JUNJIE WU
Protect Chinese Medicine, or Destroy Chinese Medicine?
Chinese medicine policy, the root cause of the dilemma faced by TCM
For Huaguo Cui and his wife, The spring festival of 2016 meant unbearable agony.

As farmers, they sacrificed a lot to support their son Fei Cui to go to school. In 2015, just before Fei Cui graduated from university, he went to Anhui Jing'an Hospital for his hair loss - it will be helpful to find a good job if his hair loss can be cured. The doctor prescribed him in total 1840g raw Polygonum multiflorum Thunb (PMT, also known as Fo-Ti Root) and 840g processed Polygonum multiflorum Thunb. After that, because the problem of hair loss still bothered him, he went to another hospital and took another 220g processed PMT again.

On 26th August 2015, during the pre-employment physical examination, Fei Cui was diagnosed as liver damage. On 1st September, he was diagnosed as drug-induced liver failure. On 31st December, Fei Cui died of liver failure. In order to save Fei Cui, his family already borrowed nearly a million yuan. It was extremely hard for his poor parents to bear such a blow of losing their son.

However, even after media coverage of Fei Cui's case, the danger of taking PMT still hasn't drawn people's attention. It is still common to see patients suffering from liver damage because of taking PMT. For example, In 2015, in another case, Mr. Guo's blood lead level rose to 767 micrograms per liter, which was serious poisoning after he took a kind of Chinese herbal medicine "black hair cream", which contains PMT and cinnabar (cinnabar's chemical composition is mainly Mercury Sulfide, which could cause mercury poisoning). But all these poisonous herbs can be produced, sold and bought directly in China, anyone can have direct access to them, without any limit.
Frequent accidents in traditional Chinese medicine treatment
Similar accidents of traditional Chinese medicine (TCM) poisoning are not just limited to the PMT. According to the National Annual Report on Adverse Drug Reaction Monitoring issued by National Center for ADR Monitoring (China) and Center for Drug Reevaluation (NMPA), in 2017, there were 252,931 cases of TCM adverse reaction. (Annual reports for the year 2018 & 2019 have not been published yet.) TCM poisoning cases also have been frequently reported by news recently.

In media coverage, hardly is the phenomenon of frequent accidents in TCM treatment ever linked to the criticism of the current TCM system. "Be careful when you use TCM because some herbs are poisonous" — that's the only stance in the article that reported Mr Guo's case. In another case in which a woman was poisoned by a prescribed Chinese medicine, news article claimed that it's because "as a poisonous herb, Rhizoma Typhonii must be decocted for more than two hours, but the patient only boiled it for one hour".

This is actually the mainstream attitudes Chinese news media take when it comes to TCM poisoning cases. "some herbs are poisonous originally", "Chinese medicine should be decocted for enough time to avoid being poisoned" are their two major arguments. In some cases, it is claimed that it is doctors' fault to prescribe too much portion of some poisoned herbs to patients.

However, none of these previous articles has thrown light on the current TCM policy in China, which has dramatically lowered the standard for doctor's registration and assessment, and the standard of Chinese medicine's quality. This system has been deemed as a way to protect the legacy of traditional Chinese medicine culture and to reinforce Chinese soft power, but is that true?
Poor reputation abroad: the dilemma of traditional Chinese medicine
Against the intensive domestic promotion of TCM in China, the international world doesn't give traditional Chinese medicine the same treatment.

For example, most Chinese herbal medicine marketed in the United States can only be sold as dietary supplements. According to the reaction of the European market, Chinese herbal medicine exported to foreign markets is often criticized for health safety issues such as pesticide residues. Take PMT mentioned before as an example, Canada, the United Kingdom and Australia have introduced policies to limit the use of PMT. In 2006, the British Medicines and Health Products Administration (MHRA) also blocked the import of PMT after receiving reports of liver damage caused by it.

Anne Zachariasen, an acupuncturist in Denmark described the awkward situation of TCM: "In 2011, the EU banned the import of TCM herbal patent products due to quality issues. Some people in Holland had been poisoned by too many heavy metals in some herb products, and the pill form containing many different herbs made it too troublesome to control the contents of these medicines."
The more, the better? — How the current Chinese medicine system has impeded TCM development
The Chinese government has been always supporting the development of TCM, it is not only because TCM is part of Chinese traditional culture, but also because promoting TCM is regarded as a way to reinforce Chinese soft power.

