Prologue

I must confess that I winced, shocked at the maliciousness of the authors of the piece titled “AYUSH Kwath or Kadha cannot boost immunity to fight against COVID-19” that appeared in ALT News on 10th August 2020^[i].

I had just taken my eyes off an engaging article published in MedpageToday, also on the same date – “Academic Medicine’s Sins Set Stage for HCQ Cult.^[ii]” I am tempted to quote a few sentences from this piece to highlight the irony of the matter. Here, it goes, “The other day some friends told me that their son has COVID. With conviction, his mother said that she told him to drink plenty of hot tea with lemon. That is good for COVID, she said. Then she realized who she was talking to and added, “At least, that is what I think is good. I didn’t correct her. I just said, “Could be.” I try not to correct along these lines when the interventions do no harm. But hydroxychloroquine is a different matter. It can do harm. And, in my opinion, its greatest harm is to bolster distorted thinking and pseudoscience.”

COVID-19 has brought to light the irregularities and inconsistencies of the so-called evidence-based approach to medicine. Did we not see the Lancet retracting a paper reporting outcomes of HCQS in a large cohort of patients because authors of the paper were unable to complete an independent audit of the data underpinning their analyses^[iii]? While the retraction is welcome, the whole episode reveals gaping holes in the “rigorous” peer review system of one of the most celebrated research journals. What did we hear some time ago? – That the editors of The Lancet and the New England Journal of Medicine blurted out that pharmaceutical companies are so financially powerful they pressure us to accept papers^[iv].

Greenhalgh from the University of Oxford catches our attention with her thought-provoking paper, “Will COVID-19 be evidence-based medicine’s nemesis?^[v]“. She argues in favor of practice-based evidence approach and remarks that rather than focusing on sample size and statistics, we should be looking at whether the intervention leads to a desirable outcome.

That brings us back to the MedPageToday article, which cites in the context of HCQS, the example of studies on the efficacy of statin where a p-value of 0.5% obtained from studies that show a difference of 1% in occurence of heart attacks in people who are on placebo and statin is blown up to give the impression that statins lower heart attacks by 30% or more. In the words of the author, “this game of finding P values of less than 0.05 and then making exaggerated claims became part of the culture of academic medicine (i.e., medical schools and biomedical research organizations).”

The house of evidence-based medicine needs to be seriously set in order. As Subhash Kak pointed out,  the Nature journal reported in 2016 that over 70%  of published research findings could not be replicated by other scientists ^[vi]. Proclaiming that “science has taken a turn to darkness”, Richard Horton, the Editor of Lancet, makes the sweeping statement that much of the scientific literature, perhaps, half may simply be untrue”^[vii]. 

The Kwath attacks

The authors who “fact-checked” AYUSH Kwath/Kadha represent the glorified allopathic medical community of India who borrow this “scientific evidence-based medical knowledge” wholesale from the West, something that they worship with such blind faith and fervor, that they turn into self-professed champions and guardians of medical truth and the health of the people. Contempt for their own culture and their culpable enthusiasm to downplay and misrepresent the rich health care heritage that they have inherited seems to be the hallmark of such self-righteous individuals. They are ever vigilant to grab and convert the slightest opportunity that comes in their way to advance their campaign against traditional medicine, wearing a garb of pseudo-rationality that skillfully cloaks their ulterior motives and intentions.

Now let us come to the AYUSH Kwath or Kadha itself. Wipe this name off your minds and go shopping at the nearby grocery store. You will find cinnamon, tulsi, pepper, and ginger in tea bags neatly stacked in attractive packages. If you mixed all these tea bags, you would get a semblance of AYUSH Kwath. Raisins, jaggery, and lemon are always there for the asking. You can also make this mix from your kitchen shelves. Irrespective of the AYUSH advisory, people are already using such teas in their day to day lives. What is there in AYUSH Kwath that irks our authors’ conscience and transforms them into Good Samaritans?

The authors have made objectionable statements and sweeping generalizations without proper examination of facts. Evidently, their intention seems to be focused on targeting the Ministry of AYUSH and the AYUSH community to downplay the role that these systems can play in contributing to the health care of the people, especially during the COVID-19 pandemic.

The very title is misinformed and misleading because the Ministry of AYUSH has not made any claims that AYUSH Kadha can boost immunity of the individual to fight against COVID-19. The guideline for self care during COVID crisis is published on the Ministry’s website (https://www.ayush.gov.in/docs/123.pdf). This guideline clearly states that there is no medicine for COVID-19 and that it is recommended to adopt a set of simple practices as a general preventive health measure and to strengthen respiratory health. The authors have imagined a non-existent issue and then proceeded to refute it with far fetched arguments.

