Respectful Insolence

It’s probably an understatement to say that I’ve been critical of the National Center for Complementary and Alternative Medicine (NCCAM). Indeed, I consider it not only to be a boondoggle that wastes the taxpayers’ money funding pseudoscience, but a key promoter of quackery. Worse, its promotion of highly implausible (one might even say magical) modalities gives these modalities a patina of scientific respectability that they do not deserve, especially given that, even under the most favorable conditions possible, they routinely fail to demonstrate any efficacy above and beyond that of a placebo control. Indeed, as I’ve emphasized time and time again, often such therapies appear to show efficacy in smaller pilot studies, which are not as rigorously controlled, but fail to show any efficacy above that of a placebo in larger, better-designed randomized trials. Indeed, acupuncture is the prototypical example, as is homeopathy.

An article from Monday in the Washington Post leads me to believe that the mainstream media may finally be catching on. It isn’t perfect, but it’s better than any straight reporting I’ve seen on the issue in a long time:

The impending national discussion about broadening access to health care, improving medical practice and saving money is giving a group of scientists an opening to make a once-unthinkable proposal: Shut down the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

The notion that the world’s best-known medical research agency sponsors studies of homeopathy, acupuncture, therapeutic touch and herbal medicine has always rankled many scientists. That the idea for its creation 17 years ago came from a U.S. senator newly converted to alternative medicine’s promise didn’t help.

Although NCCAM has a comparatively minuscule budget and although it is a “center” rather than an “institute,” making it officially second-class in the NIH pantheon, the principle is what mattered. But as NIH’s budget has flattened in recent years, better use for NCCAM’s money has also become an issue.

It’s rare to find an article in a mainstream news source begin with such a blunt statement of what we critics have been saying about NCCAM for years. Dr. Wally Sampson, for instance, is as far as I know the first who openly called for the defunding of NCCAM, and he did this back in 2002. These calls have recently gained new force given how CAM advocates are currently trying very hard to tie the legitimization of CAM to whatever health care reform legislation President Obama tries to get through the Congress, camouflaging it under the cloak of legitimate treatment modalities such as “diet and exercise,” “health maintenance,” and “prevention.”

The reporter of this story (David Brown) in a pleasant surprise, appears to have understood most of the issues involved. He quoted Steven Salzberg, a genome researcher and computational biologist at the University of Maryland, who started the infamous (in a good way) “defund NCCAM” initiative before President Obama ever took office using the Obama Transition Team’s Change.gov website. He quoted Steve Novella:

Critics of alternative medicine say the vast majority of studies of homeopathy, acupuncture, therapeutic touch and other treatments based on unconventional understandings of physiology and disease have shown little or no effect. Further, they argue that the field’s more-plausible interventions — such as diet, relaxation, yoga and botanical remedies — can be studied just as well in other parts of NIH, where they would need to compete head-to-head with conventional research projects.

The critics say that alternative medicine (also known as “complementary” and “integrative” medicine, and disparagingly labeled “woo” by opponents) doesn’t need or deserve its own home at NIH.

Which is the point that I’ve been making all along. The NIH funded studies of diet and exercise as means of maintaining health and preventing disease perfectly well long before NCCAM was a misbegotten dream in Tom Harkin’s fevered little mind. It could do so again. Herbal medicines, another of the more plausible treatments from the grab bag of unrelated and mostly implausible remedies that make up CAM (or, as it’s being called more recently, “integrative medicine”) are a similar case. The study of natural products is nothing more than the time-honored subdiscipline of pharmacology known as pharmacognosy. Indeed, it was through the study of natural products that a large percentage of our currently used drugs were discovered (aspirin, taxol, and numerous others), and there is no reason to think that such studies could not be funded just as well by other Institutes and Centers within the NIH. After all, that’s how it was before the misbegotten Center of Woo known as NCCAM came into being. Indeed, pharmacognosy would arguably be strengthened because pharmacognosy would no longer be tainted by its association with all the woo that goes along with CAM. Truly, NCCAM is a victim of its own history, and one of the major complaints I have against it is that, by lumping together the plausible (diet, lifestyle, exercise, herbal medicines) with the implausible (energy healing, homeopathy), from a scientific standpoint it taints the plausible modalities with the brush of woo.

Unfortunately, all is not sweetness and light, as Mr. Brown succumbed to two instances of the journalistic “balance” of the kind that drives me crazy. As much as I’d like to give him a pass on a little bit of the old Respectful Insolence, I can’t. You wouldn’t respect me anymore if I didn’t. Here’s number one:

At the same time, it’s difficult to determine the clinical implications of some of the positive studies.

For example, reiki — but not sham treatment — blunted the rise in heart rate, but not the rise in blood pressure, in rats put under stress by loud noise. Therapeutic touch, a different modality, increased the growth of normal bone cells in culture dishes, but decreased the growth of bone cancer cells.

I’ve dealt with the infamous “reiki for rats” and “therapeutic touch for bone cancer” studies before. Suffice it to say that neither study represented “positive” studies of energy healing.

