The SkeptVet Blog

A reader recently sent me a first-hand account of her experiences with the placebo effect by proxy and the general unreliability of our subjective assessments of medical interventions. Her story is engaging and nicely illustrates these common issues, and she has kindly agreed to allow me to reproduce it here. Enjoy!

AN EXAMPLE OF HOW TO FOOL YOURSELF – AND HOW THE PLACEBO EFFECT CAN WORK IN ANIMALS
Alison Averis

Once upon a time, a horse owner said to an alternative therapist: “Thanks very much for treating Billy last week. He was much more relaxed than usual in the stable that night, and he went really well when I rode him the next day – more forward going, more supple and more willing than usual.  I’d like you to come and do him again”.

Very satisfactory for all concerned.  The horse was going well, the owner was happy and the therapist had a new client.  Except for one thing – the therapist hadn’t treated Billy last week.  She’d gone to the yard as requested and met not the owner but the groom, who through a misunderstanding had asked her to treat another horse.  The owner, not knowing this, had ridden Billy the next day and had attributed her good ride to the treatment she thought the horse had had the day before.

Now this alternative therapist had an enquiring and scientific mind and decided to conduct an experiment.  She asked a friend of hers whether she could give the friend’s horse a free session of her therapy.  She didn’t want the friend to watch what she did, but she did want the friend to give her feedback afterwards.  And she didn’t do anything to the horse at all.  While the friend thought she was doing the treatment, she was actually sitting in the manger reading a book and the horse was eating his hay.  When the therapist later asked the friend what had happened, she was not altogether surprised to hear a tale about a very relaxed horse who “went so much better than usual when I rode him the next day”.

Unlike most stories that begin ‘once upon a time’, this one is true.  It illustrates very nicely the danger of attributing a change in our horse’s behaviour or performance to something we have just done.  Or, as in this case, that we think we have done.

The therapy in question, unlike many, actually had some biological plausibility: it was a manipulative technique that many people find relaxing and invigorating, and it is not beyond the bounds of possibility to suppose that horses might also get at least temporary benefits.  The point is that the intervention (or non-intervention) could have been anything: a veterinary treatment; a new feed or feed supplement; a new saddle or bridle; a visit from the farrier or equine dentist – you name it.  The only necessity was for the owner to believe that any improvement in the horse’s behaviour following the intervention must have been a result of that intervention.  As we have seen, the intervention didn’t even have to happen.  All that was required was for the owner to want to make that connection.

The fact is that a horse will vary from day to day in how lively, enthusiastic, supple or willing he feels and there can be many reasons for this: working hard the day before, a slip in the field, more time than usual in the stable, the weather, the time of day, his social relationships and the amount of sleep he’s had, to name only a few of the possibilities.  It is just unfortunate that we, with our pattern-recognizing, all-too-human brains, are likely to come to the wrong conclusions about the reasons why, because of what we want to believe.  If we have given the horse something we believe will improve his performance – and especially if we’ve paid a lot of money for it – we are likely to think that any subsequent improvement in performance is a result of what we did.  As you can see, the fact that a change in behaviour followed an intervention does not prove that the intervention caused the change, and this is why the scientific method is necessary.

One of the most common responses I get when I point out the lack of evidence for particular CAM therapies is, “So what? If it doesn’t do any harm and if people feel better, even just because of a placebo effect, then why do you want to convince them this stuff doesn’t work?”

Of course, the first answer to this has to be challenging the assumption of safety which seems to adhere to most CAM therapies, and I have done that at length. However, beyond that issue, it seems to me a fair question whether the truth matters when it takes away something benign that people want to believe and which might offer some relief from symptoms via a psychological mechanism, if not by way of actually changing the underlying disease process. I have several answers to this question, some personal and philosophical, others more pragmatic and directly relevant to medicine.

On a personal level, I share the sentiments of R. Barker Bausell, author of Snake Oil Science. He sees investigating the truth about the claims of alternative medicine as part of the larger project of science, and his research and writing are motivated at least “partly [by] a common professional objective for a scientist: to be able to claim a personal victory in one small skirmish in the perpetual struggle between knowledge and ignorance.” Though I understand that many, perhaps most, people don’t share the sentiment, a lot of us in science are driven by a visceral sense that truth matters, and that even unpleasant truths are to be embraced and comforting untruths disdained. I don’t see imparting this sense to others as a core goal, or justification, for challenging bogus medical claims, though I do hope my passion for what is true may resonate with some readers. But I must be honest and confess that this feeling is a large part of why I engage in my various projects promoting science-based medicine.

