What is the modality’s place in the profession?
Posted April 12, 2017
Dr. Monique Maniet, a semiretired small animal practitioner, vividly remembers the case of the German Shepherd Dog that couldn’t walk. The owner had spent thousands on veterinary specialists, but the dog was still in pain and absent a diagnosis. As a last resort, the owner brought the dog to Dr. Maniet, who practices at Veterinary Holistic Care in the Washington, D.C., area. She noticed that the dog had been given a Lyme disease vaccine the week before signs were first observed. Her diagnosis was that the dog was having a reaction to the vaccine. Dr. Maniet treated him homeopathically, and after six months, “He was back to normal, and it was like nothing happened,” she said. “Even sometimes in cases when people think there is no hope, you can turn it around.”
Homeopathy is, depending on whom you ask, a gentler and more natural alternative to traditional medicine or an unproven and useless modality, at best.
Last November, the Federal Trade Commission declared that homeopathic products cannot include claims of effectiveness without “competent and reliable scientific evidence.” The Food and Drug Administration appears poised to issue new regulations for homeopathic products later this year. The agency currently does not evaluate these products for safety or efficacy.
Meanwhile, homeopathy’s place in veterinary medicine remains a source of contention.
||In homeopathy, the “law of minimum dose” holds that the more diluted a homeopathic preparation is, the greater its effectiveness will be. Strength of homeopathic preparations is indicated by the dilution ratio (C for a 1:100 dilution; X for a 1:10 dilution) and number of successive dilutions. Thus, a 5C preparation is a 1:100 dilution done 5 times. Dilutions beyond 12C (or 24X) are unlikely to contain a single molecule of the original substance.
The validity of homeopathy was debated by AVMA leadership and members in 2013, when the Board of Directors referred to two councils a resolution proposing to discourage the use of homeopathy because of ineffectiveness.
The Council on Research scanned the literature and found that studies claiming a benefit from homeopathic products in veterinary medicine were either anecdotal in nature or generally flawed in their experimental design or analysis. It also found that well-controlled clinical studies typically failed to substantiate any beneficial effect of homeopathic preparations and concluded that there was no clinical evidence to support the use of homeopathic preparations to treat or prevent diseases in animals.
For its part, the Council on Veterinary Service reviewed the AVMA policy on Complementary, Alternative, and Integrative Veterinary Medicine, made some revisions, and said the policy clearly states that the same standards must be applied to any treatment modality, whether traditional or alternative. Ultimately, the 2014 House of Delegates and the Board agreed the current policy was sufficient, and the HOD disapproved the resolution, saying the AVMA would not take a position specific to a particular modality.
More recently, a petition in the United Kingdom from an equine veterinarian has asked the Royal College of Veterinary Surgeons to prevent veterinarians from selling or recommending homeopathic products. The regulatory body is due to report back in the coming months.
“Like cures like”
Homeopathy was started in the late 1700s by German physician Samuel Hahnemann and is based on what he described as the law of similars: the idea that a substance capable of causing particular symptoms in a healthy individual will cure similar symptoms in a person with disease.
Homeopathy “refers to treatment of disease with sometimes extreme dilutions of substances that in undiluted form might cause symptoms of that same disease.”
Merck Veterinary Manual
An introductory book on homeopathy, “Beyond Flat Earth Medicine” by Timothy Dooley, MD, a naturopathic doctor, explains: “The basic idea is that the medicine stimulates the natural recuperative processes of the patient towards health. The disease resolves naturally as the patient recovers. The disease is not being directly treated and so, for a given disease, there are hundreds of medicines which might be indicated. It depends on the patient. Likewise, for a given medicine, there are hundreds of diseases in which it might be indicated.”
For example, Coffea cruda (a homeopathic preparation made from coffee) is used to treat patients with “insomnia associated with an overly alert mind.”
