” It’s the Catch-22 of clinical trials: to protect pregnant women and children from the risks of untested drugs….we don’t test drugs adequately for them.
In the last few decades, we’ve been more concerned about the harms of research than of inadequately tested treatments for everyone, in fact. But for “vulnerable populations,” like pregnant women and children, the default was to exclude them. ”
Hilda Bastian is Editor etc at PubMed Health, blogger at Scientific American, commenting on the science of unbiased health research with cartoons at Statistically funny.
Continue reading Women and children overboard
by Hilda Bastian, 23 April 2013
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6 thoughts on “Catch-22: Clinical Trials Edition”
I’m confused by the article. Who in their right mind would be involved in a clinical trial if they are pregnant ? Or allow their child on a drug study? Unless they were dying, no women or child would go near one. I’ve worked on several NDA’s, clinical trials and personally been in clinical trials. It’s a difficult situation for most women and children. But there is not clear and safe way to test these patients without substantial risk. That said, by the time they get to Phase III, they do have a pretty good idea of how the drug works but not always. So the question becomes how do we serve this population, get adequate testing and not harm or kill them. It can’t be both ways. Big Pharma may not be totally to blame here because you just can’t use pregnant women and in a lot of cases, small children. And therefore you can’t blame “inadequate” testing. Has anyone given thought that medicine is just as much art as it is science? I must be missing something here. But it has gotten better in the last few decades. I lost my aunt to a heart issue in 1974. In those days they NEVER looked at women for heart issues, let alone a 42 year old women. Well since then, we do trials including women in heart studies, lots of them and because we have now included that population I am alive today. I had the same problem and nearly died 5 years ago. But I’m here because research is done on women today. Also we have echocardiograms, that helps too.
I don’t know “how” drug could be technically tested on pregnant women, I have no medical neither scientific background.
But we all know the DES was prescribed to pregnant women supposedly to prevent miscarriages while it has devastative effects on at least three generations so far.
My point is that DES is STILL prescribed today in Kenya for example…
The same thing with Thalidomide, STILL prescribed today in Brazil for example…
Idem with Bentakin, Dépakin, Topamax, Topiramate, Valproate which are STILL prescribed today in France, UK and US for example…
Thanks for sharing Dom
Thank you for sharing valuable information.