The Male Body is considered the Standard in Medicine

Did you know that women were underrepresented in clinical trials for a long time? Did you know the resulting health consequences for female patients? Neither did you? Then read our blog post today to be enlightened about how the male body has been used as an equivalent for the medical treatment of women.

What moment in history shaped the medical database on which medical personnel still rely today?

The thalidomide incident in the 50s and 60s of the last century has not yet been forgotten [1]. This accident, in which pregnant women took the drug thalidomide to regulate their nausea, had serious negative consequences. Children with malformations of the arms and legs and numerous infant deaths immediately after birth were the result. But these tragic cases were not the only consequences of the thalidomide scandal. After this tragedy was clarified, men were favoured in research and female test subjects were excluded from clinical trials. The male body was considered the standard. Some 60 years later, we now have a huge database that discriminates against women and jeopardises their medical treatment [2].

But why were women subsequently no longer wanted as clinical trial participants?

Unlike women, men are not subject to major hormonal fluctuations during a menstrual cycle. And unlike women, men cannot suddenly become pregnant during a clinical trial. Two main reasons why female trial participants were and often still are underrepresented [3]. Health risks such as adverse events are the consequences of underrepresenting population groups in trials [4].

What are the consequences of underrepresentation of marginalised populations in clinical trials?

Reduced certainty of drug efficacy and increased risk of adverse events for underrepresented groups are the long-term consequences of trials with structural deficits [3].

How can the mistakes of the past be corrected?

Finally, more female study participants are needed for gender-specific analyses. Ideally, meaningful gender-specific studies have a proportion of women that is at least as high as the proportion of women with the specific disease. This means that if 80% of patients affected by autoimmune diseases are female, then 80% of participants in clinical trials should also be women.[3]

The European Union has stipulated in EU Regulation No. 536/2014 that clinical trial participants must be representative of the population groups likely to use the medicinal product being investigated in the clinical trial. This implies the representativeness of differentiated gender and age groups. EU Regulation No. 536/2014 was already adopted in 2014, but only came into force on 1 January 2022. [4]

In order to be able to better research the needs of female patients, the awareness of study physicians must also be increased. [5]

---

Takeaway points:

• After the thalidomide scandal, men were favoured in studies because of the fear that women would distort the results due to hormonal fluctuations and possible pregnancies.
• Women and other marginalised population groups were neglected in studies for a long time, which led to uncertain drug efficacy and higher risks of side effects for them.
• Solution: Include more women and other marginalised populations in studies to obtain representative data.
• EU Regulation No. 536/2014 requires the representativeness of different groups in studies.

For more Information

EQUAL CARE certifies medical intervention with a balanced gender representation in data and evidence. Join EQUAL CARE today and lead the health market with our certification. Together, we can set a new standard for healthcare excellence and create a future where everyone receives the care they deserve.

Let’s meet: https://calendly.com/thao_equalcare/30min

If you would like to find out more about the topics of gender-specific medicine and the related work of EQUAL CARE,
visit us on Instagram, X, LinkedIn or on our website www.equal-care.org.

Sources: