Selling Veterinary Stem Cell Therapies: Medivet’s Dodgy Advertising

Posted on December 29, 2010 by skeptvet

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

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

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

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

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

1. Appeal to emotion in lieu of presenting real evidence

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

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

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

5. Playing to fears about conventional medical treatments

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

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

1. Appeal to emotion

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

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

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

 

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

The marketing materials for vets uses this tactic as well.

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

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

2. Claims of major scientific breakthrough:

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

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

3. Use of Testimonials:

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

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

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

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

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

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

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

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

5. Playing on fears about conventional medicine:

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

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

6. Appeal to nature:

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

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

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

7. Claiming a benefit with complete safety:

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

Show Me the Money

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

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

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

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

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

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

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

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

Posted in Science-Based Veterinary Medicine | 48 Comments

American Animal Hospital Association Promotes CAVM and Quackery

Posted on December 27, 2010 by skeptvet

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A) Acupuncture:

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

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

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

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

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

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

B) Chiropractic

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

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

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

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

C) Physical Therapy and Massage

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

D) Homeopathy

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

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

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

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

E) Herbal Medicine and Nutraceuticals

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

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

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

Posted in General, Miscellaneous CAVM | 29 Comments

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

Posted on December 16, 2010 by skeptvet

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

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

Regulation of Homeopathic Remedies

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

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

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

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

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

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

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

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

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

Regulation of Herbal Remedies and Other “Therapeutic” Dietary Supplements

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

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

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

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

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

Where Do We Go From Here?

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

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

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

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

References

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

CAM and the Law Part 3: Malpractice Law

Posted on December 14, 2010 by skeptvet

This is a cross-post from Science-Based Medicine- CAM and the Law Part 3: Malpractice Law 

It is with some trepidation I venture into the next subject in this series — malpractice law. This is a touchy subject for healthcare providers, for obvious reasons. Regardless of the flaws in the system, however, malpractice law is one of the mechanisms put in place by government to regulate the practice of medicine. Like the other such mechanisms touched on so far, licensure and scope of practice law, malpractice laws apply to alternative medicine practices in ways that are broadly similar, but sometimes subtly and significantly different, from how they apply to scientific medicine. 

So far, alternative practitioners are sued for malpractice relatively infrequently compared with physicians, presumably because they represent a much smaller fraction of the care provided, they tend to be utilized by those with an ideological bias in favor of their approaches, and they are not viewed as nearly as rich a target for litigation. But this may change if the political and cultural winds blow in the direction of greater utilization of alternative medical approaches. 

General Principles of Malpractice Law

In order to establish a claim of medical malpractice, a plaintiff must show four basic elements.1

1. A duty was owed by the defendant to the plaintiff.
2. That duty was breached.
3. The breach was the proximate cause of an injury.
4. The injury involved actual damages.

It is in the interpretation of what constitutes a duty and the breach thereof and the establishing of causation that much of the opportunity for judicial interpretation lies. Such interpretation also comes into play when typical defenses against malpractice claims are invoked, such as theories of contributory negligence and assumption of risk. One of the most contentious issues with regard to malpractice cases involving alternative therapies is what constitutes an appropriate standard or care, which defines the duty and condition of breach.

Standard of Care

Traditionally, medical doctors accused of malpractice were judged according to the so-called “local rule,” in which a doctor was expected to adhere to the standards of other doctors in his or her geographic area. This has been largely supplanted by the “national rule,” in which physicians are judged by the standard or other physicians in the same specialty.1 However, what about chiropractor, acupuncturists, naturopaths, etc? What standard is used to judge their duty and quality of care? (It may seem in the subsequent discussion and examples that I am picking on chiropractors. This is just an artifact of the volume of legal opinions concerning this method, since chiropractors are the most widespread, legally recognized, and often sued of alternative medicine practitioners).

A key case looked to as a precedent in many states was Kerkman v. Hintz, argued before the Supreme Court of Wisconsin.2 In this case, a patient was seen by a chiropractor, diagnosed with a cervical subluxation, and treated with several chiropractic adjustments. His condition worsened, whereupon he was seen by a neurosurgeon who identified a ruptured intervertebral disk. After two surgeries for this, the patient had significant lingering disability. The patient sued the chiropractor for malpractice, arguing that the D.C. ought to have recognized that his problem was not suitable for chiropractic treatment and referred him for appropriate care.

The legal standard of care invoked by the plaintiff in this case was a 1923 ruling in which it was held that “in evaluating a patient’s condition prior to treatment, a chiropractor must exercise the same degree of care and skill which is usually exercised by a recognized school of the medical profession.”3 However, the state supreme court overruled this precedent, arguing that while chiropractors were not a separately licensed profession in 1923, and so could be viewed as just another “recognized school of medicine,” by 1988 the practice of chiropractic had been defined, limited, and specifically distinguished from the practice of medicine by state licensing statutes. Since these statutes limit chiropractors to “the analysis and correction of subluxation,” it is not appropriate to allow or require them to make medical judgments that go beyond this. The court did not seem perturbed at all by the issue of whether the “subluxation” was a real medical entity or a phantasm. It was only concerned about whether it was a recognized entity from the point of view of state law, which it is.

Based on this reasoning, the court established a new standard for chiropractic.

In summary, we hold that a chiropractor has a duty to (1) determine whether the patient presents a problem which is treatable through chiropractic means; (2) refrain from further chiropractic treatment when a reasonable chiropractor should be aware that the patient’s condition will not be responsive to further treatment; and (3) if the ailment presented is outside the scope of chiropractic care, inform the patient that the ailment is not treatable through chiropractic means. In determining whether a chiropractor breaches these duties, the chiropractor is held to that degree of care, diligence, judgment, and skill which is exercised by a reasonable chiropractor under like or similar circumstances.2

Moreover, the court specifically exempted chiropractors in Wisconsin from any duty to refer patients for care by a physician.

Having explained to the patient that the problem is not within the chiropractor’s license to treat, the chiropractor does not have a duty to refer the patient to a medical doctor…because implicit in a requirement that a chiropractor refer a patient to a medical doctor is the imposition on the chiropractor to make a medical determination that the patient needs medical care, such a determination could not be made without employing medical knowledge. Because a chiropractor is not licensed to make such a determination, we hold that a chiropractor does not have a duty to refer.2

From a science-based perspective, of course, this seems ludicrous. Chiropractors are specifically licensed to treat an imaginary cause of diseases, and they are given the sole authority to decide as a community which illnesses will or will not respond to treatment of this faux etiology. They are expected to tell patients when their treatment is not going to work, but they aren’t expected to recognize if these same patients have a condition for which they should be seen by a medical doctor, because making that judgment would require them to know something about real medicine, which they are legally prohibited from doing. 