On a more practical level, there is clear evidence that the comfort taken from untrue beliefs in medicine does harm beyond the direct damage particular medical therapies may cause. While some turn to CAM only when they have exhausted the options provided by science-based medicine, CAM therapies are often promoted as an alternative to scientific medicine. However, when CAM is used in lieu of the more effective, better understood therapies of scientific medicine, people suffer and sometimes die unnecessarily. We see this happen in the asthma patients who have poorer compliance with drug therapy, and poorer quality of life scores, then they substitute herbs for medicine, and in the cancer patients who eschew effective mainstream treatment or palliation in favor of alternative therapies, leading to greater suffering and earlier death. What is more, because CAM therapies are so amenable to placebo effects and to false assessments of real efficacy, even casual experimental use in conjunction with conventional therapies can lead to a belief in not only the efficacy of the alternative interventions but create sympathy with the philosophical underpinnings of these interventions and skepticism of the underlying foundations of science.

CAM proponents frequently emphasizes supposed philosophical differences between alternative medicine and science. Some of these are marketing points rather than true differences, such as the nonsense about CAM treating the whole patient rather than just the disease, or scientific medicine treating only symptoms while CAM treats root causes of illness. However, there are some genuine philosophical differences between science as an epistemological approach and the world view of many CAM adherents. CAM often rests on a foundation of vitalism, the notion that invisible spiritual or “energy” forces are the true source of animation for living beings, and that disease is not a manifestation of disorders in the physical body but in these mystical forces. Vitalists claim to be able to sense and manipulate such forces, but these claims are never demonstrable by any objective means and must be accepted on the basis of faith alone.

This is in contrast to the position of methodological naturalism, in which scientists agree to put aside any personal intuition or revelation of a spiritual nature when investigating and treating the causes of disease, and focus solely on mechanisms and causes which can be objectively and repeatedly demonstrated to anyone. The claims of some CAM advocates that this approach is doomed to failure because it ignores the “real” nature of life and health are belied by the astounding success of the technology and medicine it has generated. Millennia of vitalist approaches to medicine failed to achieve the improvements in health and longevity a naturalistic approach has accomplished in only a couple of centuries. There’s a reason why mystical health care theories have had more success being adopted in the treatment of chronic diseases, particularly involving subjective symptoms like pain, and have failed to be widely accepted in acute, life-threatening situations. Homeopathic birth control hasn’t caught on too well either, so perhaps there is more to be said for “reductionism” than CAM proponents often credit.

Yet vitalist philosophies have an emotional and aesthetic appeal, and I understand the historical and psychological reasons they are so attractive and widespread. Nevertheless, I feel the evidence of history conclusively demonstrates naturalism to be a more accurate and successful model of reality, and there are real dangers in choosing to ignore this reality and adhere to comforting but unsuccessful paradigms when dealing with health and disease.

Similarly, many CAM advocates hold to an extreme relativism born of the post-modernist philosophical movement. This sees all models of reality as purely social constructs with no sound basis to give preference to one over another. Any attempt to assert one model is more faithful to an objective physical reality than another is dismissed as merely an attempt to justify a particular social and political power structure, to the advantage of one cultural group over others. Thus, even claiming objective reality exists and can be described is denounced as a form of political and cultural oppression. All points of view are held to be equally valid, and no truth claims are defensible.

This philosophy has had much success in the rarefied air of academe, though even there it is beginning to fray. It is buttressed by the reality that all of our models of reality are in fact  influenced by cultural factors, and that oppression is often justified by its intellectual apologists through the promulgation of scientific and pseudoscientific theories. However, postmodernism throws the baby out with the bathwater, and in an attempt to eliminate xenophobia and ethnocentrism it eliminates any hope of understanding the universe or improving our lives. Again, the history of science, technology, and medicine clearly and forcefully demolish the notion that there is no objective reality and that we can have no true knowledge of it. Such a perspective has no usefulness, and should have no place in medicine.

On a more practical level, one reason to care about the efficacy of CAM methods is simple economics. A 2009 study from the NCCAM found Americans spent $33.9 billion on “alternative” therapies (though the definition used in the study was quite loose). This is a lot of money to put into treatments of dubious effectiveness, and even if they have some positive effects in terms of subjective symptoms like pain or nausea, I think it is fair to wonder whether such resources could be better spent discovering more effective therapies or making health care more available to those who cannot afford even basic care.

