Vioxx: The 21st century's punching bag

David Graham has stated that Vioxx may have harmed as many as 139,000 users, rather than the initial estimate of 28,000. On one hand, it's not entirely surprising -- Vioxx was a blockbuster drug, and drugs don't become blockbusters because they're sparsely prescribed. If it was widely prescribed, and cardiovascular events have been associated with its long-term use, it's not entirely shocking that the number of those affected might be greater than initially estimated.

It's starting to feel like a broken record. Vioxx was overprescribed. It had only been on the market since 1999, so it was hardly a time-tested therapy. And it was designed for a specific group of people, when the actual use was much, much more widespread. Drugs do things to your body, good and bad. FDA's responsibility is to make sure that the good outweighs the bad, and as far as toxic drugs go, I don't necessarily think Vioxx was even up in the top 5. (Accutane? Yes, for its implication in massive birth defects. Vioxx? Not so much.) The cardiovascular side effects were a surprise, but that is one of the risks of taking new drugs.

Now, the remaining COX-2 inhibitors are in question and will likely be removed from the market (or in the case of those not yet in the market, may never make it there.) These are useful therapies for the target population that won't be made available to them (and thanks to the negative press, even if it were, nobody would want to take it, useful or not.)