SkeptVet’s Acupuncture Adventure- Part 1

I have written extensively about acupuncture since it is one of the most widely used and accepted of the alternative therapies. It is also complex, with many different definitions, associated theories, and a huge body of relevant research evidence. Sorting through all of this to make a rational, evidence-based assessment of whether any of the various practices called acupuncture have legitimate, demonstrable medical value is challenging. Over the years, my assessment has evolved, so I want to start by summarizing how I currently view this practice.

What is Acupuncture?
A general definition of acupuncture that captures most of the claims and practices of modern practitioners would probably be something like, “the insertion of fine needles into specific locations on the body with the intent of producing beneficial health effects.” This is necessarily vague because there are so many different and mutually inconsistent rationales and theories for how acupuncture is supposed to work and so many different clinical practices. Some say acupuncture manipulates mystical spiritual “energy” while others claim it works by stimulating nerves or inducing release of a variety of neurotransmitters or other endogenous compounds. Some acupuncturists place needles at points all over the body, and others limit their needling to the hand, or the ear, or other specific parts of the body. There is nothing like a consistent, agreed-upon definition or map of acupuncture points and channels. Even the use of needles is not universal, and sometimes needling is accompanied by electrical stimulation, the burning of herbs on needles, and many other practices.

Some of the theoretical constructs used to explain or justify acupuncture are clearly more religious than scientific, and there is no point in talking about Qi or spiritual energies if one is trying to seriously evaluate the use of acupuncture as a medical therapy. However, there are more plausible potential explanations involving the physiological effects of needling in locations associated with nerves and other anatomic structures. My current view is that while needling undoubtedly has physiological effects, it has not been convincingly demonstrated that these are predictable, repeatable, and controllable to achieve beneficial clinical outcomes. I also am not convinced that acupuncture points or channels exist as a consistent network of identifiable anatomical structures that can be predictably identified and manipulated to achieve a desired clinical goal. It is not impossible that this is true, but the literature is not compelling.

Does Acupuncture Work?
There is an enormous amount of basic and clinical research on acupuncture, and a lot of it appears to show meaningful clinical effects. However, acupuncture is challenging to study because it can be hard to define “real” and “fake” acupuncture, it can be difficult to effectively blind patients to whether they are receiving real treatment or the sham, and it is impossible to blind acupuncturists. The demeanor and style of communication of acupuncturists has been shown to affect the perception of patients as to whether or not they benefit from treatment, so this inability to blind therapists is a real problem.

Ultimately, much of the acupuncture literature cannot be viewed as very reliable due to these and other sources of bias. The best controlled studies seem to suggest that acupuncture affects subjective symptoms and perceptions more than objectively measurable indicators of disease. This is most consistent with a placebo effect, and perhaps some very non-specific physiologic effects. However, there is some room for rational uncertainty about the extent to which acupuncture might have small benefits in terms of pain, nausea, and a couple of other clinical symptoms.

Is It Safe?
There are definitely risks associated with acupuncture. Human patients have experienced dizziness and other unpleasant subjective symptoms, though again whether this is directly due to acupuncture or a nocebo effect is difficulty to determine. Infections and injuries from needles, sometimes serious, have been reported. Overall, serious adverse effects seem to be quite rare when experienced, formally trained acupuncturists are doing the needling.

Bottom Line
Most of the theories behind how acupuncture might work are either complete nonsense or at best not fully validated by convincing evidence. There is clinical research that shows some benefits from acupuncture treatment, but this is mostly in terms of subjective symptoms and seems likely to be predominantly a placebo effect. Acupuncture is pretty safe, though there are some risks, especially when proper technique is not used.

My Acupuncture Adventure
Given this assessment, it will likely come as a surprise that I have signed up to take a training course in acupuncture. There are several reasons for this, and since I intend to share my experiences through this blog, I thought I would start by describing my goals and intentions at the beginning.

While I am perhaps 75-80% convinced acupuncture operates primarily as a placebo, as I said there are some plausible potential mechanisms by which it could have true clinical benefits, and there is some reasonable quality clinical literature to support these. In the interest of a truly skeptical evaluation of acupuncture, and following the principles of proportioning judgment to the evidence, I am interested in exploring some of the claims, theories, and evidence for acupuncture in more detail. The best way to do this is not only to seek information from sources that agree with my existing views of the practice but to engage with supporters and advocates who have different views. Challenging one’s own beliefs is a core value of skepticism, and I am hoping to put that into action.

Additionally, acupuncture is quite popular in veterinary medicine, at least where I practice. I have a moderately large number of clients who seek it out, as well as a number of colleagues who practice conventional, science-based medicine exclusively yet recommend or refer for acupuncture treatment. Currently, I share with clients who ask about acupuncture the views I have outlined above and emphasize that the existing evidence in veterinary medicine is limited, weak, and gives little reason to expect much harm or much benefit from the practice.

Despite this uncertainty, pet owners will often choose to try acupuncture anyway, even without much evidence it will benefit their pets. Currently in my area, the only way for them to receive this therapy is through a few local holistic veterinarians who not only practice acupuncture but who are fully committed to TCVM and other pseudoscientific practices and who actively counsel their clients to avoid science-based care. Despite some misgivings, I have come to feel that these patients would be better served receiving this therapy from someone who will be honest with clients about the lack of good evidence for real benefits and who will continue to provide them appropriate, evidence-based care as well. If acupuncture is, at worst, a relatively low-risk placebo therapy, then these patients will be better served by this approach than by being handed over to practitioners with a broader alternative, anti-science agenda.

I have long been interested in investigating acupuncture more directly, but I simply could not stomach the thought of slogging through textbooks and lectures than talked about Qi, Ying and Yang, the Five Elements, pulse diagnosis, and all the other TCVM folklore as if it were a legitimate way to approach health and disease in the modern world. Fortunately, I have the opportunity to take an acupuncture training course that largely eschews this sort of mysticism, Medical Acupuncture for Veterinarians (MAV), taught by Dr. Narda Robinson.

Dr. Robinson is a professor at the Colorado State University School of Veterinary Medicine, where she teaches and practices comparative and integrative pain management. She is one of the rare proponents of alternative medical practices who I believe has a genuine commitment to evaluating these through rigorous science, and she is a well-known opponent of pseudoscience in veterinary medicine. Dr. Robinson and I have spoken together at the AVMA annual conference, and we have interacted through our efforts on behalf of the AVMA resolution condemning homeopathy and through this blog. We often disagree about the conclusions that should be drawn from the evidence concerning acupuncture, glucosamine, and other specific topics. But it is not necessary to always agree in order to respect someone else’s efforts and goals.

Dr. Robinson describes medical acupuncture this way:

Scientific medical acupuncture utilizes modern medical knowledge of anatomy and physiology to design treatment protocols based on rational mechanisms of action and objectively identifiable endpoints without resorting to folkloric diagnostic approaches or metaphorical ideations. Veterinary medicine should be scientific and evidence-based.

I think that is a perfectly sound and reasonable way to approach the practice, and while Dr. Robinson has not yet convinced me that the evidence actually supports medical acupuncture as more than a placebo therapy, I accept that we share a commitment to a scientific approach to the question, so I am willing to evaluate her claims and the evidence she uses to support them carefully and seriously.

MAV consists of a series on online modules, followed by an onsite practical training course. Over the next eight months, I will be working through the online modules and preparing for the practical training. I plan to evaluate the content of the modules as thoroughly as I can, drawing on critical appraisal of published evidence, and then share my thoughts through a series of posts. If I ultimately begin providing acupuncture services to clients, I hope to write about those experiences as well.

This adventure, of course, raises the question of whether I am succumbing to the exhortations often made by advocates for alternative therapies to “try it and see for yourself.” If I start treating patients with acupuncture, even while clearly disclosing that it is most likely an elaborate placebo, and these patients appear to improve, will I become a convert to this therapy and start sliding down the rabbit hole into a Wonderland where every therapy works so long as someone has tried it and thinks it does? That seems unlikely.

I am well aware of the many cognitive biases and other sources of error that make uncontrolled personal experience a poor guide to cause and effect relationships. I make use of many treatments for which there is little real scientific evidence, as everyone who practices veterinary medicine unfortunately must given the paucity of high-quality research in our field. And some of these therapies sure look like they work! But I am always aware that this perception is based on shaky ground, and I have so far had no difficulty accepting new practices and abandoning familiar ones when good quality research evidence emerged that contradicted my intuition and experiences.

My goal in learning about and potentially employing acupuncture is not to validate or invalidate the practice through my own clinical experience, since this is not how science-based medicine works, but to engage with the theories, claims, and evidence in more depth and to hopefully minimize the exposure of my patients and clients to the egregious pseudoscience and anti-science ideologies of most of the veterinary acupuncturists they currently have access to.

Posted in Acupuncture | 3 Comments

Veterinary Medicine is a Business, and that Includes Alternative Medicine

Medicine is a business. That is an often uncomfortable but always unavoidable fact. There is plenty of room for debate about whether or not it should be, but as things currently work, veterinary medicine is a business. It is not only a business, of course. For most of us, medicine is a passion and a vocation. For all the years spent in school, and the money borrowed to pay for those years, most veterinarians could make a lot more money doing something else. So money is not the reason we practice, but nevertheless veterinary medicine is how we make our living, pay our bills, support our families.

The question of whether or not making money from our work as doctors influences the recommendations we give clients is an important and complex one. There’s not much in the way of controlled research on the subject, and studies of this would be difficult to do, so we have little more than speculation and opinion to work with. Having known an awful lot of vets, I am confident that deliberate deception, promoting goods and services that are unnecessary or ineffective simply to make more money, is incredibly rare. As I’ve already pointed out, people with that sort of ethic and drive to make money would be doing something else for a living.

That said, I also know how vulnerable people are to unconscious bias, despite the best of intentions. I have little doubt that in a more subtle way, money does influence veterinary decision making in a variety of ways.  Funding source probably influences research to some extent, and the potential profitability of particular therapies probably influences how likely vets are to offer them. The claim that vets are “just in it for the money” is clearly nonsense, but we shouldn’t be naïve enough to imagine that the fact that we make our living from our work as doctors has no influence on our thinking or behavior.

The question of financial bias often comes up in debates about alternative veterinary medicine, usually in the form of an unsophisticated and self-serving claim that conventional vets are “in it for the money,” whereas “holistic” vets are simply doing what is best for their patients. Here are just a few examples I’ve received personally over the years:

Obviously this website is biased against complementary integrative veterinary medicine….keeping comments and ideas one sided and supported pharmaceutical and commercial pet food monopolies which have been raking in the money for many decades…Threatened financially and ideologically, they must resort to political tactics of attack, shock and awe using headlines inspired by the National Inquirer or some other ladies gossip rag…If you were a legitimate blog looking for the Truth and not a shill for the pharmaceutical companies, you would have researched both sides of any issue.

The old 70 year old urologist told me I was crazy for believing that acupuncture helped my stone. I think he is crazy for thinking I would have let him make another 15 grand off of a surgery that caused me more pain and suffering than I had ever experienced. I wish someone would have told me that I could have just bought a 12 dollar bag of herbs. They don’t taste so great, but hey, it beats the heck out of feeling like the mob got a hold of your kidney with a bat. Or should I say the rich Mob Doctor MD.

