AR-News: Top scientists now required to reveal financial ties to companies dealing with agency

Sat Mar 6 21:06:18 EST 2004

From: primfocus 
http://www.biomedcentral.com/news/20040304/03

New ethics rules at NIH
Top scientists now required to reveal financial ties to companies dealing
with agency | By Ted Agres

Senior officials at the National Institutes of Health (NIH) must now file
public financial disclosure forms revealing their incomes as well as any
stock, fees, and payments from pharmaceutical and biotechnology companies
that have dealings with the agency. The policy change was announced Monday
(March 1) at the first meeting of NIH's Blue Ribbon Panel on Conflict of
Interest Policies. Previously, NIH officials had been required to disclose
this information, but the reports remained confidential.

Edgar M. Swindell, associate general counsel for ethics at the Department of
Health and Human Services, told the panel that all NIH directors, deputy
directors, scientific directors, and clinical directors are now required to
file public disclosure forms, known as SF 278s, rather than the confidential
OGE 450s. The change, which was requested by NIH director Elias A. Zerhouni
and issued February 6, affects 66 senior officials. "An evaluation is
underway to identify other positions with equivalent authority and
responsibilities who may meet the statutory test" for public filing,
Swindell said. "The assistance of the panel in that endeavor will be
welcome."

Zerhouni instructed the 10-member conflict of interest panel to review the
NIH's rules and procedures regarding financial conflicts of interest and to
make recommendations within 60 days. While telling the panel to "leave no
stone unturned," Zerhouni also cautioned against making "one-size-fits-all"
or "blanket" suggestions. The panel is co-chaired by Bruce Alberts,
president of the National Academy of Sciences, and Norman R. Augustine,
chairman of the executive committee of Lockheed Martin. NIH has created a
Web site where it will post conflict of interest resources and information.

An examination of the NIH's policies was triggered after the Los Angeles
Times reported in December 2003 that several high-level NIH scientists and
officials have received more than $2.5 million in consulting fees and stock
options from drug companies, including some doing business with the agency.
In January, Zerhouni restructured NIH's system for implementing ethics
regulations, suspended approval of all new consulting deals, and appointed
the ethics task force. The consulting deals have become the topic of a
Senate hearing and other inquiries on Capitol Hill. Zerhouni and other
senior NIH officials have denied any impropriety.

Swindell invited the ethics panel to also consider the broader issues
involved. "I would ask the panel to evaluate whether NIH employees should
hold 'drug or biotech' stocks or be allowed to consult with companies in
these industries," he said. A related issue is whether NIH employees should
be allowed to accept awards and lecture fees from universities or institutes
that receive research grants or do business with the NIH, he said.

"Keep in mind that a strict resolution of the question likely would preclude
the NIH director from receiving the Nobel Prize in physiology or medicine
because the awarding entity, the Karolinska Institute, collaborates in
research matters with the NIH," Swindell added. But practically speaking, if
the consulting process were stopped, "what effect would such a prohibition
have on recruitment and retention of eminent scientists? If not a total ban
for all employees, should senior employees, at least, be subject to such a
ban?" he asked.

Officials and representatives of professional research societies have argued
that NIH needs to be competitive if it is to recruit talented people. "We
have to be cautious not to diminish NIH's ability to attract and retain the
best scientific leaders in medical research," NIH spokesman John Burklow
told The Scientist. "NIH must do what it can to enable top scientists to
consult," said Robert D. Wells, president of the Federation of American
Societies for Experimental Biology. "But, of course, it must be done with
the appropriate guidelines and rules and regulations."

Two House Democrats last week (February 26) asked 10 major pharmaceutical
companies to reveal how much they have paid in stock options, consulting
fees, and other financial arrangements to NIH scientists since 1995. The
letters were sent by Rep. Henry A. Waxman (D-Calif.), ranking minority
member of the House Committee on Government Reform, and Sherrod Brown
(D-Ohio), ranking minority member of the Energy and Commerce Subcommittee on
Health.

The companies, including Allergan, Bristol-Myers Squibb, and Merck, were
also asked to name the NIH employees and describe "the exact nature of the
financial arrangement, the duties performed by the scientists, [and] the
duration and time frame of the financial arrangement." The companies were
asked to respond by March 11.

Waxman and Brown have also asked the General Accounting Office, the
investigative arm of Congress, to look into the consulting arrangements. The
Department of Health and Human Services inspector general also has opened an
inquiry into NIH's conflict of interest policies.

Rep. James Greenwood (R-Penn.), chairman of the House Energy and Commerce
Subcommittee on Oversight and Investigations, has questioned NIH's use of
consulting fees to pay senior scientists and institute directors more than
they otherwise would be entitled to earn. Greenwood's subcommittee plans to
hold public hearings on this and the consulting contracts later this year.

Links for this article
National Institutes of Health Conflict of Interest Information and Resources
http://www.nih.gov/about/ethics_COI.htm

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

T. Agres, "NIH defends consulting deals," The Scientist, January 23, 2004.
http://www.biomedcentral.com/news/20040123/05/

T. Agres, "NIH probe expands," The Scientist, February 19, 2004.
http://www.biomedcentral.com/news/20040219/04/

T. Agres, "NIH ethics investigation," The Scientist, June 30, 2003.
http://www.biomedcentral.com/news/20030630/06/

Letter to Raymond V. Gilmartin, Chairman, President, and Chief Executive
Officer, Merck, from Henry A. Waxman and Sherrod Brown, February 26, 2004.
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_admin
_nih_gao_pharm_manufacturers_feb_26_let.pdf

"Greenwood expands investigation into questionable NIH practices," Letter to
Tommy Thompson, February 4, 2004.
http://energycommerce.house.gov/108/letters/02042004_1206.htm

the wild, cruel beast is not behind the bars of the cage. he is in front of it - axel munthe

"Never doubt that a small group of dedicated citizens can change the world. 
Indeed, it's the only thing that ever has."      Margaret Mead
-------------- next part --------------
An HTML attachment was scrubbed...
URL: http://lists.envirolink.org/pipermail/ar-news/attachments/20040306/e0232cc8/attachment.html