Is Enough Ever Enough? Wasting Resources on Clinical Trials for Magic and Pseudoscience

A recent editorial from Trends in Molecular Medicine does an excellent job explaining why clinical trials testing the effects of highly implausible therapies, like homeopathy and energy medicine, are not an example of evidence-based medicine but of science tricked into serving as advertising.

Gorski DH. Novella SP. Clinical trials if integrative medicine: testing whether magic works?
Trends in Molecular Medicine 2014; In Press

Clinical trials are the last in a series of steps to evaluate potential therapies, and those that fail at earlier levels, or that have not been subjected to appropriate pre-clinical testing, should not be inflicted on patients. It is unethical and dangerously misleading to conduct such clinical trials.

When poorly designed and conducted, such trials generate spurious positive findings that mislead. When properly designed and conducted, they most often generate negative findings (read Snake Oil Science for numerous examples). However these negative studies do nothing to discourage the use of these therapies among proponents. Conducting such studies in hopes of finding a rare exception in which they prove effective and long-standing scientific principles are overturned is not an efficient use of limited resources for testing novel therapies. We should focus our energy on therapies that don’t conflict with well-established principles of basic science and which are promising on the basis of pre-clinical research. Most of these will fail at the clinical trial level as well, of course, but at least the odds are somewhat better than for trials on what amounts to magic.

This is relevant to veterinary medicine as well as human medicine, though as usual the scope of the problem is smaller. For example, conducting trials of homeopathic remedies for cancer (Banerji Protocol as Adjunct Nanotherapy for Treating Canine Appendicular Osteosarcoma: A Double Blind, Randomized Study Design), despite the overwhelming evidence that homeopathy is inconsistent with fundamental and well-established laws of physics and chemistry and has consistently failed pre-clinical and clinical testing (1, 2), is simply unjustifiable ethically and scientifically. It is an irrational use of limited resources for investigation of novel treatments.

Here is part of Dr. Gorski and Dr. Novella’s conclusion from the editorial:


In RCTs [randomized controlled clinical trials] testing modalities with low pre-test probability (i.e., low plausibility), confounding effects are vastly magnified, easily producing false-positives. In these days of extreme scarcity of research funding, it is difficult to justify spending precious research dollars carrying out RCTs of treatments where the likelihood of producing a true positive trial is so low and that have real risks that can lead to outcomes like the TACT or pancreatic cancer trials. All clinical trials, not just RCTs, should be based on scientifically well-supported preclinical observations that justify them, preferably with biomarkers to guide patient selection and follow-up. Until specific CAM and IM modalities achieve that level of preclinical evidence, RCTs testing them cannot be scientifically or ethically justified. That is science-based, rather than evidence-based, medicine.

Sadly, many of the vets I talk to, even those who are sincerely committed to science and evidence-based medicine, appear to still believe that conducting clinical trials on even the most egregiously pseudoscientific therapies is appropriate and will make a difference in whether these therapies are chosen by clinicians. There was a time when I believed this. Unfortunately, this view doesn’t reflect the reality of alternative medicine research.

The problem is that the clinical trial literature, which is often questionable in mainstream human medicine and frequently poor quality in veterinary medicine overall, is consistently abysmal when it comes to alternative medicine research. I have previously reviewed the positive literature presented by the Academy of Veterinary Homeopathy last year in defense of homeopathy, for example. It took many hours of locating and reading dozens of papers in detail to determine that this evidence was thoroughly unconvincing. And yet these poor quality studies are constantly put forward as supportive of continued clinical use for these modalities, and the majority of clinicians simply don’t have the time or interest to go beyond the abstracts and appraise them critically.

Such studies create the appearance of legitimacy, which is used to make such modalities more widely acceptable even when the literature doesn’t actually support efficacy. In some cases, for example in China, negative trials of alternative therapies are virtually never published, which illustrates the uniquely unreliable nature of this literature. It is effectively marketing rather than science.

So in light of this, clinical trials of highly implausible treatments don’t accomplish their ostensible purpose. They don’t accurately evaluate safety and efficacy, and they don’t discourage the use of modalities that are pretty clearly ineffective. The work of the National Center for Complementary and Alternative Medicine (NCCAM) is another great example. This agency has spent billions of dollars testing therapies that have not met basic preclinical plausibility criteria. The vast majority of these trials have found no evidence of efficacy. And these results have had little effect on the popularity or use of the modalities studied. (3, 4, 5).

Now of course by saying “alternative medicine,” I am lumping together many very different approaches, most of which are mutually incompatible theoretically as well as sometimes inconsistent with the mainstream scientific understandings of health and disease. But I am not suggesting none of these deserve to be evaluated in clinical trials. Many herbal remedies, manual therapies, dietary manipulations, nutraceuticals, etc. are quite plausible and can and should be evaluated scientifically like any other novel therapy.

But when talking about methods which could only work if fundamental scientific principles upon which much of our technology and medicine is based is wrong (e.g. energy medicine, homeopathy, the theoretical structures of TCM, etc.), or which have effectively been disproven already (e.g. homeopathy, magnet therapy) I can see nothing to gain from clinical trials. They will almost certainly be of low quality and evidentiary value, and even if negative they will not discourage the use of such therapies.

And yes, there are plenty of different evidentiary problems with conventional medicine. Pharmaceutical companies often shamelessly manipulate data, treatments like hyperbaric oxygen and stem cell therapy are rushed into use well before sufficient evidence is available to justify this, and so on. But clinical trials examining therapies which either can’t work, unless much of established science is wrong, or which have already been extensively tested and failed to show evidence of efficacy, are simply wasteful and misleading.

And from an ethical perspective, it is truly disturbing to see veterinary cancer patients treated with homeopathy, especially when otherwise respected individuals and institutions are involved.. I think this is unfair to the patients even in the context of a clinical trial when there is so much evidence in human medicine that there have been systematic reviews of the systematic reviews of research on homeopathy (which, as I have discussed previously, have shown that the positive results come only from inadequately controlled studies).

It seems fundamentally unethical to do work such as this in the name of science when it is clear that nothing short of a miraculous overturning of established science could allow for a positive result, and it is equally clear that no one who believes in homeopathy is going to give it regardless of a negative outcome in such a trial. Such research wastes resources, creates no clarity, does not allow for real falsification, and exposes patients to therapies for which there is really no reasonable expectation of a benefit.

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23 Responses to Is Enough Ever Enough? Wasting Resources on Clinical Trials for Magic and Pseudoscience

  1. Art Malernee Dvm says:

    Brennen, I have read dozens of comments in rebuttal of what you are saying above. I find their rebuttal comments both in the human and veterinarian field always lacking. I kept wishing someone from the early days of the EBM movement would comment so I could be sure I was getting a good balanced rebuttal. I keep asking myself which will produce better clinical outcomes EBM or SBM. I “believe” SBM will. I think that is the question to ask those who do not agree with you.

  2. Art says:

    “XXXX ”

    Here is another rebuttal.

  3. skeptvet says:

    Art,

    I would like to see this discussion continued here since VIN is a closed platform and few people get to see the conversation there. Unfortunately, I’ve been told quite clearly in the past that quoting from threads there without permission isn’t allowed, and I don’t want to violate that Perhaps you could paraphrase and offer your own responses to the objection you refer to?

  4. Art says:

    Brennen,
    how would you paraphrase the sentence I quoted?
    As I’m sure you are aware,my grasp of the English language is to basic for me to do it properly. I think that’s why “fair use” law is a limitation to copyright law. What I need is a computer program that I can put a medical quote into and have it paraphrase the quote for me.

  5. Art says:

    I just found a paraphrase tool online. I pasted the quote into it and this is what came out.

    a state of mind of undaunted outright and destiny, shutting the entryway on further attention.

  6. skeptvet says:

    That’s pretty funny! Computer translation has a long way to go.

    The discussion has wound down, and the position of those who disagree with the editorial basically hinges on the idea that it is fundamentally wrong to ever claim any idea is too far out to be worth studying or to deny someone the right to explore a hypothesis they are committed to. This seems to me connected to the “right to try” idea and the fundamental biases of American culture. Individual freedom trumps reason, scientific fact, or the more utilitarian notion of the common good in almost all situations.

