Free Webinar- Understanding aging in dogs: From principles to practice

Posted on November 5, 2024 by skeptvet

Next week, I am giving a free webinar in collaboration with Dr. Monica Tarantino and Dr. Lisa Lipman of the Senior and Geriatric Dog Society!

What you’ll learn:

  • Understand how a familiarity with the underlying mechanisms informs clinical assessment and treatment of senior canine patients.
  • Explore the clinical manifestations of aging and how to assess the needs of senior patients.
  • Learn how to set up a consistent, systematic program for evaluating and caring for senior dogs in your practice.

This program has been RACE-approved for 1 hour of continuing education credit in jurisdictions that recognize RACE approval.

Posted in Aging Science | Leave a comment

Should You Give Your Dog Rapamycin?

Posted on November 3, 2024 by skeptvet

Not too long ago, I wrote a post discussing the various categories of regulatory oversight for veterinary medicines.  These range from pretty good evidence of safety and efficacy for approved drugs to no meaningful requirement for scientific evidence (and usually pretty little of it) for supplements and herbal remedies. 

While I have focused a lot in the past on the weakest evidentiary category, unapproved supplements and remedies, I also regularly point out the problems with the others. In particular, I have repeatedly tried to get vets and pet owners to understand that even medications with a plausible, science-based rationale can turn out to be less effective, and less safe, than we hope if used without high-quality research evaluating them for the same problem and the same species we are trying to treat. Most of the examples in my latest lecture on practices we should consider abandoning involve such treatments.

I recently ran across a particularly egregious example of this in my own current field of canine aging and longevity science. Several vets (e.g. Petspan, Dr. Toman) are actively advertising their wiliness  to prescribe the drug rapamycin to dogs and cats for the purposes of extending lifespan. This would count as an off-label use of a drug approved for humans but not for dogs and cats. This means that there is absolutely no clinical trial evidence showing this drug extends lifespan in these species. Even more problematic, that is not what the drug is approved for in humans, and there are no clinical studies showing it makes us live longer either! So this is definitely a practice based entirely on extrapolation from basic science and research in species and circumstances radically different from those of our pets.

Rapamycin is probably the most publicly well-known of the potential longevity medicines currently being studies. There is a solid physiologic rationale for why it might extend healthspan and lifespan, involving effects on cellular and molecular pathways known to significantly impact longevity. There is positive evidence of lifespan extension in animal models (e.g. fruit flies and mice), and some evidence from human studies of positive effects that might reduce age-related disease and extend lifespan (though no actual evidence yet exists showing increased longevity in humans attributable to this drug). 

There is even some research on rapamycin in dogs and cats. One study in dogs found no significant objective effects, positive or negative, of low-dose rapamycin, though subjectively owners saw changes they perceived as positive more often in dogs on the drug than in those on a placebo. Another group ran a similar trial study which found no negative effects and no positive likely to be clinically meaningful, and a longer clinical trial is under way. Similar small studies have been done in cats, and one showed promising results for delaying the progression of a specific type of heart muscle disease. 

Such research is a key step in the process of moving from basic biology to a clinically safe and effective therapy. However, while there is lots of excitement about the potential of rapamycin to extend healthspan and lifespan, and this is based on plausible and encouraging science, it is far too early to be prescribing this drug with lifespan claims. The vast majority of drugs which look promising in early research turn out to have less efficacy or more risks than first hoped once they are tested in larger, more diverse populations. While I think there is some reason for optimism about the potential benefits of rapamycin, I think it is not responsible to prescribe it and not ethical to make longevity claims about it in dogs based on the existing data. If we were talking about a medication that might treat an aggressively painful or fatal condition, acting on the basis of limited and early evidence might be justified. When we are talking about slowing aging and extending lifespan, which is effectively preventive medicine for health dogs, the bar for safety and efficacy should be much higher, and rapamycin has not yet cleared it.

I also suspect that such prescriptions are not legal, based on the rules for extra-label use of prescription medication in veterinary patients. These required-

  • A valid ongoing veterinarian-client-patient relationship (VCPR). While some states are getting more flexible in their tolerance of virtual VCPRs, I think an online relationship with a vet for the sole purpose of prescribing an off-label drug to extend lifespan is pushing the limits and violating the spirit, if not the letter, of the law.
  • “FDA’s requirements for extra-label drug use in animals limits this use to situations where an animal’s health is threatened or where the animal may suffer or die without treatment.” While it can be argued that aging is the #1 cause of suffering and death in the long run, this is clearly not how the rules were written or intended. When the risks and benefits of a drug are as uncertain as they currently are for long-term use of rapamycin in healthy dogs, these can only be offset by an urgent need for treatment based on current suffering and imminent death or disability, which is not the case with normal aging.

It is unlikely that the FDA will take action against this practice given their limited resources and the political climate, which seems to discourage enforcement of such rules intended to protect veterinary patients. Therefore, it is up to consumers and veterinarians to be both informed and mindful of the scientific uncertainty and the ethical concerns such practices entail.

Posted in Aging Science | Leave a comment

FDA, XCA, RXE: What Does the Alphabet Soup of Conditional Drug Approval Mean for Veterinarians?

Posted on October 27, 2024 by skeptvet

Making Evidence-based Treatment Choices
The core of evidence-based medicine is integrating the best current scientific evidence with our own clinical expertise and the needs of the patient and the client when making diagnostic and treatment recommendations.1 Accurately understanding the potential risks and benefits of a treatment is necessary for us to guide clients in making choices about their pets’ care. 

However, it is impossible for each of us to be an expert on all the treatments available to choose from, and the time needed to keep current with the complex and expansive body of research evidence can be prohibitive. Clinicians frequently use shortcuts or proxies to help us understand how much confidence we can have in a given therapy and how much scientific uncertainty there is about it.

One of these proxies is the degree of regulatory evaluation and oversight applied to a product. There are different general categories of medicines available for vets and pet owners to choose from, and understanding the differences between these categories, including the evidence available supporting the safety and efficacy of each, can be a useful aid in evaluating our treatment choices. 

A relatively new category of regulatory approval is Expanded Conditional Approval (XCA).2 In the last few years, some useful new drugs have become available to veterinarians through this pathway, such as Laverdia and Panoquel. Some not-so-new drugs have also been approved under this process, such as Vetmedin and potassium bromide. But what is conditional approval? How is it different from “regular” FDA approval? 

This session will review the broad general categories of treatments available (in terms of regulatory oversight), with special focus on XCA and how vets can explain the significance of these categories to clients.

 What Are Our Options?
In general, vets can choose among medicines in several broad categories:

  1. Prescription drugs fully approved under the supervision of the Food and Drug Administration’s Center for Veterinary Medicine (the FDA CVM)*
  2. Prescription drugs conditionally approved under a formal FDA process
  3. Drugs approved for use in humans or other species and used “off label”† in dogs
  4. Dietary supplements or other non-prescription treatments not tested or approved under a specific regulatory process

*Some veterinary products are regulated by other agencies, such as certain parasite preventatives (EPA) and vaccines (USDA), but FDA is responsible for approving most prescription drugs.
†”off label” is a common term vets use to describe what the FDA more often calls “extra-label” drug use. I explain the details of what this means a bit later.

There is also a category of fully approved drugs that can be labeled for use without the supervision of a veterinarian.13 These over-the-counter (OTC) drugs have the same approval requirements as prescription products, but the manufacturer has demonstrated to the FDA that the drug can be safely and effectively used without supervision by a veterinarian, relying only on the directions on the label, so a prescription from a vet is not required. (This is slightly different from the process for approving OTC drugs for human use, which does not always require a regular drug approval process.)14

In general, the strength of the evidence identifying both the benefits and the risks of these treatments in the target species is greater the closer to the top of the list they are. For example, it takes a lot more research and data in dogs to achieve FDA approval for a prescription medication to be used in dogs than is required for a human drug used off-label or for a dietary supplement. 

The FDA has legal authority to set the conditions for the use of any “drug,” which the agency defines as anything “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and anything “(other than food) intended to affect the structure or any function of the body.”3 The agency regulates drugs for both humans and other animals, but the guidelines are often different depending on the species a product will be used in. 

The categories of available treatments reflect the need for a compromise between the best possible evidence and the availability of treatments. Ideally, every medicine would go through the rigorous testing required for a fully approved prescription drug, or even more than that! However, this is a lengthy and expensive process, and a strict requirement to have this level of evidence for everything would drastically limit the treatment options available for vets and dog owners. Therefore, the FDA allows vets to use products other than approved prescription drugs. The agency also sets specific guidelines for each category to minimize the potential risk associated with the greater uncertainty in categories that require less extensive pre-approval testing.

This is helpful to veterinarians because it gives us more treatment options, but it also requires us to understand, and explain clearly to clients, the differences between these categories and what this means for how confident we can be in the safety and effectiveness of different types of treatments. 

Fully Approved Prescription Drugs
The highest bar for scientific evidence is set by full FDA drug approval. This is a complex process that requires demonstrating to the agency that a drug proposed for use in dogs is safe, for the dogs taking it as well as for the humans around them, and that it is effective, meaning it consistently does what it is expected to do. Full approval requires showing that a drug can be consistently made to a high standard of quality. The FDA also has specific requirements for labeling the drug, for disclosing the evidence produced to support approval, and for what a company can and cannot claim about the drug once it is approved. 

