Healthy Skepticism Library item: 10800

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goldstein J.
Data Crunching Hints at Risk of Cholesterol Drugs
The Wall Street Journal Health Blog 2007 Jul 3
http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/?mod=yahoo_hs

Full text:

Fancy software and giant databases allow researchers to suss out signals of drug risks that would until recently have been undetectable. But there’s no algorithm that tells public health officials how to respond when they find a faint signal that may or may not be real.

A case in point is a suggestion that statins, the class of popular cholesterol-lowering drugs that includes Pfizer’s Lipitor, may increase the risk of Lou Gehrig’s disease (also known as ALS) and related disorders, the WSJ reports.

Ralph Edwards (pictured), who runs the World Health Organization’s collaborating center for drug monitoring, recently published a report describing cases that suggest a connection; the FDA, which was also aware of the signal, decided not to publicize it after digging deeper. That decision was based in part on the fact that a review of all of the long-term clinical trials for statins, which included about 120,000 patients, the number of ALS cases was equally split between patients who took statins and those who took placebo.

Edwards’s finding came from a database that included nearly four million reports of adverse events. Out of 172 cases of Lou Gehrig’s or something similar in the database, 40 were in patients who had taken statins. The FDA has a similar database, but investigates its findings with a lot of caution. Databases of adverse-event reports are notoriously difficult to make sense of, in part because they don’t include anything about people who took the drug and did not develop problems. The Lancet and British Medical Journal rejected Edwards’s paper, which was ultimately published in the journal Drug Safety (click here for the abstract).

It’s likely that new research could shed more light on the issue before too long. A University of California, San Diego researcher is studying case reports of patients who took statins and developed ALS-like symptoms. And Stanford researchers are trying to figure out whether there is a link between ALS and statins among members of HMO Kaiser Permanente.