Tuesday, October 19, 2010

What I didn't know about clinical trials

I had never really wondered when clinical trials started or how we got to where we are with a dysfunctional system. Between my two recent posts on thyroid cancer and long term side effects of medications, I was doing some research and found this article talking about the history of Synthroid or levothyroxine as it is named now. Then I found this timeline which shows how the FDA didn't have as much authority until 1988 - just over 20 years ago.

I found several things surprising in this information:

- Medical doctors recognized thyroid issues a long time ago - late 19th century but it took another 60 years before they had a medicine to replace it.

- Some of the early medical treatments make my skin crawl - pig thyroids, vinegar, boiling oil, etc. YUCKY!

- Synthroid or now Levothyroxine (it took me a long time to learn to pronounce that hence my personal rule that you can't take any medicine or have any ailment unless you can spell and pronounce it) was unapproved for so long and that the doses were never tested until ten years ago. When I started taking Synthroid it was the only brand on the market. I was given a dose that was .200 mg (milligrams - 1000th of a gram) or 200 micrograms. My dose over time has changed from 200, to 150, 125, 137. But I know there was a time when as many variations were not available as for a while my endocrinologist had me taking half a pill on Sundays.

- Prior to 1962, drug companies only had to say a drug was safe. There was no regulation. If a drug was marketed before 1962, it was grandfathered into the system and no clinical trials were required. It was only after complaints that Synthroid went through clinical trials in 2000-2002.

I can also add that I was part of a lawsuit of Synthroid purchasers who were forced to pay high prices for it for years because it was the only one on the market - the manufacturer had monopolized the market and forced higher prices for it on to the consumer. I think I got nine dollars and change for this.

So now nearly 50 years later into clinical trials, and just over 20 years of FDA regulation we have a system which is over burdened and stressed. It hasn't taken that long for the system to fall apart.

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