The Trans Experiment+ could be the most broad unregulated experiment the medical field has produced. Litigation is coming (a discussion on the civil aspects can be read here.)

Introduction

Herein I discuss legality issues with the Trans Experiment. Current research has summarized and expanded what is known, with what quality, and what is not known in Trans research. In the realm of law regarding experimenting on human subjects, medical ethics barriers were ignored or bypassed creating the current situation: a Trans Experiment being conducted on entire populations without controls, safety protocols, or independent review of the entire scope. To address this systemic failure of the medical system, tort litigation is necessary and appropriate. Quotes regarding the documentation of these issues in the Trans Experiment are from the following review paper: “Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults” by Stephen B. Levine, E. Abbruzzese& Julia M. Mason (https://www.tandfonline.com/do…)

The violations described are my opinion, and I reserve the right to change it pending further data.

At the bottom of this article is a draft letter for concerned community members to send to their area’s schools and the administrators of any other organizations in which children socialize.

Medical Research Safety Introduction (https://biotech.law.lsu.edu/IE…)

The Federal Regulations

The National Science Foundation (NSF) and the Public Health Service (PHS), which oversees the National Institutes of Health (NIH), have slightly different definitions for misconduct. NSF defines misconduct as:

“(1) fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from research; (2) material failure to comply with Federal requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals; or (3) failure to meet other material legal requirements governing research.” (45 CFR s 689.1)

The PHS defines misconduct as:

“fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.” (42 CFR s 50.102)

One their face, neither of these definitions is unreasonable. Both depend on the notion of seriously deviating from accepted practices. (Since PHS fraud investigators are much more active than those at the NSF, the remainder of this articles deals with the PHS rules.) The problem is that “accepted practices” are not well defined, leaving considerable room for misunderstandings between researchers and investigators.

[EAJ Note: the PHS misconduct is presumed to be violated by all of the descriptions below in which an NSF violation is noted.]


The Trans Experiment

  • The American Academy of Pediatrics endorsed social transition in the absence of data showing its benefits or harms:

“There have been eleven research studies to date indicating a high rate of resolution of gender incongruence in children by late adolescence or young adulthood without medical interventions (Cantor, 2020; Ristori & Steensma, 2016; Singh et al., 2021). An attempt has been made to discount the applicability of this research, suggesting that the studies were based on merely gender non-conforming, rather than truly gender-dysphoric, children (Temple Newhook et al., 2018). However, a reanalysis of the data prompted by this critique confirmed the initial finding: Among children meeting the diagnostic criteria for “Gender Identity Disorder” in DSM-IV (currently “Gender Dysphoria in DSM-5), 67% were no longer gender dysphoric as adults; the rate of natural resolution for gender dysphoria was 93% for children whose gender dysphoria was significant but subthreshold for the DSM diagnosis (Zucker, et al., 2018). It should be noted that high resolution of childhood-onset gender dysphoria had been recorded before the practice of social transition of young children was endorsed by the American Academy of Pediatrics (Rafferty et al., 2018). It is possible that social transition will predispose a young person to persistence of transgender identity long-term (Zucker, 2020).”

Violated regulation by bypassing the research step: “(2) material failure to comply with Federal requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals”

  • The Endocrine Society guidelines broadly applied recommendations based on low level evidence:

“The Dutch study subjects’ high level of psychological functioning at 1.5 years after surgery, which was the study end point, was an impressive feat. However, both of the studies suffer from a high risk of bias due to their study design, which is effectively a non-randomized case series—one of the lowest levels of evidence (Mathes & Pieper, 2017; National Institute for Health & Care Excellence, 2020a). In addition, the studies suffer from limited applicability to the populations of adolescents presenting today (de Vries, 2020). 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 (Hembree et al., 2017).”

Violated Regulations by bypassing the research step: “(1) fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from research; (2) material failure to comply with Federal requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals;”

  • Professional Medical Societies (at-large) endorse BELIEF in safety and efficacy of pediatric gender transition (WPATH in particular):

“It is common for gender-affirmative specialists to erroneously believe that gender-affirmative interventions are a standard of care (Malone, D’Angelo, Beck, Mason, & Evans, 2021; Malone, Hruz, Mason, Beck, et al:, 2021). Despite the increasingly widespread professional beliefs in the safety and efficacy of pediatric gender transition, and the endorsement of this treatment pathway by a number of professional medical societies, the best available evidence suggests that the benefits of gender-affirmative interventions are of very low certainty (Clayton et al., 2021; National Institute for Health & Care Excellence, 2020a; 2020b) and must be carefully weighed against the health risks to fertility, bone, and cardiovascular health (Alzahrani et al., 2019; Biggs, 2021; Getahun et al., 2018; Hembree et al., 2017; Nota et al., 2019). Recently, emphasis has also been placed on psychosocial risks and as yet unknown medical risks (Malone, D’Angelo, et al., 2021).”

“The most foundational aspect of the diagnoses of “gender dysphoria” (DSM-5) and “gender incongruence” (ICD-11), requisite for the provision of medical treatment, is in flux, as professionals disagree on whether the presence of distress is a key diagnostic criterion, as stated in the DSM-5, or is irrelevant, as is the case according to the latest ICD-11 criteria (American Psychiatric Association, 2013; World Health Organization, 2019). Further, these diagnoses have never been properly field-tested (de Vries et al., 2021).”

“There are no randomized controlled studies demonstrating the superiority of various affirmative interventions compared to alternatives. There isn’t even agreement about which outcome measures would be ideal in such studies.”

“There are few long-term follow-up studies of various interventions using predetermined outcome measures at designated intervals. Studies that have been conducted are, at best, inconsistent. Higher quality studies with longer-follow-up fail to demonstrate durable positive impacts on mental health (Bränström & Pachankis, 2020a; 2020b).”

“Rates of post-transition desistance, increased mental suffering, increased incidence of physical illness, educational failure, vocational inconstancy, and social isolation have not been established.”

