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"Sex Matters" when it comes to prescription drugs

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  • "Sex Matters" when it comes to prescription drugs

    great (well, not so great if you're a woman) 60 Minutes episode on not only how drugs affect the sexes differently, but also how testing and research in some cases is so badly biased you wonder about the efficacy of the results at all.

    Video (c14:00) and transcript:


    http://www.cbsnews.com/news/sex-matters ... fferently/

  • #2
    Re: "Sex Matters" when it comes to prescription drugs

    I'm amazed that this news is new.

    I have a bad feeling that a progressive view of gender and increasing gender parity might have the negative consequences of assuming that women are exactly the same as men. We're seeing that problem with the military relaxing standards so that women can serve on the front line.

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    • #3
      Re: "Sex Matters" when it comes to prescription drugs

      and what the hell does pure science have to do with emotion-perceived judgmentally?!!!

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      • #4
        Re: "Sex Matters" when it comes to prescription drugs

        Biggest problem is that the clinical drug trials are done almost exclusively on males, simply because everybody wants to avoid females of reproductive age for the risk of pregnancy. I may have missed it in the article, but I don't think they mentioned it.
        "A beautiful theory killed by an ugly fact."
        by Thomas Henry Huxley

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        • #5
          Re: "Sex Matters" when it comes to prescription drugs

          no, they never mention pregnancy, but it's the menstrual cycle they cite as the reason:

          << That’s because, she says, there was no evidence at the time that the difference mattered. That was 20 years ago, when if someone said “women’s health,” it usually meant what they call “bikini medicine” -- breast and ovarian cancer, pregnancy, menstrual cycles. But for parts of the body men and women share -- hearts, kidneys, the brain -- most of the studies were done predominantly on men.

          Lesley Stahl: If you want to understand me, they study you?

          Larry Cahill: And here’s why they do that. Because there’s this assumption that you are me with pesky hormones.

          Lesley Stahl: Oh…with pesky hormones.

          Larry Cahill: I’m being only partially facetious. The idea is that the fundamental things are similar between you and me. So that ironically the best way to study you is to study me.

          Lesley Stahl: Cause you don’t have pesky hormones.>>

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          • #6
            Re: &quot;Sex Matters&quot; when it comes to prescription drugs

            Originally posted by gh
            great (well, not so great if you're a woman) 60 Minutes episode on not only how drugs affect the sexes differently, but also how testing and research in some cases is so badly biased you wonder about the efficacy of the results at all.

            Video (c14:00) and transcript:


            http://www.cbsnews.com/news/sex-matters ... fferently/
            It is not just differences in dosing. There is another side to this story altogether. Many medicines with high efficacy in one patient population don't even get to market because they cause side effects in a different race, gender or population. You shouldn't blame big Pharma for this - it is just plan difficult to discover and develop medicines that are universally effective and without side effects of some sort.

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            • #7
              Re: &quot;Sex Matters&quot; when it comes to prescription drugs

              What I took away from the video was that dosing is the least of the problem. The big gorilla in the room is that the whole testing protocol is flawed by the sexual makeup of the test panels. But BigPharm doesn't really seem to care.

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              • #8
                Re: &quot;Sex Matters&quot; when it comes to prescription drugs

                Originally posted by gh
                What I took away from the video was that dosing is the least of the problem. The big gorilla in the room is that the whole testing protocol is flawed by the sexual makeup of the test panels. But BigPharm doesn't really seem to care.
                I probably did not express myself accurately before. The reason for this difference in sexual makeup in testing is the fear of potential terratogenicity of the tested drug. That is the primary reason why women of childbearing age are excluded.Those lawsuits are costly and unpleasant.
                "A beautiful theory killed by an ugly fact."
                by Thomas Henry Huxley

                Comment


                • #9
                  Re: &quot;Sex Matters&quot; when it comes to prescription drugs

                  Originally posted by gh
                  What I took away from the video was that dosing is the least of the problem. The big gorilla in the room is that the whole testing protocol is flawed by the sexual makeup of the test panels. But BigPharm doesn't really seem to care.
                  That's a common, flawed assumption. BigPharm cares a lot. When people say this, I always wonder, what possible benefit would it be to them to do bad studies, that are flawed, and that could cause them liability issues later? As Pego said, we have to be very careful with females because of possible pregnancies issues. Its also why drugs aren't tested in children as often, because of concerns about what it may do to growth issues. I can tell you we ask woman of child-bearing age if they are pregnant before an x-ray. We don't do that for men. It is safer to study adult men, and that's why BigPharm does it, not because they don't care.

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                  • #10
                    Re: &quot;Sex Matters&quot; when it comes to prescription drugs

                    Originally posted by bambam
                    ... I always wonder, what possible benefit would it be to them to do bad studies, that are flawed, and that could cause them liability issues later? …..
                    well, for a start, let's assume that men and women each take 50% of the Ambien that's prescribed. If women, in reality, only need half the dose and started doing so, that would mean a 25% drop in sales revenue.

                    You don't think the bean counters know that?

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                    • #11
                      Re: &quot;Sex Matters&quot; when it comes to prescription drugs

                      While I would never underestimate the power of bean counters, I do not believe economics determines the recommended dose.

                      BTW, while I fully recognize physiological gender differences, I would never have predicted such a difference in hypnotic dosage.
                      "A beautiful theory killed by an ugly fact."
                      by Thomas Henry Huxley

                      Comment


                      • #12
                        Re: &quot;Sex Matters&quot; when it comes to prescription drugs

                        Originally posted by gh
                        Originally posted by bambam
                        ... I always wonder, what possible benefit would it be to them to do bad studies, that are flawed, and that could cause them liability issues later? …..
                        well, for a start, let's assume that men and women each take 50% of the Ambien that's prescribed. If women, in reality, only need half the dose and started doing so, that would mean a 25% drop in sales revenue.

                        You don't think the bean counters know that?
                        Dosing is determined quite early in the clinical trials process, many years before the medicine reaches the market (if it even makes it). No "bean counters" have a say in this decision - its a purely medical determination and can often occur in a different company than the one that finally markets the medicine. Over-dosing would be silly because it increases the likelihood of side-effects with no therapeutic benefit. What's more, Ambien has been generic for about seven years and therefore it is a different set of companies making and selling it now from those that originally discovered and developed it.

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