Overdiagnosis is now recognized as a common and serious problem in human medicine that causes substantial harm in terms of unnecessary costs, wasted resources, and patient and caregiving suffering. International conferences (e.g. Preventing Overdiagnosis) and special features in major medical journals (e.g. Too Much Medicine in the British Medical Journal and Less is More in the AMA journal) have been dedicated to discussions of overdiagnosis and overtreatment. In 2012, a consortium of 70 specialty groups created the online resource Choosing Wisely to help physicians and patients make evidence-based decisions that reduce overdiagnosis and overtreatment. Even an influential popular book has been written on the subject: Overdiagnosed: Making people sick in the pursuit of health.

Changes in clinical practice guidelines and public education strategies have resulted from the growing recognition of the risk of overdiagnosis in human medicine, including highly publicized changes in recommendations for prostate cancer screening in men and breast cancer screening in women.

However, there seems to be little discussion in the veterinary literature or veterinary curriculum of the problem of overdiagnosis and the risks it poses to veterinary patients. In the past, IK have discussed the evidence regarding potential sources of overdiagnosis in veterinary medicine, such as pre-anesthetic blood testing (also c.f. 1, 2). However, among veterinarians and animal owners, there seems to be a near total lack of awareness of the fact that sometimes testing for and diagnosing a condition can actually lead to a worse outcome for the patient than not diagnosing it.

This is a counterintuitive idea, but it is well-established in human medicine.  Changes in guidelines for prostate cancer screening, breast cancer screening, thyroid cancer testing, and many other conditions have come about because of the recognition that inappropriately targeted diagnostic tests can harm patients and waste resources on treatments that do not make people better. It is time we took a serious look at this issue in veterinary medicine, and made an effort to collect the data needed to understand its scope and causes so that we can better serve our patients. Since I was unable to find virtually any discussion of the subject in the veterinary literature, I have written a commentary raising the subject, which I hope will stimulate needed discussions on this topic.

McKenzie, BA. Overdiagnosis. Journal of the American Veterinary Medical Association. 2016:249(8);884-889.


Posted in General, Science-Based Veterinary Medicine | 2 Comments

Evidence Update- Yunnan Baiyao: Still No Persuasive Evidence of any Benefits

Back in 2010, in the early days of this blog, I reviewed the evidence for the Chinese herbal supplement Yunnan Baiyao. At the time, I found only very low-quality evidence concerning the potential risks and benefits of this product.  Some in vitro studies suggested possible mechanisms by which the product might help limit bleeding. However, clinical trials were sparse, low quality, and often at high risk of bias. Many studies have been conducted in China, and these must be viewed very skeptically given that past reviews have found extreme publication bias for alternative medicine studies in China (one review found absolutely no negative studies were published there), and a recent investigation by the Chinese government found up to 80% of drug trials published there were fraudulent or otherwise unreliable. Also deeply concerning was the fact that the company producing the product refuses to disclose its exact ingredients.

So the bottom line in 2010 was that Yunnan Baiyao is an unregulated and largely untested secret recipe, and it is unclear how it can have its purported effect, stopping bleeding, without having any potential risks, including most obviously excessive blot clotting, which is the cause of strokes and other serious medical problems. So what new information is there since 2010?

There have been a few additional studies published, but they tend to fit the profile of those already available five years ago: mostly from China and mostly not clinical trials with robust design and execution. A couple of new studies have been published directly related to veterinary use.


Shmalberg J, Hill RC, Scott KC. Nutrient and metal analyses of Chinese herbal products marketed for veterinary use. J Anim Physiol Anim Nutr (Berl). 2013 Apr;97(2):305-14

This study evaluated the nutrient and metal content of a number of Chinese herbal products, including Yunnan Baiyao. The Yunnan Baiyao did contain potentially toxic heavy metals,  such as lead, though the single batch tested suggested the levels were probably not high enough to cause illness, at least at typical doses over a limited period of time.


Wirth KA, Kow K, Salute ME, Bacon NJ, Milner RJ. In vitro effects of Yunnan Baiyao on canine hemangiosarcoma cell lines. Vet Comp Oncol. 2016 Sep;14(3):281-94.

This study found that Yunnan Baiyao could kill cells of the canine cancer hemangiosarcoma in vitro. This kind of study is a necessary precursor to clinical testing of drugs, but it is important to point out that it says nothing about whether the substance tested would be useful in actual patients. Bleach, for example, kills cancer cells in vitro, but that doesn’t make it a useful cancer drug.


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]

This study actually evaluated a common clinical use for Yunnan Baiyao. Dogs with tumors on the right atrium of the heart and fluid in the pericardium, the sac around the heart, almost always have a type of cancer known as hemangiosarcoma. This cancer typically lodges in places like the spleen, liver, or heart, and it usually causes severe bleeding. The conventional therapies available aren’t very effective, and most dogs with this disease die or are euthanized within a few days to a few months. As always, there are exceptions who survive much longer, but generally the outlook for this disease is poor, especially for the form that occurs in the heart.

