Medical Safety: Risk Study of Gender Medicine, Part 1

Elizabeth Jensen -

One of the fundamental issues with Gender Medicine is the lack of rigorous research to support how it is being practiced (see references within Expert Report of Dr. James Cantor; Cantor, 2022 Report to Florida). The best research with respect to children is that the treatment approach to Gender Identity issues is “watchful waiting” (e.g. Levine et al., 2022). However, that’s with the classic pre-puberty presentation of gender dysphoria. Research is almost entirely lacking with the new teenage presentation which has not prevented permanent medical treatments to unknown causes (also Levine et al., 2022; Kaltiala-Heino et al., 2018). With respect to adults, the best research is showing that the suicide rate either doesn’t change from 0.03-0.04% BEFORE treatment or increases by a significant factor AFTER treatment* (e.g. Dhejne et al., 2011; Wiepjes et al., 2020). So this article and the next are a 2-part series that begins to look at the questions: Where are the safety controls to Gender Medicine practices? How does the suicide rate change when Gender Medicine is involved, and why is our information so bad if it is so important politically? (Not to mention medically and ethically important, too.)

If medicine is a scientific discipline, then the Scientific Method must be applied to medicine. To quote from the Encyclopedia Britannica, “In a typical application of the scientific method, a researcher develops a hypothesis, tests it through various means, and then modifies the hypothesis on the basis of the outcome of the tests and experiments. The modified hypothesis is then retested, further modified, and tested again, until it becomes consistent with observed phenomena and testing outcomes. In this way, hypotheses serve as tools by which scientists gather data. From that data and the many different scientific investigations undertaken to explore hypotheses, scientists are able to develop broad general explanations, or scientific theories.”

To highlight the disconnect between research and practice in the field of Gender Medicine, Levine et al. (2022) discusses the Dutch Experiment (de Vries et al., 2011 and 2014). “The interventions described in the study are currently being applied to adolescents who were not cross-gender identified prior to puberty, who have significant mental health problems, as well as those who have non-binary identities—all of these presentations were explicitly disqualified from the Dutch protocol. Despite these limitations, the Dutch clinical experiment has become the basis for the practice of medical transition of minors worldwide and serves as the basis for the recommendations outlined in the 2017 Endocrine Society guidelines..” To summarize what this statement is saying: Practice guidelines/standards have been adopted for children who do not have the illness characteristics of the studied population. If we were to translate this to a safety paradigm, it is saying that the procedures that are being examined for a trench operation are equally valid for a confined space with a toxic atmosphere. Doing that when you know better can get an OSHA Willful Citation: “A willful violation is defined as a violation in which the employer either knowingly failed to comply with a legal requirement (purposeful disregard) or acted with plain indifference to employee safety.”

This point is qualitatively made in other ways. For example Dahlen et al. (2021) states, “Some extracted statements [from WPATH SOC] might have been intended as recommendations or standards, but many were flexible, disconnected from evidence and could not be used by individuals or services to benchmark practice. After discussion of this incoherence within WPATH [World Professional Association for Transgender Health] SOCv7 and our inability therefore to compare recommendations across all CPGs [clinical practice guidelines], it was decided not to revisit inclusions post hoc but to abandon this protocol aim.” This means that the guidelines published by WPATH were “disconnected from evidence” and incoherent, a.k.a. unscientific.

When medical practice deviates from research in this way, it is similar to using PPE (personal protective equipment) in a way that it wasn’t designed to be used. In the case of the American Psychological Association (APA) adopting WPATH guidelines (which include recommendations for children), this is like obtaining the operators manual for your PPE from a 3rd party because the current manual is very poorly written and narrow in scope for the PPE’s potential uses. The Endocrine Society’s guidelines while advocating for Gender Medicine at least acknowledge that the “true effect maybe” or “is likely to be substantially different from the estimate” (Balshem et al., 2011) as summarized by Cantor (2022), “In every category [each Endocrine Society guideline for pediatric Gender Medicine], without exception, the research quality was rated [by the Endocrine Society] as ‘low’ or ‘very low’..” To take this into a safety paradigm, this is like providing fall protection to a worker in which its effectiveness is unknown. There are other Endocrine Society guidance that are similarly ranked this poorly for effectiveness; however, the measure for how problematic this is depends on the effect of the treatment. Gender Medicine impacts the entire body and is permanent (e.g. Lesbians United, 2022). So the result is that Endocrinologists working in Gender Medicine based on these guidelines are doing so unscientifically and unsafely; they know how poor the estimate for a positive outcome is, and they know the risk is a lifetime of potential damage to the entire patient’s body. What else do they know?

