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Why TCM products are seen as poison pills abroad

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On August 20, Britain's Medicines and Health Care Products Regulatory Agency issued a press release warning that extreme caution should be used with a number of traditional Chinese medicines (TCM) because they could contain dangerously high levels of toxins, including lead, mercury and arsenic.

The release said the drugs are not authorized for sale in Britain, but can be bought on the Internet. "People are warned to exercise extreme caution when buying unlicensed medicines as they have not been assessed for safety and quality, and standards can vary widely," it says.

The TCMs named include Niuhuang Jiedu Pian for the treatment of tonsillitis, toothaches and other maladies; Bak Foong Pills, often used for the treatment of menstrual pain; and Fabao, used to treat baldness.

In early August, Hong Kong authorities ordered the recall of Bak Foong Pills because the city's health authorities found they exceeded acceptable levels of lead by two times and Fabao because it surpassed mercury levels by 11 times. In July, the Swedish National Food Agency also found extremely high levels of arsenic in Niuhuang Jiedu Pian and warned other European Union countries that it constitutes a serious health risk.

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Richard Woodfield, the British regulatory agency's head of policy for herbal medicines, said in the press release: "The adulteration of traditional Chinese medicines with heavy metals is a significant international problem and can pose a serious risk to public health." He urged the public to choose herbal medicines that meet quality and safety standards, and have Britain's Traditional Herbal Registration certificate on their packaging.

Since the beginning of this year, TCMs have repeatedly been questioned, mainly by foreign official and private drug testing organizations. Apart from being potentially toxic, another common concern is that the herbal remedies often contain pesticide residue.

Two Greenpeace reports issued on July 1 said that out of the 36 kinds of frequently used Chinese herbal products tested in Germany, France, Britain, the Netherlands, Italy, the United States and Canada, pesticide residues were detected in all but one of the products. Among those cited were nine of China's leading drug brands, such as Tong Ren Tang and Yunnan Baiyao.

The industry's reaction toward safety issues has been the same for years: avoidance. No company responded to the Greenpeace reports. A public relations official at one the companies cited told Caixin that his peers all have a standard answer to questions over product safety: "We are in line with national standards. EU standards do not apply to China domestically." He said pesticide residues are found not only in TCM products, but also in fruits and vegetables.

"We dare not say anything (in public), otherwise we can easily become a target," the PR source said.

The 'health food' problem

More or less all medicines, whether Western or Chinese, have side effects. Over the thousands of years that TCM has developed, the concept that all medicines are in a certain sense a sort of poison has always been acknowledged.

The difference is that Western medical practices require the side effects of drugs to be clearly identified, says Wei Lixin, a professor at the Chinese Pharmacopoeia Commission, which in charge of drafting the official pharmacopoeia, a book that describes TCM treatments and their preparations.

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However, there are no such guidelines on toxicity for TCM, says Wei. As a result, Chinese and foreign commercial health care companies have often bragged that their herbal preparations are not harmful.

Yu Zhibin, of the China Chamber of Commerce for Import and Export of Medicines and Health Products, said that among the numerous incidents involving acute TCM side effects in the West, one cause is that these countries do not regard the Chinese medicines as drugs, but as health foods. As a result some in the public take medicines as though they were food.

Work to be done

Theory behind TCM has long held that blending several herbal ingredients mitigates the toxicity of substances, and methods have been developed to make toxic substances react with each other, thus diluting or decomposing toxins.

Also, Wei said that when discussing the toxicity of Chinese medicines, the elements of the chemical compound, dosage and the period of treatment should be taken into account. Simply declaring that a certain substance is poisonous can be misleading. He used the example of cinnabar, the common mercury ore, which is a mineral drug that can, of course, be toxic in high doses.

"It's an incomplete statement to say cinnabar is poisonous," Wei said. "The truth is that it will become harmful to humans in high and extended usage."

For decades, the Chinese medicine community has been trying to use modern Western methodologies to measure toxicity in herbal remedies. Chen Keji, president of the Chinese Association of Integrative Medicine and a member of the Chinese Academy of Sciences, said that in the current pharmacopoeia, 18.3 percent of Chinese medicines do not have instructions for dosage or any toxicity analysis.

(Read more: China says Glaxo executives confess to bribing doctors)

Many TCM practitioners say that it will be a long time before authorities can provide a systematic analysis for all substances used in Chinese medicine. The effort does, however, continue. At the national level, three Chinese medicine safety evaluation centers and four clinical trial centers devoted to standardizing TCM have been established in recent years. New TCM drugs are required to satisfy the standards of a safety evaluation system before receiving regulatory approval. They must also come with safety guidelines.

Wei says he hopes the central government will launch a comprehensive toxicity study, but says it will require an enormous amount of time and energy to conduct scientific safety evaluations for all TCM products. "A toxicity problem is often not addressed until a poisoning incident is reported," he said.

More from Caixin Online:

Traditional medicine: handle with care
With funds flowing in, health-care firms are hale and hearty
Debate erupts after mercury found in chinese medicine

Lost business

The inability of Chinese products to meet the norms of modern medicine and provide safety assurances has, ironically, left China behind in the international TCM market, a US$30 billion annual business. Japanese and South Korean companies own 70 percent of the market. China accounts for a mere 5 percent, mostly represented by the export of raw materials to Japan and South Korea.

Shen Zhixiang, president of the Chinese Folk Medicine Research Association, said there are two reasons for this. "In reference to safety and effectiveness, Chinese TCM companies have given neither enough effort nor funding," he said. It was up to the industry to do the required research, he said.

But most Chinese TCM producers invest heavily in new product research that can boost stock prices, not in time-consuming clinical or safety studies.

Yuan Jinghua, an investment manager at China Meheco, said China launches over 1,000 TCM products every year. Meanwhile, Japan had almost no new TCM product in the last 30 years, and companies in that country concentrate their efforts on clinical studies and meeting international standards.

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Without certification, it is impossible for Chinese TCM products to be used as medicine in developed countries. Thus they are not recognized by mainstream American and European medical institutions.

Britain was the first European country to set up proper legal regulation of TCMs, though the majority of products are sold as health products or food because it is hard for them to meet drug standards.

No Chinese TCM products have received certification from the U.S. Food and Drug Administration, meaning they are locked out of the country's herbal medicine market, which is worth US$ 2 billion annually. The only likely candidate is a product under Tianjin Tasly Holding Group, which just passed the second phase of an FDA clinical trial. If all goes well, a brown pill used to treat angina can be sold in the United States as early as 2014.

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