Giving untested remedies to vulnerable people in a pandemic violates ethics
By Lancelot Pinto
The scientific method is agnostic to the belief system or school of thought that is being tested. In clinical medicine, practicing scientifically evolves from either a biological plausibility or a series of observations which then leads to small clinical trials, hopeful outcomes from which stimulate larger trials, which then either prove or disprove a hypothesis. Most drugs for Covid-19 have gone through these pathways.
An example of biological plausibility is the question “is it plausible that a drug developed to combat one virus will work on another?” This led to testing of drugs such as Lopinavir-Ritonavir (used for HIV), and Remdesivir (originally developed to treat Hepatitis C).
A similar question: “Will a drug that works at high doses on the virus in a laboratory work in humans” led to Ivermectin being tested as a potential cure. The observation that individuals with autoimmune diseases being treated with hydroxychloroquine might have a lower incidence of Covid-19 led to the testing of the drug as a potential cure. Despite having such biological plausibility or showing promise, none of these drugs have been proven to work for Covid-19.
Why should we then applaud a system of medicine that has had so many failures in giving us a drug for Covid-19? Because at the core of the scientific method for medicine are ethical tenets firmly grounded in the first principle of ‘primum non nocere’. The “null hypothesis” that is the starting point for every drug trial is that the treatment is no better than placebo. The burden of proof is upon the treatment to prove its worth “beyond reasonable doubt” (reflected in the principle of statistical and clinical significance).
The phases of a drug trial are also designed to ensure maximum safety, before the drug reaches a large number of people, and can potentially cause irreparable harm. Individuals participating in such trials also do so with voluntary consent and no inducements, preventing experimentation and exploitation.
The above principles should apply to any form of medicine, and when applied rigorously, could possibly result in the discovery of new remedies that have been used traditionally in a non-standardized way. Unfortunately, a majority of traditional medicines do not go through the same level of scrutiny. This is risky.
One assumes that something that is “traditional” or “natural” can do no harm. There are several examples to the contrary. St John’s wort (Hypericum perforatum) is a flowering plant that was used by herbalists for a thousand years for a variety of ailments. We now know that this can cause life-threatening reactions and interactions with multiple medications. Foxgloves, a group of plants, was used by herbalists till it was found that the difference between a useful and a lethal dose wasn’t very much.
Inhalation of steam, which was earlier thought to be innocuous, is now being questioned as being a contributor to the mucormycosis pandemic, as the high temperature could potentially burn off the natural defense mechanisms that the nasal passages have against the fungus. As a pulmonologist, I have treated patients in whom the sniffing of ghee/oil has resulted in lipoid pneumonia.
When traditional medicines are prescribed as being effective (without undergoing methodologically stringent testing) during a pandemic, several ethical principles could get violated. The novelty of the disease, coupled with the widespread fear and paranoia, now being reinforced not only by the news, but also by personal experiences of loss and witnessed tragedies, make individuals extremely vulnerable.
Vulnerable individuals have a compromised capacity to consent, especially in a field like medicine, in which the knowledge asymmetry is stark. If such individuals are offered remedies that haven’t been rigorously tested, they are in effect being experimented upon without their consent.
The argument that an individual has free will does not really apply in such a scenario, as in the present milieu of “doing whatever it takes”, individuals cannot be expected to make rational judgments. This is why it is extremely important for regulators to intervene, and prevent the pushing of remedies that are unproven.
Is it risky to push or promote traditional medicine in a pandemic? As much as it is risky to push unproven conventional medicines, outside the scope of a clinical trial. Rather than criticize any system of medicine, one needs to audit the rigor through which the efficacy of a treatment has been proven beyond doubt, the transparency with which the potential adverse effects of the treatment have been reported, the conflicts of interest that may have influenced such reporting, and the peer-review that the report has been subjected to.
I end with a quote from Carl Sagan: “Extraordinary claims require extraordinary evidence”. A pandemic and the need for an early cure should not permit the lowering of the bar for safety and efficacy to any system of medicine.
– The writer is Consultant Respirologist, PD Hinduja National Hospital and Medical Research Centre, Mumbai
Clinical practice is proof that Ayurveda helps manage Covid, so let’s break silos
By Darshan Shankar
Can traditional medicine systems like Ayurveda help in the Covid pandemic? There is increasing evidence that they do.