I believe that traditional veterinarians are today motivated by GREED and the medicine they practice does as much harm as much as it helps…And how about the local vet’s push for more and more, now found to be harmful, vaccines they are always telling us pet owner are needed- just so they can make more money, not to mention the those oh so toxic flea meds,

it looks like the only faith you have is in your holier than though self. You remind me of our consulting vet. you can show him and show him, but when it comes down to the bottom line what the drug companies will do for him, he will jump on their bandwagon even when it doesn’t work

After reading your “rant” (so accurately described by another reader), I am left feeling like you must have a financial interest in big pharma, for that is the only logical reason I can see that you would put such effort in condemning a product that has successfully treated and prolonged the lives of so many animals… Maybe you should conduct a clinical research study with neo and see the results for yourself? Oh wait, you wouldn’t make the money using neo as you do with chemo and radiation, my bad. It sure does seem like your motives are financial,

You are a skeptic because it could put you out of business.

The FDA is a sub contractor for Monsanto. Come to think, so is this website!

You’re sole reason to exist is to try to hold back the tide that threatens your alternative medicine buddies in big pharma.

It’s all about the bottom line, folks. Now that the pet industry is a multi-billion dollar a year industry, unfortunately it appears the vets and “pet-care” companies are using our pets in the same way the human medical establishment has done…cause confusion and watch the big bucks roll in!

Huh, sounds a lot like what you say you aren’t – a pet food company lackey. The strong reason in favor of healthy, appropriate, homemade diets is the health of our pets…the strong reason against is two-fold – money and sickness – both of which I am sure you have no problems with. Sick animals are good for business.

What a HORRID article! If everyone in this world was healthy and living without chronic disease, then how would the pharmaceutical companies make money?

Who is paying you to write all this crap? The AMA? Jeez.

Another example of Government out of control serving Big Pharma both in an alliance and both disserving the unknowing blinded public while they RAKE IN $BILLIONS IN PROFITS. It’s the Government and its Agencies like the FDA THAT CANNOT BE TRUSTED! Do we need any more evidence for this? No, it is clear. SkeptVet clearly takes THEIR side.

You are a typical vet who just wants to stand behind the prescriptions that pay for your lifestyle.

I know one thing for sure……Vets scoff because it is about the $$$$…..they focus on keeping us coming back for the prescription food, meds and their $$$’s…….I do not trust doctors for humans let alone for my precious little ones. They are ALL about the money

To all you ignorant people bought off by Big Pharma . It is getting old by now you all not getting it. America is a fat, diseased very sick nation. The irony of thinking we are this Great nation when we are the international laughing stock. Europe has a seperate factory for making send out food to America because the Ingredients we allow are not allowed in their country due to most are toxic. Even the little cashier at World Market know’s this… If people were well and did not need prescription medicine their would be no money to be made in this billion dollar Big Pharma Industry. They want us sick!

Another sellout medical doctor…Medical doctors and mainstream people are so arrogant. They think they know everything, when behind closed doors, the people who fund these foods and treatments are actively trying to harm them.

I think you’d find it more eduational than blindly working for the pharmaceutical industry who are constantly being sued for lying about test results on their products.  Why would they lie if their products have been properly tested and proved to be safe?  I don’t suppose it’s occurred to you that they’re not in the business of healing.  They’re in the business of making as much money as they can… Most vets who switch to a holistic practice earn far less money than you do, so what possible reason could they have for changing?  Has it occurred to you that they have actually bothered to pay attention and have realised that they are hurting our animals with unnecessary medications? That their consciences have stepped in and prevented them from continuing to cause chronic disease in our pets?  Obviously not. Our animals need healers working with us owners, not drug sales people.

Who’s paying you!!?? Talk about biased. I’d like to know the serious side effect of taking cats claw… I always read opposing info when researching but this is so slanted its crazy. So I figure you are either a vet or you are paid/paid off by them. Let’s all feed science diet, shall we!… Seriously, who pays you!!??

If you don’t get a payment from the drug company, it’s not worth recommending.

After reading this blog and these testimonials, I think the skeptics here are for the most part, on someones payroll. Science has been Hijacked long ago, and the truth is being continually sacrificed on the alter of Corporate profits. I dont know what they are paying you to slander this company, too much if you ask me,

The drug industry ARE the quacks. Its a protection racket. This skepvet is a living testament to that. Ignore them and do what works not what their rigged trials tell you should work.

Someone is paying you to discredit vitamins, glandulars and minerals as beneficial remedies. You probably are a stupid medic. Breast feeding at age 80 off the pharmaceutical TIT. Die quickly so u can be reborn and do something to help someone.go pop a pill. You are an idiot.

Another sellout medical doctor…. These people probably promote heavy metal-laden vaccines; liver destroying drugs and toxic foods that contain genetically modified organisms. Go ahead, be ignorant and take the medical industries junk. They will be happy to benefit off of your illnesses. Big pharma and agribusiness work hand-in-hand

These sorts of comments are pretty obviously ridiculous in a lot of ways, but specifically the idea that somehow science-based medicine is more influenced by financial bias that alternative medicine is demonstrable nonsense. I have yet to meet an alternative vet who gives away all of their products and services just to bring healing and expects no payment in return. All of the potential sources of bias that are in play in conventional medicine pertain to alternative therapies as well.

  1. Research on alternative products is often paid for by companies selling those products. That is the case for the majority of products I have reviewed here, and it is a general rule in the business of alternative medicine. The claim that “natural” products can’t be patented and so make nobody any money is nonsense. Herbal remedies and dietary supplements are multi-billion dollar industries (also 1 and 2) involving large corporations, in many cases some of the same companies that make money from the conventional medicines and commercial pet foods “holistic” practitioners complain so much about. And not only do these companies make enormous profits from these supposedly unpatentable “natural” products, because they are minimally regulated they return a far lower proportion of this profit to research than the pharmaceutical industry does.
  2. Similarly, vets make a lot of money selling supposedly “natural” products, include herbal remedies and supplements and raw and other alternative diets. Publications aimed at “holistic” vets actively promote these kinds of products as profit centers. This is as true of alternative practitioners as it is of conventional vets.
  3. Continuing education for alternative vets is itself a profitable business, and also often financially supported by companies selling products and services for these vets. One well-known proponent of so-called Traditional Chinese Veterinary Medicine (TCMV), Dr. Xie, teaches TCVM, including herbal medicine and even a business management course for integrative veterinary medicine, and he also sells the same herbal medicines he teaches vets to use. How is this any different from Pfizer or Roche teaching doctors to use the conventional medicines they then sell to those doctors?
  4. Continuing education conferences for alternative vets are also sponsored by companies selling them supplements and other products, just as is the case for conventional veterinary conferences. There is a real issue of potential bias in this, but it applies just as much to alternative medicine and conventional medicine and so is not an argument in favor of one over the other.

Bottom Line
The bottom line is that financial bias is a real issue in veterinary medicine at all levels, and it has to be investigated and managed. However, this is not the same as saying there is widespread fraud or a sinister conspiracy involving vets and companies that do business with them. There is no reason to believe that the majority of vets are doing anything other than the best they can to help their patients and clients. And there is absolutely no reason to believe vets offering alternative therapies are any less subject to financial bias or any purer in their motivation or behavior than vets practices science-based medicine.

Posted in General | 1 Comment

Australian GPs Take a Stand Against homeopathy

In the wake of the latest in a series of evidence-based reviews that all agree homeopathy has no clinical value beyond placebo and causes more harm than it is worth (e.g. 1, 2), and in the context of the overwhelming evidence behind this conclusion, the Royal Australian College of General Practitioners (RACGP) has taken a strong, principled stand against the use of homeopathy by physicians and pharmacists and against the waste of healthcare insurance resources on this useless treatment:

The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making.

In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:

1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.

2. Pharmacists should not sell, recommend, or support the use of homeopathic products.

3. Homeopathic alternatives should not be used in place of conventional immunisation.

4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products.

 

In doing so, the RACGP has joined many other groups of healthcare workers, scientists, and public health officials in condemning this deceptive and worthless practice. A number of veterinary groups have taken similar positions, including:

The British Veterinary Association:

The BVA cannot endorse the use of homeopathic medicines, or indeed any medicine making therapeutic claims, which have no proven efficacy.

The Australian Veterinary Association:

That the Board agreed that the veterinary therapies of homeopathy and homotoxicology are considered ineffective therapies in accordance with the AVA
promotion of ineffective therapies Board resolution.

The Evidence-based Veterinary Medicine Association

The American College of Veterinary Clinical Pharmacology

The American Academy of Veterinary Pharmacology and Therapeutics

However, many other organizations of veterinarians have refused to take a position on this issue, even when the opportunity arose with the introduction of a resolution in the AVMA House of Delegates to acknowledge homeopathy is ineffective. This refusal to accept the overwhelming evidence concerning perhaps the most egregiously unscientific of alternative therapies and to take a public position that defends our patients and clients from pseudoscience is regrettable and diminishes the integrity of our profession. While it would be ideal for the AVMA to be in the vanguard of protecting our patients and their owners, I hope that eventually ethics and science will triumph over politics and self-interest and they will join the growing chorus of reason.

 

Posted in Homeopathy | 4 Comments

Evidence-based Veterinary Medicine: What Is It & Why Does It Matter?

The following is a summary and the slides for a presentation I gave recently on evidence-based veterinary medicine:

WHAT IS EVIDENCE-BASED MEDICINE?
Evidence-based medicine (EBM) has been defined as the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”1 More generally, EBM is the formal application of the philosophy and methods of science to generating knowledge and making decisions in veterinary medicine. What distinguishes evidence-based veterinary medicine from other approaches is the explicit and formal integration of scientific research evidence into the clinical decision-making process. Evidence-based veterinary medicine (EBVM) is the adaption of EBM principles and techniques to the environment and circumstances of veterinary medicine.

As clinicians we need information to evaluate our patient’s health problems and to provide effective preventative and therapeutic interventions. EBVM provides tools and guidance to those who generate this information (through clinical research), those who disseminate it (through publication, continuing education, clinical practice guidelines, etc.), and those who utilize it (in clinical practice as well as public health and policy making). With better information, and more efficient information management, we are able to make better decisions, provide the best patient care possible, and more reliably achieve our intended outcomes.

WHY DO WE NEED EBM?
In the absence of EBM practices, clinicians typically base their decisions on a number of sources of evidence other than formal research data. Studies of veterinary decision making have found that veterinarians rely largely on the opinions of colleagues and perceived experts.2-3 To the extent that clinicians refer to research findings to guide their practice, they appear to utilize an informal, haphazard consultation of textbooks, journal articles, consensus statements and clinical guidelines. Above all, veterinarians, come to rely on their own clinical experience, judgment, and intuition in making diagnostic and therapeutic decisions. This collection of strategies is often referred to as opinion-based medicine.

