NASEM Report Finds Compounded HRT of No Clinical Benefit
Transcript from video produced by Alliance for Natural Health
Over 2.5 million women rely on compounded bioidentical hormone replacement therapy and have used these treatments to alleviate the effects of hormone depletion from menopause and other causes for nearly 90 years. But a problem has arisen. Because the FDA budget relies on fees collected from pharmaceutical companies, the FDA’s policies protect pharma interest and compounded bioidenticals are a competitor to those corporate interests. Thus, the FDA has initiated a step-by-step approach to eliminate this competitor.
- Step one, the opportunity. FDA used a meningitis outbreak linked to a single compounder as justification to go after treatments completely unrelated to this incident, including bioidenticals.
- Step two, the investigation. FDA cited public health as it undertook an investigation into the safety and efficacy of all compounded products.
- Step three, divide and conquer. FDA created two separate categories of compounders, created lists of products each could produce, and moved to target smaller traditional compounders who create compounded bioidentical hormone replacement therapy.
- Step four, legitimize. FDA contracted the National Academies of Science, Engineering, and Medicine (NASEM) to study the safety and efficacy of compounded bioidentical hormone replacement therapy.
- Step five, stack the deck. The committee was appointed without representation from anyone who either compounds BHRT or uses these treatments in a medical practice.
- Step six, the report. NASEM’s report, just released, found no clinical utility for cBHRT, and cited it as a public health concern. These findings fly in the face of its exemplary safety record and much clinical data.
- Step seven, the kill. This is coming. FDA has reached its end game unless we all fight back. Take action now.