Finally, Simon Singh and Edzard Ernst make the case in Trick or Treatment: The Truth about Alternative Medicine that it is nearly impossible to benefit from the placebo effect of a medical therapy without either lying to the patient or at a minimum deliberately ignoring the evidence against the placebo therapy. Most CAM practitioners obviously genuinely believe their methods work. However, maintaining this belief requires ignoring the principles and practice of science and evidence-based medicine. In today’s world, with the knowledge that scientific research has accumulated in the last few hundred years, sticking with such an attitude requires a kind of deliberate ignorance. CAM practitioners who utilize clearly disproven methods or concepts, such as homeopathy, the vertebral subluxation, and so on, must reject the very principles of science and the most basic, and well-established scientific understanding of the world. This is an act of faith that makes their approach more of a religion than a medical science.

There are those who honestly try to apply the principles of science and evidence to CAM. Unfortunately,  there are few CAM therapies that one can honestly justify in this way. Acupuncture for pain and nausea, chiropractic for idiopathic back pain, and a few well-studied herbal remedies and nutritional supplements are about all CAM can justly claim to be supportable by any sort of real research evidence, and even some of these claims amount to a primarily psychological, rather than disease-modifying, set of effects. There are important ethical questions associated with the use of placebo therapies, whether in mainstream medicine (where antibiotics and vitamins are often used to this end) or in CAM (where arguably the majority of the benefits seen are placebo-based). As I’ve argued before (here and here), the benefits may well be outweighed by the harm done to the caregiver/patient or client relationship by introducing deliberate deception, or even more the more subtly disingenuousness in sticking with what one’s experiences and intuition say and ignoring robust evidence against one’s approach, into this relationship. Though it is a philosophical point, and as such not provable in any objective way, I cannot help but feel that we are better served by honesty and a commitment to the truth than by accepting the short-term benefits associated with deceiving others or even ourselves.

Though it’s certainly not an original observation, I’ve begun to see some repeating patterns of behavior associated with unreliable and unscientific medical claims, and I think it might be useful to review some possible warning signs that one is dealing with quackery or nonsense. Certainly, not all of these markers will be found in the claims or marketing of every unsubstantiated medical approach, and some of them may well be found attached to legitimate or correct claims. However, viewing hem as risk factors or red flags can help one to separate the pseudoscientific from the scientific and the truly helpful from the nonsense.

1. The Galileo Complex-

Most idiosyncratic ideas that conflict with the mainstream understanding of reality turn out to be wrong. As Michael Shermer puts it: “History is replete with tales of the lone scientist working in spite of his peers and flying in the face of the doctrines of his or her own field of study. Most of them turned out to be wrong and we do not remember their names…The person making the extraordinary claim has the burden of proving to the experts and to the community at large that his or her belief has more validity than the one almost everyone else accepts.”

The exceptions stand out precisely because they are exceptions. People with questionable ideas like to compare themselves to Galileo or other historical figures who were widely doubted and whose ideas were vilified and suppressed in their own era but who were later vindicated by science and history. This is a neat little bit of self-aggrandizing spin that is a lovely example of the availability heuristic and cherry picking fallacies. Because such cases are unusual, they stand out in our minds, which makes us likely to see them as more common or representative of the norm than they are, and because we wish to validate our own ideas we tend to notice and cite only those examples which support our claims and ignore those which do not. So any book, web site, or lecture which makes comparisons to Galileo or other such figures should be suspect in terms of the soundness of the reasoning and the intellectual honesty and humility of the author.

A lovely example of this is a book by a lawyer who often defends alternative medicine providers against government regulation, Richard Jaffe, who titled his own book about his work Galileo’s Lawyer.

2. The Dan Brown Gambit-

Despite some worrisome signs of growth and the lax oversight by government thanks to effective legislative lobbying, alternative medicine is a fairly small, largely marginal element of healthcare overall. It tends to serve primarily affluent clients with chronic complaints, often involving largely subjective symptoms such as pain or fatigue, and people with philosophical predilections towards it such as postmodernist liberals, some varieties of libertarians, and those generally suspicious of modernity, materialism, and methodological naturalism. Mainstream science-based medicine has earned the confidence of people by producing unequivocal results, it is generally preferred by most people unless they have one of these philosophical objections to it or a condition which science does not yet have clearly effective treatments for.

