In an effort to provide patients with more health care information, startup companies AdverseEvents and Clarimed have launched online databases with searchable adverse event reports for more than 4,500 prescription drugs and 130,000 medical devices, the Wall Street Journal reports.
Need for Comprehensive Data
According to the Journal, FDA has collected millions of adverse event reports since 1969 for thousands of prescription drugs. However, the database -- known as the adverse-event reporting system, or AERS -- is not cumulative, and information can contain errors and inconsistencies that make it difficult for consumers to use.
Brian Overstreet -- president and co-founder of AdverseEvents -- said, "There are at least 440 different ways to spell Ambien, and each had a separate file at the FDA."
Similarly, the FDA database for medical devices -- called the Manufacturer and User Facility Device Experience, or Maude -- does not contain sales information for many products, according to Clarimed CEO and founder Nora Iluri.
Though FDA defends AERS as a safety surveillance tool, its website states that AERS files "cannot be used to calculate the incidence of an adverse event in the U.S. population."
Gerald Dal Pan -- director of surveillance and epidemiology at the FDA Center for Drug Evaluation and Research -- said that the best sources for information on drug side effects are product labels themselves and doctors or pharmacists.
Details of New Databases
AdverseEvents developed an algorithm that filters out adverse event report duplicates and combines spelling inconsistencies. It has reduced more than 200,000 drug names in AERS to about 4,500. Consumers are able to easily search for and compare thousands of conditions and side effects associated with prescription drugs dating back to 2004.
While basic searches can be done at no cost, AdverseEvents plans to charge users $10 per month starting Feb. 1 for access to more comprehensive reports. More detailed data also will be available to health care providers and businesses for additional fees.
According to the Journal, Clarimed could follow suit and charge for its medical device database, which contains information on products such as syringes, stents, tanning beds and diagnostic machines.
Both companies say their services can empower patients, many of whom search Internet discussion boards for medical data.
Reaction to Startup Databases
Kate Connors, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said FDA is the most appropriate source of information on adverse events.
However, some experts said that the AdverseEvents and Clarimed services can benefit users if they understand the data's limitations.
Thomas Moore, a senior scientist at the Institute for Safe Medication Practices, said, "If you just want an impression of the side effects of a drug, those impressions are pretty accurate" (Beck, Wall Street Journal, 1/31).