New Studies Show Hyperbaric Oxygen Therapy Helps Treat Concussion, but no more than Placebo Treatment

Posted on November 18, 2014 by skeptvet

I’ve written previously about the evidence concerning hyperbaric oxygen therapy (HBOT). There are a few specific conditions for which there is reasonable evidence HBOT is a useful therapy. Unfortunately, it is becoming something of a fad treatment in veterinary medicine, and there are many claims and recommendations for HBOT that are not supported by real evidence. A new series of studies in humans from the Department of Defense has provided some additional useful evidence regarding this treatment.

Reported in the LA Times, these studies specifically examined HBOT as a therapy for symptoms of concussion in service members. The results so far consistently show no difference between HBOT and placebo, suggesting no real therapeutic benefit for the treatment. In one study, 72 patients were randomly assigned to HBOT or sham HBOT. Both groups showed a 30% improvement in symptoms reported on a patient questionnaire, with no difference between the real and placebo treatment. This is in agreement with two previous randomized clinical trials of HBOT of concussive symptoms, neither of which reported any benefit greater than placebo. The fourth, largest and most rigorous trial is still in progress.

What is especially interesting about these results is that both HBOT and placebo groups showed significantly more improvement than patients given standard care. This reflects the very similar results of acupuncture trials and studies of many other therapies which are no better than their sham placebo comparators but which appear to provide a benefit when compared to nothing at all or to minimal standard care.

Does this mean that placebo effects represent real healing? Absolutely not! Many studies have shown that placebo effects only change the perception of one’s symptoms and certain autonomic values (like blood pressure and heart rate) that are strongly influenced by psychological factors, not the objective measurements of one’s illness. What the results mean is that the ritual of care, particularly the more elaborate and involved the ritual is, improves how people feel even when the therapy does not actually change their physical condition.

It is useful to remind ourselves of this phenomenon for two reasons. First, it reinforces that we cannot believe the positive results seen in studies that do not have an effective sham or placebo treatment, because they cannot distinguish real improvement from the psychological effects of therapeutic rituals. Secondly, it gives human healthcare workers the opportunity to take advantage of such effects to improve patients’ experience of care. This should not be done by providing ineffective or fake therapies, of course. But there are many ways to generate a comforting therapeutic ritual while still providing scientific, evidence-based care.

In veterinary medicine, sadly, it is likely such rituals treat animal owners much more than our patients themselves (the caregiver placebo effect). Though this may have some value anyway, it raises the significant risk that we will convince ourselves and our clients we are helping their pets when we actually are not. Therefore, we in veterinary medicine have to hold our selves to the strictest standard of evidence we can to avoid fooling ourselves and our clients at the expense of our patients.

 

 

Posted in Miscellaneous CAVM | Leave a comment

More Delusional Homeopaths-Homeopathy for Trauma and Shock in Dogs

Posted on November 17, 2014 by skeptvet

Homeopaths, naturally, refuse to recognize that their entire profession is nothing more than the selling of placebos. The evidence against any true benefit for homeopathic therapy, beyond the psychological benefits of the therapeutic interaction, is overwhelming. Reviews by scientists and government agencies consistently find no reason to believe homeopathy is a real, effective medical practice. Homeopaths themselves have waded through 150 years of research and found virtually nothing better than anecdotes to suggest homeopathy is worthwhile. Yet homeopaths continue to have faith, since after all homeopathy is more of a faith-based belief system than a science.

This unshakeable faith leads homeopaths to advocate some pretty frightening and ridiculous uses of their treatments. Homeopaths have advocated their magic water for treatment of everything from cancer to ebola. This would be funny if it didn’t subject patients to serious danger, primarily from homeopaths recommending their remedies in place of real medicine. However, even most homeopathy advocates tend to acknowledge that science-based medicine is more appropriate than homeopathy as the primary treatment for victims of trauma. The idea of homeopathy as an emergency therapy is so ludicrous as to have been lampooned by popular British comedians Mitchel and Webb:

 

 

It is true that one of the more extreme veterinary homeopaths I have written about, Dr. Will Falconer, has claimed his nonsense can help people avoid taking their pets to a veterinarian for emergency treatment even in the face of life-threatening acute illness, but I had hoped he was an isolated case that might be ignored, if not publically disavowed, by other veterinarians promoting alternative therapies. However, sadly I have found yet another veterinarian who shares the delusion that it is ethical or appropriate to recommend homeopathy as a therapy for shock in pets.

Blogger “Dr. Jessie” has a recent post referencing a case report in the Journal of the American Holistic Veterinary Medical Association entitled, apparently without irony, Homeopathic Remedies for Canine Trauma. In the article, she describes the case of a dog who attacked a passing car and suffered broken teeth and possibly neck and head trauma. The article then describes the use of two homeopathic remedies for this patient, and strongly implies that they alleviated the dog’s pain. Hopefully, real pain medication and other medical treatments were provided, but none are mentioned in the post, again implying that homeopathy alone would be sufficient treatment for a patient like this.

Since the AHVMA does not routinely make its journal available to non-members, and it is not referenced in most databases of real scientific journals, I have not yet been able to find a copy of the original case report. Again, I hope that the homeopathic remedies were used in addition to real medical treatment and, as is so often the case, simply given credit for improvement more likely due to other treatments. Unfortunately, I have seen other so-called holistic veterinarians also claim miraculous results from the use of homeopathic remedies in animals hit by cars or suffering other forms of  trauma, though most then use conventional therapies as well. However, the very idea that a practicing veterinarian would suggest homeopathy as an adequate or appropriate therapy for shock or trauma demonstrates a frightening disconnect from reality that undoubtedly puts patients at risk of inappropriate treatment.

