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.

Historically, neuroscientists have had a range of tools to manipulate and observe neural circuits in the brain. These techniques, however, have often lacked the ability to isolate the contribution of specific neurons or types of neurons to the overall network. With optogenetics, researchers can now discretely control neuronal activity by using pulses of light to activate or inactivate specific populations of neurons. These tools are giving neuroscientists the potential to unlock many of the remaining mysteries of how individual groups of cells in the brain control perception and behavior.

The term optogenetics was first coined by one of its pioneers, Karl Deisseroth at Stanford. The technique, which recently won the 2010 Nature Methods method of the year award, makes use of a group of ion channels and other proteins discovered in bacteria and algae called “opsins.” These proteins are light sensitive and can therefore be activated by pulses of light of an appropriate wavelength. Depending on the opsin expressed, this will either excite or inhibit the neurons. The expression of opsins in mammalian neurons is achieved by inserting the encoding DNA into the target cells, which then produce the opsin proteins. The process of DNA addition is called transfection, and is typically accomplished by using a specially selected virus as a carrier to deliver the new DNA. Variants in the viral delivery and DNA coding sequence allow for specific subtypes of neurons to be targeted. Once opsins are expressed in the neurons, the firing rate can then be controlled in vivo by light from an implanted fiber-optic cable or through a small window in the skull.

This technique gives researchers enormous flexibility and control of the behavior of specific cell types in a given brain region. Spatial resolution comes from the location of the injection and the neural cell-type specificity of the viral vector. Temporal control is produced by the frequency of the delivered light pulses, which via the opsins drives the cells to fire at the same frequency as the pulses of light, or alternatively prevents them from firing at specific times.

For example, a group of neurons in a specific area of the brain could be transfected with an opsin that excites the cells, and then is activated at various frequencies to see how this changes the animal’s perception of a stimulus directed to this area of the brain. It can also be used to completely silence a set of neurons during specific behavioral tasks in order to determine the effect of those neurons on that behavior. With this level of precise control, many systems neuroscience questions that had imprecise answers previously can now be addressed by observing awake, behaving animals.

Some of the recent articles published using this technique have demonstrated new insights into previously vexing problems in neuroscience. For example, there has been a tremendous amount of debate about the mechanism of deep brain stimulation, or DBS, utilized to treat movement disorders resulting from Parkinson’s disease.

This treatment uses electrical stimulation targeted to a region of the brain involved in motor output and control, and its mechanism of action is not well understood. It has previously been difficult to assess whether this intervention affects the neurons nearby the electrode directly, the inputs to those neurons, or the targets of the output from these neurons in this circuit.

Researchers utilized a mouse model of Parkinson’s disease and optogenetics to dissect the circuits of the brain involved in the response to electrical stimulation of the targeted area. Their results suggest that rather than leading to a simple excitation or inhibition of the neurons in the targeted area, DBS is activating connections arising from another area, and that this activation is necessary for the effectiveness of the treatment.

Another recent article demonstrated the importance of a single type of neuron to cocaine addiction in mice, suggesting a target for future clinical interventions. Because this particular type of neuron represents only 1 percent of the cells in the investigated area (the Nucleus accumbens), they have been difficult to study up until now, and their function has been the subject of much debate in scientific literature. The precise genetic targeting of the opsins allowed for just this population of neurons to be manipulated during the experiment.

The implications of this new technology for the field of systems neuroscience are profound. Its potential is being realized as the technique is implemented more broadly and more difficult circuits and systems are teased apart. A better understanding of the circuits underlying psychiatric and neurological disorders will hopefully also lead to improved clinical treatments.

One question for the future is whether or not these new techniques may be directly used to treat some human disorders as well. For example, a future version of DBS might be coupled with optogenetics to provide more specific targeting of cells in the basal ganglia, directly affecting the firing patterns of the cells responsible for disrupted movement in Parkinson’s disease. In addition, research efforts in the past year have successfully demonstrated the feasibility of utilizing optogenetics in nonhuman primates. Use of this technology in humans, however, would combine the ethical dilemmas of gene therapy with those of brain-machine interfaces such as DBS. While the road to safe and efficacious use of this technology for treatment in humans is uncertain, it is already providing great benefits to scientists in understanding circuits and their complex regulation in the brain.

As Congress turns back this week to the continuing resolution to fund the government through the end of fiscal year 2011, it is important that we keep in mind the essential role of federal funding in facilitating scientific advances like optogenetics. The original project in Dr. Deisseroth’s laboratory, the first attempt to integrate the microbial opsins into mammalian cells, was funded by a grant awarded by the National Institutes of Mental Health and National Institutes of Health, as are many of the above-mentioned projects that followed. The first scientists describing the light-sensitive proteins in 1971 could not have predicted that their findings would lead to such a profound change in neuroscientific research. These discoveries are one of the best arguments for continuing to fund basic biological research as well as more translational research: We often don’t know where the breakthroughs are going to come from that will be the basis for the next generation of treatments for disease, or that will allow us to better understand the complex systems that make up our daily habits, thoughts, and decisions.

John A. Wolf, Ph.D., is a neuroscientist at the Center for Brain Injury and Repair in the Department of Neurosurgery at the University of Pennsylvania.

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.

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.

The American Recovery and Reinvestment Act directed an additional one-time stimulus of $10 billion to NIH last year, a sum that helped offset the flat funding for the agency from 2004 to 2008. But “flat” actually meant that the NIH saw the purchasing power of its inflation-adjust budget dip 13 percent over that period.

In the letter, the governors point out that their states received $19 billion in grants from NIH last year, and funding from the agency directly supports 350,000 jobs around the country.

But most importantly, the governors write that the “greatest contribution NIH makes is to the health and well-being of Americans.” The agency funds research on everything from vaccines to cancer therapies—from investigations into the genetic roots of disease to the traumatic brain injuries suffered by U.S. combat troops.

Shortly after the White House released its budget request in February, leaders of United for Medical Research, a coalition of research universities and advocacy groups, explained here at Science Progress that every $1 of NIH investment produces more than $2 of economic benefits. Moreover, they described how the basic biomedical research NIH supports leads to innovations that drive leading U.S. industries: 50 percent of respondents in a recent biotech industry poll reported that their companies were founded on licensed ideas generated by these technologies.

In short, an investment in NIH is an investment in the health, wealth, and security of the whole nation.

There are three major provisions in the new law that promise to bring care-enhancing innovations to patients everywhere. The Cures Acceleration Network, or CAN, will speed new therapies from bench to bedside. The Patient-Centered Outcomes Research Institute will bring develop and disseminate information on the effectiveness of different treatments. And the Qualifying Therapeutic Discovery Project Credit will support small biotech firms investing in new treatments for unmet and chronic care needs.

The goal of the Cures Acceleration Network, introduced by Sen. Arlen Specter (D-PA), is “to accelerate the development of high needs cures,” defined by the legislation as priority treatments “for which incentives of the commercial market are unlikely to result in adequate or timely development.” These therapies may include regenerative medicine treatments that rely on decoding genes and mapping complex biochemical pathways for diseases like Parkinson’s, ALS, or multiple sclerosis.

The new law authorizes $500 million for fiscal year 2010, allocated through grants or contracts that may not exceed $15 million. The contracts are termed “partnership awards” and require the recipient to contribute matching funds of one dollar for every three federal dollars, whereas the “grant awards” do not require a match. The National Institutes of Health director is also given the authority to dispense no more than 20 percent of the appropriated funds at his own discretion for “flexible awards.”

As well, another component of the Cures Acceleration Network mission will be to facilitate Food and Drug Administration review of these high-needs cures. The bill instructs the FDA to coordinate its approval requirements with CAN’s activities and to provide technical assistance in order to expedite product development and approval.

CAN will also promote personalized medicine by supporting the development of diagnostics, preventative therapies, and behavioral therapies, as well as biomarkers that can predict the safety and effectiveness of such therapies for patients based on their individual genetic makeup.

Senators Max Baucus (D-MT) and Kent Conrad (D-ND) originally introduced the Patient Centered Outcomes Research Institute last summer in separate legislation. I explained then that the project was “designed to ramp up medical innovation for the common good by championing a new era of personalized medicine.”

This Institute will be tasked with organizing, funding, aggregating, and disseminating comparative effectiveness research, which looks at two or more treatments side by side to see which produces better health outcomes for a particular group of patients. The version of the Institute enacted in the health reform bill will be established as a non-profit entity that is completely separate from the federal government. A dedicated tax stream will fund the Institute’s trust fund beginning in 2013, but the law also appropriates Treasury funds for the trust fund from 2010 until 2019, when both sources of funding sunset.

Research at the Institute will pay special attention to the needs of subpopulations including “racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, or quality of life preferences.” It will explore the impact of where treatments are in the product development process and the skill level of health professionals administering the treatment to see how those factors impact effectiveness. These are real-world considerations that other forms of research like clinical trials often miss.

Most importantly, the Institute is charged with making its data comprehensible, protecting patient privacy and confidentiality, and explaining the data’s limitations and relevance for subpopulations. The Personalized Medicine Coalition, a non-profit representing a broad array of private, public, non-profit, and academic stakeholders has praised the bill’s establishment of the Institute and its thorough incorporation of personalized medicine.

The law also contains good news for small biotech companies, specifically those with less than 250 employees. These firms will be eligible for a tax credit equal to 50 percent of their investment in any “qualifying therapeutic discovery project.” These can include pre-clinical studies, clinical trials, or other clinical studies conducted for the purpose of winning FDA approval of a treatment, diagnostic, or treatment delivery technology. Companies will need to apply for these tax credits and the total amount may not exceed $1 billion for FYs 2009-2010. The projects must possess certain attributes, such as the potential to treat chronic conditions or ailments in areas of unmet need, reduce long-term health care costs, or contribute to curing cancer. The selected projects must also have “the greatest potential to create and sustain high quality, high-paying jobs.”

Another issue addressed by the law has to do with the biologics industry. Biologics are drugs composed of large, complex molecules that are manufactured through complicated cellular processes, as opposed to small-molecule drugs that are manufactured through simple chemical reactions. Since these drugs are so complex that a firm can create a generic version of an existing drug that is similar enough to fit into the same drug class but different enough to avoiding infringing the patent for the reference drug. These generics are referred to as “biosimilars” or “follow-on biologics.” The health reform law alters the landscape for biologics by establishing a clear FDA regulatory pathway for biosimilar drugs while simultaneously establishing a 12-year period of market exclusivity protection for the companies that create the original biologics. Early reports indicate that the new law seems positive for the biotech industry as a whole.

The legislation also leverages transparency efforts to reduce conflicts of interest within medical research and clinical practice. In 2013, the Department of Health and Human Services will begin tracking the funds and gifts that the medical industry provides to physicians, researchers, and hospitals through reporting requirements. This information will then be made available in a public database.

Michael Rugnetta is a research assistant with the Progressive Bioethics Initiative at the Center for American Progress.

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

The collaboration consists of three components:

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

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

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

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

Granted, biomedical science is not the most obvious answer on most people’s minds when it comes to our economic woes. And certainly, it is not the only solution. But far too often, it is overlooked as a major source of American innovation, economic progress, and perhaps most importantly, better and longer lives for our fellow citizens.

