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Thread: Drug trials ignore effects on women

  1. #1

    Default Drug trials ignore effects on women

    Article in the Times today raising the lack of studies on women for drugs such as statins - something I know Zoe has often pointed to. Since this is behind a paywall here is the article -
    Some of the world’s most commonly used drugs such as statins have not been properly shown to work in women because of sexism in science, researchers claim.

    An absence of women in clinical trials and failure to report results by sex have resulted in an evidence gap that is likely to be hampering treatment, doctors argue. Medical journals should force researchers to report results for men and women separately to be sure that new medicines are safe and effective for both sexes, they insist.

    “Women are not small men,” said Jeanine Roeters van Lennep, of the Erasmus Medical Centre in Rotterdam, who is leading the project. “There are biological differences in hormones and body composition. Women have smaller kidneys so it’s more difficult to clear medication. They have a different fat and water composition.”

    Previous research has found that eight out of ten drugs withdrawn from use after approval in the US over a three-year period turned out to have higher risks for women.

    “If they had had enough women in the trials, then maybe this medicine wouldn’t have even come to market,” said Dr van Lennep, who set out to analyse trials of heart drugs to see whether sex differences had been considered.

    Cholesterol-lowering statins are Britain’s most commonly prescribed medicine but in 45 trials she analysed, 82 per cent of those studied were men and only five trials made data available on men and women separately.

    This meant that there was not enough data to show statins prevented heart attacks, strokes and deaths in women with an acceptable number of side-effects, unlike for men.

    She said it was likely that statins did work for women, with previous studies suggesting a similar benefit for both sexes, and is not advising women prescribed them to stop. However, she argues it is not good enough that doctors cannot be certain because of sexism which is largely unconscious.

    “It’s shocking. Men forget to do sex-specific analysis, to be really polite about it. If 50 per cent of the population is female you can’t just say it’s an optional extra. It’s a blindspot because right now the triallists are generally men. I don’t think it’s malice that they don’t want to perform this analysis; they just really don’t think about it.”

    Last month a study showed that trials were more likely to report results for women separately if they had a female lead author, with only one in three papers reporting results separately. The Lancet, which published that research, is one of the few major journals that tell researchers to analyse separately.

    Dr Van Lennep said: “We think journals should make it compulsory to report results for men and women separately.”
    Last edited by JaneS; 8th March 2019 at 05:10 PM.

  2. #2


    I don't know why this is "news" the paper on which it is based comes from here 2017 Published by Elsevier Ireland Ltd
    Why women are not small men
    You don't have to pay for access as what you can see on the preview is all there is.

  3. #3


    Lipid-Lowering Therapies: Risks in Women and Evidence-Based Options
    The results, however, revealed that women taking rosuvastatin had a greater increase in HbA1c level and more risk of developing new DM than did women who took a placebo.
    sounds like compelling evidence to me but as it's only women perhaps they think it doesn't matter?

  4. #4
    Club Member grumbleweed's Avatar
    Join Date
    Feb 2011
    a city in the West Country


    Quote Originally Posted by TedHutchinson View Post
    Lipid-Lowering Therapies: Risks in Women and Evidence-Based Options
    sounds like compelling evidence to me but as it's only women perhaps they think it doesn't matter?
    ...and it's International Women's Day
    Dear Stomach,you are bored,not hungry. So shut up.

  5. #5


    Quote Originally Posted by grumbleweed View Post
    ...and it's International Women's Day
    Is it?? I hadn't realised!
    The worst bigots in the world are those who most loudly proclaim their ‘tolerance’

  6. #6


    One of the comments on the article was clearly a person who has become embroiled in the trans-sexual debates which are raging at the moment. They certainly had my recommendation for their comment that "women are not small men, some of them are big men" because it made me laugh out loud and anything which does that seems good to me!
    Gilli - DLTBGYD but more importantly KCHO

  7. #7
    Super Member Mamie's Avatar
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    Mar 2010
    Village in rural Lancashire


    Love it Gilli.

  8. #8
    SuperMember 2014-19 Lindam's Avatar
    Join Date
    Apr 2013
    Up North


    If you’re interested in a really good read - just released: ‘invisible women, exposing data bias in a world designed for men’ by Caroline Criado Perez. Fascinating and eye-opening read
    My mind is like my PC screen: 19 tabs open on the top bar, 3 of them are frozen, 25 half written emails on the bottom bar, and I have no idea where the music is coming from...


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