Eli Lilly Pushes the Envelope

Image from the "For Family and Friends" page of Eli Lilly's Xigris website.

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Even among the other scandals the drug industry has produced lately, the behavior described in the latest New England Journal of Medicine stands out as particularly stunning. According to a Perspective written by Peter Q. Eichacker, a National Institute of Health senior investigator in critical care, the drug giant Eli Lilly, seeking to incrrease sales of an anti-sepsis drug, Xigris, that had fallen short of its blockbuster expectations (in 2002, e.g., Lilly projected sales of $475M but didn't break $100M), hired a public relations firm to not only advertise the drug but to fund an "independent" group of doctors who would help spread the idea that hospitals, wary of the drug's $6,800 treatment cost, were "rationing" the drug. They then went on to manipulate practice guidelines in order to raise the drug's credibility and visibility. Here's the program as described in the New England Journal essay:

To improve sales of rhAPC, in 2002, Lilly hired Belsito and Company, a public relations firm, to develop and help implement a three-pronged marketing strategy.1 First, the product's sales were to be supported by marketing initiatives targeted to physicians and the medical trade media.1 Second, because rhAPC 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.1,3 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.3 Finally, the Surviving Sepsis Campaign was established, in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines.

The first phase of the Surviving Sepsis Campaign was introduced at an October 2002 meeting of the European Society of Intensive Care Medicine (ESICM). In the second phase, launched in June 2003, international experts in critical care and infectious diseases were convened to create guidelines for sepsis management, which were published in Critical Care Medicine in March 2004.4 Lilly provided more than 90% of the funding for these two phases, and many participants had financial or other relationships with the company.1,4 According to the Council of Public Relations Firms, Belsito helped to assemble the VERICC Task Force and launch the campaign, and initiated a media-outreach program to "raise awareness" of alleged rationing in severe sepsis with the intent of generating demand for rhAPC.1

You'll be pained to know the guidelines campaign was successful. The company is now pushing states to adopt the guidelines as "quality standards," which would raise the rate at which insurance companies would reimburse for use. All this despite that trials and other effectiveness measures since the drug's approval have shown it to double the chance of severe bleeding (from 3.5 to 6.5%) and to be less effective than the original clinical trials suggested.

Atop this, of course, came the usual massive advertising and "physician education" campaign. The entire effort, notes the Boston Globe, apparently succeeded, as the drug's sale rose even as clinical trials showed it increased the chance of dangerous bleeding and other studies showed it to be ineffective.

If the drug companies wonder why the public increasingly thinks them unprincipled (a kind term for what many people think of them) , they need look no further than stories like this -- mighty damning if even half of it is true. Indeed, one wonders that an industry that knows it's under fire would indulge in such antics. Yet this entire campaign, says the NEJM article, "continues unabated."

You can take more of it in, slack-jawed, via the New England Journal "Perspective," the Boston Globe story, or a chillingly matter-of-fact account of the campaign at the Council of Public Relations Firms.