>> Some Doctors Say Company Had a Hand in Guidelines For Handling Blood Infection
Associated Press October 19, 2006
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 today'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.
Lilly said in a prepared statement that it is taking the concerns raised "very seriously" and has examined the issue closely. It defended its activities by saying that it had an educational obligation to inform patients and providers about the disease, about which little had been known when the drug made its debut in 2001. "The standards for Lilly grants, then as now, are high, and we will continue to examine policies and procedures to ensure that our behavior in all things match our core values..." the company said in the statement.
Beyond paying for the initiative, Lilly said it didn't believe it played a role in developing guideline content. It said that its funding for grants was fully disclosed.
A doctor who helped oversee writing of the guidelines also rejected the accusation. He said that the guidelines 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 Dr. Phil Dellinger, of Cooper University Hospital, in Camden, N.J. The guidelines committee and a larger information campaign on sepsis were heavily funded by the Indianapolis-based pharmaceutical company.
The two-year-old sepsis guidelines urge that very ill patients at risk of dying get the novel anticlotting 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 U.S. each year, and nearly one-third prove fatal.
The Food and Drug Administration approved Xigris in 2001, despite an evenly split vote by its advisory committee. The lead author of today'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," Dr. 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. Later studies spurred fresh concerns about its effectiveness, bleeding risk and heightened mortality in some patients.
Lilly defends the drug on its Web site, calling it "a breakthrough therapy that has helped save thousands of lives." <<
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