Coalition of Scientists and AIDS Advocates Calls on Congress to Support Clinton AIDS Research Reform Proposals

ISSN 0036-8075
5 FEBRUARY 1993
VOLUME 259
NUMBER 5096

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Reorganization Plan Draws Fire at NIH

At last summer's international AIDS conference in Amsterdam, a fledgling activist
outfit called the Treatment Action Group
(TAG) issued a two-volume critique of AIDS
research at the National Institutes of Health
(NIH). The heavyweight report (nearly 200
pages) sank without a trace at the conference. But over the past 6 months, it's resurfaced to receive serious attention in another
venue: the United States Senate. So seriously
has it been considered there that TAG's recommendations form the basis for legislation
that would dramatically overhaul how NIH
coordinates and funds AIDS research by
drastically strengthening the hand of its Office of AIDS Research (OAR). The legislation has stirred concern at NIH-where institute directors see their power being erodedand it is making waves for new Secretary of
Health and Human Services (HIHS) Donna
Shalala before she's had time to get her sea legs.
Proposed by Senator Edward Kennedy.
(D-MA), who chairs the Senate's Committee on Labor and Human Resources, the controversial AIDS reform is tucked into the
NIH reauthorization bill. A version of the
bill, without the AIDS provisions, was vetoed by former President George Bush last
year because it would have lifted the ban on
therapeutic research involving human fetal
tissue. The bill became a top priority for the
Senate to push through under President Bill
Clinton, and, indeed, it was the first piece of
legislation introduced in the Senate this year.
The AIDS portion of the revamped bill
gives OAR control over NIH's $1.1 billion
AIDS budget. OAR currently coordinates
AIDS research at all 21 institutes under the
direction of Anthony Fauci, whose main job
is heading the National Institute of Allergy
and Infectious Diseases (NIAID). While
OAR can tell an institute that a certain
project is redundant or unnecessary, the office does not touch AIDS money, which

travels directly from Congress to each institute. In addition to beefing up OAR's funding role, the bill would increase responsibilities for the agency's director, require a strategic plan to guide budget decisions, and establish a discretionary fund OAR can use to
bankroll "emergency" AIDS research and fill
gaps in existing programs. And those are just
the kinds of things the activists had called
for. "The TAG report is the genesis of this
legislation," says a staffer
for Senator Nancy Kassebaum (R-KS), the ranking minority member of
the labor committee.
When contacted by
Science, Fauci and several
other institute directors
said they had no comment
on the legislation. Yet on
22 January, the day after
Kennedy introduced the
bill, the NIH institute directors held an emergency
meeting with NIH Director Bernadine Healy. and
insiders say some voiced
heated objections. The di- No objection. HH
rectors agreed to detail Donna Shalala su
their complaints in a formal memo to Healy, which she forwarded to
Shalala that Friday afternoon.
Neither NIH nor HHS will publicly release the memo, and, in a highly unusual
move, Shalala's office even declined to give
it to a Senate staff member. But Science has
learned that a key concern was the increased
budgetary authority delegated to OAR. The
institute directors said they would not object
to OAR being given authority in the planning process to hash out with each institute
which projects deserved what funding. But
they balked at the notion of having all
AIDS funding pass through OAR. Their chief
SCIENCE * VOL. 259 * 5 FEBRUARY 1993

argument was that-by adding another layer
in the process whereby funds are delivered
-the measure would create delays in the
awarding of contracts and grants.
The next day, 23 January, National Cancer
Institute director Samuel Broder worked with
HHS and Senate staff to modify the legislation. In the draft of the bill that Kennedy's
committee unanimously marked up on 26
January, OAR will have no say over the funds
that institutes already have committed to
AIDS research projects. This "commitment
base," which funds 3- to 5 -year projects, accounts for
about 80% of the AIDS
t budget.OAR will,however,
control funding of all new
and competing programs;
moreover, each year about
20% of the committed
money frees up, meaning
that after 5 years, OAR will
control the entire NIH
AIDS budget-a prospect
that many researchers find
disturbing. "It adds another
layer of bureaucracy," says
AIDS researcher Dani Bolognesi of Duke University.
Secretary "I think it's going to be a
orts the bill. disaster."
Kennedy has already received positive letters from more than a dozen
scientists, however, including Mathilde Krim
of the American Foundation for AIDS Research, former Food and Drug Administration official Ellen Cooper, and Arthur
Ammann of the Pediatric AIDS Foundation.
AIDS activist Gregg Gonsalves, who coauthored the TAG report with Mark
Harrington, says OAR needs the budgetary
authority to compel reforms. "We're quite
concerned that OAR will remain a paper
tiger without teeth to enforce its plans," says
Gonsalves. TAG member Derek Hodel of
the AIDS Action Council, a Washington,
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D.C.-based lobbying group, adds: "Culturally, it's a different way of doing business and
that alone is very threatening. The institute
directors now have ultimate authority and
understandably they resist the notion that
they have to give up some."
Faced with the prospect of upsetting
Kennedy and the AIDS activists, Shalala threw
her support behind the bill in a letter to Vice
President Al Gore. "jT]he Clinton Administration supports strengthening AIDS
research programs," wrote Shalala. "We believe the bill provides a framework for directing AIDS research in an effective manner."

The letter did not raise any of the objections
made by the NIH institute directors. Shalala
declined to comment on the bill to Science.
NIH Director Healy also was uneasy about
discussing the bill, but she conceded that when
the institute directors met with her on 22 January, they were not four-square behind it.
"There was a strong sense at our meeting...that
we must show strong support for the president, Secretary Shalala, and the AIDS community," said Healy. "Though some aspects of
the legislation were unappealing to many and
odious to some, it was inappropriate for NIH
to take a do-or- die position at this time."

Sometime during the first week in February, the Senate is expected to pass the bill
with little opposition. The House has yet to
introduce a similar AIDS reform provisionthough it probably will take up the issue with
Shalala when she appears on 3 February for a
hearing on the bill-and may simply approve
the Senate addition in a conference committee. If the bill is approved, Fauci likely will
have to give up either the OAR post or his
position as NIAID director, leaving the field
open for the Clinton Administration to find
itself a new AIDS top dog.