Wednesday, February 01, 2012

Mining FDA's AER Database: Heaven for Hypochondriacs, Hell for Pharma

A story in yesterday's WSJ Health featured AdverseEvents Inc., a start-up company that has streamlined the FDA's "often impenetrable" adverse drug event database and made it easy to search the adverse-event reports (AERs) for more than 4,500 drugs, free and online (see here).

I interviewed Brian M. Overstreet, founder and president of Adverse Events, last September on my Pharma Marketing Talk show. You can use the widget below to listen to that interview>

The pharmaceutical industry is a bit nervous about consumers getting easy access to FDA's "hidden" treasure trove of AERs:
Kate Connors, a spokeswoman for the Pharmaceutical Research & Manufacturers of America, which represents most drug makers, said the group isn't familiar with AdverseEvents and believes the FDA is the most appropriate source of information. "We think it's important for this information to be framed within context and to be properly evaluated," she says.
But the FDA passes the buck as far as being the authoritative source for AE info. As reported in the WSJ, FDA's site warns that its AER files "cannot be used to calculate the incidence of an adverse-event in the U.S. population." For consumers who want more information on drug side effects, "the best source is to read the product label and talk to your doctor or pharmacist," says Gerald Dal Pan, director of surveillance and epidemiology in the FDA's Center for Drug Evaluation and Research.

"Read the product label"! That's a joke, right? FDA hasn't made much progress simplifying drug labels either because of industry resistance or being forced to do endless studies on the issue (see, for example, "FDA Plans to Test New Standard for Easy to Understand Rx Labels").

Meanwhile, how risky are Rx drugs? I invite you to take "Harry's Drug Risk Parlor Game" and rate the overall risk of Rx drugs (you will be able to see the results to date afterward).

[Hat Tip to @Pernajl for the "heaven for Hypochondriacs" part of this blog post title.]

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