Spigot Closed on Industry Consulting for NIH Scientists
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Yesterday the National Institutes of Health announced sweeping new rules restricting consulting arrangements between its scientists and pharmaceutical and biotech companies. Going into effect in a few days, the new rules will ban NIH scientists from consulting privately for drug companies, insurance companies, health care providers, and even some educational institutions that apply for NIH grants. In further changes, an NIH official announced that the informed consent process for clinical trials will have to disclose to trial volunteers whether trial investigators receive royalty payments for the treatment at hand. NIH researchers will continue to be permitted to receive private payment for writing textbooks, chapters, and articles.
Announced by NIH director Elias Zerhouni, the changes follow investigations over the past months into abuses of existing rules, which since the mid-90s had allowed paid consulting and required disclosure. Several newspapers yesterday reported details about this investigation, conducted by the NIH and the House Energy and Commerce Committee; see, for example, the New York Times article.
In the afternoon, Zerhouni and other agency officials said at a press conference that top-level NIH scientists would no longer be allowed to own stocks in pharmaceutical or biotech companies, and that lower-level employees can own no more than $15,000 worth of stock. NIH scientists will no longer be able to accept prizes and lecture awards from institutions that themselves apply for NIH grants. Industry payments for CME (Continuing Medical Education) courses can come only in the form of unrestricted educational grants.
Zerhouni said he was aware that the new rules would make it harder for the NIH to recruit and retain its best scientists. Reactions of NIH scientists ran the gamut from “we needed this” to threats to “walk across the street,” he said. However, while most of the consulting activities by approximately 5,000 NIH scientists were proper, some were not. Particularly galling to Zerhouni were cases where senior NIH investigators lent their names and NIH positions to what he called “product placement” of pharmaceutical products. “That is what drove us to say you need a bright line separating NIH employees from the biotech and pharmaceutical industry,” Zerhouni said.
The new rules currently apply to federal employees of the intramural system. Whether any of them will at some point be extended to extramural investigators who receive NIH support is undecided, Zerhouni said.
“The new regulations are more severe in their effect than the ones in place before 1995. The reason is that…the growth of biotech and pharma and the differences in marketing require us to have a more proactive stance in order to reestablish the trust that we deserve,” Zerhouni concluded.—Gabrielle Strobel.
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I definitely have mixed emotions about this issue. If it harms the NIH's ability to recruit the best minds in our country, we have definitely lost. Surely these professionals can be trusted to conduct themselves with dignity without these new rules.
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