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.

The only publicly identified member of the DSMB is Dr. Patrizia Cavazzoni, the Director of CDER. Cavazzoni spent her entire career prior to the FDA working for Big Pharma. Despite claiming “Rigorous” and “Wide Ranging” efforts in “safeguarding the nation’s prescription[s]” she fully ignored around 70,000 adverse events from puberty blockers in each of her annual reports. 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.

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.