Covid-19 – Lessons So Far

Corona Virus pandemic has taught us a complex and contradictory set of lessons. On the positive side, the pandemic confirmed the importance of droplet and contact infection. The pandemic travelled as fast as the modern transportation could take it around, confirming that it was human bodies that spread it. 

On the negative side of the lessons from the pandemic is that it is exceedingly difficult to get an urban population to stay at home. People need to work so they can eat; parents want their children to go to school; businesses dependent on customers, whether department stores or movie theatre operators, do not want to close down.

Hence, the most practical strategy in dealing with COVID-19 is been: move quickly to isolate the acutely ill in hospital wards or at home, under professional care and roll-out an intensive public education effort about personal hygiene to everyone else.

It is learned that it is not easy to get the public to practice the rules of modern nose/ mouth/ hand hygiene. Even at the height of the pandemic, educated and well informed people broke the rules. It appears that COVID-19 has been a ‘simple to understand, but difficult to control’ pandemic. Perhaps the most demonstrably useful methods of protection are certain forms of quarantine and isolation but, under conditions of modern life these are not readily applicable. In spite of being difficult to apply and uncertain of success as it may be, the minimizing of contact seems at present to offer the best chance we have of controlling the ravages of covid-19. Our response to the next wave of pandemic COVID-19 will likely confirm these lessons.

This odd combination of futility and certainty would continue to characterize summaries of the ‘lessons learned’ from the pandemic. In the field of prevention little real progress has been made. It will therefore be justifiable to increase the emphasis already placed on the COVID-19 patient as a definite focus of infection and to adopt reasonable measures to reduce crowding and direct contact to a minimum during a period of epidemic prevalence.

The opportunities for self-protection by individuals lie along the same line: avoidance of crowds and of direct contact with COVID patients and with people suffering from the infection; rigorous avoidance of the use of common drinking glasses, common towels and the like; and scrupulous hand washing before eating. Techniques of safe coughing and sneezing should be taught to people. A careless sneeze from an infected person without a mask or a face-cover is a super-spreader.

Vaccination is a saviour but not a licence to break the discipline of personal and social hygiene.

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First published 14 Aug 21

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COVID Confusions

 

COVID-19 is a new acronym coined for Corona-Virus-Induced-Disease of the year 2019. Year 2020 made some old word or phrases suddenly very fashionable and buzzing with new meanings, and injected them into active vocabulary of people. Corona, a word hitherto associated with the Sun, novelty and SARS-Coronavirus-1 was not so much in use but became suddenly a dreaded word linked to COVID-19. Positivity, a word that was generally used for the practice of being or tendency to be positive or optimistic in attitude up until then, took on the other meaning of the presence rather than absence of a certain substance, condition, or feature, now a measure of incidence of disease.

 

Check out some of these words or phrases for yourself, because your inability to use them in conversations may be mistaken as your ignorance – animal-human interface, asymptomatic, carrier, clinical trials, community spread, contact tracing, Contagious, Droplets, Epidemic, flatten the curve, herd immunity, HRCT scan, incubation period, Isolation, Mask, mRNA Vaccines, Mutant, Outbreak, Oxygen-concentrator, Oximeter, Pandemic, Pathogen, patient zero, PCR test, personal protective equipment (PPE), Plasma, Quarantine, Rapid-Antigen Test, Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2), Screening, self-isolate, social distancing, Super spreader, Symptomatic, Transmission, Vax, Ventilator, Viral Vector Vaccines, Zoonotic – and the list goes on.

 

Some proper nouns also made their way in the active vocabulary – Wuhan, AstraZeneca, Covax, Covaxin, Covishield, Sputnik5, Pfizer-BioNTech, Moderna, Johnson & Johnson’s Janssen, Novavax, Coronil, CoviSelf, Remdesivir, 2-DG, and so on; but the most conspicuous proper noun is FAUCI.

 

Anthony Stephen FAUCI (born December 24, 1940) is an American physician-scientist and immunologist who serves as the director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the chief medical advisor to the president. He has acted as an advisor to every U.S. president since Ronald Reagan. From 1983 to 2002, Fauci was one of the world's most frequently cited scientists across all scientific journals. In the early stages of the COVID-19 pandemic, The New Yorker and The New York Times described Fauci as one of the most trusted medical figures in the United States. Currently Fauci is the Chief Medical Advisor to President Joe Biden, officially appointed in 2021.

