Popularity, not Evidence of Efficacy, Drives Growth of Alternative Medicine

A new survey adds evidence to a contention I’ve made before, that the growth in the popularity of alternative therapies has little to do with a growth in the evidence that they are safe and effective. Demand is driven by perception, and perception is created through marketing. Once the perception exists that an intervention is safe and beneficial, or unsafe and harmful, the demand for that intervention among patients (or in the veterinary field, clients) will drive the availability of the product or service. A rational analysis of the evidence for or against an intervention has far less impact on the use of that treatment.

A recent survey of hospitals found, “The number of hospitals offering complementary and alternative medical services has tripled since 2000, driven principally by patient demand…” This will undoubtedly be seized upon by advocates of alternative medicine as evidence that these therapies are now “mainstream” and this must mean they work. But the details of the survey tell a different story.

Forty-two percent of the 714 hospitals surveyed said they provide unconventional therapies, and executives listed patient demand as the top criterion in choosing which therapies to offer… “They are responding to the needs of their patients and the communities they are serving, while trying to differentiate themselves in the marketplace,” said Sita Ananth, a Samueli Institute researcher who wrote the report… Though 70% of executives at hospitals providing unconventional therapies said they are doing so because they are clinically effective, only 42% said they use patients’ health outcomes to gauge the success of the alternative medicine programs. Instead, they are principally using patient satisfaction and volume as evaluation metrics, the report said. The programs were most often started by hospital administrators, with physicians championing the idea 20% of the time.

Clearly, patient demand and perception, not proof of efficacy, are driving the expansion of alternative therapies in these hospitals.

Most of the growth in alternative services is in the alternative services offered comes in the “soft” aspects of CAM- treatments like “massage, guided imagery, meditation and the “healing touch” practice known as Reiki.” This is consistent with the results from previous surveys of hospice providers and with the National Health Interview Survey of 2007, which found that practices which focus primarily on psychological comfort and relaxation, and which arguable aren’t truly medical interventions intended to affect a patient’s physical health, make up most of the CAM use in the United States. “Hard” CAM practices, like homeopathy, chiropractic, acupuncture, TCM, herbs and supplements, and others that claim to prevent or cure disease, are far less widely used.

Personally, I have no objection to relaxation and comfort therapies, and I suspect they have some meaningful psychological value for people struggling with illness. But it is misleading and disingenuous to label these as “alternative medicine” and then either claim they are truly medical therapies, rather than forms of supportive care. There is no consistent or high-quality evidence that suggests these sorts of therapies have meaningful effects on disease outcome or physical health, and for some, such as Reiki, the evidence is quite clear that they do not. And it is equally misleading to cite the popularity of these therapies and then imply that other, “hard” CAM treatments are widely accepted as safe and effective medical treatments.

The question then arises, what harm is there in the acceptance of such comfort therapies in mainstream hospitals? I would argue that the therapies themselves are unlikely to be harmful, particularly since they are rarely substituted for science-based therapies, and they probably do offer legitimate comfort to human patients (though the case is far less clear for veterinary patients). However, there is an inherent problem in allowing patient demand, rather than scientific evidence of safety and benefit, to dictate what care hospitals offer. It is very easy to stray into areas of alternative therapy where the risk to benefit ratio is far less favorable.

And insofar as these “soft” CAM interventions form a bit of a bait-and-switch, in which the positive feelings and negligible risk of these comfort interventions are implicitly extended to more questionable practices which share the ideological/political label of CAM, thus opening the door to these interventions as well, then the overall quality of healthcare patients received may be at risk.

There is no question that part of the appeal of CAM is that providers of such therapies often address the psychological needs of patients more effectively than the mainstream medical system. We should certainly be willing to accept that conventional medicine has its flaws and that there are useful things to be learned from the approach many CAM providers take to communicating with and comforting their patients. But this cannot be at the expense of a rigorously scientific approach to evaluating the safety and efficacy of particular interventions, or we will risk diluting the unprecedented strength of the scientific medical approach, which has proven its superiority to any other countless times in actually preventing and treating disease.

 

 

Posted in General | 2 Comments

DogtorRx from Pet Equinox–Style without substance and a model of snake oil marketing

Even when I’m not working, I’m still a veterinarian and a skeptic, and I tend to notice things related to those subjects wherever I am. In this case, I was stopped at a traffic light when something caught my eye, and I noticed the car next to me was covered with advertising for a product called DogtorRx. Along with the name and logo for the product was a website (petequinox.com) and a list of conditions presumably treated by DogterRx:

Frail Geriatric Dogs
Regulates Cortisol
Dog Joints & Ligaments
Dog Separation Anxiety
Pet Skin Hot Spots
Pet Fur Shedding

When I had the time to investigate further, I was not shocked to find a web site with all the usual warning signs of quackery including:

Sweeping yet vague claims of miraculous benefits and guarantees of absolutely no side effects

Sloppy and misleading use of scientific terms

Claims of scientific research and proof backed up only by opinions and anecdotes, not published clinical studies

Collections of meaningless testimonials from customers and veterinarians

A human product from the same manufacturer with the same ingredient but marketed for entirely different uses (primarly as a “natural” alternative to anabolic steroids for atheletes)

And many others…

What Is It?
The web site is quite vague, but here is how they describe the product:

The natural growth factors in DOGtor Rx’s Formula are comprised of clusters of low molecular weight oligopeptides, which are quickly and easily assimilated and transported through the bloodstream to their specific receptor sites. Each of these growth factors has unique, bio-stimulating properties…

The active ingredient in DogtorRx is fertilized chicken egg extract, which contain heterologous oligopeptides that are able to cross the gastrointestinal mucosa. These peptides have a demonstrated adaptogenic effect and act at TWO levels:

  • Normalize the adrenal cortex activity (androgens, glucocorticoids, mineral-corticoids).
  • Cellular/tissue level (exert cyto-stimulating, cyto-protective and anti-oxidative properties).

Fancy and impressive language, but unfortunately largely meaningless and unsupported by any documentation. “Oligopeptides” is simply any protein with between two and twenty amino acid constituents, and this say nothing whatsoever about its function. Proteins are normally destroyed in the stomach by normal digestion, which is why you can drink insulin or rattlesnake venom without effect, but you will experience significant effects if you inject them into your body. So the claim that the ingredients in this supplement can be absorbed orally and work medical magic is an extraordinary one that ought to be backed up by extraordinary evidence. Nowhere, however, is any such evidence provided on the site for the veterinary or human products.

The site also makes use of the appeal to authority fallacy by pointing out that the inventor of the egg extract and the process used to manufacture it is a legitimate scientist.

Dr. Gheorghe Mihaescu, M.D. is an international expert in such fields as Experimental Immunology in Oncology, Steroid Biochemistry, Radio-assay Methodologies, and Geriatric Nutrition. Dr. Mihaescu has authored 32 published scientific papers in the aforementioned fields. He also holds 15 invention patents, which have been recognized and prized by the European scientific community at the prestigious Brussels and Geneva Conventions.

