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Whose Duty Is it Anyway?

Whose Duty Is it Anyway? Editorial Annals of Neurosciences 1 –3 © The Author(s) 2021 Reprints and permissions: in.sagepub.com/journals-permissions-india https://doi.org/10.1177/09727531211009800 DOI: 10.1177/09727531211009800 journals.sagepub.com/home/aon 1,2,3 4 Akshay Anand and Bhushan Patwardhan Received 23 March 2021; accepted 23 March 2021 to be repurposed for COVID-19 management as it had far The recent article from Nature emphasizes the need for more published scientific data than either HCQ or Remdesivir research in the AYUSH system, suggesting mild COVID put together. No one tried to ask this scientific question, yet patients as cohorts for RCT before repurposing is initiated. many frequently asked why the national AYUSH protocol However, it falls short of identifying whom to address this was approved or why other drugs containing Ashwagandha right question. In order to develop an in-depth understanding were being used for post-COVID-19 management. The of the complex ecosystem of health care in India, the COVID impending failure of Remdesivir, which was “hyped” to crisis provides an excellent screening tool for evaluating our generate “hope,” looms large. As a result, the drug was sold general approach to disease management. When the COVID- in the black market at exorbitant prices, causing both fear and 19 pandemic spread across the globe, no sustainable solution panic. It is well known that the shares of this company soared was in sight. Therefore, it provided a level playing field for all even though the post-surveillance data was not made available systems of medicine to be tapped in repurposing potential to experts. Surprisingly, even the pharmacovigilance data was drugs, preferably by comparative effectiveness. The health also not made available. In USA, National Institutes of Health managers in India and elsewhere decided to repurpose HCQ (NIH) is usually involved in regulating their country’s as an alternative drug for COVID-19 without conducting any treatment protocol in coordination with CDC which includes clinical trial. Many research papers were subsequently sero-surveillance. In health emergencies in India, when published showing that the repurposing potential of HCQ was decisions are to be taken by the health servicing Department, inconsequential, and these were soon retracted. At a time ICMR stepped in and must be held accountable for the when the uncertainty of pandemic was raging, these managers finalization of protocols. 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 Postgraduate Institute of Medical Education and Research (PGIMER), proposing its use for the vulnerable population and health Chandigarh, India care workers unlike what was suggested for the repurposing Centre for Mind Body Medicine, PGIMER, Chandigarh, India of Ayurvedic drugs. In other words, there seems to be one Centre of Phenomenology and Cognitive Sciences, Panjab University, scientific yardstick for the translation of benefits of one health Chandigarh, India management system, and another for the other. As expected, University Grants Commission the Remdesivir experiment failed again and was subsequently Corresponding author: removed from the national protocol for COVID-19. At a time Akshay Anand, Postgraduate Institute of Medical Education and Research when the allopathy had no solution for COVID-19, many (PGIMER), Chandigarh, India. questioned if it is meaningful for Ayurveda or other systems E-mail: akshay1anand@rediffmail.com Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution- NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-Commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https:// us.sagepub.com/en-us/nam/open-access-at-sage). 2 Annals of Neurosciences It was after these repeated failures, the Ministry of AYUSH of the World Health Organization agreed to set up a Global came out with the national protocol soon after the Katoch Centre for Traditional Medicine in India. This now provides a committee and the AYUSH’s interdisciplinary committee unique opportunity to spearhead the global integrative health 3,4 cleared the same. These committees had reviewed and initiative through multinational clinical trials ensuing 7,8 examined the in vitro, in vivo, and clinical studies based on seamless knowledge advancement in the field. which this decision was taken through due process. ICMR was Based on these developments, we need to ask the right also a member in approving the national AYUSH protocol. question to ICMR and not AYUSH as to who should be This protocol was recommended for prophylaxis and mobilized to undertake biomedical research in this domain of management of mild COVID patients as well as for post- interdisciplinary area where Ayurvedic or Yogic biology COVID recovery. No sooner had the protocol been finalized, framework can provide the answers. Prof Valiathan’s idea of the Indian Medical Association (IMA, a nonscientific union of collaborative research between Ayurveda and biomedical doctors) came out with a rejoinder opposing the AYUSH research requires implementation. In our opinion, scientific preventive protocol meant to benefit the patients based on their research on ISM is a fiduciary responsibility of the Indian preferences. While the evidence-based medicine needs to be scientific and medical community and not just the AYUSH supported by practice-based experience, IMA now calls for a sector. In this context, it is a right question being asked to a national protest and dissolution of NITI Aayog study groups wrong person. We are probably barking up the wrong tree. made to implement an integrative health system in the country. Every national laboratory, especially those belonging to The bizarre claim of IMA, a union of Indian doctors, medical institutes and other government-funded institutions, calling Indian System of Medicine (ISM) a “placebo” is should research AYUSH systems, collectively funded by unfortunate. It smacks of blasphemous collusion with the national agencies. For this, the faculties of AyurYog will need journal Science that promptly voiced