Safety sturm und drang

Merck & Co. Inc.'s decision to withdraw Vioxx rofecoxib has provoked the predictable breast beating and finger pointing by politicians that accompanies every high-profile drug withdrawal, as well as the usual feeding frenzy from trial lawyers. The furor could easily result in policy changes that would be bad for everyone involved, even the patients they would be designed to protect. However, some ideas have been put on the table that actually could be beneficial.

These may be hard to spot, as true to form, much of the political discussion, and virtually all of the media attention, reflects fundamental misunderstandings about drug development and drug safety. In the Vioxx case, this involves especially unrealistic expectations about the ability of FDA to detect and quantify the risk of rare adverse events prior to approval.

Starting from this false premise, politicians and pundits are prescribing their favorite public policy nostrums. In particular, because it is sharing the media spotlight with other recent drug safety stories, Vioxx has renewed interest in Congress in "fixing" the FDA.

This appetite for reform was whipped up by the star witness at last week's hearing of the Senate Finance Committee, where David Graham of FDA's Office of Drug Safety, acting in a whistleblower role, declared the Vioxx situation to be perhaps the biggest drug safety catastrophe in the "history of the world."

Of course, it is easier to grandstand than to take real action, and the reality is that most major policy changes would require Congress to write and pass new law and allocate funds. It is far from clear that politicians will find drug safety a compelling issue when they return to work in January, and the congressional track record for adequately funding FDA is unimpressive.

But even if Congress does not act, the close proximity of the Vioxx flap to Chiron Corp.'s flu vaccine meltdown, along with the

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