Summary
In April 2024 the four-year, NHS England-commissioned review of the state of pediatric gender medicine was submitted by Hilary Cass. The Cass Review has been fully accepted by the NHS, supported by both of the U.K. major political parties, and broadly embraced by the U.K. clinical community. On July 1, 2024, a 39-page paper titled “An Evidence-Based Critique of the Cass Review” appeared on the Yale Law School website, arguing that the Review was not trustworthy. The paper, written by Meredithe McNamara, and co-authored by some of the most prominent figures in gender medicine activism — including Johanna Olson-Kennedy and Jack Turban — alleged that the Cass Review “repeatedly misuses data and violates its own evidentiary standards,” was “rife with misapplications of the scientific method,” and failed to evaluate the evidence "in a neutral and scientifically valid manner.” The paper asserted that the Cass Review’s recommendation to limit youth transitions to research-only settings is "coercive and unethical," and advocated that puberty blockers, cross-sex hormones and surgery should continue to be essential treatment options for youth, as recommended by the World Professional Association for Transgender Health's (WPATH) Standards of Care Version 8.
The claims in this online-only, non-peer-reviewed paper by McNamara et al. attracted significant international attention, in no small measure due to the imprimatur of Yale University, which hosts the so-called "Integrity Project" under whose auspices the paper was posted. Although a disclaimer was eventually added that the work did not represent Yale's views, the narrative that "Yale debunked the Cass Review" took root in some circles, leading to a surprising decision by the British Medical Association (BMA) UK council, made without consultation with its members, to "publicly critique" the Review.
In response to growing national and international attention to the McNamara et al. paper, Archives of Disease in Childhood (ADC) — an international pediatric journal from BMJ and the Royal College of Paediatrics and Child Health (RCPCH) — published a peer-reviewed analysis scrutinizing the claims in the paper. This newly-published analysis, co-authored by several of the U.K.'s leading clinicians including the past President of RCPCH, concluded that the paper by McNamara et al. is not a credible scientific effort, but rather, an attempt to influence U.S. litigation while masquerading as scientific critique.
On the same day the critique of the Cass Review appeared online, its lead author, McNamara, introduced it into evidence in the U.S. Federal Court case of Boe v. Marshall, where she serves as an expert witness. The same co-author group submitted another version of the paper in the U.S. Supreme Court as part of an amicus brief in the case of United States v. Skrmetti. McNamara and several of the paper's co-authors serve as paid expert witnesses in over a dozen similar cases concerning youth gender medicine in the U.S., opposing state-imposed age restrictions on the practice (see Table 1 below). Both the Integrity Project and its contributing authors have openly stated that their primary goal is to re-interpret the evidence for U.S. courts and judges, with the goal of overturning various laws imposing minimum age restrictions on youth transitions.
The ADC analysis notes that McNamara et al. either misunderstood or misrepresented the process, goals, and findings of the Cass Review. The central premise of McNamara et al.'s paper is based on a fundamental confusion: they read the Review as if it is a clinical practice guideline, which it is not. The Cass Review is an "independent review," a regulatory process specific to the U.K.; clinical practice guidelines are developed using a distinctly different process. The analysis also highlights several factual errors and misrepresentations found in the paper being examined, including its portrayal of the research conducted by the University of York. The authors conclude that it is time to move forward and focus on the implementation of the Cass Review's recommendations, in line with the NHS and the U.K.’s main medical societies.
The "Integrity Project"
While it is important to understand the specific errors and misrepresentations in the "An Evidence-Based Critique of the Cass Review” by McNamara et al. (addressed below), it is equally, or perhaps even more, important to understand the litigation goals and tactics of the so-called "Integrity Project," which has produced and hosted the paper. The Integrity Project is led by Meredithe McNamara, a Yale-affiliated pediatrician, and Anne Alstott, a Yale-affiliated attorney. The effort appears to have emerged in 2022 in response to state legislation in Alabama and Texas regarding youth gender medicine. Since then, over 20 U.S. states have passed legislation that imposes minimum age restrictions on youth gender transitions, and some have also restricted public funding for gender transitions. The Integrity Project's stated goal is to defeat these legislative restrictions by providing a counter-narrative to the mounting peer-reviewed evidence that a substantial percentage of the youth who undergo gender transitions do not benefit from these potentially harmful treatments.
