Drug trials ‘ignore’ effects on women

[Pimmsnlemonade]

The impact of sexism on women's health:

www.thetimes.co.uk/edition/news/drug-trials-ignore-effects-on-women-26wsnfbqh

This can only get worse if we no longer recognise the biological differences between the sexes.

Sharetoken link:

www.thetimes.co.uk/article/drug-trials-ignore-effects-on-women-26wsnfbqh?shareToken=e719e5c097ee2eb964e16e9412d51995

I work in medical research, I think testing on women has more obstacles as often the outcomes fluctuate with our hormonal cycles and there are real ethical issues over giving women, who could fall pregnant, untested medication.

It should be done, of course, but I don't think most testing is done on males because they see them as more important, I think they are seen as simpler and no risk of repeating the thalidomide scandal.

Also, I don't think there is even a whiff of combining the sexes/ignoring sex differences in scientific/professional circles.

There was a thread on here about how women are treated by medical staff and their symptoms ignores, dismissed, presumed to be related to hormonal changes. Also women are more likely than men to be on more than one type of medication and the interactions between them are rarely studied. (Anti depressants and hormonal contraception for example)

I think testing on women has more obstacles as often the outcomes fluctuate with our hormonal cycles Surely this alone makes research necessary!!!!

I don't think most testing is done on males because they see them as more important, I think they are seen as simpler and no risk of repeating the thalidomide scandal.

Drugs can affect the sperm, and that can cause miscarriage or birth defects.

Of course it makes it necessary - just much more difficult. I worked on an autoimmune condition for a while and even the different types of contraception women took had to be considered and had influences. Most drug testing is only done on men who are completely medication free.

I only mentioned the difficulties and ethics to show it wasn't just that women were considered unimportant. It should be standard to test on men, then women and people of different ethnicities. However, unless this is done globally, the company taking their time to do this will lose out to those happy to just test on men then send the drugs to market.

There is a difference between explaining why something happens and condoning it. I was just adding info, not saying this is ok.

However, unless this is done globally, the company taking their time to do this will lose out to those happy to just test on men then send the drugs to market.

So then there needs to be pressure put on the FDA, the EMA, and the PMDA.

I've seen this excuse used by researchers before. But it's no excuse to only test it on men and then give it to mostly women, as they do with many drugs. You just have to test it on women and make note of their cycles, ffs.

Why are medications approved if they haven't been adequately tested for women?

FDA recommendations on testing of drugs in women. You'll notice it was banned in Phase I and II trials in the aftermath of the thalidomide scandal because of fears of harming foetuses but later recommendations include assessing the impact by race and sex (I'd assume in Phase III but I'm not an expert on clinical trials).

I also work in medical research. Trials are supposed to reflect the population the drug will be used in, so unless it’s a sex specific indicaton like prostate or ovarian cancer you usually aim for 50:50 sex inclusion. However it’s not easy to get that exactly unless the protocol and the electronic screening systems are set up like that. A trial usually is conducted at multiple ‘sites’ and patients will arrive and be screened and initiated into the trial at the sites separately. So say site 1 has five Male patients then sites 2-5 do as well. You’d need to set up the systems to say ‘we have enough women’ and not everyone designing and coding the systems does this (I have done it ;) ) capping the number allowed in can cause issues with recruitment and

Most of the trials I’ve worked on actually have had a correct sexual distribution. It is seen as a gold standard thing and it should be done. The exceptions have been where the condition is far more prevalent in one sex (for example fibromyalgia trials tend to have more women and schizophrenia more males) or where the drug is suspected to be strongly teratogenic. All trial participants should be on two or more forms of contraception and women are pregnancy tested at every visit.

Trial design and ‘rules’ improve constantly. So for newer drugs this (inclusion) is not as much of a problem although data analysis often lacks.. For older drugs though, it really is an issue.

FWIW when I run a trial or contribute to one I always ask: 1. How do we ensure correct sex ratios and 2. How do we report sex based data?

I should say the above applies to phase III.

Phase 2 is strongly Male biased.