Posted in Homeopathy | 8 Comments

The State of Science-Based and Alternative Veterinary Medicine Today

Posted on November 10, 2014 by skeptvet

Prompted by Dr. Hall’s recent assessment of the state of science-based medicine in Australia, I thought it was time to offer a “state of the profession” update on how science-based and evidence-based medicine in the veterinary field are doing in competition with opinion-based or faith-based medicine and outright woo. The situation resembles that in human medicine in many ways, of course, but the context is quite different, and that difference tends to put science-based medicine at a bit of a disadvantage.

The Context
The scale of the veterinary medical market is diminutive compared with that of human medicine. Perhaps the largest commercial player in veterinary pharmaceutical research, Zoetis (formerly a division of Pfizer) spent an estimated $400 million in 2013. By contrast, Pfizer itself has drastically cut its research budget for human medicines to a mere $6.5-7 billion for 2013. The difference in revenues is similar, and this provides less incentive for investment in the kind of research needed for truly science-based medicine.

The quality and quantity of research evidence in veterinary medicine is inevitably far lower than is commonly expected in human medicine, and consequently so are the standards of evidence clinicians and clients expect. Even with the best of intentions, we simply can’t expect to match the standards of our big-city cousin, human healthcare.

And due to the lesser societal value placed on animal health, except where it intersects with human health and the food supply, there is far less in the way of regulatory oversight of veterinarians. Most of the drugs we use, for example, are never licensed for the species or indication in which we use them. Off-label use based only sparse research or uncontrolled clinical experience is the standard.

Also, because animals are technically property, owners are free to do virtually anything they want to them. The application of almost any kind of quackery is completely legal under most circumstances. And even when there are rules about the claims and uses of a particular therapy, the understanding is that government will not enforce these unless there is a perceived direct impact on human health.

A recent example of this is the use of stem cell therapies in veterinary medicine. The FDA does not currently license any stem cell therapies for human use. The International Society for Stem Cell Research, which presumably consists of scientists convinced such therapies are very likely to prove safe and beneficial for at least some uses, still cautions people that the evidence for this is not yet available and that they should not seek out such therapies in countries where regulators do not prohibit them.

We have all heard about the extraordinary promise that stem cell research holds for the treatment of a wide range of diseases and conditions. However, there is a lot of work still needed to take this research and turn it into safe and effective treatments.

The International Society for Stem Cell Research (ISSCR) is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective.

Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.

Remember, most medical discoveries are based on years of research performed at universities and companies. There is a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people.

The evidence for the safety and efficacy of such therapies in veterinary patients is even weaker than that in humans, and yet stem cell therapies are widely marketed and in veterinary medicine. The FDA has jurisdiction over this practice, and the agency recently asserted its authority to require licensing of these products. However, even in the document claiming the right to regulate these treatments, the agency has indicated it is unlikely to do so when they do not clearly impact directly on human health or the food supply:

Although [autologous  stem cell therapies] require [FDA approval], conditional approval or index listing to be legally marketed, FDA recognizes that these products pose a lower risk to human and animal safety than other categories of [stem cell therapy] when used in non-food producing animals and are, therefore, a lower enforcement priority.

The same understanding applies in most areas of veterinary medicine, so veterinarians are largely free to market any and all therapies without regulatory approval. While this may be necessary to ensure that therapies are available to veterinary patients in the absence of sufficient financial incentives to drive companies to seek licensing, it opens the door much more widely to woo than is generally the case in human medicine.

The Good News
The good news is that there are individuals and organizations in veterinary medicine committed to science and evidence-based practice. Efforts to promote this approach have grown dramatically in the last decade, and they are beginning to have an impact on at least the language, if not the underlying thoughts or actions, or practitioners. It is impossible to attend a veterinary continuing education conference without hearing titles like “An Evidence-Based Guide to Therapy X,” though the content is often less true to the principles and methods of EBM than such titles would suggest.

The organization I am most directly involved with is the Evidence-Based Veterinary Medicine Association (EBVMA). A small organization of about 75-100 people, promotes EBM at veterinary continuing education meetings, lobbies for incorporating EBM standards in research, publishing, clinical guidelines, and so on, and provides a small amount of funding (currently $1500/year) for research targeted at promoting evidence-based veterinary medicine.

The Centre for Evidence-based Medicine (CEVM) at the University of Nottingham is a funded academic center aimed at conducting and supporting research to facilitate more evidence-based veterinary practice. The center has begun producing some very useful resources, such as a database of veterinary systematic reviews, and a small but growing collection of critically appraised topics for veterinary practitioners.

Such resources may seem rudimentary to physicians accustomed to much more voluminous and accessible synthetic literature, but these are essential first steps in helping veterinarians get accustomed to relying on science more and personal experience less. A recent study, for example, found that the number of systematic reviews in the veterinary literature has increased exponentially in the last ten years. It is still only a tiny number compared to the more than 5,500 systematic reviews produced by the Cochrane Collaboration alone by 2013, but it is a necessary start.

Sys rev numbers

Perhaps the most exciting recent development in support of more science-based veterinary medicine has been the involvement of the Royal College of Veterinary Surgeons (RCVS) charitable arm in organizing and funding evidence-based veterinary medicine. The RCVS Knowledge group has offered grants in support of EBVM research and activities and has organized an international EBVM conference this fall.

In the absence of substantial government funding, private resources support most veterinary research. Industry is the largest player, including pharmaceutical companies, pet food companies, and the like. This money is, as I’ve mentioned, a tiny fraction of the equivalent R&D investments in human medicine, and it likely comes with the same risks of bias and other problems identified in human healthcare (though there is little research on this subject in veterinary medicine).

Private non-profit organizations and academic institutions make up most of the rest of support for the science behind veterinary medicine. As an example, the Morris Animal Foundation is the largest non-profit supporter of veterinary research, offering several million dollars annual in grant funding. Morris is currently funding the first longitudinal lifetime health study in dogs.