There are five objectionable claims that the authors have identified for their fact check analysis

1. Immunity boosting is used to treat or prevent COVID-19 infection

2. Natural plants or herbs can boost the immune system to prevent infections

3. AYUSH Kwath (kadha) herbal formulation boosts immunity against COVID-19

4. The herbs of AYUSH Kwath boost immunity against COVID-19

5. AYUSH Kwath has no side effects of prolonged use

“Immune Boosting” Whataboutery

Before responding to the above statements, it needs to be clarified that the authors have interpreted the term “immune boosting” in the framework of the mechanistic understanding in biomedical science where a boosted immune system could mean a hyperactive immune system as seen for example, in an autoimmune disease. Suppressing or shutting down the immune system, accordingly, is the line of management in modern medicine, for such diseases. From this viewpoint, they maintain that suppressing, rather than “boosting” the immune system is the line of management in severe cases of COVID-19.

In systems of medicine like Ayurveda, such a concept or approach to suppress the immune system does not exist. “Immune boosting”, which is only an approximate translation of a network of Ayurvedic sanskrit terms like bala, vyadhiksamatva and so on, does not mean activating of immune system into a state of hyperdrive. When traditional medical systems like Ayurveda use the term “immune-boosting”, it only means optimizing the body’s resources and mind to cope with a stressful situation, including infection in an efficient manner. Proper sleep^[viii] and moderate exercise^[ix] have also been found to have beneficial effects in enabling the body to fight infections. There is no claim from the Ministry of AYUSH that any of its recommendations for self-care during COVID-19 will confer specific immunity against SARS-CoV-2 by activating adaptive immunity as inferred and implied by the authors. Considering that this term “immune-boosting” is loaded with sensitivities and sensibilities that unintentionally overlap with biomedical concepts of immunity, I recommend that the use of this term be discarded by practitioners of traditional medicine systems and the Ministry of AYUSH as well. Thus, the accusation that Ministry of AYUSH has proposed Immune Boosting to treat or prevent COVID-19 infection is misconstrued on two counts – 1. The interpretation of the term “Immune Boosting” and 2. That the formulation has claimed to boost immunity against COVID-19.

The authors point out that there is no scientific basis to support the claim that natural plants or herbs can boost the immune system. The statement in the AYUSH Ministry’s guideline is as follows – “These measures are recommended by following eminent Vaidyas from across the Country as they may possibly boost an individual’s immunity against infections.”. The phrase “may possibly boost an individual’s immunity against infections” needs particular attention as it reflects a very careful statement of facts based on rigorous review of Ayurvedic literature (API, Part 1 p. 138, 151, Part 2 p. 170 and Part 3 p. 115) and research papers. The authors complain that the quality of the studies in support of the herbs in AYUSH kwath for management of infection is poor and that there are metholodogical limitations with respect to sample size. The authors must keep in mind that this advisory is released in the situation of a pandemic crisis and even in modern medicine, guidelines for self care and clinical practice have been released on the basis of best available evidence that does not meet the stringent criteria that the authors are demanding for AYUSH kwath. Even when a drug like HCQS was recommended as a prophylactic for COVID-19, only weak pre-clinical evidence was available. (https://www.healio.com/news/rheumatology/20200428/evidence-still-lacking-for-prophylactic-chloroquine-hydroxychloroquine-in-covid19). In fact, all the drugs repurposed for treatment of COVID-19 have been recommended on the basis of weak rationale and evidence.

A search query on the PubMed database using keywords Infection and Medicinal Plants returns 6168 search results and reveals that interesting works are in progress. With the emergence of anti-microbial resistance, medicinal plants’ potential as an alternative for both prevention and management of infections is being investigated. The authors reveal their prejudice against traditional medical systems by their fierce and hasty dismissal of any possible role for herbs or herbal formulations in preventing infections before proper investigation is done. Do these herbs really help in preventing infections? There are many research studies that support such an hypothesis, but further studies are warranted. The wordings in the guideline of Ministry of AYUSH that reads “may possibly boost immunity against infections” reflects the implications of the available evidence honestly.