Then, true to the usual tenets of journalism, Mr. Brown couldn’t resist bringing in the naturopath:

Although the overall effect of therapies such as homeopathy and acupuncture may be small, individual response can be large. The route to the placebo effect — if that’s what it mostly is — also varies in method and efficiency.

“What can be done to generate a better placebo? Why isn’t that an interesting and valid area of investigation?” said Calabrese, who was on NCCAM’s advisory council from 2004 to 2007. “Here we have a totally harmless intervention that seems to get a better result in some people than others. Why wouldn’t you want to study that?”

This is an astounding quote, so astounding that the fact that Mr. Brown got Calabrese to admit this very basic fact about CAM greatly blunts my disappointment that he was forced by journalistic convention to quote “the other side.” Consider: Calabrese just flat out admits that CAM therapy is placebo therapy! Of course the placebo effect is a very interesting physiological phenomenon. It’s very complex, and it’s true that it is variable, but it’s not as variable as Calabrese makes it sound. More importantly, though, there is a serious ethical dilemma in trying to maximize placebo therapy effects due to CAM.

It requires in essence lying to the patient through representing ineffective therapies to the patient as something they are not, namely effective.

Which brings me to something that disappointed me greatly, namely fellow ScienceBlogger Janet Stemwedel’s take on the whole NCCAM issue. Unfortunately, her discussion of NCCAM, sparked by a post by blog bud PalMD, reveals her unfamiliarity with the issues involved. Then she had to compound the problem by posting a followup listing various studies funded by NCCAM. I don’t want to be too hard on her, but unfortunately she did lay down at least one real howler.

After making a point that I entirely agree with, namely that the ethics of human studies are paramount in not just human studies in general but in human studies in CAM, unfortunately Janet went off the rails a bit. That she relied primarily on what is on the NCCAM website to make her point shows that she lacks a deeper understanding of background history of NCCAM, a history that one will not find anywhere on the NCCAM website; it is always perilous to rely solely on a website that is there to put NCCAM’s best foot forward. One wonders if Janet would rely on the website of, say, Merck or Pfizer as her sole source of information regarding the influence of the pharmaceutical industry. On the one hand, it’s hard to blame Janet too much for that, given that she has apparently only recently examined the issue, but her relying pretty much solely on the propaganda on the NCCAM website (and what is on government websites but propaganda designed to make the government agency for which the website was designed look as good as possible?) reveals a failure of skepticism on this issue, which is why I generously suggest that she search “NCCAM” on my blog and on Science-Based Medicine for a taste of what she’s missing, including the $30 million boondoggle of an unethical trial known as the TACT trial of chelation therapy. In essence, Janet either misunderstands or mischaracterizes the concept of prior plausibility in wondering why it’s not a good idea to study many of the magical therapies that fall under the CAM rubric:

Going forward with a clinical trial that we have good reason to think would be harmful to the human subjects crosses the line ethically. I think there’s also a feeling that plausibility ought to play a role in the evaluation of whether a clinical trial is ethical. Plausibility is tricky – it’s a question about whether a particular kind of intervention could possibly be effective given the current state of our understanding (of human biology, of this sort of intervention, etc.). Clearly, the current state of our understanding is incomplete and subject to revision; this is why scientists are still involved in conducting research.

Does “X could plausibly treat condition A” mean that there must be some clear mechanism by which X might act to cure or improve condition A? There have been compounds whose efficacy was widely accepted before we had anything like a detailed understanding of the mechanisms by which they worked (think aspirin). Does “X could plausibly treat condition A” mean that there already exists a body of empirical data demonstrating its efficacy? If this were the standard, no compound that wasn’t already being used by a significant number of people could ever make it to clinical trials.

That is not what critics of NCCAM mean when they criticize studies of implausible remedies based on a lack prior plausibility. Really, it’s not. It’s a straw man argument to say that what critics of CAM are arguing is that we have to have a detailed understanding of the mechanisms by which a drug works before we have sufficient prior plausibility to justify a trial. The example of aspirin is, in fact, not a good one to argue this point. The reason, of course, is that, although scientists may not have necessarily known exactly how aspirin works, whatever its mechanism may be was (and is) entirely consistent with our scientific understanding that aspirin is a molecule that must be able to interact with proteins in cells in some way in order to produce the effect that it does. Scientists may not have known the details, but those could be worked out and there was no reason to suspect that they involved head-on collisions with what we understand of science. Such is not true with many CAM modalities, such as “energy healing techniques,” that postulate the existence of not just a “life energy” (qi) that no scientist has ever been able to detect and that, based on the characteristics attributed to it would require the overthrow of many fundamental principles of our current understanding of physics, but also of the ability of human “healers” to manipulate that undetectable energy for healing effect. Another problem is that scientists definitely knew that aspirin had an effect over and above that of a placebo–strongly so. Consequently, even if they didn’t know how it worked, they did know that it did work. No such statement can credibly be made of most CAM therapies, whose effects, even when reported, struggle to rise above random noise (another reason why for most the evidence is most consistent with placebo effect). So not only does the vast majority of CAM other than diet/exercise and herbal remedies consist of highly implausible treatments, but these treatments have no compelling evidence for their efficacy. Finally, as John Ioannidis showed, combining low prior probability with weak effects is a recipe for numerous false positive trials.