Kerkman v. Hintz is a widely cited ruling that has had a significant impact on the assessment of standard of care for alternative medicine practitioners, but not all states follow this opinion, and other courts or state legislatures have imposed a duty to refer on chiropractors. The Supreme Court of New Jersey, for example, ruled in a 1984 case that chiropractors are “expected to diagnose and refer patients whose conditions require medical or other treatment.”4 Other appeals courts, in Washington and Colorado for example, have also upheld judgments against chiropractors for failing to recognize a problem they were not qualified to treat and for not referring the patient to a medical doctor. 

And in California, the regulations that govern licensed chiropractors in that state specifically identify failure to refer a patient whose condition is not amenable to chiropractic treatment as an example of “unprofessional conduct.”5 This is ostensibly only intended to be the basis of action against the license of the chiropractor, but some scholars hold that such regulatory provisions can be the basis for establishing a standard of care in a malpractice case. There are, however, also rulings that do not allow practice act standards to be used in this way (e.g. Wengel v. Herfet Court of appeals of Michigan (1991) 6). As usual, then, there is a lack of consistency among the states in the legal theories or specific interpretations of relevant law and precedent.

Breach of Duty or Standard of Care

Once a standard of care is defined, a malpractice case hinges next on whether this standard has been breached. In addition to failing to recognize a problem not amenable to the alternative method of treatment being used, and failure to refer for medical care where required, there are several other ways in which alternative practitioners may breach the applicable standard of care.

For physicians utilizing alternative therapies, one possible breach of the standard of care is simply by utilizing methods that deviate from accepted medical practices. In a case involving Dr. Nicholas Gonzalez, of the infamous Gonzalez Regime for cancer treatment, the Supreme Court of New York articulated what seems to me a simple and rational view of the issue that is seldom seen outside of science-based medicine advocacy circles:

The standard for proving negligence in a malpractice case is whether the treatment deviates from accepted medical standards…it would seem then that no practitioner of alternative medicine could prevail on such a question as the reference to the term “non-conventional” may well necessitate a finding that the doctor who practices such medicine deviates from “accepted” medical standards. This indeed creates a problem for such physicians which perhaps can only be solved by having the patient execute a comprehensive consent containing appropriate information as to the risks involved.7

In other words, since alternative medicine by definition does not conform to accepted standards of care, it should only be defensible if it is undertaken as an experimental therapy, with all of the informed consent requirements and other protections for patients participating in clinical trials. 

Of course, this standard only applies to medical doctors who employ alternative methods, so the principle unfortunately cannot be applied to chiropractors or others licensed in specific alternative methods who are held to different standards. And in practice, alternative therapies are usually not subject to automatic classification as malpractice by virtue of being alternative, because the courts have more frequently held that they should not be judged by the standards of conventional or scientific medicine, but only by their own internal standards.

Malpractice Defenses

The most straightforward defenses against a malpractice claim (insofar as any issue subject to litigation can ever be straightforward) are that the actions of the defendant were not the cause of any injury and that no actual damages were sustained. These are, for the most part, questions of fact which can often be substantiated in relatively objective ways. However, greater ambiguity and complexity are involved in defenses which address whether a duty of care exists or has been breached. 

As we have seen, alternative practitioners have some avenues of defense in arguing that they cannot be guilty of breaching a duty based on standards of conventional medicine but only on those limited standards that pertain to their particular mode of treatment. One form this defense takes is the so-called “two schools of thought” doctrine.8 This is a Byzantine bit of legal reasoning in which the courts try to avoid adjudicating scientific disputes between factions within the medical community. This seems at first a quite appropriate goal given that lawyers, judges, and juries are not generally qualified in knowledge or training to determine the scientific truth behind disputes among scientists. 

However, it leads to the unfortunate consequence that courts may make the mistake journalists so often make of treating the two “sides” in a scientific dispute as equal when in fact the dichotomy may actually be between an overwhelming majority backed by solid evidence and a few extremists with a wild, unsupported notion.

One case before the Supreme Court of Pennsylvania, Jones v. Chidester, illustrates this doctrine nicely.9 According to the court, “a medical practitioner has an absolute defense to a claim of negligence when it is determined that the prescribed treatment or procedure has been approved by one group of medical experts even though an alternate school of thought recommends another approach.” 

The court then examines in detail different standards previous courts have used to determine whether a given position constituted a legitimate “school of thought” to which this rule could be applied. Some courts have used a quantitative standard, ruling that a “considerable number” of experts must approve of an approach for it to be deemed legitimate. Other courts have used a more qualitative standard, for example acceptance of the approach by “respectable, reputable, and reasonable” practitioners. The most generous standard seen in some states is requiring only a “respectable minority” of physicians to agree with an idea for it to be an acceptable “school of thought.” Ultimately, the Pennsylvania court chose to apply a combination of quantitative and qualitative standards:

Where competent medical authority is divided, a physician will not be held responsible if in the exercise of his judgment he followed a course of treatment advocated by a considerable number of recognized and respectable professionals in his given area of expertise.8

The court left the details of words like “considerable” and “recognized” or “respectable” to the discretion of other courts hearing particular cases. And they specifically placed the onus of supporting the contention that one’s approach is a legitimate “school of thought” on the defendant: “The burden of proving that there are two schools of thought falls to the defendant. The burden, however, should not prove burdensome…Once the expert states the factual reasons to support his claim that there is a considerable number of professionals who agree with the treatment…there is sufficient evidence to warrant an instruction to the jury on the two ‘schools of thought.’ It then becomes a question for the jury to determine whether they believe that there are two legitimate schools of thought such that the defendant should be insulated from liability.”8

Clearly, under this doctrine widely accepted practices like chiropractic and acupuncture would qualify as legitimate schools of thought, and no claim of liability based solely on the scientific evidence against their claims would be allowed. This leads to a pretty glaring inconsistency. The courts wish to avoid adjudicating scientific disputes, and yet as an alternative they make determining the legitimacy of a medical therapy a sort of popularity contest and then leave it to a jury to decide if the approaches employed are sufficiently popular to be acceptable.

Informed Consent and Assumption of Risk

In addition to straightforward factual defenses and to the approach of establishing that one’s treatment  is consistent with the practices of a legitimate “school of thought” within the medical community, practitioners accused of malpractice can defend against liability by arguing that the patient had implicitly or expressly assumed any risk of treatment by assenting to the treatment, thus absolving the practitioner of liability for damages. As The U.S. Court of Appeals for the Second Circuit argued, “we see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment. While a patient should be encouraged to exercise care for his own safety,[eschewing conventional treatment] is within a patient’s right ‘to determine what shall be done with his own body.”10 And if a patient makes such an informed decision, then it would make no sense to hold the practitioner liable for any undesirable outcome that was an inherent risk of the treatment. 

