Pox Parties for Dogs: Brought to You by Veterinary Homeopaths

When I first heard of Pox Parties, I found it amazing, and frightening, that people actually fear vaccines so much that they will deliberately expose their children to infectious disease to avoid them. Such parents take their children to play with others who have active infections, or even mail infectious material to each other to expose their children (which is illegal as well as stupid).

It is true that some children exposed in this manner will develop a protective immunity. Some will also have to endure an active infection, which for those of us old enough to have experience can dimly recall is very unpleasant. And a small umber of these children will experience serious, even life-threatening or permanently disabling injury from these infections.  Given the well-demonstrated and remarkable safety and effectiveness of vaccines, there is simply no excuse other than ignorance and irrational fear for this behavior.

I was somewhat surprised to see recently that some veterinarians are apparently recommending a version of the Pox Party for dogs in order to avoid vaccinating for parvovirus and canine distemper, two common and very serious infectious diseases. I was not, however, surprised that these veterinarians were homeopaths.

An article by Dr. Will Falconer (about whose bizarre and dangerous view of medicine I have written before here, here, and here) and posted on the Facebook page for the Academy of Veterinary Homeopathy, shares the “exciting” news about how to avoid evil vaccines for parvo and distemper.

Imagine avoiding risky vaccinations while getting very strong immune protection against parvo and distemper, the two potentially deadly diseases of puppies.

You know vaccinations are grossly over provided in our broken system of veterinary medicine. The pushing of vaccinations by Dr. WhiteCoat throughout your animal’s life doesn’t add to her immunity…And you know that vaccines are harmful. Chronic disease often follows vaccination, even a single vaccination.

Despite his assumption that his readers share his understanding about the devastating consequences of vaccination, Dr. Falconer is actually completely deluded on this point. While vaccines have risks, like any medical therapy with any effects at all, they also have benefits, and the two must be balanced against one another. Vaccination has greatly reduced, and in some cases completely eliminated infectious diseases that afflicted humanity and caused enormous suffering and death for millennia, and the risks have proven to be surprisingly few in light of the enormous benefits.

Vaccine protocols are changing in veterinary medicine in recognition that these therapies provide even greater protection than once thought and do not need to be given as often as they traditionally have been. However, no reasonable veterinarian, and no legitimate scientific evidence, supports these kinds of hysterical claims about the dangers of vaccination or the idea that they can or should be entirely avoided.

The alternative Dr. Falconer and his colleagues propose to vaccination for parvovirus and distemper is further illustration of a truly astounding level of delusion and ignorance of history:

A lecture on parvo by Dr. Todd Cooney lit us up, as he showed us statistics from his homeopathic practice in Indiana that the vaccinated pups had less chance of surviving parvo than those not vaccinated for that disease!

Parvo vaccine itself was immune suppressive.

Parvovirus was ubiquitous in the environment.

Animals treated homeopathically when sick with parvo had far better survival rates than those treated with the usual drugs.

Distemper was prevented by taking pups to a known wildlife area where raccoons with distemper lived.

Dr. Rosemary Manziano learned of the outbreak of canine distemper in raccoons in her area through the CDC. She boldly suggested to her puppy owners over a period of 11 years that they visit a pond known to be a hangout for these raccoons. After a brief period of sniffing around the bushes and maybe drinking the water, the pups were brought home.

This was repeated a week later, and on the third week, the good doctor would test for distemper titers, the evidence of immune response. Lo and behold, these pups had fantastic titers indicating strong immunity! And, in case you’re wondering, not one puppy ever got sick in the least. This happened in well over a hundred pups and was, as Dr. Manziano called it, “fool proof immunization.”

After eleven years, it stopped working. She assumed that the disease in raccoons had run its course, natural resistance having been gained by their population.

Dr. Manziano suggested that her new pup owners who wanted natural immunization take short, five minute visits to the most popular dog parks. Those parks with the highest dog traffic were recommended.

This kind of irresponsible advice is not supported by scientific evidence, but then that sort of evidence is of no concern to people who practice the mystical discipline of homeopathy anyway. The reality is that these veterinarians appear to be discouraging their clients from making use of safe and effective therapies that have dramatically reduced the risk of life-threatening illness in dogs and instead recommend exposing dogs to these very serious diseases in the bizarre belief that they are more likely to develop protective immunity without active infection or harm. This belief requires a dramatic ignorance of the entire field of immunology and the history of vaccination or simply a complete rejection of science in favor of the infallible wisdom of uncontrolled personal experience.

In either case, it seems indefensible and unethical. It is a sad comment on the state of the veterinary profession that these doctors are allowed to promote such practices while maintaining the appearance of legitimacy, and the exclusive right to practice veterinary medicine, that comes with being licensed veterinarians. Their behavior not only places their patients at unnecessary risk but undermines the legitimacy of the veterinary profession and the confidence of the public.

 

Posted in Homeopathy, Vaccines | 7 Comments

Australian National Health and Medical Research Council Review Concludes Homeopathy Doesn’t Work

When I reviewed the case against homeopathy as part of the debate over the AVMA resolution to acknowledge it as a placebo therapy, there were many previous reviews to refer to. In addition to the numerous systematic reviews of the scientific literature, the UK House of Commons Science and Technology Committee had recently conducted an extensive review and hearings and concluded:

In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos. We could find no support from independent experts for the idea that there is good evidence for the efficacy of homeopathy.

Many other organizations have, upon reviewing the evidence, come to the same conclusion, including:

The British Veterinary Association-

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

The Australian Veterinary Association-

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

And even the AVMA Council on Research-

There is no clinical evidence to support the use of homeopathic remedies for treatment or prevention of diseases in domestic animals.

A new, comprehensive review similar to that of the House of Commons committee, complete with input from homeopaths, has just been complete and submitted for public comment by the Australian National Health and Medical Research Council, comes once again to the only rational, evidence-based conclusion:

NHMRC concludes that the assessment of the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.

The organization reviewed the scientific literature, including evidence specifically submitted by homeopaths in defense of their claims. I have reviewed such evidence before and found it not reliable or supportive of these claims, and the NHMRC review aggress:

There were no health conditions for which there was reliable evidence that homeopathy was effective. No good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than a substance with no effect on the health condition (placebo), or that homeopathy caused health improvements equal to those of another treatment.

**For some health conditions, homeopathy was found to be not more effective than placebo.

**For other health conditions, some studies reported that homeopathy was more effective than placebo, or as effective as another treatment, but those studies were not reliable.

**For the remaining health conditions it was not possible to make any conclusion about whether homeopathy was effective or not, because there was not enough evidence.

The review discusses the evidence examined and the procedures used to evaluate it in detail. All of the procedures were vetted by the Australian Cochrane Centre and correspond to the standard practices of evidence-based medicine applied to conventional therapies. The conclusion was clear:

Based on all the evidence considered, there were no health conditions for which there was reliable evidence that homeopathy was effective. No good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment.

The evidence, and independent systematic review of the evidence concerning homeopathy is unequivocal. Homeopathy is no better than a placebo. Failure to accept this conclusion does not represent a scientific controversy but a fundamentally religious faith in homeopathy that is not capable of being altered by any evidence.

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“Electroacupuncture” as a Treatment for Nausea & Vomiting Caused by Morphine in Dogs

A study was recently published investigating the possible effects of “electroacupuncture” on nausea and vomiting induced by morphine in dogs. This study illustrates some of the challenges of evaluating acupuncture in general, and it shows how the ambiguity in study results can allow for positive or negative conclusions depending on one’s point of view.

Koh RB, Isaza N, Huisheng X, Cooke K, Robertson S. Effects of maropitant, acepromazine, and electroacupuncture on vomiting associated with administration of morphine in dogs. J Amer Vet Med Assoc 2014;244(7):820-29.

The Study

222 dogs who were going to be neutered were included in the study, 37 in each of six groups:

saline injection (placebo control)
maropitant injection (anti-emetic medication)
acepromazine injection (anti-emetic/sedative medication)
electrical stimulation/needling at 1 acupuncture point
electrical stimulation/needling at 5 acupuncture points
electrical stimulation/needling at location not designated as acupuncture point

Twenty minutes after one of the treatments above, the dogs were given an injection of morphine, a narcotic pain reliever commonly used for surgical patients. Morphine frequently induces nausea and vomiting shortly after injection, so the authors evaluated the dogs for the occurrence of vomiting or retching, the number of times dogs vomited or retched, the time it took for vomiting or retching to stop, and signs of nausea evaluated on a subjective numerical nausea assessment scale.

The dogs were randomly assigned to the treatment groups, and there appeared to be no significant differences between the dogs in the various groups. Assessment of vomiting and retching were made by an investigator aware of the treatment used in each dog. Assessment of nausea was made using a video recording assessment by a blinded investigator.

In terms of the objective sign of response to treatment, the occurrence of vomiting and retching, these events occurred significantly less in the medication groups than in the placebo and acupuncture groups, which did not differ from each other. Out of the 37 dogs in each group, the number (percentage) experiencing vomiting or retching were as follows:

Saline- 28 (75.7%)
maropitant- 14 (37.8%)
acepromazine- 17 (45.9%)
1 acupuncture point- 24 (64.8%)
5 acupuncture points- 26 (70.3%)
location not designated as acupuncture point- 32 (86.5%)

When the number of vomiting or retching episodes in total were counted, the pattern was similar, but the two acupuncture groups appeared to have fewer episodes than the control groups:

Saline- 88
maropitant- 21
acepromazine- 38
1 acupuncture point- 35
5 acupuncture points- 34
location not designated as acupuncture point- 109

In terms of the number (percentage) of dogs showing signs of nausea, the results were as follows:

Saline- 11 (29.7%)
maropitant- 12 (32.4%)
acepromazine- 3 (8.1%)
1 acupuncture point- 7 (18.9%)
5 acupuncture points- 4 (10.8%)
location not designated as acupuncture point- 15 (40.5%)

Nausea scores were calculated on a 4-point scale 10min, 15min, and 20min after the morphine was given. The average scores ranged from 1.1 to 1.6, so there was little difference between groups. Statistically, the scores for maropitant, saline, and sham acupuncture were higher than before the morphine at 2 of these 3 time points while the score did not change after morphine for the other three groups.

What Does It Mean?

