FDA Exposed: Hundreds of Drugs Approved without Proof They Work

  FDA Drug Approval Process

- The FDA has approved numerous drugs without proof of effectiveness or despite evidence of harm.

- A two-year investigation revealed the FDA often ignores its own scientific standards.

- An expert described the FDA's evidence threshold as already very low.

Weak Evidence in Drug Approvals

- 73% of drugs approved from 2013 to 2022 did not meet all four criteria for “substantial evidence” of effectiveness.

- Only 28% met all criteria; 40 drugs met none.

- Basic criteria include control groups, replication in trials, blinding, and clinical endpoints.

Regulatory Flexibility and Expedient Pathways

- Increased pressure led the FDA to prioritize speed over rigorous evidence.

- Many drugs are approved with the promise of follow-up studies that often remain incomplete.

- Half of approvals relied on preliminary data, lacking solid evidence of patient benefit.

Failures in Cancer Drug Approvals

- Only 3 out of 123 cancer drugs approved during the study met all FDA scientific standards.

- 81% were approved based on surrogate endpoints (e. g. , tumour shrinkage) without evidence of improved survival.

- Copiktra is an example where post-marketing data showed reduced survival for patients.

Ineffectiveness and Danger of Approved Drugs

- Elmiron, approved with minimal initial data in 1996, showed no benefit compared to placebo after 18 years; caused serious side effects still being prescribed today.

- “Dangling approvals” are drugs still on the market despite missing or failed follow-up trials, like Avastin.

Financial Costs and Lives Lost

- Between 2018 and 2021, Medicare and Medicaid spent $18 billion on drugs requiring follow-up studies that were often never done.

- A 2015 study found many cancer drugs showed no evidence of helping patients live longer.

- Prescription drugs contribute significantly to annual deaths worldwide.

Misleading Drug Labels and Physician Awareness

- A 2016 survey revealed many physicians misunderstand what FDA approval means.

- Only 6% of surveyed doctors accurately understood the FDA approval process.

- Many doctors rely on the assumption that FDA approval equals safety and effectiveness.

Concerns About FDA's Independence

- Interviews revealed widespread concern that the FDA has lost focus on public health.

- The FDA’s funding relies heavily on industry fees, raising questions about its independence.

- Calls for reform to ensure the FDA is more autonomous and relies on high-quality science in drug evaluation.

Conclusion and Trust Issues

- Patients may unknowingly participate in untested drug studies.

- The trust in the FDA's regulatory role may be increasingly misplaced, leading to potential harm for patients.

https://brownstone.org/articles/fda-exposed-hundreds-of-drugs-approved-without-proof-they-work/