Funny for Some of You

(From Veterinarians Behaving Badly. Hasn’t happened to me yet, but I’ve been taken to task, and others I know have been banned for expressing their critical thinking)

Posted in Humor | 10 Comments

Misleading Advertising for Raw Pet Food (again)

H.G. Wells is credited with saying, “Advertising is legalized lying,” though I cannot imagine he is the first person to have thought so. Of course, the difficulty with identifying actual lying in advertising is that it is impossible to know whether the person making false claims actually believes their statements are true. When talking about inaccurate advertising of alternative medicine, supplements, unconventional diets, or even conventional therapies such as stem cell injections, I try to make the safer and more charitable assumption that the advertiser believes what they are saying, however egregiously implausible and inaccurate it may be.

Unfortunately, whether inaccurate claims made to sell a product are genuine misconceptions or deliberate deception, the truthfulness of the claims is often not something the consumer can judge, so false claims sell just as effectively as the truth. And because of the undeniable effectiveness of science as a means of identifying the truth, claims of “scientifically proven” benefits are often made in advertising healthcare products and services, which creates an undeserved and false appearance of legitimacy to unsupported, pseudoscientific ideas.

The latest example I have run across of this phenomenon, and a particularly brazen one, is the advertising of Souly’s Raw Pet Food. I’ve written in detail about raw diets before, and the bottom line is that there is no reliable research to indicate any benefits at all to feeding our pets raw food. The theories behind these diets are a mixture of reasonable supposition and nonsense, but there is no sound evidence to support any of them. There is, however, abundant evidence that cooked food is more nutritious than raw food, and that raw diets come with serious risks, including nutritional inadequacy and contamination with harmful bacteria. Despite this lack of any real reason to believe raw diets are good for our pets, manufacturers and promoters of these diets are not shy of making aggressive claims.

A press release from the makers of Souly’s sounds like a report on a new scientific study, but a close reading finds no evidence of any research at all, merely unsupported opinion and error.

Soul’y Raw Pet Food Discovers that Switching Your Pet to a 100% Handmade Raw Food Diet has been Successful as an Alternative Treatment for Coprophagia

The most common cause [of coprophagia] is usually a dog that is lacking a diet that provides him with sufficient vitamins and minerals to quell the desire to seek out other food sources to make up for the deficiency….Soul’y Raw Pet Food in San Marcos CA has noticed that the practice of dogs consuming their own feces or that of other dogs has all together stopped in their loveable following of furry friends when transitioned to their high quality raw food diet. One could say that this simple breakthrough in successfully deterring pets from seeking out feces as an alternative food source is just what the Doctor ordered.

To begin with, the consensus among veterinary nutritionists is that medical and nutritional causes of coprophagia are quite rare. It is usually behavioral in origin and can be a normal activity for healthy dogs and cats. The claim that it is the result of a nutritional deficiency is not supported by any evidence, and the implication that a raw diet would prevent such a deficiency better than conventional commercial diets is even more preposterous. And in this case, the “evidence” appears to be nothing more than the opinions and observations of the diet manufacturer and their friends, which hardly merits a press release announcing a scientific “breakthrough.”

But further reading clearly illustrates that the folks at Soul’y Raw Pet Diets do not understand nutritional science and care little about what scientific evidence supports or doesn’t support.

Soul’y Raw Pet Food does not chemically alter any of our ingredients by cooking or any other manufacturing process. Research has shown that most pet food allergies are derived from denaturing the ingredients and their bodies are not able to recognize them as a protein and their bodies will try to fight off the foreign body which creates the chronic allergic reactions.

This explanation is, in fact, the exact opposite of the true nature of dietary allergies. Whole proteins are the primary trigger for allergies in animals predisposed to have them. And when there is a malfunction in the GI tract such that it fails to break proteins down into small enough pieces, this can make allergies more likely. Finally, one of the most effective treatments for food allergies is to feed hydrolyzed protein diets, diets in which the proteins are chemically processed (gasp!) into small enough pieces that they cannot trigger an allergy reaction.

I certainly don’t expect lay people to be experts in the mechanics of digestion and food allergies, but this level of ignorance is frightening and inexcusable in a manufacturer of a pet food. It also indicates the blatant disregard for scientific fact so often seen in the marketing and promotion of raw and other unconventional pet diets.

The company’s web site contains many other examples of unproven or simply incorrect assertions. Their diet is claimed to be “PROVEN” to control allergies, though there is no research to support this. The company also claims eating their diet will prevent lawn staining, reduce vet bills through the ever-popular “strengthening the immune system” nonsense, and even prevent flea infestation! These are all implausible claims presented with no real evidence.

Finally,  the terms “human grade” and “restaurant grade” are frequently used for the ingredients despite the fact that these are not legally defined terms or part of the USDA meat grading system. Use of such meaningless terms cannot be anything but misleading and deceptive since they appear to indicate an official judgment on the quality of the food’s ingredients when the manufacturers must know that no such judgment has been made by anyone but them.

My purpose is not to pick on a single manufacturer, though the advertising by this company is certainly inaccurate and misleading. The unfortunate truth is that advertising full of unproven claims and inaccuracies is widespread in the marketing of veterinary health products. A blithe disregard for the meaning of the term “scientifically proven,” as shown by using this term and others like “research proves” and “studies show” without citing any actual published scientific studies, is a warning sign for the consumer. Such terms are meaningless at best and a signs of active deception at worst.