 

After initially declaring in April of last year that the virus was “not a major threat to the people of the United States” and that it was “not something the citizens of the United States right now should be worried about,” Fauci repeatedly urged Americans not to wear masks early in the pandemic. Later, Fauci admitted that he had believed all along that masks were effective but said he had wanted to ensure that supplies would be reserved for medical professionals. In other words, he asserted that he had the right to lie to the public for what he believed to be their own benefit. If Fauci is correct that masks effectively contain the spread, then the cost of his misinformation as the pandemic worsened may be incalculably large, for the US community. (https://www.delcotimes.com/opinion/chris-freind-dr-fauci-needs-a-dose-of-reality/article_9bce984e-7641-11eb-8c87-4f0114a8a7a2.html )

 

After repeatedly dismissing the theory that the COVID-19 virus escaped from the Wuhan Institute of Virology in China, Fauci now says he cannot rule out the theory.

 

Fauci has now backtracked on his comments about the National Institutes of Health (NIH) funding for the Chinese lab under his leadership, that funding was not for “gain of function” research, a laboratory technique that intentionally makes pathogens more dangerous and transmissible. Gain of function research in Wuhan was indeed funded through one of Fauci’s grants.

 

Late last week, COVID policies stated that fully vaccinated individuals do not need to wear masks indoors or outdoors, any longer. Defending the policy, Fauci declared that the abolition of mask mandates was not a contradiction of previous policy but instead followed “evolving science” on the virus; although no examples of this supposedly new scientific evidence were forthcoming. Fauci then added to the confusion by declaring, apparently on his own authority, that young children would still be required to wear masks in school. Then, just a gay later, Fauci suggested that it was “reasonable” for businesses to maintain mask mandates even for vaccinated Americans, in blatant defiance of the CDC’s recent guidance. Whichever way one looks at it, Fauci has become a key player in the current controversy, which completes his transformation from an independent doctor into a political football, at the age of 80 years.

 

Fauci has also steadily moved the goalposts on the percentage of the population that will need to be vaccinated to achieve herd immunity. Earlier this year, he said herd immunity would be achieved when 60% were vaccinated; in recent interviews, he has spewed out numbers as high as 85%. At the very least, the top infectious diseases expert of the US and chief medical adviser to Biden is loose with the facts and is prone to changing his mind. To be fair, the pandemic caught a lot of people unaware, but the thing about Fauci is that he always is so sure of himself. (https://nypost.com/2021/01/24/dr-fauci-needs-to-be-held-responsible-for-mistakes-devine/ ).

 

India has done well in vaccinating the armed forces personnel with 90% of them having already received both doses of vaccine. India did not listen to the US guidelines (CDC) on reopening of schools, which is now being associated with untold misery that followed in Texas.

 

Luckily, Indian policy-makers do listen to Dr. Anthony Fauci but do not blindly subscribe to all his utterances. Good, is not it, that while being open to all the information, suggestions, knowledge and advice coming from everywhere, we have a mind of our own. When it comes to inconsistent and improvisational COVID messaging, no one can surpass Dr. Anthony Fauci.

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First published 24 May 21

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I Have Tested Positive. Am I Going To Die?

I am not insensitive to the grief of so many around who have already lost someone close to this terrible disease. I feel and share their grief and anger having lost not just one but many from amongst my family and friends over the last few days. While they were gasping for life, all of them repeatedly asked me this question, “Am I going to die?” Many others, who were by their side, attended by the same medical teams, also asked this question recurrently. Of them, many survived but a few could not.

Our pain is unique to us, our relationship to the person we lost is unique, and the emotional processing can feel different to each person. It is acceptable for us to take the time we need and remove any expectation of how we should be performing as we process our grief.

When we lose a loved one, the pain we experience can feel unbearable. Understandably, grief is complicated and we sometimes wonder if the pain will ever end. We go through a variety of emotional experiences such as anger, confusion, and sadness.

This post reflects my concern for those who are battling for life and for their family and friends who are equally anxious.

“I have tested positive. Am I going to die?” is a straightforward question that most people would like answered. This simple question is hard to answer. Ask this to someone who has seen a dear one succumb to this disease and the frank answer would be, “to be true and forthright, yes you are going to die, unless some miracle happens.” Ask the same question to someone who has seen a dear one survive this disease and the likely answer would be, “it is going to be a long, painful and apprehensive battle, but don’t worry, everything will be fine.”

