It's... been around for about a half a century, and used pretty regularly for better than twenty years. Not sure if young is the right word for that.
Basically what TD1 said. Clinical trial research isn't just testing new drugs/procedures/medicines/treatments, but also testing new applications of them/different application methods/different combinations/methodologies e.t.c.
A good example would be one biologic drug we worked on that was already approved for use in asthma, but not yet for nasal polyps. Even though the drug was approved for one use it's treated as a completely new therapy when used for a completely different purpose. Clinical trial research on HRT goes back to the 90s for post-menopausal treatment in AFAB women, 2008 for aging treatment in AMAB men in their 40s-50s, and there have been some starts from 2016 onwards into HRT for gender reassignment (FTM and MTF). Some countries have not had any trial studies done yet, and some areas of the therapy are lacking in study and attention, e.g.:
To date, no studies evaluating the perioperative risk of thromboembolism have been conducted in patients receiving feminizing hormone therapy.
Some reasonable inferences and comparisons with other populations can be inferred, but are not
sufficient, since everyone's body is unique and will respond to different therapies in different ways. Without that body of evidence it's harder to make an accurate and informed assessment over what are the most likely adverse outcomes.
AM. whereas there is a lack of comparable data on available, accessible and quality transgender-specific healthcare, and products used in hormone replacement therapy are not properly tested and licensed;
Refer to this 2017 European Parliament notice discussing various gender related issues, including the paucity of clinical trial information
GnRHas were being prescribed by GIDS as an ‘off-label’ treatment – meaning the medication is not being used for its licensed purpose – to treat gender dysphoria in adolescent children after the commencement of normally timed puberty. Off-label use of medication is relatively common, particularly for paediatric populations. The caveat, however, is that there should be justifiable scientific evidence that the treatment is safe and beneficial for the patient. The safety data here is paramount, as it helps prevent catastrophic unintended consequences of untested medications, as seen in the thalidomide scandal of the 1950s.
A lack of evidence
The court found that for PBs, the evidence for safety and efficacy was lacking. Indeed, the judges found the absence of data on the age distribution of patients (until 2019-20), the proportion of children referred to it for the treatment with an ASD diagnosis and the percentage who move on to take cross-sex hormones “surprising”.
The judges also noted an incongruence between the GIDS claim that puberty blockers were “fully reversible” and other evidence, including the NHS website’s section on the treatment of gender dysphoria, which states, “little is known about the long-term side effects of hormone or puberty blockers in children with gender dysphoria” (para 67).
Therefore, due to the lack of both safety and efficacy data on the use on GnHRas for gender dysphoria, the court has considered the treatment to be experimental in nature.
For experimental medicines to become licensed, they need to progress through a strictly defined series of clinical trials, starting from small-scale safety studies and then increasing in size and complexity as the efficacy of the treatment is tested. The design of the studies is agreed in advance, including all the data to be collected, and the patients are carefully monitored. It is an issue which is currently writ large in the public imagination, as we watch the Covid vaccine make its way through these hurdles. To date, GIDS has been unable to produce data from the types of clinical trials that would set puberty blockers along the road to licensing for gender dysphoria. But it has also not produced sufficient scientific evidence to justify their use as off-label medication.
Clinical trials for HRT for gender reassignment started in 2019, so whether as gender identity treatment or as age/treatment/disease-related replacement therapy it's young. It's not an important distinction, and I don't know if there is any political value in a therapy being young or old, because the only value is really in as a descriptor between a therapy that has had hundreds of millions of users and generations of research in side-effects & uses like with salbutamol, versus ones where long term effects/side effects/applications are unknown and you literally just have to wait until studies are completed before you fill that blindspot, as with biologics.
This is only compounded in the youth of clincal studies into gender dysphoria itself, which is best seen in the dramatic implosion of the Tavistock centre:
In 2011 Gids adopted the early intervention study, a research protocol that lowered the age at which young people could access puberty blockers from 16 to 12.
The service scrambled to recruit and train staff to cope with increased demand, and they began to notice how the profile of those seeking help also changed. The cases were more complex, and there was a huge increase in the number of children and teenagers seeking support.
In her report, Cass explained how the “increase in referrals has been accompanied by a change in the case-mix from predominantly birth-registered males … to predominantly birth-registered females”.
“You could feel the tensions building,” recalls Wren. “We knew it was a crisis, and NHS England knew it was a crisis. Because the patient profile had changed, we felt we needed more time to understand what was going on, but the waiting list just grew and grew while the metrics for young people’s distress, not just about gender, were getting worse.”
Aidan Kelly joined Gids in 2016 as a junior clinician. He remembers the service was creaking under the weight of demand. “The team had almost doubled in size; they were trying to train up new clinicians, manage the waiting list and meet the needs of all these young people.”
Kelly, who left Gids in 2021, recalls how some staff became unsure about whether the young people they were seeing were indeed transgender – or expressing mental distress linked to trauma, abuse or autism.
The internal divisions led to some staff “splitting, becoming embattled and then leaving in a destructive way because they felt their concerns weren’t being heard”.
