The Problem of Negative and Inaccurate Advertising of Alternative Veterinary Medicine

Posted on November 16, 2011 by skeptvet

Advertising is a form of communication intended to influence the behavior of potential consumers with regard to specific products or services. As such, it is inherently competitive to some degree, attempting to encourage consumers to choose the advertiser’s product over those offered by competitors. However, widely accepted ethical principles, and often specific laws, require that advertising be fundamentally truthful, within fairly elastic bounds. And there is no inherent need for advertising, though it is competitive, to be negative. It is possible to promote one’s own services without claiming that one’s competitors are incompetent, dangerous, dishonest, or guilty of some other malfeasance against the customer.

We all know that in reality, advertising often falls short of the ideal of factually accurate and civil content. While many practitioners of complementary and alternative veterinary medicine (CAVM) advertise in a way that is at least civil, if not in my opinion factually accurate, I also frequently find examples of advertising for alternative veterinary products and services that are not only inaccurate but also blatantly hostile towards conventional, scientific medicine.

This makes sense in that “alternative” medicine, by definition, must consist of therapies intended to replace conventional medicine, and such therapies would have no value if conventional medicine were accepted as generally safe and effective. “Integrative” and “complementary” interventions are, at least theoretically, not incompatible with conventional medicine, so they could more easily be advertised on their own claimed merits, without the need to claim that scientific medicine is unsafe and ineffective. But even when labeled with these less confrontational buzzwords, such interventions are often promoted on the basis of at least implying, of not claiming outright, that scientific medicine is harmful and not very effective.

Despite disagreements over the theories and scientific evidence associated with alternative veterinary medicine, it seems to me that there might be some common ground possible between skeptics, such as myself, and more reasonable advocates of CAVM to agree that advertising by veterinarians which is egregiously hostile or which depends on painting one’s colleagues as incompetent, venal, or otherwise not genuinely interested in the well-being of their patients is inappropriate. Despite the fact that this blog consists primarily of critiques of therapies I believe make claims not supported by reasonable evidence, I make great efforts to repeatedly affirm that most practitioners of these therapies have honest intentions and are truly seeking the best for their patients and client. I am seldom accorded the same courtesy by my own detractors.

I have previously discussed examples of what I believe to be inaccurate and inappropriate advertising by alternative veterinary practitioners (such as Andrew Jones, Gloria Dodd, and Erik Weisman, all of whom have face legal or regulatory board action for their actions). And to be fair, I have also criticized advertising of conventional interventions that are advertised in inappropriate ways, such as Medivet’s stem cell therapy.

Recently, I came across a couple of web sites which exemplify the worst sort of advertising rhetoric and techniques found in CAVM promotion. If the more reasonable proponents of alternative methods wish to be treated respectfully they might consider challenging such practices among their own colleagues.

Dr. Jenifer Preston of HolisticVetExpert.com provides several examples of negative and inaccurate advertising. The claims and comments made on this veterinarian’s web represent the use of exaggerated and unsupported allegations, and lack of regard for fact, that characterizes the more extreme CAVM propaganda.

Dr. Preston, for example, claims to have an herbal remedy that prevents and cures heartworm disease and other parasitic infestations. Such a claim, if not supported by FDA licensure, is illegal according to the terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which forbids prevention and treatment claims and allows only vague “structure and function” claims.

These claims are also dangerous in that they can mislead consumers into failing to properly protect their animals from this deadly disease or to treat them appropriately when they become infected. And because there is no scientific support for these claims, they are sold through disparaging and misleading criticism of truly effective heartworm preventative and treatment agents and the implication that veterinarians sell these “poisonous chemicals” knowing they are dangerous out of simple greed.

Heartworm preventatives are a huge income to both veterinary clinics and the big pharmaceutical companies that manufacture the drugs…There are other alternatives to these poisonous chemicals…

Our parasite formula has been used for several years now to treat heart flukes successfully….In my holistic practice, I find flukes and a host of other rarely diagnosed parasites through radionic testing.

We are now using our HVE Parasite Formula to treat all stages of heartworms. As with heart flukes, we have found that a slow killing of these heart parasites is much safer to the patient than the immediate kill-off with drugs such as Melarsomine (Immiticide). We are recommending a therapy (by weight) of daily treatment for seven days for a total of three rounds with two- four day breaks in between. In other words, treat the heartworm-positive dog once daily for seven days; stop for four days; repeat for seven days; stop for four days and repeat daily for a third round of seven days. In severe cases, we may have to go another round or two of therapy.

So far, we have NO side effects in these positive cases–all dogs are doing very well. I also believe that HVE Parasite Formula can be used to prevent heartworm infections.”

This is the most beautiful natural wormer we have found. It is a liquid herbal wormer that we have found to be effective against:

Intestinal Flukes
Liver Flukes
Lung Flukes
Heart Flukes
Intestinal Flukes
Blood Flukes
Cryptostrongyloides (roundworms in the lungs)
Sparganosis (migrating tapeworm larvae)
Pin Worms
Threadworms
Hook Worms
Whip Worms
Roundworms (in any organ including the brain)

Dr. Preston tests for these in her practice, and this is the number one wormer she uses.

There is no evidence to suggest that the undisclosed ingredients in this product, or any herbal product, is a safe and effective preventative or therapeutic agent for heartworm disease, and even many proponents of herbal and holistic therapies acknowledge that conventional medications are the safest and most effective agents for this purpose. What is more, though there are well-known risks to conventional prevention and treatments, these pale in comparison to the tens of thousands of dogs who have been spared illness and death by these products.

Regardless of what I am sure is Dr. Preston’s genuine, though deluded, belief in the statements she makes here, there is no justification for regulatory agencies, or responsible proponents of alternative veterinary medicine, to allow these kinds of claims to go unchallenged.

The rest of the site contains many other cases of misleading and unsupported claims about the dangers of conventional medicine and the superiority of her approach. Dr. Preston’s bio contains a fairly typical conversion story indicating that she began practicing as a conventional veterinarian and then became convinced that she was doing far more harm than good, which led to a conversion to alternative methods. The narrative contains the usual unsupported claims that vaccines and medicines are terrible toxins responsible for most of the diseases science hasn’t yet found a clear cause of or cure for, laments about the unpleasant fact that not all illness can be prevented of cured, and claims that alternative medicine is obviously safer and better but that it is suppressed by greedy corporations and the blindness of  unenlightened mainstream veterinarians.

Dr. Preston practiced allopathic medicine for twenty five years before realizing that the vaccinations and drugs she dispensed daily were causing more problems than they ever solved and often to a more severe degree. So the leading income-producer in her practice–vaccines–was obviously creating havoc in most of her patients. The drugs prescribed every day were literally destroying healthy organs and shortening lives.

Ten years ago, Dr. Preston turned to holistic veterinary medicine–it seemed to be the only answer to the overwhelming set of diseases that were not responding to conventional therapy. For decades, allopathic medicine has been revered and taught in every veterinary college in this country without exploring alternatives! One only needs to realize that many of the biggest subsidizers of veterinary schools across America and Europe are Big Pharma. Who donates new, expensive equipment? Who provides large scholarships? Who provides most of the grants to research veterinarians? Major pharmaceutical companies. She realized that their goal was not to improve the lives of millions of companion animals but to line their own pockets.

