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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 ...

Saturday, July 24, 2021

Is the US into the 4th ( or 5th) surge of Covid

 Is the US already into the 4th surge of covid pandemic?

Cases and hospitalizations and ICU admission are definitely trending upwards.

Physicians in Alabama,Mississpii,Arkansas and Louisiana are pleading with the public to get vaccinated as they see cases in their hospitals surge and young people are being intubated.

In California, mask mandates are back while in other states governors deny the need and at least one governor (Colorado) said no restriction or mask mandates are necessary until  it is clear that hospitals are being over whelmed. 

It is time already for masks to come back .The CDC mask lifting in May was premature and widely misunderstood and IMO has been  in part, perhaps in large part,responsible for the rise in cases caused by the Delta variant.

The public experts interviewed on TV appropriately emphasize the importance of the unvaccinated getting the jab but if miraculously everyone rushing to the largely empty vaccination sites today it would be over a month before immunity would be obtained. Meanwhile the vaccinated as well as the unvaccinated need to wear mask indoors and in congregate settings. 

The Israeli data and British data differ significantly regarding the effectiveness of the Pfizer vaccine as regards preventing infection (33 %- 88 %) but agree as to a 90 Plus %value for prevention of death or serious illness. But in the worse case scenario many vaccinated persons can contract disease and likely spread the disease making in the short and intermediate term masks and social distancing a high priority. Fully vaccinated parents can contract the disease and spread it to their under 12 year old children who are currently not eligible for vaccination.

Unfortunately until the CDC makes important revisions in its mask recommendations businesses are not as likely to reinstitute mask mandates and masking is essential  until a sea change occurs in the large segment of the population who continues to be vaccine "hesitant". 

Dr. Scott Gottlieb tweeted "CDC has consistently been through,meticulous and late" and that they are not suited to provided quick solutions to emergent problems. He also said CDC's decision to tell the vaccinated that they could unmask was based in part on the demonstrated low risk of a fully vaccinated person to  contract or spread  the earlier variants of covid. That advice clearly does not apply to the Delta variant. 

 


Friday, July 23, 2021

Heavy viral loads with Delta results in greater infectivity setting up 4th US surge

 The 4th covid  wave is already in the US. It is  fueled by the much greater infectivity (1) of the Delta variant  arriving at a time of nationwide reduction in masking and social distancing in part driven by what a increasing number of public  health officials  believe to be a premature and widely misunderstood lifting of the mask mandate\by the CDC.

Some virologists are estimating the R naught of Delta variant to be as high as five. Anecdotal report from Australia indicates that viral transmission occurred with simply passing an infected person in a mall.That seemed to me unlikely until I read of the Chinese study demonstrating a viral load in Delta infected persons greater  than one thousand times that of the original Wuhan strain. Their report found that high viral loads persisted up to 4 days in asymptomatic patients. Asymptomatic spread from  persons with high viral load is pretty  good if not perfect storm for spread in a population who just recently were officially relieved of need to mask or distance.

The report of  transmission of the Delta variant among fully vaccinated people at an outdoor wedding event  in Houston seems to strongly indicate that transmission can happen in fully vaccinated people which should mean that not just the unvaccinated should wear masks in public but so should the vaccinated.

The vaccinated should wear masks in public for two reasons; 1) they can spread the disease to the unvaccinated which includes children who are too young to be currently eligible for vaccine  and of course the elderly and immunocompromised 2)there are "break through" cases  i.e cases in the vaccinated These are usually described as "mild" but some are not and there have been deaths largely in the elderly. 

Israel quickly reacted to increased Delta cases by reinstituting  a mask mandate  as did Los Angles County in California. The medium term answer is more vaccination but the short term answer is masking and social distancing .Already governors in Colorado,Florida  and Texas have said they will not mandate masking for the public and will not "allow"  mask mandates for kids returning to school although that is the recommendation of the American Academy of Pediatrics.

 

With this wave it looks like there will be fewer deaths in the elderly ( mainly because of the higher vaccination rate in the old folks) but reports from Alabama, Arkansas and Louisiana hospitals indicate that ICU admissions and some  deaths are occurring in the younger group. Whether  that indicates a greater lethality  from Delta is not determined at this time.