The lack of highly effective conventional treatment makes this disease a popular target for alternative therapies, and Yunnan Baiyao has come to be used fairly frequently. Though the evidence has not been available to substantiate any benefits, there is a “what is there to lose?” attitude in these cases, so even many conventional vets are willing to give it a try. Though there are, as always, plenty of miraculous anecdotes out there (and, of course, not many negative ones since who goes out of their way to tell everyone about something they tried that didn’t work?), this study is the first formal research in regular clinical patients.

The study was retrospective, meaning that the authors simply looked through records of animals that had been treated for a right atrial mass and fluid around the heart. Some were treated with only conventional supportive care, and some got Yunnan Baiyao, either alone or with another potential anti-bleeding drug called aminocaproic acid. There was no randomization and no blinding, so it is possible that any results could be due to factors other than the drugs given. However, the authors checked for differences in many characteristics of the patients that might influence the results and didn’t find any.

So what were the results?

The median time to recurrence of clinical signs in the treated group (12 d, range 1–186 d) was not significantly different from the control group (14.5 d, range 1–277 d)…The median survival time of dogs in the treated group (18d, range 1–186 d) was not significantly improved compared to the control group (16 d, range 1–277 d; Table 1, Figure 1). The median survival of the 8 dogs that received YB and EAC (17 d, range 1–88 d) was also not significantly improved compared to the 16 dogs that received YB alone (31 d, range 1–186 d). There were no side effects attributed to the YB or EAC use in any dogs during the study period.

Basically, there were no differences in any of the symptoms or in the survival of dogs whether or not they got Yunnan Baiyao. There were no apparent side effects either, but that isn’t too surprising in a group of dogs that only lives 2-4 weeks after being treated.

While this study, like all research has limitations, it is the best evidence concerning real-world clinical use of Yunnan Baiyao in dogs so far, and it found no effect at all. This is not the final word on the subject, of course,  since there are other conditions, other circumstances, other doses, and all sorts of other ways in which the product could be tested. However, as of now the evidence does not support any benefits. And the fact that, as the authors point out,  “its

exact compositional formula is a closely guarded secret by the manufactures and like many nutritional supplements, is not subjected to any quality control measures as compared to pharmaceuticals.” Most vets, and certainly most alternative medicine vets, would lose their minds if it was suggested we should use a drug company product not only without evidence of effectiveness but without even knowing what is in it! Yet, for some reason, a different standard is often applied to herbal remedies like Yunnan Baiyao, which places our patients at unnecessary risk.

Bottom Line

Despite some suggestive in vitro and low-quality studies, the best evidence available so far does not support that Yunnan Baiyao has any benefit for dogs. The fact that it is unregulated, that there is demonstrated inconsistency in the mineral and metal contents of Yunnan Baiyao from different sources, and that the ingredients are still kept secret by the manufacturers, should also give clinicians pause in considering this for their patients. While use in desperate circumstances when there are no established effective therapies may be reasonable, clients should clearly understand that this is at best a rolling of the dice and that the safety and effectiveness of this product for any use has not been established.

Posted in Herbs and Supplements | Leave a comment

IAABC Interview Discussing CAVM and EBVM

Here is an interview I did recently with an association of animal behavior consultants. We discussed a number of subjects that appear frequently here,  including the role of evidence and anecdote in evaluating treatments for animals, and the risks of alternative medicine.


Posted in Presentations, Lectures, Publications & Interviews | 1 Comment

Scientists Warn that Donald Trump is the Most Anti-Science Candidate for President

Since my review of the presidential candidates’ positions on science issues earlier in the week, I have seen a number of efforts by other scientists to warn the scientific community and the public that Donald Trump stands out as the most egregiously and consistently anti-science candidate in this year’s election.

One effort is an open letter authored by a number of prominent scientists, including Harriett Hall and Steven Novella, two prominent skeptics and authors of the Science-Based Medicine Blog:

Scientists say: “Donald Trump is Not Who We Are”

As members of the scientific community, we invite our colleagues to stand together in making it clear that Donald Trump’s views on many pressing topics are at odds with scientific reality and represent a dangerous rejection of scientific thinking.

There should be no place for this kind of rhetoric – or this kind of attitude toward expertise itself – in the halls of government.

As a community, we affirm the values that make us who we are: curiosity, skepticism, integrity, and simple adherence to the facts.

Vaccines save lives every day, but Mr. Trump has stoked discredited fears about vaccines and autism and accused doctors of lying to people about them.

Every major country on Earth is adapting to a changing climate and reducing emissions from fossil fuels, but Mr. Trump has claimed it is a hoax, a statement that prompted a response from hundreds of members of the U.S. National Academy of Sciences, the country’s leading scientific advisory body.

Mr. Trump’s running mate, Mike Pence, has a similarly disconcerting record:

He also dismisses the evidence that climate change is caused by burning fossil fuels.

He delivered a speech to the House of Representatives challenging the teaching of evolutionary science in classrooms based on a misreading of how evolution works.

Nearly 40 years after the Surgeon General first warned us about the dangers of smoking, Pence claimed that “smoking doesn’t kill” and said there was no direct link between smoking and lung disease.

These are not the words and thoughts of responsible leaders.

The letter currently has 712 signatures, including mine.

