Drug maker Eli Lilly & Co. used questionable marketing practices to promote its drug to fight blood infections, according to several doctors. A whistleblower report in the New England Journal of Medicine accuses the company of initiating false reports of a shortage of the drug, Xigris.
The plan involved a public-relations firm hired by Eli Lilly, which then spread the word that its very expensive drug was being "rationed," the report says. It also included descriptions of physicians being "systematically forced" to decide who would live and who would die.
Xigris was designed to fight sepsis, a condition that kills more than 200,000 Americans annually. It is the only approved drug for sepsis, and it costs $8,000 to treat a single patient. Lilly hoped it would be a blockbuster, with sales of at least a billion dollars a year. But after five years on the market, sales are only $200 million.
That led the company to take unusual steps, according to Dr. Robert Danner, an infectious-disease expert at the National Institutes of Health. Danner emphasizes that in this case, he is speaking as a private citizen, not an NIH employee.
Danner says Lilly hired a P.R. firm that created the message that doctors were being forced to ration Xigris because of its high cost. That message was promoted by a newly formed task force on ethics. Lilly funded the task force with $2 million.
Next, a group of physicians, many with financial ties to Lilly, founded the Surviving Sepsis Campaign. Lilly provided the great majority of the funding. The campaign's first task was to formulate new practice guidelines for treating sepsis.
At least 11 medical groups endorsed the new guidelines. But the influential Infectious Diseases Society of America did not.
Dr. Naomi O'Grady chaired the panel of the Infectious Diseases Society that reviewed the guidelines.
"Let me choose my words carefully," said O'Grady, who is not involved with the current report. "This guideline really, I believe, was designed to promote a product."
O'Grady says her panel felt the guideline was developed hastily, and did not properly weigh the evidence for Xigris. The committee also didn't like the fact that Lilly funded the process.
Eli Lilly spokeswoman Judy Kay Moore insists that the company did not mastermind the ethics task force or steer the guideline-writing process.
And it was only a coincidence, Moore says, that the ethics task force and the Surviving Sepsis Campaign used the same P.R. firm, Belsito and Company.
We did not intend for or direct Belsito and Company to act on Lilly's behalf in this regard," Moore says. "Lilly did not recommend that they hire Belsito. And Lilly gave a grant to these groups and off they went to do their work."
But Lilly says that it is taking the criticism "very seriously."
Dr. Mitchell Levy, of Rhode Island Hospital, is a leader in the Surviving Sepsis Campaign. He says there's nothing wrong with a drug company funding the efforts, as long as everybody's open about it.
"In an ideal world, where there was enough NIH funding," Levy says, "for purity it would be great to not have to use industry funding."
Levy is working with a respected Massachusetts firm, the Institute for Healthcare Improvement, to turn the complex treatment guidelines into a boiled-down version that hospitals pledge to implement.
Many believe the guidelines set the stage for how doctors ultimately will be paid -- that is, according to whether they adhere to treatment guidelines. Robert Danner, one of Eli Lilly's critics, says this gives drug companies an even greater motive to influence guideline-writing.