She is confident that HolisticVetExpert supplements will tackle diseases that have up to now baffled you and your pet, such as:

-cancer
-mild to severe arthritis and degenerative joint diseases
-joint injuries
-hypo- or hyper- thyroidism.
-cushings disease
-liver and kidney disease
-cystitis-acute or chronic
-urinary incontinence
-constipation
-asthma
-allergies
-obvious or unobvious underlying parasitic diseases
-chronic infections in any system or organ
-vaccinosis–diseases caused by vaccines themselves

As is common in the advertising of “holistic” medicine, the emphasis in this site is on sweeping statements about the dangers of conventional care  and sweeping claims about the superiority of alternative care, all presented with no supporting evidence beyond opinion and anecdotes. The ignorance of conventional veterinarians is portrayed as a positive danger to their patients.

Allopathic veterinarians are trained to relieve symptoms with little or no emphasis placed on the consequence(s) of the treatments selected…

Over the years, drugs and vaccines have made our pets, our beloved companions, seriously sicker and have shortened their natural life span. Why do we so often see premature aging? How do we STOP this trend? Treat holistically! Naturopathic veterinarians have found that these alternative products are accepted so much easier by the animal’s body and therapy is so much quicker and more complete!

By using natural, holistic supplements, we all enjoy a better quality of life, because we ourselves are not exposed to the toxins that go onto or into our pets’ systems!

Here’s another example.

Epilepsy in dogs and cats can develop at any age. Allopathic veterinarians do not give you any real reason that this develops in your beloved dog or cat.

What the vets don’t realize is that they themselves have very likely created this syndrome with vaccines. Yearly administration of multi-valent vaccines assault the animal’s immune system over and over. More and more animals are developing ‘auto-immune’ diseases and the allopathic community has no idea why.

The culprit for seizures – except for the cases of malignancies of the brain or chemical poisonings-is often distemper and/ or rabies vaccines.

One other common contributor to seizures is the use of topical flea products-any brand-they are all nasty.

Another case of dodgy advertising that caught my attention recently, though I have discussed the individual’s advocacy of alternative veterinary nutrition before,  is the site of Dr. Tom Lonsdale, who promotes his book, products, and overall agenda with inflammatory statements like these:

Why there is an alliance between junk pet food makers (‘barfers’ included), many veterinarians and fake animal welfare groups designed to keep pet owners confused and in the dark?

See how incompetence and maladministration characterise the veterinary endeavour.

 The situation is grim and starts with the veterinary profession’s inattention to detail. Whilst it is obvious to most folks…that junk foods are bad for health the veterinary profession appears to have been too busy to notice. Once pointed out, the fact that an artificial diet fed monotonously either directly or indirectly poisons animals, the profession should have risen up and acted. Instead the professional ethic ruled that a mass cover up should apply. With the cover up safely in place profits were to be made. Increasingly elaborate ploys are now used in persuading the populace to a. keep more animals and b. feed them high priced artificial concoctions.

It is my belief that the profession’s political mismanagement and acquiescence is matched by a naive scientific methodology… Our way out of the mire is via a holistic assessment…. Since the holistic approach is not usually taught or practised, here are a few tips which may be of help. Firstly, make sure to have fun. There are no columns of meaningless figures in this approach nor disembodied dry facts.

We have standardised error such that incompetence has become the standard.

Such negative advertising may not be the rule for alternative veterinary practitioners, but it is by no means rare. There is a natural tendency for proponents of alternative methods to promote them in terms of the inadequacies or dangers of conventional medicine. Insofar as they present reasonable evidence to support their criticisms, this is fair play. However, at a minimum, there should be some attempt to offer such evidence, and efforts to claim superiority by insinuating greed, ignorance, or stupidity on the part of the majority of veterinarians practicing conventional should be eschewed.

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From Occam’s Razor: A Scientific View of Pseudoscience

Posted on November 15, 2011 by skeptvet

One of my favorite podcasts is Occam’s Razor, the science podcast of the Australian Broadcasting Corporation’s (ABC) Radio National. In a recent episode, A Scientific View of Non-Scientific Beliefs, Dr. Craig Cormick of Canberra does an excellent job of laying out a cogent view of how intelligent people come to and maintain unscientific beliefs despite powerful evidence against them. Though not as comprehensive a treatment of the subject as a book like Michael Shermer’s Why People Believe Weird Things, this short essay outlines some of the key issues, and points out some of the major challenges for those of us trying to counter pseudoscientific, or simply inaccurate, beliefs.

Dr. Cormick Begins with some frightening statistics (which are also oddly comforting only in that they challenge the assumption I sometimes make that the United States is the center of gravity for antiscientific thinking).

So what are we to make of the facts that in Australia roughly every second person believes in psychic powers such as ESP, one in three believes in UFOs and one in five believes in magic?

And a 2005 survey published in the Medical Journal of Australia stated that half of all Australians are taking alternative medicines with one in four not even telling their doctor they are taking them.

Other surveys conducted in Australia and in the USA indicate that about 80% of the population hold at least one paranormal belief which includes astrology. One in ten Americans said that astrology was ‘very scientific’, in the UK belief in UFOs is about evenly divided into thirds between those who say UFOs have visited the earth, those who say they have not and those who were undecided…

According to the US Centre for Disease Control, one in five Americans believes that vaccines can cause autism and two in five Americans have either delayed or refused vaccines for their children. And in Australia according to the Australian General Practice Network vaccination rates have been dropping over the past seven years, with now only 83% of 4 year olds covered which is more likely to lead to outbreaks of fatal, but preventable, diseases.

And in some areas, usually where there are high pockets of alternative lifestyle supporters such as south-east Queensland, the northern rivers of NSW and Adelaide Hills and the south-west of Western Australia vaccination rates are as low as 70%.

He then goes on to point out that providing facts and data which contradict unscientific beliefs doesn’t seem to be very effective in undermining these beliefs. As an example, he points out that despite the comprehensive disproof against the notion that childhood vaccines cause autism, and despite the retraction of the original paper by Andrew Wakefield and the revocation of ex-Dr. Wakefields medical license, belief in a vaccine-autism connection has not been much reduced. Dr. Cormick then gives examples of a number of factors that promote pseudoscientific beliefs based on current research.

The first on our list is scales of belief. People don’t divide into simple for and against camps on those things…There’s usually a wide scale, or a continuum of strengths of belief. So just because you believe in homeopathy and think that genetically engineered crops are unnatural it doesn’t mean that you don’t prescribe to a scientific view of the world on other things. But the further along the continuum you travel towards extreme anti-science thinking end, the more science-thinking is rejected and people at that end are very unlikely to ever shift their position.

It seems quite true that there are such scales of belief. I know of one prominent advocate for alternative veterinary medicine who seems reluctant to criticize the more mystical and obviously faith-based alternative approaches despite being an outspoken critic of religious belief (though I cannot say if the person is truly a believer in these spiritual forms of alternative medicine or is merely being politic). I know another perfectly rational person who proudly claims to be an advocates of evidence-based medicine and who also practices Healing Touch, a non-denominational form of faith healing. So it can be difficult to clearly identify exclusively pseudoscientific thinking because it is often accompanied by perfectly sound scientific thinking in the same brain.

However, as well as being a problem, this could potentially be an opportunity for those of us advocates of the scientific approach. Recognizing that promoters of approaches that are unscientific in some aspect may also me supporters of science in other domains might give us common ground and a common language, which could facilitate dialogue and perhaps education. Or am I being too optimistic?

Next, Dr. Cormick talks about heuristics, the “mental shortcuts” that lead us into false beliefs and keep us there. I have discussed these many times before, but Dr. Cormick takes a slightly different approach to the subject.