After 10 years of research at the Department of Nuclear Medicine at the Institute of Physical and Engineering Research in Bucharest, Romania, Dr. Mihaescu and his team were the first scientists in the world to demonstrate (in vivo) that embryonic peptides extracted according to his own technology are able to cross the intestinal membrane to act beneficially as growth factors, without producing toxicity or immunological side effects. This amazing accomplishment led to the invention of  HumanofortTM

Unfortunately, the credentials of the inventor don’t prove the invention works. Linus Pauling, for example, was a brilliant scientist, and arguably a really good person who won a Nobel Prize for chemistry and a Nobel Peace Prize. He was also spectacularly and obstinately wrong about the health benefits of megadoses of Vitamin C.  There is no more reason in this case to simply take Dr. Mihauscu’s word for the miraculous benefits of chicken embryo protein supplements.

Does It Work?
Apart from the implausibility of the underlying idea, that proteins extracted from chicken eggs can be ingested orally and somehow have wide-ranging benefits and absolutely no side effects, is there any real scientific evidence for the claimed benefits and the assertion that the product has been scientifically proven? Shockingly, no.

A number of research studies are referred to in the advertising materials for both the veterinary and the human product.

Effects of Oral Administered Humanofort on Steroid Hormones Level and on Oxidative Stress” by Prof. Gh. Mihaescu, T. Stoica, F. Oancea, Medicine Pharmacy University „Carol Davila” Bucharest, Romania

Oxidative Stress decrease in Old Age Patients Treated with Drugs Containing Embryonic Peptides” by Professors Gh. Mihaescu, O. Mihaescu, I. Mihaescu, National Institute for Geriatrics and Gerontology „Ana Aslan”, Bucharest, Romania

Clinical Trial of Humanofort Effect on Overweight Endocrinology Institute „C. I. Parhon” Bucharest, Romania

The human studies mostly utilized individuals older than 35. According to the authors who reported the results, the fertilized chicken egg extract works as a general tonic and stimulates the adrenal gland, normalizing its function.

DOGtorRx™ formula is having profound effects on over 66% of the 65+ canine and feline participants in an ongoing clinical study at the Holistic Pet Care clinic, New Jersey.

In 2004 I conducted a small study at the Belmont Pet Hospital to support the safety and efficacy of the DOGtorRx™ formula. The study focused on aging dogs with orthopedic challenges and dogs with suspected or diagnosed Cushing’s disease.

A study involving 23 human subjects was completed in Ohio June of 2003. The results were impressive and confirm many results and observations made in the Romanian studies. A summary letter from the Doctor who conducted the study follows:[but it doesn’t]

Twenty-eight healthy male rugby players (age 20-32) volunteered to participate in a 21 day clinical trial.

I was only able to find two studies that had actually been published anywhere, and none of them were among those referenced here. This suggests that the rest are either uncontrolled and unpublished pilot studies or even “try-it-and-see” use misrepresented as a “clinical trial,” or that the manufacturer is outright lying.

The two reports (1,2) I did locate were from a small, uncontrolled human study published by Dr. Mihaescu in the Romanian Journal of Internal Medicine. Subjects took the human version of the supplement and blood samples were taken, apparently fishing for some difference that could be attributed to the supplement (without the full text of the studies, it is impossible to determine the exact methodology). What was reported was a lowering of cholesterol (though it is unclear whether the initial values were normal or abnormal: “the initial values of the biochemical parameters were shifted towards pathological range. Following the administration of EP…cholesterol (total and LDL) were shifted towards the physiological limits for their age.”) The levels of a growth factor, IGF-1, and insulin were also apparently altered after the subjects took the supplement.

So that’s it. One small and poorly controlled study that showed the human product might reduce cholesterol levels and alter the levels of a few other substances in people. This, and the inevitable testimonials, are all that’s given to justify claiming the product can treat or prevent glandular disease, arthritis, allergies and other skin disease, and separation anxiety and even prolong life, all without any possible side effects! This sort of marketing in the absence of any meaningful scientific evidence defines a snake oil.

Bottom Line
The marketing of DogterRx is a perfect example of the deceptive, pseudoscientific advertising that characterizing quack remedies. The underlying theory, that mysterious “oligopeptides” extracted through a secret, patented process from chicken eggs can magically survive normal digestion and treat a wide range of unrelated medical problems with absolutely no risks is implausible in the extreme. And the sweeping, vague claims of benefits without risks, combined with the complete absence of any relevant scientific evidence to support them, is nothing less than fraud (ethically at least, if not legally since the usual Quack Miranda Warning is provided in small print at the bottom of the web page).

The testimonials provided are, as always, great advertising and useless as proof of any of these claims, and the lack of any published studies to confirm the assertions that these claims are “scientifically proven” is as perfect an example of snake oil pseudoscience as one could find. It is impossible, of course, to conclude from the complete absence of evidence that the product doesn’t have any of the claimed benefits. But it is also impossible to prove, without any evidence, the President isn’t actually a space alien in disguise, and ultimately the burden of proof is rightfully on those making and profiting from wild claims. Without real scientific evidence, spending your money on a product like this is the medical equivalent of going to Vegas and hoping you get lucky. Surely our pets deserve better?

Posted in Herbs and Supplements | 12 Comments

Honey for Allergies in Dogs and Cats

Among the alternative recommendations for pet allergy treatment I have seen in some of my recent reading, a popular one is raw unpasteurized local honey. Many alternative veterinary medicine sites confidently proclaim that this safe and natural product can cure or at least markedly improve allergy symptoms in dogs, and possibly cats (though this is less commonly recommended, likely due to the oddity of imaging giving honey to an obligate carnivore).

The theory is that bees collect pollen while feeding on the nectar they use as the raw material for honey, and that some of this pollen is in the honey they produce. If a pet has allergies to local pollens, which are fairly common, feeding small amounts of these pollens daily may function over time as a form of hyposensitization or allergy immunotherapy. Conventional immunotherapy is an effective way of reducing allergy symptoms by injecting miniscule amounts of the specific proteins a person or animal has shown a sensitivity to in allergy testing. Over time, the immune system ceases to react so excessively to these proteins.

There are some problems with this theory. There is some controversy about whether oral immunotherapy is as effective as injectable immunotherapy in humans, though it appears to be a good alternative for at least some allergy patients. There is no comparable research I am aware of in dogs and cats.

Also, the allergens used in immunotherapy are selected for the individual patient based on allergy testing. It may not be correct to assume that the pollens in honey are the same as those causing allergy symptoms. In fact, there is some reason to think this is not the case. Plants that bees feed on have coevolved with bees and other insects for insect pollination. Their pollens are relatively heavy and generally stay attached to the plant until picked up by a pollinating insect. Those plants that are most commonly associated with allergies are usually wind pollinators, which is why their pollens are so problematic. So if the specific allergens one is allergic to aren’t in the honey one is eating, how ould this be a viable form of immunotherapy?

As usual, there is little in the way of good quality clinical research on this subject, none I am aware of in dogs and cats. One small but well-designed study in humans has been published:

Rajan TV, Tennen H, Lindquist RL, Cohen L, Clive J. Annals of Allergy and Asthma Immunology. 2002 Feb;88(2):198-203. Effect of ingestion of honey on symptoms of rhinoconjunctivitis.

Allergic rhinoconjunctivitis is a common disorder, affecting >20% of people of all socioeconomic strata. Despite this high prevalence, relatively few sufferers seek professional medical help, presumably because of a widespread reliance on complementary remedies.

We investigated the widely held belief among allergy-sufferers that regular ingestion of honey ameliorates the symptoms of allergic rhinoconjunctivitis.

