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Old Tue, Aug-22-23, 09:47
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Default Bempedoic Acid: Drug Trials, Approval Methods, Pharma Practices

For general awareness, an article on the recent bempedoic acid trial (completed this year) appeared in my inbox from Maryanne Demasi. Bempedoic acid is a cholesterol lowering drug that is now being touted as more effective than statins:

Quote:
Critics push back

Despite the enthusiastic press coverage, notable researchers were quick to point out flaws in the analysis.

- Subgroup analyses

John Mandrola, a cardiac electrophysiologist at Baptist Health in Kentucky, was particularly critical of the methods used in the analysis.

“I'm going to try and stay calm through this,” said Mandrola. “I learnt very early on in my career that you cannot slice data the way they did.”

“You could excuse this if they were junior researchers who didn't know better,” he said, “but the authors clearly know it's a dubious analysis. The JAMA editors know it's dubious, and yet there it is, published and promoted in media.”

Here's the link to the full article:
https://maryannedemasi.substack.com...isFreemail=true

As we discuss the GLP-1 Agonists and the rapid increased use of these drugs once exclusively prescribed for diabetics now being commonly used for weight loss, there is a dynamic that has emerged over the past 25+ years that is becoming more concerning. The dynamic is the quality of the drug trials used to gain approval for new drugs and how these trials are designed, conducted, and reported. The concern I have is that current practices favor drugs being approved despite the fact that not all trial results and data are shared or reported. The most recent is the one completed earlier this year on bempedoic acid approved for cholesterol lowering.

This should serve as a continuing "wake up" call for those who are intimately involved in improving their health, and for those who haven't become aware yet, that prescriptions today are readily dispensed for chemicals that have not been rigorously and transparently tested. That these chemicals may provide relief of symptoms, but do not address the root causes and come with many side effects that have never been reported. That long-term health effects can be involved that do not necessarily increase human longevity or quality of life. I'll continue to remain a humble skeptic for my own protection.

A couple books and an article that inform on the pharmaceutical and medical industries practices further:

1) The Decapitation of Care: A Short History of the Rise and Fall of Healthcare by David Healy
2) Shipwreck of the Singular: Healthcare’s Castaways by David Healy
3) https://www.medicalbrief.co.za/the-...search-scandal/
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