Xigris - Pharma's Biggest Flops

Drug: Xigris
Company: Eli Lilly

The promise: Back in the early 2000s, Eli Lilly was facing the loss of patent protection on Prozac. Enter Xigris, which acts within blood vessels to treat severe sepsis. It was seen as a potential major money-maker for Lilly-some were even predicting sales $2 billion in three years. "Sepsis is an absolutely phenomenal opportunity for Lilly," said Trevor Polischuk, an analyst with Lehman Brothers, back in 2001. "Doctors in the intensive care units are a practically untapped market."

The FDA approved Xigris at the end of November 2001. But sales were not as brisk as anticipated.

What went wrong:  In Lilly's 2002 annual report, then-CEO Sidney Taurel (photo) said the uptake of Xigris "was slower than expected, weighed down by a narrow label and prescriber caution when evaluating this unprecedented and unique therapeutic option. We saw it would take considerably more time, effort, and investment to deliver the full promise of Xigris." But not everyone was sold. In September 2002, an article appeared in the New England Journal of Medicine in which the authors stated that the data on Xigris are encouraging but insufficient to make it the standard of care, according to MedScape.

During the first half of 2006, Lilly sold just $98 million of Xigris worldwide, a drop of 16 percent from the same period the year before, according to a New York Times article. Then Lilly was criticized by three NIH doctors--Peter Eichacker, Charles Natanson and Robert Danner--for its efforts in promoting Xigris. 

In a NEJM article, the three accused Lilly of financing a task force called "Values, Ethics and Rationing in Critical Care," to spread the word that doctors were "rationing" the expensive Xigris. Lilly funded the task force with $2 million, according to NPR.

But it didn't end there. A group of physicians--many with financial ties to Lilly--founded the Surviving Sepsis Campaign. Lilly provided the great majority of the funding, NPR reported. Dr. Naomi O'Grady, who chaired the panel of the Infectious Diseases Society that reviewed the guidelines, tried to be careful in choosing her words. "This guideline really, I believe, was designed to promote a product," she said, as quoted by NPR. A Lilly spokeswoman denied that the company masterminded the ethics task force or steered the guideline-writing process. 

Xigris - Pharma's Biggest Flops