There are a number of limitations to these approaches. Personal experience and opinion, even that of intelligent, educated, and experienced individuals, is subject to a wide range of cognitive biases and other sources of error that make it less reliable that is generally believed. Limitations in human perception, cognition, and memory and the influence of our beliefs and expectations lead us to erroneous conclusions which undermine the safety and efficacy of our interventions.4

There are many examples of how such error-prone assessment has supported ineffective or dangerous medical practices. Historically, interventions such as bloodletting, have been able to become ubiquitous and to persist for centuries with the best and brightest minds in medicine convinced they were effective, only to disappear rapidly when controlled scientific research revealed no benefits and significant risks.

In modern times, informal assessment not based on objective research has led to the similar widespread adoption of ineffective practices in many areas of healthcare. Based largely on the opinion of one individual, the practice of putting infants to sleep on their bellies to prevent Sudden Infant Death Syndrome (SIDS) was once nearly universal. This behavior persisted for two decades past the discovery of adequate scientific evidence to show it actually increased the risk of SIDS. Only once this external research evidence was integrated into public health recommendations and parent education did the practice, and the rate of SIDS, rapidly decrease.5

Surgical procedures such as internal mammary artery ligation and arthroscopic knee surgery have been widely employed until shown by controlled trials to be no more effective than sham surgery.6-7 In the veterinary field, practices such as prescribing antibiotics for young cats with hematuria and the nearly universal use of oral glucosamine as a therapy for osteoarthritis illustrate the potential for common and persistent use of ineffective or inappropriate therapies in the absence of a rigorous evidence-based approach to evaluating our interventions.8-9

It has been said the three most dangerous words in medicine are “In my experience.” And one definition for clinical experience is “Making the same mistakes with increasing confidence over an impressive number of years.” The reality is that our judgments are far less reliable than we feel them to be, and we are easily fooled by circumstances, by the complexity of the living organisms we deal with and their diseases, and by our own perceptual and cognitive biases. EBVM offers strategies and tools to help compensate for the limitations of uncontrolled observation and judgment.

THE STEPS OF EBVM
While EBM is concerned with the production and reporting of scientific research as well as its use in guiding clinical decision making, from the point of the clinician the most important elements are the steps involved in integrating research evidence with clinical experience and the circumstances of a particular case in order to inform patient care. The basic steps of an EBVM clinical process are these:

  1. Ask useful questions
  2. Find relevant evidence
  3. Assess the value and reliability of the evidence
  4. Draw a conclusion
  5. Assign a level of confidence to your conclusion

This is an iterative process that will be repeated regularly to build a body of knowledge with a known degree of uncertainty that can guide our clinical practice.

Asking Useful Questions
Vague or overly broad questions impede effective use of research evidence in informing clinical practices. “Does drug X work?” or “What should I do about disease Y?” are not questions that are likely to lead to the recovery of useful information from published research. There are a number of schemes for constructing questions the scientific literature can help answer. One of the easiest is the PICO scheme.

P- Patient, Problem Define clearly the patient in terms of signalment, health status, and other factors relevant to the treatment, diagnostic test, or other intervention you are considering. Also clearly and narrowly define the problem and any relevant comorbidities. This is a routine part of good clinical practice and so does not represent “extra work” when employed as part of the EBVM process.

I- Intervention Be specific about what you are considering doing, what test, drug, procedure, or other intervention you need information about.

C- Comparator What might you do instead of the intervention you are considering? Nothing is done in isolation, and the value of most of our interventions can only be measured relative to the alternatives. Always remember that educating the client, rather than selling a product or procedure, should often be considered as an alternative to any intervention you are contemplating.

O- Outcome What is the goal of doing something? What, in particular, does the client wish to accomplish. Being clear and explicit, with yourself and the client, about what you are trying to achieve (cure, extended life, improved performance, decreased discomfort, etc.) is essentially in evidence-based practice.

FIND RELEVANT EVIDENCE
Experienced clinicians typically have opinions on the value of most interventions they routinely consider. Unfortunately, we rarely know where those opinions originally came from or how consistent they are with the current best scientific evidence. And given the constraints of time and resources, practitioners will rarely have the ability to find and critically evaluate all the primary research studies relevant to a particular question. Fortunately, there are sources of evidence that can provide reliable guidance in an efficient, practical manner.

The best EBVM resource for busy clinicians is the evidence-based clinical practice guideline. These are comprehensive evaluations of the research in a general subject area that explicitly and transparently identify the relevant evidence and the quality of that evidence and make recommendations with clear disclosure of the level of confidence one should place in those recommendations based on the evidence.

Sadly, many guidelines produced in veterinary medicine are not evidence based but opinion-based (so-called GOBSAT or “Good Old Boys Sat At a Table” guidelines). These are no more reliable than any other form of expert opinion. Excellent examples of truly evidence-based guidelines are those of the RECOVER Initiative for small animal CPR and the guidelines produced by the International Task Force for Canine Atopic Dermatitis.

After evidence-based guidelines, the next most useful resources are systematic reviews and critically-appraised topics (CATs). These are more focused but still explicit and transparent reviews of the available evidence on specific topics. Systematic reviews can be identified by searching the VetSRev database, a free online resource produced by the Centre for Evidence-based Veterinary Medicine (CEVM) at the University of Nottingham. Unfortunately, getting full-text copies of these reviews can be challenging for vets not at universities, but there are a number of options depending on where one practices.

Critically appraised topics are also produced by CEVM and freely available on the web as BestBetsforVets. There are a number of other free CAT resources, including the Banfield Applied Research and Knowledge web site.

Finally, primary research studies are a useful source of guidance for clinicians, though they take more effort and expertise to find and critically evaluate.

ASSESS THE VALUE OF THE EVIDENCE
All research has limitations, and these must be formally assessed through the process of critical appraisal (discussed below). Only when the limitations of a study are clearly understood can we decide how much confidence to have in the results and conclusions of the study and whether it should lead to changes in our clinical practices. And even the best studies may not be applicable to our patients if the population studied differs in important ways from our patient population, or if the tools and techniques described are unavailable, impractical, or unacceptable to our clients. It is not enough merely to read published research reports. We must critically evaluate them in terms of reliability and applicability to our needs.

DRAW A CONCLUSION
Ultimately, the job of a veterinarian is to guide the client in making decisions about care for their animals. When the clinician is aware of the existing evidence and its limitations and clearly appreciates the degree of uncertainty, then he or she can best help the client to understand their options. Making evidence-informed decisions and clearly communicating with clients about the needs and choices for their animal is the core of clinical veterinary medicine, and this is what the tools and methods of EBVM exist to support.

ASSIGN A LEVEL OF CONFIDENCE TO YOUR CONCLUSIONS
Often, the relevant research evidence is incomplete or flawed, and sometimes there is little or no such evidence applicable to a given patient’s needs. EBVM is still useful in this situation, because it allows us to clearly, systematically identify and communicate the uncertainty inherent in our work.

EBVM is, above all, an approach for helping clinicians reach conclusions that can guide their decisions about the diagnosis and treatment of individual patients. It is often believed that a determination in Step 3 that the evidence is weak or flawed precludes making clinical decisions and taking action, and that this limits the usefulness of EBM in the veterinary field, where research evidence is often severely limited in quantity and quality. However, this is incorrect. The purpose of assessing the reliability of the research evidence is to assign a degree of confidence to conclusions or decisions based upon it. If the evidence is weak, it is often still be necessary to make a decision and act on it, especially if there is an urgent clinical problem. EBVM does not prohibit or undermine such action, it simply facilitates a clear and accurate understanding of the degree of uncertainty involved. This helps the clinician and also allows fully informed consent for the client.

It is also important that we openly discuss with clients our use of evidence to inform our recommendations. Research has suggested that clients want to be told about the uncertainties involved in the treatment of their animals, and that discussing this does not reduce their confidence in their veterinarians.10 Clients also identify truthfulness as their highest priority in communication with their vet.11 By explicitly discussing our process in identifying and evaluating relevant evidence, we enhance our clients’ understanding of the role we play, and we help them to appreciate the value of our expertise, not only the products and procedures we sell.

CRITICAL APPRAISAL
Critical appraisal is the term used to describe the formal assessment of the quality and limitations of published research evidence. Different study designs have strengths and weaknesses that bear on how the reliability and applicability of their results. And many individual aspects of how a research study is designed, conducted, and reported influence how much weight the study results should be given in developing an answer to a specific clinical question.

The well-known hierarchy of evidence, often used as a symbol for EBVM, is simply one of many tools employed in the critical appraisal process. There are also a number of key methodological factors that need to be evaluated when deciding how much confidence to place in the conclusions of a given research study:

  1. Control Group- If a treatment is applied to a group of subjects and there is no control group receiving a placebo or alternative treatment, there is no way to be sure any changes observed in the treatment group are actually due to the treatment or are greater than would be seen if we did something else or nothing at all. Uncontrolled trials are very weak evidence.
  2. Allocation- How the subjects are assigned to the different groups in a study is important. If there is not truly randomized allocation, in which every subject has an equal chance of being assigned to any group, then there is a risk that subjects will be assigned in a biased manner and that any differences seen between the groups will be due to inherent differences between subject rather than any treatment being tested.
  3. Blinding- One of the greatest strengths of formal scientific research is that it can compensate for the cognitive biases that lead us to the wrong conclusions when making informal observations. If, however, investigators and animal caregivers are able to determine which group in a study particular subjects are in, all of these biases can operate freely, and any assessments of the subjects, especially those that are at all subjective, can be skewed by unconscious bias. Unblinded or ineffectively blinded studies almost always find what the investigators expect to find, and this is no accident. Research has shown that in veterinary clinical trials, owner perceive a response in patients on placebo treatment nearly 57% of the time, and veterinarians perceived a response in these subjects 40-45% of the time.11
  4. Statistics- While the details of evaluating the statistical analysis in a given paper are complex and beyond the expertise of most veterinarians, it is important to bear in mind that research has demonstrated statistical errors are extremely common in published veterinary research and that even properly applied analyses are often inappropriately used to draw conclusions.
  5. Effect Size- Statistical significance is largely irrelevant to the question of whether an effect observed in a study is real or important. The effect size, or the absolute value of the effects seen and the differences between groups, is far more important. One can often show a statistically significant difference that would be clinically undetectable and irrelevant.
  6. Replication- No single study is ever sufficient to confidently demonstrate any hypothesis to be true or false. Replication is essential to uncovering the truth in science, and any conclusions based on research that has not been replicated should be viewed as tentative at best.

The studies which have evaluated the reliability of published veterinary research is not encouraging. Significant flaws are present in the majority of published studies, and this limits the confidence that can be placed in the results or conclusions of these studies.13-23

RESOURCES
Print Resources

Buczinski, S. Vandeweerd, J. (Eds.). Evidence-Based Veterinary Medicine for the Bovine Veterinarian.  Veterinary Clinics of North America: Small Animal Practice. 2012 March: 28(1).

Cockroft, P. Holmes, M. (2003). Handbook of Evidence-Based Veterinary Medicine. Oxford: Blackwell.

Ramey DW. (Ed.). Evidence-based veterinary medicine. Veterinary Clinics of North America: Equine Practice. 2007 Aug;23(2).