Unable to accept this fact, many CAM advocates argue that their methods are better but have failed to replace scientific medicine due to a conspiracy of suppression by the medical-industrial complex. A nice example of this comes from one of the more extreme alternative medicine sites, Shirley’s Wellness Café:

“Dr. Guylaine Lanctot, M.D. – The medical establishment works closely with the drug multinationals whose main objective is profits, and whose worst nightmare would be an epidemic of good health. Lots of drugs MUST be sold. In order to achieve this, anything goes: lies, fraud, and kickbacks. Doctors are the principal salespeople of the drug companies. They are rewarded with research grants, gifts, and lavish perks. The principal buyers are the public – from infants to the elderly – who MUST be thoroughly medicated and vaccinated…at any cost! Why do the authorities forbid alternative medicine? Because they are serving the industry, and the industry cannot make money with herbs, vitamins, and homeopathy. They cannot patent natural remedies. That is why they push synthetics. They control medicine, and that is why they are able to tell medical schools what they can and cannot teach. They have their own sets of laws, and they force people into them. That is a mafia. This sensational expose’ also uncovers the truth behind vaccines, AIDS, cancer, the World Health Organization, the Rockefeller Foundation, the World Bank, and more. Dr. Lanctot, M.D is the author of The Medical Mafia  How To Get Out of It Alive and Take Back Our Health and Wealth.”

These arguments resemble those found in many Dan Brown novels, in which thin threads of evidence are used to claim that venal cabals of robber barons collude with doctors to maintain people in a state of constant illness, despite the availability of cheap, natural cures for all diseases, solely because of their devotion to profit and power. This is closely related to both the Galileo Complex and what I have elsewhere called the David and Goliath Myth. As in most every other human endeavor, claims of shadowing conspiracies to silence the truth ought to be viewed skeptically, as they are often a cover for the simpler fact that vacuous and mistaken ideas fail to find acceptance because people simply aren’t fooled by them.

3. Deep Secrets-

Difficult to disentangle from the phenomena already cited is the slightly twist on the underlying theme I call Deep Secrets. Many advocates of alternative medicine will claim they have found simple and obvious knowledge that has been hidden from the rest of us, either by our own slavish acceptance of the propaganda of the Medical-Industrial Complex or because the secrets have been actively suppressed. A couple of examples of this are Dr. Andrew Jones book The Veterinary Secret, Kevin Trudeau’s Natural Cures “They” Don’t Want You to Know About, but there are many others. Claims of secret wisdom uncovered by lone geniuses and available to you free (as long as you buy their book, DVD, etc), should always raise one’s suspicions.

4. The One True Cause of All Disease-

Harriett Hall at Science-Based Medicine has written eloquently about this phenomenon. Many CAM proponents claim their method is based on understanding the “true underlying cause of disease,” while scientific medicine is merely treating symptoms. Most times, this “true cause” is some sort of perturbation of a vitalist energy detectable only by the intuition of the practitioner. While people prefer the simple and definitive to the complex and ambiguous, reality is under no obligation to conform to our wishes for it, and reality is often complex and ambiguous. If there were one simple and obvious true cause for all illness, I cannot imagine that it would not have been found and manipulated at some point in human history with such great success as to eliminate all disease and displace all other models of health and well-being. The failure of this to happen is one of the better bit of evidence against the claim. And I have wondered aloud before how CAM proponents rationalize the use of multiple therapies concurrently each of which is based on totally incompatible One True Causes of disease. A cause for doubt if ever there was one.

5. If It Sounds Too Good To Be True, It Is-

An old maxim, but a sound one. People will often investigate with a sharp, critical inquiry the details of a new electronics or automotive purchase looking for solid evidence on which to make a choice, and yet the same people will throw common sense and skepticism away when fed an appealing line of pseudoscientific sales patter by an alternative medicine advocate. Practitioners of scientific medicine are often at the public relations disadvantage of having to be truthful with our patients and clients, including admitting to the limitations of our knowledge an ability to solve their medical problems. Anyone who claims dramatic and unprecedented success with no risks should be pressed to produce more than their word or the testimonials of fellow believers to back up such claims, because such claims so often prove false in every area of human endeavor and medicine is no exception.

Readers of this blog will be familiar with Dr. Shawn Messonier and his style of promoting alternative veterinary medicine by lying about scientific medicine and veterinarians who practice it (e.g. Here, Here, and Here). The latest example of this behavior is also a fine example of the bogus CAM marketing approach known as “healthcare choice.” I written about this strategy before, but in brief it is the claim that any argument against alternative methods, and certainly any attempt at regulation that requires proof of safety and efficacy before marketing a medical intervention, is an unjust suppression of people’s right to choose their own form of health care. Usually the argument is paired with accusations or implications that anyone who questions whether CAM works or is safe is only interested in protecting their own income.

Dr. Shawn makes this argument in its classic form in a recent blog post.