The reputed medical journal (J-AIM) managed by the Center of Excellence for Integrative Health, Pune University, has compiled peer-reviewed case studies from different states on Ayurveda management of Covid, which indicate that physicians effectively manage respiratory symptoms, fevers, fatigue , metabolic disorders and low saturation with safe, classical formulations. The scale of interventions is small due to policy constraints and because case studies form the foundation of the pyramid of evidence.
At the outset I would like to categorically state that in my view it is incorrect for traditional physicians to claim that Ayurveda pharmacopoeia has anti-virals for the management of Covid. So how does Ayurveda contribute without antimicrobials? To understand this phenomenon it is necessary to break the myth that anti-virals are the only means for managing symptoms of Covid.
A glimpse of insights from trans-disciplinary scientific collaboration between Ayurveda and biology may help. In 2005, a pathbreaking paper published by Prof Bhushan Patwardhan (professor of health sciences, Pune University) demonstrated the correlation between Ayurveda phenotypes and genotypes (HLA gene polymorphism). This was a milestone in the history of biology, as Ayu-Genomics illustrated that biological concepts of classification of human populations, derived from different cultural views of nature (panchmahabhutas and molecular biology) could converge to create new knowledge of contemporary relevance. A decadal research program on Ayurveda-Biology, endorsed by the Indian National Science Academy and led by the distinguished cardiac surgeon Prof MS Valiathan followed Patwardhan’s work, with strategic outcomes published in reputed journals related to metabolism, immunity and regenerative biology.
Moving from examples of scientific potential of Ayurveda to the ground reality of clinical practice, it is evident that Ayurveda and other traditional systems clinically manage dozens of health conditions, alongside an understanding of their ‘systemic’ aetiologies, which correspond in biomedicine to ‘infectious’ diseases like diarrhea, herpes zoster, UTIs, gangrenous wounds, viral fever and mycosis, without use of conventional antimicrobials.
While it is justified to treat Covid-19 and other infections with appropriate antimicrobials in biomedicine, it is irrational to insist that they must be managed similarly by another system of medicine, which has a different way of understanding biological change. I may be forgiven for taking recourse to a music analogy — consider how absurd it would be for a dominant community of musicians to insist that only jazz, symphonies or sonatas can be music.
Ayurveda has a ‘systemic’ biological theory (dosha vichar) to diagnose and treat complex physiological imbalances. It has an incredibly large armory of 400,000, herbal and herbo-mineral formulations documented in GOI-CSIR’s database called the Traditional Knowledge Digital Library (TKDL).
Policy makers must realize that the test of any knowledge is not based on any unique method or concepts, however profound, but by assessing if competing theories and practice can consistently be applied to transform and solve real-life problems. To reject and ignore a solution because its logic of mode of action is different from a particular dominant knowledge framework is sheer prejudice and ignorance of plurality and its implications.
Furthermore, while evidence from high quality outcome data is indeed a credible way to establish effectiveness, it must be realized that absence of data is not tantamount to lack of evidence. Data is directly a function of public investment in clinical research and the truth is that such investment in AYUSH has been pathetically low. The recent Clinical Case Repository Portal designed by the Ministry of AYUSH is the first step in this direction.
Demanding clinical trial data as the sole prerequisite to establish credibility, without substantial investment in data generation, is like asking great cooks in ethnic communities unexposed to competition, to produce a Michelin award to certify their competence, when this is evident from the fact that millions consume ethnic delicacies with delight.
Ayurveda is India’s living cultural heritage. Physicians are only its carriers. The entire scientific community in ‘public interest’ needs to assume ownership and responsibility for its revalidation. The analysis of the last 10 years of data on real life clinical practice, from clinical records of at least a hundred good Ayurveda hospitals and thousands of clinics should be the first “joint” health sciences venture.
We need to break silos across medical streams. More immediately, one needs to bury narrow interests, and in public interest recalibrate the national Covid management policy to adopt integrative health care protocols. This is especially important for post-Covid syndrome where anti-virals may be irrelevant.
– The writer is Vice Chancellor of the University of Trans-Disciplinary Health Sciences and Technology, Bengaluru