A commonly-used drug, on the market for years, is proven to be completely useless

Not even better than nothing

For infants and the elderly, a danger hangs over every hospital stay.

That danger is sepsis, where blood borne bacterium overwhelms a vulnerable immune system, which can lead to septic shock, organ failure, and death.

And now we find out that for the past 10 years there’s been an additional danger: a drug that doesn’t work.

We’ve just learned that a widely-used and very expensive septic shock treatment called Xigris — a drug that many patients and their families pinned their survival hopes on — had no beneficial effect at all.

For nearly 10 YEARS this drug has been in use! And over the past 20 years the septic shock death toll has nearly doubled.

How many times does this sort of disaster have to happen before the public catches on that the FDA drug approval system is seriously broken?

End of a hapless era

The Xigris story is simple and sadly familiar: bad drug, great marketing.

When Xigris was approved by the FDA in 2002, executives and marketers for Eli Lilly (the maker of Xigris) had to overcome a significant hurdle.

At the time, the drugs most commonly used to treat septic shock cost about $50 per treatment.

And the Xigris price tag? At that time, each treatment cost $6,800! (The price went up over the years.)

As you can imagine, sticker-shock made Xigris slow to catch on. So Lilly hired a public relations firm that established the Surviving Sepsis Campaign, allegedly designed to raise awareness about Xigris, but offered to the medical profession as raising awareness about sepsis.

In 2003, Lilly assembled a group of critical care experts to create new sepsis management guidelines. Lilly provided the funding, of course, and — surprise! — the guidelines promoted Xigris over treatments that cost thousands of dollars less.

And that’s how a useless drug becomes a wild success.

Xigris was finally run to ground by additional research that was required by the European Medicines Agency. Results showed no difference between the drug and placebo in reducing all-cause-mortality in septic shock patients. And although the results are considered “statistically insignificant,” the death rate was actually slightly higher in the Xigris group.

And with that, Xigris is gone — removed from the market by Lilly executives who had a solid, lucrative 10-year run for a do-nothing drug.

Meanwhile, the FDA had little to say, and said it as plainly as possible: “Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris.”

What a shameful decade of “care” — lives lost and patients’ money wasted.

Meanwhile, as I mentioned earlier this year, the FDA is waging a campaign that could actually suppress a safe, inexpensive vitamin treatment that’s been shown to be effective in controlling sepsis.

I seriously doubt this campaign will be modified due to the Xigris debacle because the treatment is intravenous ascorbic acid (IAA), which has also been shown to cure certain cancers, encephalitis, measles, dangerously advanced cases of the flu, and other conditions.

Believe me, this is a treatment that drug companies DO NOT want on the market, and it appears that the FDA is only too happy to help move it aside to make way for “proven” drugs that eventually add up to a perfect zero.

Sources: 
“FDA Drug Safety Communication: Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit” FDA, 10/25/11, fda.gov