The Integrity Project's key tactic to achieve this legal strategy has been to label research that brings to light problems in the scientific evidence underpinning the practice of youth gender transitions as "disinformation" and "science denialism." The Project's efforts to discredit the Cass Review and the University of York research follow the same pattern as its prior attacks on other evidence appraisal efforts, including an attack on the work by researchers from McMaster University (world-renowned for being the birthplace of evidence-based medicine), as well as its efforts to discredit SEGM. The Integrity Project's authors have written extensively on their approach, which focuses on producing "rapid-response, in-depth rebuttals" which are "cited in litigation" and also turned into "material for direct intervention in legal processes in the form of amicus briefs and regulatory comments."
After analyzing all three of the Project's recent efforts to attack evidence appraisal teams, a pattern emerges. The Project, led by McNamara and Alstott, identifies specific scientific evidence appraisal efforts or evidence curation deemed threatening to their litigation goals. A rotating group of co-authors, in addition to McNamara and Alstott, co-write lengthy online papers that level attacks on the research teams, accusing them of various research “violations,” "misrepresentations," and of spreading “scientific misinformation.” The substantiation for such serious allegations is either absent, or based on demonstrably inaccurate assertions that cannot withstand a credible peer-review process; the latter is not a barrier, since the Project does not subject these papers to an external peer-review process.
These lengthy papers, which the Project calls "white papers," are then posted on a Yale University web page, which lends them visibility and infuses them with the credibility of an Ivy League educational institution. Next — and key to the Project's litigation-focused strategy — these same papers (or their altered versions) are subsequently introduced into evidence in numerous ongoing lawsuits regarding the practice of youth gender transition in the U.S., where a number of the papers' co-authors serve as paid expert witnesses. In addition to writing lengthy online "white papers," the Integrity Project's authors also publish much shorter pieces (often opinions and often citing the "white papers") where they consolidate their claim that the scientific challenges to the practice of youth gender medicine are akin to "science denialism." These papers are also widely disseminated. Recently-unsealed court documents indicate the Integrity Project's dissemination efforts are aided by WPATH and the office of Rachel Levine at the HHS, with a stated joint goal to "fight relentlessly and aggressively" against state-imposed age restrictions on youth gender transitions, in order "to ensure equal access to care for all".
To counteract the mounting scientific evidence that the practice of youth gender transitions operates on an exceptionally weak evidence basis, the Integrity Project asserts that the evidence appraisals are merely "mischaracterizations" of the practice that originate from "non-experts," some of whom also hold animus towards transgender people. Dr. Kuper, who has co-authored several Integrity Project papers, writes:
"Misunderstandings and mischaracterizations of the field’s standards of care, clinical best practices, and scientific research base are featured prominently in political discourse and legislative actions, which are often amplified in public media outlets and on social media. Much of this misinformation relies on a very small, nonrepresentative sample of the available literature, which is often inaccurately interpreted. Testimony has also been elicited from professionals who lack expertise in the field and have ties to discriminatory advocacy organizations."
Source: Kuper LE, Cooper MB, Mooney MA. Supporting and advocating for transgender and gender diverse youth and their families within the sociopolitical context of widespread discriminatory legislation and policies. Clinical Practice in Pediatric Psychology. 2022;10(3):336-345. doi:10.1037/cpp0000456
The Integrity Project juxtaposes this implied lack of integrity of the critics of the evidence in youth gender medicine with their own "integrity," evidenced by their self-attested freedom from conflicts of interest and their self-proclaimed superior subject matter expertise:
"We have written rapid-response, in-depth rebuttals of science denialist claims that have been cited in litigation and provided material for direct intervention in legal processes in the form of amicus briefs and regulatory comments. Reports such as these are composed by subject-matter experts without conflicts of interest and made publicly available to inform members of the media, the medical community, and legal organizations seeking to understand these quickly evolving issues. Scientists, clinicians, and legal experts who face science denialism in its many forms may consider similar undertakings."
Source: McNamara M, Lepore C, Alstott A. Protecting Transgender Health and Challenging Science Denialism in Policy. N Engl J Med. 2022;387(21):1919-1921. doi:10.1056/NEJMp2213085
Although the Integrity Project papers' co-authors' activism in the field of youth gender medicine is formidable, their claims of superior specialized clinical expertise and freedom from conflicts of interest are not well supported. For example, a recently-unsealed deposition of Meredithe McNamara, lead author of the majority of the Integrity Project's listed papers and a key expert witness in a number of relevant U.S. court cases (see Table 1), unexpectedly revealed that her clinical practice has never involved prescribing any "gender-affirming" treatments, and that her experience of referring adolescents to gender clinics is limited to one to two youths in her entire career.
