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FDA Approved — And Ineffective
Key Excerpts from Article on Website of The Lever

Posted: July 24th, 2025
https://www.levernews.com/fda-approved-and-ineffective/
The woman, in her 60s, was losing her eyesight. [She] happened to be taking Elmiron, a drug for a bladder condition called interstitial cystitis. By the end of 2024, hundreds of patients on Elmiron had suffered vision loss or blindness. Others taking the drug were even more unlucky. Dozens of patient deaths associated with Elmiron were reported to the Food and Drug Administration (FDA), and 45 patients were hospitalized with severe colitis. Another problem? There’s no good evidence that Elmiron works. When the government approved Elmiron in 1996, the manufacturer provided close to zero data that the drug effectively treated interstitial cystitis. Elmiron is just one of hundreds of drugs that have been approved by the FDA over the last several decades on the basis of flimsy or nonexistent evidence. Drug companies have been allowed to market hundreds of prescription drugs to doctors and sell them to unsuspecting patients despite glaringly inadequate evidence that they offer any benefit and in many cases amid clear signs that they pose a risk of serious, often irreparable harm. From January 2013 until Dec. 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. In the U.S. 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.
Note: This article is also available here. A JAMA study reveals how Big Pharma spends more on ads for low-benefit drugs to push consumer demand for treatments doctors are less likely to prescribe. For more along these lines, read our concise summaries of news articles on government corruption and Big Pharma profiteering.
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