and significance of the risk factors for breast cancer are not a simple reflection of the disease’s increased deadliness. Risk, as many anthropologists, sociologists, historians, and others have reminded us, is a cultural construct that bears a problematic and often indirect relationship to death rates or other “objective” markers of danger and bad outcomes. In our contemporary response to breast cancer, risk is an elusive term with different meanings and uses. It may be used to describe a quantitative assessment of disease incidence or mortality in a defined population upon which policies such as annual screening mammography are built or it may describe a highly individual, subjective sense of danger, which might influence lifestyle “choices” such as the timing of a first child, the use of oral contraceptives, or starting a low fat diet.

Epidemiologists, doctors, and laypersons often use terms such as risk factors, risk reduction, and risk assessment in a way that implies or assumes that the important causes of breast cancer are mostly a matter of individual – rather than social or communal – concern and responsibility. There is also often a problematic quantification in some risk-factor discourse that makes it appear that we know more than we do about the precise causes of breast cancer and the relative impact of different putative risks. While existing risk factors sometimes help mediate the gap between aggregate data and individual decision-making, they are hardly an unfailingly wise guide to lifestyle, clinical, and policy choices. They can obscure as much as clarify.

Thus we should not understand breast cancer risk ideas and terms as a merely logical or self-evident way of conceptualizing and communicating about danger, choice, cause, or responsibility. Modern risk discourse often reveals more about our present and past assumptions, priorities, and investments than it expresses new etiological, preventive, or therapeutic insights.

Nothing seems more new, objective, and insightful than recent developments in the genetics of breast cancer. In the early 1990s, molecular biologists identified mutations in two “susceptibility” genes for hereditary breast and ovarian cancer (BRCA1 and BRCA2), and epidemiologists began to correlate genetic mutations with particular ethnic groups, most notably the association between specific mutations and Ashkenazic Jewish women. These discoveries have already led to widespread genetic testing and risk assessment, prophylactic surgery for some genetic mutation carriers, and ethnicity-based disease advocacy and community programs. It is likely that lay and biomedical interest – as well as finite economic and intellectual resources – will shift in a problematic and disproportionate manner from the much more common sporadic cases of breast cancer to the seemingly more certain, mechanistically rationalized, “genetic” cases. The test for a breast cancer susceptibility gene is likely to be one of the first of many such tests that will transform our view of individual health from a complex group of consequences of one’s heredity, environmental exposure, lifestyle choices, and chance to a more specific, precise, and frightening “at risk for” con-sciousness.

Yet, however profound these changes may appear, they cannot be understood as direct, unmediated consequences of new genetic knowledge. There are many continuities between the seemingly revolutionary impact of genetic insights and earlier experimental, pathological, epidemiological, and clinical insights. For example, the enthusiastic medical and popular reception of genetic insights and the rapid deployment of genetic tests reflect a historically familiar calculus of change. Clinicians and laypersons have often made fundamental decisions – to encourage or consent to some type of cancer surveillance, to consult a doctor for a breast lump, to choose one type of therapy over another, or to promote this or that educational message – because of the vision of the future with which they most closely identify. Promise more than evidence from clinical trials or the lived realities of disease and clinical practice has repeatedly played a determining role in many personal, clinical, and policy decisions and developments concerning breast cancer. Knowledge of these historical continuities can help clinicians and patients respond more thoughtfully to the many clinical and policy conundrums presented by genetic tests, screening mammography, lifestyle interventions, and prophylactic surgery and chemotherapy.

II

But why an Unnatural History? The choice of title partly goes against – and distinguishes my approach from – the more fashionable trend of emphasizing the natural, that is, the biological and adaptive, basis of complex behaviors and social structures, in paper, book, and lecture titles, for example, the natural history of parenting, sex, alcoholism, fear, and so on. But the history of the meaning, perception, and experience of breast cancer in the nineteenth and twentieth centuries can be thought of as “unnatural” in several other ways. First, for much of breast cancer’s modern history, we have radically transformed breast cancer’s epidemiological, clinical, and personal meaning, often without significantly changing its natural history, that is, its destructive course within the body. Second, the most important initiators and mediators of these transformations are best understood as social (e.g., lowered thresholds for seeking medical attention for breast lumps or expanding definitions of cancer) rather than biological/natural. Finally, there is the historical contingency of the natural history concept itself. In each era and setting, researchers, clinicians, and laypersons have often meant, assumed, or focused on different basic identities and definitions of breast cancer – macroscopic or molecular, one disease or many, constitutional or local, a disease from within or without, predetermined or treatable, discrete from or continuous with “premalignant” and benign conditions. “What is breast cancer?” has been a recurrent, central, if often unarticulated, question just below the surface of so many controversies about cause, prevention, treatment, prognosis, and policy. It also lies just below the surface of many individuals’ difficult decisions.

