5 ms·

The mothers fighting a scandal bigger than thalidomide

100 points by isomorph 3y ago

Simulacra 3y 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 3y ago
  An epilepsy medication
mouse_ 3y ago
Godspeed. Take them for all they're worth.
magnetowasright 3y 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.
- giantg2 3y 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 3y ago
    I've had doctors literally just Googling medications and reading whatever page from Healthline (or similar) that came up.
  - amluto 3y 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 3y 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 3y ago
Good postmortem on who knew it was bad and when here: https://ebm.bmj.com/content/24/4/127 https://ebm.bmj.com/content/24/4/127
cko 3y 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-drug-safety-communication-valproate-anti-seizure-products-contraindicated-migraine-prevention https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...
- verisimi 3y 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.
- giantg2 3y 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_Machine 3y 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 3y 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.
- giantg2 3y 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 3y 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.
    - giantg2 3y ago
      "This is a relatively uncommon anti-seizure drug" Sure, if you compare anything to hormonal birth control it will be relatively uncommon - they hand that stuff out readily and even consider making it OTC. This antiseizure drug is still commonly prescribed in many countries. "extremely high risks" A 700% on a 1.6% base rate, right? How does that compare with cumulative risk increases for cancers or vascular issue with hormonal birthcontrol? For example, they see a 60% increase in cervical cancer risk alone. That's pretty significant too if it's not being disclosed for patients to make an informed decision. Keep in mind, my argument was never that the risk of hormonal birth control were more than this drug or any other drug. My argument is that patients are still not informed of substantial risks that may not be as readily apparent as the minor issues that are more common.
giantg2 3y 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 3y ago
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-children-born-mothers-who-took-valproate-products-while-pregnant-may 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.
muhus 3y ago
[dead]
PH95VuimJjqBqy 3y 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 3y 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_Machine 3y 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-Inj-FK-45982G-10-2015-PI.pdf http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-I...

100 points by isomorph 3y 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 3y ago
An epilepsy medication

mouse_ 3y ago

Godspeed. Take them for all they're worth.

magnetowasright 3y 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.

giantg2 3y 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 3y ago
  I've had doctors literally just Googling medications and reading whatever page from Healthline (or similar) that came up.
- amluto 3y 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 3y 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 3y ago

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

cko 3y 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-drug-safety-communication-valproate-anti-seizure-products-contraindicated-migraine-prevention https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...

verisimi 3y 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.
giantg2 3y 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_Machine 3y 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 3y 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.

giantg2 3y 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 3y 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.
  - giantg2 3y ago
    "This is a relatively uncommon anti-seizure drug" Sure, if you compare anything to hormonal birth control it will be relatively uncommon - they hand that stuff out readily and even consider making it OTC. This antiseizure drug is still commonly prescribed in many countries. "extremely high risks" A 700% on a 1.6% base rate, right? How does that compare with cumulative risk increases for cancers or vascular issue with hormonal birthcontrol? For example, they see a 60% increase in cervical cancer risk alone. That's pretty significant too if it's not being disclosed for patients to make an informed decision. Keep in mind, my argument was never that the risk of hormonal birth control were more than this drug or any other drug. My argument is that patients are still not informed of substantial risks that may not be as readily apparent as the minor issues that are more common.

giantg2 3y 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 3y ago

https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-children-born-mothers-who-took-valproate-products-while-pregnant-may 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.

muhus 3y ago

[dead]

PH95VuimJjqBqy 3y 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 3y 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_Machine 3y 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-Inj-FK-45982G-10-2015-PI.pdf http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-I...