HealthyMouth Water Additive: Does It Help Prevent Dental Disease?

I am often asked by clients or readers about specific products, and while I certainly can  only investigate a small proportion of all the stuff marketed to pet owners, I try to look at as many of these things as I can. Some of my colleagues have begun using a product called HealthyMouth , a water additive reported to reduce accumulation of plaque and retard the development of dental disease. This product has received a seal of acceptance from the Veterinary Oral health Council (VOHC) and  an endorsement from Dr. Fraser Hale, a dental specialist and someone who generally takes a skeptical, evidence-based approach to dental therapies. Dr. Fraser has gone from being skeptical of the product to actively recommending and distributing it. These are sources I believe are trustworthy, so I thought I ought to take a closer look at the product. In keeping with my general approach, I will review the product in terms of the following general issue: 

1. Basic plausibility for proposed effect/mechanism of action
2. Pre-clinical, non-target species research
3. Clinical trials
4. Marketing claims 

Individual Ingredients
The product ingredients list is extensive, though specific quantities/concentrations are not provided. Only two are described as “active” ingredients, papain and zinc gluconate, but I will discuss several others that appear to be included for some specific effect. Theoretical rationales are provided for some ingredients but not others. Many ingredients are described as “organic,” which I suspect has little relevance. The dog and cat products appear from the ingredient list to be identical except for the addition of the amino acid taurine to the feline product.

1. Pomegranate- No specific claim is made about this ingredient.
There are a few in vitro trials that suggest anti-bacterial effects from pomegranate juice. There are also a number of human clinical trials suggesting anti-plaque and anti-bacterial effects for oral rinses containing this ingredient (1,2). There appear to be no clinical trials in dogs other than the two unpublished studies conducted by HealthyMouth, and no trials at all in cats. Clinical trials in humans and lab animal studies show little risk, though allergic reactions in humans have been reported, and there are some concerns about possible interference with the metabolism of other supplements or drugs.

2. Yucca- I was not able to find any in vitro research suggesting a benefit for yucca extract in preventing or treating dental disease. There have been a couple clinical trials of one yucca extract in dogs (3) and one in cats (4) reporting some decrease in the odor of flatulence, and no significant adverse effects were reported. There are reports of yucca extracts causing gastrointestinal symptoms. I was not able to find any clinical trials of yucca extract as a preventative or therapeutic for dental disease in humans or in dogs or cats.

3. Zinc gluconate- The claim made for this ingredient is that ” zinc gluconate operates as an antibacterial agent.” There are clinical trials of zinc gluconate containing rinses and toothpastes in humans which appear to show decreased plaque and gingivitis, but the compound is almost always combined with triclosan or other antibacterials, so it is unclear what role the zinc itself has in any effect seen. There are no clinical trials investigating the use of this agent in preventing or treating dental disease in dogs or cats. Excessive zinc ingestion can cause serious and even life-threatening complications.

4. Blueberry- I found one study suggesting a particular blueberry extract might have a weak effect reducing the aggregation of bacteria found in the human mouth (5). There appears to be no lab animal, or clinical trial evidence in humans or other animals that blueberry is useful in the prevention or treatment of dental disease. Blueberry’s are reported to contain substances which have anti-oxidant properties, but the clinical significance of this is unclear, and no apparent connection exists to prevention of dental disease.

5. Papain- A combination of proteolytic enzymes found in papaya, papain does not appear to have been studied extensively as an agent for prevention and treatment of dental disease, though it is occasionally found in toothpastes. I was not able to find any clinical trials in humans, or in dogs or cats regarding dental disease. There are some safety concerns as large amounts have been reported to cause perforation of the esophagus in humans, allergic reactions are possible, and there is some potential risk of reducing blood clotting function, especially in combination with some other herbal ingredients including cloves which is one of the flavoring agents in HealthyMouth.

6. Vitamins B2 and C- These appear to be included as “anti-oxidants” and to “increase the immune response.” The notion of boosting the immune system is a meaningless marketing device and while there is some preliminary suggestion that preventing oxidative damage can sometimes be a good thing, oxidation is also one of the ways the body suppresses cancer and fights infection, so it is not appropriate to assume that reducing it, even if these substances actually do that in a living animal, is a good thing.

7. Clove and cinnamon- These are apparently added as flavoring agents, and I found no research to suggest benefit or risk associated with them in dogs and cats. I wouldn’t expect them to be especially appealing to cats, but the company claims they love it.

Clinical Trials
As I mentioned, HealthyMouth has been awarded the Veterinary Oral Health Council (VOHC) seal of acceptance. VOHC is an independent organization that reviews the evidence for products claimed to have value for prevention and treatment of dental disease in animals. The organization requires clinical trial evidence to support product claims, and they have pretty specific protocols to ensure these claims are adequately demonstrated. However, I still have some concerns about the trials HealthyMouth uses to support its product claims.

As I often point out, all of us have biases about the ideas and beliefs we hold. We naturally believe our hypotheses to be true, and this can lead us to see what we want or expect to see, to focus on confirming information and ignore or minimize contrary information (e.g. confirmation bias and cognitive dissonance). And non-ideological motives, such as financial incentives, can also influence our interpretation of what we see even if our intentions are quite honest. It is well established in human medicine that trials funded by industry, for example, tend to have findings favorable to the products of the funder. The purpose of formal clinical trials is to help us test our ideas in a way that hopefully prevents these biases from inappropriately influences our findings.

It is important to be aware of the potential biases involved in a clinical study, not because this information allows us to automatically dismiss the findings but because it helps us spot weaknesses in the methods and evaluate the results in context.

In the case of HealthyMouth, the two clinical studies in dogs were both funded by the company that manufactures the product. And thought the chief investigator, Dr. Jean Dodds, is a well-respected veterinarian who has done much fine work for the veterinary  profession and animal welfare, she is also a prominent advocate of “holistic” veterinary medicine, having even received the Holistic Veterinarian of the Year award from the American Holistic Veterinary Medical Association, an organization I’ve discussed frequently before. These facts are relevant because they indicate the high potential for a bias favorable to the product in these trials, and so we must look carefully at the methodology of the trials to see if there are adequate controls.

It is difficult to evaluate all the details of the methodology since the trials have not, as far as I can tell, been through peer review or been published in the scientific literature. The information I evaluated about them comes from the HealthyMouth web site. It appears that two trials, with 40 different dogs in each study and a duration of 28 days (requirements of the VOHC protocol) were conducted by Dr. Dodds in a greyhound dog rescue center and blood bank she founded and manages. The advantage to this, apart from logistics, is that the husbandry of the dogs was likely pretty uniform, which reduces sources of variation between groups. The disadvantage is that the dogs were all of one breed (and one in which dental disease is a particular problem), and the conditions were likely very different from those experienced by typical pet dogs.

The VOHC standards recommends randomization of subjects, but it does not appear that procedure was used in this study. Subjects were allocated to groups based on kennel housing so that the access to treated or untreated drinking water could be more easily controlled. This introduces some small potential source of difference between groups other than the treatment itself.

The dogs had a full dental cleaning under anesthesia at the start of the trials, and their plaque scores measured at intervals, as recommended in the VPHC protocol. A big concern about the study, however, is that there was apparently no blinding. The treated and untreated water were easily distinguished, and the staff managing the dogs and evaluating their oral health were apparently aware of which group they were in. This always introduces a strong potential for bias, and it is especially a concern in a trial like this where there is a strong presumption of safety and efficacy in advance on the part of the organizers of the trial (the company making the product) and possibly among the investigator and her staff. In any case, the evidentiary  value of a clinical trial is substantially lower if it is not properly and effectively blinded, and such trials almost always find a positive treatment effect.

In any case, the trials both showed a strong positive effect on plaque scores. No trials have yet been made public in cats, and no independent evaluation of HealthyMouth appears to have been done.

Marketing Materials
As is probably inevitable, the marketing of this product involves a lot of “satisfied customer” testimonials. Stories of dogs and cats who apparently experienced great benefits are told, and of course no stories from pet owners who do not believe their pets befitted are told. This creates the impression of a safe and effective product, but of course it is a form of advertising, not a reliable source of information about whether the product actually works.

Dr. Hale gives the company founder credit, appropriately in my opinion, for marketing HealthyMouth as an adjunct to appropriate home and professional dental care, not a magic cure-all or substitute for other, established preventative and treatment methods. This is a point in the company’s favor.

Not so encouraging is the frequent use of words like “natural” and “artificial” to imply that the product must be safe. The advertising even goes so far as to claim there are “no chemicals” in the product, which is nonsense since water, blueberry juice, and every other ingredient is a “chemical.”

As I have often pointed out, botulism and uranium are “natural” and polio vaccine and penicillin are “artificial,” so these words don’t really mean what they are implied to mean. In any case, several of the ingredients have recognized health risks in humans, and most have not apparently been tested for safety in dogs or cats. And it is impossible to tell from the web site how much of the various ingredients are in the product, so no definitive statements about safety can be made.  I would be surprised if there are any significant risks from the product since it would require an awful lot of most of the ingredients to be dangerous as far as I can tell, so I’m not especially worried about the safety issue. But the claims of safety are really assumptions based on the naturalistic fallacy, and supposedly safe herbal and homeopathic remedies have turned out to be harmful in the past (e.g. cinnamon bark and homeopathic belladonna), so at least a little caution is appropriate.

Summary
There are some very limited in vitro and human clinical data to suggest it is plausible that the ingredients in this product might have some benefit in preventing dental disease. The only research actually testing the product in a veterinary species (dogs) showed benefits, but some caution is warranted in interpreting these results because they are unpublished, industry-funded trials with a lack of robust methodological controls for bias and other non-treatment effects. There is no significant evidence of any real risk from the product, though it doesn’t appear that most of the ingredients, alone or in combination, have been tested for safety in cats and dogs. The company generally markets the product in a responsible way, though it does make use of some misleading advertising strategies such as promotion through testimonials and invocation of the naturalistic fallacy.

Overall, I am inclined neither to recommend the product nor to recommend against it. I applaud the company for taking the first steps in conducting the research necessary to obtain VOHC approval, and I hope additional research, ideally independent and better designed, is eventually carried out to further clarify whether this product has real safety and meaningful efficacy. I agree wholeheartedly with the company that dental disease is a serious condition and that most pets do not receive adequate preventative care or treatment, so I hope additional research does eventually show this product to be a useful adjunct to other oral care practices, but I think it the case has not yet been effectively made.

