Pharma’s Cutting Edge

At the time of this post, this editorial from Avorn is free to the public.

I find myself strangely in agreement with the usually pedantic Dr. Avorn, who injects a needed dose of pragmatism into the drug-safety debate. As I’ve discussed in this space previously, the failure to detect drug safety signals is a systematic failure of postmarketing safety surveillance. Rare adverse events will remain hidden from detection in all but the largest pre-marketing programs, and even when studies provide adequate power to detect rare adverse events, rarely will the number of cases be sufficient to determine with any confidence a causal relationship to study drug. Uncommon but serious adverse events, like those associated with Vioxx use, require appropriate studies and responses to signals pre-marketing, but, just as importantly, they require careful attention in “real-world” patient studies after marketing to distinguish true drug-related adverse reactions from drug-associated “signals”.

The U.S. trails countries like the UK in its obligation to ensure the safety of its new medicines. It deserves better, and there are mechanisms in place that provide for better. The FDA’s Office of Drug Safety has indicated its interest in implementing and routinely using prospective surveillance systems., and it has taken preliminary steps in this direction If we had real leadership in the U.S. government, a comprehensive surveillance program would be in place already. But, as a large majority of Americans acknowledge, we do not. I’m still holding out hope that the U.S. will have a world-best surveillance program in place before the end of this decade.