NIH funding directly and indirectly contributes to good jobs and is a proven engine of economic growth. Each year, biomedical funding through the NIH directly supports 325,000 good-paying jobs in research institutions in all fifty states and the U.S. territories, with a positive economic impact rippling far beyond the labs themselves. The Recovery Act will have created or saved roughly 50,000 jobs, as well. But the impact of biomedical investment goes far beyond the lab.

Each research facility runs like a small business, hiring junior staff and purchasing space, supplies tools, and equipment—not to mention the communities they help support. This directly contributes to new business for the companies around the country that supply these resources. In fact, it has been estimated that every $1 of NIH funding results in more than $2 in additional business activity and economic output.

Some of the nation’s largest employers—companies in the biotech and pharmaceutical industries—also seize upon NIH-funded discoveries to produce the next generation of treatments and cures. A recent biotechnology industry poll of its members showed that 50 percent of respondents said their companies were founded on such licensed ideas and technologies.

All this adds up to a vibrant national bio-economic system that grows and flourishes with the right starter funding and seed money from NIH. We have only begun to tap the potential of NIH-funded research as an economic growth engine. It is a catalyst for even further growth that should not be overlooked.

But NIH funding is also at the center of a game-changing movement: the revolution in biomedical science that promises to transform the scale and scope of new treatments and cures in the decades ahead. Using newly gained knowledge about biological structures and functions, scientists now have the opportunity to combat disease in unimagined ways. They no longer have to be reactive—merely describing the symptoms of a disease, applying the treatments at their disposal and watching to see what works.

Instead, they are applying the knowledge gained through decades of arduous scientific study to zero in on a disease, its triggers, and crucial steps in its development. Using discoveries and new technologies made in just the last decade—like the mapping of the human genome—scientists can now understand the molecular drivers of disease and more importantly, how to affect them. As the president pointed out in his budget announcement earlier this month, that means there is potential for cancer treatments that target the disease while leaving healthy cells unharmed; or new treatments that rewire the brain after a stroke, allowing patients to reclaim their bodies.

Combined with the increasingly rapid evolution of sophisticated biotechnology and information technology tools, this revolution in biomedical science means there can be a much shorter distance and time between basic discovery and new treatments. And patients will be the greatest beneficiaries.

We will witness a transformational shift from one-size-fits all treatments that don’t always work to tailored treatments that meet the unique needs of very different patient populations, ensuring efficient and effective care. And that means higher quality health care, with less waste and at less cost—a win for all.

This week will mark the one-year anniversary of the 2009 Recovery Act, which infused more than $10 billion into the biomedical research community through the NIH. We applaud the president on continuing the consistency of his commitment after ARRA. The kind of transformations we’re talking about—in health and the economy—can only come to full fruition if funding remains relatively consistent.

Science cannot progress in cycles of boom or bust, but rather with predictable and robust financial commitments. The right choice is to make a wise, long-term investment in NIH research. It’s an investment with strong economic returns and priceless value: better health for our families, neighbors, and friends.

Clyde Yancy is President of the American Heart Association. Edward D. Miller is the Dean of the Medical Faculty and CEO, Johns Hopkins Medicine. Greg Lucier is the CEO of Life Technologies.

The American Heart Association, Johns Hopkins, and Life Technologies are all members of United for Medical Research.

If successful, the vaccine would be the first designed for use against an illegal drug. And as Mark Meier explained in an article last year at SP before the trial began, the project represents a novel scientific pathway built with novel sources of public-private funding. The National Institute on Drug Abuse supported the trial, run by Thomas Kosten, M.D., of Baylor College of Medicine in Houston.

The immune response triggered by the vaccine produces antibodies that attach themselves to the tiny cocaine molecules, neutralizing their ability to cross the blood-brain barrier. Unable to reach the brain, the drug cannot get the user high, severing the link between use and euphoria.

“You probably want to be sure they’re going to work so that your crab claws don’t turn into a complete exoskeleton,” he explained.

But in all seriousness, to design stem cell therapies that are effective and safe, scientists need to understand the full mechanics of the cell from its earliest developmental stages, and therefore must pursue many avenues of research. And that, as we have explained previously at Science Progress, will take time. Earlier this year, James M. Wilson, of the University of Pennsylvania underscored the importance of creating safe, responsible trials for stem cell therapies in an article in Science. Wilson understands first-hand the pitfalls of proceeding too quickly with a novel therapeutic technology, as he was the principal investigator in a gene therapy trial that resulted in the death of 18-year-old Jesse Gelsinger in 1999.

Collins also hit all the right notes in his explanation of personalized medicine, saying that it’s about “getting the right drug, at the right dose, for the right person.” It’s about “doing prevention in an individualized way instead of one-size-fits-all—taking advantage of the fact that we’re all different,” he said.

Just a few weeks ago Collins penned an article for Parade Magazine on the importance of pharmacogenomics and family history in treating cancer. It’s an important field of work, but the orchestra of federal agencies involved in the research and policy of personalized medicine is in need of a conductor, as Whitney Kramer and I explain in our recent report.

Here’s the full interview as Collins Reports to Colbert:

The president paid a visit to the NIH campus in Bethesda to announce what officials hinted at a few weeks ago: the agency has so far distributed $5 billion in American Recovery and Reinvestment Act funds. As of today, that means that the ARRA has funded more than 12,000 projects, and 1,800 of those grants have gone to researchers who have never before gotten a major NIH award, according to Collins.

According to a video posted posted on the White House blog, NIH estimates that the $10.4 billion in Recovery Act funds will support approximately 50,000 jobs. In his speech today, Collins said the new funds have gone to “some of the most innovative and creative directions for research that I have seen in 16 years at NIH” and that the galaxy of new grants “is not just about ‘doubling the recipe.’”

Obama emphasized the dual benefits of the “the single largest boost to biomedical research in history”: advances in treatments for life-threatening diseases and job creation. He pointed specifically to projects aimed at cancer, heart disease, and autism research.

Remarks from the director and president are available via streaming video; the Washington Post has a transcript of the president’s speech. (HT: Jocelyn Kaiser at ScienceInsider)

One way the National Institutes of Health tries to keep members of the next generation of life science researchers from leaking out of the pipeline is by specifically channeling grants their way. But as Gardiner Harris reports in The New York Times today, those awards come at the expense of proposals that reviewers have deemed more scientifically meritorious:

Many of the favored recipients are “new investigators,” or scientists who had never before received a grant from the health institutes. By skipping projects submitted by older scientists and instead choosing to issue grants to projects from less experienced scientists, agency managers hope to use the scientific equivalent of affirmative action to encourage graduate students and newly minted professors to make careers in academia.

Part of the issue, as Kirshenbaum, Harris, and Beryl Benderly note, was the five years of flat funding for the NIH that followed a doubling of the agency’s budget. The increase grew the size of the research enterprise, as Benderly explained here at SP, without significantly expanding permanent career opportunities for scientists moving up the ladder.

The other reason for “skipping” some of the projects proposed by established scientists is to direct funding toward riskier new ideas—another important approach that federal funding agencies have strayed away from over the years.

Harris reports as well on pressure for greater oversight for the NIH to make sure that there are appropriate systems to monitor decisions to ignore reviewer recommendations and fund lower-ranked proposals. Improving accountability is certainly a good idea, and  might also improve assessments for how effective the policy is at retaining young scientists.

But increased accountability shouldn’t cut funds for researchers who swing for the fences with untried new ideas. Some of those will inevitably fail, and that’s okay. Scientists can learn a great deal from experiments that don’t work, and a commitment to biomedical innovation means a commitment to visionary, untested ideas.

The site is the next step in the implementation of the Obama administration’s stem cell policy, announced in March, which established ethical guidelines for this important research, which will allow the United States to remain a leader in the field of regenerative medicine.

Along with the site, NIH announced members of the new Working Group for Human Embryonic Stem Cell Eligibility Review, chaired by Jeffrey R. Botkin of the University of Utah School of Medicine. The panel will review lines submitted to ensure that they meet the guidelines finalized in July.

Hudson, who co-authored a popular SP article on how to engage the scientific community with the American public, was formerly head of the Johns Hopkins Genetics & Public Policy Center. She told The Scientist that talks were ongoing about how to manage the additional $10.4 billion dollars in NIH funding provided by the American Recovery and Reinvestment Act, but the Institutes are wasting no time in getting money to researchers. “Five billion dollars are going out the door this month,” she said.

In talking to NEJM, Collins acknowledged the tension between supporting “big science” projects like the Human Genome Research Project and investigator-driven studies. He offered this synthesis: “The foundation of advances in biomedical research will continue to be the bright ideas of individual investigators, but if they are empowered by tools and databases and technologies that big science has made available, then we can go faster,” he said.

Collins also said that the question of what happens when the ARRA funds run out weighs heavy, saying: “There is much discussion about the NIH falling off a cliff. Scientific research is not a 100-yard dash. It is a marathon. Two years is way too short to take a cool idea and develop it to some sort of end point.”

Ensuring a smooth funding transition in 2010 should be a priority for Congress, and that process begins now, by ending the five-year streak of flat baseline funding for the NIH. There’s no shortage of good science to fund, and biomedical research creates good jobs as it improves the health of Americans and the economy.

According to Nature, the International Committee of Medical Journal Editors has required, since 2000, that authors submit trial information to databases like ClinicalTrials.gov in order to have their manuscripts published.

But one study, appearing in the Journal of the American Medical Association, examined published articles that relied on registered trials and found that only 45.5 percent were adequately registered—that is, researchers submitted data before the end of the trial and clearly specified the outcome.

Results from industry-sponsored trials registered at ClinicalTrials.gov lead to publications in only 40 percent of cases, according to another report appearing in PLoS Medicine. NGO-funded trial results saw publication 56 percent of the time, but government-funded trials only 47 percent.

Dr. Keith Yamamoto, Executive Vice Dean of the University of California San Francisco School of Medicine and member of the NIH Advisory Committee to the Director, explained the process at a briefing of the Congressional Biomedical Research Caucus on “Finding and Funding the Best Science: Peer Review at NIH” last week.

The peer review system has “intrinsic complexities,” but it is a “terrific system” and “works extremely well,” said Yamamoto, a veteran reviewer. However, he went on to say that there is always room for improvement.

The NIH’s $30.5 billion annual research budget, which saw a $10.4 billion boost included in the ARRA, supports a large variety of biomedical science projects, but each proposal must undergo peer review to be considered for funding. The NIH Center for Scientific Review oversees expert scientists across the country who review 70 percent of the applications, Yamamoto explained. The institutes review the remaining applications in a very similar process.

Applications are divided into 23 review groups based on subject, such as AIDS & Related Research or Immunology. Each review group further separates the applications into more specific study sections. Study section scientists assess the scientific merit of each proposal. Applications are then sent to the institute councils, comprised of both scientific and nonscientific members. Patient advocates often serve as nonscientific members, Yamamoto said. The councils, which hold the grant dollars, evaluate each project’s relevance to the institute.

