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Is the new professionalism and ACP's new ethics really just about following guidelines?

The Charter ( Medical Professionalism in the New Millennium.A Physician's Charter) did not deal with just the important relationship of ...

Friday, May 08, 2020

Exercise and the aging heart versus aging in the sedentary heart

What are the arc (s?) of the normal aging heart ( the sedentary ageing heart and the exercising ageing heart).Are they different?

 Humans seem good at finding patterns-sometimes even from patternless noise.One of the stories told  by physiologists and cardiologists regarding the age related downhill course of cardiac function seems to go  something like this.

One way to simplify  cardiac function is to consider two parts of the cardiac cycle,1) contraction and ejection of blood and 2) relaxation and the refilling of the ventricle.

There are data indicating that the first signs of an impending problem are seen in the filling phase ie. diastole.From extensive echocardiographic and invasive physiologic measurements in humans the following sequence can be sketched out and penciled in.

First, there is impaired relaxation following by decreased elastic recoil and later diminished  compliance ( which is to say increased stiffness) and then -at least according to work from the IEEM group- remodeling of hearts with thicker walls and smaller ventricular volumes).Simply put- a sedentary ageing  lifestyle leads to a small stiff heart and long time endurance exercise leads to a larger more easily filled heart.The contractile function of the heart is well preserved with ageing , at least as indicated by measurement  of the resting ejection fraction.( increasing stroke volume with exercise is another matter as is left ventricular stress measured by speckle echo.)

This is largely consistent with the mainstream echocardiographic model which proposes a predictable,progressive process beginning with impaired relaxation,followed by decreased compliance and ultimately- as a compensation- elevated left side filling pressures.This model describes three phases of diastolic dysfunction indentifiable by combination of echo findings believed to reflect  how well or poorly blood flows into the ventricles from the atrium. This model recognizes that the various indices ( e.g E/A ratio, IVRT,maximal E wave velocity and the time constant of isovolumic pressure decay (Tau) change with age so that what would be abnormal in a 20 year old is normal in a 75 year old.It is thought that that filling pressure can be estimated by use of this model. NOTE-see end note 1 for reference to data that challenges the mainstream model by in part  providing data that cardiac cath measurements of left sided pressures do not regularly correspond with the three echo defined stages of diastolic dysfunction)

Next, I consider  what I have labelled as the "Dallas or IEEM theory" of cardiac ageing.
I do not know if Dr. Ben Levine would approve of my label or not. Maybe we could call it the Levine Theory.  see end note 2

A series of articles from the University of Texas Southwestern Medical School and the IEEM have provided extensive invasive and noninvasive data regarding cardiac function at various ages and the effect of longtime endurance exercise versus sedentary ageing on  cardiac structure and function.

Levine et al first demonstrated that lifelong endurance athletes ( 25 years or more of running a lot) had left ventricular compliance virtually identical to those of sedentary 20-30 years olds. Then they compared ventricular compliance in four groups of 25 each of people who exercised at various levels over a 25 years period. These were all subjects over the age of 64 and were screened to excluded pre-existing heart disease.Group 1 was sedentary people who exercised no more than one session per week. Group 2 were labelled "causal exercisers" and exercised 2-3 times per week. Group 3 (Labelled as committed exercisers}worked out 4-5 times per week and the "competitive" group trained 6-7 times per week and regularly raced.The racers had the most elastic  or compliant ventricles while group 3 was "very close" in terms of ventricular compliance while groups 1 and 2 has significantly stiffer hearts.Note: while exercise seemed to help maintain compliance , long time endurance exercise did not mitigate the age related loss of ventricular relaxation-as measured by the isovolumic relaxation time  (ivrt) which is the time from aortic valve closure to mitral value opening.

Next, Levine studied a group of 70 year old subjects  and an vigorous  exercise program was unsuccessful in improving the reduced compliance observed in that group. Next another study demonstrated that middle age subjects with a year long exercise program ( that involved in part high intensity interval training) were able to increase their ventricular compliance.This implies that past some point in time you cannot improve LV compliance with endurance training  with some interval training but middle age may not be too late.This does definitely not mean that exercise for those 70 years of age and older gain no benefit from aerobic exercise,,just that it looks like they will not  improve left ventricular compliance (at least withinthe time frame of Levine's subjects)

In another article Levine said that exercise in the range of that performed by the "committed exerciser" might be adequate.


My main question in this regard is "how much exercise "is sufficient to maintain a healthy compliant left ventricle." Levine's amazingly compliant  (pun intended) subjects not only stuck with program for a full year but after the first 6 months participated in a hig intensity interval program using the demanding 4X4 workout program that involves 4 minutes of exercise at 95% of maximal heart rate followed by 4 minutes of rest done four times.


End note 1. Grant et al (Grant A, Grading diastolic function by echocardiography:hemodynamic validation of existing guidelines.Cardiovascular Ultrasound 2015 513 :28) compared echocardiography results with  left heart catherization data in 460 patients.The data demonstrated that there were no differences in regard to left ventricular pressures between patients with normal diastolic function and those with grade 1 or 2 diastolic dysfunction but there were differences between normal and grade 3 diastolic dysfunction in patients with reduced ejection fraction.In those patients with preserved EF, there is no statistical difference between normal and any grade of diastolic dysfunction. (see figure 5 of their article which graphically illustrates the lack of the "predictable, progressive process "which characterizes the  current paradigm.)If the detection of elevated LV pressures which generally correlates with exertional shortness of breath is in part the goal of echo studies of diastolic function it appears to not be reached based on Grant's data.

end note 2. Dr Ben Levine is the director of the Institute for Exercise and Enviromental Medicine (IEEM) housed at the Texas Health Presbyterian Hospital Dallas and professor at University of Medicine Southwestern. His group have done a series of comprehensive physiological studies on subjects recruited from the Dallas Heart Study, a population based sample of 6100 subjects in Dallas .

