I’m pleased to share our research paper that was published in the peer-reviewed journal Drug Safety this week that debunks one of the major limitations that has prevented the greater use of data from the FDA’s Adverse Event Reporting System (FAERS) for comparative drug studies and post-approval safety monitoring.
The full study can be downloaded here.
The initial media reaction to the study and its implications can be seen here.
Our press release can be seen here:
As you already know, raw FAERS data is the basis for the information and analytics that AdverseEvents develops and offers to our clients. One of our long-term goals is to systematically address and break down the few established – and we believe mistaken – concerns that exist among drug safety professionals that have historically prevented wider use of these data.
Today’s publication deals with the so-called ‘Weber Effect’, which is one of the most widely cited limitations to using FAERS data. The ‘Weber Effect’ is the notion that after approval of a drug, the adverse event reporting for that drug increases over the first two years, peaks near the end of year two, and then reliably, and rapidly, diminished with further time on the market. It is that differential clustering of report timing that drug safety professionals often cite in explaining why FAERS data should not be used for drug-to-drug comparative studies or inter-class or inter-indication studies.
The ‘Weber Effect’ was described in a paper in 1984 and has become gospel in the industry for the past thirty years. But our first-of-its-kind broad research study firmly shows that the ‘Weber Effect’ does not actually exist in modern FAERS data.
Why Does This Matter:
While this all may seem like academic minutiae, today’s research publication is actually very important for AdverseEvents and the shared mission of many people to limit serious drug side effects and improve patient outcomes.
As I stated in the accompanying press release:
Drug Safety’s acceptance and publication of this study is a major milestone in AdverseEvents’ mission to unravel the misinformation that has built up around the FAERS dataset. For far too long, these data have been vastly underutilized due to a lack of understanding and a general distrust over what these data can and cannot do. Clinical trials are so limited in scope that the true safety profile of a particular drug can only be determined once it reaches the public market. Therefore, the only way to fully review a drug’s safety is to track and monitor side effects as the general population begins utilizing the drugs on an ongoing basis in real world circumstances. Debunking the ‘Weber Effect’ is only our first step in the process of redefining the dogmatic – and, we believe, incorrect - limitations that the drug safety industry assumes and assigns to these data.
We welcome your questions or thoughts. See how AdverseEvents has systematically set out to debunk all three of these FAERS myths through the use of peer-reviewed studies in major academic journals.