FYI...here's the answer to the question of how RCTs became the "Gold Standard" for FDA approval of

drug treatments...and as you have acknowledged...HCQ+ never provided such data. It's not like the FDA never gave Dr. Risch, et al the chance to prove their claim...they did provide an EUA...
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AI Overview
Randomized Controlled Trials (RCTs) became the gold standard for FDA drug approval because the Kefauver-Harris Drug Amendments of 1962 legally forced drug makers to prove their products actually worked, not just that they were safe.

Taylor & Francis Online

The Turning Point: 1962
Before 1962, the U.S. Food and Drug Administration (FDA) only checked if a new medicine was safe, leaving claims about whether it healed people mostly unverified.

RAPS
The Thalidomide Crisis: Public panic over severe birth defects caused by the drug thalidomide in Europe led to an urgent demand for stricter U.S. drug laws.

EBSCO

The New Law: Pushed by Senator Estes Kefauver and signed in October 1962, the new amendments required companies to provide "substantial evidence" of effectiveness through well-controlled clinical investigations.

Yale School of Public Health

How the FDA Shaped RCTs
To enforce the 1962 law, the FDA and clinical scientists needed a reliable way to test if a drug caused an improvement by pure chance or actual effect.

National Institutes of Health (NIH) | (.gov)

Eliminating Bias: Randomly assigning patients to a treatment group or a placebo (fake pill) group stopped doctors and researchers from accidentally skewing the results.

National Institutes of Health (NIH) | (.gov)

Proving Cause and Effect: By the 1970s, the FDA interpreted "well-controlled trials" to mean randomized, double-blind testing. This method became the clearest way to prove causality.

Yale School of Public Health

Becoming the Global Gold Standard
By the 1980s and 1990s, the rise of evidence-based medicine placed RCTs at the absolute top of the scientific hierarchy for proving medical value. Because the FDA enforced this strict standard for every major drug application, global regulatory bodies adopted the same method, cementing the RCT as the international benchmark for modern medicine
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