Lack of access to healthcare for the trans population leads to non-inclusion in clinical research

The development of new drugs, treatments and vaccines undergoes clinical trials before being applied to the population, but the lack of diversity can make some social groups unfeasible.

A study published in 2020 in the journal Contemporary Clinical Trials Communications looked at how many cancer databases had information on transgender and gender diverse (non-binary) people in their searches. Of the total of 6,986 studies analyzed, only 153 (2.2%) included trans and diverse gender people.

Clinical trials can involve thousands of individuals and seek to ensure the efficacy and safety of drugs in the general public. These researches begin in humans after the attestation of safety and minimal action in other animals.

The lack of inclusiveness and diversity in trials, however, can lead to a lack of data on how some drugs might behave in specific populations, penalizing transgender and transgender people in particular.

Almost no clinical trial for new drugs counts transgender people among the volunteers. In general, eligibility criteria include age, previous health conditions and gender – which is defined, in most cases, by biological sex, which excludes trans populations.

“This is a debate that we always have because bodies are not the same, the trans bodies of black people, they should not be seen as being the same as that population that is mostly white and cis”, says Altamira Simões, psychologist and coordinator of Cippe (Commission Intersectoral Policy for the Promotion of Equity), linked to the National Health Council.

For her, the lack of information about the trans population in health goes further. “It’s not even a question of biologically the trans population being treated as equals, it’s totally invisible to science,” he says.

Another dilemma is that the databases themselves have problems compiling gender identity. A 2019 article looked at digital systems for recording clinical trials, such as Clinicaltrials.gov, the largest of its kind in the United States.

When adding an essay on the page, the only options were for biological sex — “male”, “female”, or “both”— and surveys that recorded the identity of trans people could not add this data.

Renata Rangel, speech therapist and coordinator of the Trans Center at Unifesp (Federal University of São Paulo), cites the example of a survey that was carried out at the center to raise the difficulties of the LGBTQIA+ population during the pandemic. The study featured a questionnaire to report the identities of respondents.

“We believe that this categorization has to be well defined so as not to put it in the same basket [grupos distintos] and infer conclusions that are not attributed to all people”, he says.

In addition to forms with inclusive fields, researchers interested in developing clinical trials should actively seek out this population for inclusion.

This is what Carlos Sorgi, chemist and professor at USP in Ribeirão Preto, defends – and does – defend. The researcher set up, together with colleagues at the institution, a research consortium to study health data in the trans population. The main ongoing research now seeks to assess whether there are markers linked to having a more severe Covid condition in this community.

“We know that, for Covid, there are several risk factors that can indicate a more aggravated condition, such as age, comorbidities, or being male. But will a trans man receiving hormonal treatment [com testosterona] Will you be at greater risk than a cis woman? And, if the person who is trans contracts the coronavirus, should they stop hormone treatment? There is a gap about this because we have no studies,” he says.

The research, which sought out transsexual people who are being treated at the outpatient clinic linked to the CRT (STI/AIDS referral and testing center) and who are on the streets, is developed in conjunction with a professor at the School of Nursing at the Faculty of Medicine of Ribeirão Preto and coordinator from the USP Diversity program, Ana Paula Morais Fernandes. The study also offers free testing for Covid and other infections.

“Our study group is made up of 1,500 people, of which, in those who test positive for Covid, we will take a blood sample and look for these molecular markers in the laboratory. We also want to understand whether a co-infection with other viral agents, such as HIV, can act”, explains Sorgi.

In addition to the research with Covid, the Center for Research in Trans Persons, which received financial support from the Deans of Culture and Extension and Research at USP, will now carry out other studies with this target audience.

“It is necessary to start testing more classic medicines in this population, it is called precision medicine, and if necessary, put different guidelines in the package inserts”, says Sorgi.

Another point that permeates the health of trans people is understanding the various problems that affect them, such as stigmatization related to STIs (sexually transmitted infections, as STDs are called), says Emilia Jalil, an infectious disease specialist at the STD Clinical Research Laboratory and AIDS from the Evandro Chagas National Institute of Infectious Diseases (INI/Fiocruz).

“What we have observed is [que] the vulnerability of trans people is far beyond merely an STI,” he says.

She also advocates respect for the identities of people who are not cis. “Often, when you go into more ‘hard’ biomedical research, there is even information about sex, but not about gender identity,” he says.

The same is proposed by Theodoro Rodrigues, 38, a trans man and the first national health counselor with this identity of the body that provides assistance to the Ministry of Health.

“It is necessary to start in the curriculum of all courses in the health area, the issue of access to health and specifically for the trans population. Even today, when we go to a consultation, we go to a general practitioner, and often this professional does not knows how to deal with diversity”, says he, who also advocates for the valorization of the scientific production of trans people.

“We do not place ourselves today only as ‘research objects’, we have our specificities and produce knowledge, and this must be valued”, he says.

The Fiocruz researcher also draws attention to a SUS system in which, when opting for a mammogram, there is only the option for females. “If a trans man needs to have a mammogram, the system blocks it.”

“Our body is not an alien body. Mastectomy surgery is already offered in the SUS for women diagnosed with breast cancer, it is also necessary to better guide and raise awareness of care for a trans man who seeks this procedure, and if he can do it for example during hormonal treatment or not”, says Rodrigues.