Former FDA advisor: Biden’s FDA failed to report 70,000 negative reactions to puberty blockers

CV NEWS FEED // A former member of the Food and Drug Administration (FDA) wrote that over the past 20 years, there have been 70,000 reports of adverse reactions to puberty blockers; however, the FDA has never disclosed these reactions to the public. 

Pharmacologist Dr. David Gortler wrote in an article for Brownstone Institute that the FDA’s Drug Risk Management Board (DRMB) is responsible for monitoring the safety concerns of drugs available to the American public.

Gortler stated that since 2005, the FDA’s Adverse Event Reporting Database (AERS) has received 70,000 reports of adverse events occurring as a result of puberty blockers. However, the DRMB’s reports have not mentioned any. 

The FDA’s Drug Safety Priority report, which is published annually and available to the public, also did not mention any of the negative effects of puberty blockers. 

Gortler explained some of the negative side effects of puberty blockers, which were previously only used to treat life-threatening endocrine disorders or cancers in the elderly. These synthetic hormones are “not at all your everyday drugs,” according to Gortler. 

“Hormones are especially potent, synthetic versions of signaling compounds made by one’s anterior pituitary (A/K/A the ‘master gland’),” he wrote. “Hormones (natural or synthetic)  are therefore seen by the body’s receptors as a particularly forceful command.”

While hormones released by the pituitary gland ensure normal development, sex-incongruent hormones disrupt normal development, he wrote.

“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,” Gortler stated.

Technically, Gortler wrote, the FDA has listed the negative side effects of puberty blockers, including brain swelling, headaches, vomiting, blindness, and tumor-like masses in the brain, but the list is not readily accessible to the public. It remains “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.” 

While the FDA has consistently buried the risks of synthetic hormones, they also over-publicized the risks of using drugs such as hydroxychloroquine and ivermectin off-label, and Gortler noted, “neither of which have anywhere near the breadth or incidence of safety issues compared to that of transgender pharmacotherapy.”

He added that the FDA’s website that advises against the use of hydroxychloroquine for COVID-19 was based on only 331 reports of adverse events made within six months, significantly less than the reports regarding puberty blockers. Further mitigating the number of adverse events reported, Gortler wrote that many of the hydroxychloroquine events were cases of “obvious misuse with wildly incorrect or lacking critically important dosing and/or timing information.”

“Clearly, the FDA knows exactly how to inform Americans about critical drug safety matters…if it wants to,” he wrote.

Gortler concluded by noting that while Trump’s executive order banning transgender treatments on minors is a step in the right direction, there still needs to be a substantial overhaul of the FDA, with greater transparency and non-political coverage of drug safety.