Whose Duty Is it Anyway?

The recent article from Nature emphasizes the need for research in the AYUSH system, suggesting mild COVID patients as cohorts for RCT before repurposing is initiated. However, it falls short of identifying whom to address this right question. ¹ In order to develop an in-depth understanding of the complex ecosystem of health care in India, the COVID crisis provides an excellent screening tool for evaluating our general approach to disease management. When the COVID-19 pandemic spread across the globe, no sustainable solution was in sight. Therefore, it provided a level playing field for all systems of medicine to be tapped in repurposing potential drugs, preferably by comparative effectiveness. The health managers in India and elsewhere decided to repurpose HCQ as an alternative drug for COVID-19 without conducting any clinical trial. Many research papers were subsequently published showing that the repurposing potential of HCQ was inconsequential, and these were soon retracted. ² At a time when the uncertainty of pandemic was raging, these managers decided to take the Remdesivir repurposing forward, and the necessary approvals were provided by the Indian Council of Medical Research (ICMR). Despite the failure of HCQ, these agencies continued to pursue the dogmatic approach by again proposing its use for the vulnerable population and health care workers unlike what was suggested for the repurposing of Ayurvedic drugs. In other words, there seems to be one scientific yardstick for the translation of benefits of one health management system, and another for the other. As expected, the Remdesivir experiment failed again and was subsequently removed from the national protocol for COVID-19. At a time when the allopathy had no solution for COVID-19, many questioned if it is meaningful for Ayurveda or other systems to be repurposed for COVID-19 management as it had far more published scientific data than either HCQ or Remdesivir put together. No one tried to ask this scientific question, yet many frequently asked why the national AYUSH protocol was approved or why other drugs containing Ashwagandha were being used for post-COVID-19 management. The impending failure of Remdesivir, which was “hyped” to generate “hope,” looms large. As a result, the drug was sold in the black market at exorbitant prices, causing both fear and panic. It is well known that the shares of this company soared even though the post-surveillance data was not made available to experts. Surprisingly, even the pharmacovigilance data was also not made available. In USA, National Institutes of Health (NIH) is usually involved in regulating their country’s treatment protocol in coordination with CDC which includes sero-surveillance. In health emergencies in India, when decisions are to be taken by the health servicing Department, ICMR stepped in and must be held accountable for the finalization of protocols.

It was after these repeated failures, the Ministry of AYUSH came out with the national protocol soon after the Katoch committee and the AYUSH’s interdisciplinary committee cleared the same.^{3, 4} These committees had reviewed and examined the in vitro, in vivo, and clinical studies based on which this decision was taken through due process. ICMR was also a member in approving the national AYUSH protocol. This protocol was recommended for prophylaxis and management of mild COVID patients as well as for post-COVID recovery. No sooner had the protocol been finalized, the Indian Medical Association (IMA, a nonscientific union of doctors) came out with a rejoinder opposing the AYUSH preventive protocol meant to benefit the patients based on their preferences. While the evidence-based medicine needs to be supported by practice-based experience, ⁵ IMA now calls for a national protest and dissolution of NITI Aayog study groups made to implement an integrative health system in the country.

The bizarre claim of IMA, a union of Indian doctors, calling Indian System of Medicine (ISM) a “placebo” is unfortunate. It smacks of blasphemous collusion with the journal Science that promptly voiced IMA’s version as “a fraud on nation” with an alacrity never seen before. ⁶ This happened within a week of IMA’s claims flashing in the Indian media. This has led to many burning questions about the politics of medicine and money. The quality of scientific temper and ethics, often attributable to medical science communication, remain to be addressed. This journal had earlier landed itself in a controversy when an unprecedented political statement was issued by its editor, asking its readers not to vote for Mr Donald Trump in the US presidential elections. It is our considered view that journals should avoid political posturing and instead focus on hard science, than predictive science. Regardless, others argued that IMA is facing flak at the hands of patient support organizations after the Medical Council of India (MCI) was replaced by the National Medical Commission (NMC) and patients' growing preference for the AyurYog version of the public health approach was weighing on them. The recent defamation suit filed by an Ayurveda practitioner claiming AyurYog to be the “mother of modern medicine” is also aligned to this dwindling patient mood.

The perpetuation of dissociation between patent-based knowledge advancement of modern clinical research and indigenous AyurYog has become so pervasive that some medical practitioners have begun to assume that they are the true owners of this medical progress and everything else is a “placebo.” India spends a considerable foreign exchange for importing the medical devices, drugs, and technology used by the Indian medical community. The concept of Atma Nirbhar Bharat or self-reliant health structure provides them with an opportunity for leadership in the field of traditional or integrative medicine-related knowledge economy. On November 13, 2020, at the proposal of the honorable Indian Prime Minister, Shree Narender Modi, the Secretary General of the World Health Organization agreed to set up a Global Centre for Traditional Medicine in India. This now provides a unique opportunity to spearhead the global integrative health initiative through multinational clinical trials ensuing seamless knowledge advancement in the field. ^{7, 8}

Based on these developments, we need to ask the right question to ICMR and not AYUSH as to who should be mobilized to undertake biomedical research in this domain of interdisciplinary area where Ayurvedic or Yogic biology framework can provide the answers. Prof Valiathan’s idea of collaborative research between Ayurveda and biomedical research requires implementation. In our opinion, scientific research on ISM is a fiduciary responsibility of the Indian scientific and medical community and not just the AYUSH sector. In this context, it is a right question being asked to a wrong person. We are probably barking up the wrong tree. Every national laboratory, especially those belonging to medical institutes and other government-funded institutions, should research AYUSH systems, collectively funded by national agencies. For this, the faculties of AyurYog will need to be installed in these Institutions so that they may identify the relevant clinical questions for research. This may include cost-effectiveness trials. This will ensure that the discoveries from ISM knowledge receive acknowledgement, much like the Nobel prize-winning work of Chinese Prof Tu Youyou. Prof Tu had spearheaded the application of Traditional Chinese Medicine (TMC) at the time of a malaria epidemic in the 1960s. The Chinese Medical Association wholeheartedly supported this as a matter of national pride. ⁹

ISM is in a containment zone with an access to subcritical resources and disjointed from the infrastructure of premier hospitals and medical institutes. In such a hostile environment, the expectation for AYUSH to advance scientifically would be wrong. While TCM has flourished because of Chinese administration bringing the basic scientists and TCM together, India's integrative health research has remained a prisoner of the dominant Western medicine, aided by erstwhile MCI. As MCI has now been replaced by NMC, ISM must be provided with resources and capacity building in order to bridge the chasm. ¹⁰

Even though the USA and many Western countries do not have a long history of traditional medicine and practice, it has been adopted to endorse NIH's focus from “medicine” to “health,” much like Indian PM's repeated emphasis on wellness. ¹¹ The USA's NIH/National Center for Complementary and Integrative Health model provides a way forward. It has evolved from an Office of Alternative Medicine, once regarded as Senator Harkin's folly and criticized by the scientific community, into National Center for Complementary and Integrative Health. The research capacity in India’s health sciences, not just AYUSH, should be taken on priority so that the newly formed working groups of NITI Aayog on integrative health can address the health, wellness, and knowledge economy of India in an evidence-based manner.