In humans, there is some evidence acupuncture may be effective at reducing nausea and vomiting in a variety of situations, though some reviews for some conditions find no benefit. The tricky part in assessing this is that nausea and vomiting are very subjective and influenced by mental states which are highly subject to placebo effects and bias. It is challenging to blind patients to whether or not they are receiving acupuncture, and it is impossible to blind the people giving the acupuncture therapy, so some residual bias exists in all acupuncture studies. This is problematic because the attitude and demeanor of the acupuncturist has a significant effect on outcome in acupuncture studies, so unblinded therapists, patients, and investigators make the results of studies looking at highly subjective symptoms difficult to rely on.

In this study, the sham control for the acupuncture treatment was application of the same therapy (needling and electrical stimulation) at a location not considered an acupuncture ;point. The biggest problem with this is that there is no such thing as an acupuncture point. The locations for needling in dogs are determined subjectively based on interpretation of historical texts for humans which were themselves based on mystical and supernatural criteria, and the localization of acupuncture points is highly subjective and inconsistent depending on the individual acupuncturist and the school of acupuncture in which they were trained. They have not been consistently correlated with identifiable anatomic structures, and they cannot be consistently and repeatedly detected by acupuncturists tested under controlled conditions.

More challenging still is the question of whether the “electroacupuncture” tested in this study is really acupuncture at all. Sticking needles in the skin and running electrical current through them undoubtedly has physiologic effects. Transcutaneous electrical nerve stimulation (TENS) is a conventional therapy that uses this process to treat pain and nausea. The only thing that qualifies the therapy used in this study as acupuncture is the choice of needling location based on meridians and acupuncture points. However, since these don’t really exist, it is not clear that the sham treatment was really sham or the “real” acupuncture treatment real or distinct from any other method of using needles and electrical current.

As for the other treatments used, maropitant is a widely used and well-studied anti-emetic which has good evidentiary support for its effectiveness. Acepromazine is a sedative which has been reported to have anti-nausea effects, though it is less widely used for this purposes because of its sedating effects. And certainly, morphine is well-known to cause nausea and vomiting in dogs. So in general the study design was reasonable apart from the question of how acupuncture or “electroacupuncture” are defined.

The investigator assessing vomiting and retching was not blind to treatment, so even though these are pretty objective measures, it is possible for there to be some bias in this assessment. The results show pretty clearly that dogs given maropitant or acepromazine were less likely to vomit than those given placebo and that acupuncture had no more effect than the placebo. So for the most obviously important and objective measure, the acupuncture did not seem to work and the medications did.

When the total number of vomiting and retching episodes were counted, it appeared that the acupuncture was almost as effective as the maropitant. However, this measure by definition only included dogs who vomited. So if this is a true representation of the effects of these treatments, it would mean that maropitant and acepromazine prevents vomiting and acupuncture does not, however if the patient does vomit acupuncture is about as good as acepromazine, though not as good as maropitant, in reducing the number of times the dog vomits. This is a possible interpretation, however it is a bit convoluted and raises the question of whether using acupuncture instead of maropitant makes sense since it would seem preventing vomiting is better than simply reducing the number of times a dog vomits after getting morphine.

The blinding was appropriate for the assessment of signs of nausea, though this measure is inherently more subjective, and the nausea scale is not a validated instrument. However, the results for this measure make little sense. The number of dogs showing signs of nausea at all was lower for the acupuncture treatment groups and the acepromazine group than for the sham acupuncture, placebo and maropitant groups. For this to be true result, it would mean that acupuncture was better at reducing nausea than maropitant even though maropitant is better and preventing vomiting. This is possible, of course, but it seems the more plausible interpretation is that the results don’t make sense because this measure is not reliable.

The results of the numerical nausea scores are similarly dubious. Again, the score increased after morphine for the saline, sham acupuncture, and maropitant but not for the acepromazine and acupuncture treatments. This might mean that the acupuncture reduced nausea and the maropitant didn’t, but again this makes little sense given the extensive evidence for the anti-emetic effects of maropitant and the significantly lower number of dogs given this drug who vomited compared with those treated with placebo or with acupuncture. It is also hard to believe that a drug so effective in preventing vomiting was worse than saline placebo in preventing nausea. It seems more likely that the unvalidated nausea scale simply wasn’t a useful measurement tool.

It is also not clear that the differences in scores seen, even if they are real, are meaningful. The largest change for the maropitant seen was an increase from 1.0 to 1.5 on a 4-point scale. In humans evaluated with nausea scales, the smallest change in nausea considered even marginally significant is a change of 15%. The largest change measured in this study was only 15% for the sham acupuncture, and the change for the saline placebo was no more than 10%.

Bottom Line

The most positive interpretation possible for this study is that sticking needles into patients and running electrical current through them might reduce morphine-induced nausea marginally but does not prevent vomiting compared with maropitant. The question of whether or not this procedure can be legitimately called acupuncture, rather than TENS, hinges on whether or not the locations selected by these particular acupuncturists yield a better outcome than other locations.

While this study suggests they might, the bulk of the literature in acupuncture suggests needling locations don’t really matter for the effects of needling. Different acupuncture schools use so many different locations, ranging from locations on the entire body to just those on the ear or the hand, that any point at all would be considered an acupuncture point by someone. Acupucnturists are inconsistent in where they locate specific points, and no consistent detectable anatomic or physiologic structure has been associated with all the points claimed to be special. So it seems unlikely that using any particular traditional scheme for selecting needling location would be beneficial over any other.

In any case, the amount of change in nausea was not only clinically insignificant, but it requires us to accept that a drug which clearly prevents vomiting is less effective than a saline placebo in preventing nausea, which makes little sense.

The results also suggest that the nausea scale employed is not a very useful instrument. It would be worthwhile to have a validated measurement tool for this problem in veterinary patients, but developing it beginning with testing of a controversial intervention such as “electroacupuncture” is probably not the best way to proceed. Once such an instrument has been validated with more evidence-based therapies, using it to evaluate acupuncture would be reasonable.

This study provides little evidence for the value of acupuncture in treating morphine-induced nausea. Replication with a valid instrument would be necessary to document that there is, in fact, an effect of acupuncture on nausea and vomiting in dogs, but even if this were done this study suggests such effects are unlikely to be clinically significant, so there is little reason to substitute acupuncture for medications with clear efficacy, or even to add acupuncture to these treatments.

 

 

 

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The 2012 AHVMA Annual Conference: An illustration of Conflicts between Science-Based Medicine and Holistic Veterinary Medicine

In response to my criticism of individuals offering or promoting alternative medicine for pets, it has been pointed out that the community of such vets is diverse, and that one cannot fairly assume that all share the beliefs or practices of the more extreme members. That is undoubtedly true, and there are certainly individuals who claim to be “holistic” or “integrative” doctors who still have a basic commitment to the scientific method and with whom I agree on the merits or lack of merits for specific practices.

However, the whole raison d’etre of so-called complementary and alternative veterinary medicine (CAVM) as a category is to argue for special treatment for some therapies, and usually to suggest some either cannot or should not be expected to meet the scientific standards of evidence expected for conventional medical practices. The category itself is an ideological and political one which incorporates many ideas that are incompatible with the philosophy and practice of science.

And regardless of the diversity of the CAVM community, this community acts as a body to influence the practice of veterinary medicine. Much of this action happens through the membership organizations that bring together CAVM practitioners in general and proponents of specific therapeutic approaches.

I have often written about the Academy of Veterinary Homeopathy (AVH), the American Holistic Veterinary Medical Association (AHMA), and the American Holistic Veterinary Medical Foundation (AHVMF), organizations which represent many CAVM practitioners and which have had clear influence on the veterinary profession. These organizations may not speak for all CAVM practitioners, but they clearly represent many, and they are the voice and advocacy tool by which the CAVM community speaks to the rest of the profession and the public. Some of the actions such groups take and the ideas they espouse are troubling to those of us committed to science-based medicine.

For example, the AVH and AHVMA worked together to help defeat the resolution before the American Veterinary Medical Association (AVMA) identifying homeopathy as an unscientific and ineffective therapy by using a combination of fear tactics and misinformation. The AHVMA is now an affiliate organization of the AVMA House of Delegates with a vote on official policy matters, which raises the specter of further obstruction to efforts to encourage the continued growth of evidence-based veterinary medicine.

And the AHVMF has raised almost $900,000 in the last two years to promote alternative veterinary medicine. This money has been used to encourage veterinary student interest in alternative medicine, to support faculty positions at veterinary and training programs in alternative therapies, and to support research projects focusing on veterinary alternative medicine. Such efforts encourage the perception of scientific legitimacy for therapies promoted by these individuals and organizations. However, there is reason to believe that these efforts are more about marketing and promotion than about legitimate scientific inquiry.

For one thing, the leadership of these organizations often expresses a perspective that embodies a lack of understanding or an outright rejection of the principles and methods of science. And while the organizations often ostensibly claim to be interested in real science when speaking to the veterinary community as a whole, when speaking amongst themselves, their members sometimes express a very different point of view.

One example of this I recently ran across is the offerings at the AHVMA’s 2012 continuing education conference. The talks presented do illustrate some diversity of approach in the CAVM community. But they also illustrate quite dramatically some consistent themes which are undoubtedly incompatible with the scientific foundations of modern medicine. These are not simply disagreements about the evidence for specific therapies but fundamental disagreements about whether or not science is necessary or appropriate for evaluating medical treatments and what alternative methods are preferred in the CAVM community.

Some presentations at this meeting were science-based, in particular the talks about nutrition offered by Dr. Susan Wynn and Dr. Patricia Schenck. However, many of the talks quite openly questioned the value of the scientific method in general. And a significant number presented a clearly spiritual, faith-based rationale for their therapies.

It is important that the public and the mainstream veterinary community understand the philosophy behind alternative therapies and the degree to which this is or is not consistent with the scientific approach. As pet owners and as a profession, we cannot make informed choices about the degree to which we want to integrate alternative therapies into our patients’ and pets’ lives unless we understand the true rationale for these therapies and their relationship to the conventional scientific paradigm.