Schmidt, PL. (Ed.). Evidence-Based Veterinary Medicine.  Veterinary Clinics of North America: Small Animal Practice. 2007 May: 37(3).

Smith RD. Veterinary clinical epidemiology. 3rd ed. Boca Raton, FL: CRC/Taylor & Francis, 2006. 280 pgs. ISBN: 0849315662.

 

Electronic Resources
Evidence-Based Veterinary Medicine Association
http://ebvma.org (includes an extensive EBVM bibliography curated by Susan Whittaker)

Centre for Evidence-Based Veterinary Medicine
http://nottingham.ac.uk/cevm

VeSRev- A database of veterinary systematic reviews http://webapps.nottingham.ac.uk/refbase/

BestBetsfor Vets- Critically appraised topics
http://bestbetsforvets.org/

BARK_Banfield’s EBVM resources
http://www.banfield.com/veterinary-professionals/resources/research

BOTTOM LINE
EBVM is the formal, explicit integration of controlled scientific research into clinical decision making. It can reduce error and lead to better patient outcomes. However, published clinical research is not always reliable, and clinicians must carefully assess the limitations of specific studies and the applicability of their results to individual patients.

REFERENCES

  1. Sackett DL, Rosenberg WMC, Muir Gray JA, et al. Evidence based medicine: what it is and what it isn’t. British Med J 1996;312:71.
  2. Vandeweerd JMEF, Vadeweerd S, Gustin C, et al. Understanding veterinary practitioners’ decision-making process: Implications for veterinary medical education. J Vet Med Edu 2012;39(2):142-51.
  3. Everitt S. (2011) Clinical decision making in veterinary practice. (Unpublished doctoral dissertation). University of Nottingham, U.K. Available at: http://etheses.nottingham.ac.uk/2051/
  4. McKenzie, BA. Veterinary clinical decision-making: cognitive biases, external constraints, and strategies for improvement. J Amer Vet Med Assoc. 2014;244(3):271-276.
  5. Gilbert R, Salanti G, Harden M, See S. Infant sleeping position and the sudden infant death syndrome: systematic review of observational studies and historical review of recommendations from 1940 to 2002. International Journal of Epidemiology. 2005;34:874–887.
  6. Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal-mammary-artery ligation by a double-blind technic. New England Journal of Medicine 1959;260(22):1115–8.
  7. Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP . A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New England Journal of Medicine. 2002;347(2):81–8.
  8. Dru Forrester S, Roudebush P. Evidence-based management of feline lower urinary tract disease. Vet Clin North Am Small Anim Pract. 2007; 37(3):533-58.
  9. McKenzie BA. What’s the evidence? There is only very weak clinical trial evidence to support the use of glucosamine and chondroitin supplements for osteoarthritis in dogs. J Am Vet Med Assoc. 2010 Dec 15;237(12):1382-3.
  10. Mellanby, RJ. Crisp, J. DePalma, G. et al. Perceptions of veterinarians and clients to expressions of clinical uncertainty. J Small Anim Pract. 2007 Jan;48(1):26-31.
  11. Stoewen, DL. Coe, JB. McMartin, C. et al. Qualitative study of the information expectations of clients accessing oncology care at a tertiary referral center for dogs with life-limiting cancer. J Am Vet Med Assoc. 2014 Oct 1;245(7):773-83.
  12. Conzemius MG. Evans RB. Caregiver placebo effect for dogs with lameness from osteoarthritis. Journal of the American Veterinary Medical Association. 2012;241(10):1314-1319.
  13. Sargeant JM, Elgie R, Valcour J, Saint-Onge J, Thompson a, Marcynuk P, et al. Methodological quality and completeness of reporting in clinical trials conducted in livestock species. Prev Vet Med. 2009 Oct 1;91(2-4):107–15.
  14. Sargeant JM, Thompson A, Valcour J, Elgie R, Saint-Onge J, Marcynuk P, et al. Quality of reporting of clinical trials of dogs and cats and associations with treatment effects. J Vet Intern Med. 2010;24(1):44–50.
  15. Elbers A, Schukken Y. Critical features of veterinary field trials. Vet Rec. BMJ Publishing Group Limited; 1995 Feb 25;136(8):187–92.
  16. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995 Feb 1;273(5):408–12.
  17. Lund EM, James KM, Neaton JD. Veterinary randomized clinical trial reporting: a review of the small animal literature. J Vet Intern Med. 1998;12(2):57–60.
  18. Brown DC. Control of selection bias in parallel-group controlled clinical trials in dogs and cats: 97 trials (2000-2005). J Am Vet Med Assoc. 2006 Sep 15;229(6):990–3.
  19. Brown DC. Sources and handling of losses to follow-up in parallel-group randomized clinical trials in dogs and cats: 63 trials (2000-2005). Am J Vet Res. 2007 Jul;68(7):694–8.
  20. Arlt S, Dicty V, Heuwieser W. Evidence-based medicine in canine reproduction: quality of current available literature. Reprod Domest Anim. 2010 Dec;45(6):1052–8.
  21. Simoneit C, Heuwieser W, Arlt S. Evidence-based medicine in bovine, equine and canine reproduction: Quality of current literature. Theriogenology. Elsevier Inc.; 2011;76(6):1042–50.
  22. Giuffrida MA, Agnello KA, Brown DC. Blinding terminology used in reports of randomized controlled trials involving dogs and cats. J Am Vet Med Assoc. 2012 Nov 1;241(9):1221–6.
  23. Giuffrida MA. Type II error and statistical power in reports of small animal clinical trials. J Am Vet Med Assoc. 2014 May 1;244(9):1075–80

SFT Slides to Post

 

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Essiac Tea: More Snake Oil for Pets with Cancer

I recently had a patient I was treating for lymphoma, a white blood cell cancer, whose owner was interested in giving the dog Essiac Tea, a well-known herbal remedy sometimes recommended for cancer patients. In order to advise this client, I investigated this remedy, and I want to share the results of that investigation.

What Is It?

Essiac tea contains four plants:

Burdock root

Sheep Sorrel

Slippery Elm

Indian Rhubarb root

There is also a related product, Flor Essence, that contains an additional four ingredients:

Watercress

Blessed thistle

Red clover

Kelp

The inventor of this concoction claimed it to be a Native American recipe, however there is no evidence this is actually true, and some reason to doubt this story. In any case, the product came into use in the 1920s, and since it has been recommended as a cancer therapy and treatment for many other health problems. It is marketed as a dietary supplement, which means there is no requirement for scientific evidence showing it is safe or effective so long as those selling it don’t make any specific claims that it can prevent or treat disease. This does not stop many people, however, from making numerous claims about health benefits for a wide range of conditions, including the potential to treat or even cure cancer. These claims are made for pets as well as humans.

Does It Work?

The short answer is, “No.” The longer answer is that there is no reason to believe it has any benefits at all based on the limited research that currently exists. It is never possible to completely disprove any possible effects of any chemical compound, even eith extensive clinical testing. However, with no sound biologic rationale and no compelling evidence so far despite miraculous claims made over nearly a century, the chances of any real benefits being yet undiscovered is vanishingly low. Here are the conclusions of a number of existing:

1. Katja Boehm, CAM-Cancer Consortium. Essiac.

“There is no evidence from clinical trials to indicate that it is effective. No clinical trial has been carried out to assess its efficacy and the only published uncontrolled clinical investigation did not suggest that Essiac has an effect on tumour burden.

2. Cancer Research UK- Essiac

“There is no scientific evidence to show that Essiac can treat, prevent or cure cancer or any other serious illness in humans.”

3. National Cancer Institute- Essiac

“There is no evidence reported in peer-reviewed scientific journals to show that the exact formulas of Essiac and Flor Essence are effective in patients with cancer or other health conditions…”

4. Ulbricht C, Weissner W, Hashmi S, Rae Abrams T, Dacey C, Giese N, Hammerness P, Hackman DA, Kim J, Nealon A, Voloshin R. Essiac: systematic review by the natural standard research collaboration. J Soc Integr Oncol. 2009 Spring;7(2):73-80.

“A review of the literature on Essiac and essiac formulations showed a lack of high-quality clinical trials to substantiate any of Essiac’s traditional uses. Weak evidence from preclinical, animal, and laboratory data warranted a discussion regarding Essiac’s use for cancer, but the results are inconclusive. Several other essiac preparations are noted in the literature, adding confusion to the exact formula and its proposed benefits. In general, there is a lack of both safety and efficacy data for Essiac and essiac formulations.”

There are no research studies at all to establish efficacy in dogs and cats.

Is It Safe?
The short answer is, “Who knows?” The limited evidence in lab animals has turned up some potential risks, including actually increasing the risk of cancer. However, the quality of evidence concerning safety is no better than that concerning any benefits. All of the individual ingredients have been reported to have undesirable side effects in humans, though the seriousness of these or the effects of using the individual ingredients together has not been studied. It is important to remember that anything which has any effect at all on the body can potentially have undesirable effects. The lack of good evidence does not mean the product is safe, only that we don’t know whether it is safe or not.

Bottom Line
There is no reason to believe Essiac has any benefits for dogs or cats with cancer or any other medical condition. The research evidence is limited, but without a good reason to think there might be benefits, the lack of evidence means no claims of benefits are justified. An absence of evidence, especially given nearly a century of claims for dramatic results, is more consistent with there being no benefit rather than with the product being a powerful treatment. Additional research could possibly show actual benefits in the future, but for now any use of this product is simply rolling the dice with your pet’s health.

Similarly, the evidence does not show whether or not the product is safe. Safety cannot be assumed in the absence of evidence, and it is more appropriate to assume there is some risk until safety is proven. Even individuals with cancer can have their lives made worse by the harm done by untested treatments, so there is currently no justification for inflicting this remedy on dogs and cats.

As usual, I will probably receive numerous anecdotes along the lines of “Well, I tried it and it worked for me/my dog.”  I have responded many times in detail as to why these are not useful in evaluating therapies like Essiac, so to save time I will list the articles that address this topic for anyone who thinks anecdotes contribute something to answering the questions of safety and efficacy:

Why We’re Often Wrong The Role of Anecdotes in Science-Based Medicine Why We Need Science: “I saw it with my own eyes” Is Not Enough

Don’t Believe your Eyes (or Your Brain)

Medical Miracles: Should We Believe?

Testimonials Lie

Alternative medicine and placebo effects in pets

Medical Practices Once Widely Accepted that Proved Ineffective or Harmful when Studied Scientifically

 

 

 

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Mammary Tumors in a Population of Dogs in Mexico

One of the topics that comes up most commonly in my ongoing coverage of the research concerning neutering dogs is mammary tumors. Mammary tumors occur overwhelmingly in female dogs, and they are far more common among intact females than neutered females. Though a recent systematic review identified significant limitations in the existing research on mammary tumors and neutering in female dogs, the evidence that does exist, including basic physiology, human health research, and the limited studies in dogs, all support intact status as a major risk factor for the development of mammary cancer and all suggest that neutering is protective against this disease. A recent retrospective study of biopsy samples analyzed at a university in Mexico illustrates many of the limitations of the available literature, and yet it too supports the association between intact status and mammary cancer in female dogs.