IMA’s version as “a to be installed in these Institutions so that they may identify fraud on nation” with an alacrity never seen before. This the relevant clinical questions for research. This may include happened within a week of IMA’s claims flashing in the cost-effectiveness trials. This will ensure that the discoveries Indian media. This has led to many burning questions about from ISM knowledge receive acknowledgement, much like the politics of medicine and money. The quality of scientific the Nobel prize-winning work of Chinese Prof Tu Youyou. temper and ethics, often attributable to medical science Prof Tu had spearheaded the application of Traditional communication, remain to be addressed. This journal had Chinese Medicine (TMC) at the time of a malaria epidemic in earlier landed itself in a controversy when an unprecedented the 1960s. The Chinese Medical Association wholeheartedly political statement was issued by its editor, asking its readers supported this as a matter of national pride. not to vote for Mr Donald Trump in the US presidential ISM is in a containment zone with an access to subcritical elections. It is our considered view that journals should avoid resources and disjointed from the infrastructure of premier political posturing and instead focus on hard science, than hospitals and medical institutes. In such a hostile environment, predictive science. Regardless, others argued that IMA is the expectation for AYUSH to advance scientifically would facing flak at the hands of patient support organizations after be wrong. While TCM has flourished because of Chinese the Medical Council of India (MCI) was replaced by the administration bringing the basic scientists and TCM National Medical Commission (NMC) and patients' growing together, India's integrative health research has remained a preference for the AyurYog version of the public health prisoner of the dominant Western medicine, aided by approach was weighing on them. The recent defamation suit erstwhile MCI. As MCI has now been replaced by NMC, filed by an Ayurveda practitioner claiming AyurYog to be the ISM must be provided with resources and capacity building “mother of modern medicine” is also aligned to this dwindling in order to bridge the chasm. patient mood. Even though the USA and many Western countries do not The perpetuation of dissociation between patent-based have a long history of traditional medicine and practice, it has knowledge advancement of modern clinical research and been adopted to endorse NIH's focus from “medicine” to indigenous AyurYog has become so pervasive that some “health,” much like Indian PM's repeated emphasis on medical practitioners have begun to assume that they are the wellness. The USA's NIH/National Center for true owners of this medical progress and everything else is a Complementary and Integrative Health model provides a way “placebo.” India spends a considerable foreign exchange for forward. It has evolved from an Office of Alternative Medicine, importing the medical devices, drugs, and technology used by once regarded as Senator Harkin's folly and criticized by the the Indian medical community. The concept of Atma Nirbhar scientific community, into National Center for Complementary Bharat or self-reliant health structure provides them with an and Integrative Health. The research capacity in India’s health opportunity for leadership in the field of traditional or sciences, not just AYUSH, should be taken on priority so that integrative medicine-related knowledge economy. On the newly formed working groups of NITI Aayog on November 13, 2020, at the proposal of the honorable Indian integrative health can address the health, wellness, and Prime Minister, Shree Narender Modi, the Secretary General knowledge economy of India in an evidence-based manner. Anand 3 Declaration of Conflicting Interests 6. Pulla P. ‘A fraud on the nation’: Critics blast Indian govern- ment’s promotion of traditional medicine for COVID-19. The author declared no potential conflicts of interest with respect to https://www.sciencemag.org/news/2020/10/fraud-nation-crit- the research, authorship, and/or publication of this article. ics-blast-indian-government-s-promotion-traditional-medicine- covid-19 Funding 7. WHO to set up centre for traditional medicine in India, PM says matter of pride, November 13, 2020, Hindu. https://www.the- The author received no financial support for the research, authorship, hindu.com/news/national/who-to-set-up-centre-for-traditional- and/or publication of this article. medicine-in-india/article33091388.ece 8. Anand A, Tyagi R, and Kaur P. Incubating integrative medicine References in India through PMO's Atal Incubator Scheme of Niti Aayog. 1. Kumar J and Sinha P. Time to bring scientific rigour to the com- Ann Neurosci 2017; 24(3): 131–133. plex challenge of Ayurvedic medicine. . https://www.naturea- 9. Su X-Z and Miller LH. The discovery of artemisinin and the sia.com/en/nindia/article/10.1038/nindia.2020.101 Nobel Prize in physiology or medicine. Sci China Life Sci 2. Mehra MR, Desai SS, Ruschitzka F, et al. Hydroxychloroquine 2015; 58: 1175–1179. or chloroquine with or without a macrolide for treatment of 10. Rudra S, Kalra A, Kumar A, et al. Utilization of alternative COVID-19: A multinational registry analysis. Lancet 2020. systems of medicine as health care services in India: Evidence 3. National Clinical Management Protocol based on Ayurveda on AYUSH care from NSS 2014. PLoS One 2017; 12 (5): and Yoga for Management of Covid-19, Ministry of AYUSH, e0176916. Government of India. https://www.ayush.gov.in/docs/ayush- 11. Sen S and Chakraborty R. Revival, modernization and integra- Protocol-covid-19.pdf tion of Indian traditional herbal medicine in clinical practice: 4. Golechha M. Time to realise the true potential of Ayurveda Importance, challenges and future. J Tradit Complement Med against COVID-19. Brain Behav Immun 2020. 2016; 7: 234–244. 5. Islam MN. Repackaging ayurveda in post-colonial India: Revival or dilution? S Asia: J S Asian Stud 2012; 35: 503–519. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Annals of Neurosciences SAGE

