Moonlighting Federal Watchdogs

Some of the National Institute of Health's top officials have received hundreds of thousands of dollars in consulting fees from drug companies whose products they were responsible for monitoring, the Los Angeles Times reported Sunday.

The newspaper, citing records it said it began gathering five years ago, reported that in some instances officials of the federal institute operated as consultants for companies whose drugs were linked to the deaths of patients taking part in NIH studies.

Dr. Ruth L. Kirschstein, who as deputy director and acting director of the agency since 1993 approved many of the consulting arrangements, told the newspaper she did not believe the public's interest had been compromised.

"I think NIH scientists, NIH directors and all the staff are highly ethical people with enormous integrity," she said. "And I think we do our business in the most remarkable way."

She said she would consider making changes in the consulting arrangements.

"Systems can always be tightened up," Kirschstein told the Times during an interview in October. "And perhaps, based on this, we will do so."

A month after that interview, NIH Director Elias A. Zerhouni told agency leaders he would form a committee to study the appropriateness of employee consulting work.

He told the Times he wants the institute "to manage not just the reality, but the perception of conflict of interest."

Medical ethicists said the consulting arrangements represent a clear conflict of interest.

"If I am a scientist working in an NIH lab and I get a lot of money in consulting fees, then I'm going to want to make sure that the company does very well," said Dr. Arnold S. Relman, former editor of the New England Journal of Medicine.

He said the arrangement also raises concerns about patient safety.

One patient the Times said died was Jamie Ann Jackson, who had been listed as "Subject No. 4" in an NIH study of the treatment of kidney inflammation related to lupus, a disease that attacks the body's immune system.

The cause of death was linked to a complication involving use of a drug made by Schering AG, for which Dr. Stephen I. Katz, the senior NIH official involved in the study, was a paid consultant.

Katz didn't stop the study after Jackson's death or warn doctors outside the agency, which could have threatened the market potential for the drug, the Times said.

Katz said his connection to Schering AG had no influence on his decisions and his work for the company had been approved by top NIH officials.

Katz has been paid between $476,369 and $616,365 in company fees over the past decade, the Times said, citing his income-disclosure reports.

Dr. John I. Gallin, director of the NIH's Clinical Center, the nation's largest site of medical experiments on humans, has received $145,000 to $322,000 in fees and stock proceeds for consulting work done between 1997 and 2002, the newspaper said. In one case, the Times said, he co-wrote an article on the gene-transfer technology done by a company he consulted for.

Several other NIH officials were cited as receiving hundreds of thousands of dollars, including one who received more than $1.4 million. Some of them also were paid by companies involved in the agency's research or whose products were the subjects of NIH studies.

Each of them told the newspaper their consulting work was done with the approval of top institute officials.

Uncovering such payments is difficult, the Times said, because the NIH allows more than 94 percent of its top-paid employees to keep their consulting income confidential.

The NIH has been at the forefront of medical research for decades, leading the government's battles against cancer, AIDS and other diseases. More recently, President Bush pressed the institute, part of the Department of Health and Human Services, into service in the fight against biological terrorism.