The best chance for us to identify what is truly beneficial for our pets is not to rely on advertising but to demand claims be supported by actual scientific evidence. Where such evidence doesn’t exist, claims that the benefits of a product are “proven” should be regarded as deceptive. The most that should be said in the absence of true scientific evidence  is that a product might have benefits and that some people believe they have seen it work. The same, of course, has been said of every health practice ever invented, whether it worked or not, so this is not a very reliable guide to the truth of such claims, but at least it is not actively misleading.

 

Posted in Nutrition | 11 Comments

EBVMA Symposium 2012– Evidence-Based Veterinary Medicine: It’s Happening Now!

This is the only event, and the only organization, dedicated entirely to promoting evidence-based veterinary medicine, and I encourage anyone interested to join us in New Orleans!

When: Wednesday May 30, 2012, 9am-5pm (One day before the start of the ACVIM Forum, one of the most popular CE events of the year!)

Where: Springfield Suites Marriott Downtown, New Orleans, LA

Program An Introduction to Evidence-Based Veterinary Medicine This interactive workshop, led by some of the leading teachers and practitioners in the field, will introduce you to the key concepts and methods of evidence-based veterinary medicine.

The Latest in Applied Evidence-Based Veterinary Medicine A series of lectures discussing recent research and practical application of evidence-based medicine methods, including the latest Veterinary Emergency & Critical Care guidelines for CPR, research reporting guidelines, outcomes assessment tools, and more. Speakers include Dr. Daniel Fletcher (Cornell), Dr. Paul Morley (CSU), and Dr. Sandi Lefebvre (Banfield).

Registration Morning Workshop (9am-12pm)- $50 (students $25) Afternoon Lectures (1pm-5pm)- $50 (students $25) EBVMA Business Meeting for members (5pm-7pm)- no charge

Combined all-day registration (includes 1-year EBVMA membership for first-time members)- $75 (students $40)

Late Registration (after April 15)- $65 each session ($40 students), $100 combined (students $65)

Details and Online Registration at www.ebvma.org

 

Posted in General | 2 Comments

Verm-X Herbal Parasite Control: No Real Evidence to Show it is Safe or Effective

I was recently asked by a reader to take a look at a product that had been recommended for deworming their dog, Verm-X. Unfortunately, there is little I can say about this product since, as is all too often the case, the manufacturer manages to make a good living selling it without having to generate any scientific information about the effectiveness or safety of the product. There are, as usual, many classic signs of snake oil:

Broad claims of efficacy and safety given without evidence.

A “kitchen sink” combination of ingredients with no research evidence on the combination and little to no evidence supporting use of the individual components.

Vague references to scientific validation with no actual published studies.

Reliance on testimonials to convince potential customers.

What Is It?
The company web site lists the ingredients for the dog product as:

Ingredients include: Allum sativum [garlic, should be allium];

Cinnamomum zelandicum [cinnamon, should be zeylanicum]

Mentha piperita [peppermint]

Thymus vulgaris [thyme]

Galium aperine [herb with various names]

Capsicum minimum [cayenne pepper]

Brown Rice, Poultry Meal, Refined Chicken Fat, Beet Pulp, Potato, Potato Starch, Verm-X Canine Blend, Brewers Yeast, Chicken Liver, Salmon Oil, Seaweed, Green Tea Extract, Prebiotic FOS, Prebiotic MOS, Minerals and Vitamins.

Though I haven’t gone through every one of their products, the herbal components appear to be the same for all species, with some differences in the other ingredients (flavors, vitamins, etc)

Does It Work?
As is so often the case with these unregulated concoctions, the bottom line answer is “who knows?” Apart from the garlic, which has been demonstrated to be ineffective as a flea control product and can cause an oxidative anemia in dogs and cats, I was able to find no published evidence concerning the safety and effectiveness of these ingredients, nor the combination, as parasite control. One of the company sites does say, “ Successful trials at Plumpton College, West Sussex have been carried out on its action as repellent of internal parasites.” I have not been able to locate any such studies in any directory of published research or on the company sites.

As usual with such products, the absence of evidence probably is evidence of absence, since any convincing scientific research support would be an invaluable marketing tool. The company has been fined in New Zealand for unsupported medical claims about its product, but enforcement of what little regulation there is for veterinary herbal products in the U.S. is virtually non-existent, so no proof of any sort is likely to be required here.

Bottom Line
With a hodgepodge of unproven herbal ingredients, no apparent research evidence to show the product is safe or effective, and a number of warning signs, I would not recommend this product. Available conventional parasite products have abundant research evidence of safety and efficacy and are a better choice.

Posted in Herbs and Supplements | 6 Comments

Book Review: Lessons from the History of Medical Delusions

A brief reference on the web site The Quackometer recently drew my attention to a very short book (really more of a pamphlet, in the historical sense) by Dr. Worthington Hooker, Lessons from the History of Medical Delusions, which I thought might be of interest to readers of this blog. Though published in 1850, the book contains many eloquent observations that are just as relevant to understanding how pseudoscience and quackery persist and even flourish in what we otherwise assume to be an age of scientific medicine. The book is available online as a Google eBook, and relatively cheap printed facsimiles are available as well.

