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NIH to Ban Deals With Drug
Firms
Federal researchers will
no longer be able to accept fees to consult for companies,
officials say. The lucrative pacts have sparked ethics
probes.
Under a far-reaching
reform to be announced today, all staff scientists at
the National Institutes of Health will be banned from
accepting any consulting fees or other income from drug
companies, and the employees must also divest industry
stock holdings, officials said.
The new regulations — drawn up by administrators
from the NIH, the Office of Government Ethics and the
Department of Health and Human Services — are
aimed at halting lucrative deals that have led to conflict-of-interest
inquiries at the government's premier agency for medical
research.
The changes exceed the partial and temporary curbs on
outside income proposed earlier by the NIH director,
Dr. Elias A. Zerhouni. Although the new rules could
be reassessed after one year, officials familiar with
the matter said they viewed the changes as permanent.
For the last decade, government scientists at the NIH
have quietly been allowed to consult for biomedical
companies under policies that defenders have said helped
attract talented personnel to the agency. Hundreds of
scientists took millions of dollars in fees and stock
from industry. Most of the payments were hidden from
public view, raising questions about the scientists'
impartiality in overseeing clinical trials and in making
recommendations to doctors for treating patients.
In some cases, NIH scientists worked for drug companies
that directly benefited from their recommendations to
doctors. In other cases, scientists appeared at public
forums and commented upon or endorsed treatments or
drugs without revealing that they were on the payroll
of companies making the products.
News Agencies have recently revealed the existence of
the deals — along with the secret policy changes
that made them possible. Zerhouni appointed a blue ribbon
panel last year to examine the NIH's policies, and congressional
leaders, citing articles, asked him to provide details
on all biomedical industry payments to agency scientists
for a five-year period.
Four congressional hearings into conflict of interest
at the NIH were convened last year, three in the House
and one in the Senate.
Full details of the new and restrictive rules were held
tightly on Monday by NIH officials. Those familiar with
the changes, speaking on a condition of anonymity, provided
these particulars:
All NIH scientists will be prohibited from accepting
consulting fees, speaking fees and any other form of
income from all biomedical companies, professional societies
and other outside entities. The scientists must sell
or otherwise dispose of any stock or stock options they
hold in individual pharmaceutical or biotechnology firms.
On the other hand, the government employees will be
allowed to accept paid outside positions as physicians
at hospitals or in other clinical settings. They also
will be allowed to accept fees in some circumstances
from universities for teaching or writing and editing
services. The number of NIH employees required to file
annual financial-disclosure reports open to public inspection
under the Freedom of Information Act also was to be
expanded.
Two members of the House Energy and Commerce Committee,
whose leaders sought the documents about drug company
payments to NIH scientists, praised the new rules.
"NIH's ethics requirements were appallingly lax —
not at all what the public would expect from our nation's
premier research institution," said Rep. Diana DeGette
(D-Colo.).
In a written statement, Rep. Henry A. Waxman (D-Los
Angeles) praised news agencies reporting and said "we
need to restore integrity and trust in NIH. I am glad
NIH recognizes it has a problem and is now beginning
to address these issues."
Word of the new rules also drew applause from other
present and former officials.
"It's a very, very salutary move," said Dr. Philip R.
Lee, who served presidents Lyndon B. Johnson and Bill
Clinton as assistant secretary of Health. "It returns
NIH to where it should be in terms of the public's confidence
that the people who work for NIH are working for them,
and not for some drug company or some biotech company."
Last month a deputy director of the NIH, Dr. Raynard
S. Kington, said in an agency newsletter that investigations
of potential conflicts of interest among agency employees
were under way. Kington told the newsletter that "fairly
soon, we'll enter the penalty phase of these investigations
.
Some employees have substantially violated rules and
regulations."
According to officials familiar with the matter, the
inspector general's office at the Department of Health
and Human Services was investigating an Alzheimer's
disease researcher at the NIH, Dr. P. Trey Sunderland
III. Records showed that from 1998 through 2003, Sunderland
accepted $508,050 in consulting and speaking fees from
Pfizer Inc. — without seeking permission or reporting
the income to the agency as required.
Over the last year, Zerhouni had insisted that any employee
who violated the existing conflict-of-interest rules
would be held to account. But the NIH director also
said repeatedly that he wanted most agency scientists
to remain at liberty to moonlight for the companies
because that would help "translate" scientific discoveries
from NIH laboratories into useful medical products.
However, no evidence of any such translations was presented
throughout the congressional hearings, or during sessions
convened by the blue ribbon panel.
Rigorous case-by-case screenings of ongoing or proposed
moonlighting deals, Zerhouni said, would adequately
safeguard against conflicts of interest. He appointed
an ethics advisory committee last year to do just that,
joining other agency efforts that NIH administrators
said would "manage" conflicts of interest.
In December 2004, one of Zerhouni's appointees to the
ethics advisory committee, Dr. Harvey G. Klein, the
top blood-transfusion expert at the NIH, accepted income
from companies whose activities overlapped with his
area of expertise.
The article, based on government and company records
and interviews, reported that Klein from 1999 to last
year accepted $240,200 in consulting fees plus 76,000
stock options from five companies active in marketing
or developing blood-related products.
Klein said that other officials at the NIH approved
all of his outside arrangements.
Zerhouni in the last year made several attempts to contain
the controversy over the drug industry payments.
He first proposed to ban outside paid consulting for
top-level NIH leaders — while allowing most of
the agency's 5,000 or more other scientists to enter
into such deals.
Reference
Source 130
February 2, 2005
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