Sliding Down the Pyramid

Evidence for gender affirming care in clinical practice, policy and law

A lot of the debate around gender affirming care turns on “the evidence.” This can be a source of confusion because evidence can mean different things and be used in different ways in medical practice, public policy and law.

The Pyramid of Evidence

The basic principles of assessment of evidence in medical studies are reviewed by Dr. James Cantor in an expert’s report prepared for a lawsuit in Texas. He refers to this diagram of the pyramid of evidence from Openmd.com.

opemd.com

At the top are systematic reviews which analyze the results of all available studies on an issue. The highest quality research study is a randomized control trial in which subjects are randomly assigned to two groups. One receives the treatment being tested and the other an alternate treatment or placebo. These studies are often double blind which means that neither the patients nor their doctors know who is receiving the treatment being tested. Next come cohort studies which follow a group of patients over a period of time. At the bottom of the pyramid is expert opinion based on clinical experience.

Supporters of the current affirmative model claim that critics of the model say that the evidence base is deficient because puberty blockers and cross sex hormones have not been tested in randomized control trials. They then respond that randomized control trials for puberty blockers would not be ethical or even possible. This position combines the straw-man fallacy (misrepresenting an opponent’s position) with the fallacy of false alternatives.

The evidence pyramid has multiple levels and it is necessary to consider them all. As the Interim Report of the Cass Review explains:

The best type of single study is considered to be the randomised controlled trial (RCT), but sometimes this is not feasible. Even where RCTs are not available, it is usual to at least have data on the outcomes of sufficient cases or cohorts to understand the risk/ benefit of the treatment under consideration.

James Cantor’s experts report, referred to above, reviewed the existing cohort studies on puberty suppression and found that they either showed no improvement in mental health, found no advantage to medical intervention or had confounding factors which made it impossible to distinguish between the effects of psychological support and medical intervention.

Evidence in Clinical Practice

Evidence based clinical practice attempts to apply the best available scientific evidence to the treatment of individual cases. The basic principles are summarized by the McGill University Best Practices in Psychology portal:

• Efforts to provide the best possible services (which minimize the risk of harm and maximize the chance of benefit) for those seeking psychological treatment.

• A reliance on peer-reviewed, scientific research evidence as the basis for treatment selection, with preferential attention given to studies based on research methodologies that control threats to both the internal and the external validity of the research findings.

• Respect for the dignity, lived experiences, and preferences of individuals seeking psychological treatment, as manifested by consistent communication and collaboration between the clinician and the service user.

• The monitoring and evaluation of services provided to clients and patients. Practitioners should regularly and systematically monitor clients’ reactions as well as changes in their symptoms and functioning throughout treatment. This can be done through progress tracking and outcome monitoring.

• A willingness on the behalf of practitioners to alter the treatment plan based on ongoing treatment monitoring, discussions with the client or patient, and a reconsideration of the relevant research evidence.

All of these principles are being ignored in gender medicine. While there is a great deal of peer reviewed material available the quality is low. The existing clinical guidelines are low quality and countries which have conducted systematic evidence reviews, which now includes Finland, Sweden and the United Kingdom, have consistently found the evidence base is insufficient for safe and effective practice.

Respect for the preferences and lived experiences of patients can be selective. Detransitioners report that their experience and preferences are not respected.

Monitoring of outcomes is inconsistent. So-called informed consent clinics often refer a patient for hormones after one or two sessions and do not provide any ongoing psychological support. Even larger clinics do not bother with follow up. Failure to collect adequate data was one of the many criticisms that the Cass Review had of the Tavistock Clinic Gender Identity Development Service.

Practitioners of gender affirming care show little willingness to alter their treatment plans. Indeed, they they often invoke conversion therapy bans to intimidate anyone who suggests any departure from the medical pathway.

Evidence in Public Policy Making

An evidenced based policy process would largely follow the pattern in clinical practice. There was a time when this did happen in Canada. The government would start the process by issuing a Green Paper which described the issue and presented various alternative approaches. The government would then seek further input from the public and issue a White Paper which contained specific policy recommendations. Finally, the government would prepare legislation which would be debated in Parliament and studied in committees which would hear further public and expert input.