In order to lay the basis for this assumption of risk defense, practitioners need to inform patients of the potential risks of treatment and of the alternatives. Courts have wrestled with the details of defining the parameters of this informed consent. There are two dominant standards in use. About half of the states use the so-called “patient standard,” in which a provider is expected to disclose any fact which might reasonably be expected to affect the patient’s decision whether or not to undergo the therapy. No expert testimony is required to establish if adequate disclosure occurred under this standard because this would imply that medical experts, rather than lay people, should determine what constitutes adequate disclosure, and this is considered by some to be paternalistic or open to abuse if physicians ultimately decide what patients need to know. 11

The rest of the states use the “professional standard,” which requires disclosure of any fact that a reasonable physician in the same circumstances would disclose. Under this theory, expert testimony is needed to establish what a “reasonable physician” would be expected to do in the specific circumstances and whether or not the defendant did it.12

How then are the principles of informed consent and assumption of risk applied in malpractice cases associated with alternative medicine? In one scenario, a provider may be sued for failing to adequately disclose the risks of forgoing conventional medical care. 

An example of this is the case previously referenced, Charell v Gonzalez, in which a victim of the Gonzalez cancer regime sued Dr. Gonzalez after undergoing his bogus treatment. In this case, the state supreme court did find that Dr. Gonzalez failed to provide adequate disclosure concerning the risks of his therapy and of eschewing conventional cancer treatment. However, the court also concluded that the patient “was a well-educated person who, together with her husband and daughter, did a significant amount of investigation regarding the treatment…and hence became quite knowledgeable on the subject…[Thus] it was within the province of the jury, based on the evidence, for it to find that plaintiff independently obtained sufficient information about the treatment so as to conclude that there was an implied assumption of risk when she agreed to follow defendant’s protocol.”7

By this reasoning, it would seem very difficult for someone who sought out an alternative therapy to successfully sue for malpractice even if the risks of the therapy were not adequately explained to them since it might be assumed by the court that in seeking the therapy they had discovered and understood the risks well enough to make an informed choice to accept them.

Of course, alternative practitioners may be sued, just like physicians, for failing to adequately disclose the risks of the therapies they provide. When his happens, the courts will judge the duty to disclose under whichever of the two standards described above is used in that jurisdiction, the “patient” or “professional” standard. However, the details of the risks involved and what the practitioner can reasonably be required to know and disclose are likely to be judged by the standards of the particular “school of thought” the practitioner belongs to. 

Therefore, for example, the court may view the risk of stroke associated with cervical chiropractic manipulation as chiropractors do, as an unproven or at least very rare complication balanced by the overall safety and efficacy of the treatment, rather than as a thoroughly unjustifiable risk of an ineffective and unscientific treatment, as many of us in scientific medicine view it.

In a strange twist to informed consent rules, some physicians have been sued for not informing patients of the availability of alternative therapies. So far the courts seem to have taken the position that there is no duty to inform a patient of the availability of a therapy that is generally not accepted by the medical community. However, as more doctors and medical schools integrate alternative therapies into their practices, there may come a time when not telling a patient that they could try acupuncture, chiropractic, or some other form of alterative therapy instead of conventional treatment could be viewed as a failure to provide sufficient disclosure to allow an informed consent/assumption of risk defense.

Summary

As usual, of course, the rules and standards set by state legislatures and courts are inconsistent and variable, so firm, predictable rules cannot be deduced. However, it is possible to make a few tentative generalizations about the position of alternative medicine with regard to malpractice law:

  1. Alternative therapies generally cannot be successfully attacked through malpractice litigation solely on the basis of their implausibility or lack of convincing scientific evidence for safety and efficacy. Particularly in the case of widely accepted and often state licensed approaches such as acupuncture and chiropractic, charges of malpractice will be judged by standards set within the paradigm of the particular method, not by any broader scientific or evidence-based standard.
  2. Alternative medicine providers can, of course, be guilty of malpractice if they perform their interventions below the commonly accepted standards of their own communities. They may also have liabilities for injuries caused by discouraging patients from seeking conventional care and, in some jurisdictions, for not recognizing when a patient’s condition is beyond the scope of their form of treatment and subsequently referring the patient for treatment by a medical doctor.
  3. The courts and legislatures give great weight to the autonomy of the individual to make decisions about their own healthcare, and they are likely to view sympathetically malpractice defenses based on the theory that by choosing an alternative approach a patient understands and assumes the risk of that approach.
  4. The licensure of alternative methods by states, their integration into academic institutions, and the tacit approval of their legitimacy conveyed by government organizations like NCCAM and insurance provider who pay for them all contribute to the perception of these methods as legitimate alternatives to scientific medicine, and this makes it very difficult for patients injured by these approaches to successfully pursue a malpractice action despite the lack of good scientific evidence that these methods are safe and effective. As we have seen repeatedly, when evaluating alternative medicine the law is far less concerned with scientific evidence than with political, cultural, and philosophical arguments.

References

  1. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010 Return to text.
  2. Kerkman v. Hintz, Supreme Court of Wisconsin, 418 N.W. 2d 795 (1988). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 103-11. Return to text.
  3. Kuechler v. Volgman, 180 Wis. 238, 192 N.W. 1015 (1923). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 105. Return to text.
  4. Rosenberg v. Cahill, 492 A.2d 371, N.J. (1984). from website: http://www.fpamed.com/forensic_psychiatry/2008/05/a-paradox-about.html Return to text.
  5. State of California, Board of Chiropractic Examiners Rules and Regulations, Rev. June, 2010. Article 2, § 317. from website: http://www.chiro.ca.gov/res/docs/pdf/business/chiroregs_june2010.pdf Return to text.
  6. Wengel v. Herfert, Court of Appeals of Michigan, 473 N.W.2d 741 (1991). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 114-16. Return to text.
  7. Charell v. Gonzalez, Supreme Court of New York, New York County, 173 Misc. 2d 227 (1997). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 117. Return to text.
  8. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 146-152. Return to text.
  9. Jones v. Chidester, Supreme Court of Pennsylvania, 531 Pa. 31 (1992). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 146-152. Return to text.
  10. Schneider v. Revici, United States Court of Appeals for the Second Circuit, 817 F.2d 987 (1987). cited in Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p.152-4. Return to text.
  11. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 160-73. Return to text.
  12. Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 174-8. Return to text.
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Safety and Efficacy of NSAIDs for Canine Arthritis

Posted on December 11, 2010 by skeptvet

A common justification for the use of alternative therapies, with or without evidence concerning safety and efficacy, is that they are appropriate when conventional medicine does not have an established effective treatment for the problem. This is a legitimate argument in that there is always a balance to be struck between the degree of uncertainty about whether a treatment works or is safe and the urgency of treatment. For mild, self-limiting diseases there is little excuse for using therapies of uncertain safety or efficacy. And when there is ample evidence a therapy is ineffective (such as homeopathy) or unsafe (such as cervical chiropractic treatment or some herbal remedies), there is no justification for its use.