    No one has yet provided a response, though, to the ethical problem of subjecting clinical trial patients to therapies that almost certainly don’t work. This seems a real problem for the argument that researchers should be free to follow their interests if it involves patients being given highly implausible or already disproven therapies.

  7. Art says:

    I found the original quote pretty funny. Maybe that’s why the thread is winding down.

  8. Art says:

    “Isn’t too much prior plausibility consideration just an invitation to trust our usually pretty good but sometimes totatlly mistaken preconceptions?”

    This quote above is the best rebuttal I could find

    The quote is Brennen’s that he wrote years ago. 🙂
    I had not made up my mind about EBM vs SBM when he wrote it. But I realized even then that I needed to practice EBM not just preach it. Preaching EBM has been defined by the health writer of the nyt as ” the discipline that insist on proof that traditional medical practices actually work.” Preaching EBM is the easy fun part. Although practicing EBM is getting easier for me,I believe mainly due to the evolving Internet and the fact I have been trying it for about a dog generation on my patients, it is really really hard to go from the expert opinion medicine training that veterinarians had in school to
    1 find the evidence,
    2. critically evaluate
    3 communicate it to the client so you provide real informed consent not a sales pitch.
    4. figure out if existing laws based on expert opinion that have not been critically evaluated will be a lawsuit risk to me
    5. then get paid initially at least for doing less. I do not see anyone making much money even teaching SBM in the human field either.
    I believe EBM vs SBM brings additional evidence to the table and is inclusive of the RCT. I think SBM strengthens the value of the RCT rather than weaken it. SBM solves the parachute argument for me. I must confess, asking for more expensive scientific RCT study’s on medicines that have nothing in their bottles but water sounds like a bad joke to me.
    A little like going to the opera and saying you want to hear more cow bell. 🙂

  9. skeptvet says:

    Though I cannot cite the specific comments of others from the VIN discussion without their permission, I think it might be interesting for a wider audience to hear some of the arguments. So I will try to provide brief summaries of the arguments put forward by other participants and then copy my own responses.

    In response to my opening post, which was very close to the article I posted here, a couple of colleagues responded that they are concerned that these therapies (we are using homeopathy and energy medicine as our primary examples) are being used already without much scientific support so it seemed worthwhile to gather more evidence through additional studies. They also pointed out that while poor quality studies are inappropriate, this is a problem in conventional medicine as well. My response was:

    “I see your point, and I would have agreed a few years ago. The way you phrase your point, it is quite reasonable. Unfortunately, it doesn’t reflect the reality of this kind of literature.

    The problem is that the clinical trial literature, which is often questionable in human medicine and frequently poor quality in vet med overall, is consistently abysmal when it comes to alternative therapies. I reviewed the positive literature presented by the AVH last year for homeopathy, for example, and it took hours of locating and reading dozens of papers in detail to determine it was thoroughly unconvincing. And yet these poor quality studies are constantly put forward as supportive of continued clinical use for these modalities, and the majority of clinicians simply don’t have the time or interest to go beyond the abstracts and appraise them critically.

    Such studies create the appearance of legitimacy, which is used to make such modalities more widely acceptable even when the literature doesn’t actually support efficacy. In some cases, for example in China, negative trials of alternative therapies are virtually never published, which illustrates the uniquely unreliable nature of this literature. It is effectively marketing rather than science.

    So in light of this, such trials don’t accomplish their ostensible purpose. They don’t accurately evaluate safety and efficacy, and they don’t discourage the use of modalities that are pretty clearly, demonstrably ineffective. The work of the National Center for Complementary and Alternative Medicine (NCCAM) is a great example. This agency has spent billions of dollars testing therapies that have not met basic preclinical plausibility criteria. The vast majority of these trials have found no evidence of efficacy. And these results have had little effect on the spread of the modalities studied.

