Ayurveda under the scanner

SWAMI RAMDEV. The many miraculous cures he promises, and the "scientific" evidence he cites for them, offer a window into the sad state of scientific research in Ayurveda. - V.V. KRISHNAN

The efficacy and safety of Ayurvedic drugs, especially those claiming to provide miraculous cures, need to be subjected to scientific scrutiny.

Charaka, the legendary healer and complier of Charaka Samhita, the ancient textbook of Ayurveda, does not mince words when it comes to the subject of quacks. He calls them "imposters who wear the garb of physicians... [who] walk the earth like messengers of death". These fake doctors are "unlearned in scriptures, experience and knowledge of curative operations, but like to boast of their skills before the uneducated". Wise patients, Charaka advises, "should always avoid those foolish men who make a show of learning."

The recent expose of false labelling of drugs and exploitation of workers at the swami's Haridwar-based pharmacy has created a huge uproar. But all the noise and sloganeering is drowning out the real questions that must be asked not just of Ramdev, but of all traditional or alternative medicines: how effective are these medicines in curing the diseases they claim to cure? Can their medical claims pass the muster of rigorously conducted clinical tests? Even if the label on the bottle scrupulously identified each and every "vegetarian" and "non-vegetarian" ingredient, the question still remains if the drugs are effective and safe when measured by the modern standards of scientific research.

The facts of the famous Ramdev-Brinda Karat controversy are well-known. In April 2005, Swami Ramdev's Divya Yoga Mandir Trust fired 115 workers who had been protesting against poor wages and deplorable working conditions. These workers complained of having to collect and grind human skulls and bones manually, otter (udbialo) testicles and antelope horns - work that Brahmins among them considered polluting. Acting on these complaints, Brinda Karat, a Polit Bureau member of the Communist Party of India (Marxist) and a Member of Parliament, sent samples of two formulations meant to treat epilepsy and sexual weakness to relevant government authorities for testing. In January 2006, the results came out positive: the samples were found to contain human and animal DNA (deoxyribonucleic acid). The swami's "herbal medicines" had been delivering something not very herbal.

What happened after that was a spectacle to behold. Incredibly, the same Swadeshi-Hindutva-vegetarian gang that attacked McDonald's eateries in Mumbai upon discovering a small amount of beef flavouring in their fries sold in the United States (but not in India), saw no problem with ingesting drugs containing roasted and powdered human skulls. Equally incredibly, Ramdev and his allies ended up painting Brinda Karat, the communists, and other left groups as puppets of Western drug companies, and enemies of Hinduism and the nation.

Rather than answer questions about his own dubious manufacturing and marketing practices, Ramdev and his allies succeeded in putting Karat and her allies on trial. The debate got framed entirely in terms of defence of the nation and its traditions, with no room for raising any questions about the objectivity of the medical claims that Swami Ramdev was making for his Divya brand of yoga and Ayurvedic drugs.

In the end, the swami could be faulted only for not disclosing fully that he was using "non-vegetarian" ingredients in his drugs. But on the larger issue that fed the public passions - namely, the propriety of using human and other animal products in Ayurvedic formulations - Ramdev was very much on the right side of the tradition.

The Ayurvedic tradition considers all substances, whether they come from animals, vegetables, or the earth (that is, minerals) as medicines, provided they are applied in a proper way and for specific purposes. The ancient doctors recommend the use of the following in medical concoctions: bile, fat, marrow, blood, flesh, excreta, urine, skin, semen, bones, tendons, horns, nails, hoofs, hair, bristles and pigments obtained from a variety of animals. This follows as a logical consequence of the Ayurvedic philosophy that like-nourishes-the-like: flesh is nourished by flesh, blood by blood, fat by fat, bones by cartilage, marrow by marrow, semen by semen, foetus by eggs... and so on.