There are five core review criteria: impact, approach, innovation, investigator, and environment. Peer reviewers evaluate how important each project is to “advancing the ball,” Yamamoto explained. Experimental designs must be sound and principal investigators and their collaborators should be well trained to execute them. Institutional support and the project’s potential to “challenge existing paradigms” are also valuable attributes for approval, he said.

Although Yamamoto believes the NIH peer review system is the “best system in the world,” he says it is hard to escape from “intrinsic conflicts of interest and conservatism.” Reviewers are likely to assess proposals similar to their own work, which may create a conflict of interest. Conservatism is a concern if reviewers follow the “if you think like I think, then I think you’re really smart” philosophy Yamamoto said—complexities that are “likely to require new policies.”

In an effort to address these concerns and enhance the quality of their peer review, NIH conducted a year-long system evaluation, culminating in a final report released in March 2008. Currently, NIH is focused on supporting early stage investigators, attracting and retaining the best reviewers, maintaining the 60:25:15 ratio of clinical to translational to basic research, and shortening the length of research plans while de-emphasizing preliminary and experimental data, Yamamoto said.

Jonathan Moreno, Senior Fellow at the Center for American Progress and David and Lyn Silfen University Professor at the University of Pennsylvania, applauds President Barack Obama’s announcement that he intends to nominate Dr. Francis Collins as director of the National Institutes of Health.

Dr. Collins is a world-renowned leader in biomedical research who led the government’s Human Genome Project, which decoded the DNA sequence that forms the basis of human life and opened pathways to understanding how we develop, how genes influence illness, and how medicine can harness genetics to diagnose and cure disease.

“I’ve known Francis for many years and have observed close up his deep understanding that American science needs to be informed by our values,” said Moreno. “No one else possesses the remarkable combination of qualities he brings to this important position.

“His tenure as director of National Human Genome Research Institute was remarkable for its inclusivity and for how as director he went out of his way to make sure that all points of view were represented around the table on important points of science and medicine,” Moreno added. “He was always mindful that his strong personal convictions and faith remained just that—personal—and that science and medical policy reflected the best interests of the public well-being, not a political or religious ideology. I’m confident these same qualities will garner him the goodwill and support of Congress and the confidence of the American people, and will mark his leadership at NIH.”

At the National Human Genome Research Institute, Dr. Collins demonstrated a progressive dedication to our nation’s continued investment in the scientific research and innovation that powers our economy, improves our quality of life and well-being, and expands our knowledge of the natural world. His expertise in genomics will be a key asset as we move into an era of personalized medicine.

Dr. Collins is an outspoken man of science and an outspoken man of faith. His commitment to each framework of human understanding is emblematic of the pluralistic ethos of the United States. Indeed, a recent survey released by the Pew Center for People and the Press indicates that 61 percent of Americans see no conflict between science and their religious beliefs. As a researcher, his work has revealed the genetic basis of ailments ranging from cystic fibrosis to Huntington’s disease. As a citizen, he has worked to educate others about the fact that science and religion are not in opposition.

If confirmed by the Senate, Dr. Collins will no doubt support progressive approaches to research and innovation that embrace both science and ethics.

But a dearth of transformative work isn’t the only thing missing from the biomedical system in the United States. As Merrill Goozner reported here on Science Progress, there’s a lack of data-driven clinical trials that compare what works with what doesn’t.

Of course, the question of how to develop better cancer treatment’s isn’t either-or. We need both more transformative research and more evidence-based medicine. But as funding for the National Institutes of Health increases, a re-think of the grant review process will be necessary to get resources to promising but untried ideas and to the younger generation of scientists.

Lead author Kenneth Manton at Duke University and colleagues looked at four four significant causes of death over the period from 1950 to 2004: cardiovascular disease, stroke, cancer, and diabetes. They estimate that investments in NIH funding helped avoid more than 35 million deaths over that period, and that for the first three ailments, death rates started dropping more rapidly about ten years after a significant increase in research investment.

NIH funding supports public health, they conclude, as well as workforce competitiveness:

Evaluation of the level of investment in research suggests that a significantly greater, and more prolonged, investment in NIH, and indeed all, federal research would provide a greater stimulus to U.S. economic growth.

Jocelyn Kaiser at ScienceInsider grabbed the study’s closing recommendation for her headline yesterday: “Need More U.S. Workers? Quadruple the NIH Budget.” Or as Manton et al. put it: “To compensate for the slower future growth of the U.S. labor force (e.g., from 1.2% per annum in 1996 to 2006 to 0.3% after 2017) on economic growth, the size of NIH expenditures relative to GDP should quadruple to about 1% ( $120 Billion) and be done sufficiently rapidly (10 years) to compensate for the slowing growth of the U.S. labor force.” Proponents of merely doubling the budget over ten years now have that proposal to consider.

Heidi Ledford, reporting for Nature, notes that the study was of course funded by a grant from the NIH. But she also spoke with Cary Gross at Yale’s School of Medicine, who points out that evidence that biomedical research improves public health and economic growth is important, but the conclusion should not allow observers to lose sight of the importance of basic research: “The opposite of that argument is that if scientific research does not directly relate to health, then it’s not important.”

The beauty of the NIH is that it supports both critical basic research and applied work on the interventions that help U.S. citizens live healthier lives.

Image: The NIH campus in Bethesda, Maryland (NIH)

20,894: The total number of Challenge Grants applications received by the NIH.

At least $200 million of Recovery Act funds will support these new grants. These applications come on top of the 16,312 regular applications received for the current funding cycle. Some 18,000 reviewers will help read and score them all, a workload that has NIH Center for Scientific Review Director Antonio Scarpa worried about the time it will take for each reader and the inevitable low acceptance rate. The projects that are funded will generate jobs, grow the economy, and support the search for cures.

49,015: The total number of comments the NIH received on its draft Guidelines for Human Stem Cell Research.

Jocelyn Kaiser at ScienceInsider reports that the Institutes’ policy chief estimates the amount is roughly equivalent to when the NIH issued draft guidelines on the same issue in 1999.

$5,000: The threshold for earnings that should trigger mandatory disclosure under financial conflict of interest rules for NIH-funded researchers, as recommended by the Association of American Medical Colleges and the Association of American Universities.

The two major academic associations, which both represent significant proportions of the institutions where scientists conduct NIH-funded research, submitted their joint comments in a letter Wednesday. NIH grantees are currently obliged to report a financial interest if they earn more than $10,000 in income or own more than $10,000 in stock plus 5 percent interest in a company, but the AAMC and AAU believe the threshold is too low to ensure research integrity. The recommendations were in response to the NIH’s request for comments on promoting objectivity in research. Patti Tereskerz recently explained the complexity of managing the conflicts of interest that result from the necessary mix of public and private research funding in Science Progress—including those that arise from corporations funding research through foundations and nonprofit institutes.

Still, you have to admire the “Rock Stars of Science” campaign—Rock S.O.S.; hat tip Mary Spiro—which launched with a four page portfolio in GQ magazine that paired up musicians with scientific “celebrities” (none of whom are household names) for a high-end photo shoot. The idea seems to be that having Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Harold Varmus, co-chair of the President’s Council of Advisors on Science and Technology, groove with Sheryl Crow will reflect some of the latter’s rays on the former. The campaign—which advocates for increased funding for biomedical research—is sponsored by Geoffrey Beene Gives Back, the philanthropic arm of the clothing design company. In case it isn’t obvious already, they know how to make anyone, even frumpy scientists, look good.

I am not nearly snooty enough to pooh-pooh this kind of initiative. Rather, I applaud it. For after all, I’ve long felt that when it comes to the cultural standing of science in America, our problem is a lot bigger than a poor educational system, bad test scores, or rampant scientific illiteracy. It is at least as troubling that very few Americans can name Fauci, Varmus, or Francis Collins, former director of the National Human Genome Research Institute—and that very few American kids want to be them. A scientific research career, if you can get it, is a pretty good life—one could set one’s sights far, far lower. But it’s not clear that as a culture today, we recognize this.

Rock S.O.S./Geoffrey Beene Gives Back

Anthony S. Fauci, M.D., Director of the National Institute of Allergies and Infectious Diseases, Sheryl Crow, and Harold Varmus, M.D., President of the Memorial Sloan-Kettering Cancer Center and Co-Chair of the President’s Council of Advisors on Science and Technology

Other countries do: The crashing down of South Korean stem cell researcher Hwang Woo-Suk amid fraud allegations in 2006 was shocking precisely because Woo-Suk had become a nationally known figure, a celebrity, by virtue of his scientific success. The sense today that America may be “falling behind” in science isn’t just about the numbers of researchers we produce: It’s also based on the accurate recognition that in South Korea, or in China, there is a very different perception of science as central to the national future. It’s a perception we ourselves had 50 years ago, inspired in large part by those dreaded Sputnik bleeps. But times have changed, and it’s an open question as to whether we as a nation can ever go back there again—without, I hasten to add, abandoning any of the lessons learned since.

Initiatives like the Rock S.O.S. campaign, or the National Academy of Sciences’ Science & Entertainment Exchange, suggest that maybe we can. Finger to the wind prognostications aren’t worth much, but one gets the sense that with the Obama administration, the place of science in American culture may be changing—improving. Maybe we were at an artificial low under the Bush presidency.

Yet one also wonders whether the GQ spread does enough to combat prevailing stereotypes of scientists as nerdy, as weird and anti-social, or as mean and condescending religion bashers. Some of the researchers featured in GQ get beyond the geek, but mostly, the contrast between them and the rock stars is sharp and heightened.

It is particularly difficult to miss the fact that while the rock stars are far more diverse, the scientists are all older, white, and male. Yes, it catches your eye to see such scientists rocking out. But it would be even more bracing to see female and racially diverse young researchers—with tattoos! Believe me, they’re out there.

Nevertheless the Rock S.O.S. initiative makes several unforgettable points: Billions of dollars of scientific research can remain invisible without a good marketing campaign. And scientists, while undeniably respected, simply do not sit atop the totem pole of American culture—celebrities, musicians, and sports figures do.

Next stop for Geoffrey Beene: In the pages of Sports Illustrated, I want to see young, athletic scientists catching passes from Peyton and Eli Manning.

Chris Mooney is contributing editor to Science Progress and author of several books, including The Republican War on Science and the forthcoming Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

The National Institutes of Health recently published advanced notice of rulemaking and a request for comments concerning the responsibility of applicants for promoting research objectivity related to Public Health Services funding.[1] This push for more stringent regulation of financial conflicts of interest, referred to as COIs, is predictable, given the intense scrutiny Congress has placed on these financial conflicts.

But managing conflicts of interest is a complicated policy matter, as researchers and their institutions often receive both public and private funding to support research that leads to new treatments. The proposed rules provide much-needed guidance that has been lacking in the past and support greater disclosure and transparency. But they fail to address other complex matters, such as the route corporate dollars can follow through non-profit institutions and into the salaries of biomedical researchers. Further, my colleagues and I have conducted research demonstrating that financial conflicts are widespread, ingrained within the research infrastructure, and in some cases endanger the well being of research participants.

