Neutricks(tm): Another Nutraceutical for Canine Cognitive Dysfnction

Posted on January 19, 2011 by skeptvet

Yet another product has entered the market aimed at treating Canine Cognitive Dysfunction Syndrome (CDS). This age-related brain disorder is analogous to dementia in elderly humans, and it involves a number of significant behavioral changes. Affected dogs may get lost in the house, they may have disrupted sleep and restlessness at night, they may show changes in social interactions with people and other animals, and they may experience a breakdown in housetraining. All of these are important symptoms that can adversely affect the quality of life for both pets and owners.

There are no dramatically effective treatments for this disorder, but there are plenty of remedies for sale. The prescription mechanism selegiline has been approved by the FDA for use in this condition, and there is some limited clinical trial evidence to support a benefit, however it is not by any stretch of the imagination a cure. As is typical for incompletely understood diseases with no clearly effective conventional treatment, CDS presents an attractive target for marketers of alternative therapies. And while it is laudable to seek to discover and promote a remedy for an otherwise untreatable disease, unfortunately most of the products targeted at CDS are brought to market well before adequate legitimate research confirms they are safe or effective. Rather than seeking an FDA label approval, which requires significant efforts to prove safety and efficacy, many companies prefer to market their remedies as supplements or nutraceuticals, taking advantage of the lack of effective regulation of such products.

I have previously written about nutraceuticals and CDS (updated here), but the newest product takes a novel approach. Rather than vitamins, antioxidants, or herbs, this product contains as its “active” ingredient apoaequorin, a protein found in certain jellyfish that has long been used in molecular biology research as a tool for monitoring the level of calcium inside of cells. The cleverly named Neutricks (as in “teach an old dog new tricks,” though I can’t help hearing an echo of the unrelated product Neuticals), supposedly reduces the symptoms of CDS by protecting nerve cells in the brain from damage associated with excessive calcium levels.

The company web site references a number of studies showing that injecting apoaequorin into rat brains can protect nerve cells from death when they are later removed from the rat and deprived of oxygen in test tubes (1, 2, 3). This is an interesting finding, but obviously a long way from showing that the product has any clinical benefits in dogs with CDS. Such preliminary animal model research is a necessary first step on the road to proving such a real-world benefit, but by itself it is totally inadequate to justify putting the product into your dog.

One very important step that the maker of Neutricks seems to have skipped (though, as always, I may simply not be able to find all the relevant information, so I am certainly open to being shown additional evidence) is demonstrating that the protein can be absorbed and get to meaningful levels in the brain of dogs when given orally. Proteins are usually destroyed in the stomach (that’s primarily what this organ is for), so many compounds that have significant effects when injected are useless taken orally. A classic example is rattlesnake venom, which can easily kill you when injected by the snake’s fangs into your body, but which is perfectly safe to drink.

The same company also markets apoaequorin as a supplement to treat symptoms of Alzheimer’s and dementia in humans, under the name Prevagen. The company is apparently enrolling and planning a large number of clinical trials studying apoequorin as a treatment for Alzheimer’s disease, other cognitive and memory disorders, autism, multiple sclerosis, Parkinson’s, and apparently any disorder whatsoever involving nerves and calcium. There is apparently only one clinical trial actually completed, and as another blogger has also already pointed out, this pilot trial of 56 participants was uncontrolled, unblinded, and methodologically quite weak. Again, such preliminary studies are appropriate to identify possible side effects or benefits that influence the decision to continue with further research, but they prove nothing and certainly do not justify marketing a product for actual use in patients.

(The company has also issued several press releases discussing “promising interim results” from a human trial involving apoaequorin and memory, but the details of the trial are not yet available, and no peer-reviewed publications of any results have appeared, so it is impossible to evaluate the quality or significance of the results)

As for veterinary research, the company apparently contracted an outside research firm to run a trial of Neutricks in dogs. The study involved 24 laboratory Beagles 9-17 years of age. The subjects were randomly assigned to a placebo group, a low-dose treatment group, and a high-dose treatment group. The subjects were selected from a larger group on the basis of preliminary testing to find animals that  reliably performed certain cognitive testing tasks but which “tended to perform at below maximal levels to allow for the possibility of seeing memory enhancement.” The treatments were given and testing done in a properly blinded manner.

The results of pre-treatment testing showed no difference in performance between the three groups. There were three cognitive tests administered: a delayed non-matching to position task (DNMP), a discrimination task, and an attention task. The results were as follows:

1. DNMP Task- No significant difference was seen in performance of the three groups. The report lists some post-hoc manipulation of the data which also show no statistically significant differences but the notorious “trend” often used to imply an effect where the data doesn’t actually show one.

