Doing The FDA's Work For Them

AdverseEvents Inc. Seeks to Provide Adverse Event Information to Patients and Healthcare Professionals

A couple of weeks ago a new health-tech start-up company came on the scene, which I am sure has the rapt attention of pharmaceutical manufacturers everywhere.  Adverse events, as you may know, are bad reactions that patients have to prescription drugs.  The current system has doctors voluntarily reporting events to the FDA.  It is estimated that only 10% of actual adverse events are ever reported.  The FDA database of these events is notoriously bad: lots of mistakes and extremely difficult to search.  As a result, some dangerous drugs lurk on the market making billions of dollars each year for the manufacturers until the problems become overpowering and make front page headlines (Vioxx, Avandia).  

AdverseEvents' goal is to provide accurate, real-time information about drug side effects to patients and healthcare professionals.  To do this, they use a "proprietary 17-step data refinement process that standardizes and normalizes the data from the FDA's Adverse Event Reporting System (AERS) into a user-friendly, fully searchable, database of over 4,000 approved medications."  Now is where you say "I thought that was the FDA's job!".  Yes, it is.  Unfortunately, they are not doing it, or they just can't with the resources they have.  Then you might ask "Don't the drug companies have access to a lot of that information?".  Yes, they do.  The problem there is, if they find out about bad information on their drugs, they have a legal duty to report it to the FDA.  So, how do I put this,  THE DRUG MANUFACTURERS DON'T WANT TO FIND OUT BAD INFORMATION ABOUT THEIR DRUGS.  That's where AdverseEvents comes in.  They don't intend to keep bad information a secret either.  AEI has already made public some of the analytical work they have done.  For instance, they have already reviewed the data on birth defect - adverse events related to epilepsy drugs, and have asked whether it is time for warning label changes.  Keep in mind, this is information the FDA already had available to them.  This is really ground breaking stuff.  It will be interesting to see if they can avoid getting crushed by big pharma and become a resource that actually does good for consumers.  I'll keep you  informed.