Posted in Herbs and Supplements | 141 Comments

AVMA Solicits Comment on Model Veterinary Practice Act

The American Veterinary Medical Association maintains a model state veterinary medical practice act, which states often refer to when crafting their own practice acts for licensing and regulating veterinarians. Periodically, the AVMA solicits comments from its members and updates this document. The organization is currently accepting such comments until February 15, 2011. The document can be viewed here, and AVMA members can make comments on specific sections.

As I have discussed before, in general terms and with reference to specific veterinarians, it can be difficult for state veterinary medical boards to effectively enforce a reasonable standard of care and protect pets and their owners from inappropriate or pseudoscientific treatments if the language of the law does not offer specific grounds for such enforcement. Since the language of the AVMA model practice act is often used as a basis for states when drafting their own laws, it has some influence on these laws. And because the AVMA is a membership organization dedicated primarily to representing the veterinary profession, the language of the model practice act is dependent on the internal politics of the organization. As with most such processes, the apathy of the majority increases the influence of those who choose to participate. 

I encourage any AVMA member veterinarians to examine the act and offer comments. Below are a few suggestions I have made with regard to my concerns about alternative veterinary medical practices.

Section 2-7 Complementary and Alternative Medicine

The language “may differ from current scientific knowledge” and “may diverge from veterinary medicine routinely taught…” both imply separate but equal bases for knowledge and curriculum standards. However, as a science-based profession, all veterinary medical therapies should be held to the same standard of evidence, namely that of accepted science-based research. It would be more appropriate, and more effective in protecting the public, if the language read:

“…at the time they are performed are not consistent with established scientific knowledge or supported by broadly accepted scientific research…”

“…theoretical bases and techniques are not part of the science-based veterinary medicine routinely taught in accredited…”

Section 14-Discipline of Licensees

An important element of a medical practice act is protecting the public from substandard or inappropriate care. Unless the basis of actions against veterinarians providing inappropriate care are clearly defined in the practice act, courts are reluctant to discipline licensed veterinarians. The following are examples of language, drawn from the Federation of State Medical Boards (http://www.fsmb.org/pdf/2003_grpol_Modern_Medical_Practice_Act.pdf) and specific medical practice acts regulating M.D.s, which give the medical board adequate authority to enforce an acceptable standard of care.

“making a false or misleading statement regarding his or her skill or the efficacy or value of the medicine, treatment or remedy prescribed by him or her or at his or her direction in the treatment

of any disease or other condition ”

“representing to a patient that an incurable condition, sickness, disease or injury can be cured”

“any adverse judgment, award or settlement against the licensee resulting from a medical liability claim related to acts or conduct similar to acts or conduct that would constitute grounds for action as defined in this section”

“providing treatment or consultation recommendations, including issuing a prescription, via electronic or other means, unless the [veterinarian] has obtained a history and physical evaluation of the patient adequate to establish diagnosis and identify underlying conditions and/or contraindications to the treatment recommended/provided”

“employing methods of treatment or diagnosis that do not conform to the standards of acceptable and prevailing scientific medical practice”

Posted in Law, Regulation, and Politics | 9 Comments

Skepticism about Glucosamine for Arthritis in Dogs and Cats is Growing

Ok, maybe not. But still, any sign that folks are questioning this ubiquitous practice is a good thing.

I have written a number of times about the question of whether or not oral glucosamine and chondroitin are useful for arthritis in dogs and cats. Overall, the evidence in humans suggests it is likely no better than a placebo, and the much more limited evidence concerning veterinary uses is no better. Despite this, many veterinarians refuse to acknowledge the lack of support for their assumptions that glucosamine is beneficial. In looking for any skeptical perspectives on this subject, I was only able to find a couple.

A recent short feature in the Journal of the American Veterinary Medical Association posed the clinical question,

Would treatment with a supplement containing glucosamine and chondroitin be likely to yield a clinically meaningful improvement in the signs of chronic osteoarthritis in a dog without unacceptable adverse effects, either as an alternative or adjunct to NSAID treatment?

The answer, based on a brief review of the limited available literature was,

there was insufficient evidence to support a recommendation of glucosamine and chondroitin as an alternative to NSAID medication for treatment of clinical signs attributed to osteoarthritis in dogs…No literature addressing the possible use of a glucosamine-chondroitin product as an adjunct to NSAID treatment was identified.

A popular veterinary blog has also commented on recent studies in humans showing oral glucosamine to be no better than placebo for arthritis. The author expresses succinctly my own feelings on the subject:

I wish oral glucosamine worked. I want it to work. But I want many things that I cannot have. Effective arthritis treatment with oral glucosamine evidently is one of them.

Interestingly, the only other critical comments on veterinary glucosamine use I found was from a decidedly unscientific perspective. A proponent of BARF diets (which, as I’ve discussed previously, is even less rational a practice than using glucosamine) turns the unscientific and evidence-free arguments for raw diets against glucosamine supplements, He claims that,

glucosamine for dogs cannot work for any canine on a commercial dog food diet when the cocktail of chemicals they are comprised of routinely strip bones and joints of much needed nutrients…Only dogs on a diet of raw meat and bone have the proper balance of nutrients to ensure good bone and joint health throughout life.

Not exactly a position I can endorse, even if it sounds on the surface like it leads to the same conclusion on joint supplements. Glucosamine may not have significant proven benefits, but the risks are also apparently negligible. While the evidence does not suggest raw diets are beneficial, the evidence of potential harm is certainly greater than that for glucosamine, although still apparently quite small.

Obviously, the majority of veterinarians and pet owners are still more influenced by personal experiences and anecdotes that suggest glucosamine is beneficial than by the solid research data that shows it is not. Hopefully, the presence of at least a few skeptical voices will motivate more people to question the hype surrounding this supplement and to look closely  at the evidence.

If anyone finds any additional skeptical points of view on this subject, please let me know!

Posted in Herbs and Supplements | 96 Comments

Study finds maternal use of CAM decreases compliance with recommended childhood vaccinations

One of the concerns I have about complementary and alternative medicine (CAM) is that it tends to come packaged with a philosophy or point of view which is hostile to scientific medicine. Even if specific CAM interventions are themselves harmless or even beneficial, CAM use seems to go along with irrational and unfounded or exaggerated fears of conventional medicine so that on balance the patient is harmed by not being able to utilize established therapies. The case of Dr. Gloria Dodd I recently discussed is a textbook example of this.

While the “complementary” approach in CAM is supposed to avoid this by marketing CAM interventions as compatible with conventional medicine, the underlying vitalist philosophy and epistemology of many CAM approaches is fundamentally incompatible with a scientific understanding of the world, so I suspect there is still a tendency for those who are attracted to CAM to shun much of conventional medical science.

A small  bit of evidence to support this suspicion is contained in a study recently released in the journal Vaccine:

Jessop LJ, Murrin C, Lotya J, Clarke AT, O’Mahony D, Fallon UB, Johnson H, Bury G, Kelleher CC, Murphy AW; Lifeways Cohort Study Steering Group. Socio-demographic and health-related predictors of uptake of first MMR immunisation in the Lifeways Cohort Study. Vaccine. 2010 Aug 31;28(38):6338-43.

I haven’t been able to access the complete study, so I can’t comment on the methodology or whether the definition of CAM is appropriate (though I would appreciate it if anyone who can could pass it along or comment). But the conclusions are at least consistent with other evidence on the subject. According to the authors, “These data confirm prospectively for the first time that in addition to factors associated with disadvantage, other health practices and beliefs, particularly mother’s complementary and alternative medicine use, are associated with decreased MMR uptake (adjusted OR 2.65 (1.76-3.98)).”

Lower socioeconomic status is well-established as a factor reducing compliance with recommended childhood vaccination regimes. And decreased compliance is clearly associated with increased occurrence of vaccine-preventable diseases. However, this study also appears to show that a mother’s use of CAM is also associated with decreased compliance with recommended vaccination. Such indirect risks of CAM must not be ignored in evaluating the balance of risks and benefits for such approaches since they do represent a real source of harm to CAM users.

Update: January 9, 2011

A kind reader sent me a complete copy of the study, which I have had a chance to review. It provides an interesting look at the factors that influence compliance with recommended immunizations in Ireland, a country which has seen measles outbreaks, predominantly among unvaccinated children, in the aftermath of the Wakefield MMR/Autism hoax. I am particularly interested in the issue of whether CAM use is predictive of non-compliance with vaccine recommendations. I suspect it would be, since I believe one of the forms of indirect harm attributable to CAM is the rejection of conventional medical interventions, due to certain attitudes and philosophical positions that likely underlie both. However, I’m not aware of extensive research to support this hypothesis, and it is unclear to what extent this study can be seen as providing supportive data.

One big challenge in surveys examining CAM use and associated attitudes or behaviors is defining CAM. The authors of this study used the definition of the National Center for Complementary and Alternative Medicine (NCCAM) at the NIH:

a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine

This is a pretty loose definition, and of course begs the question of what “conventional medicine” is and how it differs from CAM. But the more salient issue is how exactly the survey participants were asked about their CAM use. A general question involving language such as that in the definition above is likely to generate different responses than, for example, a series of questions asking about specific CAM practices (acupuncture, chiropractic, TCM, etc). The latter would probably be more useful, but of course is harder to accommodate within the logistics of a survey.

This issue has been discussed with respect to previous surveys looking at the popularity of CAM. The significance of the results obtained depends on the definitions used. If respondents are asked about massage, prayer, diet, or other common practices, they may report high rates of CAM usage. But these practices do not necessarily share common philosophical underpinnings with more specific CAM modalities such as acupuncture or homeopathy, so these reports can be misleading if one’s goal is to assess underling attitudes or predict responsiveness to public health education.

I have not yet been able to ascertain how the CAM use data was collected in this study, but I have contacted the lead author to see if that information is available.

Januray 15, 2011

The lead author was kind enough to respond to my query. The original questionnaire apparently had only one question that essentially asked if the respondent had ever used complementary and alternative medicine, with no definition or examples provided. The authors also found that those who self-reported they had seen an alternative practitioner were less likely to have had primary imunizations given to their children, as well as the boosters discussed in the paper referenced above.

Obviously, more specific, detailed information regarding the relationship between specific CAM practices as well as CAM generally and use or avoidance of conventional medicine is needed. But the results of these studies certainly bolsters the impression, found also in much CAM advertising, that the ideology behind CAM use is often hostile to scientific medicine.