Various classics of Ayurveda recommend a variety of medical treatments that make liberal use of animal products, including cow urine cooked in ghee for treatment of epilepsy, skull bones mixed with cow's urine as a cure for ulcers, and beef, to quote Charaka Samhita, for "rhinitis, irregular fever, dry cough, fatigue, heightened digestion and wasting of muscles". Contemporary Ayurvedic medicines routinely - and legally - use 75 ingredients derived from animals.

Swami Ramdev, then, could be faulted not for using human and animal body parts, but for not disclosing their presence in the drugs he was selling. This lack of transparency is not a trivial matter, for consumers have a right to know what goes into the medicines they depend upon. Karat and the workers of Divya Yoga Trust have undoubtedly brought an important issue to light.

But proper labelling should be the beginning, not the end, of a serious investigation of the medical claims that are routinely made for Ayurvedic remedies.

Let us imagine that by some miracle, each and everyone of the 361,881 licensed Ayurvedic doctors in India begins to abide by the new laws requiring full disclosure and good manufacturing practices. Let us stipulate that all the loopholes have been closed and that all Ayurvedic preparations meant for export or for sale at home, come with detailed information of traditional and botanical names of all the herbs, the names and amounts of all animal and mineral ingredients, the traditional recipes according to which they are made, the batch number, the date of expiry, the risks and contra-indications.

Is all this enough to ensure the efficacy and safety of Ayurvedic drugs? Will faithful adherence to traditional recipes produce drugs that work? Unless the ingredients and methods followed by traditional Ayurvedic books themselves have been subjected to rigorous clinical and laboratory tests, mere disclosure and good manufacturing practices will not do.

Without an objective understanding of the fundamentals of Ayurveda, and without rigorous, controlled clinical tests of the ancient Ayurvedic formulations, we may end up faithfully reproducing many of their limitations and dangers, along with many of their possible benefits.

The simple truth is that there is a lack of good quality research in Ayurveda. Even staunch advocates of Ayurveda like Dr. M.S. Valiathan, an eminent cardiologist, admit that "clinical studies that would satisfy the liberal criteria of WHO [World Health Organisation] have been alarmingly few from India, in spite of patients crowding in Ayurvedic hospitals." (India generally follows WHO standards, which do not demand stringent clinical tests for traditional medical systems with long historical traditions.) The general consensus of international experts is that, to quote the National Centre for Complementary and Alternative Medicine (NCCAM) in the U.S., "most clinical trials of Ayurvedic approaches have been small, had problems with research designs, lacked appropriate control groups, or had other issues that affected how meaningful the results were."

This lack of reliable scientific research is partly the result of a deep-seated contradiction between wanting to appear scientific while holding on to ancient traditions. On the one hand, policymakers and the bureaucrats at AYUSH, the government agency responsible for scientific research on Ayurveda, make extravagant promises for "massive research and development" for the purpose of "scientific validation" of Ayurveda. On the other hand, traditional healers and modern gurus continue to insist that no amount of research can alter, or refute, the "Eternal and Absolute Truths" of Ayurveda, which were supposedly revealed to the Vedic seers at the very "beginning of time". Even AYUSH describes Ayurveda as having "originated with the origin of the universe itself". (What could this possibly mean?)

This anxiety to affirm our ancient traditions has led to a deep and widespread confirmation bias in research on traditional sciences. Ayurvedic researchers, in other words, tend to look for and notice only what confirms their existing beliefs, while they either do not look for, or ignore and explain away, the evidence that contradicts their beliefs. Indian intellectuals and scientists, moreover, have been only too ready to find fanciful analogies between advances in modern biology and the traditional concepts of body and disease.

Years of this kind of advocacy research has created a big problem. The problem is that traditional medical formulae and recipes have not been put to a systematic test using the best available scientific knowledge, methodology and instrumentation available today. Their claims for curing diseases are entirely based on traditional lore, anecdotal evidence and the authority of gurus.