Students frequently ask me how physicians and patients could use the word cancer in the era before microscopic descriptions of abnormal cells and in clinical situations where nothing remotely like twentieth- or twenty-first-century diagnostics were done. They also question any historical comparisons between whatever we mean by cancer today and these older entities. I often respond by pointing out that categorizing and diagnosing cancer is contingent on tools, medical knowledge, and the social and medical uses of labels, in the past and now. To bring this point home, I imagine a future medical world where students wonder how early twenty-first-century physicians and patients accepted chemotherapy for small “breast cancers” and surgery for some “prostate cancers” when they did not yet have the XYZ test that predicts with a high degree of certainty which tumors will be lethal and which will be slow-growing and unlikely to metastasize.

I am a doctor as well as an historian, and my clinical experiences and training have shaped my historical approach. I have been influenced by teachers and mentors who have had a skeptical, empirical, and quantitative “evidence-based” approach to clinical practice and health policy. My clinical experiences and those of my patients, friends, and family members, some of which are discussed in this chapter, have often reinforced my skepticism about many existing public health and clinical strategies in breast and other cancers. But at the same time I worry about the implications of this skepticism. It has been personally difficult, for example, to reconcile my belief that past and present prevention and treatment efforts in breast cancer are less effective than widely believed with my responsibility for the health of patients, friends, and family. I recently talked with a friend in her 40s who said that she was still not getting screening mammograms “thanks to you.” I immediately protested that our previous conversations were about my historical research and not meant to suggest specific courses of action in the here and now. But I also knew that I was on thin ice. Like the many historical actors whose actions and beliefs I closely examine here, I would like to eat my cake (in this case, draw general historical implications for the present) and have it too (not be tied to specific clinical recommendations, especially since the evidence is often unclear and almost always changing). One result of this awareness has been to redouble my efforts to approach the different actors in historical and contemporary controversies in an empathetic, balanced, and nonpolemical manner.

Robert A. Aronowitz, M.D., is an associate professor in the History and Sociology of Science Department and Family Medicine and Community Health at the University of Pennsylvania.

And that’s troubling.

Read an excerpt from Dr. Aronowitz’s recent book, Unnatural History: Breast Cancer and American Society, where he presents breast cancer as a disease that has entered the bodies of so many American women and the concerns of nearly all the rest, mostly as a result of how we have detected, labeled, and responded to the disease.

In other words, we’ve changed what we call cancer by catching it “earlier” and at a more ambiguous stage.

Neither improvements in surgery nor new biomedical insights seem to be driving such rapid change. Many women, it seems, are becoming increasingly fatalistic about getting and ultimately dying from breast cancer. They are, as one woman put it, “waiting for the axe to fall.” Some patients say that they simply want “to be done with it”—no more mammograms or biopsies. They want certainty and freedom from fear.

Looked at one way, women today should fear breast cancer no more than their mothers did. Breast cancer mortality (when adjusted for the aging of the population) remained constant from the time accurate statistics were kept in 1930 until about 1990, when it began to fall.

But women have other reasons to fear breast cancer. The 1:8 lifetime odds of developing breast cancer are widely touted and frightening, and confirm many women’s sense that breast cancer is everywhere.

What many people don’t necessarily know is that those odds reflect not only the incidence of destined-to-harm breast cancer but also “pre-cancerous” tumors that may or may not develop into metastatic disease. In other words, we’ve changed what we call cancer by catching it “earlier” and at a more ambiguous stage.

The two most prominent pre-cancer diagnoses are lobular carcinoma in situ (LCIS) and ductal carcinoma in situ (DCIS). The number of these diagnoses increased an astounding eightfold between 1975 and 2002. Diagnoses of invasive breast cancer rose during this period as well. Widespread use of screening mammography has played a substantial role in both these increases.

But a good deal of the disease increase we’re seeing probably reflects overdiagnosis. Many of these women might have been better off if they had not had screening and been subjected to the subsequent trauma of fear, uncertainty, and unnecessary biopsies and treatments. We desperately need better ways of distinguishing these women from those who will be helped by treatment.

This problem is most often understood and experienced as an individual treatment dilemma when a woman is diagnosed with breast cancer, especially LCIS or DCIS. But at the population level, the massive increase in breast cancer diagnoses, trumpeted in cancer education and awareness programs, has radically transformed how we perceive and react to this disease.

We need to come out and say that fear of breast cancer has too often been oversold.