Salas Y, Márquez A, Diaz D, Romero L (2015) Epidemiological Study of Mammary Tumors in Female Dogs Diagnosed during the Period 2002-2012: A Growing Animal Health Problem. PLoS ONE 10(5): e0127381. doi:10.1371/journal.pone.0127381

The study involved reviewing biopsy samples from dogs submitted to the university pathology lab. This kind of study always raises questions about the applicability of the results to canine patients in practice since the population studied are only those whose owners have had biopsy samples sent to a university lab. This is likely to be a very different population from that seen in primary practice, so the relationships identified may be different. However, when the data are quite consistent with multiple other studies in different populations, as these are, in can compensate somewhat for this limitation.

The study found that the vast majority of mammary tumors came from intact female dogs (99%). Of these, about half were benign and half malignant, which is a typical proportion. There were some differences between breeds, and though this is one of the results most affected by bias in the selection of the study population, the general pattern of tumors being more common in small breeds than in large breeds is consistent with data from other studies.

The overall proportion of biopsies that were from mammary tumors was pretty constant over then ten year study period, at about 16.8%. However, the relative proportion of these tumors that were malignant appeared to increase, suggesting that mammary tumors in this population may be becoming more frequently malignant. The authors offer some speculation about possible causes for this, but this is not the kind of study that can provide any causal evidence.

journal.pone.0127381.g003

journal.pone.0127381.g003

On the whole, this study offers limited additional information relevant to the issue of neutering and mammary cancer, but it is at least consistent with the majority of studies that do find this to be a disease almost entirely confined to intact females, which strongly supports neutering as a preventative measure. Of course, this represents only one risk/benefit issue to consider in the larger, and quite complex, decision whether or not to neuter an individual dog.

 

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Stem Cells for Kidney Disease in Cats?

I have written about stem cell therapy pretty frequently here for a couple of reasons. I consider it a very promising avenue of investigation based on lab animal and human studies, and I expect someday specific beneficial therapies based on stem cells will be available for dogs and cats. I also believe that stem cell therapies have been marketed aggressively and well beyond the actual evidence concerning risks and benefits. A general rule of medicine, in my opinion, is that any therapy that has real benefits also has real risks, and only rigorous controlled research will elucidate these. A recent review of the current status of research into stem cell therapies for kidney disease in cats illustrates well both the potential benefits and risks of stem cell therapies and the currently inadequate evidence about both that makes use of such treatments only appropriate under experimental conditions.

J.M. Quimby, S.W. Dow. Novel treatment strategies for feline chronic kidney disease: A critical look at the potential of mesenchymal stem cell therapy.  The Veterinary Journal 204 (2015) 241–246.

This review briefly outlines different types of stem-cell therapies, such as bone-marrow-derived cells, fat-derived cells, and cells from the patient or from other donor individuals, and discusses the potential advantages and disadvantages of each. This is useful in reminding us that stem-cell therapy is a complex collection of different processes and interventions, and we need good evidence for each specific intervention to make useful judgments about safety and efficacy.

The authors then briefly review the extensive lab animal evidence, which suggests potential benefit for stem cell therapies in animals with kidney disease. They do point out, however, that there are important differences between experimental disease in rats and natural disease in cats, so such studies can only suggest risks and benefits, not conclusively demonstrate them.

Finally, the review looks at the few small studies done to date in cats. These are interesting in their illustration of potential risks and benefits from stem cell therapies and also the complexity of identifying type of cell, route of administration, dose, and measures of effect to demonstrate real clinical impact from these treatments.

One study of 6 cats (2 healthy and 4 with kidney disease) involved injecting either bone-marrow-derived or fat-derived stem cells directly into the kidneys. Some improvement in measures of renal function were seen. However, the study also illustrated that getting cells from old and ill patients was very difficult and that this, along with the expense and risk of the procedure, would likely make this approach impractical in the real world of clinical medicine even if significant clinical benefits were ultimately found.

Three additional small studies have evaluated different doses and forms of fat-derived stem cells given intravenously to cats with stable chronic kidney disease. One group showed statistically significant changes in some bloodwork values, but these were not judged to be large enough to be clinically meaningful. In the other two groups, no significant change was seen in measures of kidney function. However, in one of these two groups, some undesirable adverse effects were noted in most of the cats, possibly due to inflammatory reactions or small clots caused by the stem-cell injections. This illustrates the general principle that any therapy which has significant effects on the body can cause harmful as well as beneficial effects, and the key to making good therapeutic choices is understanding both risks and benefits and being able to compare them in the context of an individual patient’s situation.

Another study of eight cats, this time with randomization, blinding, and a placebo control, investigated intravenous use of stem cells. Over a short-term followup of 6 weeks, no significant effects, for good or ill, were seen, but the study is still ongoing in order to observe any potential effects over a longer term.

From the various pieces of evidence reviewed, these authors draw a conclusion which seems to me to apply well to many potential uses of stem cell therapies in addition to the treatment of kidney disease in cats:

Although it holds much promise, at this time MSC therapy for CKD in cats should still be considered an experimental and unproven therapy. Notably, none of the studies conducted in cats with CKD by our group has been able to replicate the efficacy of MSC treatment reported in numerous rodent models of experimentallyinduced CKD.. Although rodent studies illustrate the impressive potential of MSC treatment for kidney disease, results of these models should be interpreted with caution for the reasons noted above. A conservative interpretation of the available data from studies in cats with CKD is that the current approach of IV administration of allogeneic MSCs is not likely to exert marked clinical benefit, although more animals should be treated before this conclusion can be firmly established.

There are still many questions to be answered regarding the logistics of MSC therapy. The optimal route of MSC administration, the ideal source of MSCs (allogeneic vs. autologous; culture expanded MSCs vs. SVF) and the impact of tissue donor status (attributes such as age, disease status and sex) on MSC function remain to be determined. Studies are currently under way investigating many of these aspects and additional information is eagerly awaited.

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Update: RenAvast Banned by the FDA Due to Illegal Claims

Last year, I wrote about a supplement marketed for dogs and cats with kidney failure, RenAvast. AT the time, the Bottom Line conclusion for this supplement was this:

The ingredients in RenAvast™ are deliberately not disclosed by the company beyond the fact that they are amino acids and some sort of peptide. Therefore, it is impossible to evaluate the plausibility of the proposed mechanisms of action or any preclinical research on these ingredients.

The only data presented for safety and efficacy is a poor quality, small trial with clear and significant risk of bias that is essentially useless as evidence. There are, of course, plenty of testimonials and anecdotes suggesting the product works, but that is true for every therapy ever invented, so either no idea in medicine ever fails, or anecdotes are very reliable.

There is no way to determine at this point if the product is safe or effective. However, the way that it has been marketed shows a clear disregard for both the regulations intended to prevent inappropriate and unproven claims for dietary supplements and the basic principles of medical research. The combination of secrecy and misuse of sloppy science suggests a great deal of skepticism is in order when dealing with this company and its products.

I also pointed out that in 2012, the FDA had warned the company about making illegal claims about the safety and efficacy of the product which had not been proven by appropriate clinical trials. Clearly, as of last year the company was still ignoring the law and defying this warning. Well, the wheels of regulatory enforcement turn slowly, but three years later the FDA has finally taken action against this firm:

On July 10, 2015, the United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.

According to the complaint filed with the consent decree, the defendants have marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. It is illegal to market new animal drugs without first requesting FDA pre-market review and obtaining legal marketing status. The FDA pre-market review process evaluates whether products are safe and effective for their intended use, can be consistently manufactured, and are truthfully and completely labeled.

The decree, filed on FDA’s behalf by the U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney’s Office for the District of Nevada, prevents Bio Health Solutions LLC and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce. The firm would not be able to market the drug unless and until it obtains an approved new animal drug application or meets the requirements for an investigational new animal drug exemption.

“The Federal Food, Drug, and Cosmetic Act’s new animal drug approval requirements provide important protections for consumers and their animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “We believe consumers should be able to trust that the drug products they administer to their pets have been proven to be safe and effective.”

It remains to be seen how the company will respond to this legal injunction, but hopefully this product will be taken off the market until and unless real clinical trial evidence is available to establish any risks or benefits it has. Sadly, that leaves scores of other similar products out there, but it is good to see that at least occasionally the FDA is willing to take action to prevent such flagrant illegal marketing of snake oil to pet owners.

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When Does Alternative Medicine Become a Religion?

I have written previously about the philosophical foundations of alternative medicine and how they differ from those of science-based medicine, and I feel this is a critical issue for those of us advocating for the latter. It is important to remember that while proponents of alternative therapies may use the language of science to market their products and ideas, they often don’t really accept the principles that underlie the scientific method. Much of alternative medicine is based on ideas about how health and disease work and how knowledge is acquired and tested that have far more in common with religion than with science.

I recently ran across a fairly explicit example of this from a Dr. William Pollak, who has written at length about the beliefs underlying his holistic practices, and who demonstrates why so-called holistic medicine often requires an outright rejection of the practice of science and the means by which science produces knowledge. Dr. Pollak redefines science and knowledge in terms that allow him to preserve his belief system regardless of the evidence arrayed against it, and he rejects some of the most fundamental and well-established principles of scientific medicine.

This raises the question, of course, why such people can take advantage of the exclusive professional rights and privileges that go along with being a licensed veterinarian. If the legal and ethical standard of medical care is based on science, as is explicitly stated in many of the laws and ethics statements that define the practice of veterinary medicine, how is it possible to reject science and still practice medicine? Should not this sort of healing practice be treated more as a form of personal faith, not a form of regulated, professional medicine? While there will always be differences of opinion in medicine, how far does one need to go in rejecting the foundations and core principles of a discipline before one can no longer legitimately claim to be a practitioner of that discipline?

Scientific Method- The Marriage of Intellect and Intuition

In this essay, Dr. Pollak essentially redefines science, complete with cherry-picked quotes from Einstein and others, to suggest that intuition is as useful as intellect and far better than objective scientific data for guiding our understanding and medical practice. He uses the tropes of post-modernism to make this claim, arguing that there really is no objective knowledge only a point of view. And he invokes the once popular idea that the Heisenberg Uncertainty Principle, which involves measurements at a subatomic level, somehow invalidates all objectivity because of some mystical unity of all things.

Dr. Pollak goes further, implying that scientific experimentation is just a ritual for confirming belief, rather than a mechanism for uncovering the truth about nature. While I believe the evidence is clear this is untrue, even if it were it is hard to see how uncontrolled intuition and opinion would be more reliable or less subject to bias. Dr. Pollak’s essay is quite poetic in places, but it is poetry without logic or any connection to the real world outside his own thoughts. It is simply the projection of his own feelings and desires, as are all models of nature that do not test themselves against reality in a systematic way.

Heisenberg’s uncertainty Principle states that an electron can be either be a wave or a particle depending on how you set up the apparatus to view it. The experiment set up in most cases structures the results of the investigation. The experimental result includes the intent of the researchers from the beginning; consciously or unconsciously; through attention and desire the outcome is created. It is just what it is — a set up.