The major components of FDA approval for animal drugs are called the major technical sections. These include:3

  • Target Animal Safety (TAS)
  • Effectiveness
  • Human Food Safety
  • Chemistry, Manufacturing, and Controls
  • Environmental Impact

    Of greatest interest to clinicians are the TAS and effectiveness sections because these relate directly to our assessment of the potential risks and benefits of a drug for our patients. The TAS typically involves testing the drug at both the intended label dose and higher doses in healthy animals of the species for which the drug is intended. This helps establish the potential side effects of a drug and gives a sense of the “safety margin” or possible consequences of exposure to doses higher than the label dose or of using the drug in animals that are not healthy or may be especially sensitive in some way.

Effectiveness is often determined in a field study, which is usually a randomized, blinded, controlled clinical trial of the drug in individuals of the target species with the condition the drug is meant to treat. Such trials are conducted with oversight by the FDA, including review of the methodology before the study is run and review of the data after it is completed. This oversight helps reduce the influence of bias on the results.

All research studies involve bias, processes which systematically influence the design, conduct, or analysis of a trial in ways that alter the outcome. It is well-known, for example, that studies funded by industry are more likely to produce results favorable to the study sponsors than independently funded research.4 This is sometimes misunderstood as meaning that companies or researchers deliberately “fudge” the data to get the results they want, but that is rarely how bias works. 

Most of the time, bias in research takes the form of small, unconscious effects on the numerous decisions that must be made at every step of designing and conducting a study and analyzing the data. Such processes are just as problematic when they involve ideology (e.g. homeopaths rarely conduct studies that show homeopathy doesn’t work), career advancement, or factors other than financial interests.5 

Such biases occur in every study, and the classic research methods of randomization, blinding, and placebo controls are a few of many scientific methods that help minimize the influence bias has on the outcomes of research studies. Independent regulatory oversight, as is part of the FDA drug approval process, is another useful tool in minimizing the influence of bias on study results, and it allows us to have greater confidence in the findings of such clinical trials. 

The FDA also requires companies marketing prescription drugs to monitor the experience that patients and vets have using the drug and submit regular reports after the drug comes on the market. This further strengthens our ability to identify and fix any problems once a product is in regular clinical use.

Of course, no scientific or regulatory process is ever perfect. Biology is complicated, so the effects of drugs are also complicated and never completely predictable. However, the standard of FDA approval is rigorous, and an approved prescription drug has been tested extensively and has more scientific evidence to support safety and efficacy than other categories of treatments available to us. 

Expanded Conditional Approval- XCA
Established in 2018, the expanded conditional approval process is a relatively new regulatory category which recognizes that for conditions that are serious or life-threatening and for which there is no existing effective treatments, a quicker process that makes new drugs available for vets to use sooner is beneficial.1,6 The clinical studies needed to demonstrate effectiveness under the full approval process can be lengthy and complex for some kinds of drugs, and while these studies are necessary, patients may go for years without treatment while waiting for such research to be completed.

XCA is available for drugs intended for use in the seven designated “major species” (horses, dogs, cats, cattle, pigs, turkeys, and chickens) if they meet two core criteria:

  • They are intended to address a serious or life-threatening condition, but demonstrating effectiveness would require complex or particularly difficult studies

    OR
  • They address an unmet animal or human health need, but demonstrating effectiveness would require complex or particularly difficult studies

XCA requires most of the same evidence needed for full approval, including all of the major technical sections except for the usual effectiveness package. Therefore, confidence regarding safety and manufacturing quality can be just as high as for fully approved products. Evidence is still needed to establish effectiveness, but the specific standard is different.

Under XCA, rather than the “substantial evidence” for effectiveness standard, which typically requires a clinical trial in the target species, expanded conditional approval requires a “reasonable expectation of effectiveness” (RXE). This standard can potentially be met with studies that involve fewer dogs and shorter time periods than the clinical trials needed for full approval or with evidence already existing in the scientific literature from studies done previously. This shortens the time necessary to achieve approval which should ideally make it possible to bring needed products into use faster.

The XCA process is not intended to permanently replace the standard approval requirements. Unlike full approval, conditional approval is limited to one year. It is possible to renew XCA annually for up to five years so long as the company marketing the drug is making progress in generating the evidence required to meet the substantial evidence standard. Ultimately, the drug must be given full approval once this evidence is provided and accepted by the agency, or it must be withdrawn from the market. 

A number of novel drugs have been approved under the XCA process, such as Laverdia (verdinexor) for treatment of lymphoma in dogs7 and Panoquel (fuzapladib) for management of canine pancreatitis symptoms.8 However, some drugs that have already been in widespread use under a different category, such as off-label use of products approved for humans or other species, have also been given XCA for specific uses in dogs. 

Vetmedin (pimobendan) was fully approved for treatment of congestive heart failure (CHF) due to mitral valve disease (MMVD) or dilated cardiomyopathy in dogs in 2007 (and the generic version was approved for this indication in 2024).9,10 However, Vetmedin was approved conditionally under XCA in 2022 for use in ACVIM Stage B2 MMVD cases to delay the onset of congestive heart failure.11 The drug is the same, but the indication is different, and it is approved for CHF and pre-clinical MMVD under two different regulatory processes.

There are some differences in the rules for use of drugs that are fully approved versus those approved under XCA. The most significant is that vets cannot use a conditionally approved drug off-label, meaning for any purpose or in any way other than what is dictated by the label directions. For example, if a drug is only conditionally approved to treat staphylococcal skin infections in adult dogs, it would not be legal to use the drug to treat a urinary tract infection, a puppy, or a cat. 

This restriction applies even if there is reason to believe the drug might be effective for these other uses, such as published research literature or anecdotal reports of such uses. This is a major difference from fully approved drugs, which sometimes can be used off label. Fortunately, it is easy for vets to recognize a conditionally approved drug because these will have the designation “CA” as part of the name (CA1 for the first conditionally approved use, CA2 for the second, and so on).

The XCA process allows needed treatments to be available to patients more quickly but also ensures a high standard of evidence. Vets using conditionally approved drugs can be confident that the evidence for safety is as robust as for any other drug, and the evidence for effectiveness is strong, though not as extensive as for a fully approved drug. Understanding this, vets can counsel their clients about the differences between full and conditional approval so owners can make informed choices about the risks and benefits of these treatments.

Off-label Use of Drugs Approved in Humans or Other Species
Many more drugs are approved and available for use in humans than in dogs, obviously because the biomedical industry for humans is much larger and better funded than veterinary medicine. The FDA recognizes that many potentially beneficial drugs are available in people, or other species, that will never be put through the approval process for use in dogs due to limitations of time, money, or other factors. Since 1994, the agency has allowed vets to use these drugs under specific conditions, and this is known as “extra-label” use (more commonly called “off-label”).12

Because the testing required for approval of a drug used off label was not specifically meant for the species or indication a clinician intends to treat, the approval data are less reliable indicators of how safe and effective the drug will be for this new use. As we all know, extrapolation across species is a necessary evil in veterinary medicine, but there are plenty of cases in which a drug that is safe and effective in one context may be neither in another. Tylenol is safe enough to be designated an over-the-counter (OTC) medication in humans, but it must be used with great caution in dogs and never in cats!

In recognition that the standard of evidence supporting off-label use of approved drugs is lower than for drugs fully or conditionally approved for the target species and indication, the FDA has set some rules for extra-label drug use. 

Veterinarians must, of course, have an established veterinarian-client-patient relationship (VCPR) in order to prescribe a drug off-label, just as they should for any medical treatment. The FDA provides a set of criteria for the existence of a valid VCPR:

  • you have recently seen and are personally acquainted with the keeping and care of the animal by virtue of examination or, for food animals, a visit to the place where the animals are housed
  • you have assumed responsibility for making medical judgments about the health of an animal, and  the owner has agreed to follow your instructions
  • you have sufficient knowledge of the animal to form at least a general or preliminary diagnosis of the medical condition
  • you are readily available for follow-up in case of adverse reactions or treatment failure.

In addition to establishing a valid VCPR, vets can only use an approved drug off label when an animal’s health is threatened or where the animal may suffer or die without treatment. 

Off-label use of such treatments for cosmetic or performance enhancement purposes would not be allowed. Because the confidence we have in the safety and effectiveness of drugs used off-label is lower, the risks are considered greater, and thus there must be a meaningful need to justify taking those risks. 

Vets also cannot use a drug off-label when there is an equivalent drug already approved for dogs, unless they determine that the approved drug is not appropriate or effective for a specific patient. Exactly what is necessary to determine this is not spelled out, so there is some uncertainty and room for discretion here.  There are also detailed requirements for record-keeping, labeling, and compounding of drugs used off label.

Extra-label use of drugs approved for humans is one of the most common types of medication use in veterinary medicine. We understand that the evidence for safety and effectiveness in our patients is not as strong as it is for approved animal drugs, but these drugs are an indispensable clinical tool. As long as we, and our clients, understand the limits of the evidence, we can balance the potential risks and benefits, and the limits of the evidence, in a rational way and monitor patients appropriately.

Supplements
Dietary supplements are the category with the least oversight and the greatest uncertainty about safety and efficacy. In veterinary medicine, this is not even an official category. As the FDA explains, “there is no ‘dietary supplement’ regulatory classification for animal food substances and products.”15 The law that regulates dietary supplements for humans, the Dietary Supplement Health and Education Act of 1994 (DSHEA) has been ruled not to apply to veterinary species. Products marketed for these species “are considered either ‘foods’ or ‘new animal drugs’ depending on the intended use.”15 

Essentially, anything that is intended to cure, treat, or prevent disease is considered a drug and should, in principle, go through the process for full or conditional approval before being marketed for use in companion animals. Some health claims are allowed for therapeutic diets, if they can be supported with evidence, but these are limited. Despite complex legal language and some degree of uncertainty, the bottom line is that food is food and medicine is medicine. If something is meant to be used as medicine, then it is a drug and not food. Foods don’t need to be approved by the agency before being marketed, but drugs do.