Posted in General, Vaccines | 2 Comments

Dr. Gloria Dodd-A Case Study in the Failure of Government Regulation of Veterinary Medicine

I have written at length about the relationship between unproven, unscientific, and pseudoscientific alternative medicine and the legal and regulatory systems intended to protect the public from quackery (including Medical Licensure, Malpractice Law, and Regulation of Drugs, Supplements, and Homeopathy). In researching these issues, I discovered how little importance scientific validity has as a criterion for establishing and judging the legality of medical practices. Politicians, lawyers, and judges are more concerned with the issues of their own domains, including what the public wants, the tension between the public good and the rights of the individual, the right of individuals to earn a living, and others. These are all legitimate issue, but the debates and legal decisions related to alternative medicine often seem backwards to me. If a therapeutic approach is clearly ineffective or dangerous then it makes no sense to protect it as a “choice” or a “right.” And if the claims a provider makes about their therapies are manifestly untrue by objective scientific standards, then how can they have a “right” to lie to people, even unknowingly? How is prohibiting people from selling false hope and ineffective therapies to the sick or dying an inappropriate government interference with individual rights?

In any case, past attempts of government to regulate medical practices have certainly had some beneficial effects. Though most “healthcare choice” and alternative medicine advocates ignore or don’t recognize it, there is ample evidence (and here) that in the freewheeling days before the Food and Drug Administration and state medical licensure quacks of innumerable varieties sold useless or outright harmful nostrums and procedures that hurt or killed people. Unfortunately, there is also clear evidence that these efforts have been far less successful than we might hope, and quackery continues to thrive.

A case example in the veterinary field is Dr. Gloria Dodd. According to her web site, Dr. Dodd graduated from the University of California at Davis School of Veterinary Medicine in 1960. She is a bit of a celebrity and well-regarded in the alternative veterinary medicine community. She is an author and speaker and is involved in the American Holistic Veterinary Medical Association and other CAVM organizations. Her state veterinary license is current, though she states that she is retired, and she has a consulting business and an internet-based store for selling a variety of healthcare products, Everglo Natural Veterinary Services.

Dr. Dodd is a proponent of truly alternative medicine. Apart from a few emergency measures, such as intravenous fluids, fracture repair, blood transfusions and so on, she universally condemns conventional medical treatments as “toxic” and “traumatic and foreign to the body.”  Her overall philosophy of healthcare is classic vitalism, which views illness in the physical body as a secondary symptom of primary abnormalities in the spirit of “Life Force” of the patient, most of which are due to unnatural human activities. Here is a selection of descriptions of her theoretical approach from her web site.

3000 years of oriental medicine has proven there is a Life Force energy (Chi) that flows like the arborization of a tree throughout the entire body, touching every cell of every organ of every system in the body…Health is maintained by a balance of two opposing energy flows, Yin and Yang, which make up this Life Force. Each cell of each organ of each system has both Yin and Yang energy flows. Any imbalance, either deficiency or excess of these energies produce aberrations that filter down into the physical body and produce what we see as “symptoms”. Any “cure” in the patient as seen by the doctor as a relief of these symptoms, MUST occur in the balancing of this excess or deficiency of these two opposing energy flows.

Cure CANNOT be achieved in the physical body alone…It is as if there is a dirty spot on a lens of a slide projector that is projecting an image on a screen. The traditional doctor works away on scrubbing the spot off the screen, while the holistic doctor cleans the lens, the cause of the spot on the screen.

…WE GET SICK FROM ANY AND ALL THINGS THAT WEAKEN THE BODY’S PROTECTIVE ELECTROMAGNETIC FORCE FIELD OR LIFE FORCE. We have to stop thinking of our animals as physical beings alone. All things exist in physical and energy forms…

Why Do Animals Get Sick?

  • Inheritance of a genetic code that is flawed and produces a weakened constitution. This may produce impaired organ function, immune response or coping with stress. Yes animals do suffer illnesses due to stress as we do.
  • Environmental toxins– chemicals in the food, water and air that is foreign to the metabolism of the body. To this I add the toxic affects of drugs and vaccines.
  • Trauma to any part of the body but especially to the head, which deranges the natural flow of Chi or Life Force. This touches every cell in the body depriving it of the needed energy for health.
  • Noxious energy fields where we work and live. These are EMF’s of the earth known as Geopathic forces and man-made noxious EMF’s. Geopathic forces are produced where two underground streams of water intersect, giving up a ray of energy. Any animal confined over this point for a period of time will develop painful arthritis, malfunction of the internal organs and impairment of the immune system. I have seen cases of cancer in animals in such areas. In Europe there are documented areas known as “Cancer” houses where people and animals living there, have developed this disease down through the years… Man-made noxious energy fields are more important, because this element is becoming more omnipresent. Every electrified building, system of telephones, computers, radios, television, telecommunication of every nature from cellular telephones to military and commercial satellites in the stratosphere, which circle this planet, are radiating an ever widening destructive force field to our bodies.  
  •  
  • Chronic Stress of emotional, physical illness, and toxicity and exposures to noxious energy fields in the environment. Please see my new product Anti-Stress Support Formula 30C
  • CHANGE THE ENERGY OF THE ENVIRONMENT BOTH INTERNALLY AND EXTERNALLY.

Despite the best health care that this country has available, many animals and people still suffer from chronic degenerative diseases. There are many reasons for this; i.e., misdiagnosis, failure of the patient to follow through with therapy, adverse affects of combining different drug therapies prescribed by more than one doctor (iatrogenics), the deleterious affects of persistent chemical exposures of environmental pollutants and pesticides, poor nutrition, genetic weaknesses and persistent stress.

However, there is one more factor that has just come to light in the United States and this is the noxious energy radiation fields from the earth…What are geopathic noxious energies? These are noxious earth rays that come where underground water veins cross; locations of earthquake fracture faults, underground voids (caverns or hollows) in the rock structure and certain deposits of coal, oil and minerals.

These are natural disturbances in energy flows, but there are noxious energies that are man-made too. These are microwave, television, electrical transformers, high- energy electrical power lines, and all electrical units; fluorescent lights (which are insidiously weakening to the health), computers, printers, copiers, cellular telephones, your electrical typewriter and radio. Additional noxious energy fields by man are the increasing numbers of satellites launched overhead by both the military and commerce…There is an increased griding[sic] of this planet by telecommunications on land, in the air and within the oceans. Especially damaging are the ELF rays, (extremely low frequency bands) broadcasted by the military and foreign countries.

Many of these ideas are truly alternative in the sense that for them to be true, many fundamental established principles of science must be false. And many of these are fundamentally faith claims because they cannot be proven or disproven by any objective means but must be believed in and understand through personal intuition and experience.

Such untestable beliefs are, of course, common. Most people in the world believe in things science cannot test, examine, or prove true or false. The problem with basing medical therapies on such beliefs, however, is that there is no way beyond the experience and faith of the individual to know if you are right or wrong. And as I have discussed many times, the evidence is overwhelming that individual judgment and experience is unreliable in deciding which medical therapies work and which don’t.

Science functions on the basis of doubt and skepticism, and these have been stunningly successful strategies in compensating for the natural tendency of people to believe what they want and to seek only confirmation of these beliefs. In contrast, trying to prove something wrong is actively discouraged in vitalist philosophies such as that of Dr. Dodd because such “negative” thinking supposedly interferes with the processes involved in maintaining and restoring health.

Such intuitive, faith-based theories were the basis for medicine, such as it was, for most of human history, and these medical approaches were a dismal failure. Human life remained short and uncomfortable for thousands of years, and the scourges of malnutrition and infectious disease raged unchecked. The scientific approach has changed this dramatically in a mere couple of centuries. The evident failure of so many methods based on such beliefs, and the successes of scientific medicine, argue strongly that a scientific, naturalistic approach to medicine works better, regardless of how one feels about the underlying issue of belief in supernatural forces.

Dr. Dodd does stray out of the territory of pure mysticism and into pseudoscience in her theories as well, by claiming to be able to photograph the Life Force and both measure and manipulate it with electronic devices. The specific processes she uses have been soundly disproven, as have most of the more “mainstream” alternative methods she uses.

In the interest of brevity, rather than critiquing all of the specific methods she uses and why they are, in most cases, utterly useless and without merit, I will simply list a number of those she highlights on her web site with a brief description and links to more detailed discussions of each. In general, her therapies involve underlying principles that contradict well-established principles of science, have not been and perhaps cannot be objectively proven or disproven, and have primarily or exclusively testimonial evidence to support them. None of them come close to meeting the prevailing standards of acceptable care in mainstream, science-based medicine which, theoretically at least, state licensing laws and malpractice laws require doctors to adhere to.

1. Kirlian Photography: This is a pseudoscientific practice that advocates claim can take pictures of the “aura” or “Life Force” of a patient and identify abnormalities and response to treatment. Dr. Dodd has several examples of such photos purporting to show abnormalities and improvements with treatment. (1, 2)

2. Dowsing: Dr. Dodd claims “health hazard earth-made energies can only be detected and diverted by a skilled dowser.” Dowsing is a process of locating water, minerals, or apparently “energies” through mystical intuition and some sort of tool, from a simple forked stick to complex devices. Apparently, Dr. Dodd does not even need to come to your house to detect and “divert” noxious energies. You just have to email her a plan of the house and a list of health symptoms and for only $200 she will deal with the problem remotely. (3)

4. Hair Analysis for Heavy Metals: A classic quack medical test designed to provide a rationale for equally bogus “detoxification” treatments. (4, 5)

5. Color Therapy: In this bit of nonsense, the body is believed to have locations (chakras) which are magical energy centers that somehow have associated colors, and thus diseases in particular organs are due to energy imbalances which can be corrected by exposing the patient to that color. (6, 7).

