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Time for an intervention – an urgent call to end “gender-affirming” treatments for children

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From the Macdonald Laurier Institute

By J. Edward Les

Despite the Cass Review’s alarming findings, trans activists and their enablers in the medical professions continue to push kids into having dangerous, life-altering surgeries and hormone-blocking treatments. It needs to stop.

If nothing else, the scathing final report of the Cass Review released this week (but commissioned four years ago to investigate the disturbing practices of the UK’s Gender Identity Service), is a reminder that doctors historically are guilty of many sins.

Take the Tuskegee syphilis study, one of the greatest stains on the medical profession, in which impoverished syphilis-infected black men were knowingly deprived of therapy so that researchers could study the natural history of untreated disease.

Or consider the repugnant New Zealand cervical cancer study in the 1960s and 1970s, which left women untreated for years so that researchers could learn how cervical cancer progressed.  Or the Swedish efforts to solidify the link between sugar and dental decay by feeding copious amounts of sweets to the mentally handicapped.

The doctors behind such scandals undoubtedly felt they were advancing scientific inquiry in pursuit of the greater good; but they clearly stampeded far beyond the boundaries of ethical medical practice.

More common by far, though, are medical “sins” committed unknowingly, such as when doctors prescribe toxic treatments to patients in the mistaken belief that they are beneficial. When physicians in Europe and Canada latched onto thalidomide in the late 1950s and early 1960s, for instance, they thought it was a wonder drug for morning sickness. Only the fine work of Dr. Francis Kelsey, an astute pharmacist at the FDA, prevented the ensuing birth-defects tragedy from being visited upon American women and children.

And when Oxycontin hit the medical marketplace in the 1990s, physicians embraced it as a marvellous — and supposedly non-addictive — solution to their patients’ pain. But the drug was simply another synthetic derivative of opium, and every bit as addictive; its use triggered a massive opioid overdose crisis — still ongoing today — that has killed hundreds of thousands and ruined the lives of countless individuals and their families.

Physicians in the latter instances weren’t driven by malevolence; but rather by a deep-seated desire to help patients. That wish, compounded by extreme busy-ness, repeatedly seduces doctors into unwarranted faith in untested therapies.

And no discipline in medicine, arguably, is more frequently led astray by the siren song of shiny new things than the field of psychiatry. Which is understandable, perhaps, given the nature of psychiatric practice. Categorizations of mental disorders — and the methods used to treat them — are based almost entirely on consensus opinion, rather than on direct measurement.  Contrast that with other domains of medical practice: appendicitis is diagnosed by imaging the infected organ, and then cured by surgically removing the inflamed tissue; diabetes is detected by measuring elevated blood sugar, and then corrected by the administration of insulin; elevated blood pressure is calibrated in millimetres of mercury, and then effectively reduced with antihypertensives; and so on.

But mental disturbances remain largely the stuff of conjecture — learned conjecture, mind you, but conjecture, nonetheless. The Diagnostic and Statistical Manual of Mental Disorders, the “bible” of mental health professionals, is the collective effort of groups of tall foreheads gathered around conference tables opining on the various perturbations of the human mind. Imprecise definitions abound, with heaps of overlap between conditions.

The current version (DSM-5) describes schizophrenia, for example, as occurring on a spectrum of “abnormalities in one or more of the following five domains: delusions, hallucinations, disorganized thinking (speech), grossly disorganized or abnormal motor behavior (including catatonia), and negative symptoms.” Each of these five domains is open to professional interpretation; and what’s more, the schizophrenia spectrum is further subdivided into ten sub-categories.

That theme runs through the entire manual – and imprecise definitions lead on to imprecise solutions. Given the blurred indications for starting, balancing, and stopping medications, it’s no accident that many mentally unwell patients languish on ever-changing cocktails of mind-altering drugs.

None of which is to downplay the enormous importance of psychiatry, which does much to address human suffering amidst unimaginable complexity; its practitioners are among the brightest and most capable members of the medical profession. But by its very nature the discipline is submerged in — and handicapped by — uncertainty. It’s unsurprising, then, that mental health professionals desperate for effective treatments are susceptible to being misled.

The dark history of frontal lobotomies, seized upon by psychiatrists as a miracle cure but long relegated to the trash heap of medical barbarism, is well known. The procedure (which garnered its inventor the Nobel Prize in Medicine) basically consisted of driving an ice pick through patients’ eye sockets to destroy their frontal lobes; thousands of patients were permanently maimed before saner heads prevailed and the practice was halted. Many of its victims were gay men: “conversion therapy” with a literal, brain-altering “punch.”

