Age is such a dominant factor in the equation that a 75 yesar old male with perfect other factors is till over 13 in the calculation. Essentially you are sying tht every older person should be taking a statin if you follow the recommendations. That seems prima facia dubious --are countries, eg, france, where people are outlinging our population tsakng statins lso universally? No. So you are missing other factors, eg, exercise for one.
As I wrote, "Probably worth a follow-on article." I, for one, would benefit if someone way more expert than me would write a follow-on article to factor in statin "side effects" - nature and prevalence - and to further help me understand the "accuracy"/pros and cons of those risk calculators.
Interventions & Violence have this in common - once used, there's no way to know if alternative actions, or no action at all, would have yielded different outcomes in a wholly uncertain illusion of our future. Time is an illusion and our primate thinking about it makes us very poor stewards of connected planetary existence - since we nominated ourselves to the role of Gods on Earth. What happens to human societies over longer time periods who experience peace, good food, and societal stability? Do we even have a reference point to check? We all know the answer.
George Maldanado and Sanders Greenland have an excellent article on this topic, going back to the platonic ideal of how to establish causality and working forward to understand real world limitations. I spent a couple of semesters in George's seminar in grad school, and this paper was an eye opener in truly understanding research design as well as the need to understand and question assumptions.
Maldonado G, Greenland S. Estimating causal effects. International journal of epidemiology. 2002 Apr 1;31(2):422-9.
This study is not evidence of anything. Authors conclude that their suppositions about possible nocebo effects on reported side effects might be possible---no scientific justification for any of their statements. The last paragraph before their Conclusions states: "There are limitations to our study owing to the nature of the voluntary reporting system in FAERS. Passive surveillance might underestimate the true number of AEs as the total number of patients exposed to the drug is not known, the true incidence rate cannot be calculated from this information."
That a supposedly reputable medical journal would print junk like this is sad but not unexpected.
A former MPH student of mine at Purdue, Felicia Trembath, did her thesis looking at the evolution of ACOG guidelines for vaginal births after C-sections. She found that the "expert panels" evolved the guidelines to stigmatize vaginal deliveries and reduce patient autonomy, misusing data on risks of uterine rupture after a vertical incision as applicable to ALL VBACs after a prior Cesarean, even though the evidence showed no real elevation in risk after a lateral incision. The changes trended to empower the doctor over the patient and to promote the riskier and better reimbursed invasive surgical delivery over a vaginal birth.
I review for several journals, and am probably one of the tougher reviewers out there. I am shocked at how many papers fail to present a solid theoretical basis for why the researchers would even expect a relationship to exist, fail to understand how their results contribute to a broader intellectual arena than merely the relationship at hand, fail to consider potentially confounding relationships (a particular problem with papers that explore relationships between SES or race and health outcomes), and have authors who do not understand the mathematical assumptions of their statistical model. The siloed nature of the modern academy creates a tunnel vision that is anti-intellectual rather than serving the ideals of the academic endeavor. I tend to recommend far more rejections than acceptances, or even acceptances with major revisions.
The failure to balance risk abated by a preventive measure with risk from the measure is a good reason for the backlash against the COVID vaccines. Looking at risk from the disease compared to vaccine side effects, it is clear that no net benefit exists for those under age 25 (thanks to negligible risk from the disease) and even an increased risk for males in the cohort less than 25 years old. In contrast, there is a net reduction in overall risk of morbidity for mortality with a vaccination for those over age 25, increasing significantly after age 60. Because public health leaders chose to downplay or ignore treatment-induced risks, they adopted a strategy that came back to bite them in the ass when the risks became known to the general public. This is not a condemnation of the vaccine - ALL vaccines carry some risk - but rather the strategy of public health leaders to pursue a universal vaccination goal and not ignore, but actively downplay the tradeoffs.
It is not the first time we have seen this in the Public Health community. Neustadt and Fineberg documented the same pattern in the 1975-76 Swine Flu incident in an evaluation commissioned by former Secretary of Health, Education, and Welfare Joseph Caliafano. I documented problems with framing the need to improve the public health system's ability to deal with infectious diseases by tying it to the fear of bioterrorism in a 2004 article in the journal Public Administration Review, and made similar criticisms of WHO and CDC communications over the 2009 Influenza epidemic in an interview I gave CBS.
The problems with much of the leadership in public health are a monotechnic focus on a single solution without consideration of opportunity and transaction costs as well as an unwillingness and inability to communicate issues of risk to the public. With the latter, there are structural incentives that exist in the fact that communicating fear increases agency power and improves budgetary position.