 

 





1)Viral infection and transmission in a large well-traced outbreak caused by the Delta SARS-CoV-2 variant - SARS-CoV-2 coronavirus / nCoV-2019 Genomic Epidemiology - Virological

Tuesday, July 20, 2021

More covid lessons from Israel and Houston Wedding

 Recent data from Israel. Of 61 patients hospitalized because of covid , 24 were unvaccinated  and 37 were fully vaccinated, Of the 37- 36 were over age 60 and one was in their fifties.

Clearly being fully vaccinated does not provide 100% protection against being seriously ill. Older people are not immune to developing serious covid 19 illness even after 2 shots of the mRNA vaccines.

Earlier the Israeli Health Ministry released the following summary without the detailed data on which the conclusions were made:

 The effectiveness of the Pfizer vaccine for prevention of disease was said to be 64% and the effectiveness as regards prevention of serious disease was 93% . Both values were in in the 90s from the randomized clinical trials for Pfizer.  

Why are they so different. Perhaps the antibody levels induced by the vaccine have decreased over time to a point at which the disease protection ability has also decreased. The other likely explanation is increasing number of cases due to the Delta variant.Both could be operative.

From the Houston wedding case report we have to conclude that serious covid 19 disease can occur with spread of the virus from vaccinated person(s) to another vaccinated person. 

An important question is:

1)Can a fully vaccinated person transmit the virus to another person? The Houston wedding  story makes it apparent that the answer is yes. While we do not know with a solid level of certainty the chain(s) of transmission in that spreader event  it seems most likely that at least one fully vaccinated person gave it to at least one other fully vaccinated  person.For that conclusion to be valid we have to assume there were no unvaccinated individuals, perhaps a service  person or a valet parking attendant  who could have transmitted the virus to all six of the infected attendees. 

Those type epidemiologic details would be important because if the fully vaccinated can transit the disease to the fully vaccinated and of course to the unvaccinated than the CDC advice for the vaccinated to do whatever they were doing before the pandemic without masks needs to be revisited and revised particularly as the Delta variant spreads

Further if vaccinated persons can spread the virus and since we know there can be asymptomatic spread and we know that there is aerosol spread then vaccinated persons should not go mask less in congregate settings such as grocery stores and churches to mainly protect others as well as themselves.

What about protection of children too young to be eligible for vaccination? Vaccinated parents should wear masks in public to minimize the risk of bring a covid virus home to infect the child.The vaccinated parents are very unlikely to get seriously ill from the Delta variant but may be  able to transmit the virus to their unvaccinated child. 

Mask wearing became a political issue earlier on in 2020 and when the discussion turns to why do folks oppose mask reading one purposed reason is "libertarian thought".

There is nothing libertarian about the vaccinated tossing the masks away if there is asymptomatic spread even among the vaccinated. One does not have the right to put others at risk. The foundational libertarian principle is that of non aggression i.e. one does not have the right to initiate force against another, Libertarian thinking is sometimes blamed for mask aversion but if someone believes he can spread a potential fatal disease to others  and if he does not wear a mask that is not libertarian exercise of a right  but rather a hostile act. 

So what are the lessons from recent Israel data and the Houston wedding story.

1) If and when the Delta variant is increasing in a community ( particularly  in a community with low level of complete vaccination ) people who have been vaccinated should not believe themselves to immune to covid They can spread the disease and there are break through cases..The CDC proclamation was poorly understood  or taken to mean to be no mask at all under most all circumstances. More troublesome is the obvious fact that everyone who is mask less is not fully vaccinated. Less than 50% of residents of Harris county Texas,home of Houston, have been vaccinated but try and find more than one or two people with masks when a crowd shot is shown at a Astros home game.Further, one shot of either of the two mRNA vaccines does not protect against the Delta variant.

2)Vaccinated people can get seriously ill from Covid and  some will  die.

3)With the increasing spread of a many time more contagious everyone should wear a mask in congregate setting to as was true in the beginning of the pandemic to protect others and yourself.

