Fallas éticas del tratamiento trans 4

Este es el episodio No 20 de la tercera temporada de nuestro podcast  GRANDES FRAUDES CIENTIFICOS.
Son muchos los aspectos éticos que están en juego; en relación con el tratamiento estándar de la "afirmación de género"; no solo su uso sin la debida consideración de la medicina basada en la evidencia sino también la falta de beneficencia y la presencia de maleficencia. Sobre esto hablé en el episodio anterior. Pero a esto se suma la falta del respeto a la autonomía del paciente, especialmente al ignorarse su derecho al conocimiento informado. Estos temas los abordo en este episodio. Además, en este episodio seguiré estableciendo el contexto, el marco de referencia para aplicarlo, en el siguiente episodio, en la realidad actual de la atención clínica de la disforia de género. 

REFERENCIAS
Reporte CASS
https://cass.independent-review.uk/wp-content/uploads/2024/04/CassReview_Final.pdf

https://www.rcpsych.ac.uk/news-and-features/latest-news/detail/2024/04/22/detailed-response-to-the-cass-review's-final-report

https://contraelborradodelasmujeres.org/relatora-especial-onu-la-implementacion-del-informe-cass-es-clave-para-proteger-a-las-ninas-de-danos-graves/

https://www.wma.net/es/policies-post/declaracion-de-helsinki-de-la-amm-principios-eticos-para-las-investigaciones-medicas-en-seres-humanos/#:~:text=INTRODUCCION,material%20humano%20o%20información%20identificables

https://www.paho.org/sites/default/files/2023-10/belmont-informe.pdf

https://www.elsevier.es/es-revista-revista-medica-clinica-las-condes-202-articulo-consentimiento-informado-S0716864010705824
https://www.fda.gov/patients/informed-consent-clinical-trials/el-consentimiento-informado-para-participar-en-los-ensayos-clinicos

Para abordar otros temas relacionados que podrán también ser de mucho interés, los invito a adquirir mi libro: LOS DOS GRANDES FRAUDES CIENTIFICOS DE LOS SIGLOS XX y XXI. Este lo pueden adquirir como libro físico en todas las sucursales de la librería panameña EL HOMBRE DE LA MANCHA. Igualmente, puede ser adquirido como ebook haciendo clic AQUI
Los invito a suscribirse a mi sitio web donde podrán acceder a nuestro podcast y a mucha otra información de interés. Este lo pueden encontrar también en los directorios de Apple podcast; de spotify y todos los mayores directorios de podcasts. Pueden enviar sus comentarios y observaciones  a través de mi sitio web, así como a mi correo electrónico estebanmoralesvk@gmail.com

Chapters

• 0:00 Presentación e introducción
• 2:25 El informe CASS
• 8:07 La Resolución de Helsinski
• 15:55 El "consentimiento informado"
• 20:47 Conclusiones y despedida

Transcript

Presentation and Introduction   0:00

Let's listen to Chilean parliamentarian Johannes Kaiser in another segment of the interview he was given a few weeks ago.

VIDEO (not available)

Hello, welcome to episode No 20 of the third season of our podcast GREAT SCIENTIFIC FRAUDS.

I am your host Dr. Esteban Morales van Kwartel

The issue of the treatment of gender dysphoria, especially in boys, is increasingly becoming an ethical debate. This is a management and treatment that, apart from the fact that a solid literature on its efficacy is absent, many serious health consequences linked to its use and application are documented.

There are many ethical aspects at stake; not only its use without due consideration of evidence-based medicine but also the lack of beneficence and the presence of maleficence. Added to this is the lack of respect for the patient's autonomy, especially by ignoring their right to informed knowledge. 

In this episode I will continue to establish the context, the framework to apply it, in the next episode, in the current reality of clinical care for gender dysphoria.

CASS Report  02:25

In previous episodes, I have emphasized the existence of studies that prove the lack of evidence on the efficacy of the use of puberty blockers, cross-hormones, and surgeries for the treatment of gender dysphoria, especially in boys. I reviewed some meta-analyses on the topic and analyzed some publications that disqualify studies that support these treatments. But it is worth highlighting one of the studies that warns about these treatments, due to its importance and significance due to the recentness of its publication and for having been promoted by the institution in charge of health in the United Kingdom: The CASS Report. 

In 2020, the UK's only youth gender clinic was in chaos. The waiting list had become impossible to meet; The staff felt enormous pressure to care for patients who were rushed into puberty-blocking and hormonal treatments. There were complaints and lawsuits from patients that they had been placed under these treatments "after a series of superficial conversations with social workers," and that they were subsequently suffering serious complications.

