Drug Companies’ Consulting Fees at Issue

Last month, the chairman of the House Energy and Commerce Committee called the National Institutes of Health an “ethical Potemkin village,” where a facade of tough-sounding rules had shrouded permissive dealings with drug companies.

NIH ethics rules, tightened last year, prohibit employees from accepting any form of pharmaceutical company stock and most types of drug industry fees. But the agency’s director, Dr. Elias A. Zerhouni, recently said that NIH was assessing whether the stricter rules had driven away talented scientists. The assessment may determine whether rules are changed.

The payments from the drug companies to the federal scientists have raised questions about decisions surrounding which products make it into NIH clinical trials, as well as the scientists’ safety decisions and interpretation of results.

Question: How many government scientists at the NIH have taken consulting fees or stock awards or options from drug companies?

Answer: After six congressional hearings spanning more than two years, we still don’t know because not all of the financial arrangements have been revealed. When the Energy and Commerce Committee asked 21 drug companies for information about recent relationships with NIH scientists, scores of previously undisclosed arrangements were identified. And many drug companies were not contacted, so there may be additional undisclosed payments.

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Q: For how many years did NIH scientists accept fees or stock from the drug companies?

A: This also is hard to know, although many veteran employees said they saw little or no consulting with the companies before the mid- to late 1980s.

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Q: Did a single event open the door more widely?

A: Yes. In a November 1995 memo, then-NIH Director Harold E. Varmus informed directors of the agency’s 27 research institutes and centers that he was rescinding a policy that had barred them from accepting consulting fees and payments of company stock. Other conflict-of-interest rules that Varmus changed: For the first time, all NIH employees were allowed to accept industry stock or options. A limit of up to $25,000 per year in total outside income and a requirement that an employee not spend more than 500 hours a year on outside activities also were rescinded.

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Q: Why have drug companies sought to hire NIH scientists as consultants?

A: Many companies say the scientists bring valuable expertise. In some instances, companies acknowledged that the luster of the NIH was seen as an asset in attracting investment capital.

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Q: Why have NIH scientists sought paid consulting deals?

A: Some have said that working with industry gives them new perspectives on delivering a product or technology that could be used by the public. Varmus has acknowledged an additional motive for drug-company consulting among NIH scientists: money.

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Q: How much does the NIH pay its scientists?

A: Among those who have reported industry consulting payments, annual federal salaries at the NIH have often ranged from $130,000 to $200,000.

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Q: Aside from the now-banned paid arrangements, do NIH scientists still collaborate with industry on research?

A: Yes -- these “official duty” activities are encouraged under federal law and often result in the NIH teaming with a company to test an experimental product.

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Q: Of the 103 scientists who came under internal investigation, typically because their arrangements with drug companies had not been pre-approved, how many were fired?

A: None, although NIH administrators have recommended the terminations of two senior researchers. Decisions in those cases are pending. Six other scientists left the NIH before investigations were completed.

david.willman@latimes.com