October 27, 2011
Xigris: “Another over-hyped and over-marketed drug bites the dust”
As he so often does, Merrill Goozner offers some important historical perspective to the news, as he headlined it: “Xigris Pulled – $1 Billion Later.” Excerpt:
“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.”
Here’s my piece, “Eli Lilly not lily-white on Xigris promotion?” from almost exactly 5 years ago today.
Comments
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T. Johns RN
October 27, 2011 at 5:32 pmYour 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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