Similarly, the fabricated “recovered memories of sexual abuse” saga of the 1980s and early 1990s suckered mental health practitioners into believing it was legitimate. Hundreds of professional careers were built on the “therapy” before it was all exposed as a fraud, leaving many lives ruined, families torn asunder, and scores of innocent men imprisoned or dead from suicide. In a 2005 review, Harvard psychology professor Richard McNally pegged the recovered memory movement as “the worst catastrophe to befall the mental health field since the lobotomy era.”

Until now, that is. That scandal pales in comparison to the “gender transition/gender affirming care” craze that has befogged the medical profession in recent years.

Without a shred of supporting scientific evidence, many doctors — led by psychiatrists, but aided and abetted by endocrinologists, surgeons, pediatricians, and family doctors — have bought into the mystical notion of gender fluidity. What was previously recognized as “gender identity disorder” was rebranded as gender “dysphoria” and recast as part of the normal spectrum of human experience, the basic truth of binary mammalian biology simply discarded in favour of the fiction that it’s possible to convert from one sex to another.

Much suffering has ensued. The enabling of biological males’ invasion of women’s spaces, rape shelters, prisons, and sports is bad enough. But what is being done to children is the stuff of horror movies: doctors are using medications to block physiological puberty as prologue to cross-gender hormones, genital-revising surgery, and a lifetime of infertility and medical misery — and labelling the entire sordid mess as gender-affirming care.

The malignant fad began innocently enough, with a Dutch effort in the late 1980s and early 1990s to improve the lot of transgendered adults troubled by the disconnect between their physical bodies and their gender identity. Those clinicians’ motivations were defensible, perhaps; but their research was riddled with ethical lapses and methodological errors and has since been thoroughly discredited. Yet their methods “escaped the lab”, with the international medical community adopting them as a template for managing gender-confused children, and the World Professional Association for Transgender Health (WPATH) enshrining them as “standard of care.” Then, as American social psychologist Jonathan Haidt is the latest to observe, the rise of social media torqued the trend into a craze by convincing hordes of adolescents they were “trans.” Which is how we ended up where we are today, with science replaced by rabid ideology — and with condemnation heaped upon anyone who dares to challenge it.

An explanation sometimes offered for the massive spike in gender-confused kids seeking “affirmation” in the past fifteen years is that today it’s “safe” for kids to express themselves, as if this phenomenon always existed but that — as with homosexuality — it was “closeted” due to stigma. Yet are we really expected to believe that the giants of empirical research into childhood development —brilliant minds like Jean Piaget, Eric Erikson, Lev Vygotsky, and Lawrence Kohlberg — somehow missed entirely the trait of mutable “gender identity” amongst all the other childhood traits they were studying? That’s nonsense, of course. They didn’t miss it — because it isn’t real.

The fog is beginning to dissipate, thankfully. Multiple jurisdictions around the world, including the UK, Sweden, Norway, Finland, and France have begun to realize the grave harm that has been done, and are pulling back from — or halting altogether — the practice of blocking puberty. And the final Cass Report goes even further, taking square aim at the dangerous practice of social transitioning and concluding that it’s “not a neutral act” but instead presents risk of grave psychological harm.

All of which places Canada in a rather awkward position. Because in December of 2021 parliamentarians gave unanimous consent to Bill C-4, which bans conversion therapy, including “any practice, service or treatment designed to change a person’s gender identity.” It’s since been a crime in Canada, punishable by up to five years in prison, to try to help your child feel comfortable with his or her sex.

As far as I know, no one has been charged, let alone imprisoned, since the bill was passed into law. But it certainly has cast a chill on the willingness of providers to deliver appropriate counselling to gender-confused children: few dare to risk it.

A conversion therapy ban had been in the works for years, triggered by concerns about disturbing and harmful practices targeting gay children. But by the time the bill was presented in its final form to Parliament for a vote it had been hijacked by trans activists, with its content perverted to the degree that there is more language in the legislation speaking to gender identity than to homosexuality.

To be clear, likening homosexuality to pediatric “gender fluidity” is a category error, akin to comparing apples to elephants. The one is an innate sexual orientation, the acceptance of which requires simply leaving people be to live their lives and love whomever they wish; the other is wholly imaginary, the acceptance of which mandates irreversible medical (and often surgical) intervention and the transformation of children into lifelong (and usually infertile) medical patients.

And the real “elephant” in the room is that in a troubling number of cases pediatric trans care is conversion therapy for gay children because for some people, it’s more acceptable to be trans than it is to be gay.

