NIH Seeks 'Higher Standard'

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The director of the National Institutes of Health, Dr. Elias A. Zerhouni, said that rules he announced Tuesday banning all staff scientists from taking drug-company fees would help the federal research agency set the highest ethical example.

Referring to the pervasive intermingling of pharmaceutical marketing with medical research nationally, Zerhouni said the time had come for the NIH to provide "at least one source of public health information in the country that can be completely trusted."

"We believe that we need to hold NIH and ourselves as scientists at NIH to a higher standard, because we do have national public health responsibilities," he told a news conference at the agency's headquarters.

The new restrictions, agreed on by Zerhouni and senior officials with the Office of Government Ethics and the Department of Health and Human Services, are intended to be permanent, he said.

According to a summary issued by the NIH, employees also would be banned from moonlighting for research institutions receiving NIH funds, for health insurers and for "related trade, professional or similar associations." And virtually all staff scientists at the NIH would be prohibited from holding investments in biomedical companies.

Zerhouni, 53, said that his endorsement of the restrictions marked a turnabout.

For the better part of the last year, the NIH director had fought against imposing an across-the-board ban on industry consulting, saying that the paid arrangements generally helped translate scientific discoveries into medical remedies for patients.

"I've changed my mind," Zerhouni said.

"I'm not confident that we can continue to pretend that we have a system that works," he told reporters. "We will never go back to the old rules -- that's for sure."

Last year, Zerhouni supported banning only the most senior officials at NIH, including the directors of the agency's research centers and institutes, from moonlighting for pharmaceutical and biotechnology companies. The vast majority of the NIH's more than 5,000 staff scientists should be allowed to work for the companies, Zerhouni had said, because those employees did not have the power to dispense research grants.

In explaining his change of position, Zerhouni pointed to evidence brought to his attention over the last 14 months. He cited reports published in December 2003 by the Los Angeles Times as raising "real concerns" that prompted him last year to appoint an advisory committee focused on conflict-of-interest issues.

The 2003 reports, along with articles published by The Times last year, raised questions about NIH scientists' impartiality in overseeing clinical trials and in making recommendations to doctors for treating patients. The articles were cited by congressional leaders in their requests to Zerhouni a year ago for documentation of the drug industry payments to NIH scientists. Those and other records reviewed recently by The Times identified at least 530 NIH scientists who accepted fees, stock or stock options from biomedical companies from 1999 through 2003.

The scientists typically were required by the companies to sign confidentiality agreements as a condition of their outside employment, inhibiting their freedom to discuss related scientific matters with colleagues at the NIH. The compensation paid to the agency scientists totaled in the millions of dollars.

Zerhouni's support for the new restrictions drew bipartisan praise Tuesday.

"I want to commend Dr. Elias Zerhouni for taking a step that is both difficult and necessary," said Rep. Joe Barton (R-Texas), chairman of the House Energy and Commerce Committee, whose oversight and investigations subcommittee conducted three hearings last year into conflicts of interest at the NIH.

Barton added: "For the National Institutes of Health to do the complex work of thwarting disease and saving lives requires near-absolute public confidence in the people who conduct the research. If the notion that private gain is supplanting public service as the guiding light for health research, NIH's value to our nation will plummet."

Sen. Tom Harkin of Iowa, senior Democrat on the Senate appropriations subcommittee that oversees the NIH budget, said, "I welcome [NIH's] decision today to ban consulting deals between all of its employees and pharmaceutical and biotech companies. NIH's well-deserved reputation as the world's premier biomedical research agency was in danger of being tarnished as a result of recent revelations that some NIH scientists had flouted the agency's guidelines on preventing conflicts of interest."

The new rules will not prevent all paid outside activities.

According to Zerhouni aides, employees will still be allowed to teach courses at universities, write general textbooks and perform reviews for scientific journals. They will be allowed to work shifts at hospitals and to otherwise practice medicine part time. Agency employees could also accept fees for speaking to physicians at medical-education events funded by biomedical companies, if the money came in the form of an unrestricted grant and if the subject to be discussed did not overlap with the scientist's area of expertise at the NIH.

Zerhouni and other senior administrators declined Tuesday to discuss the status of internal conflict-of-interest investigations. The director says that "the cases concern a few dozen scientists."

Zerhouni told reporters that though the crackdown on industry payments had drawn mixed reactions from staff scientists, he had had no recent difficulties recruiting talented personnel.

Without referring to his predecessor by name, Zerhouni also suggested that the seeds of the NIH's difficulties with conflict of interest were sown in 1995, when then-agency Director Harold E. Varmus quietly lifted a range of restrictions on moonlighting in the industry. Varmus allowed all NIH employees -- including institute and center directors -- to enter into deals with drug companies and to accept stock and stock options as compensation.

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