Data Dredging For The Masses
Part of what Congress passed in response to the perceived prescription drug crisis of 2007, Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962), includes a directive that the FDA "conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter." A single sufficiently serious adverse event may be enough to constitute a "potential signal". The number of potential signals being detected are increasing rapidly and on the most recent quarterly Potential Signals report thirteen additional drugs have been listed including such widely prescribed medications as Zithromax (the highly effective Z-pack) and Premarin for producing signals of serious risks of liver failure and angioedema respectively.
What will be the impact of releasing what is essentially raw data divorced from any analysis of its meaning or discussion of the plausibility of what it implies? In other words, what good will come from this sort of transparency? Other than tempting the unwary to the wrong conclusion thanks to the post hoc ergo proptor hoc logical fallacy it's hard to see any good coming of this; unless of course you're a personal injury lawyer. Google "Zithromax lawyer" and you'll find that though the new potential signal report is only a few days old there are already numerous "Zithromax attorneys" anxious to represent you in your claim for liver failure.
At the end of the day it may well be that the so called prescription drug crisis that the Congress was responding to in 2007 was in fact merely a prophecy only now being fulfilled thanks to the AERS Potential Signals reporting system.