It’s the way we respond to rapid and complex information being fired at us. We need to quickly sort it into categories and an easy way to do this is to sort it according to our existing belief systems or values…the cultural cognition effect which put simply, argues that our values are more strongly going to influence our attitudes than any standard demographic like age, gender, race or socio-political status…And through ongoing affirmation and reinforcement of wacky ideas, they become values or beliefs and don’t easily move for anything. If you doubt this, just google “The Royal Family are Seven Foot Shape Shifting aliens’ and look at the sheer amount of confirmation on different sites about this.

Access to the enormous breadth of opinions on the internet has revealed that people, when swamped with information follow up by ‘motivated reasoning’ which means only acknowledging information that accords with our beliefs and dismissing information that does not accord with them.

The next item on Dr. Cormick’s list is the depressing reminder that because of this values-based, motivated reasoning, facts don’t change beliefs very often.

Brendan Nyhan at the University of Michigan undertook a study that found that when people were shown information that proved that their beliefs were wrong they actually became more entrenched in their original beliefs. This is known in the business as ‘backfire’. And what’s more, highly intelligent people tend to suffer backfire more than less intelligent people do, making us immune to any facts that are counter to our strongly held beliefs…

Dr Andrew Binder at North Carolina State University found that most people when faced with an issue related to science and technology fairly quickly adopted an initial position of support or opposition based on a variety of mental shortcuts and predisposed beliefs. Dr Binder stated ‘This is problematic because it suggests that individuals are very selective in choosing their discussion partners and hearing only what they want to hear during discussions of controversial issues.

Dr. Cormick then addresses the “fear factor,” the phenomenon by which the emotional content of issues, particularly those that generate anxiety or fear, impedes a reasoned judgement based on facts. When an alternative medical approach, for example, is marketed through fear, fear of toxins, chemicals, or other nebulous dangers, then people are more likely to accept it despite the evidence against it.

Lastly, Dr. Cormick touches on what I believe is one of the most important factors, one related to the issue of fear: control. Alternative approaches are especially attractive to those who feel a need for more control, over their health or other sources of fear. Simple, confident, direct answers are reassuring and appealing even if they aren’t consistent with the often complex and ambiguous nature of reality. Pseudoscience has an inherent marketing advantage over science in catering to people’s anxiety and need for control because it is not constrained by the true nature of reality.

At the heart of a lot of our non-science beliefs is control. We live in an ever uncertain and more out of control world, but superstitious beliefs and pseudoscience can give people a sense of control and certainty, providing simple answers, which reduces our level of stress which again is a necessary adaptive mechanism and something we tend to be wired to seek out. But here’s the cruncher – science is predominantly based on uncertainty and the simple answer to this simple statement is that unfortunately there is no simple answer.

So what to do? Well, Dr. Cormick doesn’t claim to have a comprehensive answer (which increases his credibility, since any such answer would likely be wrong), but he does have some sensible suggestions.

…good science education can help. There is some evidence that adults with more science training will more often reject astrology or lucky numbers and more often accept things like evolution. Likewise a 2002 PhD study by Alyssa Taylor in Queensland found that a course on critical thinking led to significant decline in belief in paranormal claims.

So we need to educate people before attitudes and beliefs are strongly formed and in this it is more important to teach them how to think than what to think. The only way to make people bullet-proof to pseudoscience is to effectively teach the values and ways of science thinking whilst still young before alternative belief systems have formed.

 

 

 

 

 

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Cooking increases the caloric value of meat and starches

Posted on November 13, 2011 by skeptvet

I have reviewed the claimed benefits of raw pet diets previously, as well as the potential risks of these diets (1,2,3). The bottom line is that there is no credible evidence that these diets have any health benefits or that they are safer or more nutritious than conventional commercial diets or properly formulated cooked homemade diets. Given they have small but clear risks, there is reason to avoid them. There is now a small bit of additional evidence arguing that, in fact, the nutritional value of cooked meat is actually greater than that of raw meat.

Carmody, RN. Weintraub GS. Wrangham, RW. Energetic consequences of thermal and nonthermal food processing. Proceedings of the National Academy of Sciences. 2011 [EPub ahead of print)

One of the authors, Richard Wrangham, is an ecologist who has studied the impact of food on the evolution of humans and other primate species. Last year, in his book Catching Fire: How cooking made us human, Dr. Wrangham presented the thesis that a key event in human evolution, the rapid development of a large brain, was made possible by the discovery of cooking, which not only made food safer by destroying parasites and infectious microorganisms, but also increased the energy available in the food. He was able to cite extensive evidence that the difficulty finding adequate calories is a key constraint on the health and reproduction of animals in the wild, including early humans, and that cooking made dramatically more energy available from plant foods. As the authors of the current study put it, “Energy availability is a routine constraint on metabolic processes, including growth, disease suppression, and reproduction, and therefore, it is a key variable for human nutrition and evolutionary fitness.’ The same is, of course, also true for other animals.

In his book, Dr. Wrangham was also able to report studies showing that modern humans relying on exclusively raw foods, for ideological reasons, are chronically undernourished as a result. A missing piece in his argument for the value of cooking, however, was evidence that cooking increases the caloric value of meat, which was suggested by a number of indirect studies but which hadn’t ever been clearly demonstrated. This new study supplies this missing piece.

The study compares the energy intake and weight gain of mice fed either sweet potato or beef. Different groups were fed these foods unprocessed, pounded but not cooked, cooked but not pounded, or pounded and cooked. The results for both sweet potato and beef showed that the mice gained more energy from the cooked foods than from raw or pounded foods, and that cooked foods were preferred.

Of course, dogs and cats are not mice, and they are not fed individual ingredient diets. The point of this study is not to evaluate the issue of the benefits and risks of raw pet diets, which is a much more complex subject. However, it does challenge one common claim made in support of raw diets, which is that raw foods have greater nutritive value. While cooking does reduce the levels of some nutrients, it makes others more available. One crucial nutritive component of food is the energy it provides, measured in calories. And this study demonstrates that the energetic value of both starches and meat are increased by cooking.

Since many of our pets are overweight, one could argue that we shouldn’t care about the greater calorie value of cooked foods since calories are not a limiting resource for domestic animals, as they are for wild animals. Clearly, we need to limit the caloric intake of our pets to maintain a healthy body condition. However, there is still no reason to think that raw diets are superior to cooked diets for this purpose, since the best way to ensure appropriate calorie intake in our pets is to feed them an appropriate quantity of nutritionally balanced food and monitor their body condition. The notion, often advanced by proponents of raw diets, that cooking is an entirely destructive process in nutritional terms is clearly not supported by this study, which reinforces the fact that cooking has been universally practiced by human populations for tens of thousands of years because it improves the nutritional value and safety of food.

Posted in Nutrition | 3 Comments

Homeopathy for Nasal Fungal Infections in Dogs?

Posted on November 6, 2011 by skeptvet

A case report recently appeared in the Journal of the American Animal Hospital Association (online only edition) describing the complete resolution of nasal aspergillosis (a fungal infection) in a dog following the use of an ultradilute homeopathic remedy. So what does this mean? Is this evidence for a clinical effect from homeopathy? Is it justification for further research? Is it justification to start giving these remedies to dogs with aspergillosis along with, or instead of conventional treatment?

Epstein, S. Hardy, R. Clinical Resolution of Nasal Aspergillosis Following Therapy with a Homeopathic Remedy in a Dog. Journal American Animal hospital Association 2011;47:e110-e115.