The conference covered a tremendous variety of subjects, and of course there was great detailed presented about the specific use of individual therapies. My purpose here is not to reproduce or evaluate the lectures but to focus on how they illustrate the underlying philosophy that runs through much of CAVM. There are three themes in particular which recur frequently and which present the greatest concern from the point of view of science-based medicine:

  1. Many CAVM therapies are founded on models of health and disease that are different from, and incompatible with, the scientific understanding. These models are viewed as equally legitimate or even superior to the scientific view, even if      they are relics of pre-scientific folk medicine developed during times when the health and longevity of human beings were far poorer than they have become since the advent of science.
  2. Many CAVM practices are united by a reliance on spiritual forces that cannot be detected or evaluated by scientific means but that must be understood and accepted as central to health solely on the basis of intuition or faith.
  3. Conventional medicine is often portrayed as fundamentally mistaken, ineffective, and even dangerous.

Keynote Address:  Dr. Jean Dodds
I have written about Dr. Dodds before. She is deservedly respected for legitimate contributions to veterinary medicine. Unfortunately, she has also been a consistent advocate for a variety of theories and practices not widely accepted as scientifically valid. In her keynote, she quite explicitly describes CAVM as separate from science-based medicine and suggests it is a better approach.

My background comes from the perspective of a classical research scientist, both during and after graduating from veterinary college, who then became an applied clinical research scientist. Then, I saw true path and light after meeting our extended veterinary holistic family at the AHVMA conference…

Standard allopathic treatments for immunologic disorders can be replaced with holistic alternatives and homeopathic remedies.

Dr. Dodd characterizes the role of scientific research in judging veterinary therapies as problematic. For example, she views the judgment of CAVM practices by RACE and specialty boards as mere “bias” and suggests that CAVM practitioners should be the sole judges of their own methods. She also mischaracterizes evidence-based medicine (EBM) and suggests an alternative that is more accepting of the value of individual clinician opinion:

Even the “holy grail” of evidence-based medicine is being challenged today. This concept has recently been revised to become evidence-based practice. Evidence-based practice represents a more complete discipline that combines research science and publications with the art of medicine, namely clinical and patient experience plus expert opinion.

All the mainstream definitions of EBM acknowledge the role of clinical experience, so this is not missing from EBM. The distinction Dr. Dodds is trying to make between EBM and evidence-based practice is a purely ideological rebranding intended to diminish the reliance on objective scientific evidence in favor of subjective opinion.

Truly Alternative Medicine
Many of the speakers at this meeting emphasized the value of models for health and disease different from, and incompatible with the understanding generated by science. While science produces and obviously and eternally incomplete and imperfect model of reality, as do all human systems of understanding, it has demonstrated its superiority over prescientific paradigms through a dramatic and unprecedented increase in our abilities to understand and manipulate nature.

Whether or not we have always made wise use of this power (and clearly we often have not), it is foolish to argue that the explanations of health and disease that existed before the advent of scientific methods were as good or better than the current model. If this were true, why did we fail to achieve any of the improvements in health and longevity brought about by the scientific understanding?

The emphasis these speakers put on pseudoscientific and spiritual explanations for disease belies the superficial claims the AHVMA makes about a genuine interest in scientific evaluation of CAVM. How can blatantly false theories (such as those behind homeopathy), or theories which are fundamentally religious and not amenable to scientific evaluation be a sound foundation for veterinary medicine? How is the acceptance of such approaches on an equal footing with all others consistent with a commitment to the scientific approach?

Speakers on the subject of homeopathy provided a consistent example of the rejection of science and faithful adherence to the received wisdom of a historical prophet often seen at this meeting. The central figure in the pantheon of homeopathy is the originator of the practice, Samuel Hahneman. His theories, developed in the 18th and early 19th centuries, are treated as nearly infallible gospel, and homeopaths frequently claim his understanding of health and disease to be superior to all the scientific knowledge gained in the last 150 years. These theories are quite clearly incompatible with science and rest primarily upon Hahneman’s view of disease as a spiritual, rather than physical problem.

Sue Armstrong-
Hahnemann tells us how psychic and emotional insults to an individual can allow the slumbering psora to manifest e.g. ‘The sudden death of a son causes the tender mother, already in ill health an incurable suppuration of the lungs or a cancer of the breast’.

Most importantly he recognised that there are in addition to the susceptibility, exciting/irritating or suppressive causes on the mental, emotional and psychic levels that can in homeopathic terms activate the dormant miasms e.g. grief, injury, burns drugs, alcohol, improper food and sexual suppression. This understanding of the cancer process by Hahnemann differs little in its core to the way we understand the essence of it now which is so true of so much of his teaching.

Christina Chambreau-
Finally I was introduced, through books and courses for people and animals to the philosophical underpinning of homeopathy. From that point on I have been confident that it is possible with homeopathy to really cure animals…The longer I practice homeopathy, the more I realize how successful homeopathy can be when the principles of Dr. Hahnemann, the founder of homeopathy, are followed.

Larry Bernstein-
The beliefs that Samuel Hahnemann held dear almost 200 years ago ring true today.

This reliance on a historical authority and rejection of subsequent evidence which disproves the theories he developed is fundamentally antithetical to the scientific perspective. The speakers further illustrate this incompatibility with their negative caricaturization of conventional medicine.

Larry Bernstein (quoting at length homeopath Julian Winston) gives a long list of supposed examples of conventional medicine failing to see the obvious truths perceived by homeopaths. For example:

When the German coal-tar pharmaceuticals and aspirin came along, the homeopaths saw the dangers

After the 1918 flu epidemic came and went the figures spoke for themselves. Allopathic death rates were often as high as 30%, while homeopathic rates were 1%.

Then the vaccine therapies made their play. The homeopaths said, “They will see the folly of their ways and seek us out.” They didn’t

Then Sulfanilamide comes along which kills enough people to become the impetus for stricter government drug regulation, as embodied in the FDA Legislation of 1938. The homeopaths said, “Well, now, they will finally understand.” They didn’t

He goes on to say that conventional medicine is still blind to the obvious superiority of homeopathy.

A patient, given up as “terminal,” comes back alive. “I used homeopathy;” she says. “Spontaneous remission,” says the physician.

Another patient, cured of her allopathically “untreatable” illness, returns to the specialist. Re-doing tests and x-rays, the previous illness is gone.

Says the specialist, “It must have been a misdiagnosis. What you had was not curable.”

The explanation given for this stupidity on the part of science-based medicine is simply an inability to cope with the real complexity of disease. Again, quoting a fellow homeopath:

The piece of homeopathy that is most threatening to the conventional model is…the idea that the therapy must be individualized for each case and the homeopaths have a methodology for doing this.” The idea that there are not a finite number of illnesses makes them crazy.”

Another homeopathic practitioner, Joseph Demers, presents yet another model of disease inconsistent with the scientific approach. In this view, all illness is caused by the failure of the body’s “innate intelligence” to eliminate toxins:

In Homotoxicology, the symptoms/signs are an expression of the defense system attempting to neutralize and eliminate self-toxins which we term “homotoxins”…if a patient is ill, the body was unable to eliminate the homotoxins…If the homotoxins are not eliminated then the body try’s to burn up the homotoxins with inflammation… then the innate intelligence parks the toxins with deposition in low viable tissues…If the homotoxins are being produced and stored faster than the toxins can be eliminated then…degeneration of tissue and organs occur. If the progressive process of illness continues, cellular dedifferentiation and cancer occurs.

Speaking on the subject of herbal medicine, Dr. Joyce Harman demonstrates the common notion that the wisdom of individual observation prior to the scientific era is still sufficient to validate traditional therapies.

Western herbology is based on observations from centuries of experience along with an understanding of the pharmacology of the herbs and modern research. Many of the old texts, from the 1800’s and earlier are still valid sources of information as the authors of the day wrote detailed observations about cases they treated.

Furthermore, she seems to hold the postmodern notions that all models of health and disease are fundamentally equivalent and there is no legitimate reason to prefer one over another, so science has no claiming to being “right” compared with any other way of understanding illness.

Make your assessment based on the modality you know well or think will be the best one to start with (i.e.: what is the imbalance?) Ex: Chinese-Spleen Qi deficiency; allopathic–elevated liver enzymes, homeopathic–weak vital force with watery diarrhea, etc.

Medicine as Religion or Religion as Medicine
In perhaps the most explicit example of an alternative therapy discussed at this meeting that is more religion than medicine, Rev. Alicia Aratyn gave a presentation on the mystical technique of dowsing. It is hard to understand any organization truly committed to a scientific evaluation of medicine supporting the promotion of what is clearly a form of faith healing at their annual continuing education conference.

Many practitioners not satisfied with what modern medicine has to offer, turned to the old wisdom, which we inherited from Atlantis. Their outstanding knowledge about vibrations, frequencies and energy work came to Egypt and from there, due to the work of French Egyptologists and scientists, spread throughout Europe and the world . It is called Sacred Geometry.

Dowsing is deeply spiritual and scientific technique assisting dowsers to get precise answers to questions of almost any nature.

Due to the many changes on Earth and its energy fields over 90% of the population today is sensitive enough to become a successful dowser…the effect of the spiritual awakening that has been going on for the last almost 40 years.

White Light contains all colors and frequencies corresponding to chakras. We can then hold the pendulum over specific chakra and ask the pendulum to check and then either remove energy…or emit the matching energy to balance a chakra.

Many therapists use Remote Dowsing to access and correct an animal’s energetic system remotely. By using any sample of an animal energy (a few pieces of hair, saliva, a piece of a collar) we can send or remove energy from its body.

Other speakers, however, also emphasized the magical energy at the core of many alternative therapies.

Doug Knueven-
[Holistic medicine is] an alternative approach to health care and prevention of disease which integrates the body as a whole, including mind and spirit, rather than separate systems.

Most holistic modalities believe in some kind of energy system. In Japan it is called “Ki.” In China it is known as “Qi.” In India it goes by “Prana.” The homeopaths call it the “Vital Force” and the chiropractors call it the “Innate Intelligence.” Holistic medicine is guided by the belief that there is a difference between animate and inanimate objects, that there is a vital energy that is responsible for life and wellbeing.

Dr. Knueven’s belief in the magical power of the mind is truly a religious faith not open to scientific evaluation. He misunderstands the nature of the placebo effect dangerously and considers it just an example of this incredible mind power.

The placebo effect can be quite strong as seen in the case of Mr. Wright. He had been diagnosed with advanced Lymphoma and given a new drug called krebiozen. Immediately he gained weight and his tumors shrank. He later read a newspaper report that said krebiozen was not as good as first though and he started to lose weight and the tumors began to grow.

