NIH defends consulting deals
At Senate hearing, top officials deny wrongdoing; Zerhouni
appoints review panel cochairs | By Ted
Agres
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.”
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.
“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.
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.”
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.”
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.
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.
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.
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.
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.
“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.
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.
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.
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.”
Links for this articleD. 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 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/ T. Agres, “NIH revises conflict rules,” The
Scientist, January 12, 2004. http://www.biomedcentral.com/news/20040112/01/ |