Working from home today. I wanted to continue processing images using my remote desktop application but somehow we already used up 75% of our internet usage and we still have a week and a half to go.
I have decided to catch up on articles I have been saving to read for my project instead.
One of the articles I read has made me really concerned about health care systems, regardless of country. For years we have been ignoring potential sex differences when conducting clinical and preclinical research. The NIH only established their policy on considering sex as a biological variable in January 2016. Canada was a little fasting having done so in 2009. But still, this should have been done years ago.
In the article, they also point out that it took 20 YEARS before the recommendations or dosing for women was changed in some drugs that had adverse side effects for women very early on. Often the drugs were not even tested on women when they were designed for women; ridiculously if you ask me. How did that even get past and ethics board?
I feel like the following exert really puts this problem into perspective:
“ Another example in which sex bias in preclinical re-search may have increased the risk of undesirable out-comes in clinical research is in the pharmacological testing of the libido-enhancing medication flibanserin (Addyi™), for women [31]. In preclinical investigations of flibanserin’s effects on serotonin receptors, behavior, and cognition, almost all animals were male despite the drug being developed for use in women [32,33]. This sex bias carried over into pharmacokinetic testing of flibanserin in which the participant breakdown included 28 male and 10 female healthy volunteers [34]. Moreover, to investigate the potential interaction of flibanserin and alcohol with respect to increasing the potential risk of fainting in Phase I clinical trials, 25 participants underwent administration of both flibanserin and alcohol at varying doses [35]. Of those 25 participants, only two were female [36].” - Zakirniaeiz et al., 2016, Balance of the Sexes: Addressing Sex Differences in Preclinical Research
Even today, potential sex differences in disease and response to medication are not properly investigated or understood. What is worse, is when considering differences between males and females the menstrual cycle should be considered as the different sex hormones have been shown to have different physiological effects and their levels vary greatly throughout the menstrual cycle, and it is often not considered or very poorly controlled for. With oral contraceptives increasing in popularity, and often very accessible in industrialized countries, it is hard to recruit healthy women who do not take hormonal contraception. As a result, these studies hard to conduct. Now we struggle to find participants for studies that could have been easily conducted 20 - 30 years ago, unfortunately most seemed to not care back then.