As in human medicine, most vets are probably shruggies; they practice mostly conventional medicine, but they think of themselves as “open-minded” and don’t see a problem with the integration of alternative therapies into routine practice. There is a bit of a cultural taboo, at least in the U.S., of criticizing the practices of other vets, so challenges to alternative practices often draw hostile responses not only from CAVM advocates but other veterinarians who don’t themselves offer alternative therapies. The notion that civil, substantive critique is essential to progress and the scientific method is not widely appreciated.

Science, and an evidence-based approach to practice, are only rarely specifically endorsed by veterinary institutions. Even fewer openly reject alternative therapies. The American Veterinary Medical Association, for example, used to have a policy on CAVM that stated:

The theoretical bases and techniques of CAVM may diverge from veterinary medicine routinely taught in North American veterinary medical schools or may differ from current scientific knowledge, or both.

The AVMA believes that all veterinary medicine, including CAVM, should be held to the same standards. Claims for safety and effectiveness ultimately should be proven by the scientific method… Practices and philosophies that are ineffective or unsafe should be discarded…Recommendations for effective and safe care should be based on available scientific knowledge and the medical judgment of the veterinarian.

Under pressure from CAVM advocacy groups, that has since been amended to remove any reference to science:

The AVMA believes that all aspects of veterinary medicine should be held to the same standards, including complementary, alternative and integrative veterinary medicine, non-traditional or other novel approaches.

  • The foremost objectives in veterinary medicine are the health and welfare of the patient.
  • Diagnosis and treatment should be based on sound, accepted principles of veterinary medicine and the medical judgment of the veterinarian.
  • Veterinarians should have the requisite knowledge and skills for every treatment modality they consider using.
  • A valid veterinarian-client-patient relationship must exist1.
  • Owner consent1 should be obtained prior to initiating treatment.
  • Medical records should include outcomes of treatment.
  • Veterinarians should be aware of and abide by local, state, and federal statutes.

In contrast, the Australian Veterinary Association (AVA) has a policy rejecting any support for ineffective therapies generally, and specifically identifying homeopathy and homotoxicology as examples of such therapies:

Australian Veterinary Association (AVA) resources will not be used to promote therapies that, in the Board’s opinion, are not compatible with current understanding of physiology and pathophysiology and have been demonstrated to be ineffective by the current accumulated body of knowledge.

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

An attempt to pass a similar resolution in the AVMA was defeated overwhelmingly. Only a few other major mainstream veterinary organizations have taken formal positions on science and alternative medicine:

European Board of Veterinary Specialties

The veterinary profession received the prerogative for diagnosis and treatment of animal diseases based on the assumption that veterinarians are guided by scientific methods. The EBVS therefore only recognises scientific, evidence-based veterinary medicine which complies with animal welfare legislation Specialists or Colleges who practise or support implausible treatment modalities with no proof of effectiveness run the risk of withdrawal of their specialist status. No credit points can be granted for education or training in these so-called supplementary, complementary and alternative treatment modalities.

British Veterinary Association

The BVA cannot endorse the use of homeopathic medicines, or indeed any medicine making therapeutic claims, which have no proven efficacy. As with any medicine, BVA believes that veterinary medicinal products must be evidence-based, with any medicinal claims made by a manufacturer supported.

Federation of Veterinarians in Europe

[veterinarians should] work only on the basis of scientifically proven and evidence-based methods and to stay away from non-evidence-based methods.

The American Association of Veterinary State Boards (AAVSB), which is responsible for certifying continuing education (CE) courses for veterinarians taken in support of continued state licensure through the Registry of Approved Continuing Education (RACE), explicitly requires that subjects approved for RACE continuing education credit be based on sound scientific evidence, and the teaching of ineffective or unsafe practices cannot be approved as continuing education for veterinarians:

CE offerings shall be designed to…refresh the participant in the standards for practice and the foundational, evidence-based material presented in accredited colleges or schools of veterinary medicine… CE programs that advocate unscientific modalities of diagnosis or therapy are not eligible for RACE approval.

Furthermore, those programs that promote treatments known to pose significant risks, dangers that outweigh benefits or unproven effectiveness are generally not considered approvable. All scientific information referred to, reported or used in RACE Program Applications in support or justification of an animal-care recommendation must conform to the medically accepted and scientifically supported standards of experimental design, data collection and analysis.

This means in practice RACE will not certify most CAVM education. The Academy of Veterinary Homeopathy (AVH) actually sued the AAVSB to try and force them to accredit homeopathy CE courses. When this failed, CAVM proponents created their own CE accreditation organization to rubber stamp their own CE offerings, which unfortunately many states are accepting as legitimate.

Overall, the majority of veterinary medicine offered is at least compatible in theory with science-based medicine, though often the level of evidence available to support it is less than would be acceptable in human medicine. Most veterinarians stay away from the most egregious quackery, such as homeopathy and “energy medicine.” However, there is also bad news.

The Bad News
Apart from the serious lack of adequate scientific evidence to support even most mainstream veterinary practices, questionable or outright quack practices are widespread and appear to be growing in acceptability and popularity. Some of this reflects similar trends in human healthcare. People often begin to inquire about dietary supplements, herbal remedies, acupuncture, and chiropractic, as well as even more dubious practices, for their pets after having employed them for themselves or heard encouraging anecdotes from friends and family. While there is not any formal research evaluating the popularity of CAVM treatments, subjectively they certainly appear to be infiltrative academia and general practices at a frightening pace.

A large part of the credit/blame for this likely belongs to CAVM advocates, who are far better organized and funded, and far more aggressive than proponents of EBVM. The American Holistic Veterinary Medical Association (AHVMA) and its associated fundraising arm the American Holistic Veterinary Medical Foundation (AHVMF) have proven very successful at promoting CAVM and paying lip service to science and EBVM while clearly being interested only in promoting what they already believe without, or despite the scientific evidence. They promote the most ridiculous quackery at their CE meeting, like “Earth Acupuncture” to heal the planet, dowsing, and of course homeopathy, Traditional Chinese Veterinary Medicine, Reiki, and all the others. Yet they have managed to raise over $1 million in the last year to promote “research” and teaching of alternative veterinary therapies.  By the standards of veterinary medicine, this is not small change!

