First of all, Happy April Fools day. I thought about writing a fake-trial post. But thought the better of it. I normally tell you about a single study on Monday. This week, I want to alert you to the potential bigness of next weekend, when the American College of Cardiology meets in Atlanta. Sunday is an especially important day, as we will hear the results of three clinical trials—each of which could change cardiology in major ways.
I hope you will post about the results with maybe links to the reports here so that those of us who aren't medical experts will get access to this knowledge. I read about those pump failures and injuries recently and that sounded terrible. Chelation of heavy metals, how long the reduction from chelation lasts, and maybe how to avoid consuming foods or other exposures that put people at risk would be great.
There is another recently reported clinical trial that some say will change care in cardiology but I am convinced it should not. Coincidentally, I posted on that today. I would love to hear what your readers think.
This all bodes as a wonderful subtext for this upcoming ACC meeting: lessons in evidence-generation, and the regulatory/approval process.
1. Positive subgroups are hypothesis-generating only. Go out and prove it.
2. Don’t approve things based on biologic plausibility; demand outcome studies (this is true even if the impella study is positive…adopters will be vindicated but their “logic” will not be).
3. “Settled science” needs to be re-examined from time to time.
Very interesting! And I hope you will report back here, as I didn't expect the American major news outlets to a) CARE or b) report correctly and accurately the findings.
Thanks for the previews of these various trials. I'll be interested to hear about the results.
I wonder if you could talk to someone at the conference about improving the ACC's risk calculator for developing ASCVD, which has absurdly nonsmooth properties which undermine its credibility. According to a calculator, a 52 year old Caucasian male, total cholesterol 179, LDL 110, HDL 50 , BP 110/70, nonsmoking, no diabetes/meds has a lifetime risk of 5% (light blue bar below):
If you increase total cholesterol from 179 to 180 (a negligible increase) and leave the other values the same, lifetime risk jumps from 5% to 36% !?!?! It's just not plausible that such a tiny increase in total cholesterol should lead to such a giant jump in lifetime risk. The ACC can do better than this. Millions and millions of people are being advised about whether to take a statin, whether to change their diet and lifestyle, etc, in part based on this calculator. Since it's available to anyone online, it's easy enough for numerically-inclined skeptical patients to find it online, play around with it, discover its ridiculously nonsmooth behavior and lose some confidence in the medical system.
There are thousands and thousands of data scientists out there who would love the chance to collaborate with the ACC on improving that calculator. The current calculator can't possible be based on rigorous methodology if it jumps from 5% to 36% when total cholesterol goes from 179 to 180.
Why aren’t ALL doctors in ALL specialties not demanding emergency hearings on the WPATH files? A huge scandal. I know it is not the topic of this great essay, but I could not help but be struck by the call for emergency FDA hearings if the device turns out to not show benefit in spite of 18 yrs of cardiology “ believing “ it works.
The WPATH files are much more devastating and effects young people . Surely the industry of gender affirming troubled kids with outright lies and no informed consent deserves emergency action.
This is NOT about legal protection for trans adult which is just. WPATH( world professional assoc of trans health) has knowingly violated every norm standard and ethic that has been the bedrock of the doctor patient relationship. It is way beyond malpractice which is about accountability for errors.. Sterilizing kids first with hormonal manipulation and then with aggressive surgical interventions($$$$$ for those who do these interventions) without any evidence( but lying and claiming evidence) and without informed consent is a travesty ( There is no word to that captures the enormity of what these WPATH practitioners are doing still) and every doctors’ business. This is not an error on their part. It is however a grave error on the medical profession if we fail to stand for what we KNOW is right and protect these ever growing number of confused troubled kids.
I hope you will post about the results with maybe links to the reports here so that those of us who aren't medical experts will get access to this knowledge. I read about those pump failures and injuries recently and that sounded terrible. Chelation of heavy metals, how long the reduction from chelation lasts, and maybe how to avoid consuming foods or other exposures that put people at risk would be great.
