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At 81st ACD Meeting
Budget Was a Struggle, But New Center Plans Are Clear

By Rich McManus

Way back in the last millennium — say, about a month ago — NIH acting director Dr. Ruth Kirschstein convened the 81st gathering of the advisory committee to the NIH director amid great uncertainty over the FY 2001 budget, which was then more than 2 months overdue. But that was just a passing cloud on an agenda that included much that was crystal clear: NIH guidelines on sharing of research tools are gradually gaining acceptance, NIH's "Results Act" report card gained first honors, the nation's blood supply is "amazingly safe," the new National Center on Minority Health and Health Disparities has a man and a plan, and the ACD's recommendations on consensus development conferences have a new science-based confidence.

The President had asked for a 5.6 percent increase in NIH's 2001 budget, and Congress, intent on its goal of doubling NIH's appropriation within 5 years, wanted to keep NIH on track for this goal — now in its third year — by adding 15 percent. But after extensive negotiations between the President and Congress "largely on issues having nothing to do with NIH," a vote on the NIH budget hadn't come up as of the Dec. 7 ACD meeting.

"We've made some wonderful plans, but at the moment they are all basically on hold," said Kirschstein. Because of election indecision, the request for the NIH FY 2002 budget was also delayed until a new administration takes office, so Kirschstein cautioned that budget hearings for the spring would undoubtedly be pushed back.

Reporting on how well the world has welcomed year-old NIH guidelines on the sharing of research tools was Dr. Maria Freire, director of the Office of Technology Transfer, who said that despite international interest in the recommendations, she is concerned that many scientists are as yet unaware of them. She debunked a variety of myths about the principles NIH is promulgating, including that they discourage patents, prohibit exclusive licensing, undermine commercialization and harm small biotech companies. "Hopefully, we are putting these concerns to rest," she said.

She noted that problems remain in sharing between for-profit and not-for-profit institutions — "All agree that problems of negotiation persist," she said. Committee member Dr. William Brody, president of Johns Hopkins University, said there is incredible pressure on his institution to transform ideas into industry, but it doesn't come from his board. "It comes from the governor and from the mayor. Almost weekly, I get calls asking me, 'What new links are you forging with industry?'"

Dr. Lana Skirboll, NIH associate director for science policy, summed up NIH's straight-A report card, required by the Government Performance and Results Act, in 55 areas, noting that NIH has a pluripotent capacity to provide evidence of its success: "I asked the Office of Management and Budget, 'Do you want our accomplishments in a notebook, a briefcase, a wheelbarrow, or a truck? I can give it to you any way you want."

The glowing report, not formally due until this month, was no surprise to advisor Rebecca Eisenberg, a professor of law at the University of Michigan. "The results of these kinds of surveys are often a no-brainer. Isn't there some way we could tap the expertise [of the blue-ribbon panel that collected information for the GPRA report] for double-duty?"

Certainly the most amusing, as well as inspiring and ultimately consequential, report came next from Dr. Harvey Alter, cowinner of the 2000 Lasker Award for clinical research. Embellished by slides, poetry, philosophy, comedy and science, his account of almost 30 years of study that has resulted in virtually eliminating the risk of hepatitis C from the nation's blood supply had something satisfactory for everyone. A member of the Clinical Center's department of transfusion medicine for virtually his entire career, he credited NIH's open and collegial atmosphere with allowing him to follow serendipity, an excellent mentor (Nobel laureate Dr. Baruch Blumberg) and his own dogged persistence along the trail from discovering what was known as the Australia antigen (later known as the hepatitis B surface antigen) through indirect characterization of what later turned out to be the hepatitis C virus.

"I am very privileged to have spent almost my entire career at NIH," he said. "It was easy to foster collaborations — you didn't need any CRADAs or MTAs in those days, you just did it. Long-term studies with unpredictable outcomes were allowed to go on; most of what we were doing probably wouldn't be funded on the outside. NIH has been an incredible place for me to work."

