Uninformed Consent
What do consent forms in pediatric gender medicine really say?
Medical transition of children and adolescents has been increasing exponentially for the last ten years. Not surprisingly, this has now led to a huge increase in detransition and regret as more young gender patients reach their twenties. These young people are going to be looking for answers to the question of how they were allowed to change their bodies permanently before their minds were fully developed. One of the places they will look is the informed consent documents which they and their parents signed to start the process.
This form used by the Gender Pathways Service of the London Health Sciences Centre is an example of the state of informed consent in Canada. It is for administration of Lupron Depot for suppression of puberty in a natal girl.
Lupron Depot is one of a class of drugs known as gonadotropin-releasing hormone analogue (GnRHa). These drugs act on the pituitary gland. This is the master gland of the body which regulates the release of hormone by other glands. A GnRHa drug prevents the pituitary gland from sending signals to the testicles to produce testosterone in males or the ovaries to produce estrogen in females. These are the hormones which stimulate the physical changes of puberty. As long as a patient is taking the drug, the normal progress of puberty is blocked.
A lay person reading this brief description might jump to the conclusion that interfering with the function of the body’s master gland must have some serious risks. This conclusion is shared by many endocrinologists, but these concerns are not reflected in the consent form.
One of the many disturbing aspects of this form is that it is part of a package intended for use by a general practitioner prior to the child being seen by a specialized gender clinic. The guidelines endorsed by the Endocrine Society and WPATH for treatment of gender dysphoria recommend that hormonal treatment in children and adolescents commence only after approval by a mental health professional and supervised by a pediatric endocrinologist.
However, due to the increased demand for gender transition services, general pediatricians and family doctors are being asked to write the prescriptions. This means that the prescribing doctor may not have the knowledge required to fill in some of the gaps in the written material provided by the gender clinic.
Who is Consenting?
While the consent documents are written in the first person, as though they will be signed by the young patients, they should not be regarded as the primary audience. Puberty blockers are normally started at Tanner Stage 2. This is the age when the first signs of puberty appear and can be as earlier as 9 or 10 in girls. There is no minimum age for consent to medical treatment in Canada, with the exception of Quebec where it is set at 14. In other provinces, the question of capacity is decided on a case by case basis by application of the mature minor doctrine.
While there have been cases of 14 year old children being given cross-sex hormones over parental objections, it would be very unusual for a doctor to prescribe a life altering medication to a 10 or 11 year old without parental consent. The language in the forms is therefore really directed to parents and the family physicians who are now being asked to supervise treatment.
The Goals of the Treatment
The most basic requirement of informed consent is that the patient must understand the goals of the proposed treatment. This is what the form says:
I am receiving treatment for gender dysphoria. I understand that this means that, although I am genetically and biologically female, I think of myself as a male. I want to receive treatment that will stop further female puberty, so that I can continue with counseling without the worry of permanent body changes happening out of my control.
It has been explained to me that my doctors are suggesting and prescribing Lupron Depot® because they believe that this will allow me more time to explore my gender and other developmental issues.
The form does not use the term “Pause Button” which is often seen in discussions of puberty suppression or explicitly claim that puberty suppression is reversible, but the same thing is implied. Parents may find this language reassuring. Stopping puberty will relieve some immediate distress and give time to work out issues before a final decision is made.
However, the actual clinical experience of puberty blockers suggests something different. Studies have found that around 98% of children who receive puberty blockers proceed to cross-sex hormones, which are definitely irreversible. By comparison, earlier studies found between 65 and 90 percent of gender distress children resolved their issues with the onset of puberty. The real reason for prescribing puberty blockers is that they facilitate the process of medical transition by minimizing physical changes which would otherwise be difficult to reverse. Rather than a pause button, they are a start switch.
The form also refers to ongoing counselling, but in many cases the counselling available at gender clinics is minimal and almost entirely directed towards supporting transition to the opposite sex.
Long Term Goals
Since starting puberty blockers is likely to be the beginning of a much more extensive process of medical transition, informed consent requires some discussion of these later stages of the process. Here is what the form has to say:
Therefore, my treatment will include counseling to help me understand all possible results and consequences of going all the way through a full physical change, called “transition”, from female to male so that my sex would match my gender identity (my sense of myself) as a male. This could eventually include testosterone therapy to cause male body changes and sex-reassignment surgery to remove or reshape my internal and external female reproductive structures. Taking Lupron Depot® now does not mean that I will eventually want, need, or have testosterone therapy and/or surgery. The decision to start testosterone therapy will be made jointly between me, my parents or caregivers, and my medical doctors and counselors. Sex-reassignment surgery has to be discussed in detail when I am further along in my transition (usually after 18 years of age), and final decisions can only be made after I have been living continuously for a period of time in the gender role that fits with my gender identity as a male.
