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How Can We Trust Clinical Studies When Scientists Have a Conflict of Interest?
Just because a scientific study exists, doesn't make it reliable. This adage became excruciatingly clear in the December 7, 2003 Los Angeles Times exposé of officials at the National Institute of Health (NIH), who have worked as consultants for companies whose drugs were linked to the deaths of patients taking part in NIH studies. According to the report, it's also become common for scientists who work for the NIH to consult at private companies for stock options and/or hefty consulting fees. 1
The consulting deals between drug companies and employees at the NIH, however, have gone all but unnoticed, the Times said, because the NIH allows more than 94 percent of its top-paid employees to keep their consulting income confidential.
Interviews and corporate and federal records obtained by the Los Angeles Times document hundreds of consulting payments to ranking NIH officials. Here are a few:
- Dr. Stephen I. Katz, director of the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, collected between $476,369 and $616,365 in company fees in the last decade. One company paid him more than $140,000 in consulting fees, and went on to win $1.7 million in grants from his institute.
- Dr. Ronald N. Germain, deputy director of a major laboratory at the National Institute of Allergy and Infectious Diseases, has collected more than $1.4 million in company consulting fees in the last 11 years, plus stock options. One of the companies collaborated with his laboratory on research. The founder of another of the companies worked with Germain on a separate NIH-sponsored project.
- Dr. Richard C. Eastman, the NIH's top diabetes researcher in 1997, wrote to the Food and Drug Administration that year defending a product without disclosing in his letter that he was a paid consultant to the manufacturer. Eastman's letter said the risk of liver failure from the drug was "very minimal." Six months later, a patient, Audrey LaRue Jones, who was taking the drug in an NIH study that Eastman oversaw, suffered sudden liver failure and died. Liver experts found that the drug probably caused the liver failure.
Medical ethicists have said the consulting arrangements represent a clear conflict of interest. The problem is, a scientist who gets a lot of money in consulting fees is going to want to make sure the company paying him does very well, and sometimes that results in the death of a research participant.
Death of a patient had no impact on continuance of a study
Jamie Ann Jackson, who had been listed as "Subject No. 4" in a NIH study of the treatment of kidney inflammation related to lupus, died because of a complication involving the drug Fludara, made by Schering AG. As it turns out, Dr. Stephen I. Katz, the senior NIH official involved in the study, was a paid consultant for Schering AG. Katz could have stopped the study immediately after Jackson's death or warned doctors outside the NIH who were prescribing the drug for similar disorders. But he did neither, because, as the Times reported, either step might have threatened the market potential for Schering AG's drug.
According to the Times, in an article published in the May 2001 issue of the journal Pharmacotherapy, the doctors, three from Katz's institute, wrote that Fludara "was well tolerated" and thanked the company for providing the drug and "analytical support."
It wasn't until December, 2003, 4 1/2 years after Jackson died, that these same doctors published a full-length article in the journal Transfusion describing her death.
"Such dual roles - federal research leader and drug company consultant - are increasingly common at the NIH, an agency once known for independent scientific inquiry on behalf of a single client: the public," writes David Willman, author of the Times report. And, in fact, conflicts of interest among university medical researchers have also received wide attention in recent years.
Private consulting fees distort interpretation of study results
Dr. Curt D. Furberg, former head of clinical trials at the National Heart, Lung and Blood Institute, is quoted in the Times article as saying "Science should be for the sake of gaining knowledge and looking for the truth. There should be no other factors involved that can introduce bias on decision-making
"Private consulting fees tempt government scientists to pursue less-deserving research and to 'put a spin on their interpretation' of study results," he adds.
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