In a nut shell the concept is that everyone with aging develops some degree of diastolic dysfunction related to impaired relaxation and loss of diastolic suction,Later aging (particularly sedentary ageing) is associated with loss of ventricular compliance ( AKA increased stiffness). A long term endurance exercise program is capable of mitigating the changes in compliance but not the decrement in relaxation and diastolic suction. IEEM's studies  further indicate that a sedentary lifestyle may lead to a small stiff heart which may be the precursor to heart failure with preserved ejection fraction (HFpEF) ) and the Dallas group suggest that an appropriate amount of endurance type exercise begun no later than early middle age may play an important role in the prevention of HFpEF.

"Humans are pattern-seeking story -telling animals and we are quite adept at telling stories about patterns, whether they exist or not".Michael Shermer.

End note 3:In 2008, Shermer coined the term "patternicity" -the tendency to find meaningful patterns in meaningless noise. I am not suggesting that the extensive,very carefully done research referenced above is meaningless noise.I just really like the quote but I certainty hope the "Dallas hypothesis" is a reasonably accurate approximation of the ways things  really are at least sometimes- having spent a lot of time running a lot over the last 40 plus  years.


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Saturday, April 25, 2020

Has the issue of keep closed longer or open up quicker now a political non-debate?

The following is a quote from a commenter named Handle on Arnold Kling's blog from 4/25/2020 entitled Henderson-Wolfers Non-Debate.

"One of the most terrible things than can happen in our society is that some important and formerly neutral questions becomes politicized and the position one espouses become a strong signal of affiliation to a particular team....once there is a party line on the matter thinking ends all together."

Two  examples-Several members of the Republican party appear in Congress not wearing masks
presumably to make a point. ER Nurses stage a counter protest against a open things up protest,shouting matches break out.

Thursday, April 16, 2020

Should Runners,walkers,cyclists beware the Coronavirus slipstream

The slipstream is the zone behind a person moving (walking, running,etc) which pulls the air along with the person.In the racing world it is known as drafting.

A recent news article about a study done by Belgian engineers has gone a bit viral itself.The wave of air flowing carrying respiratory droplets or drops  in the wake of a runners goes behind him   for distances greater than the magic 6 feet that we are admonished to respect as regards proximity to other humans in the world or preventive social distancing. At least the animations released by the researchers give that impression as do their data which at this writing has not yet been published in a peer reviewed journal.

See here for details.

If their  animations reflect the actual path  of exhaled particles,one might decide that even when you are out for a run to wear a mask at least some of the time.

See here for some questions and answers from one of the authors of the paper.

My personal take home is that when a runner passes me I should move to the side to avoid potential particles in his slipstream and ( with an abundance of caution) pull my mask up until the passer is 20 to 30 thirty feet  away. In the increasingly unlikely instance in which I actually overtake a runner and pass her I should move to the side and keep to the side to keep the passed person out of my slipstream.

Perhaps the equivalent of "My mask protects you,your mask protects me" for runners could be
"I'll keep you out of my slipscreen,you keep me out of yours"


According to the authors data a cyclist should stay 60 feet directly behind the bike in front or keep off to the side. Also they suggest that 16 feet behind a walker and 32 feet behind a runner to be approximations of the "aerodynamically equivalent social distance" which is six feet for stationary people.







.

Sunday, March 29, 2020

Role of masks for COVID prevention outside of hosptial use


The following is my opnion and not a medical recommendation.

 Public face mask use appears to be common in Asian countries and also is now required in 
the Czeck Republic where people wear masks as a civil duty with the  shared realization that "I protect you by wearing a mask and you protect me by wearing a mask."


Corona virus is spread by droplets by infected persons even if they are asymptomatic and both simple surgical type face masks and the more expensive and protective N 95 masks can significantly reduce spread of coronavirus.

Both type of masks have been scarce in the US as Covid 19 cases exploded. Expectations and then realization of actual mask shortages in medical care facilities lead public health officials to discourage the public from using masks in the hope that more would be available for health care workers

Sometimes it has been argued that the masks were not effective when used by the public while at the same time saying that the masks should be reserved for medical personnel use in whose hands they would somehow offer important protection to them. Of course, protection is not a function of one's profession.

It is likely that it was believed that  officially recommending masks would lead to a large public demand  , making it even more difficult for health facilities to obtain masks.

As Covid  19 cases continue to increase and the mask shortage worsened, the CDC  said that masks can be reused and ,that homemade masks and scarfs could be used as a last resort by health care workers. This was a major change in CDC recommendations.Home made masks and scarfs can be used to protect the public as well, although that was not said by CDC.

Jeremy Howard,a Deep Learning specialist from Stanford, has posted an excellent review of the use and value of face masks by the general public to decrease COVID spread and describes widespread use by the public in many countries.See here

He gives links to sites with important information on how to clean masks and how to make masks at home from towels, t shirts etc. Some may worry about being accused of taking masks away from doctors and nurses if they wear a mask in public. Home made masks hopefully defuse  that issue.