To begin with, a case report is the least useful form of published evidence. It is essentially an anecdote, though with more detail than the usual testimonials and anecdotes used to advertise unproven therapies. It is a story told about a single individual patient, with no attempt to control for the biases that make all anecdotes of very limited usefulness in figuring out whether a medical treatment works or not. Case reports are useful for identifying new observations that might or might not ultimately lead to useful conclusions based on more formal investigation. What they cannot do is prove any particular hypothesis. So on the most basic level, this case report is not evidence that homeopathy is an effective therapy for nasal aspergillosis, or anything else.

The conclusion of the paper, and the conclusion almost always drawn from such case reports, is that further study is needed to determine if the apparent association between the treatment and the outcome (in this case, the apparent resolution of the disease) is a true association or a coincidence, and if there might be a causal relationship between treatment and response. However, there is ample reason, both within this case report and in other evidence and information available to us, to argue that no further study is in fact justified by this report.

The case against homeopathy in general has been exhaustively made many times (e.g. 1, 2, 3). In brief, the theory of like-cures-like and potentization by dilution and succussion are inconsistent with the well-established fundamental principles that underlie all of the rest of chemistry, physics, and medicine, and there is no evidence that suggests these principles might be true despite this inconsistency. Decades of research has failed to establish any consistent benefit from homeopathy greater than placebo. So for this case report to be taken as evidence that homeopathy cured this patient requires, essentially, that it be seen as a miracle that defies established science. It is not simply an extension of previously documented theory and evidence, but a narrative akin to the healing miracle stories told in support of religious claims. If it is true, it represents a fundamental change in how we understand reality.

The alternative, which seems far more plausible to me, is that this dog experienced a resolution of his disease, or at least his symptoms, that was either spontaneous or aided by the conventional therapy he had received prior to being given the homeopathic remedy. Spontaneous resolution of nasal aspergillosis in dogs has not been reported in the literature. However, other kinds of aspergillosis have been demonstrated to go away without treatment, including invasive pulmonary aspergillosis in humans, and aspergillus granulomas in humans. And in my own practice, I have seen presumed spontaneous resolution of nasal aspergillosis in a dog. The patient, a middle-aged golden retriever, had been having nosebleeds for several weeks when he was brought to see me. Rhinoscopy with biopsy and culture ultimately confirmed invasive nasal aspergillosis. The owners declined treatment due to the cost, and after a couple months the nosebleeds ceased. The dog never had any further nasal symptoms and died of an unrelated disease several years later. I know one other veterinarian with a similar story of a dog whose symptoms went away with no anti-fungal treatment.

I doubt if the authors of the current report with consider spontaneous resolution as an alternative explanation for the result seen in their case even had these two cases been published, but it is a far more plausible explanation than that homeopathy cured the patient. The only way to know for certain, of course, would be to compare homeopathic treatment with no treatment to see if those cases treated only with homeopathy recovered any more often than those not treated at all. However, this would be unethical since spontaneous resolution is likely rare, the disease is serious, and there are established effective conventional therapies available. I would argue that even comparing homeopathy with conventional treatment would be unethical since there is no sound, plausible case to be made that homeopathy has any benefit, and using it exclusively would amount to not treating the patients at all.

That leaves using homeopathy as a “complementary” or “integrative” therapy along with conventional treatment as the only ethical option. Again, there is no reason to think it would increase the chances of success for conventional therapy, but such a study could be rigorously and ethically done. If it turned out homeopathy significantly improved the outcome in a properly designed and conducted study, it would indeed be miraculous and require skeptics such as myself to re-evaluate the whole method of homeopathy. This is certainly a reason for practitioners of homeopathy to seek such a study.

For myself, I think the limited resources available for clinical research in veterinary medicine could be better spent on more plausible approaches, but I see no reason such a study should not be attempted if proponents of homeopathy are willing to fund it. But given the paradigm-changing nature of a positive result, the quality of the research would need to be extraordinary (e.g. independently replicated double-blinded, randomized, controlled trials). Such studies have never before succeeded in proving the benefits of homeopathy, so I would not expect this case to be different.

Unfortunately, if such studies are never done, or if they are done and no benefit from homeopathic treatment is found, this case report will continue to be cited as a justification for trying homeopathy on dogs with nasal aspergillosis. The appearance of an anecdote in a journal doesn’t make it any more valuable as evidence, but it makes the story far more valuable as marketing. The American Holistic Veterinary Medical Association (AHVMA) has exhorted its members to publish such case reports for exactly this reason. In fact, a previous report of homeopathic treatment for nasal aspergillosis by the same author is specifically cited as an example of the kind of report needed to promote CAVM. That case was published in the AHVMA journal because mainstream journals declined to publish it due to limitations in the quality of the information gathered and provided.

The emphasis in this effort is clearly not identifying whether or not CAVM methods work but convincing mainstream veterinarians that they do, which presumably practitioners of these methods already know from personal experience despite the absence of supportive scientific evidence. This is a classic example of scientific publication used as marketing rather than as a genuine effort to figure out whether therapies actually are effective or not. Below is an excerpt from a paper in the AHVMA journal encouraging CAVM practitioners to publish case reports (emphasis added).

The Research committee of the AHVMA has recently been reactivated with the purpose of increasing the amount of published material, which can be used by veterinarians and other interested parties to demonstrate effective clinical uses of CAVM, as well as, to assist legislative and regulatory bodies such as state boards in properly evaluating consumer complaints and legislative requirements regarding CAVM practitioners and practices. (AHVMA 2006a) This committee is working to increase the number of high-quality, useful pieces of literature, which can be used to establish the validity and applicability of CAVM, and sees this as an important action at this time. It is hoped that competent CAVM clinicians and researchers will use EBVM to document their successes. Establishing proper scientific literature and making it more readily available allows for more interested parties to learn about many of the miraculous results seen in CAVM practice. (AHVMA 2006b) Doing such actions allows for the expansion of knowledge, the expansion of CAVM acceptability and for the improvement of our profession;”

Case reporting is one way that CAVM practitioners can record their results publicly so that others can benefit from their labors. We know that investigator bias can affect research results and quantum physics has clearly demonstrated that the observer can affect the results of phenomena in the physical universe. This effect can lead to positive results that are not repeatable by others, as well as negation of procedures due to improper environment….

Critics of CAVM are quick to point out the lack of double-blind randomized studies in our field, often without recognizing the situation present in conventional veterinary practice. In many situations, this type of study is not readily applicable to CAVM processes as therapy is individualized to each specific patient’s particular situation. As an example, homeopathic cases are not easily studied in this manner, while acupuncture and herbal medicine can be.

CAVM procedures do work. We all see this daily. Because of the increasingly cooperative efforts by board certified referral practices and CAVM practitioners, it is hoped that such barriers to publication will be minimized in the future as more and more cases are occurring which have excellent conventional and alternative documentation. Case reports have been perceived to be less important in the present environment of scientific literature as they form a lower level of scientific evidence. However, case reports are an important area of scientific enquiry and one that is entirely appropriate for the CAVM community.

 

 

 

 

 

 

Posted in Homeopathy | 7 Comments

Aural Hematoma Review and Other New Info from the EBVMA

Posted on November 2, 2011 by skeptvet

The Evidence-Based Veterinary Medicine Association (EBVMA) is continuing to try and support evidence-based medicine for veterinarians, and the latest activity in that effort is producing a series of brief, pragmatic literature reviews on common clinical problems and therapies. The first in the series is now available:

Aural Hematomas in Dogs. Prepared by Annette O’Connor, DV and Teresa Hershey, DVM. Sept., 2011

The review illustrates well the process of locating and evaluating the available evidence for a particular intervention. It found, as is all too often the case, that the evidence was not sufficient for a definitive conclusion to be made.

