NCPA - National Center for Policy Analysis

Searching for Side Effects

February 3, 2012

Two startup companies are attempting to revolutionize the reporting of side effects by the U.S. Food and Drug Administration (FDA).  AdverseEvents Inc., and Clarimed LLC are organizing hundreds of thousands of incident reports for drugs and medical equipment, respectively, and attempting to improve transparency for consumers.  Previously, these reports were held in disorganized and indecipherable databases of the FDA, where a number of clerical errors made them impossible to use.  These two companies are seeking to reverse that trend, says the Wall Street Journal.

  • AdverseEvents has streamlined the FDA's "AERS" database for drug incidents, allowing for searches and in depth reporting on 4,500 different drugs.
  • Clarimed LLC has undergone a similar process for the "Maude" database of medical equipment, allowing for greater transparency for some 130,000 medical devices.
  • Both companies offer some free services, but will rely on payments for more in-depth information as their primary sources of revenue.

The FDA's databases have been accepting reports of adverse events for years.  AERS alone has received 6.4 million drug reports over its lifetime, with volume increasing gradually over time.  It received 759,000 reports in 2010 alone, while Maude received 238,000 reports for medical equipment.  However, as the companies' spokespeople were quick to point out, the databases were impossibly disorganized and plagued with clerical errors.

  • The databases did not account for spelling errors in the name of the drug when reports were filed, creating multiple data bins for the same drug -- AdverseEvents arrived at a final number of 4,500 drugs from a starting figure of around 200,000.
  • Furthermore, attempts to glean specific information about a certain drug and its side effect risks usually returned outrageously voluminous amounts of data that was impossible to use due to its sheer size.
  • Additionally, because the FDA does not present comprehensive information about drug sales, users could not compare the frequency of incidents between drugs.

By compiling the information in easy-to-use databases that are searchable and comprehensive, the two startups hope to create greater transparency in the market for pharmaceutical drugs.  Their operations will augment users' understanding of the risks associated with certain treatment options.  Additionally, they can also have the aggregate benefit of allowing administrators to more quickly identify troubling trends for specific drugs that necessitate further investigation or having them pulled from the market.

Source: Melinda Beck, "Searching for Side Effects," Wall Street Journal, January 31, 2012.

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