The study was conducted at the University of Connecticut Health Center’s Lowell P. Weicker General Clinical Research Center. Thirty-six participants who complained of allergic rhinoconjunctivitis were recruited. All recruits were scratch-tested at entry for common aeroallergens. The cohort was randomly assigned to one of three groups, with one receiving locally collected, unpasteurized, unfiltered honey, the second nationally collected, filtered, and pasteurized honey, and the third, corn syrup with synthetic honey flavoring. They were asked to consume one tablespoonful a day of the honey or substitute and to follow their usual standard care for the management of their symptoms. All participants were instructed to maintain a diary tracking 10 subjective allergy symptoms, and noting the days on which their symptoms were severe enough to require their usual antiallergy medication.

RESULTS:

Neither honey group experienced relief from their symptoms in excess of that seen in the placebo group.

This study does not confirm the widely held belief that honey relieves the symptoms of allergic rhinoconjunctivitis.

So while it is not impossible that oral honey might have benefits in reducing allergy symptoms, the underlying theory has flaws and there is no supporting clinical evidence and even some negative clinical evidence in humans.

Posted in Miscellaneous CAVM | 8 Comments

Integrating Myths and Nonsense with Standard Advice for Allergic Pets

I hear a lot of claims from clients about the cause and treatment of their pets’ allergies that sound like myths or misunderstandings to me, and I expect that. Obviously, a huge part of my job is educating my clients. But it especially bothers me when clients with such claims bring “proof” for them in the form of recommendations or opinions from other veterinarians.

The Academy of Veterinary Dermatology does a pretty good job regularly reviewing the evidence for various allergy treatments, and this is helpful is advising clients on what is likely to be helpful for their pets. There is, of course, always some uncertainty and room for differences of opinion, but the principles of how allergies work and the information concerning the pros and cons of common treatments is pretty solid. The problem is that there are few cases in which allergies can be cured, and there are risks as well as benefits to most effective treatments. This reality creates an opportunity for those who wish to market supposedly risk-free therapies or purported cures without real supporting evidence.

I recently ran across an example of an “integrative” approach to allergy treatment, which essentially means that standard recommendations and a certain amount of truthful information about the causes and treatment of allergies is integrated with unfounded accusations about how conventional medicine causes or fails to help allergies and a skewed perspective of the balance between risks and benefits, combined with promotion of unproven and implausible alternative treatments. These are opinions presented as facts, without good quality evidence to support them.

For Treatment of Flea Allergy Dermatitis-

I avoid recommending any…chemically-laden spot-on pesticides for your pets.

I realize many people like to use spot-ons because they are convenient and effective. But as far as I’m concerned, there’s just too much evidence of potential unhealthy consequences for your pets…In my opinion, the risks of these products are simply too great to warrant their routine (monthly) use.

And what “evidence” is there for the health dangers of these products? The usual source cited is a document from the Environmental Protection Agency (EPA) which references reported adverse reactions associated with topical flea and tick products and announces some changes in labeling and reporting rules. The problem is that the adverse reactions studied are simply reports made to the manufacturers by pet owners and veterinarians, and as the report states, “The incidents have not been verified and may have causes other than exposure to the pesticide.” While the precautionary response of the EPA is entirely appropriate, the bottom line is that when a pet becomes ill about the time a topical flea or tick product has been used, the conclusion that the product is to blame is natural but not reliable. People, particularly those with exaggerated fears of “toxins” and “chemicals,” are likely to look for such things to blame for anything bad that happens. It requires controlled study to identify whether these products truly cause any of the problems blamed on them.
Instead of topical flea control, this “holistic” practitioner recommends “natural” alternatives:

A soothing bath will kill any fleas on your dog, help heal skin irritation, and make her feel more comfortable and less itchy. Also, clean animals aren’t as attractive to fleas. Pick a non-grain (no oatmeal) herbal shampoo.

Make liberal use of an all-natural pest repellent like Natural Flea and Tick Defense…

Here are the natural Brazilian oils and ingredients found in Natural Flea & Tick Defense spray …
Lemongrass oil
Cinnamon oil
Sesame oil
Castor oil
Purified water

Bathing may reduce the numbers of fleas temporarily, but it provides no lasting protection, and dogs with flea allergies will continue to suffer if they are not protected from flea exposure. There is, not surprisingly, no scientific evidence to show that the alternative product recommended is effective or safe.
For Treatment of Food Allergies-

If your dog is over a year old, consider using Dr. Jean Dodds’ Nutriscan saliva test to determine if your pet is allergic to beef, corn, wheat, soy, eggs and/or milk (the most common antigens for dogs).

If your pet has been eating the same food every day for months or years, there’s a good chance she’s developed an allergy to it…She might be sensitive to the single source of chemically-laced protein she’s been getting (chances are the meat is loaded with antibiotics and hormones causing immune system over-reaction). She’s also probably grown sensitive to certain allergenic ingredients in the food, typically grains and other carbohydrates.

Work with your holistic vet to develop an allergy elimination diet to help pinpoint the source of the problem. I recommend a three-month diet, which is longer than what many vets suggest. I like to give adequate time for an animal’s body to clear the allergenic substances, detoxify, and clean out cellular debris…

The diet I recommend is preferably raw, either homemade (again, as long as it’s balanced) or commercial. Rotating the protein sources your dog eats is extremely important, as is strictly limiting or eliminating grains…

Your holistic vet should also suggest natural supplements to help with detoxification, allergy relief and immune system support during and after the elimination diet.

There is no research to suggest that the saliva testing is useful for identifying food allergies. It is sold based on questionable theory and anecdotes, which have little evidentiary value. And as far as uncontrolled testing, at least one dermatologist has run the test in dogs with confirmed food allergies responsive to diet change, and the test results were highly inaccurate.

There is absolutely no evidence for the implication that allergies to meat proteins is associated with mysterious chemicals or hormones in the meat. These notions, the references to “detoxification: and “cellular debris,” and the faddish obsession with grains are all part of an ideology which respects belief more than facts. If something sounds “natural” it must be safe and effective, and if it sounds “unnatural” then it must be harmful.

Of course, I’ve written about the raw diet nonsense before, and there is, once again, no evidence that raw diets have any benefit in terms of preventing or treating allergies. As for supplements, apart from limited evidence that fish oils can reduce the dosage of other drugs needed to control allergy symptoms, there is no solid data to support supplement recommendations. Overall, this section makes erroneous and misleading implications about the causes of food allergies, recommends a dubious diagnostic test, and then suggests treatments that have not been demonstrated to help.

Treatment of Environmental Allergies-

Make sure your dog’s drinking water is high quality and doesn’t contain fluoride, heavy metals or other contaminants.

Don’t allow your dog to be over-vaccinated or over medicated. Vaccines rev up your pet’s immune system – too many vaccinations can send it into overdrive. An over-reactive immune system sets the stage for allergic conditions.

 

Honestly, are we still on about fluoride in the water?! This issue has been studied intensively for 60 years, and there is no reliable evidence to support significant health risks. Heavy metals are certainly potential toxins and should be avoided, but they are not a cause for atopy in dogs. Again, we see the vague and irrational fear of supposed contaminants, which bears a superficial resemblance to reasonable concern about known toxins at levels shown to be harmful, but which underneath is really more of an irrational extension of the emotion of disgust and the fear of contagion.