I doubt it. Calcification is just one part of the pathophysiology of atherosclerosis and can vary quite a bit from person to person. No one really knows whether it portends a significantly greater risk of heart attack or stroke---the two main complications of atherosclerosis which are said to begin with a disruption of the arterial lining. If it is an indicator of severity of disease, the question remains what are you going to do about it. Dr. Mandrola has reviewed a number of studies on this website showing that prophylactic "treatment" with stenting or coronary bypass has virtually no benefit in terms of mortality or reduction in future strokes or heart attacks in asymptomatic patients. This is also true for reduction of cholesterol levels.
The failure to balance risk abated by a preventive measure with risk from the measure is a good reason for the backlash against the COVID vaccines. Looking at risk from the disease compared to vaccine side effects, it is clear that no net benefit exists for those under age 25 (thanks to negligible risk from the disease) and even an increased risk for males in the cohort less than 25 years old. In contrast, there is a net reduction in overall risk of morbidity for mortality with a vaccination for those over age 25, increasing significantly after age 60. Because public health leaders chose to downplay or ignore treatment-induced risks, they adopted a strategy that came back to bite them in the ass when the risks became known to the general public. This is not a condemnation of the vaccine - ALL vaccines carry some risk - but rather the strategy of public health leaders to pursue a universal vaccination goal and not ignore, but actively downplay the tradeoffs.
It is not the first time we have seen this in the Public Health community. Neustadt and Fineberg documented the same pattern in the 1975-76 Swine Flu incident in an evaluation commissioned by former Secretary of Health, Education, and Welfare Joseph Caliafano. I documented problems with framing the need to improve the public health system's ability to deal with infectious diseases by tying it to the fear of bioterrorism in a 2004 article in the journal Public Administration Review, and made similar criticisms of WHO and CDC communications over the 2009 Influenza epidemic in an interview I gave CBS.
The problems with much of the leadership in public health are a monotechnic focus on a single solution without consideration of opportunity and transaction costs as well as an unwillingness and inability to communicate issues of risk to the public. With the latter, there are structural incentives that exist in the fact that communicating fear increases agency power and improves budgetary position.
If every doctor did this i think fewer patients would be on statins.
Patient centered decision making requires humility/ patience on the part of the prescriber. Is there a section on the medical school application for assessment of that?
Also, Can someone educate me, why isnt family history in either calculator?
Thank you, Dr. Mandrola - you've always offered excellent explanations of these complex health management issues. Especially for us nonprofessional health care people (but health conscious and curious!).
Totally agree that the treatment thresholds (for primary prevention) are completely arbitrary. And having arbitrary thresholds creates false dichotomies. Is someone with a 10 year risk of 7.4% really meaningfully different than someone with a 7.6% risk? There is no biologic reason to treat those 2 people differently.
So your point is well made and well taken. The reason to potentially treat those 2 people differently lies in how their personal values and preferences might diverge, rather than from the calculated risk profiles.
I really like your approach. Up till now I say things like “taking a pill will reduce your risk slightly” (I focus much more on ARR than on RRR). But I think doing the math for the pt and showing your work would be a great tool for illustration.
I would only add that your assumption of 25% RRR is based on 1mmol LDL reduction (in SI units)….which is about 40 in US units (is that mg/dL?). Depending on starting LDL and dosage of high intensity statin, you might exceed that (I usually use 40% reduction for high intensity statin and 20% for ezetrol for quick math).
My advice to patients over many years of practice was to ignore things like risk calculators. They are based on inaccurate and mostly meaningless data such as cholesterol levels. Preventive medicine is largely a wishful fantasy. The doctor's function is to diagnose and treat disease. The figures on prevention are pretty pathetic. If you think that changing diet or exercise patterns will help you stave off disease, then go for it. But don't take medication that may alter your normal physiology. I would also spend time explaining how the figures quoted for risk reduction are very misleading. Typically, a 25% relative risk reduction means something like reducing absolute risk from 2% to 1.5%. Pointing this out usually reduces the enthusiasm for the "preventive" treatment.
Combine the tiny absolute risk reduction with the side effects of the statin meds and it's hard to see why anyone would take them. Especially over many years.
Population statistics mean nothing to the individual who is the black swan. Risk/benefit decision is also an individual decision. Give the patient the relevant data and let each decide .
Age is such a dominant factor in the equation that a 75 yesar old male with perfect other factors is till over 13 in the calculation. Essentially you are sying tht every older person should be taking a statin if you follow the recommendations. That seems prima facia dubious --are countries, eg, france, where people are outlinging our population tsakng statins lso universally? No. So you are missing other factors, eg, exercise for one.
Be careful with your “rational medicine” and individualized care. You are upsetting the PBM-Pharmaceutical Collusion.
I worked with the AHA physicians cholesterol education project in 1983. I wish we knew what we were doing.
