Let’s begin with the basics: the difference between sex and gender. Sex considers the biological makeup we’re assigned at birth. Gender refers to socially constructed roles, identities, behaviors, and expressions. Our personal identity is based on our internal awareness, and those who feel that their gender is different from their sex are considered transgender (or trans). 

Nowadays, there’s rightly much more visibility and conversation surrounding transgenderism, but this hasn’t stemmed from anywhere. In fact, identities beyond the ‘traditional’ Western understanding have been noted and celebrated across various cultures around the world throughout history. 

Still, although people are now better able to characterize their feelings of gender incongruence, the trans community sadly continues to face discrimination, violence, and poverty. Social factors like the aforementioned can have huge implications on the health of trans individuals, both psychologically and physically. Did you know that 82% of the trans community has considered suicide, and 40% attempted it?

But that’s not all. No, when looking at healthcare at large, a 2021 survey found that almost half of the respondents felt pharmaceutical companies could do more to understand and engage with members of the queer community, particularly those who identify as lesbian, transgender, or non-binary. 

Today, we’re going to look at the healthcare challenges trans people face and how the pharmaceutical industry can better support the community and address health inequity. 

A Lack of Understanding

A 2018 report by Stonewall found that 62% of the trans community had experienced a lack of understanding from healthcare professionals (HCPs) in specific trans needs. Likewise, another study found that only 69% of physicians felt they were capable of providing routine care for transgender patients. Not only does this mean trans people are subject to experiencing poorer health outcomes, it also means that because of these experiences, trans people are also less likely to seek care. 

For the most part, HCPs lack confidence in their decision-making for trans patients because of the uncertainty surrounding the influence therapies can have on hormone treatments. This only highlights the sheer lack of research into hormonal differences in trans people versus cis. 

Just think about it… dosages are routinely tweaked throughout pregnancies due to hormonal differences, yet the same adjustments aren’t made for those in the trans community, despite the fact that there’s a similar need for tailored dosages due to hormonal changes.  

Speaking of dosages, even those who identify as trans but are yet to undergo their medical transition must also be considered. That’s because, without hormone therapies and surgeries, our assigned sex at birth can also influence what dosage we should receive due to the amount of water in the body and the number of drug-binding sites that person holds. 

No Representation in Clinical Trials

While HCPs lack the knowledge to confidently prescribe treatments to trans patients, the data gap largely comes down to the exclusion of the transgender community in clinical trials. For most, the reason is that hormone treatments can potentially complicate the interpretation of clinical trial data. 

On top of that, trans-specific research is, unfortunately, minimal. You might be wondering why.

Well, for most pharmaceutical companies, there’s no business incentive to invest in hormone therapies because they tend to be both off-patent and prescribed off-label. That means that for companies to research these products independently, the investment needs for researching and developing new treatments far outweigh the profitability of developing new drugs because they can no longer be patented. 

The Effects of Hormones on Other Treatments

While it could take some mighty convincing to get pharmaceutical companies to research trans therapies, there is an enormous opportunity to investigate how hormone therapies influence the effects and safety of other prescribed treatments for needs that are disconnected from transitioning. 

For example, an NYU study on cancer found that 80% of oncologists admit they don’t feel they know enough about treating the trans community, and a respondent from a Transgender OUT Cancer survey commented, “my oncologist really wanted me to stop T [testosterone] during treatment. I didn’t want to, so I didn’t, and everything was okay. I think he didn’t know how it would affect the treatment, and every time I saw him, he asked if I was willing to stop T.”

It’s worth noting here that hormone therapies have significant psychological benefits for transgender people. Being taken off their hormone therapies can be profoundly distressing and even dangerous as they can increase the risk of violent attacks for no longer ‘passing’ as their identified gender. 

On top of that, stopping the use of hormones can have even more detrimental effects, increasing the risk of suicide. For this reason, it is absolutely essential that the industry researches and understands the interplay between hormone therapies and other treatments.

Looking Towards Trans Needs

Another valuable initiative (with a business incentive for pharmas) would be to investigate clinical trial data on drug combinations for illnesses that disproportionately affect the trans population, for example, HIV. 