Similar feelings of fear drove demand for the now discredited radical mastectomy, originally dubbed the “complete operation” and meant to end the need for repeat surgery that followed “incomplete,” less radical operations. A generation of patient advocates and skeptical physicians ultimately won the battle against routine use of this mutilating surgery, arguing that less extensive surgery had similar results, completeness was an illusion, fear of cancer had led to overreaction, and that the harm to women had been minimized.

It is disturbing, in light of that achievement, that we now seem to be moving backward, to an environment ruled by fear.

More accurate information on breast cancer and screening and treatment effectiveness would help, as would better shared decision-making between women and their doctors. But my sense is that the “cancer fear” problem and the troubling implications of our new breast cancer risk world won’t be solved at the individual level, especially at the point of extreme vulnerability when patients and their doctors confront a new diagnosis of cancer. As a physician, I would not second-guess anyone who carefully considered her options and decided to remove both breasts to extinguish the chance of breast cancer recurring.

But we need to examine and reassert more critical control over the many medical and societal level forces that have increased our fear of breast cancer and made the future for “women at risk” seem so troubling. We need to fall back from fear-promoting awareness campaigns that rely on scary and misleading risk statistics and exaggerate the benefits of screening and prevention options, especially mammography for younger women and pills to reduce breast cancer risk. We may need a more sophisticated educational campaign that emphasizes that breast cancer is more treatable than ever and that accurately explains the nuances of risk.

We need to come out and say that fear of breast cancer has too often been oversold. Acknowledging this might lead all of us—as a society and as individuals—to respond to breast cancer in different, more thoughtful ways.

Robert A. Aronowitz, M.D., is an associate professor in the History and Sociology of Science Department and Family Medicine and Community Health at the University of Pennsylvania. He is also the author of the new book Unnatural History: Breast Cancer and American Society (Cambridge University Press).

Notes

1) T. M. Tuttle, E. B. Habermann, E. H. Grund, T. J. Morris, and B. A. Virnig, “Increasing Use of Contralateral Prophylactic Mastectomy for Breast Cancer Patients: A Trend Toward More Aggressive Surgical Treatment.” Journal of Clinical Oncology (published online, October 22, 2007).

Malaria kills more than a million people a year around the globe. At an October meeting, Bill and Melinda Gates announced a long-term vision to eradicate the scourge. Science reports on the repercussions of the announcement within the global health community: “Even with those caveats, the call has ignited a debate on whether it is wise—given a long history of broken health promises—to dangle potentially unattainable goals before the public.” Many of the necessary tools—insecticide-treated bed nets, new drugs, and insecticide sprays—are available, but more powerful approaches are necessary in the most heavily effected areas, including vaccines, monitoring techniques, new drugs and insecticides.

How to improve U.S. student performance in mathematics? Start with the algebra curriculum. A forthcoming report from the National Mathematics Advisory Panel will describe in detail what a rigorous algebra curriculum should look like. Tensions within the math education community over prescribing standard approaches vs. student-tailored methods have slowed consensus. Science reports that “the report’s most important points are the need for students to master fractions, the importance of early childhood education, and the value of developing teacher skills, both during their training and after they are hired,” according to Education Secretary Margaret Spellings.

A federal panel convened to investigate the July death of Jolee Mohr, who was participating in a gene therapy trial aimed at alleviating her rheumatoid arthritis, has concluded that the the gene transfer treatment was likely not the cause of the fungal infection that killed her, although uncertainly on the questions remains. The FDA lifted its hold on the trial, conducted by Targeted Genetics Corp of Seattle, WA, last week.

Intelligence officials are asking for scientists to peer review their efforts to counter bioterrorism threats. “In addition to helping screen and design projects to combat bioterrorism, the [Biological Science Expert Group] will analyze research findings, review the scientific validity of intelligence assessments, and occasionally conduct its own studies.” There are plans to extend this review model to other areas of intelligence research and avoid fumbles like the 2002 misidentification of Iraqi bioweapons labs, which subsequent scrutiny revealed where hydrogen production facilities for weather balloons.

Three hundred drug and medical instrument manufacturers have been shut down; pharmaceutical companies withdrew 7,300 applications for drug approval; and 1,100 previously approved drugs and medical appliances were found to have been approved illegally. Wu Zhen, deputy commissioner of the SFDA told a press conference that, “the pharmaceutical companies are examining themselves in this special campaign and their awareness for drug safety has been greatly enhanced.”

Internal corruption has also plagued the SFDA. Former director Zheng Xiaoyu was executed in July for taking some $850,000 in bribes during his tenure.

Open-source standards and net neutrality can support and improve global health—especially in developing nations (Global Health Report).

An NIH panel concludes that gene therapy was not the cause of death for a patient receiving experimental treatment for rheumatoid arthritis (The Scientist Blog).

