Clearly, the FDA knows exactly how to inform Americans about critical drug safety matters if it wants to.

In contrast, the last two decades of puberty blocking reports to the FDA’s Adverse Event Reporting Database (AERS) reported around 70,000 adverse event reports yet never received a solitary mention in any FDA Drug Safety Priority report over the past decade.

With President Donald Trump’s return to the White House, former FDA-ers like myself look forward to seeing a substantial overhaul at the agency,

America’s FDA leadership has been making decisions based on ideology, not drug safety.

Back in the early 2000s, the FDA launched the Safety First Steering Committee (SFSC). It was created to address the safety concerns of marketed drugs of noteworthy concern to Americans. Today, the acronym is still found ubiquitously throughout FDA documents, but links to its web page no longer function.

It appears to have been replaced by the Drug Risk Management Board (DRMB). The DRMB has no public-facing webpage, but it seems that the DRMB is 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.

Although the DRMB staff or meeting minutes are not made public, the FDA Drug Safety Priority yearly 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.”

That’s despite several recent studies finding that cross-sex hormones and puberty blockers are correlated with dramatically increased (seven-fold) risks of stroke, heart attack, and blood clots along with additional studies showing serious life-threatening adverse events and other permanent, physiologically devastating consequences.

One would think that these types of adverse events are something that the FDA would want to warn consumers about, but for one reason or another, it hasn’t.

Puberty blockers are a particularly notable case for a safety discussion, as they are used off-label to block the natural progression of biological puberty in healthy children and adolescents. Before being used for gender alteration, these drugs were typically prescribed for life-threatening endocrine disorders or cancers in the elderly or in older adult populations.

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, also known as 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. Adult human beings have ~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 like trying to drive your car across America by alternately and simultaneously pressing the gas and brake pedals, and 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 tumor-like masses in the brain, it has only done so deep within regulatory notifications and publications where it can’t 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 that of transgender pharmacotherapy.

When the FDA chose to speak out against hydroxychloroquine for COVID, it launched a salvo of social media ads plus multiple dedicated webpages and videos against the drug. It did so following just 331 adverse event reports over six months–many of which were obvious misuse with wildly incorrect or were lacking critically important dosing and timing information.

The FDA even advertised its success of warning consumers over the internet, which caused its website to become the number one internet search leading to FDA webpages and put it “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.

In contrast, the last two decades of puberty blocking reports to the FDA’s Adverse Event Reporting Database (AERS) reported around 70,000 adverse event reports yet never received a solitary mention in any FDA Drug Safety Priority report over the past decade.

With President Donald Trump’s return to the White House, former FDA-ers like myself look forward to seeing a substantial overhaul at the agency, transparency, and nonpolitical coverage of drug safety. Trump’s executive order on Protecting Children From Chemical And Surgical Mutilation is a step in the right direction, but FDA’s leadership should have been concerned with that on their own years ago.

The FDA needs nonpolitical, nonpartisan, and equitable monitoring of drug safety across all classes and fully independent of White House politics. America’s health depends on it.

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