Dr. Knueven then describes how the doctors deliberately gave this patient placebo injections, which put his cancer back into remission, but once the patient read a scientific study suggesting the drug he thought he was taking was not effective, his cancer returned and he died. This is a popular story among proponents of magic healing practices, but there is no unbiased evidence that it is actually true.

Dr. Knueven goes on to scoff at and reject the notion that mind is merely an expression brain activity and commit fully and openly to a spiritual foundation for his medical practices. While he is unquestionably entitled to whatever religious beliefs he chooses, it is less clear that we should wish for a spiritual rather than a scientific foundation for veterinary medicine as a profession.

I too find the idea that my thoughts, personality and consciousness itself come from my brain, very unsatisfactory…The mind is a non-physical force that affects the physical universe…our thoughts affect the animate and inanimate things around us

This classic dualism is then employed to serve as a rational for a specific medical therapy.

The foundation of acupuncture is the concept of Qi.,,,[It is] “life force energy…” matter on the verge of becoming energy and energy on the threshold of materializing….Qi is the substance from which the body is formed…the energy that flows through the channels of the body which allows the organism to function properly. Disease is a result of an abnormal flow of Qi…

In Bioenergetic Acutherapy the idea is to connect to the animal’s energy field through the acupuncture points and use the power of our minds to affect the quantity of Qi and the quality of its flow.  Acupressure uses the force of touch to stimulate the points; we will use the power of our minds…allow the wisdom of the animal’s body to balance itself… We are coaxing the body’s electric field template to readjust to a healthy state.

The theme of magical energy as the basis for medical treatment is continued by numerous other speakers.

Nita McNeill-
Basic Muscle Testing is a query using the vibration or field of a substance, or word (thought carries the same vibration), or touching or pointing to a location on the body to challenge the status of the physiological system.

Deborah M. Mitchell-
Infinite energy flows through the universe, infusing and permeating all life forms…Whatever our culture or beliefs we all recognize that everything alive has Qi or energy… Whether we prefer to think of higher Qi energy as Goddess or God, a Higher Self or a First Source, it is the same.

We can learn to tap and channel this inexhaustible Qi to revitalize us and to improve our physical, spiritual, and emotional well-being. We can use it to enhance the body’s innate powers of healing…: in short, to heal ourselves and others.

Dr. Mitchell explicitly contrasts this vitalistic view with the materialist viewpoint of science, with the implication that science is inferior and incomplete.

Western (allopathic) veterinary medicine offers a reductionist, mechanistic, linear view of the world…The body became divided into systems, similar to the parts of an automobile. We still view the heart as a pump, the nervous system as a telephone network or a computer. We still view symptoms as manifestations of disease, and it is considered a “cure” when we eliminate the symptoms.

From this perspective, mystical therapeutic systems such as Traditional Chinese Medicine (TCM) or Reiki, are superior because they focus on the spiritual roots on disease.

TCM provides a holistic view of the world in which unbalanced energy patterns contribute to disease and disease contributes to unbalanced energy patterns; there is no cause and effect… Treatment is directed towards balancing the body’s Yin and Yang qualities of Qi.

Reiki allows us to direct or channel the flow of energy in a meditative, spiritual manner, to both the practitioner and the recipient. One experiences healing energy and becomes able to transmit it to those in need of it…

Dr. Susan Wagner also expounds on the universal spiritual truths behind the universe, which science, in her view, is only beginning to appreciate.

Something went awry, and we became disconnected from the universal energy intended to guide us…. Many types of religions and philosophies developed…Each is based in unconditional love and compassion. We may look to a higher being for guidance, whether it is God, Christ, Buddha, Krishna or Allah, or we may flow into the beauty of the Tao. The energy is the same. We are all one.

Scientists now know that the space previously thought to exist between the nucleus of an atom and its orbiting electrons and protons…is composed of a vibrating substance they have termed dark matter. Researchers have also discovered a vibrating energy…called the cosmic lattice….What do you think dark matter and the cosmic lattice really are? They are electromagnetic radiation, god, Buddha and the Tao. They are Krishna and Allah, joy and peace. They are the vibration of what humanity has the potential to be – pure, powerful unconditional love.

Like Dr. Knueven, Dr. Wagner appears to believe that such a spiritual understanding of the nature of the universe gives us power over the body through use of the mind.

Our energy field creates our reality, and if we can learn to take control of our energy, we change our lives.

The concepts of resonance and entrainment form the basis for energy medicine modalities such as Healing Touch, Healing Touch for Animals, Therapeutic Touch, Reiki, Pranic and Reconnective Healing. The practitioner’s energy field entrains the patient’s energy field and changes its vibration, allowing the body’s instinctive healing mechanisms to work more efficiently… So in order to be an effective practitioner of any type, we must create a healing state with our own energy field.

Every cell in the body has its own energy field and its optimum frequency. When all cells are vibrating at their best, the entire body is in tune, which helps it stay healthy… The body also has major energy centers called chakras… Many energy techniques balance and strengthen the chakras. Disruptions in chakra energy can also be used for diagnostic purposes.

An effective energy practitioner connects his “in tune” energy field with a higher energy, then links to the patient/client.

Again, these individuals are free to hold whatever spiritual beliefs they choose. But I think the AHVMA owes it to the veterinary community and the public to be open and honest about the fundamentally religious nature of many of the therapies the organization promotes. To claim as their goal legitimate scientific evaluation of these therapies and then to explicitly reject the scientific view in favor of a faith-based approach to medicine is disingenuous.

And many of the speakers at this meeting were quite explicit about rejecting the value of scientific methods and evidence. For example, Dr. Stephen Blake, in his discussion of Bach flower remedies, dismissed the concern that science does not support the validity of this therapy. The intuition of the individual is given pride of place in this approach.

[The inventor of Bach flower remedies] found the teaching he received in medical school, did not agree with what he found in general practice. His frustration led him to the conclusion that the majority of medical problems in man were due to emotional imbalances rather than physical etiology.

…there have been no double blind studies done on animals and we only have anecdotal evidence that it does in fact work…If you were to have this chemically analyzed, you would find no measurable amount of the essential flowers but only alcohol and water.

My feelings are that the cellular memory of the plants is recorded on the liquid crystals that make up the water and alcohol. This information is then transferred to the patient upon ingestion or contact… the signature of the particular plant that has the same emotional symptoms as that of the animal, can help balance its energetic field

Dr. Blake goes even farther, blaming most of the disease we see in our patients on the “toxic” conditions of modern life, including medical therapies such as vaccines and pharmacuticals.

The reason we see so much chronic disease in our patients, is due to the drugs, Electro/magnetic fields, toxins, microbes, cell death, miasms, and chemicals and over use of vaccines that has impacted the genome of our patients…. Hormones, vaccinations, EMF’s, cell phones, repeater towers, drugs and petrochemicals are rampant in our society… The toxins that are a product of our environment, miasms and our own metabolic processes can block replication of normal cells. Without these cell replications, we have organ failure, which are the chronic disease processes we see in our practices.

Another speaker, Dr. Shauna Cantwell, also suggests that the lack of scientific validation to CAVM therapies is not problematic and that it represents a failure of science, not of those therapies. She argues that “clinical wisdom” is ahead of science and sufficient to act on while we watch for science to catch up to our knowledge.

…the question remains as to whether clinically the data support effectiveness, and whether the right questions are being asked to produce illustrative data. Evidence-based medicine is the integration of the best research evidence with clinical expertise and patient needs. Research in this field has yet to catch up with clinical wisdom.

This is a dangerous, cart-before-the-horse approach to testing medical therapies.

What’s the Point?
Though I know my intent in this article will likely be misunderstood, I will try to be as clear and explicit about it as I can. Many individual practitioners of CAVM, and many of the organizations which represent CAVM practitioners within the veterinary profession and in society at large, purport to be interested in scientific evaluation of their methods and to accept that such evaluation is necessary. This is the ostensible justification for the efforts of the AHVMF to establish research centers, training programs, and faculty positions involving CAVM in veterinary schools.

However, amongst themselves many of these organizations and individuals imply or explicitly endorse approaches which are inconsistent with science. One such belief is the notion that pre-scientific, pseudoscientific, and spiritual models of health and disease are as legitimate, or even superior to the scientific approach to understanding nature. The evidence of history is strongly contrary to this view. Another anti-science belief widespread in the CAVM community is the belief that history, tradition, and personal experience and intuition are equivalent or superior to objective scientific research. And often CAVM is promoted by denouncing supposed deficiencies or dangers of conventional medicine, generally without good supporting evidence.

I have no objection to people promoting alternative models of health and disease, though I will certainly challenge or dispute the specific claims they make if the evidence is not there to support them. Still, of course, everyone is entitled to advocate for their beliefs, just as everyone is entitled to critique the claims of others.

However, it is important that the veterinary profession and the public have full and honest disclosure of the nature of these models. If one truly believes that acupuncture is beneficial because it balances Qi, that homeopathy works by identifying and treating the underlying spiritual disturbances that lead to disease, or that energy therapies treat physical disease by manipulating the spiritual energies of the universe, one should be explicit about this and not pretend that one is advocating a scientific medical theory.

Since CAVM proponents often downplay the extent to which their therapies are based on beliefs or principles incompatible with the scientific world view, and are truly “alternative” at their core, it is useful to refer to the content of the textbooks, journals, and educational conferences CAVM organizations create to illustrate the underlying beliefs that so often inform these approaches. My goal in discussing this conference is simply to evaluate the perspective on science and medicine and the philosophical underpinnings of the CAVM practitioners involved as well as to illustrate why the commitment of the AHVMA and the AHVMF to legitimate scientific evaluation of CAVM is suspect. I don’t discount that there are CAVM practitioners with a genuine interest in scientific investigation of CAVM therapies, but I suspect they are a minority.

Posted in General | 4 Comments

Because Evidence Matters: EBVMA Symposium 2014

EBVMALogo2012B&W

The EBVMA 2014 Symposium “Because Evidence Matters” will be held online

Friday November 14,2014

Here is all the information you need to submit a proposal for a presentation (accepted until May 30, 2014), to attend, or to sponsor this symposium:

http://symposia.ebvma.org/

This should be a fantastic educational event, so please consider attending!

