Source: FDA. 2012 data estimated based on first 6 months. |
The project would have developed "predictions for safety signals that have not yet been recognized for drug candidates that have come to the FDA as New Drug Applications (NDAs)," which is a pretty radical idea, especially if it caused fewer dangerous drugs from being approved in the first place.
It does seem that more dangerous drugs are being approved by the FDA. As shown in the chart above/left, DEATHS reported to the FDA via its adverse event reporting system have increased dramatically in the last few years for which data is available.
Between 2003 and 2012, FDA received 588,000 death notices via Adverse Event Reports (AERs). This is scary considering that FDA's adverse event reporting system is notoriously inefficient. I've heard that FDA captures only about 10% of drug adverse events.
The number of adverse event reports received by FDA is also increasing dramatically as shown in the following chart:
Source: FDA http://bit.ly/6mK0y |
The FDA has NO system in place to mine the ADRs. In effect, all it has is a big basket of complaints.
ReplyDeleteIt's fallen to independent organizations, such as the commercial AdverseEvents.com and non-commercial Rxisk.org, to mine the FDA ADR repository. This is a disgrace that could only be explained by political influence. Why collect ADRs if you're not going to look at them in any systematic way?
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