But if there is a significant clinical problem for which science has not yet found a safe or effective therapy, there is some justification for accepting the risk and uncertainty of using an unproven approach, so long as the patient/client understands the degree of uncertainty and the unpredictability of the outcome. Despite the assumptions and accusation of some alternative medicine proponents, those of us dedicated to science and evidence-based medicine don’t object to trying unproven approaches when there is little else available. What we object to is offering these approaches with unjustified claims about their safety and efficacy based on anecdote, personal experience, of scant and sloppy research. Whether it is ostensibly “scientific” treatment like adipose-derived stem cell therapy or clearly unscientific approaches like “energy medicine” and the like, there is an ethical duty on the practitioner offering the unproven method to provide honest, objective disclosure to the client or patient about the state of the evidence so they can make an informed decision balancing the needs of the patient and the potential risks and benefits of treatment.

Far more often, however, this argument is used to justify the use of alternative therapies when there really are established, science-based treatments available. In the case of arthritis in dogs, for example, there is a long list of unproven or disproven alternative therapies available, such as acupuncture, fish oil supplements (and here), electromagnetic devices, fat-derived stem cell injections, and of course the ubiquitous glucosamine, which seems to be taken by nearly every dog I see as a preventative of therapy for arthritis despite the voluminous evidence that it has no benefit (c.f. 1, 2, and 3). These therapies range from safe but useless (such as glucosamine) or safe but with little demonstrated benefit (acupuncture), to truly uncertain long-term safety and efficacy (such as stem cell therapy and most herbal approaches). But apart from the evidence against the claims that these treatments help, the argument for their use is further weakened by the existence of safe and effective conventional treatments for arthritis in dogs.

Much arthritis in dogs is related to congenital or developmental diseases, such as hip and elbow dysplasia, which can be prevented through aggressive testing and breeding programs and proper nutrition for puppies. Arthritis secondary to such problems can also be prevented by timely surgical treatment (and here) of affected animals.

A prime factor in the development of arthritis and its symptoms, for both humans and dogs, is obesity. There is good evidence that controlling weight is a very effective therapy for canine arthritis (1, 2).

And, of course, there are many effective medications for the treatment of osteoarthritis in dogs. The best among these are the non-steroidal anti-inflammatory drugs (NSAIDs), though drugs such as tramadol, gabapentin, amantidine, and other can be of benefit. In every study or review of arthritis treatment for dogs, nothing comes close to the effectiveness of NSAIDs (c.f. 1, 2, 3).

Of course, as I have often said, there is no free lunch in physiology. The body is a complex system with innumerable interactions, and anything that has a beneficial effect on one element of the system is going to have effects on others as well, and not always beneficial effects. Despite the claims of something for nothing often made by proponents of alternative therapies, anything that helps will have some risk of harm. Unfortunately, proponents of alternative therapies for arthritis frequently downplay the benefits and exaggerate the risks of conventional therapies, and NSAIDs in particular seem to generate a lot of unjustified fear and hysteria.

A recent paper reviewed the literature concerning the safety and efficacy of these drugs in dogs:

Innes JF, Clayton J, Lascelles BD. Review of the safety and efficacy of long-term NSAID use in the treatment of canine osteoarthritis. Vet Rec. 2010 Feb 20;166(8):226-30.

As usual, the quantity and quality of the veterinary research on the subject is less than ideal. However, a number of studies have been conducted, and they show unequivocal efficacy. Most subjective measures by owners or veterinarians improve by close to 90%, and when objective measures are used they almost always show clear benefit. Certainly, these results are far stronger than the equivalent results in studies claiming positive effects for glucosamine and many other alternatives to NSAIDs. And there is even some limited evidence that these drugs may reduce the development or progression of arthritis, though the findings are only preliminary and may or may not turn out to be clinically relevant (1, 2)

And what about the risks? The quality of the data on this subject was often poor, especially given that placebo controls were not used in many studies, which would tend to exaggerate the appearance of harm done by the drugs. However, the rate of adverse events ranged from 0 to 0.31 with no significant difference in the rate of adverse events between the NSAID and placebo when placebos were used. out of 1589 dogs in the studies reviewed, only 1 experience a severe reaction requiring hospitalization for treatment.

Other evidence, including trials used to gain FDA approval, show that dogs on NSAIDs can experience minor problems, such as self-limiting vomiting and diarrhea, or potentially more severe problems such as stomach bleeding, worsening of pre-existing kidney disease, or liver failure. However, the rates of these problems are extremely low, and they must be balanced against the life-limiting pain caused by arthritis, the clear efficacy of NSAIDs in relieving this pain, and the great deal of uncertainty about the safety or benefit of alternative treatments.

Owners can only evaluate the risks and benefits of treatment options if they have accurate information about these. It is a disservice to our clients and our patients to guide them towards unproven therapies, at the risk of unexpected side effects or continuing, unrelieved pain, on the basis of inaccurate or exaggerated assessments of the risk of established therapies such as NSAIDs. These are very effective and very safe medications which literally save the lives of thousands of animals who would be euthanized due to pain and unacceptable quality of life without this treatment.

Posted in Science-Based Veterinary Medicine | Comments Off on Safety and Efficacy of NSAIDs for Canine Arthritis

How Nutraceutical Research Should be Done: Lycopene for Osteosarcoma in Dogs

Posted on December 3, 2010 by skeptvet

Proponents of nutraceuticals, nutritional supplements thought to have therapeutic or preventative effects, often promote the use of such products despite little or no legitimate evidence to suggest they will be safe or helpful. When skeptics challenge these unsupported claims, they are frequently accused of being opposed to nutraceuticals or supplements per se regardless of the evidence, or of not wanting such things to be studies for fear that “free” remedies (not that any of these aren’t making a buck for somebody) would crowd the drug companies’ territory.

These are empty strawmen, of course, but it is true that I often find myself criticizing the inadequate evidence given to support using such products, or the poor quality of the research cited. I am pleased, then to be able to cite an example of how good quality, science-based research into the potential benefits of nutritional supplements should be done.

Wakshlag JJ, Balkman CE. Effects of lycopene on proliferation and death of canine osteosarcoma cells. American Journal of Veterinary Research 2010;71(11):1362-70.

The authors begin by pointing out that despite the fact “there is little evidence that single dietary carotenoids are beneficial,… carotenoid-rich nutraceuticals are available as over-the-counter products in both the veterinary and human market, and the incidence of nutraceutical use in pets with cancer is approximately 40%; therefore, understanding the functional importance of such carotenoids is extremely important, particularly when other chemotherapuetic agents are used.” The market, and those making money selling such supplements, are as usual well ahead of the research. However, there is some evidence of possible benefit in humans, so preliminary, pre-clinical studies to see if there might be benefit in dogs is appropriate.

One level of such research is showing that the substance can be taken orally by dogs and reach meaningful levels in the blood. One of the weaknesses in the preclinical data concerning glucosamine was the uncertainty over this point, which ought to be established before resources are wasted on clinical trials. According to the authors of this paper, such studies have been done and do show potentially meaningful blood and tissue levels of lycopene can be achieved by oral administration, so there is enough plausibility to justify further research.

