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Article questions Eli Lilly marketing push

NIH team: Firm aimed to shape drug guidelines

WASHINGTON -- Eli Lilly and Co. funded medical guidelines created for the treatment of a deadly infection in an effort to boost sales of a drug with questionable benefits, according to an article in today's issue of the New England Journal of Medicine .

The allegation was made by a group of senior scientists at the National Institutes of Health. The scientists said Lilly tried to shape the guidelines for use of the drug Xigris by sponsoring a three-pronged marketing campaign. Xigris is used to treat sepsis, a massive inflammatory response to a blood infection.

In the first phase of the campaign, underwritten by a $1.8 million Lilly grant, a task force spread word that hospitals, wary of Xigris's $6,800 cost, were rationing the severe sepsis treatment. According to the task force, the ``alleged rationing" forced doctors ``to decide who would live and who would die," the journal article said.

Lilly then ``orchestrated" the development of practice guidelines to treat sepsis to help drive sales of Xigris, the authors wrote.

Now, Lilly is sponsoring lobbying efforts to turn the guidelines into quality standards, the article said. Hospitals that follow such quality measures receive higher payment from insurers.

Dr. Peter Q. Eichacker , a senior investigator in NIH's critical care medicine department and primary author of the paper, said patients and physicians deserve guidelines that are free of industry bias and based on ``the best research and clinical experience available."

Instead, Eichacker and his co authors wrote, pharmaceutical companies see medical guidelines as ``a potentially powerful vehicle for promoting their products."

Lilly, in a prepared statement, said it was ``proper" to provide funding for the Surviving Sepsis Campaign. ``We do not believe that Lilly had any role in the development of guideline content, beyond funding the initiative," the company said. ``The campaign worked independently and autonomously, and our funding for these grants was openly disclosed."

In the New England Journal perspective piece, however, the authors charted an uptick in Xigris sales as Lilly's marketing campaign matured. The sales boost came even as clinical trials showed the drug slightly increased serious bleeding risks for patients. Other studies have called its effectiveness into question.

From its introduction in 2001, Xigris has sparked debate because it was approved by the Food and Drug Administration based largely on a single late-stage study showing it extended survival by 28 days.

Dr. Mitchell Levy, a Brown Medical School professor who independently assembled the task force of physicians and bioethicists concerned about under-use of Xigris and other treatments for critically ill patients, said Lilly's funding ``is an example of beneficial partnership with industry."

Some 750,000 sepsis cases occur each year in the United States , a figure expected to rise as patients grow older and high-risk surgeries increase, according to another paper in today's New England Journal of Medicine . Mortality rates from severe sepsis can be as high as 40 percent .

``You have an illness that is responsible for more deaths in the United States than breast cancer, lung cancer, and colon cancer combined. There are new interventions that over the last five years have been demonstrated to improve survival," Levy said.

Clinicians take a long time to begin using new treatments, he said, and ``this campaign is an attempt to reverse that tide a little bit."

Diedtra Henderson can be reached at dhenderson@globe.com.

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