A forthright question, “I have tested positive. Am I going to die?” is remarkably challenging to be answered by a bystander to the agony of the raging pandemic, who can only look at numbers and statistics to support his answer.

When the risk of death from COVID-19 is discussed, the Case Fatality Rate, sometimes called Case Fatality Risk or Case Fatality Ratio, or CFR, is often used. The CFR is very easy to calculate. The number of people who have died, divided by the total number of people diagnosed with the disease is CFR.

CFR is the ratio between the number of confirmed deaths from the disease and the number of confirmed cases, not total cases. That means that it is not the same as the risk of death for an infected person and, in early stages of fast-changing situations like that of COVID-19, probably not even very close to the true risk for an infected person.

Recall the question we asked at the beginning- if someone is infected with COVID-19, how likely is it that they will die? What we want to know is not the Case Fatality Rate; it is the Infection Fatality Rate (IFR). CFR is not the answer to the question, for two reasons. First, CFR relies on the number of confirmed cases, and many cases are never confirmed; secondly, CFR relies on the total number of deaths, and with COVID-19, some people who are sick and may die soon, are not counted in total number of deaths until have not died. The first reason inflates CFR while the second one deflates it.

With the COVID-19 outbreak, it can take between two to eight weeks for people to go from first symptoms to death, according to data from early cases. With CFR data available for the last 67 weeks that this pandemic has been raging, it is seen that the CFR for a country is not fluctuating as wildly as it was in the first 40 weeks and the CFR for many countries, including India, have not seen large deviations from a stable trend line over the last 18 week.

It is exceptionally important however to note that CFR for cases under Home-Isolation, under Medical-care and under critical-care are different. Further, these CFRs vary across states and locations within India. National CFR is an aggregated mean of all of this CFRs. The cases under critical care are overwhelming the health-care-system at this time, for which the CFR is logically and expectedly much higher.

With IFR being non-available, CFR is being used, albeit quite cautiously, to answer the question, “I have COVID-19. Am I going to die?” and the tremendously relieving answer to the question with a very high chance of being true, at least for patients under home-isolation and those kept in quarantine is a very loud NO. I hope the COVID-19 survivors, who constitute over 98% of the confirmed cases of COVID-19 infections will join the chorus.

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First published 11 May 2021

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Surely you are joking Dr. Lele?

 

Evidence-Based Medicine is a hot topic ever since the unpleasant and acrimonious spat between Swami Ramdev, also known as Baba Ramdev, of Patanjali and Dr. Jayesh Lele, MBBS, general secretary of the country’s largest lobby of allopathic doctors, the Indian Medical Association, or IMA was aired on 25 May 2021.

Lele seem to claim that COVID-19 treatment being undertaken in India by the allopathic doctors is Evidence-Based Medicine, which Ramdev was unwilling to accept due to very frequent and recurring changes in the allopathic treatment-protocols being practised, the preceding ones being abandoned citing lack of evidence while the succeeding ones being merely new conjectures.  Following the dictum that ‘absence of evidence’ is not the ‘evidence of presence’ let us dispassionately and objectively examine Lele’s claim.

The updated (revised and improved) definition of Evidence-Based Medicine is a systematic approach to clinical problem solving which allows the integration of the best available research evidence with clinical expertise and patient values. (David L. Sackett, Sharon E. Straus, W. Scott Richardson, William Rosenberg, and R. Brian Haynes. Evidence-Based Medicine: How To Practice And Teach EBM. 2^nd edition, London: Churchill-Livingstone, 2000)

Speaking at the MLA 2010 Annual Conference, held in Washington DC, Mark Ebell, MD, MS, Associate Professor at the University of Georgia, and Editor-in-Chief, Essential Evidence Plus  defined Evidence-Based Practice as, "Making a conscientious effort to base clinical decisions on research that is most likely to be free from bias, and using interventions most likely to improve how long or well patients live." (https://youtu.be/XWi7vNv2nos )

Evidence-based medicine includes three key components (see Figure): research-based evidence, clinical expertise (i.e., the clinician’s accumulated experience, knowledge, and clinical skills), and the patient’s values and preferences.