Keeping in line with the safety analogy, the effect of advocating for the 3rd party operator’s manual and wide-spread sales of the PPE is that beta-testing is now occurring through the entire customer base. Obviously this is not safe. The hazards to health are serious (e.g. brain development impacts, early-onset osteoporosis, sterility, auto-immune issues, and more) and the extent of these problems developing over time is unknown (e.g. Cass Review). Drafting guidelines/standards without supporting research also is not scientific. Cantor (2019) discusses how the American Academy of Pediatrics (AAP) proceeded with their Gender Medicine guidelines/standards without rigorous review. The “experimental” results from these Gender Medicine practices are no longer being collected in order to modify the hypothesis when this happens. The situation has been created where researchers, who ordinarily would not be able to conduct an experiment on this scale with this population for ethical reasons, are now ad-hoc attempting to collect data on how effective/harmful unscientifically-practiced Gender Medicine is.

As Cantor (2022) states, “The initial enthusiasm for medical blocking of puberty followed largely from early reports from the Dutch clinical research team suggesting at least some mental health improvement. It was when subsequent research studies failed to replicate those successes that it became apparent that the successes were due, not to the medical interventions, but to the psychotherapy that accompanied such interventions in most clinics, including the Dutch clinic.” Recall that the Dutch Experiment is the basis for pediatric Gender Medicine; subsequent research showed that it wasn’t the invasive medical treatments that were effective, and Cantor argues that it was the psychotherapy. The guidelines/standards discussed previously which were adopted by the APA, AAP, and Endocrine Society are all built on a fundamentally flawed, low quality, research experiment, a research experiment that permanently altered the children’s bodies on a cellular level. This means they expanded a poorly designed experiment with serious risks and unlikely benefits into the population as whole, and no results are being collected to modify the hypothesis.

With Gender Medicine practices unscientifically disconnecting from research, the implication is that the public as a whole becomes an unconstrained experiment. However, unlike an actual scientific experiment, the results are susceptible to the full spectrum of organizational responses, some of which I’ve identified as Organizational Failure (ACS, 2022). To reiterate the elements of Organization Failure: (1) Conflict of Interest (CoI) among medical practitioners, (2) medical practitioners making decisions based on emotional preference as opposed to known data, (3) medical practitioners suppressing/punishing workers/clients investigating the outcome of these emotional decisions, (4) Clients/Workers are perceived with hostility/malignant condescension, and (5) Insular training of medical practitioners. CoI appears when the providers of Gender Medicine receive financial rewards from businesses selling the medical treatments or some other form of emotional reward (e.g. Richardson, 2008-2009). Organizational Failures (2), (3), and (4) all contribute the failure to collect or maintain data necessary for evaluating the results of Gender Medicine practices, the failure to properly respond to incidents of harm, and the failure to properly conduct valid scientific research (a.k.a. “cooking the data”). These will be discussed in more detail in the following article on pre-/post-medicalization suicide rates. Finally, Organizational Failure (5) consists of unscientific practices being taught to medical practitioners. While there are examples of (5) available across media, none meet the higher standard of court record or peer review here in the United States (e.g. Irvine et al. 2022 Letter; Isaac, 2021; Kimberly, 2022 Letter). Further sworn testimony and legally admissible evidence is expected in the near future.

Gender Medicine as currently practiced is unrestrained by the unsound guidelines/standards that have been adopted (e.g. Mahfouda et al., 2018; Milrod, 2014; Milrod and Karasic, 2017; Olson-Kennedy, 2018). Treatment research that previously could have been halted due to risks to their subjects can now be conducted with subjects that are already experiencing a treatment. For example, a widely adopted treatment across schools is called “Social Transitioning” which likely increases dysphoria rather than relieving it (e.g. Zucker, 2020 and references therein). When a treatment is harmful rather than helpful, it is iatrogenic; regardless, social transitioning has become widely adopted (e.g. Health and Human Services, Office of Population Affairs, 2022). This enabled a low quality research study that attempted to measure the effect of this practice. How the study was designed suffered from fundamental flaws which are worth discussing to understand what makes the guidelines/standards unsound.

“Gender Identity 5 Years After Social Transition” by Kristina R. Olson, PhD et-al was published in 2022. It suffered from many flaws (Society for Evidence Based Gender Medicine, 2022 Public Release Statement), and a few of the most concerning are listed below:

  • The study participants did not represent the socially gender transitioning population “the ratio of natal boys to girls in this study is approximately 2:1 [most transitioning children are natal girls]...early age of social transition (average 6.5 years) [most are teens]..excellent mental health function [most do not have this level of mental health, e.g. Autism]”. While all this could be considered caveats, the fact that results from this study don’t apply generally to pediatric Gender Medicine isn’t sufficiently emphasized (e.g. Cass Review; Kaltiala-Heino, 2018).
  • The participants were filtered. No children were in the study who had been socially transitioned for less than 1.5 years. “Thus, it is likely that the study under-represents families where the child had experienced a briefer period of social transition and who then detransitioned [note Olson uses ‘retransition’ instead of ‘destransition’].”
  • The drop out rate from the study is unknown. My personal note: Every study of gender identity MUST include an accounting for whether former participants died as opposed to leaving the study. As I show in the next article, the suicide rate for transition medicine (AFTER medicalizing) has significant error bars but the question of the treatment being uniquely fatal needs to be investigated.
  • Limitation in hypothesis. The researchers’ “main concern with early social gender transition is that the process of re-identifying with their natal sex following a period of social transition may be distressing to a child”. However, “the researchers noted that in many cases the “distress” criterion, necessary for the DSM-5 [gender dysphoria] diagnosis, was not met. This allows for the inclusion of children with a certain parent profile: one who is heavily invested in the idea that their child is transgender even if they don’t meet diagnostic.”
  • “The children and adolescents’ pattern of sexual attraction/ orientation is not noted. This is an important omission, as gender incongruence in childhood is strongly associated with future homosexuality. If a significant proportion of the youth in the study are attracted to the individuals of their natal sex, it would suggest that early social transition poses risks of iatrogenic harm to LGB youth by exposing them to highly invasive and unnecessary medical interventions.”
  • Commingling of interventions and lack of control group. In the Scientific Method, a control group enables establishing whether a difference developed; if not, then no conclusions can be made. Also, making social-transition-impact conclusions when many subjects have moved on to medicalization (60%) eliminates being able to distinguish the effect of social transition alone.