The AYUSH Advisory is for self-care during the pandemic and is not a guideline for treatment. The Ministry clarifies that there is no medicine available for COVID-19 and that simple a self-care guideline is provided. In the wake of a pandemic like COVID-19, we face the challenge of providing preventive and clinical care even in the absence of medicines or interventions backed up by rigorous research. In a country like India, with a pluralistic healthcare system, people cannot be prevented from choosing alternative approaches for self-care, especially for a pandemic like COVID-19. Issuance of guidelines for self-care ensures that people will not be misled to experiment with dangerous interventions. The AYUSH self-care guidelines include simple measures to cleanse the nasal and oral cavity and preserve the digestive and respiratory systems’ health in addition to the herbal tea. It must be noted that rinsing of nasopharynx and oropharynx has been recommended in other countries, even with weak evidence^[x]. Over time, the benefits of such practices in mitigating the spread of the disease have also been reported^[xi].

FearMongering – Side Effects

Now, let us come to the most severe issue of side effects. Please keep in mind that this accusation comes from respectable professionals who represent a medical system that has owned up the responsibility for being the third leading cause of death in countries like the United States after heart disease and cancer[xii]. These are the people who deal with highly toxic medicines that offer only a small therapeutic window for the safe use of highly purified chemical compounds. It is quite understandable that the professors of this system are overtly sensitive to the side effects of drugs and may become paranoid about the safety of items like ginger, pepper, cinnamon, and the like that are commonly used in the kitchens of India and other parts of the world to spice up foods and drinks.  The apprehension of the authors about the interaction of these herbs and the detrimental effects of its chemical constituents is unfounded and far fetched. These herbs are widely used in day to day life as spices in the kitchen and herbal teas made out of these ingredients are available freely in shops and markets. The question of safety and toxicity arises only when these herbs are used as concentrated extracts and in high doses. The AYUSH kwath is to be used as a tea – an infusion of the herbs in hot water, which does not deliver high toxic doses of chemical constituents of the herbs.

The authors have also pointed out that many products have been released in the market in the name of AYUSH Kwath claiming efficacy in the prevention or management of COVID-19. In fact, this is the major focus of the contentious article written by the authors. The authors who accuse Ministry of AYUSH of having promoted the manufacturing and sales of AYUSH Kwath claiming efficacy for COVID-19 are blissfully unaware of the fact that the Ministry had issued notifications under the Contravention of the Provisions of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules 1955; and Drugs and Cosmetics Act, 1940 and Rules, 1945 concerning not only the Product “AYUSH KADHA” but many other products that were introduced into the market by AYUSH manufacturers for making misleading claims related to COVID-19. As a result, misleading advertisements were taken down from social media and labels were rectified removing objectionable claims. The Ministry of AYUSH has taken appreciable steps to curb false claims and practices related to COVID-19 as can be seen from various orders and notifications published on its website. This includes the order to stop and prevent publicity and advertisement of AYUSH-related claims for COVID-19 treatment^[xiii],  the order prohibiting State License Authorities to issue license for AYUSH products related to COVID-19 without scrutiny of the Central Government^[xiv], the notification for undertaking research on COVID-19^[xv] and so on. Some years ago, the Ministry has also launched the National Pharmacovigilance Program in AYUSH sector which tracks unethical products and misleading advertisements. It is quite evident that the authors have not really done a thorough fact check and are just dressing up their bias using scientific parlance.

Ayurveda is one of the earliest health care systems that has warned us that there is no safe substance in the world. Every material used as medicine has potential for good and harm^[xvi]. Safety lies in the judicious use and is not an inherent feature of any substance. Classical Ayurvedic texts even discuss methods to purify spices like pepper before use. In modern medicine, the dosage of the drug is adjusted so that therapeutic effects are maximized and side effects minimized, though not eliminated. In Ayurveda, pharmaceutical processing is done to reduce toxicity, whereas, adding other ingredients is another strategy to reduce toxicity apart from the careful adjustment of the dose.

AYUSH KWATH or KADHA is a misnomer in one sense because the name implies that we are making a concentrated decoction of the recommended herbs, whereas, the instructions are actually to make a hot infusion or PHANTA. The recommended quantity and proportion of the herbal ingredients and the actual extraction of active chemicals in the warm herbal tea is well within safe limits for human use. The authors warn us that even ginger can cause side effects.