    Now of course by saying “alternative medicine,” I am lumping together many very different approaches, most of which are mutually incompatible theoretically as well as sometimes inconsistent with the mainstream scientific understandings of health and disease. But I am not suggesting none deserve to be evaluated in clinical trials. Many herbal remedies, manual therapies, dietary manipulations, nutraceuticals, etc.. are quite plausible and can/should be evaluated as any other novel intervention. But when talking about methods which could only work if fundamental scientific principles upon which much of our technology and medicine is based is wrong (eg, Energy medicine, homeopathy, the theoretical structures of TCM, etc.), or which have effectively been disproven already (eg, homeopathy, magnet therapy) I can see nothing to gain from clinical trials. They will almost certainly be of low quality and evidentiary value, and even if negative they will not discourage the use of such therapies.

    And yes, there are plenty of different evidentiary problems with conventional medicine. Pharmaceutical companies often shamelessly manipulate data, treatments like hyperbaric oxygen and stem cell therapy are rushed into use well before sufficient evidence is available to justify this, and so on. But the issue of clinical trials examining therapies which either can’t work unless much of established science is wrong or have already been extensively tested and failed to show evidence of efficacy are simply wasteful and misleading. “

  10. skeptvet says:

    The next response stated it was inappropriate to rule out research based on our imperfect assessment of how plausible the therapy being tested was. My response was:

    “I guess we just see this from different perspectives.

    Homeopathy is not simply implausible in light of popular opinion. It is fundamentally impossible unless we reject basic laws of physics and chemistry. And it has been examined for 150 years without developing convincing supportive evidence. If we cannot even agree to abandon a therapy of this kind, then I’m not sure what the point of the business of falsification of hypotheses is. How can anything be falsified if we continue to believe it is ethical and appropriate to expose sick patients to a therapy like homeopathy, or to the modern varieties of faith healing like Healing Touch and Reiki? Is nothing, then, ever beyond the pale no matter how unlikely the theoretical foundations and how many preclinical and clinical failures it has experienced?

    Certainly, these are extreme examples, and we would likely agree on the need for appropriate testing of many of the therapies lumped under the CAM umbrella. But I continue to be surprised at how reluctant people who claim to trust science and evidence-based medicine are to reject anything at all in this vein…it seems like credibility is lost by the whole profession when we refuse to give up on even such obvious failures as homeopathy and energy healing.

    And form an ethical perspective, it truly disturbs me to see veterinary cancer patients treated with homeopathy by a respected oncologist. I think this is unfair to the patients even in the context of a clinical trial when there is so much evidence in human medicine that there have been systematic reviews of the systematic reviews of research on homeopathy (which, as you know, have shown that the positive results come only from inadequately controlled studies). It seems fundamentally unethical to do work such as this in the name of science when it is clear that nothing short of a miraculous overturning of established science could allow for a positive result, and it is equally clear that no one who believes in homeopathy is going to give it regardless of a negative outcome in such a trial. Such research wastes resources, creates no clarity, does not allow for real falsification, and exposes patients to therapies for which there is really no reasonable expectation of a benefit. “

  11. skeptvet says:

    The point was again made that despite low prior probability, the fact that therapies such as those we are discussing are already in use makes it important to conduct rigorous research on them. My response:

    “Well, of course I think the evidence is strong that these trials are virtually never rigorous since they are more marketing than science most of the time. Certainly, the AHVMF, which is raising significant funding for such studies, has given us ample reason to believe that they intend the studies they fund to promote, not really to test or falsify, the methods they advocate.

    But for the sake of argument, I’d love to explore the criteria those of you who support clinical trials of highly implausible therapies are using to evaluate therapies like those I mentioned, such as homeopathy and energy medicine. The abundant evidence against any effect beyond placebo for homeopathy is available in my posts above. And an 11 year old girl conducted a very impressive study of the energy therapy known as Therapeutic Touch, showing that practitioners were unable to detect above chance the energy they claim to be manipulating.

    So would you be willing to say that further trials on these methods are inappropriate? If not, how would you decide that any specific method was unsuitable for further study?

    Would you support clinical trials of something like Psychic Surgery or ritual sacrifice (practiced commonly in parts of Africa), by which I mean to ask is there any degree of implausibility that would rule out conducting controlled studies?