The U.S. Patent Office tests peer review of applications (Cairns Blog).

A McKinsey & Company report concludes that current technology can get the U.S. to the 2030 emissions goals in current proposed legislation, and at manageable costs (Hill Heat).

Google announces it will invest in renewable energy that is cheaper than coal (SciGuy).

“There aren’t good blueprints for how to ‘broaden the impact’ of one’s research and the resources to develop such things are thin.” Excerpts from an interview on science and public discourse with Dr Chris Brodie, associate editor of American Scientist magazine (Terra Sigillata).

The United Nations University Institute for Advanced Studies recently published a report on human cloning offering the international community two choices: either prepare for the legal and ethical issues associated with living, cloned humans, or prohibit human reproductive cloning. The report suggests an opinio juris for a prohibition on human reproductive cloning; there is multinational opposition to human reproductive cloning, and more than fifty nations forbide the practice.

Therapeutic cloning techniques generate human embryos through somatic cell nuclear transfer to harvest embryonic stem cells. Reproductive cloning techniques seek to create humans with nuclear DNA identical to a currently or previously existing human.

Brendan Tobin, a human rights lawyer and co-author of the report explains:

Failure to outlaw reproductive cloning means it is just a matter of time until cloned individuals share the planet…If failure to compromise continues, the world community must accept responsibility and ensure that any cloned individual receives full human rights protection.

The report cautions that without an international prohibition, researchers could practice reproductive cloning in nations without a regulatory framework.

Reflecting on the history of UN efforts to ban cloning, the report highlights the best of possible solutions as outlawing human reproductive cloning and permitting therapeutic cloning. The report comes after a lengthy UN debate beginning shortly after the 1997 adoption of the Universal Declaration on the Human Genome and Human Rights, In 2004, the Bush administration pushed for a global treaty banning both reproductive and therapeutic cloning, which failed by one vote to pass the General Assembly. The administration settled in 2005 on the UN Declaration on Human Cloning (A/RES/59/280), a non-binding statement against both reproductive and therapeutic cloning. The success of the declaration largely hinged on it being non-binding, allowing nations to use therapeutic cloning for research without consequence.

In the United States, congressional action paralleled U.S. advocacy for a global ban. The House of Representatives twice voted in favor of criminalization of research on human cloning in 2001 and 2003 (H.R. 2505, H.R. 534), but these bills failed both times in the Senate (S. 245, S. 658). In 2002, the President’s Council on Bioethics voted 10-7 in favor of a moratorium of therapeutic cloning and unanimously for a prohibition of human reproductive cloning.

As is the case for stem cell research policies, a current patchwork of state policies exist regulating cloning, where not overarching federal framework guides. Most states prohibit reproductive cloning and the majority allowing therapeutic cloning foreruns the U.S. stem cell research efforts.

Kanzius’s technique proved highly effective in early preclinical trials at the University of Texas M.D. Anderson Cancer Center. In lab experiments, two lines of liver cancer cells and one pancreatic cancer cell line were completely destroyed after being injected with nanotubes and exposed to radiofrequency energy. Carbon nanotubes are hollow cylinders of pure carbon that measure about a billionth of a meter, or one nanometer, across. A similar technique called radiofrequency ablation has been used for a number of years to treat tumors in the body. However, the novel technique developed by Kanzius makes radiofrequency cancer treatment much less damaging to surrounding tissue.

One problem, unfortunately, is that scientists don’t have an accurate method for targeting cancer cells. Researchers are currently in the process of searching for acceptable molecular targets in the tumor tissue onto which the nanotubes can bind. It has been difficult to find targets unique to cancer cells and researchers must resolve this issue before the nanotube technique can live up to its promise of being an effective and noninvasive procedure. For these reasons, the scientists believe that clinical trials are still three to four years away.

Stem cell research is currently in the spotlight, but this new technique reminds us both of the promise of other treatments under development, as well as the potential for nanotechnology in the medical sciences. The treatment, even though still at the preclinical stage, is evidence that even far-fetched scientific ideas can and do become successful.

Richard Dimino, president of the Boston business and transportation committee A Better City, wrote in the Boston Globe of a recent study from his group, which found that:

That one major advantage of our life sciences cluster is its geographic compactness….Our tight-knit web of institutions and companies allows a physician-researcher to see patients at a hospital, teach at a university, attend a seminar, and work in a laboratory – sometimes all in one day.

But dense clustering leads to congestion, so facilitating the exchange of ideas also depends on maintaining and expanding the public transportation infrastructure to keep pace with the scientists, innovators, and ideas shuttling around greater Boston. The map featured in the executive summary of the report shows the established and emerging centers of research around the city:

The lessons from this report (pdf) have the potential to fuel smart growth and new innovation in emerging science and technology clusters around the country.

