Over the last several decades, the FDA has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with clear signs that they pose a risk of serious harm (Jun 2025) Article

[Michael Harrop]

https://jacobin.com/2025/06/fda-approval-drugs-effectiveness-risk/

In 2009, the FDA authorized Avastin for recurrent glioblastoma, a fatal brain cancer. In 2017, after the requisite “confirmatory” trials, the agency granted it full approval — even though the follow-up studies failed to show it helped patients live any longer.

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From January 2013 until December 31, 2022, the FDA approved 429 drugs, most of which were authorized on the basis of inadequate evidence that they worked, according to a database of government records created for this investigation. Based on an analysis of these records, the agency has allowed dozens of treatments, like Elmiron, to remain on the market even when subsequent studies failed to show they are effective. This investigation found that from 2013 through 2022:

• Seventy-three percent of drugs approved by the FDA did not meet the agency’s four foundational standards required to show they work as expected.
• More than half of drug approvals were based on preliminary data rather than sound evidence that patients had fewer symptoms, improved function, or lived longer.
• Fifty-five of the 429 drugs approved met only one of the four standards needed to show that a drug is safe and effective; thirty-nine drugs met none of them.

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Many of the issues with drug approvals uncovered in this investigation are particularly concerning with regard to cancer treatments.

These statistics come after billions of dollars and years of lobbying by the pharmaceutical industry and patient advocacy groups pressuring Congress to loosen the FDA’s scientific standards.

The resulting seismic shift from proving drugs work before they are approved to showing they work only after approval — if ever — has been quietly accomplished with virtually no awareness by doctors or the public. Insurers and taxpayers effectively pay for research after drugs hit the market as pharmaceutical companies reap the profits. Patients serve as the unwitting guinea pigs — with very real consequences.

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In the United States alone, an estimated 128,000 people are killed each year by side effects of prescription drugs that are properly prescribed. That number excludes opioid overdoses and is more than deaths from all illegal drugs combined. And the rate at which the agency approves unproven drugs has accelerated dramatically in the last ten years.

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Seeing the rewards to be reaped, companies began lobbying Congress to force the FDA to apply the looser AIDS standards to all sorts of drugs

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According to a 2022 analysis by the US Department of Health and Human Services Office of Inspector General, more than one-third of drugs approved on an accelerated pathway have never seen a confirmatory trial. When they did conduct the studies, regulators found companies took anywhere from a few months to twelve years to do so. This investigation found that confirmatory trials can take even longer — up to thirty years — and may not be performed at all.

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This article is part of an investigation into the Food and Drug Administration’s drug approval process and what it means for the public’s safety and health. The project is supported by the Lever and the McGraw Center for Business Journalism at CUNY’s Newmark Graduate School of Journalism.

Read part one here.
"The Food and Drug Administration has approved controversial drug treatments for Alzheimer’s disease amid excess deaths, questionable efficacy, and conflicts of interest between regulators, patient advocates, and Big Pharma."

This article was first published by the Lever, an award-winning independent investigative newsroom.

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