A recent Congressional investigation, led by Senator Chuck Grassley (R-IA), revealed several unfortunate failures to disclose financial arrangements by investigators. In one reported case, a highly influential Harvard child psychiatrist, Dr. Joseph Biederman, whose research contributed to the increased use of antipsychotic medicines in children, earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007. However, he allegedly did not report much of this income to his university officials.[2]

In the months that followed, the investigation led to accusations that another prominent Emory University psychiatrist, Dr. Charles Nemeroff, received $2.8 million dollars from a drug company and did not report much of the income. At the same time, reports indicated that Nemeroff was overseeing a NIH study on five anti-depressants produced by the research funder, GlaxoSmithKline, between 2000 and 2007.[3]

These are but two of the more public cases identified as part of the investigation.[4] And, just as this piece was being written, there came news that a former Walter Reed Army Medical Center surgeon, who was a paid consultant for a medical device company, published a study allegedly containing false claims and overstated benefits of the company’s product.[5]
Recently, my colleagues and I (including Science Progress Editor-In-Chief Jonathan Moreno) published a national study, funded by NIH through the Office of Research Integrity, on industry-sponsored research and research integrity which further illustrates the problematic nature of financial COIs, which inevitably attend partnerships between researchers and the private sector.[6]

Researchers and research institutions often receive both public and private funding to support their work. The majority of those we surveyed in our study who received industry support for research indicated that this funding was important to their research or publications. Yet, the more important the industry support was to respondents, the more likely they were to report first-hand knowledge of compromises in research integrity. And we found that knowledge of compromises in research integrity is widespread. Perhaps most alarming were respondents who reported first-hand knowledge that the well being of research participants was compromised because of industry sponsorship.

Other results from the study included first-hand knowledge of compromises in research initiatives (35 percent), publication of results (28 percent), interpretation of research data (25 percent), and scientific advancement (20 percent) in all cases because of industry support. Also of concern was that industry-supported research occurred more often among the most senior and prolific researchers, those who no doubt are more likely to be leaders in their fields and have the ability to influence young trainees. Our findings follow many earlier studies that have raised concerns about the undue influence of industry sponsorship on research.[7]

As with the individual cases uncovered by the Congressional investigation, this empirical evidence suggests that there is a gap between policy and practice, signifying that current regulatory measures to manage financial COIs are not sufficient to manage the public/private partnerships that have been an important component in the acceleration of translational research from bench to bedside.

Cases emerging from the Congressional investigation and data emerging from studies point to areas upon which there is need for much greater scrutiny, and the proposed rulemaking makes important strides in addressing some of the limitations of the current regulatory scheme. For example, current federal regulations do not provide specific guidance on managing COIs that involve projects supported by the Small Business Administration’s Small Business Innovation Research Program or the Small Business Technology Transfer Program, with the exception that support for Phase I clinical trials is excluded from COI regulations.⁹ Yet, there has been a substantial increase in NIH SBIR/STTR awards in recent years, but the institutions receiving the funds are responsible for managing COIs.¹⁰ SBIR/STTR programs are set aside programs of federal agencies’ extramural budgets to provide funding for domestic businesses to undertake research and development that has potential for commercialization. Often this involves partnerships between academia and industry, and in the case of STTR’s this is required.

In 2002, NIH requested that 300 of those institutions provide a copy of their policy on COIs and reviewed a representative sample of over 100 policies. At that time, 96 percent of the policies did not mention SBIR programs in the policy document. It is ironic that some of the most complex and difficult financial arrangements emerge with SBIRs/STTRs, yet circumstances specific to these COIs are afforded little to no federal guidance for identification and management. Clearly, this is an area that needs to be addressed.

Importantly, the NIH’s proposed rulemaking identifies additional areas where guidance has been lacking and is urgently needed. For example, the notice questions whether the new rulemaking should include required education of investigators, independent assurance of institutional compliance with the regulations, enforcement mechanisms, and the need to address institutional conflict. Articulated guidance in these areas, establishing effective regulatory requirements, would be an important step forward.

The proposed rulemaking also includes consideration for expanding the scope of the regulation and disclosure of interests and questions whether all financial interests should be disclosed, in contrast to current regulations that require disclosure when the money involved reaches certain threshold levels. No doubt the threshold levels for disclosure are arbitrary. But to require reporting of any financial interest may be unduly burdensome on institutional administrations.

While many of the matters under consideration for expanding the regulations are necessary, they may not be sufficient. The proposed rulemaking does not seem to take into account opportunities for circumventing the intent and spirit of the proposed rules.

For example, the proposed rulemaking appears content with excluding salaries that are remuneration from one’s own research institution. There are researchers whose institutions have had research contracts with a given industry sponsor for years, and this funding is used to support the researcher’s salary year in and year out. Clearly, it is not lost on the researcher as to who is floating the boat. This means that the opportunity for influence and developing loyalty to an institutional underwriter still exists, even if the money paid to the investigator comes in the form of an institutional salary. Does passing the funds through the research organization remove the conflict of interest or just keep it out of public view? These pass-through arrangements may be particularly egregious because of their lack of public transparency. Further, these conflicts may reach beyond the investigators to the institutions themselves, since research contracts with institutions typically provide indirect funding for the institution.

Likewise, financial interests from seminars, lectures, or teaching engagements, or service on advisory committees sponsored by public or non-profit entities are excluded from disclosure requirements. Again, the problem is that many for-profit companies can create non-profit foundation counterparts and have funds filtered through these entities to bypass the language of the rules.

The proposed rulemaking is grounded in the need for transparency. Complete transparency of any financial arrangement that has the potential to compromise research integrity should be absolutely required. But it should be necessary only for those conflicts that cannot be avoided in the first place. Disclosure can only do so much and won’t cure a moral wrong.[8] Emphasis should focus on preventing, rather than managing, COIs in research, whenever possible. And, to a limited extent, the proposed new rules suggest this by asking whether investigators involved in participant selection, informed consent, and management of a trial should be prohibited from having a significant financial interest.

But in some instances collaboration between investigators and industry is necessary for innovation to move forward. The example that comes to mind is in the development of medical devices. So overall the challenge remains the same—how do we continue to encourage public/private partnerships so that translational research can continue to move forward at a rapid pace without compromising research integrity?

Perhaps it is time to think outside of the box and consider completely new models to better avoid COIs in the first place. This may require some major changes in how we go about the business of underwriting privately sponsored scientific research in this country. Some experts have proposed such models, but no one has seriously pursued them.[9] The Obama administration puts a premium on research integrity, possesses the intellectual acumen to embrace creativity, and has the courage to promote change. So the time is ripe to challenge experts to devise new ways to encourage public/private partnerships but simultaneously shield research objectivity from financial conflicts of interest. It will not be easy, but it can be done.

Patti Tereskerz, JD, Ph.D. is an Associate Professor, Research and the Director of the Program in Ethics & Policy at the Center for Biomedical Ethics and Humanities at the University of Virginia School of Medicine.

Notes

[1] Department of Health and Human Services, “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors,” request for comments, Docket No. NIH-2008-0002, RIN 0925-AA53, Federal Register, 74 (No.88) May 8, 2009, pg. 21610.

[2] Harris, G. and Benedict, CA., “Researchers Fail to Reveal Full Drug Pay,” The New York Times, June 8, 2008.

[3] Akre J., “Million Dollar Conflict-Of-Interest By Emory Psychiatrist Uncovered By Grassley,” available at http://www.uslaw.com/library/Personal_Injury_Law/Million_Dollar_ConflictOfInterest_Emory_Psychiatrist_Uncovered_Grassle.php?item=259739 (last visited May 13, 2009); Harris G., “Top psychiatrist didn’t report drug makers’ pay,” The New York Times, October 3, 2008.

[4] See http://thomas.loc.gov/cgi-bin/cpquery/13?&sid=cp1111Nlmz&l_f=1&l_file=list/cp111cs.lst&hd_count=50&l_t=14&refer=&r_n=sr013.111&db_id=111&item=13&sel=TOC_195021& (last visited May 21, 2009).

[5] Wilson D. “Doctor Falsified study on injured G.I.’s, Army says,” The New York Time, March 12, 2009.

[6] Tereskerz PM, Hamric AB, Guterbock TM, Moreno J., “Prevalence of industry support and its relationship to research integrity,” Accountability in Research 16:78-105, 2009.

[7] See, for example, Bekelman Justin E, Li Yan, Gross Cary P., “Scope and impact of financial conflicts of interest in biomedical research: a systematic review,” JAMA (January 22, 2003), 289(4):454–465; J Lexchin, LA Bero, B Djulbegovic, and O Clark, “Pharmaceutical industry sponsorship and research outcome and quality: systematic review,” Br Med J (2003), 326:1167-1170; HT Stelfox, G Chua, K O’Rourke, AS Detsky, “Conflict of interest in the debate over calcium-channel antagonists,” N Engl J Med (1998), 338:101-106; RA Davidson, “Source of funding and outcome of clinical trials,” J Gen Intern Med (1986), 1:155-158; LA Bero, D Rennie, “Influences on the quality of published drug studies,” Int J Technol Assess Health Care, (1996), 12:2009-2037; M Friedberg, B Saffran, TJ Stinson, W Nelson, CL Bennett, “Evaluation of conflict of interest in economic analyses of new drugs used in oncology,” JAMA 1999, 282:1453-1457, LL Kjaergard, B Als-Nielsen, “Association between competing interests and authors’ conclusions: Epidemiological study of randomized clinical trials published in the BMJ (2002), 325:249.

[8] Katz J, “Informed consent to medical entrepreneurialism,” in Spece RG, Shimm DS, Buchanan AE, eds., Conflicts of Interest in Clinical Practice and Research, (New York, NY: Oxford Univ Press, 1996), 286-299.

[9] For some examples, see Tereskerz P., “Developing a new model: Preserving scientific objectivity, trust, and the informed choices of human subjects,” in Riding the Green Wave. Financial Conflict of Interest in Industry-Sponsored Clinical Research, Chapter 10, (University Publishing Group, Hagerstown, MD, 2007), pgs. 153-168; or Moses III H, Martin JB, “Academic relationships with industry: a new model for biomedical research,” JAMA (2001), 285:933.

Congress will provide the TRND program with $24 million a year for five years to conduct preclinical research and work on product development for rare and neglected diseases. If a drug survives the preclinical stage, TRND will contract a company to test the treatment clinically. These funds come from the $10.4 billion the NIH received from the stimulus package, intended to be spent by September 2010.

The NIH is targeting these diseases because private companies avoid this small market with little profit appeal, leaving patients with no treatment options. Only about 200 rare diseases have effective treatments today, as there are high barriers of entry for the pharmaceutical industry. Studies estimate that a potential drug requires between 8 and 15 years and upwards of $800 million to develop a new drug and introduce it to the market. The preclinical process, a focus of the TRND program, is the most difficult hurdle, costing $10 million and between two to four years itself. Without a successful preclinical stage, a treatment only has a 10 to 20 percent chance of reaching clinical trials, hence the nickname for this period, the “Valley of Death.” The NIH plans to use its funding and in-house academic resources to ease this process. The program will also address the difficulties in working with rare diseases, such as recruiting enough clinical trial patients, by partnering researchers with patient advocacy organizations and disease-oriented foundations.

