So depressing .. Johnson & Johnson de-gendering clinical trials ....

[SpringCalling]

We all know how bad the Pharma industry has been at in trialling their drugs with females as well as males - 'cos of our pesky hormones getting in the way, and besides we're just default males right? I had hoped this was changing, but now we get this - de-gendering of trials so that no-one feels excluded.
https://www.pharmavoice.com/news/jnj-johnson-diversity-trans-inclusion-clinical-trial-erleada/713902/

"Some companies don’t even collect sexual orientation and gender identity (SOGI) data in their clinical trials."

Er, because medicine generally doesn't care if you're gay when deciding whether to work? Why would they need to collect irrelevant data?

Gender identity doesn't matter either, merely whether you are taking any drugs for it. And they do collect what medication you are on.

FFS.

The don't disaggregate data by sex in most trials when doing so could save countless women's lives but they want to make trials "gender neutral"? Paging Caroline Criando Perez...

“We don’t recognize a cancer by sex" - well you bloody should, mate, as only males get prostate cancer. Gender is irrelevant but sex is pretty bloody basic when it comes to prostate cancer.

And as usual, gender neutral language makes things harder for everyone for whom English is not a first language. Uterus-havers, people with prostates... not exactly crystal clear for non-English speaking population is it?

But never mind the health of those pesky immigrants, let's think about the feels of trans-identifying males who won't take appropriate cancer medication unless their pronouns are respected.

Surely this is ripe for a legal challenge under the EA2010? Not collecting sex data historically clearly discriminates against the sex class of women in terms of equal quality healthcare? And possibly also men? There are some conditions which affect men worse - e.g. covid. Having women cluttering up the data but not knowing they're women could obscure this effect.

It's not at all inconceivable you could have a drug where the risk / benefit is very very different for men and women. They're opening themselves up to huge liability I'd have thought.

Sure, 'degender' if you want - so long as sex is crystal clear in data and communications. In the case of an inherently sexed cancer such as prostate the data should be unambiguous at least.

They haven't said they'll stop collecting sex as a data point?

In the case of an inherently sexed cancer such as prostate the data should be unambiguous at least.

But that's presumably the minority of cases - it sounds as if they're making an effort to not explicitly record sex, therefore you would only be able to deduce sex from data if sexed body parts were directly involved.

How bloody stupid can this get? I am quite sure that any body who has a prostate is aware of the fact that they were born male, conversely any one with a cervix will be aware that they were born female. The medication for any illness needs to be accurately tested, for the sex of the people it is to be used on. If thalidomide had been tested on "transwomen " it's harms would not have been discovered.

I read it as a lot of words to basically say they want to use 'inclusive' language. So instead of saying they want to study men, theyll say people with prostates.

"We don’t recognize a cancer by sex. We recognize it by somebody who has a prostate,” he said.

I don't get from the article that they are disregarding sex for studies that include men and women. Its just that they are going to use other words for sex when advertising.

A whole lot of clinical trail data or pharma adverse effect data is not sex disaggregated anyway. Which is utter shite, because we know that pharmaceutical drugs can have different effects on male and female bodies. Usually we just don't test on women but then just give them the same dose of the same drug that worked on the default male, and then shrug when it doesn't quite work the same.

The vast majority of clinical data is collated from adult men anyway. So actually nothing will change.

i wonder what this is reallllly about? J&J are American aren’t they?

<irrelevant> I used to work with mark Wildgust’s dad. He was nice.

So what about trials that aren't about sex specific conditions, will they still record sex for those and, if so, how?

It makes a big difference whether this is just an advertising thing or will affect language used in scientific papers. The latter could be hugely detrimental to systematic reviews by messing up the searches.

"We don’t recognize a cancer by sex. We recognize it by somebody who has a prostate,” he said.

This really is very silly. WTF, in practice, is the difference between recognising this cancer by sex, and recognising it by the presence of a sexed organ?

Please consider reporting this to the Sullivan review (details in post here)

Is this something that can be submitted to the Sullivan call for submissions of data?

www.ucl.ac.uk/ioe/departments-and-centres/centres/centre-longitudinal-studies/review-data-statistics-and-research-sex-and-gender#Call%20for%20evidence

I’m sure TW are gonna love their Big
Pharma rebrand, ‘Prostate People’ has got a nice ring to it!