We can all agree that beginnings are challenging. And, considering how the scientific community and science itself have engaged with the existence of women until now, it can be tough to choose how or even where to start. So, after deep consideration and, who am I kidding, a lot of scrolling, I have decided to introduce myself with a piece that, I hope, will illustrate the grandiosity of this issue – the inclusion of women in the testing of drugs.

To reach the market, medicinal products must undergo a series of tests to prove they do what they are supposed to (that is, their level of efficacy), while causing no harm to whoever takes them (meaning their safety). Before these products are tested on people, clinical trials are the last step in this terrible minefield, that is putting a drug on the market, when finally, these products are tested on people. Thanks to this pipeline, we should be able to take any treatment with the confidence that they are as effective and safe as their manufacturer assures them to be– but can we really?

In 1977, the US Food and Drug Administration (FDA), the leading organisation for promoting and protecting public health throughout the western world, published a guideline titled ‘General Considerations for the Clinical Evaluation of Drugs’. This document recommended pharmaceutical companies to exclude women of childbearing age from participating in the first phases of clinical trials. With this mandate, their goal was clear: to protect potential unborn children from side effects.

Clinical trials are divided into diverse phases. The difference between these phases are parameters such as, the number of people tested or the objective of such testing. It is precisely in these early phases that safety is the primary check. Hence, ultimately, FDA’s early recommendation meant that treatments that would end up being consumed by females could potentially loophole their way into the market with close to no information about their safety in women. To give you an example: everyone has heard of Prozac, right? Prozac (Fluoxetine), probably the most widely known antidepressant, reached the market in 1988. At that time, the 1977 FDA guideline was still the go-to bible for any pharmaceutical company designing a clinical trial. Which begs the question: how many women had even tried this so popular drug before it could be prescribed to them?

Let’s flash forward a little bit: the year is 1993, the first Jurassic Park is showing in theatres, Whitney Houston is rocking the charts with her song ‘I Will Always Love You’ and, somewhere in Europe, the CERN is about to make the protocol and code for a little something called the World Wide Web available to the world. This year will also mark the official ‘entrance’ of female subjects into clinical trial territory when the FDA decides to update their last recommendation. The new title said it all: ‘Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs’. From there on, the initial concern related to unborn children was and is easily fixed by including pregnancy tests as routine throughout the length of a clinical trial and encouraging either abstinence or the use of contraceptives among subjects.

Other similar documents saw the light around the same period and stressed the importance of other factors like age or ethnicity. This meant that someone had finally decided to acknowledge something which today is common knowledge in the medical world: when treating a disease, different people might need different doses of the same drug, or even a different approach altogether. Since each individual comes from a particular socio-economic background and showcases differences in plenty of physiological parameters (body size, hormonal cycles, hepatic or renal function, enzyme activity, to name a few), it is crucial to have available clinical data that takes into account these parameters before a product can be manufactured.

Following the North American lead, in 2005, the European Medicines Agency (EMA) released a summary entitled ‘ICH - Gender considerations in the conduct of clinical trials’ which recapitulated all existing guidelines and stressed this undeniable gender issue. And finally, in April 2014, Europe adopted a new legislation altogether, Regulation (EU) No 536/2014, which directly contains a list of specific populations that need to be included in a clinical trial for a drug to reach the European market. Moreover, in a fascinating turn of events, takes steps towards the inclusion and protection of pregnant and breastfeeding women in clinical trials, when appropriate. I know it sounds wild to test drugs using someone carrying a baby. Still, it is imperative to do so, as mothers with chronic conditions like asthma, diabetes or HIV/AIDS cannot be deprived of their medication during gestation.

It is a long journey we have covered together in just a few paragraphs, but isn’t it just absurd if you think about it? Women have experienced centuries and centuries of discrimination due to being ‘different’. We are constantly called ‘the weaker sex’ and have been treated as inferior or dependant for ages. I am not even being dramatic here! Girls over the legal age could not open a bank account on their own until as late as 1974 in the U.S. and 1975 in the UK or Spain. Goddamit, they usually can’t even do it right now in Saudi Arabia without the permission of a male guardian. Funnily enough, when it came down to our physiology, the only difference between men and women was assumed to be our ‘sexual and reproductive organs’ and the results obtained from men ‘could simply be extrapolated to women’. Which is a bogus assumption with ever-lasting effects.

As I already said, it’s been a long journey, but sadly, there is still a long way to go. Even though now we know that some treatments have a distinct effect depending on gender, we don’t know for how many treatments that’s the case or, even if identified, how this difference applies. On top of that, it is important to stress that both documents published in 1993 and 2005 are guidelines, not rules. Therefore, their contents are mere suggestions. We still need to catch up with decades of lost data. And even if the new European regulations date from 2014, they only came into effect by October 2018. So, it will still take time until we can fully see its effects.

I feel that the ultimate goal of this post is not to tella story, but to make you doubt. I want to prompt you to ask yourself questions about all those drugs you have been prescribed; the ones you can see behind the counter of pharmacies or even those you already have at home. I want your brain to be filled with interrogations. And hopefully, you can find the answer here to some of those.