I would highly recommend people read The FDA for the Average SBM Consumer by Martin A. Lessem, J.D. which was posted today on Science-Based Medicine. It’s a fascinating look at how the Food and Drug Administration came into being, and contains much that I did not know about this rather important US government body.
The FDA is, even more than Orac or Big Pharma, the whipping boy of the alternative medicine movement. It’s a funny argument that they present, arguing that since the FDA once “allowed” thalidomide to be given to pregnant women, clearly over 50 years later we simply cannot trust them to look out for our best interests. This is a fantastical mauling of the facts, but a fine example of how we can’t always believe what we google.
As the article states:
| Thalidomide came on to the European Markets in 1957 and was used as a pain killer and tranquilizer6. Another key reason for its use was that it was found to combat morning sickness in pregnant women….When Thalidomide, also known as Kevadon, came across her desk she*decided that the safety documentation was not sufficient to support the requested indication of relief from morning sickness. The Application was rejected8. Richardson Merrell (Now Marion Merrell Dow), the manufacturer, then attempted to apply pressure to have their drug approved, but Dr. Kelsey remained firm in her desire for safety studies. What Richardson Merrell did manage to do was distribute 2.5 million pills to approximately 1,200 doctors in the US with the understanding that this product was not approved and still “under investigation”. As Dr. Kelsey dug deeper into the product, the 10,000 birth defects became publically known and Richardson Merrell rescinded their Application. Seventeen (17) children in the US were born with birth defects as a result of Thalidomide.
… The Thalidomide incident led directly to the Kefauver-Harris Amendment of 1962. This is also known as the “Drug Efficacy Amendment”9. The main effect of this Amendment on the FDA was that they now had the authority to mandate clinical studies to show that a Drug is both safe and effective. |
* Dr. Frances Oldham Kelsey, a reviewer for the FDA
So in short, the drug company sleazed thalidomide into the hands of doctors without FDA approval, and the resulting nightmare led to granting the FDA the power to prevent a situation like this from happening again. Not exactly in line with the way the information is presented, now, is it?
What’s most interesting to me is the argument that, since the FDA is supposedly not good enough to safeguard us from Big Pharma and it’s greedy desire to murder the population, we should trust unregulated and untested products and services by unlicensed non-professionals for our health care needs. That’s quite the leap of faith, if you ask me.
At any rate, an excellent article well worth enjoying, so I figured I’d send you that way. Happy reading!
Jim