In practice, the FDA does not aggressively enforce this policy, and it typically does not insist on removal of supplements marketed for pets even if they have not been through the required drug approval process. In the past, the agency had an articulated policy indicating it would not object to marketing of pet supplements so long as they did not claim to treat or prevent disease or make other inaccurate claims and so long as there was no specific evidence suggesting they were harmful.16 That policy was withdrawn in early 2020, so exactly how the agency views regulating these products at this point isn’t entirely clear.17

The importance of this for veterinarians is that we must be aware that supplements for pets aren’t required to prove they are safe and effective before, or after, being marketed. Most of these products have never been tested in clinical trials, and the few studies that are done are typically set up and run by the company selling the product without any independent supervision. These studies can be interesting, but not surprisingly they often come up with results favorable to the company, and without the independent FDA monitoring, it is harder to be confident that these results are objective and unbiased.

There is also no official regulatory monitoring of quality for most dietary supplements. One study found, for example, that the labels for many probiotic supplements were inaccurate—often the products didn’t have the species or amount of probiotic organism claimed on the label.18 Similar results have been found for tests of other supplements.16

Even if a specific supplement might have therapeutic effects, your patients won’t benefit from these if the product you use doesn’t actually contain the ingredients it’s supposed to have! There are voluntary industry groups that make some effort to establish guidelines for supplement quality, but these are not mandatory nor independent of the manufacturers.

There may be research evidence relevant to determining the safety and efficacy of specific dietary supplements intended for companion animal species. However, the research is often sparse and rife with potential bias and error, and independently evaluating it for every product is impractical for most veterinarians. The absence of a robust regulatory process for pre-market approval of such products leaves the veterinarian with less guidance and less confidence in these treatments than we can have in those that are subject to more regulatory oversight.

Bottom Line
Science is imperfect, and medicine is an imperfect science. No medical treatment, whether a prescription drug or a dietary supplement, is ever completely effective or completely safe for every patient. There is always some level of risk in doing anything in medicine, and this has to be balanced against the potential benefits of the treatment in the context of the degree of evidentiary uncertainty.

As veterinarians, we can only decide what is best for our patients on the basis of the best evidence we have, integrated with our clinical expertise and the needs and goals of our clients. Uncertainty is inevitable, but the more evidence we have, the less uncertainty there is and the easier it is to make confident recommendations.  Understanding the different levels of regulatory oversight for various categories of treatments can help us assess the strength of the scientific evidence and the degree of confidence we can have in the medicines we recommend. 

References

  1. Cockroft, P. Holmes, M. (2003). Handbook of Evidence-Based Veterinary Medicine. Oxford: Blackwell.
  2. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs Guidance for Industry. 2021. Accessed on July 18, 2024. Available at: https://www.fda.gov/media/130706/download
  3. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process. Accessed on July 18,. 2024. Available at: https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process#approved
  4. Resnik DB, Elliott KC. Taking financial relationships into account when assessing research. Account Res. 2013; 20(3): 184-205. 
  5. Simmons JP, Nelson LD, Simonsohn U. False-positive psychology: undisclosed flexibility in data collection and analysis allows presenting anything as significant. Psychol Sci. 2011; 22(11): 1359-1366. 
  6. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). Conditional Approval Process Explained. Accessed on July 18, 2024. Available at: https://www.fda.gov/animal-veterinary/resources-you/conditional-approval-explained-resource-veterinarians 
  7. Anivive Lifesciences, Inc. Corrected Freedom of Information Summary Conditional Approval Application: Application Number 141-526. 2021. Accessed on July 18, 2024. Available at: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/10270.
  8. Ishihara Sangyo Kaisha, Ltd. Freedom of Information Summary Conditional Approval Application Application Number 141-567. 2022. Accessed July 18, 2024. Available at: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13134
  9. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). Oral Dosage Form New Animal Drugs; Pimobendan. Fed Reg. 2007; 72(95):27733. 
  10. Cronus Pharma Specialities India Private Ltd. Freedom of Information Summary ANADA 200-728. 2024. Accessed July 18, 2024. Available at: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15345
  11. Boehringer Ingelheim Animal Health USA, Inc. Freedom of Information Summary Conditional Approval Application Application Number 141-556. Accessed July 18, 2024. Available at: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12512
  12. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians. Accessed July 18, 2024. Available at: https://www.fda.gov/animal-veterinary/resources-you/ins-and-outs-extra-label-drug-use-animals-resource-veterinarians 
  13. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). Frequently Asked Questions about Animal Drugs: What are the differences between an over-the-counter animal drug, a prescription animal drug, and a veterinary feed directive animal drug? Accessed July 18, 2024. Available at: https://www.fda.gov/animal-veterinary/safety-health/frequently-asked-questions-about-animal-drugs#difference
  14. U.S. Department of Health and Human Services Food and Drug Administration. OTC Drug Review Process: OTC Monographs. Accessed July 18, 2024. Available at: https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs
  15. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). Product Regulation. Accessed July 18, 2024. Available at: https://www.fda.gov/animal-veterinary/animal-food-feeds/product-regulation#:~:text=Thus%2C%20there%20is%20no%20%22dietary,intended%20use%20(see%20below).
  16. Finno CJ. Veterinary Pet Supplements and Nutraceuticals. Nutr Today. 2020;55(2):97-101. 
  17. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM). CPG Sec. 690.100 Nutritional Supplements for Companion Animals. Accessed July 18, 2024. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-690100-nutritional-supplements-companion-animals-withdrawn-2202020
  18. Weese JS. Evaluation of deficiencies in labeling of commercial probiotics. Can Vet J. 2003 Dec;44(12):982-3.
Posted in Law, Regulation, and Politics | Leave a comment

The Entourage Effect: Science or Folk Belief?

Posted on October 20, 2024 by skeptvet

While pre-scientific folk medicine traditions have always relied on trial-and-error learning passed down through generations, most have also had underlying theoretical frameworks used to explain the origins of disease and to guide the choice of treatments. In this blog, and in my book, I have explored some of these frameworks, such as those behind Traditional Chinese Medicine, Ayurvedic Medicine, and homeopathy.

There are many common elements to these systems, even when they arose in very different places and eras. We all share ways of seeing and understanding the world as a result of the inherent structure and operation of human brains, so it is not surprising that we should often come to similar conclusions about how it works. 

For example, vitalism, the notion that living things are distinguished from inanimate objects by the presence of a non-physical vital essence, is common to nearly all such systems. The human mind seems bound to see intention and agency everywhere, and to attribute life to an invisible internal force, which admittedly is a lot more intuitively appealing than the bewilderingly complex array of electrical and molecular events that science describes, if less useful.

In herbal medicine traditions, another frequently shared notion is that whole plants or combinations of plants are inherently safer and more effective that isolated chemicals, such as those used in science-based medicine. There are a number of rationales for this, which often relate back to the religion or philosophy underlying the particular folk medicine system. Chinese medicine involves a lot of Taoist ideas about balance and harmony in nature, whereas Western folk traditions may claim that God intended plants to be remedies for human ailments and so designed them to contain beneficial mixtures of substances. None of these explanations, of course, are scientific or empirically testable.

The leading textbook on veterinary herbal medicine1 explicitly promotes the idea that a multiplicity of compounds in an herbal remedy is inherently a good thing:

In herbal medicine1, polypharmacy is de rigeur…When asked which is the active ingredient of any herb, the drumbeat of the herbalist will always be: The Plant Is the Active Constituent!

  • The whole herb or whole extract is already understood from history and clinical trials.
  • The herb’ constituents have complex actions that may benefit the patient through additive, antagonist, or synergistic effects.
  • Most active constituents may be unknown

Offering a plant drug with multiple actions gives the body a multitude of possible solutions at one time.

As proponents of herbal medicine attempt to generate more scientifically compatible explanations for beliefs like this that they already hold, they come up with other ways of describing such ideas. One common belief among the more scientifically minded advocates of herbal treatments is the concept of the “entourage effect.” (EE) This is most frequently used to describe the belief that the multiplicity of compounds in cannabis have beneficial effects in combination that are not seen in isolated components, such as THC or CBD. As one author put it,2

Herbalists contend that polypharmaceutical herbs provide two advantages over single-ingredient synthetic drugs: (1) therapeutic effects of the primary active ingredients in herbs may be synergized by other compounds, and (2) side effects of the primary active ingredients may be mitigated by other compounds. Thus, cannabis has been characterized as a “synergistic shotgun…

This idea has become quite entrenched, and it is often treated as an accepted and proven phenomenon. However, there a few problems with the concept of the EE. For one thing, there is no logical reason that the interaction of multiple compounds in a plant should always be beneficial (reducing side-effects and increasing intended effects) and never harmful. This is not consistent with the basic principles of chemistry, and the assumption is rooted in philosophical notions of nature as inherently benign, even if modern herbalists are explicitly less committed to those kinds of explanations these days. 

More importantly, there is virtually no reliable evidence that there is always a net benefit to whole herbs or mixtures with multiple components. There is, in fact, evidence of examples where the reverse is true. In some cases, mixing CBD and THC reduces the effectiveness in children with seizures or exacerbates the side effects. And as I have discussed elsewhere, the development of the antimalarial medication artemisinin is also an example of the superiority of pharmacognosy (isolating medicines from plants) over folk herbalism. 

