Monday, October 11, 2004

How far should the FDA go in protecting us?

Now all of the -coxib (Cox-2 inhibitor) drugs are getting scrutiny for their effect on cardiovascular problems. It seems that there's a delicate balance between vasoconstriction and platelet-coagulation (associated with Cox 1 production) and vasodilation/blood-thinning (Cox 2). NSAIDs such as aspirin, ibuprofen, and naproxen inhibit both enzymes (with aspirin showing some blood-thinning and cardioprotective effects). If you inhibit Cox 2, so the theory goes, you take away some of the checks and balances on vasoconstrictive effects, thereby allowing situations where blood thickens and has to pass through a smaller opening when there really should be thinner blood or larger vessels. This of course is bad news for Pfizer (maker of Celebrex) and Novartis (who has a Cox-2 inhibitor under review at the FDA right now).

What struck me the most was a comment on the article I linked to by a man named "Old Patriot." He brings up the quality of life argument, and I don't think it's one that has been adequately addressed. Even with the conservative safety protections in place, no prescription drug, or even OTC drug, is completely safe. As consumers, we deserve to know the safety information. But who is to tell us which drugs we can or can't take based on the safety profile? Who is to judge that a longer life of pain is better than a shorter life where movement is manageable?

Why isn't a black label on Vioxx (and other Cox 2 inhibitors, if warranted) enough?

(Note: in all fairness I should say that it was Merck that removed Vioxx, not the FDA. However, there is a climate in regulatory circles that "unsafe" drugs should not be on the market unless there's no alternative.)