    I’m not trying to be polemical here, I just wonder if we are differing on the details of specific examples or on the fundamental idea that it is ever appropriate to rule out clinical trials of something that some practitioners believe in and employ.”

  12. skeptvet says:

    I was then accused of playing God and lacking humility for declaring that I was fit to judge which therapies should or should not be studied in clinical trials. It was also suggested that this represented a lack of faith in science to lead us to the truth about these therapies and that I have neither the right nor the power to make decisions about which therapies are to be studied and which aren’t. My response:
    [in response to the assertion that good studies would produce negative results of the therapies actually don’t work]
    “Right, but my point is that they already have and yet more studies are always called for. What is the standard for enough is enough if not homeopathy?

    [in response to the suggestion I was afraid of testing these therapies]
    I’m sure you don’t intend anything negative by it, but you keep suggesting that the case I am making “fears” studying these methods. This is an argument often made by proponents of these methods who suggest conventional clinicians and scientists avoid studying these things because they are afraid the results will validate the methods and overturn their current paradigm. I am not afraid of the results of these trials. I simply feel they are a waste of resources and unethical for the reasons I’ve already discussed. Language matters a little bit in these sorts of discussions, so I just wanted to be clear.

    [in response to the comment the speaker trusts science and so should I]
    Right, as do I. But “science” is more than RCTs, and part of the point here is that we have ample evidence to reject things like energy medicine without the expense and unnecessary risk to patients of testing them in clinical trials.

    I’m not suggesting any individual gets to make all the decisions about what research is done, so it’s not a question of anyone playing God. Of course, every individual has a right to their opinion, and to voice it is=n a substantive and civil manner. My opinion, which I have shared here, is that clinical trials on faith healing like Reiki and homoeopathy are wasteful and unethical. I think there is a strong argument and good evidence to support that opinion, so it is not capricious, and I certainly don’t think it is a failure of humility to have or share such an opinion.

    On a practical matter, decisions about what research gets done and what doesn’t are made all the time, and the question you really seem to be asking is how these should be made. There are obviously sources of funding who have a right to decide what qualifies as worthwhile research to support, and I would hope that issues of a priori plausibility and ethics of patient treatment form part of their decisions. There are also rules for how research subjects should be treated, and again I would hope these include safeguards against being exposed to interventions which do more harm than good or which are almost certainly not going to offer a benefit.

    So I think the idea that suggesting some research shouldn’t be conducted because it is pointless and unethical is somehow infringing on free speech or arrogant is silly. Freedom of speech is not freedom to conduct clinical trials on any idea you like, so any limitations placed on such research by funders or regulators is not a violation of the first amendment. And good intentions don’t excuse subjecting cancer patients to therapies like homeopathy when it is already well demonstrated that it doesn’t work.”

  13. skeptvet says:

    I was then asked if I felt any studies of homeopathy were justified. My response:
    “For homeopathy, I would say no, I don’t believe additional clinical trials are appropriate. The rationale for this has several factors:

    1. As mentioned, the theoretical foundations, such as the Law of Similars and the principle of potentization via dilution and succession conflict with well-established basic principles in biology, physics and chemistry. While this does not guarantee they cannot be true, it is a big strike against them. Modern attempts to deal with this, such as the concept of water memory or water ultrastructure and nanoparticles, have so far not been accepted as convincing by anyone except homeopaths. If mainstream physicists and chemists begin to replicate the work or theoretical principles in this area, I will certainly be open to reconsidering the plausibility of these concepts. However, at this point, they are the theoretical equivalent of notions such as vital humours and other pre-scientific principles widely accepted during Hahneman’s time by various schools of medical thought, including that which led to conventional science-based medicine. None of these have held up well, and most have been abandoned outside of protected ideological zones such as the homeopathy community.

