On the Finding That Over 80% of Substandard-Drug Samples Are Chinese Materia Medica

On July 13, the Zhejiang Provincial Food and Drug Administration issued Drug Quality Announcement No. 4 of 2019, reporting that 51 batches of drugs had failed sampling. According to the announcement, more than 80% of the substandard drugs were Chinese materia medica; both Chinese herbal decoction pieces and finished patent Chinese medicines contained large numbers of failing products.

If you search Baidu for the historical drug-quality announcements of the National Food and Drug Administration (CFDA), almost every year's figures show that over 80% of substandard drugs are Chinese materia medica.

In 2017, 82% of substandard drugs were Chinese materia medica. In 2018 the substandard drugs were concentrated among Chinese medicinal materials, finished Chinese patent medicines, and chemical drugs: 2,385 failing batches of Chinese medicinal materials, accounting for 72.98%; 613 failing batches of Chinese patent medicines, accounting for 18.76%; and 253 failing batches of chemical drugs, accounting for 7.74%.

Chinese medicine, with a history of two to three thousand years, has long been an important aid to the health care and treatment of China's residents. The recurring drug-quality problems cannot be ignored. Treating patients with substandard medicinal materials not only fails to solve their problems but may actually harm their bodies.

For a long time the erroneous belief, widespread among China's residents, that Chinese herbs have no side effects has also led many patients and their families to abuse Chinese medicine without ever consulting a TCM physician in person; some have suffered serious consequences.

The renowned TCM educator Professor Zhang Tingmo once called on everyone to adopt the view that "Chinese herbs have toxicity—use them without causing harm." Yet, regrettably, one can still turn on the television and easily be brainwashed by commercials proclaiming "pure Chinese medicine preparation, with absolutely no toxic side effects."

Ordinary Chinese residents have almost no concept of the serious consequences of misusing Chinese medicine. Besides the abuse of antibiotics, our residents also heavily abuse Chinese herbs. Every year I see many patients who have suffered serious harm from Chinese herbs, acupuncture, and moxibustion.

According to China News Service, Dr. Yang Zhiyin, chair of the Behavioral Medicine Branch of the Chinese Medical Association, stated that of the 50 million hospitalized patients in China each year, 2.5 million are admitted because of improper drug use. In addition, the number of patients in China who die each year from improper drug use is around 200,000.

Medication safety bears on every patient's right to life and health. I often meet patients I have never seen, who demand that I prescribe treatment for them over WeChat. Even though a considerable number of them have diseases I am not familiar with, they still demand that, out of "the benevolent heart of a physician," I write them a prescription. No amount of explaining that this is unsafe helps; many take such explanation as an excuse. I of course refuse, because once a medical accident occurs I will be in serious trouble.

As for the enquirers who again and again morally coerce me to act with "the benevolent heart of a physician," I generally just delete them. Though many of them, failing to understand, hurl abuse at me, I can only endure it, answer no abuse with abuse, and get away from them to let the matter rest. Compared with the risk of criminal liability after a medical accident, I would rather put up with a few curses.

Although I can understand that some patients, urgently wanting to solve their problems, will abuse drugs, gamble with their own health, skip even the most basic diagnostic procedures, and take medicine directly or have someone prescribe for them, I am unwilling to pander to such irrational behavior, nor am I willing to stake my own life and livelihood on performing for them the "benevolent physician" of their imagination.

Improper drug use is unsafe; Chinese medicine is not harmless either. Especially with today's herbs—so many of them substandard—abuse is all the more harmful.

As far as I know, many effective TCM formulas, if prepared with top-grade materials from the wholesale market, would cost several times the current retail price of the patent medicines made by many manufacturers.

Take Chuanbei (Fritillary): if the finest Song Fritillary were used, the selling price of the great majority of patent medicines containing it would be below cost. The reason so many patent medicines can be sold cheaply is that in manufacture they use only inferior rejects and scrap, corner-cutting materials.