Keep going…
Ty will start using over old cv risk calculation when egfr available
As I wrote, "Probably worth a follow-on article." I, for one, would benefit if someone way more expert than me would write a follow-on article to factor in statin "side effects" - nature and prevalence - and to further help me understand the "accuracy"/pros and cons of those risk calculators.
Interventions & Violence have this in common - once used, there's no way to know if alternative actions, or no action at all, would have yielded different outcomes in a wholly uncertain illusion of our future. Time is an illusion and our primate thinking about it makes us very poor stewards of connected planetary existence - since we nominated ourselves to the role of Gods on Earth. What happens to human societies over longer time periods who experience peace, good food, and societal stability? Do we even have a reference point to check? We all know the answer.
George Maldanado and Sanders Greenland have an excellent article on this topic, going back to the platonic ideal of how to establish causality and working forward to understand real world limitations. I spent a couple of semesters in George's seminar in grad school, and this paper was an eye opener in truly understanding research design as well as the need to understand and question assumptions.
Maldonado G, Greenland S. Estimating causal effects. International journal of epidemiology. 2002 Apr 1;31(2):422-9.
I just remembered something that I believe you wrote a long time ago (+10 years?) concerning statins. If memory serves me, it went like this:
If you have borderline high cholesterol (200–250) and 2 or more of the below conditions, you should consider taking a statin.
Obese
Family history of CVD
Smoke
Hypertensive
Diabetic
Wondering if the above guidelines are outdated, and we should make our statin decisions based on the new calculators, not the above list?
Wondering how to factor in considerations based on recent reports of statin side effects?
Again i am being evidence based
https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007480
This study is not evidence of anything. Authors conclude that their suppositions about possible nocebo effects on reported side effects might be possible---no scientific justification for any of their statements. The last paragraph before their Conclusions states: "There are limitations to our study owing to the nature of the voluntary reporting system in FAERS. Passive surveillance might underestimate the true number of AEs as the total number of patients exposed to the drug is not known, the true incidence rate cannot be calculated from this information."
That a supposedly reputable medical journal would print junk like this is sad but not unexpected.
A former MPH student of mine at Purdue, Felicia Trembath, did her thesis looking at the evolution of ACOG guidelines for vaginal births after C-sections. She found that the "expert panels" evolved the guidelines to stigmatize vaginal deliveries and reduce patient autonomy, misusing data on risks of uterine rupture after a vertical incision as applicable to ALL VBACs after a prior Cesarean, even though the evidence showed no real elevation in risk after a lateral incision. The changes trended to empower the doctor over the patient and to promote the riskier and better reimbursed invasive surgical delivery over a vaginal birth.
I review for several journals, and am probably one of the tougher reviewers out there. I am shocked at how many papers fail to present a solid theoretical basis for why the researchers would even expect a relationship to exist, fail to understand how their results contribute to a broader intellectual arena than merely the relationship at hand, fail to consider potentially confounding relationships (a particular problem with papers that explore relationships between SES or race and health outcomes), and have authors who do not understand the mathematical assumptions of their statistical model. The siloed nature of the modern academy creates a tunnel vision that is anti-intellectual rather than serving the ideals of the academic endeavor. I tend to recommend far more rejections than acceptances, or even acceptances with major revisions.
More reviewers with your perspective would certainly improve the quality of medical journal articles.
The failure to balance risk abated by a preventive measure with risk from the measure is a good reason for the backlash against the COVID vaccines. Looking at risk from the disease compared to vaccine side effects, it is clear that no net benefit exists for those under age 25 (thanks to negligible risk from the disease) and even an increased risk for males in the cohort less than 25 years old. In contrast, there is a net reduction in overall risk of morbidity for mortality with a vaccination for those over age 25, increasing significantly after age 60. Because public health leaders chose to downplay or ignore treatment-induced risks, they adopted a strategy that came back to bite them in the ass when the risks became known to the general public. This is not a condemnation of the vaccine - ALL vaccines carry some risk - but rather the strategy of public health leaders to pursue a universal vaccination goal and not ignore, but actively downplay the tradeoffs.
It is not the first time we have seen this in the Public Health community. Neustadt and Fineberg documented the same pattern in the 1975-76 Swine Flu incident in an evaluation commissioned by former Secretary of Health, Education, and Welfare Joseph Caliafano. I documented problems with framing the need to improve the public health system's ability to deal with infectious diseases by tying it to the fear of bioterrorism in a 2004 article in the journal Public Administration Review, and made similar criticisms of WHO and CDC communications over the 2009 Influenza epidemic in an interview I gave CBS.