Derived from a plant used in Traditional Chinese Medicine, artemisinin is an effective treatment for malaria. Dr. Youyou Tu was awarded the Nobel Prize in Medicine in 2015 for discovery of this drug. This well-deserved honor is often cited as evidence that TCM herbalism is a validated medical practice. However, the true lesson of Dr. Tu’s work is that science is much more effective at creating effective treatments for disease than the anecdotal, trial-and-error processes of folk medicine. 

In the 1960s and 1970s, Dr. Tu evaluated about 2,000 Chinese herbal preparations and found over 600 that had some effect on the malaria parasites in mice. Hundreds of specific chemical compounds were isolated from these preparations and evaluated. After many years of work one, artemisinin, was found to inhibit the growth of this parasite in a way that could be clinically useful. 

However, the amount of artemisinin produced varies dramatically different species of the Artemisia plant. There is too little present in most species to extract for medical use. Many different species of Aretemisia were tested, and the one with the highest quantity of artemisinin was used as a source for the compound, which was then extracted and purified for medical use. 

Even more research and modification of the original remedy were then necessary to make an effective medicine. Artemisinin itself has pretty weak effects on the malarial parasite, so Dr. Tu also had to alter the compound chemically to make it more stable and more effective. And it turned out a capsule form allowed for much better absorption of the drug than a pill or the original plant material. 

Ultimately, however, after decades of work, Dr. Tu had found an important, life-saving medicine in a plant used by TCM. So isn’t this evidence that TCM is a worthwhile medical approach which can sometimes accomplish things scientific medicine can’t?

There are a number of reasons why this view of Dr. Tu’s story doesn’t hold up. For one thing, Artemisia wasn’t used in TCM specifically to treat malaria, it was used to treat fevers of any kind. This is because TCM doesn’t distinguish fevers caused by viral infections, bacterial infections, autoimmune diseases, or parasites such as the one that causes malaria. Without a scientific understanding of the different causes of these diseases, the potential value of Artemisia for malaria patients was unrecognized, and it was commonly used in many other patients for whom it would have no benefit. What is more, the raw plant itself would not be effective even for patients with malaria since, as I mentioned, there is not enough artemisinin in the plant tissues to effectively inhibit the parasite, and what is present is unstable and poorly absorbed when eaten whole or drunk in an infusion, as is usually done in TCM.

Furthermore, to find this one medicine, Dr. Tu had to hundreds of compounds from thousands of herbal preparations in rigorous scientific studies, from mice in the laboratory to human patients in the field. The vast majority of the remedies and compounds she tested were not useful. Despite thousands of years of trial and error with herbal remedies, TCM never properly identified the cause of malaria and never found an effective treatment for it even when it had such a such a treatment hidden in its collection of herbal remedies. Dr. Tu’s research illustrates not only the power of science to find useful treatments for disease but the inability of haphazard folk medicine methods to do so. 

A few authors2-3 have questioned the EE and pointed out the absence of compelling evidence to support the concept, but you will still see this idea taken as fact even in discussions of cannabis and other remedies that are relatively science-based and free of folk beliefs. It is important for pet owners and veterinarians to understand that such ideas are a residue of the mysticism and unscientific beliefs that underlie many herbal medicine practices. 

References

  1. Wynn S. Fougere B. (eds) Veterinary Herbal Medicine. St. Louis Mo.: Mosby Elsevier; 2007
  2. Cogan PS. The ‘entourage effect’ or ‘hodge-podge hashish’: the questionable rebranding, marketing, and expectations of cannabis polypharmacy. Expert Rev Clin Pharmacol. 2020 Aug;13(8):835-845.
  3. Christensen C, Rose M, Cornett C, Allesø M. Decoding the Postulated Entourage Effect of Medicinal Cannabis: What It Is and What It Isn’t. Biomedicines. 2023 Aug 21;11(8):2323. 
Posted in Herbs and Supplements | Leave a comment

Your Annual Reminder that there is no Reason to Believe Homeopathy Can Help Your Pet

Posted on October 10, 2024 by skeptvet

I have devoted far too much time and energy to the least plausible of alternative therapies in veterinary medicine, homeopathy. From a comprehensive literature review in 2012 to a detailed response to the best evidence the Academy of Veterinary Homeopathy could muster, and much more, I have done my best to make sure pet owners don’t get taken in by the baseless claims for this bogus practice. I know, of course, that such efforts will never be complete, but over the years, I’ve rather lost interest in the subject. There are only so many ways to say, “It doesn’t work,” and the evidence isn’t likely to change without the complete upending of centuries of established science.

That said, every once in a great while, I feel the need to remind everyone that, nope, homeopathy still doesn’t work. Earlier this year, yet another systematic review of the veterinary homeopathy literature was published:

Bez, I. C. C., Paula, G. Z. de, Revers, N. B. M., Oliveira, A. C. da F. de, Weber, S. H., Sotomaior, C. S., & Costa, L. B. (2024). The use of homeopathy in veterinary medicine: a systematic review. Semina: Ciências Agrárias, 45(3), 783–798.

Goodness knows, we don’t need more studies or more reviews to serve as a few more nails in the coffin of this idea, but hope and delusion spring eternal in the human psyche, so here we are. Despite the lack of a plausible reason for conducting it, and the almost certain pro-homeopathy bias of researchers still looking under rocks for evidence that it does something, the review followed pretty standard guidelines and practices for systematic reviews. The results?

  • 161 studies found
  • 8 studies that met the minimum criteria for analysis
  • 3 studies that were consider to have a low risk of bias

Of these, one was in cows, one in cats, and one in dogs. The cow and cat studies found no effect. The dog study did report a positive outcome.

Raj PAA, Pavulraj S, Kumar MA, Sangeetha S, Shanmugapriya R, Sabithabanu S. Therapeutic evaluation of homeopathic treatment for canine oral papillomatosis. Vet World. 2020 Jan;13(1):206-213.

This was a small study, involving 16 dogs, and it was conducted in India, where homeopathy is more widely used and believed to be effective than in other parts of the world. The condition was viral papilloma, an infectious wart that typically goes away without treatment within 4-8 weeks. According to the paper, the dogs were randomly assigned to homeopathy (8, a mixture of remedies at the 30C dilution, which means no trace of the original ingredient could possibly remain) or placebo (8, distilled water).

The reported results are quite dramatic. All of the dogs given the homeopathic remedy were “cured” by less than three weeks, while many of the dogs given placebo still had lesions up to 5 months (20 weeks).

This certainly looks like compelling evidence. You will not be surprised, however, to hear I am not convinced. If hundreds of studies are done by people committed to proving what they already believe, some will appear to succeed even with reasonable attempts to eliminate bias. We have already seen this in previous studies of homeopathy. A famous study published in the prestigious journal Nature in 1988 appeared to show incontrovertible proof of biological effects of highly dilute homeopathic remedies in vitro. Subsequent investigation found the results could not be repeated if the investigators were effectively blinded, as they ought to have been in the first place.

There are a number of red flags in this paper. The persistence of lesions much longer than normal in the placebo group raises questions about the original diagnosis and whether these were normal papillomas in normal dogs. Did the treatment group resolve much faster because of the remedy, or could there have been some hidden bias in how the dogs were selected, treated, or evaluated?

I certainly don’t have an explanation for the results, but given the consistent failure of homeopathy in scientific investigations for many decades, the explanation that homeopathy cured these dogs is not the most likely. Replication of these results in other studies by different, independent investigators would be needed to even begin to suggest that as a realistic possibility, and more likely explanations, such as residual bias or error, would have to be eliminated.

Thus does the zombie of homeopathy lurch along, sustained by the desperate proliferation of numerous studies, most methodologically poor, and the occasional apparent success which mysteriously, is never replicated or proven to be true.

Posted in Homeopathy | 4 Comments

WSAVA Adds Chinese Medicine Pseudoscience to Continuing Education Conference Held in China

Posted on August 18, 2024 by skeptvet

The World Small Animal Veterinary Association (WSAVA) regularly sponsors a continuing education conference, as many such veterinary membership organizations do. This year is the first time the conference is being held in China. This is also the first time the conference has included a set of sessions devoted to so-called Traditional Chinese Veterinary Medicine (TCVM). 

I have written about TCVM extensively on this blog (first in 2011, and most recently in my review of the Chinese herbal product Yunnan Baiyao last week). There is also a huge amount of discussion of the main components of TCVM, herbal medicine and acupuncture, occupying several chapters in my book.  The history, philosophy and science related to the mélange of ideas and practices associated with TCVM is a vast area with lots to explore, but the core facts are these:

  • TCVM is not “ancient.” It is a syncretist blending of disparate traditions and practices, many of which were never historically applied to animals, that was created by Mao and the Chinese communist government for ideological and pragmatic reasons in the 1950s.
  • The model of health and disease underlying TCVM is a mishmash of folk mysticism, Daoist philosophy, and other beliefs that has no basis in science or a scientific understanding of nature. It has no more legitimacy as a basis for the practice of medicine than the mystical folk beliefs of Ancient Greece, Indian Ayurvedic medicine, Native American Shamanism, or any other pre-scientific way of understanding health.
  • The specific practices usually associated with TCVM include acupuncture, herbalism, cupping, and a variety of diet and manual therapies. None of these has been proven effective by rigorous scientific testing despite decades of efforts to do so. Given the implausible unscientific rationales for how these methods ae supposed to work and the consistent failure to show they do work in robust scientific studies, it is most likely that they don’t work. 
    (The fact that plants have chemicals in them which can, and sometimes do, have medical benefits is not a validation of TCVM herbalism. That is an example of the bait-and-switch technique of promoting pseudoscience)

Unfortunately, the WSAVA has chosen to support the pseudoscience of TCVM by including it as part of their conference. They have attempted to distance themselves from the practice slightly, claiming it is being offered by local vets “alongside” the official conference, but this is a distinction without a difference. There is no reasonable way to view this as anything other than an endorsement of an unscientific, and likely ineffective, alternative practice.

