Old Drugs, New Bottles

The ad marks a trend: the reinvention of a hoary healing tradition in the crucible of modern science. As drug companies know only too well, the label 'scientific' clicks well with the educated urban mindset. For many people, what ultimately works is what matters, and legions still visit the good old local vaidya. But for a growing number of informed urban consumers, the quality, packaging and aesthetics of the product does make a difference. To these, the stamp of science, even if fake, acts as a certificate of guarantee.

And so, drug companies like Dabur, Zandu and Himalaya Drug Co are investing crores in modern analytical tools to validate the efficacy of many traditional medicines. Their brochures, though dealing with ancient ayurvedic medicines, speak the lingo of modern medicine - clinical trials, placebos, dose-response, markers, active ingredients....

It's an uneasy alliance. For it attempts to reconcile two diametrically opposed views of healing - the downright reductionistic with the downright holistic. This apparent contradiction raises questions, both practical as well philosophical. Is the pudia dispensed by a vaidya less effective than a capsule containing a measured dose of the medicine? In other words, is the traditional way of preparing medicine inferior to the modern, scientific one? Does it make a difference who's dispensing it - a vaidya or a general practitioner? To a vaidya, every patient is an individual with his or her distinct idiosyncrasies, while to a GP a patient is more or less a body machine, every defect of which requires a standard treatment. Then again, does it make sense to do clinical trials of medicines, however differently formulated, that have been in use for thousands of years? More importantly, do these trials - which are not half as rigorous as those for modern drugs - have any scientific validity?

The fact is, once an ayurvedic herb is reformulated in modern terms, it loses its original character. The break with tradition - defined by the vaidya, his empirical knowledge of herbs and their concoctions, and his ideas about how they would work on a patient - is complete. The new drug is like any other modern drug. Pop it in and it elicits a standard response from the body. It becomes irrelevant who dispenses it - the vaidya, the GP or a chemist. Technically speaking, therefore, it's not an alliance between two forms of medicine, but a defection.

Yet philosophy aside, the claim that the drugs are scientifically tested and validated is slightly problematic. Take, for example, two ayurvedic drugs that were recently launched with claims of research and clinical validation.

The first, called New LivFit and marketed by Dabur, is promoted as a cure for Hepatitis B (hbv). In a double-blind clinical trial - where neither the doctor nor the patient knows whether the latter is taking the drug or placebo - at the Calcutta Medical College, 19 chronic hbv patients were administered New Livfit and another 21 put on placebo. After 12 weeks of treatment, 13 (68 per cent) of the 19 New Livfit-treated patients were cleared of the virus while in the placebo group only three out of 21 became negative for the virus.

 This demonstrates two facts. One, the efficacy of the drug and two, the natural clearance of the virus was only about 14 per cent, against the expected 95 per cent,  says Raj Mehrotra, a doctor at Lucknow's King George Medical College and developer of this drug. Currently an allopathic drug called Interferon is the most effective weapon to fight the virus, but it can clear the virus in only 40 per cent of the cases. Besides, it's very expensive.

New Livfit is a concoction of 11 herbs, all described in ayurvedic texts, and has been in the market for some time now as a pick-me-up for a sluggish liver in hepatitis patients.  But following reports that some patients had been cured of the disease by the drug, we decided to investigate,  says D.B. Narayana, chief of r&d at Dabur. New Livfit was was first tried on ducks by Mehrotra at King George Medical College and was found to be effective. Dabur now plans to do more trials across the country to further validate their claim. They have already applied for patent protection in the US, Europe and Japan.

However, S.K. Panda, professor of pathology at aiims and an acclaimed expert on hepatitis viruses, is not impressed.  The mere presence or absence of the virus antigen - which is what they have recorded - is no guarantee that the virus has gone. The claim that the drug reduces the hbv antigen to 32 per cent means nothing to me. Unless they look for viral dna and not find it, it's a lie to say that the virus has been conquered,  he says bluntly.

Panda also questions the way the tests were conducted.  The number of patients in the trial is unacceptably low. For a trial of this kind to be meaningful, there have to be at least 4,000 patients, 2,000 for the drug and 2,000 for the placebo. Besides, there should be simultaneous trials in at least three hospitals for the study to show valid results. This study meets neither criteria. 