2. Discrimination Task- The low-dose group showed a score and error rate statistically greater than the control and the high-dose group, which did not differ. This is, of course, the opposite of what you would expect if the agent worked since a dose-response relationship, in which the effect increases as the dose increases, is by far the most common result seen with effective medications. It seems most likely that this was simply the inevitable apparently positive result one sometimes sees when testing multiple effect measures in a clinical study. If it is repeatable in multiple studies and by different investigators, then it could turn out to be a real finding.

3. Attention Task- No significant differences between groups were seen in overall performance. The report keeps mentioning results that were “marginally significant” or “approaching significance,” but these are meaningless spin terms. The purpose of significance testing is only to decide, with a pre-determined level of assurance, whether the result could be due to random chance or not. If the usual cutoff of 5% (P=0.05) is used, then a significant result only means that the finding would appear by chance alone only 5 out of 100 trials. It doesn’t mean that the result is due to the effect of treatment or any other specific hypothesis. And when test results don’t reach this 5% level of probability, they are by definition not significant, period.

Some additional post-hoc manipulation of the data yielded a significant difference between the high-dose and the control groups in 1 out of 3 different conditions, with no difference at the other conditions or for the low-dose group.

No adverse events were reported.

Overall, the results of this trial clearly do not justify the clinical use of apoaequorin in treating CDS. The company has not apparently demonstrated even the most basic element in building a case for such use, that the product is absorbed when taken orally and reaches meaningful concentrations in the brain. They have not reported in vitro or laboratory model results that have any direct relevance to the pathology or clinical features of canine cognitive dysfunction. The clinical trial they are using as a marketing tool was conducted on healthy laboratory research Beagles, not owned pets with CDS, and even in this trial there were almost no significant effects seen in subjects getting the product.

Could it work? Sure.

Is there clear evidence it doesn’t work? No.

Is there any significant evidence of risk? No.

And finally, is there any meaningful evidence of beneficial effects? Nope.

So while I certainly would love to see additional, and more relevant testing of apoaequorin and the underlying hypothesis behind its  use, at this time it is just another example of selling wishful thinking to people without a lot of better options. I understand why desperate pet owners are willing to grasp at such straws, but I consider it ethically questionable, and certainly scientifically insupportable, to sell them.

Posted in Herbs and Supplements | 51 Comments

U.K. Veterinary Medicines Directorate Promises Crackdown on Unproven Alternative Remedies

Posted on January 17, 2011 by skeptvet

In December John Fitzgerald, the Director of Operations for the British Veterinary Medicines Directorate, announced that the regulatory agency will begin more aggressive supervision of medical claims made for alternative medicine products. According to the announcement,  

Some of these products are claiming to be effective and safe when no scientific evidence has been presented to us to show they are

Animal owners have a right to know if a product does what it claims. The products claim to treat diseases which can cause serious welfare problems and in some circumstances kill animals if not properly treated. So in some cases owners are giving remedies to their pets which don’t treat the problem

The agency will begin contacting manufacturers of homeopathic and herbal animal remedies and nutraceuticals to request scientific evidence of safety and efficacy. Unfortunately, if such evidence is not provided, the products will still be legal to sell, however they must remove any label claims suggesting a medical use of the product. Likely, manufacturers will then switch to the vague yet still misleading “structure and function” claims the FDA allows in the U.S. for herbs and supplements without adequate evidence to support true health claims.

Still, it is encouraging to see a government agency somewhere at least making the statement, which is bizarrely controversial in some circles, that before selling pet owners a medicine for their animals the manufacturer ought to prove the medicine actually works and isn’t harmful. Whether or not the VMD will be able to effectively enforce such a regulation given the ease of Internet marketing and distribution of home remedies is uncertain, but it’s nice to see them making the effort.

If nothing else, the publicity surrounding any attempt to sanction a company selling an unproven remedy, and the likely outcry from devoted users, will bring greater attention to the discussion of what is or is not real scientific proof, and will make it more likely that pet owners will at least know that scientists and the government do not accept the manufacturer’s claims. I suspect there are significant limitations to what government regulation can accomplish in terms of protecting the public from ineffective medical therapies, but it can certainly serve as a source of reliable information and a “bully pulpit” for the science-based perspective.

