Ethics Policy Announced for NIH Officials – LAT

Ethics Policy Announced for NIH Officials – LAT

Tue, 2 Mar 2004

This is a case demonstrating the power of the press ( the “fourth estate”) in its most important role providing a check on the abuse of government power.

An investigative report by David Willman, Pulitzer Prize winning journalist of the Los Angeles Times (Dec. 7), spearheaded several investigations and the convening of a blue-ribbon panel to examine conflicts of interest at the National Institutes of Health (NIH). Until the LA Times revealed the concealed conflicts of interest by top NIH scientists, “more than 94% of the top-paid employees at NIH were not required to disclose their outside income on forms available to the public.”

Indeed, industry influence and conflicts of interest at NIH have set the tone within the entire US medical research community. Those conflicts of interest have undermined patient safety and the integrity of research and the scientific literature.

A major policy change was announced on Monday, requiring full disclosure of all outside payments to NIH scientists.

The importance of preventing conflicts of interest in medical research was underscored by Diana Zuckerman, president of the National Center for Policy Research For Women & Families. “Our center has great respect for the important work of the National Institutes of Health. However, we are concerned about how conflicts of interest are undermining the integrity of medical research. More and more research studies are being reported at professional meetings and in medical journals by individuals with a product or point of view to sell.”

The Alliance for Human Research Protection urges the Congressional committees that investigated NIH to similarly investigate conflicts of interest at the upper echelon of the FDA.

We believe that pharmaceutical companies have inordinate influence at the FDA, and that influence is similarly undermining the safety of patients–including children. Drugs that pose severe hazards are prescribed carry no warnings about the drugs’ hazards. For example, children are being prescribed antidepressant drugs even though the drugs have failed to demonstrate a benefit for children–as acknowledged by FDA officials at a Feb 2, 2004 advisory committee meeting. The drugs have driven some children to commit suicide.

See compelling testimonies by 60 families whose harrowing experience persuaded the FDA advisory committee that the problem was real. The committee urged the FDA to put prominent warning labels immediately in order to prevent additional deaths. FDA officials have yet to act. See transcript at: http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugs

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://www.latimes.com/news/nationworld/nation/la-na-nih2mar02,1,1664018.story?coll=la-home-nation
THE LOS ANGELES TIMES
THE NATION
Ethics Policy Announced for NIH Officials
By David Willman, Times Staff Writer
March 2, 2004 Front page

Top scientists will be required to disclose outside income from biomedical firms. New panel may also evaluate consulting restrictions.

Some of the National Institutes of Health’s top scientists are also collecting paychecks and stock options from biomedical firms. Increasingly, such deals are kept secret.

BETHESDA, Md. — Federal ethics lawyers announced Monday that scores of high-level scientists at the National Institutes of Health will now be required to publicly disclose any income from drug companies or other outside employers.

Lawyers from the U.S. Office of Government Ethics said that all deputy directors, scientific directors and clinical-research directors at the NIH would now have to state their outside income and other assets on a yearly basis. A total of 66 senior officials were immediately affected by the change, which was put into effect Feb. 6 following a request by NIH Director Elias A. Zerhouni.

The announcement came at the first meeting of the newly formed NIH blue-ribbon panel on conflict-of-interest policies. The panel was formed after a report in the Los Angeles Times on Dec. 7 documented hundreds of payments of consulting fees and stock options from biomedical companies to NIH employees. The Times also reported that more than 94% of the top-paid employees at NIH were not required to disclose their outside income on forms available to the public.

The panel also learned Monday that the inspector general of the Department of Health and Human Services had opened an examination of NIH’s conflict-of-interest policies. The inspector general oversees federal health programs and is empowered to subpoena documents and to question witnesses, and also may impose civil or administrative penalties.

Edgar M. Swindell, the department’s associate general counsel, encouraged the 10-member panel “to evaluate whether NIH employees should hold ‘drug or biotech’ stocks or be allowed to consult with companies in these industries.”

Swindell also questioned the NIH policy of allowing employees to consult for pay “with various companies involved in scientific research.”

“Should this practice be stopped?” Swindell asked. “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?”

Zerhouni, the opening speaker before the panel, said that he intended to “leave no stone unturned” in an effort to strengthen the NIH’s ethics policies.

However, Zerhouni discouraged what he termed “one-size-fits-all” or “blanket” remedies. He said that, while “the public has the right to see whether its resources are directed for private gain,” he also did not want to jeopardize arrangements that help “translate” ideas into worthy medical treatments.

Zerhouni has asked the panel to submit its recommendations, which will be advisory, by early May.

The NIH director appointed each of the members and named two co-chairmen, Bruce Alberts, president of the National Academy of Sciences, and Norman R. Augustine, the former top executive of Lockheed Martin Corp.

Another member of the panel, Stephen D. Potts, was head of the Office of Government Ethics in 1995 when then-NIH Director Harold E. Varmus lifted a wide array of restrictions related to outside income.

Potts said that at the same time, “dozens” of other agencies enacted special rules to control potential conflicts of interest.

“I don’t know whether I ever knew the reason that NIH decided not” to follow suit, said Potts, who along with other panel members spoke in favor of streamlining the financial disclosure forms.

The importance of preventing conflicts of interest in medical research was underscored by Diana Zuckerman, president of the National Center for Policy Research For Women & Families.

“Our center has great respect for the important work of the National Institutes of Health,” Zuckerman said. “However, we are concerned about how conflicts of interest are undermining the integrity of medical research. More and more research studies are being reported at professional meetings and in medical journals by individuals with a product or point of view to sell.”

In addition to the blue-ribbon panel and the newly opened inspector general’s examination, various members of Congress also are demanding information from the NIH about the nature of drug company consulting deals with agency scientists.

The House Oversight and Investigations Subcommittee is gathering the information in preparation for a public hearing; Reps. Henry A. Waxman (D-Los Angeles), John D. Dingell (D-Mich.) and Sherrod Brown (D-Ohio) have asked the General Accounting Office, the investigative arm of Congress, to examine company payments to NIH scientists. A representative of the GAO told the blue-ribbon panel Monday that her office would probably begin its work this spring.

Waxman and Brown last week also wrote to the chief executives of 10 major drug companies, asking them to release details by March 11 about any payments made to NIH employees dating back to 1995.

Two other members of Congress with influence over the NIH budget, Sens. Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa), warned Zerhouni during a Senate appropriations subcommittee hearing on Jan. 22 that he needed to make swift and far-reaching changes.

Related articles:
Drug Firms Asked to Divulge NIH Payments
February 27, 2004
No Dollar Figures Yet From NIH on Consulting Deals
February 26, 2004

NIH Directors No Longer Drug Firm Consultants
January 23, 2004
U.S. Scientists’ Deals With Drug Firms Under Review
December 29, 2003
Stealth Merger: Drug Companies and Government Medical Research
December 7, 2003

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