Xigris Pulled – $1 billion Later

October 26, 2011
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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 the New 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? If anyone knows, please comment.

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4 Responses to Xigris Pulled – $1 billion Later

  1. Jim on October 26, 2011 at 8:49 am

    Standard of care for sepsis has not materially changed since the PROWESS trial. The study was poorly designed, with a significant change in the study protocol midway through enrollment. Multiple subsequent trials and post-hoc analyses either failed to show benefit or showed trends towards harm. This is not an issue of improvement in standard of care – the drug just never worked. The FDA should have mandated a confirmatory trial immediately, especially in light of the narrow approval vote.

  2. joe on October 28, 2011 at 7:14 am

    I sold this drug for Lilly and it was such a joke. Most docs wouldn’t use it since they new egdt worked the same if not better. But every single day management pushed and pushed us to promote the drug especially during the flu season. I quit after unwashed told iwasnt taking enough risks sneaking into the ICU to talk to docs. Glad to see this drug is off the market!!!!

  3. Gary Black on October 30, 2011 at 9:31 am

    Hello,
    I am a survivor of severe sepsis. I was not given Xigris, but quickly treated with fluid resuscitation,oxygen and broad spectrum antibiotics.
    I have a new book published: Gyroscope, A Survival of Sepsis
    It takes you through the mental,physical and even spiritual dimensions of this devastating illness that has no panacea drugs to cure it. I spent 31 days in the hospital.
    Check my website http://www.sepsisawarenesstoday.com
    I enjoyed your article.
    Sincerely,
    Gary Black, author

  4. T. Johns RN on October 31, 2011 at 8:04 am

    Your Xigris article hit the mark!
    However, your definition of sepsis as “a hospital-acquired systemic infection” is incorrect. Sepsis is a systemic response to ANY infection that has “overwhelmed” the body’s immune system and caused SIRS (systemic inflammatory response) and organ failure. Yes, sepsis can develop from a surgical wound infection, but it can also develop from pneumonia developed after a bout with the flu or from a “simple” urinary tract infection.

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