Another open letter signed by 375 members of the National Academy of Sciences warns of the dangers of  denial of human-caused climate change and of a refusal to participate in international efforts to combat it, both positions embraced by Donald Trump and rejected by all of the other candidates:

An Open Letter Regarding Climate Change From Concerned Members of the U.S. National Academy of Sciences

Human-caused climate change is not a belief, a hoax, or a conspiracy. It is a physical reality.

During the Presidential primary campaign, claims were made that the Earth is not warming, or that warming is due to purely natural causes outside of human control. Such claims are inconsistent with reality.

The political system also has tipping points. Thus it is of great concern that the Republican nominee for President has advocated U.S. withdrawal from the Paris Accord. A “Parexit” would send a clear signal to the rest of the world: “The United States does not care about the global problem of human-caused climate change. You are on your own.” Such a decision would make it far more difficult to develop effective global strategies for mitigating and adapting to climate change.

Posted in Law, Regulation, and Politics | Leave a comment

Science and Presidential Politics

I generally try to stay away from politics per se on this blog, though I often cover political issues when they touch on the areas of science and alternative medicine. Usually, this falls in the general category of government failure to regulate unproven or pseudoscientific therapies properly or protect the public from quackery. However, this post is more directly about the current election. Regardless of your political perspective or which candidate you support on the basis of other issues, there is a bit of information out there concerning the presidential candidates’ positions on science issues, and that is what I’m going to address today.

Since 2008, the non-profit, non-partisan group ScienceDebate has been trying to get all major and third-party candidates for president to participate in a debate specifically focused on science and technology issues. Such a debate, sadly, has never happened, which says a lot about the degree to which science is valued by politicians and voters. However, candidates often provide written answers to questions about science policy, which allows some comparison of their knowledge and views on these topics.

Both Trump and Clinton, as well as Green Party candidate Jill Stein and Libertarian Gary Johnson, provided answers to these questions this year. There isn’t much surprising about these answers.


Clinton’s answers reflect a mainstream moderate-left view, and in general she makes moderately specific policy proposals involving increasing government investment and/or regulation. Her responses are the longest and most specific and substantive of the candidates. In particular, she acknowledges anthropogenic climate change and supports international efforts to combat it, and she is a strong proponent of vaccination and public health programs.

Apart from her answers on this questionnaire, Clinton has been frustratingly sympathetic to naturopathy and some varieties of alternative medicine, so she is by no means a crusader for a strongly science-based approach to medicine. And her positions on GMOs have been inconsistent.


The positions of the minor party candidates also fit pretty closely the expectations one would have based on their political affiliations. Jill Stein’s answers mostly emphasize environmental protection positions, such as aggressive action on climate change. Unfortunately, she also strongly supports a number of positions suggesting she is either misinformed about the scientific evidence or prefers ideology to scientific facts. She aggressively promotes organic agricultures, despite the lack of evidence to support any health benefits. This may be because of perceived environmental benefits, and there is somewhat better evidence for these, though is also controversy on this subject. Stein is also strongly opposed to GMO research and supports misleading labeling laws intended to discourage progress in this area, which reflects a fear of GMO not supported by the evidence.

While Stein has been accused of being anti-vaccine, the evidence does not support that view. She does tend to respond to any question about vaccines by talking mostly about conflict-of-interest issues within regulatory agencies and suggesting that distrust of vaccination is driven more by this than anti-vaccine propaganda. I tend to agree with concerns about conflict-of-interest, but I disagree that this is the major driver of anti-vaccine fears. I think complaints about industry and government relations, even when often valid, are used as a justification for anti-vaccine ideologies based more in pseudoscience and fear than in genuine concern about impartial science. However, her statements suggest that despite this rhetorical focus, she appears to accept the scientific consensus on the safety and benefits of vaccination, she’s just less concerned about those issues than about big bad corporations.

It’s also true that the Green Party platform has been supportive of homeopathy and other alternative therapies. That has been dropped from the current platform, though it was present when Stein was the nominee in 2012. Finally, Stein is also adamantly opposed to any use of nuclear power under any circumstances,  without any apparent interest in the scientific evidence concerning the pros and cons of it.


Libertarian Gary Johnson, not surprisingly, answers pretty much all of the questions in a way that allows him to emphasize his view that government is almost always the problem and not the solution. He rarely has much to say about the scientific issues per se, since he’s much more concerned about free markets and eliminating most government functions. Though he doesn’t say much about science, his answers generally don’t reveal any significant departures from mainstream science. He even appears, grudgingly and weakly, to accept a role of human activity in climate change and the need for compulsory vaccination, at least sometimes.

Johnson is, however, adamantly opposed to any meaningful regulatory role for the FDA in drug safety, which is clearly counter to the best interests of patients. And I suspect he would support the continued lack of meaningful regulation of dietary supplements, herbal remedies, and so on, in favor of the “buyer beware” approach, which proved utterly ineffective in the 18th and 19th centuries.

Donald Trump

And then there’s Donald Trump. Without question, his ScienceDebate answers and other comments make him soundly the most anti-science candidate running, in terms of positive policy positions and a general ignorance of the issues and the facts. His answers to the questions are typically short, vague, and often completely off point, indicating a total lack of interest in the subject. Overall, he too disdains much role for government in science and technology, preferring the free market to be allowed to do as it pleases. His response to the issue of public health strongly suggests he sees little to no value in the national public health system or institutions.

Where Trump sets himself apart from the other candidates in terms of science issues is in his rejection of climate change science and his deeply anti-vaccination views. He has indicated a belief that climate change is not real and is merely a ploy to give China an economic advantage over the U.S. And he is the candidate of choice for the anti-vaccine movement due to his open acceptance of the tired and long-disproven myth that vaccines cause autism. Here are some examples of how popular Trump is with the anti-vaccine crowd.


The keynote conclusion of this article on the notorious quackery site is this:

This November, VOTE TRUMP or prepare for the DEATH of everything you love

Subtle, eh? Here’s another example:


Yup, that’s right. The uber anti-vaxer Andrew Wakefield has been personally assured by Trump that he understands vaccines cause autism. This endorsement has brought along other anti-vaccine loons, including veterinarians like the notorious Patricia Jordan, author of the bizarre extremist screed Vaccinosis-The Mark of the Beast, about whom I’ve written frequently. And another inhabitant of an alternate reality I’ve written about, Dr. Al Plechner (Here and Here), also appears to be a Trump supporter, though for somewhat different reasons. Here are a few snippets from his Facebook page:





Trump has also been quite friendly towards alternative medicine. He has had business interests involving quack urine testing and vitamin and diet schemes. However, this may be more  a reflection of his greed and lack of business ethics than a sign of a true ideological commitment to alternative medicine.

Bottom Line
None of the candidates have a spotless record in terms of science policy positions. Politics, values, personal experience,  and emotions often trump scientific evidence in the development and defense of beliefs. However, Donald Trump has consistently inhabited an alternate reality and shown flagrant disregard for facts and experts in many areas, and science is no exception. His embrace of anti-vaccine myths, and the support this has generated from the anti-vaxer fringe,  as well as his denial of climate change science make him easily the most egregiously and consistently anti-science candidate in the field.


Posted in Law, Regulation, and Politics | 1 Comment

More Evidence that Laboratory Testing of Healthy Dogs and Cats Uncovers Lots of Abnormalities of Questionable Significance

A new article has just been published adding some information to a subject I’ve addressed before, the value of blood testing and other diagnostics in clinical health dogs and cats (discussed Here and Here). In the past, I have come to the following conclusions on this subject:

  • If you test, you will find abnormalities
  • The clinical significance of these abnormalities is often unclear
  • You will find more abnormalities, and these will be easier to interpret, if pre-test probability is high, that is if there is a reason to suspect a real medical problem. For example,
    • Some symptoms of a problem in the history
    • Some identifiable abnormality in the physical exam
  • There is, as yet, no evidence that most tests of healthy veterinary patients reduce the occurrence of disease or death

This paper seems to support these conclusions and the results of previous research.

Dell’Osa D, Jaensch S. Prevalence of clinicopathological changes in healthy middle-aged dogs and cats presenting to veterinary practices for routine procedures. Aust Vet J. 2016 Sep;94(9):317-23

The authors did a wide range of blood tests and a urinalysis on 406 dogs 5-8 years old and 130 cats 6-9 years old who came to the vet for routine examination, vaccination, parasite treatment, and other reasons but without an ongoing or new medical problem. This population is probable fairly representative of those animals who come to see their veterinarian when they are healthy, though of course it doesn’t represent well those who only come when ill or who don’t get regular veterinary care.

The study results certainly confirm that when you test healthy individuals, you will find abnormalities and most of those abnormalities will either not represent real disease or will be difficult to interpret.

  • 86% of dogs had one or more abnormality. Only 6.2% of these were subjectively judged to justify further evaluation.
  • 80% of cats had one or more abnormality. Only 19.2% of these were subjectively judged to justify further evaluation.

Common abnormalities that were judged to be errors, testing artefacts, or otherwise clinically unimportant included:

  • 124 cats had abnormal platelet counts, none of which were thought to be real or important
  • Electrolyte abnormalities and liver enzyme elevations were common in dogs and were generally mild and considered insignificant
  • Low thyroid hormone levels were frequently seen without any clinical evidence of thyroid disease
  • High red blood cell concentrations were common and attributed to excitement from the visit and blood sampling
  • A number of dogs and cats had enzyme elevations that suggested the presence of pancreatitis, though none have clinical symptoms of this problem

The authors did not provide any information on the final diagnosis or clinical outcomes for the animals in this study, so it is impossible, in most cases, to tell how many might have had actual disease or been helped or harmed by the initial and subsequent testing and treatment. They did identify 3 cats (2%) and 5 dogs (1.2%) with Stage 2 or 3 kidney disease. There is evidence that diet change can prolong survival in asymptomatic animals with Stage 2 or higher kidney disease, so a case can be made that these results would likely have benefitted the patients if their owners followed recommended treatment guidelines.

However, there was no other information to identify any benefit or harm from this testing to the animals in the study. This is one of the common problems with research in this area. It is clear that performing diagnostic tests without any specific reason to do so will uncover abnormalities.  What is not clear, is how often these results will lead to benefit to the patient through detection and treatment of disease.

As I have discussed previously, there is a real risk of overdiagnosis and overtreatment associated with diagnostic tests done without any specific clinical suspicion of a disease. Most will be meaningless, and this is, at least, a waste of money and resources. Some will be incorrect, as many of the results in this study likely were (especially platelet counts, thyroid testing, and pancreatitis testing). This can lead to unnecessary further tests or treatment, which not only wastes resources but can cause direct harm to patients.

It is also unclear how clients will react to abnormalities, whether or not the veterinarian believes them to be significant. If I tell an owner their older animal has Stage 1 kidney disease, mild liver enzyme elevations, or mild chronic anemia, it is quite possible they will come to view their pet is sick or “aging.” This can easily lead owners to decline testing and treatment that might actually benefit the pet. Comments like, “Well, he has kidney disease,” or “He already has a liver problem” are often made prior to declining dentistry, surgery for curable tumors, and other treatments I recommend for older pets.

Generally, screening tests like these of healthy individuals are very seldom recommended because the evidence has been developed to show they offer few benefits and some real risks. The authors of this paper make the fair observation that this might be different in veterinary medicine since we get less direct information from our patients about how they feel, so we may not be able to pick up signs of disease as soon as in humans. However, the evidence doesn’t exist to demonstrate this hypothesis, as reasonable as it is. And often, the evidence does not exist to show we can do anything useful to help animals with asymptomatic disease in most cases (kidney disease being an exception). So the value of a diagnosis in the face of no available treatment is somewhat questionable.

The subject of overdiagnosis is controversial, and discussions about it often become emotional.  It is very difficult not to fall prey to anecdotal reasoning, especially in the absence of high-quality controlled research evidence. However, just as we frequently extrapolate in our testing and treatments from human medicine, it is reasonable to consider the evidence from human medicine that overdiagnosis is a real risk, and there may be times when not testing, especially in individuals who are clinically well, may be the best choice. I’m not arguing that such testing is not beneficial or is harmful, only that we don’t yet have the evidence to say for sure, most of our thinking on this subject is anecdotal, and we rarely consider the possible costs and risks of such testing.

Posted in General, Science-Based Veterinary Medicine | 1 Comment

Update- Hemopet Sues Pet Food Companies to Claim Ownership of the Idea of Nutrigenomics

Way back in 2012, I wrote about a lawsuit filed by Hemopet, an organization known primarily for being a non-profit blood bank but also involved in some unconventional laboratory testing (as Hemolife) and alternative medicine ( as the Hemopet Holistic Care Center). This founder and director of this organization is Dr. Jean Dodds, about whom I’ve written several times as she is a prominent advocate for a number of alternative medicine practices. Dr. Dodds, via the Hemopet organization, has filed a number of patents for her unconventional diagnostic tests (involving thyroid disease testing and food allergy detection) and for her proposed method to use genetic data to predict the appropriate diet for pets. She originally sued a couple of pet food companies (Purina and Hills) claiming that the very idea of “nutrigenomics,” or using genetic information to formulate diets, was owned by her through these patents.

Though I have since reviewed in detail Dr. Dodds dubious claims about nutrigenomics, her bogus food allergy testing process Nutriscan, and her misleading “studies” on vaccine dosing for small dogs (here and again here), I had lost track of this lawsuit. However, a recent VIN News article about Hemopet drew my attention back to the organization. This article was actually not about the lawsuit but an unrelated issue. Apparently, Hemopet had been pushing the State of California for a tax exemption and implying that its blood-banking service might have to close if the exemption wasn’t granted. The legislation granting the exemption was passed by the legislature but vetoed by the governor. However, Hemopet now says it will remain in operation and will continue to press the state not to require it to pay some $81,000 in back taxes.

This is an interesting subject in its own right. The relationship between the blood bank, diagnostic laboratory, and clinical practice isn’t entirely clear from the Hemopet tax and non-profit filings available on the California DOJ web site. Perhaps something I’ll investigate another time, but as a vet rather than a tax attorney, I’m not sure I can make heads or tails of such issues. In any case, the subject did draw my attention back to the lawsuit I originally wrote about, and this led me to find the subsequent developments I’m reporting here.

In the original post, I concluded that the subject of Hemopet’s nutrigenomics patents seemed to me entirely too vague to qualify for patent protection, though I acknowledged I’m no expert in the subject:

So what appears to have been patented here is the idea of collecting a wide range of pieces of information about an animal in a computer, passing it around to people, and using it to “reduce morbidity and mortality, and improve the quality of life and lifespan” in companion animals. It’s hard to see how this could be a patentable idea, or even truly original apart from the unsubstantiated general claims about the links between gene sequences and health, but again I’m not expert in patent law.

I was more concerned by the lack of a clearly valid and established scientific principle behind the attempt to own the concept of nutrigenomics:

despite a list of scientific papers included with the patent application (but not used as specific citations to support particular claims), it’s not clear that there is an actual preventative or therapeutic healthcare intervention here…it’s a bit baffling how these two organization can compete for ownership of an idea which doesn’t really exist in a tangible form yet…It does seem, however, like putting the cart before the horse, since who gets to profit from a new approach to health and nutrition should at least have something to do with whether the approach actually works and who has done the work to demonstrate this.

Based on my exhaustive review of Dr. Dodds’ subsequent book on nutrigenomics from last year, it’s clear that she still has not validated her concepts or methods, despite now selling them as a product. That, at least, is sufficiently within my area of expertise for me to be able to state with some confidence. However, I was pleased to see that the courts have so far agreed with my far less informed view of the intellectual property questions as well. In November, 2014, the U.S. District Court in California granted a motion by one defendant, Hill’s Pet Nutrition, Inc., for summary dismissal of the lawsuit. The decision explains why, according to legal precedent, the claims made by Hemopet are insufficient to qualify for patent protection, so the patents are not valid nor defensible:

…the formulation and preparation of pet food is nothing more than an extension of the abstract idea of “determine” a dog or cat’s diet. The creating or formulating processes directed in the claims are couched in the most general terms, lacking any specifics that would allow a practitioner to learn how to actually develop or produce such a diet…Therefore, all of the claims are squarely within the realm of “abstract ideas” as defined by the Supreme Court.

Only the final step, “determine a nutritional diet for the canine or feline companion animal; and formulate and prepare a nutritional diet product based on the relationship,” relates to the creation of a “different state or thing.” However, whether considered individually or in combination with the other steps, the claims do nothing more than instruct the practitioner to implement the abstract ideas of the first few unpatentable steps in the final step…This is nothing more than telling the practitioner to “apply it” in general terms. Hemopet’s claims do not describe in detail a step-by-step method for developing a nutritional diet product.

…the functions performed by the computer, database, or software routine at each step of Hemopet’s process are “well-understood, routine, conventional activity, previously engaged in by those in the field.”

[Hemopet’s] claims simply recite the abstract concept of determining a nutritional diet for a dog or cat based on naturally occurring relationships and fail to include any express language to define how the nutritional diet is actually formulated, developed, or produced.

For these reasons, the Court finds that the claims at issue are drawn to a patent-ineligible abstract idea.

The bottom line is that in addition to being scientifically dubious and unproven, Hemopet’s claims about Nutriscan are vague and amount to no more than a rearranging of established and theoretical ideas about genetics and nutrition, not a specific and original process for selecting and formulating a diet. As such, they don’t qualify for patent protection.

This judgement was upheld by the appellate Circuit Court in September, 2015. I have not been able to ascertain what happened with the separate lawsuit on the same grounds filed against Nestle Purina Pet Care, Inc. If anyone with greater legal research skills would like to look into this, I’d be interested in the outcome. However, it appears likely that the outcome of that case was substantially the same as the case against Hill’s, because now Hemopet has filed an appeal in the Hill’s case with the U.S. Supreme Court.

Given that Hemopet’s claims appear vague and unpatentable even to me, and more importantly to the far more qualified judgement of the state district court judge and the federal appeals court judges, it is hard to imagine the Supreme Court granting this appeal. Of course, even if it does that won’t speak at all to the scientific legitimacy of the ideas Hemopet claims to own. But even from a scientific perspective, the ownership of general ideas seems counter to the spirit of scientific discovery and likely to impede research and discovery. I think it far more likely that beneficial therapies and inventions will come from allowing widespread dissemination of ideas and information and from research by many different and competing parties.


Posted in Law, Regulation, and Politics | 3 Comments

EBVMA Podcast- What Is Evidence-based Veterinary Medicine?

Back in April, I was privileged to participate in the inaugural podcast of the Evidence-based Veterinary Medicine Association, a group I have worked with for many years, as a membership of the Board of Directors and former President. In this first podcast episode, I discuss the basics of evidence-based veterinary medicine with Sharyn Esposito, a small animal veterinarian and instructor at the Bel-Rea Institute of Veterinary Technology, and Erik Fausak, the Host and also an instructor at Bel-Rea. Enjoy!


Posted in Presentations, Lectures, Publications & Interviews, Science-Based Veterinary Medicine | 3 Comments

Acupuncture for Opioid-induced Nausea and Vomiting in Dogs

Having written extensively about acupuncture and the research associated with it during my acupuncture training, I haven’t been inclined to revisit the topic for a while. However, I ran across a recent study which I though illustrated the issues and ambiguities in acupuncture research nicely, so I thought it worth covering.

Scallan EM, Simon BT. The effects of acupuncture point Pericardium 6 on hydromorphone-induced nausea and vomiting in healthy dogs. Vet Anaesth Analg. 2016 Sep;43(5):495-501.

The Study

The purpose of the study was to investigate whether acupuncture could reduce the nausea and vomiting commonly seen with the use of narcotic pain medications before surgery in dogs. The study had some nice design features, including effective randomization and a reasonable sample size.  However, there were also some issues with the study that are common to acupuncture research and make the results more difficult to interpret.

Eighty-one healthy dogs presented for neutering at a veterinary college hospital were randomly assigned to received acupuncture (dry needle stimulation) at PC 6 (a point near the wrist thought to reduce nausea and vomiting), LU 5 (a point near the elbow chosen as a sham point because it is associated with a different nerve and has no history of use for nausea and vomiting), and a group that received no treatment. The dogs were observed for vomiting and signs of nausea (drooling and licking their muzzles).