The second drug, Learnol-Plus, is being marketed as a boon for 'mentally retarded' children. Developed by Dalmia Centre for Biotechnology in collaboration with the Centre for Psychosomatic and Biofeedback Medicine at Banaras Hindu University (bhu), it is a blend of three herbs - brahmi, vacha, and jyotishmati - all mentioned in ayurveda. bhu's G.P. Dubey, the principal investigator, says 280 cases were followed up in a double-blind trial over two years.  We monitored the progress every three months, through specific IQ tests and through interviews with parents and teachers of the kids. We tested for factors such as aggressiveness, concentration span, articulation, short- and long-term memory and basic arithmetic.  After six months, they claim, the child starts doing well in IQ tests, becomes more predictable in behaviour and bedwetting is controlled in 95 per cent of the cases.

The drug is currently being tested in various rehabilitation centres across the country. However, parents of kids taking the drug are vague about the effect of the drug. One says there is 30 per cent improvement, another says there is no change at all. The syrup costs Rs 1,125 for a three-month treatment.

This study too falls far short of scientific standards. Says Ranjit Roy Chaudhury, professor emeritus at National Institute of Immunology and chairman of the project on traditional medicine initiated by the Indian Council of Medical Research (icmr):  I would say 60-70 per cent of all clinical trials are meant for the wastepaper basket. Clinical trials need a lot of money and effort, which the drug companies are just not willing to invest. Selling brahmi, which was known to our vaidyas for centuries, as something novel and revolutionary is plain cheating.

The crux of the problem: if most trials are shoddy, the drug shouldn't be allowed to make it to the shelves at all. Regulations clearly state that if traditional medicines are prepared and preserved in exactly the same way as described in the classical medical texts, then these medicines do not require approval or registration. This, says Chaudhury, proves that most drug firms do clinical trials merely to get their products registered as dietary supplements abroad.

Since clinical trials for traditional medicines are optional, there is also no peer review of such trials. Nor are the results published in a reputed journal so that experts can scan it for any flaws. In fact, Panda wasn't even aware of New Livfit's trials.  In the absence of a regulation,  says Panda,  a drug company can easily rope in doctors, even in an institute like aiims, to do dubious clinical trials for them. And since the company needn't go to the Drug Controller of India for approval, it can simply bribe the local licence body to sell the drug in the market. 

 But,  clarifies Chaudhury,  if it's a novel preparation not described in the texts, there is no regulation to indicate that the requirements before release of such  new  but old herbal medicines are in any way less demanding than those for synthetic medicines.  And since good clinical trials are expensive - they may cost Rs 25-50 lakh - and laborious, most drug companies are loth to experiment with new drugs. Particularly as the cost of developing a new drug from a plant is $5-6 million.

There are other problems. For instance, a 1998 Supreme Court judgment banned cross-over prescription. This means doctors trained in non-allopathic medicine cannot prescribe allopathic medicine and vice versa. Says C.K. Katiyar, scientist at Dabur Research Foundation:  This makes it difficult to conduct clinical trials of herbal remedies in big hospitals. We circumvent this problem by adding an ayurvedic consultant to a team of doctors. What's worse, the Indian Medical Council is now asking GPs not to prescribe any non-allopathic medicine. 

Part of the reason for the hesitation in prescribing herbal medicine is that these medicines are not standardised.  The manufacturer is responsible for the quality of the medicine and I don't think there is any check on that,  says Chaudhury.  It must be understood,  he cautions,  that without standards for extracts of several other active substances in a plant, no amount of clinical trial will be of any use.  Unfortunately, we are still far behind the Chinese in this regard. And I think neither the government nor most drug companies are doing anything to make quality control the primary objective. 

This is why despite being the land of ayurveda, India accounts for less than 1 per cent of the $12 billion global market for herbal medicines. If it is to make a dent in the international market, or even at home, it's time policymakers came up with a comprehensive policy on research on herbal drugs - standardisation, clinical trials and commercialisation - so that only high-quality drugs come into the market.Else, drug companies will keep cutting corners in the name of Science.