Ethics in Modern Practice of Traditional Chinese Medicine (TCM). Claims of Efficacy and Safety
Part III. Claims of efficacy and safety
Principle: Educators, researchers, and practitioners must relay honest, carefully considered, educated assessments of efficacy and safety when describing the services and treatments in a setting where TCM is offered.
Problem: Frequently, claims of success are made on the basis of cursory observations and by relaying information from sources that have not been properly scrutinized. Assurances of safety are sometimes given on a theoretical basis rather than from consulting the evidence. As a result, potential and existing users of TCM services may be misled, with impact on their financial expenditures and time commitments. It is not in the interest of patients to rely on uninformed or inadequately informed decision-making for determining their health care priorities.
a) As a traditional medicine system, TCM developed over the centuries under the influences of the culture and historical experiences of China. Prior to the 20th century, no systematic method of determining therapeutic efficacy and safety existed. Highly acclaimed texts of Chinese medicine typically described which therapies (e.g., acupuncture points, herbs or herbal formulas) were indicated for certain disease conditions, but did not give information about their efficacy. Sometimes, suggestions were made for a next step in the therapeutic process if the treatment failed or if an adverse consequence occurred. During the first half of the 20th century, laboratory research was conducted on active components of Chinese herbs, and some evidence was gained to indicate that pharmacological activity of the herb or one or more components correlated with traditional therapeutic claims. However, the large gap between laboratory work and detailed study of human clinical applications was not bridged. During the second half of the 20th century, many thousands of studies were carried out in China, examining the full array of TCM modalities, including acupuncture, massage, moxibustion, qi gong, and herbal formulae (orally consumed, topical, injection, and other routes). It has been demonstrated by careful evaluation of the published reports, that virtually all such studies were conducted with inadequate techniques and that the stated results were not reliable (Dharmananda 1997a). Therefore, few of the conclusions of efficacy derived from the vast collection of Chinese medical reports during this period can be utilized to make statements about Chinese medicine. At the beginning of the 21st century, efforts are being made to correct this situation, but success in this area has been limited. Thus, reliable information about efficacy is still difficult to obtain.
b) Patients have the need to make rational decisions about their health care. Health care costs are spiralling upward, not just for standard medicine, but also for various natural, alternative, and complementary health care methods. Expenditures for even minimal TCM intervention over one month, such as an initial office visit and a few follow-up visits plus cost of herbs and other supplements, can involve hundreds of dollars. Time commitments for TCM therapies (including transportation to and from a practitioner office) can involve several hours per month (Dharmananda 2003). Sometimes decisions must be made by patients, such as whether to schedule undesirable therapies, such as surgery, or to initiate a drug therapy which would otherwise be avoided, that will depend on the potential for success of TCM methods. In order to make rational decisions, patients must have a reasonable estimate of costs, time, therapeutic efficacy, and risks involved with TCM.
c) The field of TCM is still in its infancy in the West, leaving it vulnerable to negative impressions. For example, in the U.S., there was little access to TCM just 30 years ago; not all states in the country have provision for licensing practitioners; and the total number of licensed practitioners is relatively small; there are 40 medical doctors for every licensed acupuncturist in the U.S. Similar conditions prevail in Europe and other regions where TCM was introduced in the 20th Century. Therefore, the reputation of TCM is still uncertain. False claims of efficacy and safety, even when made by a relatively small number of practitioners, can impose a heavy burden on the profession by conveying a negative impression.
While all false or exaggerated claims are potentially harmful, the ones that are especially damaging are those whereby it is claimed that a disease which is not known to be curable can be cured, perhaps even easily cured. This has been done, for example, with cases of cancer, autoimmune diseases, and neurodegenerative diseases. There are a number of reasons why a person makes such a claim and the basis for such actions today runs parallel to causes that have been the basis of cautionary advice in the past. Huai Yuan, a Qing Dynasty medical ethisist, wrote a warning to physicians of his day, in a book dating from 1808 (Unschuld 1979), addressing this issue under the heading “decisions.” Although he talks about accepting or rejecting the patient who can not be cured, the discussion can be adapted to the current situation. He makes the clear point about the necessity for an honest assessment:
“If I am faced with the case of a disease which cannot be cured under any circumstances, and I attempt to save the patient in spite of this fact, I must have accumulated knowledge in regard to the “middle” [that is, the affairs of men] and experience with similar cases in the past. Yet, when I examine the results of my attempts at saving, I will come to the conclusion that it does not correspond to my expectations. There was, in fact, no other possibility. Is it not better to decide immediately in such hopeless cases to give up the case? Two reasons are responsible for such decisions not being made. For one thing, the emotional ties with relatives play a part. Because one can not bear their loss, one thinks up a hundred plans to protect them, in the hope that ultimately one will fortunately lead to success. Yet, thereby the physician merely causes the patient to become angry. The second reason for reluctance quickly to reject the treatment of an incurable case lies in the hope of great profit. In such cases magnanimous words are to cover everything, until chance will perhaps bring about a success. Yet, thereby, a physician attracts only slander. Therefore, if in a situation of danger the physician has clearly recognized the course of the phenomena, he should preferably make the decision early not to treat, and not worry about profits and emotional ties.”