On 1st July 2017, Chinese Medicine Law of the People's Republic of China ("Chinese Medicine Law") was officially implemented. The law is aimed at strengthening the inheritance of TCM and promoting international communication, mainly by expanding the scale of TCM hospitals and increasing the number of TCM doctors. According to Xiaofeng Ran, the team leader of the Chinese Medicines Group of the National Pharmacopoeia, the current problem of TCM is "the number of TCM hospitals is far less than that of Western hospitals, as well as the number of TCM doctors". Therefore, "the more, the better" became the main idea behind the Chinese medicine law.

However, facing the awkward dilemma of TCM mentioned above, will the current TCM policy be a panacea, or a placebo, or just a poison that will impede the long-term scientific development of traditional Chinese medicine?
Defective TCM doctor registration policy
In terms of TCM doctor registration, according to the Law, "the person who learns TCM in a teacher-study manner or who have practised for years, has expertise in medical skills, recommended by at least two doctors, and has passed the assessment of practical skills, can get the qualification of TCM practitioner." Regarding the filing of the clinic, according to the law, "when holding a TCM clinic," the applicant only needs to "report the name, address, the scope of treatment, and staffing to the local department of TCM at the county level".

This means the Chinese government has made it easier to become a doctor and open hospitals of TCM. Since July 2017, students studying traditional medicine no longer need to pass the national medical exams. Instead, they can just attend apprenticeship training and pass a skill test. And, practitioners who want to open a clinic no longer need approval and reviews from the China Food and Drug Administration (CFDA), they only need to register with the authority.
The low standard of TCM medicine production — the lack of Chinese medicine scientific clinic test & adverse reaction instructions
When it comes to the production of medicine, according to the law, "for TCM compound preparations directly from the ancient TCM classics, when applying for drug approval number, the producer only needs to provide non-clinical safety research materials". In October 2017, CFDA also issued a regulation that traditional medicines can skip clinic trials as long as manufacturers prepare ingredients using essentially the same method as in classic Chinese formulations.

This means, production of any medicine from the ancient TCM classics doesn't have to submit relevant data like samples of quality indicators, pharmacological and toxicological test results, and clinical trial — Chinese medicine system advocates that since these medicines have been recorded in classics for many years, there's no need to test them any more. Clinical-testing requirements for TCM that are made according to classical recipes will be totally scrapped.

Due to the lack of scientific clinic test data, usually, in the instructions for proprietary Chinese medicines, both "adverse reactions" and "contraindication" can be marked as "NOT YET CLEAR". Compared to hundreds of words of the "adverse reactions" and "contraindication" in Western medicine manuals, Chinese medicines can easily make people misunderstand that there are no adverse reactions and contraindications — which is obviously not the truth.

The new policy has raised the question of safety issues. The minimizing clinical-trial requirements could put more patients at risk. One example is that, on 23rd September 2017, the CFDA recalled batches of two injectable TCM after about ten people fell ill with fevers and chills. According to statistics, more than 60% of Chinese medicine products rejected by importing countries are due to "heavy metals and pesticide residues". Some researchers claim that "For TCM to gain international legitimacy, its practitioners will have to isolate compounds and subject them to academic studies and regulatory approvals in countries where research and approval standards are high. China, with its corrupt FDA and culture of academic misconduct, doesn't qualify."

With the lack of scientific clinic test and instructions of adverse reactions, it is fair to say that the Chinese Medicine Law is a backwards step for the Chinese medicine system. The law will make it more difficult for Chinese medicine to squeeze in the international market. Only controlled, the scientific clinical test can meet the international standard — this has already been proved by Japan's Kampo medicine.
Strict quality control: what can we learn from Japan's Kampo medicine
Kampo, literally meaning "Han (Chinese) medicine", has developed rapidly in Japan on the basis of TCM. In 2001, China's TCM exports amounted to 560 million US dollars, accounting for only 3.6% of the international market total of 16 billion US dollars. In 2015, this ratio has dropped to 2%. On the contrary, according to Chinese Herbal Medicine, Japan's Kampo medicine has accounted for 90% of the world's TCM market.