Janet also makes an observation that she doesn’t quite attach the correct conclusion to:

It’s worth noting, though, that at least some of the “alternative” treatments that turn up in NCCAM studies involve stuff a good number of people do everyday that they might not consider a medical treatment – drinking cranberry juice or herb tea, eating tofu, getting a massage, meditating, doing yoga. At least from my vantage point in the land of veggie restaurants and yoga studios, I don’t imagine that these “alternative treatments” are feared to be harmful in themselves. Rather, they are probably viewed as “risky” to the extent that they may replace medical interventions that are well-grounded in empirical evidence – or to the extent that funding to study them in clinical trials might waste funds that would be better directed to studying interventions judged more likely to be effective.

Yes! That’s exactly what CAM promoters want you to think! They want you to link CAM with all sorts of activities that are not inherently “alternative, such as diet and exercise. As I’ve said many times before, such activities are the Trojan horse, within which CAM advocates hide all the real woo, like homeopathy, reiki, and even shamanistic healing practices. Worse, in the case of NCCAM, studies of highly improbable therapies, such as chelation therapy for cardiovascular disease and the Gonzalez protocol for pancreatic cancer, end up with no publications providing guidance for physicians or patients. Indeed, in the case of the Gonzalez protocol, arguably negative results have been suppressed.

Unfortunately, Janet compounds her mistake in her second post, where she in essence lists a bunch of trials from NCCAM and then concludes:

To my eye, some of these trials have studied pretty improbable treatments (like distant healing). However, if these treatments are the kind of things actual patients are seeking out and using, I have to believe that they don’t seem improbable to everyone.

It hurt me to read that last sentence. My simple retort is that ghosts, alien abduction, and various other forms of paranormal phenomena seem very plausible to someone. Bigfoot seems plausible to someone, as does the Loch Ness Monster. That some credulous person finds an idea plausible is not a reason to assign the idea sufficient plausibility to spend millions of dollars investigating it! Quite frankly, I don’t give a rodent’s hindquarters if some woo or other is plausible to “someone.” I care only whether it’s scientifically plausible, and, for instance, when it comes to distant healing under current scientific understanding there is no plausibility. I concede that there will be gray areas in this argument, in which reasonable people can disagree with whether an idea is scientifically plausible or not, but, by and large, for “energy healing” modalities, homeopathy, and most other CAM modalities other than diet/exercise/herbal remedies, it ain’t even close.

After that, Janet gets more reasonable:

This raises an ethical conundrum. If people who think treatment X is plausible are faced with results from a carefully designed and conducted clinical trial, will they revise their view of whether X is a plausible treatment? Would such a revision be a big enough benefit to justify conducting what seems at the outset to be a pretty implausible clinical trial? And, in the absence of such concrete scientific findings, what options do you have to convince the X-seeker about the implausibility of X as a treatment?

What Janet does not understand is that this issue goes deeper than that. It is, quite literally, a clash between two opposite world views over the very rules that will determine the scientific method. Science-based medicine emphasizes repeatable, observable phenomena and testing new therapies yielded by scientific investigation on patients in carefully controlled, blinded, randomized trials. There may be weaknesses in this approach, the main one of which is applying population-level data to individuals (which can be sometimes tricky indeed), but these shortcomings pale in comparison to the difficulties posed by the methodology CAM advocates, namely anecdote-based studies, where personal experience trumps science.

Unfortunately, the two world views are completely incompatible, and the reason NCCAM is failing is because of this incompatibility. I’ll give Janet an example that is relevant. There are numerous–and I do mean numerous–studies that have failed to find even a whiff of a correlation between vaccination and autism. Yet Jenny McCarthy is still out there pushing the myth. Generation Rescue is still out there raising money for “biomedical research” (i.e., quackery) to treat “vaccine injury.” The DAN! doctors are still out there selling quackery in the form of chelation therapy, supplements, diets, and many other dubious therapies. Thousands upon thousands of parents are still terrified of vaccinating, and Age of Autism continues to defend Andrew Wakefield, author of the MMR scare in the U.K. a decade ago, against well-documented charges of undisclosed conflicts of interest and falsifying data. Nothing has changed.

Just like CAM.

There are numerous studies that have failed to find an effect for homeopathy, acupuncture, reiki, and numerous other modalities greater than that of placebo. Yet homeopathy thrives, and reiki is invading my old hospital. That’s because data don’t matter to CAM believers. Heck, there are even still people out there going to Mexico for laetrile, even though randomized clinical trials in the 1980s showed that it doesn’t work.

Data don’t matter to true believers.