In the midst of all this, the English health service (NHS) commissioned Dr. Hilary Cass, one of England's leading pediatricians, to carry out an independent evaluation of the outcomes of gender identity services for children and adolescents, particularly with regard to the use of puberty blockers and hormone replacement therapies. She worked with a team of academics and scientists from the University of York.

After almost four years of work, in April 2024 Dr. Cass presented her final report. This caused a stir in the country and the rest of the world; The report made the front pages of all British newspapers; "Pandora's Box" had been opened. The report, while presenting extremely cautious language, said the medical evidence is extremely weak to justify the interventions that were performed on many minors.

Analysis of the database examined supporting these interventions proved to be highly unreliable; on the other hand, when evaluating the research on the subject, they had to discard 41.75% of them due to their low quality. But, in reality, only 2% of the remaining studies were of high quality.

This research concludes that the Systematic reviews of the published scientific literature on the use of puberty blockers and hormones for trans adolescents or adolescents with gender identity-related disorders indicate that the available evidence is still scarce and the results do not allow "conclusions to be drawn about the impact on gender dysphoria, mental and psychosocial health, or cognitive development" of patients in the medium and long term.

It is important to note that the report stresses that any "gender-affirming" intervention must be carried out with "extreme care." However, according to the complaints and lawsuits that have been filed, this does not appear to have been used to date.

It is interesting to note that the CASS report emphasizes that there is a lack of long-term follow-up data on those who start treatment at a younger age. This has great implications since treatments lacking evidence are being used, this incorporates the process within the experimental field, in which not only inadequate information is obtained about the range of results for this group, but the ethical aspects of the research are violated.

I will talk about these aspects in the next section. 

Helsinski Report.  8:07

In 1964 in Helsinki, Finland, the World Medical Association (WMA) adopted the Helsinki Resolution as a fundamental document in the ethics of experimentation on people. This was mainly motivated by the horror caused by the atrocious medical experiments carried out by Nazi doctors during World War II. In fact, the very creation of the WMO in 1946 was largely motivated by these medical deviations during the war.

This document seeks to lead doctors and other health professionals who carry out research, along a path of respect for the individual, their right to self-determination and to make informed decisions. This is what was later called the "principle of patient autonomy." The document also seeks to guide these researchers so that research is based on a careful knowledge of the scientific field and an evaluation of risks and benefits.

In accordance with these principles, the physician must always take into account the well-being of the research subject and must also inform the patient about the aspects of care related to the research; This includes that the patient's refusal to participate in research must not disturb the doctor-patient relationship. 

This, however, is not the only document that establishes ethical guidelines for research. In the United States, the National Research Act in the United States became law on July 12, 1974, resulting in the creation of the National Commission for the Protection of Biomedical and Behavioral Research. This commission drafted the so-called Belmont report that was published in 1979 by the United States Department of Health, Education and Welfare (as it was called at the time)

This document sets out the ethical principles and guidelines for protecting humans in research. The report establishes three fundamental ethical principles: Respect for people, Beneficence, Justice. It also includes other ethical considerations, such as Informed Consent, Assessment of risks and benefits, Selection of subjects.

It was from this report that two members of the commission, Drs. Tom Beauchamp and James Childress, formulated the ethical principles for health care that we discussed in the previous episode. But in the context of medical research involving human subjects, I want to highlight at this point the principle of "informed consent" that also applies in medical care.

Informed consent means that the purpose of the research was explained to them, including what their role would be and how the trial will work, so that they can make an educated decision about whether or not they will participate in a clinical trial. For this, people need to know:

• what is going to be done to them;

• how the protocol (the research plan) works;

• what risks or discomforts they might experience.

The decision on their participation must be voluntary.

No intervention that involves invasive activity of our body should be imposed; The transgression of this would take us back to past or present times of tyrannical governments. 

For example, it is of important ethical consideration to note that the implications of sterilizing a child, which is one of the risks of "affirmative treatment," without the consent of his or her parent or guardian, represents a serious ethical violation in an experimental process. This applies to the health care aspect as well. In this case, a risk of this type should be a reason to evaluate alternative treatment options, since other ethical aspects pertaining to medical care would be violated.

Those responsible for our health very often fail to apply this principle. In the case of the application of the treatment that has been called the DG standard, a large sector of the population, unfortunately most of them children and young people, have participated in an experiment, without even being informed. Not only that, but they have been taken through an informal, tacky process of research where, as revealed in the CASS Report, there was "a lack of long-term follow-up data on those who start treatment at a younger age." 

Finally, something that should be very clear and that is often overlooked or unknown, is that the term "informed consent" is not the mere obtaining of a signature of a consent form. This is only one component of the process that includes, inter alia, allowing sufficient time and opportunity for participants to weigh information and for sufficient question-and-answer sharing; and it must take place in circumstances that minimize the possibility of coercion or undue influence. This is not then something that is marked by a specific time. It could take anywhere from hours to days to do properly.