6. Crystal Healing: Yet another form of “energy medicine” in which mystical energies are thought to be manipulated through magic crystals. (8, 9)

7. Oral Oxygen Therapy: This relies on the mistaken belief that disease is caused by inadequate oxygen in the blood (wait, I thought it was caused by unbalanced Chi, or Yin/Yang. Or was it noxious geopathic energy waves? Toxins? How many “most important” causes of disease are there?). Of course all living things need oxygen, but this is pure pseudoscience, mixing bits of basic chemistry, atmospheric science, and biology with magical thinking. In cases where a patient needs more oxygen is needed in their blood (such as carbon monoxide poisoning or anemia), they certainly won’t be helped by drinking hydrogen peroxide or Dr. Dodd’s magical “crystal-charged” spring water. And too much oxygen can be toxic. Fortunately, she also sells anti-oxidants! (10, 11)

7. Homeopathy: The old classic but with one new twist (new to me anyway): “I see a bright future for homeopathy in eugenic treatment, treating animals in utero. Homeopathy lessens genetic tendency toward disease and by strengthening the breeding stock, “super babies” are produced.” (12, 13)

8. Radionics Broadcasting: This bit of quackery speaks for itself (14):

Today our planet’s air, water, food crops and livestock are polluted by Man’s intervention into Nature. It is his alphabet soup of chemicals, vaccines and doctor produced illness by drugs that must be sequentially detoxed with homeopathic nosodes made from these specific causative agents before acupuncture can be of benefit…A wonderful adjunct therapy to my use of German Sequential

Detoxification and Support with German homeopathic Nosodes/ Support homeopathy, is the European method of Radionics Broadcasting. Strange as it may seem, one can take the exact homeopathics that are needed to treat a patient, and make them into the highest potencies of DCM and place them in an electromagnetic machine (a Radionics machine) and broadcast this energy to the patient via the patient’s own witness.

A witness can be a photo, blood spot or hair sample of the patient. This energy is received and utilized by the patient! Many times, the patient improves with this broadcasting alone, even before giving the remedies orally.

This list could go on for a long, long time, with a lot of other truly bizarre nonsense as well as a solid dose of the standard “mainstream” CAVM  like acupuncture and chiropractic. But the big picture should be pretty clear:

A) Most disease is caused by unnatural human activities, with scientific medicine and nutrition being a leading culprit despite the apparent (but I suppose imaginary) improvements these have brought about in human and animal health.

B) All unscientific or pseudoscientific medical theories are true so long as they make some reference to some kind of mystical energy or Life Force and avoid imaging that the cause and solution to disease lies in the bodies of our patients. The fact that the details of chakras, Chi, chiropractic’s innate intelligence, and all the other vitalist theories contradict one another is not a concern.

C) There is no scientific evidence accepted as legitimate outside of the circle of CAM true believers to support any of these therapies. This is also not a problem because Dr. Dodd has actually seen these things work for herself, and she spent 16 years practices the inferiors kind of scientific medicine the rest of us still believe in so she knows it doesn’t work.

Apart from the extremity of her views and practices, Dr. Dodd is not unlike many notable figures in alternative veterinary medicine. She has some background in conventional medicine, which she has rejected as inadequate. She has adopted a wide variety of theoretically incompatible treatment methodologies that are also mostly incompatible with established science. She truly believes, based on her personal experiences, that these therapies work, and she dismisses any objective evidence that contradicts her beliefs. She is also deeply religious and sees faith in the unseen as an indispensible part of understanding how the world works, including understanding health and disease. I have no doubt she is a nice, caring, and sincere person.

The reason I chose to use Dr. Dodd as a case study is because her interactions with the government mechanisms intended to regulate veterinary medicine and, in theory, ensure some standard of legitimate, effective care illustrate especially well the problems with such mechanisms. She makes her living providing healthcare products and treatments that mainstream scientific medicine judges as questionable at best and often outright useless. She deliberately and openly rejects both the mainstream scientific approach to disease, all the evidence for it and against her methods, and any attempt by government to require her to adhere to standards of care the veterinary profession believes are appropriate.

Dr. Dodd was the subject of a California Veterinary Medical Board (VMB) action which was decided by an administrative law judge and ultimately reviewed in superior court. The superior court decision is available on the internet and describes the  VMB allegations and the administrative law judge’s ruling, though it does not detail the evidence presented to support and defend against the allegations. The accusations of the VMB were as follows:

The accusations three cause[s] for discipline were characterized as Sales of Products via Internet, Treatment of Phido,  and Violation of Local Rabies Ordinance. These charged Dodd with false or misleading advertising, violation of federal drug laws, violation of a local rabies ordinance, and fraud, deception, negligence and/or incompetence in the practice of veterinary medicine. (See Bus. & Prof. Code,  4883, subds. (f), (g)(3) & (i).) They also alleged she had dispensed dangerous drugs or devices without a license. (Health & Saf. Code,  11352.1.) Additionally, they stated Dodd had, in treating Phido, violated two state regulations. (See Bus. & Prof. Code,  4883, subd. (o).) The first regulation requires veterinarians to act in a manner consistent with current veterinary medical practice in this state. (Cal. Code Regs., tit. 16,  2032 (regulation section 2032).) The other regulation section 2032.1requires establishment of the veterinarian-client-patient relationship.

According to an account of the original judicial review (written by a supporter of Dr. Dodd who testified as an “expert” witness on radionic therapy), the VMB presented facts about Dr. Dodd’s practices and the relevant laws and regulations, while Dr. Dodd responded with client and colleague testimonials to her skill and efficacy. According to the same source, VMB documents had characterized Dr. Dodd’s practices this way:

Its[sic] a smoke and mirror power of magic type of practice…bizarre…no medically scientific basis for the idea that she can detect disease in a patient who is 3000 miles away…ludicrous that she can broadcast therapy across the same distance…claims defy basic established principles of physics

These certainly seem fair, even self-evident characterizations to me, and it is not surprising that the VMB might have expected the courts to view them in the same light. But unfortunately, as I discussed in my articles on medical law, courts rarely take a scientific perspective on medical matters.

The Dodd supporter and “expert” witness records being optimistic that the administrative law judge would rule in Dr. Dodd’s favor because he appeared to be ethnically Chinese and so “may have been familiar with Chinese medicine and the functions of “chi”, which, in the Chinese system, is a kind of “vital fluid” or “force” operating on a non-mechanical “subtle” level.” I’m not sure if this witness was correct, but according to his report the judge seemed convinced by the testimonial evidence Dr. Dodd presented that her practices were generally appropriate.

In any case, according to the summary from the superior court judgment, the ruling was overwhelmingly in Dr. Dodd’s favor:

In the revised proposed opinion adopted as the Boards decision, the ALJ noted the Board had the burden of proving cause for discipline under the clear and convincing standard of proof. (See Ettinger v. Board of Medical Quality Assurance (1982) 135 Cal.App.3d 853, 856.) With respect to the cause for discipline entitled Violation of Local Rabies Ordinances, the ALJ concluded the Board had not met its burden of proof. Similarly, regarding the cause for discipline relating to Sales of Products via Internet, the ALJ concluded that the Board had failed to show that Dodd had engaged in false or misleading advertising, or that she had committed fraud, deception, negligence and/or incompetence…On the other hand, the ALJ concluded that the Board had shown cause for discipline for violation of a federal drug law (Bus. & Prof. Code,  4883, subd. (g)(3)), in that Dodd herself had acknowledged such a violation in connection with federal regulations requiring licenses for the preparation and production of biological products. The ALJ noted, however, that Dodd was now in compliance with federal requirements.[this refers to an FDA action against Dr. Dodd, discussed below]

As for the cause for discipline concerning Treatment of Phido,  the ALJ concluded the Board had shown a cause for discipline for unprofessional conduct. (Bus. & Prof. Code,  4883, subd. (g).) Again, this was based not so much on the evidence presented by the Board as on Dodds acknowledgment that she was subject to discipline on this ground after dispensing lactated ringers and hypodermic needles to G.E. Otherwise, the ALJ concluded the Board had not proved any false or misleading advertising, any violation of federal drug laws, or any fraud, deception, negligence and/or incompetence in connection with her treatment of Phido.

The judge did find against Dr. Dodd on the issue of not conducting physical examinations of her patients, and revoked her license. However, he immediately suspended the revocation and put her on probation with the understanding that she would actually see and examine patients if she intended to be their primary doctor. He did allow that she might not have to meet this requirement if she were to act only as a “consultant,” which is how she now advertises her services.

On balance, the judge felt that the VMB had not proved its allegations. This may have been the fault of the VMB, which may have assumed as I would have that the conduct at issue was so manifestly irrational and incompatible with accepted medical standards that providing extensive evidence and testimony to this effect would not be necessary. If the characterization of her methods attributed to the VMB above accurately reflects the Board’s attitude, then this may well be the case.

However, there are suggestions that the judge also found in Dr. Dodd’s favor for reasons that have more to do with how lawyers and lay people see the issues of medical regulation than a simple failing of the VMB to adequately argue its case. Again, from the superior court’s summary:

[the administrative law judge] detailed other circumstances mitigating against the license revocation sought by the Board, including evidence that she had changed or ceased the conduct found to be a cause for discipline, the lack of evidence she had ever actually harmed an animal, the lack of any prior disciplinary action in over 45 years of practice, and scores of testimonials from clients and fellow veterinarians attesting to Dodds[sic] integrity and the quality of her care.

The lack of evidence of direct harm is often a point raised in favor of permitting the practice of ineffective or bogus therapies. This argument is mistaken on several bases. First, there often is direct harm from therapies marketed as safe or “natural.” Even something like homeopathy, which is usually nothing more than water, can be harmful when it actually contains some of the original compound, such as the teething remedy for babies containing poisonous belladonna. And far more difficult to quantify is the indirect harm caused by discouraging patients from seeking truly effective therapies or blaming imaginary causes for illness rather than finding and dealing with the real cause.

The issue of testimonials as evidence is, of course, a core issue distinguishing science-based medicine from alternative medicine. As non-scientists, judges are unfortunately rather likely to mistakenly imagine that scientific truth is a popularity contest, and if they are presented with testimony from doctors or patients/clients that a quack therapy has been effective, they may accept this regardless of the state of the actual objective evidence.

Dr. Dodd appealed even the limited probationary terms that required she “obey all federal and state laws and regulations substantially related to the practice of veterinary medicine” because she argued they would prevent her from practicing her profession and deny clients access to her services. The supporting briefs filed on Dodd’s behalf by clients and other veterinarians argued “the Boards[sic] interpretation of regulation section 2032.1, so as to require a physical examination of an animal patient in order to establish a veterinarian-client-patient relationship, is calculated solely to attack [Dodds] form of alternative veterinary medicine without any substantive justification.”

