Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

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Read the full source article:  Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

According to the article:

"Commercials for Prevagen have insisted that “it’s safe and effective,” an assurance Quincy echoed to regulators. But an investigation by WIRED now shows that for years officials at the FDA questioned the basis for the company’s claims. Multiple FDA inspections, most of which have not been reported before, found significant issues with Quincy’s manufacturing processes, complaint handling, and the quality control testing that was supposed to ensure its products were safe.

And thousands of Americans have reported experiencing “adverse events” while taking Prevagen, including seizures, strokes, heart arrhythmias, chest pain, and dizziness. While the existence of adverse event reports alone don’t prove a product is the cause, the nature and pattern of complaints about Prevagen worried FDA officials, according to agency records. One internal report from 2015 stated that the “numerous adverse events reported” indicated “a serious safety hazard.” "

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Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence

Look into this crystal ball:  Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence:

"First the 21st Century Cures Act passes, weakening the FDA. Next, we’ll very likely end up with either a batshit nutty libertarian who doesn’t believe the FDA should require evidence of efficacy before approving drugs or a real, honest-to-goodness pharma shill as the next commissioner of the FDA. It’s going to be a long four years."

'via Blog this'

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Testing Approved Drugs In The Real World With Real People

Updated November 25, 2022

The original link broke.

You can still read about the same topic here:

New Arena for Testing of Drugs: Real World - TuscaloosaNews.com

---  the original post follows below  ---

In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World." I find the story so compelling for the following reasons . . .

1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

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