Much of this money has been given to veterinary colleges in the form of grants to support teaching and research activities by dedicated CAVM proponents. The University of Tennessee, University of Florida, and University of Louisiana veterinary schools have received large grants and have become the leaders in veterinary quackademic medicine as a result. The comments of the leaders of the AHVMA and AHVMF make it clear this money is intended not for any kind of rigorous research evaluation of plausible CAVM practices, but simply to promote these and give them a patina of scientific legitimacy.

The AHVMA and AHVMF also organize student alternative medicine clubs at veterinary colleges and offer scholarships and other support for students wishing to study CAVM methods. The influence of this on what will be considered mainstream, legitimate medical practice in the future is potentially significant, and quite disturbing.

Apart from their fundraising success, these two organizations have been able to infiltrate and influence mainstream veterinary organizations. Along with the American Academy of Acupuncture, the AHVMA has been admitted to the governing body of the American Veterinary Medical Association. Perhaps not coincidentally, this organization effectively lobbied to kill the resolution in the AVMA House of Delegates to declare homeopathy an ineffective therapy. The AVMA statement on CAVM was also amended to remove any talk of science or scientific evidence at about the same time the AHVMA was admitted.

There are, of course, many other CAVM organizations also proselytizing and marketing their particular brand of alternative medicine. In addition to the organizations of homeopaths and acupuncturists, there are national and international academies and associations for veterinary chiropractic, traditional Chinese medicine, naturopathy, herbal medicine, pet psychics (sorry, “animal communicators”), and pretty much any other variety of alternative medicine you can imagine. And all of them offer certifications which, though not recognized by the official AAVSB, are indistinguishable from real, meaningful credentials to pet owners and most regular veterinarians. And all of these groups raise money, lobby, and otherwise promote their own brands of woo and most of the others at a volume that cannot be matched by advocates of EBVM and science-based medicine.

The internet is, of course, the Wild West for quack therapies. Claims are made for miracle treatments that are not only unsupported or unquestionably ridiculous but blatantly illegal. The FDA, FTC, and other relevant agencies almost never take any action, so it is very much a buyer-beware marketplace. The vast majority of the health information available to animal owners on the internet is marketing from someone with a product or practice to sell. I play whack-a-mole here as best I can with the most egregious misinformation, and a few others do the same, notably fellow SBM contributor David Ramey. But this is a mere drop in the CAVM propaganda ocean.

Where Do We Go From Here?
It is difficult to see the situation in veterinary medicine with respect to quackery improving any time soon. The resources, passion and momentum, and political environment all appear to favor the greater infiltration of alternative therapies into the mainstream of veterinary practice. The development of evidence to validate or invalidate the plausible among CAVM treatments is glacial. And the culture of veterinary medicine favors extreme individual autonomy and discourages open criticism and debate on the subject.

Professional institutions, such as the AVMA and specialty boards, are reluctant to criticize or discourage any practice that veterinarians can legally sell or to take any position on what constitutes scientifically legitimate medicine. And academic, research, and teaching institutions appear to be opening their doors to CAVM, with the hinges greased by contributions from the CAVM lobby. This raises the specter of the next generation of veterinarians being taught that homeopathy, energy medicine, and similar nonsense is legitimate, respectable, even “evidence-based” veterinary medicine.

Fortunately, there are organizations and individuals who see the problem, the danger the philosophy and practices of alternative medicine represent to our patients and our profession, and who are making an effort to stem the tide. SBM has had significant impact on the discussion or CAM in human medicine, and to a lesser extent those of us advocating for science-based medicine in the veterinary domain are attempting to do the same in our field.

At a minimum, continuing to challenge the claims of CAVM proponents mars their efforts to make their practices seem uncontroversial or ordinary and legitimate. Our efforts to highlight the facts may save at least some animal owners from being misled or buying into unproven or quack therapies. And perhaps we may even influence the next generation of vets ourselves, and sustain the skepticism needed to resist CAVM narratives.

Though the current state of science-based veterinary medicine is a bit shaky, there is hope. I encourage anyone interested in defending animals and animal owners from CAVM to get involved in one of the organizations I mentioned that are defending evidence-based veterinary medicine. Make it clear to your clients and colleagues, if you are a veterinarian or veterinary technician, or to your vet if you are an animal owner, that that science-based and evidence-based medicine are the right approaches to animal care, and that CAVM is not a safe, effective, or ethical alternative. Ask for evidence whenever a claim is made, and demand more than personal experience and testimonials.

And if you can, contribute not only your time and energy but financial support. Donations to non-profit groups supporting real research, like the Morris Animal Foundation,  or promoting evidence-based medicine, can help balance the resources currently pouring into veterinary medicine in support of CAVM. And your choices of where you spend your money as an animal owner can make a difference too. Some vets offer CAVM because they believe in it. Plenty of others offer it becomes it sells! Make sure your vet knows that you want to pay for science-based care, not untested and implausible products and services or outright quackery.

 

Posted in General, Science-Based Veterinary Medicine | Leave a comment

EBVM 2014 Conference Highlights

Posted on November 10, 2014 by skeptvet

This video shares some of the highlights of the recent evidence-based veterinary medicine conference I participated in, EBVM 2014. The full presentations will eventually be available as well, and I will post those also.

