As you meander through the posters at ARVO, it's easy to become ensnared in and impressed with the minute details of the studies. That's why it's disturbing to see some of the reports and opinions of those whose perspective rises above the bench or the lab to a more global view of research in the United States and the challenges—in some cases, crises—the medical research community faces.

In the short-term, this year's recently approved federal budget appears to break with the much-touted five-year plan to double the NIH's budget. The American Medical News reports that, accounting for inflation and leaving aside money earmarked for bioterrorism research, this year's NIH budget may not contain any real increase, and could mean reduced grant duration and amounts.¹ The longer view is even more troubling.

Much has been made of the potential for medical breakthroughs following the announcement of the sequencing of the human genome. Not as publicized, however, is a growing concern over the efficacy of the research and product development system in this country and elsewhere, and its inability to match advances in basic science with products that improve patients' health.
In pharmaceuticals, for example, basic-science research has raised the number of drug targets from 500 to more than 5,000 in recent years.²

Yet, in many ways, that exponential increase in basic-science knowledge is hindered by inefficient back-end product development systems in place and essentially unchanged in decades. Because of that inefficiency, a medical compound entering clinical trials today has an 8-percent chance of reaching the market, down from the traditional 14-percent batting average, according to the FDA. It's not hard to see where all the R&D money goes. Even a 10-percent improvement in the ability to predict failures before clinical trials could save $100 million in development costs for one drug.³ The same issues bedevil medical device developers.

On the plus side, the agency recognizes the problems and spells them out, along with the prospects for addressing them, in a new white paper available at the link below. Anyone with an interest in the future of medical research will find it eye-opening.

1. AMNews. Feb. 9, 2004.
2. Cockburn I. The Changing Structure of The Pharmaceutical Industry. Health Affairs 2004;23;10-22.
3. Challenge and Opportunity on the Critical Path to New Medical Products. U.S. Department of Health and Human Services, Food and Drug Administration, March 2004, available at
www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf.