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Can alternative medicine be subject to modern rigour

Can alternative medicine be subject to modern rigour?

1. CONTEXT OF THE NEWS

Recently, an Indian firm developed an Ayurvedic Medicine and claimed it as a cure for the COVID-19 pandemic. Medicine was criticized for making unsubstantiated claims of efficiency.

This editorial discusses the possibility of subjecting alternative medicine to the same levels of evaluation like modern medicine.

2. PROCESS OF DEVELOPMENT OF A NEW DRUG

2.1 The process of Development of a New Drug in modern medicine

  • Step 1: Discovery and Development of a new drug.
  • Step 2: Preclinical Research is done before testing the new drug on people to determine its toxicity on the human body.
  • Step 3: Clinical Research is trials done on humans to study how the drug interacts with the human body.
  • Step 4: Review of the drug by the Nation's Drug Administrative Authority where the study was done on the drug is submitted by the developer and examined by the authority for approval.
  • Step 5: Post-Market Safety Monitoring of the Drug - it takes months or even years to fully understand all the aspects of a new drug. In this step, the Administrative body reviews all the reports on the drug-related to prescription and over-the-counter drugs and cautions or usage information etc. are added.

2.2 Procedure for testing a new investigational drug in Ayurveda:

  • There are two aspects to the clinical use of Ayurvedic drugs.
  • The first category of drugs belongs to those drugs that are described in the classical texts and are listed in the Drugs and Cosmetics Act of India.
  • They have a prescribed formulation to be used in certain specified conditions and have been used for several hundred years in India as well as other parts of the world effectively.
  • If these drugs are found useful in case of a new condition (like many ayurvedic drugs found to be effective in case of COVID-19 infections) and there is textual evidence to suggest their efficacy, such ayurvedic drugs can proceed to human trials straight away because their toxicity and pre-clinical aspects have already been well understood are researched.
  • The second category of drugs, with an entirely new formula for a new set of conditions, has to follow the same path of toxicity, preclinical efficacy, and subsequent clinical trials as modern medicines.

2.3 The need for rigorous testing for alternative medicines:

  • A large number of practitioners of alternative medicine feel that there is a disproportionately higher burden of proof on alternative medicine vis-a-vis modern medicine but each and every drug must be tested for safety and effectiveness before it can be prescribed widely.
  • Past experience or quoting classical texts or literature cannot be a certain proof for the efficacy of the drug against a new disease.
  • The results of certain drugs, which worked well in the case of Ebola, were extrapolated to use the drugs for treating COVID-19, but they did not work.
  • Many a time successful preclinical trials (medicines working in Petri dishes) do not work with the same efficacy on the human body.
  • There are some basic scientific principles aimed to minimize the bias that must be followed by all branches of medicine whether alternative or modern.

3. EVALUATING A NEW DRUG FOR COVID-19

3.1 Lack of a reference point:

  • There is no difference in the standards of testing for evaluation of the safety and efficacy of ayurvedic medicine vis-a-vis modern medicine.
  • Presently there is no standard of care or an effective drug for COVID-19 to reliably compare a new drug with.
  • Drugs are evaluated on the basis of an expected specific outcome.
  • In the context of disease management, neither does a single drug work for the entire population nor does a single drug works with the same efficacy during a patient's lifetime.
  • The CCRS (Central Council for Research in Ayurvedic Sciences) provides guidelines and procedures for the evaluation of an ayurvedic drug.

4. IS AYURVEDA UNSCIENTIFIC?

4.1 Lack of peer review and journal:

  • In the pharmaceutical sector, usually, the trial results of new drugs are reviewed by peers and published in a journal, which is then evaluated for the drugs' benefits or non-efficacy by independent experts.
  • Many people cite a lack of this practice in alternative medicine and there are claims that negative results are not reported in alternative medicine. However, there is more than meets the eyes.
  • Ayurvedic research publications generally do not find a place in well-reputed, high-impact medical journals but still there is no denying that there is a lack of negative outcomes being published but at the same time, it is not a problem with Ayurveda alone.
  • Clinical trials by universities and research counselors, thesis reports of research students keep appearing in Ayurvedic journals, however, there is certainly a need to upgrade the quality of these journals.

4.2 Lack of technological interventions in Ayurveda:

  • There is a definite need for technological interventions and medical instruments as ventilators and pulse oximeters for diseases like COVID-19.
  • It is a common misconception that Ayurveda is allergic to modern technological devices.
  • Ayurveda and alternative medicine not only relies on natural concoctions but also integrates modern medical facilities and technologies in the clinical protocols of these medicine systems.
  • However, Ayurveda also relies on the assessment of disease in an ayurvedic style which includes a focus on both the virus as well as certain baseline health parameters like diet and sleep which indicate the efficacy of treatment.

4.3 Lack of testing of Ayurvedic Medicines:

  • Ayurvedic medicines are generally not allowed anywhere to be tested in severe or critically ill situations, which could improve outcomes.
  • The modern medical world and society both need to be taken in confidence and assured that ayurvedic medicines can be tested in those conditions as well.