“Numerous cross-sectional and prospective studies of transgender adults consistently demonstrate a high prevalence of serious mental health and social problems as well as suicide (Asscheman et al., 2011; Dhejne et al., 2011). Controversies about how to deal with trans-identified youth must consider the well described vulnerabilities of transgender adults.”

“It is equally important to realize that to date, research about alternative approaches, such as psychotherapy or watchful waiting, shares the scientific limitations of the research of more invasive interventions: there are no control groups, nor is there systematic follow-up at predetermined intervals with predetermined means of measurement (Bonfatto & Crasnow, 2018; Churcher Clarke & Spiliadis, 2019; Spiliadis, 2019).”

Violated regulation by bypassing the research step: “(2) material failure to comply with Federal requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals” Update: AAP appears to realize this is bad.

AAP Does not respond to the issues with its statements

See Footnote +++ with respect to experiment or treatment


  • The Clinicians:: brief evaluations, inaccurately-informed consent, gender-affirmative model, minority-stress theory, inadequate education, reductionism, discounting evidence, propagating misinformation regarding suicide, high rate of desistance/natural resolution of gender dysphoria in children is not disclosed, destransitioners – iatrogenic harm:

“When uncertain parents of children and teens consult their primary care providers, they are usually referred to specialty gender services. Parents and referring clinicians assume that specialists with “gender expertise” will undertake a thorough evaluation. However, the evaluations preceding the recommendation for gender transition are often surprisingly brief (Anderson & Edwards-Leeper, 2021) and typically lead to a recommendation for hormones and surgery, known as gender-affirmative treatment.”

“The informed consent process consists of three main elements: a disclosure of information about the nature of the condition and the proposed treatment and its alternatives; an assessment of patient and caregiver understanding of the information and capacity for medical decision-making; and obtaining the signatures that signify informed consent has been obtained (Katz et al., 2016). The current expectation that clinicians and institutions are required to thoroughly inform their patients about the benefits, risks, and uncertainties of a particular treatment, as well as about alternatives, has a long legal history in the United States (Lynch, Joffe, & Feldman, 2018).”

“Although following the informed consent model of care for hormones and surgeries for youth may diminish clinicians’ ethical or moral unease (Vrouenraets et al., 2020), we believe this model is the antithesis of true informed consent, as it jeopardizes the ethical foundation of patient autonomy. Autonomy is not respected when patients consenting to the treatment do not have an accurate understanding of the risks, benefits, and alternatives.”

“Gender dysphoric children and teens can intensely occupy the belief that their lives will be immensely improved by transition. Clinicians who have embraced the gender-affirmative model of care operate on the assumption that children and teens know best what they need to be happy and productive (Ehrensaft, 2017). These professionals, responding to the youths’ passionate pleas, see their role as validating the young person’s fervent wishes for hormones and surgery and clearing the path for gender transition. In doing so, they privilege the ethical principle of respect for patient autonomy (Clark & Virani, 2021) over their obligations for beneficence and non-maleficence.”

“Many of the gender-affirmative clinicians subscribe to the theory of minority stress – the supposition that the frequently co-occurring psychiatric symptoms of gender dysphoric individuals are a result of prejudice and discrimination brought about by gender non-conformity (Rood et al., 2016; Zucker, 2019), and that gender transition will ameliorate these symptoms. Some even claim that gender-affirmative care will successfully treat not only depression and anxiety but will also resolve neurocognitive deficits frequently present in gender dysphoric individuals (Turban, 2018; Turban, King, Carswell, & Keuroghlian, 2020; Turban & van Schalkwyk, 2018). These latter assertions have proven controversial even among the proponents of gender-affirmative interventions (Strang et al., 2018; van der Miesen, Cohen-Kettenis, & de Vries, 2018). The minority stress theory as the sole explanatory mechanism for co-occurring mental health illness has also been questioned in light of the evidence that psychiatric symptoms frequently pre-date the onset of gender dysphoria (Bechard, VanderLaan, Wood, Wasserman, & Zucker, 2017; Kaltiala-Heino, Sumia, Työläjärvi, & Lindberg, 2015; Kozlowska, Chudleigh, McClure, Maguire, & Ambler, 2021). Other clinicians recognize the limits of gender-affirmative care and are aware that youth with underlying psychiatric issues are likely to continue to struggle post-transition (Kaltiala, Heino, Työläjärvi, & Suomalainen, 2020), but, unaware of alternative approaches such as gender-exploratory psychotherapy or watchful waiting (Bonfatto & Crasnow, 2018; Churcher Clarke & Spiliadis, 2019; Spiliadis, 2019), these well-meaning professionals continue to treat youth with gender-affirmative interventions despite lingering doubts.”

“It is common for gender-affirmative specialists to erroneously believe that gender-affirmative interventions are a standard of care (Malone, D’Angelo, Beck, Mason, & Evans, 2021; Malone, Hruz, Mason, Beck, et al:, 2021). Despite the increasingly widespread professional beliefs in the safety and efficacy of pediatric gender transition, and the endorsement of this treatment pathway by a number of professional medical societies, the best available evidence suggests that the benefits of gender-affirmative interventions are of very low certainty (Clayton et al., 2021; National Institute for Health & Care Excellence, 2020a; 2020b) and must be carefully weighed against the health risks to fertility, bone, and cardiovascular health (Alzahrani et al., 2019; Biggs, 2021; Getahun et al., 2018; Hembree et al., 2017; Nota et al., 2019). Recently, emphasis has also been placed on psychosocial risks and as yet unknown medical risks (Malone, D’Angelo, et al., 2021).”

“Perhaps the single most problematic assumption held by some gender clinicians is that the young patients have simply been “born in the wrong body.” This assumption seemingly frees clinicians from having to contend with the ethical dilemmas of recommending body-altering interventions that are based on very low-quality evidence. Despite the principle of development that biology, psychosocial factors, and culture generate behavior, these clinicians may believe that atypical genders are created by biology. This reductionistic approach has been criticized repeatedly (Kendler, 2019).”