This long paragraph has many problems. The first is the phrase “understand all possible results.” It is very unlikely that any Canadian gender clinic will have discussed alternative means of coping with gender dysphoria, or conducted a screening for autism and other associated mental health issues. Any counselling that might assist in reconciling a child’s sense of self with their body without risky medication will almost certainly have been considered “conversion therapy” and therefore unthinkable.
If the possibility of detransition and regret were discussed, it was most likely limited to a comment that they are very rare. No one would be likely to explain that the studies which found these low detransition rates were based on adult transition under a mental health based model of care.
The second is reference to “full physical change, called ‘transition’ from female to male so my sex would match my gender identity.” This is a dangerous falsehood. Humans cannot change sex.
Surgery can remove your reproductive organs, but it will not give you the reproductive functions of the other sex. Your capacity for sexual pleasure will be diminished or lost.
What medical transition can do is make cosmetic changes which give your body a superficial resemblance to the opposite sex. This comes at the price of being dependent on artificial hormones for life. Many adult trans people understand this but nevertheless have found that the ability to “pass” as the opposite sex relieves their gender dysphoria.
Children just beginning puberty will not understand this. They are being set up for serious disappointment when the reality that sex is unchangeable finally sinks in.
Off Label Use
The form does not disclose is that Lupron is being used “off-label” to treat gender dysphoria. Drug regulators such as Health Canada and the Food and Drug Administration approve drugs for use with specific medical conditions which are described as indications. The manufacturer may only promote the use of the drug for approved indications. Lupron has been approved to treat four conditions: prostate cancer in men, endometriosis and fibrosis in women, and central precocious puberty in children of both sexes.
However, doctors are free to prescribe the drugs for other indications or to vary the dosage recommended by the manufacturer. These are called off-label indications. Off-label prescribing is common practice and not necessarily negligent. It has been estimated that 80 percent of prescriptions for children are off-label. There are many medical conditions where there is credible evidence that a drug will be beneficial but the condition is too rare to allow a manufacturer to recover the costs of the approval process, particularly if the drug is out of patent protection.
Off-label prescribing is acceptable medical practice provided that there is scientific evidence to support it. However, it does carry higher risks because individual clinicians must make their own assessment of the safety of the drug without assistance from the manufacturer or regulator. It is an open question as to whether a doctor must disclose that a drug is being used off label as part of the informed consent process.
There is no clear case law on this issue in either Canada or the United States. As a matter of medical ethics, there are arguments on both sides. On one hand, it is argued that off-label use is often associated with increased risk and the principle of shared decision making requires that all relevant information be provided to the patient. The contrary argument is that the simple fact of off-label use is not medically relevant. Approved drugs can also have serious risks. Focusing the patients attention on regulatory approval is a distraction from the actual discussion of risk which may lead a patient to reject safe and beneficial treatments.
Scientific Evidence for Puberty Suppression
Regardless of whether a drug is use on or off-label there needs to be scientific evidence to support its use. The evidence supporting the use of puberty suppression is in fact very weak. The initial study from Amsterdam which was published in 2014 followed a group of 55 young people from puberty to 1.5 years after gender reassignment surgery. There was no control group, no evaluation of their physical health and no long term follow up.
The quality of the evidence has not improved since then. Systematic reviews in Sweden and Finland resulted in the national health authorities issuing new guidelines which severely limit the availability of puberty suppression and hormone therapy. The Cass Review of gender identity services for children and young people in the United Kingdom seems to be moving in the same direction.
The Florida Department of Health has also conducted an evidence review and has now issued a guidance statement which recommends against all use of puberty blockers and cross sex hormones in patients under the age of 18.
This article by Jesse Singal reviews seven studies which are commonly cited in the media to support giving puberty blockers and hormones to children. They range in quality from inconclusive to shockingly bad. None of these concerns are reflected in the consent forms and concerned parents are unlikely to hear of them unless they do their own research.