 

 

Posted in Presentations, Lectures, Publications & Interviews | Leave a comment

Update: Producer of Tumexal Warned by FDA to Stop Illegal Marketing of Unproven Cancer Drug

Posted on November 7, 2014 by skeptvet

Back in May, I wrote about yet another “cancer wonder drug” called Tumexal. As usual, claims were made by the company that were not supported by real research evidence but only by unreliable testimonials and pseudoscientific  verbiage. There were many warning signs of quackery in the company advertising, and my conclusion was this:

TumexalTM is yet another purported wonder drug with a “secret ingredient” that has been discovered by a lone genius and offered to the public out of altruism. It is supposed to be very effective and perfectly safe, and anyone who doesn’t take the company’s word for this is a “cynic” with questionable motives or a lack of compassion. Such claims are cheap and easy to make, but they are worthless without real scientific data, and none are available for TumexalTM. While it is impossible to prove it doesn’t work based on the nothing the company will tell us about it, it is not the job of skeptics to prove such wild, implausible claims untrue. It is the job of those who make them to prove they are valid. Anecdotes aren’t data, and cannot be used to prove a medical therapy is safe and effective. So to date, the company expects us to buy their product and administer it to our ill pets based only on their word for the safety and effectiveness of TumexalTM. Does this seem like a good idea?

Now, the FDA has taken the rare but welcome step of warning the company that produces tumexal to stop making illegal unsupported claims about the product’s safety and efficacy. The FDA has authority to require veterinary medicines be proven to work and to be safe before being marketed, as human medicine must be. But the agency has neither the resources nor the political support to enforce this vigorously, apart from products that in some way affect human health or food safety. However, when a product violates the rules intended to protect the public egregiously enough to draw complaints, sometimes the agency will act.

As I also said in my article on Tumexal, “Unproven remedies are as likely to hurt your pet as to help them, especially when substituted for real medicine. And even in the face of a disease as terrible as cancer, it is possible to make your pet’s life worse by rolling the dice on a snake oil like Tumexal.” The fact that the FDA has taken this action illustrates how irresponsible and dangerous the behavior of this company has been in selling snake oil as if it were real medicine for pets with cancer.

Posted in General | 4 Comments

UT Integrative Veterinary Medicine Fellowship: A Case Study in Alternative Medicine Propaganda

Posted on November 3, 2014 by skeptvet

I have previously discussed the problem with so-called “integrative medicine.”  It is ultimately a Trojan Horse intended to gain acceptance for alternative therapies without the bother of demonstrating they actually work through rigorous scientific research. Proponents of integrative medicine want to generate the impression that there is no meaningful difference between cardiology and acupuncture, oncology and chiropractic, surgery and homeopathy. All of these are just equivalent areas of specialization within medicine. The problem is that this is a lie.

Most alternative therapies are either unproven or already disproven, which is why they are in that category to begin with. And while some do deserve serious research to determine whether or not they are safe and effective, proponents aren’t interested in doing this, because they already “know” these methods are effective based on personal experience and faith. They only wish to convince their mainstream colleagues, and they view science as a marketing tool rather than a way to find out the truth about these practices.

I have also previously written about the integrative medicine program at the University of Tennessee veterinary school as an example of this problem. It is funded in part by the American Holistic Veterinary Medical Foundation (AHVMF), whose leaders have repeatedly demonstrated their commitment to pseudoscience and their fundamental rejection of basic scientific principles. The center also receives funding from the Mercola Healthy Pets, a branch of the web site founded by Dr. Joseph Mercola, one of the most effective promoters of quackery and opponents of science-based medicine out there. Of course, accepting funding from these sources does not automatically mean the program shares their goals and methods, but it is reason to look closely at the program itself.

A recent interview with Dr. Raditic, founder of the UT integrative medicine program, and Dr. Danielle Conway, the inaugural fellow in integrative medicine at UT, published on the Mercola veterinary web site, provides examples of the CAM marketing strategy embedded in the notion of integrative medicine (Part 1, Part 2).

Dr. Conway, in a previous interview, explained that her faith in alternative therapies is founded on her personal experience as a child. She recounts her parents’ decision to turn to a naturopath for help with a serious illness she experienced. According to the interview, “After a few rounds of herbs, homeopathy and acupuncture, she was able to be a normal kid again.” Given the evidence that homeopathy is a useless placebo, most herbal therapies remain unproven and have significant risks, and acupuncture is almost certainly a placebo as well, this anecdote-driven faith seems misplaced. Yet Dr. Conway has already received training in the pseudoscience that is Traditional Chinese Veterinary Medicine, and it seems likely that she comes to this fellowship with her mind pretty well made up. This is not a perspective conducive to rigorous, open-minded scientific work.

This attitude seems to underlie an anecdote from the interview which is clearly intended to imply alternative therapies can be not only equal but superior to conventional medicine. Dr. Conway relates seeing a patient that had already been seen by numerous veterinary specialists “who hadn’t been able to help.” Despite being a brand-new veterinarian, Dr. Conway claims to have been able to properly identify the problem these experts missed thanks to her alternative training.

She was at that moment very grateful for the complementary medicine training she had already received in acupuncture and chiropractic, because it added a new dimension to her physical examination of the dog.

Dr. Conway began to do some basic chiropractic manipulations on the dog, paying attention to little subtleties that veterinary students don’t learn about in conventional vet medicine training. She realized there was something going on with the dog’s larynx. She thought to herself, “It’s stuck. It’s just not right.”

Shockingly, Dr. Conway turns out to have been right when conventional veterinarians were wrong, as the dog reportedly had an abscess of the larynx. The story goes on to suggest that the dog was successfully treated by alternative medicine alone, though I suspect some details of the diagnosis and therapy have been left out in the interest of creating a narrative that serves the purposes of CAM promotion:

Not only was Danielle able to accurately diagnose the dog, she was also able to treat him successfully with aromatics.

The article goes on to strongly imply that alternative practitioners are more skilled at physical examination and that conventional medicine relies too heavily on technology. Just as exercise, nutrition, and other completely conventional and mainstream health practices are often labeled “alternative” to suggest that CAM practitioners employ them and conventional doctors do not, so the universal expectation that veterinarians should learn and perform an effective physical exam as a routine part of clinical practice is twisted to suggest that this technique is somehow a feature of alternative medicine that mainstream doctors often don’t understand or apply.

In addition to such disingenuous spin, the story also ignores the overwhelming evidence against the theory and most clinical applications of chiropractic, which relies on a vitalistic understanding of health and disease completely incompatible with the real science both Drs. Conway and Raditic claim to also value.

The article reinforces in several other ways the role of programs such as this as advertising vehicles rather than true efforts to discovery the real value of alternative therapies. Dr. Raditic, for example, implies that preventative health care, like a good physical exam, is an alternative, rather than mainstream practice:

Seeing patients as puppies and kittens and embarking on a proactive approach to their lifelong health care is the goal. To do that, integrative programs must be available in every veterinary school.

And she once again identifies the goal of research as not discovery of the truth but marketing and promoting alternative medicine:

And good-quality research needs to be done. Danielle says, “That’s how I think we’re really going to change hearts and minds, and convince veterinarians to incorporate complementary medicine into everyday practice.”

To be fair, both Dr. Raditic and Dr. Conway acknowledge the importance of basic science and conventional veterinary medicine, and I don’t doubt they are sincere. Like most CAM vets I have met, they are most likely nice people and competent conventional clinicians. However, despite their genuine belief that they are working in the best interests of patients and veterinary medicine and in a way consistent with the principles of science, the reality is that their statements and actions are deeply inconsistent with the principles of scientific medicine. A deep, unshakeable faith in therapies that have not yet been proven or, in many cases, have already been demonstrated to be ineffective is not compatible with an open or scientific mindset.

The purpose of integrative medicine programs like the one at UT is clearly to promote therapies despite the lack of evidence for them or the evidence against them. By making such therapies familiar, by implying they are equivalent to scientific medical specialties, by mischaracterizing science-based medicine and appropriate as “alternative” aspects of conventional care, such as nutrition and physical exam skills, these advocates hope to spread their faith in alternative therapies regardless of the scientific evidence for or against them.

This is not, despite all the best intentions, truly what is best interests of patients. More homeopathy, chiropractic, acupuncture, aromatherapy, and the like will not bring better health to our patients. Rigorous scientific evaluation of plausible therapies will. The right way to handle alternative therapies is to discard the category itself and simply treat them like any other kind of medicine. Those that show plausibility through basic science and pre-clinical study should be subjected to high-quality clinical trials. If they demonstrate consistent, meaningful benefit and acceptable risks, they should simply become “medicine,” not “alternative medicine.” Those that fail this test should be abandoned. An honest, fair, science-based approach will separate the worthwhile from the worthless, rather than merely making the unproven or worthless seem more scientifically legitimate, as integrative medicine programs like this currently do.

 

 

 

Posted in General | 3 Comments

Duralactin for Arthritis

Posted on November 2, 2014 by skeptvet

I was recently asked by a reader to comment on yet another product marketed for arthritis treatment in dogs and cats: Duralactin. Because arthritis is a very common disease for which there is no definitive cure, it is a popular target for commercial remedies. I have reviewed many of these, but of course there are far more out there I have not addressed. Some, like non-steroidal anti-inflammatory drugs (NSAIDs) are well-researched and their risks and benefits are clearly known. Others, like glucosamine, are quite popular despite little or no evidence of efficacy. Some, like homeopathy, are certainly useless quackery. Duralactin falls into that enormous area of remedies that have so little evidence associated with them almost nothing definitive can be said about their safety or efficacy.

What Is It?
According to the manufacturer, Duralactin is “a patented milk protein concentrate from the milk of hyperimmunized cows.” That sounds very “science-y,” but it really isn’t very revealing. Theoretically, this means the product contains antibodies extracted from the milk of cows stimulated by some means to produce those antibodies. What these antibodies are, how they were produced and processed, and of course what if anything they do for patients with arthritis is not revealed.

Does It Work?
I have not been able to find any published research evidence to answer this question. This is never a good sign. In fact, marketing a product with vague ingredients described in “science-y” language and supported primarily by anecdotes and testimonials is part of a constellation of warning signs for snake oil.

The company does refer to some in vitro experiments which suggest that injecting cows with a bacterial vaccine can stimulate production of compounds in the milk that reduce the activity of some cells involved in the inflammatory response. It is a long, long road, however, from there to a clinical therapy for arthritis, and the company does not appear to have paved the way with much relevant research.

The company also refers to a clinical trial comparing the product to a placebo in dogs. The value of this evidence is, however, quite low as it is a study performed by the company and not apparently published in the scientific literature. Even the limited report available on the company web site suggests some problems with the study. Fifty dogs entered the trial but only 35 completed it, which is a pretty high dropout rate which could easily bias the results. Outcome measures were entirely subjective, and the reported response ranged from 10-14 points over placebo on a 100 point scale, which is of questionable clinical significance.

The company does, of course, offer plenty of testimonials to suggest the product works well, but it is well established that such testimonials are highly biased and misleading.

Is It Safe?
Once again, the answer has to be “Who knows?” The company reports no adverse effects in their unpublished clinical study, but without formal assessment under more reliable conditions, the risks are, like the possible benefits, unknown.

Bottom Line
Ultimately, real proof that a medicine is safe and effective requires careful, rigorous, and often expensive and time-consuming research. It is easier and cheaper for companies to produce supplements that can be marketed without this level of proof and then provide far less reliable sources of evidence that their products do more good than harm. Duralactin may well have benefits for patients with arthritis, though there is currently little to support this claim. And while there is no obvious reason to think it is harmful, without real research this is as much of a guess as the question of whether or not it helps.