The National Organization for Rare Disorders keeps a current database of rare diseases and associated organizations.

Image: AP/Marcio Jose Sanchez

SP contributor Beryl Benderly tackled precisely this issue in her January piece, reporting that mismanagement of future NIH growth could have devastating ramifications for the long-term health of the research community in the United States:

Labor market experts agree that without major structural reforms in how research is organized, additional funding will not remedy—and could substantially worsen—a central failing of the nation’s scientific enterprise. That failing is the dismal and worsening career prospects of young Americans who want to spend their lives doing scientific research. Like other students with the talent and drive to excel at rigorous studies, the scientifically gifted hope for a profession that will afford them at least a comfortable middle-class lifestyle and reasonable financial security. The current university-based research structure severely inhibits that quest.

Pharmboy is equally blunt: “We’ve got to show restraint and responsibility by not training another few thousand postdocs who still won’t have faculty slots to pursue in three years.”

In their recent SP column, Neal Lane and Leslie Berlowitz expand on this to argue that funding high-risk, high-return research, along with young scientists, should be a priority for situations just like this:

Federal agencies should set up, or in some cases expand, programs that are devoted exclusively to funding early-career investigators and the most innovative, potentially transformative research. If the research budget increases, then these programs should be the first to get new funds.

With swift deadlines and lots of funding to move, readers may have their own applications open in front of them. Any additional thoughts on ways to ensure that we support up-and-coming researchers?

Science Insider: NIH details are sketchy, but include increases; NSF would see 8.5 percent bump; more for scientific facilities though DOE’s Office of Science; earth science research funding and Orion money for NASA; 37.5 percent increase for EPA.

The Intersection and Yale e360: spending initiatives assume passage of cap and trade legislation, a significant political maneuver.

The Washington Post has a useful comparison graphic (article) showing the 2007-2008 budget and the 2009-2010 with stimulus funds side-by-side for several agencies and departments.

Also notable: the budget outline includes $1.3 billion for NOAA “weather satellites and climate sensors”; $50 million to support creation of regional innovation clusters; and says that the Patent and Trademark Office will be granted full access to its fee collections, a problem because Congress has previously dipped into the funds, which are the source of operating funds for the overburdened office.

As the Science Insider reporters point out, the format of the release as a pdf is “decidedly old-school style for the digitally minded Obama Administration.” Let’s be honest: this information needs to be available in a fully machine-readable format. They could take some cues from the NYT’s unveiling this week of its API.

Image: flickr.com/afagen

Conservatives with a limited understanding (or, it seems, interest) in economics have decided that do-nothingism is a fair 21^st century complement to know-nothing ancestors. But not only do economists agree that funds injected into the economy is exactly what is needed now, investments in science and technology are perhaps among the most stimulative for the long and the short term. Among the package’s goals are to preserve and create jobs and promote economic recovery and to provide investments that will increase economic efficiency by spurring technological advances in science and health.

As we recently pointed out, a raft of studies has shown that science and technology incubators are among the best ways to create jobs, most recently one from the Department of Commerce. But basic research not only leads to technologies that can be applied, it also creates and supports jobs right away. As Senator Harkin emphasized during the Senate debate on the president’s proposal, “[E]very time a researcher gets a grant, it supports an average of seven jobs.”

Dr. Kington’s pointed out that the responsibility of all the agencies receiving these funds is to ensure that their effects are felt within the next two years. Among the buckets he described will be short-term grants, targeted supplements to current grants, and new challenge grants with expectations of progress within two-years.

This unprecedented opportunity for American science has been met with great excitement in universities around the country, many of which are experiencing severe retrenchment that will make it difficult for them to fulfill their missions, even as more people decide to seek degrees until the recession passes. At the same time, talking with colleagues around the country, I note the grave sense of obligation to meet the president’s goals.  Over the next few weeks we will continue to follow the plan’s specifics and the scientific community’s progress in meeting the goals of the package.

Image: flickr.com/gregclarkephotography

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A boost this significant would go a long way towards stabilizing an agency that has seen flat funding for five years, and a concomitant 13 percent decrease in buying power as a result of inflation.

Hopefully, a new policy on that lifts restrictions on federal funding of human embryonic stem cell research will follow passage of this stimulus. Increased NIH funding will give greater heft and meaning to the new stem cell policy. Indeed, some scientists have expressed skepticism about real change in the research environment if the policy shift opens up new stem cell lines to non-existent federal funding. Paul Basken reports in the Chronicle of Higher Education (subscription): “If Mr. Obama promises a policy reversal without finding significantly more money, ‘it will tend to ring hollow’,” according to Dr. Arnold R. Kriegstein of the University of California at San Francisco.

The article goes on:

A move by Mr. Obama might even bring scientists a counterproductive renewal of attention to the politics of stem cells. For all the attention Mr. Bush attracted with his 2001 order, stem-cell research has largely been redirected rather than blocked.

For more on the positive economic impact of NIH work and biomedical research in general see our recent post: “Data Bank: NIH Funding By the Numbers.”

Plaudits from a galaxy of research luminaries indicate that there’s a lot in the new administration’s statements and actions for senior scientists to like. But the strains of “Happy Days Are Here Again” are harder to hear among the people who do most of the actual labor of American science—the poorly paid post-doctoral researchers and graduate students putting in years of 70-hour-weeks at the bench. Despite the change in administrations, their future still looks bleak. The reason: Channeling substantially more money—as much as 100 percent more over the next 10 years—through the existing university-based research structure ignores the fact that in certain crucial respects this structure is severely dysfunctional.

This mismatch between effort and outcome is, according to leading labor force economists, the central obstacle discouraging many of America’s most talented young people from pursuing advanced scientific studies.

Labor market experts agree that without major structural reforms in how research is organized, additional funding will not remedy—and could substantially worsen—a central failing of the nation’s scientific enterprise. That failing is the dismal and worsening career prospects of young Americans who want to spend their lives doing scientific research. Like other students with the talent and drive to excel at rigorous studies, the scientifically gifted hope for a profession that will afford them at least a comfortable middle-class lifestyle and reasonable financial security. The current university-based research structure severely inhibits that quest.

Training as a research scientist takes a demanding decade and starting a real career today generally requires landing a faculty position. Such openings are so painfully few, however, and each one available already draws hundreds of qualified applicants. These days, therefore, the investment of time, effort and opportunity needed to prepare for a research career very rarely pays off in the desired result.

This mismatch between effort and outcome is, according to leading labor force economists, the central obstacle discouraging many of America’s most talented young people from pursuing advanced scientific studies. This problem is so grave and so intrinsic to the way America’s academic research system is now organized that fundamental reform is needed to fix it. Simply providing more funding for basic scientific research won’t solve this fundamental problem.

A Decisive Choice

For several decades now, the United States has in fact pursued policies that systematically destroy the incentives that could draw America’s best—and very plentiful—homegrown talent into research careers. Despite claims of a shortage of Americans capable of doing topflight science, education statistics clearly show that the nation produces an abundance of young people with the ability to do science and math at the very highest levels. But, in the words of a foreign postdoc who has spent years working in American university labs on a temporary visa, “no American in his [or] her right state of mind would get into a career in academia. You can end up very easily in your 40s without a future ahead of you.”

Today’s crisis is not accidental. It grew out of decisions made, with little thought about labor force consequences, in the years after World War II.

Bright undergraduates at the nation’s universities see the grad students and postdocs laboring in their professors’ labs and the lives of penury, toil, and insecurity that await those who follow in their footsteps. In response, many of our best math and science students chose medicine, law, finance, or other careers over scientific research. Rebuilding the incentives that can once again make research a career of choice for Americans with the potential to do outstanding science is essential to assuring the nation’s future as the leader in innovation.

Today’s crisis is not accidental. It grew out of decisions made, with little thought about labor force consequences, in the years after World War II. In that dawn of massive federal research budgets, policymakers chose to finance science by awarding grants for specific projects to university professors who would use their students and, eventually, their postdocs, to provide the labor. This system worked well for a while.

But it had a hidden—and ultimately fatal—flaw that in the end turned it into an intellectual pyramid scheme. In addition to a stream of new findings, these “self-replicating” professors also produce a constant stream of new PhDs seeking to start research careers of their own. As American higher education expanded rapidly through the mid-1960s, young scientists could generally find the opportunities they sought. But when the growth in faculty openings drastically slowed, the production of new PhDs did not. Universities continued to give fellowships and postdoc appointments based on the amount of research money they received, not on the career opportunities awaiting their graduates.

By the mid-1970s, PhDs seeking faculty jobs far outnumbered the available career opportunities. Where once scientists had generally moved into faculty posts by age 30, now they went in large numbers into low-paid, temporary, postdoctoral “training” positions while they searched for assistant professorships. Before long, five or more years as a postdoc became “normal” in many fields. But even as the typical postdoc period grew, the chances of getting that faculty post shrank and labor force observers began calling extended postdoc training “disguised unemployment.”

Smart undergraduates began noticing the poor professional and financial payoff from science graduate study, and their professors began importing large numbers of PhDs and graduate students from abroad to provide the highly skilled but low-paid labor that keeping their grants required. Today, the majority of the nation’s estimated 60,000 or more postdocs are foreigners on temporary visas.

A New Ladder Needed

Pouring more money into this same dysfunctional system will obviously do nothing to attract more young Americans to careers in science. It will only, as our foreign postdoc puts it,  “create more postdoctoral training jobs when we have thousands and thousands of people who have already been trained for many years under the present system” who can’t start careers. But don’t get me wrong. The nation needs increased research funding to meet our ambitious goals in health care, energy independence, green energy, and more. Doubling expenditures over a decade makes excellent sense.

But how the we spend that money is as important for the nation’s future as how much we spend. The last sharp hike in research funding, when the National Institutes of Health budget doubled between 1998 and 2003, produced some excellent research. But it also did real damage to countless careers because it led to a large number of new researchers who cannot get permanent jobs or grant funding.

This time, we must spend the increased funds in a way that builds, not destroys, long-term career opportunities for scientifically talented young Americans. Instead of the failed strategy of simply giving professors more money to pay more postdocs and grad students, we need to start constructing new career ladders that provide appealing long-term opportunities for large numbers of gifted young scientists. Small programs that provide special grants to a few hundred handpicked young investigators will not suffice, because the odds of winning them are too low to motivate people who have many options to persevere through a decade or more of demanding training.

Instead, we need to break from the present system of tying career opportunities in research to winning one of the tiny number of faculty openings available each year—a number that appears to be shrinking even further as today’s cash-strapped universities impose budget cuts and hiring freezes. In place of the old, counterproductive job structure, the nation needs a new one with plenty of solid, professional, career opportunities that offer young PhDs salaries, status, security, and chances for advancement that befit their long training and specialized skills. These jobs need not carry the title “professor” or to be at universities, but they must provide talented young Americans who choose graduate school in science, and hope to spend their lives doing research, a reliable chance of realizing their dreams.