As a result, many obsolete and even harmful chemicals, methods of diagnosis and procedures still continue to be prescribed. What is worse, many of them are presented to the public as if they have been validated by advances in modern science and medicine. As Dr. R.A. Mashelkar, the Director of the Council for Scientific and Industrial Research (CSIR), recommended in his famous "Golden Triangle" speech (where he spoke of building a golden triangle between traditional medicine, modern medicine and modern science), there is a need to "trim" Ayurvedic products so that we can rationally understand what works and what does not, what is healthful and what is harmful, what is living and what is dead in traditional Indian medicine.

Unfortunately, rational, evidence-based evaluation is nowhere in sight in the mass-marketing of Ayurveda practised by Swami Ramdev. Indeed the many miraculous cures that Swami Ramdev promises, and the "scientific" evidence he cites for them, offer a window into the sad state of scientific research in Ayurveda.

The first example comes from Swami Ramdev. According to media reports, the famous udbilao testicles that the workers at Divya Yoga Pharmacy were made to collect and crush were meant for a poly-"herbal"-mineral formula sold under the name "Divya Yauvanamrata Vati". Ramdev's pharmacy advertises it as a tonic for enhancing men's "staying power" and for "increasing sperm" - a cure for what is politely described in India as "sexual weakness".

The otter's humble contribution to men's sexual prowess is, of course, not acknowledged in the list of 10 ingredients for Yauvanamrata Vati. This omission was the source of the Ramdev-Karat controversy. But one of the ingredients that is disclosed is "swarna bhasam", or a herbal ash made out of gold. This swarna bhasam is not without its own set of problems.

Swami Ramdev makes grand claims for his gold bhasam. When taken as part of Yauvanamrata Vati, it is supposed to cure sexual weakness, but when taken alone, it is supposed to "work as a miracle in TB, chronic fever and nervous debility", and it is supposed to be useful in cases of "poisoning, ... gout, kalagar (sic) fever [kala azar fever?] and mdaria (sic) fever [malaria fever?]" and it is supposed to purify blood and remove toxins. The presence of gold makes these drugs exorbitantly expensive: Divya Yuavanamrata sells for Rs.210 for five grams, while Divya Swarna Bhasam for Rs.1,600 for one gram. (Divya Pharmacy sells an even more expensive bhasam, which is made out of diamonds and sells for Rs.2,000 for one gram. This "Heerak bhasam" is supposed to cure cancers.)

The problem is that not one of these claims is substantiated by properly gathered and tested scientific evidence. It is true that Charaka Samhita recommends the use of gold, along with five other metals (silver, copper, lead, tin and iron) and minerals like arsenic, antimony, sand, lime and red chalk. It is also true that tantric alchemy, which equates gold with immortality, has left its influence on Ayurveda. And it is fair to surmise that these complex herbal-mineral bhasams must have shown some medicinal value over the centuries, for if they brought no relief at all, it is hard to explain how they could have survived the test of time.

But this traditional lore is all we have. There is no clinical evidence backing any one of the claims. The only well-established use of gold in modern medicine, as far as clinical studies have been able to establish, is for treatment of rheumatoid arthritis. According to Dr. P. Viswanathan, an Ayurvedic physician at the Kottakkal Arya Vaidya Sala Agency in Hyderabad, who was consulted for this essay, "Gold bhasams are useful in auto-immune diseases. Gold is also used in modern medicine for arthritis. I think there is no substance in the various claims about gold bhasam curing tuberculosis and such. I think gold bhasams being used for sexual power is just a marketing strategy."

While gold bhasam is being sold at exorbitant prices and extraordinary claims about its curative powers are routinely made, no one seems to know if it is gold or the herbs, or otter testicles, or something else entirely that is doing the healing (if there is any). Perhaps the Yauvanamrata Vati would be as effective (or ineffective) in curing impotence with gold as without it? Perhaps it is the otter testicles that men should be consuming, instead of the gold and/or the herbs? We simply do not know. Such studies have not been done. After years of promising "scientific validation" we are no closer to knowing to what extent these medicines actually work, what their active ingredients are, and what side-effects they have.