The current study was intended investigate whether lycopene has an effect on canine osteosarcoma cells in vitro (that is, outside of the body), and also critically whether or not the substance appears to interfere with the effect of a common chemotherapy drug used against this cancer. As I’ve mentioned before, Vitamin C has been shown to potentially reduce the effectiveness of chemotherapy, and since many of the supplements now touted for cancer treatment are anti-oxidants, there is a real risk that they will interfere with the oxidative mechanisms by which established cancer treatments work, yielding a net loss for patients. In this case, the lycopene did seem to have a significant effect inhibiting the growth of the cancer cells, and it did not seem to enhance nor impede the effect of the chemotherapy agent tested.

Now, in vitro studies are important in establishing potential mechanisms by which drugs might have benefits, and in identifying potential sources of harmful effects. But the test tube is not the body, and they are not very reliable guides to the chances for real-world benefits in actual patients. After all, bleach kills cancer cells in a test tube, but it wouldn’t make a very good drug for cancer patients. The overwhelming majority of substances that show promise in the lab turn out not to be useful in actual patients, which is part of why development of effective medicines is so expensive.

Proponents of herbs and dietary supplements often try to support their claims with such laboratory research without recognizing the important limitations of such studies. To their credit, the authors of this paper not only did excellent research, but they recognized the limits to what their research means.

…regardless of the similar biological nature of osteosarcoma cells clinically, their reactivity to antineoplastic agents in vitro and in soft agar assays can differ dramatically from their in vivo reactivity, and further investigation into the antiproliferative effects of lycopene in vivo would be needed to prove the potential efficacy of such treatment.

Lycopene concentrations in tissue range from 100nM to 5?M, which makes tissue distribution highly variable but promising depending on tumor location. However, without knowing tissue concentrations of lycopene in tumors and having knowledge about cellular distribution, any suggestions of physiologic relevance are merely speculative.

The fact that physiologic doses of lycopene may be achievable in dogs, in conjunction with the efficacy of the in vitro study reported here, warrants future investigation into the use of lycopene as a chemopreventative, and possibly even as a chemotherapeutic, agent in the treatment of osteosarcoma in dogs.

It is likely that this study will eventually be cited in support of recommending lycopene for dogs with osteosarcoma. Regardless of whether or not the substance eventually turns out to be useful for treating this cancer, recommending it on the basis of this paper would be inappropriate. The authors themselves have the humility to understand this and not to extend the significance of their results beyond appropriate bounds. I wholeheartedly support such research, and I agree that the plausibility suggested by this report justifies further study.

While it is painful to see patients in my practice suffering from osteosarcoma, and to not have therapies as safe and effective as I would like to offer them, I understand, as do the authors of this excellent study, that I am doing my patients no service by recommending supplements that have yet to demonstrate they are safe and effective unless I am prepared to do so within the context of a research project appropriately designed to find this out. False hope and uncontrolled, haphazard use of nutraceuticals is not good for our patients, and if we really want to help them we must have the humility and discipline to accept and disclose the limitations in our knowledge.

I hope the authors of this study continue to pursue this promising line of research, and if at the end of the line is a therapy of real benefit I will be joyful. And if the end of the line is one of the far more common dead ends, I am confident the authors will see and accept that and move on to investigate other promising avenues. Such careful and honest work is why science-based medicine is so successful.

Posted in Herbs and Supplements, Science-Based Veterinary Medicine | 1 Comment

Politics Trumps Science: Continuing Education Credit for Pseudoscience thanks to the AHVMA

Posted on November 25, 2010 by skeptvet

I’ve written before about the ludicrous subjects the American Holistic Veterinary Medicine Association offers “continuing education” courses on, including “Earth Acupuncture” to heal the Earth by poking sticks in the ground and adoption into a fake Native American religion to avoid federal laws concerning use of drugs and other medical therapies, as well as the more usual nonsense therapies such as homeopathy and homotoxicology. In my previous post, I also discussed briefly the process by which educational offerings qualify for credits needed to maintain licensure as a veterinarian, via the Registry of Approved Continuing Education (RACE) established by the American Association of Veterinary State Boards (AAVSB). There is no point to requiring veterinarians to stay current on the scientific knowledge in their field if there were no standards for what qualified as continuing education. Getting credit for a course on using astrology to choose the timing of drug therapies or some such would violate the intent of the continuing education requirements, to ensure the public that licensed veterinarians are knowledgeable about the current science in their field.

However, the RACE committee and the AAVSB are, like all organizations involved in medical licensure and regulation, subject to the influence of politics and the ideologies of its members. The quality of scientific evidence concerning a medical approach is not always the deciding factor in whether or not teaching this approach can qualify as continuing education for licensing purposes.

Recently the most ridiculous pseudoscience promoted by the AHVMA has failed to qualify for RACE approval as continuing education. This has been due in large part to the effort of RACE committee member Dr. Narda Robinson. While Dr. Robinson and I disagree about the evidence supporting some CAVM methodologies, most notably acupuncture, she does at least attempt to do what many proponents of alternative medicine do not, which is to apply an objective scientific standard to evaluating CAVM. The natural consequence of this approach is, of course, not to legitimize pseudoscience by supporting it as continuing education material for veterinary licensure.   

The AHVMA is, not surprisingly, seeking ways to gain such legitimacy regardless of the lack of sound scientific support for some of the nonsense they promote. And they are clearly attempting to use political means to accomplish this, which is certainly easier and more likely to succeed than trying to rigorously test their methods scientifically to see if they actually work.

The AHVMA web site provides links to a couple of documents concerning the continuing education credit process. First, regarding RACE and Dr. Robinson:

The RACE committee denied approval for CE credits for over 60% of the 2009 AHVMA annual conference. AHVMA appealed this and as of October 14, 2010, had still not heard about any decision of the AAVSB (parent organization of RACE). After the conference we received notice that AAVSB had denied our appeal. Their website states that the appeal is directed to the AAVSB Board of Directors. However, the letter of denial indicated that if it has merit, they direct it back to the RACE committee for final evaluation. We would not have bothered with this procedure if we had known it would be submitted back to the RACE committee, since we already know the attitude of the RACE committee’s sole judge of CAVM, Narda Robinson.

Subsequent to their communication with us, the RACE committee has denied credit to an increasing variety of CAVM meetings. At the same time, many states have approved those meetings for CE credit. Most states have reciprocity with other states for approved CE. AHVMA applied to the state of Kentucky for approval of this meeting for CE credits. Just before the meeting we were told that because we do not have RACE certification, we are not approved in Kentucky. However, with the help of convention center staff, we hope to reverse this at the next meeting of the Kentucky state board in December.