    2. In the roughly 150 years since the invention of homeopathy, there have been numerous attempts to demonstrate objectively measurable biological effects in vitro or in animal models. These have been highly inconsistent in their results, and there is a strong trend (identifiable in the systematic reviews done of this literature) for negative results the better the methodological quality and controls for bias and confounding. A major “breakthrough,” the Benveniste experiment published in Nature, turned out to be an artefact of an unblinded assessor, and numerous subsequent attempts at replication have not validated this or other in vitro models. So while it is always possible to identify reports of positive results, the inconsistency and lack of replicability and the tendency of such results to go away once better studies are conducted strongly suggest there is no effect to be found.

    3. There are literally hundreds of clinical studies in humans and other animals already. The pattern is the same as for the preclinical evidence- the systematic reviews are consistently unable to find positive results once methodological quality is taken into account, since the best studies are consistently negative and the majority of poor quality studies are inconsistent. All of the details are available in the two loooonnngggg documents I linked to above, where I collected much of the evidence and also responded in detail to dozens of papers put forward by supporters.

    Now science is always about provisional answers, and I won’t claim that the lack of plausibility and consistent failure after a century and a half of preclinical and clinical study to produce convincing results make it absolutely impossible for homeopathy to have clinical benefits. I will claim, however, that this is vanishingly unlikely, along the lines of discovering that people could actually fly unaided if only they could flap their arms in precisely the right way. It is possible only in the most abstract philosophical sense. I also think that the appearance of benefits is much more sensibly explained in terms of direct and proxy placebo effects. Given this, it seems irrational to me to continue to beat this almost certainly dead horse when there are so many more promising options. At some point, enough must be enough or we would still be conducting clinical trials on blood-letting, phrenology, mesmerism, and lots of other once popular and now abandoned therapies.

    I have high hopes for truly effective therapies to emerge out of herbal medicine practices, and I think there is ample evidence to suggest further study of alternative dietary practices, some manual therapies, nutraceuticals, and many other such practices. Well-designed trials of these would be useful regardless of the outcome, so long as we are committed to their rigor and to taking their conclusions seriously, whatever they turn out to be. But homeopathy, energy medicine, and certain limited pre-scientific ideological approaches involved in TCM, Ayurveda, and the like strike me as essentially conducting clinical studies on magic, and I would hope we could choose as a community to make better uses of our talent and resources.”

  14. skeptvet says:

    The discussion then turned to the ethical issues, particularly the question of subjecting clinical trial subjects to a therapy that is almost certainly only a placebo, and more generally when placebo therapies are justified in clinical trials.

    “The question about the pros and cons of placebo controls generally is an interesting one, and I don’t think firm universal rules can be drawn. But my point here was that if the existing evidence strongly indicates that a therapy is no different from placebo, doesn’t testing it against a placebo in a clinical trial leave the subjects essentially receiving no treatment at all? Equipoise ( http://en.wikipedia.org/wiki/Clinical_equipoise ) requires there be significant uncertainty about the benefits of a therapy to justify testing it in a clinical trial. In the case of homeopathy, I believe there is virtually no uncertainty and that it is pretty clearly a placebo. So it seems wrong to subject patients to a clinical trial of a placebo against a placebo because they will not receive any actual treatment.

    As for informed consent, it is traditionally understood as requiring that patients/clients be given reasonably accurate and thorough explanation of the risks and benefits from a scientific perspective. For therapies like homeopathy and energy medicine, truly informed consent would require telling clients that there is no compelling scientific evidence to validate the theory (why it might work) or the actual efficacy (that it does work). You can’t really ethically give a placebo therapy without telling the patient it is a placebo, which negates most of its effects. So I worry about informed consent for trials of such therapies because they either implicitly or explicitly suggest that the treatment may have a benefit when the scientific consensus is that it doesn’t and probably can’t.

    Placebos in clinical trials-
    I’m not sure there is a single or simple answer to when placebo controls are ethical and when they aren’t. It depends on the degree of uncertainty about the value of the test treatment, the risks to the control group, the availability of other therapies for the indication being studied, and other such factors. Certainly, if there are treatments available with reasonable evidence of efficacy and the condition is serious, then an active therapy should be the comparator rather than a placebo.

