Understanding Transgenderism

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Sex
Transgenderism
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Off-label use

What is sex?
The Cambridge Dictionary defines sex as ‘the state of being either male or female’. Male and female are defined as:

Male : used to refer to men or boys, or the sex that fertilizes eggs, and does not produce babies or eggs itself.
Female : belonging or relating to women, or the sex that can give birth to young or produce eggs.

Your sex is determined at the moment of conception when a sperm fuses with an egg to create a new human. Both gametes (sperm and egg) contain a single copy of each of the 23 pairs of chromosomes from the parent. Chromosomes are the bundles of genetic information, DNA, that are present in almost all cell types that make up your body. Because the mother does not have a Y sex chromosome (the sex chromosome that makes a male a male) but has two copies of the X chromosome, the mother always passes on one of her X chromosomes. The father has one X chromosome and one Y chromosome and will pass on one of these two sex chromosomes in each sperm. This means that the sperm that fertilises the egg determines the sex of the future baby.

The sex of the child can be observed on an ultrasound scan before birth, and this can be confirmed when the baby is born. The sex of the baby is not assigned, as is sometimes suggested: no one is pulling ‘female’ or ‘male’ out of a hat. Sex is observed and recorded at birth based on the appearance of the external genitalia of the baby. The external genitalia are unambiguous in the vast majority of people making it easy to determine the sex of the child by just looking at the genitals. However, a small percentage of babies have ambiguous genitalia, meaning that by looking at the genitals, it is not clear whether the child is female or male. The doctors will then run tests to gain more insight into the sex of the child, which can include trying to find whether testes are present, taking a blood sample to determine the chromosomes of the baby, and ultrasound investigation of the pelvis and abdomen to look for undescended testicles, a uterus, or vagina. They may then identify a disorder of sexual development (DSD) meaning that somewhere during development of the foetus, something went wrong with sex development. This can affect both females and males and having a DSD does not make someone a third sex.

Sexes exist within a system of sexual reproduction, meaning that an organism reproduces by combining parts of their genetic material with that of another individual of the same species but who is of the opposite sex. In order to create another human, you need an egg and a sperm, nothing more, nothing less. There is no third gamete, so there is no third sex (who would be producing such a hypothetical third gamete).

What is transgenderism?
Transgenderism, or transgender ideology, or trans ideology, is the worldview that states that humans have a gender and that this gender is different from sex but somehow also tied to sex because most females are said to have the gender 'woman' and most males are said to have the gender 'man' (these people are called 'cis' or 'cisgender'). According to transgenderism, in some people this gender does not align with the person’s sex (a female does 'not feel like a woman' or 'feels like a man', etc.) making this person 'trans' or 'transgender'. This misalignment is experienced as a host of negative emotions by such a person and these negative emotions are gathered under the term gender dysphoria. This ideology believes that someone who experiences gender dysphoria can only reduce or resolve this by transitioning (changing their gender/changing their sex).

A subset of people who consider themselves trans think that you can be trans even if you do not experience gender dysphoria. In their view, trans is an identity you can adopt if you feel like it, or the experience of gender euphoria (positive feelings when you present as your true gender, different from your sex) is evidence that you are transgender even in the absence of gender dysphoria.

Transgenderism also holds the idea that it is possible to change your sex, meaning that there are things a female can do to change her sex to male, and vice versa. It is not clear where the line is to have changed your sex, whether this is taking cross-sex hormones (testosterone for females, oestrogen for males), having had genital surgery, or simply having changed your fashion. According to some, it is none of these as they claim that 'women can have penises', meaning that they must think that any man can claim to be a woman (or even female) by simply saying so.

This worldview is confusing as it is not consistent: if sex and gender are not the same thing, why is it that almost everyone who is female either sees themselves as a woman (or girl) or hasn't thought about 'gender' and just gets on with life (and the same for males seeing themselves as man/boy)? If your body does not determine your gender (and some even think it does not determine your sex), why do trans-identifying people feel the need to change their body to 'match their gender'? If me being female does not make me a woman (the claim of some transgender activists), howcome a male having long hair, wearing lipstick, wearing a skirt, or saying he is a woman, make him a woman?

