by A Midwestern Doctor, Lew Rockwell:
Why do so many innovative therapies never see the light of day
For most of my life, I’ve observed the FDA belligerently suppress natural treatments and any unorthodox therapy which threatens the medical monopoly while simultaneously railroading through a variety of unsafe and ineffective drugs regardless of how much public protest the agency meets. Consider this 2004 Senate testimony by the FDA scientist who got Vioxx banned that accurately described exactly what would come to pass with the COVID vaccines two decades later.
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As such, I do not hold the FDA in a positive light, especially given that during COVID-19, I (like many others) spent hundreds of hours trying to get the agency to allow the limited use of off-patent therapeutics for COVID-19—all of which ultimately went nowhere due to the unjustifiable roadblocks the agency kept putting up.
Over the past year, especially since Trump’s election, I’ve received many questions about FDA reform. To address the issue properly, I’ve carefully examined both sides.
In medicine, “sensitivity” refers to a test’s ability to correctly identify those who have a condition (e.g., detecting an infection), while “specificity” measures how well the test avoids false positives (i.e., correctly identifying those who don’t have the condition). The challenge is that improving one often reduces the other. For example, increasing the PCR cycle threshold in COVID tests made it more likely to detect infections (higher sensitivity), but also increased false positives (lower specificity). This trade-off leads to problems, like breast cancer screenings, where high sensitivity can result in false positives and unnecessary “treatments” for women who don’t actually have cancer.
The FDA faces a similar challenge: it must prevent harmful foods and drugs from reaching the market while ensuring useful products aren’t blocked. Though this seems straightforward, it’s incredibly difficult, and the FDA has often failed at both, even with leadership dedicated to public health.
Crime Against the Food Law
In the late 1800s, food producers were selling adulterated products, and pharmaceutical companies peddled medicines with secret ingredients like opium and alcohol. Public outrage grew, especially after exposés like Upton Sinclair’s The Jungle, which helped spark the 1906 Pure Food and Drug Act. This law gave the Bureau of Chemistry the power to ensure accurate labeling and prevent harmful additives in food.
The director of the Bureau of Chemistry (and thus the first head of the FDA), Harvey Wiley conducted tests on food additives, proving they made healthy volunteers sick. While the public and many scientists supported his findings, the food industry fought back with powerful lobbyists and legal tactics.
Note: the additives Wiley scrutinized were boric acid and borax, salicylic acid (aspirin) and salicylates, benzoic acid and benzoates, sulfur dioxide and sulfites, formaldehyde, sulfate of copper (used to green produce), and saltpeter (nitrates).
Gradually, the food industry hijacked the presidency, and in 1912, Wiley resigned, realizing he could achieve more for America’s health as a private citizen than within the government.
Wiley’s book “The History of A Crime Against The Food Law” details much of the same abhorrent industry tactics we see happening now. For example, a series of investigative reports recently showed that the processed food industry’s lobbyists worked fervently behind the scenes to block RFK’s nomination and had there not been widespread public protest, would have stopped us from Make America Healthy Again.
Those tactics also highlight a key point Wiley made—the only way to create change in this industry is to coax the public at large to demand it, as the moment you rely upon the members of the government to fix it, lobbyists will crush those efforts.
Generally Recognized as “Safe”
Many food additives are “generally recognized as safe” (GRAS), meaning they’re widely used without regulation. Wiley faced two major issues: food industry counterfeiting and harmful additives. The industry often faked products to cut costs, like selling grain alcohol as whiskey or using polluted waters to enlarge oysters.
Despite evidence of harm, the food industry claimed these additives were essential for production, even though competitors showed higher-quality (and ultimately more profitable) products could be made without them. Wiley also warned that chronic exposure to additives could cause long-term health issues, such as organ damage and aging.
Sadly, his concerns were ignored as industry influence grew and he was unable to ban them—rather they were eventually reclassified as “generally recognized as safe.” As a result, these “safe” additives have contributed to widespread chronic illness in society.
