The FDA is tasked with the immense responsibility of tracking adverse events, both major and minor, from over-the-counter and prescription medications. Recognizing the seeming impossibility of spotting serious side effects before they become a national problem, the agency is now looking toward big data for help. Dangerous drug attorneys at Pintas & Mullins detail this new effort, and how it could involve your own personal medical records.
This new government project, called Mini-Sentinel, costs around $116 million, and will mine national databases of medical records for adverse events from medications (this does not include supplements, as they are not regulated by the FDA). The current system used by the FDA to track adverse events is notoriously sub-par - it relies on voluntary reports from patients, doctors and pharmacists. The information received in this outlet, then, is random and cannot reflect true patient outcomes.
The director of the FDA's Center for Drug Evaluation and Research stated that the agency desperately needs a faster way to monitor drug safety. In its effort to do so, the FDA contracted with Mini-Sentinel, which manages the health records of nearly 180 million Americans. Almost all data used by the FDA is from billing records, meaning the agency is not looking at the actual doctor charts and notes, just codes from tests and procedures done for patients.
It took five years to build the pilot program and the team notes that it is impossible to mine the data based on individual doctors or patients, so privacy is kept intact. Mini-Sentinel is now a routine part of the FDA's safety monitoring, conducting hundreds of queries per year.
If the FDA notices a trend of side effects from a certain drug, they call on Mini-Sentinel to conduct a data search into it. For example, a high blood pressure medication sold as Benicar was recently linked to serious intestinal problems in patients. Although initial reports denied a link between the two, a second investigation by Mini-Sentinel found a definitive link - but only in patients who had been taking Benicar for longer periods of time.
As a result of this comprehensive search, the FDA released label updates for Benicar warning patients of the risk of serious intestinal side effects. Officials state that such a quick and definitive answer would have otherwise been unavailable.
The ability to sift through huge mines of patient data seems like the most obvious opportunity for the FDA to track, monitor, and release information on drug safety information. What is at issue now, is how to properly do the sifting. Some experts believe that billing data was not meant to be used in this way, and are concerned that patients may get a false sense of security about the safety of medications.
The FDA's contract with Mini-Sentinel is up in September 2014; however, the agency is still trying to discern the best way to conduct its data searches. The agency is acutely aware that how you phrase questions about a drug's safety will greatly impact what the answer is.
For its part, Congress recently established a foundation called the Reagan-Udall Foundation for the FDA, which is researching how to use large databases to study drug safety. Needless to say, there is a lot of work that needs to be done to get a handle on this new science and to create set guidelines and methodology. One of the problems with the Reagan-Udall Foundation, however, is that nearly all of its funds come from Big Pharma: Johnson & Johnson, GlaxoSmithKline, Merck, Pfizer, etc.