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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Some Unsought Advice for the Prime Minister Shri Modi !!

The situation where you are running from pillar to post to find a hospital bed or an oxygen cylinder for your loved one, and there is nowhere to go, you feel frustrated, helpless and angry.  If you are the lucky one to find some place, the ban on visitors makes you more edgy because you could not be with your loved one to offer comfort and support when he/she needed it most. The thought of not being able to see or comfort a loved one who is living with an advanced illness is heart breaking.

Time seems to freeze when you learn that someone you love has slipped from medical care to critical care in a COVID-19 facility. Maybe you instinctively pushed the news away, or perhaps you cried, or swung into action. You and your loved one may have pursued promising treatments and perhaps enjoyed some respite from the illness over the last few days.

The loss of a loved one is life's most stressful event and can cause a major emotional crisis. All kinds of emotions, denial, disbelief, confusion, shock, sadness, yearning, anger, humiliation, despair, guilt, can flood people’s minds.

 

SUCCESS, WHICH THE GOVERNMENT IS TRUMPETING

The data given out by Ministry of Health and Family Welfare website https://www.mohfw.gov.in/.

COVID-19 CASES IN INDIA as on: 15 May 2021, 08:00 IST (GMT+5:30)

Active – 3673802   Discharged – 20432898    Deaths - 266207    

Until date (15 May 2021), 24372907 people have been identified to be infected, of which 15.07% (3673802) are Active cases right now, 83.83% (20432898) have successfully survived the infection but unfortunately, the balance 1.09% (266207) could not survive and have died.

Yes, your government is right that Indian has done exceedingly well, on an aggregate basis, in management of the COVID-19 crisis as compared to any of the countries in the world. Nevertheless, the fact remains that the mismanagement of second wave of COVID is hidden behind the exemplary management of the COVID. Your government was successful in flattening the curve of cases and deaths of the first wave over a period of 11-months, something which the Western world could not do. The same cannot however be said for the second wave.

 

FAILURE, WHICH OVERWHELMED INDIA

You do not have to go to any other source of data to see this. Failure, which overwhelmed India, is buried, not too deep, in these very numbers.

Please have a relook at the data given out by Ministry of Health and Family Welfare website https://www.mohfw.gov.in/.

COVID-19 CASES IN INDIA as on: 15 May 2021, 08:00 IST (GMT+5:30)

Active – 3673802   Discharged – 20432898    Deaths - 266207    

COVID-19 CASES IN INDIA as on: 15 April 2021, 08:00 IST (GMT+5:30)

Active – 1471877   Discharged – 12429564    Deaths - 173123    

Of the 24372907 people identified as infected so far (over the last 15 and one half month – the first case was reported on 30.01.2020), 10499082 (43.08%) cases came during the last one month. Out of 266207 deaths recorded so far, 94122 (35.36%) deaths occurred during the last one month.

This is not a joke or a mere spike. It is a deluge.

·        Of all the cases – 43% came in last one month;

·        Of all the people dying – 35% died in last one month.

COVID-19 began 𝗁𝗂𝗍𝗍𝗂𝗇𝗀 𝗐𝖺𝗒 𝗍𝗈𝗈 𝖼𝗅𝗈𝗌𝖾 𝗍𝗈 𝖾𝗏𝖾𝗋𝗒𝗈𝗇𝖾'𝗌 𝗁𝗈𝗆𝖾. What were merely numbers for people during the first wave, started turning into names and those names 𝗂𝗇𝗍𝗈 real 𝗉𝖾𝗈𝗉𝗅𝖾 whom people know?

 

WHAT WENT WRONG

With micro-situations continuously evolving and rapidly changing, managing Pandemics at the ground level is a very complex phenomenon involving case-by-case tactical and urgent decisions that need ‘thinking fast’. However, the policy level, at which the office of the Prime Minister sits, the foresight and strategy based thereon, is an important decision that allows wider consultations, reviews and ‘thinking slow.’

At the strategy level, dealing with pandemics involve only two sub-strategies, ensuring that the pandemic does not spread (Restriction strategy) and ensuring that those infected are able to recover from the disease (Treatment strategy).