 

 

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Tumexal: Wonder Drug or Snake Oil?

Introduction

Cancer is a common disease in our pets just as it is in humans, though not necessarily for the reasons often claimed by proponents of alternative medicine. While there are certainly environmental triggers for many cancers, smoking being a classic and important example, it is not an established fact that we are facing an epidemic of cancer because we live in an “unnatural” and “toxic” environment.

For one thing, some toxic causes of cancer are actually less of a problem than in the semi-mythical “old days” before industrialization and modern science. Not too many chimney sweeps are getting scrotal cancer from soot these days, thanks to the identification and control of this risk through scientific research. And stomach cancer rates have fallen dramatically since the early 20thcentury, possibly due to less reliance on salting and smoking meats for preservation and the increased availability of fresh fruits and vegetables in urban areas, both consequences of technological advancement.

Perhaps more importantly, cancer is clearly a disease most often associated with old age, and one reason we see so much of it in humans and in our pets is that we, and they, and not dying as young as we used to of other things, like infectious disease and malnutrition.

Nevertheless, cancer is still a serious problem in our pets, and one which is being intensively studied in an effort to find effective prevention strategies and treatments. Again in contrast to the simplistic and inaccurate characterization of science-based cancer therapy, the reality is that there are effective therapies for many cancers, even cures for some, and these therapies consistently improve the length and quality of patients’ lives. Sure, we are a long way from preventing and curing cancer with the kind of success we’ve had preventing and curing infectious diseases, but the best hope for getting there is good, rigorous science.

Unfortunately, for individuals with pets who have cancer and who either don’t have good results with existing science-based therapies, or who are afraid of them due to the propaganda from proponents of alternatives, there are all too many untested snake oils freely available. There are far too many for me to evaluate them all, but occasionally I am asked to look at a specific product, and I feel it is important to remind desperate pet owners that even in the face of a terminal disease for which there is no proven cure, gambling on some concoction from the internet is risky. While it is not impossible that some of these products may work, it is less likely than the folks selling them would have you believe, for reasons which I will discuss.

And it is absolutely possible to make a bad situation worse with an untested treatment. Human patients with pancreatic cancer, which is highly aggressive and for which there are no truly effective conventional therapies, have unfortunately demonstrated this danger for us. Subjected to a bizarre diet, untested supplements, and coffee enemas under the Gonazalez cancer regime, these patients not only did not live as long as those on conventional therapy, they had significantly worse quality of life. Even in a situation where it seemed like they had ”nothing to lose,” a quack cancer therapy made these patients’ remaining days fewer and more uncomfortable than standard care. This is always a risk, for us and for our pets, with unproven treatments no matter how many testimonials and anecdotes companies give us to suggest their treatments are safe and effective.

An example of just such an untested therapy is Tumexal™.

What Is It?

As was the case for the equally “miraculous” and unproven kidney failure treatment RenavastTM I wrote about recently, the short answer is “Who knows?” Once again, the company selling this product refuses to disclose what it contains. This is a key warning sign for snake oil, and it is a clearly unethical way to promote a medical therapy. It is hard to imagine the public tolerating a pharmaceutical company trying to sell us a drug not only without any clinical studies to show it is safe and effective but without even disclosing what is in it, yet for some reason people tolerate this from companies selling mystery potions like TumexalTM. It is also, as the American Veterinary Medical Association (AVMA) Principles of Veterinary Medical Ethics states, unethical for veterinarians to foist such nostrums on their clients:

It is unethical for veterinarians to promote, sell, prescribe, dispense, or use secret remedies or any other product for which they do not know the ingredients.

Does It Work? Is It Safe?

The company has published a Powerpoint presentation claiming to explain the “science behind TumexalTM.” This presentation spends a lot of time describing one of many pathways to cancer formation, involving inactivation of the p53 tumor suppressor gene. The author then claims that TumexalTM stops cancer by inhibiting an enzyme called G6PD and that it “duplicates p53 function.” Without knowing what the substance is and with no published data showing if or how it does this, the truth of this claim cannot be evaluated. A recent published scientific paper discussing G6PD suppressors, however, does state ”To date, only a few G6PD inhibitors have been available. However, adverse side effects and high [concentration needed for a significant effect] hamper their use as therapeutics and basic research probes.” This argues against the claim that this company has found a perfectly safe and effective G6PD suppressor that the rest of the scientific community doesn’t know about.

Of course, the company behind TumexalTM has an explanation for why they have succeeded where the rest of the biomedical industry has not:

How is it that the scientists of CanineCare.US have come up with a treatment like Tumexal™, and not one of the big pharma drug houses?…Big pharma scientists are encumbered by a business model that insists in an absolute manner that every drug put into active development have billion dollar sales potential…Tumexal™ is a natural product for which a new composition of matter patent is not possible. But since CanineCare.US scientists are focused not on sales potential, but rather upon using cancer biology discoveries most effectively, we have been able to make progress far out of proportion to our numbers. Tumexal™ may never be a billion dollar drug, but it very well could help more dogs than all the billion dollar drugs of all the big pharma companies combined.

In other words, money-grubbing pharmaceutical companies have ignored the potential of safe and natural cancer treatments because they fear they won’t be able to patent and make any money off of them, but CanineCare.US is far more altruistic and doesn’t care about profits but only about making life better for your dog.

This is a common, and in this case completely incredible, explanation for the supposed story of a lone genius discovering a wonder drug. For one thing, there is plenty of profit potential in unpatentable “natural” products, which is why dietary supplements and herbal medicines are a multi-billion dollar industry that Big Pharma is actively interesting in participating in. For another, the owner of this company, Jonathan Nyce, has already been a lavishly compensated CEO of a multi-million dollar pharmaceutical company, Epigenesis Pharmaceuticals, which forced him out when the supposedly revolutionary asthma drug he was developing failed to prove viable.** So the idea that pure altruism has motivated CanineCar.US to produce a wonder drug that the rest of the biomedical industry could not have found due to a blind pursuit of profit is not believable.

There are plenty of other warning signs of snake oil associated with this product. It is advertised primarily by sowing fear and distrust of conventional cancer therapy, exaggerating the dangers of chemotherapy, surgery, and radiation and completely ignoring the manifest benefits of conventional treatment. The slide show touting the product has all sorts of pictures of soldiers in WWI suffering the effects of chemical weapons and implies that because some chemotherapy drugs were developed based on these compounds that chemotherapy is merely “poisons as cancer medicine.”

The logic here is as flawed as it is simplistic. Smallpox and polio vaccines are made from smallpox and polio viruses, so are they simply “infections” the way cancer drugs are “poisons,” doing more harm than good? Many antibiotics are derived from bacteria and fungi, so are they automatically harmful “molds” with no real benefits? Of course not. Such therapies have dramatically reduced suffering and death for millions of people. The source of the medicine does not tell us anything about the balance of risks and benefits of the medicine itself. Only good scientific research can do this. Such research tells us what the pros and cons of cancer medicines are, but there is no such evidence to tell us the risks and benefits for TumexalTM.

Another red flag of quackery for TumexalTM are the claims of dramatic benefits with little to no risk.

TumexalTM : Effective, Safe Monotherapy for virtually all forms of Canine Cancer

Tumexal™ is also remarkable for its lack of harmful side effects. Unlike standard chemo drugs that can significantly reduce the quality of life in a treated dog, Tumexal™ is virtually toxicity free because of its novel mechanism of action.

And with Tumexal™ there is virtually no toxicity! In fact, Tumexal™ will almost always restore a cancer-stricken dog’s appetite, spirit and energy!

Such claims are always unlikely to be true, but when presented in the absence of any evidence and with a refusal even to disclose the ingredient in the drug, there is simply no reason to take them seriously at all.

The Powerpoint Dr. Nyce has produced to sell the product does claim there is scientific research evidence that TumexalTM is effective, but this is highly suspect for several reasons. The evidence consists of a series of charts purporting to show laboratory beagles with cancer induced by researchers using toxic chemicals and then treated with TumexalTM or nothing. Invariably, they show that Tumexal works. Here is one example:

tumexal ppa chart

There is no evidence these experiments were ever published, or done at all for that matter. They also raise ethical questions about the use of these animals for fatal experiments since there is no information about the conduct of the studies or the care of the subjects, and since the studies were apparently never published to make the data useful to the scientific community but instead are used merely to promote a commercial product.

Dr. Nyce attempts to head off objections to these experiments by claiming “this work was done several decades ago using animals scheduled for destruction by animal control” and he “wouldn’t have the heart” to do this work today. Apart from the fact that this statement seems as implausible as the data themselves, it begs the question of why TumexalTM has only recently been developed, and only by Dr. Nyce, if  extensive and costly research from decades ago produced such dramatic data that it is a potentially effective therapy for many cancers? Who did this research? Why was it not followed up? How was Dr. Nyce involved, if at all? Why was none of the data published?

All of this is highly suspicious, but of course impossible to evaluate objectively since the company does not provide any of the usual information, in the form of published research or regulatory documents, by which the value of potential new cancer therapies are judged.

What CanineCare.US does provide, of course, are testimonials, the sine qua non of quack therapies. Undoubtedly, people will comment on this post by saying I can’t prove TumexalTM doesn’t work, and lots of anecdotes show it does so what’s the problem? The problem, of course, is that such anecdotes and miracle stories prove nothing. They are available for every therapy ever invented, including many which have been definitively proven not to work, and they are deeply misleading. A responsible scientist and company generate and provide scientific data to show their products work, rather than simply posting heartwarming and meaningless anecdotes.

The defenses provided by CanineCare.US for their unproven claim, use of testimonials instead of data, and secrecy are self-serving and unconvincing. They amount to just a repetition of their claims, with no actual evidence provided, and snide denigration of the rest of the biomedical industry and anyone not willing to take the company at its word alone:

Very few people who have tried Tumexal have been disappointed in its results… It can extend life, and maintain a high quality of life, sometimes in dramatic fashion. It is important to note that every testimonial on our website is an authentic, unsolicited report from an owner whose dog has been treated with Tumexal. When cynics say that these testimonials are “too good to be true,” they are merely comparing them with the results they are accustomed to with traditional chemotherapy, or no treatment. In comparison, to such a cynic, the results obtained with Tumexal may indeed appear “too good to be true.”

