4 ms·

>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

>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.
    - lostmsu 3y ago
      I resent that you omitted base rate for cervical cancer (0.7%).
      - giantg2 3y ago
        I did not have base rate available, thank you.
    - sturmdev 3y ago
      While I agree that medical communication can and should be better, it’s worth pointing out that hormonal birth control also lowers the risk of endometrial, ovarian, and colorectal cancer by a similar amount according to cancer.gov (see: https://www.cancer.gov/about-cancer/causes-prevention/risk/hormones/oral-contraceptives-fact-sheet https://www.cancer.gov/about-cancer/causes-prevention/risk/h...).
- alistairSH 3y 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.
  - giantg2 3y ago
    "The risk isn't just to the patient, but to their unborn child." Any reasonably adept provider should be considering the care for the fetus (assuming it isn't being terminated). The main problem in this case was the lack of disclosure. And those disclosure problems are widespread. Anti seizure meds specifically are tricky. If you are on these meds and plan to become pregnant, they all increase defect risks. While some have lower risks, the effectiveness of the drugs can be highly specific to the individual. Some individuals may be required to take the higher risk drugs is the current low risk standard doesn't effectively control thier issue.
    - alistairSH 3y ago
      Absolutely. If seems like this drug should have been placed on the "high risk - don't take while trying to conceive" lists from the outset. And from what I can tell, it's only on that list in the US when being prescribed for migraine control (but not seizure control). This will sound callous, but sometime a person has to pick between managing their personal health and having a child. I have a friend who's on some nasty drugs and when faced with the choice between "go off drugs, relapse", "stay on drug, risk birth defects", and "stay on drug, don't have a kid" she chose the last option (correctly IMO, but it's definitely not my place to interject).
      - giantg2 3y ago
        "If seems like this drug should have been placed on the "high risk - don't take while trying to conceive" lists from the outset. And from what I can tell, it's only on that list in the US when being prescribed for migraine control (but not seizure control)." That's because they're doing the risk profile. Seizures pose a risk to the fetus too while migrains do not. So they aren't doing it based solely on risk, but on the overall risk profile including "rewards" or reduction in other risks.
- messy 3y 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 3y 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.
  - giantg2 3y ago
    "They are clearly stated in the package insert" I guarantee they are not all on there. For example, risks of glioma related to progestin, or cervical cancer risks. This type of scenario is the entire basis of the article. Most patients (and many doctors) make the choice without reading the insert anyways. The insert is generally not provided to the patient prior to purchase and most don't care read it anyways due to other concerns. "But indeed, for a lot of women a pregnancy would be far riskier than the side effects of birth control." For a subset, sure. But for the majority of women prescribed (young and generally healthy), that statement may not be true. The majority of contraceptive use is primarily of social desire. Medical necessity is a secondary concern. We can easily see this in the fact that most women are never consulted about the medical risks of either scenario when requesting birthcontrol and an overall consultation on possible options is usually limited and in some cases absent (although it has been improving as more options become more mainstream).
noqc 3y ago
I wonder why it is that people don't "trust experts"?
- abfan1127 3y 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?
  - noqc 3y ago
    To be clear, I'm not arguing the validity of the position of "trust experts", I' arguing the inanity of encouraging people to trust experts who have taken the position of lying, out of their professional expertise.
whycome 3y ago
Funnily enough, the article seems to describe anxiety that bore fruit: action, change, and awareness.

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.
  - lostmsu 3y ago
    I resent that you omitted base rate for cervical cancer (0.7%).
    - giantg2 3y ago
      I did not have base rate available, thank you.
  - sturmdev 3y ago
    While I agree that medical communication can and should be better, it’s worth pointing out that hormonal birth control also lowers the risk of endometrial, ovarian, and colorectal cancer by a similar amount according to cancer.gov (see: https://www.cancer.gov/about-cancer/causes-prevention/risk/hormones/oral-contraceptives-fact-sheet https://www.cancer.gov/about-cancer/causes-prevention/risk/h...).
alistairSH 3y 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.
- giantg2 3y ago
  "The risk isn't just to the patient, but to their unborn child." Any reasonably adept provider should be considering the care for the fetus (assuming it isn't being terminated). The main problem in this case was the lack of disclosure. And those disclosure problems are widespread. Anti seizure meds specifically are tricky. If you are on these meds and plan to become pregnant, they all increase defect risks. While some have lower risks, the effectiveness of the drugs can be highly specific to the individual. Some individuals may be required to take the higher risk drugs is the current low risk standard doesn't effectively control thier issue.
  - alistairSH 3y ago
    Absolutely. If seems like this drug should have been placed on the "high risk - don't take while trying to conceive" lists from the outset. And from what I can tell, it's only on that list in the US when being prescribed for migraine control (but not seizure control). This will sound callous, but sometime a person has to pick between managing their personal health and having a child. I have a friend who's on some nasty drugs and when faced with the choice between "go off drugs, relapse", "stay on drug, risk birth defects", and "stay on drug, don't have a kid" she chose the last option (correctly IMO, but it's definitely not my place to interject).
    - giantg2 3y ago
      "If seems like this drug should have been placed on the "high risk - don't take while trying to conceive" lists from the outset. And from what I can tell, it's only on that list in the US when being prescribed for migraine control (but not seizure control)." That's because they're doing the risk profile. Seizures pose a risk to the fetus too while migrains do not. So they aren't doing it based solely on risk, but on the overall risk profile including "rewards" or reduction in other risks.
messy 3y 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 3y 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.
- giantg2 3y ago
  "They are clearly stated in the package insert" I guarantee they are not all on there. For example, risks of glioma related to progestin, or cervical cancer risks. This type of scenario is the entire basis of the article. Most patients (and many doctors) make the choice without reading the insert anyways. The insert is generally not provided to the patient prior to purchase and most don't care read it anyways due to other concerns. "But indeed, for a lot of women a pregnancy would be far riskier than the side effects of birth control." For a subset, sure. But for the majority of women prescribed (young and generally healthy), that statement may not be true. The majority of contraceptive use is primarily of social desire. Medical necessity is a secondary concern. We can easily see this in the fact that most women are never consulted about the medical risks of either scenario when requesting birthcontrol and an overall consultation on possible options is usually limited and in some cases absent (although it has been improving as more options become more mainstream).

noqc 3y ago

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

abfan1127 3y 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?
- noqc 3y ago
  To be clear, I'm not arguing the validity of the position of "trust experts", I' arguing the inanity of encouraging people to trust experts who have taken the position of lying, out of their professional expertise.

whycome 3y ago

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