Although sperm banking is now a vital part of this new frontier of baby making, the industry remains largely unregulated in the United States.

Only now, more than 100 years later, is third-party reproduction beginning to shake off this aura as policy changes roil the field in Europe and new attitudes begin to lap up on American shores. In the United States, the U.S. Food and Drug Administration requires that donors be tested for diseases such as HIV and hepatitis while their sperm are frozen and quarantined, only to be released six months later when certified disease free. But today’s “sperm banks” are under no obligation to report numbers of births, place any limits on births to individual donors, track the health of donors, or make information available to children born of donor insemination.

This poses some serious scientific, medical, and ethical questions. Should individual men be able to procreate perhaps hundreds of children anonymously? Over the long haul, what does this mean for human genetic diversity? What about genetic diseases? And should children “fathered” via sperm banks be allowed to know who their father is? These are questions that are only now being asked—despite the long history of “artificial insemination,” as it was once quaintly called—not just in the United States but also abroad. The answers, as we shall see, are as controversial as the questions.

How We Got Where We Are Today

Dr. Pancoast’s tactic—artificial insemination using another man’s sperm—was for decades the only way to redress male infertility. Doctors most often donated sperm surreptitiously in this manner, but the practice really took off after World War II when soldiers returning with war wounds and sexually transmitted diseases faced infertility.

In the 1950s came the advent of technologies to freeze and store sperm. Still, the sperm was most often secured from impecunious medical students who were paid modest sums to masturbate for posterity. Banked sperm was chosen to match the physical characteristics of the infertile husband, and the sperm of the husband and the donor was sometimes mixed to give the husband plausible deniability. Doctors told patients to lie to their offspring about how they came into the world.

Beginning in the 1960s, individual states began updating laws to recognize that, at least where a doctor or clinic was involved, the third-party sperm donor was not a father in any legal sense. Under such schemes, donors would not have any visitation rights or say in the rearing of their children, nor would they be responsible for any financial contributions. In the early decades of sperm banking, these arrangements were seldom called into question, not surprisingly, given how few donor offspring were told the truth about their conception.

Today, approximately two dozen commercial sperm banks operate in the United States. An untold number are also associated with university fertility clinics, banking sperm for pre-vasectomy and pre-chemotherapy and radiation treatment patients—no one keeps track of how many. Nor can it be said with any certainty how many children are born each year as a result of donor insemination, although the most frequently cited guesstimates range between 30,000 to 50,000.

Lesbian couples and women who are single by choice now comprise, by some rough estimates, two-thirds of sperm banking’s clients. The cost: between $255 to $315 for a vial of regular, unwashed sperm that is implanted through intracervical insemination at home; or slightly more costly for sperm that is washed, which means it was prepared for intrauterine insemination by a health care professional and comes with more information about the donor or the promise of donor identity release.

But shipping and storage fees also add up. “A typical bill for conception, which takes roughly six once-a-month inseminations, using IUI, identity-release sperm with a photo match, is between $2,345 and $2,945,” writes Lisa-Jean Moore, medical sociologist and gender studies scholar in her Sperm Counts: Overcome by Man’s Most Precious Fluid (2007).

If sperm donor is a misleading tag, sperm banking is not, at least insofar as it suggests a profit-seeking commercial enterprise.

And who are the sperm donors? Some are young men depositing sperm in anticipation of their own future infertility, including those about to go off to war. But the vast majority of donors—or perhaps more accurately, sperm vendors—are men who sell their semen for $40 to $60 per “donation.” No longer are donors almost exclusively medical men, though doctor semen remains in great demand. Education is still a highly sought-after attribute, with sperm banks seeking donors through advertisements in college newspapers.

If sperm donor is a misleading tag, sperm banking is not, at least insofar as it suggests a profit-seeking commercial enterprise. Market forces shape how the supply of sperm meets the demand. In the early days of sperm banking, race, hair color, and eye color were typically the only traits revealed. Nowadays, buyers still seek sperm of certain ethnicity and physical characteristics; taller men are the rule, no shorties need apply.

But it doesn’t stop there. Some banks offer “premium” sperm, which they maintain comes from donors with doctorates or other graduate degrees. This service is reminiscent of Robert Graham’s notorious “Repository for Germinal Choice,” the California sperm bank that claimed to offer sperm from “geniuses,” including that of a handful of Nobel Prize winners. Graham’s bank operated from 1980 to 1999, creating more than 200 children amid considerable controversy about its explicit eugenic goals and the expectations heaped upon the superbabies, as Slate deputy editor David Plotz recounts in his book, The Genius Factory: The Curious History of the Nobel Prize Sperm Bank (2005).

