China has joined the World Trade Organisation, and the globalisation of her traditional medicines has begun. Dr. Mae-Wan Ho asks if that's good for health
The United States Food and Drug Administration (FDA) has approved a phase II trial of Kanglaite, a preparation made from a staple food-grain in southeast China (see Chinese Cancer Cure, this series)
The drug is China's best-selling cancer treatment. There are perhaps a dozen others, but this is the first made from a staple.
The success of Kanglaite has spurred scientists in China, Hong Kong and Taiwan to screen the 10 000 or so plants described in the Chinese herbal medicine literature for new drugs, as well as investigating the herbal remedies themselves.
Traditional Chinese Medicine (TCM) has entered the political agenda. Hong Kong's Chief Executive Tung Chee Hwa has laid out a ten year plan for making the city an "international centre for Chinese medicine". His government is currently funding 18 TCM research projects including clinical trials, developing quality standards and basic pharmacological studies. The Hong Kong Jockey Club Charities Trust is equipping research labs and donating US $64 million to get research started at a new Institute of Chinese Medicine.
Last year, Taiwan's President Chen Shui-bian proposed spending US$1.5 billion over 5 years to develop the country's Chinese medicinal herb industry, pending a detailed plan.
China's Ministry of Science and Technology has made the modernisation of TCM one of the 12 focal points in its current Five-Year Plan, and $3.6 million has been allocated to screening both conventional chemical compounds and medicinal herbs for potential drugs. "Screening [herbal remedies] is a way for China to try to catch up with Western countries in developing new drugs," said chemist Yang Xiuwei, director of the National Research Lab of Natural and Biomimetic Drugs at Beijing University of Medical Sciences.
Biochemist S.D. Kung, who is coordinating herbal medicine research at Hong Kong University of Science and Technology, says the timing is right. A new generation of Western-trained scientists is taking up the challenge to demonstrate the efficacy of traditional remedies to the US food and Drug Administration and the rest of the world.
But like many traditional healthcare systems, TCM has suffered from decades, if not centuries of cultural imperialism from the dominant mechanistic model of the West and its powerful propaganda machine. As a result, people in many Asian countries have been increasingly turning away from their traditional medical systems to embrace modern biomedicine even as all kinds of 'complementary and alternative medicine' are gaining in popularity in the West. A 1999 survey by the Hong Kong government found only 22% of outpatient medical consultations provided by Chinese practitioners.
One obstacle to improving the popularity of TCM is the lack of regulation over the quality of the medications and the qualifications of practitioners. Hong Kong is addressing that. "Once the regulatory system is in place and we upgrade professional standards," says microbiologist Edmund Lee, who heads the Hong Kong Jockey Club Institute of Chinese Medicine, "I'm sure the usage rate [for TCM] will increase."
Another obstacle to the general acceptance of Chinese herbal remedies is undoubtedly the traditional practice of using mixtures of many herbs in formulations, which goes against the grain of the dominant medical model based on using single pure chemical compounds. Faced with a typical mixture of 10 or more herbs, the average Western scientist can only respond with utter disbelief, if not utter despair in ever succeeding in isolating the active principle. Nevertheless, there have been a few transfers from Chinese to Western medicine.
The first chemical originating from Chinese herbal remedies to enter the Western pharmacopoeia was ephedrine, an amphetamine-like stimulant. A Japanese scientist isolated it in the 1880s from the Chinese herb, mahuang (Ephedra sinica), traditionally used to treat congestion, and is a common ingredient in over-the-counter decongestants and prescription medications for bronchial asthma. But the abuse of mahuang in 'dieting aids' and as a legal way to get high in 'herbal ecstasy' has resulted in a growing list of adverse effects, and several countries have banned non-prescription uses. I hasten to add that this abuse has never occurred within TCM itself.
The next drug originating from a Chinese medicinal herb came a century later in the 1970s. Chinese scientists isolated a compound called artemisinin from qinghao, or Artemisia annua, a relative of the sweet wormwood found in North America. Qinghao is traditionally used to treat fever; but the researchers found that artemisinin killed even chloroquine-resistant strains of Plasmodium the malaria parasite transmitted by mosquitoes. Recent research in US and Europe suggests that artemisinin may also have anticancer properties. Zhou Weishan, chemist at the shanghai Institute of Organic Chemistry, who led the efforts to synthesize artemisinin, says they never patented any part of the work.
Chinese researchers are determined not to repeat the mistake when developing the next drug, which is why Li Dapeng has got a "very capable" patent lawyer to protect Kanglaite before taking it to the rest of the world. The company he set up in Hangzhou China, the Zhejian Kanglaite Pharmaceutical Company Ltd, already owns a subsidiary in the United States, Kanglaite USA Inc., located in Salt Lake City.
Another US biopharmaceutical company, Oncoherb, Inc. is collaborating with "a well-known US cancer centre in New York" on the phase II clinical trials. This was announced at a symposium on "Modernizing Traditional Chinese Medicine" held in July 2001, which featured a talk by Ren Dequan, deputy director-general of China's State Drug Adminstration. Ren commented on the challenges for TCM after China has joined the World Trade Organisation.