"Informed consent". 15:55

In general terms, informed consent is a mandatory requirement both in research with human subjects and in the clinical care of patients. 

The different experimental phases for the production of any medical product are precisely aimed at knowing, as precisely as possible, the risks that they pose, in order to be able to warn the people who are going to use them; This is the reason for the so-called informed consent of the patient for the use of the product that has been recommended by the doctor, which is handled in the doctor-patient relationship. 

The final decision for its use or not is made after weighing the risks and benefits of the drug. This applies to medications, diagnostic procedures, surgeries, vaccinations, etc.

The discussion of "informed consent" goes beyond the medical aspect itself. This has to do with respect for people, freedom, the right of people to decide based on access to information.

The CASS report not only highlights the ethical violations committed by health providers throughout this time in the area of lack of informed consent but also in the areas of lack of beneficence and non= maleficence, in the care of children and young people with GD. But it can also be considered a violation of their human rights.

This is stated by the United Nations Special Rapporteur on violence against women and girls, Reem Alsalem, who, to my surprise, agreed with the report. In her endorsement of it, she stated the following, and I quote: 

"The findings and recommendations of the Cass review are fundamental and their implications go beyond the UK... In my opinion, it has shown very clearly the devastating consequences that policies on gender treatment have had on the human rights of children."

She goes on to say, "These policies have violated fundamental principles, such as the need to uphold the best interests of the child in all decisions that affect their lives and the right of children to the highest possible standards of health." 

This report stood out for its great rigor and methodological discipline, which is why it also achieved the endorsement of the Royal College of Psychiatrists of England. These, after making a second independent review of the report, expressed that they were in full agreement with the results and recommendations, stressing the need to always make "an adequate evaluation of the risks and benefits of any intervention."

They also alluded to the report's emphasis on the need for evidence-based medicine, and I quote: 

"The report highlights concerns about the evidence-based content of these interventions... Children and young people in other spheres of health care routinely receive evidence-based treatment and rightly so. This should be the same for young people and children who are seeking support for their gender identity."

In the next section some conclusions and the farewell.

Conclusions and farewell . 20:47

In the midst of all the debate that the report aroused, one of the main problems that hinder and still prevent this came to light, with the detriment of children and young people. This is what the United Nations rapporteur, Reem Alsalem, alludes to, who in her note of support for the report expressed, and I quote:

"The need to ensure that people, including researchers and academics, who express their views on such interventions are not silenced, threatened, or intimidated simply for holding and articulating those views." 

Unfortunately, as the reactions to this report demonstrate, these intimidations not only continue to occur but have intensified.

I believe that two great lessons can be derived 

of this report; First, that we should not cling to the use of "affirmation therapy" as a dogma of faith to treat GD. There are alternative treatments based on psychotherapy that can benefit most of these young people to treat the distress stemming from their sexual incongruence.

Second, the medical care of these young people should not focus only on anguish derived from a sexual incongruence. That patient must be seen in a comprehensive way, looking for all the possible causes related to his disorder, as a way to seek his adaptation and he can find his happiness.

Fortunately, the English NHS validated the report and stopped the use of this approach and the therapies associated with puberty blockers and hormone replacement. The British health system has maintained its compassionate, supportive and caring attitude to these patients; In fact, this was the reason for their request to do this evaluation: to seek the best possible care for these patients. At the moment, the available evidence does not allow "affirmation therapy" to be classified as correct, safe and efficient. 

In the next episode I point out the specific violations of the contents of the different codes of ethics.

In the description of the episode you can consult all the references on today's topic.

I invite you to purchase my book: THE TWO GREAT SCIENTIFIC FRAUDS OF THE TWENTIETH AND TWENTY-FIRST CENTURIES. Here I describe and analyze in a simple way and with responsible scientific evidence everything related to climate misrepresentations. This can be purchased in all branches of the prestigious Panamanian bookstore, EL HOMBRE DE LA MANCHA.

I also invite you to access our website estebanmoralesvankwartel.com to which I invite you to subscribe. Here you can also access all the episodes of our podcast and find a lot of other information of interest. Through my website you can also purchase our book THE TWO GREAT SCIENTIFIC FRAUDS OF THE TWENTIETH AND TWENTY-FIRST CENTURIES.

IT HAS BEEN A PLEASURE TO BE WITH YOU. I HOPE I HAVE MET THE EXPECTATIONS OF OUR RESPECTED LISTENERS FOR INFORMATION THAT IS HONEST AND USEFUL FOR THEIR OWN LIVES, FOR THEIR FAMILIES, AND FOR THE COMMUNITY IN WHICH THEY OPERATE.

See you soon and thank you for honoring us with your attention.