The authors also cannot be said to be free from conflicts of interest. With the latest addition of several gender clinicians (such as Dr. Olson-Kennedy) who derive significant income from the practice of youth transitions, the financial conflicts of interest are significant. However, the intellectual conflicts of interest are even more profound. The Integrity Project's stated goal is to achieve a specific outcome in U.S. litigation related to the practice of youth transitions. It cannot be ignored that nearly all of the authors of “An Evidence-Based Critique of the Cass Review” have worked as paid expert witnesses in over a dozen high profile U.S. court cases in the area of youth gender medicine, arguing against age restrictions on the practice (see Table 1), and using the papers they write as a key tactic to try to win these legal cases.
The Integrity Project's claimed freedom from conflicts of interest is also challenged by recent revelations that it sought and received WPATH endorsement of its work, and requested "help to disseminate report critiquing science behind Texas and Alabama measures to criminalizing care" (the Integrity Project's first gender-related "white paper"). The unsealed partially-redacted court documents reveal an exchange between the paper's authors and WPATH with the stated intention to "work together to counteract those who oppose equality and evidence-based care for TGD people," indicating more than an arm's length relationship between the Integrity Project and WPATH. This casts significant doubt on the trustworthiness of the Integrity Project's recent "appraisal" of the Cass Review, which casts the Cass Review as deeply methodologically flawed and to be ignored, while upholding WPATH's Standards of Care Version 8 recommendations as "evidence-based" and to be widely followed.
The "Integrity Project" and the Cass Review
McNamara et al.'s 2024 "appraisal" of the Cass Review is the latest product of the Integrity Project. The paper does not hide the litigious reasons for attacking the Cass Review. The Cass Review's findings of deep problems in the evidence base for youth transitions, and its recommendation to restrict hormonal interventions for youth to research-only settings, threaten the Integrity Project's legal goals of overturning minimum age restrictions on youth transitions:
"The Cass Review has already been cited in U.S. legal battles over transgender rights. It is likely to feature heavily in the months and years to come. From 2022 through 2024, twenty-five US states enacted legislation that bans gender-affirming healthcare for transgender youth. Litigation is ongoing in at least ten states, and the nation’s highest court has agreed to hear one case, United States v. Skrmetti, in the fall 2024 term. Other nations’ health ministries are anticipated to use the Cass Review to inform their own policies on access to youth gender care."
At first, the scientific community did not consider McNamara et al. deserving of an academic response. The paper had not been peer-reviewed, was undergoing multiple online changes, and was published by a group of authors with a stated litigious goal. However, the presumed endorsement of Yale University imbued the paper with undue credibility, leading the British Medical Association (BMA) Council to issue a motion to evaluate the Cass Review by the end of the year. McNamara et al.'s paper was also referenced in ongoing debates regarding the future of youth gender medicine in other countries, and erroneously referenced as a "Yale" effort. Although a disclaimer that the work did not represent the Yale University's views was eventually added, the notion that "Yale debunked the Cass Review" took root in some circles.
In response to the growing international attention to McNamara et al.'s work, the Archives of Disease in Childhood (ADC) — an international pediatric journal from BMJ and the U.K. Royal College of Paediatrics and Child Health (RCPCH) — published an analysis of their claims. The analysis concluded that McNamara et al.'s paper is not a credible scientific effort, that much of its “critique” is based on a fundamental misunderstanding of the U.K. healthcare regulatory system, and that McNamara et al. misrepresented the Cass Review, its process, and its findings.
The key themes from the ADC publication, entitled "Gender medicine and the Cass Review: why medicine and the law make poor bedfellows," are presented below:
1. McNamara et al.’s paper was written to influence U.S. courts, under the guise of neutral scientific inquiry
The ADC analysis notes that the high number of errors and unusual tone in McNamara et al.’s paper are atypical for an academic publication. However, when the document is understood as a legal weapon crafted to address U.S. state restrictions on gender transition for minors — rather than a neutral scientific analysis of the strengths and limitations of the Cass Review — these idiosyncrasies make sense. Not submitting the paper to a credible academic journal allowed the authors to:
- Avoid peer review, thereby disseminating numerous inaccurate and misleading statements about the Cass Review and the University of York evidence appraisals.
