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Medicine or Empty Promises?
by Isadora Stehlin
Some of the medicines
of homeopathy evoke positive images--chamomile, marigold, daisy, onion. But
even some of Mother Nature's cruelest creations--poison ivy, mercury, arsenic,
pit viper venom, hemlock--are part of homeopathic care.
a medical theory and practice that developed in reaction to the bloodletting,
blistering, purging, and other harsh procedures of conventional medicine as
it was practiced more than 200 years ago. Remedies made from many sources--including
plants, minerals or animals--are prescribed based on both a person's symptoms
and personality. Patients receiving homeopathic care frequently feel worse
before they get better because homeopathic medicines often stimulate, rather
than suppress, symptoms. This seeming reversal of logic is a relevant part
of homeopathy because symptoms are viewed as the body's effort to restore
The Food and
Drug Administration regulates homeopathic remedies under provisions of the
Food, Drug, and Cosmetic Act.
In the late 1700s,
the most popular therapy for most ailments was bloodletting. Some doctors
had so much faith in bleeding that they were willing to remove up to four-fifths
of the patient's blood. Other therapies of choice included blistering--placing
caustic or hot substances on the skin to draw out infections--and administering
dangerous chemicals to induce vomiting or purge the bowels. Massive doses
of a mercury-containing drug called calomel cleansed the bowels, but at the
same time caused teeth to loosen, hair to fall out, and other symptoms of
acute mercury poisoning.
a German physician disenchanted with these methods, began to develop a theory
based on three principles: the law of similars, the minimum dose, and the
The word homeopathy
is derived from the Greek words for like (homoios) and suffering (pathos).
With the law of similars, Hahnemann theorized that if a large amount of a
substance causes certain symptoms in a healthy person, smaller amounts of
the same substance can treat those symptoms in someone who is ill. The basis
of his theory took shape after a strong dose of the malaria treatment quinine
caused his healthy body to develop symptoms similar to ones caused by the
disease. He continued to test his theory on himself as well as family and
friends with different herbs, minerals and other substances. He called these
But, as might
be expected, the intensity of the symptoms caused by the original proving
was harrowing. So Hahnemann began decreasing the doses to see how little of
a substance could still produce signs of healing.
With the minimum
dose, or law of infinitesimals, Hahnemann believed that a substance's strength
and effectiveness increased the more it was diluted. Minuscule doses were
prepared by repeatedly diluting the active ingredient by factors of 10. A
"6X" preparation (the X is the Roman numeral for 10) is a 1-to-10 dilution
repeated six times, leaving the active ingredient as one part per million.
Essential to the process of increasing potency while decreasing the actual
amount of the active ingredient is vigorous shaking after each dilution.
remedies are so dilute, no molecules of the healing substance remain. Even
with sophisticated technology now available, analytical chemists may find
it difficult or impossible to identify any active ingredient. But the homeopathic
belief is that the substance has left its imprint or a spirit-like essence
that stimulates the body to heal itself.
Finally, a homeopathic
physician generally prescribes only a single remedy to cover all symptoms--mental
as well as physical--the patient is experiencing. However, the use of multi-ingredient
remedies is recognized as part of homeopathic practice.
In 1938, Sen.
Royal Copeland of New York, the chief sponsor of the Food, Drug, and Cosmetic
Act and a homeopathic physician, wrote into the law a recognition of any product
listed in the Homeopathic Pharmacopeia of the United States. The Homeopathic
Pharmacopeia includes a compilation of standards for source, composition and
preparation of homeopathic drugs.
homeopathic drugs in several significantly different ways from other drugs.
Manufacturers of homeopathic drugs are deferred from submitting new drug applications
to FDA. Their products are exempt from good manufacturing practice requirements
related to expiration dating and from finished product testing for identity
and strength. Homeopathic drugs in solid oral dosage form must have an imprint
that identifies the manufacturer and indicates that the drug is homeopathic.
The imprint on conventional products, unless specifically exempt, must identify
the active ingredient and dosage strength as well as the manufacturer.
behind [the difference] is that homeopathic products contain little or no
active ingredients," explains Edward Miracco, a consumer safety officer with
FDA's Center for Drug Evaluation and Research. "From a toxicity, poison-control
standpoint, [the active ingredient and strength] was deemed to be unnecessary."
involves alcohol. Conventional drugs for adults can contain no more than 10
percent alcohol, and the amount is even less for children's medications. But
some homeopathic products contain much higher amounts because the agency has
temporarily exempted these products from the alcohol limit rules.
"Alcohol is an
integral part of many homeopathic products," says Miracco. For this reason,
the agency has decided to delay its decision concerning alcohol in homeopathic
products while it reviews the necessity of high levels of alcohol.
disparate treatment has been primarily based on the uniqueness of homeopathic
products, the lack of any real concern over their safety because they have
little or no pharmacologically active ingredients, and because of agency resources
and priorities," explains Miracco.
products are not exempt from all FDA regulations. If a homeopathic drug claims
to treat a serious disease such as cancer it can be sold by prescription only.
Only products sold for so-called self-limiting conditions--colds, headaches,
and other minor health problems that eventually go away on their own--can
be sold without a prescription (over-the-counter).
for nonprescription labeling include:
- an ingredients
for safe use
- at least one
- dilution (for
example 2X for one part per hundred, 3X for one part per thousand).
Over the past
several years, the agency has issued about 12 warning letters to homeopathic
marketers. The most common infraction was the sale of prescription homeopathic
drugs over-the-counter. "It's illegal, it's in violation, and we're going
to focus on it," says Miracco.