That’s not to say that we should never study this stuff. It does mean that in the case of the truly implausible therapies, such as homeopathy, distant healing, or various other “energy healing” modalities, we can safely dismiss them on the basis of current scientific knowledge alone, as accepting them would require a rewriting of our physics and chemistry textbooks. In the absence of truly compelling evidence that makes us doubt our current understanding of physics and chemistry at a truly fundamental level, there is no more reason to consider them than there is to consider whether fairies exist. Show me a fairy, and I’ll reconsider my opinion on their existence. Until, then, I can safely conclude that they do not exist. In the case of modalities like homeopathy or acupuncture, combining prior knowledge alone plus the clinical trials that have been done thus far would provide sufficient evidence to reject them as having any efficacy above that of a placebo, although the clinical trials that have already been done are merely icing on the cake of an argument from lack of prior plausibility.

In fact, according to the Helsinki Declaration, it is unethical to study such wildly implausible therapies, which fail to meet this requirement for human subjects research:

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

(Emphasis mine.)

Testing modalities that go against very well-established tenets of science–indeed, very basic, well-founded scientific theories–without extraordinary evidence supporting such modalities, evidence sufficient to call the scientific theories that preclude these modalities into doubt, is unethical. Moreover, many–if not most–of these modalities have not been adequately tested in preclinical models to show the possibility of efficacy, the “reiki for rats” and “therapeutic touch for bone cancer” studies notwithstanding. For example, in a proposed clinical trial of chelation therapy for autism, the study in essence proposed to skip any cell culture and animal research altogether and go straight for a human trial, which is profoundly unethical.

Whatever good NCCAM might have been capable of, it’s long gone. Woo-friendly legislators like Tom Harkin are displeased with it because it doesn’t deliver up the positive results supporting CAM that they want. It’s embedded itself into the very fabric of medical education by funding “educational” and “training” fellowships in CAM, truly a case of putting the heart before the horse. Moreover, there is nothing that NCCAM does that couldn’t be done as well or better either in or funded by the other existing Centers and Institutes of the NIH, and the things that it does do better are things that shouldn’t be done at all on an ethical basis. After all, it’s not ethical to promote a therapy before it’s been proven safe and effective, but that’s exactly what NCCAM does through its funding of CAM fellowship training programs.

It’s time for the abomination that is NCCAM to be buried once and for all.

Comments

  1. #1 Mu
    March 18, 2009

    Just refocus the NCCAM as NCCM – funding studies into complimentary approaches like diet and exercise, with yoga and meditation to placate the alternative crowd. Then we rename it to NCHMP (health maintenance and prevention) and get actually useful data from it.

  2. #2 Karl Schwartz
    March 18, 2009

    Thanks, Orac.

    Sad too that false hope promotions distract proactive patients from evaluating (with expert help) promising investigational agents and protocols, which target disease pathways, which will lead to better treatments in future.

  3. #3 TimK
    March 18, 2009

    I wonder if misunderstanding of “prior plausibility” could be similar to the “just a theory” problem. When Orac says, “Homeopathy is implausible”, he does not simply mean “Homeopathy is unlikely to work.” Of course it would be inappropriately conservative to restrict inquiry only to interventions likely to work. Rather I think what Orac means by “Homeopathy is implausible” is “Homeopathy working is inconceivable (given current scientific consensus about how the universe works)!”

    Let’s allow basic researchers to freely ask inconceivable questions—that’s the stuff of potential Nobel prizes—so long as they can convince fellow scientists that their work is rigorous enough to justify funding and publishing. But surely it is unethical to test inconceivably likely interventions on humans suffering from treatable disease. At the very least, it is a shameful use of taxpayers’ money.

  4. #4 Mu
    March 18, 2009

    I’m not sure the word means what you think it means

    sorry, showing my age group here

  5. #5 Lee
    March 18, 2009

    I took a look at the NCCAM website today (http://nccam.nih.gov/) and found that it is the only place where one can hope to find an unbiased evaluation of alternative remedies — whether there have been scientific studies conducted to prove or disprove the efficacy of alternative remedies or of herbs, whether there are studies currently being conducted, advisories, etc.

    Seems like whomever is running NCCAM is pretty careful to cast a skeptical eye on alternative therapies.

    Don’t you think there’s a need for such a clearinghouse, especially as 30-40% of adults in the USA use at least some form of alternative therapy?

    And what if we’re wrong? What if something we think is bs really does work — how would we know this without testing it?

  6. #6 David
    March 18, 2009

    a good post, and I generally agree that NCCAM is a shame and a waste of money. On one point, I disagree.

    “Medical research involving human subjects must conform to generally accepted scientific principles” – I interpret this to mean that research should be conducted according to scientific principles. If a quack treatment is in widespread use, it creates a potential public health risk. In that circumstance, although the treatment may have no credible basis, the research would be justified.

    My problem with NCCAM isn’t just that it funds second-rate research, but that the results are sometimes not published and the institute does little to disseminate negative results. I wouldn’t mind spending the money on NCCAM if it had the effect of eliminating sham treatments as well as validating those that work.