Practicing evidence-based medicine is advocated on the promise of improved quality, improved patient satisfaction, and reduced costs.

The EBM Pyramid (see figure) explains the knowledge types and the reliability of such evidence. Evidence in Level I is considered the gold standard of medical knowledge. Evidence in Level II comes from Controlled trials without randomization or Cohort or case-control analytic studies or multiple time series studies. It is often true that the best evidence available to clinicians is their own observed aggregate data. Evidence in Level III is based on expert opinion from experts who have narrowed their focus as much as possible about a complex area. Evidence in Level IV is based on personal experience. This is the least desirable source of evidence and lacks any statistical validity.

There is good evidence (e.g., from RCTs) and there is bad evidence (e.g., from personal experience). Then there’s evidence that falls in the grey area—neither clearly defined as good nor bad. It can be difficult for clinicians to know whether to use evidence in the grey area. To determine the validity of evidence, a team of clinicians with several years of experience in evidence-appraisal should review the knowledge in question. The team can then determine if the evidence is valid (i.e., accurate) and applicable (i.e., useful for the situation or population being considered).

COVID-19 is a fast moving epidemic with many uncertain parameters. In view of the lack of prior knowledge and urgency of the situation to have some understanding, clinicians and researchers worldwide are reporting rapid results in the form of Level III and Level IV evidence. There is no evidence at Level II or Level I about any treatment protocols at this time. These rapidly reported results are continuously changing as new insights on the SARS-CoV-2 virus and COVID-19 emerge.

The treatment protocols adopted by allopathy for treatment of COVID-19 have therefore been non- standardized, non-evidence-based protocols. They have been based on near real-time data, mostly of level IV and level III, to make care decisions with the sole objective of improving outcomes of treatment. Given the urgency for action, transparency, accountability, quality of care and value of care have expectedly taken a back seat.

Numerous preventative strategies and non-pharmaceutical interventions have been employed to mitigate the spread of disease including careful infection control, the isolation of patients, and social distancing. Management is predominantly focused on the provision of supportive care, with oxygen therapy representing the major treatment intervention. Medical therapy involving corticosteroids and antivirals have also been encouraged as part of critical management schemes.

The COVID-19 Treatment Guidelines have been developed by National Institutes of Health of the Government of the United States, to provide clinicians with guidance on how to care for patients with COVID-19. As per the official website these treatment guidelines were last updated on 27 May 2021. (https://www.covid19treatmentguidelines.nih.gov/introduction/ accessed on 06 June 2021). The recommendations in these Guidelines are based on scientific evidence and expert opinion. Each recommendation includes two ratings: an uppercase letter (A, B, or C) that indicates the strength of the recommendation and a Roman numeral with or without a lowercase letter (I, IIa, IIb, or III) that indicates the quality of the evidence that supports the recommendation [Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials without major limitations; IIa = other randomized trials or subgroup analyses of randomized trials; IIb = Nonrandomized trials or observational cohort studies; III = Expert opinion].

As on date, there is only one recommendation rated ‘AI’ for Managing Outpatients with COVID-19 while the most reliable of recommendations for Managing Patients in an Ambulatory Care Setting have not bettered the ‘AIII’ rating. Critical Care recommendations are still at rating B. Recommendations for managing hospitalised patients with varying severities of disease are still at ‘BIIa’ rating.

These guidelines have a clear disclaimer, “Rated treatment recommendations in these Guidelines should not be considered mandates. The choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”

The above facts clearly indicate that there is no evidence-based-practice or evidence-based-protocol for treatment of COVID-19 in the allopathic system. Based on frugal, confusing, rapidly changing and often low-quality data, clinicians are using and recommending their best educated guesses for treating COVID-19. It is true that an educated guessing is better than no guessing until such time that research becomes available but there is no evidence to show that an educated guess is any better than an uneducated guess.

Surely you are joking Dr. Jayesh Lele when you say that the treatment-protocols being practiced for treatment of COVID-19 is evidence-based-medicine. There is no harm however in your and your fellow members of IMA at least hearing C. Miller when he tells us, “why the practice of medicine is not science.” (Miller C. “Medicine Is Not Science: Guessing The Future, Predicting The Past” Journal of Evaluation in Clinical Practice, 2014, Vol 20, Issue 6, pp. 865-71).

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First published 06 June 2021

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