None of the 70,000 Adverse Events of Puberty Blocking Drugs Were a “Safety Priority” for Biden’s FDA
Data on the dangers of transitioning follows.
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.
It appears to have been replaced by the Drug Risk Management Board (DRMB).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:
“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 every six months 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.
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David Gortler, Pharm D, is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of: FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic pedagogy and bench research, as part of his nearly two decades of experience in drug development. He is a senior fellow in healthcare and FDA policy at the Heritage Foundation in Washington DC and a 2023 Brownstone Fellow.
The Brownstone Institute originally published this article.
In 2022, malone.news wrote articles on the extreme medical dangers of transitioning.
The harms inflicted on children through transitioning will last a lifetime. Many of these harms are irreversible. Remarkably, President Trump has put a stop to this nonsense. But more is required; hospitals and physicians must be held accountable for a lack of informed consent.
The dangers of puberty blockers, as documented by the peer-reviewed literature, is significant. An abstract from a peer-reviewed paper is (copied) below.
The Dutch Protocol for Juvenile Transsexuals: Origins and Evidence
Journal of Sex and Marital Therapy, Sept 19, 2022
It has been a quarter of a century since Dutch clinicians proposed puberty suppression as an intervention for “juvenile transsexuals,” which became the international standard for treating gender dysphoria. This paper reviews the history of this intervention and scrutinizes the evidence adduced to support it. The intervention was justified by claims that it was reversible and that it was a tool for diagnosis, but these claims are increasingly implausible. The main evidence for the Dutch protocol came from a longitudinal study of 70 adolescents who had been subjected to puberty suppression followed by cross-sex hormones and surgery. Their outcomes shortly after surgery appeared positive, except for the one patient who died, but these findings rested on a small number of observations and incommensurable measures of gender dysphoria. A replication study conducted in Britain found no improvement. While some effects of puberty suppression have been carefully studied, such as on bone density, others have been ignored, like on sexual functioning.
The paper goes on to describe the off-label drugs that are being used:
In the nomenclature of transgender medicine, “puberty blockers” denote GnRHa drugs (alternatively known as Luteinizing Hormone-Releasing Hormone agonists) which stop the production of sex hormones.1 Drugs in this class include triptorelin (branded Decapeptyl or Gonapeptyl), which is used in the Netherlands and Britain, and leuprorelin (branded Lupron) in North America. GnRHa drugs are licensed to treat several medical conditions including precocious puberty in children; endometriosis and uterine fibroids in women; and advanced prostate cancer and sexual deviance in men. The drugs have never been licensed as a treatment for gender dysphoria.
Then the issue of puberty blockers and Bone Density:
The detrimental effect of GnRHa on the accrual of normal bone mass has been documented in several longitudinal studies from the Amsterdam clinic (Klink et al., 2015; Schagen et al., 2020; Stoffers et al., 2019; Vlot et al., 2017), the London clinic (Biggs, 2021; Joseph et al., 2019), and a clinic in Ottawa (Navabi et al., 2021). Less obviously, adolescents who seek GnRHa for gender dysphoria have a lower distribution of bone density compared to the population of the same sex and age (see also Lee et al., 2020). This reflects in part the high prevalence of eating disorders.
The paper also documents that puberty blockers negatively affect IQ of children transitioning, and cites a number of studies indicating that these practices are creating a class of teenagers who will never experience a normal puberty.
The effects of puberty suppression on emotional and cognitive development are more difficult to ascertain, but more consequential as they could potentially affect the capacity to consent to cross-sex hormones and surgery. One case report of puberty suppression commencing just before age of 12 measured a drop in IQ by 10 points after 28 months (M. A. Schneider et al., Citation2017). A single case is insubstantial, of course, but there are similar findings from children treated with GnRHa for precocious puberty. A study of 25 children measured a drop of 7 points after two years (Mul et al., Citation2007); another study found a gap of 8 points between 15 treated children and a matched control group (Hayes, Citation2017; Wojniusz et al., Citation2016)… A small study from the clinic found that 8 adolescent males undergoing puberty suppression performed worse in a test of executive functioning than three control groups; the differences are statistically significant, but the samples are small (Staphorsius et al., Citation2015). Randomized control trials of non-human animals provide evidence of the substantial effects of puberty suppression.
In sheep, GnRHa impairs spatial memory, and this effect remains after the treatment is stopped—thus demonstrating the irreversibility of puberty suppression (Hough et al. 2017a; Citation2017b).
While the use of GnRHa to suppress puberty helped to create the juvenile transsexual, it could now be creating another “new way of being a person” (Wren, 2020): a sexless adult. This follows from the premise that natal puberty can be a kind of disease, and therefore failure to prevent an “irreversible development of secondary sex characteristics … may be considered unethical” (de Vries et al., 2011, p. 2282).
To conclude, there is ample scientific evidence that this massive experiment in transhumanism inflicted on our children has been an abject failure. These procedures are essentially experiments.
These procedures and drugs are unethical and dangerous.
These procedures and drugs are unethical and dangerous.
Adolescents, their parents, and adults who have undergone essentially experimental medical and surgical procedures have not been fully informed of the associated risks. Furthermore, these human research subjects (since these procedures are experimental) have been exposed to marketing, advertising, and “nudge” technologies, which have compromised their ability to make informed decisions on behalf of themselves and their children.
My hope is that these medical malpractice victims seek justice through the court system and that physicians, insurance companies, and medical NGOs, such as the AMA and The American Academy of Pediatrics (AAP) (AAP), are held accountable in a court of law. I hope that physicians lose their licenses and that some even end up being convicted of intentionally harming patients.
President Trump executive order could be rescinded when a new president enters the oval office (as early as 2028), so we need to ensure that this never happens again. For this reason, Congress must legislate these practices out of existence in the United States. On then, will our children be truly safe.
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People should be in prison for the mental and physical abuses they visited on children and teens.
I wonder how much money Patrizia Cavazzoni was paid in kickbacks and or donations from Pfizer and the rest of Big Pharma. Where are these people’s integrity?
Remember the good old days when the US government agencies worked to protect the American population from dangerous risky drugs. And the CIA would mess with our enemies government, create havoc to try to create a free society. Now they have turned it on us as though we are their new guinea pig society to test their psychological warfare on.