    My objection in the case of homeopathy is that there is no equipoise (usually defined as existing “if there is genuine uncertainty within the expert medical community — not necessarily on the part of the individual investigator — about the preferred treatment.”) We already know the therapy almost certainly doesn’t work, so there is no knowledge to be gained to balance against the risks to the trial subjects. Placebo controls are only ethical if there is real uncertainty about the value of the test intervention.

    The NIH statement on research ethics says:

    “An answer to the research question should be important or valuable enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease. Only if society will gain useful knowledge …can exposing human subjects to the risk and burden of research be justified.”

    Similarly, the Declaration of Helsinki, which is the international standard for clinical trial ethics says:

    ” Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

    The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

    Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

    Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

    and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

    Extreme care must be taken to avoid abuse of this option.”

    So as I’ve said, I think the uncertainty about the potential value of these kinds of therapies is too low to justify putting patients in a clinical trial where the best evidence suggests none will receive an effective therapy and no real knowledge will be acquired. It is sort of like the example of conducting a placebo-controlled study of the efficacy of parachutes for preventing death when jumping out of an airplane. The outcome is so close to certain that the study would be unethical. “

  15. skeptvet says:

    The discussion also touched on the question of informed consent, with the idea being that it was ok to test or use therapies like these so long as the test subjects or patients were properly informed about the evidence concerning them.

    “Informed Consent-

    Do you believe that homeopaths and Reiki healers inform their clients that these therapies are inconsistent with well-established science and believed by most scientists to be placebos? Or do they advertise these as therapies with dramatic established benefits, often far greater than those of conventional medicine? I can show you dozens of examples of the latter, and I have yet to see the former. So I would argue that while clinical use of placebo therapies might be ethical with proper informed consent, it would likely eliminate most of the perceived benefits and it is not realistically going to be offered by those who believe in the efficacy of these therapies regardless of the evidence. The fact that people are using these therapies is not evidence that they are effective or that additional research would provide useful information to guide their use or to encourage not using them.

    I agree that the purpose of clinical trials is to generate knowledge useful to the whole community, and that this inevitably entails putting subjects at risk, through placebo treatment or use of untested therapies. However, as I’ve said, there has to be a sufficient justification of this risk in terms of the likely benefit of the novel therapy or the knowledge gained. In the case of homeopathy and energy medicine, I believe no real knowledge is gained, no benefit is likely, and negative studies do not alter the clinical practices of those who believe in these methods despite, not because of the scientific evidence. So the risk to subjects is not balanced by any real gain.”

  16. v.t. says:

    Q’s – everyone knows homeopathy doesn’t work, it is beyond time it is discarded, for good. Why don’t the VINer’s know this? Did they all miss the memo?

    When is it ever ethical to subject veterinary patients to clinical trials involving homeopathy, reiki, energy therapy, and so many more “alternatives” when informed consent is not possible, when the owners (who do or do not consent) are likewise being deceived?

    Ok, so take away the veterinary from patients, and you have lab rats (for the purpose of clinical studies). What’s the difference? Why is the absence of informed consent from animals never an ethical issue in these discussions?

    I can’t believe you were accused of playing god. But glad to see you set them straight.

  17. Art says:

    “I am for flexibility of discourse and think everybody has a right to be a numbskull and I am for deliberately outlined investigative research yet one all the more crudely done homeopathy study isn’t going to help anybody with the exception of the individuals who need to keep on discovering reasons to do it.”

    The computer translation above of the one vet on vin that supported brennen’s position seems to be spot on. Maybe the problem with computer paraphrase is the computer has trouble telling personal attacks from scientific discourse.

  18. skeptvet says:

    The latest comment suggested that the discussion of these issues was largely pointless, since no practical mechanism for preventing such trials was likely to be developed, and that it merely provides ammunition for advocates of these therapies to imply that those of us who raise such concerns are part of a conspiracy to suppress their work. My response:

    “I never suggested that the point of this discussion was to establish a practical mechanism to prohibit specific trials.

    The point was to raise awareness of the issues and have a discussion as a community about them. Presumably, some of us learn something or think about things they might not have given much thought to in the past, or at least get exposed to a variety of perspectives to consider. Occasionally, opinions do change as the result of discussion, though more as a gradual process over time, not as the result of a single “aha!” moment during a discussion or debate. I have certainly changed many of my views on many subjects over time as a result of discussions with others.