In the current debate in the United Kingdom on conversion therapy legislation, some version of this process still appears to operate. The government issued a discussion paper, which was open for public debate. As a result of the public response, the government has said that the proposed legislation will not include gender identity. The process has its flaws but the basic mechanism of sound policy making is still there, even if the politicians often ignore it.

However, in Canada, any pretext of evidence based policy making has long been abandoned. White Papers and Green Papers dropped out of use during the Stephen Harper government and the current government shows little interest in reviving them. In its place we have a process which appears to be largely driven by the political staff in the Prime Minister’s Office. The Canadian legislation on conversion therapy was developed in consultation with a small group of activists on one side of the issue and pushed through Parliament with minimal debate.

Evidence in Court

When the legislatures mess up, people turn to the courts for relief. Cases relating to gender affirming care are starting to work their way through the court system. Most cases are still at the pre-trial stage. Most of the reported decisions are on applications for pre-trial injunctions, which are normally decided on affidavit evidence. I have not seen any trial decisions where the expert evidence on both sides of the case has been fully examined.

Experienced trial lawyers know that it is very difficult to get expert witnesses to change the opinion to change the opinions in their reports. Instead, a lawyer will try to demonstrate that the opinion is not relevant to the legal issue the court has to decide.

Different types of cases will raise different issues of evidence. An expert opinion which might be conclusive in one type of case will be irrelevant in another. The strength of the evidence required to convince the court will also vary greatly.

Insurance Litigation

The type of case where the issues considered by a court most closely align with the issues in clinical practice is a dispute over whether a public or private health insurance plan is required to cover the cost of “gender affirming” care. The obligation of an insurer to pay for the cost of medical care is governed by the terms of the policy or the applicable legislation.

A recent case in Arizona is an example. The issue is whether the state Medicaid plan is obliged to fund “top surgery” (breast removal) for gender dysphoric teens. In its decision to deny the plaintiffs a preliminary injunction order the state to pay for the surgery, the court considered evidence that “there is no high-quality study showing male chest reconstruction surgery is safe, effective or optimal for treating minors with gender dysphoria.” The Society for Evidence Based Gender Medicine and a group of detransitioners filed amicus briefs in support of the state. The case was dismissed without going to trial.

Another case has been filed in Florida to challenge that state’s decision not to cover gender related care under Medicaid. The plaintiffs may be facing an uphill fight as Florida’s position on gender affirming care is supported by a comprehensive evidence review.

Negligence Litigation

The question in a medical negligence case is whether a doctor’s treatment of a particular patient met the professional standard of care. The court determines the standard of care based on expert evidence. Courts are starting to give more weight to formal clinical guidelines in negligence cases but they are not conclusive.

The House of Lords decision in Maynard v. West Midlands Regional Health Authority, [1985] 1 All E.R. 635 described the standard of care as follows:

It is not enough to show that there is a body of competent professional opinion which considers that theirs was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. It is not enough to show that subsequent events show that the operation need never have been performed, if at the time the decision to operate was taken it was reasonable in the sense that a responsible body of medical opinion would have accepted it as proper...

Differences of opinion in practice exist, and will always exist, in the medical and in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other: but that is no basis for a conclusion of negligence.

What this means is that the courts in a negligence case will not pass judgment on the strength of the science behind a particular treatment model. As long as a “body of competent professional opinion” supports it, that is sufficient.

Constitutional Litigation

In constitutional challenges to a law, the court is not supposed to consider whether the law is good policy. That is a matter for the legislature. Instead, the court must answer two questions. The first is whether the law infringes on some constitutionally protected right or freedom. This is primarily a legal question.

If the court finds an infringement it then considers whether the government is able to demonstrate that the law serves an important public purpose that justifies the infringement. This issue requires evidence but the nature and quality of the evidence is different from what is required in ordinary policy making.

The case of Brandt v. Rutledge illustrates these principles. The case was a challenge to the Arkansas law which banned all forms of medical transition for minors. The Plaintiffs obtained an injunction against enforcement of the law and the 8th Circuit Court of Appeal upheld the order granting it.