As for vaccines, while it is true that both allergies and vaccines have something to do with the immunes system, the notion of “over-vaccination” is a fuzzy ideological one with no clear meaning, and there is no consistent evidence that excessive vaccination, however that might be defined, has any causal role in pet allergies.

Bottom Line

Allergies are a serious medical problem that causes a great deal of suffering for pets and their owners. Causes are complex and involve both genetic, developmental, and environmental factors, and symptoms tend to come and go unpredictably, which makes evaluating the effects of any particular intervention challenging. While there are many safe and effective therapies that can help manage allergy symptoms, there is no cure. Only complete avoidance of the antigens the individual is allergic to can eliminate symptoms entirely, and this is often not possible. No treatment that has any benefit is completely without risks, and the risks and benefits must always be carefully and rationally weighed.

The variability and chronicity of the symptoms and the complexity of the causation create fertile ground in which to sow myths and misconceptions about causes and treatments, as this article does vigorously. Providing treatments based on sound scientific understanding of the physiology of allergies and supported by reliable scientific evidence of safety and efficacy is the best way to help patients with this serious condition. Myths about allergy causes and treatments that are without a rational, scientific foundation or any real evidence of safety and efficacy are not legitimate “choices” or “options” to offer pet owners looking for real help. Integrating unproven methods and outright nonsense with established allergy therapies doesn’t add value or reduce risks, it diminishes our ability to help these patients and their human families.

 

 

Posted in Miscellaneous CAVM | 16 Comments

Stem Cell Researchers Caution Against Using Unproven Stem Cell Therapies

One of the therapies that has arisen within conventional veterinary medicine, but which shares many of the worrisome features of an alternative approach, is stem cell therapy. Though it is a plausible intervention with promising preclinical evidence to support investigating its possible clinical benefits, it remains an unproven and inadequately investigated form of treatment. As a result, it is currently legal for human use in the U.S. only under very restricted conditions.  Unfortunately, many people seek such therapies in other countries with less robust laws and regulations protecting the public, through so-called “medical tourism.” And since the same strong public health laws rarely apply to our veterinary patients, stem cell therapies are aggressively marketed in the U.S. despite having even less evidence to support their use than is available for human medical uses.

I have written about this marketing and about the concern researchers in human stem cell therapies have expressed about the premature clinical use of inadequately tested stem cell treatments. Some of these researchers have recently reiterated their cautions about medical tourism and stem cell therapies, and their arguments are just as applicable to the domestic market in veterinary stem cell treatments.

Master Z, Resnik DB. Stem-cell tourism and scientific responsibility.EMBO Rep. 2011 Jul 29.

With a few exceptions—such as the use of bone-marrow haematopoietic cells to treat leukaemia—novel stem-cell therapies are often unproven in clinical trials. Even well-proven therapies can lead to tumour for­mation, tissue rejection, autoimmunity, permanent disability and death. The risks of unproven and unregulated therapies are potentially much worse…

Any medical innovation is ethically responsible when it is based on animal studies or other research that guarantee evidence of safety and clinical efficacy. Adequate measures must also be taken to protect patients from harm, such as clinical monitoring, follow-up, exclusion of indi­viduals who are likely to be harmed or are unlikely to benefit, use of only clinical-grade stem cells, careful attention to dosing strategies and informed consent.

The authors also address the issue of educating patients and doctors about the inadequate evidence for most stem cell therapies and the dangers of employing these therapies without a clear understanding of their risks and benefits. Their conclusions, however, are disappointing for those of us involved in such educational efforts, regarding both stem cell therapy and other kinds of unproven or even disproven methods.

Educating patients about the risks of unproven therapies can also help to address the problem of stem-cell tourism. However, education too has significant limitations, since many people will remain ignorant of the dangers of unproven therapies, or they will simply ignore warnings and prudent advice. For many years, cancer patients have travelled to foreign countries to receive unconventional and unproven treatments, despite educational campaigns and media reports discussing the dangers of these thera­pies. Since the 1970s, thousands of patients have travelled to cancer clinics in Mexico to receive medical treatments not available in the USA.

Education for physicians on the dangers of unproven stem-cell therapies can be helpful, but this strategy also has limitations, since many will not receive this education or will choose to ignore it. Additionally, responsible physicians might still find it diffi­cult to persuade their patients not to receive an unproven therapy, especially when con­ventional treatments have failed. The history of cancer treatment offers important lessons here, since many oncologists have tried, unsuccessfully, to convince their patients not travel to foreign countries to receive questionable treatments.

Given the lack of impact educational efforts often have on patient and clinician behavior, another possible method for limiting the potential harm of inadequately tested therapies is regulatory oversight requiring a reasonable degree of scientific evidence before such therapies can be marketed outside of the clinical research and compassionate use contexts. This has worked to prevent much inappropriate use of stem cell therapies in humans in the U.S., though the practice of medical tourism is a way around such regulations. Regulations on veterinary therapies are far less restrictive, and this has both benefits and costs. Lax regulation makes investigating novel therapies easier and cheaper, which may lead to more rapid and affordable development of new therapies. However, the same loose regulatory environment also subjects pets and their owners to unproven therapies which may not benefit them and may even be harmful. In any case, regulation is often not an especially effective way of constraining the use of therapies not supported by reasonable scientific evidence.

The recommendation these authors make for reducing stem cell tourism involves denying essential materials to practitioners overseas who use unproven stem cell therapies. This is, obviously, not relevant to the issue of veterinary stem cell therapies marketed in the U.S. What is relevant is the fact that leading researchers into stem cell therapies for humans, those scientists most likely to believe in the promise of such therapies because they have made investigating them their life’s work, are consistent in warning against the premature clinical use of these treatments without adequate supporting research evidence. Caution about such therapies seems prudent when even their advocates recommend it.

Posted in Science-Based Veterinary Medicine | 5 Comments

Chemotherapy Doesn’t Work? Not so Fast….

I’ve written a bit about “integrative” veterinary cancer care previously and how it is often marketed with claims that are unsupported by evidence. A recent example of this is a post  on the Huffington Post blog in which a prominent CAVM advocate suggests that his conversion from skepticism to belief in alternative medicine is due in part to his realization that a therapy he judged to be quackery actually works. In reality, the therapy is still unsupported by anything stronger than anecdote and personal opinion.

Such unproven therapies are often marketed on the basis of claims that conventional therapies for the same problems are useless, or do more harm than good, and so it makes sense to try alternatives even if they don’t have good evidence behind them. This is an argument commonly made about chemotherapy and alternative cancer therapies, and it is made explicitly in the comments following the HuffPo article.

Fortunately, today Dr. David Gorski at Science-Based Medicine has posted a thorough and cogent response to the bogus claim that chemotherapy is useless. He does a great job of explaining both the value and the limitations of chemotherapy as well as pointing out the weaknesses of the evidence CAM advocates use to support their claims about chemotherapy. I encourage every to have a look at Dr. Gorski’s article.

Posted in Science-Based Veterinary Medicine | 7 Comments

Evidence-Based Guidelines For Pet Care

The American Veterinary Medical Association (AVMA) and the American Animal Hospital Association (AAHA) recently released a set of Canine and Feline Preventative Healthcare Guidelines. The primary reason for doing so seems to be evidence from several surveys that suggest the demand for veterinary services has decreased in the last 10 years despite a significant increase in the population of dogs and cats in the United States. The surveys indicate that some of the reason for this decline is the increasing reliance of pet owners on the Internet for pet healthcare information, and the lack of awareness of the importance of preventative healthcare for pets.