If AYUSH KWATH is a threat to the safety of millions of Indian people in the country, then these herbs should first be banned from the grocery stores, supermarkets, and the kitchens in the country’s households. Ginger may be toxic if taken in excess of 6g^[xvii] In the very article that the authors have quoted to highlight the toxicity of cinnamon^[xviii], it is clearly mentioned that “The available data suggests that despite the safety of cinnamon use as a spice and/or flavoring agent, its use may be associated with significant adverse effects in medicinal uses with larger doses or longer duration of use and should be clinically monitored.” Toxicity of Tulasi is also seen only in higher doses^[xix]. The recommended quantity of pepper does not exceed the amount used regularly on the dining table. All these research papers point to the fact that toxicity becomes a concern only when these herbs are consumed in large doses over a long period of time.

The Empire has struck

An ancient Ayurvedic treatise, the Carakasamhita proclaims in public interest – “the intelligent person should refuse an irrational medical prescription in the interest of his or her health and longevity even if it comes from a qualified physician”^[xx]. The war is against irrationality and not against specific medical systems.

In the guise of checking facts and standing up for truth, the authors have betrayed their malicious intent, that of belittling AYUSH systems and the Ministry of AYUSH.

The protection of the Empire – the “territory” of a medical system flourishing on political will, powered by the global Pharma lobby & validated by an ostensibly “scientific” community – continues unabated.

The authors (Dr Sharfaroz Satani , Dr. Sumaiya Shaikh) are liable to provide an explanation and an apology for misleading the public and spreading panic by publishing an article in social media that misconstrues facts and makes baseless accusations against the Ministry of AYUSH and the AYUSH community.

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References:

^[i] https://www.altnews.in/ayush-kwath-or-kadha-cannot-boost-immunity-to-fight-against-covid-19/

^[ii] https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/87991

^[iii] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31324-6/fulltext#articleInformation

^[iv] https://healthimpactnews.com/2020/editors-of-the-lancet-and-the-new-england-journal-of-medicine-pharmaceutical-companies-are-so-financially-powerful-they-pressure-us-to-accept-papers/

^[v] https://science.thewire.in/the-sciences/will-covid-19-be-evidence-based-medicines-nemesis/

^[vi] https://medium.com/@subhashkak/the-reproducibility-crisis-of-medicine-and-logic-b1168eb967df

^[vii] https://physicstoday.scitation.org/do/10.1063/PT.5.8119/full/

^[viii] Ibarra-Coronado EG, Pantaleón-Martínez AM, Velazquéz-Moctezuma J, et al. The Bidirectional Relationship between Sleep and Immunity against Infections. J Immunol Res. 2015;2015:678164. doi:10.1155/2015/678164

^[ix] Nieman DC. Exercise, infection, and immunity. Int J Sports Med. 1994;15 Suppl 3:S131-S141. doi:10.1055/s-2007-1021128

^[x] https://economictimes.indiatimes.com/magazines/panache/nasal-rinsing-gargling-with-saline-water-may-help-fight-against-coronavirus/articleshow/75600340.cms

^[xi] https://economictimes.indiatimes.com/magazines/panache/new-study-shows-gargling-with-mouthwash-may-inactivate-coronavirus-lower-spread-of-covid-19/articleshow/77479461.cms

^[xii] https://www.cnbc.com/2018/02/22/medical-errors-third-leading-cause-of-death-in-america.html

^[xiii] https://www.ayush.gov.in/docs/121.pdf

^[xiv] https://www.ayush.gov.in/docs/Order-regarding-AYUSH-product-approval-COVID%2019.pdf

^[xv] https://www.ayush.gov.in/docs/127.pdf

^[xvi] Carakasaṃhitā, Siddhisthānaṃ, 11th Chapter, 11th Verse

^[xvii] Desai HG, Kalro RH, Choksi AP. Effect of ginger & garlic on DNA content of gastric aspirate. Indian J Med Res. 1990;92:139-141

^[xviii] Hajimonfarednejad M, Ostovar M, Raee MJ, Hashempur MH, Mayer JG, Heydari M. Cinnamon: A systematic review of adverse events. Clin Nutr. 2019;38(2):594-602. doi:10.1016/j.clnu.2018.03.013

^[xix] Narayana DB, Manohar R, Mahapatra A, Sujithra RM, Aramya AR. Posological Considerations of Ocimum sanctum (Tulasi) as per Ayurvedic Science and Pharmaceutical Sciences. Indian J Pharm Sci. 2014;76(3):240-245

^[xx] Carakasaṃhitā, Sūtrasthānaṃ, 1st Chapter, 127th Verse