NIH Launching $2B, 5-Year Initiative To Increase Participation in Medical Research

Specific Goals
There are 28 initiatives under the roadmap (Boston Globe, 10/1). Under initiatives included in the roadmap, NIH will:

• Create "cross-disciplinary" research centers through which teams of experts from various specialties will work together to update the "centuries-old" research model, where scientists work alone or in small teams on "narrowly focused problems," the Post reports;
  
• Expand and decentralize human clinical trials so that family doctors and their patients can participate;
  
• Develop a medical dictionary that could be used by all federally funded research programs, rather than the current 17 different medical dictionaries used by such programs (Washington Post, 10/1);
  
• Create a picture gallery of the three-dimensional structure of all proteins in the human body, which are thought to be linked to some diseases;
  
• Create a "public collection" of hundreds of thousands of chemical compounds that scientists could test to speed up new product development, the Times reports;
  
• Catalog the "intricate networks" that disperse information between genes, molecules and cells, the Times reports. Some scientists believe that disturbances in this information sharing can cause disease (New York Times, 10/1);
  
• Standardize regulatory requirements for patient studies, which differ from hospital to hospital, so that researchers follow the same guidelines (Neergaard, AP/Miami Herald, 10/1);
  
• Create five-year, $500,000 grants for some scientists to pursue "bold ideas that have a high risk of failure" but also could produce "important results" if successful, the Baltimore Sun reports. The NIH will award 10 such grants in the first year of the plan (Bor, Baltimore Sun, 10/1);
  
• Remove some of the regulations researchers must follow in clinical trials, such as establishing a standard patient-consent form; and
  
• Establish a liasion office to initiate and expand collaborations among private and public researchers (Boston Globe, 10/1).
  

'Potentially Controversial' Initiatives
Two of the initiatives under the roadmap are "potentially controversial" -- one that would encourage more public-private partnerships and one that would "streamline" federal clinical trial requirements, the Times reports. Some members of Congress have "expressed concern" over arrangements in which private and public entities work together on medical research, because they say that previous NIH collaboration with private companies has allowed the private sector to "reap large profits" from research conducted with public money, according to the Times. Sen. Ron Wyden (D-Ore.) said when the government invests in drug development it must "get an adequate return" and ensure that patients can afford the final product, the Times reports. Some members of Congress also have said the federal government has not adequately overseen or regulated certain types of research, including gene therapy (New York Times, 10/1).

Reaction
Zerhouni said, "This is truly not business as usual. We believe there are opportunities to revolutionize the way clinical research is done in this country" (Boston Globe, 10/1). The Journal reports that universities and patients groups expressed support for the plan because it addressed "important areas not likely to be tackled by individual NIH institutes," which often focus on specific diseases (Wall Street Journal, 10/1). Sen. Arlen Specter (R-Pa.) called the plan "spectacular," adding that the NIH officials are "fundamentally reorganizing the way they attack dreaded maladies, reengineering clinical research and developing new pathways to discovery" (New York Times, 10/1). Dr. Alan Leshner, CEO of the American Association for the Advancement of Science, said, "I think the average person may not tomorrow see an effect. [But the NIH Roadmap is] laying out an important vision for where biomedical science can and will go, and how to ensure that gets translated into real life improvement in the health of the American people" (AP/Miami Herald, 10/1). Dr. Michael Klag, vice dean for clinical investigation at Johns Hopkins School of Medicine, said, "The plan for clinical research really hits the nails on the heads. The issues that people think are important are all in here" (Baltimore Sun, 10/1). Some industry insiders noted that the NIH is "under growing pressure" to produce results. "Like it or not, with all the money pumped into the NIH, the public is eager to see some practical benefit," David Korn, senior vice president of the Association of American Medical Colleges, said (Wall Street Journal, 10/1). The agency has a $27 billion annual budget. Other experts noted that the plan could falter if the NIH budget does not continue to grow at its current pace. Congress is currently considering a 2.5% to 3% NIH budget increase for fiscal year 2004, a "far cry" from 15% increases in recent years and the 8% to 9% increase advocates have called for, the Post reports (Washington Post, 10/1). Steven Hyman, provost at Harvard and former director of the National Institute of Mental Health, said the proposed changes would be welcome but that large research collaborations could become "unwieldy and expensive" at a time when the NIH's budget may not be able to handle it, the Globe reports (Boston Globe, 10/1).