Shoes, Ships, and Sealing Wax

Drugs

There's been a lot of drug news this week, with the COX-2 inhibitors, the jury verdict in the "Zoloft defense" case, the news about suicide and SSRI antidepressants, and the new prostate cancer therapy.

Lots of news. I have lots of thoughts, and notes all over the place, and I think I was trying to cram too much into this post. So I'm starting over, with just a few suppositions and (I'm going to try, really) one point.

The suppositions are:
Drug companies don't want to kill people. (Or even hurt them, for that matter.)
The FDA doesn't want to keep people sick or suffering.
People who lobby for bans believe the risks of a drug outweigh the benefits overall.

The point is:
People need to understand what they are doing when they take drugs.

You know those pamphlets that are stapled to your prescription bag when you pick up medicine at the drug store? Not the really long piece of paper inside the box that's covered with small type and folded 300 times...that's the manufacturer's FDA-approved label. I'm talking about the one with big type that say "You are taking Vioxx ..."

I used to write those.

And while it is good for a patient to know "Call your doctor if you notice black tarry stools," the pamphlet doesn't explain that black tarry stools probably mean you are passing blood because you have an ulcer that maybe was caused by the drug. Nor will it explain that not only might the drug directly irritate the lining of your stomach because of its acidity, but that in blocking the prostaglandins that were causing you pain, it also blocks the prostaglandins that help protect your stomach from irritating acids. (Actually, one of the selling points for the COX-2s is that they are more selective in the prostaglandins they block...but I'm going off on a tangent again.)

Now really, prostaglandins are beyond the scope of that drug store pamphlet. (And beyond my understanding too; I only get the basics.) But the point is that in the chemical processes that make a drug work, there are some chemical processes that cause adverse effects. And not everyone is going to have the adverse effects...and for that matter, not everyone is going to benefit from the intended effect, either. I have a particular type of headache I get sometimes that won't respond at all to ibuprofen, but if I take acetaminophen, it helps. (Why? Something in the chemical reactions, but I'm damned if I know what.)

Ok, back to the one point to which I was trying to stick: patients need a more sophisticated understanding of how drugs work in the body in order to understand that side effects occur, why you can't always divorce adverse effects from wanted effects, and why the same drug will have different effects in different people.

I don't think the problem is that people are stupid or that they expect the FDA to be a nanny protecting them from all harm, I think that most people are just naive. They don't understand the complex chemistry behind pharmaceuticals, and have probably never even stopped to think about the fact that there is complex chemistry at work. It's changing, but I'd guess that most people still don't really question their doctors when they get prescriptions. I don't know how many people understand the limitations inherent in testing drugs before approval, or the idea of off-label use.

So my point was...in order to take responsibility for themselves and to be able to weigh risks and benefits, people need to understand this stuff.

If the education were up to me, I'd start by recommending a trip to http://www.fda.gov/. No, the FDA isn't a flawless institution (and there's still a lot of politics), but the information on the web page satisfies needs at a variety of levels.

Posted by Nic at February 18, 2005 05:49 PM