Restriction is about reducing the number of cases, which is accomplished through controlling the spread of infection (Appropriate Behaviour and immunisation through vaccines). Where the disease is contagious, isolation and quarantine of the prospect (contact tracing) and the suspect case (symptomatic cases) is as important as that of the confirmed case. In case like COVID, where not every infected person shows the symptoms of being infected (asymptomatic cases) the inter-people-contact has to be clamped down.

Treatment is about reducing the mortality rate among the cases through proper and timely diagnosis and treatment.

 

YOU HAVE RIGHTFULLY TAKEN CREDIT FOR MANAGING THE FIRST WAVE

You had the foresight and the promptness in March-April 2020, in using the Restriction strategy, when the first wave of the pandemic broke out, which resulted into definitive reduction in spread of infection and reduction in the mortality rates. Numbers speak for themselves.

However, the second wave, which started knocking at our doors towards the end of February 2021 and is peaking now, has left much to be desired at your level.

 

SHOW THE GRIT IN ACCEPTING THE DISCREDIT FOR MISMANAGING THE SECOND WAVE

COVID-19 patients tend to be sick for a long time, spending weeks in the intensive care unit in some cases. Patients improve up to a point, and then it can be several weeks before one would see them continue to improve. Families need to prepare for that, as well as peaks and valleys seen so often in the sickest patients. Hospital restrictions that prohibit visiting COVID-19 patients have been major stressors for families, as well as those in the hospital. In the unfortunate events of patients losing the fight against COVID-19, not every one of their families and friends have the emotional strength of suffering the pain sagaciously or silently. Patients, their families, and other caregivers have little patience or tolerance, and their short fuses can explode on the very people trying to care for them.

Doctors and nurses are withstanding the worst of a much angrier, more frustrated, and weary bunch. Medics falter when they witness rudeness and other bad behaviour. It interferes with their working memory and decreases their performance. Frustrated patients are making health care workers’ jobs even harder.

No medical-care infrastructure, in terms of both physical dimensions and human dimensions, can have the capacity to deal with such deluge.  No society can cope with such agony and death. Yes, Treatment Strategy has limitations in dealing with such tsunami of cases.

However, you have faltered in making use of the Restriction Strategy once the coming of the second wave was clearly visible towards the end of February 2021. This failure has resulted into the ‘unforeseen’ deluge of cases and deaths. In ability to see these coming, is itself a failure of leadership and his advisors.

Overtly or covertly, this failure is being attributed not to any lack of your foresight regarding COVID, but to your political ambitions in West Bengal and other states. I am not a political strategist, but the results tell us a story.

 

FAILURE IN STATE ELECTIONS 2021

Ever since you brought in the US Presidential style of electioneering to Indian politics in 2014, people vote for the leader as much as they vote for a party. Your inability to win Rajasthan, Punjab, Maharashtra and Madhya Pradesh had shown an association in your inability to project an unambiguous leader who could campaign in the same style in the state as yours in the national elections.

When you or any of your central leaders campaign in a state election, the electorate asks themselves – are you or any of those central leaders going to be their Chief Minister? Even when they wish to vote for your party, they do not know who is going to rule them. As they say, a known foe is better than an unknown friend is, the electorate ends up making choices, which may look poor from a larger perspective, but they are the best picks that the electorate could make from within the choices available to them.

Let us not forget that a day after the first round of polling took place on 20 May 1991, former Prime Minister Rajiv Gandhi was assassinated while campaigning. The remaining election days were postponed until mid-June and voting finally took place on 12 and 15 June. When the surge in COVID cases was so visible by the end of March for everyone to see, not postponing the elections was neither good strategy nor good politics. The votes polled in your favour in successive rounds of polling have shown a negative association with the rising COVID-cases in the country. Who knows, if the state elections were postponed for a better time, their results for you could have been better.

 

WHAT NEXT

Dear Prime Minister! As a leader, please accept the fact that you won the battle against the first wave but lost the battle against the second wave. You do not win all the battles. It is important that you win the war – war against COVID-19.

You won people’s mandate because they trusted you. You used your high visibility and high credibility in winning over their emotions. Trust is after all an emotion.

All Indians are one but they are not the same. Similar people are grouped into states. That we have 29 states shows similarity of people within the states but dissimilarity of people across the states. Indians are not like Americans, who have little diversity in language, culture or religion.