I certainly agree that preventative healthcare is extremely important, and that reliance on the Internet as a source of information in lieu of professional veterinary care is a mistake. And as a general practitioner, I strongly believe that evidence-based guidelines are indispensible. Such resources have made evidence-based medicine practical for busy primary care clinicians without the time, skills, or energy to critically evaluate the medical literature themselves on an ongoing basis. Such tools would be of great benefit to veterinary medicine, and creating them is one of the goals of the Evidence-Based Veterinary Medicine Association (EBVMA), which I am involved with.

However, it is important that such guidelines be constructed in a way that is truly based on objective scientific evidence. If they are simply a way of promulgating the opinions of individual experts, they will constitute a quite low level of evidence justifying specific clinical practices. If they are not explicit and formal about the primary research evidence they are based on, it is impossible to judge whether they represent an evidence-based assessment or merely opinion, and this will reduce their reliability. And it is important that such guidelines be free from undue influence or bias of individuals or groups with potential conflicts of interest that could compromise the integrity of the evidence gathering and assessment process or the ultimate content of the guidelines.

The difference between truly evidence-based guidelines and opinion-based guidelines is a bit like the difference between a systematic literature review and a narrative or traditional literature review. Systematic reviews use explicit, predetermined criteria to identify and evaluate the primary research relating to a specific, focused question in order to allow a summary with as little bias as possible which can be replicated by others to check its validity. A narrative review is an informal search of the literature, usually covering a broader and less clearly defined subject than a systematic review. In a narrative review, the methods for finding and assessing the primary research literature may not be formally established or fixed in advance, and there is a strong likelihood that the opinions and biases of the reviewer will influence what research is examined and how it is evaluated and weighted in drawing conclusions. Narrative reviews can be useful, but they are a lower level of evidence than systematic reviews and less reliable due to the high risk of bias.

The new preventative guidelines published by the AVMA and AAHA appear to be much more like a narrative review. Despite being promoted as evidence-based, they are really a summary of previous consensus statements and other forms of expert opinion. The topic covered is broad and not clearly defined, the criteria or methods for selection and evaluation of the scientific literature are not stated, and there appears to be a high risk of bias in the content. The effort was also sponsored, and presumably funded, by the Partnership for Preventative Pet Healthcare. This organization, established in July, 2011, is a consortium of 16 organizations, including the AVMA and AAHA as well as 13 corporations selling veterinary products and services. Obviously, this presents the appearance, and the very real risk, of a conflict of interest that has to be considered in evaluating the content of the guidelines.

Many of the guidelines seem quite reasonable to me as a primary care veterinarian. It is hard to object to the idea that pets should have regular checkups, that veterinarians should consider medical health, nutrition, behavior, infectious and zoonotic diseases, and other important issues when evaluating pets, and that veterinarians should communicate clearly with clients and keep good records.

However, even these apparently obvious and sensible guidelines ought to be supported by reasonable and explicit scientific evidence, if possible. Plausibility is an important factor to consider in evaluating a healthcare practice, but it isn’t the end of the line. There is some evidence, for example, that in apparently healthy humans annual physical examinations may not have any real benefits in disease prevention, and the subject is the subject of some debate and controversy. And while it seems reasonable to assume that screening tests are always a good thing that can aid in prevention of illness, I’ve discussed before why this isn’t necessarily true (here and here). So simply because the recommendations seem reasonable, it is not enough to simply assume they are appropriate without looking for supporting evidence. There is a government agency, the U.S. Preventative Services Task Force, devoted entirely to evaluating the evidence and making recommendations concerning preventative healthcare for humans because it is recognized in human medicine that such recommendations ought to be based evidence-based.

There is also the question of whether the AVMA and AAHA can truly be both objective advocates for best clinical practices and also lobbying organizations for veterinarians. Both organizations have historically been more interested in defending the prerogatives of the profession and pleasing their own constituencies than in promoting or policing evidence-based standards of care for veterinary medicine.

AVMA has failed to clearly and consistently defend science-based veterinary medicine and challenge unscientific practices. I wrote earlier this year, for example, about the AVMA’s Model Veterinary Practice Act, which is being revised, and how the weak language concerning alternative veterinary practice could be improved to more clearly identify that most CAM is not consistent with established science or the curriculum taught in most veterinary schools. Instead, the AVMA chose to eliminate any mention of scientific validity in describing CAM. As a membership organization, the AVMA must follow the wishes of its members, and so it is unlikely to be able to effectively advocate for a standard of care that would threaten the practices of any significant number of members.

Similarly, I find it difficult to take seriously the claim that AAHA supports scientific, evidence-based medicine in the face of their recent e-newsletter which lauds the benefits of veterinarians working with animal communicators and previous owner education pieces promoting decidedly non evidence-based practices.

Undoubtedly, some will characterize these new guidelines as at least partially targeted at generating income for veterinarians and others with a financial stake in veterinary healthcare. That is a difficult accusation to defend against given that the guidelines were sponsored primarily by corporations who sell products and services which the guidelines recommended. This is especially true when there is an absence of explicit and good quality evidence provided to support the recommendations. Recommending continuous, year-round broad-spectrum parasite and flea prevention for all dogs and cats regardless of individual risk factors, for example, does not seem consistent with an objective evaluation of the evidence, but it does seem consistent with the objectives of the sponsoring organizations who market parasite and flea preventatives.

I don’t doubt the individual integrity of the members of the committee that drafted the guidelines. I have often pointed out that bias rarely involves straightforward dishonesty or malfeasance, and that we cannot simply dismiss arguments on the basis of the presumed financial motives of those making them. As a clinician and advocate for science-based medicine, I deal every day with pet owners and critics of mainstream veterinary medicine who are suspicious of the role of money in the veterinary profession. The best defense against such suspicions is a transparent assessment of the scientific evidence supporting our practices, and a lot of my efforts are directed at illustrating why the evidence clearly supports conventional, scientific medicine far more than most of the proposed alternatives. So I would have liked to see these guidelines produced in a manner that made them truly evidence-based, with appropriate controls for bias, financial and otherwise, so that I could enthusiastically promote and defend them. As it is, while I think much of the content is reasonable and appropriate, the process and the details appear deeply flawed, which significantly reduces the reliability and value of the guidelines.

I also recognize that no organization and no process for developing consensus or general guidelines can be perfect, and I don’t wish to make the perfect the enemy of the good. However, there is another set of guidelines currently being developed which I think illustrate a superior, and truly evidence-based process that should be a model for future efforts of this kind.

The Veterinary Emergency and Critical Care Society (VECCS) has an ongoing project to establish  evidence-based guidelines for CPR in veterinary species. The Reassessment Campaign on Veterinary Resuscitation (RECOVER) project  seems to me an outstanding example of what a truly evidence-based process for establishing such guidelines should be. Criteria for selection and evaluation of the primary literature and focused clinical questions were established in advance, a formal process of grading the literature was
followed, and both the primary literature used and any potential conflicts
of interest were explicitly disclosed.

This project illustrates the potential for how such guidelines can be developed in an evidence-based way, avoiding many of the concerns that I think weaken the AVMA/AAHA guidelines. The former is much more like a systematic review and the latter more of a traditional narrative review. Both can be useful, but the systematic and explicit process of the RECOVER initiative is likely to lead to a more reliable end product, more useful and less subject to allegations of bias or hidden economic agendas.