“A growing number of clinicians and researchers are noting that the dramatic rise of teens declaring a trans identity appears to be, at least in part, a result of peer influence (Anderson, 2022; Hutchinson, Midgen, & Spiliadis, 2020 Littman, 2018; Littman, 2020; Zucker, 2019). Some have noted yet another influx of trans-identified youth emerging during the COVID lockdowns, and have hypothesized that increased isolation coupled with heavy internet exposure may be responsible (Anderson, 2022). While the research into the phenomenon of social influence as a contributor to trans identification of youth is still in its infancy, the possibility that clinicians are providing treatments with permanent consequences to address what may be transient identities in youth poses a serious ethical dilemma.”

“There is a growing recognition that rapid evaluations which disregard factors contributing to the development of gender dysphoria in youth are problematic. In November 2021, two leaders of the World Professional Organization for Transgender Health (WPATH) warned the medical community that the “The mental health establishment is failing trans kids” (Anderson & Edwards-Leeper, 2021). Frequently, evaluations provided by gender clinicians may only ascertain the diagnosis of gender dysphoria (DSM-5) or its ICD-11 counterpart gender incongruence, and screen for conspicuous mental illness prior to recommending hormones and surgeries. These limited, abbreviated evaluations overlook, and as a result fail to address, the relevant issue of the forces that may have influenced the young person’s current gender identity.”

“Confirming the young person’s self-diagnosis of gender dysphoria or gender incongruence is easy. Clarifying the developmental forces that have influenced it and determining an appropriate intervention are not. Contextualizing these forces involves an understanding of child and adolescent developmental processes, childhood adversity, co-existing physical and cognitive disadvantages, unfortunate parental or family circumstances (Levine, 2021), as well as the role of social influence (Anderson, 2022; Anderson & Edwards-Leeper, 2021; Littman, 2018; 2021).”

“In sharing the information with patients and families, two key areas of uncertainty must be emphasized. The first one is the uncertain permanence of a child’s or an adolescent’s gender identity (Littman, 2021; Ristori & Steensma, 2016; Singh, Bradley, & Zucker, 2021; Vandenbussche, 2021; Zucker, 2017). The second is the uncertain long-term physical and psychological health outcomes of gender transition (National Institute for Health & Care Excellence, 2020a; 2020b). Unfortunately, gender specialists are frequently unfamiliar with, or discount the significance of, the research in support of these two concepts. As a result, the informed consent process rarely adequately discloses this information to patients and their families.”

“Problematically, it is common for gender clinicians to emphasize the risk of suicide if a young person’s wish to transition gender is not immediately fulfilled. There is a significant amount of misinformation surrounding the question of suicidality of trans-identified youth (Biggs, 2022). Providers of gender-affirmative care should be careful not to unwittingly propagate misinformation regarding suicide to parents and youths. They should also be reminded that any conversations about suicide should be handled with great care, due to its socially contagious nature (Bridge et al., 2020; HHS, 2021).”

“There have been eleven research studies to date indicating a high rate of resolution of gender incongruence in children by late adolescence or young adulthood without medical interventions (Cantor, 2020; Ristori & Steensma, 2016; Singh et al., 2021). An attempt has been made to discount the applicability of this research, suggesting that the studies were based on merely gender non-conforming, rather than truly gender-dysphoric, children (Temple Newhook et al., 2018). However, a reanalysis of the data prompted by this critique confirmed the initial finding: Among children meeting the diagnostic criteria for “Gender Identity Disorder” in DSM-IV (currently “Gender Dysphoria in DSM-5), 67% were no longer gender dysphoric as adults; the rate of natural resolution for gender dysphoria was 93% for children whose gender dysphoria was significant but subthreshold for the DSM diagnosis (Zucker, et al., 2018). It should be noted that high resolution of childhood-onset gender dysphoria had been recorded before the practice of social transition of young children was endorsed by the American Academy of Pediatrics (Rafferty et al., 2018). It is possible that social transition will predispose a young person to persistence of transgender identity long-term (Zucker, 2020).”

“Comparing these much higher rates of treatment discontinuation and detransition to the significantly lower rates reported by the older studies, the researchers noted: “Thus, the detransition rate found in this population is novel and questions may be raised about the phenomenon of overdiagnosis, overtreatment, or iatrogenic harm as found in other medical fields” (Boyd, Hackett, & Bewley, 2022 p.15). Indeed, given that regret may take up to 8-11 years to materialize (Dhejne, Öberg, Arver, & Landén, 2014; Wiepjes et al., 2018), many more detransitioners are likely to emerge in the coming years. Detransitioner research is still in its infancy, but two recently published studies examining detransitioner experiences report that detransitioners from the recently-transitioning cohorts feel they had been rushed to medical gender-affirmative interventions with irreversible effects, often without the benefit of appropriate, or in some instances any, psychologic exploration (Littman, 2021; Vandenbussche, 2021).”

“Suicide among trans-identified youth is significantly elevated compared to the general population of youth (Biggs, 2022; de Graaf et al., 2020). However, the “transition or die” narrative, whereby parents are told that their only choice is between a “live trans daughter or a dead son” (or vice-versa), is both factually inaccurate and ethically fraught. Disseminating such alarmist messages hurts the majority of trans-identified youth who are not at risk for suicide. It also hurts the minority who are at risk, and who, as a result of such misinformation, may forgo evidence-based suicide prevention intervention in the false hopes that transition will prevent suicide.”

“The notion that trans-identified youth are at alarmingly high risk of suicide usually stems from biased online samples that rely on self-report (D’Angelo et al., 2020; James et al., 2016; The Trevor Project, 2021), and frequently conflates suicidal thoughts and non-suicidal self-harm with serious suicide attempts and completed suicides. Until recently, little was known about the actual rate of suicide of trans-identified youth. However, a recent analysis of data from the biggest pediatric gender clinic in the world, the UK’s Tavistock, found the rate of completed youth suicides to be 0.03% over a 10-year period, which translates into the annual rate of 13 per 100,000 (Biggs, 2022). While this rate is significantly elevated compared to the general population of teens, it is far from the epidemic of trans suicides portrayed by the media.”

