Report on the

First International Conference on Siddha Medicine

Kilavayal, Tamil Nadu, India

May 2002

Medicus sanat, natura curat -- Hippocrates

Note: This report is only a brief review of some highlights of the conference. It is hoped that complete abstracts from the conference will be available in the near future.

Conference Background

This conference was most atypical in that the site was a very rural area of the southeastern Indian state of Tamil Nadu. The site is part of Gandeepam, a project that includes growing medicinal plant gardens and providing them to local villages. The project serves approximately 30,000 people, providing them with means to manage common ailments with locally available plants, as they are used in the Siddha tradition. The conference was organized by the site's founder, Dr. Ramani and his family, along with the help of local practitioners of Siddha medicine and others, including Dr. Gerald Bodeker of GIFTS of Health and Oxford University.

Several delegates were invited from various parts of the world, including Japan, the Dominican Republic, France and the United States. Numerous press conferences were held to discuss Siddha medicine and the contributions the foreign delegates might be able to offer. These were in a lively mix of Tamil and English.

It has been estimated by a 1983 WHO inventory of 91 countries that globally there are some 20,000 plant species being used for medicinal purposes. In India, there are over 2,500 recognized medicinal plants, used in Ayurvedic pharmacies and elsewhere. It is a large and growing business, but, as is so often the case, benefits are not always fairly shared with the farmers, villagers, practitioners and others who do much of the work in harvesting and utilizing these resources. According to the WHO, some 80% or more of the world's population relies upon indigenous medical systems for their healthcare. Earlier in May of this year, the WHO through the World Health Assembly identified the study of traditional medicines as a priority.

Some interesting parallels between the U.S./west and India were brought up at these and other discussions. India has for the most part embraced the "allopathic" or western approach to medicine. This very often leads to conflicts and sometimes arrogant dismissal of their own traditions, just as happens frequently among physicians, researchers and policymakers here in the United States. This is further reflected in governmental policies which may impede practice of traditional medicine systems while at the same time providing only limited accreditation. For Siddha medicine, there is virtually no recognized method for accrediting practitioners. The better known Ayurveda system has more established institutions throughout India and can serve as both a model as well as a caution to avoid pitfalls they may have experienced.

For many Siddha physicians, they feel there is no need to validate what they know works. Others, however, fear that the traditions may die if there is inadequate interest to sustain them; they wish to reach out. Thus, in order for the system to survive and thrive, those of us who are ignorant or those who are skeptical of the possibilities need to have some kind of external validation.

There is good news, however. The Gandeepam organization is already in the process of developing a school for new Siddha practitioners. One of the attendees was a vocal spokesperson who underscored the efforts being made legislatively on the national level to bring greater recognition to the many great traditions of India, lest they be lost. And indeed, there appears to be a movement within the Indian government to retain the value of these ancient traditions.

Such accreditation processes are also being developed in the United States among different traditions, albeit at a glacial pace and not without some controversy. Should practitioners be required to obtain accreditation at a cost that is prohibitive to effective practice? How can those who are not operating within the money economy (i.e., barter or services economies) be subsidized to assure that appropriate training is received while not compromising the traditions themselves?

Such challenges await the very capable people I met and I believe that they will be ultimately successful. The world is moving more toward recognizing that health care is a right, and not merely a means to make ludicrous amounts of money. The failed system in the United States that eliminates nurses, steals them for cheap from developing countries, does not capitate HIV physicians, fails to provide adequate healthcare to those with insurance, charges ludicrous amounts for drugs and procedures, and fails to cover well over 40 million of its citizens while providing dismal services to a vast number more should not be a source to emulate, but rather a model to avoid almost entirely.

Ultimately, why should anyone care about an ancient medical system? What in the world have they got to offer someone living with a really serious disease like HIV or hepatitis C? Actually, there are no ready answers to these questions. This is part of the reason that FIAR was born. Indeed, at the conference some interesting claims were put forward about successful treatment of HIV with Siddha medicines. Are they valid? We don't know. But we were also able to identify individuals who were willing to work with us to help conduct a clinical study. A report from one small, uncontrolled study suggested some benefit. However, the data were limited and unclear. If there are treatments for HIV, related infections and ways to manage ARV side effects, FIAR hopes that its collaborations with Gandeepam and others will be helpful in establishing their validity--and assuring that commercial benefits are realized by the local villagers and farmers.