The unified central-command structure of decision making which you could use so successfully in running the Government in Gujarat may not be an optimal design for running the Union Government. Please remember that the entire bureaucracy that you handled in Gujarat was a unified Gujarat cadre but when you handle the union Government, your bureaucracy is not one cadre. The rules of engaging with the opposition leaders and bureaucracy within Gujarat are not suited to engaging with the opposition leaders and bureaucracy in the matters of the Union.

They still trust you but the untold agony and death, which they have seen over the last one month, has broken them emotionally. Fear & grief of COVID-19 is overwhelming ordinary people and your political rivals and bruised media (you have taken away many of their free bees) are adding fuel to this fire. Emotions are contagious. Our brains are wired to mirror the body language and emotion of others. In an era of social media, opinions occlude information and truth becomes matter of opinion. Absolute truth makes way for pre-truths, half-truths, developing truths, post-truths, my truths, your truths and no-one-knows whose-truth.

There is no denying that you are suffering from a loss in your credibility. Your high visibility and waning credibility is untenable in public space. You cannot be complacent or disheartened. You need to make a serious course-correction.

You have to rise as a leader and restore the confidence of people in their ability to overcome and succeed under your leadership. Please work towards decreasing the COVID-19 test-positivity rate & case fatality rate and increasing the EMOTIONAL POSITIVITY among the people of India.

To everyone locked inside their homes, in fear or anxiety, and to everyone locked out from the joys of life as usual, please put a confidence in them that the sun will come again. Remind them of the vibration that passed all over their lives, make them remember everything that they shared with their loved ones, thank the Gods who helped them face the untold grief over the last one month.

You have to rise from the ashes of the second wave. YOU HAVE TO WIN ALL THE FORTHCOMING BATTLES AGAINST THE THIRD AND THE FOURTH WAVE. YOU HAVE TO WIN THE WAR.

 

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First Published 17 May 2021

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Neither a ‘MODI-BHAKT’ nor a ‘FAMILY-LOYALIST’

 

Loyalty is behaviour in which one stays firm in one’s friendship or support for someone or something. Loyalties are feelings of friendship, support, allegiance or duty.

I am loyal to my country and to my family. I neither need nor seek anyone’s certification for my loyalty.

BHAKTI literally means "attachment, state of mind where the devotees surrender himself or herself unquestioningly to God.

Bhakti in Indian culture is "emotional devotion" particularly to a personal God or to spiritual ideas. Thus, bhakti requires a relationship between the devotee and the deity. The term also refers to a movement, pioneered by Alvars and Nayanars, which developed around the gods Vishnu (Vaishnavism), Brahma (Brahmanism), Shiva (Shaivism) and Devi (Shaktism) in the second half of the 1st millennium CE. The union of the human soul with a supreme God, man's love and devotion for God are some of the concepts, which were dwelt upon by the saints. In ancient texts, such as the SHVETASHVATARA UPANISHAD, the term simply means participation, devotion and love for any endeavour, while in the BHAGAVAD GITA; it connotes ‘Bhakti Marg’ one of the possible paths of spirituality and towards moksha.

Bhakti is also found in other religions practiced in India. Nirguni bhakti (devotion to the divine without attributes) is found in Sikhism, as well as Hinduism. Outside India, emotional devotion is found in some Southeast Asian and East Asian Buddhist traditions. 

It grew rapidly in India after the 12th century in the various Hindu traditions, possibly in response to the arrival of Islam in India.

Loyalty other than the loyalty to one’s country and one’s family is slavery; slavery enforced upon someone or accepted by someone due to that one’s weakness. Loyalty is otherwise a trait found in some animals. Such loyalty in those animals is appreciated and acknowledged. Dogs are thought to be the most loyal to their MASTERS. Horses are also loyal to their MASTERS. The expression MASTERS is not about ownership; it is more akin to as in RINGMASTER in a circus.

I do not intend to make judgments about my friends or strangers, many of whom are completely at ease being a MODI-BHAKT or a GANDHI-NEHRU-FAMILY-LOYALIST. I merely wish to say that BHAKTI and LOYALTY are not the two poles of the same characteristic but two entirely different characteristics.

For me, Loyalty to my country comes first, followed by loyalty to my family. Then comes Bhakti to my God and religion. All other kinds of Loyalty and Bhakti is redundant and a mere reflection of my weaknesses. A caveat though, all other kinds of loyalty or Bhakti to any other being or any other object is the same thing.

 

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First published 17 Feb 2021

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