by Matt Agorist, The Free Thought Project:
The U.S. Food and Drug Administration (FDA) has approved hundreds of drugs over the last several decades with little to no evidence that they work, according to a new investigation by The Lever.
Many of the drugs are permitted to stay on the market, despite ample evidence that they don’t work and that they cause serious and irreparable harm.
The Lever’s two-year investigation into the FDA-approved drugs analyzed government reports, internal FDA documents, investigators’ notes, congressional testimony, court records and more than 100 interviews with researchers, federal officials and patients.
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The investigation found that from 2013 through 2022, 73% of drugs approved by the FDA didn’t meet the agency’s four foundational standards required to show the drugs work as expected. Fifty-five of the approved drugs met only one of those four standards, and 39 met none of them.
More than half of drug approvals were based on preliminary data, which meant the pharmaceutical companies didn’t submit evidence that patients had fewer symptoms, showed improvement or had their lives extended.
The approval rate of such drugs has accelerated over the last decade, according to the U.S. Department of Health and Human Services Office of Inspector General.
Cancer treatments, in particular, raised serious red flags. Only 2.4% of the 123 cancer drugs met all of the criteria, and 29 met none. The FDA approved 81% of cancer drugs based on preliminary data.
The report did not evaluate any vaccines.
The Lever wrote:
“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.”
The outlet also reported that an estimated 128,000 people are killed each year by side effects from prescription drugs prescribed as indicated.
Demand for drugs during the AIDS epidemic led to lowered standards
The FDA regulates $3.9 trillion worth of products each year, including drugs, food, supplements, tobacco and medical devices, according to The Lever.
Until the AIDS epidemic in the 1980s, the agency had stricter regulatory procedures. However, demands by activists seeking faster access to new drugs in the context of the AIDS crisis, with the support of the pharmaceutical industry, resulted in the loosening of requirements for some drugs.
For example, requirements that pharmaceutical companies submit more than one randomized controlled clinical trial showing that a drug is effective meant that researching drugs took time — the entire approval process could take up to 12 years.
In 1992, the FDA created the “accelerated pathway,” allowing companies to submit only preliminary data showing AIDS drug effectiveness. Companies were expected to submit further evidence of effectiveness after the drugs were on the market.
The new rules also allowed companies to win approval without showing clinical outcomes — evidence that a drug positively affected a patient’s life. Instead, they could test for “surrogate outcomes,” considered “reasonably likely to predict” a clinical benefit.
For example, instead of a medication for strokes showing that it stops strokes, it can show a surrogate endpoint, such as controlling blood pressure. The AIDS drug AZT won approval on that basis — it increased the number of T-cells needed to fight viruses, but had no effect on AIDS and instead proved extremely toxic to those who took it.
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