When I treat my own family, the same formula, if I personally buy good-quality herbs, is very effective; but buying the finished products made by some patent-medicine manufacturers is ineffective.

Sometimes with the very same prescription, because Patient A and Patient B source their herbs through different channels, the therapeutic effect differs dramatically. Some patients who buy herbs from cheap pharmacies even experience no small side effects after taking them.

The lack of unified standards and effective management for Chinese materia medica is an awkward problem facing TCM. Without unified standards and effective management, it is hard to guarantee either the efficacy or the safety of TCM treatment.

Many patients trust me and leave the screening of medicinal materials to me. But honestly, I am not an old-time master herbalist, and it is hard for me either to judge the quality of materials. The only thing I can do is help them, as far as possible, choose herbs from the pharmacies with the best reputation.

On the other hand, certain old-fashioned ideas remain widespread among our residents, leaving many people knowing very little about the toxic side effects of specific Chinese herbs.

For instance, Chinese people generally believe that Heshouwu (Fallopia multiflora / Polygonum multiflorum) is a tonic with no toxic side effects whatsoever. But since the UK's MHRA first issued a warning in 2006 about Heshouwu causing liver injury, more than 150 cases of Heshouwu-induced liver damage have been reported at home and abroad.

Some patients have even died from improper use of Heshouwu; not long ago there was a news report of a woman who died from it and whose family sued the prescribing physician.

Many Chinese hold an unshakable superstition toward the ancient classics. Yet even in such materia-medica classics as the Shennong Bencao Jing, the Leigong Paozhi Lun, and the Bencao Gangmu, there are no few errors that should not be underestimated. A number of violent poisons—such as mercury preparations and Maqianzi (Strychnos nux-vomica)—are labeled in these works as non-toxic.

And Xixin (Asarum), used in large quantities in Zhang Zhongjing's classical formulas, has been shown by modern toxicological experiments indeed to be strongly carcinogenic; over 80% of experimental mice developed liver cancer from Xixin.

Some widely circulating folk remedies have also harmed many people. Banzhilian (Scutellaria barbata), for example, is hepatotoxic; yet many cancer patients and their families, unaware of this, abuse a folk anticancer pair of Baihuasheshecao (Hedyotis diffusa) and Banzhilian long-term without pairing it with any liver-protecting herb, so that some patients develop serious liver damage.

Many patients or families use so-called folk remedies to treat themselves or their relatives; although the remedy seems to solve one problem, it brings on other, more serious ones. This kind of trade-one-problem-for-another drug abuse is frightening.

There are always people attacking modern TCM education and the new TCM textbooks, scorning modern TCM training as too "Westernized" and claiming TCM should return to the "classics." What they fail to realize is that it is precisely modern pharmacological and toxicological knowledge that has prevented countless casualties.

TCM should move with the times rather than rest on its laurels. It was precisely with the help of modern pharmacology that Professor Tu Youyou discovered artemisinin and saved millions of lives—something no TCM physician in history, ancient or modern, has ever achieved.

Pointing out these obvious errors easily invites attacks from some people. Once many people fall in love with TCM, they disregard these basic facts and allow no one to voice criticism. For TCM to advance, it cannot close its eyes to such problems.

For TCM to develop healthily, questioning of the facts of Chinese medicine—including its classics and the toxic side effects of its herbs—must be permitted. Only by constantly verifying and improving through questioning can we better serve patients.

Medicine is a practical science; the people most frightening are those who, having learned a little theory, fight paper battles and imagine every disease under heaven is easy to cure. Medicine is too special a field because lives are at stake; I dread dealing with people who disregard facts and talk glibly about medicine. I think it would actually be a public service if such people studied medicine and treated themselves to death.

Genuine clinical TCM practitioners should treat medication safety as the top priority of their work. Because unsafe medication makes patients unsafe, and unsafe patients leave the physician's own safety unprotected.

Times have changed; in today's social environment, a physician who does not take medication safety seriously is gambling with both his patients' lives and his own.