Volume 108 Number 2
60 AJHM Summer 2015
Homeopathic Product Regulation
life. I don’t want to believe that. Can homeopathy help?
Sick people want to get well, to feel better. Many,
despite undergoing extensive testing and faithfully tak-
ing their prescribed medicines, do not feel well. They
are turning to acupuncture, biological products, home-
opathy and other modalities. In a free society such as
ours I would say this freedom of choice is a good thing
with the caveat that the products do no harm.
Query 2:
Do consumers and health care providers have ad-
equate information to make informed decisions about drug
products labeled homeopathic?
The cynical part of me wants to say probably not. I
know when I treat myself I am reminded of the great Sir
William Osler who said, “The physician who treats himself
has a fool for a patient.”
However, the truth is everyone self-diagnoses and self-
treats. It is part of being human. I have a headache. I have
arthritis. I am depressed, and so on and so forth. With
the advent of the internet there is more medical informa-
tion available, both reliable and useless, than at any time
in human history. Millions of people are using the internet
every day to learn more about what ails them looking not
only for a diagnosis but alternative ways to treat them-
selves. Whether the consumer can self-treat reliably and
effectively is another matter.
Our panelist, Dr. Theresa M. Michele, posted on the FDA
website her criteria for OTC products. She stated these
were her views and not necessarily those of the agency.
She wrote that these products
• Can be adequately labeled such that – The consumer
can self diagnose, self treat, and self manage the con-
dition being treated – No health practitioner is needed
for the safe and effective use of the product
• Drug has low potential for misuse and abuse
• Safety margin is such that the benefits of OTC avail-
ability outweigh the risks
-
Theresa M. Michele, MD, FDA website
Can homeopathic products be labeled in such a way as
to aid in self-diagnosis and self-treatment? I would say yes.
The crucial part of Dr. Michele’s schema is that the Drug
has low potential for misuse and abuse. In the case of OTC
homeopathic products, such potential is virtually nil and
the safety margin is such that the benefits of OTC avail-
ability outweigh the risks.
A word about OTC nonsteroidal anti-inflammatory
drugs (NSAIDs). Perhaps the best known OTC drug in
the world is aspirin followed closely by other nonsteroi-
dal anti-inflammatory drugs (NSAIDs). These drugs are
dangerous.
In an article published in
American Family Physician
,
March 1, 2012 issue, it was reported that there were over
400,000 hospital admissions per year in the United States
because of gastrointestinal bleeding. The authors state,
It [gastrointestinal bleeding] has been associated with
increasing NSAID use…
No homeopathic product is re-
motely as dangerous as aspirin and other NSAIDs.
Until the FDA has compelling evidence that OTC ho-
meopathic products are harmful they should continue to be
as widely available as are OTC pharmaceuticals. As I sug-
gested earlier, the homeopathic mixtures probably should
have more comprehensive labeling.
Chronic disease is merciless and relentless, and to cure it
requires the best of all schools of medicine. The medicine
of the future will be an astute mélange using technology and
chemistry to diagnose with patients having the opportunity
to choose treatment from among several well-developed
schools of medicine: conventional (allopathic) medicine,
homeopathy, traditional Chinese medicine, Ayurveda, and
perhaps others.
In sum, I wish to emphasize that homeopathic medicines
are at least an order of magnitude safer than conventional
pharmaceutical drugs and, in the hands of an expert pre-
scriber, can be equally or more effective.
Thank you.
Karl Robinson, MD
Brief biography of Dr Karl Robinson:
BAYale 1960
MD Hahnemann College (now Drexel University) 1972
Internship St. Vincent’s Hospital, NYC 1972-73
Residency, Internal Medicine, Harlem Hospital 1973-75
Author:
Small Doses Big Results How Homeopathic Medi-
cine Offers Hope in Chronic Disease
, CreateSpace, 2014.
Taught homeopathy in Cuba, Honduras, El Salvador and
Guatemala over the past 15 years
Private practice of homeopathy for the past 39 years
Testimony of Alvin J Lorman, Esq.
Good morning. Thank you for giving me the opportu-
nity to speak today. My name is Al Lorman and I’ve been
a food and drug lawyer for 38 years. In that time, I’ve
represented clients involved in all areas of FDA regulation.
Among my clients are a number of homeopathic drug com-
panies as well as the industry trade association, the Ameri-
can Association of Homeopathic Pharmacists. I also pro-
vide advice to the Homeopathic Pharmacopeia. Because of
these relationships, I’ve spent many years thinking about
the subject of this hearing. Just as to a hammer, everything
looks like a nail, I tend to look at issues from a legal and
public policy perspective.
While most of my clients likely
agree with what I’m going to say today, I consider my re-
marks to be my own.
To steal a phrase, I was “Present at the Creation” of the
current Compliance Policy Guide as the attorney for the
industry group that initiated the discussions with FDA.
Prior to the issuance of the CPG in 1988, FDA followed
a different compliance policy guide, one which asserted