 The CDC said that masks may still have to be worn when government regulation (Federal or state or local) so indicates. Unfortunately in some states the legislature and or the governor have decreed that business may not demand a "vaccine passport" and/or that public schools cannot mandate vaccination or masks regardless of what the level of risk may be.

As cases again begin to spike, CDC needs to revise its mask guidelines and when a virus is on the ascending limb of spread time is of the essence.


 



Sunday, July 18, 2021

Documented cases of Delta variants in fully vaccinated patients

 The setting was an outdoor wedding near Houston Texas for which only vaccinated persons were allowed to attend. Fully vaccinated and outdoors-and yet six cases with 2 hospitalized and one death. 

See here for the pre print .

Of particular interest in patient 1 who had received the Pfizer vaccine and had no comorbidities.He required hospitalization and was treated with Regeneron antibody with recovery.

Patients 0a and 0b traveled  to the wedding from India and tested negative before the flight.Patient 0a was hospitalized and died from covid19 complication one month after the event. Both of the visitors from India had received the Indian covid vaccine.

The planners of the wedding were careful-having the event outdoors and required the quests to all be fully vaccinated. The report does not mention whether masks were worn but according to CDC recommendation masks are not required for outdoor events for fully vaccinated people.

Eight fully vaccinated health care workers apparently contracted covid 19 at a swimming party.All were mildly ill with upper respiratory symptoms and self quarantined. See here for link.These cases were much milder than some of Houston wedding guests who contracted covid and also seemed linked to the Delta variant. 

Clearly fully vaccinated does not mean fully protected from the Delta variant.


Should the CDC's mask advice be fine tuned in view of the increasing number of Delta variant cases and its apparent increased infectiousness and possibly capability to evade the vaccine's protection.Another element in the argument is that Israel's Health Ministry has stated that the Pfizer now appears to have effectiveness in the 60% range for protecting against infection but still has protection against serious illness and death in the 90% range. 


Sunday, July 11, 2021

Masks and social distancing in the vaccinated elderly

 The CDC, when it lifted its mask recommendation, stated that- in general- people who have been fully vaccinated do not  need to wear masks except in certain situations such as planes,trains and hospitals and contact with the elderly and immunocompromised  They further said that one " should consider" wearing a mask if you have a condition that weakens your immune system" or if you lived in an area of the country where the infection rate was high.(High was not defined by the CDC).The "not wearing masks" was heard and little else was remembered and the take home message was the long awaited "take off your masks".

Remembering back to the early days of the pandemic in 2020 we were told that it was a priority to protect the vulnerable which was taken to mean the immunocompromised and the elderly. 

Were the elderly ignored in the surprise turn around from the CDC's mask guidance? They did not seemed to be specifically mentioned.

In an earlier blog posting I commented about two studies that addressed the immune status of the elderly following Covid vaccination and I wrote the following:

"Muller et al (1) conducted a cohort study on subjects less than 60 years of age and those over the age of 80 who received the Pfizer vaccine. Specific IgG antibody tiers against SARS-COV-2 spike protein were lower in the elderly and the elderly had no detectable neutralizing antibodies. In the younger group 2.2% had no detectable antibodies."

A large Danish Cohort study (2) compared vaccine effectiveness in health care workers and long term care patients. After the second dose the effectiveness in the patients was 64% ( 95% CI  14-84) while in  health care workers the   effectiveness was 95% (95% CI  82 -95. The median age of the 39 040 patients was 84 and there were 488 PCR confirmed cases of SARS-COV 2 cases. If this study can be generalized the widely quoted 90 % plus vaccine efficacy does not apply to the elderly. It should be noted that may well represent the worse case in that the eldely in long term care are a less resilient group that 80 years old independently lived in the community. Note  also sometimes  I am saying effectiveness and sometimes efficacy, they sound alike but in epidemiology they are terms of art and mean different things. More on that below. Also see footnote 1 for explanation of efficacy.

More data on that topic of how well vaccines really work. has  become available.

