This is the final of several blogs from AAUW Chief of Strategic Advancement Jill Birdwhistell written during her recent trip to Paris on behalf of AAUW to attend a UNESCO conference.
A Case for Sex- and Gender- Based Analyses
Sometimes, the little things are the big things. And so it was for all of us participating in the expert working group on gender, science, and technology at UNESCO last week when a pharmacologic researcher and physician from Italy spoke to us about the lack of sex and gender analysis in medical research. In the United States, most people are fairly well informed about the lack of drug testing on women subjects before the mid-1990s, and even the relative lack of post-marketing data collection about the effects of these drugs on women. Likewise, many are aware that in addition to size and body mass differentials among men and women, there may be considerable differences about the ways that drugs perform in their bodies.
Further, some diseases like heart disease, the leading killer of women, are expressed symptomatically in women quite differently than in men, a fact that has led to far less public awareness of the symptoms of heart disease in women and in significant morbidity and mortality due to undiagnosed or misdiagnosed heart attacks.
But I have to admit that most of us in the working group, and I daresay most of the general public throughout the world, didn’t know about the “little things” that contribute to development of drugs that either don’t perform well or that perform differently than anticipated in women: MICE! Male mice, to be precise.
Apparently, it is common to sex segregate lab mice. Our speaker explained that there is a great deal of evidence to show that when laboratory mice are kept in male-only cages, the males are much more active and anxious, and this is reflected in higher levels of excitation and elevated vital signs. Alternatively, when males and females are caged together, the males are calmer and their vital signs read closer to their normal rates.
As she explained, it’s the sex-segregated mice that are typically used for preclinical drug development. In other words, the process is neither sex-neutral nor sex-balanced, and may even be skewed by gender-based factors stimulated by the culture of the sex-segregated cage at the inception of the drug development.
So, what are the health implications of using this methodology? Without a sex and gender analysis in advance, this remains an open question. Sex analysis means that the sex of the anticipated end user is considered before the project is started, because you can’t go back again and figure out how the experiment would have worked if you had tested the other sex. Likewise, lacking gender analysis, if there are sociocultural, political, or legal factors that could affect the process or outcome, you can’t just go back and guess that such and such would have probably worked without testing the proposition.
Unfortunately, both sex and gender analyses are more often overlooked than implemented, and frequently not even considered. And apparently this issue is even more complicated than it appears, as we in the working group learned. It turns out that there are three sexes, sort of: men, women, and pregnant women.
We are all aware that there are a lot of regulations and reservations about testing on pregnant women. But the fact is that there are many drugs on the market that have not been tested on pregnant women and that behave in pregnant women far differently than they do in men or in women who aren’t pregnant. No wonder we are advised to take nothing, if possible, during pregnancy.
These are two examples of a much larger problem — the widespread failure of science and technology to account for male and female differences. Sex and gender analysis methodology should be widely communicated to and understood by scientists and other researchers as a necessary best practice standard. And funders should use the power of the purse to demand such rigor as a condition of their support. Without a doubt, this affects every single one of us — and it is time to make an issue of it!
Although the fact that women and men (and pregnant women) react differently to particular drugs which we have known for some time, it is shocking that the same methodology for testing drugs is still going on: tests with males only (mice are cited). Why hasn’t the scientific community woke up?