Gold bhasams brings us to the next issue, namely, heavy metals. A 2004 study published in the Journal of American Medical Association (JAMA) found significant levels of toxic heavy metals such as mercury, lead, and arsenic in 20 per cent of Ayurvedic preparations that were made in India and went for sale in America (Figure 1). The situation is far worse in India where 64 per cent of sample collected were found to contain significant amounts of mercury, arsenic and cadmium.

In the wake of the bad publicity created by the JAMA report, the Indian government wants all export quality drugs to certify that their heavy metal content is within the acceptable limits. Ironically, drugs intended for domestic consumption are to remain free from such requirements, at least until the time more laboratories for testing this are established.

It is in the attempt to explain and control the toxic levels of heavy metals that the lack of rigorous science shows up. Some of the contamination could no doubt be due to environmental pollution and "unsatisfactory agricultural and cultivation practices", as AYUSH has tried to explain. But at the same time, by agreeing to initiate chemical analysis and animal studies for toxicity of eight bhasams, AYUSH has tacitly admitted that the problem could be integral to these medicines themselves. According to Dr. P. Viswanathan, all eight formulations contain heavy metals well-known for their toxicity: Kajjali is a powder of mercury and sulphur, Rasmanikya is tri-sulphide of arsenic, Nag Bhasama is a bhasam of lead, Rasasindoor is a bhasam containing mercury and sulphur. The other four drugs - Basantkusumkar Ras, Arogyavardhini Vati, Mahayograj Guggul and Mahalaxmi Vilas Ras - contain mixtures of all common bhasams, and are extensively used for diabetes, liver disease, arthritis and respiratory diseases.

The presence of toxic heavy metals in Ayurvedic preparations is not surprising. There is a long tradition in Ayurveda, as well as in tantric and Siddha alchemy, for ingesting mercury and gold for medicinal purposes. Charaka and Susurta Samhitas permit the use of mercury, but for external use only. Vagbhatta (6th-7th century A.D.) recommends internal uses of mercury for therapeutic ends. The Italian traveller Marco Polo, who visited India in the late 13th century, reportedly met "ciugi" (yogis or jogis) who apparently lived long and healthy lives because they consumed a drink made of mercury and sulphur. The French traveller Francois Bernier who visited India at the close of the 17th century has left behind a record of Hindu holymen who knew how to make gold and prepare mercury for health purposes. In this Siddha alchemical tradition that Marco Polo and Bernier observed, mercury and gold were considered elixirs of life which could confer immortality. The Ayurvedic tradition incorporated many of these alchemical ideas over time. Gradually complex processes of making bhasams evolved through which mercury, gold, arsenic, lead and precious stones were first purified by repeatedly heating and cooling them in herbal extracts (a process called sodhana) and then grinding them with herbs and heating them in closed earthen crucibles by burning cowdung cakes (a process called bhasmikaran).

There is thus a long and well-respected tradition of using heavy metals in Ayurveda. But, after so many years of promising us a scientific account of Ayurveda, we know practically nothing about what happens to these metals when they are subjected to the traditional processes of sodhana and bhasmikaran. We constantly hear assurances from the proponents of Ayurveda that the traditional process of turning heavy metals into bhasams "detoxifies" them and makes them harmless. The message is that if the manufacturers faithfully followed the instructions in the classic Ayurvedic texts, there would be no problem of toxicity.

But we are supposed to accept these assurances of faith alone, for they are not based upon any actual research. We do not even know, after all these years of "research," if the process of making bhasams turns these heavy metals into oxides or some other kind of compound altogether. According to Dr. C. Viswanathan, an orthopaedic surgeon who is also well versed in Ayurveda, "the oxide of mercury is certainly toxic and is a health problem... . I think it is just wishful thinking to suggest that any amount of baking with herbs is going to make mercury non-poisonous."