  7. #7 BB
    March 18, 2009

    Lee: please reread Orac’s post. NCCAM funds studies that fly in the face of physics (reiki) and chemistry (homeopathy). You would also benefit from reading the posts by David Kroll (http://www.sciencebasedmedicine.org/?page_id=231); he explains in even greater detail what is worthy of study (but rolled into other NIH divisions) and what is tax-payer-funded quackery.
    I’d rather not waste what little money I have. Maybe you have dough to flush. In that case, may I interest you in a little scheme…..

  8. #8 D. C. Sessions
    March 18, 2009

    we can safely dismiss them on the basis of current scientific knowledge alone, as accepting them would require a rewriting of our physics and chemistry textbooks

    I worry less for the textbook publishers than you do, and am mindful of the fact that textbook authors would actually benefit.

    On the other hand, what are we to do with all of those very useful calculations used in industry? Homeopathy, for instance, directly contradicts the fundamentals of the semiconductor industry: if the Law of Infinitesimals is correct, the computer you’re using cannot possibly work — because it depends on very precise effects of extreme dilution.

    NB: Please note that Dr. Stemwedel holds a PhD in chemistry as well as her qualifications in philosophy. She does, manifestly, know how to reason quantitatively even if that ability is not in evidence on the present topic.

  9. #9 Lee
    March 18, 2009

    we can safely dismiss them on the basis of current scientific knowledge alone, as accepting them would require a rewriting of our physics and chemistry textbooks

    Like we don’t already revise them frequently, along with all the other science textbooks? If not, then something more than funding research on reiki is a problem.

    Re: homeopathy — I read this article not too long ago – “When a little poison is good for you” — while it’s not homeopathy, it suggests maybe we just don’t know all there is to know yet about low doses vs. high doses of anything. And about other things that couldn’t possibly be true based on our current state of knowledge at the time we declare something bunk or not bunk.

    Maybe it’s a good thing to have an agency charged with being the official government debunker of record (or validator of record). As long as the scientific method is sound.

    What is the NCCAM budget, anyway, and what percentage of that is it of overall NIH funding? And how do you battle woo without being able to prove it’s woo?

  10. #10 Orac
    March 18, 2009

    Like we don’t already revise them frequently, along with all the other science textbooks? If not, then something more than funding research on reiki is a problem.

    Actually, when it comes to the fundamental scientific principles that, for example, homeopathy violates, we don’t “rewrite the textbooks” that often.

    For a fundamental tenet of science to be overthrown and replaced, two things must happen. First, there must be compelling evidence that there is a defect in the theory–evidence at least as compelling as the evidence supporting the theory. Then, the new theory must explain these anomalies and still explain all the previous observations that led up to the old theory. Think Einstein’s theory of relativity, which at speeds very small in comparison to the speed of light reduces to Newton’s laws of motion, which, it turns out, are simply good approximations of relativistic motion for low velocities.

    There is no such compelling evidence for homeopathy, reiki, or any of the other woo out there that would compel scientists to rethink the fundamental laws and theories of science as we understand them now. If homeopaths and reiki healers can produce sufficient compelling evidence, then it might be worth considering. They haven’t. They don’t. And it’s highly likely that they won’t.

    In the meantime, the more plausible of therapies claimed by CAM (exercise, diet, herbal medicines) can easily be studied via the Institutes and Centers of the NIH that existed before NCCAM. The implausible ones we shouldn’t waste our money on until someone can provide evidence compelling enough that the laws of physics as currently understood are seriously wrong about, for example, the existence of qi, how it might be manipulated, or perhaps about the “memory” of water.

  11. #11 Aaron
    March 18, 2009

    I was talking with a co-worker recently, more on the point of his personal habit of taking herbal remedies.

    His main point was that all the research goes into treatments that drug companies plan to use and legitimately effective herbal remedies aren’t studied.

    I suspect there’s a sizable portion of the population who has a like mindset, who is susceptible to woo on the grounds that they don’t think it’s been studied adequately.

    I think it might be worthwhile to have an agency like the NCCAM that does high quality studies of things like physic healing and homeopathy. Then they can have a big press release, “we’ve done a huge study and homeopathy does nothing” and it bounces around the press for a while. Of course its obvious to all in the know that homeopathy is bunk but the public isn’t in the know. Don’t think of it as science but with a big public education campaign.

  12. #13 Dr Benway
    March 18, 2009

    Oops, try again:

    Dr Camwoo’s Grant Renewal

  13. #14 Chris
    March 18, 2009

    Here you go Dr. Benway:
    http://tuftedtitmouse.blogspot.com/2009/03/dr-camwoos-grant-renewal.html

    Anyway, is foie gras worth the price in dollars, and in fat calories?

    Though, in reality no goose may have been sacrificed to make any oscillococcinum (or maybe it was one several years ago!).

  14. #15 daedalus2u
    March 18, 2009

    You are not going to come up with a better placebo by trying random stuff and seeing which works better, you are only going to come up with a better placebo by understanding the physiology behind the placebo effect. If there is such a thing as the “placebo effect”, there must be physiology that causes it. Figure out what that physiology is and then figure out how to trigger it.