They are not able to explain what a woman is either. They will say something along the lines of 'a woman is anyone who identifies as a woman'. But this is circular reasoning, it does not explain what a woman is. They may also say something like 'anyone who feels they are a woman, is a woman'. But when you ask what it means to 'feel like a woman', they have no answer or they may refer to regressive sex stereotypes such as 'I feel girly', 'I like the colour pink', 'I like looking pretty', 'I don't like rough play', 'I like playing with girls/socialising with women', 'I don't feel masculine', etc.

What is transition?
Transition is the process of ‘changing sex’ or ‘changing genders’. This can include a range of changes to someone’s lifestyle and body with the aim to make the outside world see them not as the sex they are but as the opposite sex. Not all people who transition will choose to undergo all of the steps outlined below. However, for the typical prepubescent child who has supportive parents and has access to affirmative care, transition will look something like this (although some steps may be taken in a different order):

  1. Child realises/thinks they are transgender
  2. Child tells their parents they are transgender
  3. Parents take the child to an affirmative healthcare professional
  4. Child starts puberty blockers (drugs, a part of medical transition) and receives some kind of counselling (this may be very minimal)
  5. Child comes out to their social circle
  6. Child starts presenting as the opposite sex by adopting a new name and wearing clothes, a hairstyle, accessories etc. that are stereotypical for the opposite sex (this is called social transition)
  7. Child can start cross-sex hormones when they are considered old enough according to local laws and regulations (as young as 12 years of age in some countries)
  8. Child can undergo a double mastectomy ('top surgery'; removal of the breasts) if they are female when they are considered old enough according to local laws and regulations (as young as age 12 years in some countries)
  9. Child can undergo permanent hair removal for facial hair if they are male
  10. Child can undergo permanent hair removal on the genitals in the case of a male who wishes to undergo vaginoplasty (a kind of 'bottom surgery' that creates a skin tunnel in the perineum) or on the donor site for phalloplasty ('bottom surgery' that creates a skin roll attached to the pubic area) in a female
  11. Patient can undergo bottom surgery when they are considered old enough according to local laws and regulations. Genital surgery as part of transition is usually only performed on people aged 18 years and older, but there are stories of younger people who underwent this kind of genital surgery. TLC TV show star Jazz Jennings underwent vaginoplasty at age 17. Mermaids charity CEO Susie Green took her son to Thailand for genital surgery as part of transition when he was only 16 years old.
Adult transitioners will not require puberty blockers and can go on to cross-sex hormones immediately. Hormones generally precede surgeries, but some people opt to start hormones after surgery or will never take hormones (by choice or because of a pre-existing medical condition that makes them unsuitable for cross-sex hormones).

Puberty blockers and cross-sex hormones may affect fertility. When the gonads (testes, ovaries) are removed as part of 'bottom surgery', the person will be permanently infertile. Additionally, when the gonads are removed, the person will need to use hormones for the rest of their life (cross-sex hormones, or the correct hormones for their sex if they ever choose to detransition) because their own body can no longer produce enough itself.

What are puberty blockers?
Puberty blockers are drugs that stop puberty. These drugs are called Gonadotropin-Releasing Hormone (GnRH) Analogues and are indicated for (meaning: approved for) use in children who suffer from precocious puberty (onset of secondary sexual characteristics before 8 years of age in females and 9 years in males), and for treatment of prostatic cancer, breast cancer, and management of endometriosis. These drugs are not approved for use in physically healthy people of any age. Puberty blockers can be administered in the form of an implant placed in the arm (histrelin acetate) that needs replacing after one year, or in the form of an injection (leuprolide/leuprorelin acetate) administered every couple of months.

