Volume 108 Number 2
AJHM Summer2015 57
Homeopathic Product Regulation
ic rigor, transparency, and clinical research of all medicine.
I have been a member of the AIH and the Homeopathic
Pharmacopeia Convention of the United States (HPCUS)
for more than 20 years and have been impressed with the
scientific rigor and integrity I have witnessed within these
groups. Homeopathic drugs are used by licensed practitio-
ners and consumers in Africa, Asia, and Australia, Europe,
North America, and South America.
In 2009 the World Health Organization (WHO) pub-
lished a review of safety issues related to homeopathic
drugs. The WHO consulted with more than 400 review-
ers from 105 countries. Members of the WHO Expert
Advisory Panel on Traditional Medicine, the WHO Ex-
pert Advisory Panel on International Pharmacopoeia and
Pharmaceutical Preparations and the WHO Collaborating
Centers for Traditional Medicine, as well as relevant non-
governmental organizations, participated in this process.
National regulatory authorities in more than 100 countries
received advance copies of the drafts of this document.
With regards to the United States they noted that offi-
cial homeopathic products are classified as drugs and must
have a monograph in the HPUS, as opposed to non-official
homeopathic drugs which may be marketed if ingredients
are generally recognized as homeopathic. The FDA dis-
tinguishes between official (HPUS-listed ingredients) and
non-official homeopathic drugs both of which are legal.
Eligibility for inclusion in the HPUS requires that the
homeopathic product is proven to be safe, effective and
prepared according to HPUS provisions.
Homeopathic products must meet the standards for
quality and purity set out in the HPUS. The presence of
the initials HPUS on the label of a product assures that
legal standards of strength, quality, purity and packing
are respected. Homeopathic products intended solely for
self-limiting disease conditions amenable to self-diagnosis
and treatment may be marketed as over-the-counter (OTC)
drugs. Homeopathic products for conditions not amenable
to OTC use must be marketed as prescription products.
Homeopathic products must be manufactured in confor-
mity with GMP requirements outlined in the HPUS.
David Riley, MD
Testimonyof MichelleDossett,MD, PhD,MPH
American Institute of Homeopathy
Good afternoon and thank you for the opportunity to
speak today. My name is Michelle Dossett. I am an inter-
nist and clinical researcher at Massachusetts General Hos-
pital and an Instructor at Harvard Medical School. I have a
PhD in immunology and a masters in public health in clini-
cal effectiveness. I became curious about homeopathy on
seeing some of its clinical effects and reading the research
literature. I will be speaking on behalf of the AIH on the
safety of homeopathic medicines and public perceptions.
My only financial disclosure is 2 hours of consulting for a
homeopathic pharmaceutical company last year.
First, I will address the FDA’s question regarding safety
or risks of products labeled as homeopathic. I will not be
discussing efficacy today due to time limitations. Dr. Jonas
did an excellent job yesterday of discussing some of the
challenges in interpreting the research in this field and the
importance of critically analyzing the methodology used.
Physician
s within the AIH report that while adverse
events do occur with homeopathic treatment, such occur-
rences are magnitudes less in frequency than their experi-
ences with conventional medicines, and these events tend
to be mild and transient in nature. Many relate that the
safety of homeopathic medicines is helpful in prescrib-
ing for complex patients, such as older patients who are
on multiple conventional medications for chronic medical
conditions. As the number of medications increases, the
risk for interactions and adverse drug reactions increases as
well. AIH members find that homeopathic medicines rep-
resent a much safer alternative for self-limited conditions
in these patients. Rather than using an OTC drug like an
NSAID which might be contraindicated, short term use of a
homeopathic medicine can help alleviate symptoms while
reducing concerns for adverse drug reactions. While such
anecdotal information is informative, let’s review research
on the safety of homeopathic medicines.
In 2000 Dantas and Rampes published a systematic
review of the literature from 1970-1995.
1
They found 19
clinical trials with detailed information on adverse events
and found a mean incidence of adverse events of 9.4 in
the homeopathic groups and 6.17 in the placebo groups.
The adverse events were mild and transient. The major-
ity of case reports described aggravations of pre-existing
symptoms rather than new symptoms and the overall level
of causal association was low. Some reports described
products that were mislabeled as homeopathic.
For
ho-
meopathic pathogenetic trials, there was great heterogene-
ity. The mean incidence of effects was 54%, and overall
they were similar to nocebo effects in phase 1 RCTs.
The health technology assessment commissioned by the
Swiss government examined the safety of homeopathy and
concluded that “
the use of medium and high potencies is
free from toxic and unexpected organ effects.”
2
I’ll now
review some of the data that has been published since.
In 2012, Jong and colleagues examined pharmacovigi-
lence data from Germany on the use of homeopathic and
anthroposophic solutions sold for injection.
3
The practice
of injecting homeopathic medicines is far more common in
Germany than in the U.S. Of 303 million ampoules sold
for injection, there were 486 case reports encompassing a
total of 1180 adverse drug reactions. Only 46 of the reports
were classified as serious and in nearly half of those cases,
the homeopathic injection was deemed unlikely to be the
cause of the event. Serious adverse drug reactions oc-
curred significantly more frequently in those who received
complex products and products diluted less than 1:10,000.
The overall reporting rate of adverse drug reactions was