Hopefully, more focused and evidence-based guidelines will become available to general practice veterinarians in the future. I believe this will significantly improve the quality of veterinary care available to pets. But this benefit can only be realized, and pet owners can only be made to have confidence in their veterinarians’ recommendations, if transparent and truly evidence-based processes are utilized to develop such guidelines. I think the RECOVER initiative is an excellent model for such a process, and I hope it will illustrate how an evidence-based approach can be practical and can provide the most effective clinical tools and also the best defense against suspicious about the motives or integrity of the veterinary profession.

Posted in Science-Based Veterinary Medicine | 6 Comments

CAM Conversion–From Skeptic to Believer

I frequently find that advocates of alternative medicine present themselves as converted skeptics. Of course, many came to veterinary medicine with a preconception that alternative methods were beneficial. But quite a few veterinarians or MDs who promote alternative methods tell stories about coming from a position of doubt or even outright antagonism towards unconventional practices to a position of strong belief.

These narratives have the effect of establishing the doctor’s credentials as a hard-nosed, critical thinker, which presumably makes the methods they are selling seem more legitimate. Such “spin” is necessary only because many people recognize that some alternative practices are highly implausible and require an element of faith without evidence to accept. So promoters of such methods wish to present themselves not as excessively credulous but as skeptics won over by the undeniable strength of the evidence.

I have no doubt that these folks tell these narratives honestly. I am fairly sure they are genuine, though I am less convinced they are accurate. It is clear from extensive research in psychology that such biographical narratives, and human memory in general, are seldom accurate factual reproductions of the past. Rather, they are stories continuously revised to fit into the current structure of our beliefs about the world and ourselves (for more detail, see Don’t Believe Everything You Think, On Being Certain, and Mistakes Were Made: But Not By Me). Neat parables about one’s conversion from skeptic to believer seem a perfect example of how such unconscious revisionism sevres to reinforce our beliefs and self-concept.

Such conversion stories are remarkably consistent thematically, though of course there is variation in the details. Often, the practitioner relates how they initially practiced conventional medicine but became frustrated by the limitations of scientific care. They also frequently describe miraculous individual cases, or even experiences involving their own health, that convinced them there was real validity to alternative methods.

Obviously, there are diseases we don’t understand and cannot treat very effectively, and it is natural for any caring doctor to be frustrated by suffering they cannot relieve or illness they cannot prevent. Unfortunately, this understandable emotion born out of compassion and empathy becomes harmful  when it leads us away from a sound, scientific pursuit of better understanding and interventions and towards a comforting but mistaken faith in unproven, ineffective, or even entirely magical treatments. And while individual experiences are very psychologically compelling, they are not reliable as proof that a therapy is safe or effective. So if they lead us to believe that ineffective practices work, they may be relieving our frustration while not actually doing a better job of treating our patients.

This example of such a conversion narrative illustrates both the frustration with the limitations of medicine and also the experience of having come to believe in alternative therapies through a perceived benefit for one’s own health. Since the conversion was to a belief in homeopathy, which is about as magical and unscientific a therapy as one can find, it is also a clear example of how one can be mislead by emotion and experience into rejecting useful practices for useless ones.

“Homeopathy is one of the rare medical approaches which carries no penalties – only benefits”
— Yehudi Menuhin, Violinist

Yehudi Menuhin’s statement reflects an important reason that I became interested in homeopathy. After practicing traditional Western medicine for roughly ten years, I became disenchanted with chemical drugs as being the only approach in dealing with disease. I was frustrated with the lack of effective treatments for chronic disease, behavior problems, and the epidemic of allergic conditions. During my search for alternatives, my personal health was greatly improved with homeopathic treatment, leading me to the study of homeopathy and the incorporation of this great system of medicine in my veterinary practice.

These stories often have an implicit, or even explicit, religious tone to them, illustrating an opening of the mind to realms of healing beyond the physical body, which is where medicine traditional directs its efforts. For example:

[I] practiced traditional veterinary medicine for 16 years. Gradually I became frustrated at the limitations of these methods and went abroad to Europe and South America to study healing methods practiced by holistic medical doctors. I incorporated these methods of natural healing in my own practice and found I could do so much more for my sick and painful patients… Why? It has to do with the philosophy, cause and effect of the two different methods of diagnosis and treatment of the patient…

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

Holistic medicine benefits Body, Mind (Emotional) and Spirit and recognizes these are also interdependent in maintaining health. Traditional medicine mainly concentrates on the body.

Some of these conversion stories do claim that the transition from skeptic to believer was brought about by thoughtful consideration of real scientific evidence. Here is one example. It manages to read like a pure religious conversion, with a series of miracle stories and even fainting brought on by the power of the revealed truth, and yet it claims to be an awakening based on a scientific approach to knowledge:

Before I knew about integrative medicine, it was easy to tell someone that nothing else could be done… There was truth in the statement and in knowing that “we had done everything we could,” but there was also sadness and loss in the failure that burned quietly at the core of my being.

In the 80s a series of crazy life changing events lead me to discover something wonderful.

… a mutual friend told me that her lovely Golden retriever had lymphoid cancer and she was being ripped off by a “quack alternative medicine doctor…” I decided that this “quack” should not be practicing and became determined to end his professional career.

I flew to New York to spend a week investigating the doctor, and found things that literally made me faint… I simply passed out rather than face the fact that the man I thought was a crook was actually a gifted healer…

One of the “snake oils” used to treat that dog for cancer was a mixture called Poly-MVA… After 30 years of testing over 20,000 products, Dr Garnett discovered Poly-MVA. His discovery created an entirely new field called electrogenetics, which is the study of electrical activity on the DNA. Poly-MVA appears to shuttle electrons in such a way that the susceptible cancer cells die while normal cells continue to survive.

… Gradually, scientific investigators began looking at Poly-MVA… The first major clinical veterinary study of its kind looked at 800 animals treated for various cancers and showed a clear improvement in quality of life.

…I began my quest into integrative medicine so many years ago to prove that this substance was quackery because I “knew” that there was no such solution. Through my scientific training and through common sense investigation, we found that it was useful and began treating patients with Poly-MVA over 15 years before further study demonstrated its usefulness. And now through proper scientific method, we are understanding that the dose needs to be further evaluated.

This narrative represents a skeptic as one who arrogantly rejects ideas they know nothing about. It illustrates how watching seemingly miraculous events should convince the open-minded skeptic that the things they believe are nonsense are actually true. And it claims that 15 years after seeing the truth, the revelation has been validated by science.

Unfortunately, skeptics are not those who judge things as false based on ignorance, but those who reserve judgment until reliable, scientific evidence is provided. Anecdotes, testimonials, and individual “miracles” do not constitute such evidence, because they are frequently misleading. And in this particular case, Poly-MVA is still an unproven nostrum based on questionable theory and without sound scientific validation.

Here’s what the American Cancer Society says about Poly-MVA:

Available scientific evidence does not support claims that Poly-MVA is effective in preventing or treating cancer….­reports of Poly-MVA’s effectiven­ess are anecdotal or small studies that have not been confirmed or published in scientific journals.

No studies of Poly-MVA in humans have been published in peer-revie­
wed medical journals..­.