“As an integrative, naturopathic doctor, my practice is all about choice. While I hope I can convince my pet owning clients that using natural therapies whenever possible is the better, safer, usually less expensive, and healthier way to go, ultimately the choice of therapy chosen is up to the client.

If the client chooses a more conventional drug therapy, that’s her choice and I will never interfere with that choice…

It seems to me however that skeptics who rally against natural therapies don’t want their patients or clients to have this choice.
For many of these skeptical doctors, it’s “their way or the highway!”

They consistently try to talk patients out of a more natural approach to healthcare, all the while demeaning and insulting this choice, as if this choice is invalid or irrational…

The only answer I can come to after researching this question is this: economics.

If a doctor only offers one choice, in this case conventional drug or surgical therapy, and you choose a more natural approach, that means you will have to find another doctor. Your current doctor loses your business, and your choice punishes his pocket book. He won’t like that and will do anything to keep you as a patient.”

This argument is, of course, merely a cynical attempt to convince pet owners to choose Dr. Shawn’s methods by hypocritically claiming to offer more “choice,” which sounds better than admitting he has nothing but his word to offer as proof that his alternative methods actually are better for his patients. He criticizes conventional veterinarians for trying to talk clients out of using unsupported or outright quack therapies yet he admits to trying to convince his clients these therapies are better than scientific medicine, to which end he has many books, a radio program, and of course his web site, all of which are ways he makes his living. The argument is blatantly hypocritical on the face of it.

On his website, the good doctor discourages vaccination; claims commercial diets are full of toxins that lead to cancer; refers to pets taking conventional drugs as “pharmaceutical cripples” and encourages pet owners to “say NO to drugs,” and in many other ways discourages conventional medical therapies. Granted, he also makes use of many of the treatments provided by sound scientific medicine, and his practice philosophy seems to consist mostly of adding the unproven and the opinion-based on top of conventional medicine, but this is not about giving pet owners more choice, it is about pushing his own beliefs and opinions and then slandering anyone who challenges him to back those up with real evidence. If trying to convince clients about what one believes to be the true facts regarding a particular treatment is “interfering” with teir choice, than Dr. Messonier is as guilty of this as anyone.

CAM practitioners often claim to promote choice while actively claiming scientific medicine is mistaken and causes great harm. And it is not unusual to find statements such as the following from self-professed “holistic” veterinarians:

“Use of Other Modalities and Medications

The treatment program that we use is not compatible with the simultaneous use of conventional drugs such as antibiotics, corticosteroids, thyroid hormones, etc. As the cases progresses, you may be guided in the gradual discontinuance of some or all these medications. This is necessary so that our methods can take full effect. In addition, if other symptoms appear during treatment (or older, previous conditions return) you will be expected to contact us for appropriate response rather than use drugs that you may have used before. The reappearance of older problems can be a very good sign that the body is beginning to heal and this is usually a very delicate and important time. The use of conventional medications and treatments might make this healing impossible!”

However, the “health care choice” argument is wrong in many ways besides merely being hypocritical. It evades the underlying issue of what the choices being offered actually are. If a client is told that an unproven treatment is safe and effective and that conventional preventative or treatment interventions are toxic and harmful not helpful, then they are being deceived, intentionally or by the genuine mistaken beliefs of the practitioner. A choice to rely on placebos or therapies that don’t work and may very well do harm based on an “educational” harangue is not a true informed choice in an meaningful sense. The whole point of evidence-based medicine is to support our recommendations with objective scientific research, not merely our own biases and opinions. And the motivation behind practicing evidence-based medicine is better patient care, not simply making money.

Alternative therapies have not earned any special exemption from rigorous objective testing or criticism. They should be judged, as scientific medicine is judged, on their merits, not on the strength of the faith their proponents have in them. Viewing the implausible skeptically and asking for evidence rather than taking Dr. Shawn’s or anyone else word for the safety and efficacy of alternative methods is the right way to protect the well-being of our patients, an trying to label it an unfair restriction of consumer choice motivated by greed is simply another example of the unprofessional, hypocritical, and vapid marketing strategies many CAM proponents have to rely on absent the real convincing evidence they fail to provide.