Why create an elaborate structure to justify a belief? This is done if there is a need to convince others. The “others” might be officials who want proof before something is allowed; or it may be industry that needs to convince others of a product’s potency or safety. The scientific method, conscious attention, and allocated resources take an already given intent and clothe it in a garment of supposed objectivity. The ends justify the means, money well spent.

[Intuitive personal observation] is in contrast to measuring, an action performed by people who claim to be scientists but still assume that they are separate from what they are measuring.. Measuring can thus never reveal the truth of anything because the separation between observer and observed is an apparent one…

This approach of science devoid of intuition is still quite prevalent in the world today, as intuition is not a valued part of experience in our society. Lower scientists (would be measurers, as it is less inclusive) set out not to seek truth, but to justify their original supposition through manipulating physicality to produce the wanted end.

This mask of the truth of the laboratory coat without intuition gives rise to the strength and conviction behind most of the scientific studies at universities and industries today. It is the common… assumption that by scientifically showing results of scientific studies, that certain implications by association are likely to be true. This type of lower science is a paid exercise in measurement, created to prove a point that the measurers already know and want to make beforehand. It attempts to objectify when it is impossible to do so- in the name of Science.

More accurate diagnosis and treatment does not require more facts or fancies, but a free exchange of intuition and intellect from one form to another in the field of our conscious attention. There in the playing ground of our thoughts and feelings, the joyful dancing duo will make the music that will sing to us and remind us of a most proper course of action to allow the healing to flow to those around us who want it.

The Energetics of Immunization and Vaccination

Dr. Pollak rarely deals in specifics, preferring vague poetic musings on the nature of the universe that can mean whatever one wants to project onto them and are too slippery to really analyze. However, he does sometimes try to connect his philosophical speculations to his alternative medical practice, and this is most specific in his discussion of vaccination.

He begins by suggesting that vaccination is an idea copied from the “like-cures-like” notion of homeopathy, which is of course nonsense in its own right and ignores the fact that the foundations of immunization, such as variolation, were known and practices well before Hahnemann invented homeopathy. He then goes on to argue that vaccines don’t actually prevent disease but simply exchange acute illness for chronic illness, again despite the complete absence of evidence this is true and the overwhelming evidence for the efficacy of vaccination. Finally, he starts down a path he will delineate more clearly in other essays suggesting that infectious organisms don’t actually cause disease and even that disease doesn’t really exist except as a projection of the human psyche.

The concept of vaccination is based on the mechanics initially understood from homeopathy. In this system of remedies, “like cures like”; giving the biological system an artificial short term disease (a remedy), temporarily displacing a more long term situation in which symptoms are seen.

Vaccination does not confer immunity. Vaccination might express an underlying pre-existing immunity in term of observable titers or might stimulate the latent immune capabilities of the biological system and thus enhance quicker more efficient action in the future. A healthy immune system does not need vaccination, as it is capable and waiting to perform its function with minimal disturbance. [The overwhelming evidence that vaccination does, in fact, protect against disease, and that the introduction of vaccines has saved billions from unnecessary suffering, disability, and death somehow doesn’t count against Dr. Pollak’s personal observations or theories]

In an ideal sense vaccination in its unfounded basis attempts to use an indication of weakened immunologic function (the organism itself or its products) as a means to strengthen the immune system. This is not only unfounded but often times counter productive. Where in fact vaccination agitates, distorts, and helps to corrupt the less competent immune systems…In the short run it appears that susceptibility to a specific disease has been reduced (allaying human fear), when in fact this fear transfer is deposited deeper in the biological system as seeds for future chronic disease. [Again, the evidence does not actually support the claim that vaccination is a significant risk for chronic disease.]

Humans fear disease, animals know it as transient restriction, easily making adjustments with very little complaint. Disease as a real thing for animals is non-existent; for they are ever in the flow of nature herself, yet they reflect how we see them. As the companion animal is the recipient of human thought, feeling and action it absorbs unconditionally the fear as well as the love. The human fear of acute disease as expressed in unsubstantiated over vaccination can only result in added chronic disease, fibrosarcomas and end stage renal disease are some of the best indicators of this disease transfer. [The idea that disease is simply a projection of human fear and at the same time caused by vaccines we give to assuage our fear is ludicrously anthropocentric and denies the palpable reality of both physical disease and the effects of vaccination]

Vaccination as it is currently being over used in Veterinary medicine today helps alleviate the fear of acute disease in the client (and veterinarian) and transfers it into chronic disease in the patient. The Veterinary profession is viewed as “protecting” the animals for which it is monetarily compensated. Protecting from what? [Pain and death, mostly.]

Epilepsy

Another area in which Dr. Pollak makes fairly specific claims about medicine and medical treatment, claims which are contradicted by scientific evidence and supported only by his personal faith, is on the subject of epilepsy. He blames commercial diets, vaccines, medicines (the bulk of science-based healthcare, in other words) and parasites for seizures and claims to be able to cure them in most animals with raw diets, parasite treatment and, of course, withdrawal of conventional medical care. Detailed discussion of the evidence that Dr. Pollak is wrong about this would be beside the point since these theories are based entirely on personal experience and ideology, and he has already rejected the idea that scientific evidence could ever legitimately contradict personal experience or belief. It is sufficient to point out that real experts in neurology who know a great deal more about the subject of epilepsy, and the accumulated scientific evidence of decades, do not agree with Dr. Pollak’s theories, and there is no real evidence to support them. This is simply another example of the utter rejection of science and medicine in favor of idiosyncratic individual theories and belief.

Most commonly seizures in the younger and middle aged animals are due to parasites combined with a poor diet… The most common major factors that layer upon each other and predispose the nervous system to seizures is: 1. Parasites along with 2. the extensive feeding of a solely commercial pet food diet, along with 3. over-vaccination and 4. over treatment of chemical based medicines.[As usual, no reliable evidence to support this, and if we are taking mere opinions seriously, the overwhelming majority of opinions among veterinary neurologists disagree with Dr. Pollak’s.]

The poor diet in these pets predisposes the body to seizures due to the migrating larvae (immature stages of the parasites) that roam throughout the body, including the CNS. The nutritionally compromised system (on a solely processed diet) overreacts in a disjointed fashion to this disturbance. Animals fed a natural raw food diet better limit the parasitic numbers and are much less likely to seizure in response to them.[Raw foods are actually a risk factor for parasites, which is one of the main reasons we cook our food.]

Today’s modern approach to dealing with these problems is the administration of more chemicals,.. These chemicals oftentimes do not work and further confuse the biological system as already described earlier. The underlying imbalance is not directly addressed. Deranged metabolic disorders due to chemical shortages or imbalances are superficially addressed by further limitations in the diet; i.e.even more severely processed foods. These efforts though well intended are short sighted and short lived. After a brief period of lessened clinical signs the system must restabilize at a lower level of health, due to the continued lack of essential raw materials in a natural state. This results at best, in the reoccurrence of the disease and at worst, a deeper set of symptoms (“another” disease— that is really the same disease) or death. [The neat thing about this claim is that if no evidence is required to support it one can simply claim any disease that ever happens is the result of this supposed misguided attempt to prevent disease. You basically can’t lose!]

An active electrical network surrounds the physical body in all sentient beings. The CNS is constantly generating this network; this is the subtlest functioning of the DNA relationship. This non-physical energy of the relationship of matter resonates with the electrical fields of all other resonating bodies. When there is some threat; real or otherwise, the electrical system responds by either short-circuiting or overloading to some degree. This is a signal to the physical body to respond. If the body does not succeed, the imbalance is physically manifested… A seizure is an obvious instance of electrical overloading, without the appropriate physical response. [This sort of vague mixing of real physical phenomena like electricity and DNA with spiritual concepts like universal “energy” is a common bit of misdirection designed to steal some of the legitimacy from real scientific concepts and paint it on faith-based beliefs. This sort of explanation for disease was the norm for most of human history, with little in the way of success compared to the benefits realized by a scientific understanding of nature.]

Vitalism

The core idea that seems to underlie Dr. Pollak’s rejection of science and scientific method is vitalism, the belief that the physical aspects of nature are only a part of reality and that the real cause and management of illness lies with some non-physical spiritual essence of life force. This is a core idea behind many alternative practices, and it undermines any distinction between medicine and religion. While people are welcome to believe whatever they choose about the ultimate nature of reality, medicine is not simply any belief anyone chooses to have about health and disease.

If one believes God will cure disease if petitioned through prayer, that is their business. However, using this belief as a basis for calling oneself a doctor and then selling not only prayer but herbs, supplements, and other medical therapies to cure illness is not legitimate. Science has proven far more effective than any other means for understanding nature, and it has led, in a mere few centuries, to better health and less disease than all of the beliefs and practices that went before it in all of human history. Because of this, science has been granted a special position as the foundation of medicine, and society expects doctors to treat patients with methods compatible with and supported by science. Faith healing may be a fine spiritual practice, but it is not medicine and it cannot be sold as such.

Yet Dr. Pollak very clearly blurs the line between his private spiritual beliefs and the practice of medicine until he becomes far more of a shaman than a doctor, and it is disingenuous to market his services in any other way.  He claims that the true cause of disease, insofar as the concept of disease has any reality at all, is in non-physical entities that cannot be objectively studies, measured, or manipulated. If true, then all medicine is a spiritual exercise based entirely on what each healer intuits about the spiritual essence of the patient and the general nature of the Universe. While it is not possible to disprove a notion like this, it is clear that moving away from such ideas and towards a science-based approach to medicine has had tremendous, unprecedented benefits, so we should be wary about giving up the distinction between medicine and religion or giving personal faith equal weight with scientific evidence in healthcare.

Physical substance no matter how crude or refined is only a partial vehicle for the life giving flow that is healing. [But, of course, the non-physical is detectable only by intuition or belief, so not claim about it can ever be proven or falsified, which leads us to abandoning any hope of knowledge and leaves us relying on idiosyncratic and ephemeral personal opinion as the only guide to how to treat disease. Not a successful approach in the past!]

When the physical substance (gross, essence or quintessence) is seen as the only balancing agent in the pursuit of greater health the doctor has removed the predominant health giving force. This makes health care impotent; not much better than a system that pushes disease from one system of the body to another while every specialist claims “Cure”.

Scientific/objective research attempts to remove the practitioner from the scenario of healing by only allowing a framework that takes into account physical substance. An almost total intellectual perspective and lots of commercial money drive the current type of research…what is sought is a specialist’s panacea; and there are many, for if disease is defined narrowly, within that narrow definition cure will readily be found again and again. Keeping the scope of investigation within the physical framework keeps the illusion of cure very much alive. [So attempts to control error and bias through systematic scientific investigation are futile. But we can see the real truth by just letting our intuition and imagination free. Uh-huh….]

The use of holistic measures to eliminate disease is the key to enhancing wellness. This flow of higher balance (resulting in cure) can come on three levels; the first is from physical substance, usually natural, vibrant material. The second source of cure is from the essence or sound of the material (homeopathic potency or any pure essence or thought of such material). The third and most powerful means of cure is the direct infusion of wholeness into the patient, either directed through the healer via “hands-on healing”, telepathic, prayer or under the guise of any modality.[So anything works, as logn as you believe it works.]

