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Herbal medicine research and global health: an ethical analysisJon C Tilburt a & Ted J Kaptchuk b
Abstract Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research.
Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical
framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated
dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social
value, scientific validity and favourable risk–benefit ratio. Significant challenges exist in determining shared concepts of social value,
scientific validity and favourable risk–benefit ratio across international research collaborations. However, we argue that collaborative
partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international
herbal medicine research can, and should be, resolved. By “cross-training” investigators, and investing in safety-monitoring
infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine
research that contributes to global health.
Bulletin of the World Health Organization 2008;86:594–599.
Une traduction en français de ce résumé figure à la fin de l’article. Al final del artículo se facilita una traducción al español. .الرتجمة العربية لهذه الخالصة يف نهاية النص الكامل لهذه املقالة
Introduction not faced in more conventional drug It is already widely used for immune
Traditional herbal medicines are development. boosting in AIDS. In vitro pharma-
naturally occurring, plant-derived As attention and public funding cokinetic studies suggest potential
substances with minimal or no industrial for international traditional herbal interference with vaccines, and animal
processing that have been used to treat medicine research collaborations models show liver toxicity at very high
illness within local or regional healing grows, more detailed analysis of ethical doses. There are no systemic side-effects
practices. Traditional herbal medicines issues in this research is warranted. reported for humans in the literature.
are getting significant attention in global Scant literature has addressed selected A few case series have shown mixed
health debates. In China, traditional issues such as informed consent and results. Local leaders are requesting the
herbal medicine played a prominent independent review related to tradi- government agency conduct a large,
role in the strategy to contain tional herbal medicine research.6,7 Here randomized controlled trial (RCT) of
and treat severe acute respiratory we apply a practical, comprehensive Africa Flower to test its efficacy as a
syndrome (SARS).1 Eighty per cent of and widely accepted ethical framework novel adjunctive therapy to slow pro-
African populations use some form to international traditional herbal gression to AIDS.
medicine research.8 We examine in de-
of traditional herbal medicine,2,3 and
the worldwide annual market for these
tail difficult questions related to social Ethical framework
value, scientific validity and favourable Cases like these present challenging
products approaches US$ 60 billion.2
risk–benefit ratio. We conclude with questions related to the role of traditional
Many hope traditional herbal medicine
implications for future research in this herbal medicines in public health.
research will play a critical role in
area, focusing on the importance of In general, international research on
global health. China, India, Nigeria,
collaborative partnership. traditional herbal medicines should be
the United States of America (USA)
and WHO have all made substantial subject to the same ethical requirements
research investments in traditional Case as all research related to human subjects.9
herbal medicines.2 Industry has also A government agency from a devel- An ethical framework previously
invested millions of US dollars looking oped country is conducting an HIV- outlined by Emanuel et al. and revised
for promising medicinal herbs and treatment trial in Africa. A traditional for international research 8 offers a useful
novel chemical compounds.4,5 This is herbal medicine, Africa Flower, has starting point for thinking about the
still a relatively modest investment been used for decades to treat wasting ethics of international traditional herbal
compared to the overall pharmaceutical symptoms associated with HIV. Local medicine research. This framework
industry; however, it raises interesting traditional medicine healers believe includes eight ethical requirements
ethical questions, some of which are Africa Flower is an effective antiviral. for clinical research (Table 1). 8
a
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, United States of America.
b
Osher Institute, Harvard Medical School, Boston, MA, USA.
Correspondence to Jon C Tilburt (e-mail: jontilburt@yahoo.com).
doi:10.2471/BLT.07.042820
(Submitted: 2 April 2007 – Revised version received: 2 October 2007– Accepted: 25 October 2007 )
594 Bulletin of the World Health Organization | August 2008, 86 (8)
, Special theme – Ethics public health
Jon C Tilburt & Ted J Kaptchuk Ethics and herbal medicine research
These ethical requirements are universal
Table 1. A comprehensive framework for research ethics
and comprehensive but must be adapted
to the particular social context in which
Ethical requirement Definition
the research is implemented.8 Of these,
fair subject selection, independent Collaborative Research leadership must include bilateral representation based
review, informed consent, and respect partnership on mutual respect between equal partners with community advice.
