Ayurvedic cancer treatment

Battle for recognition

Print edition : October 27, 2017

Vaidya Balendu Prakash during a workshop at the Rashtriya Rasa Karyashala. Photo: By Special Arrangement

Prakash Dairy, a unit of the Shashi-Chandra Rasa Shala (SCRS), is home to numerous cattle. It is located in Nawabganj village in Rampur district of Uttar Pradesh. It was started in 2012. Both the SCRS and the dairy farm work closely with the local community and generate rural employment. Photo: By Special Arrangement

Learning to make medicines at the SCRS. The organisation manufactures drugs and trains physicians and plans to add a clinical wing. Photo: By Special Arrangement

The gobar gas plant installed on the campus uses cow dung from the dairy farm to generate 10 kilowatts of energy a year. Photo: By Special Arrangement

Solar panels installed on the campus generate 35 kW of energy annually. Photo: By Special Arrangement

A project to establish scientific parameters for Ayurvedic cancer treatment has been hanging fire despite the Modi regime’s claims of promoting Indian medical practices.

“MINIMUM government, maximum governance.” Vaidya Balendu Prakash was completely taken by the phrase when he first heard Prime Minister Narendra Modi utter it, claiming it would be his government’s motto. That was more than three years ago, in May 2014, when the Bharatiya Janata Party-led (BJP) National Democratic Alliance (NDA) government was sworn in. Hundreds of thousands of Indians across the world expressed similar enthusiasm for Modi’s governance mantra, but there were special reasons for Prakash’s fascination for and optimism about it. This Dehradun-based Ayurvedic physician, who heads the Vaidya Chandra Prakash Cancer Research Foundation (VCPCRF), has made proposals to successive governments to advance research aimed at evolving and enhancing the scientific parameters, through clinical and other trials, for certain unique and indigenous herbo-mineral Ayurvedic medicines and therapeutic practices for the treatment of acute promyelocytic leukaemia (APML). No decision has come from those governments for nearly two decades. Hearing the enunciation of Modi’s new minimum governance dictum, Prakash felt that he “would finally see the proverbial light at the end of the tunnel with the help of the proactive Modi government”. Every government over the past two decades as well as scientists and officials who headed the Central Council for Research in Ayurvedic Sciences (CCRAS), now an autonomous body under the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy), in this period had, in principle and on paper, endorsed and upheld the relevance and veracity of the proposals put up by Prakash. But when it came to actually following it up with composite trials and laboratory tests or sanctioning resources for them, the political and administrative establishment was consistently seen to be backtracking. Prakash believed that the self-professedly action-oriented Modi government would break this stalemate.

In terms of specifics, Prakash told Frontline, hope was founded on three factors. First, Modi’s own loud claims that he had adeptly run the Gujarat State government during his three terms as Chief Minister following the “Minimum government, maximum governance” motto and assertions about the commitment to replicate it at the Centre. Second, the widespread corroborations these claims evoked, including from sections of the political class, bureaucracy and academic community. Third, the BJP’s oft-repeated proclamations about the party’s and the larger Rashtriya Swayamsevak Sangh-led (RSS) Sangh Parivar’s abiding commitment to support and promote indigenous and alternative forms of Indian medical practices. Three years down the line, however, Prakash is utterly disillusioned as there is no marked difference from the past in the style and content of governance of the present regime.

“It is business as usual in almost all spheres of governance and especially at the level of advancing scientific research and innovations in Ayurveda and other indigenous disciplines of medicine. In fact, the sense of letdown is much more agonising now because the bombast is so high that people get carried away and start nurturing great expectations which ultimately get dashed. I can say from personal experience that the approach of the Prime Minister’s Office [PMO] itself is blatantly casual when dealing with matters relating to research in indigenous medical systems,” he said. (See interview.)

Prakash’s hopes soared in August 2015 when a group of senior officials and researchers associated with the CCRAS, led by its Director General Professor Kartar Singh Dhiman, visited the VCPCRF. The visit led to discussions to revive Prakash’s long-pending proposal for evolving and enhancing scientific parameters for the VCPCRF’s treatment of APML.

Speaking to Frontline in July 2017 about the 2015 visit, Dhiman said that the CCRAS team did know that there was a VCPCRF proposal pending for many years. Dhiman added that during the visit the CCRAS team inspected, and was satisfied with, the systems, facilities and upkeep of the VCPCRF. On that basis, it was decided to revive and advance a collaborative project titled “Development of Metal Based Ayurvedic Formulation (MBAF) for the treatment of acute promyelocytic leukaemia”.