Summary:
Covid 19  is spread by droplets by asymptomatic as well as symptomatic persons
Various kinds of masks decrease risk of spread
Masks can be made at home and worn in public  without shame .A great DIY project
Masks  protect others perhaps even more than they protect the wearer
It has been suggested that it would be unpatriotic for the public to wear masks.I suggest the opposite.
wearing masks is patriotic.An asymptomatic covid 19  infected person being in public exposing others to the disease is certainly not patriotic.
I am not recommending  to bid up prices of masks,No one wants to take masks away from HCWs.
 But if you already have masks on hand ,wear them .If not they really can be made at home and will offer some important protection . Yes, less than the properly fitted and correctly worn N 95 and less than surgical masks but significant protection nevertheless.
Bottom line wear masks in crowds (including grocery shoping)

Finally, imagine for a moment if only 25% of subway riders in New York (8 million riders per day) wore masks for the last 2 -3 weeks what the results might have been. Also imagine the potential benefit after we all come out emerge from sheltering in place how potentially important wide spread use of mask might be in decreasing the risk and/or impact of a second wave.

The following quote is from Scott Alexander writing on his blog slatestarcodex.com on 3/23/20 giving a detailed analysis on the research of various masks and the protection they provide;

". So should you wear a mask?

Please don’t buy up masks while there is a shortage and healthcare workers don’t have enough.

If the shortage ends, and wearing a mask is cost-free, I agree with the guidelines from China, Hong Kong, and Japan – consider wearing a mask in high-risk situations like subways or crowded buildings. Wearing masks will not make you invincible, and if you risk compensate even a little it might do more harm than good. Realistically you should be avoiding high-risk situations like subways and crowded buildings as much as you possibly can. But if you have to go in them, yes, most likely a mask will help.

In low-risk situations, like being at home or taking a walk, I mean sure, a mask might make you 0.0001% (or whatever) less likely to get infected. If that’s worth it to you, consider the possibility that you might be freaking out a little too much about this whole pandemic thing. If it’s still worth it, go for it.

You are unlikely to be able to figure out how to use an N95 respirator correctly. I’m not saying it’s impossible, if you try really hard, but assume you’re going to fail unless you have some reason to think otherwise. The most likely outcome is that you have an overpriced surgical mask that might make you incorrectly risk-compensate.

If you are a surgeon performing surgery, bad news. It turns out surgical masks are not very useful for you (1, 2)! You should avoid buying them, since doing so may deplete the number available for people who want to wear them on the subway."
Here is a quote from a blog post by Tomas Pueyo entitled "Coronovirus:The Hammer and the Dance"which has attracted considerable interest.Here is the link.https://medium.com/@tomaspueyo/coronavirus-the-hammer-and-the-dance-be9337092b56

Pueyo considers masks part of the solution." (my bolding)
"the massive impact of policies like those of Singapore or South Korea:
  • If people are massively tested, they can be identified even before they have symptoms. Quarantined, they can’t spread anything.
  • If people are trained to identify their symptoms earlier, they reduce the number of days in blue, and hence their overall contagiousness
  • If people are isolated as soon as they have symptoms, the contagions from the orange phase disappear.
  • If people are educated about personal distance, mask-wearing, washing hands or disinfecting spaces, they spread less virus throughout the entire period."

(note the blue and orange wording references refer to charts in his article)

Maybe it is this simple: If asymptomatic patients are not contagious, the masks only for the symptomatic rule works, but if the  asymptomatic are contagious that rule does not work.

addendum: 4/11/20 Several glaring typos finally corrected. Also now the CDC has blessed the wearing of face masks by the general public, preferably of the home made variety.Two days ago at the grocery about 50% of the shoppers wore masks, most not of the DIY type.

Addendum 5/8/20 Today at Krogers only 2 of the approximately 40-50 person did not have masks.All of the store workers did and now they have erected plexiglass barriers shielding the checkers.

Wednesday, March 25, 2020

Do ARBs and ACEis make COVID 19 infection worse?

A recent article in the BMJ raised concern that drugs that inhibit parts of the RAAS system might be harmful to patients infected with the new novel corona virus  known as SARS-COV2 while the disease it produces is named COVID 19.

 Coarse grain epidemiologic data from the Wuhan outbreak indicated that one of the risk factors for bad outcomes was hypertension.It was then hypothesized that the increased mortality might be due to the subset of hypertension patients who were taking ARBs or ACEi as those may increase levels of ACE2 which has been shown in animals and possibly humans and ACE2 is the receptor for both SARS-CoV and SARS-COv2. So with more ACE2 would the results be a higher viral load?

On the other hand in an animal model of SARS-COV ARMS seems to reduce lung injury.

All this and a detailed recitation of the RAAS system as it relates to Corona viral infection can be found in the link found at the end of this post as can the citation for the BMJ article..That link is an article by Dr. GM Kuster et al published March 20 2020 in the European Heart Journal which reaches this conclusion:

In conclusion, based on currently available data and in view of the overwhelming evidence of mortality reduction in cardiovascular disease, ACE-I and ARB therapy should be maintained or initiated in patients with heart failure, hypertension, or myocardial infarction according to current guidelines as tolerated, irrespective of SARS-CoV2. Withdrawal of RAAS inhibition or preemptive switch to alternate drugs at this point seems not advisable, since it might even increase cardiovascular mortality in critically ill COVID-19 patients.
This is in agreement with a recent statement made by ACC/AHA.See herehttps://www.acc.org/latest-in-cardiology/articles/2020/03/17/08/59/hfsa-acc-aha-statement-addresses-concerns-re-using-raas-antagonists-in-covid-19



https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaa235/5810479?utm_medium=Email&utm_source=ESC&utm_campaign=ESC+-+Newstetter+-+week+13


addendum 4/620 clarification of the nomenclature for the virus and the disease caused by it

Thursday, March 19, 2020

Can Asymptomatic persons positive for covid-19 transmit disease

I believe we need to act as if they can.