Trans-rights activists often claim that puberty blockers function as a ‘pause button’ so that the child has ‘time to think’ about their gender identity before they commit to cross-sex hormones. It is also often stated that puberty blockers do not cause permanent changes meaning that the effects are reversible. However, there is no data that support these statements.

All approved drugs have a patient (information) leaflet/medication package insert with information for lay people describing what the drug is, what it does, how to use it, what the known effects and side effects are, etc. It is smart to always read this fully before taking any medication yourself or before giving your child or another dependent any medication (this applies even for over-the-counter medications). Additionally, even as a lay person, you can find a lot of detailed information about drugs online. One type of important document for each drug is called the summary of product characteristics (SmPC). The SmPC can be found online on drugs database websites or government drug agency websites and should be freely accessible:

For the UK: https://www.medicines.org.uk/emc/
For the USA: https://nctr-crs.fda.gov/fdalabel/ui/search

Look for ‘leuprorelin acetate’ using the UK page linked above (you can find similar information looking for ‘leuprolide acetate’ using the USA link). In November 2022, three results were shown: two for administration via injection (at a different dose), one for an implant. In the overview of search results you can see a link to ‘SmPC’. Clicking on the SmPC for the higher-dose injection, we can see the following overview: https://www.medicines.org.uk/emc/product/4651/smpc. The first tab (that should be shown) is the SmPC; the second tab is ‘Patient Leaflet’, and the third ‘User Manual’.

Looking at the SmPC, we can learn a lot about the drug. As a lay person, the most important information is in section 4 ‘Clinical particulars’. ‘4.1 Therapeutic indications’ lists for which diagnoses the drug is approved for use. We can see that this is for prostate cancer, management of endometriosis, breast cancer, and in children: for central precocious puberty (a condition that causes early sexual development in girls and boys). Note that gender dysphoria or gender transition are not mentioned anywhere in this document. This means that the drug is not approved to treat gender dysphoria or for the purpose of gender transition.

In section 4.2 we can see that in endometriosis, the drug is recommended to only be used up to 6 months, but for puberty blocking in children for ‘trans’ reasons, this drug may be prescribed for a couple of years. Is this use too long? When will a child have had enough ‘time to think’? Further, there is a suggestion that women who used this drug for endometriosis may have suffered bone mineral density loss (making bones weaker) and vasomotor symptoms (hot flashes, night sweats). For children with precocious puberty, treatment with this drug should be under the overall supervision of a paediatric endocrinologist, and bone age should be monitored every 6–12 months. The question is: is this always done for children who are given this drug for gender reasons, or do they not need this kind of monitoring?

In section 4.4 we can read ‘Special warnings and precautions for use’. The document states there is an increased risk of incident depression when using this drug. But what about if the child was already depressed or had a low mood before starting this drug? There are also reports of seizures in both children and adults who used this drug and reports of idiopathic intracranial hypertension (high pressure around the brain; which can have the following signs and symptoms: severe/recurrent headache, vision disturbances and tinnitus). These seems like serious side effects. Should a child be able to choose to take such risks because they are struggling with their gender? Further concerns include:



Then we get to section 4.8 ‘Undesirable effects’ showing a table each for men, women, and children, listing adverse reactions (side effects) according to how common they are. As these people will all have a medical condition (otherwise they would not have been prescribed this drug), it is not clear whether physically healthy children who get this drug for gender difficulties will have similar risks of adverse events. Nonetheless, this is the best data presented for this drug so it should be considered.

In children (who have precocious puberty as they were prescribed this drug for that condition), common (≥1/100 to <1/10; meaning in 1% or more, but in less than 10% of patients) adverse reactions were:

In men, very common (≥1/10; meaning in 10% or more of patients) adverse reactions were:

In men, common (≥1/100 to <1/10; meaning in 1% or more, but in less than 10% of patients) adverse reactions were:

In women, very common (≥1/10; meaning in 10% or more of patients) adverse reactions were:

In women, common (≥1/100 to <1/10; meaning in 1% or more, but in less than 10% of patients) adverse reactions were:

The use of these drugs in children to treat gender dysphoria or for the purpose of gender transition is experimental because this mental health condition is not an indication for this drug. Moreover, this current use may not usually be part of a clinical trial. To know what this means, we first need to learn what a clinical trials is.