Dr. P. Viswanathan of Kottakal states: "As far as I know, there have been no tests that proved that the mercury used in bhasams is safe for human consumption. The end products of mercury in bhasams have not been studied for their toxicity."

Simply following age-old Ayurvedic formulas is no guarantee of safety. The fundamental processes and concepts on which these ancient processes are based must be exposed to serious experimental investigation.

As a final case, let us look at Swami Ramdev's prescription of parnayam as a "miraculous" cure for "all diseases, from A to Z". Ramdev lists some 260 conditions, including infectious diseases (cholera, leprosy, syphilis), hormonal disorders (diabetes, thyroid disorders) and complex, life-threatening, systemic diseases of heart, liver, kidneys, brain, reproductive system. Yoga and parnayam (deep breathing exercises) alone, he promises, can "completely" cure all of these ailments. He claims that patients show significant improvements in their blood-sugar level, blood pressure, cholesterol and triglyceride levels, lung functioning and obesity by doing yoga and parnayam for just eight days in the "yoga-science" camps he organised periodically through 2004-05.

There are undeniable benefits of yoga. But curing diabetes? Curing infectious diseases? There is no credible scientific evidence for any of these claims. In the refereed medical literature, yoga has only shown some benefit for reducing hypertension (that too, only in combination with aerobic exercises and extremely low-fat diets). There are also some reports that show marginal and short-lived improvement for asthma and carpal tunnel syndrome (a condition affecting the hand and wrist). Yoga is also shown to improve strength and flexibility, but not any more than other physical exercises, including walking.

Can Ramdev's claims for "miraculous cures" be trusted? His "scientific evidence" does not meet even the most minimum standards of clinical trials. But the poor quality of evidence seems to be almost beside the point in the debates about Ayurveda. The majority of those who believe in Swami Ramdev's cures seem to be convinced by anecdotes and personal stories they hear from friends, relatives and from those who testify on television.

One cannot, however, put too much confidence in anecdotal evidence and personal testimonies. As Dr. C. Viswanathan explains, going by testimonies alone, one will have to grant that all kinds of miracles work. After all, there are many people who testify to all kinds of cures by prayer alone. The problem with anecdotal evidence, according to Dr. C. Viswanathan is that many times, patients and doctors are not familiar with the natural history of the disease, and they end up giving unwarranted credit to some treatment method for a `cure,' which would have occurred naturally. Moreover, it is a well-recognised fact of medical science that even when a treatment does not work, it helps people to reinterpret their symptoms and experience them as less severe. (That is why clinical trials include controls on those who receive fake treatments or placebos.)

Anecdotal evidence of people reporting that they are feeling better cannot provide sufficient grounds for "scientific" validation of Ayurveda or any other kind of medicine.

We have heard many claims of Ayurveda and yoga being the "complete" and "highest" sciences. It is time now to expose these ancient sciences to the test of medical and biological sciences, as we understand them today.

Toward that end, it will be useful to keep in mind the wise words of Marcia Angell and Jerome Kassirer from their famous 1998 editorial in the New England Journal of Medicine:

"There cannot be two kinds of medicines - conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work .... Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments."

Charaka would have certainly agreed. After all, it was Charaka who advised his fellow healers to "always strive to acquire knowledge. There is no end of medical science. Hence, heedfully thou shouldst devote thyself to it... And even if possessed of sufficient knowledge, thou shouldst not boast of that knowledge."

(The author would like to thank Dr. P. Viswanathan, M.D. (Ayurveda), Consultant Physician, Kottakkal Arya Vaidya Sala Agency, Hyderabad, and Dr. C. Viswanathan, M.S. (Ortho), Senior Lecturer in Orthopaedics, Government Medical College, Thrissur, Kerala for their valuable medical opinion.)

Meera Nanda is a Fellow in Religion and Science (2005-2007) at the John Templeton Foundation, U.S.