Two health IT startups aim to help patients sift through the reams of adverse event data collected by the U.S. Food and Drug Administration, according to a report today in the Wall Street Journal.
The two companies, AdverseEvents and Clarimed, have developed websites backed by algorithms that sort FDA adverse event reports, streamline the data, back out misspellings or inaccuracies, and make it easier for consumers to understand FDA's findings.
AdverseEvents provides an online search process for FDA's adverse event reporting system (known as AERS), and covers about 4,500 medications now on the market. Clarimed does essentially the same thing, but for the 130,000 medical devices listed in the FDA's Manufacturer and User Facility Device Experience (also known as MAUDE), the Journal reports.
The basic search is free, but AdverseEvents is planning to launch a new fee-based service this week, charging users $10 per month for more detailed information and reports. And Clarimed may soon do the same, according to the Journal.
Clarimed founder Nora Iluri compares her service to the J.D. Power and Associates safety ratings for cars. "Suddenly, manufacturers started competing on quality. The best way to drive quality improvements is to make things crystal clear and transparent as possible," she tells the Journal.
However, there are caveats. Experts note that FDA's data can't parse out when a severe side effect is actually due to the drug itself, another contra-indicated medication, or just sheer coincidence. And with medical devices, its databanks can't clearly indicate the effects of operator error or other non-device-related factors.
The numbers also have little context, the Journal notes. For example, the FDA data doesn't indicate the overall use levels of any particular drug. So, a drug like Lipitor may have a larger number of adverse events than others in its class, such as Crestor, because it is prescribed far more often, not because it is more dangerous.
Still, experts say AdverseEvents and Clarimed can be helpful. "If you just want an impression of the side effects of a drug, those impressions are pretty accurate," Thomas Moore, a senior scientist at the Institute for Safe Medication Practices, tells the Journal.