The potential risks and side effects of Poly-MVA are not known, as no results from human studies have been reported. Palladium compounds have the potential to cause allergic reactions in some people. Because lipoic acid is a powerful antioxidan­t, Poly-MVA may make radiation therapy or chemothera­py less effective. While this concern is based largely on theories of how cancer treatments work, it is supported by some recent studies.
 

And here’s a comment from Dr. Andrew Weil, who certainly cannot be accused of not being open-minded and friendly to alternative medical therapies:

I have seen no scientific evidence demonstrating that Poly-MVA either prevents or effectively treats cancer. Indeed, I have found no reports of any well-controlled scientific studies. Most of the “success stories” cited by promoters are simple testimonials or come from studies that have not been published in scientific journals. Poly-MVA may not be dangerous in and of itself, but when you’re dealing with a life-threatening illness such as cancer, it is always ill advised to substitute an unproven treatment for one that has been scientifically demonstrated to help. At best, Poly-MVA would do no harm. At worst, by using it as an alternative cancer treatment you could lose valuable time that might be better spent fighting the disease with therapy that has some medical merit.

Poly-MVA may or may not have benefits in cancer patients. At this point, no one really knows since there are no controlled research studies on the question. If poly-mva played a role in converting this doctor from a skeptic to a believer in the promise of alternative medicine, it is not because the scientific evidence proved his skepticism unfounded.

Obviously, people do sometimes experience profound shifts in their world view. And there is nothing inherently wrong with sharing these experiences with others. However, these medical conversion stories are frequently held up as examples of the flaws of science and skepticism and as paradigms for how a skeptic should, if they are really open-minded, become a believer in some deeper and more effective approach to medicine simply because of a few seemingly miraculous cases. They make nonsense seem scientific and legitimate and rejection of nonsense seem dogmatic and closed-minded. And they are ultimately examples of circular logic since they only make sense if we accept that “truth” discovered by the storyteller is actually true, which it often is not.

Posted in General | 2 Comments

Celebrate (or Mourn?) National Holistic Pets Day

Oops, looks like I just missed the party! Apparently, yesterday was National Holistic Pets Day. This holiday was created by Colleen Paige… I was going to give a brief description of who exactly Ms. Paige is, but I don’t think I can. Her website describes her this way:

Colleen Paige is one of America’s premier Family & Pet Lifestyle Experts…She is also an Animal Behaviorist, Best Selling Author, Interior Designer for both people and pets, Artist, Gourmet Cook, Beauty Expert, former Paramedic, Child & Pet Safety Expert, Family Crisis Counselor, Wellness Aficionado and Publisher of Pet Home and Style & Bliss Magazines.

Wow! She also apparently likes to create holidays, usually to raise awareness and money for some animal-related cause; 19 holidays according to her foundation website. She sounds like a remarkable person, and browsing through her various web sites, I am impressed by her energy, creativity, and the depth of her commitment to her vision of animal welfare. She is undoubtedly doing a lot of good things for pets and people.

Unfortunately, as is so often the case, sincerity and a commitment to doing what is best for pets don’t always correspond with a deep or accurate understanding of what actually is best, at least in the area of healthcare. Her description of National Holistic Pets Day includes all too many of the usual myths and misconceptions and fuzzy thinking that characterize the meaningless buzzword “holistic.” Ms. Paige dedicates this holiday to a companion she lost to cancer, and her description of the experience is both touching and representative of the mixed up thinking behind the idea of holistic medicine:

After the Feb. 2010 death of my fur child Tinkerbelle, from a brain tumor…I began to think about her diet and health regimen and wondered if somehow I could have done better in terms of her health care. I gave her filtered water, fresh filtered air at home and only all-natural food and treats void of corn, wheat, sugar and chemicals.

I didn’t however, give her vitamins and supplements. Could the addition of these have fought against free radicals and other toxins in her body that caused this tumor? Maybe, maybe not, but it made me really uneasy to know that there were other things I could have done that would have at least left me with the surety that I did everything I could.

Already committed to the belief that illness is caused by mysterious “toxins,” despite the lack of evidence for most specific chemical suspected to be harmful and ignoring the role of genes, age, and simple random bad luck, Ms. Paige followed many “holistic,” and completely pointless, guidelines in trying to protect her pet from “this overly toxic world we live in.” When her pet unfortunately developed cancer anyway, did this cast any doubt on the theories or practices she followed? No. Sadly, Ms. Paige was just filled with a vague guilt that she hadn’t kept her pet’s life “pure” enough and was somehow responsible for the cancer. So she rededicated herself to adding still more unproven and largely irrational preventative measures to her pet care routine. If her subsequent companions develop cancer, will she follow the same road even further? And if they don’t, will this constitute “proof” that the new additions worked?

This is an understandable but very dangerous pattern of thought that we are all in danger of succumbing to. We fear pain and illness and loss, naturally, so we try to prevent them and comfort ourselves with the idea that we are in control of our fate, that if we do the “right” things in terms of our physical and spiritual care of ourselves and our loved ones, we can prevent the suffering and pain we fear. But the universe gives little us little reason to believe that our magic rituals really work. The only thing in all the history of humankind, with all the myriad of lifestyle and spiritual practices we have employed, that has ever made a dramatic and unequivocal improvement in the length and quality of our lives has been the development of science, and the growth of true understanding and effective manipulation of the world science has allowed us. Many things are, maddeningly, beyond our control. But magical thinking, however sincere and well-intentioned, is not truly the best way to give our pets the best lives we can.

Other supporters of National Holistic Pets Day go even farther than Ms. Paige in misleading the public with comforting nonsense. This press release (ostensibly from the PetMD web site, though I can find no mention of the holiday on the PetMD site, and it would be a bit inconsistent for this company to promote the myth of holistic medicine since it runs a pet food and pet pharmacy business selling all the “toxins” the holistic crowd) contains the usual clichés from some of the usual sources.

homeopathy can treat the deepest constitutional causes of dog diseases and cat diseases…”While the ‘find it and kill it’ Western medical approach may work for infectious diseases, holistic medicine takes preventative measures by treating the whole body,” says Dr. Nancy Scanlan, executive director of the American Holistic Veterinary Medicine Association (AHVMA). “Holistic veterinary care can be much more effective when treating chronic illnesses like heart disease.”

While I respect Ms. Paige’s motives and efforts to improve the lives of pets in many different ways, it is unfortunate that her misconceptions about medicine have led her to throw those efforts behind the kind of nonsense that only drains energy, talent, and resources away from finding and employing truly effective healthcare for our pets. Many of the pets in the U.S. have too little access to preventative healthcare, or even treatment for illness, due to both economic factors and misconceptions about the need for regular care and the reliability of information found on the Internet. A campaign to raise awareness about the need for veterinary care should focus on those measures that are proven to benefit our pets, and despite Dr. Scanlon’s assurances, this is not the case for so-called holistic medicine. Perhaps we need a National Science-Based Pet Medicine Awareness Day?

Posted in General | 9 Comments

Standard Process=Standard Nonsense

Standard Process is a company that has been selling dietary supplements since 1929. It was founded by a dentist, Royal Lee, who developed a number of unconventional theories about the role of nutrition in health and disease. In essence, Dr. Lee and his successors take rational, scientific principles and extend them well beyond reason and evidence to promote claims that the particular plant and animal extracts they provide have near magical medicinal qualities. This is the very paragon of pseudoscience, the presentation of unsupported, often irrational hypotheses, mingled with scientific terminology and a sprinkling of tangentially related actual scientific facts to create a set of faith beliefs that appear to be scientific but do not actually conform to the philosophy, methods, or data of legitimate science.

