As Congress debates a major economic stimulus package, investment in energy research is high on the agenda. While this promises benefit to our economy and security, it highlights the value of reinvigorating our investment in another area of science -- biomedical research.The wealth and health of the nation can be measured in breakthroughs in the treatment of heart disease, AIDS and cancer, high quality jobs, and profitable industries. A recent report from the UK suggested a return on investment in biomedical science of 40%. So far, the US has managed to sustain its pre-eminence in biomedical research. Research publications and patent filings suggest our continued (though narrowing) leadership in innovation, our research universities continue their dominance of the global rankings, and the US remains the leading site of research conducted by pharma and biotech. But both the academic and industry sectors of our biomedical research enterprise are highly vulnerable. The...
and security, it highlights the value of reinvigorating our investment in another area of science -- biomedical research.The wealth and health of the nation can be measured in breakthroughs in the treatment of heart disease, AIDS and cancer, high quality jobs, and profitable industries. A recent report from the UK suggested a return on investment in biomedical science of 40%. So far, the US has managed to sustain its pre-eminence in biomedical research. Research publications and patent filings suggest our continued (though narrowing) leadership in innovation, our research universities continue their dominance of the global rankings, and the US remains the leading site of research conducted by pharma and biotech. But both the academic and industry sectors of our biomedical research enterprise are highly vulnerable. The budget of the National Institutes of Health (NIH) has declined by more than 10% in real terms over the past 5 years. Most strikingly, initial success rates for grants that mark scientific independence have dropped into single figures and the average age of first recipients is now in the mid forties. Ironically, just as other countries invest in science and base their funding strategies on the NIH, our system is reverting to the model previously prevalent in Europe and Japan: aging leadership and indentured scientific servitude of the young. Given the increasing options elsewhere, our restrictive visa policy post 9/11 and the cultural legacy of the Bush years, our workforce is vulnerable. Just as China finances our economy, it also provides much of the human capital that sustains our biomedical research enterprise. Both forms of support are vital, yet mobile.Many large pharmaceutical companies are, for now, cash rich and casting around for acquisitions. However, just like the auto industry, their current business model is unsustainable.The number of new drugs approved by the FDA has fallen linearly from 53 in 1996 to 17 in 2007, the same number as in 1983. A slight bump upwards to 21 approvals in 2008 includes 3 drugs eventually approved on reconsideration and 3 radiocontrast agents. In other words, it doesn't buck the trend. This coincides with downward pressure on drug pricing. The growth in prescription drug sales -- 10% of the $286.5 billion US healthcare budget in 2007 -- had plummeted even before the present crisis: generics now account for roughly 60% of the market and are rapidly growing in market share. Pharma has reacted by shedding jobs in the US -- more than 100,000 over the past 5 years -- and moving research to join drug production in lower cost economies overseas. Anticipated future revenue for the industry has shifted dramatically towards Asia. The current crisis is likely to accelerate these trends.As pharma conserves its resources, it becomes less likely to extend credit to the academic sector -- a source of funds for biomedical research complementary to the NIH. Indeed, the same political factors that will depress drug prices are likely to drive down Medicare reimbursements to our major academic health centers. This will be compounded by the dramatically shrinking endowments, both of our universities and the charities that support biomedical research.Given these interacting pressures, how might a portion of the stimulus package be used to reinvigorate the enterprise?- Restore funding for the NIH. The new director must have resources to fuel innovation by individual investigators and invest in infrastructure -- including the national integration of healthcare information systems -- to allow universities translate the fruits of basic discovery into clinical benefit. Welcome as the stimulus money will be, it is a 2-year injection of resources. It can best support research programs and preserve jobs by providing bridge funding for those many grants now funded on the second round of review. Restoration of programmatic stability will require an increase in year - on year funding for the NIH. The touted funding of 1500 2 year R01 project grants by April would be a foolhardy Procrustean response to the constraints of stimulus funding.- Accelerate this translational process by integrating strategically the disparate missions of the NIH and the Department of Health and Human Services -- particularly its Agency for Healthcare Research and Quality and the Food and Drug Administration (FDA).- Introduce a more graded process of drug approval and withdrawal. Use this reform specifically to reward innovation and to foster the progressive personalization of medicine. Fund programs that foster interaction of the FDA with academia. This would afford FDA scientists access to critical mass in emerging sciences. It would also provide a neutral testing ground where unanticipated concerns or opportunities relating to drugs, before or after their approval, might be pursued -- something of a Jet Propulsion Lab for the FDA.- Incentivize both the academic and industrial sectors to reform outmoded restrictions on intellectual property. These are configured on unrealistic expectations and impede the evolution of a modular interaction between the sectors as a drug moves from discovery through development.- Finally, foster the re-engagement in science of American youth. Develop integrated programs from grade school to graduate school. Develop training programs that blend traditional disciplines both for "blue skies" research and for development of new therapies. Reinvest in the programs that had accelerated the time for visa approval for visiting scientists. Develop strategies, just like our competitors, to recruit and retain top talent from abroad.Garret FitzGerald directs the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania and serves on the Peer Review Advisory Committee of the NIH and the Science Board of the FDA.
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