    The “best placebo” would result from the pharmacological triggering of the pathways that mediate the placebo effect. If that “best placebo” could be found, the Declaration of Helsinki would require that when a placebo is used in a treatment trial, that the “best placebo” be used. If there were a method to pharmacologically trigger the placebo effect that would be more effective than any placebo actions such as therapeutic touch or acupuncture. It would be better than an inert placebo such as homeopathy.

    My understanding (and it is not my original idea) is that the placebo effect is caused by the neurogenic production of NO, which switches physiology from the “fight or flight” state to the “rest and relaxation” state. Those two states are not simple; they each entail many thousands of physiological pathways working in sync and which we mostly do not understand. There can be much overlap and idiosyncratic differences depending on the “details”. Essentially under conditions of “fight or flight” ATP resources are held in reserve and diverted to immediate consumption for life-critical needs such as “running from a bear”. Long term needs, such as healing do not have the time urgency as does escape from a bear. The organism that can shut down healing and divert the ATP that would have been used for healing to escape will escape from more bears than will the organism that can’t. The ability to time-optimize ATP production and consumption reduces the metabolic overhead of ATP production and allows more resources to be allocated to reproduction.

    http://daedalus2u.blogspot.com/2007/04/placebo-and-nocebo-effects.html

    The diversion of ATP and other metabolic resources away from healing is an explanation of why “stress” impairs health and delays recovery from sickness and injury. With this perspective, a placebo is simply the triggering of the neurogenic “standing down” from the fight or flight state, where resources are re-allocated back to healing after being held at the ready for “running from a bear”.

    With this understanding of the placebo effect, the effect is only about the physiology of the person receiving the treatment. When ATP and metabolic resources are maximally allocated to healing, there is nothing more that physiology can do to speed healing. The placebo effect should “saturate”, that is it should be possible to maximally invoke the placebo effect after which, no placebo will have any effect because physiology is already maximally allocated to healing.

    I think that my NO producing bacteria will pharmacologically trigger the placebo effect. If you have nothing wrong with you, they won’t have any effect. If you are in any kind of “fight or flight” state, the NO they produce will add to neurogenic NO and help you switch more to a “rest and relaxation” state and allocate resources to healing. If you can maximally trigger the “rest and relaxation” state and maximally allocate resources to healing, there is nothing than any additional placebo can do.

    If there was a pharmacological placebo effect, the Declaration of Helsinki would require it to be used in all placebo controlled trials (as the best available placebo). Against a maximally effective placebo effect, the placebos that are CAM would be less effective and would fail.

  15. #16 jesmith
    March 19, 2009

    who’s an angry boy then? – I could recommend some herbs

  16. #17 Tracy W
    March 19, 2009

    Lee – And what if we’re wrong? What if something we think is bs really does work — how would we know this without testing it?

    There are cheaper ways of testing than conducting multiple medical trials. Say that there is a form of “life energy”, not known to physicists. If it exists it can be studied in a lab to work out how it is detected and how it interacts with other objects.
    There’s no need to go immediately to medical trials, and what’s more, knowing what we do of past scientific discoveries, it probably would be very dangerous to do so. For example, radiation energy is terribly dangerous, it killed Marie Curie, and its effects can take a long time to emerge. If there really is a “life energy” who knows what long-term damage it could be doing?

    Or the effect of energy on matter can be complicated by the properties of that matter, for example strong low-frequency electromagnetic fields are dangerous to humans indirectly because the fields have a strong effect on conductors, and thus can send metal objects flying across a room and hitting anyone who is in the way. What effects could a possible “life energy” have that are like that?

    If “energy healers” do honestly believe that they might be on to something, they are in fact behaving incredibly unethically by experimenting on humans without a proper understanding of the energy they are working with. I’m amazed that they get so many people to sign up for it.

    Note, I have no general objections to conventional medicine’s use of energy healing, for example the use of heat energy to warm hypothermia victims, or nutritionists using chemical energy to improve their patient’s welfare, food and heat have been studied for a long time, I am only talking here about healers who claim to be using some mysterious different form of energy.

  17. #18 BB
    March 19, 2009

    @Lee: SERIOUSLY? You compare a biphasic response to homeopathy? Did you read the article you linked?
    Which one do you need explained to you, what a biphasic response is, or that dilutions of stuff beyond the level of Avogadro’s number means that not a molecule is left in solvent?

  18. #19 daedalus2u
    March 19, 2009

    Be careful, foie gras has a lot of amyloid in it. There are some indications that amyloid has properties similar to prions and ingesting amyloid might not be the best course of action.

    http://www.pnas.org/cgi/content/abstract/104/26/10998

  19. #20 Joe
    March 19, 2009

    Posted by: Lee | March 18, 2009 2:37 PM:
    “I took a look at the NCCAM website today (http://nccam.nih.gov/) and found that it is the only place where one can hope to find an unbiased evaluation of alternative remedies –”

    What you mistake for an unbiased evaluation is actually biased promotion of nonsense, and that is bad. Bias may be a concern when discussing social issues; but, in science, we can discover facts that trump opinions. Such is the case with CAM. It is a fact that homeopathy is phony and any suggestion to the contrary comes from ignorance, not an “open mind.”

