8 Comments

Many thanks for your honest assessment of these studies. I'm not a medical person (and don't play one in any of my life formats.......). As a reasonably good critical thinker, I'm struck by how much obfuscation and biassed "science" we're seeing of late. Or has it always been this way?

The COVID mess has brought much of this to light for me. It certainly seems like the FDA/CDC are not promoting open and honest science. What surprises me is how easily professionals in the medical field so willingly just follow along. Too much big $$$ at play?

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Short answer. NO. Statistical manipulation and skulduggery to find a desired result destroys credibility of medical research.

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Here is a follow up article on research so bad it’s used in schools as an example of how not to interpret research.

It’s important work pointing out research skewed for more funding or whatever the point.

Thank you for doing this work.

The costs are devastating.

https://www.virology.ws/2020/01/13/trial-by-error-the-2018-pace-reanalysis-and-the-smcs-expert-appraisals/

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The use or misuse of devices / therapies in heart failure and in cardiology is a long list that may require a separate paper in itself. The misleading sales pitches by company representatives and their acceptance by cardiologists and now with the involvement of hospital managers and other decision makers with financial goals as the objective has magnified the issue. There are too many levels at which this is accepted …. and the FDA Panel made judgements on CardioMEMS apparently based on limited access to care during that period (with just the right pressure from industry and physician leaders) compounded the problem.

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Ahhh our gov’t. Surely verifies cynicism [uninformed] patients like me harbor. They hope we don’t ask questions. Thanks Doc John.

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Hello Dr. John. Very interesting. A point on style. Please avoid acronyms. Several in this essay were never defined, and some were hard to remember. If you MUST use acronyms, please include a table of same. Acronyms, imho, (there, I've used one), are designed to privatize medical writing to the smallest groups of specialists so no one else will be able to understand them. And maybe so no one will be able to understand them. IMHO.

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Thank you again, Dr. Mandrola, for your clear, concise, and no-nonsense parsing of cardiology evidence. Your TWIC is appointment reading (I’m not huge on podcasts). I followed your writings extensively on Medscape regarding the Guide-HF saga, and am not sure how one comes away from that without a cynical outlook. The FDA approving the device based on Guide undermines confidence in the FDA. Full stop.

Your “neutral martians” should be a troupe that tours the cardiology world and opens our eyes to the big pharma undercurrent that affects all of us. I am also mindful of your constant refrain, that it’s not nefarious on the part of the authors who make dubious claims based on weak evidence. To paraphrase your POV, ‘it’s not personal; it’s science’.

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No need to cook the numbers for that MRI-guided trial. There's no money in MRIs for proceduralists, device companies, and hospital coffers.

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