- products promoted
as homeopathic that contain nonhomeopathic active ingredients, such as vitamins
or plants not listed in homeopathic references
- lack of tamper-resistant
- lack of proper
- vague indications
for use that could encompass serious disease conditions. For example, a
phrase like "treats gastrointestinal disorders" is too general, explains
Miracco. "This phrase can encompass a wide variety of conditions, from stomachache
or simple diarrhea to colon cancer," he says. "Claims need to be specific
so the consumer knows what the product is intended to treat and the indication
does not encompass serious disease conditions that would require prescription
dispensing and labeling."
In addition to
enforcement, the agency is also focusing on preventing problems by educating
the homeopathic industry about FDA regulations. "Agency representatives continue
to meet with homeopathic trade groups to tell them about problems we've had,
difficulties we've seen, and trends we've noticed," says Miracco.
FDA is aware
of a few reports of illness associated with the use of homeopathic products.
However, agency review of those reported to FDA discounted the homeopathic
product involved as the cause of the adverse reaction. In one instance, arsenic,
which is a recognized homeopathic ingredient, was implicated. But, as would
be expected, FDA analysis revealed the concentration of arsenic was so minute
there wasn't enough to cause concern, explains Miracco. "It's been diluted
of highly individualized treatments based on a person's genetic history, personal
health history, body type, and present status of all physical, emotional and
M.D., who has a family practice and is licensed to practice homeopathy in
Washington state, spends at least an hour and a half with each new patient.
"What I do is review the lifetime history of the patient's health," she explains.
"Also I ask a lot of questions about certain general symptoms such as food
preferences and sleep patterns that usually aren't seen as important in conventional
medicine. In looking to make the match between the person and the remedy,
I need to have all of this sort of information."
Why does someone
trained in conventional medicine turn to homeopathy? "With chronic illnesses
such as arthritis and allergies, conventional medicine has solutions that
help control the symptoms but you don't really see the patients getting better,"
says Jacobs. "What I have seen in my homeopathic work is that it really does
seem to help people get better. I'm not saying I can cure everyone but I do
see where people's overall health is improved over the course of treatment."
abandoned conventional medicine completely. "My daughter is 17 and she's never
taken antibiotics, but I would have no hesitation to use antibiotics if she
had pneumonia, or meningitis, or a kidney infection," says Jacobs.
About a third
of Jacobs' practice is children, and ear infections are one of the most common
problems she treats. "Ear infections are something that seems to respond well
to homeopathy," she says. "Of course, if a child is not better within two
or three days, or if the child develops a high fever, or if I feel that there's
a serious complication setting in, then of course I will use antibiotics.
But I find that in the majority of cases, ear infections do resolve without
In addition to
treating patients, Jacobs has conducted a clinical trial the results of which
suggest that homeopathic treatment might be useful in the treatment of acute
childhood diarrhea. The results were published in the May 1994 issue of Pediatrics.
In the article, Jacobs concluded that further studies should be conducted
to determine whether her findings were accurate. A subsequent article appearing
in the November 1995 issue of Pediatrics indicated that Jacobs' study was
flawed in several ways.
is published by the American Academy of Pediatrics, Jacobs' study and several
others published in such journals as The Lancet and the British Medical Journal
are considered "scanty at best" by the academy. "Given the plethora of studies
that are published [on other topics] in scientific journals, I wouldn't say
there are a lot of articles coming out," says Joe M. Sanders Jr., M.D., the
executive director of the academy. "Just because an article appears in a scientific
journal does not mean that it's absolute fact and should be immediately incorporated
into therapeutic regimens. It just means that the study is [published] for
critique and review and hopefully people will use that as a stepping stone
for further research."
are under way. For example, the Office of Alternative Medicine at the National
Institutes of Health has awarded a grant for a clinical trial of the effects
of homeopathic treatment on mild traumatic brain injury.
Even with the
dearth of clinical research, homeopathy's popularity in the United States
is growing. The 1995 retail sales of homeopathic medicines in the United States
were estimated at $201 million and growing at a rate of 20 percent a year,
according to the American Homeopathic Pharmaceutical Association. The number
of homeopathic practitioners in the United States has increased from fewer
than 200 in the 1970s to approximately 3,000 in 1996.
for a homeopathic practitioner, it's important to find someone who is licensed,
according to the National Center for Homeopathy. Each state has its own licensing
requirements. "Whether that person is a medical doctor or a physician's assistant
or a naturopathic physician, I feel that anyone who's treating people who
are sick needs to have medical training," says Jacobs.
or Wishful Thinking?
Many who don't
believe in homeopathy's effectiveness say any successful treatments are due
to the placebo effect, or, in other words, positive thinking.
supporters counter that their medicine works in groups like infants and even
animals that can't be influenced by a pep talk. Jacobs adds that sometimes
she mistakenly gives a patient the wrong remedy and he or she doesn't get
better. "Then I give the right remedy, and the person does get better," she
says. "So it's not like everybody gets better because it's all in their head.
I think it's only because we don't understand the mechanism of action of homeopathy
that so many people have trouble accepting it."
Medical Association does not accept homeopathy, but it doesn't reject it either.
"The AMA encourages doctors to become aware of alternative therapies and use
them when and where appropriate," says AMA spokesman Jim Fox.
American Academy of Pediatrics has no specific policy on homeopathy. If an
adult asked the academy's Sanders about homeopathy, he would tell that person
to "do your own investigation. I don't personally prescribe homeopathic remedies,
but I would be open-minded."
applies only to adults, however. "I would have problems with somebody imposing
other than conventional medicine onto a child who's incapable of making that
decision," he says.
who practice homeopathy warn that nothing in medicine--either conventional
or alternative--is absolute. "I'm not saying we can cure everyone [with homeopathy],"
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