Dr. Shawn has the zeal of a true believer, and the inability to consider the possibility he might be wrong. Claims like his of offering more freedom of choice than conventional veterinarians are simply a marketing strategy based on caricaturing and slandering veterinarians who practice science-based medicine and evading the challenge of backing up their medical practices with something more convincing than their own opinion and experience. Such language is unfortunately often effective in a society that sees choice as automatically a virtue and that likes simple, personalized arguments rather than complex, nuanced, and fact-based ones. We who adhere to the standards of evidence-based medicine are at the disadvantage of not being able to make any claim we like regardless of whether we can support it, and those of us who believe in challenging ideas and arguments rather than people and their motives are at a disadvantage in such debates as well. Rarely do you see too sober, polite, and well-informed adversaries arguing complex scientific issues on daytime television, since it is far less compelling to watch than vapid appeals to emotion like the “healthcare choice” argument. More’s the pity.

CAM proponents often engage in the rhetorical fallacy known as special pleading. Wikipedia’s definition of this is adequate: “a form of spurious argumentation where a position in a dispute introduces favorable details or excludes unfavorable details by alleging a need to apply additional considerations without proper criticism of these considerations themselves. Essentially, this involves someone attempting to cite something as an exemption to a generally accepted rule, principle, etc. without justifying the exemption.”

Because many forms of CAM, such as homeopathy and various “energy” and “mind-body” therapies are based on principles inconsistent with established scientific knowledge, their advocates sometimes have to try and find ways to justify why these methods should be taken seriously despite this major weakness. They frequently argue that their methods rely on principles science does not yet, or perhaps cannot, understand. They argue that, despite the incontrovertible success in the last few hundred years of established methods of scientific investigation in figuring out and manipulating phenomena in the real world, these methods are culturally defined (i.e. “Western”) and only apply to their cultural of origin, or that they are incapable of dealing with new kind of phenomena.

These arguments seem pretty weak in the face of historical reality, but there is of course always a chance that a given “paradigm shift” or “revolutionary” new principle of biology, medicine, or physics has been discovered that turns all we know out the door.  However, this is an extraordinary claim, and it cannot be defended simply by pointing to a few anecdotes, one’s personal experience, or the ultimate foundation I believe it really rests on, faith. The whole reason we even have a category of medicine called “alternative” (or as I prefer to call it, “faith-based medicine”) is because people believe things they cannot convincingly demonstrate to those who do not share their faith or their trust in personal experience.

In 2008, there was a symposium held at the UCLA Center for East West Medicine (note the postmodernist bias that all knowledge is culturally relative even in the very name of the organization) and reported in eCAM. The purpose of the symposium was, as always, to try and convince mainstream medicine and the public of the scientific legitimacy of CAM.

“Its purpose was to address the finding by the National Center for Complementary and Alternative Medicine (NCCAM) that IRB’s may be unfamiliar and/or uncomfortable with unconventional medical modalities thus apt to disapprove studies of those modalities. The hope was to better this state of affairs by familiarizing the audience with some of the major controversies surrounding CAIM research and its regulation.”

NCCAM has been widely criticized for being a tool of the CAM political lobby and of wasting taxpayer money trying to validate implausible therapies only because they are favored by powerful politicians or well-funded lobbies. This criticism, and questions about the scientific legitimacy and ethics of NCCAM-funded research was raised by critics at the UCLA symposium, and the responses of CAM advocates are enlightening in that they demonstrate the special pleading CAM requires because it cannot meet the evidentiary standards of scientific medicine.

According to the eCAM article, “Dr Ary Goldberger, Director of the Margret & H. A. Rey Institute for Nonlinear Dynamics in Medicine at Boston’s Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School….suggested that conservatism in science extends to the underlying approach to physiological systems, often wrongly privileging homeostasis (‘constancy as the wisdom of the body’) over complex adaptability, multi-scale dynamics and emergent properties. In as much as they are non-linear, non-stationary, non-additive and show time irreversibility, however, complex systems may be inaccessible to conventional analytic techniques, according to the speaker. Dr Goldberger left the impression that he believes both investigators and NIH Centers in general ought to be more open to novel but rigorous research designs and methodology.”

So here’s the claim that because CAM methods don’t seem to get validated by conventional scientific investigations, the flaw must be not with those methods but with the very nature of science. We need to invent new ways of studying nature, despite the wild success of our current approach, because the methods he favors don’t get validated the way we do things now. Again, paradigm shifts do happen, but they are rare, and the vast majority of revolutions proclaimed by outsiders in science are nothing more than desperate attempts to defend failed ideas.

Next, Distinguished Professor Edwin Cooper (Editor in Chief, Evidence Based Complementary and Alternative Medicine) “raised questions about what passes for good research methodology, asking whether studying ancient, whole systems of medicine using Western, reductionistic techniques doesn’t strip them of essential features.”

