How medical research is failing women. For years, the process for developing and testing new drugs has focused disproportionately on male bodies — to the detriment of female patients.

There is indeed a long history of male emphasis in medicine. That said, I don't know how current some of the issues raised are, at least in the US. Like the article noted, in 1993 the NIH became required to have stipulations in funding opportunities requiring the inclusion of women in studies, and that made a huge difference. As far as the educational pipeline goes, that will be much more fractured, but the story of the school text not covering breasts is just embarrassing for that school. They should call them out.

The things in the article that didn't quite make sense to me are the following:

"People need to ask their physician: was this drug tested for me? The physician needs to ask the drug rep, and then the drug rep needs to ask the pharma company that produced the medicine, and they need to ask the researchers who carried out the fundamental science.”

That seems like really clumsy advice, which if followed, would likely deprive you of needed medications.

In recent years, the FDA has said it is safe for women of “child-bearing potential” to join studies before animal-testing is completed, provided they are monitored, including for pregnancy. But Fisher says that researchers would often “rather just restrict the participation of women [of child-bearing age] than inform them: ‘Please don’t get pregnant during this clinical trial’ and trust that they won’t do so.”

Yet by excluding small numbers of women from clinical trials in an environment where trouble is quite quickly dealt with “you’re just moving that experiment to the real world, with many more women exposed and very little surveillance”, Womersley adds. “We’re missing an opportunity to capture data, and we’re probably introducing a huge amount of risk in the process."

I feel like these paragraphs are confusing an issue and misrepresenting how IRBs work. The first paragraph is saying women are being excluded and told not to get pregnant without proper monitoring. Which seems contradictory.

But my larger issue is that a competent IRB shouldn't approve a protocol with women of child bearing age without requiring a lateral flow assay pregnancy test at each study visit where drugs are introduced. That's a quick and easy way to address the risks of pregnancy.

But there is real risk, to the subject and the study when fetuses are involved. It's very difficult to get approval to test drugs on pregnant women, and inadvertent exposure to a fetus of drug is often a reportable event that can result in a black mark on a PIs record and can hinder their future research.

I remember a reportable event where a female subject was screened and consented into a study, and given an initial dose of the study drug. It was later discovered that the site has used a pregnancy test that was a few days out of date. That becomes a reportable event to the IRB. We ultimately concluded that this meet the criteria to report to our oversight body. There's a lot of technical detail I have to omit, but it's an example of why drugs aren't tested on pregnant women. The risks to fetuses are taken very seriously by pretty much everyone.

I don't think it's an overstatement to say that the fastest way to get an IRBs attention is the phrase "pregnant study participant."

Another challenge that the article mentions once but glosses over, is that it is hard to recruit people into studies, period. Most studies take real time and energy, are often uncomfortable or painful, and have unknown benefit to the participant because they don't know if the will be randomized to the control group or not. For a sleep study a reviewed recently, it involves a specific protocol to deprive the subject of sleep for 36 hours with hourly attention tests as part of the study. That's a hard sell.

This skews the participants to those who are able to make the time, or who need the money (some studies offer thousands of dollars via $x/per visit incentives). This can skew the participating demographic so that statistically significant sub group analysis is difficult. I e., you have a study size target to power your analysis to a specific threshold, but that doesn't leave you with large enough subgroups for the same analysis confidence. It can take months or years to recruit enough people, so even if you had enough money to dramatically increase the study size, it could take prohibitively long to do so.

But beyond those points, and a few minor nitpicks, the article is on point. So much of our established drug knowledge was gained from testing on men. And especially on the elite school side of the house that attracts big egos, there is still a very dominant make perspective. While that is changing, at least in the US, unless a funding agency offers funding to repeat past studies with more representative cohorts, I don't see that changing much.

I do think that precision health will slowly change things as well. Unlike the article, I've never met anyone in the precision health realm who questions factoring sex into bespoke treatments. Indeed, that sounds like it's coming from critics of precision health in general.