I was included in a recent news article in the journal Veterinary Record discussing this controversial decision, along with several other regular proponents of science-based veterinary medicine. The Executive Director of the WSAVA has responded to criticism of the TCVM conference track by essentially acknowledging that this was a political decision intended to accommodate the beliefs of the host country-

The lectures in question have been designed by our local Chinese veterinary associations, a benefit that every host country has had at WSAVA congresses for many years. This year, the TCVM stream features speakers from across Asia and wider afield. Given the deep history and cultural significance of traditional approaches to veterinary medicine, not just within China but across Asia, and considering the large number of attendees from this region, we believe it is fair and justified for this content to be included.

His subsequent statement that this is “not necessarily an endorsement of the scientific validity” of TCVM rings pretty hollow. Membership organizations like the WSAVA are often quite political, and they are not fond of taking principled stands on the scientific merits of questionable practices favored by some of their members. I have seen this in exhaustive detail firsthand when participating in an unsuccessful effort to get the American Veterinary Medical Association (AVMA) to acknowledge that homeopathy is worthless pseudoscience.

Unfortunately, despite attempts to have their cake (make TCVM vets in China happy) and eat it too (claim to support evidence-based medicine), the WSAVA decision to include TCVM in their conference actively promotes a pseudoscientific practice that should not be used to treat animals without appropriate scientific validation of specific claims and methods. This is yet another case of politics trumping science and of a professional veterinary organization failing in their responsibility to support the best medicine for our patients and appropriate scientific standards of practice for their members.


Posted in General | 5 Comments

Evidence Update: Yunnan Baiyao- Where are we Now?

Posted on August 12, 2024 by skeptvet

One of the longest running subjects for posts here has been the Chinese herbal product Yunnan Baiyao (YB). Purported to help stop or prevent bleeding, this stuff seems to be pretty commonly used in veterinary medicine, mostly for dogs with an aggressive form of cancer prone to bleeding, hemangiosarcoma (HSA). Despite this popularity, and the perception of “well, it can’t hurt,” there is very limited research evidence on YB, and what exists is not encouraging. 

My first review was in 2010, and my most recent in 2017 (2010, 2016,  Feb 2017, June 2017). In the latest, my conclusions were largely the same as in the first:

The TCM rationale for using Yunnan Baiyao is part of an unscientific, quasi-religious belief system and cannot be accepted as a sufficient basis for using an otherwise unproven remedy on patients, especially when the ingredients in that remedy are not fully disclosed or regulated for quality, consistency, and safety. The more plausible scientific hypotheses for how Yunnan Baiyao might work remain unproven.

The clinical research evidence is mostly negative, and even positive studies have not shown any significant effects on clinically meaningful objective outcomes.  No clear evidence of harm has yet been found, though the limited nature of the evidence does not ensure that the product is truly safe.

I also created a table listing all of the animal studies I had been able to find, with the following summary- “Of these ten studies, 5 found no effect at all, and 2 others showed mixed results, with possible effects in some measures evaluated in the studies but not in others. Of the three fully positive studies, two did not report any of the major methods for controlling for possible bias and other sources of error.”

New Evidence
Given it has been seven years since I last addressed the topic, I took a look for new animal studies done since then, and I have found several, which I will review here.

  1. Tansey C, Wiebe ML, Hybki GC, Patlogar JE, Murphy LA, Bianco D, Nakamura RK. A prospective evaluation of oral Yunnan Baiyao therapy on thromboleastographic parameters in apparently healthy dogs. J Vet Emerg Crit Care (San Antonio). 2018;28(3):221-225. 

This study evaluated laboratory measures of blood clotting in 18 apparently healthy dogs of various breeds (mostly large dogs, with an average size of over 60lbs). All dogs received 250mg of the product twice a day (5.8–13.4 mg/kg) for 1 week, with no blinding or control group. A large number of in vitro measures of clotting were evaluated (see the table) with a few statistically significant changes from baseline.

  • “TEG changes consistent with increased clot strength and reduced fibrinolytic activity. may suggests that YB produced an increased in clot strength, although these parameters remained within the reference interval.” 
  • “YB also apparently reduced fibrinolytic activity as evident by the significantly reduced values for LY30 and LY60 noted at 1 week recheck; changes in these parameters remained within the reference range as far as we could determine.”

No significant changes were seen in any other measures, including those related to platelet function, which has previously been claimed to be the suspected mechanism by which YB might affect clotting. The authors pointed out that these results were inconsistent with a previous study in beagles (Lee, 2017) and suggested the differences could be due to different methods for testing blood clotting or differences in the YB products used since there is very little consistency and no reliable quality control guidelines for the production of Chinese herbal medicines.

No apparent adverse effects were noticed.

2. Patlogar JE, Tansey C, Wiebe M, Hybki GC, Trostel T, Murphy LA, Nakamura RK. A prospective evaluation of oral Yunnan Baiyao therapy on thromboelastographic parameters in apparently healthy cats. J Vet Emerg Crit Care (San Antonio). 2019;29(6):611-615.

The same group also conducted a very similar study in cats. Seventeen healthy cats were enrolled, and most received the same 250mg dose of YB twice a day for a week, a much higher dose relative to body weight than the dogs were given (31.71–90.91 mg/kg). 

No significant changes in any of the numerous measures of blood clotting were seen in these cats. However, the cats receiving YB did have a significant decrease in their red blood cell count (HCT) and a close-to-significant decrease in weight. Once cat dropped out due to severe vomiting after receiving YB, and two others has some vomiting but were able to complete the study. Though the HCT remained in the reference range, these changes suggest that YB at this dose could have detrimental effects on cats especially if given for a longer time.

3. Rodriguez A, Shiau D, Levinson K, et al. Preoperative oral administration of Yunnan Baiyao and its effect on coagulation parameters in tick-borne disease and/or heartworm seropositive dogs: A pilot study. Am J Trad Chin Vet Med 2021; 16(2):23-30.

In a rather odd study, published in a journal dedicated to so-called Traditional Chinese Veterinary Medicine (TCVM), 12 dogs scheduled for neutering and also known to be positive for antibodies showing exposure to several tickborne diseases or canine heartworm disease (though actual infection was not determined) were given YB. The rationale was that these patients might be more likely to bleed during surgery, though there is limited evidence showing this.

The dogs were randomly divided into equal groups to receive either YB or a placebo, and some individuals were blinded to treatment, though it is not clear if this included those running the tests, doing the surgery and estimating blood loss, or analyzing results. The dogs were given approximately 100mg/kg every 12 hours for three doses. 

Multiple lab tests assessing clotting were run, and a visual estimate was made of blood loss during surgery. No statistically significant differences were seen in any measure except for a decrease in prothrombin time (an indicator of increased clotting ability) in the placebo group. The authors interpret the non-significant differences seen as suggesting, on the whole, a pro-clotting effect, but in a small study with no statistically significant results, this is only a hypothesis, not a valid conclusion. 

4. Oakley C. Bruyette D. Chretin J. Hazzah T. Bergman P. Thromboelastography to evaluate coagulation changes in dogs on Yunnan Baiyao with hemangiosarcoma: a pilot study. J Amer Hol Vet Med Assoc. 2021;64:49. 

I have not been able to obtain a full-text copy of this article, published in the rather notoriously unscientific journal of the American Holistic Veterinary medical Association, so I cannot properly evaluate the methods. Based on the abstract alone, this was a double-blinded crossover study of 19 dogs with confirmed (14) or suspected (5) HSA. The dogs were given the chemotherapy agent doxorubicin and then 60mg/kg per day of a YB product or a placebo. At 21 days, the dogs were switched from one treatment (YB or placebo) to the other. Multiple blood tests were run at baseline and days 7, 21, 28, and 42 of treatment.

The handful of statistically significant findings reported in the abstract are difficult to interpret without additional information. Some differences between groups were seen in some measures on some days that might suggest a pro-clotting effect, but whether there was an overall pattern suggesting a real effect, and whether this was clinically relevant to the dogs, is unclear. 

The final statements of the abstract suggest that a real effect is unlikely since the changes seen were not consistent when the dogs were switched from one treatment to the other:

Although patients on YB in the first leg of the study were more hypercoagulable and patients on YB in the second leg of the study had a higher red cell count than those on placebo, these findings were not repeatable via crossover. TEG did not detect consistent coagulation changes as it relates to treatment with YB. 

Based on assessment of these new studies, I have updated by tabulation of animal study results:

What Does It All Mean?
This brings the total of studies I have seen to 14. Of these, a majority (8) are clearly negative, and the others mostly show mixed results. Many have significant methodological limitations that make the real-world relevance of their findings questionable. 

There is also inconsistency in the results between studies. Positive findings in one are often contradicted by negative results in another. Despite decades of animal research, no consistent pattern has emerged showing even a clear and verifiable mechanism of action, much less any meaningful clinical benefits in real patients. 

While few studies have reported significant negative side-effects (except for the relatively high-dose study in cats), the available literature does not convincingly address significant concerns about safety. The composition of YB in general, much less individual products or different batches of the same product, is not clearly established, and there is no meaningful quality control to ensure consistency or the absence of harmful contaminates. There is a large literature showing that Traditional Chinese Medicines often contain dangerous ingredients or contaminates (e.g. 1, 2), which cause significant harm to patients (e.g. 3, 4), and there is no assurance that YB is free of these.  The blithe assumption of safety for supposedly “natural” herbal products is unjustified, and the idea that no harm can be done in patients with advanced neoplasia has also been shown to be wrong (e.g. 5).