“As the lead Dutch researchers have begun to call for more research into the novel presentation of gender dysphoria in youth (de Vries, 2020; Voorzij, 2021) and question the wisdom of applying the hormonal and surgical treatment protocols to the newly presenting cases, many recently educated gender specialists mistakenly believe that the Dutch protocol proved the concept that its sequence helps all gender-dysphoric youth. Although aware of the Dutch study’s importance, they seem to be unaware of its agreed upon limitations, and the Dutch clinicians’ own discomfort that most new trans-identified adolescents presenting for care today significantly differ from the population the Dutch had originally studied. These facts, of course, underscore the need for a robust informed consent process.”

Violations on a case-by-case (institution-by-institution) basis where documentation shows that the Clinician(s) had poor education, experience, and/or training for how they handled patients (obtained during Discovery phase of a lawsuit): “(1) fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from research; (2) material failure to comply with Federal requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals; or (3) failure to meet other material legal requirements governing research.” At issue is whether they were independently conducting research, in the sense of how research is defined. Otherwise the issue falls under malpractice. It has been reported that detransitioners cannot sue their Clinicians for malpractice as the treatment was “experimental”. If that is the case, then the violation falls under research.

  • Schools and other child activity organizations can face litigation now with regard to parental informed consent (see attached draft letter):

“There have been eleven research studies to date indicating a high rate of resolution of gender incongruence in children by late adolescence or young adulthood without medical interventions (Cantor, 2020; Ristori & Steensma, 2016; Singh et al., 2021). An attempt has been made to discount the applicability of this research, suggesting that the studies were based on merely gender non-conforming, rather than truly gender-dysphoric, children (Temple Newhook et al., 2018). However, a reanalysis of the data prompted by this critique confirmed the initial finding: Among children meeting the diagnostic criteria for “Gender Identity Disorder” in DSM-IV (currently “Gender Dysphoria in DSM-5), 67% were no longer gender dysphoric as adults; the rate of natural resolution for gender dysphoria was 93% for children whose gender dysphoria was significant but subthreshold for the DSM diagnosis (Zucker, et al., 2018). It should be noted that high resolution of childhood-onset gender dysphoria had been recorded before the practice of social transition of young children was endorsed by the American Academy of Pediatrics (Rafferty et al., 2018). It is possible that social transition will predispose a young person to persistence of transgender identity long-term (Zucker, 2020).”

“Informed consent for social transition represents a gray area. Evidence suggests that social transition is associated with the persistence of gender dysphoria (Hembree et al., 2017; Steensma, McGuire, Kreukels, Beekman, & Cohen-Kettenis, 2013). This suggests that social gender transition is a form of a psychological intervention with potential lasting effects (Zucker, 2020). While the causality has not been proven, the possibility of iatrogenesis and the resulting exposure to the risks of future medical and surgical gender dysphoria treatments, qualifies social gender transition for explicit, rather than implied, consent.”

Potential violation in the event of socially transitioning a child without explicit parental informed consent: any number of parental rights laws.

  • Medical practitioners fail to evaluate recommendations from Clinicians:

“The quality of evidence underlying the practice of pediatric gender transition is widely recognized to be of very low quality (Hembree et al., 2017). In 2020, the most comprehensive systematic review of evidence to date, commissioned by the UK National Health System (NHS) and conducted by the National Institute for Health and Care Excellence (NICE), concluded that the evidence for both puberty blocking and cross-sex hormones is of very low certainty (National Institute for Health & Care Excellence, 2020a; 2020b).”

“According to the NICE review of evidence for puberty blockers, the studies “are all small, uncontrolled observational studies, which are subject to bias and confounding, and are of very low certainty as assessed using modified GRADE [Grading of Recommendations, Assessment, Development and Evaluations]. All the included studies reported physical and mental health comorbidities and concomitant treatments very poorly” (National Institute for Health & Care Excellence, 2020a, p.13). NICE reached similar conclusions regarding the quality of the evidence for cross-sex hormones (National Institute for Health & Care Excellence, 2020b).”

“Problematically, the implications of administering a treatment with irreversible, life-changing consequences based on evidence that has an official designation of “very low certainty” according to modified GRADE is rarely discussed with the patients and the families. GRADE is the most widely adopted tool for grading the quality of evidence and for making treatment recommendations worldwide. GRADE has four levels of evidence, also known as certainty in evidence or quality of evidence: very low, low, moderate, and high (BMJ Best Practice, 2021). When evidence is assessed to be “very low certainty,” there is a high likelihood that the patients will not experience the effects of the proposed interventions (Balshem et al., 2011).”

“In the context of providing puberty blockers and cross-sex hormones, the designation of “very low certainty” signals that the body of evidence asserting the benefits of these interventions is highly unreliable. In contrast, several negative effects are quite certain. For example, puberty blockade followed by cross-sex hormones leads to infertility and sterility (Laidlaw, Van Meter, Hruz, Van Mol, & Malone, 2019). Surgeries to remove breasts or sex organs are irreversible. Other health risks, including risks to bone and cardiovascular health, are not fully understood and are uncertain, but the emerging evidence is alarming (Alzahrani et al., 2019; Biggs, 2021).”

Violations: At present unknown as the author is not fully informed on malpractice law. That such major life-altering treatments are undertaken on physically healthy patients warrants investigation. Update: one doctor appears to be aware that the trans identity can be transient. (Side note: doctor practicing in trans medicine received emergency experimental treatment outside of a study )

  • News and Social Media Companies role in transmitting information recruiting participants/supporters for the Trans Experiment and/or suppressing valid concerns:

“A growing number of clinicians and researchers are noting that the dramatic rise of teens declaring a trans identity appears to be, at least in part, a result of peer influence (Anderson, 2022; Hutchinson, Midgen, & Spiliadis, 2020 Littman, 2018; Littman, 2020; Zucker, 2019). Some have noted yet another influx of trans-identified youth emerging during the COVID lockdowns, and have hypothesized that increased isolation coupled with heavy internet exposure may be responsible (Anderson, 2022). While the research into the phenomenon of social influence as a contributor to trans identification of youth is still in its infancy, the possibility that clinicians are providing treatments with permanent consequences to address what may be transient identities in youth poses a serious ethical dilemma.”