Whose Duty Is it Anyway?

Annals of Neurosciences , Volume OnlineFirst: 1 – Jan 1, 2021

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Abstract

Editorial Annals of Neurosciences 1 –3 © The Author(s) 2021 Reprints and permissions: in.sagepub.com/journals-permissions-india https://doi.org/10.1177/09727531211009800 DOI: 10.1177/09727531211009800 journals.sagepub.com/home/aon 1,2,3 4 Akshay Anand and Bhushan Patwardhan Received 23 March 2021; accepted 23 March 2021 to be repurposed for COVID-19 management as it had far The recent article from Nature emphasizes the need for more published scientific data than either HCQ or Remdesivir research in the AYUSH system, suggesting mild COVID put together. No one tried to ask this scientific question, yet patients as cohorts for RCT before repurposing is initiated. many frequently asked why the national AYUSH protocol However, it falls short of identifying whom to address this was approved or why other drugs containing Ashwagandha right question. In order to develop an in-depth understanding were being used for post-COVID-19 management. The of the complex ecosystem of health care in India, the COVID impending failure of Remdesivir, which was “hyped” to crisis provides an excellent screening tool for evaluating our generate “hope,” looms large. As a result, the drug was sold general approach to disease management. When the COVID- in the black market at exorbitant prices, causing both fear and 19 pandemic spread across the globe, no sustainable solution panic. It is well known that the shares of this company soared was in sight. Therefore, it provided a level playing field for all even though the post-surveillance data was not made available systems of medicine to be tapped in repurposing potential to experts. Surprisingly, even the pharmacovigilance data was drugs, preferably by comparative effectiveness. The health also not made available. In USA, National Institutes of Health managers in India and elsewhere decided to repurpose HCQ (NIH) is usually involved in regulating their country’s as an alternative drug for COVID-19 without conducting any treatment protocol in coordination with CDC which includes clinical trial. Many research papers were subsequently sero-surveillance. In health emergencies in India, when published showing that the repurposing potential of HCQ was decisions are to be taken by the health servicing Department, inconsequential, and these were soon retracted. At a time ICMR stepped in and must be held accountable for the when the uncertainty of pandemic was raging, these managers finalization of protocols. 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 Postgraduate Institute of Medical Education and Research (PGIMER), proposing its use for the vulnerable population and health Chandigarh, India care workers unlike what was suggested for the repurposing Centre for Mind Body Medicine, PGIMER, Chandigarh, India of Ayurvedic drugs. In other words, there seems to be one Centre of Phenomenology and Cognitive Sciences, Panjab University, scientific yardstick for the translation of benefits of one health Chandigarh, India management system, and another for the other. As expected, University Grants Commission the Remdesivir experiment failed again and was subsequently Corresponding author: removed from the national protocol for COVID-19. At a time Akshay Anand, Postgraduate Institute of Medical Education and Research when the allopathy had no solution for COVID-19, many (PGIMER), Chandigarh, India. questioned if it is meaningful for Ayurveda or other systems E-mail: akshay1anand@rediffmail.com Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution- NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-Commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https:// us.sagepub.com/en-us/nam/open-access-at-sage). 