Too bad.

It seems that the FDA is rethinking our pain medications.

Apparently, acetaminophen, taken at the current dosage levels, can cause irreversible liver damage. So, the FDA is currently looking at reducing the daily dosages while still maintaining the drug's effectiveness. Death, as a side effect, does not sell product.

Needless to say, Johnson & Johnson, makers of Tylenol, strongly disagree. Wyeth Consumer Healthcare, makers of Advil, as you can imagine, are beyond deliriously happy…

But it got me thinking as to what does the FDA really do and what drugs have been, after the fact I might add, rethought, re prescribed, or removed from our drug store shelves.

How FDA approves drugs is a fairly interesting read. Part of the explanation is as follows"

"If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:

   Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year)
   Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years)
   Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine     effectiveness and identify adverse reactions. (about 3 years)."

Here's the big question.  Who ARE these people that volunteer? What's the motivation? For the good of humankind…? It's all very altruistic, I suppose, but really….

And then, years later, when it appears that the drug has been effective in treating what ails, an announcement is made that states, hmmm, not. Sorry. Cease and desist usage.

I suspect, at the end of the day, there is no other way to go about this. So, carefully read the warning label, ask your doctor if he/she is sure about this, and then hope that you don't see a press release, or a story on the 11 o'clock news recalling your drug of choice.