[EAJ: My personal experience has been that social media blogs that are self-identified left-leaning will ban users posting links to data and research regarding the issues above. This phenomenon should be measured for its impact on the availability of quality information to gender-questioning teens. Algorithms on social media platforms in general and the lack of news reporting on the poor quality of data underlying the Trans Experiment should also be measured.]

Violations: At present unknown as the author is not fully informed on the range of applicable laws. At issue is whether members of the media organizations were aware of the correct information regarding critical aspects the Trans Experiment and chose to censor or misrepresent it.

Update: Assessing Damages/Harm

Any lawsuit includes standing, which varies from topic to topic and jurisdiction to jurisdiction. The page linked below will be constantly updated with information on damage/harm that various victims of the Trans Experiment have experienced.

Draft Letter from Parents & Concerned Members of the Public to Schools and other Children’s Activity Organizations

To legally notify school districts, you need to go to the school district’s website, find the Superintendent (or equivalent) & send (a) an email with read receipt and (b) a certified letter that includes this letter and the printed out article, “Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults” by Stephen B. Levine, E. Abbruzzese& Julia M. Mason (https://www.tandfonline.com/do…). Then do the same for each of the school district’s board members (elected). Their emails may not be available in which case you ask the Superintendent to forward the email.

[Date & Letter front matter]

Re: Research Review on Gender Dysphoria Raises Legality Issues For Schools

Dear [Superintendent name],

I would like to officially notify you that the school district’s policy regarding students with gender issues needs to take in account parental informed consent. As the attached scientific review paper states, “Informed consent for social transition represents a gray area. Evidence suggests that social transition is associated with the persistence of gender dysphoria (Hembree et al., 2017; Steensma, McGuire, Kreukels, Beekman, & Cohen-Kettenis, 2013). This suggests that social gender transition is a form of a psychological intervention with potential lasting effects (Zucker, 2020). While the causality has not been proven, the possibility of iatrogenesis and the resulting exposure to the risks of future medical and surgical gender dysphoria treatments, qualifies social gender transition for explicit, rather than implied, consent.”

The body of the paper generally explains the experimental nature of Trans research and the need for parents and patients to receive complete information regarding the state of the Trans Experiment when making permanent life/health-altering decisions. The primary issue is that it is EXPERIMENTAL. School districts have no role in conducting scientific research of this nature, and school district policy must reflect this. This letter is to make you aware that the district is now liable if students are permitted to socially transition without explicit informed consent from his/her parents/guardian.

Sincerely,

[Your name & Letter back matter]

When you send this information to the organizations, please forward the documentation to us here at Referee PAC (with read receipt):

info@refpac.org

Elizabeth Jensen, PhD, PE, CSP
Referee PAC, Treasurer
https://refpac.org

Organizations for which I have documentation that they were contacted with the letter above:
Texas
Aldine ISD
Austin ISD
Burleson ISD
Clear Creek ISD
Conroe ISD
Cy-Fair ISD
Dallas ISD
Fort Bend ISD
Galveston ISD
Granbury ISD
Houston ISD
Humble ISD
Huntsville ISD
Katy ISD
Klein ISD
Lake Travis ISD
Lamar ISD
Magnolia ISD
Pearland ISD
Sheldon ISD
Spring ISD
Tomball ISD
USA
Scouts BSA

I also contacted the Bioethics Department at the National Institute of Health to report this widespread unregulated human experiment currently being conducted; the response did not answer my question & consisted of discredited information justifying the affirmative model. This has been forwarded to Congressman Dan Crenshaw and Senator John Cornyn with the accompanying letter:

Subject: ISSUE: Transgender medicine is essentially unregulated human experiment

Dear Senator Cornyn,
I'm writing due to my very grave concerns that we are experiencing the worst widespread unethical medical experiment ever seen. In the last two years, I noticed 7 teens decide that they were transgender, 6 of them are/were females. This ran contrary to everything I had ever seen before, so I began to do some literary research on what was going on. I'm a forensic engineer and safety expert, I run my own small business, and I have a lot of knowledge, experience, and training to identify signs of failure in an organization. What I have discovered is what I would characterize as an unregulated human experiment that is expanding exponentially due to currently unknown (but suspected) causes.

To begin with, teenage girls have never identified as transgender until very, very recently, around 2012. The transgender population previously was entirely male, and consisted of very few individuals. Now, the number of individuals seeking help for transgender identity has exponentially grown, with the growth driven by teenage natal girls. While this is what appears to be a mental health problem, how the medical community has responded is what I would characterize as superficial, costly, and iatrogenic.

Transgender science is not a developed field of research. As the attached paper on Informed Consent discusses (Bioethics pdf), there is very little research that is above "very low quality" (meaning no conclusions can be taken from it), and there is a lot of research that has not been conducted. Regardless, the results of these very low quality studies using carefully selected individuals have been expanded to apply to whole populations, including individuals that were deliberately not included in the studies. The process for this expansion is the adopting of standards by various organizations such as the Endocrine Society, the American Medical Association, the American Association of Pediatricians, and so on. These organizations canonized a treatment path for patients that was not based on any science. The result is "gender affirmation". This is essentially agreeing with the patient that they are transgender unquestionably and moving on to make their mental distress permanent. Doctors criticizing this approach describe it as putting an anorexic patient on a fasting diet. As the Informed Consent paper discusses, agreeing with patients is easy, evaluating them to understand how they got to this mental space is hard. There are even organizations out there that virtually skip the evaluation phase and deliver cross-hormones (which cause permanent changes) immediately such as Planned Parenthood. The end result for many patients is sterility as well as the need to take toxic levels of hormones for the rest of their lives. None of this is approved by the FDA.

A lot of emphasis has been put on transgender people being a suicide risk. As the Informed Consent paper discusses, this risk is not nearly as significant as the media reports AND THERE IS NO REAL CHANGE BEFORE/AFTER TRANSITION. So, NO, transitioning does not address suicide concerns. Many clinicians will scare families seeking help with the FALSE argument, "Do you want a dead girl or a live boy?"

