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Some contend that Chinese and western medicines are two different systems, so western standards cannot be used to judge. This is in fact a convoluted way of thinking. Chinese medicine can’t escape the hurdle of serious testing By Li Tie (李铁)??? April 30 was the last day for producers of herbal medicines to register their products to be eligible for certification in the European Union. Unfortunately, not one Chinese company completed the process. This means that every Chinese herbal medicine company which had aspirations of competing in the European market was somehow wiped out along the way.??? In order to strengthen the safety and regulation of herbal medicines, the E.U. introduced the “Directive on Traditional Herbal Medicinal Products” in 2004. It mandates that companies which fail to complete the registration process by April 30, 2011 are not allowed to use or sell their products within the borders of the E.U. This process was in fact simplified for countries like China and India in order open up to their traditional herbal medicine networks. It does not have the same safety and testing requirements as other medicines. Instead they only need to provide proof of how long they can safely be used. The directive also gave a seven year transition period for these companies.?? Despite having a simplified process and extremely low requirements, not Chinese company was able to complete the registration because prior to this they had sold their products as health food and not medicine.?? Over the past few years we have seen time and again how Chinese medicine piques the interest of outsiders [墙内开花墙外香]. We seem to think that foreigners are seeking it out while Chinese use it less and less. However, this is not true at all. Not only are there no Chinese medicines in the E.U., the United States Food and Drug Administration has yet to approve any either. They are sold as food or “dietary supplements.” For example, Yunnan baiyao solution, a well known prescription drug in China with a secret formula, has the following description on the FDA website: “This product may not be used for diagnosing, treating or preventing illness.”? Some contend that Chinese and western medicines are two different systems, so western standards cannot be used to judge. They say Chinese medicine can only be used on an individual basis for treatment and it is not appropriate to verify it through clinical testing. This is in fact a convoluted way of thinking which cannot be substantiated.?? The FDA’s requirements for herbal medicines have been greatly relaxed compared to other modern medicines. According to their 2004 guide to herbal medicine, there are only two things that need to be certified before a company can apply for [permission to sell] a new Chinese drug. The first is that it is nontoxic and the second is that it must prove to be effective. It is not necessary to evaluate the active components nor is it necessary to know the precise pharmacology. One only needs to conduct a clinical test compared with a placebo in order to prove it has a curative effect. Any honest person will admit that this standard is not only used in the West but is a basic practice used by people from all ethnicities and cultures.??? If we look back at the history of the development of medicine we see that it is not just Chinese ones which have resisted the FDA and E.U. Most traditional western medicines have gone through the same process. Before the modern era there was no real dividing line between Eastern and Western medical systems like we have today. People used natural plants, animals and minerals as ingredients. If you peruse the The London Medical Dictionary of 1618 you will find that there is no qualitative systematic difference with the [Chinese] Compendium of Materia Medica [本草纲目]. Western therapies quite often would use a combination of scented herbs which are very similar to Chinese methods.?? The dividing line appeared not too long ago. Modern medicine appeared in the 19th Century and had gradually matured by the middle of last century. Most traditional western medicines were discarded by the medical community because they were unable to pass rigorous tests for toxicity and efficacy, even though many had been seen as effective for a very long time. This process of elimination continued through the 1960s. As of 1966, the United States had over 300,000 kinds of non-therapeutic medicine before the FDA conducted their large scale experiments, a large portion of which were rejected after rigorous testing.?? There was a Harvard University professor in the late 1900s named Clark who was considered a “heretic.” He doubted the effectiveness of medicines and treatments which had long been used in the western medical establishment. He proved those methods and medicines to be useless through facts and statistical data derived from careful investigations. He even found some to be harmful.??? Clark used rational observation to deposit certain popular fallacies in the dustbin of history. And the history of medical research would later prove again that so-called experience cannot truly prove a drug effective. It is not easy to evaluate treatments. There are a myriad of examples of the many pitfalls which can lead to erroneous results. Just as Wolf proclaimed in his book A History Science, Technology and Philosophy in the 16th and 17th Centuries: “ Not often do people differentiate between the three situations of recovering after some kind of treatment, recovering because of a treatment, and recovering irrespective of treatment.”?? Similarly, Chinese medicine with all of its history and extensive scholarship cannot prove that any kind of medicine is nontoxic or that it is in fact effective. For example, a liver cleansing pill sold by the time honored pharmacy of Tong Ren Tang can cause renal failure and the Yinqiao vitamin C tablets used by hundreds of millions have safety issues. These discoveries remind us that tradition ought not to prevent thorough study of Chinese medicine. Sooner or later they have to be tested to see what they can really do. This is a hurdle which Chinese medicine can no longer avoid.?? Strict testing of Chinese medicine like that done by the FDA in the 1960s would not be disrespectful to the tradition. On the contrary, this is the most respectful thing we can do. If we truly love our tradition, we should repay it with the dignity of the truth and let Chinese medicines compete fairly with other medicines around the world. NOTE: This is a translation of a commentary which appeared in Southern Weekly on May 12, 2011. The original is here. |
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