The following is from Children’s Health Defense.

A new two-year investigation by The Lever finds that the US Food and Drug Administration (FDA) approved hundreds of drugs over the past decade without reliable evidence they work. Many of those drugs are still on the market—despite evidence they offer no benefit and may even be harmful.

The probe, based on internal FDA documents, court records, and more than 100 interviews, found that 73% of drugs approved from 2013 to 2022 failed to meet all four of the FDA’s own foundational standards used to assess safety and effectiveness. These criteria include the use of control groups, clinical endpoints, blinding, and replication of results in more than one trial. The report did not evaluate any vaccines.

Among the findings:

• Cancer drugs were the worst offenders. Only 2.4% of the 123 cancer drugs approved met all the agency’s criteria, while 29 met none. The FDA approved 81% of them based only on preliminary data.
• Pharmaceutical companies often relied on surrogate outcomes, such as tumor shrinkage, instead of proven clinical benefits like extended survival or reduced symptoms.
• Avastin, a drug approved in 2008 to treat metastatic breast cancer, is a notable example. After five trials showed no clinical benefit—and revealed serious risks like blood clots, heart issues, and kidney problems—the FDA pulled its approval in 2011. Drugmakers lashed out at the agency and patients, discouraging further withdrawals since.

The FDA’s loosening of standards can be traced back to the AIDS crisis, when pressure from activists and the pharmaceutical industry led to the creation of the “accelerated approval pathway” in 1992. This allowed approvals based on limited early data. Congress later codified this in the Prescription Drug User Fee Act, which was accompanied by a surge in pharmaceutical campaign contributions.

Critics argue this shift turned the public into test subjects, with insurers and taxpayers footing the bill while pharmaceutical companies collect profits. An estimated 128,000 Americans die each year from side effects of prescription drugs that were prescribed as directed.

The Lever also created a searchable database showing how many drugs approved from 2013 to 2022 meet FDA criteria. Vaccines are not included in that database. According to Children’s Health Defense Senior Research Scientist Karl Jablonowski, vaccine trials often fall short of these same standards—using improper placebos, inadequate blinding, and endpoints that fail to measure real-world protection.

For more information, read the full article here.