Comments on: The FDA, speed, and thalidomide

By: Micha Elyi

Micha Elyi — Wed, 29 Jun 2016 02:07:39 +0000

I recall that Thalidomide was prescribed to relieve morning sickness during pregnancy.

Around this time (1960), Australian obstetrician Dr. William McBride discovered that the drug also alleviated morning sickness.

By: wGraves

wGraves — Tue, 21 Oct 2014 16:46:36 +0000

Sensible policy requires that intelligent experts, like Dr. Kelsey, be allowed to make their own judgements. The relationship between risk and reward is always there, and may be difficult to quantify. Treatment of a probably terminal condition may militate for a more relaxed policy. A medical device which detects a dangerous condition but offers no personal risk might be placed on a very fast track for evaluation. The disquieting observation about the ‘Ebola Crisis’ is that political operatives rather than intelligent medical experts appear to be in charge. And that may become a formula for disaster.

By: Ymarsakar

Ymarsakar — Tue, 21 Oct 2014 16:25:53 +0000

The case of bad things creating infinite regulations is when mass murderers go around shooting people, which means everybody else will have to go under restrictions designed for insane serial killers.

By: Ymarsakar

Ymarsakar — Tue, 21 Oct 2014 16:24:06 +0000

The “caution” is really so they can be bribed and do the CYA.

By: JamesB

JamesB — Tue, 21 Oct 2014 13:35:56 +0000

The Thalidimide incident occurred prior the creation of the modern FDA. The FDA was created in response to the Thalidimide incident.

When the new FDA was created, the significant difference between it and its predecessor was not safety, but effectiveness. Prior to the modern FDA, the government didn’t require approval of effectiveness – only safety. This, despite the fact that Thalidimide didn’t have effectiveness concerns.

The “crisis” of Thalidimide created the atmosphere by which drug companies could lock in their position by requiring effectiveness approval. Effectiveness approval is far more expensive than safety approval. Thanks to the “Thalidimide” crisis, no non-patented treatment will ever be given approval (no matter how easy the safety standard is to reach). The costs of obtaining effectiveness approval are too high – and can’t be justified without a patent.

Vitamin D appears to be an exception to the above insight – as its widely used and tested for by MDs. But even in that case, no “effective” designation has ever been granted by the FDA.

By: blert

blert — Tue, 21 Oct 2014 08:37:08 +0000

neo…

My B-in-L’s brother was one of the VERY few hit by Thalidomide. (Inside the USA)

Until your sats I had no idea just how rare his circumstance was.

BTW, the Germans were permitting over-the-counter Thalidomide — circa 1957 !

By: jmb

jmb — Tue, 21 Oct 2014 02:47:28 +0000

I remember travelingin Germanyy in the early 80’s; many cars with bumperstickers “A heart for children” . I asked; charity sticker for thalidomide babies.

By: neo-neocon

neo-neocon — Tue, 21 Oct 2014 02:30:12 +0000

blert:

I’m not sure what you mean by “wildly against the odds.” Do you mean it’s against the odds that you know someone who was affected by thalidomide? That’s certainly true.

But since there were only a few hundred pregnant women in the US who took thalidomide during pregnancy, the figure of 17 born affected isn’t so strange.

By: blert

blert — Tue, 21 Oct 2014 02:16:00 +0000

neo…

You write of 17 Americans…

Which is wildly against the odds…

My B-in-L’s brother is a child of Thalidomide.

The result is horrific.

By: neo-neocon

neo-neocon — Tue, 21 Oct 2014 01:20:25 +0000

G Joubert:

The US thalidomide FDA refusal story was mostly during the Kennedy administration, actually.