FDA – the regulatory facade – approved hundreds of drugs with no proof they worked – turning patients into unwitting guinea pigs

The U.S. Food and Drug Administration (FDA), once regarded as the gold standard for drug safety, has devolved into little more than a rubber stamp for Big Pharma — approving hundreds of medications with shockingly little evidence that they actually help patients. A bombshell two-year investigation by The Lever reveals that the agency has abandoned its own scientific standards, fast-tracking dangerous and ineffective drugs while leaving patients to suffer the consequences.

Key points:

• 73% of FDA-approved drugs from 2013-2022 failed to meet the agency’s four foundational standards for proving effectiveness.
• 55 drugs met only one standard, while 39 met none at all — yet they remain on the market.
• More than half of approvals relied on preliminary data, with no proof of symptom relief, improved health, or extended life.
• Cancer drugs fared worst — only 2.4% met all criteria, while 29 met none.
• Pharmaceutical lobbying and political pressure have systematically gutted FDA oversight, prioritizing profits over patient safety.

The FDA’s accelerated pathway: A license for corporate greed

The FDA’s descent into regulatory negligence traces back to the AIDS crisis of the 1980s. Desperate patients demanded faster access to experimental treatments, and Big Pharma seized the opportunity to push for looser standards. In 1992, the agency introduced the “accelerated pathway,” allowing drug makers to submit preliminary data—often based on unreliable surrogate markers—instead of concrete clinical outcomes.

One notorious example was AZT, an AIDS drug approved solely because it increased T-cell counts—despite failing to improve survival rates and causing severe toxicity. GlaxoSmithKline (GSK) raked in $2 billion before the truth emerged.

Congress cemented this reckless approach with the Prescription Drug User Fee Act (PDUFA), effectively turning the FDA into a pay-to-play operation. Pharmaceutical lobbying skyrocketed, with campaign contributions doubling from 1.9 million in 1990 to 3.6 million in 1992—just before the bill passed.

Flimsy science, deadly consequences

The Lever’s investigation identified four basic criteria the FDA once required to prove a drug’s effectiveness:

• Control group comparison (placebo or existing treatment).
• Replication (at least two well-controlled trials).
• Blinding (patients and doctors unaware of who receives the drug).
• Clinical endpoint (measuring real-world benefits like survival or function).

Yet only 28% of approved drugs met all four. Shockingly, 29% met just three, and 9% met none.

Cancer drugs were among the worst offenders. Many were approved based on tumor shrinkage — a surrogate marker — while ignoring whether patients actually lived longer or suffered fewer symptoms. Avastin, a breast cancer drug, earned Roche $6.8 billion before studies revealed it caused blood clots, strokes, and organ damage — with zero clinical benefit. The FDA eventually revoked approval, but not before countless patients were harmed.

Vaccines: The untested elephant in the room

While The Lever’s database excludes vaccines, experts warn they follow the same flawed approval process. Karl Jablonowski, senior research scientist at Children’s Health Defense, notes that vaccine trials often:

• Use fake placebos containing toxic adjuvants.
• Fail proper blinding, skewing results.
• Rely on antibody responses instead of real disease protection.

For example, Merck’s HPV vaccine Gardasil was never tested against actual cancer outcomes — just surrogate markers. “There is no such thing as a prospective 30-year clinical trial,” Jablonowski said, exposing the fraudulent basis of its approval.

The FDA’s fear of Type I errors (approving harmful drugs) has been eclipsed by its complicity in Type II errors (delaying or denying life-saving treatments). Yet even this justification collapses under scrutiny: FDA-approved drugs kill over 100,000 Americans annually, according to the Journal of the American Medical Association.

The agency’s revolving door with Big Pharma ensures this corruption persists. Former FDA officials routinely join drug companies, while industry-funded lobbyists dictate policy. The result? A $3.9 trillion market where profit trumps science—and patients pay the price.

Sources include:

ChildrensHealthDefense.org

LeverNews.com

OIG.hhs.gov [PDF]