How did such a fundamentally flawed study get approval? This leads to three questions: (1) What are the safety standards for experimenting on humans? (2) Assuming they failed in this situation, where was the failure? (3) What can we learn about these safety practices to address the situation of unscientific guidelines/standards?

“Institutional Review Boards (IRBs) are federally-mandated, locally-administered groups charged with evaluating risks and benefits of human participant research at their institution.” As many IRB members are aware, federal regulations make clear that an IRB must have the ". . . professional competence necessary to review specific research activities . . .", and that an IRB may invite input from ". . . individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB" [45 CFR 46.107 (a) and (f)].  Health and Human Services (HHS) has guidance for IRBs to follow Federal law (see Office for Human Research Protections reference) . Relative to Gender Medicine in general and the social transitioning study specifically, the following IRB concerns require further inquiry:

  • Was an IRB involved in the social transitioning study?
  • If an IRB reviewed the proposed research, what are:
  1. Its members’ experience?
  2. Meeting minutes?
  3. Assurance that Federal standards on human experimentation are met?
  4. A copy of the Informed Consent provided to participants in the research?
  5. The risk/benefit analysis of the research?
  6. Any materials concerning the fair and equitable selection of participating subjects?
  7. Research design is appropriate?
  8. Copies of the assent form provided to children and the permission form provided to their parents/guardians?
  9. Conflict of Interests identified and addressed?

I reached out to multiple institutions regarding IRBs. It is concerning that the ones which did not respond to my request for more information include: (1) National Institute of Health (nihfoia@mail.nih.gov), (2) Stanford University (officesupportstaff@lists.stanford.edu ), and (3) Massachusetts General Hospital (kkpiper@mgh.harvard.edu ). One IRB staff member was available for questions and to discuss how generally this safety practice works at their institution. The outcome from the discussion is that research such as the Olson et al. (2022) study described above would require convincing IRB members of the validity of the science. In other words, the state of the Gender Medicine practices and research has to be presented as rigorous and strong; a presentation that is false. IRB members would have to independently go through the cited materials to assess the accuracy of their citations and be sufficient experts in the field to recognize what is missing from the discussion of the hypothesis. Cantor (2022) goes in to this in detail when discussing the expert witness reports filed by Drs. Brady and Antommaria. This is probably what went wrong with the Olson IRB.

Conflict of Interest takes many forms. A discussion of how to strengthen IRBs against CoI was published by the APA and hopefully implemented by all applicable institutions (Eissenberg, 2004). In the case of Gender Medicine research, there are two forms to be watchful for: (a) Researchers attempting to structure the experiment to achieve a desired outcome (e.g. Lett et al., 2022) and (b) Non-researchers attempting to prevent the experiment out of concern of a undesired outcome.

This article began with discussing how Gender Medicine is being practiced without a scientific basis. I then transitioned to discussing research in Gender Medicine and issues with how it is being conducted. This led to learning about Institutional Review Boards and their critical importance to safety in human experimentation. I then discussed where they can fail. So what needs to be done?

According to Merriam-Webster, hearsay evidence is evidence based not on a witness's personal knowledge but on another's statement not made under oath. One issue that I see reoccurring is detransitioners stating that lawyers will not take their cases. The explanation given is that it was “experimental”. As discussed previously, an experiment follows the Scientific Method. These detransitioners make no other statements indicating that they were participating in an official IRB-safety-evaluated experiment. So here are the final questions: (1) How many Gender Medicine doctors who were involved with the unscientific guidelines/standards being adopted were aware of the IRB safety protocol? (2) How many Gender Medicine doctors who are not adhering to the guidelines/standards are aware of the IRB safety protocol? (3) How many Gender Medicine researchers are misrepresenting the status of the field to their IRBs?

How many Gender Medicine doctors knew or should have known that they were experimenting outside of experimental safeguards and with no intention of collecting results or modifying their hypotheses?

Author's Request: I am looking to collect Informed Consent documents from patients.

Footnote
*Calculated from 4 suicides/100,000 human hours; another issue to be discussed in the next article is how to measure this and what is available to measure.

REFERENCES

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