Thursday, October 20, 2016

Taking Ayurveda global: Thoughts on BGR-34, and what we can learn from the Chinese example

A few months ago, India's Council for Scientific and Industrial Research (CSIR) announced the launch of a new, government-approved Ayurvedic anti-diabetic drug, BGR-34. Scientists claimed that the drug - composed of half-a-dozen herbal extracts identified after an extensive search of herbs listed in ancient Ayurvedic texts - was able to manage blood sugar effectively without any of the side effects associated with standard anti-diabetic medications.

It was jointly developed by two Lucknow-based CSIR institutes, the National Botanical Research Institute (NBRI) and the Central Institute for Medicinal and Aromatic Plants (CIMAP). A third entity, a private company by the name of AIMIL Pharmaceutical, was appointed to be the commercial producer and distributor of BGR-34. Supposedly, AIMIL conducted clinical trials of BGR-34 in which the drug exhibited hypoglycemic activity. NBRI's principal scientist also claimed that the drug had no side effects. Surprisingly, there is no evidence available to support these and other claims of BGR-34's accuracy: no peer-reviewed papers, no clinical trial registry, no data of any kind. Basically, we have a bunch of people telling us (through press conferences and advertisements, no less) that BGR-34 works really well as an anti-diabetic agent, without presenting any evidence at all to buttress their claims.

Naturally, India's scientific establishment went up in arms. Prominent scientists pointed out that in the absence of proper validation, it was unethical for a government body (CSIR) to promote the drug, thereby tarnishing its own reputation as well as casting a shadow on the public perception of Ayurveda (here's a detailed exposition of why this is the case). 

What lessons can we learn from this story? First, there is no doubt that traditional medicine systems like Ayurveda hold a lot of potential for drug discovery, and it would be very foolish to ignore such a unique and valuable resource. Second, we need to apply accepted scientific principles and standards to Ayurvedic drugs as well. 

Now some might argue that a holistic treatment system like Ayurveda cannot be expected to conform to the standards governing the more reductionist Western approach, in which the active ingredient of a drug must be subjected to extensive laboratory and clinical testing. While there is some truth to these arguments, the Government of India has actually published a draft amendment to the Drugs and Cosmetics Act & Rules which creates an alternative mechanism for validating Ayurvedic drugs by defining them as phyto-pharmaceuticals. As per this amendment, phyto-pharmaceuticals would be subjected to many of the same requirements as synthetic compound-based drugs. For example, the active ingredient must undergo chemical characterization, the potential mechanism of action must be identified, and the compound must undergo safety and efficacy testing. When approved, phyto-pharmaceuticals would have the same marketing status as small-molecule and synthetic pharmaceuticals.

Is this a lot of work, and it is likely to cost a fair amount of money? The answer is yes to both. But honestly, this is something that the Indian establishment really needs to do, at least for one flagship drug. We need look no further than China, where Youyou Tu's discovery of arteminisin, an anti-malarial agent derived from a herb used in traditional Chinese medicine (TCM), won her the 2015 Nobel Prize in Medicine. The effort to develop a new anti-malarial was strongly supported by the Chinese government, and Tu and her collaborators spent many years characterizing the molecule and turning it into a drug. The Nobel was certainly a validation of her hard work, but it also served as a global validation of TCM from the scientific establishment. If we are serious about exploiting the benefits of Ayurveda and giving it due prominence on a global scale, arteminisin and not BGR-34 is the model we need to adopt. 

1 comment:

  1. Nicely written article. I do not have any knowledge on this topic, so I cannot comment on the content. But I understood your point and I really liked your solution to the issue.