What is Siddha Medicine?

India has been the home ground for the development of several traditional systems of medicine. Perhaps the best known globally is Ayurvedic medicine. In addition are Unani, Tibetan and the Siddha tradition. Each of these systems involves the use of diagnostic techniques, the use of diet, exercise (e.g., yoga) and various plant, animal and mineral compounds to redress imbalances.

Siddha medicine grew up in the region of South India now known as Tamil Nadu, which has its own beautiful and mellifluous Tamil language. It is thought to be anywhere from 5,000 to 10,000 years old, which suggests that it may predate the development of the Ayurvedic system. Dr. JR Krishnamurthy pointed out that Siddha derives from a term meaning "attaining perfection" or satchitananda. Sid or "chit" means mind.

There are many overlaps between Ayurvedic and Siddha medicine and they even use similar underlying concepts such as the doshas (known in Ayurvedic tradition as vata, pitta and kapha). Diagnosis involves a sophisticated evaluation of the pulses and use of the five senses to evaluate the tongue, color of skin/eyes, etc., speech, eyes, urine, smells, touch (palpation) and the nadi (energy channels).

It is a tradition that encompasses a way of life to attain health that includes spiritual, religious, philosophical, alchemical, and astrological elements. Diet is a critical portion with many tastes of foods identified and associated with dosas, as in Ayurvedic medicine (e.g., astringent, bitter, salty, sour, pungent and sweet). Exercise in the form of yoga (which includes meditation practices) completes the major components of the tradition.

However, some distinctions exist, including a more refined use of pulse diagnosis in the Siddha tradition as well as a heavier reliance on the use of treated metals as medicines. These, to the consternation of western (or allopathic) physicians, include such toxic elements as mercury, cadmium, lead and arsenic. Siddha medicine claims to prepare these in such a way that the toxicity is removed and that benign but therapeutic oxides remain. Siddha medicine also uses a wide array of botanicals. Evidence suggests that many of these were transported to Rome, as evidenced by shipments of ivory, pearl, ginger, cardamom, pepper, neem, turmeric.

Internal Validation

This term describes the fact that for the practitioners of traditional medicines, there is a very long history of use of the diagnostic and treatment techniques they employ. Indeed, many practitioners come from multiple generations of practice, sometimes for over a hundred generations. They very often know what works, what the limitations and side effects may be, the length of treatment, the best time to harvest medicinal plants, the technologies needed to bring together in synergistic combinations the right medicines that will restore balance. What this conference hopes to achieve is bringing that culture and wisdom to the wider world before it is lost in the haze of hype that promulgates allopathic medicine as the only useful form of treatment for every ailment.

There are, of course, risks with seeking such external validation. One obvious one is to highlight limitations. By contrast, greater awareness of potential benefits may lead to overharvesting, reduced supply, use of legal systems to increase profits for the already wealthy (biopiracy) and deny it to those who deserve it. Further, botched clinical analyses utilizing weak methodology may lead to incorrect results and/or faulty interpretations.

The next section discusses the means and methods used to establish the potency (chemical profile) and purity (lack of contaminants) of marketed products. However, of course, a clinical standard exists within the Ayurvedic tradition for identifying plants, as well as harvesting them. This is embodied in a system comprising descriptions of the place of origin of a plant (desha), the season of its growth (kala) and a more subtle notion of dik which, for example, may suggest that a root be facing north in its growth for optimal potency. These factors, as we will see, have an influence on the potency of a plant. Means of identifying plants are also available within the traditions, however, here some disagreement may arise and where reductionist scientific techniques may augment those efforts. Again, it is about using the best available tool. Arrogance or pride in either system fails to address the most important goal of any medical system: to help the patient live long, well and in a healthy state.

External Validation: Standardization, Potency and Purity

A number of sessions were dedicated to analyses of prepared, commercial products as well as whole plants. These studies underscored the modern expertise and technologies available within India for such analyses. They included the use of high performance liquid chromatography (HPLC), high performance thin-layer chromatography (HPTLC), X-ray crystallography and diffraction studies (particularly for mineral-containing products). Essentially, these tests provide a chemical fingerprint that may both identify the plant as well as the concentration of specific chemicals thought to be of principal importance in its therapeutic efficacy. These processes are necessary to improve the global perception that high quality products are available from the Indian market. It was pointed out that even local practitioners more often today obtain their medicinals from the open market rather than collecting them themselves.