The primary pilot clinical trials were conducted in the 1997-2000 period under the joint auspices and monitoring of the CCRAS and the All India Institute of Medical Sciences (AIIMS), with the VCPCRF administering its unique, indigenous treatment.

These took place after a 10-year-long wait and became a reality on account of a variety of chance factors, including politics. Prakash’s indigenous Ayurvedic treatment had resulted in several cases of remission for many APML patients since the early 1980s. In 1987 he had requested that trials be conducted under the observation of the CCRAS and the AIIMS so that scientific research could begin as per the official guidelines of the Union government.

Things dragged on until 1996 with no concrete progress on the application. Then, the Lok Sabha elections of 1996 threw up a hung Parliament and the Congress, which had ruled between 1991 and 1996, was compelled to support the United Front comprising non-Congress, non-BJP, centrist, secular parties to form the government. Salim Iqbal Shervani from Uttar Pradesh became the Minister of State for Health. Shervani had personal knowledge of Prakash’s record in treating APML. A two-and-a-half-year-old child in his family was suffering from cancer that was diagnosed as terminal in 1987 by many major hospitals and specialists. With no other option, the Shervani family approached Prakash. The child was treated and it recorded remission in a year. (Shervani told Frontline recently that the patient is now leading a healthy life overseas.) Shervani’s stint as Minister of State for Health led to the retrieval of Prakash’s application for monitored clinical trial from the Ministry’s “cold storage” and its favourable processing.

As many as 15 patients suffering from APML were enrolled for the pilot clinical study, out of whom eight were relapse cases and seven de novo, who had not taken any anti-cancer therapy based on modern allopathic medicine. Of these 15, 11 completed 90 days’ treatment as decided in the treatment protocol. Four patients died on the third, 16th, 21st and 32nd day of treatment.

Bone marrow, peripheral blood smear, liver and kidney function tests of these patients were done at the Institute Rotary Cancer Hospital (IRCH), AIIMS, both before and after the 90-day treatment protocol. All the 11 patients who were treated exclusively by Herbo-Mineral Ayurvedic Formulations (HMAF) achieved complete remission after 90 days of treatment. Following this, all of them were kept under a periodic observation regime for the next three years. They were subjected to varied tests including liver and kidney functions as also for Hb, TLC, and DLC platelets, once again under the monitoring of IRCH at the AIIMS. The report of the clinical trials recorded that the results of these tests were found within normal limits and that patients had achieved complete remission. It was also recorded that no adverse effect or abnormalities were found in any of the patients.

These findings were discussed during the meeting of a cancer research subcommittee of the CCRAS held on November 8, 2001, at New Delhi under the chairmanship of Professor Dinesh Chandra. The committee observed that “there is prima facie evidence of its [VCPCRF treatment protocol] efficacy and safety, which needs to be developed systematically on scientific parameters”.

It also added that “there is always scope for variation among batches in absence of objective quality control parameters” and that “the chemistry of intermediates and finished material remains unknown”. It went on to add: “In the absence of the above, HMAF could not be established as medicine of choice for a large number of APML patients.”

Prakash was of the view that the “unknowns” and the “chemistry of the intermediates” could be unravelled through further pharmacological (including reverse pharmacology) and toxicity studies under the guidance and monitoring of dependable and credible government and autonomous institutions, including the AIIMS and the Indian Council for Medical Research (ICMR).

Consequently, the VCPCRF offered to open its APML treatment protocol as well as the HMAF produced and employed as part of this for these concerted studies and inspections. The aim, as delineated by the VCPCRF and Prakash, was to evolve objective quality control as well as standard operating procedures (SOPs) for each step of the preparation of the HMAF and its administration.

It was also suggested that once these studies were carried out, and if and when they cleared the “unknowns” and the “chemistry of the intermediates”, the CCRAS and the Ministry of AYUSH should get patents and move towards the development of a novel, HMAF-based standardised formulation for the treatment of APML.

“It was my constant refrain that a completion of such a process under the aegis of the government or autonomous public sector institutions would benefit thousands of people suffering from APML. I had also pointed out that with the initiation and completion of such exhaustive research and investigation, Ayurveda would be able to expand its horizons in terms of allying and integrating, wherever possible, with modern medicine,” Prakash told Frontline.