What is a clinical trial?
A clinical trial is a prospective (looking for outcomes during the study period) biomedical or behavioural research study performed on human participants designed to answer a specific question(s) on medical or behavioural interventions (treatments), often comparing a control group that received no treatment or the best available treatment, with a new treatment. A clinical trial needs to be approved before it can start to ensure that there are good reasons for this clinical trial, to ensure the study design is appropriate to answer the research questions, and to ensure the people that take part in it are as safe as possible. Clinical trials are conducted after pre-clinical trials have been performed (usually on cells grown in the lab and/or on animals such as mice, rats, dogs, or monkeys) and the new treatment still looks promising.

There are four phases of clinical trials:


When the clinical trial has been successful up to and including Phase III, the drug will be approved for use in the general population. A clinical trial can fail at any point: many clinical trials fail, sometimes already in Phase I, and sometimes later. This failure can be for different reasons, such as:

The healthy volunteers who take part in Phase I receive financial compensation for their time, discomfort, and the risk they are taking. The patients that take part in the subsequent phases choose to take part because they have the illness and are hoping for better treatment for themselves as well as for others.

The fact that puberty blockers and cross-sex hormones (as well as the genital surgeries for transition) are prescribed to children and adults without these patients having the right diagnosis for these drugs/surgeries means that this is experimental use of these drugs and surgeries. It is unclear whether this experimental use is part of clinical trials, but if I were to have to make a guess, I imagine most of these patients are getting these drugs/surgeries not as part of a clinical trial. That would mean that:

It's difficult to politely express how disconcerting this all is. Why are not more people asking these questions in the public discourse? Without trying to exaggerate, I think in 10-20 years' time as a society we will look back on this and judge the affirmation-only model and medical transition for children and vulnerable adults as a major medical scandal.

Off-label use
When a drug is used to treat a condition (illness, disease) for which it is not approved (for which it does not have a license), this is called 'off-label use'. This means that the condition is not an indication for the drug. Off-label use can also refer to other use outside of the license such as a patient outside of the age range covered in the license using this drug, or using a higher dose than listed in the license.

Off-label use is common in some diseases, such as in cancer. This could be due to a drug being efficacious for kinds of cancer that it has not yet been tested on, combinations of drugs being used that have not yet been tested, or few approved treatments being available. See https://www.cancer.org/cancer/managing-cancer/treatment-types/off-label-drug-use.html. Many people with cancer are very ill and will die if the disease is not treated or previous treatments have failed and patients become desperate to 'try anything'. In such cases, when people are very ill with a condition that will not stabilise or get better on its own and with no approved treatments available, it might be justified to use drugs off-label. After all, if you know you otherwise have only weeks or months to live, would you not be willing to try a higher dose of a drug that has been shown to work, or try a drug that has shown beneficial effects in other kinds of cancer?

But is gender dysphoria or the want to transition a life-limiting or terminal condition? Will a child who does not get puberty blockers die or need extensive surgery or become disabled within weeks or months or years if they do not receive this drug? No. We are talking about a mental/emotional health issue that might include upset, distress, depression, anxiety and other mood issues, but there is no physical health issue. There is no other emotional problem for which drugs and surgery to change a healthy body are prescribed. Puberty blockers and cross-sex hormones are not approved to treat these mental health conditions. Knowing this, is prescribing these drugs to children and adults ethical from a medical-ethics perspective? Is a medical doctor just someone that gives you whatever you want? Can you go to your doctor and ask for any other drug, just because you feel like it? You can, of course, always ask, but your doctor will refuse this request because you do not have a diagnosis for which the drug is licensed. Why is this so different for gender transition?