    Moreover, bias is not always bad. Would you complain that a social worker is biased against child abuse? I hope not.

    Bias against CAM is rational. Proponents take a lot of money in exchange for fairy dust (theft by fraud). They also interfere with real medical interventions. That can have repercussions, including death.

  20. #21 Lee
    March 19, 2009

    Your responses to my comments/questions demonstrate why large numbers of the lay public distrust doctors and scientists in general — rather than explaining what you mean, you sling your jargon (which can sound like a lot of woo to those of us not specializing in your particular slice of science or medicine) or post arrogant tsk tsks.

    There are plenty of people not convinced that doctors and scientists are the geniuses you think you are — in the case of physicians, there are too many cases where they don’t know what the hell they are talking about or don’t have a clue as to what’s causing the problem or miss obvious indicators of a disease because they’re so enraptured with their gadgets they don’t even look at their patient (this is how a hot-shot cardiologist almost killed my husband) and all too often the end result is death.

    Then you get your scientists who fake data and kill people or cause them to suffer unnecessary pain or drugs sent to market after scientists have tested them that kill people or scientists who are too lazy or arrogant to learn how to present data properly and as a result kill people.

    Yes, these are rare occurrences — but these are the ones that get reported and thus remembered and thus lead to a general distrust of the medical establishment. If someone sees that the AMA or “doctors” or whomever the responsible authority was suppressed evidence that Drug A or Procedure B has a high mortality rate, why the hell wouldn’t they believe that the same authorities are suppressing evidence that Herb A or Healing Touch B are effective because of whatever reason (they’re cheap and no money can be made from it, or don’t need a gatekeeper to get at it, or whatever … )

    Because of this credibility problem, doctors and scientists should welcome an agency that scientifically proves or disproves that something is woo. With this supposedly impartial government agency conducting the studies, I suspect most people would accept the results without assuming there was a hidden agenda. And let’s face it — we live in a nation where more than 75% of the people believe in angels, so any tool you have that arms you in the battle against actual woo is one you should embrace.

    Suggested book to read: The Black Swan by Taleb. He has a lot to teach us about fallacies and he actually makes it enjoyable.

  21. #22 Lee
    March 19, 2009

    Your responses to my comments/questions demonstrate why large numbers of the lay public distrust doctors and scientists in general — rather than explaining what you mean, you sling your jargon (which can sound like a lot of woo to those of us not specializing in your particular slice of science or medicine) or post arrogant tsk tsks.

    There are plenty of people not convinced that doctors and scientists are the geniuses you think you are — in the case of physicians, there are too many cases where they don’t know what the hell they are talking about or don’t have a clue as to what’s causing the problem or miss obvious indicators of a disease because they’re so enraptured with their gadgets they don’t even look at their patient (this is how a hot-shot cardiologist almost killed my husband) and all too often the end result is death.

    Then you get your scientists who fake data and kill people or cause them to suffer unnecessary pain or drugs sent to market after scientists have tested them that kill people or scientists who are too lazy or arrogant to learn how to present data properly and as a result kill people.

    Yes, these are rare occurrences — but these are the ones that get reported and thus remembered and thus lead to a general distrust of the medical establishment. If someone sees that the AMA or “doctors” or whomever the responsible authority was suppressed evidence that Drug A or Procedure B has a high mortality rate, why the hell wouldn’t they believe that the same authorities are suppressing evidence that Herb A or Healing Touch B are effective because of whatever reason (they’re cheap and no money can be made from it, or don’t need a gatekeeper to get at it, or whatever … )

    Because of this credibility problem, doctors and scientists should welcome an agency that scientifically proves or disproves that something is woo. With this supposedly impartial government agency conducting the studies, I suspect most people would accept the results without assuming there was a hidden agenda. And let’s face it — we live in a nation where more than 75% of the people believe in angels, so any tool you have that arms you in the battle against actual woo is one you should embrace.

    Suggested book to read: The Black Swan by Taleb. He has a lot to teach us about fallacies and he actually makes it enjoyable.

  22. #23 David
    March 19, 2009

    a good post, and interesting discussion.

    I’d like to comment on one point, which is the meaning of the Declaration of Helsinki guidance on ethical research:

    “Medical research involving human subjects must conform to generally accepted scientific principles,…”

    In my view, this means that research should be conducted in a way that conforms to scientific principles. I don’t think this means it is “unethical to study such wildly implausible therapies.”

    If a quack therapy is in widespread use, there is a potential public health issue, requiring understanding of risks and outcomes. If subjects are recruited from those who would otherwise use the quack therapy, then randomizing patients to quack therapy or placebo could be justified.