Bill C-4 received unanimous endorsement from all parliamentarians, including from Pierre Poilievre, now the leader of the Conservative Party. No debate. No analysis. Just high-fives all around for the television cameras.

It’s possible that many of the opposition MPs hastening to support the ban did so for fear of being painted as bigots. Yet the primary responsibility of an opposition party in any healthy democracy is to oppose, even when it’s unpopular. In 2015, when NDP Opposition leader Tom Mulcair faced withering criticism for resisting anti-terror legislation tabled by Stephen Harper’s Conservative government, he cited John Diefenbaker’s comments on the role of political opposition:

“The reading of history proves that freedom always dies when criticism ends… The Opposition finds fault; it suggests amendments; it asks questions and elicits information; it arouses, educates, and moulds public opinion by voice and vote… It must scrutinize every action of the government and, in doing so, prevents the shortcuts through democratic procedure that governments like to make.”

In the case of Bill C-4 the Conservatives did none of that. And by abdicating their responsibility they helped drive a metaphorical ice pick into the futures of scores of innocent children, destroying forever their prospects for normal, healthy lives.

We’re long overdue for a “conversion”: a conversion back to the light of reason, a conversion back to evidence-based care of children.

In 1962, when the harms of thalidomide became known, it was withdrawn from the Canadian market. In 2024, now that the serious harms of “gender-affirming care” have been exposed, it remains an open question as to when Canada’s doctors and politicians will finally take the difficult step of admitting that they got it wrong and put a stop to the practice.

Dr. Edward Les is a pediatrician in Calgary who writes on politics, social issues, and other matters.

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Health

‘Transgender’ males have 51% higher death rate than general population: study

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From LifeSiteNews

By Emily Mangiaracina

Research found that men who underwent a ‘gender transition’ using hormones have a 51% higher mortality rate than the general population and a ‘threefold’ greater risk of cardiovascular deaths.

A newly published study has found that males’ use of estrogen to present as “female” triples their risk of cardiovascular disease, while also heightening the risk of stroke, blood clots, depression, and cognitive impairment.

The journal Discover Mental Health on June 12 released a variety of findings regarding the negative impacts of estrogen use in males attempting to transition to “female.” One of the most significant was that current estrogen use “was associated with a threefold increased risk of death from cardiovascular events.”

In fact, a study of 966 “female transitioned” males were found to have a mortality rate 51 percent higher than that of the general population. Their main causes of death included cardiovascular disease (21 percent), cancer (32 percent), suicide (7.5 percent), and infection-related disease (five percent).

Estrogen use by males amplified other cardiovascular risks, especially with prolonged use. One meta-analysis found a 30 percent higher rate of stroke among gender-confused men who took estrogen compared with men who did not.

A review also found “strong evidence” that estrogen use by men increases their risk for vein blood clots “over fivefold.”

Estrogen use was also found to have a detrimental cognitive impact on men. For example, so-called “female transitioned” males were found to have lower scores than both their other male counterparts and women in “information-processing speed and episodic memory.”

In addition, elevated symptoms of depression were “associated with increased serum levels of estradiol” for men under the age of 60.

This recent study confirms 2023 study that found that all gender-confused individuals, whether men attempting to present themselves as women or women attempting to present themselves as men, were at significantly increased risk for a range of deadly cardiovascular conditions, including strokes, heart attacks, high blood pressure, and elevated cholesterol levels.

A 2019 study published by the National Institutes of Health (NIH) National Library of Medicine also found:

Cardiovascular disease (CVD) is the leading disease-specific cause of death for [so-called] transgender people undergoing [transgender procedures], with only suicide claiming more lives as the leader of all cause mortality.

However, for [gender-confused males], the risk of death from CVD is 3-fold higher than for all other groups.

“We already know sex hormones are important to cardiovascular health, and now we have people being exposed to high levels of sex hormones they normally would not have, which could be associated with cardiovascular benefit or risk,” said Dr. Christian Delles, a professor at the Institute of Cardiovascular and Medical Sciences at the University of Glasgow.

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Brownstone Institute

FDA Exposed: Hundreds of Drugs Approved without Proof They Work

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From the Brownstone Institute

By Maryanne Demasi

The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.

That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownleepublished by The Lever.

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.

One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”

A System Built on Weak Evidence

The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.

Yet only 28% of drugs met all four criteria—40 drugs met none.

These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”

Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.

In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving that they work, with the promise of follow-up trials later.

But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”

“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.

More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively.

And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.

The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.

Cancer Drugs: High Stakes, Low Standards

Nowhere is this failure more visible than in oncology.