Dr. Hooker was a physician, a professor at Yale, and an outspoken critic of homeopathy in it’s early days. His critique of homeopathy still resonates today, and has long drawn the ire of Hahneman loyalists, such as this one who makes reference to Dr. Hooker’s, “periodical fulminations for the destruction of Homoeopathy that have appeared like locusts or cholera at certain dates.” Though Dr. Hooker wrote an entire book discussing homeopathy, Homeopathy: An Examination of its Doctrines and Evidences, he does spare a few words here for this less-than-venerated practice:

The error I have been illustrating is carried to an extreme by the Homeopathist. He attributes palpable results to doses of medicine which are so small that they cannot produce any perceptible effect except by miracle.

He also includes a lengthy and preposterous example of a homeopathic proving, taken from a homeopathic text of the time,  illustrating the absurdity of simply listing every imaginable (and imagined) experience following the taking of a substance and then attributing the entire list to that substance in order to guide the selection and use of homeopathic remedies. However, the focus of this booklet is to illustrate more generally the sorts of errors in thinking that lead even otherwise intelligent and reasonable people to believe such nonsense.

And Hooker  makes a specific point of reminding us that belief in medical absurdities is not by any means a characteristic only of the unintelligent, the uneducated or the past.

The history of medical delusions most copiously illustrates the truth, that folly is very far from being confined to fools.

The present generation laugh at the follies of the past but have quite as great follies of their own, an follies too of a similar character, and products of the same fundamental errors.

The majority [of believers in quackery] is made up of those who are more or less intelligent and rational on most subjects, but who…are especially deluded on the subject of medicine…The exposition I make is not a partial one. It is not a one-sided argument-a plea for the doctors against the people. But it is an attempt to show how both doctors and people have ever been liable to error, and how they have been alike in the common elements, if not in the forms and modes and fashions of their delusions.

The medical profession, like the community at large, is made up of fallible men, and the elements of delusion are the same in the one class as in the other [though] the error of the physician would be refined, and would have the pomp and circumstance of erudition.

Error gilded with the pomp and circumstance of erudition….That certainly brings a few names to mind, eh?

Some of the specific examples he uses are fine tidbits of historical minutia. Apparently, one of the founding fathers of chemistry, Robert Boyle, also expressed his belief that dysentery could be cured through use of the thighbone of an executed criminal. And according to Hooker, Francis Bacon, that luminary of critical thinking and scientific philosophy, advocated for applying healing salves to the weapon that made a wound rather than the wound itself (though given the loathsome nature of many therapeutic unguents of the time, this may not have been a bad idea since apply them to wounds doesn’t sound wise).

So what are the common “elements of delusion” that Hooker wishes to warn us of? He begins with the post hoc ergo propter hoc fallacy.

The first [element] which I shall notice is the too ready disposition to consider whatever follows as a cause as being the result of that cause.

He then points out the most obvious reason why this sort of reasoning so often misleads us in medicine:

The most important of the confounding causes is “vis medicatrix naturae, or the tendency there is in the system to remove disease and cure itself….there is in the system a tendency to spontaneous restoration in case of injury and disease…This tendency is the chief agency in most cases in curing disease. Sometimes it is the only one; and very often it effects a cure in spite of the mistaken and officious interference of art.

And yet quacks, and even physicians, and the public generally, are very prone to leave this agency out of view, and to attribute cures, as a matter of course, entirely to some favorite remedy which has been used. This disposition is the chief source of medical errors of all classes of men.

Hooker also touches on several other key sources of erroneous conclusions in evaluating medical theories, including confirmation bias, availability bias, anchoring, premature closure, sloppy use of analogous reasoning, passionate commitment to theories without empirical evidence, and medical fads, though all describe in a language rather more poetic than we would ordinarily use today.

He then goes on to talk about the issue of the commercial and political success of medical nonsense, which are certainly still relevant issues often discussed here.

So extensive is the popular delusion in regard to quack medicines, that the nostrum system has become an organized system, with an enormous machinery of certificates and advertisements. It has become a monstrous business interest, and is linked in with a thousand ties with other business interests. So powerful is it in this respect, that it has almost entirely subsidized the press, forcing it to be silent except when it speaks in it’s favor. The same may be substantially said when speaking of the action of legislatures on this subject.

Similarly, Hooker touches on the unfortunate aura of legitimacy that attaches to quack therapies when they are embraced by what he calls “medical men in good standing,” which could certainly be applied to the quackademic medicine phenomenon and the endorsement of medical nonsense by the likes of Dr. Oz and others.