Dr. Hahnemann was faced with the problem of using his “medicines” in such a way as to not cause more problems. He found that if a person’s symptoms indicated the need for a particular substance, it could be given in very small doses with good results, according to the book. Through experiments, he developed a system of dilutions and agitations called “potentization.” This use of ultrahigh dilutions is what distinguishes homeopathic medicines from herbal tinctures and other natural medicines made with whole substances.
First, the substance that the homeopathic medicine is derived from is either dissolved into a tincture or ground into a powder from which a tincture is made. One part of the “mother tincture” is mixed with either 9 parts of a solvent such as water or alcohol for an X potency or 99 parts for a C potency. The newly diluted mixture is shaken vigorously, a process that Dr. Hahnemann called “succussion” and said “energizes” the dilution. After being diluted and succussed one time, the tincture is called 1X or 1C, depending on the proportions. The process continues in this way, with each step using the product of the preceding one as the basis for the next dilution. A 24C potency, for instance, has undergone 24 dilutions and succussions.
“If properly diluted and agitated, the medicines retain their ability to cause a homeopathic response even in the high potencies (high dilutions). If not properly agitated at each step, the medicine loses its homeopathic medicinal properties through the diluting process,” according to the book.
Potencies up to 30C are often referred to as low potencies and those of 200C and higher are referred to as high potencies.
The lower the potency, the more frequently the medicine typically needs to be re-administered.
Homeopathy in practice
About 20 states follow the AVMA Model Veterinary Practice Act by including complementary and alternative veterinary medicine, including homeopathy, in their definition of the practice of veterinary medicine. South Carolina and Louisiana specifically exempt homeopathy from their definition of the practice of veterinary medicine. Another 20 or so states have enacted specific or general exemptions for various regulated therapies from their definition of the practice of veterinary medicine.
The Academy of Veterinary Homeopathy, founded in 1995, is the only veterinary certifying body in the U.S. recognized by the National Center for Homeopathy. The academy currently has 120 members, 49 of whom are certified.
Certified members have completed the Professional Course in Veterinary Homeopathy offered by the Pitcairn Institute of Veterinary Homeopathy and have passed a continuing education certification process administered by the AVH. (The Registry of Approved Continuing Education does not accept these CE credits.)
Dr. Maniet is a certified homeopath. Like other advocates, she became a proponent of the modality after seeing cases that seemingly demonstrated its healing powers. She uses it mostly on young animals. “They haven’t had a chance to be messed up too much by years of drugs—heartworm prevention, overvaccination, and so forth,” she said. “Their vital force is much stronger, so their response to homeopathy is much more rapid. When you have a dog that is much older and on medication, it’s a much slower response, and people don’t have the patience for that.”
Veterinary homeopaths often do not recommend routine vaccination for dogs or cats, except for rabies vaccination, where required by law. Instead, they advocate the use of “nosodes,” a homeopathic product made from diseased tissue. They also eschew the use of antimicrobials. In any of these cases, Dr. Maniet notes, the client has to consent to her treatment recommendation.
“We have to be careful, for our license. This is not a method that is recognized by mainstream veterinarians, so we do have to be careful about what we’re doing and ensuring that our clients want it,” she said. “And if I don’t think homeopathy will work (in a certain case), I won’t try. I have other tools in my bag, like acupuncture.”
Almost any malady that can be treated by regular medicine can be treated by homeopathy, according to the AVH. There are several thousand homeopathic preparations, which are usually identified by Latin names. They come from a range of sources, such as plants, minerals, animals, microorganisms, and fungi. Homeopathic preparations are usually delivered in lactose pills or liquids.
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Dr. Maniet uses human and veterinary versions of homeopathic products. One company, Natural Health Supply, offers a veterinary kit for $275. She tells clients to get the 30C products, which are most often used on animals, so if they need to switch to another remedy, they already have it at home.
Dr. Maniet adds that an owner should have a general knowledge about homeopathy for the modality to work. “You need to have somebody who won’t rush to the ER to suppress what the vital force is expressing,” she said. “And with homeopathy, you really cannot go for homeopathic treatment and give Rimadyl. Messing up the treatment is a waste of time and money and not a service for the dog because it won’t work. I’m not putting myself in those situations; it gives a bad name to homeopathy.”
