NIH bars employees from jobs as consultants

New ethics rule aimed at biomedical companies

February 02, 2005|By Susan Baer | Susan Baer,SUN NATIONAL STAFF

BETHESDA - Under sweeping new ethics rules aimed at halting conflict of interest charges at the nation's premier medical research facility, the National Institutes of Health has barred all agency employees from working as consultants to private biomedical companies.

The regulations also prohibit top government researchers from owning stock in drug and biotech companies and restrict stock ownership for all other NIH employees.

"My goal is to create a bright line that is so clear that crossing that line will not be allowed," said Dr. Elias A. Zerhouni, the NIH director, at a news conference yesterday. "Nothing is more important for NIH than preserving public trust."

Zerhouni, who had resisted such far-reaching restrictions last year, said he hopes the new regulations will maintain the reputation of NIH as "the one source of public health information in the country that is completely trusted and void of any conflict of interest or appearance of conflict of interest."

The reforms were drawn up over the past year by NIH, the Office of Government Ethics and the Department of Health and Human Services in response to revelations that a number of government scientists had been receiving lucrative consulting fees from biomedical companies, deals that in some cases related to their NIH work.

The conflicts of interest were revealed in a series of articles by the Los Angeles Times, beginning in 2003, and led to congressional hearings over the past year that examined the financial arrangements.

The new ban on outside employment by NIH employees extends to work for pharmaceutical and biotechnology companies, research institutions that receive grants from the NIH, health-care providers and insurers, and related trade associations.

Scientists will be allowed to teach courses, write and edit articles or textbooks and give lectures related to their work.

"I don't want to isolate our scientists from the mainstream of science," Zerhouni said.

In other changes, senior employees cannot receive any award of more than $200, with exceptions made for such prestigious prizes as the Nobel and Lasker prizes.

The stock restrictions "could potentially affect every employee on campus," said Holli Beckerman Jaffe, director of the NIH ethics office.

NIH employees who file public or confidential financial disclosure reports will be required to immediately sell any stock they own in drug or biomedical companies. All other employees will be allowed to own such stock, but only up to $15,000 in any one company.

The Times articles revealed that NIH employees had received hundreds of payments from biomedical companies totaling millions of dollars, most of which were not publicly reported. In some cases, the scientists were receiving fees from drug companies that stood to benefit from their recommendations to doctors for treating patients.

Private consulting arrangements between agency scientists and outside companies had been rare until the 1980s when they began to be encouraged as a way to speed the transfer of the government's laboratory research to medical products and cures.

Such collaborations - in which NIH scientists were typically paid by private companies for their expertise - increased greatly in the 1990s.

Dr. Harold E. Varmus, Zerhouni's predecessor, saw such arrangements as a way to make NIH more financially competitive with the private sector and lure top-notch researchers to government.

In 1995, he lifted many of the restrictions on the outside income scientists could earn from drug and biotech companies and also relaxed disclosure policies about such activities, adopting a case-by-case approach to reviewing the arrangements.

`More severe' rules

Zerhouni noted yesterday that the new ethics rules are "more severe" than those in place before 1995, but said they are necessary "to re-establish the trust" in an agency with an annual budget of $28 billion.

Zerhouni, who in the past also favored a case-by-case analysis of such collaborations, had resisted proposing a blanket ban on consulting.

In June, under increasing pressure from members of Congress who discovered dozens of deals between NIH scientists and private companies that agency officials had not known about, the NIH director proposed a ban on paid consulting for only the agency's most-senior officials. The ban did not include most of the more than 5,000 scientists working there.

The Office of Government Ethics concluded a month later that tougher, more far-reaching measures were required to reverse the "permissive culture" it found at NIH and to restore public confidence.

In September, Zerhouni proposed a one-year moratorium on consulting fees for all agency employees.

Yesterday, he said the new regulations, which are to take effect as soon as the guidelines are published, will stand permanently unless they need to be re-evaluated.

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