Senate Panel Explores NIH
Response to Allegations of Conflicts of Interest
January 23, 2004 - Noting that "managing conflicts
of interest in science is a continuous process best served
by: transparency, full disclosure, independent review and
continuous monitoring, " NIH Director Elias Zerhouni,
M.D., testified Jan. 22 at a Senate Labor-HHS-Education Appropriations
Subcommittee hearing
on NIH's actions in response to recent allegations of conflicts
of interest by NIH employees consulting for industry.
Dr. Zerhouni told the subcommittee he "personally began
reviewing ethics, policies and procedures last July, when
the House Energy and Commerce Committee raised concerns about
NIH employees receiving monetary lecture awards." Based
on an initial review of policies and procedures, he announced
Nov. 20, 2003, the formation of a new trans-NIH ethics advisory
committee in the office of the director "to provide independent
peer review of outside relationships and advice for improvements
in our policies and procedures." He also "advised
all senior managers to exercise great prudence in entering
into any arrangement that could reflect poorly on NIH or could
create the appearance of conflict, even in cases where the
arrangements are permitted by law."
Dr. Zerhouni said he also "ordered an immediate review,
not only of the allegations in the press, but of all existing
outside activities, to ensure that there have not been breaches
of current rules, and to determine the entire scope of these
activities." He stated, "[T]hus far, we have not
identified any situations where patients were harmed as the
result of financial arrangements NIH employees had with outside
parties. Nor have we identified any situations where outside
activities resulted in undue influence on grant approvals
or other decisions."
Rejecting "press reports [that] have implied that NIH
and its employees willfully used alternative federal pay systems
to avoid disclosing their outside activities," Dr. Zerhouni
explained that outside activities are internally disclosed
to ethics officers and supervisors. However, he acknowledged
"federal rules sometimes do not allow public disclosure
of that information" and said "this needs to be
revisited as transparency and full disclosure are core requirements
of any viable process of oversight of these relationships."
Dr. Zerhouni also stated he has asked a Blue Ribbon Task Force
"to review all NIH ethics practices, ponder what types
of collaborations with non-government organizations are necessary
and appropriate, and make recommendations to me on reforms
or our policies and procedures within 90 days." [see
related story]
A panel including Marilyn Glynn, acting director, Office
of Government Ethics; Ed Swindell, associate general counsel
in the HHS Ethics Division; and Ruth Kirchstein, special advisor
to the director and former acting director of NIH, testified
on conflict of interest policies and procedures in place government-wide,
at HHS and at NIH. Dr. Kirchstein's testimony focused on the
evolution of the ethics program at NIH, based on the experiences
of NIH and department staff and on periodic audits conducted
by the Office of Government Ethics. Mr. Swindell noted that
FDA has in place policies more stringent than the department's
standards that could serve as a model for NIH, although he
did note the difference between FDA as a regulatory agency
and NIH's need to interact with a range of organizations and
industries.
Questions from Subcommittee Chair Arlen Specter (R-Pa.) and
Ranking Member Tom Harkin (D-Iowa) focused on whether regulatory
or statutory changes were needed, how quickly regulatory changes
could be implemented, whether relationships involving stock
options should be treated differently than fee-for-service
arrangements, whether there should be full financial disclosure
for all NIH employees, whether a blanket prohibition on all
NIH employee relationships with industry should be imposed,
and the effect of such a prohibition on NIH recruitment and
retention.
The subcommittee also heard from Stephen Katz, M.D., Ph.D.,
director of the National Institute on Arthritis and Musculoskeletal
and Skin Diseases; and John Gallin, M.D., director of NIH's
Clinical Center, who adamantly denied the allegations made
against them in the LA Times story, which Dr. Katz described
as "misleading, grossly inaccurate, and filled with false
innuendo."
Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525
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