Experts suggest various of ways of accomplishing this, all of which involve dismantling the current pyramid scheme. Instead of depending for labor on a constant stream of cheap, temporary students and postdoc “trainees,” labs need to establish many long-term positions that offer workers a realistic income commensurate with their education and experience as well as opportunities for advancement within predictable career tracks. A model that many experts favor is staffing labs primarily with bachelors- or masters-level career technicians and PhD-level permanent staff scientists while using much smaller percentages of grad students and postdocs.

Because these new-style labs would not depend on student labor, they would not need to be in universities. Rather than continuing to limit competitive research funding largely to university-based professors, major U.S. funding agencies would, like many European countries, encourage the development of freestanding research institutions based not around the teacher-and-disciple academic model, but around a staff of career scientists and technicians. The legendary Bell Laboratories, for example, supported for decades by the monopoly profits of the regulated U.S. telephone industry, worked on such a model and produced some of the 20th century’s major technological advances, as well as six Nobel Prizes for basic research.

In our own time, Janelia Farm, the Howard Hughes Research Institute’s innovative new research facility in Ashburn, Virginia, eschews university-style hierarchy and places a strong emphasis on employing long-term PhD staff scientists. These are only two of the possible arrangements that America should consider, experts say.

Building this new career structure will take bold thinking and strong leadership, but anything less cannot achieve President Obama’s goal of keeping American science pre-eminent in the 21st century. Our nation must do more than satisfy the clamor of today’s senior scientists for additional money for their labs. The time is overdue for the nation to recognize and take seriously the vital long-term challenge of ensuring the career opportunities that will motivate our best young people to make the commitment needed to do the great science of the future.

Beryl Lieff Benderly, a Washington journalist, writes the monthly “Taken for Granted” column on science labor force issues on the website of Science.

In particular, the American Recovery and Reinvestment Act would allocate $2 billion for biomedical research through the National Institutes of Health. The NIH will determine how to distribute the funds based on the merit-based grant applications they receive, and there are no shortage of projects ready for the infusion: currently 80 percent of grant requests currently go unfunded by the Institutes.

Annual increases that doubled the NIH budget between 1998 and 2003 grew the federal support for biomedical R&D across the country. But since FY2004, funding for the NIH has been flat; inflation has driven purchasing power down 13 percent in real dollars.

(Source: AAAS Budget and Policy Program)

For a full historical view of how the flat funding impacts grants to states, check out this motion chart, in which the period of contraction is readily visible. (Data from NIH.)

The proposed stimulus package is a way to simultaneously fund those biomedical projects-in-waiting, support the younger generation of researchers who must wait years to win independent funding, and create good jobs in every state. Here’s more by the numbers:

5.8: the number of additional jobs generated by each bioscience job in the national economy

1.3 million: total national employment in biosciences in 2006

350,000: total jobs supported by NIH grants in 2007

$50,537,000,000: total state economic output generated by $22,846,000,000 in NIH funding (a 2.2:1 ratio)

32: percentage of NIH research project grant proposals funded in 1999

24: percentage of NIH research project grant proposals funded in 2007

39: average age at which a researcher won his or her first independent grant in 1990

43: average age at which a researcher won his or her first independent grant in 2007

More on the benefits of increased NIH funding: “Where’s the Biomed Bailout?” and “Recovering Innovation, Innovating to Recover“

A white paper released last year by the American Academy of Arts and Sciences points to two priorities that need greater attention. The first is support for early-career researchers. The second is funding for high-risk, high-reward research that has the potential to be transformative. If our nation does not take these two steps, then the United States risks losing a generation of productive researchers and the benefits of their innovative ideas.

The recent report, ARISE, Advancing Research in Science and Engineering, was drafted by 22 leading scientists—including members of the Science Progress advisory board—from a variety of fields, including four Nobel Prize winners. It paints a worrisome picture of the status quo. Newly hired research faculty—those entering what should be their most productive years—have a hard time finding funds to support their work. On average, biomedical researchers don’t receive their first grant from the National Institutes of Health, their primary source of funding, until they are 42.

The percentage of grants from NIH going to new researchers has been falling, and most researchers spend too much time submitting multiple applications before they receive their first grant. The situation is equally bleak at the National Science Foundation where the approval rate for grant applications from new researchers has fallen to 15 percent. Recipients of NSF grants have, on average, already been out of school for nine years before they receive their first grant.

The United States is being deprived of the kinds of path-breaking work that could be the basis of future economic success

What’s more, the U.S. research system has become very risk-averse. Scientists tend to submit conservative research proposals for fear that more innovative ideas will be turned down. The result of these trends is that the United States is being deprived of the kinds of path-breaking work that could be the basis of future economic success—the next leapfrogging technology on the order of the Internet or entire new fields such as biotechnology. Investment in early-career faculty and high-risk research will provide immediate opportunities for future leaders and strengthen the foundations of our economy.

The government can take concrete, budget-neutral steps to improve the situation. The problem is as much inertia as it is a lack of funds. Federal agencies should set up, or in some cases expand, programs that are devoted exclusively to funding early-career investigators and the most innovative, potentially transformative research. If the research budget increases, then these programs should be the first to get new funds. If budgets do not increase, then money needs to be shifted into these programs from other programs, projects, and centers. Recent initiatives at the NIH, such as the Transformative R01 grants program, and at the Department of Defense substantially increase investment in basic research at academic institutions and begin to address these issues. But more needs to be done.

Ongoing programs also have to be administered so they do not disadvantage early-career researchers or far-reaching ideas. Case in point: Peer reviews of first-time and second-time grant applicants should have expectations appropriate for that career stage, paying more attention to an investigator’s promise. To promote potentially transformative research, applications should minimize detailed methodology and instead explain the impact the research would have if successful. And progress reports should explain the applicant’s most important accomplishments, not just list prior publications.

Beyond modest but far-reaching shifts in how the federal research pie is divided, the ARISE report targets several low-cost changes that could dramatically improve the science and technology research picture. These include strengthening review systems, enhancing support for program officers, and improving data collection and analysis across agencies.

In the months since the publication of the white paper, the chair of the Academy’s ARISE group, Thomas Cech of the Howard Hughes Medical Institute, and other committee members have met with agency officials, professional societies, university groups, and congressional policy makers to discuss the report in detail. We hope that this will stimulate a deeper discussion of our nation’s research and education enterprise and, in particular, the intertwined government and university policies and procedures that affect the success of early-career scientists and the opportunity to engage in high-risk, high-reward research.

Neal Lane is the Malcolm Gillis University Professor and senior fellow at the James A. Baker III Institute for Public Policy at Rice University.

Leslie Berlowitz is the chief executive officer of the American Academy of Arts and Sciences.

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

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

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

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

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

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

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

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

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

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

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

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

The Act addresses many of the critical areas that politicians and economists alike have been discussing in recent weeks. It makes investments in clean energy that will form a solid foundation upon which to build a 21st-century low-carbon economy. It addresses the creaking infrastructure needs that are slowing down U.S. business competitiveness. It helps those most hurt by the recession, invests in education, lowers health care costs, and provides necessary funds to save vital public services at the state level.

But as outlined in the Center for American Progress report, “A National Innovation Agenda,” the Act also recognizes the importance of science, technology and innovation, which “have long provided the foundation for America’s prosperity.”

A key part of this agenda is ensuring that the United States has the innovation infrastructure necessary for it to compete on the global stage.

Getting the economy back on track is not enough unless the recovery is sustained and living standards once again rise in line with economic growth and increases in productivity. The steps necessary to achieve this were set out in the CAP report, “Progressive Growth.” A key part of this agenda is ensuring that the United States has the innovation infrastructure necessary for it to compete on the global stage. Although the United States remains the world’s most innovative economy, other countries particularly in East Asia are quickly catching up. Underinvestment in recent years has precipitated this decline.

To address this, the Recovery Act announced several critical investments, including $6 billion for broadband and wireless services, $20 billion for health information technology, $1 billion for technology improvements for a more efficient and secure government, $1 billion for education technology, and $11.7 billion for scientific research.

The stimulus proposal also includes significant funds supporting research and development efforts across the physical, environmental, and life sciences. Despite a modest supplemental boost in June, assistance here comes at a time when total budgetary authority for R&D has been dropping in real dollars; adjusted for inflation, it declined 1.9 percent overall in fiscal year 2007-2008. In biomedical research, the situation is more severe. Continuous flat funding for the National Institutes of Health has dropped its inflation-adjusted research budget to a level 13 percent lower than where it was five years ago.

The Recovery Act would allot $2 billion for NIH, the amount CAP Senior Fellow Rick Weiss recommended last October. This funding can support researchers who are working on cures for a healthier country. It can potentially help the younger generation of scientists who have been squeezed out of the NIH funding process because of the tightening budgets. Some 80 percent of grant requests go unfunded at the agency, and the competitive process favors established researchers—the average age of a scientist winning his or her first NIH grant is 42 years.

Additional funding through the National Science Foundation—$3 billion—will expand opportunities for scientists working on America’s energy and health challenges, while investing in research for the future.

But just as grantmaking agencies can create and sustain good jobs with additional funding, they also have to maintain the facilities where scientists work. Just like the highway system, much of our country’s research infrastructure needs upgrading. Chairman Obey’s bill includes construction funds to renovate existing facilities at universities and institutes and build new ones: $400 million for the National Science Foundation, $1.5 billion for NIH, $462 million for the Centers for Disease Control and Prevention, $300 million for the National Institutes of Standards and Technology, and $50 million to repair hurricane-damaged NASA facilities.

Support for basic research in the physical sciences will help maintain U.S. competitiveness in the field. While the Large Hadron Collider at CERN in Switzerland may have blown a gasket before going into operation last September, it nonetheless pulled the gravitational center of particle research away from the United States. The Recovery Act provides $1.9 billion for basic research through the Department of Energy, along with $400 million for the Advanced Research Projects Agency-Energy, which pursues potentially transformative high-risk, high return work—a critical approach that has fallen, all too often, out of federal funding favor.

As a complement to the $73 billion the stimulus package proposes for clean energy projects, the Act provides for Earth sciences research to better understand the state of our planet. This includes $400 million for NASA Earth scientists and $600 million for National Oceanic and Atmospheric Administration satellite equipment and climate modeling, which will be crucial for global warming mitigation and adaptation policy.

To help translate discoveries from lab to market, there are also funds that can support regional technology-based economic development: $100 million for NIST labs to coordinate manufacturing standards, and another $100 million for the Technology Innovation Program and the Manufacturing Extension Partnership.

As Science Progress contributors explain in several recent features on regional centers of innovation, developing prosperous regional innovation clusters yields dividends to the domestic and world economies—whether it be information technology or life-saving medical advances. Regional centers also benefit local communities by attracting a talented and high-paid workforce, cultural organizations, and start-up businesses that generate tax revenue and support the cycle of growth—all key stepping stones on the path to economic recovery.

Will Straw is the Associate Director for Economic Growth at the Center for American Progress. Andrew Plemmons Pratt is the Assistant Editor for Science Progress.

