Tuesday, December 20, 2005

Docs ignore black box warnings

The large Harvard study is reported here via Medscape. We already knew this, as I blogged some time ago. In this study, compliance with black box warnings was variable. Doctors ignored the warnings almost half the time for some drugs. The study was published in Pharmacoepidemiol Drug Safety. 2005;14:1-18.

Through the years we’ve seen many drugs taken off the market as well as some class action law suits against drug companies. But studies like this should cause us to reconsider our views on drug safety. It’s simplistic to merely categorize drugs as good versus bad, safe versus dangerous. Some drug disasters are more related to inappropriate use. That’s exactly what happened to cisapride ---not inherently a bad drug, just a relatively unforgiving drug that saw widespread contraindicated prescribing. Public opinion placed far too much of the blame on the FDA and the drug company.

There are similar lessons in the Phen-Fen case. Though there was no black box warning, the two weight loss drugs were never approved by the FDA nor were they promoted by the drug companies for combination use. Nevertheless the combination became the rage in obesity treatment. A weight loss industry was born and large numbers of doctors inappropriately prescribed the cocktail. But what did the trial lawyers do? They followed Sutton’s Law and went where the money was. It had to be more cost effective to file a class action suit against a large company than to go after all those doctors individually.

What are the solutions to the problem of contraindicated prescribing? The author of the Harvard study suggests incorporating better information into the black box warnings and the use of alerts and warnings built into electronic medical records.

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