Women Vs Men: The Problem with Scientific Studies

We don’t have enough women in clinical trials

Neuro Athletes,

I hope you are all having a wonderful start to the week! If you follow me on Instagram you would have seen me riding through the streets of New York on a city bike. It is by far one of my most favourite things to do in the summer, it’s pretty much like therapy.

Last week, I interviewed Dr Stacy Sims on my podcast and was shocked when I learn that there is a lack of representation of women in medical studies.

Think about it…

Women are at greater risk for adverse side effects from medications due to a lack of female representation in clinical trials.

That’s according to recent research on the issue.

In one study, researchers from the University of California, Berkeley, and the University of Chicago analyzed data from thousands of articles from medical journals.

They say they found a gender gap in drug doses for 86 medications approved by the Food and Drug Administration (FDA).

“Sex inequality hides in plain sight today: most drugs are prescribed to women and men at the same dose,” the study authors wrote. “Many currently prescribed drugs were approved by the [FDA] prior to 1993, with inadequate enrollment of female animals in preclinical research and of women in clinical trials.”

To get a sneak peak into this topic, check out the Instagram reel I did on this topic we get into the newsletter!

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For decades, women were often excluded from clinical drug trials. Underrepresentation of either sex in clinical trials can be associated with suboptimal health outcomes, as men and women experience differences in medical test results, disease progression, treatment response, drug metabolism and surgical outcomes.

Although there’s been an increase in women in clinical trials in recent years, there are still problems with female representation in early phases of drug trials.

Women are actually well represented in the later stage trials, those known as Phase 3 studies, however, the dosing regimens used in later stage studies are based on the pharmacokinetic data collected in the early trials, where women continue to be underrepresented.

This is not just about metabolism or breaking down drugs but also what happens to them next — where do they go? Do they get absorbed? Do they get distributed or moved around? And how do they leave the body as excretions?

The early phase studies are also where we learn about how the drug works in the body, so it would be important to include women as early as possible in the drug development process.

What needs to be done

More work needs to be done to address the gender gap in clinical trials.

It’s an area of medicine that we need to put more focus on, and we need to ensure that women are involved and included in clinical studies of medications and that they participate. For instance, women with heart disease often have different reactions to medications and experience different symptoms from men, such as feeling pain in their abdomen rather than their left arm. If a clinical trial implements its intervention based on symptoms predominantly exhibited by the male population, it could miss testing interventions in women with cardiac arrest. 

The lack of representation of women relative to burden of disease specifically in oncology and cardiology clinical trials is especially troubling because cardiologic and oncologic diseases are among the leading causes of death among women in the U.S.

Additionally, participating in clinical trials is one of the only ways to access new, innovative treatments and therapies – especially in the field of oncology – so the relative deficiency of one sex contributes to disparities in health outcomes.

This Week On The Neuro Experience Podcast

In this episode we discuss: WOMEN ARE NOT SMALL MEN 

  • Why women are different to men

  • Scientific controversy around studying women

  • What we don't know

BEST WAY FOR WOMEN TO TRAIN

  • Muscle and women

  • Hormones and women 

  • Best way for women to train

  • Reproduction and exercise

BEST WAY FOR WOMEN TO EAT

  • Nutritional requirements for women

  • Should we train in a fed state or on an empty stomach?

  • How much protein do we need?

  • When is the right time to eat

Until next week,

Louisa x