Last week, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) 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 communiqué noted that these medicines are not authorized for sale in Britain, but can be bought through 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 (also called by Indian names such as Divya Kaishore Guggul and Chandraprabha Vati) for the treatment of stomatitis, tonsillitis, toothache; Bak Foong Pills, often used for the treatment of menstrual pain; and Fa-bao, a hair tonic for treating baldness.
Earlier this year, Hong Kong authorities ordered the recall of Bak Foong Pills and Fa-bao, which were respectively found to exceed by two and 11 times the levels of lead and mercury permitted by the health authority. 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 constituted a serious health risk.
Richard Woodfield, MHRA’s Head of Herbal Policy, said in the British agency’s 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,” urging the public to choose herbal medicines that meet quality and safety standards, and have received the Traditional Herbal Registration (THR) certificate on their packaging.
“Natural does not mean safe,” Woodfield concluded.
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, the most common concerns relating to Chinese herbal remedies are that they often contain pesticide residue.
For instance, two recent Greenpeace reports stated that out of the 36 kinds of frequently used Chinese herbal products tested in seven countries (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 are nine of China’s leading medicinal drug brands such as Tong-Ren-Tang and Yun-Nan-Bai-Yao.
The Chinese medicine industry’s reaction towards safety issues has remained unchanged for years: avoidance. For instance, no businesses responded to the Greenpeace reports. Similarly, a public relations official at one of the companies cited told Caixin that his peers all have a standard answer: “We are in line with national standards, EU standards do not apply to China domestically…” The source added that the issues of pesticide residue not only exists in TCM but also in vegetables and fruits.
“We dare not say anything, otherwise we can easily become the target,” the public relations official said.
Poisoning or “side effects”
In fact, whether it’s Western or Chinese, more or less all medicines produce side effects. Over thousands of years of TCM development, the concept that “all medicines are in certain sense a sort of poison” has always been widely acknowledged.
The difference is that Western medical practices require the side effects of medicinal substances to be clearly identified, explains Wei Lixin, a member of the Professional Commission of Ethnic Medicines and Traditional Chinese Medicines Standard Substances under the Chinese Pharmacopoeia Commission.
Instead, there are no such elaborate guidelines on toxicity for TCM, notes Wei. As a result, Chinese and foreign commercial health care companies have often touted their herbal preparations to be free of any harm — usually a totally false claim.
Yu Zhibin, of the China Chamber of Commerce for Import and Export of Medicines and Health Products, stressed to Caixin that among the numerous incidents involving acute TCM side effects in the West one important cause is that these countries do not regard the Chinese medicines as drugs, but as health foods. As a result some of the public ingest the products as though they were natural and non-harmful foods to eat. He believes that this could be misleading and result in the abuse and misuse of TCMs.
TCM theory
So, since so many Chinese medicines do contain toxins, how can TCM practitioners minimize their adverse effects and avoid harming patients?
Traditional medicinal theory has long held that the blending of several herbal ingredients will mitigate the toxicity of each of the substances, with methods to make toxic substances react with each other and thus dilute or decompose toxins.
China’s Food and Drug Administration stated in February of this year, “The fact that some Chinese medicines contain toxic substances cannot be automatically interpreted as displaying toxic side effects in their clinical application.”
Wei also stressed that when talking about the toxicity of Chinese medicines, the elements of the chemical compound, the dosage and the period of treatment are all to be taken into account. Simply declaring that a certain substance is poisonous can be misleading. He used the example of cinnabar, a commonly used but controversial mineral drug that can be toxic in high doses. “It’s an incomplete statement to say cinnabar is poisonous. The truth is that it will become harmful to humans in high and extended usage.”
For decades, the Chinese medical community has been trying to use modern Western medicine 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% of Chinese medicines do not have instructions for dosage or any toxicity analysis.
Many Chinese medicine practitioners believe, given the present situation, it will be a long time before authorities can provide a systematic analysis for all substances used in Chinese medicine.
But the effort continues, and at the national level three Chinese medicine safety evaluation centers and four TCM standardization clinical trial centers have been established in recent years. Newly created TCM drugs are required to satisfy the standards of a safety evaluation system before receiving regulatory approval and having safety guidelines developed.
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 concludes.
Lost business opportunity
However, the inability of Chinese products to meet the norms of modern medicine and assure its safety and pharmacology has left China behind on the international TCM market, a $30 billion annual business. Currently, Japanese and South Korean companies claim a 70% share, while China accounts for a mere 5%, mostly represented by raw herbal materials exported to Japan and South Korea.
According to Yuan Jinghua, an investment manager in the industry, China launches over 1,000 TCM products every year whereas Japan concentrates its efforts on clinical studies and meeting international standards.
Up to now Chinese TCMs rarely pass the certification of the U.S. Food and Drug Administration. Without certification it is impossible for them to be used as medicine and thus they are unrecognized by mainstream American medical institutions.
Britain was the first European country to set up proper legal regulation of TCMs, though the majority of TCMs are sold as “health products” or “natural plant foods” because it’s hard for them to pass the norms as drugs.
Shen Zhixiang, the President of the Chinese Folk Medicine Research Association, told Caixin: “In reference to safety and effectiveness, Chinese TCM companies have given neither enough effort nor funding.” He reckons that apart from national research projects led by the government, the industry itself has to enhance the required studies. Only when the fundamental work of TCM pharmacology and toxicity studies are straightened out will the business opportunity prosper.