It is quite reasonable and demonstrably true, for example, that nutritional deficiencies can cause disease, and that  supplementation with the appropriate nutrients can prevent and treat such diseases. This does not, however, support the generalization that all disease is associated with nutritional deficiencies, or that all disease can be ameliorated with proper nutritional supplementation. Food and nutrients of appropriate kind and quantity are unquestionably necessary for health and even life, but that has very little to do with whether or not the specific theories about the benefits of particular foods and nutrients sold by Standard Process are true.

Of course, Standard Process products are not simple vitamin and mineral supplements. They contain complex mélanges of plant and animal ingredients. The marketing materials talk a lot about the value of “whole foods.” The claim is frequently made that plant and animal tissues contain combinations of chemicals (never called by that dirty word, of course) that provide greater health prevention and treatment benefits in combination that individual nutrients can alone. And it is taken as a given that “processing” of any kind, including cooking, ruins the nutritional and health value of foods. The key to healthful supplements are that they contain whole, unprocessed, natural ingredients, preferably organically produced.

All of these are fairly standard arguments seen in the marketing materials for alternative approaches to nutrition. The evidence does not generally support such claims. Organic food appears to be no healthier than conventionally produced foods, though there may still be some environmental advantages to organic production methods. And while cooking and other kinds of processing do alter the nutrient content of foods, this is a pretty well-understood phenomenon. Some nutrients become more available, and those that are diminished by cooking can be effectively replaced. So the evidence does not support claimed health benefits for raw foods in humans or pets. “Natural,” of course is a meaningless marketing term. Synergy can exist between compounds in a whole plant, but it requires complex, thorough investigation to document that it actually does occur in any particular plant. And finally, the issue of “processing” of foods is a complex mishmash of fact and mythology. In general, “processed food” is used as a synonym for “junk food,” but clearly every time you wash, chop, season, or cook your food, you are “processing” it, and usually improving it. Claims about the nutritional inadequacy or deleterious effects of commercial pet foods are not supported by real evidence.

What is particularly odd about the emphasis in Standard Processes’ marketing materials on natural, unprocessed, whole foods is that their supplements cannot in any reasonable way be described by any of these buzzwords. They are complex mixtures of herbs, plant extracts, vitamins and minerals combined with “Protomorphogen” and “Cytosol” extracts. highly processed substances derived through proprietary processes from animal tissues, These mixtures are then compounded into tablets or powders. So mixtures that would never be found in nature in forms that are the result of extensive technological processing are sold as natural whole foods?

The animal tissue extracts represent another element to Dr. Lee’s unproven, pseudoscientific nutritional theories. It is true that deficiencies in the function of some glands can be remedied by supplementation with relevant substances from the same gland. However, it is usually true that purified isolates or synthetic forms of these glandular products are superior to whole organ supplements, and often the supplement cannot be given orally anyway. And none of this has any relevance to the broader claims that whole gland products or gland extracts prevent or treat disease through the action of numerous, often unidentified substances.

Ultimately, the idea that treating kidney disease by feeding ground up kidneys to the patient, as an example, is not a scientific hypothesis but yet another form of sympathetic magic. This is a descriptive term from anthropology which refers to a form of magical belief found in most cultures, that things which resemble one another in some superficial way can be used to influence each other. Mandrake root must be an aphrodisiac or fertility treatment because the root resembles a human penis; voodoo dolls that look like a particular person can be used to harm them; and diseases that involve a particular organ can be treated by feeding supplements made from that or a related organ.

There does not seem to be any real research evidence to support the claim than glandulars in general, or the “special” gland extracts sold by Standard Process, have any significant health benefits. Those who promote the use of these products support their assertions with clinical experience, case reports and uncontrolled case series, and reference to pre-clinical research showing that some chemicals from some glands have some effects. Much of the supporting research comes from publications devoted exclusively to promoting these products or alternative therapies in general. And, of course, there are plenty of anecdotes and testimonials to miraculous cures brought about by these products, which have their usual lack of probative value. Well-designed and conducted clinical trials published in mainstream peer-reviewed journals do not appear to exist, despite the fact that the company has been producing and marketing supplements for over 70 years.

As is usual with pseudoscience, claims about the products and unsupported theories are mingled with tangentially related facts from legitimate scientific theory and research. One example of the marketing materials for the Standard Process veterinary product line illustrates this technique. The document, published in Standard Process’ own pseudojournal Whole Food Nutrition Journal, begins with a list of known nutrient deficiency diseases. It then proceeds to point out that the transition from “traditional” to “modern” diets is associated with health problems. This has, of course, some truth to it, though it has nothing to do with the claims that will later come about the specific relationship between Standard Process supplements and health, and it ignores the fact that so-called “traditional” diets are themselves associated with nutritional deficiency diseases.

The infamous Pottenger study is mentioned, which is a common warning sign of veterinary nutritional pseudoscience. This is a poorly designed experiment from the 1940s that involved feeding milk and meat, either cooked or raw, to cats. The cats fed the cooked meat developed nutritional and developmental diseases, which is often cited as evidence that raw foods are healthier than cooked foods. Unfortunately, the complete lack of experimental controls or proper evaluation of the subject, and the simple fact that both diets were grossly deficient and utterly unlike the commercial pet foods the study is usually used to criticize, make the results meaningless. Pseudoscience at its best, or worst.

The pattern continues throughout the document, and is characteristic of the rest of Standard Process advertising. A mixture of hypotheses and outright fantasy with vaguely related scientific information to create the false impression that the whole is sound.  What the company is pretty careful not to do is make direct claims that its products prevent or treat actual diseases. Thanks to the ridiculously lax regulation of dietary supplements, it is possible to suggest, imply, and in a multiplicity of clever ways mislead the consumer, and even veterinarians, into believing the products have proven value in disease treatment or prevention. However, straight out claims that the products are medicinal are not allowed. The company and its founder have been sanctioned numerous times in the past by the Food and Drug Administration for illegal claims about their products. The current leadership is now more careful. However, believers in these supplements, primarily chiropractors and naturopaths as well as “holistic” veterinarians, devise and teach each other strategies for deciding which supplements to use when.

Bottom Line
The theories about the relationship between food, nutrients and health invented by Dr. Lee and still promoted by Standard Process are unscientific and not supported by scientific evidence.

The marketing claims that the products are beneficial because they are unprocessed, natural, whole foods are both meaningless and inconsistent with the real nature of the products, which are highly processed, artificial mixtures of compounds.

The promotional materials used to advertise these products to veterinarians and consumers are highly misleading pseudoscience, mixing unproven and unscientific ideas with bits of real science that do not actual have anything to do with the validity of the claims made about the company’s theories or products.

There is no evidence beyond individual opinion, anecdotes, and poorly designed case series to indicate that Standard Process products have any value in treating or preventing disease. More than 70 years after the company began manufacturing and selling supplements, there are still no good quality clinical trials demonstrating that any of their products are effective for the prevention or treatment of any medical condition.

Ultimately, the choice to use these products is a gamble, trusting that notoriously unreliable forms of evidence such as anecdotes can accurately guide us in the absence of any real scientific evidence.

 

Posted in Herbs and Supplements | 142 Comments