Lack of evidence
Opponents argue that the science simply doesn’t support the health claims of homeopathy.
The Russian Academy of Sciences officially declared homeopathy unscientific and ineffective. Homeopathic medicine contradicts “known chemical, physical and biological laws” and should have no place in Russia’s national health care system, the academy’s Commission Against Pseudoscience and Falsification of Scientific Research stated in a Feb. 6 memo. It called on the health ministry and drug-regulatory bodies to introduce mandatory labeling of homeopathic drugs and therapies, indicating their lack of proven efficacy.
Dr. Virginia R. Fajt, clinical associate professor of veterinary physiology and pharmacology at Texas A&M University College of Veterinary Medicine & Biomedical Sciences, says our current understanding of chemistry, physics, and pharmacology precludes any scientific basis for the efficacy of homeopathy.
She continued, “There have been people attempting to look at these treatments and their usefulness, but over the more than 200 years of the practice of homeopathy, there’s been very little progress, and they haven’t demonstrated that the substances do any better than placebos.”
According to the Merck Veterinary Manual, “controlled studies have demonstrated that homeopathic ‘provings’—sessions in which individuals record the symptoms caused by ingestion of the remedies—cannot distinguish between homeopathic dilutions and placebos. Indeed, no study has been able to distinguish homeopathic remedies from control solutions, by any method of analysis.”
The manual adds that nosodes “have consistently failed to provide reliable protection against infectious agents in scientific studies of both people and animals.”
As for the claims of using homeopathic preparations as a possible alternative to antimicrobials, this past December, the Veterinary Record published a review of studies published over the past 33 years dealing with the efficacy of homeopathic products in treating livestock, available here. It concluded that there was insufficient evidence to support the use of homeopathy in livestock as a way to prevent or treat infectious diseases.
Dr. Fajt, who is also president of the Evidence-Based Veterinary Medicine Association, has heard homeopaths argue that the reason for a lack of scientific evidence supporting homeopathy is that researchers don’t know how to properly design studies for these remedies, because the products work differently from traditional medicines.
“To me, that leads back to how it doesn’t fit with our modern understanding of medicine, physics, and chemistry,” Dr. Fajt said.
Medical ethics factor into consideration of the practice of veterinary homeopathy, says Dr. David W. Ramey, an equine practitioner who co-wrote the book “Complementary and Alternative Veterinary Medicine Considered” with ethicist Bernard Rollin, PhD.
“The basic question is: Do we as veterinarians have an obligation to provide effective treatments? If a client believes in magic and the job of the vet is only to make sure each and every client is satisfied, then the veterinarian should simply do magic,” Dr. Ramey says. “However, there are ethical concerns with such a position. What about the animals?”
Some might say that, although homeopathy’s benefits are questionable, the practice at least does not harm animals. Dr. Ramey counters that this reasoning is not a sufficient basis to practice medicine and that, in fact, there is an ethical obligation to do some good.
The second problem with that argument, he says, is that it has a narrow definition of harm.
“It acts as if harm is merely a question of whether the animal gets better and whether the person is OK with it. Indirect harm includes things such as people wasting resources on ineffective treatments and ineffective treatment precluding application of effective treatments,” Dr. Ramey said.
That rationale inspired Dr. Danny Chambers, an equine veterinarian near Devon, England, to submit a petition to the Royal College of Veterinary Surgeons requesting that the regulatory body prevent veterinarians from being allowed to recommend or sell homeopathic treatments.
He wrote in an editorial in The Guardian this past July: “As a vet, there are few things more heartbreaking than having to pick up the pieces after an animal has received inadequate care. Unfortunately, too many times in my career I’ve been presented with an animal whose perfectly treatable condition has been left to deteriorate, because their owners and vets were convinced that homeopathic remedies would do the trick. At best, it leads to unnecessary suffering and a reduced likelihood of a full recovery. At worst, as with the case of a horse I treated for severe laminitis, there is no option left but euthanasia.”
