Tuesday, October 12, 2004
FDA...Fooled Dem All?
The FDA has been quoted as wanting to "....maintain the gold standard in drug safety that has become a hallmark in this country." Immediately upon reading this tripe, a few issues spring to mind: Thalidomide, VIOXX (and, likely its counterparts like Celebrex) and the current shortage of flu vaccine. The last two of these are news of the last 30 days and will prove responsible for the deaths of thousands of people. Thalidomide (for you young readers) is an FDA-approved drug, which was responsible for thousands of devastating birth defects.
The facts show that, while the FDA is a terribly bloated, self-serving federal bottleneck, which adds billions of dollars of medical costs to our healthcare system annually; it could be argued that it is less effective in what it purports to do than many other countries' guardian systems.
Today many states, like Blagojevich's Illinois, are involved in a staredown with the FDA, with a goal of breaking down the barriers to affordable prescription drugs for Americans. I certainly think such rebellion is appropriate.
Sacred cows, like the vaunted FDA need close scrutiny and constant checks and balances. Neither appear to guide this juggernaut. The crucial shortage of flu vaccine for this year would never have occurred, had the FDA used a basic quality control system like ISO 9000 (used by most commercial institutions) to monitor the manufacturers of the vaccine at all stages of development and production.
The whole mystique and self-protective nature of the AMA and FDA are mirrored in the everyday "art" of the druggist (oops...I mean PHARMACIST). They (or more likely their assistants) enter and check the veracity of the prescription with a computer program (big whoop here!) Then they take the pills out of the big bottle and put them in a little bottle (whoop number 2.) On two occasions, I have been given the WRONG pills and would have taken them, had I not already become familiar with the correct appearance. I know from talking to others that this is a routine situation. I consider this abhorrent error in a task that most seventh graders could perform. It is analogous to correctly preparing an order at a Baskin-Robbins.
Most federal and state programs cry out for close scrutiny and receive none, save that of the politicians, in whose best interest it is for them to prosper. This is a travesty of the worst sort and its impact is too expensive and dangerous to bear.
The facts show that, while the FDA is a terribly bloated, self-serving federal bottleneck, which adds billions of dollars of medical costs to our healthcare system annually; it could be argued that it is less effective in what it purports to do than many other countries' guardian systems.
Today many states, like Blagojevich's Illinois, are involved in a staredown with the FDA, with a goal of breaking down the barriers to affordable prescription drugs for Americans. I certainly think such rebellion is appropriate.
Sacred cows, like the vaunted FDA need close scrutiny and constant checks and balances. Neither appear to guide this juggernaut. The crucial shortage of flu vaccine for this year would never have occurred, had the FDA used a basic quality control system like ISO 9000 (used by most commercial institutions) to monitor the manufacturers of the vaccine at all stages of development and production.
The whole mystique and self-protective nature of the AMA and FDA are mirrored in the everyday "art" of the druggist (oops...I mean PHARMACIST). They (or more likely their assistants) enter and check the veracity of the prescription with a computer program (big whoop here!) Then they take the pills out of the big bottle and put them in a little bottle (whoop number 2.) On two occasions, I have been given the WRONG pills and would have taken them, had I not already become familiar with the correct appearance. I know from talking to others that this is a routine situation. I consider this abhorrent error in a task that most seventh graders could perform. It is analogous to correctly preparing an order at a Baskin-Robbins.
Most federal and state programs cry out for close scrutiny and receive none, save that of the politicians, in whose best interest it is for them to prosper. This is a travesty of the worst sort and its impact is too expensive and dangerous to bear.
