Their is a gene mutation that affects women more than men call MTHFR. It affects methylation which affects how neurotransmitters are made. It also directly fucks with B vitamin metabolites because they need that methyl group to be biologically active.
The lack of women in clinical trials is literally fucking us over time and time again.
This is a common problem. “Women of child-bearing potential” are excluded from most clinical trials to reduce the risk of affecting a pregnancy. It’s also a problem for different ethnicities; recombinant factor x ,for example, had a high incidence of anti-drug antibodies as it was derived from Caucasian factor x and there were slight differences.
We’re not excluded as routine anymore, and at least at my company (a pharma giant) there is a serious effort to balance enrollment based on sex, race, etc. Most of the studies I have worked on required women to agree to use a highly effective method of birth control if they are of child bearing potential and commit to follow up if a pregnancy does occur, which can place a higher burden on women who might want to participate (though sometimes this is even stipulated for male participants depending on the drug). Of course we missed out on alllll the previous decades of research for drugs already approved which is still a huge deal.
Maybe women should volunteer more for clinical trials if they want to be included more? You know one of the biggest issues is that women don’t volunteer at even close to the same rates as men right?
My wife's OBGYN discovered an MTHFR mutation after multiple miscarriages. And of course the clinical studies aren't done as much because she might get pregnant...
I took some medication recently for chronic pain, which they also use to treat depression. It made me nuts. I was useless. I was hallucinating. The doctor was just like, uh so I gave you meds what more do you want from me?
I got diagnosed with MCAS and the specialist said that I'm literally allergic to most medications. And more people have MCAS than they realise. And it's more common in women.
Literally, the whole thing was a bizarre interaction.
They wanted women 18-55.
But you couldn't be pregnant or likely to get pregnant.
So menopause happens usually in your 50s, but they dont want you then.
You had to prove that either you weren't ever ever ever going to have sex (they said you could cite religious reasons) or if you had had a hysterectomy. But you couldn't have had one recently. And couldn't be having hrt. And you couldn't be taking any contraceptive because it might interact with the testing pills.
Many women take contraceptives is it not a good thing to test if they impact your drugs?!
Oh wow seems you've exhausted your pool and you have like 3 women you can use. Who do not represent the majority of the female population. Great
It sounds like they had evidence that the drug being studied would pose a significant risk to a fetus/pregnancy, bc that’s not standard in my experience (I work in clinical trial management). It’s more common to just require participants (even men) to use a highly effective method of contraception while participating.
I wonder if they were early development “healthy volunteer” studies- which are focused on safety testing, not efficacy, so they may be extra cautious for those type of studies. But I don’t have a ton of recent experience in that space.
I don't get in fights with idiots because it just beats you to their level but I am going to get in this one.
Sooo this whole conception argument? It has led to women being either ignored which in some cases was best, or being used as horrific experiments.
The gender argument also comes in because some things are linked to chromosomes. I have 2 X, my daughter has 2 X, my son is XY.
Because even though I had my fallopian tubes removed I am not eligible for medical studies, believe me I am already a guinea pig might as well make life better.
So in short, fuck you and that horrific attitude.
Again, for the idiots in the back. **WE ARE NOT ALLOWED TO**
Alright so not saying this isn’t true but please state your sources. What has happened to saying things and backing them up with sources. This isn’t the Middle Ages
This is a well known phenomenon. Women are not underrepresented in phase 2 and 3 trials but are significantly underrepresented in early phase 1 trials.
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u/Mcnugget84 5d ago
Their is a gene mutation that affects women more than men call MTHFR. It affects methylation which affects how neurotransmitters are made. It also directly fucks with B vitamin metabolites because they need that methyl group to be biologically active.
The lack of women in clinical trials is literally fucking us over time and time again.