However, there was no concrete movement towards further research and investigation. Governments came and went, new Ministers controlled AYUSH and new managements periodically ran the CCRAS. But the proposal to pursue and advance the significantly successful pilot clinical trials of 1997-2000 was not addressed substantially by any of them. Of course, throughout this period there were many academics, sections of the bureaucracy and political leaders who supported Prakash’s proposal and his efforts from time to time. While many of them had compelling personal experiences to recognise and propagate the value of Prakash’s indigenous medicine as well as his concepts on modernising Ayurveda, some others found merit in his treatment regime and medical precepts primarily on the basis of a theoretical understanding.

These included Sunita Narain, director general of the Centre for Science and Environment (CSE) and environmental activist championing the concept of sustainable development; Dr G.S. Toteja, scientist associated with the ICMR; Rajiv Gulati, former president of Ranbaxy; Dr Y.K. Gupta, Professor and Head of the Department of Pharmacology, AIIMS; and Dr Y.P. Singh, scientist at the Forest Research Institute (FRI), Dehradun.

Among political leaders, apart from Shervani, there were Harish Rawat, former Congress Chief Minister of Uttarakhand, and M.A. Baby, Polit Bureau member of the Communist Party of India (Marxist), who saw much merit in Prakash’s work.

Former President K.R. Narayanan stated in several public forums that Prakash’s work had path-breaking scientific potential. Over the past 15 years, persons with considerable standing in society and in different specialised fields sought to highlight, individually and at times collectively, Prakash’s quest in the realm of indigenous medicine and the stonewalling he faced from the system.

It is believed that the visit of the CCRAS team in August 2015 was itself a byproduct of the sustained pressure and persuasion kept up by this group of well-meaning and influential people. Whatever the reason, it was agreed in principle during the visit of the CCRAS team that the advanced studies and inspection of HMAF for APML pending since 2001 should be revived at the earliest.

Consequently, the VCPCRF presented yet another application for scientific research with listed aims that included collection of scientific evidence on SOPs leading to defining and implementing parameters of standards for metal-based Ayurvedic formulations for APML, which would be patented jointly by the CCRAS and the VCPCRF. The proposal also stated that the development of SOPs as well as their standardisation and characterisation would cover each step of preparation of the HMAF, right from the quality of raw ingredient, the shodhana/marana procedures, intermediary products and preparation of finished products. The project was to run for 30 months at a total cost of Rs.1,23,03,610. The milestones and deliverables for periods starting from the third month were also listed. The application was presented on December 11, 2015.

At that time, Prakash was of the firm belief that the votaries of “Minimum government, maximum governance” would process and take the proposal forward quickly. However, almost two years later, Prakash and his team are still waiting for a formal and substantive revival of the long-pending project. Scores of meetings of various bodies associated with research in the CCRAS, including that of the Scientific Advisory Council (SAC), have taken place since December 2015, and the relevance of the VCPCRF proposal was endorsed in many of them. Yet, these endorsements remain only on paper.

Speaking to Frontline, Dr Chandra Kant Katiyar, member of the SAC and CEO, Health Care (Technical), at the Emami group, a leading producer of health-care and skincare products based on Ayurvedic formulations, said that the VCPCRF proposal had been upheld by the SAC without any modifications. The SAC comprises specialists in various fields, including Ayurveda, pharmacology and modern medicine. Katiyar himself represents a unique combination of Ayurveda and modern medicine, having an M.D. in Ayurveda and a PhD in pharmacology.

Dhiman, CCRAS director general, said that the development of evidence-based Ayurvedic interventions for cure as well as improvement in quality of life for persons suffering from different types of cancers was a priority of the department and that it was part of the Vision Document 2030 prepared by AYUSH. According to Professor Harimohan Chandola, Chairperson of the SAC and former Dean of Gujarat Ayurved University, although the SAC approval marks the final technical clearance of a project, funds can be allocated only after obtaining sanctions from the Standing Committee on Finance of the AYUSH Ministry. Unless this committee decides to release funds, Prakash’s proposal will continue to remain where it has been over the past two decades.

It was owing to the sustained absence of any concrete follow-up on scientific and technical clearances that Prakash started appealing directly to the Prime Minister and the PMO. The fate of these appeals made it clear that it was business as usual in the so-called “Minimum government, maximum governance” regime, he said. (See box.)

A large number of senior specialists associated with the CCRAS and AYUSH said that for decades researchers in indigenous fields of medicine in India had suffered on account of the manoeuvres of technocrats and bureaucrats with vested interests. Prakash’s experience, they added, was a stark case in point. At another level, it is also the record of a long-drawn struggle against the system in the interests of scientific quest. But Vaidya Balendu Prakash asserts that he will soldier on for another two decades on this path, if need be.

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