- Not disclose the significant conflicts of interest among the author group, all of whom are involved in influencing the outcomes of this litigation, and some of whom derive a significant proportion of their income from the practice of "gender-affirming care" which the Cass Review has challenged.
- Deploy “shotgun argumentation tactics” to overwhelm the reader with the sheer volume (rather than quality) of the arguments. In a credible peer-reviewed journal, those wishing to respond to such tactics are faced with length limitations that can leave a number of erroneous claims unaddressed.
- Engage in non-collegial behavior, demeaning the professionalism and expertise of Dr. Cass and the York team, which is highly uncharacteristic of scholarly inquiry. McNamara et al. allege that the Cass Review and the University of York are woefully uninformed and inexperienced, while engaging in simple arithmetic to claim their own collective “86 years of experience” in caring for “more than 4,800 transgender youth.” This is likely done to impress those outside of academic settings, such as judges and lawyers, who may lack the expertise to adjudicate contradictory scientific claims, and who will trust the side that is perceived to be more “expert.”
- Benefit from the implied endorsement of Yale, posting the paper on a Yale Law webpage, and delaying clarification that their work—like all other products of the Integrity Project—was not endorsed by Yale University. Nearly two weeks lapsed between the paper's online publication, and the clarification on the website and in the paper itself that the work does not represent Yale. This has allowed the paper to rise to worldwide prominence not typically afforded to an online non-peer-reviewed publication.
2. McNamara et al.’s paper contains an unusually high number of factual errors.
Due to space limitations, the ADC publication corrected only two particularly concerning, key inaccuracies in McNamara et al.’s presentation of the Cass Review’s findings. Contrary to McNamara et al.’s claims:
- The Cass Review did not issue a positive appraisal of the rigor and independence of the WPATH guidelines. Neither the York appraisals nor the Cass Review issued a positive appraisal of the WPATH/ES guidelines. York found significant problems in these guidelines, specifically in the rigor of their development and applicability, and did not recommend them for implementation.
- The Cass Review did not find a 0.3% rate of detransition. McNamara et al. appear to have misunderstood the methodology of the audit of 3,306 patient records from the U.K. Gender Identity Service. The methodology did not allow for measurement of the rate of detransition, rendering any claims of detransition rates based on the audit data invalid.
The ADC publication also noted several other online critiques of McNamara et al.; however, like McNamara et al.'s paper, these critiques have also not been peer-reviewed.
3. McNamara et al.’s central critique of the Cass Review is based on a fundamental misunderstanding of the role and process of “independent reviews” in the United Kingdom.
- An “independent review” is not a “clinical practice guideline.” McNamara et al.’s chief criticism, that the Review’s processes “violate[s] standard processes” for creating a clinical practice guideline, reveals a fundamental misunderstanding of the document they are trying to critique. The Cass Review is not a clinical practice guideline. In the U.K., when an area of medicine begins to operate in a way that threatens patient safety or quality of care, NHS England, as well as other government-affiliated entities, can commission an investigation into the practice in the form of an “independent review” or “inquiry.” Such investigations are guided by “Terms of Reference,” rather than by rules for guideline development.
- The review chair’s independence from the field of youth gender medicine is not a flaw but a key strength of the Review. Dr. Hilary Cass is a renowned pediatrician with extensive experience across various aspects of child medicine. McNamara et al.’s criticism that the Review was conducted by a clinician without specialization in gender misunderstands the key goal of independent reviews. Such investigations are always led by highly respected professionals with no direct connections to the area under review in order to protect the process from undue influence stemming from conflicts of interest, which are often at the root of the problems being investigated.
- Contributors to the Review are not the Review’s authors, nor are they a “guideline development group.” McNamara et al. accused the Review of not revealing “many of the Review’s authors’ identities,” insisting that if one does not know the names of every individual consulted in the Review, its recommendations are not trustworthy. The Cass Review engaged with over 1,000 individuals, including professionals, patients, and transgender stakeholders. These people (both professionals and patients) are neither a guideline development group nor the Review’s authors. Unlike clinical practice guidelines, in reviews, the chair alone makes the recommendations to the commissioning body, and Cass is the Review’s sole author.