Such studies are first critical to assure that plants and minerals have been correctly identified. Confounding issues for accurate identification include variations in the chemical profile of a species from one ecosystem to the next as well as the not uncommon practice of the same indigenous name being used for different plant species.

As in America, testing of products on the market yields a range of results. Considerable discrepancies were found in some cases, while other samples were sometimes found to be contaminated with yeast, molds and other bacteria. By contrast, other products were reported to be of good quality using correctly identified plant or other material. Variations in alkaloid content of a study of various plant species serves as an example. Datura stramomium grows plentifully in the valleys, with fewer plants at somewhat higher altitudes. However, the higher alkaloid levels were found at the higher altitudes since they did not have the opportunity to progress to the vegetative stage and the alkaloid output appeared to be associated with formation of reproductive refluxes. Similar issues were discussed by speakers at the conference, including a fascinating discussion of Andrographis paniculata, the "king of bitters."

An essential component for proper clinical evaluation of the efficacy of some of these interventions will of course be the thorough evaluation of the products' potency and purity. Dr. Saruswathy from the Anna Hospital in Chennai was kind enough to provide a tour of their facilities. I believe they will be an excellent partner for FIAR to address this component of conducting rigorous and ethical human clinical studies in India.

External Validation: Toxicity

Researchers at Anna Hospital and elsewhere are working with animal models to evaluate the toxicity of some of the metal containing compounds. Mercury has been suggested not only in the Siddha tradition as a treatment for HIV disease, but some years ago was also put forward from the Tibetan tradition.

The notion of willingly taking such a toxic substance seems ludicrous on the face of it. However, these metals are prepared in various ways, either cooked an appropriate number of times or otherwise processed. The dose and duration of use further appears to reduce any potential toxicity. These age-old observations are being validated in the lab in tests being undertaken in rat models. So far, they are not finding any liver or kidney damage or other significant toxicities, even at concentrations exceeding physiological relevance.

Sophie Jakowska, Ph.D., pointed out as well that misuse of herbs can be harmful or fatal. She reported on cases of children being sent to local hospitals in the Dominican Republic after ingesting certain herbs. In addition, she noted the increasing need for growing areas that are free of soil, water and air pollution that can compromise a plant's medicinal activity through the presence of toxins and heavy metals. Others also discussed organic farming techniques. (As an example, the Honey Bee Network is doing interesting work in this regard, planting neem trees sporadically in cotton fields. They work effectively, through exudations, as insecticides, eliminating the need for pesticides almost if not completely. See http://www.sristi.org/first%20shodhyatra.htm.)

External Validation: Efficacy

Where did the ideas arise that different plants and such could have an effect on health? When some recipes call for picking a particular plant on a moonlit night on a particular hill side in August, doesn't it all just sound like a lot of quaint mumbo-jumbo? (But think about the moon image; plants have growing seasons; the active ingredients vary as the season progresses; we know that the chemistry changes for a plant depending on the ecosystem it may be found in such as a hillside higher up versus a grassy plain; and plants have some rudimentary diurnal cycles, not dissimilar to the daily/nightly ebb and flow of cortisol in humans. Suddenly, it doesn't look so bizarre!)

The way in which many discoveries were made is probably lost to time. But we have some knowledge. For example, practitioners would observe the eating patterns of the mongoose to try to discover herbs that might be helpful to offset snake bite. Many interventions were discovered empirically. This knowledge then has accumulated and been refined over thousands of years. Yet even ancient knowledge may contain inaccuracies. Clinical studies can bridge the gap of skepticism that otherwise may result in dismissal of important therapeutics.

Specific studies of the features of various botanical interventions were also discussed. Some fascinating in vitro work reviewed some of the biochemical mechanisms for the benefit of honey in treating diabetes mellitus, among other problems. An excellent review of various methods for treating a range of eye diseases was provided by Dr. Panamabhan. A rat study underscored the benefit of Gossypin in treating paw-induced edema and swelling. Jujube and papaya were noted for their benefit in offsetting renal failure. Another presentation reviewed interventions for the treatment of various inflammatory brain diseases. Some time was spent as well on evaluating various practices in veterinary medicine.