The literature evaluating YB has also never provided a cogent answer to the question of how promoting clotting, if the product even does this, could occur without a meaningful risk of thromboembolic events (undesirable clots such as those seen in strokes in humans and in feline aortic thromboembolism in cats with heart disease). If YB increases clot formation enough to meaningfully reduce bleeding, even the serious life-threatening hemorrhage seen in dogs with HSA, how does it do this without causes unwanted clots? The idea that you can have benefits without risks is common in alternative medicine, but science-based medicine knows better, and so should we as vets. 

When a product has been studied for over 40 years without showing even a clear and consistent effect, much less a meaningful clinical benefit, there is little justification for using it in our patients. Further and better research may be justified, though on pretty tenuous grounds at this point, but at this point we are rolling the dice blindly every time we give YB to a patient. If we are not clear about this uncertainty with clients, then we are misleading them and denying them the basic right to fully informed consent. The psychological drive to grasp at straws when we are desperate is powerful and understandable, but it is not a rational or appropriate basis for the practice of medicine.

References
Ogle CW, Soter D, Cho CH (1977) The haemostatic effects of orally administered yunnan bai yao in rats and rabbits. Comparative Medicine East and West 5:2, 155-160

Ogle CW, Dai S, Ma JC. The haemostatic effects of the Chinese herbal drug Yunnan bai yao: A pilot study. Am J Chin Med (Gard City N Y) 1976;4:147–152.

Graham L, Farnsworth K, Cary J (2002) The effect of yunnan baiyao on the template bleeding times and activated clotting times in healthy ponies under halothane anesthesia.Journal of Veterinary Emergency and Critical Care 12:4; 279; 2002 (abstract only)

Epp TS, McDonough P, Padilla DJ, et al. The effect of herbal supplementation on the severity of exercise-induced pulmonary haemorrhage. Equine and Comparative Exercise Physiology 2005;2:17-25.

Fan C, Song J, White CM. A comparison of the hemostatic effects of notoginseng and yun nan baiyao to placebo control. J Herb Pharmacother 2005;5:1–5

Murphy LA, Panek CM, Bianco D, Nakamura RK. Use of Yunnan Baiyao and epsilon aminocaproic acid in dogs with right atrial masses and pericardial effusion. J Vet Emerg Crit Care (San Antonio). 2016 Sep 26. doi: 10.1111/vec.12529. [Epub ahead of print]

Frederick J, Boysen S, Wagg C, Chalhoub S. The effects of oral administration of Yunnan Baiyao on blood coagulation in beagle dogs as measured by kaolin-activated thromboelastography and buccal mucosal bleeding times. Can J Vet Res. 2017 Jan;81(1):41-45.

Lee A. Boysen SR. Sanderson J. et al. Effects of Yunnan Baiyao on blood coagulation parameters in beagles measured using kaolin activated thromboelastography and more traditional methods. International Journal of Veterinary Science and Medicine. 2017;5(1):53–56.

MacRae R. Carr A. The Effect of Yunnan Baiyao on the Kinetics of Hemostasis in Healthy Dogs. ACVIM  Forum, National Harbor, MD, 2017.

Adelman L. Olin S. Egger CM. Stokes JE. Effect of Oral Yunnan Baiyao on Periprocedural Hemorrhage and Coagulation in Dogs Undergoing Nasal Biopsy. ACVIM Forum, National Harbor, MD, 2017.

Tansey C, Wiebe ML, Hybki GC, Patlogar JE, Murphy LA, Bianco D, Nakamura RK. A prospective evaluation of oral Yunnan Baiyao therapy on thromboleastographic parameters in apparently healthy dogs. J Vet Emerg Crit Care (San Antonio). 2018;28(3):221-225.

Patlogar JE, Tansey C, Wiebe M, Hybki GC, Trostel T, Murphy LA, Nakamura RK. A prospective evaluation of oral Yunnan Baiyao therapy on thromboelastographic parameters in apparently healthy cats. J Vet Emerg Crit Care (San Antonio). 2019;29(6):611-615.

Rodriguez A, Shiau D, Levinson K, et al. Preoperative oral administration of Yunnan Baiyao and its effect on coagulation parameters in tick-borne disease and/or heartworm seropositive dogs: A pilot study. Am J Trad Chin Vet Med 2021; 16(2):23-30.

Oakley C. Bruyette D. Chretin J. Hazzah T. Bergman P. Thromboelastography to evaluate coagulation changes in dogs on Yunnan Baiyao with hemangiosarcoma: a pilot study. J Amer Holistic Vet Med Assoc. 2021;64:49.

Posted in Herbs and Supplements | 1 Comment

Strategies for Helping Aging Dogs Today &Tomorrow

Posted on June 27, 2024 by skeptvet

Here is a talk I gave at AVMA last week. Lot of folks attended, and lots of good followup questions!

Posted in Aging Science | Leave a comment

Risk Factors for Arthritis in Dogs

Posted on June 24, 2024 by skeptvet

Last year, I participated in a research project evaluating risk factors for the diagnosis of osteoarthritis in dogs, using the large dataset in the Banfield medical records system. The research was published in November, 2023-

Graves JL, McKenzie BA, Koch Z, Naka A, Spofford N and Morrison J (2023) Body weight, gonadectomy, and other risk factors for diagnosis of osteoarthritis in companion dogs. Front Vet Sci 10:1275964.

This week, Dr. JoAnn Morrison from Banfield and I had the opportunity to present our research at the annual American Veterinary Medical Association convention. While this sort of research is not as drastic or “media-friendly” as reports of astonishing new discoveries, it is a critical foundation for understanding the health conditions our pets experience and how we can best identify and treat them or, ideally, prevent them.

RISK FACTORS FOR DEVELOPMENT OF OSTEOARTHRITIS IN COMPANION DOGS: RESULTS OF A LARGE RETROSPECTIVE STUDY 

BASICS OF OSTEOARTHRITIS
Osteoarthritis (OA) is the most common joint disorder in dogs, and it contributes significantly to pain, disability, and ultimately euthanasia in aged dogs.1,2 The reported prevalence of OA varies between populations, and differences in methodology between studies make direct comparisons of these figures challenging. Prevalence of OA from 2.5% to over 80% have been reported, depending on factors such as the age of the population and how the condition is detected.1,3,4

The prevalence will be higher in older populations because OA is an incurable condition and so will be present and available for diagnosis longer as dogs age. It is also progressive and more likely to become clinically apparent over time. The condition is typically detected earlier and more frequently with radiographs compared with diagnosis based on clinical examination or symptoms, such as lameness. However, while radiographs are more sensitive, they may not accurately reflect the clinical significance of OA.5 By any measure, however, OA is a common condition with significant impact on quality of life.

Previous studies have reported a large and varied set of potential risk factors for OA.3 Age is the strongest and most consistent of these, reflecting the nature of OA as chronic, progressive, and an aging-associated condition. Higher body weight is also frequently identified as predictive of a higher risk of OA diagnosis. However, the relative importance of body size, body condition, or some interaction between the two, is not always clear. Both larger dogs and dogs with overweight or obese body condition appear to be at higher risk.3,6

Breed is another common risk factor, though again the contributions of body size, conformation, precipitating conditions (such as joint dysplasia or a predisposition to cranial cruciate ligament rupture), and genetics are often entangled. Neuter status, sex, activity, diet, and many other factors have been associated with OA risk in some studies. These associations are often of uncertain clinical relevance, and there are frequently conflicting findings from different studies.3,6

Complex interactions between multiple factors likely influence the development and severity of OA in any one dog. However, a clearer understanding of the main risk factors, especially those which could potentially be modified in individuals or altered through breeding in populations, would help veterinarians reduce the harmful impact of this condition on the welfare of companion dogs. 

THE STUDY AND THE DATA
In this retrospective cohort study, Cox proportional hazard models were used to test for associations between osteoarthritis incidence and age at baseline, sex, maximum body weight, maximum body condition score, neuter status, and age at neutering. The same model was used to test these associations in 12 representative breeds, chosen based on breed weight and sample size.

THE RESULTS
Older age, higher adult body weight, gonadectomy, and younger age at gonadectomy were significantly associated with higher risks of osteoarthritis in the total cohort and in all 12 breeds evaluated. Higher body condition scores and sex were also significantly associated with osteoarthritis but with minimal effect sizes in the overall cohort, and these risk factors were not consistently significant in all breeds tested.

CLINICAL IMPLICATIONS
The results of this study confirm that OA is commonly diagnosed in companion dogs seen in primary care practice. The strongest risk factor by far was age, consistent with expectations based on previous research. Aging is currently not seen as a modifiable risk factor, but research in various species, including dogs, suggests that interventions may be developed which can alter the underlying aging process and delay or prevent some age-associated conditions, including OA. One study in Labrador retrievers found that alterations in metabolism and body composition in dogs exposed to lifelong caloric restriction were associated with delayed onset of radiographic and clinical joint disorders.7,8 Novel approaches involving diet, exercise, and pharmaceuticals may be developed to capture these benefits in  more targeted and pragmatic interventions.

The current study also supported the importance of body weight as a risk factor for OA.  Higher body weight was significantly associated with increased risk, as was an increase in weight after full growth, which likely represented development of overweight or obesity. Larger dogs were at greater risk overall, and they were more significantly impacted by increased weight after maturity. 

Body condition score (BCS) was also associated with an increased risk of OA diagnosis, but the magnitude of this effect was small. This is likely not an indication that overweight and obesity are not important risk factors but rather that there are significant limitations of BCS as a measure of this variable. In this study, over 80% of dogs were categorized as BCS=5 (normal weight) or BCS=7 (overweight). This limited range of scores reduced the sensitivity of BCS as a measurement tool. 