A report from the chief epidemiologist from China's CDC in early March seemed to be reassuring.
Dr. Z.Wu speaking on an online conference on March 6 told the audience that transmission from presymptomatic people is rare and indicated that the  rate was 1-5% among person in close contact with infected patients.

Subsequent reports and consideration of foci of  rapid spread, (e.g. the Boston Biogen conference,the ill- fated cruise of the Diamond princess) suggest presymptomatic transmission may not be rare.

Japanese researchers found 634 of the 3711 passengers on the Diamond Princess tested positive and estimated 17.9 percemt were asymptomatic .

Using data from Tiajin China  Dutch researchers used a mathematical model to estimate from Tiajin  that the proportion of pre-symptomatic transmission was 62% ( 95% CI 50-76 %)

Note- these two analyses give estimates  and not actual proven head counts of instances of spread from person without symptoms

Viral counts are higher in the nose and throat and peak earlier in covid 19 infections than was the case with SARS so that it seems very plausible that a pre-symptomatic person could transmit disease.

 Further, even if the outer bounds of these estimates are still overestimates  the likelihood of pre-symptomatic spread  raises  major questions regarding  some of the current guidelines and  advice from public health experts.

If exposed health care workers are allowed to return to work based on history of no symptoms and there is asymptomatic spread then other workers and patients are at risk.

Early on in the U.S, public health experts discouraged the use of masks by the general public at times with an apparently self contradicting argument that 1) masks don't really work and 2)masks should be reserved for doctors and nurses.

 Of course, Surgical masks are not as effective a N-95 units but since viruses spread by droplets , masks offer some protection. Telling the public  that masks don't work does not seem to be very good advice and that position seems to have largely walked back.

 Early on US public health spokespeople  downplayed possible pre-symptomatic transmission but now that has changed.In fact Dr. Scott Gottlieb said "We know there is asymptomatic spread".Further, in a 3/18/200 tweet he suggested that if the youth who are ignoring efforts to be socially distant they should be required to wear masks"

I believe also that high risk people who for good reason must venture into crowded areas  ( e.g. groceries) should wear masks. I know I am- being at high risk by reason of age.




Friday, February 28, 2020

What do Left bundle banch block and traditional right ventricular cardiac pacing have in common?

Although it was demonstrated at least as early as 1989 by CL Grines et al (1) that left bundle branch block (LBBB) could cause significant functional impairment of the left ventricule (LV), clinical description and  general recognition of a LBBB cardiomyopathy as a clinical entity would require a decade or more.

Pacing the apex of the right ventricule was the default method for cardiac pacemaker implantation for many years and  the path to recognition of a right venricular pacing induced cardiomyopathy and a better way to pace was neither short nor particularly straight.

In 2005 (Blanc et al ) and in 2013 (Vaillant) reports appears describing a dilated cardiomyopathy apparently induced by LBBB that in some instances were significantly reversed by cardiac resynchronization treatment (CRT).Blanc wrote "long standing LBBB may be a newly identified reversible cause of cardiomyopathy."

Further proof was offered by Barot et al (2017) in the form of a  retrospective followup report.Thirteen of 94 LBBB patients with normal cardiac function (normal ejection fraction (EF) and no evidence of coronary artery disease developed a significant reduction in LV function over a variable time.

Not only is LBBB dyssynchronopathy heart failure now recognized it has become apparent that the usual heart failure meds do not seem very effective. In 2015, NC Wang et al reported the lack of response  to medical therapy in 32 LBBB patients with new onset LBBB-associated idiopathic non-ischemic cardiomyopathy (NICM) and that "a high percentage were super-responders [to CRT]."

James Daubert and Edward Sze (3)argued in 2018 that the then current guidelines for implanting CRT require at least 3 months of guide-line directed therapy (GDMT) before implantation but there are no randomized clinical trials showing efficacy of medications and suggested that CRT should be  considered for first line therapy rather than GDMT as many  (most) symptomatic patients with LBBB do not respond to GDMT.

Since the early 1990s CRT has become an important treatment for heart failure  with reduced ejection fraction (HFrEF) and delayed intra-ventricular conduction with the greatest benefit in those patients with LBBB.CRT traditionally has meant right ventricular pacing plus pacing the left ventricle from a vein on the surface of the left ventricle accessed through the coronary sinus.This is referred to as Bi-V.  or biventricular pacing.More recently His Bundle pacing (HBP) has been suggested as being as good  and perhaps better than Bi-V or at least as an alternative in cases in which the coronary sinus lead could not be placed.In cases in which the mechanical dyssynchrony is caused by an electrical problem an electrical "fix" seems necessary.HBP would seem to be the best fix being more physiological than Bi_V pacing .


Placing a pacing lead in the apex of the right ventricle was standard procedure for bradycardia indications for many years before EP cardiologists raised the question and then gathered evidence and finally  concluded that in fact RV pacing could lead to significant loss of synchrony in the LV which   resulted in heart failure in a significant number of patients

The similarities of the EKG in right apical pacing and LBBB certainly suggested possible functional impairment from RV pacing.Cardiologists were interested in some alterenative pacing method to avoid the harm that was becoming evident in RV pacing but no good alternative presented itself, at least not until HBP.Reports of septal pacing in place of apical pacing gave conflicting results.

