The Internet of scary things

Posted Feb 3, 2017 15:18 UTC (Fri) by anselm (subscriber, #2796)
In reply to: The Internet of scary things by felixfix
Parent article: The Internet of scary things

There are quite a few drugs which were approved in the EU, but the FDA took so long to approve them for the US that thousands of people died who probably would have lived if they had been able to use the EU-approved drugs.

In the 1960s, the FDA held off approving thalidomide (a drug used to counter, among other things, morning sickness in pregnant women) in the USA although the drug had been licensed and marketed in many other places including Germany, the UK, and Canada. The pharmacologist in charge, Frances Oldham Kelsey M.D., resisting considerable pressure from the pharmaceutic industry, said that thalidomide had been insufficently studied – which was appropriate given that it turned out that for many of the women taking it, the drug caused their children to be born with malformed limbs or other organ deformations. The FDA's non-approval of thalidomide, in spite of its being approved for and marketed to pregnant women elsewhere, very probably prevented thousands of similar cases occurring in the USA. So, sometimes, taking longer is actually a Good Thing.

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The Internet of scary things

Posted Feb 9, 2017 9:59 UTC (Thu) by Wol (subscriber, #4433) [Link] (2 responses)

Note also, rather importantly, that the thalidomide *as* *tested* for safety, was *NOT* the thalidomide as sold in the market. The test thalidomide was made in small batches and was pretty much pure L-Thalidomide - WHICH IS SAFE.

Unfortunately, when they scaled up to production the new process produced racemic (equal quantities of L and R) thalidomide, and it was R-Thalidomide that did the damage.

One of those things unfortunately, an "unknown unknown" which should have been caught but nobody thought of it.

Cheers,
Wol

The Internet of scary things

Posted Feb 9, 2017 17:13 UTC (Thu) by sfeam (subscriber, #2841) [Link] (1 responses)

That turns out not to be the case, although it was bruited about as a rationalization for many years. There are two stereomeric states of thalidomide that can be separated in the laboratory, but they interconvert in vivo. So the biological effect of both forms come out the same. The underlying point remains the same - speeding up the approval process has risks as well as rewards.

The Internet of scary things

Posted Feb 11, 2017 19:59 UTC (Sat) by ssokolow (guest, #94568) [Link]

Here's a citation for that, in case anyone is interested:

Thalidomide. The role of water in the mechanism of its aqueous racemisation.
0000-0002-8635-8390
http://www.ch.imperial.ac.uk/rzepa/blog/?p=8246