2 Annals of Neurosciences It was after these repeated failures, the Ministry of AYUSH of the World Health Organization agreed to set up a Global came out with the national protocol soon after the Katoch Centre for Traditional Medicine in India. This now provides a committee and the AYUSH’s interdisciplinary committee unique opportunity to spearhead the global integrative health 3,4 cleared the same. These committees had reviewed and initiative through multinational clinical trials ensuing 7,8 examined the in vitro, in vivo, and clinical studies based on seamless knowledge advancement in the field. which this decision was taken through due process. ICMR was Based on these developments, we need to ask the right also a member in approving the national AYUSH protocol. question to ICMR and not AYUSH as to who should be This protocol was recommended for prophylaxis and mobilized to undertake biomedical research in this domain of management of mild COVID patients as well as for post- interdisciplinary area where Ayurvedic or Yogic biology COVID recovery. No sooner had the protocol been finalized, framework can provide the answers. Prof Valiathan’s idea of the Indian Medical Association (IMA, a nonscientific union of collaborative research between Ayurveda and biomedical doctors) came out with a rejoinder opposing the AYUSH research requires implementation. In our opinion, scientific preventive protocol meant to benefit the patients based on their research on ISM is a fiduciary responsibility of the Indian preferences. While the evidence-based medicine needs to be scientific and medical community and not just the AYUSH supported by practice-based experience, IMA now calls for a sector. In this context, it is a right question being asked to a national protest and dissolution of NITI Aayog study groups wrong person. We are probably barking up the wrong tree. made to implement an integrative health system in the country. Every national laboratory, especially those belonging to The bizarre claim of IMA, a union of Indian doctors, medical institutes and other government-funded institutions, calling Indian System of Medicine (ISM) a “placebo” is should research AYUSH systems, collectively funded by unfortunate. It smacks of blasphemous collusion with the national agencies. For this, the faculties of AyurYog will need journal Science that promptly voiced IMA’s version as “a to be installed in these Institutions so that they may identify fraud on nation” with an alacrity never seen before. This the relevant clinical questions for research. This may include happened within a week of IMA’s claims flashing in the cost-effectiveness trials. This will ensure that the discoveries Indian media. This has led to many burning questions about from ISM knowledge receive acknowledgement, much like the politics of medicine and money. The quality of scientific the Nobel prize-winning work of Chinese Prof Tu Youyou. temper and ethics, often attributable to medical science Prof Tu had spearheaded the application of Traditional communication, remain to be addressed. This journal had Chinese Medicine (TMC) at the time of a malaria epidemic in earlier landed itself in a controversy when an unprecedented the 1960s. The Chinese Medical Association wholeheartedly political statement was issued by its editor, asking its readers supported this as a matter of national pride. not to vote for Mr Donald Trump in the US presidential ISM is in a containment zone with an access to subcritical elections. It is our considered view that journals should avoid resources and disjointed from the infrastructure of premier political posturing and instead focus on hard science, than hospitals and medical institutes. In such a hostile environment, predictive science. Regardless, others argued that IMA is the expectation for AYUSH to advance scientifically would facing flak at the hands of patient support organizations after be wrong. While TCM has flourished because of Chinese the Medical Council of India (MCI) was replaced by the administration bringing the basic scientists and TCM National Medical Commission (NMC) and patients' growing together, India's integrative health research has remained a preference for the AyurYog version of the public health prisoner of the dominant Western medicine, aided by approach was weighing on them. The recent defamation suit erstwhile MCI. As MCI has now been replaced by NMC, filed by