BCS was a stronger predictor of OA diagnosis in smaller dogs, and there was also a wider range of scores assigned in these dogs, suggesting it may be easier for veterinarians to distinguish gradations of body condition in smaller patients. Developing more object and consistent alternatives to BCS as measures of overweight and obesity might make it easier to disentangle the relationships between body weight, body size, body condition, and OA risk.

Obviously, body condition is an important modifiable risk factor for clinicians to target. Overweight and obesity are risk factors for all-cause mortality, neoplasia, and other health conditions as well as for OA, so supporting clients in achieving a lean body condition in their dogs is a critical effort for reducing the prevalence of these conditions and improving companion dog welfare.9,10

Neuter status has been consistently identified as a risk for OA, with intact individuals at lower risk than neutered dogs.3 There is also evidence that earlier neutering is associated with an increased risk of OA and conditions predisposing to OA, though this effect is sometimes only significant in larger dogs. Consistent with this existing literature, the current study found neutered individuals were at higher risk of OA in large and medium dogs and in some, but not most, small breeds. Younger age at neutering was also associated with OA risk, though this effect diminished rapidly after 2 years of age. This relationship was found in dogs of all sizes, so the increased risk associated with earlier neutering did not appear to impact larger dogs more than smaller breeds. 

Neutering is another potentially modifiable risk factor for OA. Owners can choose whether or not to neuter their dogs and at what age to perform the procedure. The existing evidence is consistent that delaying or forgoing neutering likely reduces the risk of OA later in life. However, the exact relationship between neuter status and OA is not clear. 

Neutering does promote overweight and obesity, and it has been associated with increased risk of conditions that predispose to OA, such as cranial cruciate ligament rupture. In this study, the effect of body weight gain after maturity on OA risk was not different between intact and neutered dogs, so it did not appear that obesity was the main factor raising OA risk in neutered dogs. One previous study also suggested that obesity mediated only a small proportion of the increased OA risk associated with neutering.11 There remains, however, significant uncertainty about the exact nature of the relationship between neuter status, age at neutering, and OA. 

Based on the existing evidence, it is reasonable to consider delaying neutering until full skeletal maturity or perhaps up to two years of age, especially in larger dogs. However, discussions about this between vets and clients must include the larger context of all the known risks and benefits of neutering.12,13 The net effect of neutering on the health and wellbeing of an individual dog is difficult to predict and will involve the influence of many other variables. Increased OA risk is only one consequence of neutering, and neuter status is only one of many factors associated with the development of OA. As always, clinical decisions should consider the complete and nuanced relationship between risks and benefits in the context of each individual patient.

Sex has been inconsistently reported as a risk factor for OA in previous research. In this study, males were at statistically lower risk than females, but the effect was small and likely not clinically meaningful. There were also breed differences in OA risk, and these were generally consistent with the pattern of larger breeds being at greater risk. 

Breed is a complex risk factor involving differences in genetic makeup, body size and conformation, and potentially also lifestyle variables influenced by owners, such as feeding practices and the type and intensity of activity. Because of the enormous phenotypic variability among dogs, evaluation of the role of body weight in OA risk can easily confound the effects of body size and breed with those of overweight and other breed differences. This study confirmed the previously reported influence of body size on OA risk. Beyond that, other relevant breed variables were not examined.

Sex is, of course, not a modifiable OA risk factor in dogs. Breed may be modifiable on a population level to the extent that genetic risk factors and conformation can be impacted by selective breeding. However, from a clinical perspective, these factors are fixed and can only be factored into the overall assessment of risk for individual patients, not targeted to reduce risk.

There are many other risk factors for OA that were not evaluated in this study. Month of birth, level and type of activity during development, diet, and factors associated with the individual patient’s medical history, such as trauma and infectious diseases, are all potentially relevant to overall OA risk.3 The findings of this study, however, reinforce some of the most significant factors that clinicians can use to assess and modify OA risk in specific patients. 

Maintaining a healthy body weight will certainly benefit all dogs. Delaying neutering may reduce the development of OA, particularly in larger dogs and those with other factors that put them at increased risk. In dogs that are at high risk due to size, breed, body condition, or personal history, more aggressive surveillance and treatment may be beneficial. As with all significant health conditions, OA risk must be evaluated and managed within the overall context of the specific case and with awareness of the nuances and uncertainties of the available evidence.

TAKE-HOME POINTS

  • OA is a common and serious condition that negatively impacts the welfare of many older companion dogs
  • Major risk factors for OA include
    • Older age
    • Larger body size
    • Overweight or obese body condition
    • Neutering
    • Earlier age at neutering
  • The most important intervention for reducing OA risk is maintaining a healthy body condition
  • Delaying neutering until full maturity or up to two years of age may reduce OA risk
    • This intervention should be considered in the context of the overall risk and benefit profile for each individual patient

REFERENCES

1. O’Neill DG, James H, Brodbelt DC, Church DB, Pegram C. Prevalence of commonly diagnosed disorders in UK dogs under primary veterinary care: results and applications. BMC Vet Res. 2021;17(1):1-14. doi:10.1186/S12917-021-02775-3/TABLES/2

2. Robinson NJ, Dean RS, Cobb M, Brennan ML. Investigating common clinical presentations in first opinion small animal consultations using direct observation. Vet Rec. 2015;176(18):463-463. doi:10.1136/VR.102751

3. Anderson KL, O’Neill DG, Brodbelt DC, et al. Prevalence, duration and risk factors for appendicular osteoarthritis in a UK dog population under primary veterinary care. Sci Rep 2018 81. 2018;8(1):1-12. doi:10.1038/s41598-018-23940-z

4. Johnston SA. Osteoarthritis. Joint anatomy, physiology, and pathobiology. Vet Clin North Am Small Anim Pract. 1997;27(4):699-723. doi:10.1016/S0195-5616(97)50076-3

5. Millis D, Tichenor MG, Hecht S, Hunt T. Prevalence of Osteoarthritis in Dogs Undergoing Routine Dental Prophylaxis. In: World Small Animal Veterinary Association World Congress Proceedings. ; 2014.

6. Graves JL, McKenzie BA, Koch Z, Naka A, Spofford N, Morrison J. Body weight, gonadectomy, and other risk factors for diagnosis of osteoarthritis in companion dogs. Published online August 3, 2023:2023.08.03.550998. doi:10.1101/2023.08.03.550998

7. Huck JL, Biery DN, Lawler DF, et al. A Longitudinal Study of the Influence of Lifetime Food Restriction on Development of Osteoarthritis in the Canine Elbow. Vet Surg. 2009;38(2):192-198. doi:10.1111/J.1532-950X.2008.00487.X

8. Kealy RD, Lawler DF, Ballam JM, et al. Five-year longitudinal study on limited food consumption and development of osteoarthritis in coxofemoral joints of dogs. J Am Vet Med Assoc. 1997;210(2):222-225.

9. Marchi PH, Vendramini THA, Perini MP, et al. Obesity, inflammation, and cancer in dogs: Review and perspectives. Front Vet Sci. 2022;9:1004122. doi:10.3389/fvets.2022.1004122

10. Salt C, Morris PJ, Wilson D, Lund EM, German AJ. Association between life span and body condition in neutered client-owned dogs. J Vet Intern Med. 2019;33(1):89-99. doi:10.1111/jvim.15367

11. Simpson M, Albright S, Wolfe B, et al. Age at gonadectomy and risk of overweight/obesity and orthopedic injury in a cohort of Golden Retrievers. PLOS ONE. 2019;14(7):e0209131. doi:10.1371/journal.pone.0209131

12. McKenzie B. Evaluating the benefits and risks of neutering dogs and cats. CABI Rev. 2010;2010:1-18. doi:10.1079/PAVSNNR20105045

13. Hart BL, Hart LA, Thigpen AP, Willits NH. Assisting Decision-Making on Age of Neutering for 35 Breeds of Dogs: Associated Joint Disorders, Cancers, and Urinary Incontinence. Front Vet Sci. 2020;7:388-388. doi:10.3389/FVETS.2020.00388/BIBTEX

Posted in Aging Science, Presentations, Lectures, Publications & Interviews | 13 Comments

Age of Endarkenment: Medical Misinformation & What Vets Can Do About It

Posted on June 12, 2024 by skeptvet

Obviously, the whole purpose of the SkeptVet is to combat misinformation and to promote evidence-based pet health. I first used the term Age of Endarkenment in a post for the much more influential Science-Based Medicine blog. Then, I was focused on the relatively narrow issue of the AVMA being unwilling to acknowledge the clearly evidence fact that homeopathy is useless pseudoscience and that vets shouldn’t offer it to clients (you can refresh yourself on the whole sorry saga in these posts).

When I was honored with the VIN Veritas Award, I was invited to give a rounds presentation on the Veterinary Information Network (unfortunately, you’ll need to be a member to view this). I used the opportunity to expand on the underlying cultural currents that have led to an apparent explosion in misinformation and mistrust of science, and to compare these to the principle soft the Age of Enlightenment, which underlie the achievements and progress science has brought to many fields, including healthcare.

I have since given a shortened version of this talk at the Western Veterinary Conference, and I will be giving this again at PacVet in San Francisco next month. Here is the slide deck and a summary of the talk.

WHAT IS THE DISEASE?
Mistrust of science and science-based medicine, as well as misinformation, pseudoscience, and false beliefs around medical topics have been around as long as science as a method for understanding nature has been around. We are currently in a moment when these problems are growing and spreading, and this threatens the health and wellbeing of humans and animals.

