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NIH announces $2b initiative to aid research

WASHINGTON -- The National Institutes of Health promised yesterday to speed up the search for treatments, drugs, and cures for diseases through a $2 billion initiative designed to broaden participation in medical research and encourage innovative approaches.

Spurred by the completion of the Human Genome Project in April and the wealth of scientific data it has provided, NIH plans a five-year push to create networks of information and research partnerships. The initiative will include a drive to remove regulatory barriers in an effort to accelerate the pace of medical discoveries. Dr. Elias A. Zerhouni, the NIH director, called it "a completely new vision" for medical research.

"This is truly not business as usual," said Zerhouni, who was a dean at Johns Hopkins University School of Medicine in Baltimore before taking the NIH post last year. "We believe there are opportunities to revolutionize the way clinical research is done in this country."

Zerhouni acknowledged that the NIH plan could present "a real challenge" to university biomedical centers accustomed to competing for the best minds and largest grants and jealously guarding their research. He said there will be opportunities for the medical centers to grow under the plan, which has 28 initiatives that will cost $130 million next year.

The plan, called The NIH Roadmap, was developed over 14 months with help from more than 300 consultants in industry and academia. Specific steps to be taken include encouraging scientists to collaborate and share their findings, involving more doctors in medical research, paying closer attention to patient-advocate groups, and rewarding researchers who think outside the box.

Zerhouni told reporters he would not rule out a restructuring of NIH, the federal government's primary agency for conducting and funding medical research. With its $27 billion budget and 27 institutes and centers, NIH has been criticized for moving too slowly and focusing too little on rare conditions and too much on more widespread diseases like cancer.

The goal, he said, was not to shift NIH away from basic science, but to transform it, by conducting more research across scientific disciplines at the institute's campus in Bethesda, Md., and engaging more community-based physicians to conduct clinical studies. Currently, he said, only 3 percent to 4 percent of cancer patients and 1 percent of people with Parkinson's disease are enrolled in clinical trials.

To encourage creative thinking, Zerhouni said, NIH would offer 10 "Innovator Awards" of $500,000 annually for the next five years to scientists engaged in the kind of "high-risk" research that NIH usually avoids but could result in major breakthroughs.

Another goal is to make scientific data more accessible to researchers outside the agency through new NIH-funded biomedical computing centers and molecular libraries. Dr. Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said a scientist studying osteoporosis could use such a library to screen a gene against one million molecules that might "turn it on" to produce new bone material in a patient.

Dr. Stephen Straus, director of the National Center for Complementary and Alternative Medicine at NIH, cited the creation of a Department of Systems Biology at Harvard Medical School last week as an example of how researchers are beginning to look at whole organisms rather than genes or cells for understanding how new drugs or therapies might work in humans.

Straus, who appeared on the NIH panel with Katz and Zerhouni, said the agency is planning to create a liaison office to initiate and expand collaborations among government-funded researchers and private biotechnology companies and pharmaceutical manufacturers to speed up the development of drugs and treatments.

Katz said NIH would look to patient-advocate groups for more comments on its research agenda, and he cited the Cystic Fibrosis Foundation as an example of a group that worked closely with medical researchers to develop drugs and to increase the life expectancy of patients with the disease.

NIH also hopes to ease the regulatory burden on researchers, particularly regarding human subjects in clinical trials. One way would be a standard patient-consent form to replace the different ones that each university and medical center now require. Katz said it would take "an enormous amount of work" to get academic medical centers, which value their independence, to "buy in" to many of the NIH proposals.

Steven E. Hyman, Harvard's provost and a former director of the National Institute of Mental Health, said he would welcome some of the changes, but he warned that shared infrastructures and large collaborations can become unwieldly and expensive. And, he said, the proposals are being offered at a time when NIH's budget is growing very slowly.

"You can get too much into a Manhattan Project frame of mind," Hyman said.

"The backbone of American science is the individual investigator, sending his best ideas in for review," he said. "Centralized, planned science carries big risks. It doesn't always work out, and the price tag is big."

Daniel Perry, executive director of the Alliance for Aging Research, a patient-advocacy group, praised Zerhouni for his goals, but said the political realities of the slowly-growing NIH budget, after several years of rapid growth, and the Bush administration's limitations on stem-cell research, put NIH "in a complete straightjacket in one of the most promising areas of medical research."

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