 

Posted in Herbs and Supplements | 53 Comments

Even Mandatory FDA Recalls Can’t Make Supplement Manufacturers Stop Lying About What’s in their Products

Posted on October 27, 2014 by skeptvet

There is ample evidence that under the current lax regulatory system in the U.S., dietary supplements are frequently mislabeled and adulterated with pharmaceuticals, toxins, and other undesirable substances. Apart from the lack of evidence to support the claims of benefits for most such products, this unreliable labeling represents a real danger to consumers. There are many examples of people injured or killed by such products.

The FDA has made some efforts to control this problem, and one tool used for this purpose is the mandatory recall. A recent short feature in the Journal of the American Medical Association (JAMA) has examined the impact of such recalls and found that, unfortunately, they do not seem to be very effective in encouraging better compliance with the law or quality control on the part of supplement manufacturers.

Cohen PA, Maller G, DeSouza R, Neal-Kababick J.  Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014 Oct 22-29;312(16):1691-3. doi: 10.1001/jama.2014.10308.

According to this study, about half of the Class I mandatory recall in the last 10 years have been of adulterated dietary supplements. Over the four-year period from 2009-2012, the FDA recalled 274 dietary supplements. In this study, the authors tested about 10% of these recalled supplement for common banned substances. The results show how unconcerned this industry appears to be about consumer health and safety:

One or more pharmaceutical adulterant was identified in 66.7% of recalled supplements still available for purchase.

Supplements remained adulterated in 85% (11/13) of those for sports enhancement, 67%(6/9) for weight loss, and 20%(1/5) for sexual enhancement. Of the subset of supplements produced by US manufacturers, 65% (13/20) remained adulterated with banned ingredients.

Sixty-three percent of analyzed supplements (17/27) contained the same adulterant identified by the FDA. Six of the 27 (22.2%) supplements contained 1 or more additional banned ingredients not identified by the FDA… Some supplements contained both the previously identified adulterant as well as additional pharmaceutical ingredients.

It is particularly important to note that this was not simply a problem with supplements manufactured outside of the United States, since a majority of domestically produced supplements remained adulterated even after being recalled for representing a serious safety hazard. I completely agree with the authors’ conclusions:

More aggressive enforcement of the law, changes to the law to increase the FDA’s enforcement powers, or both will be required if sales of these products are to be prevented in the future.

Posted in Herbs and Supplements | Leave a comment

EBVM 2014: Building a Community to Advance Evidence-based Veterinary Medicine

Posted on October 26, 2014 by skeptvet

I have just returned from one of the most exciting scientific meetings I have ever attended, the EBVM 2014 conference organized by the RCVS Knowledge, the charity arm of the Royal College of Veterinary Surgeons. Over 250 people from around the world attended, full of enthusiasm and ideas for improving veterinary medicine for patients, animal owners, and veterinarians, through the development and promotion of evidence-based veterinary medicine (EBVM). Vets from teaching and research institutions, general and specialty private practice, other sectors of the veterinary profession, and affiliated industries spent two days meeting and talking about EBVM and how it can be developed and implemented to make veterinary care safer and more effective.

The conference grew out of an earlier, smaller meeting in 2012, Sceptical Vet: Evidence or Eminence?, which I also attended. The RCVS first formed an EBVM Network open to everyone interested in EBVM. Members of this network, along with the staff of the RCVS, then put together the goals and agenda for the EBVM 2014 conference. Speakers included pioneering academics involved in EBVM research and teaching, like Dr. Mark Holmes; private practitioners such as myself and Dr. David Ramey; veterinary nurses and other veterinary professionals; and representatives of existing organizations devoted to promoting EBVM, including the Centre for Evidence-based Medicine (CEVM) at the University of Nottingham and the Evidence-Based Veterinary Medicine Association (EBVMA).

The full program is available here, and eventually recordings of all the talks and associated slides will be available on the web. I just wanted to highlight a few key themes and projects addressed at the meeting.

The first of these was the importance of moving EBVM beyond the universities and specialty centers and into general practice. The vast majority of veterinary care is provided by first-opinion veterinarians, and the full impact of EBVM on the welfare of veterinary patients can only be achieved by overcoming resistance and obstacles to widespread practice of EBVM in this setting. Teaching primary care veterinarians what EBVM is, and what it isn’t, and dealing effectively with barriers to adoption of EBVM are all necessary steps that were discussed at this meeting. Examples were also presented of successful implementation of EBVM in general practice, such as a presentation about the adoption of clinical practice guidelines for small animal CPR in my own hospital.

Of course, the lack of high quality and relevant research evidence is one of the greatest barriers to widespread use of EBVM, and much discussion was focused on ways to grow and improve the evidence base. Speakers were not afraid to directly address limitations and weaknesses in the scientific evidence that might reduce the usefulness of EBVM in the clinical setting. If we are to be successful in using EBVM to improve veterinary medicine, we need to be clear-eyed about the limitations in EBVM theory and practice and the pitfalls involved in widespread adoption of it so we can successfully use EBVM methods to improve veterinary care.

Much time was also given to practical strategies for using EBVM, including the best practices for developing and implementing clinical practice guidelines, the uses and misuses of systematic reviews, the teaching of EBVM to veterinarians and veterinary students, and the economic issues of implementing EBVM in different areas of veterinary medicine, from food production and public health to companion animal practice.

Lots of ideas were discussed for future projects. The EBVMA, CEVM and RCVS Knowledge have all endorsed the AllTrials Initiative, a movement in human medicine to encourage the registration of clinical research studies and the open sharing of all data from these trials so that doctors and patients can make the best-informed decisions possible about the use of the treatments studied in these trials. There is currently no way for most veterinary researchers to register their studies, or for others to access their data, and an AllTrials Initiative for veterinary medicine was a popular idea. Projects for generating more and better research evidence, including more research conducted in general private practice, were also discussed, as well as projects to make useful critical synthesis of existing research more widely available to clinicians. RCVS Knowledge also announced their intention to produce a Journal of Evidence-Based Veterinary Practice, and to open a web-based forum for interested veterinary professionals to discuss particular projects and topics in EBVM. I will create a post specifically to provide links to these and other EBVM resources as they become available.