They go on to detail the specific courses that have qualified for credit by specific membership organizations, which often have their own requirements apart from those needed to maintain one’s state license. Not surprisingly, the Academy of Veterinary Homeopathy doesn’t share the persnickety scientific standards of the RACE committee and accepts most of the AHVMA’s offerings.

Another document on the AHVMA site discusses directly the “CE Approval Crisis for AHVMA and other CAVM organizations.”

The RACE committee of the AASVB is the body that approves courses for continuing education credits, given by organizations that are not part of the AVMA House of Delegates. In December 2008, Narda Robinson was appointed as the sole person on the RACE committee of the AASVB to judge Complementary and Alternative Veterinary Medicine (CAVM). In 2009, the RACE committee denied CE credits for all homeopathic and homotoxicology meetings. They denied credit for most acupuncture and Chinese herbal medicine that included Traditional Chinese Medicine.

Can you imagine not allowing credit for such standard veterinary practices as homeopathy, homotoxicology, or Traditional Chinese Medicine? A crisis indeed.

Sadly, the AHVMA has found at least some political solutions to this “crisis” which do not require they provide real scientific evidence for the subjects they wish to offer as continuing education. In California, for example, courses offered by the California Veterinary Medical Association (CVMA), a membership organization representing vets practicing in the state, are automatically eligible for credit. And it is possible to form an organization affiliated with the CVMA and have voting rights in the CVMA house of delegates with the signatures of only 25 CVMA members. So a group of veterinarians interested in pseudoscientific medicine, such as homeopathy, can form an organization, become affiliated with the CVMA, and then offer continuing education courses. And since many other states recognize the approval of the California Veterinary Medical Board, these credits can be used by veterinarians around the country. Here’s how the AHVMA materials describe the process:

In California, there is already a process in place to form a new organization that is recognized by the state association. In order to be able to present continuing education that the state of California will offer credits for, an association must be a member of the California Veterinary Medical Association (CVMA) House of Delegates. Those who sign the petition must be members of the CVMA. The CVMA does not care how many non-CVMA members are included in the organization, as long as they have 25 CVMA members to start the organization, and maintain 20 CVMA members once the organization is accepted….

In 2011, the AHVMA meeting will be in California and co-hosted by the California Holistic Veterinary Medical Association (CHVMA). Because the CHVMA is a member of the California Veterinary Medical Association House of Delegates (CVMA HOD), and all CVMA CE is approved by the state of California, this means next year’s meeting is approved by the California State Board of Veterinary Medicine for CE credits for all lectures. Most states have reciprocity with the state of California. As long as your state has reciprocity with California, they will accept these lectures for CE credit.

According to the president of the Academy of Veterinary Homeopathy, the AHVMA is attempting to pursue this same strategy nationally by getting the AHVMA recognized in the American Veterinary Medical Association (AVMA) house of delegates:

AHVMA has been trying to become a voting member of the AVMA House of Delegates. It is important that AHVMA has enough AVMA members to meet the requirements of membership.

Once AHVMA becomes a member of the House of Delegates, AVH RACE CE is also automatically approved since we are, essentially, part of AHVMA as an Allied Group.

Through processes such as these, the legitimacy of medical approaches is established not on the basis of scientific evidence, but through the political lobbying efforts of a minority of practitioners who believe in such approaches regardless of the evidence, and through the apathy and desire not to offend or engage in controversial debate of the silent majority who do not use such therapies. Of course, all human social institutions rely on politics to solve disputes without violence, and certainly this is appropriate. Unfortunately, when there are clear right or wrong answers in such dispute unequivocally established by objective scientific means, it is unfortunate that such mechanisms can be used to make an end run around the truth and promote failed ideas that science and reason would require us to abandon. It is certainly not in the interests of our patients or our profession to have homeopathy, Earth Acupuncture and other similar nonsense gain legitimacy as medical therapies by popular vote regardless of the underlying facts about such therapies. One can hope that enough people within veterinary organizations such as the AVMA and CVMA will recognize that politics and belief is on the verge of triumphing over truth and will object, but I fear such hope will prove unfounded.

Posted in General, Law, Regulation, and Politics | 29 Comments

Dr. Andrew Jones: Selling “Secrets” and Lies finally has a price

Posted on November 18, 2010 by skeptvet

I once referred briefly to Dr. Andrew Jones in a previous post as an example of one of the warning signs of quackery, the claim of secret knowledge that mainstream science and medicine doesn’t want you to have. Of course, his marketing activities include lots of other characteristic features of alternative medicine propaganda, including unfounded accusations about the harm done by conventional medicine and unproven or outright false claims about the safety and efficacy of alternative methods. In many ways, he is a fine example of many warning signs of quackery.

It turns out, the veterinary medical licensing authorities in Canada, where Dr. Jones lives, have more backbone than most of those in the U.S., and for years they have been warning Dr. Jones that unfairly denigrating his colleagues and making false claims is unprofessional and incompatible with the standards licensed veterinarians are expected to uphold. He repeatedly claimed he would abide by the marketing and advertising guidelines all other veterinarians are subject to in his jurisdiction, and repeated broke those commitments. Finally, the British Columbia Veterinary Medical Association (BCVMA)  imposed significant fines, and Dr. Jones has chosen to give up his license so he can market his veterinary self-help products without interference.

His supporters, of course, are trying to paint him as a victim, but the evidence is clear that he is yet another alternative guru with a messiah complex making money not only off peddling ineffective or unproven remedies but discouraging pet owners from seeking real medical care for their pets.

The details of the proceedings against Dr. Jones are included in the BCVMA reports available here:

BCVMA Investigating Committee Report

College of Veterinarians Council Final Decision

(note-these links are no longer working. For now, the ruling can be found here)

In 2003, 2004, and 2005, Dr. Jones was asked to stop using advertising language for his practice and products that implied he provided better care or was less concerned about money than other veterinarians. He advertised his own services as “affordable” and “superior” compared to other vets and said things like:

“You will find us honest, convenient, affordable, and above all caring”

“We use only the best materials and labs”

Some of this language was relatively innocuous, and his supporters have made a point of this to suggest that there is no real issue but competition and professional jealousy here. However, it should be obvious why advertising oneself as better than ones colleagues, especially with no evidence but that of one’s own ego to support such a claim, is both offensive and unprofessional. In any case, the only sanction imposed on Dr. Jones was to stop using such language, which he repeatedly agreed in writing to do. As we shall see, he not only broke these promises but engaged in far more egregiously inappropriate behavior.

Dr. Jones went on to form “Dr. Jones Inner Circle Forum,” a web-based service which charged pet owners a subscription fee to receive his “secret” knowledge and wisdom that he repeatedly claimed would make most visits to the veterinarian unnecessary. On this forum, he repeatedly accused conventional veterinarians of naked greed and a lack of interest in the well-being of their patients:

1) P.P.S My goal is to give you the most up to date, unbiased dog and cat health information to allow YOU to keep your pet in top health. I want you to be an empowered pet owner, and You will be one as part of my exclusive Dr. Andrew Jones’ Inner Circle. [I can’t help notice that hucksters and quacks have a great fondness for CAPITAL LETERS. I wonder why that is…]

2) At the end of the day it boils down to money. If the public are not lining vets pockets with unnecessary visits, purchasing processed foods from which vets also take a percentage, that’s quite a reduction in income.