Today women shop from catalogues of donors in a process that has been called “yuppie genetics.” The banks provide potential buyers with “short form” questionnaires about the desired mix of genetic attributes in the sperm they are purchasing, often supplemented by a “long form” set of answers about the health history of parents and grandparents, interests and education of the sperm donor. Banks claim that questions about health histories are exhaustive, but college-age donors don’t always know all the relevant information about family history and the temptation is great to lie or omit information that might screen them out, in a version of resume fraud.

Increasingly, banks offer pictures of the men as children (and possibly adults) along with audio and even videotaped interviews and poignant and/or cloying “mission statements” about why they’ve chosen to become donors. Here’s one such site, which boasts the tagline Creating Families Through Innovation.

Although sperm banking is now a vital part of this new frontier of baby making, the industry remains largely unregulated in the United States. In other countries, fundamental changes are being wrought in sperm banking practices. Canada and Britain now ban payment to sperm donors. Britain, Sweden, Austria, the Netherlands, and parts of Australia no longer permit anonymous donation, insisting that donors be available to be contacted by their children when the offspring reach adulthood. Some of these countries are establishing registries to help make this possible. These restrictions were put in place despite concerns they could dry up the pool of willing donors.

Do U.S. Sperm Banks Need More Regulation?

Occasional sperm bank scandals have brought episodic attention to the state-wide industry, if not much reform. When Cecil Jacobson, the renowned physician and infertility specialist, was discovered in the early 1980s to have inseminated as many as 75 women coming to his Virginia clinic with his own sperm (unbeknownst to them), prosecutors weren’t sure he had committed any crime. He was eventually convicted of 52 counts of mail fraud, wire fraud, and perjury and served time in federal prison, losing his medical license.

Such occasional scandals are outliers, say the bankers, not cause for further regulation. “More regulation of sperm banking is a solution in search of a problem,” says Sean Tipton, a Washington, D.C.-based spokesperson for the American Society of Reproductive Medicine, which is headquartered in Birmingham, Alabama. “The danger with more regulation, like more genetic testing or changing the rules about anonymity, is that you give up important autonomy and privacy at great economic expense. It is not clear what you gain.”

Wendy Kramer, a Colorado single mother and founder of the Internet-based Donor Sibling Registry, doesn’t agree. She is perhaps sperm banking’s most vocal and visible critic. “Sure, there is some regulation at the front door, screening the men who come in,” she concedes. “But what about afterwards, when the births occur? No one in the industry cares by then.”

Kramer was inspired by her son to found the Donor Sibling Registry as a Yahoo users’ group chat room seven years ago. Her son Ryan, now a handsome 17-year-old in his fourth year of college studying aeronautical engineering at the University of Colorado at Boulder, was eager to find any half-siblings. In fact, Ryan’s curiosity was even more precocious. At age two she recalls him asking, “Is my Dad dead, or what?”

Wendy Kramer conceived her son Ryan with sperm from a local bank in Colorado. “The lady at the bank just suggested a sample from someone who looked like my husband.” (She’s now divorced.) “I suppose I got the ‘high octane,’” she joked, proudly sharing stories about her bright young son’s college career.

DSR has grown from a chat room into a thriving website. At last count, the registry had more than 9,000 registered members, including parents of donor-inseminated children, some children themselves and donors who post their donor numbers and profiles to facilitate matches with families of their offspring. More than 3,800 matches have been made with half siblings or donor fathers.

After six and a half years of searching, Ryan Kramer found a half sister and was match number 2,910. “This little 13-year-old girl was just beside herself to have an older brother,” says Ms. Kramer. “I don’t try to define their relationship. They’re teenagers. They ‘IM’ [instant message] each other,” says Ms. Kramer.

The sperm-banking industry tends to dismiss the yearning to find genetic heritage and the worrying stories from DSR match ups as “anecdotal.” Says ASRM spokesperson Sean Tipton: “I don’t draw any conclusions from the Donor Sibling Registry. I don’t know if there is any counterpart organization for happy children of sperm donors.”

But even if data is not the plural of anecdotes, some of the anecdotes are enough to give one pause. Medical concerns in particular are a frequent topic of discussion when families get together on the Donor Sibling Registry. As will be detailed further below, one set of families discovered that five different children born of the same donor were all autistic. Other parents of donor children suffering from genetic diseases have found half siblings sharing the same illness.

Yet sperm banks have frequently refused to contact other potentially affected children, track down the donor, or even pull the sperm from the shelf. Most of these discoveries have come from Internet-abetted detective work, but some are even more serendipitous.

