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NIH doctors accuse Lilly of manipulating medical guidelines

Pharma Compliance Alert, October 25, 2006

Eli Lilly may have improperly influenced the development of professional guidelines for the treatment of sepsis in order to boost sales of Xigris, three physicians at the National Institutes of Health argue in the October 19 New England Journal of Medicine.

Since the Xigris was approved by FDA in 2001, Lilly has been a major sponsor of a sepsis guidelines committee and sepsis public information campaign. The guidelines recommend that very ill patients at risk of dying from sepsis be treated with Xigris, even though the evidence supporting treatment with Xigris remains controversial within the critical care professional community.

Eleven professional societies sponsored the guidelines, but the Infectious Diseases Society of America (IDSA), decided not to endorse them, citing concerns about the guidelines' development process and their sponsorship by a drug company with a financial stake in the guidelines.

"Although its advocates viewed this effort as an important approach to reducing sepsis-related mortality, the campaign appears to have usurped guideline development for commercial purposes, possibly compromising highly regarded, third-party arbiters of medical quality in the process," Peter Q. Eichacker, MD, Charles Natanson, MD, and Robert L. Danner, MD argue in the NEJM article. All three physicians work in the Critical Care Medicine Department, Clinical Center at the National Institutes of Health in Bethesda, MD.

"Such intrusion into an initiative to benefit public health is of particular concern in this instance, since the drug incorporated into the performance measures was endorsed on the basis of a single controversial Phase III trial that was still being called into question by additional studies even as the committee did its work."

According to The Wall Street Journal, Eli Lilly is taking the issues raised in the article "very seriously," but the company defends its activities, arguing that it had an educational obligation to inform patients and providers about the disease.

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