Only a few presentations discussed human clinical studies. One reviewed several cases of people with different lung infections. Individuals were provided treatment and several had improved responses. One evaluation of response was a few had clearing of lungs as depicted in X-rays. Unfortunately, most had a variety of infections from Staph. aureus to Pneumocystis carinii (one person had PCP).

Another study was of 16 patients receiving various therapies, including blends of minerals and herbs known as rasagandhi mezhugu (1 bid), amukkara chooranam (with milk,1 tsp at morning and night), and nellikkai lahyam (gooseberry; 1 tsp bid) (collectively, RAN). 11 of these patients received all three combinations along with drugs to control opportunistic infections while the remaining 5 received OI drugs alone. Some viral load reductions and T cell increases were noted in patients on RAN and there was an average weight gain of 2.2 kg, whereas the control group receiving only OI treatment had a 0.75 kg increase. These preliminary data suggest some efficacy that may lead to a larger, better controlled study.

Dr. Gerard Bailly from France discussed his experiences in addressing the AIDS epidemic in Africa. He noted some of the efforts of the director of an acupuncture group in Beijing showing the efficacy of acupuncture in managing complicated pregnancies/delivery. Teaching five simple points to midwives in Madagascar resulted in a significant reduction in complications. He also discussed the breadth of issues HIV spotlights: poverty, malnutrition, coincident TB and malaria epidemics, overcrowding, sexually transmitted diseases and so forth. Many cultures from Madagascar to Burkina Faso rely heavily on botanical interventions to address these and other ailments.

Some of the botanicals that researchers at Anna Hospital in Chennai are reviewing for anti-HIV activity include Mimosa pudica, Phyllanthus amarus, Shorea robusta, Indigofera aspalathoides, Corallocarpus epigaea, Uraria lagopoides. At the Christian College of Medicine in Chennai, they are also looking at Syzigium cummi and Polycythia longiflora (sp?).

Conservation: Supply and Demand

An entire afternoon was devoted to the extremely serious issues around conservancy, forest and ecosystem management and sustainability. Encroachment of human populations into wilderness areas as well as increasing popularity of many medicinal herbs has created a situation in some cases of demand far outstripping supply. While many herbs may be cultivated, others must be wildcrafted, meaning that they can only be picked in the wild. This adds another layer of challenge compared to plants that can be cultivated. Local growing conditions may have effects on the chemical profile of the plant, and thus the pharmacological activity. In addition, "RED" lists of some 103 endangered species were also provided.

Various methods are used to evaluate the current situation, including surveying, location and accessibility of the plants, forest conservation, analysis by the various ecosystems (forest, swamp, scrubland, etc.), altitude, etc. means to sustain cultivation and/or environmentally sustainable collection through nursery outreach, local community participation and field research were discussed. Workshops are being developed to train local villagers in the use and protection of various species. Dr. Nalinigitee noted that aside from rural training sessions, urban herb gardens can be developed on roofs and balconies. Availability of water, sun and appropriate soil needs are critical concerns. Some of the challenges faced are over-harvesting, fires, cannabis plantations, landslides.

In addition, several papers reported on efforts to conserve species through the use of gene banks, seed banks, collecting genetic material as well as plantings in urban and rural gardens. An important organization at the forefront of such efforts throughout south India is the Foundation for Revitalisation of Local Health Traditions (FRLHT). This group and others work in networks to canvass the area for understanding both common household usage and more specific use by practitioners while seeking to catalog and sustain local ecosystems.

Intellectual Property Rights

Drs. Bodeker, Utkarsh and Raju raised a number of critical concerns regarding assuring that any commercial value that may accrue from discoveries surrounding the use of Siddha medicine might be enjoyed by local populations, rather than merely enhancing the profits of large multinational corporations. The Covenant Centre for Development located in Madurai, India has done a great deal of work in providing capacity building for gatherers and cultivators along with technical support in order to, among other things, stimulate the market to adopt fair trade practices that ensure those doing the hardest work are seeing the benefit of their labor (and not avaricious middlemen). The volume of plants sold was increased through their program resulting in 20-30% increases in the incomes of collectors, while bridges were being built between resources such as financial, market, botanical research, semi-processing technology, etc.