Case in point is Laurence A. Boxer, a University of Michigan pediatric hematologist and an expert on severe congenital neutropenia, a disease of white blood cells affecting only one in 5 million children. Yet Dr. Boxer had four families show up in his office with children suffering from the disease. As Dr. Boxer and his colleagues reported in the Journal of Pediatrics last year, the culprit is almost certainly a sperm donor the children shared, donor #827 from International Cryogenics in Birmingham, Mich. The donor has moved and the sperm bank cannot locate him. The bank had supplied the donor’s sample to a university laboratory for testing, but the lab would not complete the tests because it could not secure the consent of the donor.

Such cautionary tales have inspired some Internet-age consumer activists. Kirk M. Maxey is a physician who was a paid sperm donor while working in Kalamazoo, Mich. and attending medical school in nearby Ann Arbor. He stopped donating after a worker at the sperm bank where he made his deposits claimed she had purloined his sperm to impregnate herself.

While still in medical school, Maxey had founded a company to produce biochemicals and assays for use in biomedical research. Three years ago, Dr. Maxey added a non-profit arm known as the Cayman Biomedical Research Institute. It operates the Donor Semen Archive. Says Maxey of his efforts:

“I come from a background of extreme mistrust of the banks. I don’t think they tell the truth. I don’t think they are careful because they have no real accountability. They hide all their records and no one can catch them unless they blunder over their own mistakes.”

Maxey’s Donor Semen Archive stores donor-related DNA samples retrieved from the vials and syringes used in insemination and from the children themselves, logging genetic sequences to make it easier when questions come up about genetic health and identity. “The Donor Semen Archive is just a molecular version of the Donor Sibling Registry,” explains Dr. Maxey. “If a bunch of Moms think their donor was ‘Donor No. 65,’ for example, we can tell whether it was really the same guy.” The Donor Semen Archive is poised to join forces and offer its services through the Donor Sibling Registry.

Ben now uses an Excel spreadsheet to manage relationships with the families of his 28—count ‘em, 28—donor offspring.

Concern about unwitting transmission of genetic disorders from sperm donors to many more children than would be possible in conventional families is one factor driving calls for more disclosure, traceability, and limits on the numbers of children born to a particular donor. Consider Ben, a 29-year-old practicing lawyer who masturbated his way through a Washington, D.C.,-area law school, earning about $30,000 to help pay for tuition.

Ben asked that we not publish his last name because he’s not ready for the whole world, including his professional colleagues, to know about his donor career. He explains that he saw the anguish two cousins endured trying to get pregnant, struggling through many expensive cycles of in vitro fertilization. He figured his sperm donations could help people experience the joy of parenthood, while helping to finance law school.

“It wasn’t exactly hard work,” Ben quipped in a recent phone interview. Yet as a frequent depositor at his local sperm bank, he may have spread more joy than he reckoned.

Ben, explains Wendy Kramer, is one of her “brave donors,” who posted his story with his donor number on the Donor Sibling Registry and permits contact from families who have purchased his sperm. Ben now uses an Excel spreadsheet to manage relationships with the families of his 28—count ‘em, 28—donor offspring.

“It is just easier not to mix them up that way,” he says. Ben is only a few years out of law school. His dozens of kids are still of pre-school age. Most of the contact from parents involves email questions about his health status and genetic history.

But Ben is not the bravest donor on Wendy and Ryan Kramer’s site. “I think our record is 64,” says Ms. Kramer of the number of offspring discovered by a donor registered with the Donor Sibling Registry. “We have other donors with children numbering in the 20s, 30s or 40s, says Kramer. “Some pull back after hearing about a few children, they just can’t take it emotionally.”

Other donors, however, are “lurkers,” she says, who visit the site to read the discussion threads but do not officially register, not sure whether they want to commit to being contacted. Official members pay DSR a $40 fee to be able to post information such as donor numbers or sperm bank and donor characteristics data to facilitate matching up with relatives. See how to use the site at www.donorsiblingregistry.com/howDoI.php

What To Do?

When told about Britain’s recent limit on donors to creating 10 families, Ben wasn’t sure about importing such restrictions to the United States. “Why not nine or 11,” he asked. “Any limit would have to be incredibly arbitrary.” Moreover, Ben is not sure that mandating donor identity release is warranted—even after opening up to contact from families who relied on his sperm for one or more of their children.

The question of whether to require identity release—that is, to allow children to contact their donor father when they come of age—is perhaps the hottest topic in sperm banking.