Despite the eloquent expression of many issues associated with medical nonsense that are as relevant today as they were in 1850, not all of Dr. Hooker’s book will resonate with a modern audience. Apart from the florid prose style of the time, and the unabashedly sexist language, he scoffs a bit “the skeptic,” who he describes as sitting in “his ‘doubting castle’ well-fortified against all the shafts of truth.” He also was a fan of bloodletting as a remedy, and sneered at the research of Pierre Charles Alexandre Louis and others who demonstrated its lack of effect. In general, he was no fan of the “numerical” methods which have since developed into epidemiology, and he was overly respectful of the experience and judgment on individual doctors. Citing the same sloppy reasoning as is often used by modern proponents of alternative therapies, he argues that such “numerical observations…can be of no practical use to the physician in deciding in regard to any individual case…”

However, as a whole this little historical gem is strikingly applicable to the issues this blog deals with today. And it ends with a nice description of the gradual and imperfect process of vetting ideas through scientific inquiry, from initial unjustified enthusiasm to a gradual withering of bad ideas and a fitting of good ones into their appropriate but limited places.

While many remedies, once potent to cure in the public estimation, have….been wholly discarded, others, which have more real merit, while they have lost the extravagant reputation of their nascent state, have, under the watchful eye of experience, gradually obtained very nearly their right valuation, and the circumstances which should regulate their use have been ascertained with considerable accuracy. Others, in great numbers, are now going through this searching process; and others still are just now wearing the brilliant honors of an enthusiastic reception.

He also suggests, mistakenly I hope, that direct attacks on medical nonsense rarely have a salutary impact on the popularity of such practices. However, he also describes with some hopefulness the goal of his book, which I think to some extent describes the purpose of this blog as well.

No delusion however fiercely it may have been attacked was ever killed. Each after having withstood all assaults, has laid itself down o die in the most quiet manner, benumbed into the sleep of death by the chill of popular neglect, while the warm breeze of popular favor which it once enjoyed are now bestowed upon some other delusion…

And such exposition as this essay presents, of the common causes of medical delusion, both in the profession and in the community, will, I believe, commend itself to the reason and common sense of such persons, and will therefore have some influence, in connection with other kindred efforts, in deterring them from giving heir patronage to quackery in any form…

 

 

Posted in Book Reviews | 2 Comments

Acupuncture vs Opioids for Surgical Pain in Dogs: Which is Better?

My attention was recently drawn to a veterinary acupuncture study which appears, superficially, to show acupuncture to be equivalent to opioid analgesia for post-operative pain in dogs. Unfortunately, especially for the research subjects, the design of the study was deeply flawed, and the conclusions the data support are far weaker.

D. Groppetti, A. M. Pecile, P. Sacerdote, V. Bronzo and G. Ravasio. Effectiveness of electroacupuncture analgesia compared with opioid administration in a dog model: a pilot study. British Journal of Anaesthesia 107 (4): 612–18 (2011).

What They Did
The investigators randomly assigned six healthy dogs to each of two groups. One group was sedated with the anesthetic propofol while needles were inserted into purported acupuncture points as determined by Traditional Chinese Medicine (TCM) principles. (Which is a bit misleading since traditional acupuncture was applied only to humans and the translation of the principles to dogs is a modern invention of the West). After 40 min of intermittent stimulation of these needles with electrical current, the animals were fully anesthetized and surgically neutered.

The other group was also sedated with propofol for the same period of time and also received the narcotic pain medication butorphanol at a dose of 0.2mg/kg 15 minutes before surgery.

The surgery was done routinely (though the average length of time in surgery was about 35min for both groups, which is about twice as long as the procedure typically takes an experienced surgeon. Such studies often involve surgery by veterinary students, but it is not clear from the paper who performed the operations in these subjects). The dogs were monitored and assessed up to 24 hours after surgery for signs of pain according to a subjective pain scale by observers blinded to the treatment category. Heart rate, respiratory rate, and amount of anesthetic gas needed to keep patients asleep during the surgery were measured and compared between groups. Measurements of a chemical in the blood called beta endorphin were also taken from the beginning of the procedure until 24 hours after surgery.

What They Found
There was no difference in the objective measurements of heart rate and respiratory rate during the surgery between the two groups. There was a difference in the more subjective measurement of amount of anesthetic gas needed to keep the patient at a proper plane of anesthesia, but this difference was significant at only 1 of 5 points measured.

The beta endorphin levels measured were highly variable, and differed significantly between the two groups at only 2 of 10 points measured, the end of surgery and 3 hours after surgery.

Subjective pain scores were higher for the control group than for the acupuncture group at all points measured, and this difference was significant at 12 of 14 points measured, continuously from 30min after surgery until 10 hours after surgery.

None of the dogs in the acupuncture group required additional pain medication as determined by pain score, but 4 of 6 dogs in the control group did.

No apparent side-effects were seen in the opioid group, but interestingly 4 of 6 dogs in the acupuncture group vomited after surgery.

Major Problems
There are serious problems with this study, and these undermine the conclusions of the authors that the study, “ demonstrated the ability of electroacupuncture to decrease anaesthetic and analgesic requirements in dogs during and after surgical neutering.”

1. Was the intervention studied actually acupuncture?
Obviously, electrical stimulation of needles in the skin is not a traditional Chinese therapy dating back thousands of years. Apart from the selection of locations for the needles, it bears less resemblance to TCM than to TENS, Transcutaneous Electrical Nerve Stimulation. This is a conventional therapy dating from about the 1970s that has reasonably good evidence of benefit for post-surgical pain, and which appears to work, at least partly, through general stimulation of opioid pain receptors via beta endorphin.

