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Health

US FDA plans overhaul of decades-old medical device system

Published

6 years ago

1 minute read

WASHINGTON — US health officials say they plan to overhaul the country’s decades-old system for approving most medical devices, which experts have long criticized for failing to catch problems with risky implants and medical instruments.

The Food and Drug Administration announced plans Monday aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing.

The FDA’s pledge came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls.

Matthew Perrone, The Associated Press

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Health

Oxford study finds transgender surgery increases depression, suicide ideation rates

Published on March 3, 2025

By

From LifeSiteNews

By Doug Mainwaring

This study, along with scores of others conducted in recent years, explodes the media-enforced narrative that so-called ‘gender transition’ procedures are beneficial for the gender-confused.

A study published in the Oxford Journal of Sexual Medicine found that undergoing so-called “sex change” surgery, far from reducing depression rates among the gender dysphoric, substantially increased rates not only of depression, but of anxiety, suicidal ideation, and substance use disorders. 

Males who underwent transgender surgery had a depression rate of 25.4 percent, compared to 11.5 percent in those who did not have surgery. Likewise, females who underwent surgery had a depression rate of 22.9 percent, compared to 14.6 percent in those who did not. 

The study notes that males undergoing “feminizing” surgeries demonstrated a particularly high risk for depression and substance use disorders. 

“From 107,583 patients, matched cohorts demonstrated that those undergoing surgery were at significantly higher risk for depression, anxiety, suicidal ideation, and substance use disorders than those without surgery,” the researchers found.  

Rather than concluding that so-called “gender affirming” surgery is a dangerous, unnecessary practice that should be discontinued because it puts patients’ lives at risk, the researchers instead suggest that that their findings show a need for “gender-sensitive mental health support following gender-affirming surgery to address post-surgical psychological risks.” 

Exploding the myth  

This study, along with scores of others conducted in recent years, explodes the media-enforced narrative that so-called “gender transition” procedures are beneficial or even “necessary” for the happiness and well-being of the gender-confused.  

A significant body of evidence now shows that “affirming” gender confusion carries serious harms, especially when done with impressionable children who lack the mental development, emotional maturity, and life experience to consider the long-term ramifications of the decisions being pushed on them or full knowledge about the long-term effects of life-altering, physically transformative, and often irreversible surgical and chemical procedures. 

Studies find that more than 80 percent of children suffering gender dysphoria outgrow it on their own by late adolescence and that “transition” procedures fail to resolve gender-confused individuals’ heightened tendency to engage in self-harm and suicide – and even exacerbate it, including by reinforcing their confusion and neglecting the actual root causes of their mental strife.  

Last year, a massive, peer-reviewed study provided unequivocal evidence that those who undergo so-called “gender reassignment” surgery put themselves at a vastly increased risk of suicide – an astounding 12 times that of the general population.  

The giant study, “involving 56 United States healthcare organizations and over 90 million patients,” analyzed data collected over a 20-year period, from February 2003 to February 2023, examining “suicide attempts, death, self-harm, and post-traumatic stress disorder (PTSD) within five years of the index event.”   

The researchers compared the experiences of persons aged 18-60 who visited hospital emergency rooms and who had previously undergone “transition” surgery with those who visited emergency rooms without having undergone transgender surgery: A stunning 3.47 percent of those who had surgically “transitioned” were treated for suicide attempts, versus 0.29 percent for non-“transitioned” patients.    

The authors of the study, like those of the one just published in the Oxford Journal of Sexual Medicine, sidestepped the obvious conclusion that attempts to surgically “transition” the gender-confused are both dangerous and futile.   

Instead they concluded: “Gender-affirming [sic] surgery is significantly associated with elevated suicide attempt risks, underlining the necessity for comprehensive post-procedure psychiatric support.” 

In 2016, The New Atlantis, A Journal of Technology and Society, produced a landmark report offering a summary and an up-to-date explanation of research on “sexual orientation and gender identity” from the biological, psychological, and social sciences, covering nearly 200 peer-reviewed studies.  

“The hypothesis that gender identity is an innate, fixed property of human beings that is independent of biological sex — that a person might be ‘a man trapped in a woman’s body’ or ‘a woman trapped in a man’s body’ — is not supported by scientific evidence,” according to experts Lawrence S. Mayer, M.B., M.S., Ph.D, scholar-in-residence in the Department of Psychiatry at the Johns Hopkins University, and Paul R. McHugh, M.D., professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine.  

According to their report, the vast body of scientific evidence tells a different story from the one most have been told through mainstream media. “Sexual identity” or “sexual orientation” are so commonly used that they go unquestioned and are perceived to have been derived from biological or medical science, but they are not. These terms are merely expressions of desire, behavior, and identity, all of which are fluid and may change over time. Additionally, “gay,” “lesbian,” and “transgender” are not scientific terms. People who suffer from homosexual inclinations and/or gender confusion are not separate species of human beings. 

The only thing that science actually tells us is that we are born either male or female. 

One young man, Yarden Silveira, was so distraught after “sex change” surgery that he committed suicide in 2021.    

Before taking his own life, Yarden wrote:  

I wish I never listened to the medical and psychiatric community when they told me it was possible to change my sex. What a lie. Very dangerous and unethical. Sex reassignment [sic] surgery is a hit and miss type of surgery, but they don’t tell you that. They never do. And maybe if I didn’t have autism, maybe if my brain wasn’t so defective, I would have caught on before it was too late…   

This is what I get for messing with nature… I just wanted friendship and love. I wanted life to be easier. I wanted to be a woman since I was 15. I wish I had the knowledge that I have today. I was a confused kid with no identity. I wish I could have done everything different, but it’s too late now. I’m royally screwed…  

The Transgender Ideology and its lies, along with the pro-gay media, medical and psychiatric community, have killed me. The feminization of America will continue to produce outcomes like mine. It wasn’t my fault for failing. Everyone failed me, my death shouldn’t surprise anyone.  

