FDA: Rock. Hard place.

It certainly didn’t take long for lawyers to jump on Vioxx. Just a couple of days after Merck announced they were pulling it, I saw TV commercials from local legal firms urging people who’d been taking it to contact them. With Vioxx as a warm-up, I’m sure it will take even less time for them to jump on Pfizer and Celebrex.

It kind of strikes me as ironic that just a few years ago there was much hubbub about the FDA‘s lengthy drug approval process and how it was keeping potentially life-saving/altering drugs out of the hands of people who could benefit from them. These drugs can help peeople. These drugs can save peoples’ lives. Why isn’t the FDA approving them for clinical use? What’s taking them so long? The FDA bureaucracy must be overhauled so that these wonderdrugs can be approved faster. Speed up the process!

So the FDA did streamline their drug approval process so that drugs would be approved for clinical use faster.

Now all the commotion is about how the FDA didn’t spend enough time studying the effects of things like the COX-2 inhibitor class drugs. They’re releasing drugs too soon. They shouldn’t have approved these drugs before knowing the long term effects. Why didn’t they study them longer?

Either way, the FDA is stuck between a rock and a hard place and someone at the FDA’s CDER gets screwed. Drug companies and potential drug beneficiaries (the patients) clamour for the newest drugs to be released expediently. To do that you shorten the time the drugs are studied and evaluated. That means fewer long-term studies. But then if a long-term adverse effect is discovered, the FDA gets blasted for not studying the drug long enough and rushing drugs to market before knowing the long-term effects.

People seem to forget (or conveniently ignore) the fact that for every drug that does get approved, there are several more that are blocked because adverse effects were found or failed to show as much of an effect as expected.
So how do people want it, over easy or fried hard?