Guidelines for Minimizing Commercial Influence in Veterinary Medicine

Posted on October 30, 2011 by skeptvet

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

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

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

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

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

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

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

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

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

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

Posted in Science-Based Veterinary Medicine | 17 Comments

Dry Pet Food and Dental Disease in Dogs and Cats

Posted on October 17, 2011 by skeptvet

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Nutrition | 20 Comments

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

Posted on October 11, 2011 by skeptvet

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

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

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

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

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

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

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

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

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

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

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

Claims of perfect universal effectiveness:

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

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

Dramatic testimonials of miraculous effects.

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

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

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

How to Share Protandim with Your Pet

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted in Herbs and Supplements | 63 Comments

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

Posted on October 10, 2011 by skeptvet

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

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

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

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

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

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

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

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

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

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

 

Posted in Herbs and Supplements, Nutrition | 2 Comments

Stem Cell Therapy Miracle–Maybe

Posted on October 5, 2011 by skeptvet

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

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

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

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

Selling veterinary stem cell therapies: Medivet’s dodgy advertising

Stem cell therapy: Still an uncontrolled experiment on our pets

Veterinary stem cell therapies discussed at Fully Vetted blog

Stem Cell Researchers Caution Against Using Unproven Stem Cell Therapies

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

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

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

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

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

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

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

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

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

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

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

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

 

 

Posted in Science-Based Veterinary Medicine | Leave a comment

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

Posted on October 5, 2011 by skeptvet

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

Posted on September 25, 2011 by skeptvet

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

Posted on September 20, 2011 by skeptvet

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

Posted on September 19, 2011 by skeptvet

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

Posted on September 18, 2011 by skeptvet

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