As effective as traditional CRT (i.e. Bi-v) is some 30 % plus of patients with HF do not response while some seem to be "super-responders".Patients with narrow QRS complexes do not respond and those with a LBBB pattern are more likely to respond but all patients with a similar LBBB EKG pattern do not all respond to the same degree nor do they necessarily have the identical patern of LV electrical activation.All patients with an EKG designation of LBBB are not created equal.

The typical pattern of LV contraction described in LBBB is the following:

The interventricular septum moves quickly to the left in early systole (in the isovolumic contraction phase, i.e before aortic valve opens).The LV lateral wall is pushed  outward and finally the electrical impulse traveling through myocytes reaches the lateral left wall area and it contracts pushing  the septum to the right.

The initial left shift of the septum is mainly  the result of the electrical impulse traveling from right to left (the opposite of the normal situation) and also from the pressure difference between the RV and LV as the RV contracts before the delayed LV contraction. This initial septal shift is called septal flash or septal beak and can be seen on M mode echo as well as on speckletracking echo.

Calle et al (2 ) have proposed that this septal flash may be the key to what "true LBBB" is- meaning the pattern of dyssynchrony that is responsible for the functional impairment and the pattern most "fixable" by CRT and by HBP as regards both LBBB and right apical pacing induced dysfunction.

Various other echo criteria have been proposed as the preferred measure to assess dyssynchrony and response to CRT without general agreement. About 50% of patients with the EKG pattern of LBBB are shown to have the septal flash and the associated dysfunctional out-of-sync LV contraction.

The septal flash indicates that the septum is activated from right to left initiating a sequence of dyssynchronous ventricular segmental contractions and relaxations that are deleterious to ventricular function and may result in remodeling and ultimately heart failure with reduced ejection fraction and is often reversible to varying degrees with CRT either by HBP or Bi-V.

So would CRT be expected to be useful in patients with RBBB since the septal  activation is from left to right.In theory- no but Sharma ( 3) et al have reported significant clinical improvement
 in some RBBB heart failure patients treated with HBP.Perhaps right to left septal activation ( as indicated by septal flash) is not a necessary condition for there to be improvement from CRT but I doubt one would see a super-response and the mechanism of benefit may relate more to improved atrial-ventricular synchrony improvement  and not correction of an abnormal septal activation.







1) Grines, Cl et al Functional abnormalities in isolated left bundle branch block.The effect of interventricular asynchrony. Circulation  1989 79 845-853

2)Calle,D et al, Septal Flash :At the heart of cardiac dyssynchrony. Trends in Cardiovacsular Medicine2019,14,9

3)Sze,E and Daubert,JP Left bundle blck induced left ventricular remodeling and its potential of reverse remodeling. J Intv Card Electrophysiol 52 (3) 343-352, 2018

Tuesday, January 28, 2020

How Will "medicare for alll" be like the military industrial complex?

The following quotes are from the blog "on health care technology" written by Margalit Gur-Arie:



"Go ask Northrup Grumman or Lockheed Martin or General Dynamics or even Boeing or Booz Allen or any other “beltway bandit” how getting money from the Feds really works. There are well-greased revolving doors between the Pentagon and its contractors. There are stock options and executive positions for high ranking Federal employees. There are 535 people in Congress responsible for allocating budgets, and all 535 are for sale. Most of this infrastructure is already in place for health care too and building the HHS Heptagon shouldn’t take very long. The American President has little to no power over Federal spending, and even less so when it comes to large procurement contracts, as the current occupant of the White House discovered the hard way, during the Lockheed F-35 kerfuffle....


Clearly large health systems will survive and thrive under a Medicare For All law, but how about private health insurance? Future President Bernie says they will all be banned. Is that so? Currently a full third of Medicare beneficiaries are insured and “managed” by a handful of large private health insurers. Medicare is paying those private contractors fixed amounts of money per head for their services. Medicaid is doing the same for most of its beneficiaries, and all military health insurance (TRICARE) is contracted out to the usual suspects. Basically, the vast majority of people covered by public insurance, are really insured by gigantic insurance corporations. Fact: under the hood, taxpayer funded health care is the bread and butter of private health insurance companies."

So her analysis suggests very little difference at all.

The well known revolving door in regard to government and the defense industry is paralleled by the what goes on in the health care and pharmaceutical industry.See here 

Monday, December 16, 2019

Important changes happening(and happened) in Med School Education what is it about?

Drs. Accad and Koka  discuss  major changes in Medical school education with Dr. Stanley Goldfarb.See here for the podcast.

Are the changes in the medical school curriculum designed to develop social and political advocates rather than well trained physicians?Dr. Goldfarb argues that it is.

The changes are all about population medicine,some thing I have blogged about often before see here.

Courses about climate and medical conditions are already on the curriculum of several medical schools ( see here ).One school mentioned in the linked article actually giving instructions on how to write op-eds about climate change supply a concrete example of Goldfarb's argument.Classes on
environmental justice are also appearing on the schedule.

The degree to which a progressive view point is often part of primary,high school and college education should make it no surprise that med school students are actually requesting courses
in social and environmental justice.



Friday, December 13, 2019

Should journals always report fragility index on a clinical trial.