There are many ways that aural hematomas are treated in dogs. The articles reviewed examined hematoma drainage in combination with either oral or local injections of steroids and traditional surgical treatment. There was no evidence that adding steroids to treatment protocols reduced the number of dogs that needed to be retreated. The quality of the evidence was poor which limits any interpretation that may be made.

This is often the case in veterinary medicine, and even in human medicine. However, it is important to understand the true meaning of this outcome. It is not that any and all approaches to aural hematomas are equally likely to be useful. The application of magnets or color therapy, for example, is not justified by the fact that the evidence is not strong enough to clearly say whether or not adding a steroid to treatment improves outcomes. The fact that the evidence concerning a particular question is of limited quality and quantity means only that sweeping and definitive statements about the efficacy of particular treatments aren’t supported, not that anything anyone can dream up is reasonable.

The EBVMA is also beginning to collect other educational materials from members and make them available to the public and other veterinarians. The most recent additions include two excellent lectures by Bob Larson, a professor at the Kansas State University veterinary college.

Evidence-Based Medicine-An Introduction
Here’s my favorite slide:

Four Myths of Small Numbers and Other Biases
My favorite slide:

Posted in Science-Based Veterinary Medicine | 8 Comments

Guidelines for Minimizing Commercial Influence in Veterinary Medicine

Posted on October 30, 2011 by skeptvet

The potential bias introduced into research, medical education, and individual clinician judgment by relationships with commercial entities is a perennial and serious issue in medicine, including the veterinary field. While critics of mainstream veterinary medicine frequently raise this issue when challenging the claims made for conventional diets, medications, and other healthcare interventions (e.g. 1, 2), alterative practitioners and organizations are no less involved with industry (e.g. 3). While financial bias is only one potential influence on the judgments and practices of veterinarians, and by no means the biggest problem we face, it is a source of bias that can be limited and monitored through transparency and rules concerning the kinds of interactions between veterinarians and industry.

The American Association of Veterinary Medical Colleges (AAVMC) has published a new set of guidelines addressing this issue specifically for veterinary schools, and it provides a sensible list of principles for minimizing the potential bias created by relations between industry and academia: Guiding Principles and Considerations: Ethical Interactions Between Schools/Colleges of Veterinary Medicine and External Entities. Though the document is not intended to be comprehensive, and AAVMC specifically recommends each institution develop their own rules appropriate to their unique circumstances, these guidelines identify many of the key areas in which inappropriate industry influence can arise, and they make reasonable suggestions for preventing this.

AAVMC begins with, “the expectation that educational, clinical, research and outreach programs will be based on the best, current and unbiased scientific knowledge. That information must be free of biases or inappropriate influences that may result from interactions with external entities, especially with companies that provide goods and services of value within veterinary medicine.” The same should, of course, be true for private practices. While it is clear that research and the development of new and better therapies cannot happen without the resources provided by commercial organizations, it is equally clear that it is all too easy for these organizations to inappropriately influence the content and outcome of research and the practice of individual veterinarians, and strict ethical guidelines are needed to control for this source of bias.

The document then details many of the ways in which industry can attempt to influence the veterinary profession through veterinary medical schools, including:

  • Gifts of goods and service to students, faculty and staff.
  • Gifts to individuals in the form of scholarships, research grants, and other forms of financial support.
  • Gifts to the institutions themselves, in the form of money, products, services, land, etc.
  • Remuneration for speaking, consulting, and other activities.
  • Funding and organization by commercial entities of educational events.

One of the key principles identified in this document, and often not clearly understood, is that the size or specific nature of gifts from commercial organizations to individuals is not relevant to the potential for such gifts to introduce bias. It is not simply a case of crass, direct buying of influence. Sales representatives, who often genuinely believe in the products they are marketing, build relationships and trust and a sense of personal rapport, which subtly bias the decisions of their customers through a sense of personal obligation, through a greater awareness of the products one is most frequently reminded of, and other mechanisms not requiring any malfeasance on any individual’s part. Pens and coffee cups and pizzas are laughable as bribes, and most individual veterinarians are ethical and not likely to accept deliberate bribes anyway, yet the evidence from studies of physicians shows quite clearly that interactions involving even such trivial gifts do influence the behavior of recipients even when those recipients don’t believe it does.

The principles suggested by the AAVMC for minimizing the bias introduced by relationships between industry and academia are not very detailed, but they do touch on a couple of  key elements in such an effort.

  • Transparency and the disclosure of any and all relationships with commercial entities, regardless of how trivial or legitimate they may seem.
  • Managing any and all gifts to the schools, financial or otherwise, centrally so that individual faculty, students, and staff are not directly receiving such gifts from commercial organizations.

Specific rules promulgated by individual schools will need to be considerably more specific. And in many cases, it seems to me that it would be appropriate to ban outright many of the gifts students and faculty receive from commercial entities, including food, medicine, sponsorship of events, and all the innumerable trinkets marketing departments devise. If industry wishes to contribute resources to the advancement of veterinary medicine, financial support filtered through the school administration, or better yet through independent non-profit organizations supporting research and education, would be more useful and ethically less problematic than these sorts of gifts.

What is more, similar ethics policies would be appropriate for private practices as well. I personally no longer attend continuing education dinners and other such events provided to our practice by vendors of veterinary products and services because I have come to believe the risks of such relationships outweigh the benefits, even though I personally have no influence on the product choices made by the management where I work. And while I cannot see how most clinical research could happen in veterinary medicine without industry funding, since government and private non-profit funds for small animal research are incredibly scarce, I would love to see industry support such research indirectly, through grants made to independent organizations which distributed such funds according to pre-defined and transparent criteria of scientific merit. This would allow industry to continue to support the development of needed therapies without such a risk of biasing the outcome of research studies. Such would be a truly philanthropic activity, rather than just a form of marketing. 

Posted in Science-Based Veterinary Medicine | 17 Comments

Dry Pet Food and Dental Disease in Dogs and Cats

Posted on October 17, 2011 by skeptvet

One of the most common diseases in cats and dogs that I see in practice is dental disease. According to the American Veterinary Dental Society, by three years of age 70-80% of dogs and cats will have signs of oral disease. Unfortunately,  many people think that dental disease is only cosmetic or not a real health problem for dogs and cats. However, in humans it is clear that poor oral health is not only a source of discomfort but a significant risk for other serious diseases. While there is little research on the subject, there is no reason to believe that the same is not true for dogs and cats. There is certainly no question that oral disease is a source of real suffering for our pets.

Unlike humans, dogs and cats rarely get cavities. This is probably due to differences between the bacterial flora that normal inhabits human mouths and that which lives in the dog and cat mouth. Genetics also likely plays a significant role, as this is one of the most important determinants of susceptibility to dental disease in humans. Most dental disease in dogs and cats is periodontal disease, inflammation of the gums and the tissues that hold the teeth in the jaw. Periodontal disease is responsible for pain, trouble eating, tooth loss, and potentially diseases in other organs.

Periodontal disease begins with the accumulation of plaque, a biofilm containing proteins and oral bacteria. Plaque, and the subsequent mineralized material known as calculus or tartar, initiates a cycle of inflammation in the periodontal tissues which can ultimately lead to severe pain, swelling, and tooth loss. Periodontal disease can be treated, but this requires general anesthesia and often involves extraction of diseased teeth, so of course prevention is preferred to treatment whenever possible.

While genetic factors are significant in determining if an individual is likely to develop periodontal disease, these are not readily controlled, so the focus of preventing periodontal disease is primarily on reducing plaque and calculus accumulation and maintaining healthy periodontal tissues. The most effective method for preventing periodontal disease is regular, proper home care. Brushing, in particular, is a great way to remove plaque and prevent oral disease, and many dogs and cats will tolerate it well if it is introduced when they are young.

