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Marketing Sepsis Guidelines: Eli Lilly and Protein C
Eli Lilly’s marketing campaign played a major role in the development and adoption of guidelines for sepsis treatment.
These authors carefully dissected Eli Lilly’s role in the development of sepsis treatment guidelines, which incorporate use of the company’s product, known as "protein C." The FDA approved this product in 2001 based on a single phase 3 trial, even though half the panel requested that a confirmatory trial be conducted before granting approval. Because protein C was recommended for severe sepsis only, sales were lower than expected, prompting Lilly to hire a public relations firm to develop a three-pronged marketing campaign.
The first prong was a standard marketing campaign directed at physicians and the medical media. The second prong was much more sophisticated: Taking advantage of the drug’s high cost and, therefore, potential susceptibility to rationing, Lilly convened and supported a task force to address ethical issues associated with rationing. The third prong was the establishment of the "Surviving Sepsis Campaign" to provide momentum for guideline development. Lilly provided more than 90% of the funding for the guideline development groups.
Subsequently, two controlled trials of protein C in sepsis (ADDRESS and RESOLVE) were terminated early because no difference in primary endpoints was detected between groups; another study (ENHANCE) showed a near doubling of bleeding risk with protein C. None of these results was mentioned in a guideline supplement published after the data were available.
The campaign has been remarkably successful — the guidelines have been endorsed by 11 professional societies and numerous public nonprofit bodies, including the Joint Commission on Accreditation of Healthcare Organizations and the Institute for Healthcare Improvement. However, the Infectious Diseases Society of America declined to endorse the guidelines, citing the way they were developed, the rating system used for evidence, and drug-company sponsorship.
Comment: These authors rightly decry the effort to disguise marketing as evidence-based medicine. Marketing efforts, formerly easily seen for what they are, have now become insidious. Given the widespread adoption of the sepsis guidelines by various authorities, individual physicians might find it difficult to mount cogent arguments against them. The reality is that although the majority of the guidelines’ recommendations might be sound, the process was tainted by conflicts of interest at all levels. The FDA, Eli Lilly, and participating physicians and societies should take a good long look in the mirror and ask themselves if they are confident that their conduct in this matter was admirable.
— J. Stephen Bohan, MD, MS, FACP, FACEP
Published in Journal Watch Emergency Medicine October 27, 2006
Citation(s):
Eichacker PQ et al. Surviving sepsis — Practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med 2006 Oct 19; 355:1640-2.
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