What Japan has been doing could be a model for China to learn from. In the late 1980s, Japan has already promulgated the quality management regulations for the production of Kampo medicine, as well as regulations for the cultivation of medicinal materials, requiring that chemical fertilizers and pesticides should be avoided in the production process. Standardization is a distinctive feature of Kampo medicine, which makes it easy for Kampo medicine to be accepted by the international market. For example, with scientific clinic test, Kampo medicine developed traditional Chinese medicine "Six Shen Pills" into "Jiuxin Pills", which annual export has exceeded 100 million US dollars.

Aimu Ishimaru is a student coming from Japan. She described the difference between Kampo medicine (漢方) and Chinese medicine(中医薬 Chūiyaku) in Japan: "In Japan, Chūiyaku isn't covered by insurance, so usually quite expensive. My aunt is taking Kampo to control her weight and it's working very well. Kampo is popular in Japan. I think there has been scientific proof that Kampo works as well. I mean, I don't think it'll be covered by health insurance otherwise. And I guess the proof of scientific research on Chūiyaku is not as established as Kampo in Japan. That's probably the reason why Chūiyaku isn't covered by the insurance. "

Manfred Porkert, director of the Institute of East Asian Studies at the University of Munich, said that China has never been serious about improving its own tradition: "TCM has never received proper cultural status, nor have the necessary epistemological research and rational scientific inquiries been carried out to establish its traditional scientific status." Ryuta Fujii, president of Ryukakusan Co. said that "Japanese-produced herbal medicines have achieved considerable technical progress".
Defective traditional Chinese medicine system — what should we expect in the future?
Fei Cui's parents are still in great sorrow, even it's already been almost three years since their son passed away. Nowadays, whenever they hear people talk about "liver damage" "Fo-Ti Root" or even just "hair loss", they still can't help but burst into tears.

For Mr Guo, his blood lead poisoning is still severe, his doctor said that it will take at least 20 years for detoxification of poison in his body.

There are still a lot of tragedies like this being reported frequently. The Chinese government is proud of the current TCM system based on Chinese Medicine Law. Chinese news media vigorously promote the implement of Chinese Medicine Law, claiming it "reflects the concern and support of the Party and the State for Chinese medicine. The legislation will further promote the improvement of national health and further promote the development of the entire industry". But, the implement of Chinese Medicine Law didn't seem to save the reputation of traditional Chinese medicine: there were 98,770 cases of TCM adverse reaction in 2016, in 2017, this number has soared to 252,931; the number of serious adverse reaction cases of TCM also rose from 6,857 in 2016 to 17,066 in 2017.

The idea of "the more, the better" behind the current policy is not the way to improve TCM — the ignorance of scientific test and quality control for both doctor registration and medicine production has caused a lot of medical accidents. While western medicine system has been emphasizing the evidence-backed use of medicine which demands rigorous clinical trials, China, however, is moving in the opposite direction.

And now, it's the time to reexamine the defects in the current TCM system.

Just like Professor Zhongzhi Qian, the chief scientist of the National Pharmacopoeia Commission has said, the traditional Chinese medicine needs to be interpreted by modern science. Only the scientific verification can accomplish the task of inheritance of TCM, as well as the innovation of TCM. It is necessary to come up with a set of rules that conform to the scientific standard to improve traditional Chinese medicine.

With the establishment of a more scientific, stable, and controllable quality control system and evaluation system, maybe we can expect a more effective, safe and valuable future of traditional Chinese medicine in China.
Junjie Wu
China
Junjie Wu used to work for Global People Magazine and Children's Literature Magazine in China. Before that, she completed her Master's of Law and Bachelor's of Arts at China University of Political Science and Law, then interned at the Journal of Literature and Art in Beijing. As a Journalism student, transnational cultural communication, cultural pluralism in the era of social media, identity and community construction in an ever-progressing global context have been at the core of her learning. Junjie will be studying Media across Cultures at the University of Hamburg, as a part of MA in Journalism, Media and Globalization.
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