Wall Street Journal
by Melinda Beck
31 Jan 12

….A start-up company, AdverseEvents Inc., has streamlined the FDA's often impenetrable database and made it easy to search the adverse-event reports for more than 4,500 drugs, free and online.

Another start-up, Clarimed LLC, has done the same for reports filed with the FDA on 130,000 medical devices, a far more complex group that runs the gamut from syringes to stents to tanning beds and diagnostic machines that could impact tens of thousands of lives.

Both companies, which launched in September, see their services as empowering patients, many of whom now comb Internet discussion boards for medical information. "If your doctor tells you to take a drug and it's three times more likely to give you a heart attack than another drug, not having that information seems foolish," says AdverseEvents President and co-founder Brian Overstreet.
….

Nora Iluri, CEO and founder of Clarimed, likens these efforts to the advent of J.D. Power and Associates safety ratings for cars. "Suddenly, manufacturers started competing on quality," she says. "The best way to drive quality improvements is to make things crystal clear and transparent as possible."
….

[The FDA monitors adverse effects reports but] One problem is that the data are sometimes jumbled….AdverseEvents Inc. developed an algorithm that filters out duplicates and combines spelling variations, reducing over 200,000 drug names to about 4,500. It also made the data easily searchable and comparable for thousands of conditions and side effects back to 2004.
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The FDA defends its own use of the data for safety surveillance and it issues frequent MedWatch alerts on potential problems. But its website also 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. [Ha!]

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. [Ha!]
….

AdverseEvents "is useful and necessary, but it may not be sufficient, given the problems with the FDA data," say Joe Graedon, a pharmacologist who runs ThePeople'sPharmacy.com, a website where visitors often discuss their own experiences with drugs.

Other experts say AdverseEvents and Clarimed can be helpful, as long as users understand the caveats. "If you just want an impression of the side effects of a drug, those impressions are pretty accurate," says Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices…..


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