I was cruising the blogosphere and ran across someone arguing that she didn't trust the FDA's approval of Gardisil; she used Thalidomide as an example of a bad FDA approval. Except that I've read before that the FDA didn't approve Thalidomide. So, I googled and read around, and was reminded that while Thalidomide was put into use elsewhere, the FDA never approved it in the US (well, until 2006 for something else, looks like).
Why didn't the FDA approve Thalidomide? Turns out one Frances Oldham Kelsey insisted on further testing before she'd sign off on it.
The first baby known to have been adversely affected by Thalidomide, according to the Wikipedia article on Thalidomide, was born in 1956. It came up for approval in the US in 1960.
And it was given to pregnant women to help deal with morning sickness.
I gave my Mom 5 months of unmitigated morning sickness. She reminds me of that whenever I do something particularly stubborn or irritating, insisting that she knew from the start I'd want my own way. I revealed my basic character early, no doubt.
But because of Frances Oldham Kelsey and the FDA, Thalidomide wasn't in wide use in the US (only investigational use). So my Mom, right in that period when it was being used in Europe, wasn't prescribed Thalidomide.
There's no telling, of course, whether she would have been prescribed Thalidomide if it had gotten easy approval, or if the approval would have come in time before I stopped giving her morning sickness and got on with just being a rotten kid.
But I'm grateful to Frances Oldham Kelsey for being a smart, dedicated scientist. She saved a lot of kids in the US from serious birth defects. She may have saved me.
One of the sad things in this is that we seem to have forgotten this scientist, a female scientist, trained in the 1950s, who made a significant contribution to public health in more than one way. We should celebrate her work, not forget it.
Kelsey's story of standing up to a drug company and holding out for real scientific data should be common knowledge, and not something people like me vaguely remember. And we certainly shouldn't misremember the story and forget Kelsey's contribution altogether.
It's March! And in the US, we celebrate National Women's History Month. Except I haven't seen much celebration about it.
But I'm celebrating. When I was born, it was barely imaginable that a female from my social background would go to college. Graduate school? Not so much.
When I was born, real estate agents and mortgage brokers routinely and legally discriminated against single women, so did employers of all sorts.
Things really have changed; they're not perfect, but we have made progress.
Every so often, it's time to reaffirm my values. So here goes: I'm for fighting oppression on all fronts, and my fight is informed by, and focused through feminism.
I challenge anyone who runs across this to remember one woman who's provided leadership, to encourage one woman who has potential, to recognize one woman who's contributing, especially if she's contributing in ways that aren't well-valued by the patriarchy.
Although wikipedia has lately taken a beating 'mongst the academics there is an excellent article on thalidomide to be found at:
ReplyDeletehttp://en.wikipedia.org/wiki/Thalidomide
Full credit and kudos are given to Frances Kelsey for her role in blocking the use of this drug in the US when it was used pretty much everywhere else with disastrous results.
Bonzo, an elder chemist with a long time interest in Thalidomide.
What a nice post -- I didn't realize a female scientist was the one to have the FDA hold off.
ReplyDeleteI'm really nervous about a number of drugs being pushed through the FDA recently. Perhaps we're missing the reasoned voice of this very cool woman...
Thanks -- once again I've learned something from your posts!
ReplyDeleteAnd, if I may, a quick note to KATE: Although it seems like there are a lot of drugs being introduced at this point, the actual number in comparison to the number of applications submitted to the FDA for new drugs (or new uses for old drugs) is pretty small. As someone who participates in clinical research and then watches the applications be submitted, I can tell you that the vast majority of drugs approved don't get a "fast track" approval -- most application approvals are measured in YEARS.