David Bell, then working in adult services at Tavistock and a staff governor, wrote an internal report reflecting these criticisms. He said staff told him some parents appeared to be pushing their children towards transition, that some children were recommended for treatment after only two appointments, and that the service was recruiting too many inexperienced psychologists.
Staff also told him that when they raised concerns, they were met with hostility, denial, and accusations of transphobia by senior staff.
But Hobbs argues this criticism is based on a fundamental misunderstanding of what affirmative means. “For me, affirmative is starting from a stance that says gender diversity isn’t a disorder but has existed across cultures through history. It is saying ‘I believe you’ when you tell me about your experience. It is developing a strong relationship based on trust and mutual respect, but it doesn’t mean you don’t explore.”
This is another thing that complicates how medicine & LGBTQ+ cross paths, because an endocrinologist or a gender specialist is going to be going in with the mindset of "identify pathology, identify cause(s) and come to cure" whereas for patients it's about choosing who they want to be. Which to be diplomatic, is not something someone with a "clinical" mindset may be equipped to deal with, as there's a reason why "clinical" is considered a synonym for "cold." The medical staff disagreeing even on how to identify and treat dysphoria in Tavistock is illustrative:
He had long believed a case would be brought against the trust, though he thought the most likely scenario was that a former patient would sue for damages (Keira Bell instigated a judicial review). “It was inevitable,” he says. “I warned the trust of this.” But the Keira Bell judgment has done little to alleviate his concerns. Whatever the outcome of the appeal, he believes more questions must be asked, particularly about the rise in the number of girls presenting at the clinic (three-quarters of patients are now girls; the gender balance used to be closer to 50:50). “We do not know why this is happening.” He worries that too much emphasis is placed on gender and not enough on sexuality – “the children are often gay” – and he continues to be anxious about co-morbidities such as anorexia, autism and history of trauma in its patients. “Some of the children are depressed. It’s said that it’s their gender that is the cause of this, but how do we know? And why don’t we try to treat that first?”
Bell says the trust threatened him with disciplinary action after he published his critical report.
Bell is not against puberty blockers per se – “a doctor should never say never” – but he believes that halting puberty only makes it more frightening to the child: “The child will never want to come off the hormones and 98% do now stay on them. This could be a dangerous collusion on the part of the doctor. The body is not a video machine. You can’t just press a pause button. You have to ask what it really means to stop puberty.” It should be possible, he believes, to manage the distress of a child who is suffering gender dysphoria in a less interventionist way, until he or she is an adult and can make a decision: “Consent is the issue here, nothing else.” He does not doubt that some patients will want, and need, to transition in the future. But, he says, not all children with gender dysphoria are trans. The two have been elided. More work needs to be done locally. “Gender dysphoria clinics should be part of child and adolescent mental health services (CAMHS) and available nationwide,” he says. “At the moment, children who are suffering extreme distress in relation to their bodies are sent to the Tavistock and the problem then goes away at local level, where psychotherapy services are on their knees.”
The whole centre was run very much with the mindset of dealing with the high volume backlog of patients on the waiting list, rushing to treatment despite the lack of clinical studies meaning informed consent was not provided. There are a lot of difficulties when it comes to running clinical studies of gender dysphoria and related therapies, compared to something more easily defined & observable like high blood pressure or asthma. There's also the political factor in that a lot of investigators are bloody terrified of the public attention that gender-related topics get, and the general reluctance to fund/engage with anything published that doesn't come with an easily digestible conclusion.
Now after all those dismal acknowledgements, I must add that the experimentality or youth of a therapy is not a black mark against a treatment. Novel therapies are exciting because they are new and offer solutions to problems where before there were none, or solutions were inadequate or came with undesirable side effects. The Covid-19 vaccines are very good recent examples of where treatments were rushed through normal clinical trial processes, did result in even lethal side effects in some cases, but the overall good rendered the cost worth it (and like HRT, was also used as a political football). Tavistock's failures were not because they used experimental treatments with side effects, it's because they ignored rules on informed consent and proper diagnostic procedures. The patient who took them to court for example was told hormone blockers and mastectomy would be reversible, and staff whistleblowers reported the same despite this just being an obvious falsehood. You would be mindful to inform a child and their parents that taking prednisolone for treating asthma could stunt their child's growth, so it's an aberration to say the least that Tavistock did not append the same caution to HRT or hormone blockers -_-
Apologies in advance if this comes off as highly critical or pessimistic.
There are people honestly doing good research here that is worth reading if one is interested,
and it's worth noting their methodologies, challenges, successes and failures, since they have issues with high patient attrition rates, small patient recruitable populations. And while there is always going to be the fear that to observe negative side effects or outcomes of a treatment is to discredit it completely, this is not the case, but is a necessary duty of clinical trial workers. That is obvious for any other therapy, but obviously becomes odious if one's study observing the effects on bone density or cardiovascular health on HRT is used as "ammunition" in a culture war & trans erasure. There are those who take the view it's akin to "airing one's dirty laundry" amidst the current environment where the West is arguing over whether non-binary conforming identities are valid in the court of law and civil society, but the alternative is real people get hurt and that produces far more ammunition than any published study ever will, so morally and politically it's necessary. In an ideal world there would be more observational and randomised studies already and so people would be able to find the best treatment plan out of many options, but we're not there yet
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