In terms of vomiting, the apparent effect of acupuncture depended on how the vomiting was assessed. More dogs vomited in the sham (81.4%) and no treatment groups (74%) than in the acupuncture treatment group (37%). However, in terms of the number of vomiting episodes, the sham group appeared to have more than the acupuncture group, but there were no differences between acupuncture and control or sham and control. (The paper is a bit hard to interpret on this point. The authors state, “The median (range) number of vomiting episodes in dogs that vomited were 0 (0–2) in [acupuncture],1(0–6) in [sham acupuncture], and 1 (0–3) in [control].” However, it makes no sense that there could be zero vomiting episodes in dogs that vomited. In any case, there were few vomiting episodes for most dogs, so chance likely would have a strong influence on the differences between the number of episodes in each group.)

In terms of signs of nausea, there were no differences between groups in the amount of muzzle licking that occurred, and between 92-100% of dogs licked their muzzles some. There were also no statistically significant differences in drooling between groups, though in terms of raw numbers the incidence of drooling was nearly the same in the acupuncture group (18.5%) and the sham group (22.2%) and much higher in the control group (44.4%).

So in terms of overall results, it looked like the acupuncture reduced the number of dogs that vomited, though not the number of vomiting episodes in the dogs who did, and didn’t have a significant effect on signs of nausea.

Issues with this Study

One major challenge for acupuncture studies is the effective use of blinding to reduce bias. Patients and researchers who are aware of which treatment a patient is getting in a study commonly report and interpret symptoms differently than observers who don’t have this information, and usually this difference makes the treatment look better than it actually is. While dogs don’t have beliefs or expectations that affect their response to treatments, their owners and researchers in veterinary studies certainly do, and this caregiver placebo effect is well-known to introduce bias into research studies.

The trouble with acupuncture is that it is very hard to fool patients regarding whether or not they are being stuck with a needle, and it is impossible to fool the acupuncturists. Fake needles can help, though they are imperfect, and when they are used often they seem to work just as well as real needles. Sham points, that is needling places not thought to be relevant to the symptoms being studied, is also problematic because sticking a needle anywhere in the body is going to have some effects. Acupuncturists often reject negative studies that find no difference between sham points and the supposedly real point because they argue that rather than proving acupuncture is a placebo, these studies actually prove the sham points work as well as the real ones. This, of course, raises the awkward question of why acupuncture should be seen as a rational, specific system for treating illness requiring specialized training and expertise to employ if it makes no difference where you put the needles.

In this study, the observers could clearly see whether or not the dogs had needles in their legs. Supposedly, the observers knew nothing about acupuncture, so they presumably couldn’t tell the sham treatment from the real treatment, but they could certainly distinguish any treatment from no treatment. Might this have influenced the results? It seems unlikely to have influenced the counting of the number of episodes of vomiting, which ought to be fairly discrete (though even this is a bit subjective; some might call non-productive retching vomiting while others might only count episodes where something is expelled).

However, it seems possible that this incomplete blinding might have influenced the observers’ scoring. Before any medication was given (and so before there would have been any nausea), the observers noted more licking of the muzzle in dogs with acupuncture needles (70.4% of treatment group and 66.7% of sham group) than in dogs with no needles (40.7% of control group).  There’s no reason to think that there should have been any real difference in this behavior before any medication was even given, so this suggests observers were recording behavior differently for those dogs with visible needles and those without.

The authors also noted that the incidence of vomiting in untreated dogs in this study (74-82%) was higher than has been reported in other studies of the same drug (usually around 50%, though it ranges from 25-85% depending on the study). The treatment group showed vomiting at a rate of 37%, which is within the range often seen in other studies for dogs given hydromorphone and not treated. This raises the possibility that the treatment did nothing and that differences in the incidence of vomiting among the groups were simply due to chance.

What About the Alternatives?

Finally, the real impact of any medical treatment has to be evaluated in the context of the alternatives. We have very effective and safe anti-nausea medications that have been tested for this same purpose, preventing the nausea and vomiting associated with hydromorphone given before surgery. How do they compare to the apparent effects of acupuncture in this study?

Here is a summary of the number of dogs vomiting in the treatment and control groups from the studies listed below compared with this acupuncture study:

Acupuncture Study

Acupuncture treatment- 10/27

Sham Acupuncture- 22/27

Control group- 20/27

Hay 2013

Medication group- 0/9

Placebo group- 6/9

Hay 2014

Medication group- 0/20

Placebo group- 5/20

Johnson 2014

Medication group- 0/13

Control group- 6/13

Claude 2014

Medication 30min before- 0/15

Medication at same time- 4/15

Placebo group- 13/15

Hay 2014b

Medication 60min before- 0/10

Medication 45min before- 0/10

Medication 30min before- 0/10

Medication 15min before- 2/10

Medication at same time- 6/10

Control group- 7/10

What this shows pretty clearly is that even if one interprets the acupuncture study generously in terms of the number of dogs who vomited, which is the one measure that looks like there might have been some benefit, it is far less successful that existing medication At best, the acupuncture reduced the incidence of vomiting from 75-80% of dogs to 37% of dogs. By comparison, the medication consistently eliminates vomiting entirely if given at least 30 minutes before the hydromorphone. Once one considers all of the potential issues with the acupuncture study, it becomes even more likely that the real effect was either very small or that the appearance of a benefit was entirely a function of residual bias and chance.

