The mothers fighting a scandal bigger than thalidomide

https://www.theguardian.com/society/2024/feb/22/the-mothers-fighting-a-scandal-bigger-than-thalidomide-we-were-told-the-medication-was-safe

by isomorph • 2 years ago

100 38 2 years ago

theguardian.com

Simulacra• 2 years ago

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.

dwighttk• 2 years ago

An epilepsy medication

mouse_• 2 years ago

Godspeed. Take them for all they're worth.

magnetowasright• 2 years ago

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.

giantg29• 2 years ago

Seems like most doctors rely on an Epic printout handed to the patient at checkout time, or the fact sheet provided at the pharmacy. How many people read those, let alone understand them?

nerdponx• 2 years ago

I've had doctors literally just Googling medications and reading whatever page from Healthline (or similar) that came up.

amluto• 2 years ago

A lot of those printouts are hilariously off topic and mostly worth reading for the laughs. Finding the genuinely important bits can be a challenge.

ianburrell• 2 years ago

For valproate, there are multiple forms that result in the same active ingredient. Then there are multiple brand names for each form since it has generics, and brand names are different in each country.

I briefly took Divalproex for migraines which is sodium semivalproate. My doctors called it Depakote since that was most common brand name. Two names was enough trouble finding information. I didn't realize it was valproate until now.

gadders• 2 years ago

Good postmortem on who knew it was bad and when here: https://ebm.bmj.com/content/24/4/127

cko• 2 years ago

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.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...

verisimi• 2 years ago

Why? These organisations only purport to be acting for 'the people' whilst actually working for the pharmaceutical organisations. They are there to provide the illusion of safeguards.

giantg29• 2 years ago

Because the other epilepsy drugs carry similar risks. So they leave it as an option since the individual risk profile depends on the effectiveness and efficacy of the other drugs for that specific person. Even the "safe" standard (keppra) has these risks today.

Turing_Machine3• 2 years ago

That's just for the effects on child IQ, which apparently came out of a new study around that time.

It says at the bottom that the other fetal risks have been known for a long time.

"Valproate products have long been known to increase the risk of serious birth defects, in particular, neural tube defects such as spina bifida. This risk is already described in detail in the drug labels for valproate products."

DebtDeflation• 2 years ago

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”

Ah, well, at least no one experienced any fruitless anxiety.

giantg29• 2 years ago

Same thing with basically all meds. Just look at how hormonal birth control is handled - risk of pregnancy is considered to outweigh risks of vascular issues, cancer risks (gliomas), etc and patients usually have no idea about the risks. The doctors have made that risk assessment for them. Even over OTC meds have risks that most patients don't know about, or care about, until it affects them.

throwboatyface• 2 years ago

Hormonal birth control is extremely common and generally presents minor issues. This is a relatively uncommon anti-seizure drug that has extremely high risks of causing developmental issues in children.

alistairSH3• 2 years ago

That's true, and to some extent useful, as people are generally pretty bad at risk evaluation.

At the same time, drugs with teratogenic effects "feel" like a special case. The risk isn't just to the patient, but to their unborn child. And pregnancy can be successfully avoided.

I don't know where to draw the line, but at least based on a quick read of the linked article and a few related pieces, it feels like NHS and other government bodies (both UK and elsewhere) dropped the ball with this drug.

messy• 2 years ago

I agree, and the risks go beyond personal health. It doesn't help that it's politicized and used as a tool to win votes (on either side) as a right that establishes your freedom/strength as a woman.

I couldn't even have a conversation with most women about any of the negative effects.

The effects of hormonal birth control had have trickled and Id argue they influence and effect every part of our society greatly.

Her children's development has been greatly altered and will completely change the course of their lives and the lives around them. I can only imagine, but I feel a sense of helplessness for her.

Just don't do drugs is all i feel to say.

crote• 2 years ago

The risks of hormonal birth control are widely known. They are clearly stated in the package insert, and a lot of doctors will discuss them with you and offer alternatives if you're worried about it.

But indeed, for a lot of women a pregnancy would be far riskier than the side effects of birth control.

noqc2• 2 years ago

I wonder why it is that people don't "trust experts"?

abfan1127• 2 years ago

who deems them experts? what does it take to be an expert? are experts ever wrong? History is filled with experts who were wrong. History is also filled with experts who can't even admit they were wrong. Why should I put blanket trust in someone just because someone else calls them an expert?

whycome• 2 years ago

Funnily enough, the article seems to describe anxiety that bore fruit: action, change, and awareness.

giantg29• 2 years ago

“The NHS was saying they didn’t have that information and there was insufficient research,”

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.

One thing I didn't see in the article was what the alternative meds were and their safety profiles.

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.

Mistletoe• 2 years ago

https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...

This has a lot more concrete info if you are looking for it from the story.

PH95VuimJjqBqy• 2 years ago

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.

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).

They do themselves no great service by not being more honest and forthright in the first place.

duffpkg• 2 years ago

Wrote Hacking Healthcare, former hospital system administrator, blah, blah...

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.

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.

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.

Turing_Machine3• 2 years ago

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”.

That's interesting, because in the United States this stuff has a "black box warning" that warns in no uncertain terms about fetal risk.

http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-I...

The mothers fighting a scandal bigger than thalidomide

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