This statement is quite rich in teachings about ethical behaviour, so it will be analyzed further here. It should not be taken from this passage that a person who can not be cured of their disease or whose life can not be saved by the practitioner should simply be turned away; instead, it is important not to entice the patient or falsely proclaim to the patient that the offered services will yield results that can not properly be promised. It is clear from Yuan’s discourse that making the claim that one can cure this person is unethical. The guidelines for accepting a patient with such an incurable condition are given: the first is to have accumulated knowledge—and this would imply also wisdom, spiritual discipline, intensive study, and dedication to practice—that prepares one to guide the person through this difficult medical situation in an entirely open and honest manner. And, one has to have sufficient experience with cases of similar nature to be able to understand and explain the process, without deception. In the absence of such qualities, the patient should either be referred to someone who possesses them or should be offered only the limited palliative care that can be reasonably claimed and provided at an expense that is appropriately restricted.
There are situations where practitioners may make claims that are not within these bounds due to cursory analysis of their own experiences. Thus, there are many instances where a patient with an incurable disease will come for treatment and express gratitude for the offering and describe a certain alleviation of symptoms. This may be interpreted as success in treatment of the disease by the practitioner (and it represents a type of success). But, if the patient stops coming for treatment because the benefits have not been sufficient or because they become too debilitated, and then their disease progresses and/or they succumb to it, any claims of success must be greatly tempered. If the practitioner does not take time to learn about this end result, and consider it in the prognosis to be given to the next patient, then any positive rendition of the treatment is dishonest by virtue of the failure to examine the case fully. Indeed, when people have claimed to cure cancer with various natural and alternative remedies, those who sought to actually follow-up the results find the patients were not cured. In some instances, a patient may be “diagnosed” with the cancer by an alternative method that is not recognized anywhere else as being valid, and then similarly proclaim a “cure,” but such self-contained situations are not of value in evaluating the outcomes. It is essential that practitioners learn to detect unsupported claims in the literature (Dharmananda 2000a) and how to avoid making such claims themselves. As an example of bizarre methods of interpreting cases that have been utilized, I was contacted by a practitioner who claimed to have cured a patient of cancer, and in response I pressed for details. It turned out that the patient had undergone standard medical therapies, including chemotherapy, as well as pursuing the alternative treatment. When asked why this practitioner determined that the therapy he had provided was the successful one and not the medical treatment, I was told [paraphrasing]: “Chemotherapy never works; cancer can only be cured by natural means.” By refusing to look at the entire picture, practitioners can become convinced that they do have experience of successful treatment. Only when a patient is given an honest assessment, such as: “symptoms may be alleviated for a period of time, but that there is not evidence for a cure,” will the patient be in a good position to make a judgement about how to proceed.
Huai Yuan gives two reasons that practitioners end up deceiving the patients. One is the emotional response to the plight of the patient and, especially, the patient’s relatives who are desperately seeking to save their loved one. Out of sympathy for them, one shrinks away from the bad prognosis and instead wishes to offer hope. However, false hope is not what they seek, and the failure to gain ultimate success can lead to anger, by the patient, and by the relatives; at other times, they may feel sorry for the practitioner who seems to be a victim of the failure as well. At risk though, is the fact that the practitioner, who had been viewed as a saviour, may now be seen instead as a fraud, and the field of medicine he/she practices may be deemed a sham even if it has legitimate applications. The other reason for making untenable claims is the simple self-serving desire to gain patients, retain patients, and hope to have a success that will bring more fame. The services are rendered, the money is collected, but the result is that the practitioner and the profession become open to slander. One need not quash all hopes of benefits in order to give a reasonable description that includes the expected limitations of treatment.