A patent is not possible for Tumexal, because it is a natural product that nature, not us, synthesized… As a natural product for which a NCM patent is not possible, Tumexal must be protected by trade secret law. This is why we do not disclose what it is, except to say that it is natural.

So once again, we should believe TumexalTM is a wonder drug without any evidence other than the claims of the company selling it and the testimonials they choose to put on their web site because they are goodhearted people focused on making pets healthier rather than making money and the product is “natural.” Anyone who asks for more than this is a “cynic” who, by implication, doesn’t care about the welfare of pets or is beholden to Big Pharma. A finer modern example of snake oil could not be found. And it is worth remembering, the product from which the term “snake oil” likely derives didn’t work, and didn’t actually contain any snake oil! CanineCar.US and Dr. Nyce have given us no reason to think any better of TumexalTM.

Bottom Line

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?

And while the lack of definitive evidence against TumexalTM makes it impossible to assert it is ineffective, that doesn’t mean it can be assumed to be safe. 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 TumexalTM. If your pet has cancer, please see a veterinarian, ideally one specializing in cancer care. There really are beneficial treatments available even when there isn’t a cure.

If you are looking for information about pet cancer on the internet, watch out for snake oil peddlers. Here are some real experts with real information for you if your pet has cancer:

Veterinary Oncolink, University of Pennsylvania
Pet Owner’s Guide to Cancer, Cornell University
The Cancer Center at Cares Canine Cancer Library, National Canine Cancer Foundation
Animal Cancer Center, Colorado State University

 
**There is a vivid tabloid story in Dr. Nyce’s life, complete with books by and about him, but since this has little bearing on whether or not the claims made about TumexalTM are legitimate, I did not include this material in my post.

 

 

Posted in Miscellaneous CAVM | 4 Comments

New Study Shows Belief in Medical Conspiracy Theories Associated with Use of Alternative Medicine

I was going to write a detailed post about a recent paper published in the journal JAM Internal Medicine, but since Dr. Novella at Science-Based Medicine has already covered it quite well, I just wanted to share a few tidbits.

Oliver J, Wood T. Medical Conspiracy Theories and Health Behaviors in the United States. JAMA Intern Med. Published online March 17, 2014

I have often pointed out that the advocacy and use of alternative therapies is primarily about ideology and belief rather than what is demonstrably effective at preserving and restoring health. People choose alternative therapies either out of desperation or out of a philosophical perspective that conflicts, to a greater or lesser degrees, with the philosophy of science and science-based medicine. I’ve reviewed this philosophical conflict before. There is a spectrum of degrees of conflict, but at its alternative medicine becomes a kind of religion or faith healing.

 

The significance of this is that such an ideology is often not responsive to conflicting facts or evidence, and criticism generates the kind of irrational anger usually seen when one criticizes a religious belief system. This has implications for how to effectively combat pseudoscience and quack therapies when simply pointing out the contrary evidence is likely to fail or even strengthen belief in them.

 

This JAMA paper explores a different aspect of the ideological nature of alternative medicine, the degree to which people believe in absurd medical conspiracy theories, and the extent to which this correlates with the use of alternative therapies.

 

The study presented people with six conspiracy theories about medicine. It should go without saying (though it clearly does not) that these theories are nonsense, and there is strong evidence contradicting each of them.

 

  1. The Food and Drug Administration is deliberately preventing the public from getting natural cures for cancer and other diseases because of pressure from drug companies. (37% agree, 32% disagree)
  2. Health officials know that cell phones cause cancer but are doing nothing to stop it because large corporations won’t let them. (20% agree, 40% disagree)
  3. The CIA deliberately infected large numbers of African Americans with HIV under the guise of a hepatitis inoculation program. (12% agree, 51% disagree)
  4. The global dissemination of genetically modified foods by Monsanto Inc is part of a secret program, called Agenda 21, launched by the Rockefeller and Ford foundations to shrink the world’s population. (12% agree, 42% disagree)
  5. Doctors and the government still want to vaccinate children even though they know these vaccines cause autism and other psychological disorders. (20% agree, 44% disagree)
  6. Public water fluoridation is really just a secret way for chemical companies to dump the dangerous byproducts of phosphate mines into the environment. (12% agree, 46% disagree)

 

My own experience as an advocate for science-based medicine, like Dr. Novella’s, would have led me to think belief in these ideas would be even greater than this survey indicates, so there is at least some reason for optimism. Still, this is a depressingly high level of belief is some pretty extreme, and manifestly absurd, ideas. Undoubtedly, the agreement would be even higher with more plausible, though still false, theories about the “Medical Establishment.”

In addition to the general assessment of belief in these theories, the study looked at associations between level of belief and use of alternative therapies. The kinds of associations evaluated were quite limited, and it would be interesting to tease out the relationship between belief in malign conspiracies in government and conventional medicine and the use of particular alternative therapies. Still, the results are intriguing.

For example, of those who did not believe in any of the six conspiracy theories, 13% said they use herbal remedies. However, for those who believed in 3 or more of the theories, 35% said they use herbal medicine. A similar correlation was seen for use of sunscreen and vaccines, purchasing of organic foods, and other alternative healthcare practices.

This does not, of course, suggest that using alternative therapies is a sign of being a conspiracy nut. It does, however, suggest there is a relationship between distrust of healthcare providers, scientists, and government and the use of alternative therapies. It also implies, though it doesn’t prove, that the more extreme this distrust, the more likely one is to turn to alternatives.

This isn’t surprising, of course, but it does challenge the notion of integrative medicine, which seems to be gaining wider popularity. This notion says that alternative and science-based medical therapies are all indistinguishable tools in a healthcare toolbox, and one can freely and rationally choose among them without prejudice. The reality, however, is that there are deep ideological and philosophical difference between the approach of science and the alternatives, and choosing one often involves some degree of rejection of the other. For the most ridiculous and pseudoscientific of alternative therapies, such as homeopathy, energy medicine, and so on, acceptance involves a fundamental rejection of the core principles of science. For more plausible interventions, such as dietary supplements, their use does not necessarily conflict in a fundamental way with a scientific approach, though it may still indicate a lack of thorough understanding of and commitment to the use of scientific evidence to make healthcare decisions.

I think exploring the relationship between ideology, philosophy, and faith and the use of alternative therapies is a productive way to understand the fundamental reasons some such therapies persist even when there is good reason to think they are useless or even harmful. A better understanding of why people turn to these methods can hopefully inform a more effective strategy for guiding people towards the most effective healthcare available, that based on good science.

 

 

 

 

 

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Clever New Study Illustrates the Importance of Placebo Controls In Veterinary Clinical Studies

I recently ran across a fantastic web site, Testing Treatments, which explains clearly and simply how we use science to test our medical treatments. For anyone not already very familiar with this process, this site will explain why a lot of the evidence people offer on this site for their favorite therapies isn’t really evidence we should trust. One major problem with anecdote and other kinds of low-quality evidence, is the influence of the placebo effect. Contrary to what many people believe, this is just as big a source of error in veterinary studies as in human research.

One of the most entrenched fallacies used to defend the use of anecdotal evidence to validate veterinary treatments is the idea that any perceived effect must be real because the placebo effect doesn’t work in animals. While our veterinary patients don’t experience the perception of relief, when they actually aren’t getting better, solely because of their beliefs or expectations, as humans do, placebo effects do still fool us when trying to decide if our therapies are working in our pets.

Improvements associated with human contact, better care when involved in a clinical trial, operant conditioning, the natural course of disease, and many other factors do occur, and they can fool us into thinking an ineffective therapy is working. These are aspects of the cluster of errors usually labeled the placebo effect.

In addition, there is good evidence for what is usually called the “caregiver placebo effect.” Since many of the measures for the effect of our therapies are subjective and assessed by owners and vets, not directly by the patients, the beliefs and expectations of owners and vets can often create an impression of improvement where none really exists. This is especially true when the measures are so difficult to objectively, consistently asses, such as pain, nausea, etc.

For these reasons, a placebo control is essential in any veterinary clinical study if we are to have confidence in the apparent effects of the treatment being tested. This is not controversial, except sometimes for folks pushing therapies they believe are effective but that haven’t been tested, or that have failed testing, in placebo controlled trials.

However, I have always assumed that with proper placebo controls, a clinical trial would usually be able to detect a real difference in outcome when the treatment being tested truly worked. Even though placebo effects would make the control group appear to be getting better, they would affect the treatment group to the same degree. And the real effects of a treatment that works ought to make the improvement in the treatment group significantly greater than those in the placebo group. However, a cool new study in cats suggests this may not be true, and that caregiver placebo effects may be masking the real effects of some treatments.

M.E. Gruen, E. Griffith, A. Thomson, W. Simpson, and B.D.X. Lascelles. Detection of Clinically Relevant Pain Relief in Cats with Degenerative Joint Disease Associated Pain. J Vet Intern Med 2014;28:346–350

The authors in this study were interested in whether the effect of a pain reliever in cats with arthritis could be better identified by looking for recurrence of symptoms after the medication was stopped than by looking for improvement in symptoms while the medication was being given. They compared meloxicam, an NSAID for which there is already good evidence of efficacy, to an identical placebo.

The study selected cats with significant symptoms of arthritis and used owner surveys to evaluate symptom severity. All cats got a placebo for 2 weeks, and the investigators and owners knew they were getting only placebo. This was to accustom the cats and owners to giving the medication and monitoring symptoms. Then the cats were randomly assigned to two groups, one getting meloxicam and one placebo for three weeks. During this time, both owners and investigators were blinded to which treatment each cat was getting, which reduced the influence of bias. Finally, the cats on meloxicam were shifted to placebo, but only the investigators knew this, not the owners.

During the treatment period, all cats appeared to get better according to the owner evaluations. This is consistent with placebo effects. The cats on meloxicam did not improve significantly more than those on placebo, which would seem to suggest that the meloxicam wasn’t working. However, when the cats on meloxicam were switched to placebo, without the owners knowing it, these cats got significantly worse while the placebo group did not change. This indicates that the meloxicam was having an effect, however it was swamped during the treatment period by the owner placebo effect, which influenced the results of both groups.