Disease is resistance to the changing aspect of life.. Without constant changing scenery, life would be not only boring, but unable to fulfill is purpose of containing Wholeness. Disease can be seen as allowing the attention of lack to persist longer than it’s needed and then creating a mental structure based on it; justification, blame and helplessness follow. Our animal friends of earth are there to absorb innocently what the humans around them project…Animal disease is an understanding of humans. Animal restriction viewed as disease by humans, is a lack that is not focused upon by animals. The animal and plant kingdoms are forever in the flow of life’s energy. It is just through the effect of humans that their lives are remolded through relationship, either enhanced or made shorter. The life of the animal and plant kingdoms prior to the presence of humans was serene and peaceful (and not as full). [So all disease in our animals is caused by human beliefs, since we somehow perturb the blissful state of nature that existed before us when there was no disease and no suffering. Arrogant and ridiculous.]

Disease arises through a weakened Vital Force. Strengthening the Vital Force dissolves disease through life’s nature to maintain and express greater balance.

Disease is fluid, not confined to bodily parts, it can move easily through the mind, emotions, body and environment. Movement of disease from mental to emotional to physical, and downward and out from the center of the body indicates a strengthening of the Vital Force.

Tissue changes are the ultimates (end results) of disease; not the disease itself. Tissue changes are the expression of the interplay of the nature of the flow of life energy, observing these changes allows for further refinement and expansion of life’s flow. The predisposition allowing the tissue changes lies closer to the source of disease.

The healer consciously bestows desired life force through intent and knowledge of the nature of its flow. In the intent and act of healing through any modality, a process of harmonizing is appreciated and felt to what ever extent. Tapping into this sea of potentiality with focus of intent, begins the wheels of the universe turning in the direction of that which is wanted. If healing is one’s desire, then from this foundation of wholeness, healing arises via any modality. The wholeness of the healer joins with the wholeness of the one desiring healing. The strength of resonance between the two, determines the degree of healing. Modality is a matter of preference.[All that matters is that you believe, not what you actually do. Except, of course, if what you do is vaccinate and prescribe drugs, in which case you are doing harm.]

Here, Dr. Pollak has made explicit (if not necessarily clear) his belief that attention to abnormalities in the physical body is misguided, that disease is simply one state of matter brought about by nonmaterial forces, even manufactured by human feelings and foisted upon our otherwise healthy pets. The nature of being a doctor, in this world view, is not to heal the physical body but to facilitate certain desirable alignments of spiritual energies. He claims that it doesn’t matter how one does this (“modality is a matter of preference”), which allows him to do what many alternative practitioners do, which is accept the truth of numerous mutually contradictory therapeutic practices. On the other hand, he clearly doesn’t really believe this since he derides the modalities of science-based medicine as ineffective and harmful. But perhaps this is only because our “intention” and belief as doctors is mistaken? Perhaps toxic chemicals would become as healthful as homeopathy if only we shared his understanding of the true nature of the Universe? In a world view such as this, anything is possible.

Death-Just Another Kind of Healing

In terms of my own philosophical perspective, I see death as an inevitable and natural part of the existence of living beings. In a metaphorical sense, it can be viewed as just one more natural life event or stage. However, that doesn’t mean that the death of a child from preventable infectious disease and the death of a centenarian from the accumulated physical ailments of the years are both to be viewed and treated as the same. The natural and inevitable nature of death doesn’t mean it isn’t a real phenomenon involving failure or breakdown of the physical body, and it doesn’t mean we shouldn’t make reasonable efforts to avoid it when possible.

Dr. Pollak writes at length about death from the perspective of his particular spiritual philosophy, and his views on the subject are no more or less legitimate than anyone else’s. However, his treatise on the subject is problematic from the point of view of the veterinarian’s responsibility to reduce suffering in our patients. He writes about animals as idealized archetypes of nature incapable of suffering except from a flawed human perspective. Disease and death are, in this view, not fundamentally real, and the suffering our pets experience is an illusion we project on them. Such a view may offer psychological comfort, but it also discounts the reality and the significance of the pain our pets experience in their own right, independent of any beliefs we hold about it.

The implication that our pets experience disease and pain and death only as a function of our projecting our feelings on them diminishes the reality of their experience and can discourage appropriate intervention. It denies our pets the dignity of being treated as beings in their own right, not merely reflections or recipients of our needs and fears. And coupled with belief in useless therapies like homeopathy, this raises a very real risk of inadequately treating our patients’ discomfort and accepting not only death in general but death in circumstances where it could be reasonably and appropriately prevented. And it implicitly blames the victim of disease for bringing it on themselves or on their pets with wrong thinking, as well as, of course, the error of believing in science-based healthcare.

From a truly holistic perspective, death is a continuation of the healing process.

Understanding disease from a holistic perspective as healing episodes (periods in which the individual mind/body releases or sheds what is no longer wanted or is no longer of use) will help us to understand the deeper spiritual significance of the experience of death.

At the basis of disease understanding lies the notion of fear, not so much fear of something in the world, but of fear itself. The base fear, as a metaphor, is fear of death; an obvious end with an unsure beginning. This is fear of the unknown, arising from a lack of conscious love. If symptoms are seen or felt, and the fear of fear (lack of love) is active, then dis-ease grows stronger, this can only happen when unconditional love seems so far away.[So if you get ill, it’s your own fault for having the wrong thoughts or feelings.]

Our pets do not suffer as we do, they greet the new situation of temporary restriction with ease and love rekindled; this lends itself to quick adjustment. When we extend our discomfort onto them, and see them as ourselves in situations that we greatly fear, then we can only see ugly disease, devoid of love, all around us…The basis of suffering and overwhelming pain is the interpretation we place on the temporary restriction.[And you pets only suffer because of your feelings too.]

It is natural law that physical disease will follow this kind of thinking and feeling of lack and self-unworthiness, as there is a continuum between the different levels of life, from gross to subtle and beyond. In the absence of conscious unconditional love disease will express itself in a myriad of forms as long as the underlying bed of discontent continues.

Our pets mirror us through the reflection of love. This picture is not like that of a simple mirror that hangs in the dressing room and simply reverses left and right. This new image is a reflection that passes through a mirror with crystals of unconditional love on the back, warming the light with the glow of freedom and security as it passes through. These crystals are our pet’s conscious knowing of its place in the universe combined with the joy of having a family and master all wrapped into one. This makes their living, their role in life clear, simple and extremely fulfilling, all they do in their unconditional joy is innocently reflect back.[A clearer explication the human species’ arrogance and narcissism would be hard to find.]

Sometimes our pets linger in pre-death waiting longer than is necessary because it is important to them that their master(s) is well. They oftentimes do not understand the grief that is being emitted by the master with reference to their soon be departure. Grief and loss associated with this eternal process of transformation is unknown to them. They feel uncomfortable in leaving at a time when their master seems so confused, saddened and disoriented. They will stay, as long as they can, to further bring comfort to someone they truly love. If we are incapable or unwilling to let them go, they will stay around as long as they can, even to the point of obvious discomfort.

…They wish to know with certainty, that through your relationship with them, you have gained some increased sensitivity in the nature of your own being, for it is theirs as well. Our pets are in tune with the deepest of our knowing, a mixture of projected feelings, pictures and intentions. They barely hear our words that don’t ring true, but sense to their core, our core feelings, and reflect them back in love. This is done whether they are playful in health or restful in the physical weakness of great transformation.

The Pollak Protocol for Eliminating 85% of Common Disease in the Dog and Cat

Like most believers in a simple, mysterious, universal truth about health and disease, Dr. Pollak believes he has found answers not seen or understood by other veterinarians. And like several others, he has created a simple recipe for dramatic reductions in disease which requires accepting his view of the world but doesn’t apparently require any scientific evidence to validate it. And, of course, he’s named this recipe after himself. Sadly, the vast majority of scientists and healthcare professionals don’t have the insight to abandon their ineffective approach to health and follow this simple recipe.

The Pollak Protocol addresses seven basic areas:

  1. Diseases amenable to the Pollak Protocol
  2. Feeding the Natural Raw Food Diet
  3. Transitioning on to the Natural Raw Food Diet (NRFD) and Fasting
  4. Understanding Healing Episodes
  5. Deworming (if necessary)
  6. Least Medical Interference as possible
  7. Enjoying the Onset of Cure

This simple protocol is for those who still believe, if only somewhere deep inside, that curing disease, not treating disease, is the guiding light of real health care. Following this protocol will bring results beyond imagination and give strength to an intuitive learning that has been put on the back burner in a society gone mad about treating disease while giving up on cure. [In other words, anyone who believes in scientific medicine has given up on actually curing disease, despite all of the illusory improvements in health and longevity brought about by the scientific approach.]

This protocol is based on the dramatic and consistent improvement in health and vitality seen in thousands of dogs (~10,000) and cats (~6000) (1) when dietary changes were made. Based on the large numbers, a protocol emerged that helped bring Wellness to over 90% of the animals. Success was directly related to owner compliance with the dietary changes in a large majority of the cases. Understanding the protocol and interest and appreciation by owners of their pet(s) are the primary limitations on the level of Wellness obtainable. [In other words, if it doesn’t work it’s the owner’s fault for not understanding or adhering to the magic formula sufficiently. Oh, and it must be true because he made up some numbers.]

Excessive internal heat from unnatural breakdown of processed food is also the main cause of arthritis in our pet population. Dogs or cats showing arthritis in any form will usually respond quite nicely to a diet of only raw food. Return them to cooked or any processed food and the arthritis usually returns.[No evidence, as usual, just opinion. This is very typical of the kind of pre-scientific attempts to explain disease that had us killing patients with bloodletting for thousands of years.]

Switching to raw foods is very powerful medicine. Healing episodes can occur as deep house cleaning starts in the pet’s body. This can happen within hours of starting to feed raw food. Our pets have been waiting for this raw food their whole life, and when they get it, the body can over do it a bit in trying to make up for lost time. Diarrhea is the most common symptom seen…The strengthening of Wellness can sometimes bring symptoms suggestive of disease. [Just as death is a sign of healing, so is illness. If your pet gets better using his regime, of course his regime worked. But if it gets worse, that also means the regime worked and at an even more profound level. A nifty marketing trick, making every outcome a sign of success, but it’s not a legitimate way to validate any therapy.]

Bottom Line
It is common for alternative medicine practitioners to claim a respect for legitimate science or to claim that science supports their practices. Often, however, these claims are inconsistent with the evidence or with the behavior of these practitioners when confronted by the evidence. While some undoubtedly do believe science is the best way to understand nature and guide their medical practice, many turn out to have beliefs about health and disease and about the role of healer that are inconsistent with the basic principles of science and the core knowledge of science-based medicine. These beliefs often privilege personal faith and vague, ill-defined spiritual forces above scientific investigation of the material world.

