- WASHINGTON, DC - Senior officials
at the National Institutes of Health (NIH) yesterday denied committing
any improprieties when they accepted lucrative consulting contracts from
pharmaceutical and biotech companies that had dealings with the agency.
Testifying before a Senate subcommittee, one institute director called
the allegations, reported by the Los Angeles Times, "misleading, grossly
inaccurate, and filled with false innuendo."
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- But NIH Director Elias A. Zerhouni yesterday said that
he had restructured the agency's system for implementing ethics regulations,
suspended approval of all new consulting arrangements, and was reviewing
all 365 currently active agreements. Zerhouni also announced the appointment
of two cochairs to a "Blue Ribbon Task Force" charged with reviewing
NIH ethics practices: Bruce Alberts, president of the National Academy
of Sciences, and Norman R. Augustine, former chairman of the National Academy
of Engineering and currently an executive with Lockheed Martin.
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- "I have reached the conclusion that NIH must make
changes that will appropriately restrict current practices," Zerhouni
told a hearing of the Senate Appropriations subcommittee on Labor, Health
and Human Services, and Education. But he said he would reserve judgment
on specific changes until the task force had finished reviewing NIH ethics
practices and had made its recommendations. The panel is to report its
findings within 90 days of the appointment of other task force members.
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- In addition to concerns over the consulting contracts,
other members of Congress have questioned whether "lecture awards"
and other cash gifts given to NIH officials have influenced decisions on
funding to universities and research institutes. "The issue of integrity
is one of the utmost importance," said Subcommittee Chairman Sen.
Arlen Specter (R-Penn.). "I believe there'll have to be some very
substantial remedial steps to make sure that the wall of separation between
public duty and private gain is maintained."
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- Zerhouni said about 200 NIH scientists, fewer than 3%
of the staff, are involved in outside consulting activities. Of these,
only 10 or 20 have stock ownership programs as opposed to direct compensation.
Zerhouni defended the consulting arrangements as a means to translate research
findings into therapies. "There should be a difference between a scientist
who has authority [in the grant process] and those who do not," he
said. "We do want to translate that knowledge to the field."
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- Ranking minority committee member Sen. Tom Harkin (D-Iowa)
said the NIH is expected to be actively involved in the translation of
research. "There needs some cross-fertilization in a consultative
process. But in that, the people at NIH have to have absolutely clean hands,"
he said. Contracting arrangements that benefit one company over another
may not serve the public interest, he added. But Sen. Ted Stevens (R-Alaska),
chairman of the Senate Appropriations Committee, defended industry-government
collaborations. "We have to encourage collaboration rather than put
a taint on it," he said.
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- The Los Angeles Times reported last month that several
high-level NIH scientists and officials had received more than $2.5 million
in fees and stock options from drug companies for consulting outside of
their government work over the past 10 years. The newspaper said Stephen
I. Katz, director of the National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), collected between $476,369 and $616,365 during
the past decade in fees from drugmaker Schering AG and six other companies.
During this time, NIAMS conducted clinical trials involving one of the
company's drugs and pledged $1.7 million in small business research grants
to another.
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- Katz yesterday told the Senate panel that he had followed
all NIH ethics policies and procedures, had properly recused himself when
required, and had made no decisions regarding any companies for which he
consulted. "These allegations of misconduct on my part are misleading,
grossly inaccurate, and filled with false innuendo," he said.
-
- Other NIH officials named by the newspaper also rebuked
the allegations of conflicts of interest. They included John I. Gallin,
director of NIH's Clinical Center; Ronald N. Germain, deputy director of
the Laboratory of Immunology at the National Institute of Allergy and Infectious
Diseases; and Jeffrey Schlom, director of the National Cancer Institute's
Laboratory of Tumor Immunology and Biology. Under questioning, all said
they had followed NIH guidelines and would be pleased to make their financial
disclosures public.
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- Thus far, Zerhouni said, NIH's internal review has found
no evidence that outside financial arrangements had harmed any patients
or resulted in undue influence on grant approvals or other decisions. "I
will, however, reserve final judgment until all internal and external reviews
are completed," he said.
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- Prior to 1995, Zerhouni said that NIH scientists could
earn no more than $25,000 annually from any single outside source and not
more than $50,000 per year in total. Stock or stock option payments were
prohibited, and senior NIH officials could not accept any payments from
outside sources. That changed in 1995 after an audit by the federal Office
of Government Ethics (OGE) determined that NIH's rules were more stringent
than those of other federal agencies.
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- "Agency management was concerned that NIH was at
a disadvantage in competing with the private sector for the best scientists
due to lower salaries, benefits, and the reduced ability to supplement
incomes with outside activities," Zerhouni said. Then NIH Director
Harold E. Varmus changed the ethics policies, easing restrictions on many
outside activities.
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- Marilyn Glynn, acting director of the OGE, yesterday
told the panel that her office is in the process of reviewing the structure
and staffing of NIH's ethics program, its public financial disclosure system,
and the process for approving outside activities and accepting awards.
Both she and Zerhouni told the panel that a blanket suspension against
approving consulting contracts could not be done. "I can't change
the rules without new regulations being promulgated," Zerhouni said.
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- Rep. Billy Tauzin (R-La.), chairman of the House Energy
and Commerce Committee, plans to hold a hearing on the consulting contracts
and lecture awards in the near future. Last week, a group of House Democrats,
including Reps. Henry Waxman (D-Calif.), John Dingell (D-Mich.), and Sherrod
Brown (D-Ohio), asked the General Accounting Office to investigate the
conflict of interest and other ethics allegations.
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- Specter, one of the Senate's strongest supporters of
NIH, cautioned that these allegations of financial irregularities could
end up hitting the agency where it hurts most-in the budget. "You've
gotten more money because you are on the cutting edge of discoveries,"
he told the NIH officials. "But these allegations will give fuel to
people who want to cut back on your funding."
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- Links for this article
-
- D. Willman, "Stealth merger: Drug companies and
government medical research," Los Angeles Times, December 7, 2003.
-
- http://www.latimes.com/news/nationworld/nation/la-na-nih7dec07.
story
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- T. Agres, "NIH to launch ethics review," The
Scientist, December 10, 2003. http://www.biomedcentral.com/news/20031210/06/
-
- T. Agres, "Congress, Harvard, and Klausner,"
The Scientist, November 13, 2003. http://www.biomedcentral.com/news/20031113/08/
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- T. Agres, "NIH revises conflict rules," The
Scientist, January 12, 2004. http://www.biomedcentral.com/news/20040112/01/
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- ©2003, The Scientist Inc. in association with BioMed
Central.
- http://www.biomedcentral.com/news/20040123/05
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