Ethics Policy Announced for NIH Officials

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.