The administrative law judge did not accept this reasoning, but concluded that while “the Boards[sic] interpretation was reasonable as a general rule…it may be possible to comply with the regulation in other ways (for example by remote video, telemetry, other technology, or as a consulting veterinarian).” Claiming status as a consultant has allowed Dodd’s to practice legally without even the minimal requirement that she ever see the patients she treats, so long as another veterinarian who does see the patient agrees to take formal responsibility for the case.

This seems a bit of a sham on the face of it, and it doesn’t of course address the issue of Dr. Dodd’s selling products intended to diagnosis, treat, and cure disease over the internet without any kind of relationship with client or patient at all. That, of course, would fall under the jurisdiction of the FDA rather than the state veterinary medical board. And interestingly enough, Dr. Dodd has had some interactions with the FDA over this very issue.

In 2004, the FDA sent Dr. Dodd a letter informing her that her sale of nosodes, so-called “homeopathic vaccines,” for West Nile Virus was in violation of federal law. The claims made for the safety and efficacy of these products can only be made for approved drugs which have objective research to substantiate claims about their risks and benefits. Essentially, she was selling water and claiming it could protect people and animals against a dangerous infectious disease, and the FDA quite reasonably told her to stop. This was her response:

In response to your letter of Feb. 25, 2003, I called your office to clarify the USDA’s definition of “biologics”. Essentially I learned it is any product that has the claim of immunizing an animal against disease. I sell homeopathic Nosode remedies, which do not contain any biological agents, yet historically they have proven to not only detox drug vaccines noxious effects but confer immunity. We have over 300 years written documentation of homeopathic nosodes being used to immunize livestock (re: Dr. Wilhelm Lux in Germany circa 1700’s) against Anthrax, Black Leg etc. and more recently in Great Britain, homeopathic veterinarians are using homeopathic Detox Vaccinosis nosodes to immunize against the common dog and cat virus/bacterial diseases with much success, and no serious side effects like the drug vaccines cause. However in this country in order to be licensed, I would be unable financially to undergo the rigid and expensive testing to prove their efficacy.

I have instructed my web master to edit my web page, to delete any reference to these remedies being used to immunize animals…I hope this settles the matter satisfactorily for you.

She then provides a link to a page full of myths, misinformation, and propaganda that urges voters to lobby sympathetic legislators for an exemption of nosodes from federal vaccine laws.

Of course, the claims that nosodes contain no biologic materials is true. The claim that they confer immunity is completely false. And while there are risks to vaccination, they are far smaller than Dr. Dodd claims and they must be balanced against the risk of the diseases against which they protect. (See this article for a more detailed discussion of veterinary vaccines). Unfortunately, even this extremely limited effort to apply public health protection laws to rein in Dr. Dodd’s use of ineffective therapies was itself ineffective. Dr. Dodd still sells these products, and her description of them still claims safety and efficacy in an unmistakable way, though in a way that just might comply with the letter of the law:

Detox noxious affects of the drug vaccine given and strengthen the EMF with my newly developed Detox Homeopathy West Nile Virus nosode 30C. The safe, non-toxic and effective way. There is a killed virus vaccine being sold under governmental limited license by Fort Dodge for horses, but like any drug vaccination we have found many horses develop “Vaccinosis “ following vaccination with this drug vaccine. Vaccinosis is a medical term for illness caused by vaccines. We have seen mare abortions, fetal anomalies, very high fever, lethargy and some cases of paralysis and death after the vaccine is administered. I recommend using the homeopathic nosodal form to Detox Vaccinosis and strengthen the EMF to keep your horses healthy and strong.. My Detox Vaccinosis nosode comes in two forms: Homeopathic Detox WNV nosode 30C for dogs, and orses[sic] or combined with Leptospirosis Pomona ( Homeopathic Detox WNV /Lepto Pomona nosode 30C for horses) Lepto Pomona bacteria has been incriminated in producing uveitis and blindness in horses. So I am giving you two very important nosodes for the price of one for horses. Available in 250 tab bottles for $69.95 plus S/H. [emphasis in original]

West Nile Virus Vaccinosis Detox Nosode Formula 30C- to build EMF after detoxing with 12X, 30C, 60C or if animal that has never had the drug vaccines yet, use this in lieu of drug vaccines. FDA #1042 [emphasis added]

As I stated before, I have no doubt Dr. Dodd sincerely believes she is doing good work, and that she is a caring veterinarian. I also believe she is utterly deluded in her approach to medicine, and that her remedies do little to no good and potentially harm her patients by discouraging them from receiving appropriate disease prevention and treatment. I have no doubt that her activities violate any conceivable mainstream, scientific standard of care. So why, then, do the laws and regulations in place ostensibly to enforce such a standard and protect the public against irrational and ineffective medical care fail to interfere in any meaningful way with her practice?

I think the answer is simply that government cannot be an effective arbiter of scientific truth nor an effective force of restraint against nonsense that is sufficiently popular and not sufficiently obvious and direct in the harm it causes. Scientific truth may not be a popularity contest, but of course in a democracy government largely is.

The features of our system which protect our freedom of thought and expression and our right to hold unpopular views also hamstring government efforts to enforce reasonable objective standards on medicine. The tension between individual freedom and the public good tends to be resolved in favor of the individual, and while one can debate whether this is right or wrong, it is a fact of our culture and our government.

Legislators are likely to write laws with more concern for such ideological issues, and the wishes of their constituents, than for what is actually true or false. And judges are likely to be as or more concerned about the right of an individual to practice their profession, or to choose the medical therapy they want, than about whether the therapies involved actually work or not. And not being trained as scientists, judges are often fooled by pseudoscientific arguments and the psychological power of anecdote and testimonial, and they are likely to interpret the laws from this perspective, with the objective scientific facts being a secondary consideration.

Certainly, this is not always true. And there have been cases in which even judges expected to favor a pseudoscientific position due to their personal biases have appreciated and respected the true scientific position, such as in the Dover, PA case concerning the teaching of the pseudoscientific notion of  intelligent design in public schools. However, as a general rule, we cannot expect government to have the resources or the political will to retrain any but the most dangerous and extreme forms of medical nonsense, as Dr. Dodd’s case illustrates.

So while I certainly support educating and lobbying legislators to enact and enforce laws based on sound science, I think the more productive avenue to maintaining a marginal status for ineffective or quack therapies is through education. Pet owners, and the public in general, may not have the knowledge and training to see through the pseudoscientific fog around many of these ideas, but they are not stupid, and they are highly motivated to seek the best care for their pets.

One of the most important reasons scientific medicine has largely replaced traditional folk medicine so rapidly and thoroughly is simply that it works better and people can see this. My grandmother may have only had a limited rural education, but she saw the terror of polio and how effectively vaccination destroyed it, and this and many other examples of the success of scientific medicine gave her a pragmatic skepticism of snake oil that did not require her to care about abstract philosophical principles of epistemology and the scientific method.

Of course, such principles are the cornerstone of why the edifice of science is stronger than that of opinion-based and faith-based medicine, and we certainly should teach them and good critical thinking skills. And it is important that we try to emphasize the unreliability of such empty, though compelling, forms of evidence as personal anecdotes and testimonials. But we also shouldn’t let the perfect be the enemy of the good, and this means we must use all the tools at our disposal. Web sites like What’s the Harm are an important educational tool, and though I am by temperament more inclined towards the more abstract and philosophical forms of public education, I fully support such efforts as well.

And, of course, we must educate veterinarians. As I so often repeat, the biases and blind spots that lead people to mistaken beliefs in medicine are an intrinsic part of how our brains work, and being intelligent and educated in the sciences is not enough to immunize us against them. Veterinarians, like pet owners, are highly motivated to help their patients, and though they want to do so effectively, they may not always realize the limitations of the kinds of evidence that comes from clinical experience. That is why the work of organizations such as the Evidence-Based Veterinary Medicine Association are so important.

When I first became concerned about the proliferation of unproven or ineffective veterinary approaches, I had hopes that government regulation might be an effective way to guard against the infliction of these methods on our patients and clients. Unfortunately, the more I have learned the more I understand that for better or worse the role of government in this effort is necessarily very limited. So while I will continue to advocate for the implementation and enforcement of sound laws and regulations, I will emphasize my personal efforts, as a clinician, a blogger, and a pet owner, to promote science-based veterinary medicine and challenge unfounded claims about veterinary health care.

Posted in Law, Regulation, and Politics, Miscellaneous CAVM | 54 Comments

Japanese Eyeball Poking Therapy: What Else is There to Say?

Thanks to a fellow skeptic for pointing out this CAM practice, which is sadly not any more bizarre than many others which are more popular.

Japanese Eyeball Poking

Really, what else needs to be said?

Posted in Humor | 6 Comments

Failue to Adequately Regulate CAM a Worldwide Problem

I recently saw an editorial  in the online edition of the Australian newspaper The Brisbane Times which seemed to fit with the recent series of posts I did on the subject of regulation for complementary and alternative medicine, especially the one addressing regulation of supplements and homeopathy. The editorial, entitled The Bitter Pill of Non-Medicine, begins by succinctly stating the problem:

Australians spend $4 billion a year on so-called alternative medicines, hoping against the odds that a largely unregulated industry will deliver cures and health benefits denied them by medical professionals.

It then goes on to pose the question which I tried to answer in my series:

Surely authorities would prohibit the sale of pills, ointments, syrups and contraptions that had not withstood the rigours of medical testing?

Apparently, like the U.S. government, the Australian government has neither the resources nor the  political will to require some independent evidence of safety and efficacy for CAM products. The assumption seems to be that while these products may be ineffective, they are generally harmless, so regulating them is not a priority. There is abundant evidence that this assumption is not always true,  including the recent paper from Australia showing the very real harm children can experience when treated with these methods. However, even if it were generally true, the article asks whether unrestrained marketing of these products is still legitimate:

But does absence of harm justify government inertia on this front? How is the public to know the implied promises of proven capability are empty? Should not the elaborate claims of some promoters be met with more vigour, particularly given the willingness of pharmacists to add their good reputation to assurances of the medical worth of these products?

The author then points out the problem, also seen with CAM products in the U.S., that these products rarely comply with even the limited regulations that are applied to them:

In a recent test of 400 newly listed alternative medicines, it found 90 per cent of them did not comply with regulations, weak as they are. Most infringements were relatively minor but in 3 per cent of cases flaws were serious enough for the product to be removed from sale. But here is the sting. The tiger is so toothless that banned products can reappear on shelves – sometimes within 24 hours – after re-branding.

