October 18

Press Coverage of Xigris NEJM article

Below reports in The Associated Press, The New York Times, and NPR about this week's critique of the Surviving Sepsis Guidelines in the New England Journal of Medicine by Dr. Peter Eichacker, Dr. Charles Natanson, and Dr. Robert Danner. See:  http://www.newmediavoice.com/ahrp/cms/content/view/364/27/ 

see also: www.ahrp.org/cms/content/view/366/27

The Associated Press
Eli Lilly accused of shaping drug guidelines
Critics say blood infection drug of questionable value
Oct 18, 2006

BOSTON – 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 opening 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.”
© 2006 The Associated Press. All rights reserved.

October 19, 2006
3 Doctors Assail Lilly Study of Sepsis Drug 

Three doctors at the National Institutes of Health have sharply criticized Eli Lilly for its efforts to promote the use of Xigris, an expensive treatment for patients with sepsis, an often deadly blood infection.  In an article published yesterday in The New England Journal of Medicine, the doctors wrote that Lilly — the nation’s sixth-largest drug maker — had manipulated treatment guidelines for sepsis patients to promote Xigris at the expense of older, cheaper and equally effective treatments.

Sales of Xigris have fallen far short of expectations since it was approved in 2001. In the first six months of this year, Lilly sold just $98 million of Xigris worldwide, a drop of 16 percent from the same period last year. Fewer than 150 patients a day receive Xigris in the United States. The journal article says that Lilly, in financing a task force called “Values, Ethics and Rationing in Critical Care,” had implicitly criticized doctors for “rationing” Xigris because of its expense. But in fact, the article says, evidence from clinical trials provides little support for using Xigris under any circumstances.
To promote Xigris, Lilly used “marketing strategies masquerading as evidence-based medicine,” they wrote.

The authors of the article are Dr. Peter Q. Eichacker, Dr. Charles Natanson and Dr. Robert L. Danner, who are senior investigators in the critical care medicine department at the N.I.H.
Two recent clinical trials of Xigris have been discontinued because the drug increased the risk of severe bleeding and — at best — did not reduce the overall death rate in patients who received it.
In a statement in response to the article, Lilly said yesterday that it had behaved properly and disclosed its role in financing a task force of doctors and scientists that devised treatment guidelines for sepsis.
“Lilly felt a clear obligation to support educational efforts in the health care community, both on the disease state over all and on the medicine to ensure appropriate use,” the company said.
Xigris, which costs about $8,000 for a four-day course of treatment, generated controversy even before federal regulators approved it in November 2001. To win approval, Lilly presented results from a clinical trial that showed that Xigris reduced the risk of death in sepsis patients to 25 percent, down from 31 percent with older treatments.

But the details of the data from the trial left many scientists who reviewed it unconvinced of Xigris’s efficacy. Half of the 20 scientists who reviewed the drug for a Food and Drug Administration advisory committee hearing in October 2001 said the agency should not approve the drug without more data. A month later, the F.D.A. approved Xigris, but warned that its use should be limited to the sickest patients, where it appeared to have the greatest efficacy.

The next year, Lilly gave $1.8 million to a task force of 20 scientists and hospital directors. In 2004, the group published guidelines that rated Xigris more highly than older treatments for which clinical trials treating sepsis had never been conducted.
In the New England Journal article, the N.I.H. scientists criticized those findings, arguing that the older treatments should not have been dismissed, despite the lack of clinical trials. The benefits of older treatments like antibiotics were already so well-known that withholding them from patients, even in the controlled setting of a trial, would have been unethical, the authors wrote.

Copyright 2006 The New York Times Company

Report: Lilly Promoted Drug Under False Pretenses
by Richard Knox
A new report accuses Eli Lilly of manipulating the market for its Xigris drug (top) with the help of an advocacy group and a public-relations firm (bottom). NPR 
Web Resources
• Xigris Web Site
• Surviving Sepsis Site
• Marketing Recap: Eli Lilly and Belsito
• Nat'l Guidelines: Surviving Sepsis
All Things Considered, October 18, 2006 • 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.

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