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  #1   ^
Old Tue, Aug-22-23, 09:47
GRB5111's Avatar
GRB5111 GRB5111 is offline
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Plan: Very LC, Higher Protein
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Location: Herndon, VA
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:

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:

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
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  #2   ^
Old Tue, Aug-22-23, 11:26
Ms Arielle's Avatar
Ms Arielle Ms Arielle is offline
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Posts: 19,306
Plan: atkins, carnivore 2023
Stats: 225/224/163 Female 5'8"
Progress: 2%
Location: Massachusetts

This is a frustrating subject for me. For a simple reason. High bad cholesterol is driven by a SAD diet. I thought this was put to bed long ago;maybe just for the low carb crowd. And not mainstream additionally,, cholesterol is a precursor for a tremendous number of important biochemicals in the human body.

I want my cholesterol doing its job, not clogging my arteries. By eating high quality food, real food, clean meats and fats and clean veggies and maybe occasional fruits PLUS limit consumption to a few meals . Not eat all day.

There is soooo much -money making in pharmaceuticals. I cant have reasonable conversations with my brother the pharmacist. His head is so far up the pharmaceutical b-tt he can't see any other way. Sadly,he is loosing his eyesight because of his diet and daily drink. Another man I knew, spent his life fe on the road and eating SAD.....and was surprised he had a heart attack. Never ate real food. Even when at home, ate out every night. ( He looked like hell when he told me. Heart attack had kicked him hard!! ) He, too, believed drugs fix everything.

Change cannot come fast enough.

Thanks G for posting links.
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Old Fri, Sep-08-23, 06:55
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WereBear WereBear is offline
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Plan: EpiPaleo/Primal/LowOx
Stats: 220/130/150 Female 67
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Location: USA

Originally Posted by Ms Arielle
There is soooo much -money making in pharmaceuticals. I cant have reasonable conversations with my brother the pharmacist. His head is so far up the pharmaceutical b-tt he can't see any other way. Sadly,he is losing his eyesight because of his diet and daily drink.

I am so sorry to hear that. One of the emergencies of the past month+ was my brother having a severe stroke. And the insurance turned down rehab!

Several years ago our Carnivore brother got him on low carb and he admitted he felt better. But he didn't stick with it. I'm sure he has time to think about it, but he might not want to blame himself.

It's a mess. And I don't understand it.

Isn't feeling better, losing weight, and heading off future devastating illnesses ENOUGH?
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