Here again is the postmodernist notion that truth is culturally relative, and that science somehow only applies to ideas that originated in the culture that most directly contributed to the creation of modern scientific methods. This is blatantly ridiculous, as any Chinese or Indian or other “Eastern” patient benefiting from modern scientific medicine could tell you. Our physiology doesn’t care where we live or what language we speak, physics doesn’t work differently on different continents, and while values depend heavily on culture, the truth about how our bodies work doesn’t. Millennia of traditional folk methods in India or China or anywhere else failed to eradicate infectious diseases like polio, lower infant mortality, raise life average expectancy, or otherwise improve human health and well-being to anything like the extent “Western” science has in only a few hundred years. The notion that other cultures have other medical realities is at best a sincere but weak defense of implausible or outright failed ideas based on the inappropriate translation of cultural relativism to the scientific domain. At worst, it is simply old-fashioned orientalism with the patina of scientific “open-mindedness.”

My favorite comment, though, comes from Professor-in-Residence Mark Cohen. First continuing the special pleading approach, he “expressed the view that current research tools may be inadequate for measuring the effects of some CAIM treatments.” Yeah, well prove it. But he then went on to all but admit that CAM is a faith-based belief system much more like religion than science: “he noted that taxpayers already support faith-based initiatives and questioned whether conventional science has a ‘special entitlement’ to public funds, given that orientation.” Here he is saying that because a large number of Americans accept giving government money to religious organizations for performing services previously considered the responsibility of a secular government, we should similarly support giving taxpayer dollars to study CAM rather pretending conventional science should have a special claim to research money just because it is a proven and effective approach and CAM is mostly a hodgepodge of vitalism, folk traditions, and stuff outright made up by unappreciated lone genius or know charlatans. Our faith, our belief alone should be sufficient to justify it. It isn’t possible to be much clearer about the philosophy behind alternative medicine than that.

A couple of  ”news” articles, which were essentially truncated but often verbatim reprints of a company press release, appeared today about a clinical trial looking at a mysterious new veterinary product with grand but vague claims. Naturally, this caught my attention. 

The Chemaphor company announced “it has completed its first clinical trial to evaluate the efficacy of an oral Oximunol supplement in promoting overall health and well-being of companion canines.” The only details of this trial were that it was a “blinded, randomized clinical trial involving forty six dogs recruited from the public. The animals were randomly assigned to receive either the Oximunol supplement (0.5 mg/kg body weight) or a placebo once daily over a period of six months. The Oximunol supplement’s potential benefit to canine wellness was assessed by analyzing owner responses to standardized questions regarding the health status of their pets before and after the supplement period” The press release claims, “A full report of the study is being prepared for submission for publication in a peer-reviewed journal.”

So what is Oximunol?  It is described as “a proprietary mixture containing compounds found naturally in the plant world in minute amounts as oxidized derivatives of carotenoids. The supplement is obtained via the spontaneous, full oxidation of beta-carotene.”

There are a number of red flags here right from the start. Announcing the results of a “clinical trial,” especially one conducted in house by a company trying to launch a new product, in a press release prior to publication in a legitimate journal is a marketing ploy that is rarely consistent with good science. And while it is impossible to judge the merits of the study without having it properly vetted and published, I am skeptical of a trial that starts with the hypothesis of the treatment “promoting overall health and well-being” and that reports as, presumably, its best and most newsworthy findings “improvement in coat quality and reduction of shedding[and]….a tendency to increased enjoyment of walks” as judges by subjective owner assessment. Vague and lofty goals of health promotion and vague, subjective measures of success do not inspire confidence in the reliable scientific evidence for a treatment.

The company web site indicates they are producing and preparing to market a couple products derived from oxidation of beta carotene, and they make a number of claims about these molecules:

“OxBC is a premium product embodying the untapped potential of the many non-vitamin A carotenoid oxidation compounds we believe are the true agents responsible for the various non-vitamin A activities of carotenoids.”

“OxBC possesses a wide range of biological properties that are exerted non-toxically. These include:
1. Inhibition of proliferation of cancerous cells grown in vitro (5-30 micromolar concentration);
2. Effective inhibition of growth of experimental tumours implanted in mice, (10-30 mg/kg body weight injected intraperitoneally, dose frequency every 1-3 days);
3. Promotion of cellular differentiation in vitro (concentrations roughly same as for item 1);
4. Non toxic bioactivity, in vitro and in vivo (e.g., mice, multiple injections; 150 mg OxBC/kg body weight);
5. Enhancement of intercellular gap junctional communication in vitro;
6. Induction of Phase 2 enzymes in vitro (shown for at least one component) implies cancer chemoprevention activity;
7. Promotion of growth and feed conversion in food production animals.”

