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
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
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
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
- 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
- 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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