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NIH: Company influenced sepsis treatment
2006-10-18
Several government doctors say drug maker Eli Lilly & Co. subtly orchestrated medical guidelines for treatment of an often-lethal blood infection, hoping to boost sales of a drug whose value is being debated. Such involvement could open another door to corporate interests trying to shape health care, beyond funding experiments and cozying up to doctors in labs or at luncheons. Guidelines are meant to reflect independent medical opinion. "This company is trying to insinuate its drug into many aspects of patient care that industry really shouldn't be involved in," said Dr. Naomi O'Grady, a critical care specialist at the National Institutes of Health. Three of her NIH colleagues claim in Thursday's New England Journal of Medicine that Lilly worked through medical societies to influence standards for treating the blood infection, sepsis. Ultimately, Xigris was incorporated into the guidelines. Both the guidelines committee and a larger information campaign on sepsis were heavily funded by the Indianapolis-based pharmaceutical company. Spokeswoman Judy Kay Moore defended the company's role in a written statement, saying Lilly provided the money to help "advance understanding of patient care." "We do not believe that Lilly had any role in the development of guideline content, beyond funding the initiative," the statement said. "The campaign worked independently and autonomously, and our funding for these grants was openly disclosed." Dr. Phil Dellinger, who helped lead the guidelines committee, said its standards were written to benefit patients, not the drug company. "We've been catching grief because we've been taking a lot of Lilly money -- and we're appreciative of Lilly giving it," said Dellinger, of Cooper University Hospital, in Camden, N.J. The 2-year-old sepsis guidelines urge that very ill patients at risk of dying get the novel anti-clotting drug Xigris, the only medicine that directly attacks the disease. A $6,800 treatment can help protect organs destroyed by the bacterial infection, once called blood poisoning. About 750,000 cases occur in the United States each year, and nearly one-third prove fatal. The U.S. Food and Drug Administration approved Xigris in 2001, despite an evenly split vote by its advisory committee. The lead author of Thursday's journal article, Dr. Peter Q. Eichacker, voted against approval as an adviser. The other two authors are Dr. Charles Natanson and Dr. Robert L. Danner. "There's enough controversy and questionable data about the drug that it shouldn't be a standard," Eichacker said in an interview. Some critics are unhappy that the drug, which works only for the sickest patients, was approved on the basis of a single experiment. Lilly says the drug "was shown to reduce mortality in this deadly condition." However, later studies spurred fresh concerns about its effectiveness, bleeding risk and heightened mortality in some patients. Smarting from underwhelming Xigris sales and the end of its patent on the antidepressant Prozac, Lilly hired a public relations firm in 2002, according to the journal article. The company then set out to promote wider use of its drug, the authors wrote. As Dellinger tells it, Lilly also approached academic authorities and asked them to partner in a campaign to raise awareness of sepsis and its treatments. He says the academics warned the company its money would be a questionable influence if the company took a leading role. He said the company eventually agreed to provide arm's-length grants to professional societies, who then worked independently of Lilly. Several guidelines writers and members of the sepsis campaign say Lilly had no direct role in shaping the standards. Academic officials acknowledged in the published guidelines that Lilly gave more than 90 percent of $861,000 in grants for the campaign and medical recommendations. About a fifth of the 46 guidelines writers acknowledged previously taking money from Eli Lilly for speaking, consulting or research. Several acknowledged this week that it is extraordinary for one company to dominate the funding of standards in this way. However, they differed on the role that Lilly may have played in instigating the guidelines. Panel co-chairman Dr. Jean Carlet, of St. Joseph Hospital in Paris said Lilly pushed "to make those guidelines happen." "I don't think they influenced the guidelines at all -- but I might be wrong," he said. Carlet says Xigris should now be put to a second major test to confirm the first experiment. Dr. John Marshall, a surgeon at St. Michael's Hospital in Toronto who is vice chairman of the International Sepsis Forum, said the idea of guidelines originated with his group, not Lilly. "We're a fairly opinionated group of people and would not take kindly to any attempt to strong-arm us," he said. However, Lilly sponsors the sepsis forum, one of the promoters of the publicity campaign. O'Grady, of NIH, said a panel of disease experts that she headed refused to endorse the sepsis guidelines largely because Lilly "convened the whole panel." In any case, consumer activist Dr. Sidney Wolfe of Public Citizen worries the guidelines themselves are "good for the health of Lilly stockholders -- but possibly detrimental to the health of patients." ___ Jeff Donn reported from Boston, and Medical Writer Marilynn Marchione reported from Milwaukee. ___ On the Net: New England Journal: http://www.nejm.org FDA safety alert: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm
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