NIH to launch ethics review
Zerhouni promises comprehensive look at lucrative consulting
payments to top officials | By Ted
Agres
The National Institutes of Health (NIH), stung by recent
allegations of financial wrongdoing on the part of some present and
former senior officials, plans to announce today (December 10) a
major review of how the agency handles conflict-of-interest matters
when top agency employees receive lucrative consulting contracts
from private companies.
NIH Director Elias A. Zerhouni will announce the creation of a
“blue ribbon panel” of advisory committee members and outside
experts “to review how NIH addresses outside consulting activity in
order to identify systemic solutions for improvement,” NIH spokesman
John Burklow told The Scientist.
Zerhouni will also order an “immediate review” of every outside
consulting relationship that NIH employees have established during
the past 5 years “to confirm that all rules and regulations are
being followed and that the activities are in the best interest of
the public,” Burklow said.
“It is clear that we will need to consider changes after a
thoughtful analysis of the issues,” Burklow said. “We are vigorously
investigating the allegations because openness and review are our
best allies.”
The Los Angeles Times on Sunday (December 7) reported 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.
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, the Times reported. 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. Five other present and former senior NIH officials
reportedly received up to $2.2 million in company fees and stock
options during the time period.
Janet Austin, Katz's spokeswoman, did not respond to a request
for comment yesterday. But Katz and other officials told the Los
Angeles Times that NIH officials had approved their consulting
agreements in advance and that they had recused themselves from any
decision making involving the companies.
Arthur L. Caplan, director of the University of Pennsylvania's
Center for Bioethics, said he was surprised that this type of
outside consulting was even permitted by the federal government.
“It's a big problem. If you work for the federal or a state
government and are making decisions about funding for key government
expenditures, you don't want to be seen as being beholden to or
being able to be influenced by outside funding arrangements,” he
told The Scientist.
“If you are going to distribute money from grants and if you are
going to be turned to for independent evidence about different drugs
or research ideas, which is what NIH's role is, then they've got to
be a lot more careful about generating conflicts of interest,” he
said.
On Monday (December 8), Rep. Billy Tauzin (R-La.), chairman of
the House Energy and Commerce Committee, and Rep. James Greenwood
(R-Pa.), chairman of the Subcommittee on Oversight and
Investigations, asked Zerhouni to supply by January 8, 2004, all
documents relating to the payments reported by the Times.
“The receipt of outside payments, even though approved, raises
concerns about whether the integrity of NIH clinical research has
been affected and whether the honor system used by NIH to enforce
recusals signed by NIH scientists and other conflict of interest
rules has been violated,” the congressmen wrote.
The House investigation is part of an ongoing ethics probe begun
earlier this year. In June, the committee announced it was investigating Richard D.
Klausner, former director of the National Cancer Institute (NCI),
and other current and former senior NIH officials for accepting
“lecture awards” and other cash gifts from universities and research
institutions that receive NCI and NIH research grants. Klausner and
other officials have denied any wrongdoing.
In November, the committee announced it was seeking to determine whether
Klausner steered a $40 million contract to Harvard University during
the time he was a candidate to become the school's president.
Klausner, who is currently director of the Global Health Program at
the Bill and Melinda Gates Foundation in Seattle, told The
Scientist at the time that the committee's allegations were
“bizarre” and “baseless.”
Burklow yesterday said it is important that NIH scientists “stay
involved in the science and help communities beyond NIH to share
their information broadly. At the same time, we recognize that there
must be stringent standards and transparent policies for managing
potential conflicts of interest,” he said.
“In addition, we must do everything possible to avoid even the
perception of a conflict because the appearance can be as important
as the legal technicalities,” Burklow added.
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 ethics
investigation,” The Scientist, June 30, 2003. http://www.biomedcentral.com/news/20030630/06/ T. Agres, “Congress, Harvard, and Klausner,” The
Scientist, Nov. 13, 2003. http://www.biomedcentral.com/news/20031113/08/ | 
1291995937@Top,Right1,Right2,Right3,BottomLeft,BottomRight!BottomLeft