I have no objection to spiritual beliefs per se, even when they touch on the causes and remedies for disease. And I understand that alternative practitioners will bring their core values and beliefs with them to work to some extent, as we all do. However, I do believe that science has proven itself far superior to any other system for understanding nature, and it has led to unprecedented and real improvements in health. Further, I believe society as a whole, at least in the developed world, accepts this and stipulates in the legal and institutional context of medicine that science should be the foundation for medical practice. When doctors are granted a license to practice medicine, they have great freedom to interpret and apply scientific knowledge, but they cannot legitimately reject or ignore it entirely.

When someone like Dr. Pollak explicitly rejects the definitions, principles, and core knowledge of medical science and uses personal spiritual beliefs as the foundation for his medical practice, I believe he has strayed outside the legitimate purview of the practice of medicine. He has declared himself a shaman or spiritual guide, rather than a doctor, in all but name. Again, this is fine by me so long as he represents himself honestly as such. But to call oneself a veterinarian while abandoning the epistemological foundations of the profession and declaring nearly all science-based medical practice to be vain and misguided is fundamentally misleading.

In any case, while I think the evidence against Dr. Pollak’s specific claims is strong, delineating that would be pointless since we are using entirely different systems of understanding. The best I can do is call attention to Dr. Pollak’s philosophical views, which he has expounded on at length on his own web site, and illustrate how they conflict with the principles that underlie conventional medicine. Those who share his beliefs are free to choose the shamanistic approach, and those who believe in the reality and value of science-based medicine are free to choose that approach, with the distinction made clear.

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No Vet for My Pet? Veterinary Nurses Can Sell Woo Too!

Despite the real harm unproven or bogus alternative therapies can cause, I get a lot of flak here for being critical of alternative practitioners. Some of that stems from the natural resentment of having one’s beliefs questioned. Alternative medicine is more of a philosophy, even a religion, than it is a rational approach to healthcare (1,2,3), so challenging it is much like questioning someone’s religious beliefs, and it tends to draw the same sort of response as illustrated by the sometimes vicious hate mail I get (4,5). And pointing out the lack of scientific evidence or a plausible theory behind an alternative practice can (hopefully) dissuade people from pursuing it, which obviously threatens the livelihood of some practitioners, so naturally this would engender some angry responses.

However, this criticism of criticism is pretty hypocritical given that the foundation of most alternative medicine marketing is exaggerating the risks and minimizing or ignoring the benefits of science-based medicine. The criticism alternative practitioners level at conventional medicine in promoting their own practices is often dramatic, and even those who claim their methods are compatible with conventional therapies and that they employ these still most often give more credit to the alternative treatments they use.(6, 7, 8, 9, 10, 11, 12) Ultimately, most alternatives to science-based medicine have to be sold with the claim, or at least the implication, that they work better than conventional medicine or in situations where it does not, whether or not there is evidence to support these claims.

A reader recently pointed me towards a particularly egregious example of the marketing of complete nonsense as a substitute for real medical care. See if you can spot the subtle suggestion that the methods being offered can replace conventional care.

AlyBhimjiLogo96

That wasn’t hard, was it? Now in the U.S. it is illegal to claim to diagnose or treat any disease without a license to practice veterinary medicine. I presume the same rule applies in Canada, where this quack is located, and as a result the web site is all about implying therapeutic powers without ever actually directly stating this. The usual sort of disingenuous CYA disclaimer appears on the home page:

The information contained on this website is for educational purposes only. It is not to be used as medical treatment or diagnoses. Do not alter any medical treatment, or the use of any medication without the permission of your medical care provider.

So if you aren’t supposed to use these products and services as medical treatments, why is the site called “No Vet for My Pet?” And why are there lists of medical conditions, from allergies to infections to cancer, paired with the names of specific products? Doesn’t that perhaps suggest the products are recommended as treatments for those conditions?

The site belongs to a veterinary technician/nurse named Salina Bhimji. Veterinary nurses, like nurses in human medicine, are in many ways the backbone of clinical medicine. They provide much of the direct patient care, and they serve as eyes, ears, hands, and often brain and conscience for veterinarians. I am blessed to work at a hospital with an amazing staff of highly intelligent, motivated, and trained nurses, and they make life incalculably better for me and my patients.

Unfortunately, in human medicine nurses are often a driving force for the integration of pseudoscience and nonsense into patient care, and I have seen at least some examples of the same problem in veterinary medicine. Healing Touch is the classic example of such a method among nurses in the human medical field. A form of “energy medicine,” which really amounts to a spiritual rather than a medical practice, it was invented by a nurse and has been accepted and promoted primarily by nurses despite clear evidence that it is nothing but a placebo ritual.

It is actually understandable that nurses in human and veterinary medicine might be more inclined towards alternative therapies than many doctors. Their training is often more practical and involves less basic science and scientific method and theory. And nurses provide most of the direct comfort to patients, so treating psychological, emotional, and spiritual needs more often falls within their domain than in the territory of doctors.

Most nurses, fortunately, believe in providing comfort and high-quality, science-based medical care, but a small group do tend to be sympathetic towards the kind of nonsense Ms. Bhimji sells. It is critical that those of us committed to evidence-based medicine include the nursing/technician community in our ranks and in our education and training efforts, because they are a large and indispensable part of the healthcare system for our patients.

According to her bio, Ms. Bhimji has an undergraduate biology degree and became a certified veterinary technician working at veterinary emergency hospitals. Apparently finding real medicine not to her liking, she has begun offering a wide array of the most ludicrous pseudoscientific and mystical nonsense available in the alternative medicine “toolbox.”

So what sort of alternatives does she offer? She seems to specialize in the more spiritual styles of therapy. This may be because of her personal beliefs, but I suspect it has more to do with legal restrictions on providing the more “medical” forms of alternative therapy (herbal remedies, acupuncture, chiropractic, and so on) without a license to practice medicine. She states that she is pursuing a doctorate in naturopathy, so I expect once she achieves that she will expand her product line—uh, I mean “toolbox.”

Reiki
This is is essentially a form of spiritual healing in which a healer directs a mysterious form of spiritual “energy” to heal physical disease.(13) It has the advantage over some alternative therapies of being benign in itself since it relies on magic rather than plant chemicals or needles. Nevertheless, no reliable scientific evidence has demonstrated any actual healing effects. If magic is real, then perhaps someday we will be able to demonstrate such effects, but as Tim Minchin has pointed out, “Throughout history, every mystery ever solved has turned out to be—not magic.”

The process of performing Reiki, however, might have some actual behavioral and physical effects on animals. It does, after all, involve quiet, gentle interaction and sometimes touch from a human. Anyone who has ever shared a bed or petted a dog or cat will be unsurprised by the idea that animals might enjoy this sort of interaction and find it comforting. It seems gratuitous to take ordinary kind and comforting interaction that might help shelter animals and load it down with a pile of mystical baggage and then claim that is why the animals benefit.

The use of spiritual practices in medical care does come with significant risks. While the humans involved may find such practices comforting, and that is a good thing, there is no reason to think our animals share any of our many specific and often incompatible spiritual beliefs. I have personally seen animals who are suffering be denied appropriate pain control and human euthanasia by owners whose spiritual beliefs precluded the use of these therapies. While animal owners are entitled to these beliefs, veterinarians have a duty to advocate for the welfare and interests of our patients. It is all too easy for psychologically comforting rituals like Reiki, acupuncture, homeopathy, and so on to fool us into thinking we have done something real to reduce an animal’s suffering when we actually have not. We must rely on objective scientific evidence to help us determine if what we are doing is truly comforting our patients and not just us.

Ms. Bhimji has a variety of certificates from training as Reiki practitioner. This may qualify her as a spiritual advisor of sorts to people who believe in the sort of ideas behind Reiki, but it does not give her any legitimate medical expertise or right to imply that she can treat health problems in veterinary patients.

A separate service Ms. Bhimji lists on her site is “energy healing,” but it is unclear how this differs from Reiki, which is just one of many forms of “energy medicine” (aka faith healing).

Crystal Healing
Here is how Ms. Bhimji describes this therapy:

What is Crystal Healing

This is a healing method that is used to heal animals using various types of crystals. There are many different crystals that work well with animals, it is about what crystal resonates with you.  If a crystal jumps out at you, or you are attracted to one, that is the stone that you are meant to use.

What does it do?

Using crystals in conjunction with other healing methods can enhance the healing process for an animal.  They simply amplify the energy that is flowing throught [sic] the animal.

It should be fairly obvious that this is again more religion than medicine, but there is no scientific evidence that crystal healing is anything other than a placebo therapy. (14, 15) While one can legitimately debate the merits of offering people placebos, it is clear that it is ethically unacceptable to treat disease in animals with placebos for their owners. (16)

Essential Oils
Essential oils are one of the products and services Ms. Bhimji offers which sound less obviously like religion and more like actual medicine. The claim that odors distilled from plants can heal disease, however, is still pseudoscience unsupported by reliable research evidence. There is little doubt smells can have potent emotional effects on humans, and they could potentially have behavioral effects on veterinary patients. BThere is weak evidence for beneficial effects on subjective mood states, such as anxiety, in humans, but the notion that they can influence the outcome of serious diseases, such as cancer, diabetes, and so on, is entirely unproven and highly implausible. (17, 18, 19, 20)

Ms. Bhimji specifically offers a type of essential oil therapy called Raindrop, and she proudly attributes the practice to Gary Young. Mr. Young is an infamous character with a long history in alternative medicine. Though the details are often in dispute, and Mr. Young does not hesitate to threaten legal action against those who criticize him, he has apparently been in regular legal trouble for practicing medicine without a license, making illegal drug claims, and other alternative medicine marketing activities for decades. (21, 22, 23, 24, 25, 26). This is not a source anyone should trust, and the fact that Ms. Bhimji uses Mr. Young’s method and appears to admire him speak poorly of her own judgment and reliability.

Consultations
Finally, Ms. Bimji offers consultations in person or via Skype for $50-65 per hour to help pet owners “achieve their goals in enhancing the health and wellness of their pet.” She also offers a variety of educational  presentations in person and online. While I suspect there is nothing illegal in this, it seems obviously unethical and fraudulent by every other definition. Ms. Bhimji essentially offers either spiritual guidance or completely unsupported pseudoscience and calls it “healing” or “wellness.” It is hard to imagine how anyone could come to this web site and view the material there as anything other than healthcare advice for their pets, despite all the careful language and disclaimers, so the site strikes me as misleading even if Ms. Bhimji actually believes the nonsense she is preaching.

Bottom Line
I have no quarrel with people who find comfort during times of illness from spiritual practices. And I see no problem with utilizing these practices for our pets when they are intended to give us spiritual and emotional comfort. But there is a meaningful difference between medicine and religion, and when the distinction gets muddled patients suffer. Treating serious disease in animals with religious rituals and pseudoscience in lieu of science-based medicine denies these patients real, effective medical care and causes real and unnecessary suffering. Advertising oneself as a spiritual advisor helping people cope with their pets’ illness is perfectly fair. Advertising spiritual services and bogus treatments as if they had real medical benefits is misleading and dangerous.

Ms. Bhimji seems to take great care to avoid explicit claims that could get her in trouble with the law though I suspect those will appear if and when she gets licensed as a naturopath. But she clearly creates the impression that what she offers can have real medical benefits and can replace science-based medical care, and that is wrong whether legal or not.

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