Posted in Law, Regulation, and Politics | 9 Comments

Complementary & Alternative Medicine in Veterinary Hospice Care

Posted on January 17, 2011 by skeptvet

There is a brief commentary (subscription required) in the current issue of the Journal of the American Veterinary Medical Association (JAVMA) on the subject of veterinary hospice care. I’ve written about this subject before, and I think it is one that deserves more attention and effort in the veterinary medical community.

Thanks in large part to the successful advances in preventative healthcare and treatment of disease, our pets are living longer. The natural consequence of this is that we are more frequently faced with the challenges of complex geriatric medicine and with individuals at the end of their lives who have multiple, often chronic diseases. These disease are generally not curable, but they can often be managed to provide a good quality of life for our patients. When we are able to accept the inevitability of death, which is difficult in our culture, then we can focus on trying to maintain a comfortable, satisfying life for our pets even as they are approaching the end of their lives. This is a worthy goal which presents a number of scientific, psychological, and logistical challenges.

The concern I expressed when I first wrote on this subject, about the role of CAM and associated ideologies in hospice care, is alluded to in the JAVMA commentary.

Hospice care may be more popular among those interested in alternative and complementary therapies. Thus, veterinarians engaged in hospice care should be comfortable working alongside individuals offering these therapies and be aware of the potential for conflicts and deleterious interactions between these therapies and conventional medical treatments.

Though I am not aware of any objective research data to support it, I tend to agree with the contention that pet owners interested in comprehensive hospice care, and often reluctant to consider euthanasia when their veterinarian suggests it is appropriate, are also owners more inclined towards CAM therapies. Much of CAM is vitalistic philosophically, emphasizing the “spirit” or “life force”  of the individual as the primary focus of health and disease, with the physical body considered secondary. And from such a perspective, death is likely to be seen primarily as a transition of the spirit from one state to another, with the dysfunction and breakdown of the physical body as a secondary concern.

This blog, and certainly the veterinary consultation room, are not appropriate places to debate religion or metaphysical philosophy. I don’t see it as at all my role as a veterinarian to challenge my clients’ attitudes about the fundamental nature of life and death. However, I do see my role not only as a source of support and comfort for the client but as an advocate for the welfare of my patient.

Pet owners clearly want the best for their pets, but they also are influenced by their own feelings and needs, especially at intensely emotional times like the end of life. Under such conditions, it is not difficult to project one’s own needs and beliefs onto an animal companion, especially with the facilitation of “animal communicators” or others who claim to have mystical insight into the wishes or thoughts of animals. This can lead to decisions about care which are not truly in the best interests of the pet.

Insofar as CAM is sometimes more successful at meeting people’s psychological and spiritual needs than science-based medicine, and that it is most often employed in the treatment of chronic diseases for which there is no definitively effective conventional treatment, I am not surprised that CAM and CAM providers are playing a significant role in the nascent veterinary hospice movement. CAM providers are among the most active promoters of hospice care.

While I applaud these efforts, I am concerned that ineffective, pseudoscientific therapies may come to dominate end-of-life veterinary care, and that the consequence of this may be inadequate palliation of  our pets’ physical suffering. I have had clients who were struggling to accept the inevitable loss of an animal companion and who sought any and all therapies that offered the promise of a benefit. Even when these therapies were clearly ineffective, or caused increased suffering, these clients have difficulty seeing and accepting this fact at the time (though they often come to me later and lament having persisted too long in the face of their pet’s suffering because letting go was too painful). There are plenty of examples in human medicine of ineffective alternative therapies that actually worsened the quality of life for terminally ill patients using them, and I believe this is a real risk for veterinary hospice care.

I have also seen clients whose pets were in great pain but who refused conventional pain therapy and persisted in the belief that homeopathy and other alternative therapies were effectively managing their pet’s discomfort despite clear and obvious evidence to the contrary. Again, this is not due to any lack of intelligence or compassion, but simply to the innate tendency of all human beings to see what they want and expect to see. Unfortunately, without legitimate scientific research it is not possible to know how effective a medical therapy really is, and I am concerned about patients in veterinary hospice care being denied effective palliative care in favor of bogus therapies because of a philosophical predisposition of some pet owners and hospice providers towards  CAM approaches.

I would certainly not suggest that veterinarians who wish to provide comprehensive hospice care automatically refuse to work with CAM providers or accommodate their clients’ interest in such therapies. This would likely be counterproductive as it would drive these clients away from conventional care or lead them not to disclose the CAM therapies they are using, making it harder to monitor for possible adverse interactions.