When I realized that (a) no one really knows why so many teenage girls are seeking sex changes, (b) no one really thinks about what exponential growth means population-wise, (c) no one really knows if there's any benefit to the practice of transgender medicine, (d) no one knows what defines "success", (e) the very basis for a sex change, gender dysphoria, is still being debated by professionals, (f) clinicians are not providing this information to patients, providing misinformation instead, (g) the costs to those who undergo the medical treatments is high not just financially but also in losses to their health, I came to the conclusion that I was looking at an unregulated human experiment being conducted on the population as a whole.

I was initially surprised that the only mainstream news media outlet that had published anything on these issues was Fox News. The people that I felt most needed to be informed would not be the Fox News audience. So, I took a number of different approaches to attempt to raise awareness of the scope of this problem and came to the realization that there is another facet driving the growth: critical discussion is being deliberately suppressed. For example, under one of my accounts, I attempted to reply to a Wonkette article by citing a scientific rebuttal to some transgender research summarizing it as sloppy. That account was blocked within 24 hours, and the ban extended to various other platforms. For example, I used it to create an account on DailyKos to comment on another article and discovered that it was blocked before I had even typed a word. When a transgender critical parents' organization posted an article on their blog discussing the suppression of their experiences by news media, I realized that discussing everything that I had found would be effectively suppressed. Their article is here: https://genspect.org/they-know/

So finally, I began to raise awareness myself (e.g. pdf of an email to one of my meetup groups attached). I then reached out to the NIH Bioethics Department, because I wanted to obtain details on the ethics of human experimentation. I wanted to cite precisely why the current state of medicine was so unethical. The response was unusual: it not only did not answer my question on human experimentation but it also attempted to undermine my scientific literature research (please see attached NIH pdf). The citations were all old relative to the rapidly evolving body of work available as well as incorrect. One mentioned the misinformed suicide risk and another discussed health benefits of transitioning, which has never been proven scientifically particularly since there's no agreement on how to define "heath benefits". In this, I feel that Senator Cornyn can make a significant impact.

I ran a quick back-of-the-envelope calculation, and the exponential growth means that roughly 1/3 of teen girls will experience gender distress within 1.5-1.8 years. Planned Parenthood recently received a multi-million dollar donation & will be ready to start their transitions as soon as they are distressed. Any effort concerned people take to address social media influences are blocked/suppressed. Senator Cornyn, we need your help.

Follow The Money

These are the buzzwords used to describe the profitability in medicating people for transgenderism. “hormone therapy” = “ongoing longitudinal relationship”. The amount of money in the market of lifetime medicalization is variously described. “$4.5 billion to $6 billion on medication.” ““The estimates on the size of the trans population since a decade ago has been growing 20% year over year,”

Matthew Wetschler of Plume and Lightning Bolt

Jerrica Kirkley of Plume – Widely referenced in mass media. Articles (apparently non-reviewed): (1) “Testosterone-Based Gender-Affirming Hormone Therapy: Medications and What to Expect” (2) “Estrogen-Based Gender-Affirming Hormone Therapy: Medications and What to Expect” (3) “A Practice for All Pronouns

General Catalyst, a venture capitalist firm portfolio (Olivia Lew)

Slow Ventures, a venture capitalist firm

Springbank Collective, investment firm

Christina Farr, CNBC writer: “Matthew Wetschler is a Stanford-trained emergency room doctor. He’s also a friend.”

Craft Ventures, a venture capitalist firm

Town Hall Ventures, a venture capitalist firm

Bessemer Venture Partners, a venture capitalist firm

Polaris Partners, a venture capitalist firm

Define Ventures, a venture capitalist firm

A.G. Breitenstein of Folx Health (Founder & Executive Chair), also Humedica (Co-Founder, Chief Product Officer) and investor in Lex (text-based social app)

Kate Steinle of Folx Health

Liana Douillet Guzmán of Folx Health

Tawani Foundation [Reference 2, the federalist, from this point down]

Squadron Capital

Program of Human Sexuality at the University of Minnesota received $6.5M

Pritzker School of Medicine at the University of Chicago

chair of transgender studies at the University of Victoria

Mark S. Bonham Centre for Sexual Diversity Studies at the University of Toronto

American Civil Liberties Union

Planned Parenthood

$25 million to the University of California at San Francisco for a center of children’s psychiatry

James Hekman founded the LGBT medical care center in Lakewood Ohio

David T. Rubin sits on the advisory board of Accordant/CVS Caremark

Loren Schecter is the author of the first surgical atlas for transgender surgery, author of pro-trans journals, was awarded for legal advocacy of transgenders, performs reconstructive surgeries, and is director of transfeminine conferences sponsored by World Professional Association of Transgender Health (WPATH)

Schecter is also the “surgeons only sessions chair” on the Scientific Program Committee of the newly formed United States arm of WPATH (World Professional Association of Transgender Health), USPATH, holding conferences in Los Angeles for surgeons in transgender surgeries

Robert Garofalo, a gay man, is director of the St. Lurie children’s gender clinic, head of the hospital’s division of adolescent medicine, and a professor of pediatrics at Northwestern University, which J.B. Pritzker (whom we will meet later) funds

Benjamin N. Breyer is chief of urology at San Francisco General Hospital and a professor at the University of California at San Francisco, specializing in transgender surgery

Nicholas Matte teaches at the Mark Bonham Centre for Sexual Diversity Studies at the University of Toronto, with a specialty in queer studies. Jennifer Pritzker also funds the Bonham Centre. Matte lectures around the country on transgender issues, and espouses the idea that we are not a sexually dimorphic species.