Only 3 out of 123 cancer drugs approved between 2013 and 2022 met all four of the FDA’s basic scientific standards.

Most—81%—were approved based on surrogate endpoints like tumour shrinkage, without any evidence that they improved survival or quality of life.

Take Copiktra, for example—a drug approved in 2018 for blood cancers. The FDA gave it the green light based on improved “progression-free survival,” a measure of how long a tumour stays stable.

But a review of post-marketing data showed that patients taking Copiktra died 11 months earlier than those on a comparator drug.

It took six years after those studies showed the drug reduced patients’ survival for the FDA to warn the public that Copiktra should not be used as a first- or second-line treatment for certain types of leukaemia and lymphoma, citing “an increased risk of treatment-related mortality.”

Elmiron: Ineffective, Dangerous—And Still on the Market

Another striking case is Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.

The FDA authorized it based on “close to zero data,” on the condition that the company conduct a follow-up study to determine whether it actually worked.

That study wasn’t completed for 18 years—and when it was, it showed Elmiron was no better than placebo.

In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalized with colitis. Some died.

Yet Elmiron is still on the market today. Doctors continue to prescribe it.

“Hundreds of thousands of patients have been exposed to the drug, and the American Urological Association lists it as the only FDA-approved medication for interstitial cystitis,” Lenzer and Brownlee reported.

“Dangling Approvals” and Regulatory Paralysis

The FDA even has a term—”dangling approvals”—for drugs that remain on the market despite failed or missing follow-up trials.

One notorious case is Avastin, approved in 2008 for metastatic breast cancer.

It was fast-tracked, again, based on ‘progression-free survival.’ But after five clinical trials showed no improvement in overall survival—and raised serious safety concerns—the FDA moved to revoke its approval for metastatic breast cancer.

The backlash was intense.

Drug companies and patient advocacy groups launched a campaign to keep Avastin on the market. FDA staff received violent threats. Police were posted outside the agency’s building.

The fallout was so severe that for more than two decades afterwards, the FDA did not initiate another involuntary drug withdrawal in the face of industry opposition.

Billions Wasted, Thousands Harmed

Between 2018 and 2021, US taxpayers—through Medicare and Medicaid—paid $18 billion for drugs approved under the condition that follow-up studies would be conducted. Many never were.

The cost in lives is even higher.

A 2015 study found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence that they helped patients live longer.

An estimated 128,000 Americans die each year from the effects of properly prescribed medications—excluding opioid overdoses. That’s more than all deaths from illegal drugs combined.

A 2024 analysis by Danish physician Peter Gøtzsche found that adverse effects from prescription medicines now rank among the top three causes of death globally.

Doctors Misled by the Drug Labels

Despite the scale of the problem, most patients—and most doctors—have no idea.

A 2016 survey published in JAMA asked practising physicians a simple question—what does FDA approval actually mean?

Only 6% got it right.

The rest assumed that it meant the drug had shown clear, clinically meaningful benefits—such as helping patients live longer or feel better—and that the data was statistically sound.

But the FDA requires none of that.

Drugs can be approved based on a single small study, a surrogate endpoint, or marginal statistical findings. Labels are often based on limited data, yet many doctors take them at face value.

Harvard researcher Aaron Kesselheim, who led the survey, said the results were “disappointing, but not entirely surprising,” noting that few doctors are taught about how the FDA’s regulatory process actually works.

Instead, physicians often rely on labels, marketing, or assumptions—believing that if the FDA has authorized a drug, it must be both safe and effective.

But as The Lever investigation shows, that is not a safe assumption.

And without that knowledge, even well-meaning physicians may prescribe drugs that do little good—and cause real harm.

Who Is the FDA Working for?

In interviews with more than 100 experts, patients, and former regulators, Lenzer and Brownlee found widespread concern that the FDA has lost its way.

Many pointed to the agency’s dependence on industry money. A BMJ investigation in 2022 found that user fees now fund two-thirds of the FDA’s drug review budget—raising serious questions about independence.

Yale physician and regulatory expert Reshma Ramachandran said the system is in urgent need of reform.

“We need an agency that’s independent from the industry it regulates and that uses high-quality science to assess the safety and efficacy of new drugs,” she told The Lever. “Without that, we might as well go back to the days of snake oil and patent medicines.”

For now, patients remain unwitting participants in a vast, unspoken experiment—taking drugs that may never have been properly tested, trusting a regulator that too often fails to protect them.

And as Lenzer and Brownlee conclude, that trust is increasingly misplaced.

Republished from the author’s Substack

 

Author

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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