Probe Sought Into NIH Officials’ Outside Work

Three leading House Democrats on Friday asked the General Accounting Office to investigate consulting fees and stock options paid by drug companies to employees at the National Institutes of Health.

Citing details from a Los Angeles Times article published last month, the House members called for an “investigation into potential conflicts of interest” at the federal government’s center for medical research on humans.

The General Accounting Office typically reviews such requests for several weeks before deciding how to proceed, according to a spokeswoman.

The Times identified hundreds of consulting payments, totaling millions of dollars, to senior NIH scientists. Rules prohibiting top NIH officials from accepting consulting fees and stock options from drug companies were lifted in late 1995, through an internal memorandum from the leader of the NIH that had not been made public prior to last month’s article. The Times also reported that about 94% of the top-paid employees at the NIH were not required to publicly disclose payments from outside employers, including drug companies.

The request made Friday by Reps. Henry A. Waxman (D-Los Angeles), John D. Dingell (D-Mich.) and Sherrod Brown (D-Ohio) follows the announcement of an inquiry being led by the Republican chairman of the House oversight and investigations subcommittee, Rep. James C. Greenwood of Pennsylvania. The Appropriations subcommittee on labor, health and human services and education, led by Sen. Arlen Specter (R-Pa.), also plans to question NIH officials at a hearing on Thursday.

A spokesman for NIH, John Burklow, said the agency’s director, Dr. Elias A. Zerhouni, was cooperating and “working closely with the committees.” Burklow added, “He takes these, and NIH takes these, concerns very seriously. Extremely seriously.”

In a letter, the House Democrats asked the General Accounting Office, the investigative arm of Congress, to:

* “Determine the extent to which NIH employees have financial relationships with pharmaceutical manufacturers, and determine whether there is adequate disclosure of these relationships.” The congressmen asked the General Accounting Office to “identify the specific manufacturers involved, as well as the frequency and amount of payments by these manufacturers.”

* “Review and compare the NIH’s procedures for preventing conflicts of interest to the procedures in place at other scientific agencies of the U.S. government.”

* “Provide a review of actions taken by the NIH director in response to the report in the Los Angeles Times, and determine if these actions were adequate to (A) terminate any existing conflicts of interest, real or perceived, (B) prevent future real and apparent conflicts of interest, and (C) ensure adequate disclosure of NIH scientists’ outside relationships.”

* “Provide additional recommendations to ensure that conflicts of interest, and the appearance of such conflicts, are reduced at NIH.”

In an interview, Waxman said, “It is evident that there is a real problem at NIH, when researchers can make hundreds of thousands of dollars consulting, at the same time they’re doing research paid for by the public.”

“I’m very disturbed at the idea of anybody in the NIH being able to work for a drug company, be highly compensated, and put themselves in a position where there’s an apparent conflict of interest,” he said. Institute directors at NIH receive government salaries of $200,000 and up.

NIH leaders “haven’t done a very good job” of prohibiting potential conflicts of interest, he said, and “now it’s our responsibility to find out why and to make sure that they change.” Waxman is the senior Democrat on both the oversight and investigations subcommittee and the House Government Reform Committee.

Waxman said he favored scrapping the NIH’s “honor system” intended to enforce pledges by agency employees to refrain from acting on matters involving their drug-company clients. The Times last month documented instances in which the pledges were not carried out as intended.

“No one’s enforced the rules,” Waxman said. He also said he was surprised to learn about the lack of public financial disclosure among top-paid NIH employees.

Yet Waxman said he did not want questions about conflicts of interest at the NIH to be exploited by those who oppose federal research in areas such as sexuality and embryonic stem cells. His concern was echoed by aides to several Republican and Democratic members of Congress, who pointed out that, while bipartisan majorities of Congress doubled the NIH budget in the last several years to $27.9 billion, some House Republicans have tried to discourage the NIH from funding research to which they object.

Zerhouni, the agency’s director, is the first official set to appear on Thursday before the Senate subcommittee headed by Specter. Zerhouni is to be followed by five other officials, including: the acting head of the U.S. Office of Government Ethics; Dr. Ruth L. Kirschstein, the deputy NIH director; Dr. John I. Gallin; director of the NIH Clinical Center; and Dr. Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Specter described himself on Friday as “a big booster of NIH,” adding, “But they’ve got to have some oversight, and that’s what we’re doing here.”

As for the NIH’s policy of allowing the institute directors to accept consulting fees and stock options from drug companies, Specter said, “I have grave doubts about it because of the potential for conflict of interest. But I don’t want to prejudge it until we take a look at the specifics. That’s why we’re having a hearing. I want to get Dr. Zerhouni’s view on it.”

Zerhouni, while pledging cooperation, said three weeks ago he had found “no evidence” that patients had been harmed or that medical decisions were influenced by company payments to agency officials. And in a recent address to NIH employees that was described last week in an agency newsletter, Zerhouni said: “I would rather have our scientists sought after than considered irrelevant and sought after by no one.”

Waxman said that if Zerhouni defended the status quo, he risked “being out of sync with the facts.”

“I don’t think they can say there is not a problem,” he said.