Sadly, transgender women are 66 times more likely to contract HIV, and transgender men seven times more likely. That’s a remarkably high risk, which comes down to factors such as limited work opportunities due to discrimination, increased susceptibility to bleeding and infection in the genital region following gender reassignment surgery, and barriers in accessing HIV preventative care such as PrEP. 

In fact, even for those who are able to access PrEP, adherence and compliance can be compromised due to vagueness and fears of how PrEP could interfere with their hormones and impact their hormonal transition. Not only is this information vital for trans patients, but for HCPs too, so they can deliver accurate information on the efficiency and safety of using PrEP in combination with hormones. 

Incorporating trans-focused research into clinical trials for new therapies could completely transform how HCPs prescribe treatments. But not only that, focusing on the LGBTQIA+ community would help ensure that trans patients are not put at a greater risk than their cisgender counterparts when treated with modern medicines. 

Overall, evaluating potential treatments in the context of sub-populations will only create more patient-centric drug developments. For example, research results examining the effects of treatments in conjunction with hormones for the trans community could be adapted to other sub-populations, such as those who take hormone replacement/blocking therapy to alleviate the effects of menopause or hormonal imbalances.   

Making Clinical Research Attractive to the Trans Community

Currently, as mentioned above, clinical trials are not set up to cater to those who are trans. However, to ensure that everybody receives fair access to innovative therapies and to explore the treatments in the context of sub-populations, trial recruitment and design need to be revitalized in order to be seen as an attractive and worthwhile endeavor to the LGBTQIA+ community. 

This begins with linguistic adaptations that are inclusive of trans, non-binary, and intersex individuals, particularly for conditions that are associated with a single sex. For example, ovarian cancer traditionally falls under the bracket of ‘women’s health,’ but a trans man legally registered as male can still live with the disease. 

Say a trial was to be conducted for an ovarian cancer drug; the recruitment would typically ask for women only to apply, rather than ‘people born with ovaries’. The effects of these linguistic choices marginalize trans men, meaning that even though they might be in dire need of that treatment, they wouldn’t apply. 

Looking further into the clinical trial process, paperwork must also be amended to ensure that nuances are accounted for, accommodating everyone’s needs. That means including gender and sex, including preferred name and legal name, both of which are crucial distinctions for trans people. In short, questions that might seem basic and obvious to a cisgender person can be much more complex for someone who is trans. 

On the whole, a simple code switch to be more inclusive is more beneficial than you might first think. Ultimately, by avoiding trans-exclusionary gendered language, confusion, indecision, and other discomforts trans people often face – including from the most well-meaning HCPs – can be alleviated. 

Breeding Inclusivity Throughout the Whole Process

Looking beyond language, clinical trial environments and teams must also adapt to be more inclusive, safe, warm and welcoming to those from the LGBTQIA+ community. That means reflecting diversity throughout the environment, such as removing binary categorization when it’s unnecessary and providing all staff interacting with those patients with sensitivity training. 

Luckily, there’s someone leading the way: CRO, Parexel. Parexel’s Associate Director, Liam Paschall, is a trans man, and the CRO has leveraged Liam’s internal lived-in experience, collaborated with the trans community, and held patient advisory meetings. In light of doing so, they’ve been able to provide recommendations on how the pharmaceutical industry can build trust with the trans community, from using preferred pronouns to providing and promoting inclusion and respect. 

Furthermore, pharmaceutical companies should actively pursue more diverse trial investigators and patient advocacy liaisons. Simply put, if patients can relate to industry insiders on their marginalized quality, trust in them and the research is more likely to increase, leading to more recruitment and fewer dropouts. 

Conclusion

I’m sure you’d agree that it’s only fair that all HCPs are equipped with the necessary understanding to treat LGBTQIA+ patients with respect, dignity, and the confidence to make informed decisions upon their care. 

In order for that to happen, there’s undoubtedly more work to be done regarding the inclusion of queer patients in clinical trials and understanding the impact of hormones on other treatments for the trans community. For this reason, we should actively engage with queer communities to understand how to best meet their needs in the world of research. That’s because unless these voices are purposefully sought, there’s a high chance they’ll be overshadowed by those from non-queer groups. 

To conclude, pledging and prioritizing inclusivity throughout the entire healthcare system will only nurture more trusting relationships between HCPs and LGBTQIA+ patients. In turn, this will lead to better and fairer health outcomes, which, after all, is a basic human right. 

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