Ellen Singer, a social worker and adoption program specialist with The Center for Adoption Support and Education, Inc., a non-profit organization with three offices in Maryland, says that sperm banking lags far behind the adoption field in terms of regulation and oversight. “There are still professionals who advise parents not to tell their children that they were a result of donor insemination or donor eggs,” she says.

But views are evolving. Singer sees disclosure as a human rights issue. “Kids need to know the truth about their conception,” she argues. “That doesn’t mean the whole world has to know, but the kids should.”

Who knows what is in the best interest of children born to sperm donors? Clinicians? Regulators? Parents? What about the children themselves?

But Singer empathizes with parents who worry about stigma. “The secrecy can be well-meaning and intended to protect the children,” she says. “But children don’t need protection, they need the truth and ways to cope with the challenges that come with it.” The American Society for Reproductive Medicine now advises parents to disclose to their children the details of their conception, even though it opposes more regulation of the industry.

Some sperm banks have been factoring in those privacy vs. disclosure issues for some time now. The Sperm Bank of California, a non-profit outfit established in Berkeley to cater to a largely lesbian clientèle, has offered identity-release semen for more than 20 years. That means the first children born with the option to contact their donor when they turn 18 are now coming of age—and some are beginning to do so.

U.S. sperm banks are increasingly offering donor identity-release sperm as an option. “It goes faster and costs more,” says Lisa Jean Moore, who teaches at Purchase College, State University of New York. Moore is a former board president of The Sperm Bank of California. She is also the parent of two daughters, one born with sperm supplied by a friend, the other with sperm purchased from a bank.

But not everyone thinks imposing more regulations is a good idea. Gays and lesbians, as well as single mothers by choice, may have some misgivings about how sperm banking operates, but many are nevertheless wary of opening the door to regulators who may have much more cramped notions of what should constitute a family. A lesbian couple from Colorado who found out on DSR that their daughter has more than two dozen half siblings emailed the author to say:

We would not support government regulation at any level. The government has a history of discrimination against LGBT [lesbian, gay, bisexual and transgendered] families and individuals, and we would not want to open the door to the government prohibiting sales or contributions from LGBT people.

As journalist Liza Mundy writes in her wide-ranging Everything Conceivable: How Assisted Reproduction is Changing Men, Women and the World (2007), crafting progressive policies is a challenge in this field. “[I]n this area of reproductive science, ‘progressive’ is a hard concept to pin down.” Indeed, almost everyone connected in any way to the field of assisted reproduction gives lip service to the “best interests of the children,” even though sperm banks are set up to meet the needs of doctors, patients and parents.

But, in practice, children’s best interests can be notoriously difficult to pin down. Who knows what is in the best interest of children born to sperm donors? Clinicians? Regulators? Parents? What about the children themselves?

Deborah Spar, a professor at the Harvard Business School, has examined sperm banking as part of a larger look at the reproductive marketplace, including the practices of buying and selling sperm and eggs, renting wombs, and brokering adoptions. Spar, the author of The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (2006), says she attributes the lack of political interest in regulating sperm banks to the relatively small size of the industry, politicians’ reluctance to enter the fray of reproductive decision making, and a general squeamishness about semen.

“No one likes saying the word sperm,” she explains. “Plus, the egg extraction process is surgical, but the sperm extraction process is sexual.”

Still, Spar believes such squeamishness will give way to calls for more regulation, and does not buy the argument that “as soon as you let the government in they’ll be saying that only heterosexuals can have children.” She says “there are lots and lots of places to stop along the spectrum between no government regulation and the government telling me when I should have my child and what I should name him.”

Besides, a new vocal constituency for reform is about to come of age. “It is going to be the sperm babies who are going to push for donor identification and recordkeeping,” Spar predicts. “That is what is going to spur a political debate and wake people up to the medical issues involved.”

She may be on to something. As Wendy Kramer explained, “My son Ryan is 17 and he is the tip of the iceberg. Ryan can’t even be on the Board of Directors of the Donor Sibling Registry, even though he helped found it and he’s in his fourth year of college. At least until he turns 18, that is.”

Ryan Kramer turns 18 next spring. Watch out.

Jeff Stryker is a Connecticut writer specializing in health policy and bioethics.

Here is a list of the books mentioned in the article, with links to their pages on Amazon.com:

Lisa Jean Moore, Sperm Counts: Overcome by Man’s Most Precious Fluid (New York: New York University Press, 2007).

Liza Mundy, Everything Conceivable: How Assisted Reproduction is Changing Men, Women, and the World (New York: Alfred A. Knopf, 2007).

David Plotz, The Genius Factory: The Curious History of the Nobel Prize Sperm Bank (New York: Random House, 2005).

Debora L. Spar, The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (Boston: Harvard Business School Press, 2006).