Lawmakers Assail NIH Conflict Rules

Members of Congress from both parties on Wednesday criticized conflict-of-interest policies at the National Institutes of Health and told the agency’s director that the recent recommendations of his blue-ribbon advisory panel fell short of what was needed.

After listening to the criticisms at a hearing on Capitol Hill, NIH Director Elias A. Zerhouni conceded for the first time that the agency’s policies had “failed.”

Zerhouni said that, as of this week, he was seeking to force an additional 500 senior employees to begin publicly disclosing any fees paid to them by drug companies or other parties. Two months ago, Zerhouni compelled public disclosure from 93 other NIH leaders.

But members of the House Oversight and Investigations Subcommittee said the agency was not making a serious enough effort to stop or publicly report drug company payments to NIH scientists.

Leaders of the NIH have encouraged what one congressman called “the option of corruption.” Other subcommittee members said NIH officials or lawyers with the U.S. Department of Health and Human Services had not cooperated with congressional investigators.

The hearing Wednesday opened a new phase of the controversy focusing on payments from pharmaceutical and biotechnology firms to NIH scientists. The recommendations last week of Zerhouni’s blue-ribbon panel did not satisfy the members of Congress who spoke Wednesday. The panel proposed banning paid consulting deals for top NIH management, and banning payments of stock or stock options to all NIH employees. However, it would allow many agency scientists to continue consulting for industry while not reporting their income publicly.

The subcommittee has scheduled another hearing Tuesday.

The hearings have been called in response to Dec. 7 articles in the Los Angeles Times documenting hundreds of payments by drug firms to NIH scientists, totaling millions of dollars, and reporting that more than 94% of the agency’s top-paid employees were not required to publicly disclose outside income.

More than 4,000 of those employees would remain exempt from public disclosure under the initiative announced Wednesday by Zerhouni.

“It is clear from the cases we have reviewed that some NIH scientists are either very close to the line [of propriety] or have crossed the line,” said Rep. James C. Greenwood, chairman of the House subcommittee. “This has been a persistent problem at NIH for years -- not because of confusion [about ethics rules], but because of a deliberate, permissive attitude.”

Greenwood, a Pennsylvania Republican, said that NIH officials and attorneys for the Department of Health and Human Services had yet to divulge all the payments by drug companies to NIH employees and that the subcommittee would now request the information from the companies.

A senior House Democrat, John D. Dingell of Michigan, backed Greenwood’s efforts, saying the subcommittee investigation “has been slow-rolled and stonewalled.”

“Unfortunately, certain scientists have been trusted to determine when their personal financial involvement with drug and biotech companies poses a conflict of interest with their responsibilities to the public,” Dingell said.

“And those scientists have not been subject to rigorous review or full disclosure.... The secret purchase of information and influence must stop.”

Rep. Joe Barton (R-Texas), who is chairman of the House Energy and Commerce Committee, warned Zerhouni that congressional investigators would obtain the fullest extent of information from the NIH about the financial ties to drug companies, with or without the agency’s cooperation.

Barton described “the attitude often found at NIH: ‘The rules don’t apply to us.’ Now, I sense we are hearing a variation on this theme: ‘If the rules do apply to us, they shouldn’t.’ Such permissive attitudes and practices can no longer be tolerated.”

Rep. Michael Bilirakis (R-Fla.) said his reaction on learning that one-fourth of the NIH scientists who are now paid industry consultants had gotten company stock or stock options was, “ ‘Wow,’ very loudly.”

Zerhouni said at Wednesday’s hearing that he would try to promptly implement the recommendation by the blue-ribbon panel that such stock payments be stopped.

Some of the most pointed criticism at the hearing came from Rep. Peter Deutsch (D-Fla.), who urged Zerhouni “in the strongest possible terms to end the practice today of NIH researchers taking anything of value from a drug or biotech company.”

Deutsch said current and former NIH leaders “have encouraged the option of corruption.” The NIH officials, Deutsch said, had been aided by lawyers at the Department of Health and Human Services who had helped thwart public disclosure of drug-company consulting fees and other payments.

Based on the still-incomplete information provided by the NIH, the subcommittee had determined that about 220 agency scientists were paid consultants to pharmaceutical or biotechnology companies as of December. With the increased attention on conflicts of interest at NIH recently, the number of scientists with paid industry arrangements has dropped, at least temporarily, to roughly 120.

Deutsch, the Florida Democrat, said the report of Zerhouni’s blue-ribbon panel was “an apology for the status quo.”

Under the panel’s recommendations, Deutsch said, NIH would retain conflict-of-interest policies amounting to “a system of careful twisting of the rules and overlooking of the consequences.”

“It is a report from a panel that blatantly refused to consider the most important facts,” Deutsch said. “The panel apparently felt compelled to base its recommendations on their misplaced need to excuse the inexcusable.”

The co-chairmen of the panel, Bruce Alberts and Norman R. Augustine, said at the hearing that they were convinced that allowing paid-industry consultancies might help NIH attract or retain talented scientists.

Alberts said the panel had been on the verge of recommending that public disclosure be required for all NIH employees who accept drug company fees. Among the 500 additional NIH employees who would be required by Zerhouni to publicly disclose their outside income were laboratory and research branch chiefs and program managers, said John Burklow, an agency spokesman.

Zerhouni, whose aides reviewed and commented on drafts of the blue-ribbon report as it was being written, said Wednesday that he had “reviewed all the panel’s recommendations.” He would, he said, “move ahead as appropriate.”

Rep. Henry A. Waxman (D-Los Angeles), while applauding NIH’s research preeminence, said Zerhouni should seek more public disclosure.

“I am particularly concerned that some potential conflicts of interest will still go undisclosed,” Waxman said.

“Americans need to know that when NIH reaches a conclusion, that conclusion is based on hard evidence and the scientific method.

“We need to act now to impose appropriate conflict-of-interest standards so that America and the global scientific community can continue trusting in NIH,” Waxman said.