Unfortunately, a too common response to this ethical issue is for practitioners to speak only among themselves and discuss the closed-mindedness of those who question their claims, actions, and motives, while bolstering one another’s impression of competence and assuredness in success. This approach is contrary to that recommended by the majority of practitioners, which is to work in conjunction with the modern medical profession and bring the standards of TCM research and practice to acceptable levels. Making valid claims should be the goal of all.
Chen Keji, one of the leading international proponents of TCM and its integration with modern medicine observed: “the evaluation of efficacy [for TCM] should seek truth from facts, should stand up to current international criteria” (Chen 2002). He also notes that with all its benefits, “TCM fails to provide cure from many diseases.” (Chen 2005). These views, expressed by a spokesperson for this field, are consistent with the need for an honest assessment, as opposed to claims that lack a firm basis. By acknowledging the limitations in prior studies and the limitations of TCM for certain diseases, he is not withdrawing support for TCM; rather, he is calling for a strengthening of this traditional medical system and for its integration with the rapidly developing modern medical system. .
Learning from prior examples
In an attempt to demonstrate how claims that turn out to be unjustified develop and persist, I had written about the example of a purported cancer cure known as laetrile (Dharmananda 2000b). It is worth mentioning this failed therapy in this context of discussing Chinese medicine for a couple of reasons. First, when Chinese medicine was becoming popularized in the U.S. several proponents of laetrile treatment contacted me with the hope of confirming their story with examples of traditional use in China. Laetrile (amygdalin) is an apricot seed derivative, and apricot seed (kuxingren) has been used in China for 2,000 years. It turned out that Chinese historical use of the herb was mainly focused on treatment of cough (e.g., in asthma, bronchitis, influenza) and secondarily for constipation (as a source of lubricating oil), but there was not mention of treatment of cancer. Second, a recent flurry of interest developed over the proclaimed anticancer activity of artemisinin and artesunate, a modified active component, from a Chinese herb used for malaria: qinghao. The pattern of development of the claims is similar to that which occurred with Laetrile, even the proposed mode of action is parallel. This story of this remedy has spread among some practitioners of Chinese medicine without apparent concern for the veracity of the testing and claims. Yet, when I attempted to pin down the claims being made, many of which were difficult to believe, I was given no further details by the practitioners spreading them. The University of Washington (Seattle) where two workers in the bioengineering department had done some of the initial work and had not hesitated to make provocative claims, has found it necessary to make a disclaimer, such as this one they posted on their web site (2006 University of Washington):
“IMPORTANT NOTE: The Department of Bioengineering and University of Washington do not advocate the use of artemisinin to treat cancer. The US Food and Drug Administration does not currently approve the use of artemisinin for the treatment of any disease. Research on artemisinin and cancer is still in very early stages. Human use of artemisinin should be considered experimental and taking artemisinin or any other drug should be approached with extreme caution and responsibility.”
Another case that I wrote about was the claimed successful therapy for prostate cancer, PC-SPES, which was described as a combination of traditional Chinese herbs (Dharmananda 2002). Just days before PC-SPES was pulled from the market—because it was found to have a number of drugs in it—a medical doctor in New York City proclaimed in a national news interview that this was a successful natural treatment for prostate cancer. The mechanism of action of this formulation turned out to be a reliance on an estrogen analogue to temporarily shrink the prostate cancer, while utilizing a small does of warfarin to prevent clots due to estrogen therapy. Hormone therapy for prostate cancer is already widely used for limited benefits in modern medicine. A number of other cancer-related scams have come from China, including one based on a soy bean extract sold to unsuspecting patients for a very high cost (Dharmananda 2001).
The promulgation of false medical claims often follows from lack of critical thinking. Too often, proponents of natural therapies will immediately, and without question, disseminate information and hearsay about a therapy when a study is supportive, but will demand and pursue intensive investigation and debunking of any study that gives a negative result. For a negative study on herbs, questions about botanical identification, dosage, controls, statistical analysis, and interpretation of results are raised to help assure that the study is rejected; while for a positive study the benefits are merely explained in greater detail, or even elaborated with projections of broader usage. I have written about the problem of lack of critical thinking, which is a fault that must be laid primarily at the doorstep of the colleges that train practitioners and researchers, as well as the method of recruiting students (Dharmananda 1997b). While a large effort is given to teaching the acupuncture points and indications, herbs and their uses, little time is given to analyzing the information that is to be utilized, its source, and whether any claim is verified.