One could argue that despite the use of electrical stimulation, this intervention counts as acupuncture because traditional TCM principles dictated where the electrodes were placed. However, extensive evidence shows that sham acupuncture, involving placing needles in random locations or even not piercing the skin at all, is just as effective for pain as using traditional TCM acupuncture points. The authors of this study even stipulate this when explaining why no sham acupuncture control was included:

In clinical trials, sham acupuncture is considered necessary to demonstrate how a treatment is effective. However, it was argued that every penetration of a needle through the skin, be it at an acupuncture point or not, produces physiological effects, partly due to activation of a pain-suppressing system in the spinal cord (diffuse noxious inhibitory controls).

So if TENS achieves pain control through non-specific activation of opioid receptors via beta endorphin by electrical stimulation of the skin regardless of the location, and if the intervention in this study consisted of achieving pain control through non-specific activation of opioid receptors via beta endorphin by electrical stimulation of the skin, and the effect did not depend on the location of needle placement, in what sense is this “acupuncture” at all rather than TENS? How does it validate the principles or practices of TCM?

2. Butorphanol Sucks!
The choice of comparator was wholly inappropriate in this study. Butorphanol is widely recognized as a weak analgesic inadequate to control surgical pain. Numerous studies have shown it to be weak and to have a duration of action of 20-45minutes (1-3). In one study, butorphanol was statistically no better than placebo as an analgesic.

In this study, a low dose of the butorphanol was given 15 minutes before surgery. This would likely have provided limited pain control, and would have worn off by the end of the 35-minute procedure. So the control dogs had weak analgesia during the procedure and essentially none afterwards. Apart from the fact that this choice of comparison can only serve to make the test intervention look far better than it would compared to effective, standard-of-care pain control, it seems a questionable ethical choice given the clear evidence that butorphanol is not an adequate analgesic for this sort of procedure. Fortunately, at least the dogs were given rescue analgesia with more effective drugs when the pain scale seemed to indicate it was necessary.

3. Statistics
Though it is not clear from the paper, and is a less significant problem, the authors made multiple statistical comparisons, and there is no indication of whether or not they adjusted the level of statistical significance to account for this. This is perhaps the most common statistical error in the veterinary literature. Given the small numbers of subjects in the two groups, such an error could easily create the impression of difference greater than chance where non actually exist.

What Does it Really Mean?
This paper confirms the conclusion supported by much prior research: sticking needles into the skin and running electrical current through them results in a non-specific response that elevates beta endorphin levels and can suppress pain. The same phenomenon occurs with any trauma, so one could conceivably suppress post-surgical pain by banging on the patient’s toe with a hammer. While the effects of TENS has real potential value for pain control, it has nothing to do with the traditional theoretical constructs of TCM or acupuncture, and it is misleading to refer to it as “electroacupuncture” at all.

During the time the butorphanol would be expected to be active (while the dogs were anesthetized and undergoing surgery), there were no differences in objective measures that one would expect to reflect pain, such as heart rate and respiratory rate. So the electrical simulation appears to have been as effective as the lousy opioid analgesic while the dogs were anesthetized. Similarly, there were few significant differences in beta endorphin levels between the groups (or possibly none, depending on the appropriateness of the statistical methods), which suggests that the “trauma” of the needle insertion and stimulation had only a modest non-specific effect on the opioid receptor system. Since the butorphanol likely had worn off by the end of the surgery, this small effect was clearly better than complete lack of analgesic therapy the control dogs received. But this is hardly relevant to a patient population treated properly with effective, multimodal analgesia. And given that most of the dogs in the treatment group experienced post-operative vomiting, likely due to the stimulation of the opioid receptor system, it cannot even be argued that this approach lacks significant side effects.

If the conclusions of this paper had been limited to those justified by the data, the study would be a useful bit of data to consider in investigating the role of TENS in post-operative pain control. Unfortunately, the title, abstract, and discussion sections all create the unjustified impression that somehow TCM and traditional acupuncture are as effective as opioid analgesics in controlling post-operative pain, or perhaps even better. This will only perpetuate the myths and misunderstanding surrounding acupuncture and encourage the use of traditional practices that have not, in fact, been shown to be appropriate for this purpose.

References
1. K A Grimm; W J Tranquilli; J C Thurmon; G J Benson.Duration of nonresponse to noxious stimulation after intramuscular administration of butorphanol, medetomidine, or a butorphanol-medetomidine combination during isoflurane administration in dogs Am J Vet Res. January 2000;61(1):42-7.

2. K A Mathews; G Pettifer; R Foster; W McDonell. Safety and efficacy of preoperative administration of meloxicam, compared with that of ketoprofen and butorphanol in dogs undergoing abdominal surgery. Am J Vet Res. June 2001;62(6):882-8.

3. D C Sawyer1; R H Rech; R A Durham; T Adams; M A Richter; E L Striler. Dose response to butorphanol administered subcutaneously to increase visceral nociceptive threshold in dogs. Am J Vet Res. November 1991;52(11):1826-30.