Conference presenters discussed the concept of prior art that can be utilized to fend off spurious patents. An example was provided of a university in Mississippi seeking to patent the herb turmeric for its wound healing properties. Turmeric has been used in Ayurvedic medicine for centuries for this indication. The Indian government raised a case against this nonsense and for a change, justice prevailed and the patent was thrown out. Others have not fared so well, unfortunately.

Dr. Bodeker provided the example of post-colonial assault on Cameroon, where a prostate treatment, Prunus africanus, was produced commercially by a European government. Subsequently, despite strong legal conservation measures in Cameroon, the plant was harvested nearly to extinction. This highlights the need for enforceability of traditional resource rights are to be protected. Legislation without enforcement offers no protection against exploitation. Other stories from Zimbabwe, South Africa and elsewhere underscore the riskiness of trying to thwart the efforts of the powerful pharmaceutical industry in its greed that has grown recently to genocidal proportions.

Other means, however, can be adopted to protect information. Maintaining trade secrets is another means. This can assure that a local practitioner's value is not diluted by widespread use of his methods. One international example is the formula for Coca-Cola (but at the end of the day, who cares? the stuff is just an industrial strength scrubber). Seriously, the pitfall here is that external validation can only be undertaken of a specific individual's practice and not the specific intervention. Nonetheless, it remains a valid means of protecting local knowledge. If, however, the knowledge is not passed on, then there is the risk that it will be lost when the practitioner dies.

Maintenance of records and databases of traditional arts also assures that general knowledge remains in the public domain. That is, they document the prior art. Many organizations and institutions are working on this area; Dr. Utkarsh pointed to the Traditional Knowledge Digital Library (TKDL) and the People's Biodiversity Register as examples, while Dr. Bodeker pointed to SRISTI. This also includes the development of seed and gene banks to retain the genetic heritage of indigenous interventions. Extensive and comprehensive surveys of groups like FRLHT as discussed by Dr. Hafeel are another critical resource for documenting national treasures.

According to the Convention on Biological Diversity, article 8(j) states that if it exists in the community, it is owned. However, this conflicts with the World Trade Organization's Trade Related Aspects of Intellectual Property (TRIPS) which states that the existence of an intervention does not mean it is owned, but rather is available to the world. Unfortunately, the latter interpretation is an open door to biopiracy by nations that bully others by the sheer might of their wealth, legal prowess and threats of economic sanctions.

Another aspect of the WTO agreements being pressed by the United States is the concept of sui generis regimes ("in a class by itself"). This is a concept that allows for patent protection being brought in areas that are traditionally considered public domain. The effects of such activity may at first blush be a means to protect local traditional knowledge and indeed several African and Latin American countries have used these laws to protect traditional knowledge. Unfortunately, it usually means the richer and more powerful countries can protect databases to prevent the approval of generic drugs, say, in developing nations. At the same time, the US may simply ignore judgments made in the Hague.

Finally, use patents may be taken out on specific interventions. This can be used to assure that proceeds from commercial sale accrues to the discoverer and anyone to whom she or he wishes to confer such largesse. (It is FIAR's hope to strike agreements that assure local communities also receive some significant percentage of such proceeds). The limitation is that the patent's life is approximately 17 years (barring extensions that the pharmaceutical industry is so fond of utilizing), whereupon it is open to the public domain.

Ultimately, the threat that FIAR hopes to avoid is an increase in prices that render common treatments unaffordable. Too often, patents are used as a flimsy shield to cover price gouging. The effect of this out-of-control policy by pharmaceutical companies and their interference in the rights of countries to access generically priced medications has been, for people living with HIV/AIDS, nothing short of horrifying.

Human Clinical Trials

Unfortunately, there are few, well-controlled human clinical studies for Siddha interventions. This is where FIAR hopes to collaborate with partners in India to raise funds and provide technical expertise in the design and implementation of appropriate clinical studies for the management of HIV disease.

