Sepsis -- a system-wide infection that produces an overwhelming and frequently deadly immune response in the body -- infects roughly 750,000 Americans every year. Up to 70 percent die of septic shock from the infection, while as many as 30 percent die from severe sepsis.
Though antibiotics can be used to cure sepsis, they can be slow to work. Lilly developed Xigris -- a genetically engineered human protein known as recombinant human activated protein C -- to help control the body's often deadly immune response to the infection. Xigris was tested in a single trial and found to reduce sepsis deaths from 44 percent to 31 percent among patients with the highest risk of death.
The federal researchers accused Lilly of trying to influence the sepsis treatment guidelines to benefit prescriptions of Xigris by hiring a marketing firm and paying ethicists and doctors to launch a campaign about how to choose which emergency room patients suffering from sepsis should receive Xigris. Sales of Xigris -- which fell short of its "blockbuster" projections -- were less than a quarter of expectations.
The company claimed its Xigris campaign was strictly educational, with the goal of ensuring only the appropriate patients were treated with the drug.
Dr. Peter Eichacker -- a panel adviser who voted against FDA approval of Xigris, which can cause bleeding -- of the National Institutes of Health, along with NIH staff members Dr. Charles Natanson and Dr. Robert Danner, charged that Lilly's campaign to influence the guidelines added up to "an extension of a pharmaceutical marketing campaign."
The three NIH researchers accused the drug firm of spreading word via marketing campaigns that Xigris "was being rationed and physicians were being 'systematically forced' to decide who would live and who would die," they wrote in a letter to the New England Journal of Medicine.
The researchers also said Lilly approved a $1.8 million grant to a group of doctors and ethicists to crease a task force for addressing ethical issues raised by rationing Xigris in the emergency room. The company also created a "Surviving Sepsis" campaign to raise awareness of severe sepsis and bring attention to the development of treatment guidelines, the researchers wrote.