In addition to brushing, and especially for those pets that do not tolerate it, there are innumerable products marketed for preventing periodontal disease. Most of these have little to no supporting evidence for their claims. Whenever considering using one of these products, it is useful to look for the Veterinary Oral Health Council (VOHC) seal of approval. The VOHC is an independent organization which requires reasonably rigorous, scientific evidence demonstrating efficacy in preventing plaque (which is most important) and calculus accumulation (which is somewhat less useful in preventing periodontal disease) in order to obtain their seal. Such products, including oral rinses and gels, treats, and chews, are not a substitute for brushing or regular veterinary prevention and treatment measures. But there is good reason to believe that if they have obtained VOHC approval then they have some value.

One of the most common actions recommended, by veterinarians and others, to minimize the development of oral disease is feeding dry commercial pet diets. It is often argued that chewing on kibble cleans the teeth and slows the development of periodontal disease. However, there is some reason to doubt this claim. Most dry diets made for dogs and cats do not require chewing, and the kibble is often swallowed whole. And typical kibble is very easily broken apart, so it does not seem likely that it is very effective in cleaning teeth, especially under the gum line, where  plaque and calculus cause the most inflammation and disease. And at least one study looking at the effect of diet and chewing materials on oral health did not find that feeding a dry diet only was associated with any less periodontal disease than other feeding methods.

Of course, there is also no evidence that dry diets are a significant cause of dental disease, as is often alleged by proponents of other feeding methods, and there is no evidence to support claims that feeding canned, homemade, or raw diets is better for oral health. And while there is some evidence that bones, like any abrasive chewing material, can help clean teeth, the many risks of bones, including fractured teeth and potentially life-threatening injuries to the gastrointestinal tract, likely outweigh any benefits. So while dry diets in general may not be of benefits in terms of preventing periodontal disease, this does not automatically mean that the alternatives to commercial dry foods are any better.

In fact, a new study suggests that the opposite might be true, and that dry commercial diets may have some value in preventing dental disease after all.

Catherine Buckley, Alison Colyer, Michal Skrzywanek, Katarzyna Jodkowska, Grzegorz Kurski, Jerzy Gawor, Michal Ceregrzyn.. The impact of home-prepared diets and home oral hygiene on oral health in cats and dogs. British Journal of Nutrition (2011), 106: S124-S127.

This survey of thousands of dogs and cats seen by veterinarians in Poland identified brushing and the use of dental treats as significant factors reducing the risk of oral disease. No surprise there. However, the results also showed that homemade diets were associated with an increased risk of oral disease and that exclusive feeding of dry diets reduced the risk of oral disease.

The present study aimed to elucidate the influence of feeding home-prepared (HP) food v. commercial pet food on oral health parameters in these animals and to investigate the effect of home oral hygiene on oral health. The study surveyed 17 184 dogs and 6371 cats visiting over 700 Polish veterinary surgeries in 2006–7 during a Pet Smile activity organised by the Polish Small Animal Veterinary Association. All animals underwent conscious examinations to assess dental deposits, size of mandibular lymph nodes and gingival health. An oral health index (OHI) ranging from 0 to 8 was calculated for each animal by combining examination scores, where 0 indicates good oral health and 8 indicates poorest oral health. Information was collected on age, diet and home oral hygiene regimens. There was a significant effect of diet on the OHI (P < 0·001) whereby feeding the HP diet increased the probability of an oral health problem in both cats and dogs. There was a significant beneficial effect of feeding only commercial pet food compared with the HP diet when at least part of the diet was composed of dry pet food. Daily tooth brushing or the offering of daily dental treats were both effective in significantly reducing the OHI in both cats and dogs compared with those receiving sporadic or no home oral hygiene. Feeding only a dry diet was beneficial for oral health in cats and dogs. Tooth brushing and the offering of dental treats were very effective in maintaining oral health, provided they were practised daily.

Obviously, this is only a single study, and it is impossible to evaluate the methodological quality of it from the abstract alone. Many details, such as what kind of homemade diets were included and whether there might be differences among them, are not. However, it does provide at least a bit of evidence against the often made claim that dry diets have no value in preventing dental disease or that homemade diets, such as raw or BARF diets, are superior.

There are undoubtedly many good reasons to consider alternatives to feeding only commercial dry diets. Specific medical conditions may require diets of a composition or consistency other that dry kibble. And while much of the propaganda about the health risks of commercial dry diets for cats is irrational and not supported by evidence (e.g. 1, 2), there is some reason to believe that moist diets may be superior for cats in some respects. So this study is by no means a reason to recommend feeding exclusively dry commercial diets. The overall nutritional needs of each individual must be assessed, not simply the question of dental disease.

However, for those patients, especially small breed dogs, at high risk for severe dental disease, it is important to consider the potential value of commercial dry diets in preventing the significant health risk. Diets that have obtained the VOHC seal for plaque prevention, in particular, should be considered a legitimate tool in the management of periodontal disease, and the overall health and well-being, of individual patients.

Posted in Nutrition | 19 Comments

Protandim–Snake Oil Marketing at its Best (or Worst)

Posted on October 11, 2011 by skeptvet

There are a seemingly infinite number of herbal remedies and dietary supplements marketed for pets, thanks largely to the inadequate regulation of such products and the inability of the government to enforce what rules there are. This creates an open field for unproven or outright quack remedies, which can be cheaply and profitably marketed to worried pet owners trying to prevent or treat serious illnesses. The resources spent in this way would be better used in rigorous scientific evaluation of such remedies to identify which have real value and which do not, but such is not the way of the medical marketplace.

It is impossible to look into even a small proportion of these nostrums and evaluate the evidence for the claims made by the individuals and companies selling them. However, when one of these products is brought to my attention, by a client, advertising literature, or an investigative review done elsewhere, I try to evaluate the claims and evidence for that product and make that information available to pet owners and veterinarians here. In this case, a previous review and a recent update at Science-Based Medicine, by Dr. Harriett Hall, drew my attention to a product called Protandim.

 What Is It
The reported ingredients are milk thistle, bacopa extract, ashwagandha, green tea extract, and turmeric extract, though the blend is “proprietary” and no details are given.

The marketing of Protandim [Note 7/25/2013-Link broken, original page has been removed] resembles that for the DogterRx I investigated recently, in that it has many of the classic warning signs of snake oil, including:

A mixture of multiple herbal ingredients with different proposed effects and mechanisms (though as always there is some overlap since most herbal products are claimed to be useful for a tremendous variety of problems).

Vague claims about treating “oxidative stress” and “inflammation” based on in vitro or lab animals studies, with the implication that “anti-oxidant” and “anti-inflammatory” agents must automatically be safe and beneficial.

Claims for benefits in a wide range of unrelated medical conditions, including

Better skin and coat
Increased energy & endurance
Healthier immune system
Better sleep
Better joint health and mobility
Reduced joint pain and inflammation
Stronger resistance to allergies
Stronger resistance to Valley Fever (Southwest)
Better tooth & gum health
Better cardiovascular health
Increased mental function and alertness
Reduction of age-related cognitive decline
Anti-aging effects at the cellular level
(The claims in the company patent are even more amazing.)

And apparently it is good for conditions which are exactly the opposite of each other:

If  your pet seems moody or lethargic, why not try giving them a dose of Protandim…

High energy dogs and service dogs are also excellent candidates for Protandim.