He described two routes to total elimination of hepatitis C virus from the blood supply — one relying on detection of nucleic acids, the other on an inactivation process using the chemical psoralen plus ultraviolet A light. As it stands, the risk of acquiring HCV via transfusion is now 1 in 350,000; the risk of HIV is 1 in 1 million; and the risk of hepatitis B is 1 in 109,000, he reported.

Next, Dr. John Ruffin, NIH associate director for research on minority health, walked the advisors through S. 1880, the Senate bill that on Nov. 22 authorized creation of the National Center on Minority Health and Health Disparities. As director-designate of the new center, he explained the bill's particulars and how NIH will construct the center.

"In all reality, we've had about 10 years to think about how to run such a center," said Ruffin, who has headed the Office of Research on Minority Health since it was created in 1990. The center's main priority is health disparity research; unlike ORMH, it will have authority to conduct and support research and training activities.

"The focus is on racial and ethnic minorities," Ruffin explained, "and the medically underserved, including poor whites living below the poverty line in rural Appalachia, for example."

The NCMHD must craft a strategic plan and budget in its first year, a process Ruffin says is crucial to the center's usefulness: "If we do this right, we'll be successful in the long run. We've gotten out of the blocks very fast on this."

The center will not only collaborate with all institutes and centers, it will also have formal ties to NIH's Office of Behavioral and Social Sciences Research (which will have a permanent seat on its advisory council) and the Agency for Healthcare Research and Quality, which will help assess which populations suffer health disparities.

The center's proposed appropriation in FY 2001 is around $117 million, or about $20 million more than funded ORMH in FY 2000. Although plans require final clearance by the department and Kirschstein, Ruffin said the center would have an OD, and divisions of research, community based research and outreach, and scientific planning and policy analysis.

Dr. Cecil Pickett, executive vice president for research at Schering-Plough Research Institute, who is one of six new ACD members, threw Ruffin a fastball: "I'm of the opinion that throwing more money at this problem isn't going to solve it." Ruffin assured him that, as an extension of the research clout of the IC's, the new center "can make things happen faster" in narrowing health disparities.

Another newcomer, Dr. David Burgess, professor in the department of biology at Boston College, asked, "Can even $20 million [in new money] make a dent in the indices of disparity?"

Unruffled, Ruffin replied, "If we're really friends with the IC's, the money will start flowing to us from them, rather than always from us to them. Then we can really start making progress."

Quipped Kirschstein, noting her long-term interest in this topic over the course of a lengthy NIH career, "The only thing I don't know how to do is print money."

The last speaker on the agenda, Dr. Barnett "Barry" Kramer, director of the revamped Office of Medical Applications of Research, gave an overview of the office, including more sophisticated criteria for sponsoring consensus development conferences. Asked whether the conferences, which aim at influencing physicians' behavior, actually affect medical practice, Kramer was quickly defended by Dr. Yank Coble, a Jacksonville, Fla., physician who serves on the ACD: "They're called consensus development conferences, not consensus finalization conferences...I've been involved with them for 20 years and I can tell you that I find them extremely valuable."

In other news, Kirschstein anticipated naming new directors of the National Eye Institute and Office of Equal Opportunity soon. Also, new legislation on children's health, passed on Oct. 16, mandates a pediatric research unit within the Office of the Director, with oversight on such topics as autism, fragile X syndrome, juvenile arthritis and diabetes, and other illnesses. In addition, the Public Health Improvement Act, a consolidation of some 10 different bills (many addressing emergency threats to health) passed in November, gives NIH research directions, but is not tied to any appropriation process, "leaving it hanging there to be done," noted Kirschstein. Lastly, members of a new human stem cell review group will soon be named; the group will report to the Center for Scientific Review. OSP director Skirboll said NIH does expect some stem cell research applications on the next receipt date of Apr. 15, 2001.

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