Misinformation is, by definition, information that is incorrect, not true. This may be a claim that is completely incorrect – for example, the assertion that vaccines are the cause of autism in children – or it may be something that is partially correct or even wholly correct, but in some way is misleading. The notion that vaccines have side effects is perfectly correct, for example. The notion that those side effects are far greater than their benefits is not correct. Misinformation can have elements of truth in it.

How do we know what is true or not true in terms of medical information? Ideally, we base that decision on the best current scientific evidence. Science is the best method that we have for understanding what’s true about nature and what’s not. Unfortunately, we can’t all be experts in every area of science or even every area of medicine. We do, to some extent, have to rely on the consensus of people who are experts in that area. This is probably the most problematic issue because people are often skeptical of experts, and we don’t like to be told what to think. We like to have our intellectual independence, which is a good virtue but gets us into trouble when we think the 20 minutes on the internet makes us an expert in any and all topics.

To deal with misinformation, we have to accept the fundamental premise that there are things that are true and things that are false, that science is probably the best way to distinguish those, and that sometimes we have to rely on the consensus of experts in a field to tell us what the truth is when we aren’t able to necessarily make that judgment ourselves.

HOW BAD IS IT?
The good news is that most people actually do trust science. If you survey people around the world, there are pretty high levels of trust in the things that scientists say about the natural world. That is still the majority of people almost everywhere.

People in particular trust medical scientists, especially doctors, and nurses. There are high levels of confidence in what medical people say about health and disease. Even though there is sometimes a worrisome degree of mistrust, we shouldn’t forget that the majority still think that scientists and medical scientists know what they’re doing and are on their side. This applies to veterinarians and veterinary technicians and nurses as well.

Unfortunately, mistrust and misunderstanding of science is still quite common. Here are some survey findings that should be very disturbing:

  • 36% of people only believe in scientific claims when they align with beliefs they already have for other reasons. In the same survey1
  • 35% of people feel science can be used to produce any conclusion the researcher wants. The idea that science is not actually a method for generating knowledge or understanding but rather a propaganda tool undermines confidence in scientific information needed to make sound decisions, as individuals and societies.2
  • About one-third of people felt that if science didn’t exist at all, their everyday lives wouldn’t be that different.1
  • As many as 15-20% of adults in the U.S. believe vaccines probably or definitely cause autism, despite decades of robust scientific evidence showing that this is not true.2

WHAT IS THE CAUSE?
Idols of the Tribe & the Cave- Psychological Causes
These are errors we make either because of how our brains function in general as a species, or particular sources of error that we have as individuals based on our personal experiences and inclinations.

Cognitive biases are systematic pattern of thinking arising from intrinsic features of our cognitive mechanisms. Research in psychology has uncovered an enormous number of cognitive biases that all human beings are prone to. These errors arise from faults in our memory, from quirks in how we direct our attention, and from the influence of our beliefs, desires, and expectations on what we observe. Many of these errors have direct relevance to clinical decision-making, and much of the methodology of science and evidence-based medicine (EBM) is designed specifically to correct for them.3

Logical fallacies are another psychological error source. These are arguments that are wrong, they’re invalid, and they don’t work – but they feel intuitively right and so are very hard to overcome. One example is the “false cause” fallacy. This states that if one event precedes another, the first event likely caused the second. The case of vaccines and autism is a paradigmatic example. Because children get vaccinated around the same time that autism symptoms emerge, there is a correlation in time. Because of the powerful force of this fallacy, it is very difficult to convince people this relationship isn’t causal despite strong evidence against it.

Idols of the Theater- Sociocultural Causes
Our beliefs about scientific topics are part of a larger understanding of the world we inhabit, and these beliefs are influenced by others. There is a strong psychological and social drive to keep all of these beliefs as consistent and coherent as possible and not to threaten our sense of belonging in social groups by challenging beliefs associated with membership. Political affiliation and religious beliefs are the predominant sociocultural influences that alter our views on scientific topis regardless of the objective evidence. These influences can often be quite arbitrary, and change over time. 

A powerful recent example is the shift in views of science over the last forty years. In the 1970s, people with politically conservative affiliations tended to be strongly pro-science, associating science and technology with economic growth and military power. Those further to the left politically tended to be suspicious of science, as they were suspicious of industry and the military, and favorably inclined to alternative medicine and related ideas. This relationship has shifted dramatically, and today those professing a conservative political view are more likely to doubt science and scientific experts whereas slogans such as “Trust the Science” have become more common on the political Left. It is not science or scientific evidence which has changed, but the relationship between science and political identity.

Idols of the Marketplace- The Information Ecosystem
While it is by no means the only factor, there is no question that the internet plays a role in the growth of mistrust and misinformation about science. Social media, in particular, is driven by engagement. The algorithms, which prioritize some content and deprioritize other content, particularly amplify the extremes and controversy. Inflammatory content generates more active engagement, positive or negative, than more neutral or nuanced, fact-based content. Because of this, misinformation spreads faster and reaches more people than facts.

The internet also facilitates the creation of echo chambers. We now have the option of selecting our information sources at a very granular level so that we need not ever be bothered by information that contradicts our views if we don’t want to. This makes it very easy for us to become convinced that our beliefs, however mistaken or contrary to the evidence, are widely shared because the only people we interact with are people who think the same way. This amplifies misinformation, increases confidence in false beliefs, and locks people away from information that might challenge them and cause them to rethink.

WHAT IS THE HARM?
The World Health Organization has a whole set of resources to combat what it calls the “Infodemic-”  the flood of information available to the public during a public health crisis. The U.S. Surgeon General also issued a report in 2021 address the critical importance of combatting misinformation and mistrust about public health.

The COVID pandemic was a strong example of an infodemic. Information was so voluminous that it overwhelmed people, and some began to tune out entirely, thereby missing important messages from reliable sources. There was also a lot of misinformation, and a lot of contradiction, which is confusing. All of that led to poor decision-making on the part of individuals and groups. 

An analysis from the Brown School of Public Health estimated as many as 300, 000 adults in the United States died of COVID who would not have died had everyone eligible for the vaccine got it when it was available. The study also found that those individuals exposed to misinformation about vaccines were significantly less likely to be vaccinated, leading to an increased morbidity and mortality risk.

Mistrust and myths about science also harm those in science-based professions. Healthcare providers and public health officials have been subjected to historic levels of abuse, threats, and even violence from people misled into believing that the healthcare professions are a threat to them. This has exacerbated the flight from these fields and the resulting scarcity of healthcare services and public health expertise.


WHAT IS THE CURE?
There is no cure. Many of the roots of these problems are intrinsic to human cognition and social behavior, and those causes will almost certainly stay with us. However, there are treatments, measures we can take to build and maintain public trust in science and mitigate the harm misinformation does. These are the steps I recommend for veterinarians to combat this problem:

  1. Be an expert
  2. Understand misinformation and mistrust
  3. Be an effective communicator
  4. Show Up!

Veterinarians have extensive knowledge of science and medicine. Building and maintaining this knowledge base through conscientious, evidence-based medicine practices and then sharing this with our colleagues and clients is a natural and critical part of our role. Information challenging misinformation is most potent when it comes from trusted sources, and we are among the most trusted professions.

Understanding the causes of mistrust and false beliefs is necessary to combat them. If we write off people who distrust science or question our recommendations as stupid or hopeless, we cede the field to those who mislead them. Understanding how people find and maintain anti-science beliefs helps us immunize and treat them.

Likewise, understanding what makes for effective science communication gives our input more impact. There are many resources available to help us learn effective science communication skills, with clients and as members of our personal and professional communities. 

Finally, we can have no impact if we don’t participate in the conversation. Be an advocate for your patients and your clients, so that they aren’t misled into things that are harmful. Be and advocate for your colleagues, and support them when they’re attacked and abused for saying things that are appropriate and truthful. Be and advocate for your community; participate in conversations about scientific issues in your community because you have a voice, and it’s an important one, and it can make a difference.

KEY “TAKE HOME” POINTS

  1. Misinformation and mistrust of science is widespread and growing
  2. The roots of this problem are many and complex. The main categories are
    1. Psychological causes intrinsic to how our brains operate
    1. Sociocultural causes related to our group affiliations
    1. Ideologies and belief systems that influence how we interpret information about scientific subjects
    1. The information ecosystem and how it prioritizes engagement and emotion over evidence
  3. Misinformation leads to poor individual and community decision making, with serious negative consequences for the health and wellbeing of individuals and society. It also encourages abuse and burnout among healthcare professionals, reducing our quality of life and the availability of these critical services.
  4. There is no single answer to the problem. Veterinarians can help to support science and combat misinformation by
    1. Developing and maintaining our science-based expertise
    1. Understanding the causes of mistrust and the factors that support medical misinformation
    1. Learning to be effective communicators about science
    1. Actively participating in the discussion and using our expertise and position of trust for the good of our patients, colleagues, and communities.

REFERENCES

  1. 3m. State of Science Index: 2020 Global Report. 2020. Accessed at: https://multimedia.3m.com/mws/media/1898512o/3m-sosi-2020-pandemic-pulse-global-report-pdf.pdf
  2. Pew research center survey. 2022. Accessed at: https://www.pewresearch.org/science/2022/02/15/americans-trust-in-scientists-other-groups-declines/
  3. McKenzie, BA. Veterinary clinical decision-making: cognitive biases, external constraints, and strategies for improvement. J Amer Vet Med Assoc. 2014;244(3):271-276.
  4. Misinformation Resources discussed or cited in this presentation.

Posted in Presentations, Lectures, Publications & Interviews | 2 Comments