Claims of perfect universal effectiveness:

It’s been scientifically proven to work in 100% of the people, 100% of the time!

Just one caplet of Protandim per day is clinically proven to reduce oxidative stress an average of 40%, reducing the level of cell aging to that of a 20 year old or a very young child, regardless of your age!

Dramatic testimonials of miraculous effects.

An aggressive distributed, multilevel marketing structure that tries to recruit anyone who buys the product to be an “authorized distributer.”

And of course, “Protandim is all natural, and there are no known side effects except allergic reactions to one of the ingredients…” So it can reverse aging, prevent or treat almost any illness, and fundamentally alter your body’s chemistry without any possible side effects? Amazing!

The makers also make the ridiculous assumption that any benefits in humans (as poorly substantiated as they may be) can automatically be assumed to be seen in “all mammals.” They do not make a veterinary product but simply give this advice:

How to Share Protandim with Your Pet

Start by crushing a caplet and mixing it in a treat your pet enjoys or their usual food. Use less Protandim for smaller animals, more for larger dogs (try a pinch for a small animal or cat, to a  whole capsule for large animals). Observe closely for improvements in behavior, improved energy, pain reduction, sleep, etc. When administering Protandim to an animal, err on the side of using a smaller dose and increase gradually as needed.

The company will produce a special version of Protandim just for pets in the future. But for now, cut down the yellow caplets to create pet-size dosages.  This will work just fine.

Gee, who knew that the entire field of pharmacology was unnecessary and one can just pick what looks like a “pet-sized dose” of a human medicine and it will work just fine!

Does It Work?
The underlying theory used to promote this product, that anti-inflammatory and anti-oxidant effects are beneficial for a wide range of unrelated diseases, is dubious. Anti-inflammatory medications, such as steroids and non-steroidal anti-inflammatories, do have demonstrated benefits, but not surprisingly these come with demonstrated risks. Anything that suppresses inflammation, whether or not it comes from a plant originally, is tinkering with a core physiologic process, and it is simply impossible to do this without risk. the issue of whether the benefits outweigh the risk for particular patients with particular medical conditions, is one that can only be answered with the kind of research that has not been done for this product or its constituent ingredients.

Interestingly, there is also growing doubt about the benefits and safety of anti-oxidants. The hype about anti-oxidants has turned out to be unrealistic, and risks have been seen with Vitamin C, Vitamin E, and other known anti-oxidants. Free radicals and oxidative compounds do have the potential to cause damage and disease. but they are also responsible for some of the protective activities of our immune system, for the beneficial effects of some anti-cancer therapies, and other positive phenomena. As always, tinkering blindly with a common chemical or physiological process is likely to have more risks and fewer benefits than a targeted use of specific and well-researched medicines for specific problems.

There is a fair amount of in vitro and animal model research, a little bit of clinical trial research in humans, and even the occasional small clinical trial in veterinary species, looking at the activity and effects of the individual ingredients. None of them have well-demonstrated benefits or clear evidence that there is negligible risk in using them, but several have interesting properties that warrant further study. It would not at all surprise me if compounds derived from some of these ingredients turned out to have therapeutic value, but that is a far cry from justifying the kind of claims made for this product.

And naturally, the mixture in Protandim is claimed to be more effective than individual ingredients taken separately. The web site even states quite precisely (if meaninglessly) that the ingredients have “1500% greater synergy working in tandem (together) than what they are able to achieve on their own.” This is even more impressive given that isolated and purified compounds are usually safer and more effective than variable mixtures of many chemicals. Synergism in plant-derived remedies has been demonstrated in some cases, but it is not a general rule that can be relied on. Polypharmacy (the use of mutliple drugs and herbal remedies or supplements) significantly increases the risk of undesirable interactions between compounds.  Once again, apparently the rules of pharmacology don’t apply to this product. 

Dr. Hall has reviewed the few studies on the product itself.

My original article only mentioned the 3 studies available at that time. As of this writing (October 2011), a query to PubMed brings up 8 published, peer-reviewed studies:

1. A human studyshowing changes in TBARS, SOD, and catalase.(2006)

2. A cell culture studyshowing increases in glutathione. (2009)

3. A mouse studyshowing an effect on skin tumor carcinogenesis. (2009)

4. A study in a mechanical animal model showing that chronic pulmonary artery pressure elevation is insufficient to explain right heart failure. (2009)

5. Another mouse studyshowing that Protandim suppressed experimental carcinogenesis and suggesting that suppression of p53 and induction of MnSOD may play an important role. (2010)

6. A study of muscular dystrophy miceshowing that Protandim decreased plasma osteopontin and improved markers of oxidative stress. (2010)

7. An ex vivo (tissue culture) study of human saphenous veins, showing that Protandim attenuated intimal hyperplasia. (2011)

8. An evaluation of the role of manganese superoxide dismutase in decreasing tumor incidence in a two-stage skin carcinogenesis model in mice.(2011)

…If I were a mouse being artificially induced to develop skin cancer in a lab study, I might seriously consider taking Protandim. But so far, the only study in humans measured increased antioxidant levels by a blood test but did not even attempt to assess whether those increases corresponded to any measurable clinical benefit, for cancer or for anything else.

So there is no evidence of clinically meaningful effects in humans, limited evidence of physiologic effects in humans which may or may not have any relevance to health, and of course no clinical studies at all in veterinary patients. Clearly, this doesn’t even begin to approach a reasonable justification for the wild claims made by the marketers of this product.

Is It Safe?
Who knows? The individual ingredients have been associated with some adverse reactions, both allergies and others. But in the absence of formal study, we don’t even know how common and serious these are. Far more extensive research is done on pharmaceuticals before they are released into the market, and unexpected problems still show up in those products. Our ignorance about these compounds is much greater, and therefore so is the risk of using them blindly. There is no safety information at all about the combination product.

Bottom Line
The underlying theory used to promote this product, that anti-inflammatory and anti-oxidant effects are always safe and beneficial, is highly doubtful. There is only weak in vitro and animal model research to indicate that the ingredients in Protandim, or the combination product, have potentially useful effects on cells or biochemical markers. There is absolutely no clinical trial evidence to indicate Protandim has any of the claimed benefits in humans or animals. While the absence of evidence is not proof the product is unsafe or ineffective, it is absolutely a reason to be skeptical of wild claims of miraculous benefits. At best, using this product is simply rolling the dice and hoping for the best. That seldom works out for gamblers in Vegas, and it is not an appropriate approach to healthcare except in the most dire of circumstances.

Posted in Herbs and Supplements | 62 Comments

Less is More–A reminder of why irrational dietary supplement use is a bad idea

Posted on October 10, 2011 by skeptvet

The dietary supplement industry in the United States is enormous, profitable, and growing. There is a widespread belief that nutritional supplements are inherently safe and beneficial and that everyone can benefit from taking them regardless of health status or dietary habits. The evidence has generally not supported this belief (for example, and also this summary), though the available studies are mostly observational and so cannot definitively identify risks or benefits in specific populations with particular behavior or medical conditions. However, as usual, the burden of showing safety and efficacy properly lies with those claiming supplements are useful or necessary, and particularly those using these claims to sell supplements. The supplement industry, however, benefits from virtually no regulatory oversight and so is not generally inclined to support rigorous scientific research into their products. So we must make do with the data we can get.

Mursu J, et al. Dietary supplements and mortality rate in older women: The Iowa Women’s Health Study. Archives of Internal Medicine. 2011;17(18):1625-33.

