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None of the 70,000 adverse events of puberty blocking drugs were a "safety priority" for Biden's FDA
By newseditors // 2025-02-25
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Back in the early 2000s, the FDA launched the Safety First Steering Committee (SFSC). It was started to address the safety concerns of marketed drugs of noteworthy concern to Americans. Today, the acronym is still found ubiquitously throughout FDA documents, but those links no longer function.
(Article by David Gortler republished from Brownstone.org)
It appears to have been replaced by the Drug Risk Management Board (DRMB). The DRMB has no public-facing web page, but it appears that the DRMB is just a rebranded SFSC.
Per the FDA:
It’s not really a surprise that Cavazzoni – a psychiatrist and former Big Pharma employee for nearly two decades prior to joining the FDA – would turn a blind eye to drug safety based on politics. During her leadership, Cavazzoni enacted questionable political regulatory decisions and advanced other Biden/Harris White House policies including multiple ineffective and dangerous Alzheimer’s disease products, as well as demanding cruel animal testing in place of newer, animal-free methodology.
As the chairwoman of the DRMB, Cavazzoni should objectively determine what is a priority. Cavazzoni determined that tens of thousands of puberty-blocking transgender drug adverse events – including deaths, hospitalizations, and permanent disabilities – simply aren’t a “Drug Risk Monitoring Board” priority.
Over the last two decades, around 70,000 reports of harm from puberty-blocking medications were submitted to the FDA’s Adverse Event Reporting Database (AERS). Yet the FDA “Drug Risk Monitoring Board” report never mentioned any of these submissions.
In addition to AERS, published data shows that cross-sex hormones and puberty blockers are correlated with dramatically increased (7-fold) risks of stroke, heart attack, and blood clots along with additional studies also showing serious life-threatening adverse events and other permanent, physiologically devastating consequences.
On a side note, the FDA DRMB seems to ignore Covid mRNA and several other Covid-era treatment safety issues as well.
One would think that any kind of adverse event is something that the FDA would feel obligated to warn American taxpayers about, but for one reason or another, it isn’t.
Puberty blockers are a particularly notable case for a safety discussion, as they are used off-label to block the natural progression biological of puberty in healthy kids and adolescents. Before being used for gender alteration, these drugs were typically prescribed for life-threatening endocrine disorders or cancers in the elderly or older adult populations. A price comparison for one kit (a one-month supply), leuprolide (Lupron) costs anywhere from over $12,000 to over 14,000 per month with an online coupon. Plus, under the Biden Administration, puberty blockers for transgender therapy would have been covered by the taxpayers:
Puberty Blockers and Cross Sex Hormones
The administration of synthetic, sex-incongruent hormones and/or so-called puberty blockers are hormones – not at all your everyday drugs. Hormones are especially potent, synthetic versions of signaling compounds made by one’s anterior pituitary (A/K/A the “master gland”). Hormones (natural or synthetic) are therefore seen by the body’s receptors as a particularly forceful command.
On the other end is one’s natural biological and hormonal function. There exist ~100 trillion nucleated cells with an “XX” (female) or “XY” (male) combination denoting either female or male sex, respectively. Hormones released by one’s pituitary foster normal physiological development; sex-incongruent hormones interrupt that biological function. That chaos between one’s healthy biology versus outside chemicals means that all sorts of adverse effects would emerge as one’s physiology gets bewildered.
A highly simplified mechanical analogy would be trying to drive your car across America by alternately/simultaneously pressing the gas and brake pedals, while constantly shifting into random gears. You will get nowhere and destroy the car.
Politics Dictating How FDA Warns Americans about Drug Safety
Although the FDA has warned that puberty-blocking-type products can cause life-threatening brain swelling, headaches, vomiting, a host of visual disturbances (including blindness), and/or tumor-like masses in the brain, it has only done so deep within regulatory notifications and publications where it cannot easily be found; it has not made a widespread public notification to pharmacists, physicians, or the American public.
On the other hand, the FDA very prominently and selectively warned about the dangers of off-label use of drugs like hydroxychloroquine and ivermectin, neither of which have anywhere near the breadth or incidence of safety issues compared to that of transgender pharmacotherapy.
When the FDA chose to speak out against hydroxychloroquine for Covid, it commenced a salvo of social media ads plus multiple dedicated web pages and videos against it. It did so following just 331 adverse event reports over six months – many of which were obvious misuse with wildly incorrect or lacking critically important dosing and/or timing information.
The FDA even advertised its success in warning consumers over the internet, which caused its website to become the number one internet search leading to FDA webpages, and “at the top of trending topics on social media platforms.”
Clearly, the FDA knows exactly how to inform Americans about critical drug safety matters…if it wants to.
With Donald Trump’s inauguration as president, former FDA-ers like myself look forward to seeing substantial FDA overhaul, transparency, and the non-political coverage of drug safety. Trump’s executive order to Protecting Children From Chemical And Surgical Mutilation is a step in the right direction, but FDA leadership should have been concerned with that independently, and years ago.