It includes a responsibility to invest in the scientific training and
for enrolled subjects have been discussed
capacity-building for ongoing research in a host country where such
previously in the literature on the resources are not well developed.
ethics of global health research and
raise few issues unique to international Social value Knowledge gained from the research should have the potential to
lead to new generalizable knowledge or improvements in health.
traditional herbal medicine research.8 Partners should specify in advance to whom benefits will accrue and
However, social value, scientific validity, in what way.
and favourable risk–benefit ratio raise
Scientific validity Research should be designed to produce beneficial and generalizable
specific challenges in international herbal knowledge. This includes designing research so that it can be
medicine research that have not been feasibly implemented in the settings where it will be conducted.
adequately discussed.
Fair subject selection Subjects should be selected on the basis of scientific importance, not
based on convenience, vulnerability or bias.
Social value
Favourable risk– The potential benefits of individual participation should outweigh the
All research should hold the potential benefit ratio risks of participation. Benefits to the community or population being
to achieve social value. Different entities studied should also be optimized. Compelling societal benefit can
may view the social value of traditional justify risks to individuals in certain circumstances.
medicine research differently. Public- Independent review To maintain the integrity of the research, bodies not tied to the
health officials are often eager to define investigators must agree that the risks and potential benefits of the
the safety and effectiveness of herbal research are justified.
medicines for conditions such as Informed consent Investigators must obtain valid permission for study participation from
malaria.3 Conversely, harm can arise subjects in a manner that is sensitive to the cultural context in which
with the unscrupulous use of herbs the study is conducted.
such as Africa potato (various Hypoxis Respect for subjects Researchers should have a plan for how the research results will be
species).7 While some claim that such disseminated; ensuring participants know their right to withdraw, and
medicines have “stood the test of time”, monitoring the research for relevant adverse events.
they nonetheless pose serious challenges
to investigators and regulators from
developed countries, in which standards While public-health entities may may want to use traditional herbal
of proof are closely linked to proven be concerned with defining the risks medicine research to expand the in-
efficacy in RCTs. Accordingly, there and benefits of herbal medicines al- fluence of their culture’s indigenous
has been a serious investment in herbal ready in use, entrepreneurs and cor- herbal practices in the global health-
medicine research by public-health porations hope herbal medicines may care market. For instance, Nigeria’s
bodies in many countries. China yield immediate returns from herbal president recently established a national
recently launched a safety research medicine sales, or yield clues to prom- committee on traditional medicine
programme focusing on herbal medicine ising chemical compounds for future with the expressed desire to boost
injections from traditional Chinese pharmaceutical development. They Nigeria’s market share of traditional
medicine. 10 South Africa recently test individual herbs, or their compo- medicine. 14 In developed countries,
included the need for investigating nents, analysed in state-of-the-art high- the “need” for this research may be to
traditional medicines within its national throughput screening systems, hoping protect the public.
drug policy.11 to isolate therapeutic phytochemicals The perceived need for the research
In the USA, the National Center or biologically active functional com- may justifiably differ across countries,
for Complementary and Alternative ponents. In 2006, Novartis reported but without some basic agreement on
Medicine at the National Institutes of that it would invest over US$ 100 mil- the primary source of social value for
Health spent approximately US$ 33 lion to investigate traditional medicine the research it may be difficult to judge
million on herbal medicines in fiscal in Shanghai alone.4,5 its ultimate impact. In the Africa Flower
year 2005; in 2004 the National Can- Nongovernmental organizations case above, before agreements to study
cer Institute committed nearly US$ 89 may be primarily interested in preserv- a herbal medicine are decided, partners
million to studying a range of tradi- ing indigenous medical knowledge. must fully discuss potential differ-
tional therapies.12 While this scale of One such organization, the Associa- ences about the perceived “need” for
investment pales in comparison to the tion for the Promotion of Traditional the research through public forums or
total research and development ex- Medicine (PROMETRA), based in structured debates. Based on these frank
penses of the pharmaceutical industry, Dakar, Senegal, is “dedicated to preserv- discussions, partners can assess whether
it nevertheless reflects genuine public, ing and restoring African traditional the social values of partner countries
industry and governmental interest in medicine and indigenous science”. 13 are sufficiently compatible to warrant a
this area. Governments in developing countries research partnership.
Bulletin of the World Health Organization | August 2008, 86 (8) 595
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