Caroline Criado Perez in the Sunday Times

[ErrolTheDragon]

She's got a column today about the impact of delays in assessing vaccines in pregnant women which may be of interest:

www.thetimes.co.uk/article/dont-blame-pregnant-women-for-not-getting-the-covid-19-vaccine-0837dbbg8?shareToken=922a0343d7d40a801d83594e501bc183

Thanks for sharing. Well written and persuasive by Caroline as usual. Really upsetting to read about that poor woman, Samantha Willis and bloody horrific about how badly women were treated during the Ebola outbreak. This stood out for me:

'This lack of clarity is in keeping with the approach to women in medical research. For years, women have suffered from less effective treatment and more adverse drug reactions, in no small part because of the failure to routinely include female cells, female animals and female humans in studies.'
Why the fuck are female cells, animals and humans not included routinely?

Excellent article, thank you for sharing and absolutely yes, the sexism of science is killing women and babies. It needs to be addressed urgently

Such a pleasure to read ‘pregnant women’ that I read it twice.

Yes v good.

The other issue for me has been the general dismissal of all the women reporting disruption to periods.

That's a reproductive thing and so pretty important. But the media docs etc said. In stuff I read BBC etc. Women are probably imagining it. No link.

But where was the research the proof? The studies? If they were done I haven't seen them.

If men had reported erectile issues after it I suspect the reaction would have been somewhat different.

I don't know if there's a link or not. And if so why and what that means etc.

But it's another example of the way this stuff is just not treated as important.

And we just get TOLD to do xyz.

It was in CCP's newsletter today, the fact that authorities state that there is little evidence about the effect of the vaccine on periods BECAUSE THEY AREN'T COLLECTING IT (she was justifiably shouty!)

On the one hand medical professionals (and others) are increasingly risk averse - don't eat soft cheese / drink alcohol / drink caffeine / going in a hot tub etc. whilst pregnant, andd on the other - take this vaccine where the risks to you and your child are uncertain. No wonder women are confused.

Tabbystar, the risk of being seriously ill or dying from Covid while pregnant is many times higher than any risk of vaccine side effects. The advice to vaccinate is unequivocal.
Secondly, ever since the thalidomide scandal, there has been great caution about including women in clinical trials of new drugs, in case they were unknowingly in the early stage of pregnancy, and at risk of possible teratogenesis from the drug.
Society is of course often misogynist and patriarchal, but not in this case.

The thalidomide scandal is a lazy excuse IMO. Surely that should mean the need for more research on women not less.

MoonlightApple, it is not “lazy” to be unwilling to risk damage to early embryos in trialling new drugs. It makes ethical and economic sense to test them on males first.
Thalidomide was the drug that disabled thousands of babies and cost millions in lawsuits and assisted living costs - and since then, no drug company would risk a repeat, hence the caution in trialling or prescribing any new drug to young women.

It's not a trivial problem, especially working out how to ethically test for teratogenicity. More in vitro methods where possible, but there are very significant limitations. IIRC thalidomide was tested in animals - but animal models may or may not show up the same developmental issues as in humans, and in that case they didn't.. Does anyone have practical, ethical solutions to this?

Women should be allowed to prioritise their own health, without being judged so harshly - often it's damned if you do, damned if you don't. But many of us choose not to - 'could this possibly harm my baby' tends to override everything, doesn't it?

@Babdoc I was part of the Oxford study. They tested on women of all ages but we had to sign something saying we would try not to get pregnant. So they didn't test only on males.
I assume they tested on pregnant animals before pregnant women - thalidomide had terrible effects on pregnant animals but the tests were carried out too late/ not published so the harm to humans was already done.

Most clinical research studies require female participants to be on at least one form of contraceptive & pregnancy test through the study.

IIRC the issue with thalidomide is that it was a single isomer that was studied but they then used racemic thalidomide (actually maybe it was biological conversion?)
[the two enantiomers are non superimposable mirror images - like your hands are- & only one of them is teratogenic]

Now you mean? Certainly loads of drugs were never tested on women and the dosage effectiveness etc turns out are different than for men.

When you say most clinical trials have pregnant women. Is that for new drugs? I thought that was definitely not the case. Do you have any links? I'm surprised.

Oh sorry misread! Yes sorry.

Don't they worry about hormonal contraception interacting with the drugs?

Is there a reason post menopausal women aren't the usual when looking for women to join?

@NiceGerbil depending on the type of trial, they might want people with no/ few other health conditions. Women (and men) over a certain age are more likely to have other illnesses and are often excluded on those grounds.
The effects of hormones on drugs is mainly unknown, mainly because nobody has bothered studying it.
So for the trial I was in, I was never asked about periods other than when I signed up I had to give the date of my last period. So for the Oxford trial they would have no trial data on whether it affected periods, nor whether the vaccine was more or less effective if given at different times of a cycle.
I doubt very much if they considered menopause and fluctuating hormones at all.

@NiceGerbil

Oh sorry misread! Yes sorry.

Don't they worry about hormonal contraception interacting with the drugs?

Is there a reason post menopausal women aren't the usual when looking for women to join?

Each study has both inclusion (must be between ages of x&y, be diagnosed with z etc) & exclusion criteria (must not be on these contraindicated drugs, must not be pregnant etc) I have never seen one with hormonal contraceptives or HRT excluded (not to say there aren't any - eg I would expect anything related to hormone sensitive tumours would exclude the contraception pill). Earlier stage trials have stricter criteria than the later stage trials.

If you only study post menopausal women you would only be able to get a license for post menopausal women so it would reduce your target market & an ethics committee (all clinical studies must have ethical approval) would probably ask why you were excluding 30 yr old women while 30 yr old men were allowed.

Also from a data point of view post menopausal women are likely to be on more drugs & have more additional diagnosis than younger women so the data wouldn't actually be cleaner.

In a clinical study every drug taken by the participant is recorded (even the two paracetamol for a headache/twisted ankle) and every "adverse event" is recorded (even the headache AND the twisted ankle- because if there was a trend it might reveal that the new drug is causing poor balance/loose ligaments/reduced spacial awareness).

Women being on hormonal contraception is a pretty big thing though surely?

And market depends on the drug surely?

In the end the history of drug testing did pretty much ignore women and plenty of common drugs we are treated dosed as small men.

The fact that women have all these things- monthly cycle pregnancy menopause etc is just a bit of a pita really isn't it.

If women have to be on hormonal contraception then that's a pretty big thing surely.

A woman who has made all this her focus put it. Like men but with boobs and tubes

But of course we aren't.