Interesting article in December 2019 Circulation.(See here.) that discusses the "robustness" of a number of cardiovascular disease trials.

A  purported measure of robustness is the Fragility Index (FI) which is the number needed to move from the non-event group to the event group to turn a statistically significant finding into a non-significant one. A FI of 1 would mean that if one subject was moved from the event to the non event group there would no longer be a significant  difference.

A related concept is  the comparison of the FI to the number of subjects lost to follow up. The trial's results would be considered less robust if the number lost is greater than the FI.

Ridgeon et published a review of 56 RCTs in critical care treatment topics.The median FI was 2 and slightly greater that 40% of trials had a FI of one or less.So does that suggest that clinical guidelines based entirely or in part on those low FI studies are built on shifting sands?


But wait, listen to this criticism of the concept of FI by Dr. F.Perry Wilson before rushing to trash a RCT simply because the FI is too low. Wilson shifts the problem to one of having too much reliance on the p value in the first place.



1)Ridgean EE et al Crit. Care Med 2016,vol 44 ,1278

Thursday, December 05, 2019

What could possibly go wrong when legislators think they know how to practice medicine

Here is another item from the file labelled "I'm so glad I don't practice medicine any longer"

A proposed bill from the Ohio legislature breaks new ground in the land of the  ignorant and absurd.

It would require a physician to transplant an embryo from the fallopian tubes to the uterus of the mother or face a charge of capital "abortion murder".See here

Friday, November 29, 2019

State legislatures act to increase collateral damage in the opioid epidemic war


This Thanksgiving I am particularly thankful that I am not a practicing physician any longer and
no one in my family suffers from chronic pain.

Several state legislatures have passed legislation that mandate chronic pain patients sign adhesion "contracts" and agree to periodic urine tests and a drug test prior to obtaining their first prescription for an opioid .I do not know if there are any penalties for physicians who do not comply with the law.

Here are details of the Pennsylvania law known as Opioid patients Prescription Agreement Act.It requires in order for a patient to get a prescription for an opioid for chronic pain they must sign an agreement  and consent to an initial urine drug test and then periodic tests.Credit is due to
the Pennsylvania Medical Society for their opposition to this ill advised law

Treating patients like criminals or potential criminals will do little to stem the opioid epidemic but is bad news of physicians,patients,dentists and pharmacists.

This recently enacted,effective immediately, Pennsylvania law is a poster child for an act of legislation that will make chronic pain patients lives even more miserable,doctor's practices more difficult and will decrease the number of opioid deaths not at all. To force patients to do periodic urine drug tests is to not even pretend to act for the welfare of the patient sacrificing it to some nebulous, hypothetical goal of decreasing the diversion of unused prescription drugs.(the idea here apparently being that if the patients tests negative for drugs that they may well be selling their medications) .

In an earlier era physicians would likely be pleased when their patient with chronic pain used less pain medicine- now they are expected and perhaps legally obliged to consider their patient might be involved in criminal activity.

 That is so different from the comment,traditionally attributed to
Maimonides

"May I never see in the patients anything but a fellow creature in pain"



What does a physician do if a chronic pain patient tests negative which raises the possibility of the patients diverting the pills.Is the physician obligated to investigate or call the police or the DEA? What if he doesn't?

Probably it is best to not have chest surgery or shoulder surgery or a Pacemaker implantation in Kentucky, Tenn. or Fla. as the legislatures in those states have mandated that a initial opioid prescription be limited to a 3 or 4 days supply.(1) Who would know better how to practice medicine  than the democratically elected officials ?Managing chronic medical conditions must be thought to be too important to be left in the hands of the patients and their physicians.


Dr.Jeffery A. Singer,surgeon and Cato fellow, has been studying and speaking out about  the harm done by the war on drugs for years and is worth quoting:

"Evidence continues to mount that curtailing prescription opioid use serves divert nonprescription use to heroin....most opioid users initiate drug use for non medical reason."

In short, the opioid problem is not because of the way physicians treat pain and limiting the access of patients with pain to pain relief will only make the "epidemic" worse.We have the wrong diagnosis and the wrong treatment.

1)National Conference of State Legislators. Prescribing Policies: States Confront Opioid Overdose Epidemic. NCSL website. http://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx. Published October 31, 2018

Saturday, November 16, 2019

is Google being a "business associate" of Ascension Health Care something to worry about

In you are or  have been a patent of Ascension health care system your names,diagnosis, date of birth may be accessible to employees of Google according to recent news reports on various sites.The information is reported as including names and date of birth and you do not have to give permission.

For those of you who still think HIPAA is   all about your medical privacy , think again This is said to be perfectly legal under HIPAA as Google is a "business associate" of Ascension Health Care and the data is available to Google without permission of the patients or their physicians and apparently without the need to even notify patients about it.

A detailed explanation is found in a recent article in WIRED. See here.Actually after the story was published on multiple sources both Google and Ascension made  press releases assuring all concerned that there is absolutely nothing wrong and this arrangement is nothing to worry about and that everything is perfectly compliant with HIPAA

We are told that the arrangement and Google's help is " to optimize health and wellness of the individual and the community"

The story goes that what happens in Vegas stays in Vegas but what you tell your physician in the Ascension Health system goes to the Google  cloud.

With all the errors and fabrications I have personally noted on the EHR medical records of two patients and the very big risk of the  GIGO phenomenon  Google will likely devise some interesting optimizations.