The authors do a good job of assessing the limitations of their own study, which is an important element in the discussion section for any scientific paper. The investigators were not blinded during the last three weeks, so potentially they could have influenced the owner evaluations in some way. There are also some weaknesses in how the diagnosis of arthritis was established, how the severity of disease was evaluated, and some other factors. But such limitations occur in every study, which is why no single paper can be definitive evidence. This was still an clever and illuminating project, and if it holds up when replicated, it may lead to a significant change in how placebo effects are controlled for in veterinary research.

Posted in Science-Based Veterinary Medicine | 1 Comment

RenAvast™ for Kidney Disease: Sloppy Science and Snake Oil Marketing

A reader recently asked me to investigate yet another supplement product, this one marketed for treatment of kidney disease in dogs and cats. While there are thousands of such products, and a thorough investigation of each isn’t possible, there were some interesting features to this particular product, so I spent some time looking into it.

What Is It?

The short answer is, “Who knows?” The product is called RenAvast™, and first on the list of red flags of quackery is the fact that the company won’t say exactly what it contains. The ingredients are listed as “a proprietary combination of amino acids and peptides.” While I understand that intellectual property concerns are often valid, it is also appropriate to be extremely wary of any medical therapy that contains secret ingredients. The American Veterinary Medical Association (AVMA) Principles of Veterinary Medical Ethics specifically identifies selling or using such products as unethical:

It is unethical for veterinarians to promote, sell, prescribe, dispense, or use secret remedies or any other product for which they do not know the ingredients.

I did find one site purporting to have identified the ingredients as, “300mg: L-Aspartic, L-Carnosine, L-Glutamic Acid, L-Glutamine, Glycine, L-Arginine, L-Histadine,” though I have not been able to confirm that on any site associated with the company. The inventor of the product describes it in a radio interview as “amino acids and a peptide,” but again doesn’t provide any more details.

The company research report describes the substance as:

a powerful ROS scavenger, a cytoprotective agent which reduces damage to proximal renal tubules and increases glomerular filtration rate (GFR), stimulates gluconeogenesis and suppresses proteolysis in skeletal muscle, has strong anti-inflammatory properties, is a precursor for NO production, and induces BMP-7…

It is impossible to assess these claims without knowing what the ingredients actually are. Elsewhere in the document, reference is made to seven different “biomolecules” in the product and their supposed functions. The claims made here for these functions are supported with a reference to an unnamed publication listed in the references as “PLAW 104-294.” I have no idea what this means.

There is reference to another study which showed that the molecule BMP-7 has some effect on damaged kidney cells in mice with artificially induced renal failure. Supposedly, biomolecule 7” in RenAvast™ induces production of BMP-7, though no evidence for this is provided. This tenuous connection between the mystery ingredients in RenAvast™ and kidney disease hardly justifies using the product in actual patients in the absence of additional pre-clinical research and clinical trials.  As we will see, there really aren’t any such trials.

The company makes many bold claims for the product despite the lack of tangible support for them:

RENAVAST™ MECHANISM OF ACTION

Protects cells, particularly in renal tubules.

Increases glomerular filtration rate (GFR).

Increases gluconeogenesis.

Decreases protein breakdown, especially in skeletal muscles.

Has a strong anti-inflammatory effect.

Decreases renal blood pressure.

Increases renal vasodilation.

Increases hormone that promotes renal tissue repair.

[RenAvast™ is] SAFE – More than 4,000,000 doses have been given to dogs and cats with no negative side effects reported… It is 100% safe with no side effects.

[It is] scientifically proven in an open-ended two year clinical study to supplement and promote healthy renal function. Unlike other products and drugs, RenAvast™ does not treat the symptoms of renal failure, it treats the cause.

Along with these confident claims is, of course the required Quack Miranda Warning which reminds us that the company has not felt it necessary to provide the FDA with any real evidence to support them: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” It always amazes me that companies put this disclaimer on their sites and then loudly (and illegally) proclaim that their products do treat disease.

The chutzpah necessary to do this is especially impressive in this case since the company, BioHealth Solutions, has already been warned by the FDA that their marketing of RenAvast™ is illegal:

 

WARNING LETTER

August 1, 2012

This letter concerns your firm’s marketing of the product RenAvast™.  The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.RenAvast™.com, where you promote and sell this product.  We have determined that RenAvast™ is intended for use in the mitigation, treatment, or prevention of disease in animals, which makes it a drug under section 201(g)(1)(B) of  the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)].  Further, as discussed below, this product is an unapproved new animal drug as defined by the FD&C Act and your marketing of it therefore violates the law.

Statements on your website that show these intended uses of your product include, but are not limited to, the following:

• RenAvast™™ can halt the progression of chronic renal failure
• RenAvast™™ may reverse the effects of chronic renal failure
• RenAvast™™ may help prevent kidney disease in healthy cats
• RenAvast™™ is a new, highly effective compound that has been proven through a two-year clinical study to halt the progression of Chronic Renal Failure (CRF) in cats and improve overall kidney function
• Unlike other products and drugs, RenAvast™™ does not treat the symptoms of renal failure, it treats the cause
• RenAvast™™ was highly successful in halting the progression of Chronic Renal Failure and in most cases improved kidney function.
• Finally a solution for cats with Chronic Renal Failure
• A two-year open ended clinical study proves that RenAvast™ can halt the decline in kidney function
• Until now, veterinary medicine could only manage symptoms in an attempt to maintain quality of life while the disease progressed relentlessly onward. All of that has now changed
• Chronic Renal Failure is no longer a death sentence

Because RenAvast™ is intended to mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act. Further, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

To be legally marketed, a new animal drug  must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1].   RenAvast™ is not approved or listed by the FDA, and therefore the product is considered unsafe under section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

This letter is not intended to be an all-inclusive review of your products and their promotion.  It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Unfortunately, as I’ve discussed previously, regulatory control of veterinary quackery is not very effective. This warning appears to be more than a year old, and I was not able to find any information regarding how it was resolved. Regardless, the company continues to make clear treatment claims despite the warning and disclaimer.

 

Does It Work? Is It Safe?

The general claims about mechanism of action cannot be evaluated without any information about what is in the product. If there is any plausible reason to think it might work based on in vitro or lab animal studies, we cannot determine this without knowing what is in it.

Likewise, the safety cannot be assessed simply by accepting the company’s word for the fact that they have sold lots of it and no one has told them about any problems. All that I can say with certainty is that no medical therapy with any benefits at all is “100% safe,” so this is clearly nothing but marketing hyperbole. Such claims are a hallmark of snake oil therapies.

It is possible, however, to evaluate the claim that RenAvast™ is “scientifically proven.” I’ve talked before about what that means, and it is a good deal more complicated than the promoters of this product seem to understand.

The “research” that the company promotes as evidence RenAvast™ is safe and effective is a classic example of sloppy science used as a marketing tool rather than real scientific research. Information about the study can be found in a summary on the Bio Health Solutions web site and also a more detailed report which was previously made available online by the company and then apparently taken down, but which is available through a web archive.

19 cats with CRF were enrolled in an open ended 2-year study… All cats enrolled were diagnosed by their veterinarians with Chronic Renal Failure. None were on restricted diets. None were receiving fluids. All received 300 milligrams of RenAvast™ two times per day. All had periodic blood work…

There is no information about the cats, how they were selected, how long each was given the product, what other disorders most might have had, or any other details about the population studied or how the study was conducted. It is stated that the cats were enrolled “over a two year period,” but it isn’t clear how long each subject was treated and when or how often bloodwork was measured. Without this information, a huge number of possible errors and confounders could be present.

It is also not clear how the diagnosis of kidney disease was made. Two of the cats appeared to have a urine specific gravity of >1.035, which by the most common standard would not qualify them for a diagnosis of kidney disease. This critical value was not measured in three other cats, all of whom had near normal creatinine levels. This means at least 5/19 (26%) cats cannot be definitively said to even have had kidney disease at the start of the study!

Most cats showed little change in the various parameters measured, though again it isn’t clear how long each subject was followed over the total two-year length of the study. The detailed report indicates that these values were compared from the beginning to the end of the study for each subject. There are specific statistical methods needed to perform such a paired comparison, but no information is available to assess whether or not the methods used were appropriate, so it isn’t possible to say if the statistical tests reported are meaningful.

According to the report, declined or remained unchanged in 17/19 cats. (Of course, this includes the two that probably did not have kidney disease and the three that might or might not have but whose urine specific gravity was not measured at baseline.) Excuses are made for the cats whose creatinine values worsened (one was supposedly not compliant with treatment and the other was receiving medication for thyroid disease which can affect the kidneys). The fact that such possible confounders are not reported for any cats except those whose numbers didn’t change the way the author wanted them do suggests a significant risk of bias in these data. The same pattern is reported for the other variables measured, in which most improve or don’t change and those that get worse are explained away with information not provided for other subjects.

The implication here, of course, is that the failure of these variables to get worse for most cats means the RenAvast™ was working. While this is not a fair conclusion based on the limitations of this single report, the author of the report has no hesitation in making this claim:

These encouraging results prove that AB070597 can halt the advance of chronic renal failure in felines when given as an oral supplement. Supplementation with AB070597 halted increases in blood serum creatinine, blood serum urea nitrogen and blood serum phosphorus concentrations; while at the same time halted decreases in hematocrit and urine specific gravity.

Since cats with renal disease can remain stable for long periods, the fact that there is no control group is a huge problem. It is impossible to say whether or not the product did anything at all without a control group for comparison. In an unusual step, the company has provided some additional information in the form of responses to possible objections to their “study.” It is rare to have the opportunity to see such explicit arguments against what is generally considered appropriate scientific methodology, so I think it worthwhile to examine some of these arguments.

The company FAQ about the study begins by defending the very small sample size.

Many scientific studies are done with fewer subjects and over shorter time periods. In fact, there are thousands of human studies in peer reviewed journals with less than 19 patients. Nineteen patients in a study is acceptable; not to mention the fact that there are numerous over-the-counter medications used to treat humans and animals that are not based on any studies, peer reviewed or otherwise, with only subjective and anecdotal evidence as proof of efficacy.

This seems to me a fallacious argument. The fact that other studies have been done and published with no more subjects than this one isn’t itself a justification for the small sample size. Such studies may or may not have had appropriate samples sizes for the problem and population they studied, but that doesn’t tell us if this number is adequate for this population and problem. Just because others may have also used small sample sizes doesn’t mean doing so is appropriate or that the results are any less unreliable in this case. And there are specific statistical methods for evaluating whether or not a sample is large enough to answer a given question, none of which the company apparently employed in this case.

