Expert Opinions: From Ayurveda experts and endocrinologists
Ayurvedic practitioner B Patwardhan
Bhushan Patwardhan, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune rejected the claims of these drugs and published his review in the Journal of Ayurveda and Integrative Medicine as below:
The Government regulations, oversight and surveillance is required to ensure that gullible patients are not exploited. What is being sporadically done under the pretext of herbal drug development is certainly not in line with the basic principles, ethos and practice of Indian traditions. The AYUSH community has responsibility to preserve legacy and ensure that its credibility is not compromised for cheap publicity or short term economic gains. In a long run such inept efforts can erode credibility and likely to bring disrepute to Indian traditions and knowledge heritage.
- Award winning Indian endocrinologist Prof. (Dr.) Anoop Misra
In a Lancet paper, Prof. Anoop Misra and colleagues challenged the hype of alternative therapies for diabetes in India being developed. The team also found literature pertaining to these treatments but suggested that there were several methodological problems with these trials.
Prof. Misra wrote, ‘Not only did the studies conducted faulty trials, but there could be severe dangers related to toxicity and interactions between the potential bioactive ingredients quoting the policy and guidelines suggested by the Central drugs standard control organisation, Ministry of Health and Family Welfare, Government of India. Professor Misra also stated that ‘the Indian guidelines have waived or relaxed the rules for rigorous pharmacological and toxicology studies for Ayurvedic products, provided that medicines are “prepared in same way as mentioned in ancient Ayurvedic treatises” such as Charaka Samhita or similar texts, purported to have been written and rewritten between the 6th century BCE and the 1st century CE’, which presumably, is the reason enough to accept sub-standard drug trials conducted by AYUSH and its associated research centres.
- A practicing endocrinologist Dr. Om Lakhani
In a phone conversation with Dr. Om Lakhani, MD, a Consultant Endocrinologist at Zydus Hospital and MD Internal Medicine (Gold Medalist), DNB (Endocrinology), he also refuted the ‘miraculous’ claims of both of these anti-diabetic medications. He also commented on how the scientific basis for these medications is lacking and suggested it may be against the law to promote medicines and ‘miracle cures’ on TV, Radio or newspaper according to the ‘Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954’ in India. He has also written a detailed review about these drugs here.
- Furthermore, Saper et al (2008) tested and reported high levels of lead, mercury and arsenic in 1/5th of US and Indian manufactured medicines sold on the internet by testing a randomised selection of Ayurvedic drugs across 25 different websites. This research indicates that a large proportion of locally manufactured drugs can be contaminated which emphasizes a greater need for rigorous testing.
Responsibility in drug efficacy and safety
Should the ministry of AYUSH, CSIR laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (CIMAP) be held accountable for violating these regulations and releasing these drugs without sufficient tests? Or should companies such as Kudos Laboratories be held accountable for promoting these drugs on television for the gullible patients?
If the alternative Ayurvedic medicines developed and promoted by AYUSH and its associated laboratories have such adverse side effects due to inadequate testing in human models, is it really worth taking the risk? Especially when there can be life threatening side effects, misleading claims that comes with a greater cost in comparison to the best available treatment on the market.
Conclusion
Based on the current scientific data, expert opinions from the field and consumer complaints, there is scant scientific evidence for the use of BGR34 and AYUSH82 in the management of diabetes.
These drugs may or may not work in type 2 diabetes, and would unlikely be of any use to type 1 diabetes due to a completely different pathology. Moreover, they is not evidence for toxicity tests in these drugs which are required, since there is evidence for contamination of lead, mercury and arsenics. There are also contraindication studies required to check whether these drugs interact with other drugs in the system.
Lastly, a rigorous unbiased-multi-phase double blind clinical trial needs to be conducted in healthy as well as in type 2 diabetes patients of both genders, age groups, pregnancy, patients with other disorders, etc. before its market release before making such elaborate claims.
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