Women Are Underrepresented In Clinical Research On Cannabis – Forbes

Excluding women from biomedical research can skew the results of human clinical trials. Since these trials are a large part of what informs the practice of medicine, and especially pharmaceutical guidelines, failing to take into account the differences between men’s and women’s bodies can even be deadly. And yet we still do it, to the detriment of women’s health.

Now, researchers from the University of York have shown that women are also underrepresented in one of the largest-growing fields in medical research – cannabis. In particular, we know very little about the links between cannabis and psychosis in women, meaning we can’t possibly hope to fully understand and balance the medicinal impacts and risks of the plant and its chemical compounds.

The dearth of clinical data on women has a long and complex history, but one major turning point, at least in the United States, was a 1977 FDA guideline banning most women of “childbearing potential” from participating in clinical research studies. In the aftermath of the thalidomide debacle that resulted in heartbreaking birth defects, it was thought wiser to simply take them out of the subject pool.

Now we know this was a terrible idea, and in 1983 a Health and Human Services (HHS) task force recommended a shift away from this rule since it didn’t take long to recognize that women’s average body size, hormones, metabolism, and fat distribution are different from men’s, meaning that pharmaceutical substances would have different effects on them. As a result, women often experience a disproportionate share of adverse side effects.

The FDA has worked to reverse the trend, but the bias remains. For example, women (and people of color) are far less likely to be subjects in research into cardiovascular disease, leading to less knowledge of and power over the number one killer of women. From 2005-2015, only 34% of participants in clinical trials of cardiovascular drugs were women. The underrepresentation of women is also a problem in Alzheimer’s and lung cancer research.

And now cannabis.

Now that the world is opening up access to cannabis (whether it’s THC or hemp derivatives such as CBD), we stand to miss another opportunity to avoid gender bias in clinical research if we don’t take notice and remedy the problem soon.

Dr. Ian Hamilton from the University of York’s Department of Health Sciences has reported that a literature review of the clinical research done on cannabis is heavily weighted towards the experiences of men – and this means we’re missing a big piece of the puzzle.

His research is primarily on „Cannabis psychosis,” the mental health issues caused by cannabinoids.

Without knowing how women’s bodies react differently to these compounds, we could end up under- or (more likely, as we’ve seen in the past) over-prescribing for women or formulating pharmaceuticals that simply don’t work as well in the female body.

Hamilton notes that there are two main problems when it comes to the current state of research on cannabis psychosis. One is simple gender bias and it extends to the researchers themselves – there are fewer female scientists doing addiction research. The other issue is geographical.

…We are missing a large population size in not focusing study in areas outside of America, Europe, and Australia. We could gain much more knowledge on the risk of cannabis psychosis by including other countries and cultures.

Since current clinical research into cannabis focuses on specific populations, we are failing to take into account the plethora of data from Africa, Asia, and the Middle East, where Hamilton says very little is known about the number of people that develop cannabis psychosis.

Our lack of comprehensive knowledge about cannabis could slow down clinical research or have catastrophic effects if products are pushed through too quickly without proper testing – which means testing on all kinds of bodies.

Hamilton and his co-author Mark Monaghan, who studies Social Policy at the University of Birmingham, have just published “Cannabis and Psychosis: Are We Any Closer to Understanding the Relationship?” in the July 2019 issue of Current Psychiatry Reports. In it, they take a close look at the relationship between cannabis and schizophrenia, specifically.

Not only do the researchers suggest that we need to take a bio-psycho-social approach to studying the relationship between cannabis and schizophrenia (making sure that cultural factors are taken into consideration), but that we also need to expand our subject pool:

Research needs to extend beyond males drawn from western countries if we are to advance knowledge and understanding of the link between cannabis use and schizophrenia.

With an estimated 192 million people worldwide using cannabis in some form (at least as of 2016), it is now the most popular drug after alcohol and tobacco. And the explosion of unregulated non-psychoactive compounds, such as CBD, continue to complicate research.

While new genetic analyses and a recent change in legislation could be improving research conditions soon, we still have to populate our clinical trials responsibly – that means including more women.

In the now-famous 2014 “Connors Report” from Brigham and Women’s Hospital in Boston, researchers chronicled the exclusion of women from health research over the past few decades. In light of reports like this and tragedies such as women overdosing on zolpidem (the active ingredient in sleep aids such as Ambien) because it wasn’t formulated for their bodies, the FDA is making progress, but it’s slow.

Our sometimes-ham-fisted attempts to educate people about the difference between sex and gender has played a role too, but not nearly as big as the one played by gender bias. While some find it difficult to suggest that male and female bodies (and those transitioning) are all that different, sex is a biological (not a social) construct and it can matter a great deal when you’re measuring the effects of a drug on the body.

And yes, there’s a great deal of difference between women’s bodies – but the point is that they often have more in common with each other than they do with men’s.

To top it off, we’ve long had anecdotal evidence that cannabis affects men and women differently, so why haven’t we done a better job of taking this into account in clinical research?

From the potential for pain relief to new research suggesting that cannabis can enhance the female orgasm, women have much to gain from being included in research on both medicinal and recreational use of cannabis in all of its forms.

Now that we’re aware of the risks, there’s no excuse for leaving the research half baked.

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