There was a time when all-male samples were not infrequently used to study the efficacy of some drug of treatment which, if the results were promising, would then be administered to both male and female patients. I thought that time was in the past, but I seem to be mistaken.
In late September, the Food and Drug Administration (FDA) approved a new drug, Descovy, for the prevention of infection with HIV. It's only the second drug to have been approved in that category. The first one was Truvada which is widely used. But the FDA's approval of Descovy comes with strings attached:
The first, Truvada, has become a mainstay of government efforts to turn back the H.I.V. epidemic. But the F.D.A. approved Descovy for use only in men and transgender women, because its maker, Gilead Sciences, tested it only in those groups.
The approval explicitly excludes women, and does not outline a plan for making the drug available to them. Some activists and scientists said the approval sets a dangerous precedent by allowing companies to dodge the expensive trials needed to test medicines in women.
Such an exclusion of women “should be unacceptable in these days and times,” said Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital.
It’s important to test the drug specifically in women, she added, because Descovy may work differently in the vagina than in rectal tissues.
The F.D.A., in fact, will require Gilead to study the Descovy in women, company officials said. Gilead is considering a trial in Africa.
The bolds are mine*.
It's ironic that the maker is called Gilead Sciences. Never mind, the point here is that the manufacturer just decided to exclude biological females from the study, and the FDA had to require it to conduct a further study on women.
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* That bolded sentence suffers from the same linguistic illness I see all the time online:
It mixes together two different definitions of gender without seeming to notice that it does so. Note that the inclusion of transgender women in that sentence suggests that gender identity is used as the basis for defining "women" and "men." Because the gender identity theory decouples gender from biological sex, it should then follow that the category "men" used in that sentence might also include trans men who have biologically female bodies.
But the whole quote strongly suggests that this is not the correct interpretation. Rather, the writer took one definition of gender ("men") from the old based-on-biological-sex definition and the other ("transgender women") from the new gender identity definition.
The same confusion is present later in that article:
Descovy contains a newer version of tenofovir, the active ingredient in Truvada. Gilead tested Descovy in a multinational trial that included 5,313 men and 74 transgender women who have sex with men. There were no cisgender women, and 84 percent of the participants were white.The term "cisgender" is used in the gender identity approach to refer to people who don't identify out of the gender basket associated with their registered biological sex at birth, and the term "transgender" to refer to people who do identify out of the gender basket associated with their registered biological sex at birth and then move into the gender basket associated with the opposite sex.
“They did a terrible job of inclusion for a company that dominates the market,” Mr. Johnson said.
The above quote uses that division for women, but not for men. This is the common form of this error, actually.