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Reviews can recommend the decommissioning of treatments deemed unsafe or non-beneficial. It is not necessary to issue a clinical practice guideline in order to decommission a treatment that is deemed unsafe. In the U.K., it is entirely within the scope of “reviews” and “inquiries” to recommend decommissioning a particular treatment pending additional research when signals of harm emerge, and the evidence of benefits proves to be insufficient—as the Cass Review has done with puberty blockers for the treatment of gender dysphoria in youth.
For example, the famous U.K. Cumberlege Review led to the decommissioning of the transvaginal pelvic mesh device from clinical practice. While many women reported benefits from the use of the device for pelvic organ prolapse, reports of harm began to mount. The Cumberlege Review revealed insufficient research into the long-term consequences and potential for severe harm, leading to the removal of the device from clinical use in the U.K. Of note, in the United States, the Food and Drug Administration reached similar conclusions, withdrawing the device from the market, as did a number of other countries. This illustrates that by leveraging evidence-based medicine (EBM), countries with diverse clinical and social contexts can still arrive at similar conclusions, highlighting the value of EBM as a tool for regulatory decision-making.
- Reviews and inquiries’ recommendations to their commissioning bodies do not use the GRADE framework. McNamara et al.’s criticisms that the Cass Review did not GRADE its recommendations betray the depth of their misunderstanding of the goal and process of “independent reviews.” While applying GRADE to recommendations as “strong” or “conditional” is appropriate in the context of clinical practice guidelines — to signal whether a certain treatment recommendation is expected to benefit nearly all patients (“strong”) or the majority, but not all, patients (“conditional”) — it is nonsensical to apply such GRADEs to policy recommendations addressing issues as diverse as workforce training, development, and care delivery organization.
The ADC paper provides an overview of the role of “reviews” and “inquiries” in the U.K. healthcare regulatory system, noting the seminal 2001 Bristol Inquiry, which decisively demonstrated the utility of independent, comprehensive investigations, such as the 2024 Cass Review. The Bristol Inquiry concluded that threats to patient safety came not from malicious actions but were “born of high hopes and ambitions, and peopled by dedicated, hard-working people,” whose “hopes were too high; the ambitions too ambitious,” and who became too myopic to recognize and address the problems from within. The findings and recommendations of the Bristol Inquiry centered on the role of NICE and helped establish its value in improving clinical standards across the NHS.
Supplementary material in the ADC paper provides a more detailed comparison of the Cass Review with several other well-known inquiries and reviews, among dozens conducted in the U.K. to date.
4. The critique of the York systematic reviews ranges from misrepresenting the rigor of York’s analyses to positioning common research limitations as major research “violations.”
- The systematic reviews did not omit studies that “demonstrate” the effectiveness of youth gender transitions. McNamara et al. misleadingly claim that the York appraisals failed to include key studies that purportedly “demonstrate” the effectiveness of medical gender transitions for youth. They specifically cite two U.S. studies: the problematic study by Chen et al. (which received a critical response from the Dutch researchers who pioneered youth transitions as well as four published "letters to the editor") and the widely critiqued Tordoff et al. Both studies were, in fact, included in the York reviews. Neither of the two studies “demonstrated” the effectiveness of youth transition; in fact, Chen et al. reported two completed suicides one year after the initiation of hormonal transition, raising safety concerns.
The ADC publication reassessed these two studies using ROBINS-I, which McNamara et al. stated is their preferred tool for the evaluation of the risk of bias. Both studies received a ROBINS-I rating of “critical risk of bias” (for details see the article's Supplemental material).
- York’s “single search” study strategy led to more, not fewer, studies available for analysis. McNamara et al. incorrectly assert that the “single search” strategy deployed by York for all the planned systematic reviews resulted in too few studies to review. In reality, a single search “umbrella” strategy generates the highest number of possible studies, because the search terms are broad enough to cover all the related topics. When conducting multiple systematic reviews related to a similar topic, it is common to use an “umbrella” search strategy, although researchers do have to contend with more results to evaluate.
- Appropriate adjustments to the research protocol are not a violation of research practices but a common research reality. Contrary to McNamara et al.’s claims, York’s change to the research protocol was not a major “divergence from standard practices” but was common practice. Because the single search strategy yielded such a high number of studies, not all the studies could be adequately assessed using the appraisal tool the researchers had originally planned (MMAT), so two more widely used standard assessment tools (NOS and AGREE II) were added. This change has been justified in the updated protocol.
