As of May 1, uncertified herbal medicine products are prohibited from entry to the EU, according to the Traditional Herbal Medicinal Products Directive. Some European media predicted traditional Chinese medicine would have to intensify efforts to regain its market share.
“From now on only products that have been assessed by the Medicine and Healthcare Products Regulatory Agency [in the U.K.] will be allowed to go on sale,” BBC health correspondent Dominic Hughes reported April 30.
“Manufacturers will have to prove that their products have been made to strict standards and contain a consistent and clearly marked dose.”
This stringent control is understandable, given the widespread perception of traditional Chinese medicine as nonscientific and nonstandardized. Not long ago, visitors to a Chinese herbal pharmacy might have seen the pharmacist grabbing handfuls of raw decoction pieces, weighing them on a steelyard and wrapping them up in rough white paper.
Perhaps partly due to this image, the market value of TCM is shrinking year by year. “The TCM market has been lukewarm in recent years, because society still retains an unfavorable impression of it, and the government has not worked hard enough to eradicate this stereotype and promote the sector,” said Chu Fu-lin, Secretary General of the Chinese Medicine Association.
“TCM is a set of beneficial practices and knowledge that have been passed on for thousands of years. Its decline is the nation’s loss.”
People concerned about the situation have tried to chart TCM to a more scientific direction. Yang Ling-ling, deputy superintendent of China Medical University Hospital’s Center of Translational Research on Traditional Medicine, said, “To support its claims, TCM should provide experimental evidence.”
Yang is contributing to this cause through her current project under the Department of Health investigating the exact ingredients of more than 100 varieties of Chinese herbal medicine and their interaction with Western medicine.
“Only if TCM adopts a scientific approach utilizing chemical and biological analysis will consumers be convinced of its efficacy, and only then will the world understand its long-established popularity in the Greater China region,” she said.
Yang Ling-ling, a pharmacologist at Taichung-based China Medical University, is currently tasked by the DOH with identifying the chemical composition of TCM ingredients. (Staff photo/Chen Mei-ling)
In 2004 the DOH set out guidelines for the safe delivery of Chinese medicines, requiring hygienic packaging and clear labeling of ingredients, plus limits on residues of pesticides and heavy metals. For concentrated preparations, the DOH pressed for quality control through Good Manufacturing Practice.
“In 2005 we started full-scale GMP, which is a quality guarantee system that covers the manufacturing and testing of medical ingredients and pharmaceuticals, as well as medical devices,” said Huang Lin-huang, chairman of the Committee on Chinese Medicine and Pharmacy under the DOH.
“There are now 116 firms following GMP in manufacturing concentrated preparations. Consumers looking for scientific herbal medicine are reassured when they see the GMP label.”
The thorniest aspect of overall quality control, however, lies in the fundamental difference between Chinese and Western medical theory. “Western medicine is synthesized in a laboratory, and its use is directed at a specific part of the body,” Yang said.
TCM, in contrast, relates the human body to two opposing “chi” in the environment, “yin” and “yang,” and tends to treat the body as a whole, according to Yang. “TCM doctors employ various herbs to restore the balance of yin and yang in the patient and this approach is metaphysical and thus unverifiable,” Yang said.
One of TCM’s most prominent characteristics is the use of multiple herbal ingredients containing yin-yang properties in a single prescription. “This makes it hard to standardize the effects of TCM on the human body,” said Chen Chieh-fu, executive director of the Chinese Traditional Medicine Research and Development Foundation, as the herbs tend to interact with one another, and individuals may respond differently to the mix.
Further complications arise when TCM is administered in conjunction with Western medicine, or by individuals not trained in the tradition. In a well-known case reported in 1998 by Belgian researcher L.J. Vanherweghem, women following a weight-loss regimen of Chinese herbs in combination with pharmaceuticals suffered kidney failure, and some died.
It turned out that the prescribed herb han fang ji, Stephania tetrandra, was inadvertently replaced with guang fang ji, Aristolochia fangchi, which contains aristolochic acid, a nephrotoxic compound. The herb also was used in raw powdered form, while traditional use calls for a water decoction and smaller dosages.
Following this case, aristolachia-related TCM materials were prohibited in France, the U.K. and U.S., and the call went out for more stringent control of herbal medicine.
In 2003 Taiwan’s DOH banned the use or import of five herbs containing aristolochic acid, including guang fang ji, and required companies producing herbal concoctions to use scientific methods such as microscopy and thin layer chromatography to identify han fang ji and verify lack of contamination by guang fang ji.
“Some patients may be used to accepting medical treatment without question, but as responsible authorities, we have to provide safeguards and risk-free medical aid,” Huang said.
The DOH took further measures to prevent the inappropriate use of TCM in 2004, coming out with the first edition of “Chinese Herbal Pharmacopoeia,” a book listing 200 materials used in TCM and 200 standard regimens. It details the scientific name of each herb, as well as its form, properties, means of differentiation, methods of examination for adulterants and proper storage techniques, providing information for the scrutiny of herbal materials before they enter the market.
“The promotion of TCM knowledge in combination with stricter regulations is aimed at building a safe environment for patients utilizing these medications and upgrading the relevant industry at the same time,” Huang said.
“With these steps and a DNA database of 324 kinds of herbs, we are confident that consumers are protected from damage to their health through mistakenly identified herbs.”
Another safeguard for product quality is three-phase clinical trials, according to the DOH. At the end of 2009, 15 national or regional hospitals, including National Taiwan University Hospital in Taipei, Chang Gung Medical Foundation in Taoyuan, and Chi Mei Medical Center in Tainan, were qualified by the DOH to run such trials.
Clinical trials conforming to international standards, the agency added, also help contribute to the development of new drugs attractive to R&D capital by providing better access to the global market.
With investment injected by a domestic pharmaceutical firm, Nugentek LifeScience Co. Ltd., researchers at Taichung Veteran’s General Hospital, for example, developed a herbal compound coded ZC008 that is effective in preventing liver inflammation and fibrosis in 2007. It is patented in the U.S. now.
Huang Lin-huang, chairman of the Committee on Chinese Medicine and Pharmacy, says the institution of GMP for concentrated preparations and clinical trials for new drugs are giant strides in TCM’s scientific progress.
“In 2005, we certified the first new drug in Chinese medicine—red yeast rice—through the three phases of Investigational New Drug testing. It was found to be rich in cholesterol-lowering substances such as monacolin,” Huang said.
“This was a boost for TCM development because it demonstrated that the sector is capable of producing new drugs that can be introduced to foreign markets.
“When the essence of TCM and the practice of Western science are integrated, it is good news for everyone’s health,” Huang said. (THN)
Write to Aaron Hsu at pj1210meister@mail.gio.gov.tw