Advocacy narrowly focused on a single disease is often problematic for leaders of the NIH, because such advocacy is likely to be inconsistent with the ways science works best. Furthermore, the goals of such advocacy are often spending levels that are difficult to measure accurately. For example, research on a specific neurological disease, like ALS (amyotrophic lateral sclerosis, or Lou Gehrig’s disease), should, in principle, include basic studies of nerve cells and mechanisms of cell death, in addition to clinical trials in ALS patients, which are readily classified. The basic work may be impossible to classify by disease category, since it could help to understand many neurological diseases or others. This is where the concept of scientific opportunity comes into play: Spending funds to seize a chance to understand a fundamental principle in biology is often a more effective approach to disease than mandating funds for research on a specific disease. Furthermore, efforts to understand another disease, even one that does not affect neurons, might prove to be a more valuable means to understand ALS than work on ALS itself.

He goes on to explain examples with which he is personally familiar, including studies of breast cancer leading to a breakthrough in colon cancer research, and brain tumor research improving the understanding of breast cancer.

In context, Varmus is talking about the budgetary difficulties of balancing requests from advocacy groups, Congress, and the White House. But this is also a useful example of why support for basic research in biological sciences is important: the eventual applications of that work is not always predictable, but it is sometimes serendipidous. And that benefits everyone.

Weiss’s Notebook

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Key Science and Technology Positions

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

PAS = presidential appointment with Senate confirmation

PA = presidential appointment (without Senate confirmation)

NA = noncareer appointment

FT = fixed term appointment, with length of appointment indicated

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

Building on his previous analysis, Weiss filmed an Ask the Expert video with our colleagues at the Center for American Progress. Congress needs to step up next year, says Weiss, with a minimum of $2 billion in additional funding for the NIH so that we can reap the benefits of prior investments.

Watch Weiss:

Transcript available here.

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

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

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

Weiss’s Notebook

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

iStockphoto

In the final year of the Bush administration, social conservatives have successfully pressured the Department of Health and Human Services to propose a rule that would ostensibly protect health care workers who object to performing abortion and sterilization procedures. The catch is that there are already federal laws in place that do just that. The regulation would instead open the door to denying patients access to all sorts of potentially controversial health care services. (For a look at an earlier draft of this rule, see Jessica Arons’s Science Progress article, “Contraception is the New Abortion.”)

The rule could have a variety of sweeping effects. Among them, it could:

1. Potentially allow providers to deny patients access to contraception, end-of-life care, and fertility treatments, among other forms of treatment
2. Allow providers to withhold information essential to informed consent and to refuse to provide referrals for patients
3. Extend beyond doctors and nurses to virtually anyone in the health care system, including ambulance drivers, receptionists, claims adjusters, and custodians.

But that’s not all. The rule is indeed written so broadly that it might also protect individuals who refuse to assist with research to which they object, which could include work on stem cells funded by National Institutes of Health. The proposed rule includes this language:

Entities to whom this subsection 88.4(d) applies shall not require any individual to perform or assist in the performance of any part of a health service program or research activity funded by the Department if such service or activity would be contrary to his religious beliefs or moral convictions.

The potential for interpretations of “health service program” include the effects mentioned above, but the implications of the “research activity” have been less-discussed. Needless to say, the rule is unnecessary and poorly crafted from either perspective.

The deadline for public comments is this tomorrow, Thursday, September 25th, and they can be submitted to regulations.gov or via email to consciencecomment@hhs.gov. Let the HHS know that this is one regulation health care workers and scientists alike can do without.

Weiss’s Notebook

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

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

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

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

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

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

Game over.

But of course, not.

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

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

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

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

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

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

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

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

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

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

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

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

iStockphoto/SP

The paper describing the identification technique was published in the August 29 issue of PLoS Genetics by a team led by David W. Craig at the Translational Genomics Research Institute, also known as TGen, in Phoenix, AZ. In it, Craig and his team detail a new statistical technique that allows researchers to search through genomic mixtures that contain the DNA of more than 200 individuals and identify the presence of a single person’s DNA—even if that person’s DNA only makes up 0.1 percent of the entire mixture. They were even able to show how, theoretically, they could find an individual’s DNA in a mixture containing over 1,000 people.

This technique would be a helpful to forensics experts who usually find DNA samples at crime scenes that contain trace amounts of many individual’s DNA. Specifically, the technique utilized Single Nucleotide Polymorphism chips, or SNP chips, to detect the presence of tens of thousands of SNPs in a genomic mixture. SNP detection is usually employed to study the prevalence of certain genes and their correlation with certain diseases. Academic researchers have been using SNP chips to compile databases of human genomic variation like the one at the NIH, whereas clinicians and commercial ventures such as 23andMe and deCODEme have been using SNP chips to determine if a particular patient or consumer possesses SNPs that are correlated with certain traits or conditions. In fact, the TGen study utilized SNP chips from the companies Affymetrix and Illumina, the company partnered with 23andMe.

If this method is made more cost effective for crime labs, “it would be an amazing asset,” said Commander Brent Vermeer, director of the Phoenix Police Department crime lab in the TGen press release. For some time, one of the assumptions usually made about forensic DNA tests is that it is impossible to identify individuals from pooled data. Investigators currently utilize techniques that detect about 20 SNPs and cost about $50. The chips used in the TGen study detect tens of thousands of SNPs and cost several hundred dollars.

The TGen press release also notes a bill that was passed in June in the Arizona Senate which “requires police agencies to keep DNA evidence in cases of homicide or felony sexual assault for as long as convicts are in prison or on supervised release, or at least 55 years in unsolved cases. Some like Phoenix keep it indefinitely.”

Vermeer added in the press release, “As technology advances, we need to be prepared to keep evidence that, down the road, could prove again to be useful.”

In an email to GenomeWeb News, GPPC Director Kathy Hudson explained the legal implications: “So, the unlikely but concerning scenario is that law enforcement has a DNA sample from a crime scene, searches an NIH database, finds a match and gets a subpoena to identify what researcher provided the cohort data.”

“While a fairly remote concern, and there are some protections even against subpoena, NIH did the right thing in acting to protect research participants,” she wrote.

The larger privacy concern that led to the NIH’s new database restrictions is that this technique allows anyone with the technology to go into an aggregate genomic database and search for an individual’s particular genetic signature—if, of course you already know what that person’s genetic signature is. There have not been any breaches yet, but the NIH decided to abide by the precautionary principle and make the data available only to researchers who apply for access for a certain period of time. The NIH also confirmed that other groups, including the Wellcome Trust Case Control Consortium, and the Broad Institute of MIT and Harvard, also have removed their aggregate data from public availability.

To allay any other concerns, the NIH told GenomeWeb, “even if an individual’s SNP profile was found within a pooled dataset, all that would be learned is that this profile was contained in the dataset and, thus, it could then be associated with the characteristics of that dataset (e.g., disease or control population).”

Art Caplan offered his “Six Easy Pieces” for improving medicine and life science in a recent column. But we’re not the only science publication looking forward to the possibilities of the next administration.

Yesterday, Nature’s podcast series featured a conversation (mp3) with Science Progress Editor-in-Chief Jonathan Moreno and SP Adviser and Howard Hughes Institute President Tom Cech; they talked biomedical policy with Nature columnist David Goldston and Gail Cassel, VP for scientific affairs at Eli Lilly.

Discover magazine has also started a new Science Policy Project on its Reality Base blog. The project collects answers to the question, “What are the three most important things the next president can do to positively impact scientific research in the United States?” from distinguished scientists and policy experts from around the country. They’ve already posted responses from E.O. Wilson, Craig Venter, and SP Contributing Editor Chris Mooney.

The Scientist as well devotes its main features this week to “The Future of Science Policy.”

Look for more science and tech advice for the next president in the coming weeks here at Science Progress.

Americans get the importance of science and technology.

Because the American people are not dense. Despite all the news stories about the last-ditch efforts to keep creationism in our public schools, Americans know which side their bread is buttered on, and that side is science and technology. They can see on television that science and technology are fueling the economies of Europe and Asia. Science and technology will create the good jobs in the United States and will maintain the country’s preeminence in the 21st century. That is why the fact that our kids are falling behind the rest of the world in science literacy is viewed with alarm and a fair degree of nervous joking—Americans get the importance of science and technology.

The public also understands that solutions to some of the major challenges this nation and the entire world face—affordable fuels, global warming, controlling highly infectious diseases, growing sufficient and nutritious food, reducing pollution, cleaning up the oceans and improving transportation, all depend on science and technology. And while the public may not fully appreciate the fact that there have been breathtaking bursts of knowledge in areas such as genomics and neuroscience resulting from heavy taxpayer-supported government funding, they can easily understand that it would be foolish not to make the resources and incentives available to move this new knowledge into practical application in terms of jobs and better health as rapidly as possible.

So in the spirit of three is about as far as you can get (but cheating a little to cover all the areas I am hoping to get on the next administration’s radar) here are six things: three in health and three in science and technology that the next administration ought to argue for vigorously and fund generously during its first term.

Health

Modest but ethically important reform

Most discussions of our strained health care system focus on proposals for single-payer systems, universal health care, and the value of markets and choice. But consider this: the American health care system accounts for about 17 percent of our gross national product, and this inordinate expense is straining industrial productivity and cannot be justified in terms of what we get for our money.

Healthcare expenses affect every level of U.S. industry. For large corporations health care costs mean higher prices on our products along with massive “legacy costs” to insure retired employees. For small business owners healthcare expenses make it impossible both to hire candidates they would otherwise take or to sufficiently incentivize inefficient workers to move on, damaging productivity. Some economists maintain that as many as 42 million U.S. jobs are “susceptible” to offshoring in a future where technology allows the more efficient transfer of jobs and employee health care costs are far less.

As nearly every politician recognizes, something must be done. But the new administration needs to understand that a drastic overhaul of the gargantuan, money gobbling, bloated mess that passes for American health care is not going to fly. There are just so many stakeholders in the hugely inefficient, highly inequitable, but incredibly lucrative broken system that we now have to change it quickly.

The new president should talk boldly but move slowly. Praise the drive toward some day achieving universal coverage, but accelerate change by focusing political momentum on children—the group most likely to command ethical empathy across the political spectrum. The new administration should come up with a proposed basic package, including dental, hearing and eye care, for every American child. Prenatal and post-natal care for every mom ought be there as well.

Of course we need universal coverage for basic health care, but the place to start in practical terms is with those under eighteen years of age. Millions of American children lack health insurance. Not only do they deserve it, but they are the moral key to insuring the rest of us. Show success with kids and the rest will follow.

Stem cell research is great but…

Way, way too much political energy has gone into the embryonic stem cell issue. Working with embryonic stem cells is a very exciting area of biomedical research but it is hardly the only area; nor is it the one that will have guaranteed practical payoffs any time soon. All the new president needs to do is flip the Bush administration restrictions on federal funding, which are inconsistent and wildly unpopular; gin up a new federal panel at the NIH to make sure that oversight of all stem cell research is comprehensive, including all early animal and human trials public and private, transparent, and standardized among the states; put some Federal money into the pot; and get out of the way. The stem cell scientists—adult, fetal, embryonic, induced, and cloned—will take it from there.

