Xigris Pulled – $1 billion Later

Another over-hyped and over-marketed drug bites the dust. Eli Lilly earlier this week pulled Xigris from the market after a clinical trial showed it provided no benefit for hospital patients with septic shock. From the start, critical clinicians questioned the efficacy of this drug, which is used to treat sepsis, a hospital-acquired systemic infection that often strikes the elderly in the wake of major operations. The Food and Drug Administration approved the drug in 2001 after a single, small trial showed a 28-day survival benefit. The FDA approval came despite half the members of an advisory panel voting against the drug.

Caution should have been the order of the day for physicians treating patients with this life-threatening condition. The company took an opposite path. It launched a “surviving sepsis” campaign that won endorsement from 11 professional societies (although the Infectious Disease Society of America did not join the campaign). Many of the docs who served on the guideline-writing panels for those professional societies earned consulting fees from Eli Lilly, according to a 2006 article in theNew England Journal of Medicine questioning the ethics of the Lilly campaign.  Sales of the biologic, which never reaching the blockbuster status hoped for by the company, soared to more than $200 million a year.

After the latest results of a “confirmatory” trial ordered by cost-conscious European regulators found the drug didn’t work, Eli Lilly called the results of the trial “quite unexpected. . . A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past ten years.” It promises to conduct another trial to identify which patients might benefit from the drug.

It would be interesting to go back and have a look at where the clinical practice guidelines of those 11 professional societies are today as the “standard of care” has improved. How many still recommend use of Xigris?

Merrill Goozner is an independent health care journalist. He blogs at Gooz News.