Since human psychology is pretty consistent across the world, it’s not entirely surprising that irrational attitudes towards CAM, and the consequent ineffectual public policy, are a worldwide phenomenon. But it does dampen one’s hopes for the eventual development of more appropriate policies.

Posted in Law, Regulation, and Politics | 6 Comments

Selling Veterinary Stem Cell Therapies: Medivet’s Dodgy Advertising

The primary focus of this blog is to examine carefully the claims and evidence concerning alternative veterinary medical therapies. I focus less on the failures of conventional therapies and providers to always adhere to the highest standards of science-based medicine partly because the sins of Big Pharma and other such issues are already well-covered, and partly because the problem of inadequate evidence and pseudoscience is far greater in the alternative medical domain.

However, there are some areas of conventional medicine which strike me as inconsistent with good science-based practices, and which are reminiscent of the exaggerated claims and ethically questionable marketing practices commonly associated with alternative approaches. The current wave of commercial stem cell therapies falls into this category.

As I have said before, I have no objection to the idea of stem cell therapy. Unlike some alternative methods which are based on unscientific or pseudoscientific theories, stem cell therapy is a biologically plausible approach with encouraging preclinical and pilot clinical trial research behind it. My only concern is that expensive and invasive clinical interventions are being aggressively marketed to vets and pet owners without adequate evidence to support that they are safe and effective.

There is always a balance to be struck between the need to address important clinical problems and the uncertainty about the best way to do so. I am concerned that the companies currently pushing these interventions have tipped the scale too far in the direction of acting before there is adequate information to ensure that we do more good than harm. The proponents of these interventions undoubtedly believe they work, but they seem to base this belief on personal experience and theory, not sound clinical research, and these lower levels of evidence are inherently not very reliable. There is also, without question, clear financial motivation to be the first to offer these therapies and capture the dominant market position, which will likely prove a very lucrative one if time and further research does eventually bear out the claims made for these therapies.

I recently came across some advertising materials, for veterinarians and also for pet owners, from the MediVet company, the other major provider of veterinary stem cell therapies along with VetStem. These advertising materials exhibited many of the hallmarks of quackery I have written about before. None of these warning signs allows us to conclude this therapy doesn’t work, but because they tend to be found along with unproven or clearly bogus approaches, the more of them we see, the more cautious we should be in believing the claims being made.

1. Appeal to emotion in lieu of presenting real evidence

2. Claims of major scientific breakthrough without supporting published research evidence

3.Use of testimonials to support claims and encourage use of the method

4. Claiming extensive research validates the therapy without providing this evidence

5. Playing to fears about conventional medical treatments

6. Claiming to be “natural” and invoking the fallacy that “natural” means “safe” and “beneficial”

7. Claiming to produce a benefit with absolutely no risks or side effects

1. Appeal to emotion

Of course, emotions is a more compelling marketing tool than facts, and it is unavoidable in any effort to sell something. However, appeals to emotion that are not accompanied by solid factual support for the claims being made are often a smokescreen to obscure the absence of such support. And because of the unique dangers inherent in medical treatment, and the constraints on pet owner’s abilities to make medical decisions for their companions in a purely rational way given the intense emotional connection they have with their animals, it is easy to inappropriately manipulate people with emotional appeals.

The client brochure for MediVet shows a serious looking cat and somewhat sad looking dog staring directly at the reader, and the text reads:

If your pet suffers from pain, arthritis, or joint disorders, ask your vet about the healing power of stem cells. Don’t let your pet suffer any longer.

 

Clearly an appeal to emotion, with a good dose of guilt and an implied promise of relief if you buy the product.

The marketing materials for vets uses this tactic as well.

Bring back that “PUPPY FEELING”
Enjoy long walks, running and playing again
[Pet owners benefit from] knowing they are easing the suffering from…degenerative diseases
Don’t just live and let live, live and help live.

It is, of course, perfectly appropriate to care about our pets’ pain and to feel good about making it better. This is one of the great rewards of being a veterinarian. But the implications in these materials of dramatic improvements credited to an as yet unproven therapy, and the emphasis on emotion with a relative absence of evidence is a warning sign because it is frequently associate with therapies that must rely on emotion for promotion because they don’t have real evidence of their benefits. Skepticism is appropriate when confronted by highly emotional marketing of a medical therapy.

2. Claims of major scientific breakthrough:

The leading spokesman for MediVet (and previously for VetStem), Dr. Mike Hutchinson, is quoted as saying the company’s product is “the biggest breakthrough in veterinary medicine I have seen since entering the field 24 years ago.” That’s a pretty extraordinary claim given the dramatic improvements in the technology and scientific knowledge supporting veterinary care over the last 2 decades. Elsewhere in the marketing materials, the process is described as “the miracle of stem cells.”

Again, such hyperbole is not unusual in advertising, but it creates an impression of dramatic benefits from this therapy that is not yet justified by solid scientific research. Exaggerated claims are the stock in trade of hucksters selling snake oil, but they are not the appropriate way to market legitimate, science-based medical therapies.

3. Use of Testimonials:

The MediVet pamphlet and website have heartwarming stories of individual pets who, by their owner’s description, suffered severe disability before being treated with stem cells and were dramatically better afterwards. It is always a good thing when a pet’s suffering is relieved, but the hard reality is that stories like this can be told about bloodletting, faith healing, homeopathy, glucosamine, internal mammary artery ligation, and countless other therapies that are clearly worthless or even harmful. Such stories are psychologically compelling while telling us nothing useful about the truth of the claims they support, so they are really a form of deceptive advertising. Testimonials are the mainstay of alternative medicine marketing and justification, and they undoubtedly are highly convincing and sell products and services. But they are a questionable and disappointing technique to rely on when marketing what is purported to be a legitimate, science-based medical therapy.

4. Claiming extensive, but unavailable, supporting scientific evidence.

The MediVet marketing materials claim their product is “the result of hundreds of millions of dollars of research.” Dr. Hutchinson is further quoted as saying “my independent research” supports MediVet’s claims. These sorts of statements are not consistent with the number of clinical studies of stem cell therapy published in the peer-reviewed veterinary literature (a couple of which I have reviewed previously).

There is certainly a huge volume of preclinical and early human clinical research data, but none of this supports the use of this technology even in humans, much less in our pets. An organization of researchers studying stem cell therapies in humans, the International Society for Stem Cell Research, has stated that these therapies are not yet ready for widespread clinical use, and some veterinary scientists researching stem cells have voiced the same cautions regarding their use in animals.

When academic researchers believe the science does not support clinical application of a new technology, and the researchers actively promoting such use are primarily associated with companies selling that technology, there is good reason for the consumer to be cautious. Many products are aggressively marketed during the window between the appearance of promising preliminary research and reliable clinical studies, and the clinical research often does not find the early promise of these products to be fulfilled. If this turns out to be the case for these stem cell therapies, we will at the least have wasted a lot of our clients money and at worst may have actively harmed some patients.

I’m also concerned about the general attitude towards scientific evidence demonstrated in the marketing of these therapies. In the MediVet materials sent to veterinarians, Dr. Hutchinson says he has been “encouraging all of you to use this procedure in animals as I have done over 60 times…The positive results I witnessed were incredible.” This resembles the “try it and see for yourself” argument so often made by proponents of less plausible therapies, and which for reasons I often talk about is not a reliable way to evaluate a novel therapy. Is Dr. Hutchinson’s “independent research” really just experience with clinical cases? As emotionally compelling as such experiences are, they are only a starting point for suggesting hypotheses that must then be shown either true or false by controlled clinical research. Clinical experience, even that of a smart, well-educated, experienced medical professional, is a very unreliable guide to the safety and efficacy of medical treatments, especially for the complex, chronic, waxing and waning diseases such as arthritis that this therapy is being marketed to treat.

The MediVet materials also suggest that one benefit to the company of veterinarians using their product will be to “build thousands of cases to support our findings.” It should be clear to anyone familiar with the scientific method that research should always be done with the goal of disproving, rather than confirming one’s hypothesis, since it is all too easy for our biases to lead us to see confirmation where it doesn’t really exist. And conclusions based on thousands of anecdotes or case histories is little better than conclusions based on only a few. What is truly needed is more properly controlled clinical research, ideally done independently of the companies which stand to benefit financially from the products, though this is not always practically possible.

It never surprises me when proponents of alternative medicine fail to understand what constitutes reliable scientific validation of an idea and what does not, but it is surprising and disappointing when researchers and clinicians who purport to practice science-based medicine appear not to clearly understand this distinction.

5. Playing on fears about conventional medicine:

The logo for MediVet includes the motto “Drug Free Veterinary Solutions.” The theme that a virtue of their therapies is that they avoid “drugs” is repeated throughout the company’s marketing materials. This is the worst kind of pandering to irrational fear of pharmaceuticals. All effective therapies have potential side effects, and I’m sure these scientists and doctors understand that medicines in common use have great benefits that, in most cases, clearly outweigh and justify their risks. For example, the most common therapy currently for arthritis, which is the largest target indication for MediVet’s product, are the non-steroidal anti-inflammatory drugs, and the evidence clearly shows that these are overall quite safe and their benefits far outweigh their risks when properly and judiciously used.

The marketing materials also talk about the safety of the procedure, stating it is “completely drug and chemical free.” I’d be surprised if the process is free of chemicals, since water is a chemical, as are all of the other substances that are involved in the normal functioning of living organisms. This use of the word is simply an attempt to invoke irrational fear of nebulous “toxins” and as such is more consistent with the style and ideology of pseudoscience than true science-based medicine. It is closely related to the problem of the naturalistic fallacy or appeal to nature, which unfortunately also appears in these advertising materials.

6. Appeal to nature:

The advertising materials state that “the process is entirely ‘natural.'”

“Natural” is one of the most malignant words in medical advertising. It creates an impression that what is being described must be safe and beneficial while really just being an empty buzzword with no real meaning. Cholera, bubonic plague, and hookworm are all “natural.” And antibiotics, polio vaccine, and toilet paper are all “artificial” or “unnatural.”

One could reasonably wonder, of course, whether surgically removing fat from an animal, centrifuging it, and “activating” the stem cells with an L.E.D. machine can fairly be described as “natural,” which probably explains the scare quotes used in the advertisement. But despite this, and despite the fact that the word itself has no relevance to whether the procedure is safe or effective even if it did apply, the authors of the materials undoubtedly included it because of its positive, “feel-good” associations, which again seems a disingenuous, even deceptive advertising gimmick more appropriate to bogus therapies than to real medicine.  