However, I do think veterinarians have an ethical responsibility to advocate for the welfare of their patients, even if this means telling clients things they don’t want to hear. If an owner is unable to see or accept that their pet is suffering, or mistakenly believes they are providing effective care, their veterinarian must try, as kindly but clearly as possible, to help them see the true situation. And in extreme cases, where a CAM provider is actively discouraging an owner from taking advantage of appropriate conventional care, it may not be possible to serve that owner and one’s conscience at the same time.

And while there are some people who have a philosophical or religious objection to euthanasia, I think most veterinarians and pet owners see it properly as an act of kindness to relieve otherwise untreatable suffering. If a client is unwilling to consider euthanasia, then their veterinarian may have to accept this and do whatever they can to ensure that the pet is kept as comfortable as possible while dying. But there is nothing wrong with discussing the role of euthanasia in high quality, compassionate end-of-life care. And I vehemently reject the caricature promoted by some CAM advocates of veterinarians who practice science-based medicine as callous and forcing euthanasia on their clients prematurely.   

Veterinary hospice care is a concept that needs to be developed and promoted more widely, and in order to best care for our pets as well as their owners, we need to ensure that the philosophy and techniques that make up hospice care include effective, evidence-based medicine. Offering comfort to clients in the form of therapies that don’t truly benefit our patients is not true compassion, and advocating aggressively for what we believe is the best, most effective scientific treatment available for our patients is not closed-mindedness but conscience. My hope is that conventional veterinary medicine will embrace the hospice concept, and that veterinarians committed to science-based medicine will continue to be involved in its development and implementation so that our pets get the best care possible at the end of their lives.

Posted in General | 1 Comment

Truth is a Popularity Contest (Again): This Time in Switzerland

Posted on January 15, 2011 by skeptvet

In Switzerland, as in many other European countries, the government pays for extensive health insurance coverage for its citizens. Naturally, the government and the citizenry want cost-effective healthcare for their money. One important aspect of achieving this is not to pay for therapies that don’t work. So it is understandable that in 2005, the Swiss Interior Ministry stopped paying for several alternative therapies, including homeopathy and Traditional Chinese Medicine (TCM), that failed to meet their criteria for adequate scientific proof of efficacy.

What is less understandable, is that in 2009 60% of the voters in Switzerland voted to force the government to pay for these therapies. Apparently, these voters were, as so often proponents of alternative medicine tend to be, less interested in whether the therapies worked than in their “right” to use them, even if other taxpayers had to foot the bill. The government’s own review panel recommended outright rejection of these therapies, but in a pragmatic political move the government has decided to continue funding them for a 6-year trial period, during which a supposedly independent review of existing scientific research is supposed to be conducted to determine, yet again, if there is adequate evidence of efficacy to justify providing these therapies at taxpayer expense.

One possible candidate for this external review agency is the National Center for Complementary and Alternative Medicine (NCCAM) here in the U.S. Given that NCCAM has spent over $1 billion dollars of U.S. taxpayers’ money, has failed to find solid evidence to support any specific CAM approach, and is nevertheless actively promoting an entire academic industry dedicated to researching CAM therapies (see these posts at Science-Based Medicine for details), it hardly seems a neutral party. Another candidate is the British National Institute of Clinical Excellence (NICE). This seems a better choice in that the organization exists to evaluate all medical therapies froman evidence-based perspective.

However, the unfortunate reality is that the negative findings of the original Swiss government panel were not sufficient to dissuade Swiss voters from demanding the government pay for CAM. And the extensive work NICE has done in Britain, along with strong statements from British physicians organizations about the complete fiction that is homeopathic medicine, the British National Health Service still pays for homeopathic hospitals. The negative findings of NCCAM here in the U.S. have had no discernable impact on the popularity of CAM therapies here. So the hope that a balanced, rational review of the evidence, which I have no doubt would lead to the conclusion that these methods are unproven at best or, as in the case of homeopathy, complete nonsense, is a slim one indeed.

The more I look at the evidence and people’s responses to it, including the vicious hostility of so many comments posted here by those who feel I am wrong about the evidence, the more CAM begins to look like a religion, not a rational approach to healthcare.

Posted in Law, Regulation, and Politics | 6 Comments

HealthyMouth Water Additive: Does It Help Prevent Dental Disease?

Posted on January 13, 2011 by skeptvet

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

Posted on January 11, 2011 by skeptvet

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

Posted on January 9, 2011 by skeptvet

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

Posted on January 7, 2011 by skeptvet

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

Posted on January 6, 2011 by skeptvet

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?

Posted on January 2, 2011 by skeptvet

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