Examples of those errors:

1.One erroneous diagnosis of atrial fibrillation
2.One erroneous diagnosis of hyperthyroidism
3.a diagnosis of osteoporosis which had no basis
4.two complete physical exams "documented in the chart" that never happened
5.one designation of an orthopedic abnormality in the wrong extremity
6.one designation of a  "my"primary care physician who I had never heard of

If the number of errors noted in just two patients is extrapolated to even a small percentage of medical records , you have to  be skeptical about how accurate or  useful would Google mega data magic be?.With a significant amount of garbage in won't we expect a bit of garbage out?

So with the privacy issue and the questionable reliability of HCRs ,the business associate relationship between Google and Ascension has a number of people concerned.

Sunday, November 10, 2019

Could government mandated "quality" programs be bad for your health.

Dr. Paul Hsieh explains how exactly that has happened in his recent commentary in Forbes.
He explains how the Hospital Readmission Reduction Program (HRRP) has backfired and likely caused harm. Another example is the "Never"programs in hospitals.

Certain mishaps including patient fall are deemed "never events" and hospitals are penalized for Medicare patient's falls. This apparently has lead to some hospitals and nurses taking various measures to keep patients in bed to prevent falls.Bed rest in the elderly can quickly lead to weakness and a greater tendency to fall.

This reminds one of the famous 4-hour pneumonia rule,which is a great real life example of  Goodhart's law , i.e. when a measure become a target it looses its value as a measure. The folks at CMS appeared to learn nothing from that debacle.

What may even be worse is that physicians may be intimidated by some thing called the disruptive physician concept into not saying the obvious and calling the emperor naked. I quote from an earlier blog entry:


"The mandatory and quasi mandatory nature of guidelines or quality indicators as wielded by the CMS mandarins and other institutional elites become even more dangerous with the spreading use of the "disruptive physician" doctrine. Not only must you go by the rules you can't complain about them without incurring the wrath of the hospital's disruptive physician committee.This doctrine is a brilliant control mechanism.If you challenge the disruptive physician concept you are by definition disruptive. "






Thursday, November 07, 2019

The developing Vison of Primary Care in the Big Rock candy Mountain

Probably the primary care physicians in training who authored a  commentary in the NEJM describing their view of what primary care should be may will have to google the candy mountain reference in the title or just look here.

KA Barnes,J. Kroening-Roche and BW Comfort wrote a perspective piece in the Sept 6 2012 issue of the NEJM.

In it they describe their vision of primary medical care in the U.S. I will not quote their description of what they hope primary care will be but I will quote a sentence that is the essence of what I believe to be a bogus concept.

"Primary care cannot be primary without the recognition that it is communities that experience health and sickness."

Their description of a typical day a primary care practice could be dismissed as idealistic and naive or wishful thinking as in lemon aid springs of the Big Rock Candy Mountain ( at least to an increasingly curmudgeonly old retired doc) but the quoted sentence expresses a conceptual error.

No, communities do not experience anything;nor do they choose anything nor do they suffer or rejoice. Only sentient beings can do any of those things and communities are an abstraction . Similar terms ( society,the country, etc) can sometimes be useful summary ways of thinking and talking- a useful short hand. To say that a community is ill or well is a figure of speech;to say that Mr. Brown is sick is an empirical fact. Mr.Brown can regret his earlier excessive use of alcohol, but to say the community regrets anything is a category error.

This is not to deny that there are economic factors and social factors that might impact someone's health but to the degree that such things happen they impact the health of individual, real life people not society and not a community.Government programs can improve the health of individuals, with such things as immunization campaigns and providing health care to the indigent.But it is not the community whose health improves it is the individuals who can benefit.

Society or communities are not some super being or entity apart from the individuals who comprise it. To consider that they are or to reify this abstraction lays the foundation for consideration of weighing the value of the individual against this mythical creature and presto we have the new medical ethics.

Reification refers to the treating of an abstraction as if it were a concrete real thing or an actual physical entity.In short turning an idea into a thing and treating it as if the idea posses the attributes of an actual being.

It is the public health paradigm taking over clinical medicine. I hope that when I get older and ill that the physician I consult will realize that I am her patient and not the community in which I reside or the HMO to which I belong.

Sunday, November 03, 2019

More long time followup on his bundle pacing

Dr. Francesco Zanon of Italy and Dr. Pugashendhi  Vijayaramen of the Geisinger Clinic in Pennsylvania report on the long term performance and safety of 884 patients implanted between 2004 and 2016.

The first 368 were implanted using a deflectable delivery system while for  the next 476 patients a fixed curve delivery system was used.There was a significant difference in both the capture threshold and in the complication rate between  the two groups,with the data strongly favoring the fixed curve system.

Complications  were fewer in the fixed curve group (11.9 % and 4.2%) and the capture threshold was lower (2.4 volts versus 1.7 volts)The complication rate difference could at least in part been due to  the learning curve as the fixed curve system was used later.

1) Zanon, F, Long term performance and safety of His Bundle pacing:A multicenter experience.
J.of Cardiovascular Electrophysiology, 2019, July 16







Friday, October 25, 2019

Does your doctor really work for a venture capital firm

Some of the docs who see you in the ER,or read your imaging study, or give you Propofol for an endoscopy may well be the employees of a company that is owned by venture capital companies such as KKR.And if you have been hit by a big surprise medical bill because the ER doc for example is not part of the network your insurance covers it is even more likely .Apparently at least some  medical staffing companies owned by venture capital companies are accused of being heavily into balance billing.The names  Envision and EmCare come to mind.

