Greetings. I have a few questions that I hope an obstetrician or medical researcher might be able to answer.
Recently I was reading about the drug thalidomide — an unwitting cause of many birth defects in the early 1960s, when the drug’s danger to fetuses were not yet known. For me this raised some historical and procedural questions that further reading hasn’t yet addressed:
[li]Why, specifically, weren’t thalidomide’s effects noticed before it was approved for general use? Were pregnant mammals, the usual rats and monkeys, not tested?[/li]
[li]Or alternatively, does the drug cause birth defects only in humans — hence the rude surprise after its release? (And if that’s the case, I’d be curious to know what quirk of human physiology separates us from other mammals, in this one area anyway.)[/li]
[li]Did the thalidomide scare result in a change in the mechanics or standards of drug studies, either in the US or elsewhere? This FDA page, for example, says merely that it “aroused public support for stronger drug regulation”, but doesn’t say whether that actually amounted to anything.[/li][/ol]
This whole subject is a bit disturbing I realize, but thanks go to anyone who can answer some of these questions.