    I think you may also underestimate the value of airing these issues to decision-making even when people with strong opinions don’t change their minds. Many alternative therapies have become more widely accepted and employed despite the lack good evidence for them, and this is partially a result of increasing familiarity and the persistent advocacy of supporters. Ideas become more acceptable the more one comes to believe other people in the profession accept them. If nobody raises any concerns or objections, the presumption, especially among students and younger/newer vets, may well be that there are no concerns or objections.

    There was a great study on social conformity done in the late 1950s that illustrated this. People would consistently select what the knew was a wrong answer to simple discrimination tasks when all the others around them gave that answer. But if only one person dissented from the group, the subject felt free to make an honest choice. The refusal of people to openly discuss the scientific and ethical problems with approaches like homeopathy supports the perception that they are legitimate and acceptable. Openly discussing these allows people more freedom to make up their own minds and express their own opinions.

    Now in terms of practical steps to discourage research into highly implausible or already disproven therapies, I agree that is a seemingly insurmountable challenge. The ethical standards and regulations applied to human research are far more stringent that that applied to veterinary studies, for economic and political reasons, so we frequently get away with virtually anything in practice and in research. From a roughly libertarian perspective, this may be a good thing, but that isn’t my perspective. I think stronger scientific and ethical standards for veterinary trials would improve the quality of the evidence generated and better protect patients. Sure, it is possible to create controls that are too stringent and limit innovation, but we are so far towards the more permissive end of the spectrum right now, that doesn’t concern me at this point. Nevertheless, I agree mandatory standards are not a realistic option in the current climate.

    But doesn’t that make it even more critical to have these discussions so we can make decisions as individuals based on a thorough consideration of all the issues? Many of these studies are going to be done purely because the AHVMF has been successful at raising huge amounts of money for them, and this money is being offered to veterinary schools to conduct studies or establish educational programs which seem very likely to me to be more about marketing and propaganda than about genuine scientific discovery. It is difficult to turn down such funding, So for those of us who see this as problematic, the only course of action is to raise these issues, make our case, and hope that at least some of our colleagues come to share our views about the best way to utilize our limited resources and generate the most useful knowledge in ethically acceptable ways. Advocacy has worked well for supporters of such therapies, so it seems strange to suggest it is pointless or hopeless for supporters of more science-based approaches. “

  19. Art Malernee Dvm says:

    I find it interesting that one of the two vets making the majority of the pro homeopathic vin comments teaches at the vet school at Tennessee.
    See
    The Veterinary School at the University of Tennessee recently received a $10,000 grant from the American Holistic Veterinary Medical Foundation to support “integrative medicine.” The faculty member who runs the Integrative Medicine Center at UT has written a blog post for the AHVMF which illustrates very clearly the goals of this effort.

    These goals do not appear to be focused on supporting research to identify which CAVM therapies are actually effective. They appear to be more about pursuing a marketing strategy for bringing CAVM therapies into acceptance within the mainstream by making them more familiar, part of the veterinary curriculum, and something that everyone can see works “with their own eyes,” despite the absence of controlled research support or the existence of negative research data. This is pure proselytizing rather than research.

  20. Art Malernee Dvm says:

    The other veterinarian who made the god comment owns vin.com. A online newsgroup for vets that sells homeopathic CE that I’m proud to say RACE would not approve.
    See
    http://news.vin.com/VINNews.aspx?articleId=19536

  21. Beccy Higman says:

    Thanks again for doing this, I guess you must get frustrated, tired of repeating the same arguments and facts, so those of us who agree and who benefit from your work should just say thanks every now and then!

  22. v.t. says:

    Art, somehow I’m not surprised at whom made the comment. Perhaps the wrong people are moderating VIN.

  23. Art says:

    I think a computer could do a better job moderating but we would loose a lot of good joke about how it’s done now.
    See
    http://skeptvet.com/Blog/2012/02/funny-for-some-of-you/

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