Known Risks of Lupron
Off-label use transfers the full responsibility for assessing and notifying the patient of risks from the drug manufacturer to the prescribing doctor. One would think that since off-label use is generally associated with higher risk, the disclosure of potential risk should be more extensive. In fact, the consent for has a much less extensive description of risks than the manufacturer’s materials.
The consent form says:
I understand that although Lupron Depot® is a common treatment for children with precocious (early) puberty, it has only been used in healthy young adolescents with gender dysphoria for about 20 years, and the long-term effects are not fully known.
The form refers to Lupron as a “common” treatment for early puberty which parents might assume to mean that it is safe. However, the form fails to disclose some potential side effects which the manufacturer lists in its prescribing information.
The form refers to stiffness at the injection site, an initial rise in pubertal development and possible menopausal symptoms like hot flashes, low energy, night sweats and mood changes.
The prescribing information goes further and describes a serious side effects which have occurred when Lupron is used to treat precocious puberty including psychiatric events and convulsions. In April 2022 the manufacturer updated its prescribing information for precocious puberty to include information about reports of increased pressure in fluid around the brain. It advises parents to call their doctor immediately if their child experiences headaches, eye problems, ringing in the ears or dizziness while on Lupron. Doctors are advised to screen for a history of epilepsy or seizures.
This paragraph of the form also exaggerates when it says that Lupron has been used for gender dysphoria for about 20 years. Puberty blockers were first used at a clinic in Amsterdam in the late 1990s. Puberty suppression was first available in the United States around 2009 and was introduced to Canada some time later. The number of referrals to pediatric gender clinics did not begin to take off until around 2015. It would therefore be more accurate to say that puberty suppression has been used in adolescents with gender dysphoria outside of an experimental context for at most 13 years and has only been widely used for 7 years. There are other GnRH analogues besides Lupron, so Lupron itself may not have been used for this entire period.
This is a very short time to assess a treatment which has lifelong consequences. A patient who received puberty blockers at age 16 in 2009 would be 29 years old in 2022. Most patients treated since 2015 will be under 25. In other words, they have not yet reached the stage in life where their contemporaries are marrying and starting families.
Bone Health
Puberty is a critical period for bone development. About 90 percent of maximum lifetime bone mass is accumulated before the age of twenty. As one would expect, a drug which interferes with the process of puberty, also interferes with bone development. This is what the form says on the issue:
Lupron Depot® decreases calcium uptake by the bone. For this reason, it is important that I take other measures to protect my bones such as: keeping active and ensuring good calcium and Vitamin D intake. Studies have shown that if bone density decreases while on Lupron Depot®, it returns to normal after Lupron Depot® is stopped. It is not known if using Lupron Depot® increases the risk of osteoporosis in older age. In general, Lupron Depot® therapy is not continued for more than two years unless testosterone therapy is added, because maintenance of good bone health requires either testosterone or estrogen therapy.
This paragraph contains serious problems both in what it says and does not say. Reduced bone density is a well known risk of puberty blockers, but the form understates it significantly. Studies have found that treatment with puberty blockers has resulted in abnormally low bone density in one third of patients.
The form suggests that bone density returns to normal once cross sex hormones are started. However, research has found that while bone density increased after cross sex hormones were started, treated children did not catch up with their untreated peers.
There are no studies of the risk of the effect of Lupron during puberty on the risk of osteoporosis in older age because none of the children treated during puberty have yet reached older age. However, there have been case reports of osteoporosis in treated children such as one from Sweden which involved serious damage to the verterbrae. This case was one of the factors which caused the Karolinska Institute to place a moratorium on the use of hormonal treatment of children and adolosecents.
Fertility
The loss of capacity to have children can have devastating psychological effects. Forced sterilization is an aspect of genocide and sterilization by consent requires the highest standards of informed consent. Where sterility is a possible side effect of a medical treatment, the risk needs to be fully disclosed.
This is what the consent form says about the risk of sterility:
When Lupron Depot® is stopped, puberty restarts within 3–6 months. To date, research indicates that there are no permanent effects on female fertility or ovarian/uterine/breast health if the Lupron Depot® is taken for a period of time and then stopped. There is the option of freezing eggs (known as oocyte preservation) prior to starting Lupron Depot® just in case there are long-term effects on ovarian function. Oocyte preservation requires a process similar to in vitro fertilization (female hormone therapy and transvaginal ultrasounds prior to egg retrieval). The cost of oocyte preservation is significant and current success rates are low. If I am potentially interested in this, I can be referred to a fertility specialist to obtain more information before Lupron Depot® is started.