The ADC analysis observed that the York reviews built upon the prior work of the NICE systematic reviews, which had found — using GRADE — that the evidence for youth transitions was of very low quality/certainty. York evaluated substantially more studies than NICE, and reached the same conclusion as NICE and multiple other systematic reviews of evidence. Ultimately, McNamara et al. do not dispute the finding of "low to very low" certainty in the evidence underlying the practice of youth transitions (although they do insist that these terms are merely technical jargon and should not be concerning). Since they do not dispute York's ultimate conclusion regarding the quality/certainty of the evidence, this raises questions about the purpose of their extensive criticism of York's methodology.
5. McNamara et al. incorrectly claim that pediatricians routinely offer treatments with unknown risk-benefit ratios.
After spending considerable effort criticizing Cass/York for finding the evidence base for youth transitions is of very low quality, but then agreeing with them, McNamara et al. then shift to a new tactic. They argue that GRADE designations such as "very low" quality evidence are merely technical terms that reflect uncertainty inherent in medicine, and they also insist that all pediatric medicine operates on a similar evidence base and begins 'with a dearth of evidence'. The assertion that the rest of pediatrics operates in a similar way, if true, would suggest a deeply alarming situation, given the profound problems in the evidence for youth gender transitions (none of the studies are considered reliable due to significant methodological problems in study designs, high drop-out rates, and a lack of long-term follow up).
Thankfully, the ADC analysis, co-authored by experts in pediatrics, dispels this claim. The authors highlight a number of factual errors in McNamara et al.’s assertions that pediatrics routinely operates on hubristic assumptions with little credible research to show that benefits of treatments outweigh risks. They address McNamara et al.’s assertion that GLP-1 drugs, recently recommended by the American Academy of Pediatrics treatment guidelines to treat obesity, have only been researched in pediatric populations for one to two years. The treatments have, in fact, been subjected to multiple randomized, double-blind, placebo-controlled trials in pediatric populations going back as far as 10 years and are supported by a systematic review of evidence. While longer-term research into GLP-1 is needed, there is no ‘parallel’ between the strength of evidence in the use of these drugs in obese children aged 12 and older and the use of puberty blockers and cross-sex hormones in gender-dysphoric children as young as eight or nine years old, followed by surgery in adolescence. The problem is not just the lack of long-term data: it is the lack of any credible evidence of mental health benefits stemming from endocrine gender transition for gender dysphoric minors, as demonstrated in multiple systematic evidence reviews. Nor is there any credible evidence of benefits from “gender-affirming” surgeries in adolescents, as indicated in a recent systematic review of evidence, despite their promotion as an “important” gender dysphoria treatment by a co-author of several Integrity Project papers.
The authors also object to McNamara et al.’s example drawn from neonatology and the use of oxygen in premature babies. In response, the authors of the ADC analysis, of which one is a neonatologist and another the past President of RCPCH, note that neonatology provides a “salutary lesson” about the importance of conducting quality research before adopting a treatment that “appears to make sense.” Initially, doctors routinely provided supplemental oxygen to premature babies to facilitate their breathing. Tragically, follow-up data revealed that this led to blindness in many babies. The practice of neonatology, which often deals with life-and-death situations, has learned its lesson and currently represents one of the most rigorously studied areas of medicine with extensive, long-term follow-up. Thankfully, gender dysphoria in youth is not a life-and-death situation for most (see SEGM’s Spotlight for more analysis), which further emphasizes the importance of long-term research before promoting interventions as the “standard of care.”
The ADC publication concludes by observing that medicine and law make poor bedfellows, and encourages clinicians to embrace the “crucial and exciting opportunity to advance the holistic care of gender questioning children and young people” afforded by the Cass Review, and to focus on developing a “new service model for gender dysphoric children and young people, which is, above all, safe, holistic and robustly underpinned by the evolving evidence base.”
SEGM Take-away
Brandolini’s law (also known as the “Bullshit Asymmetry Principle”) states that the amount of energy needed to refute misinformation is an order of magnitude greater than that needed to produce it. There is no question that good-faith disagreement and debate are essential in advancing science. Conversely, political, litigious, or financially-motivated efforts not only fail to further scientific knowledge, but may also erode trust in both the scientific establishment and the educational institutions that support such efforts.