Many of the ideas and projects discussed at EBVM 2014 will take shape in the two years between now and the next major EBVM meeting RCVS plans to sponsor, to be held in Edinburgh in 2016, and I look forward to participating in this process. It was inspiring to spend these two days talking with so many people full of enthusiasm for improving veterinary medicine and the care veterinary patients receive using the tools of science. Evidence-based medicine has changed the landscape of human healthcare dramatically and for the better, and I am confident it will do the same for veterinary medicine. It is truly an exciting time to be in the veterinary profession, and I am proud to be contributing in a small way to this movement.

 

Posted in Science-Based Veterinary Medicine | 3 Comments

New Systematic Review of Veterinary Homeopathy: Still no Reason to Believe It Works

Posted on October 21, 2014 by skeptvet

I have reviewed the overall evidence concerning homeopathy, from basic science through clinical trial research in great detail previously. Despite more than 150 years of effort by advocates for this practice, virtually no reliable evidence has been developed to show it can work or does work.

The same conclusion has been reached by many others, from the systematic reviews of homeopathic trials and systematic reviews of these systematic reviews, to the formal investigations of governmental agencies such as the British House of Commons Science and Technology Committee and the Australian National Health and Medical research Council. While homeopaths have had more than a century to try, they have not been able to produce a body of scientific evidence to convince anyone but themselves that homeopathy works.

In response to criticism of homeopathy based on this lack of believable scientific evidence, veterinary homeopaths have tried presenting their own review of the science, putting as positive a spin on the evidence as they possibly can. However, when I examined this attempt in detail, it was so rife with bias and poor quality research that it amounts to little more than an example of propaganda masquerading as science. Of all the studies presented by the Academy of Veterinary Homeopathy, the overwhelming majority were so clearly biased or poorly conducted that they were meaningless. Many actually found that the homeopathic intervention didn’t work but were cited as positive anyway. Only one paper had reasonably good methodology, but in the face of overwhelming negative evidence, it takes more than one study in 150 years to validate a deeply implausible practice.

There is now a new systematic review which specifically evaluates clinical trials of homeopathy in veterinary medicine and which attempts to employ conventional standards of evidence to control for bias and other study weaknesses.

Mathie RT. Clausen J. Veterinary Homeopathy: systematic review of medical conditions studied by randomized placebo-controlled trials. Vet Rec. 2014;175(15):373-81.

This review was conducted by two advocates for homeopathy, clearly with an interest in supporting the practice: “Each of us is employed by a homeopathy charity to clarify and extend an evidence base in homeopathy.” Yet despite this obvious agenda, the authors attempt to follow the conventional standards for a systematic review, and the result is not very encouraging for homeopaths.

An extensive search found only 18 clinical trials that were eligible to be evaluated. Of these, one had a low risk of bias, six had an uncertain risk of bias, and eleven had a high risk of bias. Of the seven that had a low or uncertain risk of bias, three showed a statistically significant effect, three showed no effect, and one could not be evaluated. Of these seven trials, two were judged to provide “reliable evidence” based on an overall assessment. One showed a significant effect and the other did not. Both, the authors note, had some odd design features that made them different from the standard clinical trial format.

So the best that two committed supporters of homeopathy could find when attempting an objective evaluation of the veterinary homeopathy literature were two studies that were probably pretty reliably conducted, one of which found an effect and one of which didn’t. Once again, in the face of the inherent implausibility of the practice (despite the nonsense about “nanoparticles” which these authors themselves reference as if it solved the plausibility problem), and a century and a half of dedicated effort, such a glaring lack of positive evidence is far more consistent with homeopathy being a placebo than with it being the dramatically effective therapy its proponents claim.

Radical new ideas in medicine just as widely scoffed at as homeopathy have been able to prove themselves and be widely adopted in far less time than this. The notion, for example, that a bacteria could be the major cause of ulcers in humans went from ridicule (when proposed in 1982) to a Nobel prize (in 2005). It is plainly irrational to keep claiming homeopathy has dramatic benefits and that science will one day vindicate it when so much effort has turned up virtually nothing encouraging in the way of clinical research.

Now, undoubtedly proponents of homeopathy will respond to this systematic review by saying “See, there is evidence it works, all we need are more studies!” While the authors did a pretty good job trying to follow the procedures of a good systematic review, these reviews are not infallible. Garbage in can lead to garbage out, and I’ve written before about the danger of uncritically relying on the conclusions of systematic reviews where there is a potential for bias. Even if this review, and my own, did not find obvious reasons to reject the findings of two studies of homeopathy, out of all the many hundreds of those that have been published, this is not a vindication of homeopathy. It is simply a reflection of the limitations of the scientific process to exclude every single source of error when hundreds of attempts are made by committed believers to conduct clinical trials to prove what they already believe is true. Most positive trials in conventional medicine turn out to be false, and there is far more reason to doubt the rare positive study of magical nonsense like homeopathy.

Science never closes a door all the way. Could there possibly be evidence someday that would, consistently and repeatedly and with the best possible controls for error, show homeopathy really can be a miracle cure? The possibility cannot be ruled out 100%, but it must be recognized to be as unlikely as the idea that the next time someone leaps off a twenty-story building they will soar into the sky rather than fall to their death. The odds are so long as to make continued betting a foolish waste of resources. If homeopathy truly were dramatically effective, then like Vitamin C for scurvy and the first antibiotics, the results of clinical trials should be striking and obvious, not incredibly hard to pick out from the mass of negative findings.

This systematic review emphasizes that even with the darkest of rose-colored glasses, it is impossible to see the scientific study of homeopathy as anything other than an utter failure to find real, meaningful benefits, and that the best thing medical researchers could do for patients, human and veterinary, is to give up on this failed idea and move on to more promising research.

 

 

 

 

 

Posted in Homeopathy | 9 Comments