Many concerning things are packed into the words “To date” in the section of the consent form on fertility. To the extent that there has been research to date, it is on the use of Lupron in cases of precocious puberty. These studies cannot necessarily be extended to the use of puberty blockers during the normal window for puberty.
Most experienced gender doctors agree that puberty suppression followed by cross sex hormones will lead to sterility but there are no published studies on the issue. Since over 90 percent of the girls who start puberty blockers do proceed to cross sex hormones, it will be difficult to do research on whether taking puberty blockers during the normal window for puberty and then desisting has any permanent effects.
The form implicitly acknowledges that sterility is a likely risk by providing detailed information on egg preservation. It is now common practice to offer this treatment but studies have found that less than 5 percent of adolescents choose this option.
Effect on the Developing Brain
One factor that no one seems prepared to discuss is the impact of puberty blockers on the developing brain. An article with the obscure title Consensus Parameter: Research Methodologies to Evaluate Neurodevelopmental Effects of Pubertal Suppression in Transgender Youth. The article notes that puberty is “a limited phase when developing neural connections are uniquely shaped by hormonal and experiential factors, with potentially lifelong consequences for cognitive and emotional health.”
Disrupting the flow of hormones during this critical period of brain development could have significant consequences. The article reviews the existing research and concludes, “Taken as a whole, the existing knowledge about puberty and the brain raises the possibility that suppressing sex hormone production during this period could alter neuro-development in complex ways—not all of which may be beneficial.”
The rest of the article is discussion of how to go about studying this issue. No actual research has yet been done and it may not be done for years. Meanwhile, thousands of parents will be put under intense pressure to consent to a treatment that could harm the developing adolescent brain without being told anything about this risk.
Alternative Treatments
One of the requirements of informed consent in Canadian law is that the doctor must discuss the risks and benefits of any alternative treatments with the patient. The form does contain this paragraph:
My doctor and I have discussed the benefits and risks of Lupron Depot® and potential alternative treatment options.
It is very likely that this paragraph is simply a formality. Gender clinics simply do not admit the possibility that there could be any alternatives.
The alternatives are of course there. As noted previously, many cases of gender dysphoria resolve on their own if puberty is allowed to take its natural course. Gender dysphoria is also associated with a range of mental health conditions and psychotherapy can be helpful in many cases.
Canadian gender clinics do not acknowledge that there can be any alternatives. Most professionals working in these clinics seem to take the view that any attempt to resolve gender related distress by any means other than transition is conversion therapy which is a now a criminal offence. The legislation is in fact vaguely worded and should offer space for mental health work, but not many professionals are willing to risk their livelihood in a test case.
Why?
The form as a whole proposes a treatment with serious consequences and risks while offering very few cautions and downplaying any warnings. Why would a hospital take an approach that is so different from the cautious standards of conventional medicine?
Part of the answer can be found in the covering letter to parents which refers to “your child’s gender journey.” This is the language of religion and spirituality rather than science and medicine.
The clinic still gives a formal diagnosis of gender dysphoria and discusses the treatment in terms of relief from psychological distress, but if you look deeper you will see that their actual beliefs are quite different.
If you look at the adult gender service of the same hospital you will see that it follows an informed consent model it describes as patient centred care. Under this model patients can access hormones and surgery “without the need for: gender dysphoria diagnosis, mandatory pre-transition psycho-social readiness assessments, and unwanted mental health treatments.”
The informed consent model is supported by a belief that what mental health professionals call gender dysphoria is a mismatch between a person’s gender identity and their sexed body. It is unverifiable, unfalsifiable and unchallengeable. It is not secondary to any mental health condition. The only conceivable treatment is medical transition to the extent requested by the patient.
While gender clinics in Canada do not officially apply the informed consent model to patients under 16 there are many influential advocates who believe that it should apply. The actual practice in pediatric gender clinics often differs very little from the informed consent model. Assessments are very brief and clinics do not offer mental health support or any treatment other than medical transition.
This model of care is based on ideology rather than science or clinical experience. Many prominent advocates for the informed consent model of care have no formal training in medicine or psychology and no understanding of child development. Their main qualification is their own experience of gender dysphoria which included an intense desire for medical transition regardless or any risk.
The rest of the world is beginning to move towards more caution in gender medicine for children and adolescents and Canada has a long way to go to catch up.