Happily, the conference was a means to make contacts with a variety of potential, excellent partners. First, the people of Gandeepam can serve as both a resource for medicinal plants as well as human resources and contacts with the Siddha community. Conversations with several Siddha practitioners identified a few who are willing to work on evaluating medicines for HIV or hepatitis. It was made clear that intellectual property rights would be discussed and agreements reached before hand to assure that benefits were shared locally. Contacts at Anna Hospital in Chennai yielded a place for laboratory analysis of products used. Several physicians in attending the conference may serve as conduits for laboratory blood analysis of any future clinical trial participants in terms of T cell counts, viral load or other parameters.

Many issues need to be resolved, including rigorous informed consent. Participants must be able to understand the study's aims, the completely voluntary nature of participation, any potential risks and so forth, regardless of literacy. Interventions must be selected based on the experience of Siddha practitioners. Appropriate clinical study methodology must be carefully developed. FIAR now must also seek to raise funds in order to facilitate these studies.

Through these types of means, the value of these ancient traditions will be clearer for peoples around the world. It will also help to create more bridges between traditional systems and the tools we have available today. Ultimately, the barriers that create the concept of "alternative" medicine may eventually begin to dissolve as we create new synergies and means to create and sustain human health. A condition that we hope will more and more globally be viewed as a human right.

Sites/References

GANDEEPAM:
Dr. Ramani
Gandeepam
Kilavayal
Sivagangai District 630410
Tamil Nadu, S.India
gandeepam@gandeepam.org

Dr. K. Gowthaman BAMS
Consultant Ayurvedic Physician
3/41, Indira Gandhi St.
Agaramel, (near Ayyappan Koil)
Chennai 602103
Tamil Nadu, S. India
649-4486
gowthamansudha@rediffmail.com

Dr. A. Saraswathy
Asst. Director
Captain Srinivasa Murte
Drug Research Institute for Ayurveda
Anna Hospital Campus
Arumbakkam, Chennai 650106
INDIA
Ph. 044-621-4823, 620-7566; f-620-7566

Dr. Hafeel
Research Associate
Foundation for Revitalisation of Local Health Traditions
#50, MSH Layout, 2nd stage
3rd main, 2nd cross Anandnagar
Bangalore 560 024
INDIA
tel- 91-080 333-6909/ 343-4465
f- 333-4167
a.hafeel@frlht-india.org

Dr. Sharavanan K. Pamanabhan, MBBS,PGDHHM
Managing Trustee
Sri Aurobindo Siddha Research Foundation
26, Perumal Koil Street
Pondicherry, 605 001
Tamil Nadu, S. India
Tel 0413-341046
sasrf@hotmail.com

Sophie Jakowska, Ph.D.
Arz. Merino 154
Santo Domingo, Dominican Republic
809-687-3948
jakowska@hotmail.com

Hirotoshi Fushimi, Ph.D.
Researcher
Research Center for Ethnomedicine
Toyama Medical and Pharmaceutical University
2630 Sugitani, Toyama 930-0194
JAPAN
tel 81-76-434-2281 x2829 - fax 434-5065
fushimi@ms.toyama-mpu.ac.jp

V. Daniel Kumaran
Project Director
Venture Trust
Post Box #2
Illuppur-622 102
Pudukkottai (Dt.)
Tamil Nadu, India
venturetrust@rediffmail.com

R. Deivanayagam, FRCP(E)
President
Health India Foundation
101 Usman Road
Chennai 600017 India
tel-4346233
cdeivanayagam@hotmail.com


Dr. Asmita Wele
Assoc. Prof.& HOD
Department of Ayurvedic Pharmacology
BVDU's College of Ayurveda
Bharati Vidyapeeth
Dhankwadi, Pune 411043
India
wele@vsnl.com

Dr. S. Alagumanian, MSc., Ph.D.
Lecturer in Biotechnology
JJ College of Arts and Sciences
Pudukkottai -622404
Tamil Nadu, South India
salagumanian@yahoo.co.in

(C. asiatica in vitro growth propagation)
Dr. K. Jeyachandran
Secretary
Tamil Nadu Sidha Ayurveda Unani Federation Committee
Tuticorin District
10, Payaniyar Salai
Mappalayam, Madurai
India
[Siddhar/HIV treatment]

JR Krishnamoorthy, GCIM
No. 11, Perumal Koil Street
Kunrathur, Chennai 600069
Tamil Nadu, S. India
tel/fax: 91-44-478-0874
drjrks@vsnl.com
www.webindia.com/jrksiddha