It is unclear to what extent the Yale School of Medicine, whose imprimatur Dr. McNamara leverages (and which continues to host some of the Project's papers), or the Yale Law School, which hosts the whole of the so-called “Integrity Project,” are aware of the Project’s goals and tactics, which include disseminating misleading information. For example, in an attempt to discredit an overview of systematic reviews of evidence performed by evidence appraisal experts from McMaster University, McNamara et al. focused on the lead author's clinical experience in dentistry, despite her being an expert in clinical epidemiology, a Professor of Health Research Methods, Evidence, and Impact, and, at the time, the author of over 120 peer-reviewed publications. These stellar and highly relevant credentials also went unmentioned when McNamara publicly stated, while testifying before the Florida Board of Medicine:
“…neither of the two authors of the state’s review is a subject matter expert – one individual is a dentist and the other is a post-doctoral fellow in biostatistics. At a bare minimum, a systematic review of systematic reviews should be conducted by those who are qualified to critically assess the literature. I would not trust a dermatologist’s review of the literature on a neurosurgical procedure, for instance.”
Prior to alleging that the University of York (which conducted research used by the Cass Review) manipulated the search strategy to avoid finding publications that "demonstrate" the effectiveness of youth transitions, McNamara et al. 2022 leveled a similar claim about the researchers from McMaster University, asserting that they “arbitrarily truncated sample of the literature” to avoid the discovery of favorable studies. They also accused McMaster researchers of “adopt[ing] a method that violates scientific guidelines” and of “violat[ing] the National Academy of Medicine (formerly, Institute of Medicine) standards for systematic reviews”. Paradoxically, McNamara et al. also criticized the evidence appraisal team from McMaster for its independence from the study authors whose work they were appraising, criticizing the fact that the study authors “were not contacted to verify” that the evidence appraisals were “correctly summarizing the results of their research.”
The attacks on the Cass Review regarding its use of the "low quality evidence" terminology, echo a nearly identical attack on McMaster researchers, where McNamara et al. asserted that the term "low quality" was being used to mislead readers into believing that the research is indeed low quality:
“The … analysis is highly deceptive, because it dismisses nearly all existing studies of medical treatment for gender dysphoria as “low quality,” without explaining that this is a highly technical term and not a natural-language condemnation of the studies … “low quality” in this context is a technical term and not a condemnation of the evidence.”
While some of the misleading statements by McNamara et al. may be intended to strengthen their own arguments, other mistakes appear to reflect genuine gaps in understanding. For instance, they criticized Cass for describing rising figures in the GIDS referral graphs as "exponential," asserting that this characterization was a serious error that fueled concern over the Review's “scientific accuracy.” As others have demonstrated, the GIDS referral data fit an exponential curve with high precision (R² = 0.995), suggesting that McNamara et al. struggle to grasp basic statistical data. McNamara et al. similarly accused SEGM of using an “undefined term” (GIDS) on its website, suggesting a lack of awareness that it stands for the Gender Identity Development Service—the largest pediatric gender clinic in the world at the time, based in the U.K. and universally referred to as GIDS.
Key strategies advocated for by McNamara et al., including a close collaboration between scientists and lawyers, and publishing "rapid responses" to discredit legitimate scientific concerns, bear resemblance to the strategies developed by the tobacco industry to silence emerging concerns from the scientific community. Litigation efforts against the tobacco industry led to the disclosure of internal documents that revealed the tactic of collaborating with some in the scientific community to produce "rapid responses" to peer-reviewed publications that contained content that could challenge the wisdom of promoting smoking as a stress-reduction measure. The documents also revealed a broad strategy of “lawyer management of scientific research" to promote the benefits of tobacco while underplaying the harms. In an interesting parallel, a prominent U.S. lawsuit has also revealed a close collaboration between the scientists representing the gender medical establishment and "social justice attorneys," who helped craft WPATH SOC8 research outputs (the key take-aways from the numerous unsealed documents are summarized in this Supreme Court amicus brief). These troubling historical parallels emphasize why medicine and law can make poor bedfellows, as observed by the ADC analysis.