Wow, exciting times! Looking forward to your ‘report’!!
There is another recently reported clinical trial that some say will change care in cardiology but I am convinced it should not. Coincidentally, I posted on that today. I would love to hear what your readers think.
https://williamhbestermannjrmd.substack.com/p/a-new-study-promoting-more-stents
This all bodes as a wonderful subtext for this upcoming ACC meeting: lessons in evidence-generation, and the regulatory/approval process.
1. Positive subgroups are hypothesis-generating only. Go out and prove it.
2. Don’t approve things based on biologic plausibility; demand outcome studies (this is true even if the impella study is positive…adopters will be vindicated but their “logic” will not be).
3. “Settled science” needs to be re-examined from time to time.
Next Monday’s column here should be a doozy.
Imagine limiting the exposure to toxic levels of metals by lifestyle changes. Always a drug...
Very interesting! And I hope you will report back here, as I didn't expect the American major news outlets to a) CARE or b) report correctly and accurately the findings.
I predict the the chelation on will be buried soon.
You said "In fact, if you don’t do this, you get dinged for practicing poor quality medicine."
By WHO???
What happened to the doctor/patient relationship there!? How can a doctor follow evidence from 40 Yeats ago?
Thanks for the previews of these various trials. I'll be interested to hear about the results.
I wonder if you could talk to someone at the conference about improving the ACC's risk calculator for developing ASCVD, which has absurdly nonsmooth properties which undermine its credibility. According to a calculator, a 52 year old Caucasian male, total cholesterol 179, LDL 110, HDL 50 , BP 110/70, nonsmoking, no diabetes/meds has a lifetime risk of 5% (light blue bar below):
https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/
If you increase total cholesterol from 179 to 180 (a negligible increase) and leave the other values the same, lifetime risk jumps from 5% to 36% !?!?! It's just not plausible that such a tiny increase in total cholesterol should lead to such a giant jump in lifetime risk. The ACC can do better than this. Millions and millions of people are being advised about whether to take a statin, whether to change their diet and lifestyle, etc, in part based on this calculator. Since it's available to anyone online, it's easy enough for numerically-inclined skeptical patients to find it online, play around with it, discover its ridiculously nonsmooth behavior and lose some confidence in the medical system.
There are thousands and thousands of data scientists out there who would love the chance to collaborate with the ACC on improving that calculator. The current calculator can't possible be based on rigorous methodology if it jumps from 5% to 36% when total cholesterol goes from 179 to 180.
Well I am now after your pep talk very excited about the upcoming cardiology superbowl Sunday 😃
Why aren’t ALL doctors in ALL specialties not demanding emergency hearings on the WPATH files? A huge scandal. I know it is not the topic of this great essay, but I could not help but be struck by the call for emergency FDA hearings if the device turns out to not show benefit in spite of 18 yrs of cardiology “ believing “ it works.
The WPATH files are much more devastating and effects young people . Surely the industry of gender affirming troubled kids with outright lies and no informed consent deserves emergency action.
This is NOT about legal protection for trans adult which is just. WPATH( world professional assoc of trans health) has knowingly violated every norm standard and ethic that has been the bedrock of the doctor patient relationship. It is way beyond malpractice which is about accountability for errors.. Sterilizing kids first with hormonal manipulation and then with aggressive surgical interventions($$$$$ for those who do these interventions) without any evidence( but lying and claiming evidence) and without informed consent is a travesty ( There is no word to that captures the enormity of what these WPATH practitioners are doing still) and every doctors’ business. This is not an error on their part. It is however a grave error on the medical profession if we fail to stand for what we KNOW is right and protect these ever growing number of confused troubled kids.
Modern cardiology. What an oxymoron that is! Fake drug trials...we don't need April Fools Day to see that is quite a common practice.
I find myself very excited about this, and as a pediatric transplant hepatologist it applies to none of my patients! Can’t wait for the debrief.