3) I am “positive” that many ‘conventional” veterinarians think that Veterinary Secrets Revealed is a bunch of “hocus pocus” and should be shut down.

What does this mean?

It means that other veterinarians are upset about my website, ebook, and Complete Home Study Course.

After all, I’m showing people how to treat their own pets and save money on Vet bills [at least some of the money they save, of course, will go to Dr. Jones]

4) You should check out my Complete Home Study Multimedia Course. I guarantee that you will treat your pet’s illness and ailments confidently, competently and for less than it would cost if you relied exclusively on professional Veterinary services.

5) This issue: The 6th Secret – The 6th key to extending your pet’s life is knowing when to AVOID you Veterinarian.

In his posts on the Inner Circle forum, Dr. Jones repeatedly claimed alternative or “holistic” methods were safer and more effective than scientific medicine and that the only reason that conventional veterinarians object to them is that the “Secret Society of Veterinarians” was afraid they would lose money if people learned how to keep their pets healthy without professional medical care. When challenged for proof of his claims, Dr. Jones resorted to the time-worn and thoroughly meaningless arguments of longevity, popularity, and personal experience or anecdote:

‘There is no proof…’

But how do you think that most animals in the world are treated? It’s with natural medicine…

Most people in India or China can’t afford to even see a vet or buy medication.

They use herbs, acupressure, massage, supplements, homeopathic treatments.

The animals get better, because the treatments work.

I have seen thousands of pets recover with home remedies.

That is proof.

As if we are seriously expected to believe that the cats and dogs in the third world who do not have access to real veterinary care are healthier than the pets in the developed world. Just like the people who are too poor to have access to science-based medicine are healthier than those of us in the developed world, despite the minor problems of high infant mortality, low life-expectancy, and rampant infectious and parasitic diseases most of us have never seen, I suppose? Arrant nonsense.

The list of absurd, untrue, and unprofessional accusations and claims, all made in an effort to sell books, videos, and subscriptions to the “secrets” of his “Inner Circle,” is extensive. Here are just a few examples:

1) I firmly believe in holistic medicine for pets.

We are killing them with the most of the terrible dog foods on the market along with pesticides contained in flea and tick medications and also medicines the vets want you to purchase. [a letter supposedly from a reader that Dr. Jones reprinted  because it reflected his views]

2) “…you should be leery of any LARGE pet food manufacturer- they re[sic] in the business to profit first”

3) HERBAL THERAPY. A number of herbs are used in diabetes. These include Gymnema, Bitter Melon, Fenugreek, and Ginseng. These herbs can be found in specific diabetic herbal combinations. Ginseng is the most effective of these herbs. It has been shown to lower blood sugar in people, and is believed to do the same in animals. The dose is 30 mg per lb of body weight twice daily of the dried herb, or 1 drop per pound of body weight twice daily of the tincture.[implying people can treat their pet’s diabetes alone, with unproven herbal remedies, is especially egregious because it will undoubtedly lead to suffering and death for animals with this serious disease who are not properly treated]

4) Pay Close Attention – today, I’m going to show you why conventional veterinary medicine is harming your pet and step-by-step what you must do to prevent it.

“Regular” veterinary care has lost it’s [sic] effectiveness over the years, and in some cases is causing illness in our pets.

5) The entire Pet Health Industry has a vested interest in discrediting alternative medicines which can safely, naturally and effectively allow pet owners to care for thei pets at home. [a nice example of the conspiracy-theory aspect of quackery]

6) Most veterinarians just choose to ignore the research because either they still feel the benefits of vaccines outweigh the risks, or that they don’t want to lose income from giving booster shots to all those animals each year.

Apart from such false and unproven accusations and claims, Dr. Jones engaged in inappropriate hucksterism, offering “money-back guarantees” and “cures” when such claims can never be anything but lies in medicine.

Despite all of this, the licensing board did not intend to drive Dr. Jones out of practice. He was fined substantially, both for the numerous violations of ethics laws and, even more importantly, for acknowledging in writing that he understood and intended to abide by them and then reneging on these promises in order to continue to profit from unethical and deceitful advertising. However, when he offered to give up his license, the board specifically indicated it did not consider this an appropriate or necessary punishment for the violations. Dr. Jones decision to give up his license is entirely his own.

Unfortunately, it is likely he will continue to profit from spreading lies and misinformation about the veterinary profession, and from offering dangerous advice and unproven or false treatments. He will have to walk a fine line since without a license he cannot legally practice veterinary medicine, but of course the benefits of a free society are great enough that he must be allowed to spout his nonsense as long as he does not cross the line into liable, slander, or the practice of medicine. Sadly, it wouldn’t surprise me at all if he ends up in the U.S. where regulatory authorities have proven far less willing to challenge such snake oil salesman taking advantage of pet owners and profiting from fear and ignorance.

Posted in General, Law, Regulation, and Politics | 199 Comments

Encouraging studies on probiotics for canine diarrhea

Posted on November 17, 2010 by skeptvet

I have written about probiotics previously (in general, for herpsvirus in cats, and some of the overhyping and quackery associated with them), and in general I have been cautiously optimistic about their potential, while criticizing claims that go beyond the data. I recently came across a couple of studies which illustrates some of the good positive research on probiotics and makes me more inclined to consider using them for specific conditions.

First Study

Kelley RL, Minikhiem D, Kiely B, O’Mahony L, O’Sullivan D, Boileau T, Park JS. Clinical benefits of probiotic canine-derived Bifidobacterium animalis strain AHC7 in dogs with acute idiopathic diarrhea. Veterinary Therapeutics 2009 Fall;10(3):121-30.

The first study is the better of the two for several reasons. The probiotic chosen was a strain of Bifidobacterium derived from dogs. One of the problems with the generally application of probiotics is the questionable logic of taking small amounts of an organism that does not normally live in the gut of a given species and cannot colonize it and giving this organism to “balance” the animal’s gut flora. Commensual organisms that already live in the gut, and which presumably share a history of mutual adaptation with the host, seem more likely to be beneficial in restoring a disturbed GI ecology. Previous research had been done to show this strain was able to survive passage through the stomach acid and colonize the intestine of the dog as well as to survive the processing and storage conditions used to create a product that can be shipped, stored, and given to patients. This groundwork greatly increases the plausibility of the intervention.