Jablonska et al (3) published a pre print estimating the " real life " impact of vaccination on covid mortality using data from 31 European countries and Israel from the period from Jan 2020 until April 2021. They found the vaccine effectiveness  in terms of  protection against death was equal to 72%.

Note: The Jablonska article seemed careless  ( it is a preprint after all) in the use of the words "effectiveness" and "efficacy" in that sometimes the authors said effective and sometimes efficacious in reference to their study. In the jargon of epidemiology "effectiveness " refers to real world data , i.e. how a medical intervention in used outside of a randomized clinical trial (RCT)  .The results of a RCT are expressed in terms  of efficacy.   The results of the  RCTs for the Covid vaccines are expressed as efficacy.`

The Danish cohort study and the Jablonska paper were non RCT data and expressed them major metric as effectiveness,


For prevention of severe disease Pfizer,Moderna as well as AstraZeneca and Novavax reported a 100% 
efficacy. 

Why is there such a difference.As the authors suggest age of the populations studied varied.
Only 24.7 % of subjects in the Moderna trial were equal to or older than 65 years of age and 42% of Pfizer trial subjects were over 55 years  of age and only 12.2 % were over  55 in the AstraZeneca trial.


In regards to a medical intervention the disease reducing ability as indicated from the results of a RCT is  always better and correctly expressed as efficacy than that observed when the intervention is utilized outside of the confines  of a RCT and which is correctly expressed as effectiveness. This is very well known .

A number of the public health experts appearing on TV  may have forgotten that when they emphasized  the 100% efficacy against death  that was reported in the randomized trials. It was extrapolation beyond the data to claim or at least hint  that everyone who would be vaccinated would be protected from serious illness  and death. Whether this was intended or not I believe many people were lead to believe when fully vaccinated they were almost guaranteed not to have serious or fatal covid 19 regardless of how old they are on to what degree there may be covid spreading in the community and whether or not that spread may be driven by covid variants such as the Delta variant. 

When I heard repeatedly that the mRNA vaccines were 100% effective against death after the several month duration trials were published I shuddered because I assumed that at least some of those experts knew that the effectiveness of a medical intervention is never at high as the efficacy demonstrated in a clinical trial.  

In early July the Health Ministry of Israel announced that the Pfizer vaccine now seem 65% effective in decreasing symptomatic and asymptomatic disease and 93% effective in preventing hospitalization and death.Several deaths were reported in fully  immunized patients.

From personal experience involving  acquaintances  and family it seems that the  many of the over 75 year old crowd have eagerly accepted the need- no- mask advice since they have been vaccinated and are not known to be immunocompromised and believe that masks and avoiding crowds are no longer necessary.It is not that simple although it was very easy to take away that impression from the CDC announcements.
 
I would have preferred that  the CDC at least  recommend that the immunocompromised consult with their  oncologist or hematologist, a number of which, I believe, are recommending that their patients have their antibody levels checked and in some cases take a third shot. One group in France has taken that approach with their solid organ transplant patients and given third shots which had generally demonstrated a significant increase in antibody levels which were typically low after the standard two doses of the mRNA vaccines.  As for the elderly perhaps they should have been advised to consider the level of vaccination in their community as well as the number of cases of the Delta variant before they go mask free to do things like dining out in inside eateries and attend indoor sporting events.

Of course  the fully vaccinated can gather together for food or singing or whatever and be very unlikely to get sick. This quite different from singing and drinking in bar or a crowded restaurant  in a locality  with 20% vaccination rate and increasing cases of  covid19 from a variant. 

Cases still soar world wide and more have died in 2021 from covid than in all of 2020,India and South America  are hot beds  and cases are increasing in Japan preventing live spectators in the upcoming Olympics  and for lack of vaccine much of Australia is in some form of lockdown.In parts of the world with low or zero vaccination rates variants will develop and air travel links everyone with everyone in the world. The more contagious Delta variant is already over 50% of cases in US and increasing particularly in areas with low vaccination rates.