an Ayurveda practitioner claiming AyurYog to be the ISM must be provided with resources and capacity building “mother of modern medicine” is also aligned to this dwindling in order to bridge the chasm. patient mood. Even though the USA and many Western countries do not The perpetuation of dissociation between patent-based have a long history of traditional medicine and practice, it has knowledge advancement of modern clinical research and been adopted to endorse NIH's focus from “medicine” to indigenous AyurYog has become so pervasive that some “health,” much like Indian PM's repeated emphasis on medical practitioners have begun to assume that they are the wellness. The USA's NIH/National Center for true owners of this medical progress and everything else is a Complementary and Integrative Health model provides a way “placebo.” India spends a considerable foreign exchange for forward. It has evolved from an Office of Alternative Medicine, importing the medical devices, drugs, and technology used by once regarded as Senator Harkin's folly and criticized by the the Indian medical community. The concept of Atma Nirbhar scientific community, into National Center for Complementary Bharat or self-reliant health structure provides them with an and Integrative Health. The research capacity in India’s health opportunity for leadership in the field of traditional or sciences, not just AYUSH, should be taken on priority so that integrative medicine-related knowledge economy. On the newly formed working groups of NITI Aayog on November 13, 2020, at the proposal of the honorable Indian integrative health can address the health, wellness, and Prime Minister, Shree Narender Modi, the Secretary General knowledge economy of India in an evidence-based manner. Anand 3 Declaration of Conflicting Interests 6. Pulla P. ‘A fraud on the nation’: Critics blast Indian govern- ment’s promotion of traditional medicine for COVID-19. The author declared no potential conflicts of interest with respect to https://www.sciencemag.org/news/2020/10/fraud-nation-crit- the research, authorship, and/or publication of this article. ics-blast-indian-government-s-promotion-traditional-medicine- covid-19 Funding 7. WHO to set up centre for traditional medicine in India, PM says matter of pride, November 13, 2020, Hindu. https://www.the- The author received no financial support for the research, authorship, hindu.com/news/national/who-to-set-up-centre-for-traditional- and/or publication of this article. medicine-in-india/article33091388.ece 8. Anand A, Tyagi R, and Kaur P. Incubating integrative medicine References in India through PMO's Atal Incubator Scheme of Niti Aayog. 1. Kumar J and Sinha P. Time to bring scientific rigour to the com- Ann Neurosci 2017; 24(3): 131–133. plex challenge of Ayurvedic medicine. . https://www.naturea- 9. Su X-Z and Miller LH. The discovery of artemisinin and the sia.com/en/nindia/article/10.1038/nindia.2020.101 Nobel Prize in physiology or medicine. Sci China Life Sci 2. Mehra MR, Desai SS, Ruschitzka F, et al. Hydroxychloroquine 2015; 58: 1175–1179. or chloroquine with or without a macrolide for treatment of 10. Rudra S, Kalra A, Kumar A, et al. Utilization of alternative COVID-19: A multinational registry analysis. Lancet 2020. systems of medicine as health care services in India: Evidence 3. National Clinical Management Protocol based on Ayurveda on AYUSH care from NSS 2014. PLoS One 2017; 12 (5): and Yoga for Management of Covid-19, Ministry of AYUSH, e0176916. Government of India. https://www.ayush.gov.in/docs/ayush- 11. Sen S and Chakraborty R. Revival, modernization and integra- Protocol-covid-19.pdf tion of Indian traditional herbal medicine in clinical practice: 4. Golechha M. Time to realise the true potential of Ayurveda Importance, challenges and future. J Tradit Complement Med against COVID-19. Brain Behav Immun 2020. 2016; 7: 234–244. 5. Islam MN. Repackaging ayurveda in post-colonial India: Revival or dilution? S Asia: J S Asian Stud 2012; 35: 503–519.

Journal

Annals of NeurosciencesSAGE

Published: Jan 1, 2021

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