7. Claiming a benefit with complete safety:

MediVet actually states, unequivocally, that “there are no side effects at all” to their procedure. Apart from the obvious fact that this cannot be true since the pet must undergo general anesthesia, surgical removal of tissue, and injection of something into their joint or blood, all of which have potential risks under the best of circumstances, the fact is that the research evidence is not nearly strong enough to justify such a dramatic assertion. And as I frequently point out when such claims are made about alternative therapies, there is no free lunch in physiology, so any intervention that has beneficial effects will have potentially harmful effects as well. The obvious problem here is that without systematic, controlled observations, any side effects of stem cell procedures are not noticed, correctly attributed to the procedure, or reported to the professional community. It is difficult to believe that the scientists and doctors involved in this work actually believe they can assure owners their procedures are absolutely without risks, so one must assume this is a willful exaggeration for the purposes of selling a product.

Show Me the Money

Which raises the issue of the financial motives involved in the promotion of stem cell therapies. As I’ve said, I have no doubt the promoters and scientists or doctors at VetStem and MediVet honestly believe their products work. And they may even turn out to be right! But the evidence in human medicine is clear that the source of funding behind a scientific research project influences the results obtained. Subtle, and sometimes not-so-subtle, biases associated with financial interests can easily color one’s perceptions enough to filter out disconfirming evidence and exaggerate the strength and importance of confirmatory evidence. And there is no doubt that making money is an important part of the agenda associated with the creation and marketing of veterinary stem cell therapies.

The MediVet materials aggressively promote the potential income their product will create for veterinarians.

Create a substantial additional revenue stream for your practice.
MediVet’s free marketing will that will drive additional leads to your clinic.
Participate in our “Stem Cell Day” and create an additional tier of income.
2 Procedures a week x 4 = 8per month x 12 = 96 per year. Total additional revenue stream of approximately $150,000.
65% of all animals are candidates for  Regenerative Stem Cell Therapy

The pressure to capture market share in this potentially lucrative area is great enough that there has even been litigation between VetStem and MediVet. It is especially interesting that, in the announcement of the settlement agreement between the two companies, it is stated that,

MediVet and VetStem also agree to advertise and promote only factual data regarding the methods, results, technologies, and safety of their respective systems and agree that any comparison used in promotions must be supported by objective data when named or referenced directly.

So while they advertise beneficial effects and safety claims far beyond what is supported by the scientific literature, they have at least agreed not to make claims about each other’s products that are not supported by objective data?

Of course there is nothing wrong with making money from providing high quality healthcare. As I have often pointed out, almost all veterinary medicine, whether science-based or alternative, is provided by the private sector by people who make their living doing so. However, we cannot be blind to the influence of a profit motive on our judgment and our conclusions. The drive to discover and develop effective stem cell therapies may very well be the desire to help our patients, but the drive to bring them to market before they are adequately tested and shown to be safe and effective is clearly a desire to capture market share in a profitable section of the veterinary industry. The excesses of the marketing that I have illustrated here would probably not be as dramatic if there were not potentially a lot of money to be made in this area.

My fervent hope is that stem cell therapies will eventually prove to be of great benefit to pets with many different conditions, and that they will, like most therapies that survive the rigors of proper scientific testing, have benefits which outweigh their inevitable risks. I also hope that the premature marketing of these therapies before such testing has been done will not turn out to be a mistake, either in teasing the public with promises we cannot fulfill and thereby stoking suspicion of scientific medicine or, even worse, in actually harming the patients we intend to help. If my concerns prove unfounded, no one will be more relieved than I. But for now, I am still concerned that inadequate understanding of the limitations of clinical experience, and the incentives of the market, are driving these products into veterinary practices with appropriate and necessary research has been done to ensure they are truly beneficial and safe.

Posted in Science-Based Veterinary Medicine | 48 Comments

American Animal Hospital Association Promotes CAVM and Quackery

The American Animal Hospital Association promotes itself as an organization which accredits veterinary hospitals and claims, “The Standards developed and published by AAHA are widely accepted as representing those components of veterinary practice that represent high quality care…Because of the AAHA Standards of Accreditation, you can be sure that your pet will receive top-quality care at an AAHA-accredited hospital.” Unfortunately, a recent uncritical fluff piece on “complementary medicine” on the AAHA HealthyPet.com site suggests that rigorous adherence to legitimate science-based medicine may not be a component of the AAHA standards. It does not stimulate confidence in the value of an AAHA certification if the organization freely promotes bogus therapeutic approaches.

The piece begins by assuming that complementary and alternative veterinary medicine (CAVM) is beneficial for humans and suggesting it ought to be applied to animals as well:

Have you ever basked in the luxury of a professional massage? Ever been to a chiropractor to have that creak in your back fixed? Are you a true believer in taking Echinacea to recover from colds more quickly or gingko to improve your circulation? If you answered yes to any of these questions, then you understand how alternative forms of medicine can benefit you. But did you ever think Spot or Fluffy might want to give these methods a try, too?

Massage? It is certainly relaxing and feels good, which can ease the discomfort of anyone who is ill. This is a legitimate and perfectly mainstream practice. But when massage therapists begin to claim healing or disease prevention benefits from their practice, it does become an alternative practice, and there is no evidence-based reason to believe massage affects the course of any disease or prevents any medical condition.

Chiropractic? An implausible and thoroughly debunked theory,  in humans clinical benefits only for lower back pain which are no better than standard therapy, and no reliable evidence that it is safe or beneficial in animals.

Echinacea? Thoroughly tested and consistently found to have no meaningful benefits for cold prevention or treatment.

Gingko? No benefit for cognitive dysfunction, and no benefit for intermittent claudication.

So if these remedies don’t work for humans, under what “standards of excellence” would we suggest they are good for Spot and Fluffy?

Next, the article cites an AAHA survey suggesting an increasing number of pet owners are using CAVM.

According to the American Animal Hospital Association’s 2003 National Pet Owner Survey, 21 percent of pet owners have used some form of complementary medicine on their pets. Compare this to the 1996 survey, in which only six percent of pet owners said they’ve used alternative therapies on their pets.

It’s always difficult to know how to interpret such figures because the percentage of people using CAVM depends on how CAVM is defined and explained. Does it include massage? Glucosamine? Prayer? If the trend seen in the survey is real, it certainly is a sign for concern given that most of the approaches that fall under the CAVM rubric are unproven at best or in many cases clearly worthless.

What such a figure does not indicate is anything about the safety or efficacy of such therapies. Just because something is becoming more popular does not mean it is true or a good thing. The implication proponents of CAVM make when citing such statistics is that such things are growing in popularity because they are effective or because they are becoming a legitimate and accepted part of mainstream medicine. However, science is not a popularity contest, and truth is determined by evidence not by the extent of public belief.

Next, the article drags out the tired cliché about “holistic” medicine treating the entire patient while conventional medicine treats only symptoms or isolated parts. It then offers what amounts to a guarantee that CAVM treatments are safe and helpful:

Holistic practitioners consider your pet’s entire well-being, not just individual symptoms or conditions, and mix and match treatments to best serve Spot’s or Fluffy’s needs. A holistic approach to your pet’s problem will likely prove beneficial in nearly all cases.

Unfortunately, “holistic” is a marketing term that CAVM proponents have long ago stripped of any consistent, real meaning. It is used almost exclusively as a buzzword to suggest that conventional medicine ignores any treatment or preventative that isn’t a vaccines, drug, or surgical procedure, which is patently ridiculous. Of course, considering the entirety of relevant variables in health and disease “will likely prove beneficial,” but focusing on nonexistent entities like “energy” or the vertebral subluxation, or adding worthless therapies like super diluted water to real medical treatments doesn’t provide any benefit. And the evidence of potential harm is clear.

Finally, this article lists a number of CAVM therapies and makes a variety of claims about them, most of which are unproven or outright untrue.

A) Acupuncture:

1. “Acupuncture has been practiced by the Chinese for more than 3,000 years.”

No, it hasn’t. The best available historical research shows that acupuncture, understood as the placing of small needles into the skin at points believed to have effects on internal organs or health, has only been commonly practiced on companion animals since the 1960s.

2. “Acupuncture can relieve muscle spasms, increase blood circulation, stimulate nerves, and help release natural pain control hormones and other helpful chemicals produced naturally by the body…. You may want to consider acupuncture for your pet if it has musculoskeletal, skin, respiratory, or digestive problems. It can also help with some reproductive problems.”

In humans, the only consistent beneficial effects are on pain and nausea, and these are psychologically mediated, meaning they are less than achieved with pain control medications and can be achieved through “fake” acupuncture techniques (placing needles randomly or stimulating the skin with toothpicks, for example). Beneficial effects based on psychological mechanisms, such as expectancy and therapeutic ritual, may have small but real benefit for people. Unfortunately, it is unlikely that these benefits are available to veterinary patients, so there is little reason to think that acupuncture is useful to our patients.

3. “Research shows that this complementary medical procedure can work well in many instances.”

This claim is not supported by the limited research available on veterinary acupuncture, which in the most charitable light can only be said to be inconclusive. Studies routinely claim benefits not actually seen in the data generated, or confuse the effects of electrical stimulation of nerves and muscles with the mystical Chinese practice of acupuncture.

B) Chiropractic

1.”Chiropractors believe that some illnesses result from misaligned vertebrae that diminish the flow of impulses from the spinal cord to the body’s muscles, organs and tissues. By manipulating and adjusting specific joints and cranial sutures in animals, veterinary chiropractors try to restore the flow of impulses.”

As already mentioned, though chiropractors may believe in the myth of the subluxation as a cause of disease, it is just that: a myth.

2. “Chiropractic treatments may help if your pet has a spinal disability, such as a slipped disc or pinched nerve; or even in some cases of epilepsy, skin disorders, and behavioral problems.”

There is absolutely no scientific evidence to support these claims in animals, and most of them have proven untrue in humans.

C) Physical Therapy and Massage

These approaches certainly do have proven benefits in humans. There is less research in veterinary patients, but it is quite likely that these approaches have real benefits for our patients. The problem is, they aren’t “complementary” or “alternative,” they are mainstream science-based medicine. I routinely refer patients to a veterinary physical therapy facility, and I am certainly not a CAVM practitioner. This is an example of those who are CAVM practitioners trying to falsely claim that truly effective therapies, other than drugs and surgery, are ignored by conventional medicine. Diet and exercise are frequently presented in human health care as somehow alternative therapies even though they are among the most commonly discussed and recommended strategies in primary care practice. This is a marketing strategy designed to convey a false impression of the differences between alternative and science-based medicine.