OCL-1 is Chemaphors’ primary cancer drug candidate for the following reasons:
• Non-toxic inhibition of growth in mice of tumours derived from human cell lines
• Wide therapeutic range of activity
• Available orally
• Rapid tissue distribution and penetration predicted by low molecular weight (<150 Da) and fat-soluble nature
• Antimetastatic activity
• Chemopreventive anticancer activity
• Novel – although a carotenoid oxidation product, it is virtually an unknown compound
• No known reports of biological activity of any kind prior to Chemaphor’s studies
• Unusual chemical structure with potential to elaborate into a distinct chemical class with a spectrum of biological activities
• Non-classical, non-toxic mechanism of anti-tumour action, e.g. enhanced gap junction intercellular communication
• Low manufacturing cost based on simplicity of chemical structure.”

No references are cited to support any of these claims. A quick PubMed search finds some references to in vitro studies of some similar compounds, but no clinical trial evidence of significant benefit in humans, and no studies of non-retinoid carotenoids at all in dogs. This is not to say the molecules couldn’t have beneficial effects as cancer preventatives or therapeutics or in some other application, only that the company is following the all too common and unfortunate path of building hype and marketing products without adequate evidence of safety and efficacy. As I have discussed before, this is a tried and true strategy for supplement manufacturers, trying to take preliminary hints of utility for a product and use them to support sales before definitive evidence can disprove them. It may make economic sense, but it is scientifically and ethically indefensible.

And the promotional materials for Chemaphor make it very clear that the goal is to draw investors and their dollars. They are refreshingly open about the economic aspects of their agenda.

” Chemaphor is developing a set of major, business opportunities centred on the rich, non-pharmaceutical potential of the OxBC product….In comparison to drug development, each opportunity offers shorter product commercialization times by requiring much less development work and being subject to less restrictive and smaller regulatory hurdles. Yet each business activity addresses global market biotechnology segments with major, multi-million dollar revenues.”

“ Target market areas:
• Non-antibiotic feed additives for improving growth and feed conversion efficiency in production animals (e.g. poultry and swine)
• Nutraceuticals for companion animals
• Veterinary applications
• Skin care

Intended applications of products:
• Improving growth and feed conversion in swine and poultry
• General promotion and maintenance of good health in farm animals, dogs, horses and cats (companion animal nutraceuticals; feed additives)
• Control of diseases of aging (e.g., cancer) in companion animals (pet nutraceuticals)
• Anti-aging protection of skin, including protection against skin cancer (skin care and cosmetics, e.g., after exposure to sun)
• Amelioration of pre-existing skin conditions or prevention of recurrence of treated conditions (skin care and cosmetics)
• Maintaining healthy skin by providing broad, multi-level protection against various conditions (skin care and cosmetics)”

“In the area of pet nutraceuticals, Chemaphor’s goal is to obtain entry into this rapidly growing, lucrative market with OxBC as a health-maintenance, chronic disease protecting product. The companion animal market is attractive because there is an unmet need for the type of product OxBC represents, the market is large, and it is the fastest growing segment of the animal health market, at over 6% per year. This market also poses lower regulatory hurdles to entry.”

There is, of course, insufficient information to say with certainty whether or not this company’s products have any real medical value, but these promotional materials are a classic example of what I’ve come to call Big CAM. Contrary to the mythology promoted by CAM advocates, in which small providers make available free or cheap health care miracles despite the oppressive forces of “industrial medicine” to keep our pets sick for our own monetary well-being, the reality is that CAM products represent a lucrative market and CAM manufacturers, distributers, and providers are just as interested in making a living as anyone else. The classic Big CAM features of this marketing material are:

1. Aggressively touting the benefits of a product well before adequate evidence exists to support the claims made.

2. Vague and lofty claims of treatment for a wide range of conditions, from cancer to aging skin.

3. A clear interest in taking advantage of the inadequate regulatory oversight for “dietary supplements” and other products that can avoid FDA or USDA requirements for proof of safety and efficacy.

These features justify some serious skepticism about the company’s claims. Before profiting from the belief the company is actively seeking to create, that it’s products offer health benefits to companion animals, the company ought to be obliged, by ethics if not laws, to prove that the product is truly beneficial. I hold out little hope that the regulatory agencies will enforce such an obligation, and I await with interest further indications of whether or not the company will voluntarily do the right thing and refrain from profiting from its products until it can convincingly demonstrate they are helpful and safe.