What concerns me most is the inability of McNamara et al. to understand the concept of holistic and comprehensive care that Cass emphasizes throughout her review. It seems that they really do not understand these concepts because medicine for them - and possibly in the United States in general - is all about treating the immediate sympto…
What concerns me most is the inability of McNamara et al. to understand the concept of holistic and comprehensive care that Cass emphasizes throughout her review. It seems that they really do not understand these concepts because medicine for them - and possibly in the United States in general - is all about treating the immediate symptom. "You are suffering from pain? There, it's gone now. You think that this has resulted in internal bleeding? That is not what you were here for. For that, you have to meet some other specialist." Cass understands that medicine is an inexact discipline where much is unknown (she starts the Review with a wonderful quote by Atul Gawande to emphasize this very point). In an interview with the BBC, a few days after the publication of the Cass Review, she mentioned: “I certainly wouldn't want to embark on a treatment where somebody couldn't tell me with any accuracy what percentage chance there was of it being successful, and what the possibilities were of harms or side effects." The systematic reviews (as well as the individual studies that McNamara and friends tout) show some weak evidence of short-term benefits at best. Often, we don't even get that. And that these minuscule benefits happen to be psychosocial is extremely relevant, because strong placebo responses in psychiatry have been noted for many decades now (Weimer et al., 2015). Even in double-blind clinical trials of treatments for pain or psychiatric disorders, the responses to placebo are often similar to the responses to active treatment (Colloca and Barsky, 2020). Such findings raise the possibility that these interventions might actually be causing harm. Next, we have no idea from these studies - whether individually or collectively - who exactly might benefit from them (there is no way to state, for example, that patients who show certain outcomes in an ECG test or tolerate a certain class of drugs and do not have a history of diabetes will probably be the best candidates for the interventions). And because these treatments have been repurposed for gender-affirming purposes in the last "8-10 years" (as per McNamara et al., p.16), we have very limited idea about the possible complications. Even with the pain medication oxycodone hydrochloride (known as OxyContin and approved by the FDA) at the heart of the opioid crisis and responsible for thousands of deaths ever year, it took many years before the extent of the harm became apparent to the general public – and that is for a drug that was prescribed to large swathes of the population. For drugs that are prescribed to smaller segments of the population, it can take much longer before their safety risks are established. Risks usually manifest many years after the intervention becomes routinely available. Serious adverse effects are rare and often go undetected during early evaluation (if they appeared in early experience, they would likely cause the developer to abandon the project) of the treatment in animals or volunteers. They may not appear in formal clinical trials, which are powered to detect a predicted treatment effect – and not rarer events that may be much smaller than the treatment effect. Detecting them require active post-marketing surveillance of many more patients than were enrolled in trials or the passive accumulation of case series or individual case reports. Since these observations are uncontrolled, it requires considerable knowledge of the background incidence of these effects in untreated people to determine if the occurrence in treated patients is greater than expected. None of the infrastructure to track such observations is remotely in place. And yet these people - with enormous conflicts of interest - are continuing to recommend these treatments on children and young adults. And these interventions happen to be off-label and on *minors* – whose bodies and brains are at their most vulnerable to any intervention – with lifelong consequences. What part of this basic narrative do these people not understand?
What concerns me most is the inability of McNamara et al. to understand the concept of holistic and comprehensive care that Cass emphasizes throughout her review. It seems that they really do not understand these concepts because medicine for them - and possibly in the United States in general - is all about treating the immediate symptom. "You are suffering from pain? There, it's gone now. You think that this has resulted in internal bleeding? That is not what you were here for. For that, you have to meet some other specialist." Cass understands that medicine is an inexact discipline where much is unknown (she starts the Review with a wonderful quote by Atul Gawande to emphasize this very point). In an interview with the BBC, a few days after the publication of the Cass Review, she mentioned: “I certainly wouldn't want to embark on a treatment where somebody couldn't tell me with any accuracy what percentage chance there was of it being successful, and what the possibilities were of harms or side effects." The systematic reviews (as well as the individual studies that McNamara and friends tout) show some weak evidence of short-term benefits at best. Often, we don't even get that. And that these minuscule benefits happen to be psychosocial is extremely relevant, because strong placebo responses in psychiatry have been noted for many decades now (Weimer et al., 2015). Even in double-blind clinical trials of treatments for pain or psychiatric disorders, the responses to placebo are often similar to the responses to active treatment (Colloca and Barsky, 2020). Such findings raise the possibility that these interventions might actually be causing harm. Next, we have no idea from these studies - whether individually or collectively - who exactly might benefit from them (there is no way to state, for example, that patients who show certain outcomes in an ECG test or tolerate a certain class of drugs and do not have a history of diabetes will probably be the best candidates for the interventions). And because these treatments have been repurposed for gender-affirming purposes in the last "8-10 years" (as per McNamara et al., p.16), we have very limited idea about the possible complications. Even with the pain medication oxycodone hydrochloride (known as OxyContin and approved by the FDA) at the heart of the opioid crisis and responsible for thousands of deaths ever year, it took many years before the extent of the harm became apparent to the general public – and that is for a drug that was prescribed to large swathes of the population. For drugs that are prescribed to smaller segments of the population, it can take much longer before their safety risks are established. Risks usually manifest many years after the intervention becomes routinely available. Serious adverse effects are rare and often go undetected during early evaluation (if they appeared in early experience, they would likely cause the developer to abandon the project) of the treatment in animals or volunteers. They may not appear in formal clinical trials, which are powered to detect a predicted treatment effect – and not rarer events that may be much smaller than the treatment effect. Detecting them require active post-marketing surveillance of many more patients than were enrolled in trials or the passive accumulation of case series or individual case reports. Since these observations are uncontrolled, it requires considerable knowledge of the background incidence of these effects in untreated people to determine if the occurrence in treated patients is greater than expected. None of the infrastructure to track such observations is remotely in place. And yet these people - with enormous conflicts of interest - are continuing to recommend these treatments on children and young adults. And these interventions happen to be off-label and on *minors* – whose bodies and brains are at their most vulnerable to any intervention – with lifelong consequences. What part of this basic narrative do these people not understand?
Excellent question.