Bottom Line

This study is typical of acupuncture research. Though generally well-designed, it contains a number of limitations that reduce the confidence we can have in the results.  And while this is true of all studies, a comparison with research on conventional treatments for the same purpose shows the conventional therapy to be unequivocally effective, whereas the acupuncture treatment has either a small effect of questionable clinical significance, or possibly no real effect at all.


Hay Kraus BL. Efficacy of maropitant in preventing vomiting in dogs premedicated with hydromorphone. Vet Anaesth Analg. 2013 Jan;40(1):28-34. doi: 10.1111/j.1467-2995.2012.00788.x. Epub 2012 Oct 20.

Hay Kraus BL. Efficacy of orally administered maropitant citrate in preventing vomiting associated with hydromorphone administration in dogs. J Am Vet Med Assoc. 2014 May 15;244(10):1164-9. doi: 10.2460/javma.244.10.1164.

Johnson RA. Maropitant prevented vomiting but not gastroesophageal reflux in anesthetized dogs premedicated with acepromazine-hydromorphone. Vet Anaesth Analg. 2014 Jul;41(4):406-10. doi: 10.1111/vaa.12120. Epub 2013 Dec 16.

Claude AK, Dedeaux A, Chiavaccini L, Hinz S. Effects of maropitant citrate or acepromazine on the incidence of adverse events associated with hydromorphone premedication in dogs. J Vet Intern Med. 2014 Sep-Oct;28(5):1414-7. doi: 10.1111/jvim.12414. Epub 2014 Aug 21.

Hay Kraus BL. Effect of dosing interval on efficacy of maropitant for prevention of hydromorphone-induced vomiting and signs of nausea in dogs. J Am Vet Med Assoc. 2014 Nov 1;245(9):1015-20. doi: 10.2460/javma.245.9.1015.



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Science-based Veterinary Nutrition Success Stories

In all the debates here and elsewhere about the relative merits of commercial pet diets and homemade, raw, or other alternatives, advocates of alternative diets often claim that conventional diets are unhealthy. Scientific evidence is not typically provided to support these claims, of course. Similarly, alternative dietary approaches are often claimed to be healthier than conventional diets, but there is no scientific evidence to support this belief. What this means is that, while there may be health risks associated with commercial diets and health benefits associated with alternatives, we don’t know what these are, which animals are affected, or how important the effects may be. Without real evidence, not simply anecdotes, claims about nutrition for our pets are simply opinions.

There is, however, some scientific evidence relevant to these issues. I’ve reviewed some research, for example, looking at claims regarding raw foods. This research so far fails to show any health benefits but does support the potential for risks associated with infectious organisms in raw meat. I have also reported on some of the research showing that homemade diets are often nutritionally imbalanced or incomplete, which would likely negate any potential benefits to the fresh ingredients used to make them.

A recent review paper adds a bit of perspective to this subject by reminding us that there is also research evidence illustrating the beneficial effects of some scientifically formulated diets that veterinarians use for specific health problems.

Davies M. Veterinary clinical nutrition: success stories: an overview. Proc Nutr Soc. 2016 Aug;75(3):392-7. doi: 10.1017/S002966511600029X. Epub 2016 Jun 8.

This brief article discusses the evidence for some of the clearest examples of therapeutic diets that have real benefits for patients. These include:

  1. Diets formulated for dogs and cats with kidney disease, which improve quality and length of life as well as laboratory markers of disease.
  2.  Diets for dissolving certain urinary tract stones, which allow cats and dogs with these stones to avoid surgery
  3. The discovery of the link between taurine deficient diets and cardiomyopathy, a life-threatening heart condition in cats that has been nearly eliminated by dietary supplementation of taurine.

There is also discussion of some less clear examples, including the potential use of dietary therapy for hyperthyroidism in cats and the use of special diets for treatment of arthritis and support of dogs undergoing chemotherapy treatment for lymphoma. These diets appear to have some benefits in these cases, though the evidence is not quite as robust.

Obviously, these examples don’t answer the larger questions about the relative risks and benefits of different dietary approaches. But they do illustrate that using scientific methods, we can develop diets that have measurable and significant health benefits. This is far more promising than simply relying on unsupported nutritional theories, haphazard trial and error, or anecdotes, which is the kind of evidence usually used to justify alternative nutritional practices.

As usual, I expect the comments will include the following invalid arguments, so I will address them pre-emptively:

  1. Vets know nothing about nutrition. Actually, they do know something.
  2. But I fed my dog X and then Y happened. Why We’re Often Wrong Testimonials Lie The Role of Anecdotes in Science-Based Medicine Why We Need Science: “I saw it with my own eyes” Is Not Enough Don’t Believe your Eyes (or Your Brain)





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