The other side
What has been discussed thus far is the problem of implying, confirming, or assuring efficacy of treatments when, in fact, the treatment may lack adequate evidence to support those statements. There is the other side of the ethical issue that is also quite important. If one does, in fact, have an efficacious remedy, a treatment that does not merely alleviate a minor problem but, for example, cures a disease thought to be incurable or difficult to cure, then there are responsibilities that fall to the person who has encountered or invented such a wonderful gift for humanity. A practitioner who has actually accomplished a medical feat, particularly something that is reproducible (that is, not just involving one extremely rare case), has the obligation of making a concerted effort to have the results verified and disseminated so that others suffering from the disease condition can benefit. It is not sufficient to simply say: “come to my clinic, and I will cure you,” restricting such a great potential benefit to a small group of those privileged to learn about and be able to access such a therapy or, worse, prolonging a false claim for personal aggrandizement.
During the Qing Dynasty, Xu Dachun wrote about this very issue, under the heading “On prescriptions that are kept secret,” saying (Unschuld 1990):
“The virtue of heaven and earth lies in their appreciation of life. The mind of the Sages is characterized by their devotion to the interests of the public. When the latter established prescriptions to cure an illness, they saw to it that these prescriptions became known to everyone throughout the world. To spread their knowledge has been the utmost desire of heaven and earth and of the Sages….Dishonest persons, who have nothing but profit in mind, falsely claim to possess secret prescriptions. They cheat the world and delude the masses.”
Once a person claims to be able to cure a disease that is normally incurable, or that is normally only curable by the most difficult and risky means, it becomes a duty to proceed to a next step. Today, that means something far more technical than merely making a simple disclosure and spreading it widely. Rather, the claim must be subjected to full scrutiny and spread by virtue of scientific support for the claim. There are patents and other means of protecting a reasonable financial interest in such discoveries, but there is no ethical basis to restrict access through keeping a therapy secret even from scientific scrutiny.
In this presentation, I have stuck to the discussion of the efficacy of treatment. However, the same concerns to issues of treatment safety, where unsupported claims of safety can be detrimental. A further discussion about safety of treatment is planned for a future article.
Resolution: It is essential that educators, practitioners, and proponents of Chinese medicine make the effort to critically challenge claims that are made—or that they wish to declare—about TCM efficacy and safety so that potential and current patients can be given accurate information and reasonable prognosis in order make decisions about their health care. It is essential that claims be subjected to rational evaluation and scientific scrutiny so that those treatments claimed and then proven effective can be spread widely to benefit mankind.
Chen, K. (2002), ‘The principle and practice of integrative Chinese and Western medicine’, Chinese Journal of Integrated Traditional and Western Medicine, 8(2): 82-84.
Chen, K. (2005). ‘Study of Chinese medicine—Which is after all the right way?’ Chinese Journal of Integrated Traditional and Western Medicine, 11(4): 241-242.
Dharmananda S. (1997a). Status of Chinese Medicine Research. Portland: ITM START Manuscripts
Dharmananda S. (1997b). Critical thinking for the natural healing profession. Portland: ITM START Manuscripts.
Dharmamanda S. (2000a). Analyzing claims in the literature. Portland: ITM START Manuscripts.
Dharmananda S. (2000b). The Lessons of Laetrile. Portland: ITM START Manuscripts.
Dharmamanda S. (2001). Questionable cancer therapies; the case of Haelen. Portland: ITM START Manuscripts.
Dharmamanda S. (2002). Questionable cancer therapies; PC-SPES and IP-6. Portland: ITM START Manuscripts.
Dharmamanda S. (2003). Restructuring American acupuncture practices. Portland: ITM START Manuscripts.
Unschuld, P. (1979). Medical Ethics in Imperial China. Berkeley: University of California Press.
Unschuld P. (1990). Forgotten Traditions of Ancient Chinese Medicine. Brookline: Paradigm Publications.
University of Washington. [online]. Available from: http://depts.washington.edu/bioe/about/news/artemisinin/artemisinin.html (Accessed December 2006).