The argument that many remedies are marketed on the basis of anecdote alone is also not a justification for performing a study that isn’t capable of providing reliable information. Meaningless research is hardly a big improvement over no research at all!

The FAQ then states that biochemistry samples in the study were evaluated at a variety of laboratories. This is presented as a strength, but it may actually be a weakness. Using a variety of laboratories, each with different methods and quality control, introduces a source of variation in the data which can easily alter the findings.

Next, the FAQ attempts to answer perhaps the biggest objection to the so-called study, the absence of any control group. The response rests on two principles. First, it is claimed that a control group was unnecessary because any group not treated would undoubtedly have gotten worse, so any failure to get worse must automatically be due to the treatment:

In this particular case, a separate control group was uncalled for and would not have yielded useful information. The outcome of untreated chronic renal failure is already known: biochemical and hematological blood serum values deteriorate over time.

The problem with this argument is that it is simply false. While the general trend of chronic kidney disease is to worsen over time, the specific changes and the rate at which they happen in any individual are highly variable and unpredictable. Studies routinely show ranges in survival from days to years. Many factors can influence whether bloodwork values worsen and how fast, and none of those factors were accounted for in this study.

And there are many important variables other than bloodwork values, including body condition, appetite, and other clinical symptoms, which are only mentioned in passing but not specifically evaluated in this report.

We don’t even know from the information available whether these cats were properly diagnosed with kidney disease, what stage of disease, or any other relevant prognostic factors. Some of them, at least, clearly were not. And even if these cats all truly had some degree of chronic kidney disease, the progression of the disease over whatever unreported period of time each was followed cannot simply be assumed. Without a control group, no change or failure to change can be ascribed to the treatment in this study.

The second argument presented against a control group is that having such a group would be unethical since untreated cats would certainly die of their disease.

The use of a separate control group often raises questions of unethical behavior regarding withholding treatment from or giving placebos to the control group.

The FAQ then quotes a number of statements from the Stanford Encyclopedia of Philosophy concerning the ethics of placebo controls in clinical trials. It goes on to give an impassioned statement against the use of such controls:

The researcher does not question the superiority of randomized double-blinded studies over other forms. It is a well recognized fact, though, that their use in some situations is completely unethical. The researcher considered it completely unethical to create two groups of cats, both with CRF, and treat one group with RenAvast™ while giving the other group a placebo to merely satisfy statistical correctness. He already knew the outcome of the placebo group…. We fully support the researcher’s decision. We too, find it cruel and unethical to deny cats with CRF treatment with a product that could help them simply to create a statistic.

There are several problems with this argument. The first is that it is inconsistent with the little we know about how this trial was conducted. There is no evidence the cats placed on RenAvast™ were given standard care. Dietary therapy, for example, is well-demonstrated to improve outcomes for cats with kidney disease, yet these cats were not on dietary therapy. Other common therapies are less solidly evidence-based, but there is certainly a basis in plausibility and consensus for the use of fluid and for a number of other therapies depending on the details of the individual cases. The little information we have suggests these treatments were not provided to subjects. This study apparently substituted a completely untested supplement for standard care, which would certainly not be ethical. And if the product is not effective (and there is yet little reason to think it is), this amounted to simply not treating these cats at all, which is exactly what the author of this FAQ decries.

It is recognized practice in clinical research to test new therapies by comparing a group getting standard care plus the new therapy to patients who get only standard care. It would not have been difficult to run this study in this way, ensuring that both groups received accepted diagnosis and treatment and the only difference between them was the addition of RenAvast™ for the test group. This would have potentially provided actual information about the efficacy of this product, which the results reported here do not.

The ethical argument in the FAQ also fails because, as discussed above, the outcome was not actually known in advance as the company suggests. If we could safely assume that an experimental treatment worked before testing it, we wouldn’t need to run clinical trials at all! The reason that placebo controlled trials are ethical is because they are necessary to develop effective treatments. Without them, we simply guess and, as history and the cumulative results of thousands of such trials show, patients suffer from our ignorance. It is certainly not ethical to deny a known effective treatment to patients in a trial. But since RenAvast™ is not a known effective therapy, it is ethically questionable to give it in a clinical trial without having a control group, especially if standard care is not provided as well.

We don’t conduct trials “to create a statistic” or for “statistical correctness” but to generate the real and reliable knowledge that can only come from controlled scientific research. To conduct a trial that doesn’t produce such knowledge but merely facilitates marketing an unproven medical product is where the real ethical failing lies. This is a classic example of circular reasoning, assuming a therapy works before testing it and then claiming it would be unethical to deny this therapy to patients because it works. This is how one does faux science for marketing purposes, not real science designed to generate real growth in our knowledge and therapeutic tools.

 

Bottom Line

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

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

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

 

What Else Do We Know?

In the absence of any real scientific evidence to evaluate the safety and efficacy of RenAvast™, it is impossible to draw any solid conclusion about the product. All we can say is that it is unproven, and even the basic plausibility of the proposed mechanisms is unclear.

While it won’t help us to evaluate the safety and efficacy of RenAvast™, there is some additional information worth considering using this product. As I have already discussed, there are a number of warning signs of snake oil, including claims of perfect safety, dramatic benefits not supported by real scientific evidence, misuse of the appearance of science to market a product, and others. I will not be surprised if we soon see another such sign in the form of a hostile response to this critique, though that is just a guess on my part.

The credentials of the folks making claims for this product are not directly relevant to the truth of those claims, but in the absence of any more specific evidence, they may be of some tangential interest. The detailed report on the cat study is attributed to “James Archer, Photo Research.” There are references elsewhere to a “Dr. James/Jim Archer” associated with Bio Health Solutions, the company marketing RenAvast™, and he has provided a radio interview on a program devoted to “integrative veterinary medicine” discussing RenAvast™.

According to this interview, Dr. Archer apparently invented prior to working with Bio Health Solutions. It is not clear what specific academic or research background Dr. Archer has. He appears to have worked largely for the Department of Defense, and though he is not a veterinarian, he indicates he has been a scientific consultant at a veterinary hospital in Southern California.

In his interview, he repeats many of the assertions for the effects of the ingredients in RenAvast™ without any additional details. He describes extensive research leading up to the development of this product, though apparently none of this has been published. He reports the results of the unpublished study and makes strong claims for the benefits of the product without addressing any of the limitations or problems discussed above. He recommends RenAvast™  be given permanently to all cats over 8 years of age! He does mention that a few of the cats had concurrent diseases or treatments during the study, and he confirms that the avoidance of diets for treatment of kidney disease was deliberate. He also reccommend using the product in dogs as well and mentions that there is research ongoing in this species.

The company web site only lists one other product, another nutritional supplement billed as an analgesic and anti-inflammatory for musculoskeletal diseases in animals. The marketing director, Mark Garrison, describes aggressive marketing of the product around the world. The company claims repeatedly on its web site to have a strong commitment to science, but this certainly is not consistent with the approach so far evinced in promoting RenAvast™.

Posted in Herbs and Supplements | 4 Comments

LEGS Glucosamine Study Sows Little Evidence of Real Benefit

I have written extensively about glucosamine because it is a ubiquitous arthritis therapy that nearly everyone seems to believe in and use, yet the evidence for it is poor. Only two published clinical studies are available for dogs, one showing no effect and one showing a marginal effect far less than that of non-steroidal anti-inflammatory medications (NSAIDs). Overall, the evidence is poor for the use of glucosamine in dogs, though it is limited in quantity. There appears to be little evidence of harm, however, there is no question NSAIDs are more effective by far, and overall quite safe, so it’s a shame that the caregiver placebo effect leads some vets and pet owners to deny dogs an effective treatment for their pain in favor of one that probably isn’t doing anything.

There is a great deal more evidence concerning glucosamine in humans, and though it is often conflicting, the general trend is that older, smaller, lower quality studies show a benefit and newer, better quality studies do not. Systematic reviews and meta-analyses generally conclude there is little chance this supplement is effective, and this was supported by the largest and best trial, GAIT. A study out of Australia has recently been published which appears to challenge the generally negative conclusions of the current literature, though the results are not unequivocal.

Fransen M, Agaliotis M, Nairn L, Votrubec M. et al. Glucosamine and chondroitin for knee osteoarthritis: a double-blind randomised placebo-controlled clinical trial evaluating single and combination regimens. Ann Rheum Dis. 2014 Jan 6. doi: 10.1136/annrheumdis-2013-203954. [Epub ahead of print]

This study followed slightly more than 600 people over two years, comparing glucosamine and chondroitin individually and in combination with placebo. The main outcomes of interest were changes in joint space narrowing and in self-reported pain. A number of secondary outcomes were evaluated also.

There were no effects of either supplement individually. The combination supplement did show a small change in joint space narrowing over the length of the study. If consistently seen, this change could be clinically significant and results in a small proportion of patients with knee arthritis (1 out of 14) avoiding a knee replacement surgery over a 2-5 year period of treatment. This might be more significant over a longer period, say 10-15 years. However, the statistical significance of this finding was borderline (p=0.046), so it is possible it was only a chance difference  between the groups.

This interpretation is supported by the lack of similar effects found in other studies, and the lack of any significant difference in any other outcome evaluated in this study. The other primary outcome, pain, did not differ between the groups, suggesting no benefit of the supplement in terms of pain relief. While this study does show some potential benefit of glucosamine/chondroitin supplementation, in the context of the literature as a whole, it is not very impressive.

In terms of the veterinary use of these supplements, it is particularly concerning that this study and others consistently show no benefit over placebo in terms of pain. People frequently use glucosamine-containing supplements alone to treat arthritis pain in dogs and cats, and there is no convincing evidence they work. If we are being fooled into thinking they do, however, we are leaving our pets and patients to suffer with untreated pain. This is especially unfortunate given that safe and effective therapies for arthritis pain do exist. While there is likely no direct harm to using glucosamine, it is most likely a waste of money, and there is definitely a risk of indirect harm if it is substituted for weight loss, NSAIDs, and other arthritis therapies with better evidence of benefit.

 

 

Posted in Herbs and Supplements | 2 Comments