Mark Hyman is the Pritzker Foundation Chair in functional medicine at the Cleveland Clinic and director of the Cleveland Clinic Center for Functional Medicine

Baylor College of Medicine is on the receiving end of the Pritzker School of Medicine’s “pipeline programs” for people studying to be doctors

Jennifer Pritzker has also helped normalize transgender individuals in the military with a $1.35 million grant to the Palm Center, a University of California, Santa Barbara-based LGBT think tank, to create research validating military transgenderism. He has also donated $25 million to Norwich University in Vermont

Pritzker’s funding is not confined to the United States, but reaches other countries via WPATH, in conferences for physicians studying transgender surgery and funding of international universities.

Penny has funded the Harvard School of Public Health and, with her husband through their mutual foundation, The Pritzker Traubert Family Foundation, are funding early childhood initiatives as well as providing scholarships to Harvard University medical students. The Boston Children’s Hospital Gender Management Services wing physicians are all affiliated with Harvard Medical School. Penny Pritzker also sat on the board at Harvard, where student life offices teach students, many of whom go on to lead U.S. institutions, that “there are more than two sexes.”

Pritzker Group, a private investment firm that invests in digital technology and medical companies, including Clinical Innovations, which has a global presence. Clinical Innovations is one of the largest medical device companies and in 2017 acquired Brenner Medical, another significant medical group offering innovative products in the fields of obstetrics and gynecology.

J.B. provided seed funding for Matter, a startup incubator for medical technology based in Chicago. He also sits on the board of directors at his alma mater, Duke University

J.B. and his wife, M.K. Pritzker, donated $100 million to Northwestern University School of Law, partly for scholarships and partly for the school’s “social justice” and childhood law work.

pharmaceutical giants such as Janssen Therapeutics, the health foundation of a Johnson and Johnson founder, Viiv, Pfizer, Abbott Laboratories, Bristol-Myers Squibb Company, and Boehringer Ingelheim Pharmaceuticals, major technology corporations including Google, Microsoft, Amazon, Intel, Dell, and IBM are also funding the transgender project. In February 2017, Apple, Microsoft, Google, IBM, Yelp, PayPal, and 53 other mostly tech corporations signed onto an amicus brief pushing the U.S. Supreme Court to prohibit schools from keeping private facilities for students designated according to sex.

The massive medical and technological infrastructure expansion for a tiny (but growing) fraction of the population with gender dysphoria, along with the money being funneled to this project by those heavily invested in the medical and technology industries, seems to make sense only in the context of expanding markets for changing the human body…The push is on for insurance-paid hormones and surgeries for anyone who believes his or her body is in any way “incongruent” with his or her “gender identity.”’

“In my book I demonstrate that mainstream transactivism is not a grassroots movement, but a top-down one. One part of the evidence is that rich individuals and foundations make large donations to campaign groups that, among other things, lobby to erase biological sex from law and to enshrine gender identity in its place. Some of that money is tied to campaigns for gender self-ID. I discuss the ACLU, HRC and Stonewall in most detail, but there are many others. And I give a sense of the funding that comes from rich individuals by discussing three examples: George Soros via the Open Societies Foundation; Jennifer Pritzker via the Tawani Foundation; and Jon Stryker via the Arcus Foundation.” https://www.thehelenjoyce.com/a-wild-ride/

General References: (1) https://www.axios.com/lgbtq-health-startups-funding-72a4b5bd-2fb2-4d88-9ea6-a9695255e731.html (2) https://thefederalist.com/2018/02/20/rich-white-men-institutionalizing-transgender-ideology/ (3) https://thefederalist.com/2016/04/21/drop-the-t-from-lgbt/ (4) https://williamsinstitute.law.ucla.edu/publications/how-many-people-lgbt/ (5) [article on market size of LGB population pre-2012]

Footnotes

Footnote + Documentation of Awareness of Human Experimentation:

On April 7, 2021, the UC San Francisco Child and Adolescent Gender Center offered a Zoom “training” entitled “Fertility Issues for Transgender and Nonbinary Youth” led by well-known gender therapist Diane Ehrensaft. Though best known as a gender therapist, Ehrensaft is a PhD developmental psychologist. (It’s much less widely known that in the 1990s, she also had some involvement, as a psychotherapist, in the widely-discredited “satanic ritual abuse” preschool controversy.) At this meeting, Dr. Ehrensaft stated, “Is a child really able to foresee into the future and foreshorten fertility [trans medicalization renders children sterile]… And how can a child two or three stages behind Erikson’s stage 7 anticipate what they will feel two or three stages later [as an adult]?” She provides no answer and says it’s “for us to start finding out. And we are.” [powerpoint slide]
[Text shortened from blog post, “TMI: Genderqueer 11-year-olds can’t handle too much info about sterilizing treatments–but do get on with those treatments” https://4thwavenow.com/2021/04/13/tmi-genderqueer-11-year-olds-cant-handle-too-much-info-about-sterilizing-treatments-but-do-get-on-with-those-treatments/]

Here are conversations between therapists suddenly getting feedback that maybe these treatments affect minor-aged human subjects’ sexual function. If this experiment had been reviewed, the material was already there indicating that this was a likely outcome. “Does prepubertal medical transition impact adult sexual function?” https://4thwavenow.com/2018/07/08/does-prepubertal-medical-transition-impact-adult-sexual-function/

Footnote +++
‘Just will you please tell me why you’re not taking my case?’ Newgent asked the attorney.

‘And she told me that, “Well, we looked at WPATH [World Professional Association for Transgender Health] and there’s no baseline to care. So to take your case, we have to create a baseline for care. That’s millions of dollars. That little paper that you signed, you said that it’s experimental.”‘

In medicine, a baseline of care establishes common, minimal practices and conduct that assure patients are well taken care of and aren’t harmed by negligence or abuse.

When doctors fail to follow that baseline of care, they open themselves up to liability.

However, because sex change surgeries are deemed experimental, baselines of care have never been established—and surgeons are rarely held accountable.

‘What would be involved in creating a baseline of care?’ I asked Newgent.

‘It would take a lot of case studies,’ she told me—the type of case studies that don’t exist for transitioning therapies and surgeries. ‘Companies like Lupron would actually have to run studies on hormone blockers to try to get it FDA-approved.’