The Plaintiffs challenged the constitutionality of the ban on three grounds:

1. It violated the 14th Amendment by discriminating on the basis of sex and transgender status;

2. It violated the 14th Amendment by limiting the right of parents to sex and follow medical advice for their children; and

3. It violated the 1st Amendment by restricting what physicians could say and minors and their parents could hear.

The appeal court found that the act discriminated on the basis of sex and transgender status and did not consider the other grounds. This was a question of law which did not require the court to consider evidence.

Once the court found discrimination, the onus shifted to the state to show that there was a compelling public interest to justify the discrimination. At this point, evidence was required. In American constitutional law the principle of strict scrutinty places a high onus on the state to justify discrmination or other restrictions of constitutional rights. While the state presented evidence that the purpose of the law was to protect minors from experimental treatments, the court was not convinced. It said:

According to surveys of the research on hormone treatment for adolescents done by the British National Institute for Health & Care Excellence, several studies have shown statistically significant positive effects of hormone treatment on the mental health, suicidality, and quality of life of adolescents with gender dysphoria. None has shown negative effects....

Even international bodies that consider hormone treatment for adolescents to be “experimental” have not banned the care covered by Act 626. For example, Arkansas submitted to the district court a report from the Council for Choices in Health Care in Finland in which the council concluded that “[i]n light of available evidence, gender reassignment of minors is an experimental practice,” but the report still recommends that gender-affirming care be available to minors under appropriate circumstances.

In order to meet the strict scrutiny test the court found that the it was not enough for the state to argue that gender affirming care was not beneficial. It had to show that it was seriously harmful.

There is evidence of harm of gender affirming care but most of it is currently in the form of anecdotal accounts of detransitioners rather than formal medical studies. The problem is that most of the harm of gender affirming care is long term. Detransitioners report that going on hormones provides a temporary lift and regret only sets in after a number of years. Physiological harms such as early onset osteoporosis may not be evident for 10 to 15 years. The existing studies cover too short a period to cover these instances of regret and harm. They also suffer from survivorship bias since patients who experience regret tend to avoid gender clinics so studies run out of these clinics will exclude them.

In clinical practice, the proponents of a form of treatment have an obligation to show that it is safe and effective both in the short term and long term. However, in constitutional litigation, when the state wants to justify an infringement on a constitutional right, it has the onus of proving harm. The court in Brandt v. Rutledge found that the State of Arkansas had not satisfied this onus.

This decision was on a preliminary motion where the evidence is by affidavit only. There might be a different result after a full trial where the state could call evidence of the harm suffered by detransitioners who transitioned as minors.

Other challenges to state bans on affirmative care are working their way through the courts. It will be interesting to see how they are dealt with in light of the U. S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, which appears to allow the states more latitude in regulating medical procedures.

Meanwhile, bans on medical transition are not the only way in which the state has interfered with medical discretion. Bans on so-called conversion therapy for gender identity which restrict the ability of professionals to treat gender dysphoria by psychotherapy create the reverse problem. Medical transition is made the only legal option for coping with gender related distress.

Virtually the same arguments that were made against the Arkansas law could be advanced against state bans on conversion therapy and very similar arguments could be raised against Canada’s Bill C-4 under Sections 2, 7 and 15 of the Charter of Rights and Freedoms. By imposing arbitrary limits on the availability of psychological treatment for gender dysphoria, Bill C-4 infringes on the life, liberty and security of persons suffering from gender dysphoria by leaving them no alternatives to medical treatments with known risks and unproven benefits.

The onus would then shift to the government to justify the legislation, which would require actual evidence to support the claim that the law is intended to avoid serious harm.

At this point the test should not be whether gender affirming care can be shown to be beneficial. In order to justify a ban in the terms of Bill C-4 the government should have to show that the benefits of affirming care have been so conclusively established that any other approach is literally criminal.

Conversion therapy bans on gender identity are based on the conflation of attempts to change sexual orientation, which has been shown to be ineffective and harmful, with the very different question of therapy for gender dysphoria.

Most of the studies which link conversion therapy to serious harm either relate exclusively to sexual orientation or do not distinguish between sexual orientation and gender identity. The one study which attempts to link so-called conversion therapy for gender identity with suicide risk is a study by Dr. Jack Turban et al., which relies on one question on a low quality convenience sampled survey.

The Bottom Line

Wherever evidence is being considered, the critical element is the attitude of the person considering it. No amount of evidence can convince those who have already made up their minds without any evidence.