Data-mining for drug risks

July 3, 2007

People are now looking to target older studies for possible drug risks. The problem is that these analyses are retrospective, and thus should be taken with a grain of salt. Since when did the double-blind, randomized-controlled prospective study stop being the gold standard?

As he examined data on a computer one day last fall, drug-safety reviewer Ralph Edwards saw something that concerned him: Of 172 people in his database who developed Lou Gehrig’s disease or something similar while taking prescription medicines, 40 had been on statins, the huge-selling cholesterol drugs.

Dr. Edwards, director of the World Health Organization’s drug-monitoring center, has amassed about four million reports of medical problems experienced by people taking prescription drugs. His job is to sift through these so-called adverse events, looking for “signals” of potential side effects.



Related posts:

  1. Prescription drug abuse
  2. Zero tolerance for adverse drug events
  3. Should consumer prescription drug ads be reined in?
  4. When drug side effects scare patients away from treatment
  5. Has drug seeking behavior reached the tipping point?
  6. Big Pharma, data-mining, and the AMA
  7. Are patients the real "drug pushers?"


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{ 1 comment }

1 Anonymous July 3, 2007 at 10:31 am

OK- I didn’t read the whole article because it requires a subscription, but from what we can see, it looks like less than 25% of the people with ALS were on statins. Given that ALS typically occurs in the over-60 demographic, wouldn’t it be expected that about 25% (or more!) of those patients would be on statins? It’s the old correlation/causation trouble.

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