Barriers under pestle

There is an urgent need to rationalise traditional medicinal systems to stop unscrupulous use

 
By Ritu Gupta, Tessy Koshy
Published: Wednesday 31 July 2002

-- the era of Rudyard Kipling -- 'East is East and West is West, and never the twain shall meet' -- is over. Finally the West is embracing the East. Testimony to this is the World Health Organisation's (who) recently launched global strategy aimed at bringing complementary or alternative medicines (cams) and traditional medicines (tms) into the ambit of mainstream health services.

The term cam refers to a broad set of healthcare practices that are not part of a country's own tradition, or are not integrated into its dominant healthcare system, but are being practised. These include acupuncture, chiropractice and osteopathic medicines. Traditional medicines, although considered part of cam, are referred to as a separate system and include Chinese medicines, ayurvedic cures, unani medicines and various other forms of indigenous medicine.

who hopes that its strategy will help governments evolve laws to regulate the use of these medicinal systems. Despite their growing popularity, only 25 of who's 191 members have a policy on cam/tms, and only China, North Korea, South Korea and Vietnam have fully integrated these into their public health systems. who opines that countries should urgently regulate and monitor the safety of cam/tms, recognise their role in providing essential healthcare services, and license and promote best practices among practitioners.

These requirements are a must, keeping in mind the growing popularity of these medicines. For centuries, cam/tms have been used widely in developing countries, but they are now increasingly becoming popular in the West also. The popularity can be attributed to concerns about adverse effects of allopathic medicines, and greater public access to health information. In fact, a national survey in the us showed that the majority of cam/tms users do not perceive them as 'alternative to' but rather as 'complementary to' allo pathic medicine. The growing use of cam/tms reflects in the soaring sales -- which have increased by 101 per cent between 1996 and 1998 -- of traditional medicines in the us. The world market for these is now estimated at us $60 billion. "These medicines are commonly being used and most often they are the most affordable for people," said Jonathan Quick, director of who's essential drugs policy.
Inappropriate doses But all's not well. Misuse of these medicines is widespread. A study published in The New England Journal of Medicine and commissioned by the us Federal Drug Authority (fda), states that the herb ephedra that is taken by an estimated 12 million us citizens every year for weight loss, body-building and other uses, results in high blood pressure, heart attacks, seizures and deaths. In fact, recently, a jury awarded us $13.3 million to an Alaskan woman who had a stroke after taking a weight-loss supplement that contained ephedra. "We have what I call a mess. The consumers are bewildered. A product is sold under numerous brand names. But no one knows which one is tested, if at all any is," says Varro E Tyler, professor emeritus of the Purdue University School of Pharmacy, usa.

At present, us laws do not mandate herbs and other supplements to be tested for safety or efficacy. This is particularly true for dietary supplements, which are considered neither food nor drugs and, are therefore not subject to the regulatory hurdles that prescriptions and over-the-counter medicines go through. "Current laws are not really safeguarding consumers. The public is essentially being used as a guinea pig," says Rich Cleland, a senior attorney with the us Federal Trade Commission. Moreover, most of the practitioners do not have adequate scientific knowledge about these traditional systems and their main aim to make a fast buck. "Who is taking up the responsibility? Who oversees this industry? No one," says Paul Root Wolpe, a bioethicist at the University of Pennsylvania Centre for Bioethics, usa.

In the wake of such a scenario, health advocates are calling for increased overseeing of the industry, ranging from quality control efforts to standardisation of the ingredients in products, to establishment of an independent panel to review safety and effectiveness of products. Recently, in its report, the us Presidential Commission on Alternative Medicine urged the us government to substantially broaden its support to cam/tms, especially in terms of research. However, critics question such suggestions. They say the commission should have been more forthright in identifying which cam/tms modalities are worth researching. "Research should be conducted in promising areas. It is worthless to spend us $6 million to figure out if homeopathy works," says Teoraona Low Dog, a member of the commission.

The situation is no better in other parts of the world. Even in European countries, like the uk, experts have called for stricter regulations of herbal medicines after hospitalisation of several patients who had taken Chinese herbal weight-loss preparation that contained a banned chemical known to cause serious side effects. "Patients often visit herbal outlets because they do not want Western medicines, and expect herbal preparations to be safe. But these medicines are clearly not a pure herbal product," says Cathyrn Corns, a biochemist at Southend Hospital in Westcliff, the uk. "There is a clear evidence that standards used in the production of some cam/tms are unreliable," says Alasdair Breckenridge, chairperson of uk's committee on safety of medicines.

According to experts, the way out is an independent panel to review cam/tms for safety and efficacy -- a system already in place in Germany. The German government has appointed a panel of experts known as the Commission e to evaluate herbal remedies for safety and reasonable efficacy. "The German method is certainly the best. We should have a similar system for the us," says Varro E Tyler, professor emeritus of the Purdue University School of Pharmacy, usa.

Development needed
who asserts that the need for having an evaluation system is most urgent in developing countries where cam/tms has not yet been integrated into the national healthcare system, even though much of their population depends on these medicines for healthcare. For instance, in Africa, up to 80 per cent of the population uses tms to help meet their healthcare needs. Even in China, tm accounts for around 40 per cent of all healthcare services delivered. Moreover, in some developing countries, tm is much more widely available than allopathic medicines. In Malaysia, for example, an estimated us $500 million is spent annually on cam/tms, compared to about us $300 million on allopathic medicines.