The principle competitive advantage of Kanglaite is its low toxicity, which is unusual among current conventional cancer therapies available in the West. Oncoherb is studying Kanglaite's other formulations, such as edible capsule, or inhalable mist.
But will Kanglaite be made generally available at affordable prices, as it should be; or will it fall victim to corporate monopoly, to put it out of reach of all but the rich? That's the real challenge of globalising Chinese medicine. The other is the danger of overharvesting that can cause medicinal plants to become extinct in the wild (see Herbalert to the rescue, I-SIS report).
Kanglaite is by no means the only candidate to be marketed globally as an anti-cancer agent. There are others already marketed as food supplements, often at greatly inflated prices. A typical one-month supply of one such food supplement costs more than US$500.
Other similar drugs are also on the way. A compound derived from huangchi, or yellow root (Astragalus membranaceus), isolated by Taiwanese biochemist T.S. Jiang, is in the pipelines. Like Kanglaite, it ameliorates the side-effects of cancer chemotherapy. Jiang had started screening fractions of yellow root more than ten years ago after observing its traditional use in patients said to be deficient in the vital energy 'qi' (see Traditional Chinese Medicine and Chinese culture, this series). Jiang thought that sounded just like the lethargy and weight loss that often accompany chemotherapy. Yellow root is also a widely used, widely available Chinese herb.
Scientists in Hong Kong, China and Taiwan hope that modern screening efforts will turn the previous trickle of drugs into a veritable flood. The most ambitious effort is Hong Kong University of Science and Technology's Biotechnology Research Institute, which set up a $1.6 million High-Throughput Drug Screening Centre for Traditional Chinese Medicine in 1999, supported by the Hong Kong Jockey Club Charities Trust and other local charities and private companies. The Centre is targeting neurological diseases, including Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, and diabetic neuropathy. But the Centre is not revealing the details of promising hits, so far, for fear of being scooped.
Not all herbal enthusiasts are in favour of fractionating and screening, however. Some think that's missing the point, for traditional remedies often depend on the joint action of up to 20 herbs. "Extracting only some of the ingredients from the herbs might impair the original effectiveness and cause more serious side effects," says Bian Baolin, director of research and development at the Institute of Herbal Medicine, China Academy of Traditional Chinese Medicine, in Beijing.
Unfortunately, from the Western perspective, traditional Chinese remedies fail to inspire confidence. The claims rely on anecdotal evidence instead of the requisite 'randomised, double-blind, placebo-controlled trials' that's considered the gold standard for Western medicine. Edzard Ernst, professor of alternative medicine at the University of Exeter, UK, and colleagues at the Chinese University of Hong Kong (CUHK) reviewed more than 2000 clinical trials reported in mainland Chinese journals and found them almost universally flawed.
But Tony Mok, a clinical onocologist at CUHK, pointed out that the track record for Western clinical trials is not much better. Although hundreds of trials have been conducted in the United States and Europe in recent years, "only one or two have been worthy of publication in high quality, peer-review journals," he says. Mok and his colleagues at CUHK are conducting 20 randomised, double-blind, placebo-controlled trials of traditional herbal remedies and acupuncture, with another dozen planned.
But is the randomised, double-blind, placebo-controlled trial another contradiction to the philosophy of traditional Chinese medicine, which concentrates on treatments tailored to the individual rather than to the fictional average of a population? Yet more objections could be levied at the statistical methods of analysing the data, which are based on an outmoded mechanistic biology totally inadequate to capture the predominantly non-linear behaviour of the human organism (see The excluded biology, SiS 17 ). The randomised, double-blind, placebo-controlled trial also excludes the interpersonal relationships between practitioner and patient that's crucial in all holistic health systems.
Irrespective of the many conceptual contradictions with the dominant Western model, TCM has more than 300 000 practitioners in over 140 countries. The first hospital for Chinese medicine in Europe was opened in Germany in 1990. British GPs are increasingly contracting out for acupuncture. Public health-insurance companies in Germany routinely refund part of the costs of acupuncture treatment provided by trained doctors, and in France, acupuncture is a widely accepted part of the health-care provision. Degree programmes in Chinese medicine are now offered at several British universities, and courses in TCM are established at European medical schools.
Dr. Volker Scheid, a scholar of Chinese medicine, predicts three possible outcomes with regard to the effect of the globalisation of TCM, both in terms of its widespread adoption in countries across the world and in its entry into the global drugs market. TCM may be destroyed as an independent medical tradition by the western biomedical establishment, which assimilates some of the tools, such as acupuncture, massage and pharmaceuticals, but discards the core concepts and practices, such as the notions of yin and yang, and qi. Alternatively, TCM may be institutionalised along the Chinese model, or TCM may "develop into a heterogeneous vibrant tradition that eschews political and economic power for the sake of clinical efficacy, grounded in personal experience and in modern research".
There's a deep cultural and conceptual divide between traditional healthcare systems and the mechanistic mainstream model, not a credibility gap. Rather than trying to fit traditional health systems into the procrustean bed of the mainstream model, it is the mainstream model that's more in need of change and development as it is proving itself outmoded and inadequate in many respects. There's a lot to be gained by the two sides learning from one another and growing together.
Article first published 07/04/03
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