America needs much more funding of basic research in genomics, proteomics, and bioinformatics. The “ics” hold the future in terms of mining the little we now know about a whole lot of genes. Without that investment, we will be stuck with half-witted, premature schemes to map our individual genomes—what we can call spitomics—spit-in–a-cup DNA testing. This rapidly growing sector is riding an ill-grounded wave of hype that makes weak, next-to-useless correlations between gene markers and disease states without really having much idea what to tell its customers to do about the risk information that testing companies find.

Fix public health

Our public health system is a wheezing, uncoordinated, underfunded eyesore. It needs to be rebuilt to face the challenges that 21^st century living poses to health, ranging from asthma, to diabetes, to the flu. City and county health departments need federal help across the board. Proactive public health is a key element of our national security. The next administration should demand that Congress pay for it.

So how are we going to fund all this glorious new research? In reality the price tag is not all that big—we hardly spend very much now as a percentage of gross domestic product on basic research in health, technology, and science, especially if you don’t count defense related research. But for those who want a new idea as to funding, here is a bonus suggestion for the next president: It is time to revisit the National Institutes of Health and National Science Foundation budgets and see whether a twist on the Bayh-Dole Act that gives universities incentives to work with industry makes sense.

The NIH budget does not grow in hard times. Congress won’t go there in times of deficit. Private companies wait to see what tax-payer funded basic research looks promising and then develop that, only to sell it back to the taxpayers (you and me) who originally funded the work at high prices. So why not put a 3 percent tax on all products that are generated from NIH, NSF, or other government-sponsored basic research? Keep the core budget there and adjust it to rise in response to inflation, but let American science and the American people really benefit from breakthroughs. In that way the incentives are there to translate basic research into practical products, while at the same time allowing the NIH budget to grow more rapidly without having to whine for more money from Congress every year. Here is a real incentive to universities, think tanks and academic scientists—make real and useful breakthroughs and watch your budget for future research grow!

Science and Technology

A New Push in Agricultural Research

We need safer, healthier food that has far less of a footprint on the environment. Science and technology can help but we need presidential leadership to get us there. To reduce the burden of chemically based farming that depends on fertilizers, herbicides, pesticides and huge amounts of irrigation, we need to apply the genetic revolution to agriculture. Let’s break the link forged by big agribusiness between the “old” chemically based agriculture and genomics and drive forward with a biology-based agriculture that uses genetic knowledge to screen foods and insure their safety; engineers them to make them heartier, more healthful and less oil and chemically-reliant; and creates the next generation of creative farming in cities, estuaries, empty government lands and national forests. And, for those who see creative possibilities in new forms of organic farming and alternative modes of agriculture— working to achieve the “natural” control of pests, better pollination through diversity and using less water through better soil management—give them a bit of money to let them show what they can do as well.

Clean Water

The president needs to understand that clear, drinkable water is going to be a major political issue both in this nation and worldwide very soon. If we have the technology in place to use less, to get more from the oceans, to recapture more from our current industry and farming uses, and ways to identify, track and get rid of microbial pollutants in lakes, rivers, and oceans, we will hold a key foreign policy card. Nanotechnology, micro-sensing technology, better semiconductor technology, and even improved synthetic biology are the tools to get us where we need to go. We just need a president committed to getting us there. If the new president wants to make fast friends in China, the Middle East, India, and Africa he could do worse then by promising to fund and share the science that will lead to more clean water.

Synthetic Biology

The next president and his administration can’t let human hubris about how wonderful our bodies and genes are fool them. We love to think that it is the science of human genetics and human biology that holds the key to our better future. But the fact is, microbes are usually easier to work with than human beings, and are just as useful for making gains in human health, well-being, safety, and security. That means the government should put more money into research in synthetic biology aimed at fighting diseases, making synthetic fuels, eating pollutants, cleaning the oceans and our arteries. As HIV and pandemic flu show, you cannot ever underestimate a microbe. By developing the microbial and synthetic biological science to manipulate these tiny critters, the next president can go a long way toward solving a host of our current headaches.

Keep It Real

In health care and in science and technology, the new administration can make a huge difference by keeping its eye both on what is practical and what is likely to provide the greatest return on investment. These have not always been the watchwords of health and biomedical science policy in the past. There is no need for administrations elected on a promise of “change” to let history repeat itself in the future.

Arthur L. Caplan, PhD is an adviser to Science Progress and the Emanuel and Robert Hart Professor of Bioethics, chair of the Department of Medical Ethics, and director of the Center for Bioethics at the University of Pennsylvania.

In 1998, about 32% of NIH competing Research Project Grant applications were successful; by 2007 the comparable success rate had declined to 21%. The percentage of NIH awardees aged 40 or under, already less than 23% in 1998, declined to just over 15% by 2005. Some of the reasons are well understood: First, adjusting for inflation, the value of the NIH budget has declined by about 13% from its peak in 2003. Second, the rapid annual increases from 1998 to 2003 were followed by 5 years of small annual decreases.

But Teitelbaum points out that the number of applications each year for grants has nearly doubled in the last ten years, due to the strengthening of the scientific research core as a whole between 1998 to 2003, when NIH funding was increased by 6 percent annually. He also argues that “when the increases from 2003 onward proved to be smaller than 6%,” the government undercut the benefits of the original increases. “In financial terms,” he writes, “one might say that the system became more highly leveraged, rendering it more vulnerable to unanticipated downward deflection of the increase in federal research funds.”

The article points out that this vulnerability may be due to the unique characteristics of the scientific job market: In many fields, when the demand or salary for a particular job decreases, so does the number of graduates seeking the job. Biomedical research does not follow this ebb-and-flow pattern, in part because international scientists can fill the slots. Moreover, some instability in funding streams results from use of NIH grant funds to pay for medical research facilities built on credit, as well as use of grant funds to pay for professor salaries.

Therefore, Teitelbaum argues that the problems at the NIH face are fundamentally “structural in nature” and “can be addressed only at the level of policy and administrative practice by the Congress and NIH itself.” He suggests that the NIH’s Office of Extramural Research could convene a panel to craft policies that would smooth out funding policies to counteract this vulnerability to boom-and-bust cycles.

He also acknowledges that “it may be possible to create broad political support for large annual NIH funding increases into the indefinite future.” CAP Senior Fellow and Science Progress adviser Tom Kalil has argued that Congress should again double the NIH budget by increasing funding 10 percent each year for ten years. Better oversight of internal funding decisions to counteract these “structural disequilibria” would only make that funding work harder for scientists and the American people.

While this additional funding represents a step in right direction, the additional $150 million sent to the NIH with the passage of this supplemental bill falls woefully short of the annual 10 percent, or $2.59 billion, increase that is necessary to support critical biomedical and health research. The Bush administration has held the NIH budget flat for five years, and inflation has eroded the agency’s purchasing power. In order to truly bolster work that improves our country’s health, grows our economy, fuels the development of renewable energy technologies, and supports basic research, R&D funding for several key agencies should be set on a 10-year doubling course.

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 Center for American Progress has proposed doubling the research and development funding for key federal agencies to bolster work that improves our country’s health, grows our economy, fuels the development of renewable energy technologies, and supports basic research. This doubling would take place over a 10 year period, with 10 percent annual increases. The FY2008 budget passed by Congress and signed by the President fell short of those 10 percent increases. So how does the money for the Iraq war compare with spending on R&D at these key offices, and how much of that war funding would we need to reallocate to set those offices on a doubling path?

$28,700,000,000: National Institutes of Health R&D budget for 2008, a 0.9 percent increase over 2007.
$2,586,000,000: Supplemental amount needed to boost FY2008 NIH R&D budget to 10 percent increase.
4.7: The numbers of years the NIH R&D could be funded at its current 2008 levels with latest Iraq war request.

$4,500,000,000: National Science Foundation R&D budget for 2008, a 1.1 percent increase over 2007.
$399,000,000: Supplemental amount needed to boost FY2008 NSF R&D budget to 10 percent increase.
30: The number of years the NSF R&D could be funded at 2008 levels with latest Iraq war request.

$4,000,000,000: Department of Energy Office of Science budget for 2008, 4.6 percent increase over 2007.
$166,000,000: Supplemental amount needed to boost FY2008 DOE Office of Science R&D budget to 10 percent increase.
33.9: The number of years the DOE Office of Science could be funded at 2008 levels with latest Iraq war request.

$514,000,000: National Institute of Standards and Technology R&D 2008 budget, 4.7 percent increase over 2007.
$23,400,000: Supplemental amount needed to boost FY2008 NIST R&D budget to 10 percent increase.
263.5: The numbers of years the NIST R&D could be funded at 2008 levels with latest Iraq war request.

$6,476,400,000: Department of Defense R&D 2008 budget, 0.9 percent increase over 2007.
$72,380,000: Supplemental amount needed to boost FY2008 DOD R&D budget to 10 percent increase.
21.9: The number of years the DOD R&D could be funded at 2008 levels with latest Iraq war request.

$3,246,780,000: Total supplemental amount needed to boost FY2008 funding for these five key agencies to 10 percent increases.
2.4: Percentage of the $135,421,191,000 supplemental request this boost would require.

Funding Medical Research

Funding for the NIH has been flat for four years; accounting for inflation, the Institutes have lost 6 percent of their purchasing power during that time.

37,275: Total number of NIH research grants in 2007.

$403,528: Average size of each NIH research grant in 2007.

335,593: Number of additional average-sized NIH grants that Iraq war funding in the supplemental could finance.

Energy

The Center for American Progress has more information how the $600 billion spent since the start of the Iraq war could fund critical energy research.

Peter Suber has a brief history of the movement for OA policy at the NIH at Open Access News. He hails it as a milestone: “implementation day for the world’s first mandatory OA policy demanded by the national legislature, at the world’s largest funder of scientific research.”

Harold Varmus, Co-Founder of the Public Library of Science and the former Director of the NIH, explained some of the benefits of the move for biomedical research publishing in an editorial at PLoS Biology:

Since NIH-supported investigators publish about 80,000 papers each year, many of them in journals that currently do not contribute their articles to PMC, the library will soon grow at about twice its already impressive rate. With an enlarged PMC, the virtues of full-text searches and ready access will be more obvious, encouraging still greater participation by authors of work not funded by the agencies that mandate deposition. As we all know, scientists want their work to be found, read, and cited.

Andrea Gawrylewski at The Scientist News Blog covers the controversy the policy has ignited in some corners of the scientific publishing community.

Gavin Baker explained the details of that argument and the public benefits of open access for scientific research in his January Science Progress column, “Public Science.” Full information is available at the NIH.

The plea for increased funding highlights some of the problematic internal mechanics of the Institutes. Among the issues: the constant focus on grant writing means that high-risk, high-return research does not get much support; and younger, less-seasoned investigators are leaving the labs because their proposals are less likely to get funded.

Greg Laden points out that while the almost decade-long push to increase the number of young investigators in biomedical research has been a good thing, the stagnant funding means that there are fewer dollars per scientist. In spite of their promising research, the new studies says, the average age of first-time recipients of the top-teir RO1 grants has risen from 39 in 1990 to 43 in 2008.

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.