4.4 A highly personalized medical system:

  • Ayurveda is often considered as a highly personalized system of medicine where the treatment is customized to an individual.
  • On the other hand, Modern medicine provides for the same drugs for a given set of conditions.
  • For the strictly same set of clinical indications, same ayurvedic medicines can be prescribed too.
  • At the same time, it should be kept in mind that one-drug-fits-all notion in modern medicine itself is being challenged every day.

5. WAY FORWARD:

5.1 Integration of the two systems of medicine

  • Modern medicine is a more rational, analytic, and structured approach towards treating disease.
  • On the other hand, Ayurveda has a holistic and more intuitive approach, which takes the whole person into consideration and not just the disease.
  • While modern medicine focuses only on a cell, an organ or a disease, Ayurveda believes that whole is more important than parts and focuses on the person as a whole.
  • An integrated approach would be a win-win situation for both disciplines, would provide holistic care for the patients and wholesome disease management.

5.2 Science should not be left behind:

  • However, the principles of science and ethics should not be missed during their integration.
  • The strength of modern medicine is that it focuses very strongly on meaningful outcomes of the drug including saving lives and speedy recovery.
  • Sometimes in the name of traditional knowledge, alternative medicines are pushed through without enough research and trials. Negative results are frequently hidden.
  • Traditional medicines like modern medicine should have the humility and transparency to accept that a particular drug does not work (like hydroxychloroquine, remdesivir do not reduce mortality and the dual combination of antiviral drugs does not work).

6. CONCLUSION

Both systems of medicines, modern or traditional ultimately aims to heal individuals and save lives.

An integrated approach would be beneficial for both the systems as well as for the patients. However, a certain basic set of scientific principles must be applied to all systems of medicines.

Furthermore, the products of both the systems of medicine are frequently in the hands of commercial pharmaceutical companies who aim similar tactics to increase profit. This creates more harm than good and presents a case for de-linking the nexus between pharmaceutical companies and medicine.

ADDITIONAL INFORMATION

1. The Patanjali Controversy regarding claimed COVID-19 cure

  • Recently PatanjaliAyurved owned by yoga guru Baba Ramdev released an Ayurvedic medicine ‘Coronil and Swasari’ claiming favorable results in clinical trials on COVID-19 affected patients.
  • The Union Government subsequently asked Patanjali Ayurved Limited to stop advertising the drug as a cure for COVID-19 and has sought details of the claimed 'successful trial and cure'.
  • The government has asked PatanjaliAyurved to provide details of the name and composition of the medicines that are claimed as successful in treating COVID-19. Additional details about treatment, site(s) and hospital(s) where the research study was conducted, the protocol, sample size, Institutional Ethics Committee clearance, Clinical Trials Registry-India (CTRI) registration, and results in data of the study are also being sought.

2. About AYUSH Ministry

  • AYUSH stands for Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy.
  • The Ministry of AYUSH was created on 9th November 2014
  • It aims at ensuring optimal development and propagation of AYUSH systems of health care.
  • Previously the Ministry was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) and was created in March 1995.
  • It was later renamed as Department of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in November 2003; and focused on the development of Education and Research in six systems of alternative medicine viz. Ayurveda, Yoga, and Naturopathy, Unani, Siddha, and Homoeopathy.
  • Benefits of AYUSH
    • AYUSH medical framework provides certain advantages over modern medical systems.
    • The AYUSH healthcare system is cheap and affordable.
    • It has comparatively lesser side effects than other conventional medical systems.
    • There are evidence of the effectiveness of the AYUSH system even in chronic cases.
    • Patients in the terminal stages of diseases have also benefitted from AYUSH medication.
    • There is a rise in lifestyle-associated diseases in India compared to communicable diseases like tuberculosis and AYUSH Medical System has proven effective in such diseases.

3. Central Council for Research in Ayurvedic Sciences (CCRAS)

  • It is an autonomous body of the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy), Government of India.
  • It is an apex body in India for the undertaking, coordinating, formulating, developing, and promoting research on scientific lines in Ayurvedic Sciences.
  • The research activities of the Council include Medicinal Plant Research (Medico-Ethno Botanical Survey, Pharmacognosy and Tissue Culture), Drug Standardization, Pharmacological Research, Clinical Research, Literary Research & Documentation, and Tribal Health Care Research Programme.

Objectives of CCRAS:-

  • Formulate aims and patterns of research on scientific lines in Ayurvedic Sciences.
  • Undertake any research or other programs in Ayurvedic Sciences.
  • To initiate, aid, develop and coordinate scientific research in different aspects, fundamental and applied of Ayurvedic Sciences.
  • To finance inquiries and researches for the furtherance of objects of the Central Council.
  • To undertake R & D Consultancy projects and transfer of patents on drugs and processes to industry.
  • To undertake R & D projects sponsored by industries in the public/private sector.
  • To undertake international and interagency collaboration.
  • To provide technical assistance to Govt./Private agencies in matters consistent with the activities of the Council.