The subjects in this study all had acute diarrhea, and in most cases it was idiopathic, meaning no specific cause was found. This is the most common kind of diarrhea seen in clinical practice, and it usually gets better on its own within a week or so. The goal of the study, then, was to see if the probiotic helped dogs to get better sooner than those not treated at all. This, of course, is a valuable goal, but we must be careful not to confuse this use with treatment of diarrhea that is not self-limiting and might not get better without therapy, which is an entirely different problem and for which the value of probiotics would have to be demonstrated in a study specifically conducted for that purpose. Over-generalizing is a common error behind the use of novel or alternative therapies, and it is vital to remember that if a treatment is effective for, say acute self-limiting diarrhea, that doesn’t mean it is effective for chronic diarrhea, parasitic or infectious diarrhea, food allergy diarrhea, or any other different kind of diarrheal disease.

In this study, 31 dogs with were randomly assigned to receive either the probiotic or a matched placebo. All personnel involved in care and evaluation of the subjects were blinded to the treatment groups. All dogs were screened for parasites. 3 were found to have Giardia, and I was initially concerned that if these dogs had more severe disease and happened to be in the placebo group, they might create the false impression of a better outcome for the treatment group. I contacted the manufacturer of the product who contacted the lead author to inquire about this possibility. I was informed that 2 of these dogs were in the placebo group and 1 in the treatment group. These 3 subjects were analyzed to see if their symptoms were worse than the others (they were not) and when their results were removed from the analysis it did not change the outcome.

All the dogs were young (between 1 and 2 years of age) and residents of a guide dog colony. This allows for better control of variables such as diet, environment, breed, age, concurrent diseases and medications and so on. It also might make the results less applicable to other populations, but such are the tradeoffs of all research studies.

Some of the subjects in both groups received the anti-diarrhea antibiotic metronidazole. There were more dogs medicated in the control group than in the probiotic group. The authors acknowledge this is a weakness in the study, but the trend of the results was unchanged when the cases receiving this drug were excluded from the analysis (though this did not leave enough animals to make statistical comparisons).

For dogs in the placebo group their diarrhea resolved in an average of 6.6 days. The dogs in the probiotic group returned to having normal stools in an average of 3.9 days, and this difference was not due to chance alone based on the statistical analysis. This is enough of an effect that if it is consistent in other patient populations and circumstances, it would be a meaningful clinical benefit. Overall, this study provides good evidence for the benefit of this particular probiotic in acute, self-limiting, idiopathic diarrhea in dogs. Again, we must not assume this means that all probiotics are beneficial for all kinds of diarrhea in all patient populations.

Second Study

Herstad HK, Nesheim BB, L’Abée-Lund T, Larsen S, Skancke E. Effects of a probiotic intervention in acute canine gastroenteritis–a controlled clinical trial. J Small Anim Pract. 2010 Jan;51(1):34-8.

This study involves a slightly more realistic, and thus not as well controlled, patient population and treatment and monitoring system. There are also a few other problems with methodology that make this a weaker study.

The probiotic used was a mixture of 5 different organisms, some from pigs, soil, humans, and unknown origin. It is unclear from the paper what if any prior basic research was done to establish whether these organisms survive processing, storage, and stomach passage and if they can colonize the intestines of dogs. No attempt was made in this study to see if the probiotic had colonized the subjects.

36 dogs with diarrhea (22 of which also had vomiting) were seen at a single hospital and randomly assigned to the probiotic or placebo groups. Many were screened for bacterial or parasitic causes of diarrhea, but not all. The assessment of improvement was owner evaluation of when the last abnormal stool and the first normal stool occurred. This potentially introduces some question about the reliability of these outcome measures, though it is unlikely there would be a systematic error favoring one or other treatment group. The subjects in the probiotic group had had symptoms slightly longer than those in the placebo group before entering the study, though this difference was not statistically significant.

The time from start of treatment to the last abnormal stool was an average of 1.3 days in the probiotic group and 2.2 days in the placebo group. This difference barely reached statistical significance (P=0.45). The difference of 1 day in duration of symptoms might be clinically meaningful, though less so than the difference seen in the first study.

The time to resolution of diarrhea was shorter than in the previous study, but this was for dogs who did not start treatment until they had symptoms for an average of 2-3 days, unlike the other study in which dogs with diarrhea were identified and began treatment immediately because they were residents in a colony with professional caretakers. If you count the time from onset of symptoms to end of symptoms, it was 6.1 days for placebo the group and 4.1 days for the probiotic group in this study, compared with6.6 for placebo and 3.9 for probiotic in the first study.

The other main measures looked at (time from start of treatment to first normal stool, number of stools, and duration of vomiting), there were no differences between the placebo and probiotic groups. Overall, then, this study found 1 marginally significant difference between probiotic-treated and placebo-treated dogs out of 4 outcome measures, which is a pretty weak showing.

Conclusion

So these studies do provide some support for the potential benefits of probiotics for acute, self-limiting diarrhea in otherwise healthy dogs. The better of the two studies provides pretty good quality evidence for this use, though more work will have to be done to see if these results are confirmed in other populations and more real-world circumstances. The second study provided a hint of an effect, but the results were weak and not particularly convincing.

I’m inclined to agree with the authors of the first study that a product derived from normal dog intestinal flora and adequately studied to determine that it is viable through processing, shipping, storage, and passage through the stomach is more likely to have a meaningful benefit than other products, and I would be willing to recommend using this product for acute, self-limiting diarrhea pending further research to either confirm or challenge the limited results we currently have.

Overall, I’m still cautiously optimistic about probiotics, at least for acute, self-limiting diarrhea, and these studies encourage that optimism. Clearly, there is much more work to be done to define which organisms in what doses will benefit which patients, but as long as we are careful not to imagine these products as some kind of panacea and go beyond the available data, they seem to be reaching a point where judicious clinical use is reasonable.

Posted in Science-Based Veterinary Medicine | Leave a comment

PetDiets.Com: An excellent source for science-based pet nutrition information

Posted on November 14, 2010 by skeptvet

I just wanted to point out a web site I found recently which offers excellent information on pet nutrition. PetDiets.com is the site of Veterinary Nutritional Consultations, Inc. (VNC). This organization is a independent consulting group that provides nutrition information for veterinarians and for pet owners. It is run by Dr. Rebecca Remillard, a board-certified veterinary nutritionist.

For clients interested in feeding a homemade diet, I always recommend consulting a veterinary nutritionist. Homemade diets can be an excellent feeding option, but they are notorious for being nutritionally inadequate (1), and the advice of a nutritionist can help pet owners avoid unintentionally feeding inappropriate diets.

I also like the extensive collection of pet owner questions Dr. Remillard has answered and posted on her site. She provides clear, comprehensive, and science-based answers to hundreds of questions regarding homemade and commercial diets, nutritional supplements, and other nutrition-related topics.

References

1. Lauren , S.,  et al, Computer analysis of nutrient sufficiency of published home-cooked diets for dogs and cats. Proc ACVIM Forum 2005.

Posted in Nutrition, Science-Based Veterinary Medicine | 13 Comments