 

 

Posted in Acupuncture | 7 Comments

Red Flags of Quackery

Another gem from Sci-ence.org

Posted in Humor | Leave a comment

NuVet Supplement=Same Old Snake Oil

A client recently asked me about a product, NuVet supplement, which after a little investigation seems to be the yet another fine example of snake oil marketing. It is quite similar to a product I reviewed not that long ago, Protandim, though all quack remedies share a lot of characteristics (as my reviews of DogtorRx, Supraglan, and others illustrate). Many of these characteristics are classic warning signs of snake oil, and in the case of NuVet, these include:

A “kitchen-sink” mixture of vitamins, minerals, herbs, and other ingredients, some of which are essential nutrients or have individually shown some interesting properties in test tubes and mice, but none of which shown to be safe and effective in treating or preventing any disease in dogs or cats.

This hodgepodge is advertised as treating many unrelated diseases (cataracts, Cushing’s diseases, diabetes, allergies, etc) with good results and no risks. These include:

Vague claims are made about treating “oxidative stress” and “inflammation”, with the implication that “anti-oxidant” and “anti-inflammatory” agents must automatically be safe and beneficial.

Glowing testimonials are offered to support the wild claims made, but not a single clinical study has been done to demonstrate the truth of any of them.

A money-back guarantee is offered, though how this compensates for the suffering or even death of your pet caused by relying on an untested and probably useless remedy isn’t really clear.

Too good to be true? You bet!

What Is It?
The two products NuVet promotes are NuVet Plus and the NuJoint Plus. The joint supplement contains glucosamine, chondroitin, and MSM. I have written about these ingredients before (1, 2) and the bottom line is that human and animal research evidence strongly suggests there is no benefit to taking these products for people or animals with arthritis. Barring contamination with something toxic, which happens surprisingly often due to the lack of effective regulation of supplements, NuJoint is probably harmless and useless.

The ingredient list for NuVet is much longer:

Alfalfa (Canine formula only) Alpha Amylase Amino Acids Beta Carotene Blue Green Algae Brewer’s Yeast Cat’s Claw Chicken Liver Copper Evening Primrose Oil Iron L Methionine Magnesium Manganese Oyster Shell Papain Phosphorus Pine Bark Potassium Selenium (Yeast) Shark Cartilage Taurine (Feline formula only) Vitamin A Vitamin B Complex Vitamin B1 (Thiamine) Vitamin B2 (Riboflavin) Vitamin B3 (Niacin) Vitamin B5 (Pantothenic Acid) Vitamin B6 (Pyridoxine) Vitamin B12 Vitamin C (Ester C™) Vitamin E Whey Protein (Feline formula only) Zinc

Talk about everything but the kitchen sink! The rationales given for the inclusion of each range from vague descriptions of what the normal role of some of the nutrients is in the body to totally unsupported assertions about supposed magical clinical benefits. I will address these claims in a moment.

The story behind the “discovery” of this elixir is either a perfect example of the naïve and unscientific thinking that should warn consumers they are being offered snake oil, or it is a carefully crafted marketing gimmick.

It all began years ago when I was noticing certain changes in my beloved furry companion, Elvis…Even though I had always cared for him and tried to give him the best food available, it became apparent that Elvis needed something more. After several trips to our veterinarian and at a cost that I don’t even want to think about, I was left to try and find a solution on my own. All the medications and changes to his diet wasn’t making any kind of significant difference and I feared my best buddy was quickly slipping away from me. I tried all kinds of vitamin and herbal supplements because I knew there was something his body needed that he wasn’t getting but I just couldn’t find the right stuff.

It occurred to me that, like my Elvis, many other dogs and cats were not taking a sufficient regimen of vitamins, minerals and antioxidants equivalent to advanced human supplements used to fight against the damaging effects of free radicals, which are a major cause of disease. I thought that the right combination, in the exact formulation, using only the highest quality of ingredients, would be required to rid pets of these damaging elements and would create a scenario for greater health and a much longer life span.

Blake G. Kirschbaum President

Mr. Kirschbaum goes on to claim his product is needed because of “obvious” deficiencies in conventional pet diets.

Because most pets lack proper nutrients such as vitamins, minerals, and antioxidants in their diet, even when they are getting the top of the line food, NuVet® scientists understood the necessity of filling this dangerous gap. Commercial pet foods can contain harmful “by-products” and useless fillers that can be toxic to pets, causing allergies and serious diseases. This kind of atypical diet creates a scenario whereby their food may actually be creating unstable oxygen molecules known as Free Radicals.

The next step after this brilliant insight was to set up a crack team to develop and promote the magic supplement all dogs and cats apparently need.

I decided to take matters into my own hands and established NuVet Labs®. I put together a team of highly respected scientific, medical and pet industry professionals that had the same goal as I did; to create a nutritional product that would go beyond current supplements that only gave symptomatic relief. Our objective was to make a truly effective nutritional supplement that would attack the root cause of sickness and disease, eliminating the free radicals and other sources of the problem, once and for all. This became my mission and although it took our team 8 years to perfect the formula, we finally got it right. An independent laboratory tested several dogs and cats, varying in age, size, and health conditions, under the direct supervision of a team of veterinarians. 

Our Advisory Team is composed of a veterinarian, a doctor of pharmacy, a pet supplement and pet food formulator, a doctor of optometry, a licensed financial advisor, a litigation insurance administrator and a senior hospital purchasing manager.