Dr.Roy Poses had published an excellent report entitled "Who advocates for surprise medical billing?" on this topic on his blog, Health Care Renewal.See here for some eye-opening information.

Emergency room physicians are often supplied by physician staffing firms, such as Envision and EMcare.

 According to the HCR blog commentary these two are said to be  owned by  the global investment firm KKR.However the entry on Wikepedia on EmCare gives a different description of the various buyout and mergers surrounding EMcare not mentioning KKR.In any event we are talking about the corporate practice of medicine which is still not legal (although various states have exemptions of the rule) in some states. EmCare operates in 42 states.Envision, however, was acquired by KKR in 2018 for 9.9 billion.It is more complicated than that as Em Care through a series of buyouts  may have actually become Envison.Whatever may be the history of these company's buyout name changes, the point is that  venture capital companies own corporate entities that in turn supply physicians in various roles- i.e.ER docs,anesthesia services and even ICU doctors.So in the interest of transparency those doctors could have white coats with the logo of KKR.

The wide spread operations of companies such as these does not mean that laws restricting the corporate practice of medicine are no longer enforced  even  though their control of medical practice have greatly decreased..For recent examples of medical practices and non physicians owners getting caught by corporate practice law see here.

The basis of the corporate practice doctrine is usually said to be the conflict between the fiduciary obligation of the corporation to its shareholders to maximize profit  and the fiduciary role of the physician to the patients.

It does not take much imagination to think of situations in which what is good for the corporate bottom line does not correspond to what is good for the patients.






Thursday, October 10, 2019

Aristotle trial,bad data from China,but apixaban probably still better than warfarin

In 2011, the Aristotle trial was published in the NEJM.It demonstrated aprixaban's superiority over warfarin in the treatment of non-valvular atrial fibrillation (AF)- fewer strokes, less bleeding and apparently a decreased over all death rate. But wait. The  FDA did not quickly approve apixaban.

One major problem was questionable  data from a China trial site which included mixed up medication distribution and some possibility of fraudulent data. Critics also noted that  there was no mortality benefit noted in the European cohort and that 35% of the warfarin group did not achieve a therapeutic INR.

After considerable back and forth between the drug companies and the FDA apixaban ( Eliquis) was approved for  treatment of non-valvular AF but not the claim that the overall mortality was reduced.

That should have been the end of it but recently an analysis of a number of meta analyses revealed that the original  Aristotle data ( including  the tainted China  cohort) was included.A number of these MAs claimed a benefit for Apixaban that is said to have  vanished when the questionable data were excluded.

Even with the flawed trial apixaban is preferable to warfarin for non-valvular AF.In the treatment arm, there were fewer strokes driven mainly by fewer hemorrhagic strokes there being only a slight advantage to apixaban in regard to ischemic strokes.Apixaban is safer and dietary and medications interactions much less of a problem than with warfarin and no needed for frequent follow up blood tests.

After Homer quit his job at the Kwik E mart,Abu said:

"He slept,he stole,he was rude to customers.Still there goes the best damned employee a convenience store ever had."




Wednesday, October 02, 2019

RPU-responsible physician unit-possible replacement by "systems"


The following is a re-do of an essay I wrote 14 years ago.


In the March 1, 2005 Annals of Internal Medicine the "Improving Patient Care"section deals with a case in the discussion about which the author emphases the problems associated with lack of follow up by and "hand offs" to physicians.

 A 70 year old man with a history of alcoholism presents with cough and weight loss.His chest xray showed "RUL pneumonia with a dense infiltrate with extensive fibronodular disease and upper lobe volume loss. No tb studies were done and the patient was discharged on antibiotic therapy.Through a series of lapses it is some 2 months later and after the patient was sent to and then sent back from a nursing home before the diagnosis of tb was finally made and treatment started, but apparently too late. He died of respiratory failure shortly thereafter.

The author discusses various methods to ensure followup . He does not mention, however, a well established method of obtaining follow up of lab tests. It is the RPU. This stands for responsible physician unit. The physician caring for the patient is responsible for finding out what were the results of the tests 

The clinical picture and chest film shouted r/o tb ( rule out TB). The narrative of sequential foul-ups is disturbing and the author's comments about the important of systems to ensure that reports are seen by doctors are appropriate. However, the original "fumble" occurred because of the apparent ignorance of the medicine resident ( I assume they were medical residents). While the subsequent events are alarming-and may be mitigated or eliminated by appropriate systems and safeguards- the lack of basic clinical knowledge demonstrated in this case is astonishing.

I cannot believe even a first year resident would not think "rule out tb" when he encounters an alcoholic with cough, weight loss and a upper lobe infiltrate. (the initial radiologist's report displays a equally high level of cluelessness also by not mentioning tb as a diagnostic possibility) Even if the resident was ignorant about tb,where was the attending?Not doing tb tests in this type case is comparable to not doing biomarkers for heart damage in er patients with chest pain.

At the county hospital where I trained that patient's arrival would have lead to the intern, resident and medical student spending the next few hours getting sputum samples and doing AFB stains. Even if the smears were negative the patient would have likely been hospitalized in a contagion unit to rule out tb given the very high "pre-test" probability of tb.

The author speaks of algorithms for this and algorithms for that. What is the nature of the algorithm to prevent house officers from harming patients based on their ignorance? In a earlier - less politically correct era- in regard to the first house office who saw the patient- we would have asked where did he go to med school.