D) Homeopathy

1. Homeopathic treatment relies on the administration of substances that can produce clinical signs similar to those of the disease being treated. The idea is to provide the substances in small enough amounts to be harmless, yet enough to encourage the body to develop a curative response to the disease…The substance is diluted and made more potent, after which it’s usually put into pellet or liquid form.

The Granddaddy of all Quackery, homeopathy is pure mumbo jumbo. The so-called Law of Similars described above is merely the mystical idea of sympathetic magic, and the Law of Infinitesimals that says the less of something you have the stronger it is can only be true if the fundamental principles of physics and chemistry are all wrong.

2. “Administered properly, homeopathic treatment can help a wide variety of ailments, including allergies, wounds, poisonings, viral infections and many diseases.”

No high quality, repeatable scientific study has ever shown homeopathy to be effective in treating anything, in humans or animals. Enough studies done by enough believers in the practice will eventually lead to some claiming a positive effect. But the overwhelming, consistent pattern of the available evidence is that homeopathy doesn’t work.

E) Herbal Medicine and Nutraceuticals

1. “Many modern drugs, such as aspirin, are derived from plants, but these drugs go through chemical processing that is thought by some to diminish the plant’s original healing power.”

Yes, many medicines originate from plants. But there is no sound scientific basis to the notion that impure, inconsistent, and complex mixtures of chemicals contained in whole plants are in any way as safe or as effective as purified, identified, extensively tested isolated compounds (aka “medicine”). This is a mystical belief, not an established fact, and there is abundant evidence that it is untrue. Certainly, some herbal and nutraceutical products may be safe and effective, but others aren’t. There is nothing about being an herb or dietary supplement that guarantees safety or positive effects. These things need to be tested scientifically like any other medicine, and few of them have been, mostly for political reasons.

The American Animal Hospital Association portrays itself to the public as the source of reliable standards that can ensure a pet owner the veterinarian they go will provide high quality care. It is worrisome that the organization blithely endorses the kind of misinformation in this article. If adherence to accepted scientific methods and principles is not a part of their standards, then of what value are they? If the organization is willing to promote such utter quackery as homeopathy, how can they claim to be a trustworthy source of information about the quality of veterinary care individual doctors and hospitals offer.

Posted in General, Miscellaneous CAVM | 29 Comments

CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

This is a cross-post from Science-Based Medicine- CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1

Most homeopathic remedies are available as over-the-counter products, though at least theoretically some homeopathic drugs do require a prescription. The distinction between ordinary drugs that can be sold over-the-counter and those available only by prescription is made by the FDA based on the history of use of the particular ingredients, the nature of the complaint for which they are used and, in the case of new OTC drugs, the scientific evidence concerning safety and efficacy. However, with respect to homeopathic products, the distinction seems to depend solely on the intended use of the remedy. If a complaint is expected to be easily recognized by a lay person and self-limiting or not life-threatening, then a homeopathic remedy for such a complaint can be sold without a prescription. However, remedies intended for use in conditions that are serious, not self-limiting, and not easily diagnosed by laypeople require a prescription. 

The HPCUS has promulgated detailed guidelines for approving new homeopathic drugs. According to one review:

The clinical benefits of the new drug must be established in one of the following ways: through clinical verification acceptable to HPCUS, after which there is a period of clinical verification; through published documentation that the substance was in use prior to 1962; through use established by at least two adequately controlled double-blind clinical studies using the drug as the single intervention; or through use established by data gathered from clinical experience encompassing the symptom picture before and after treatment, including subjective and any available objective symptoms.[citation omitted]

The criterion of clinical use prior to 1962 was used to grandfather many drugs during the 1970s and 1980s into acceptance. This criterion is now rarely, if ever, used, and HPCUS is rereviewing [sic] many monographs accepted under this approach. HPCUS reports that the criterion of clinical experience has never been used. Consequently, only the criteria of homeopathic drug “proving” and establishment by two adequate clinical studies are currently in actual use [citation omitted].1

This sounds very impressive and scientific if we ignore the fact that the vast majority of the “drugs” we are talking about are identical and contain nothing but water. It is a testament to the power of cognitive dissonance and faith that a complex set of laws and regulations as well as scores of dedicated professionals in government and the private sector are devoted to regulating the use of over 1200 differently labeled preparations of water. It is also a reminder that scientific facts are not as persuasive in the legal and political arenas as we might hope.

The FDA guidelines for marketing of homeopathic drugs specifies the labeling and manufacturing requirements for homeopathic remedies, but it is most interesting for the inclusion of a definition of Health Fraud:

The deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article.

The inclusion of this definition without any apparent acknowledgement of its clear application to the practice of homeopathy being regulated by the document is as fine an example of the disconnect between scientific and legal reasoning.

Regulation of Herbal Remedies and Other “Therapeutic” Dietary Supplements

Much has previously been written here at Science-Based Medicine on the subject of the Dietary Supplement and Health Education Act of 1994 (DSHEA) (e.g. 1, 2, 3, 4), and I don’t have a great deal to add. In brief, the supplement industry and sympathetic lawmakers created this law to pretend to regulate herbal remedies and other dietary supplements while effectively stripping the FDA of the ability to control the sale of these products for the  prevention or treatment of disease. This was accomplished by classifying all such products as foods and codifying the principle that they must be assumed to be safe unless the government can generate substantial evidence to the contrary. There are some restrictions on the medical claims manufacturers can make on the labels of these remedies, but they are routinely ignored and the resources and will behind enforcement of them are manifestly inadequate.

It is instructive to look at some of the judicial opinions that have been rendered in cases where the FDA did attempt to restrict the use of supplements that had clear potential to be harmful or to challenge unsupported label claims. When the FDA banned the sale of the supplement Ephedra in 2004, for example, due to strong evidence of adverse effects and deaths due to use of the supplement, the company sued and the district court ruled in the manufacturer’s favor. The argument made by the company, and accepted by the district court, was that “by injecting a risk-benefit analysis, the FDA required [the manufacturer] to make a showing of the benefits of its product.” This would be inappropriate because in passing DSHEA “Congress expressly placed the burden of proof on the government to determine whether a dietary supplement” is unsafe.2 

The Tenth Circuit court agreed with the interpretation that the law requires no burden of proof be placed on supplement manufacturers to demonstrate the safety or efficacy of their products. However,  it upheld the FDA ban on the basis that because the agency gathered all the data and conducted the analysis at its own expense and without requiring the company to prove any benefit to justify the risks identified, no inappropriate burden was placed on the manufacturer.2 At the risk of injuring myself, I have tried to imagine the public reaction to such a one-sided, industry-friendly regulatory system applied to the pharmaceutical companies, but the image of the resulting rhetorical conflagration is simply too horrible to contemplate.

In another case, a supplement manufacturer was denied permission to market their products with certain health claims on the label, due to a lack of sufficient scientific evidence to support the claims. The company sued the FDA, and the court of appeals found that denying the claims violated the company’s First Amendment commercial speech rights because the alternative of allowing the unproven claims accompanied by a disclaimer was not offered. The court did not challenge, or even address, the quality of the evidence for or against the specific claims. It simply ruled that not allowing them to be made, with appropriate disclaimers indicating the weakness of the evidence or the lack of FDA approval, was unduly restrictive of the company’s speech rights and represented a “simplistic view of human nature or market behavior” that did not give adequate credit to the ability of consumers to judge the merit of such claims for themselves.3

These cases illustrate, yet again, the priorities and concerns of justices and lawmakers with regard to the use of alternative medicine, which are often quite different from those of scientists and healthcare providers.

Where Do We Go From Here?

This series has been a relatively superficial survey of a complex subject, but hopefully I have been able to illustrate a few key issues. First, the scientific facts of claims made about alternative therapies, and the importance of using appropriate and effective epistemological methods to establish those facts, must be the foundation of a rational public policy concerning these therapies. Whether an intervention helps or harms or both is vital to the process of determining how government should approach regulating that intervention. However, the lawmakers and justices who shape public policy towards medicine are seldom themselves experts in scientific methods and the information they generate. To effectively argue the case for science-based medicine, we must understand the way the processes and data of science appear to smart, educated non-scientists, and we must be effective in communicating about science to such people. 

While I don’t want to wade too far into the debates surrounding science communication, I would recommend looking at the work of Michael Nisbet, Randy Olson, and Chris Mooney, all somewhat controversial figures who make a variety of interesting arguments about the most effective ways to communicate about science to the general public. If nothing else, these arguments are good for stimulating a healthy debate about how to promote science and science-based medicine in a culture not as friendly to science as it once was.

In addition to not necessarily understanding the nuances of scientific evidence, policy makers also have other agendas and sometimes have to serve their constituencies even when that means promoting policies based on unscientific or even irrational foundations. There are legitimate philosophical questions about the rights of the individual versus the power of the government, the most effective way to organize and run healthcare delivery systems, and other issues that are not primarily scientific but which influence law and policy concerning science and medicine. In promoting  science-based and rational policies, we must take these other issues into account. And the plain political reality remains that if enough people, or people with enough influence, support an idea, it is unlikely to be effectively combated through law and regulation even if it is inherently unscientific and not in the best interest of the public health. Such ideas are better addressed through education and lobbying to alter public opinion rather than through legal or regulatory avenues.

I’ve tried in these posts to provide a rudimentary familiarity with the basics of how the laws that govern medicine in this country relate to the practices of alternative medicine. Hopefully, this will be useful in informing our efforts to advocate for science-based medicine and further marginalize unsafe and ineffective medical approaches.

References

  1. Borneman JP, Field RI. Regulation of homeopathic drug products. Amerian Journal of Health-System Pharmacy 2006;63:p. 86-91. Return to text.
  2. Nutraceutical Corporation v Von Eschenbach, Tenth Circuit Court of Appeals, 459 F.3d 1033 (2006). Cited in: Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 208-10. Return to text.
  3. Pearson v. Donna Shalala, Secretary, United States Department of Health and Human Services United States Court of Appeals for the District of Columbia 164 F.3d 650 (1999). Cited in: Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 214-17. Return to text.
Posted in Law, Regulation, and Politics | 8 Comments