So Your Med Got Pulled

Were you a Bextra user? Did you depend on Vioxx? What do you do now that your favorite "medical miracle pill" has been pulled off the market by the FDA?

Well, it depends. You could call your doc and try something new or you could go back to the old standbys of acetaminophen or ibuprofen or naproxin (be carefull with this one too). But have you wondered why these meds get pulled after the long, arduous FDA approval process?

Well, it's like this: first someone comes up with an idea at the drug company (or some private researcher gets the idea and sells it to the drug company), then the lab produces a chemical that can be reproduced exactly the same every time (not easy). This can take years. Then they start experimenting with lab rats and other critters gradually getting to larger animals that more closely resemble humans. After years of this process, they apply for human clinial trials.

Now depending on the complexity and severity of the disease they are trying to fix, these trials can last months to years. Many AIDS meds were practically rushed to market to help people as fast as possible. Some of the long term side effects were downplayed as "reasonable risk" as AIDS is usually fatal. Some of the heart meds take literally years of testing on thousands of people before FDA approval can be applied for. And guess what? The FDA is slow.

So meds that make it throught these processes should be safe and side effects/adverse reactions should be well documented.....right? Well, maybe.

Not all meds require extensive human trials. So what happens is that after the drug is on the market, researchers utilize actual patient use/reported adverse reactions to compile additional reports. Now as anyone who does statistics knows, stats can prove almost any point. For some drugs, erring on the side of caution is necessary. For some, it's a little overblown. For example, Statins, the cholesterol reducing drugs can cause significant liver problems and muscle weakness. They are still on the market - until someone (or maybe a few) dies of liver cancer. The cox 2 inhibitors resulted in a few heart attacks (not all fatal) and they are reviled as killers. Do you have any idea how MANY patients were on these meds? Hundreds of thousands. But a few heart attacks in people with other chronic problems. The media of course blew everthing out of proportion (my opinion) and got government officials all excited by getting patients all excited.

Obviously, meds are necessary for many situations - but not all. Be wise, be carefull and THINK about what you are putting in your body. Lifestyle change is preferable to drugs: excercise releases endorphins so you don't need that anti-depressant. Cut out McD's and reduce your cholesterol level. Fresh fruit instead of cheescake (I know, bite my tongue!). Just a hint.

Okay, end of lecture.