Eight years of effort dedicated to solving the root causes of all disease finally vindicated by an unpublished test in “several dogs and cats.” Wow!

I have added the emphasis above to highlight the pre-existing faith Mr. Kirshbaum evinces in the nature of his dog’s health problems (nutrient deficiency and free radical damage) and the solution (the “right” supplement), as well as the astounding arrogance and naïveté  this narrative demonstrates. The very foundational principles behind this product are unproven and scientifically empty beliefs, not well-established principles of health and disease. And the claim being made is that the One True Cause of disease, and its solution, which has eluded all scientists everywhere in the world has now been cooked up by one visionary and his small team of mavericks Not a good start.

Does It Work?
The underlying theory that all these disparate chronic diseases for which scientific medicine does not have a definitive cause or cure are caused by oxidative damage due to poor diets is nonsense. While free radicals exist and do cause cellular damage and even disease, this little core of real science has been rebuilt into a bogeyman that bears no resemblance to the truth. Like all overly broad and simplistic ideas, the oxidative damage hypothesis has proven far less robust than initial enthusiasm for it would have suggested, and many purported anti-oxidants have turned out to provide little benefit in preventing or treating disease, and even in some cases have been shown to be actively harmful (e.g. 3, 4, 5).

While many of the individual ingredients in the product are essential nutrients, there is absolutely no reason to believe that they provide any health benefits except in cases in which a pet is deficient in a specific nutrient. Providing excessive vitamins and minerals to prevent or treat diseases is seldom beneficial and, again, sometimes actively harmful (e.g. 6, 7, 8).  And there is extensive evidence to show that while commercial diets are by no means perfect, they are not the deleterious pile of toxins and garbage described by those who are trying to sell supplements (e.g. 9, 10).

As for the other ingredients:

Alpha Amylase: There is no truth to the claim that digestive enzymes are beneficial for normal animals (11)

Bluegreen Algae- There is no reliable evidence to support the health claims NuVet makes for this ingredient (12). And some species of bluegreen can be highly toxic, especially to dogs (13).

Brewer’sYeatst- A source of B vitamins, but not an effective flea control product (14).

Cat’s Claw- There is weak clinical evidence in humans of anti-inflammatory properties to some of the chemicals in this herb, and there are also reports of serious side-effects (15). There is no controlled research evidence to show safety or any benefits in dogs and cats.

Evening Primrose Oil- There is limited evidence for benefits treating eczema in humans, and otherwise no solid evidence of benefit for any other disease (16). It may be a good source of essential fatty acids, which could theoretically have some benefits for allergic skin disease or arthritis. Obviously, the claims concerning cholesterol and atherosclerosis are irrelevant since dogs and cats do not suffer from this disease.

Papain- There is limited evidence for benefits of papain in humans for shingles and sore throat, and no reliable evidence for any other benefits (17). There is no reason to believe it has value as a “digestive enzyme,” and the limited research on it as a hairball remedy in cats and rabbits has not shown any real benefit.

Pine Bark Extract- There is some laboratory and animal model evidence that chemicals in this extract have anti-inflammatory and anti-oxidant activity, but actual clinical benefits have not been demonstrated in human or animal clinical trials (18). As always for any chemical with real physiologic activities, there is the potential for side-effects (19). I am not aware of any clinical trials investigating the use of this ingredient in dogs or cats.

Shark Cartilage- Shark cartilage has been proven ineffective for advanced cancers of various kinds, and there is inadequate evidence to show benefit for any other condition (20, 21). The harvesting of sharks for this supplement as well as for food contributes to the decline of threatened and endangered shark species (22).

And finally, as well as most important, there appears to be  absolutely no published research evidence of any kind evaluating the safety or purported benefits of this product. That is not a good sign.

Is It Safe?
As indicated for the specific ingredients above, harm can result from indiscriminate use of even essential nutrients. The amounts of each ingredient in the final product are not made available to the public, so it is impossible to evaluate the safety of the doses even for those ingredients for which safe and unsafe levels have been established.

Due to the inadequate regulation of dietary supplements and herbal products, it is impossible to ensure the accuracy of ingredient lists or the absence of dangerous contaminants, both of which have been real problems for such products (23, 24). There is also no formal system for collecting and evaluating reports of harm from such products, so the only assurance of the safety of the product is the word of the manufacturer.

Bottom Line
This product is a hodgepodge of nutrients, herbal ingredients, and nutraceuticals thrown together with no clear logic or rationale. The claims that many pet diseases are due to toxins or other deficiencies in commercial diets and to oxidative damage are unsupported by any real evidence. Only a few of the specific claims for the ingredients in the mixture are backed by research evidence, and the quality of this is generally poor and only available for humans. The advertising of the product contains many of the hallmarks of snake oil marketing, but it does not contain any research evidence at all concerning the safety or effectiveness of the product, because none appears to exist.

While I have no reason to doubt the sincerity of the manufacturer of this product, I believe it is unethical to sell a product with no research establishing the safety or efficacy of the product for any disease and with little to no research even into the safety and efficacy of its constituents. Promoting the product with unproven or outright false claims about pet nutrition and disease designed to instill fear in pet owners and with wild and ridiculous claims about the effectiveness of the product for numerous unrelated diseases is wrong regardless of how sincerely the manufacturer believes in their own pseudoscientific theories. Any responsible manufacturer of a medical therapy should be expected to demonstrate their claims through rigorous science before profiting from the desperate need of people with sick pets.

