Wrote Hacking Healthcare, former hospital system administrator, blah, blah...<p>I think the comparison to thalidomide is click bait. Thalidomide was such a problem because it was used to treat symptoms of pregnancy, not some other unrelated condition. In this situation all(?) of the first line pharmaceutical treatments for managing epileptic seizures pose at least some developmental risk to unborn children. On the other hand unmanaged epileptic seizures also pose a risk to the parent and child.<p>This was a situation of gross negligence on the part of the institutions involved in regulation AND the direct providers offering care. A classic "somebody else's problem" field. Institutions failed to identify the actual scale of the risks involved in a way that properly educated providers and providers chose an inappropriate framework with which to manage and communicate the risks to patients who could or did become pregnant.<p>The drug involved here is not really the problem, it is an effective drug at managing epileptic seizures. A reasonable approach that was not employed would be to properly identify the drugs serious dangers to developing children in those who may become pregnant to providers. As a regulator you need to hit them over the head with it. From a course of treatment standpoint selection of alternative drugs for patients who would like to become pregnant that have slightly less risk to undeveloped children need to be prioritized. Providers need to make sure that proper supplementation happens (folic acid, etc). The risk is meaningfully reduced and the patient would better understand what can happen. This type of comprehensive and nuanced course of treatment is something that is just very very difficult for healthcare, in the US anyway, to achieve.
>the Committee on Safety of Medicines (CSM), then the main decision-making body on new medicines, which concluded that the risk was low and that patients should not be informed, in order to avoid “fruitless anxiety”<p>Ah, well, at least no one experienced any fruitless anxiety.
Good postmortem on who knew it was bad and when here: <a href="https://ebm.bmj.com/content/24/4/127" rel="nofollow">https://ebm.bmj.com/content/24/4/127</a>
<a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-children-born-mothers-who-took-valproate-products-while-pregnant-may" rel="nofollow">https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...</a><p>This has a lot more concrete info if you are looking for it from the story.
> They also found the response from the Committee on Safety of Medicines (CSM), then the main decision-making body on new medicines, which concluded that the risk was low and that patients should not be informed, in order to avoid “fruitless anxiety”.<p>That's interesting, because in the United States this stuff has a "black box warning" that warns in no uncertain terms about fetal risk.<p><a href="http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-Inj-FK-45982G-10-2015-PI.pdf" rel="nofollow">http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-I...</a>
“The NHS was saying they didn’t have that information and there was insufficient research,”<p>They (and other government bodies) say this about all sorts of medications that have limited support for any harm. If generally safe is the default, proof of harm has a higher bar to dethrone the existing raring.<p>One thing I didn't see in the article was what the alternative meds were and their safety profiles.<p>Guess what? Keppra is now the standard and touted as the safest during pregnancy and that breasrfeeding while on it is still recommended. It's also listed as having potential tetrogenic issues. So this type of issue is still strong today.
For such an old drug, I'm surprised that the FDA didn't classify it as Pregnancy Category D (don't take it) until 2013.<p><a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-valproate-anti-seizure-products-contraindicated-migraine-prevention" rel="nofollow">https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...</a>
<i>It led to the report published this month by England’s patient safety commissioner, Dr Henrietta Hughes, which recommended a compensation scheme for families of children harmed by valproate taken in pregnancy.</i>
This is devastating and I don't want to take away from it but this sort of thing is even worse than just the families affected by it.<p>Many people distrust authority for reasons like this. These same people will turn around and get frustrated that so many didn't trust them about the safety of covid vaccines (and other types of vaccines).<p>They do themselves no great service by not being more honest and forthright in the first place.
Valproate is not just for epilepsy; it's also used for bipolar disorder and migraines. For people who only know the brand names of their medications or don't have even a layperson's grasp of the kinds or classes of medications they are or were on (cos a lot of physicians don't explain any of this, or the side effects) they might miss that this could apply to them too.