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Addictions

“Unscientific and bizarre”: Yet another Toronto addiction physician criticizes Canada’s “safer supply” experiment

Published on February 28, 2025

By

By Liam Hunt

“It seems to be motivated by a very small, vocal, and well-connected group of advocates” says Dr. Michael Lester

Dr. Michael Lester, a Toronto-based addiction physician with 30 years of experience, says Canada’s “safer supply” programs are “inherently dangerous” and causing “dystopian” community harms due to widespread fraud.

These programs claim to reduce overdoses and deaths by distributing free addictive drugs—typically 8-milligram tablets of hydromorphone, an opioid as potent as heroin—to dissuade addicts from consuming riskier street substances. Yet experts across Canada say recipients regularly divert (sell or trade) their safer supply on the black market to acquire stronger illicit drugs, which then fuels addiction and organized crime.

“I have a couple dozen patients in my practice who were drug-free prior to the advent of safe supply, and they’ve gone back to using opioids in a destructive way because of the availability of diverted hydromorphone,” said Lester. “Every single day that I go to work, people tell me they’re struggling with the temptation not to take diverted safe supply. They don’t want to take it, but they take it anyway just because it’s cheap and available.”

After safer supply programs became widely accessible across Canada in 2020, Lester’s patients reported an influx of 8-milligram hydromorphone tablets on the black market, coinciding with a crash in the drug’s street price from $15–$20 per pill to just $2. He now estimates that 80 percent of his patients struggling with opioid addiction have relapsed due to diverted safer supply, leading some to abandon treatment entirely.

“Even if it’s sold at the rock-bottom price of $2 or $3 a pill, a person would make tens of thousands of dollars a year, which would have a tremendous impact on their ability to buy other drugs,” he explained. “Selling hydromorphone is too tempting not to do it, which keeps them entrenched in the whole world of dealing with opioid users and having opioids in their premises.”

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Lester said safer supply is evidently “fueling organized crime” because drug seizures in Ontario now commonly include hydromorphone, “which wasn’t happening before.” He added that some individuals who try these diverted drugs later transition to stronger opioids, such as fentanyl.

In July, for example, the London Police Service announced that seizures of hydromorphone had increased by more than 3,000 percent in the city since 2020. According to London Police Chief Thai Truong, “Diverted safer supply is being resold into our community. There’s organized drug trafficking at the highest levels of organized crime, and there’s drug trafficking at the street level. We’re seeing all of it.”

While Lester acknowledges that safer supply can be useful as a “treatment of last resort, after traditional treatments have been tried and failed,” he said it is now being offered immediately to a wide variety of patients, which has “decimated” uptake of traditional addiction therapies, such as methadone and Suboxone.

As a result, conventional addiction clinics are now at risk of shutting down, meaning some communities could lose access to gold-standard treatments (i.e., methadone and Suboxone) while highly profitable, but unscientific, safer supply programs take over instead.

Lester said the evidence supporting safer supply is biased and “misleading” because, generally speaking, these studies simply interview enrolled patients and ask them to self-report whether they benefit from the programs. He noted that many safer supply researchers are public health academics, not doctors, meaning they lack clinical experience with the communities they study.

“It seems to be motivated by a very small, vocal, and well-connected group of advocates that has completely changed the landscape in addiction medicine treatment in a very short time,” he said.

Lester argues that some safer supply researchers seem to purposefully design their study methodologies to favor the programs and disregard systemic harms. He said this flawed science is then propagated by credulous journalists who fail to adequately scrutinize agenda-driven research.

While he personally knows “a couple dozen” colleagues in addiction medicine who regularly express skepticism about safer supply, many have been reluctant to speak out, fearing backlash from activist groups that “terrorize” critics.

“The stories are common of people being harassed and insulted on social media. We’ve heard of doctors being threatened [and] dropped from committees because they spoke out.”

For example, after Lester and his colleagues published two open letters criticizing safer supply in late 2023, they were targeted by a series of articles by Drug Data Decoded, a popular Canadian harm reduction Substack, which compared the doctors to Nazis and eugenicists. The articles were then widely shared on social media by safer supply activists.

Lester recalled an incident in which harm reduction activists targeted a doctor’s daughter at her high school in retaliation for her parent’s public criticism of safer supply.

“It’s just something that seems so unscientific and so bizarre in medicine,” he said. “Physicians just aren’t used to a powerful political lobby changing a treatment protocol.”

After Lester and more than a dozen of his colleagues wrote several public letters calling for reform and requested a meeting with Ya’ara Saks, the federal Minister of Mental Health and Addictions, they found themselves “sidelined and ignored.”

After months of delays, they were able to present their clinical observations to Saks, only to have her disregard them and incorrectly claim, weeks later, that criticism of safer supply is rooted in “fear and stigma.”

“The insults aren’t a big enough consequence to keep me from speaking my mind,” he declared.

After a short reflection, he then added, “If anyone doesn’t have a stigma against this population, it’s me. I’ve dedicated my life to helping them.”

Liam Hunt is a Canadian writer and journalist with an interest in humanism, international affairs, and crime and justice. This story is produced by the Centre For Responsible Drug Policy’s “Experts Speak Up” series in partnership with the Macdonald-Laurier Institute.

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