 

 

 

 

 

 

 

 

Posted in Herbs and Supplements | 187 Comments

How to Read a Scientific Study: The Pocket Guide to Critical Appraisal

I just wanted to give a brief nod to a great, little book I read recently, The Pocket Guide to Critical Appraisal by Iain Crombie. In a grand total of about 60 pages, the book gives a concise explanation of how to read and evaluate the quality of a published scientific paper.

As I’ve pointed out before, just because an idea or a study is published in a journal doesn’t mean the idea is correct of the study meaningful. The problem of Tooth Fairy Science, the creation of journals just for the purpose of promoting specific products or medical methods,  the influence of funding bias, and many other factors external to a scientific paper influence whether the results and conclusions offered are reliable. But there are also many factors to consider within the paper itself when trying to decide if the information presented is reliable or useful, and it is this internal assessment the Pocket Guide to Critical Appraisal is intended to assist.

After a brief introduction to the general issues involved in assessing scientific studies of various kinds, the book presents step-by-step checklists for the major types of study, including surveys, cohort studies, case-control studies, and clinical trials.

Despite the impression created by the media, and often proponents of dubious medical interventions, that anything published in a journal can be trusted to mean what the authors say it means, the reality is that all scientific evidence should be carefully an cautiously scrutinized before we rely on it to inform how we treat our patients, our pets, or ourselves. Otherwise, there is a great risk that we will waste resources on useless or even harmful treatments or avoid truly beneficial ones on the basis of poor evidence. This book makes such scrutiny relatively straightforward even for the non-specialist.

Posted in Book Reviews | 4 Comments

AVMA Model Practic Act Update

About a year ago, I wrote a post about the American Veterinary Medical Association’s effort to revise their Model Veterinary Practice Act, a document states often use as a template for writing laws regulating the practice of veterinary medicine. I was specifically concerned about some weaknesses in the language concerning alternative medicine.

The setion defining Complementary and Alternative Medicine read:

“Complementary, alternative, and integrative therapies” means a heterogeneous group of preventive, diagnostic, and therapeutic philosophies and practices, which at the time they are performed may differ from current scientific knowledge, or whose theoretical basis and techniques may diverge from veterinary medicine routinely taught in accredited veterinary medical colleges, or both. These therapies include, but are not limited to, veterinary acupuncture, acutherapy, and acupressure; veterinary homeopathy; veterinary manual or manipulative therapy (ie, therapies based on techniques practiced in osteopathy, chiropractic medicine, or physical medicine and therapy); veterinary nutraceutical therapy; and veterinary phytotherapy.”

My comment to the AVMA task force revising the document was:

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

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

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

The task force has published it’s recommendations, and with regard to alternative medicine, the act has been changed for the worse rather than the better. The task force describes the change this way:

“A new definition of “complementary, alternative, and integrative therapies” as meaning “a heterogeneous group of preventative, diagnostic, and therapeutic philosophies and practices that are not considered part of conventional (Western) medicine as practiced by most veterinarians and veterinary technicians…”

This change removes any mention of science from the definition and suggests that alternative methods are alternative not because they are unproven or disproven but because they are unfamiliar, unpopular, or not rooted in “Western” culture.

The legitimacy of specific methods of preventing, diagnosing, and treating disease is not determined by a popularity contest. And scientific medicine is not a mere cultural point of view, though it certainly contains ideas and metaphors associated with the cultural context in which it was born and has developed. Scientific medicine has spread throughout the world and revolutionized human and animal health in only a couple of centuries, in a way traditional folk practices failed to do for millennia, because it works whether or not you believe in it, unlike say acupuncture.

Truly Western medicine, rooted in a narrow cultural tradition the way Traditional Chinese Medicine and Ayurvedic Medicine are, actually consists of the Humoral Medicine of Ancient Greece. And let us not forget that such mainstays of alternative medicine such as homeopathy and chiropractic were both developed in 19th century America and are as “Western” as it gets.

The AVMA has long taken the position that it exists not to protect veterinary patients or consumers but the interests of veterinarians, narrowly defined in primarily economic and political terms. Rather than work towards sound scientific standards of care, the organization prefers to defend veterinarians’ right to profit from anything they can sell as veterinary medicine without competition from non-veterinarians. If unscientific therapies are in demand, the AVMA has no objections to veterinarians selling them.

And as a membership organization, the AVMA must also bow to the wishes of its constituencies. These include several groups of veterinarians, including the Academy of Veterinary Homeopathy and the American Holistic Veterinary Medical Association, who promote alternative therapies regardless of the scientific evidence, and who are far better organized and funded than the Evidence-Based Veterinary Medicine Association and others promoting evidence-based medicine.

Given such policies, the AVMA position is not surprising. But it is disappointing and dangerous in that it gives the appearance of legitimacy to “philosophies and practices” which at best are insufficiently tested and at worst are based on pseudoscience and are clearly ineffective.

Posted in Law, Regulation, and Politics | 3 Comments