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 governments 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 peoples 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
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 ones emotional state, the external environment and ones
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 treatments 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
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