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80th ACD Meeting
Shalala Gives Advisors Frank Summary of Current Events

By Rich McManus

On the Front Page...

HHS Secretary Donna Shalala dropped in on the 80th meeting of the advisory committee to the NIH director on June 8 to offer encouragement and congratulations on a variety of topics including the FY 2001 budget, NIH's effort to bolster oversight of human gene transfer, the progress of the Human Genome Project, and NIH's initiative to reduce health disparities. She also expanded upon and applauded President Clinton's decision, announced that morning, to extend Medicare coverage to participants in clinical trials, and answered questions in a relaxed and freewheeling session. "You've had me as candid as I've ever been," she enthused at the end of a visit in which she also announced her intention "to leave NIH in the best shape this institution has ever been in."


With respect to NIH's next budget, Shalala counseled patience: "The budget process is nowhere yet...We'll negotiate the whole thing in the fall in some smoky room, but at the end, NIH will be satisfied with the mark." She explained, "I've learned that politicians were those people who in college crammed the night before the final exam."

She said NIH has made "enormous progress — I couldn't be more pleased" with steps taken to improve the quality of oversight in clinical trials involving gene therapy. "We have put an enormous amount of money into NIH, and all of it is at risk from a series of incidents...Cumulatively, they look like a pattern to the public, while to us it may look like an acceptable amount of risk." To address shortcomings, her office on May 23 announced a new series of protections for human research subjects, and on June 6 she announced the appointment of a new director for the Office of Human Research Protection, which supersedes (and lifts out of NIH into the Office of the Secretary) the Office of Protection from Research Risks. "We need a much more refined office, not just one that closes down institutions and gives them a slap on the wrist."

Shalala predicted that Medicare's readiness to pay medical expenses associated with clinical trials will "coax millions more participants into research trials," and estimated a cost for the program of some $350 million.

Vowing to finish up her term as secretary "with a lot of enthusiasm," Shalala said a new office of oversight of scientific fraud is set to open with "an absolutely first-rate" person as director. She said NIH "is taking seriously the issue of health disparities," noting, "We can have the best health care in the world, but it isn't sufficient if it doesn't reach every one of our citizens. Insurance does not equal quality health care."

She said she "couldn't be happier with the Human Genome Project," adding that she gives a copy of The Double Helix to anyone who mentions the controversy between publicly funded and private genome hunters.

Asked by Dr. William Brody, president of Johns Hopkins University, how financially distressed academic health centers around the country can solve their problems, Shalala embarked on a frank discussion of political values and economic realities. Her busy schedule, however, overtook the debate and she left to a standing ovation (she had served on the ACD from April 1991 to January 1993). "Madame Secretary, we want to thank you for 7 ½ wonderful years," said NIH acting director Dr. Ruth Kirschstein.

The 15 of the 18 advisors who were on hand heard presentations on several topics:

  • Dr. Alexa McCray of the National Library of Medicine gave an update on NIH's new clinical trials database, which debuted on Feb. 29. "Response has been incredible," she said. The web site has logged 6.6 million hits so far, averaging 3,000 to 4,000 users per day (which generates some 42,000 pages of information daily). "Tuesday is our busiest day," she disclosed, "although we don't know quite why." The database is in phase 1, which includes 5,000 mostly NIH-sponsored trials; phase 2 will involve the private sector and other sponsors. "This is just totally cool and amazing," enthused ACD member Rebecca Eisenberg of Stanford Law School.

  • A working group on NIH oversight of clinical gene transfer research issued an interim report on review of gene transfer protocols. The group proposes two pathways for review, depending on whether the protocol presents novel scientific, ethical or safety issues, or not. The group concluded that "there must be assurance that subjects will not be enrolled in a gene transfer protocol until NIH's Office of Biotechnology Activities and the recombinant DNA advisory committee (RAC) has determined whether the protocol requires full RAC review and, in the case of a novel protocol, until after that review has occurred." A proposed method of RAC review envisions open lines of communication involving the many parties to the protocol, including FDA, OBA/RAC, institutional review boards, institutional biosafety committees, research institutions, sponsors and patients themselves.

  • As of June 8, the federal Human Genome Project was "within a whisker" (88.5 percent done) of achieving the working draft of the human genome that was promised for spring 2000, said Dr. Francis Collins, NHGRI director. "I can say without reservation that the sequence of the human genome is largely in hand, and up there on the web (at the GenBank site sponsored by NIH) for study." He added, "Working draft is great stuff, but finished sequence is better." More than 20 percent of the sequence is finished, he said, showing a slide illuminating disease genes (including BRCA2) whose discovery was aided by access to draft or finished sequence. Dr. David Lipman, director of the National Center for Biotechnology Information at NLM, which hosts GenBank, said GenBank gets 175,000 visits per day, in addition to hundreds of daily emails and calls. "Gene products are what most scientists are interested in, then genomic structure. Mostly, scientists want as complete and accurate information as possible on gene products." To demonstrate the value of his treasure trove, Lipman ordered up a discovery just for the ACD meeting; a colleague found a novel BRCT domain protein conserved only in humans and Drosophila. "We're very excited that, on demand, we can make discoveries with this data," Lipman said.

  • Dr. Yvonne Maddox, acting NIH deputy director, reviewed the agency's health disparities initiative, which by 2010 aims to eliminate disparities in six major health areas. A formal Center for Health Disparities can be established administratively by Kirschstein, said Maddox. She forecast that such a center might be up and running by the end of the fiscal year in order to help meet the initiative's six goals.

  • Dr. Stephen Straus, director of the National Center for Complementary and Alternative Medicine for the past 8 months, offered a "mature approach to a somewhat controversial undertaking," in his outline of NCCAM's draft strategic plan. "The public needs better guidance about which CAMs are effective," he said. Some 40 percent of Americans, and perhaps 2 of 3 people worldwide, practice CAM, he said. The center intends to start an intramural clinical research program.

  • Due to the oceans of data being generated by such efforts as the Human Genome Project, an effort is under way to train a new generation of experts in bioinformatics. Reporting on the initiative to address this need was NCI director Dr. Richard Klausner, who called for "OB-cubed," an Office of Bioimaging, Bioengineering and Bioinformatics. NIH hopes to establish Centers of Excellence in Biomedical Computing, and has asked for $10 million in planning grants for the effort in FY 2001, he said. In addition to the centers, Klausner said the field needs breakthroughs in information storage, curation, analysis and retrieval, plus investigator-initiated research and more computing infrastructure. Observed ACD member Dr. Larry Smarr, director of the National Center for Supercomputing Applications at the University of Illinois (and cochair of the working group that gave rise to the new OB3 initiative), data management nowadays is "an exponential snowball — you have to run as fast as you can to stay in the same place."

In other news, Kirschstein announced that the NIH Academy, a small pilot program established to train postbaccalaureate students in the understanding and elimination of health gaps among various populations, is accepting applications for fall 2000; noted that Dr. Neal Nathanson, director of the Office of AIDS Research, is leaving NIH on Sept. 1; and announced that Dr. Barnett "Barry" Kramer is new director of the Office of Medical Applications of Research.

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