Grassley Marches on HHS to Demand Faster Action on Alzheimer's Drugs

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  • 06/16/2006

Not really. When’s the last time you saw any pol manufacture or expend any political capital to advocate for faster cures.

By the way, on the Ketek matter. How many articles have mentioned that nearly ten million prescriptions have been written for Ketek worldwide since it was approved in Europe in 2001 and about 5 million have been written in the US since it was approved here in 2004. Over that time there have been 11 cases of acute liver failure, including the four deaths, in patients treated with Ketek, according to an FDA memo. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic. Which means the incidence for liver problems (we can assume a part of those were the result of genetic mutations and poor prescribing, neither of which can be anticipated under our current regulatory system) is about .00066 percent and a death rate of 0.0000008

Meanwhile, “Acetaminophen poisoning has become the most common cause of acute liver failure in the United States,” report the authors of a new study in the December 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). While attempted suicides still account for many cases, almost half are the result of unintentional overdose.
Now about 100 million people use acetaminophen each year. And each year about there about 56,000 ER visits and 100 deaths (liver failure) attributed to the drug. That’s an injury rate of .000056 if my math is right and a death rate of 0.0000001. This drug has the same genetic problems with metabolism as Ketek.

Meanwhile the community acquired pneumonia for which Ketek was developed and is used for — since other antibiotics are failed to beat back resistant bacter — leads to 500,000 hospitalizations and 50,000 deaths a year.

Somehow Grassley and the media has misplaced these facts, along with the incontrovertible evidence that the drug works.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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