The petition caused a lot of debate in the news media and within the veterinary community, and it has resulted in a review by the RCVS Standards Committee of its position on alternative medicines. The committee is due to report in coming months.
Dr. Ramey says veterinarians must consider another indirect harm from homeopathy, which is the cumulative harm that is being done to the veterinary profession.
“If it becomes known veterinarians only care about doing stuff to animals, and it doesn’t matter what that stuff is, that the only thing that matters is that veterinarians get paid and that clients are happy, that doesn’t speak well for a profession that purports to care for people and animals,” he said.
“The only things we have to stand on is our ethics—which says we’ll do the right things for the animal—and science, which says we’ll use a scientific system to get rid of ineffective treatments and use good ones. You give people a reason to use you and keep using you if you do the right things and use the right stuff. But if you say, ‘It’s all veterinary medicine, and we’ll do it no matter what,’ the system will break down.”
Another potential harm that the National Institutes of Health has pointed out is that, although people sometimes assume that all homeopathic preparations are highly diluted and, therefore, unlikely to cause harm, some products labeled as homeopathic can contain substances not listed on the label or sufficient amounts of the active ingredients to cause adverse effects or drug interactions.
For example, laboratory testing by the FDA in 2010 and 2016 found that Hyland’s Baby Teething Tablets contained inconsistent amounts of belladonna, sometimes far exceeding the amount claimed on the label. The FDA issued statements in both cases, going so far as to urge customers “not to use these products” after the more recent case. Hyland’s issued a voluntary recall back in 2010 but did not do so after last year’s discovery, only pulling the teething products from shelves. The company maintains its products are safe for use.
In a rare pushback from the government on these products, the FTC announced Nov. 15, 2016, that makers of homeopathic products must prove safety and efficacy. The agency, which has authority to regulate advertising claims of nonprescription drugs, is in pursuit of manufacturers of over-the-counter homeopathic products who do not back up health claims with scientific evidence. The agency said failure to do so would be considered a violation of the Federal Trade Commission Act.
Homeopathic preparations are regulated by the FDA, but not as much as consumers may expect. The Federal Food, Drug, and Cosmetic Act of 1938 recognized homeopathic preparations as drugs but with important exceptions, compared with other drugs. Exceptions include the following:
Not required to submit new drug applications to the FDA.
Exempt from good manufacturing practice requirements related to expiration dating.
Exempt from “finished product testing for identity and strength.”
May contain much higher amounts of alcohol than other drugs (which are limited to 10 percent).
Further, under FDA guidelines issued in 1988, a company can sell homeopathic products over the counter without demonstrating their safety or efficacy, and—unlike dietary supplements—their packaging can include claims about treating specific conditions, as long as those conditions are “self-limiting” and not chronic.
While homeopathic drugs are regulated by the Food and Drug Administration, the agency does not evaluate them for safety or efficacy. That may change, depending on the revised regulations on homeopathic drugs the agency is anticipated to release later this year. About 3.3 million Americans spent $2.9 billion on homeopathic medicines and $170 million for visits to homeopathic practitioners in 2007, according to the National Health Interview survey that year.
The FDA says it has deferred review of drugs labeled as homeopathic “due to the uniqueness of homeopathic medicine” and that it would review them as a separate category at a later time. In April 2015, the FDA held a two-day public hearing requesting comment on the regulation of homeopathic products. Now, the FDA Center for Drug Evaluation and Research has added homeopathic products to its agenda of new and revised draft guidance documents to be published this year.
Whether that means the agency will tighten its regulations by subjecting homeopathic products to the same premarket approval process as other drugs, for example, isn’t clear.
It also remains to be seen whether homeopathy will continue to carve out a niche in the veterinary profession or be pushed out by those who see no place for it in a science-based field. Members of each camp are convinced that they are on the right side of the debate.
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