Top NIHers can't consult
But panel would ease conflict-of-interest restrictions on most
intramural researchers | By
Ted Agres
BETHESDA, MD�Senior officials at the National Institutes of
Health (NIH) as well as staff members responsible for grants and
funding decisions should not be allowed to consult for
pharmaceutical, biotech, or other companies �under any
circumstances,� according to the long-awaited recommendations made by the NIH's �blue ribbon�
panel on conflict-of-interest policies yesterday.
But most NIH intramural researchers would be allowed�and even
encouraged�to participate in teaching, speaking, and other paid
outside activities as long as they spent fewer than 400 hours a year
of their own time doing so. Their compensation must not exceed 50%
of their annual base salary, and no one source could account for
more than 25% of their pay.
Payments in the form of stocks, stock options, or other equity
would no longer be permitted. But no limit would be placed on the
amount of money a qualified NIH employee could receive from awards,
royalties from inventions, or for work written or edited as an
outside activity. Those activities �are part of the tradition of
science and provide evidence of the value and significance of the
NIH research community to the larger scientific community,�
according to the report.
The panel presented the report yesterday (May 6) to NIH director
Elias A. Zerhouni and members of his advisory committee. In its 18
recommendations, the panel sought to �walk a narrow line� between
liberalizing conflict-of-interest rules, which could damage NIH's
credibility, and overly restricting them, which could impede
recruitment of world-class scientists, said panel co-chair Norman R.
Augustine at a meeting announcing the report.
Zerhouni said the panel's recommendations would �profoundly�
change how he managed the agency. �Our primary interest here is to
protect the agency and the public,� he told reporters after the
meeting. Zerhouni and panel members plan to meet again to determine
which recommendations could be implemented immediately and which
might require approval from the administration or Congress.
The panel's report follows months of scrutiny and action by Zerhouni following a December Los Angeles Times report that several
high-level NIH scientists and officials had received more than $2.5
million in consulting fees and stock options from drug companies
over the past 10 years. The report released yesterday found that
only 118 of NIH's 17,526 employees currently engage in consulting
agreements with industry.
However, Congressional concern and media interest have had �a
decidedly negative impact on the morale of a large number of
intramural scientists,� the report states. �There is widespread
apprehension that new rules and expanded rule interpretations will
soon make it unattractive to be an NIH scientist,� said panel
co-chair Bruce Alberts.
Between 90 and 95% of all approved outside activities have been
�small, one-time events,� Zerhouni said, such as when an intramural
scientist receives $2000 to appear on a panel. While the large
payments cited in the LA Times are unusual, he said, he acknowledged
that stocks and stock options are �of concern.� About one fourth of
the existing 118 consulting arrangements involve stocks, but those
scientists will not be required to divest of their holdings. Future
equity payments would be barred �prospectively.�
While banning outside consulting by senior NIH officials and
those responsible for funding decisions, the panel would permit
healthcare practitioners to work in outside clinical practice,
medical care, or patient services and receive up to an additional
100% of their base pay. Intramural scientists conducting research
with human subjects, however, �should not be allowed to have any
financial interest in or relationship with any company whose
interests could be affected by their research or clinical trial,�
unless special authorization is granted.
The panel also recommends NIH increase the number of employees
required to file confidential financial disclosure forms. The agency
should also require staff scientists to disclose outside paid
relationships and financial holdings in any publications and
speeches they make. The committee also said Zerhouni should seek
approval to raise the current salary cap for most senior NIH
employees beyond its current $200,000 ceiling to be able to recruit
and retain top scientific leaders.
Scientific and medical research organizations met the
recommendations with approval. Jordan J. Cohen, the president of the
Association of American Colleges, issued a statement supporting the recommendations. And
Howard Garrison, public affairs director for the Federation of
American Societies for Experimental Biology (FASEB), said �I suspect
there will be support for allowing intramural scientists to be
treated like extramural scientists.� FASEB supports �the same set of
rules for intramural and extramural researchers because there is
very little difference in what they do,� Garrison told The
Scientist.
Links for this articleBlue Ribbon Panel on Conflict of Interest Policies,
Report of the National Institutes of Health, May 5, 2004 http://www.nih.gov/about/ethics_COI_panelreport.pdf T. Agres, �NIH defends consulting deals,� The
Scientist, January 23, 2004. http://www.biomedcentral.com/news/20040123/05/ 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 �AAMC urges speedy adoption of
NIH conflict of interest reforms,� American Association of Medical
Colleges press release, May 6, 2004. http://www.aamc.org/newsroom/pressrel/2004/040506.htm | 
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