by Dr. Lyren Chiu

The Food and Drug Act has not been revised for 50 years. Yet with no consultation, the government proposed Bill C-51 to amend the Food and Drug Act, which passed the first reading in Canadian Parliament on April 8, 2008, and moved to the second reading on April 28. On May 21, the Traditional Chinese Medicine (TCM) community in BC formed a provincial coalition to oppose Bill C-51 and on July 15, a national coalition against the Bill was formed, which would also address the amendment to Bill C-51 that dismissed TCM under the “Natural Health Product Category.”

Why does the TCM community want to oppose Bill C-51? The TCM community respects the government’s intention to regulate TCM for the purpose of public safety and hopes the government will demonstrate an equal amount of respect and recognition of traditional culture and the needs of multicultural communities. And like the government, the newly formed coalition, which represents the interests of the TCM community, also wants to ensure the longevity of our public healthcare system and people’s freedom to choose.

In its present form, Bill C-51 does not protect TCM; it prohibits it. It requires that TCM comply with the measures for drug standards, which are inappropriate for holistic comprehensive medicines like TCM. According to Bill C-51, safety is determined by benefits that outweigh the risks and the benefits are determined by efficacy. In turn, according to the Bill, efficacy is determined by clinical trial, which is the wrong measure to use with TCM.

TCM is a comprehensive and rigorous medical system, with a recorded materia medica, differing in many ways from that of Western medicine. Specifically, it is a holistic approach for diagnosis and treatment, with the emphasis on prevention and harmony of body, mind and spirit. TCM and Western medicine have fundamental differences in their philosophies and concepts and both approaches must utilize their own methods in proving that a particular treatment is safe.

In brief, Western medicine focuses on disease, which is believed to be caused by pathogens, and designs drugs that will target those pathogens to effect a cure. In contrast, TCM focuses on prevention and restoration, with the belief that disease is the result of an imbalanced system.

TCM is not based on the premise that all pathogens must be eradicated; some pathogens, in fact, may co-exist with the human body. According to TCM, pathogens may grow when one suffers a loss of body vitality or experiences psychological or spiritual despair. Factors such as one’s emotional state, the external environment and one’s body constitution and lifestyle (i.e., exercise, diet, work, sex, unexpected events, etc.) can affect the balance of the system and the continuum of health and illness. Medications used in TCM are designed to restore the balance by interacting with targets other than pathogens, and the efficacy of the medicines depends on the characteristics of complex mixtures of herbs.

TCM operates within an open, dynamic system. The diagnosis and treatment process is complex and takes into account ever-changing conditions. Consequently, a homogeneous patient group in Western medicine may be seen as a heterogeneous group in TCM. For example, a prescription for an herbal treatment may require modification every few days, to manage the changing nature of the conditions. Standardization is not an option.

Typically, TCM uses herbs in combination, with one or more herbs neutralizing the toxic compounds from the other herbs, to achieve a synergistic effect to cure the disease in question: The principal ingredient of the mixture is a substance that provides the main therapeutic force, and the secondary ingredient enhances or assists the therapeutic action of the first. The remainder of the ingredients serve various functions, such as treating accompanying symptoms, moderating the harshness or toxicity of the primary ingredient, guiding the medicine to the proper organs or exerting a harmonizing effect. How individual herbs might be able to pass “scientific scrutiny” (i.e., clinical trial) represents a challenge for the profession. And how such treatments could be quantitatively researched represents yet another challenge.

Bill C-51 is adapted to the view of science as it is concerned with empirical truth, measurement and rigour, while striving towards standards of reliability and validity. Bill C-51 also suggests that one set of criteria (i.e., reliability, validity and trustworthiness) can be applied to all forms of scientific research and that clinical trial can serve as the sole evidence for a treatment’s efficacy.

Only a small number of researchers with backgrounds in complementary and conventional medicine recognize the intrinsic difficulties and limitations in using conventional research methods to assess the efficacy and safety of TCM. These authorities argue in favour of developing appropriate, rigorous and systematic evaluation methods to augment Western clinical trials. For example, to assess TCM, Whole Systems Research was suggested as a useful tool.

In Whole Systems Research, the goal is to design a system representative of the “real world,” where patient-centred outcomes, patient-practitioner interaction and diagnosis and treatment feedback are assessed. The focus on individualization vs. standardization is a crucial element of the design. Another aspect of the system includes both Western and TCM diagnoses. The method stems from a neorealist point of view, which interprets truth as “…the extent to which an account accurately represents the social phenomena to which it refers.” While this method fails to completely capture the essence of TCM in complicated research designs, it can be considered a good start.

Various types of evidence can be used to support TCM, including research evidence, clinical experiences and patient preference. The fact that TCM has been clinically tested and well documented for thousands of years must be taken into account. Furthermore, the TCM profession should develop methodologies that fit with its theory and complex mechanisms and the government should provide funding for such research.

Whether or not the same structural standards used in Western medicine can be applied to TCM should be determined on the basis of fair measurement and if the system of medicine can maintain or improve the quality of care. To develop an up-to-date policy for regulation, a responsible government must use fair methods, rather than simply increasing the penalties and giving the prosecuting inspectors more power. If the government lacks the confidence or knowledge to adequately regulate TCM, delegating power to less knowledgeable or inexperienced inspectors is not the best approach.

By using one worldview to oppress and discriminate against another, the government is acting irresponsibly. Bill C-51 is attempting to marginalize TCM, and as a consequence, a new Canadian regulatory system is now required to apply appropriate and fair criteria to regulate it.

Dr. Lyren Chiu is an academic researcher specializing in Traditional Chinese Medicine (TCM), and she acts on behalf of the interests of the TCM community. For information about a national coalition against Bill C-51, see www.acoalitionagainstbillc51.com