But if they submitted drugs like Lupron for approval, the entire world would learn the truth, not only about the terrible side effects of Lupron as it is currently used off-label for gender affirming therapy but also that transgender people who receive hormone therapy and who medically transition aren’t actually happier than those who don’t.

Lupron has been around for decades, as have sex change surgery and hormone therapy and transgenderism.

The FDA hasn’t approved drugs like Lupron for gender transitioning, and doctors haven’t established baselines of care for sex change surgeries, not because we haven’t had enough time, but because there hasn’t been the will.

‘Lupron refuses to do studies,’ Newgent told me, ‘because when they do studies, there’s no doctor in the world that’s going to sign up and go, “Yep, I’m going to sign that, yep.”‘
“‘I will never be a man, ever’: Transgender man tells author MATT WALSH that America is selling our ‘most vulnerable kids’ a medical ‘illusion’ when we tell them they can change their gender” by Matt Walsh For Dailymail.Com

Footnote +4
[Note that this is not in the US; however, it raises questions that should be asked here. Pressure applied to patients, non-followup, documentation not retained, etc. Red flag phrases include “guinea pig”, “snake oil”, “negligence”, “unethical” -EAJ]
Now 18 and trying to catch up on a chemically delayed adolescence, he feels the Tavistock treated him like “a guinea pig”…The gender clinic that sent him into the medical unknown has no record of the outcome of his case, he says. It does not know the impact of those experimental drugs on his body, or the repercussions of this supposedly pioneering treatment on his life, he claims, because no one ever asked…How, he asks, could the NHS’s main gender identity clinic for young people claim its controversial approach was working if it wasn’t recording the results?…The vast majority of children referred by the Tavistock for hormone blockers continued with their transition once they became eligible at 18, but how they are getting on remains unclear as the clinic did not collect the data – a fact that High Court judges in the Keira Bell case noted was “surprising given the young age of the patient group, the experimental nature of the treatment and the profound impact that it has”…His mother now believes the Tavistock’s approach was deeply unethical. “They were pumping Alex with an experimental drug, then beta blockers, then talking about surgeries. So to come out of that system without any follow-up – that is negligent…“When you’re doing experimental treatment, you take literally every single scrap of data you can get and you analyse it. You don’t just ignore it.”…She also believes the blockers were pushed “too early”: “They are experimenting on our children with absolutely no knowledge about how that’s going to affect their growth or their brain development…“They had no idea what that was going to do to Alex’s body. Why not allow all these normal developments to happen, then make a judgment? They are far too quick to dish it out.”…Two years on, since coming off the blockers Alex has still not experienced any sexual feelings…It has been almost three years since his last consultation and he finds it astonishing that there has been no follow-up…“I honestly look back and view the Tavistock and the blockers as some of the worst decisions I’ve made in my entire life. So it’s just horrifying to think that someone else, maybe someone even younger than I was, is being sold this same snake oil.
“My puberty was chemically delayed. I was their guinea pig” by Lucy Bannerman in The Times https://www.thetimes.co.uk/article/0bf8b08e-ebe2-11ec-8821-d2e916a7eab3?shareToken=13baed34b9083c50b534dd06e6a05efc

Footnote +5
The World Professional Association for Transgender Health (Wpath), based in Illinois in the United States, is advocating for health professionals to allow children to begin life-changing treatment with cross-sex hormones at 14, two years earlier than it recommended previously. It also believes that girls should be allowed to have breast removal surgery as young as 15…There is little evidence on the long-term outcomes of this experimental treatment on children and adolescents…Wpath claims it is unethical to withhold treatment from a child who is desperate to avoid developing into what they believe is the wrong sex…However, critics have accused gender clinics of sending vulnerable adolescents into the medical unknown too quickly, without exploring underlying causes of their gender distress…Wpath has a global membership of about 3,000 people, including non-professionals. It is not an official health body, but publishes “standards of care” recommendations for transgender healthcare…This group is making claims that have no evidential basis.
“Give irreversible gender drugs at age 14, says transgender health group” by Lucy Bannerman in The Times https://www.thetimes.co.uk/article/give-irreversible-gender-drugs-at-age-14-says-transgender-health-group-hx70c2l62

Footnote +6
Affirm-only advocates like to say that their approach has the endorsement of “all major medical associations.” As critics have pointed out, however, the statements of these associations against psychotherapy are based on an egregious misreading of the evidence. For example, when the American Academy of Pediatrics denounced non-affirming approaches as “conversion therapy” in 2018, it based that conclusion entirely on studies done on homosexuality and omitted all relevant studies on youth gender dysphoria. It even interpreted one study as supporting the affirm-only approach, despite the fact that that study explicitly recommended “watchful waiting” (psychotherapy). No one with even superficial familiarity with the politics of gender medicine can take seriously the claim that there is an evidence-grounded consensus in favor of affirmation.
Twenty-four states now ban or limit “conversion therapy,” effectively requiring mental-health experts to affirm, affirm, affirm. In California, and probably other places, parents whose teenage daughters suddenly and unexpectedly declare themselves trans and seek virilizing hormones have virtually no option to see a non-affirm-only therapist unless they go out of state. Therapists like Miriam Grossman and Stephanie Winn who disagree with the affirm-only approach believe that their field has ceded almost all grounds to affirm-only activist-practitioners—despite the absence of any evidence that affirm-only is superior to “watchful waiting” (the Dutch Protocol). The WPATH’s proposed revisions are themselves efforts to get medical experts to withhold affirming until a more robust psychological assessment can take place. Regardless, measures restricting gatekeeping for gender transition in state law tend to get smuggled in by grouping “gender identity” with “sexual orientation”—a reflection of trans activism’s deliberate effort to piggyback off the public’s warming attitudes toward homosexuality. The acronym “LGBT,” never mind its more elaborate extensions (the Biden order uses “LGBTQI+”), is surely one of the most successful marketing ploys by political entrepreneurs in recent decades.
“A Blight on the Presidency and the Nation” by Leor Sapir in City Journal https://www.city-journal.org/bidens-blighted-executive-order-on-pediatric-gender-medicine

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