Despite the latest U.S.-led attempt to destabilize the U.K. reforms by attacking the Cass Review, the U.K. appears steadfast in its intention to regulate youth gender medicine. NHS England has accepted all of the Cass Review’s recommendations, and a three-year implementation plan has begun. The Cass Review has also promoted further scientific debate in other European countries, including Germany, Norway, and the Netherlands, bringing this important issue to public attention. In contrast, the U.S. is entering a period of "lawfare," which will determine whether and how the practice of youth transitions will be regulated in the United States. Only time will tell whether medical organizations and prestigious universities will resist the powerful special interests who have leveraged these institutions' highly-regarded names and hard-earned reputations to shield the practice of youth gender transition from demands for scientific rigor and the scrutiny of evidence-based medicine.
Table 1: Legal cases
This table lists legal cases where McNamara and colleagues have acted as expert witnesses or submitted amicus briefs. While we've done our best to ensure the information is accurate and up-to-date, this list may not include all such cases.
Case | MM | KB | KC | AJ | JOK | KP | AS | JT | AA |
---|---|---|---|---|---|---|---|---|---|
Provision of gender-affirming medical treatment | |||||||||
Boe v. Marshall No. 2:22-cv-00184 (M.D. Ala. 2022) | Expert witness; Amicus brief | Expert witness | Amicus brief | ||||||
Brandt v. Rutledge No. 4:21-cv-00450-JM (E.D. Ark. 2021) | Expert witness | ||||||||
Dekker v. Weida No. 4:22-cv-00325 (N.D. Fla. 2022) | Amicus brief | Expert witness | Expert witness | Expert witness | Amicus brief | ||||
Doe 1 v. Thornbury No. 3:23-cv-00230 (W.D. Ky. 2023) | Expert witness | ||||||||
Doe v. Ladapo No. 4:23-cv-114 (N.D. Fla. 2023) | Expert witness; Amicus brief | Expert witness | Amicus brief | ||||||
Fain v. Crouch No. 3:20-cv-00740 (S.D. W. Va. 2020) | Expert witness | ||||||||
Kadel v. Folwell No. 1:19-cv-00272-LCB-LPA (M.D.N.C. 2019) | Expert witness | ||||||||
KC v. Individual Members MLB No. 1:23-cv-00595-JPH-KMB (S.D. Ind. 2023) | Expert witness | ||||||||
Koe v. Noggle No. 1:23-cv-02904 (N.D. Ga. 2023) | Expert witness | ||||||||
L.W. v. Skrmetti No. 3:23-cv-00376 (M.D. Tenn. 2023) US v Skrmetti No. 23-477 (US Supreme Court) |
Amicus brief | Amicus brief | Amicus brief | Expert witness | Amicus brief | Amicus brief | Amicus brief | Expert witness; Amicus brief | Amicus brief |
Loe v. Texas No. D-1-GN-23-003616 (201st Jud. Dist. Ct. Travis Cnty Tex. 2023) | Expert witness | Expert witness | |||||||
Poe v. Labrador No. 1:23-cv-00269-CWD (D. Idaho 2023) | Expert witness | Expert witness | |||||||
Van Garderen v. State of Montana No. DV-32-2023-0000541-CR (Mont. 4th Jud. Dist. Ct. Missoula Cnty 2023) | Expert witness | ||||||||
Voe v. Mansfield No. 1:23-cv-00864 (M.D.N.C. 2023) | Expert witness | ||||||||
Other transgender-related legal cases | |||||||||
B.P.J. v. West Virginia State Board of Education No. 2:21-cv-00316 (S.D.W. Va. 2021) | Expert witness | ||||||||
L.E. v. Lee No. 3:21-cv-00835 (M.D. Tenn. 2021) | Expert witness | ||||||||
Name Change Petition of Monae Alvarado No. 210901990 (Ct. Com. Pl. Phila. Cnty Pa. Dec. 7 2023) | Expert witness | ||||||||
R. v. Cardle 2020 ONSC 7878 (Ont. 2020) | Expert witness |
Key
MM - Meredithe McNamara
KB - Kellan Baker
KC - Kara Connelly
AJ - Aron Janssen
JOK - Johanna Olson-Kennedy
KP - Ken C. Pang
AS - Ayden Scheim
JT - Jack Turban
AA - Anne Alstott
Declaration of interest: One of the authors of the ADC paper, Evgenia Abbruzzese, is a Senior Advisor for SEGM.
Document history:
10 October 2024: Minor edits made for clarification