The problems with much of the leadership in public health are a monotechnic focus on a single solution without consideration of opportunity and transaction costs as well as an unwillingness and inability to communicate issues of risk to the public. With the latter, there are structural incentives that exist in the fact that communicating fear increases agency power and improves budgetary position.
How about a CT Cardiac Calcium Screening as a better guide to cardiac event risk than cholesterol levels.
I doubt it. Calcification is just one part of the pathophysiology of atherosclerosis and can vary quite a bit from person to person. No one really knows whether it portends a significantly greater risk of heart attack or stroke---the two main complications of atherosclerosis which are said to begin with a disruption of the arterial lining. If it is an indicator of severity of disease, the question remains what are you going to do about it. Dr. Mandrola has reviewed a number of studies on this website showing that prophylactic "treatment" with stenting or coronary bypass has virtually no benefit in terms of mortality or reduction in future strokes or heart attacks in asymptomatic patients. This is also true for reduction of cholesterol levels.
The failure to balance risk abated by a preventive measure with risk from the measure is a good reason for the backlash against the COVID vaccines. Looking at risk from the disease compared to vaccine side effects, it is clear that no net benefit exists for those under age 25 (thanks to negligible risk from the disease) and even an increased risk for males in the cohort less than 25 years old. In contrast, there is a net reduction in overall risk of morbidity for mortality with a vaccination for those over age 25, increasing significantly after age 60. Because public health leaders chose to downplay or ignore treatment-induced risks, they adopted a strategy that came back to bite them in the ass when the risks became known to the general public. This is not a condemnation of the vaccine - ALL vaccines carry some risk - but rather the strategy of public health leaders to pursue a universal vaccination goal and not ignore, but actively downplay the tradeoffs.
It is not the first time we have seen this in the Public Health community. Neustadt and Fineberg documented the same pattern in the 1975-76 Swine Flu incident in an evaluation commissioned by former Secretary of Health, Education, and Welfare Joseph Caliafano. I documented problems with framing the need to improve the public health system's ability to deal with infectious diseases by tying it to the fear of bioterrorism in a 2004 article in the journal Public Administration Review, and made similar criticisms of WHO and CDC communications over the 2009 Influenza epidemic in an interview I gave CBS.
The problems with much of the leadership in public health are a monotechnic focus on a single solution without consideration of opportunity and transaction costs as well as an unwillingness and inability to communicate issues of risk to the public. With the latter, there are structural incentives that exist in the fact that communicating fear increases agency power and improves budgetary position.
If every doctor did this i think fewer patients would be on statins.
Patient centered decision making requires humility/ patience on the part of the prescriber. Is there a section on the medical school application for assessment of that?
Also, Can someone educate me, why isnt family history in either calculator?
Thank you, Dr. Mandrola - you've always offered excellent explanations of these complex health management issues. Especially for us nonprofessional health care people (but health conscious and curious!).
Totally agree that the treatment thresholds (for primary prevention) are completely arbitrary. And having arbitrary thresholds creates false dichotomies. Is someone with a 10 year risk of 7.4% really meaningfully different than someone with a 7.6% risk? There is no biologic reason to treat those 2 people differently.
So your point is well made and well taken. The reason to potentially treat those 2 people differently lies in how their personal values and preferences might diverge, rather than from the calculated risk profiles.
I really like your approach. Up till now I say things like “taking a pill will reduce your risk slightly” (I focus much more on ARR than on RRR). But I think doing the math for the pt and showing your work would be a great tool for illustration.
I would only add that your assumption of 25% RRR is based on 1mmol LDL reduction (in SI units)….which is about 40 in US units (is that mg/dL?). Depending on starting LDL and dosage of high intensity statin, you might exceed that (I usually use 40% reduction for high intensity statin and 20% for ezetrol for quick math).
True patient centered approach!!
Thanks 🙏
My advice to patients over many years of practice was to ignore things like risk calculators. They are based on inaccurate and mostly meaningless data such as cholesterol levels. Preventive medicine is largely a wishful fantasy. The doctor's function is to diagnose and treat disease. The figures on prevention are pretty pathetic. If you think that changing diet or exercise patterns will help you stave off disease, then go for it. But don't take medication that may alter your normal physiology. I would also spend time explaining how the figures quoted for risk reduction are very misleading. Typically, a 25% relative risk reduction means something like reducing absolute risk from 2% to 1.5%. Pointing this out usually reduces the enthusiasm for the "preventive" treatment.
Combine the tiny absolute risk reduction with the side effects of the statin meds and it's hard to see why anyone would take them. Especially over many years.
Hope springs eternal and can frequently trump science and/or common sense.
Population statistics mean nothing to the individual who is the black swan. Risk/benefit decision is also an individual decision. Give the patient the relevant data and let each decide .
Gerald M Casey MD