1)Muller,L et al Age-dependent immune response to Biotech/Pfizer BNT 162b2 COVID-19 vaccination Clin infect Dis 2021 Apr 27

 2)Moustsen-Helms,IR et al Vaccine effectiveness after 1st and 2 nd dose of the BNT162b2 Covid-19 Vaccine in long term care facility residents and healthcare workers A Danish cohort study. Pre Print from Medrxiv 09 March 2021.

3)Jablonske,K et al The real-life impact of vaccination on covid-19 mortality in Europe and Israel. MedRxiv ( this is a pre print and at the time of publication had not been subject to peer review.

 Footnote 1.

Efficacy refers to the proportional reduction in disease attack rate between ARV and ARU, where ARV is the attack rate of the vaccinated group and ARU is the attack rate in the unvaccinated group.

Risk ratio is the ratio of ARV/ARU

Vaccine efficacy is 1-RR expressed as a percentage.

For example if in a given time frame 100 of unvaccinated get the disease and 5 in the vaccinated  group get the disease  we have 1-5/100 = .95 or expressed as a percentage of 95%. 

To put vaccine efficacy in some context we see that in  the 2018-2019 season the flu vaccine has a 29% efficacy .Measles vaccine is about 97% efficacious. 



Thursday, July 01, 2021

The Cures Act,clinical notes and how one well known hospital system complies

 The Cures act mandates that health care providers (HCPs) provide patients access not to just their clinical records but also to the "clinical notes".This refers to the notes that a physician takes during or shortly after the clinical encounter.The initial physician resistance to giving up their clinical notes on the grounds that the patients might not understand the medical terms and jargon had largely dried up by the time that section of the Cures Act finally became in effect.  The Cure Act did much more than mandate that patients can access their clinical notes. The lobbying effort for bill passage was lead by representatives of big pharma and medical device manufacturers.The bill made drug and device approval significantly  easier.

The Act applies all HCPs,health information exchanges and certified IT developers. Fines of up to $1,000,000 you interfere or prevent access or exchange of electronic health information. 

The Act requires that requests for medical information be accomplished "without delay"

Now  as to how one large,big city,well known hospital system complies

We will call the hospital "well known famous place" or WKFP for short and examine how they move to comply with the Cures ACT.

I requested the clinical notes from my primary care internist and from my cardiologist, both of whom are within practice groups which are part of  the WKFP system. Within 48 business hours I received both sets of clinical notes in my patient portal.The shocking number of errors in my internist's clinical notes is a subject for another day.

The most striking feature was the description of a detailed physical exam which both physicians claimed they did but did not actually perform. The Internist's exam consisted of listening to my lungs and the cardiology doc  did not touch me at all. (The usual handshake was eliminated by Covid precautions.)

So the hospital system gets an "A" for delivery of the requested records but an "F" for providing a detailed record of examination that were fabricated. I can not  think of another word to describe claiming that a physical exam was done when in fact it was not. 

Is this done to document an exam to justify the level of Medicare charge they submit? Perhaps so, I cannot think of another reason. Do the physicians involved not worry about this practice? Have the shrewd corporate lawyers found a way to protect this practice from being deemed Medicare Fraud?To my legally naïve eye charging for services not provided would appear to be fraud.(The 20210 changes in Medicare coding seemingly has decreased keying on the exam to upcode visit so maybe there may be no reason to fabricate a physical exam.Maybe that is left over from earlier coding games.)

I have been aware of this ghost exam practice before and have blogged about it. See my blog entry with following title "Has the modern electronic medical record made many physicians accomplices to lying?" Two family members underwent colonoscopies at different hospitals.In both cases the attending physician included in his endoscopy report a detailed physical exam which never happened. Another family member underwent a arthroscopy and appended to that report was the physical exam that was not done by the orthopedic surgeon.

IMO  the modern medical record with all of its electronic snazziness has devolved to be a  embarrassing collection of misinformation, errors and fabricated exams. On the positive side the patient now has a powerful tool-the Curres Act provisions- to obtain his medical record , warts and all. 


addendum: 7/10/21 I had a echocardiogram at 8:am on Thursday. by Friday at 8:p, I received a text that I had a new test results in my patient portal.It was a full report of the echo replete with the data not just the summary.