Sepsis: Blood Poisoning Kills Thousands, But No Drugs to Help


Drug's Withdrawal A Premature Decision, Some Say

But a new analysis, published Monday in the journal Lancet Infectious Diseases, throws into question whether or not Xigris should have been withdrawn at all. In it, Nebraska's Kalil analyzed the results of more than two dozen studies of Xigris, most performed in the "real-world" of clinics and hospitals, trying to save patients with sepsis.

The results suggest that Xigris is effective after all. The study found that Xigris reduced patients' risk of dying by 18 percent, similar to the results Eli Lilly had reported in its first study of the drug.

"I was expecting to see a very small effect, close to no effect. I was surprised when we saw these kinds of results," Kalil said.

So should the drug be put back on the market? The answer is uncertain and, as far as Eli Lilly is concerned, unfeasible. Putting the drug back on the market would mean conducting another long, expensive clinical trial to clear regulatory hurdles. Janes said the company has no plans to do that, even in the face of evidence suggesting the drug's effectiveness.

"We have to live with the results of our clinical trials," Janes said. "It goes back to the point of deciding what the company is going to invest in."

Although the drug would likely help hundreds of thousands of patients, it will likely never be as profitable as drugs that can help millions of patients with more common conditions, such as high blood pressure, diabetes or cancer.

And questions remain about whether the drug was ever truly helpful for patients. Doctors never really identified the type of patient who would benefit the most from Xigris. The new study suggests that perhaps only the sickest patients really improve after taking the drug. Trials of the drug in pediatric patients like Rory never succeeded.

Dr. Cliff Deutschman, a professor of anesthesiology and critical care at the University of Pennsylvania, said he was never really convinced that the drug was better than treating patients with antibiotics and fluids.

"Ultimately, it's pretty hard to know what to make of the results of these studies," he said.

Since Xigris was introduced and withdrawn, doctors and hospitals also seem to have gotten a little better at screening and stopping sepsis in its early stages. Programs like the Stop Sepsis campaign, a program started by the Greater New York Hospital Association, emphasize promoting awareness of the condition and the critical importance of getting care to patients in the first hours of their symptoms.

But many doctors say a drug like Xigris would be invaluable in saving the lives of hundreds of thousands of patients. Martin said he still believes Xigris could be that drug.

"There's real potential that this drug has the ability to treat and cure people. But we don't know who the drug works best in, and that's probably where the interest was lost," Martin said.

And for now, it seems that doctors will never know. Since Eli Lilly withdrew the drug from the market, it is no longer available even for research purposes.

Deutschman said the biggest blow is that given the Xigris's failure and Eli Lilly's experience, other pharmaceutical companies will be reluctant to spend the money to pursue any treatment for sepsis. For now, the scientific and regulatory bar for a drug is very high.

"There still may be groups of people that it [Xigris] does work on, but because the drug is no longer available we'll never know. And that's discouraging," he said.

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