IN NAME ONLY
Traditional medicines have got official recognition in many nations
Countries Have a
policy on
TM/CAM?
Have laws
for TM or
herbal
products?
Is TM
used for
treatment
India no for both yes
Sri Lanka yes for both no
Indonesia yes for both yes
Japan no for both yes
Australia no for herbal
products
yes
UAE no for both yes
Germany no for both yes
Norway yes for both yes
UK yes for both yes
Canada yes for both yes
USA no for both yes
Ghana yes for both no
Nigeria yes for both yes
The broad use of tms in these countries is attributable to their accessibility and affordability. In Tanzania, Uganda and Zambia, researchers have found that the ratio of tm practitioners to population is 1:200-1:400. This contrasts starkly with the availability of allopathic practitioners, where the ratio is typically 1:20,000 or less. A 1991 survey by the us Agency for International Development found that, in sub-Saharan Africa, traditional practitioners outnumbered allopathic practitioners by 100 to one. Besides easy access, tms is also sometimes the only affordable source of healthcare for the poor populations of these nations. In Salvador, for instance, the fee for treating a child for diarrhoea as an out-patient at a public hospital can be as high as us $50. Treatment by a tms practitioner, on the other hand, just costs us $5 or is payable in kind.

But, like developed countries, regulators in these nations are also wrestling with questions about the safety, efficacy, quality, availability, preservation and further development of this cam/tms. Many industry groups and consumers resist any health policy developments that could rationalise cam/tm practices. Moreover, tm practitioners are reluctant to give information about their preparations for fear of losing them to scientists who have modern facilities to test, analyse and perhaps reproduce them. Therefore, precise data about these is lacking.

Another major challenge facing tm practitioners is the question of intellectual property rights (iprs) and patents. The economic benefits that accrue from large-scale application of tm knowledge are very substantial. This is particularly true for countries like China, whose tm products are the most in demand. The global market for traditional Chinese medicines is reported to be us $23.2 billion in 2002 -- up from us $19.6 billion in 2000.

Experts are concerned about how these economic benefits can be shared between the innovators and holders of tm knowledge. Such concerns have induced countries like Ghana to introduce a bill that would require patents for tm. "The law is a must for protecting our traditional knowledge. It would also encourage practitioners to provide information on their preparations, and thus promote safe and high quality herbal drugs," says Nana Agyentutu Ofei, director of traditional and alternative medicine at Ghana's ministry of health.

However, countries like Pakistan and India are yet to make such substantial endevours. A lack of interest, planning and almost negligible funds have hampered promotion of cam/tms in these countries. " cam/tms have never been accorded the due recognition at the official level in Pakistan. The bureaucracy always discouraged moves for their proliferation," says Hakim Abdul Hannan, a professor at Hamdard University, Karachi. Things are now looking up in Pakistan, though. The country is soon planning to set up a national advisory board that will regulate tm, and implement measures to strengthen the tm industry.

India: long way to go
The Indian government, it appears, is still to wake up to the challenges of the cam/tm industry. It had drafted a national policy on the Indian systems of medicine in 2001, but is yet to finalise it. Even after a year of debate and despite usage of Indian tm system dating back to centuries, the sector remains disorganised and unregulated. The situation is particularly alarming as the tm industry has a huge market turnover of Rs 4,205 crore every year.

Furthermore, research about tms is inadequate and therapies are untested. Knowledge about the possible side effects is also virtually non-existent. "Our approach towards tms is outdated. Practitioners are secretive as they are scared about someone challenging their knowledge. They have joined the 'commercial bandwagon', but are not very forthcoming to scientific changes," says Balendu Prakash, an ayurvedic physician and director of the Dehradun-based Vaidya Chandra Prakash Cancer Research Foundation. His views are corroborated by Kumara Swamy, a professor at Kidwai Memorial Cancer Hospital, Bangalore. "Much of our ancient tm systems have lost their originality and authenticity due to lack of interest among practitioners," he affirms.

Moreover, these practitioners overexploit medicinal plant resources and such unscientific harvesting of medicinal plants has led to the virtual decimation of several species. Government policies provide no way out of this dilemma (see: 'Trading in contraband', Down To Earth, vol 9, no 17, January 31, 2001).

This is just the beginning of official apathy. Thanks to the bureaucracy and the scientific community, indigenous tm knowledge remains mostly untapped. "The government is spending crores of rupees on allopathic medicines, but the same vigour is lacking for tm," admits Sushil Aggarwal, chief executive of Kolkata-based Indian Board of Alternative Medicines.

The laid-back attitude also reflects in the fact that it is not mandatory for manufacturers of tm to conduct clinical trials. The vaidyas are even exempted from applying for a license. At present, the department of Indian systems of medicine under the Union ministry of health and family welfare has three main regulations for tm. Ironically, the department's joint secretary L Prasad admits that though the industry is growing at a fast pace, regulations have not been updated. They are based on ancient texts which are more than 8,000 years old.

Such an indifference helps the industry to shrug off its responsibilities. It uses the already in place who guidelines as an excuse for not conducting clinical trails. The guidelines state that if a herbal product is in use for more than 30 years, it requires no safety and toxicity studies. "Therefore, there is no need to conduct safety and efficacy trials as our tms have been used for centuries," says C K Katiyar, deputy general manager, medical services and clinical research of Dabur India Limited, Sahibabad.

Hence doubts linger on and hamper promotion of tms, especially in urban areas. "Urban residents take tms when they have lost all hopes in conventional medicines, or when they are suffering from chronic ailments. But tm takes time to show results. Therefore, many hesitate in using them," says Pramila Thakkar, managing trustee of Neem Foundation, a Mumbai-based non-profit organisation.

Experts say that cultural acceptability of tm does not undermine the fact that most tms are untested. They feel that cam/tms should be held to the same rigorous standards, as is required for conventional medicines. They hope that the who strategy would help in ensuring this. Moreover, it can act as a yardstick for the 'much debated policies' of countries like India.

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