NIH to Ban Deals With Drug Firms, (sure they will).

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" luckypig " <luckypig

Tue, 1 Feb 2005 13:35:00 -0500

 

///: NIH to Ban Deals With Drug Firms

 

 

 

this will only stay in affect for a couple of months, once the furor

dies down will be " business as usual "

 

LA TIMES

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.

By David Willman

Times Staff Writer

 

February 1, 2005

 

WASHINGTON ­ 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.

 

The Los Angeles Times in 2003 and 2004 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 the Times

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 Times 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. "

 

The Times reported Friday that, 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.

 

The Times reported in December 2004 that 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.

 

In September, he proposed a one-year, NIH-wide moratorium on paid

consulting, but it was never carried out.

 

Times researcher Janet Lundblad in Los Angeles contributed to this

report.

 

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