Three doctors at the National Institutes of Health, in an article in this week's New England Journal of Medicine, criticize the Eli Lilly drug company for its promotion of the expensive sepsis drug Xigris.
The doctors claim that Lilly manipulated treatment guidelines to give Xigris the upper hand over older, cheaper and equally effective treatments.
The authors wrote: "To improve sales of (Xigris) in 2002, Lilly hired Belsito and Company, a public relations firm, to develop and help implement a three-pronged marketing strategy. First, the product's sales were to be supported by marketing initiatives targeted to physicians and the medical trade media. Second, because (Xigris) was relatively expensive, word would be spread that the drug was being rationed and physicians were being "systematically forced" to decide who would live and who would die. As part of this effort, Lilly provided a group of physicians and bioethicists with a $1.8 million grant to form the Values, Ethics, and Rationing in Critical Care (VERICC) Task Force, purportedly to address ethical issues raised by rationing in the intensive care unit. Finally, the Surviving Sepsis Campaign was established, in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines."
Eventually the efforts of that ~$2 million task force led to treatment guidelines, as the New York Times reports, "that rated Xigris more highly than older treatments for which clinical trials treating sepsis had never been conducted."
The Times also reports that "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."
But then came the guidelines to boost use of Xigris.
The NEJM authors conclude: "The challenges involved in producing first-rate guidelines and performance standards are only exacerbated by the intrusion of marketing strategies masquerading as evidence-based medicine."