This study examines data drawn from a decades-long longitudinal study of over 38,000 women in Iowa. It examines self-reported supplement use and correlates this with total risk of mortality over time. The study illustrates the growth of supplement use. At baseline in 1986, the mean age of the women was 61.6 years, and about 63% of the women reported using supplements. By 2004, 85% of the women reported taking a dietary supplement.

Of the many supplements reported and analyzed, the only one correlated with a decreased risk of death was calcium. This is widely recommended supplement for the demographic in this study, post-menopausal women, and there is a sound rationale and some supporting evidence for using it in this group. All other supplements examined either had no association with mortality or were associated with an increased risk of death, including multivitamins, vitamin B6, folic acid, iron, magnesium, zinc and copper. Iron, in particular, showed a strong association with increased mortality risk that increased as the dose of the supplement increased.

It is not possible to demonstrate from such a study that these supplements cause an increased risk of death. But if untargeted supplementation truly had a beneficial effect on older women, it would be very unlikely to see the pattern of results shown in this study. And considering that several other similar studies have also failed to find a beneficial effect from such supplement use, it seems pretty clear that unless there is a specific deficiency or risk factor that suggests supplementation is needed, the non-specific use of single or multiple vitamin and mineral supplements is not likely helpful and may very well be harmful.

In a commentary on this study, a pair of nutritional experts remarked that the results

add to the growing evidence demonstrating that certain antioxidant supplements, such as vitamin E, vitamin A, and beta-carotene, can be harmful….

Dietary supplementation has shifted from preventing deficiency to trying to promote wellness and prevent disease….Until recently, the available data regarding the adverse effects of dietary supplements has been limited and grossly underreported. We think the paradigm ‘the more the better’ is wrong….

We cannot recommend the use of vitamin and mineral supplements as a preventive measure, at least not in a well-nourished population…

This should not be a surprising or controversial conclusion. The myth that vitamins are inherently benign and always beneficial likely can be traced to the 19th and 20th centuries, when vitamins, and diseases associated with then common vitamin deficiencies, began to be identified and understood. The effects of supplementation when there is a deficiency are remarkable and dramatic. Unfortunately, there is no free lunch in physiology. If something ahs benefits, it also has possible harms. And most nutrients have an optimal range, with diseases associated with excesses as well as deficiencies. Unfortunately, we don’t often know what this optimal range, or the appropriate level of intake is, which leaves a lot of room for baseless claims about widespread deficiencies and the need for supplements. Hopefully, as data like this accumulates, we will be better able to dispel the “more is better” myth that supports untargeted dietary supplement use, and sales.

 

Posted in Herbs and Supplements, Nutrition | 2 Comments

Stem Cell Therapy Miracle–Maybe

Posted on October 5, 2011 by skeptvet

I’ve written numerous times about veterinary stem cell therapies, and I’ve been quite critical about the proliferation of such interventions in veterinary medicine. This is not because I don’t see great hope in stem cell therapies, for I do. But to be clear, I’ll repeat what I’ve said before on the subject:

One of the hottest, most fashionable new therapies for a wide range of ailments in veterinary patients is stem cell therapy. There is extensive theoretical and laboratory work in animals and humans to indicate a variety of effects of these cells, and there is good reason to believe that clinical benefits may be possible. Unfortunately, there is no agreement about what these cells do in living animals and how they do it, and there is very little clinical research evidence to support any one of the many different commercial stem cell therapies marketed for dogs and cats. Leading researching in human and veterinary stem cell therapies caution that our knowledge about these cells and what they do is too preliminary to justify claims that they are safe or effective in real patients. I am hopeful that safe and effective stem cell therapies will one day be available, but so far none have proven themselves and using them is still a gamble.

Veterinary stem cell research: Is this the best we can do?

Vet Stem’s stem cell therapy and Chemaphor’s Oximunol join forces

Selling veterinary stem cell therapies: Medivet’s dodgy advertising

Stem cell therapy: Still an uncontrolled experiment on our pets

Veterinary stem cell therapies discussed at Fully Vetted blog

Stem Cell Researchers Caution Against Using Unproven Stem Cell Therapies

Most media coverage of stem cell therapies is unfailingly positive, and the difficulties of developing and validating a complex set of entirely new therapeutic practices are generally glossed over. So I was pleased to see some mention of these challenges and uncertainties in a recent article at Philly.com. As usual, the notes of caution come from stem cell researchers themselves, who certainly cannot be viewed as an ignorant or reflexively negative source on the subject. The reality is that the very scientists who will hopefully one day bring us revolutionary new therapies based on stem cells are those who see most clearly that commercial stem cell therapies currently marketed are insufficiently understood and not yet proven safe and effective to a reasonable standard.

The article tells the story of Bernie, a pit bull abandoned on a hot roof who suffered severe burns to his paw pads. The veterinarian who treated him was concerned the burns would not heal with conventional wound therapy, so he obtained a compassionate use dispensation from the FDA to try a stem cell therapy not licensed for use in dogs and marketed by Celavet, Inc, a company apparently run by one of the veterinarian’s clients. According to the company, the cells it markets are taken from fetal dogs and cats but have some of the properties of embryonic stem cells, which should enable them to grow into mature cells of any type, including skin. Bernie’s wounds healed, and the case was lauded as an example of a miraculous recovery credited to stem cell therapy.

Of course, I have discussed many times why anecdotes about individual patients aren’t reliable evidence of the safety or efficacy of a particular treatment. In the Philly.com article, researchers from the University of Pennsylvania discusses why this story should not be taken as proof of the usefulness of this therapy.

The stem cells may not have been necessary for Bernie’s recovery, said John Gearhart, director of the University of Pennsylvania’s Institute of Regenerative Medicine and one of the first to isolate human embryonic stem cells.

From examining the company’s literature and pictures of the dog’s paws, he concluded that the new skin was unlikely to have been made from the stem cells. The cells may have helped to produce a protective covering, but Bernie’s paws in the after pictures are most likely covered in his own skin.

“Ultimately, was this animal helped or harmed?” Gearhart asked. “That’s the key question.”

Penn dermatology professor George Costarelis had the same skeptical reaction to the images before and after treatment. In the before pictures, he noted that the dog still had some skin around the wounds and this might have been capable of slowly growing slowly over the injured site.

The stem cells may have covered the wound temporarily, Costarelis said, but he agreed that they probably had been rejected and replaced with the dog’s own skin.

“I’m skeptical this is any different from what would have happened if the dog had good wound care” without stem cells. With no controlled studies, he said, it’s impossible to know.

Such sensible caveats are seldom found in mainstream media coverage of cases like this, and are never mentioned in the advertising materials that promote veterinary stem cell therapies. So while the use of this experimental therapy may be appropriate in such desperate circumstances, the outcome should not be used to fan the flames of public enthusiasm for as yet unproven stem cell treatments. As Dr. Gearhart put it,

The publicity surrounding stem cells has made the public “nuts,” he said. Desperate people contact him all the time, the most emotional of whom are seeking treatments for their animals. “There’s a long history, from the animal side of things,” he said, “of clinics popping up that take advantage of folks.”

He also points out that Celavet did not profit from the use of its product for Bernie, so one cannot criticize the motives of the company. But heartwarming stories like this are the core marketing tool for all unproven and outright bogus medical therapies, and even though they are ultimately unreliable, they are emotionally very compelling. It is up to scientists like Gearhart and Costarelis, and to us as veterinarians, to point out that stories like this do not justify widespread sale or use of such therapies before they have met appropriate standards of scientific scrutiny. Ultimately, the risks of bypassing proper study are greater than the potential benefits.

 

 

Posted in Science-Based Veterinary Medicine | Leave a comment