Read more at: Brownstone.org
“The DRMB is a cross-CDER governance board responsible for three key objectives: (1) facilitating and coordinating decisions around major product safety issues, (2) providing clear and consistent guidance enabling an appropriate response to major safety issues, and (3) systematically communicating decisions and resulting actions across the Center and to other stakeholders as appropriate. In addition, the DRMB facilitates and coordinates all new and existing marketed product-safety initiatives.”The Drug Safety Monitoring Board was chaired by Dr. Patrizia Cavazzoni, the head of the FDA’s Center for Drug Evaluation and Research (CDER). Cavazzoni unexpectedly resigned just hours prior to Donald Trump’s inauguration on Jan 20th, 2025. Although neither the DRMB staff nor meeting minutes are made public, the FDA Drug Safety Priority annual reports are. One of the more conspicuous things missing from those reports over the past decade or so is any mention of the widespread off-label promotion of hormone modulators (also referred to as GnRH modulators or puberty blockers) and/or cross-sex hormones in kids, in the name of “gender transition.”
It’s not really a surprise that Cavazzoni – a psychiatrist and former Big Pharma employee for nearly two decades prior to joining the FDA – would turn a blind eye to drug safety based on politics. During her leadership, Cavazzoni enacted questionable political regulatory decisions and advanced other Biden/Harris White House policies including multiple ineffective and dangerous Alzheimer’s disease products, as well as demanding cruel animal testing in place of newer, animal-free methodology.
As the chairwoman of the DRMB, Cavazzoni should objectively determine what is a priority. Cavazzoni determined that tens of thousands of puberty-blocking transgender drug adverse events – including deaths, hospitalizations, and permanent disabilities – simply aren’t a “Drug Risk Monitoring Board” priority.
Over the last two decades, around 70,000 reports of harm from puberty-blocking medications were submitted to the FDA’s Adverse Event Reporting Database (AERS). Yet the FDA “Drug Risk Monitoring Board” report never mentioned any of these submissions.
In addition to AERS, published data shows that cross-sex hormones and puberty blockers are correlated with dramatically increased (7-fold) risks of stroke, heart attack, and blood clots along with additional studies also showing serious life-threatening adverse events and other permanent, physiologically devastating consequences.
On a side note, the FDA DRMB seems to ignore Covid mRNA and several other Covid-era treatment safety issues as well.
One would think that any kind of adverse event is something that the FDA would feel obligated to warn American taxpayers about, but for one reason or another, it isn’t.
Puberty blockers are a particularly notable case for a safety discussion, as they are used off-label to block the natural progression biological of puberty in healthy kids and adolescents. Before being used for gender alteration, these drugs were typically prescribed for life-threatening endocrine disorders or cancers in the elderly or older adult populations. A price comparison for one kit (a one-month supply), leuprolide (Lupron) costs anywhere from over $12,000 to over 14,000 per month with an online coupon. Plus, under the Biden Administration, puberty blockers for transgender therapy would have been covered by the taxpayers:
Puberty Blockers and Cross Sex Hormones
The administration of synthetic, sex-incongruent hormones and/or so-called puberty blockers are hormones – not at all your everyday drugs. Hormones are especially potent, synthetic versions of signaling compounds made by one’s anterior pituitary (A/K/A the “master gland”). Hormones (natural or synthetic) are therefore seen by the body’s receptors as a particularly forceful command.
On the other end is one’s natural biological and hormonal function. There exist ~100 trillion nucleated cells with an “XX” (female) or “XY” (male) combination denoting either female or male sex, respectively. Hormones released by one’s pituitary foster normal physiological development; sex-incongruent hormones interrupt that biological function. That chaos between one’s healthy biology versus outside chemicals means that all sorts of adverse effects would emerge as one’s physiology gets bewildered.
A highly simplified mechanical analogy would be trying to drive your car across America by alternately/simultaneously pressing the gas and brake pedals, while constantly shifting into random gears. You will get nowhere and destroy the car.
Politics Dictating How FDA Warns Americans about Drug Safety
Although the FDA has warned that puberty-blocking-type products can cause life-threatening brain swelling, headaches, vomiting, a host of visual disturbances (including blindness), and/or tumor-like masses in the brain, it has only done so deep within regulatory notifications and publications where it cannot easily be found; it has not made a widespread public notification to pharmacists, physicians, or the American public.
On the other hand, the FDA very prominently and selectively warned about the dangers of off-label use of drugs like hydroxychloroquine and ivermectin, neither of which have anywhere near the breadth or incidence of safety issues compared to that of transgender pharmacotherapy.
When the FDA chose to speak out against hydroxychloroquine for Covid, it commenced a salvo of social media ads plus multiple dedicated web pages and videos against it. It did so following just 331 adverse event reports over six months – many of which were obvious misuse with wildly incorrect or lacking critically important dosing and/or timing information.
The FDA even advertised its success in warning consumers over the internet, which caused its website to become the number one internet search leading to FDA webpages, and “at the top of trending topics on social media platforms.”
Clearly, the FDA knows exactly how to inform Americans about critical drug safety matters…if it wants to.
With Donald Trump’s inauguration as president, former FDA-ers like myself look forward to seeing substantial FDA overhaul, transparency, and the non-political coverage of drug safety. Trump’s executive order to Protecting Children From Chemical And Surgical Mutilation is a step in the right direction, but FDA leadership should have been concerned with that independently, and years ago.
Read more at: Brownstone.org
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