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.
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.
To read previous Times coverage on the NIH, go to latimes.com/nih.