    NCCAM could be a tool to improve public health, but it hasn’t lived up to that potential.

  23. #24 Orac
    March 19, 2009

    If a quack therapy is in widespread use, there is a potential public health issue, requiring understanding of risks and outcomes. If subjects are recruited from those who would otherwise use the quack therapy, then randomizing patients to quack therapy or placebo could be justified.

    That’s simply incorrect.

    Another principle of the Helsinki Declaration is that all patients in a study must receive at minimum the standard of care. It is not ethical to randomize patients to only a placebo or a quack therapy that the investigators have no reasonable expectation as being effective. The same principle is at work in the study of HIV in Third World countries, about which there was a discussion in the NEJM not that long ago. In essence, if a therapy is not available in a Third World country, it is no longer considered ethical for researchers to study treatments in that country that fall below the standard of care. It’s a similar principle with quack remedies or placebos. It’s not ethical for an investigator to randomize patients to such groups. It does not matter if the patient wouldn’t accept scientific medicine anyway and would prefer the quack remedy.

  24. #25 Prometheus
    March 19, 2009

    Lee comments:

    “Your responses to my comments/questions demonstrate why large numbers of the lay public distrust doctors and scientists in general — rather than explaining what you mean, you sling your jargon (which can sound like a lot of woo to those of us not specializing in your particular slice of science or medicine) or post arrogant tsk tsks.”

    Lee comes very close to answering his (or her) own question when he (she) says: “…your jargon (which can sound like a lot of woo to those of us not specializing in your particular slice of science or medicine)…”

    The point is that technical language – “jargon” if you like – isn’t meant to keep “outsiders” from understanding what we say. It is simply the most accurate way to describe what we mean – it limits the confusion that can result from using less precise terms. Thus, the layman’s “germs” can mean viruses, bacteria or even protozoal parasites – all very different and distinct organisms causing diseases that are distinct in their presentation and treatment.

    Ironically, it is the “alties” who truly use “jargon” – they dress up their magical thinking in science-sounding terminology as a way to hide the true nature of what they are doing.

    Lee is probably unaware – as are a surprising number of non-scientific people – that this pseudoscientific use of “jargon” is usually immediately detectable by someone who is trained and educated in the subject.

    It is like hearing someone claiming to be an “expert” on baseball talk about “goals” and “red cards” in a baseball game. To me, much of the “sciency” jabberwocky of the “alties” is as obvious as saying that the square root of orange is turquois.

    Lee goes on to say:

    “Because of this credibility problem, doctors and scientists should welcome an agency that scientifically proves or disproves that something is woo.”

    Ah, if it were only so. There are two problems: first, few reputable scientists want to waste time “proving” something (like homeopathy or “Energy Medicine”) that is inconsistent with what is known about biology, chemistry and physics. Secondly (and partly the result of the first), the studies funded by the NCCAM have been of poor quality and even those that “disproved” a “CAM” therapy have concluded that “more study is needed”.

    Lee continues:

    “With this supposedly impartial government agency conducting the studies, I suspect most people would accept the results without assuming there was a hidden agenda.”

    Clearly, Lee hasn’t been following this ‘blog for very long. Or reading the newspapers. The people who want to believe nonsense are rarely convinced by studies, especially those done by (or funded by – the NCCAM doesn’t “do” studies, it funds them) “the government”.

    If a study – no matter who does it or funds it – doesn’t show what the “believers” expect, then they see the results as more proof of a “massive govenment/Big Pharma/AMA conspiracy to hide the TRUTH”. It’s a hermetically sealed delusion – nothing gets in and nothing gets out.

    Prometheus.

  25. #26 Tracy W
    March 20, 2009

    If someone sees that the AMA or “doctors” or whomever the responsible authority was suppressed evidence that Drug A or Procedure B has a high mortality rate, why the hell wouldn’t they believe that the same authorities are suppressing evidence that Herb A or Healing Touch B are effective because of whatever reason

    What is puzzling is the large number of people who are never skeptical about Herb A or Healing Touch B. Scientists develop medicines that have dangerous side effects, okay, I can see how that develops a distrust of science, but why then do the same people not worry about the possible side-effects of Herb A or Healing Touch B?

    There certainly is ample evidence that people other than scientists and doctors lie.

    This is of a piece to me with how “health shops” can have shelves stocked with organic this and 100% natural that, along with shelves stocked with plastic bottles full of pills of decidedly unnatural looking supplements.

  26. #27 Kathryn
    March 21, 2009

    @Tracy W: “This is of a piece to me with how “health shops” can have shelves stocked with organic this and 100% natural that, along with shelves stocked with plastic bottles full of pills of decidedly unnatural looking supplements.”

    In fact, sometimes those supplements are effective because they contain undocumented NON-natural ingredients which carry their own risk of side effects and/or interactions. Here’s today’s example of a supplement being recalled for this:

    http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zencore

  27. #28 Skemono
    March 21, 2009

    Your responses to my comments/questions demonstrate why large numbers of the lay public distrust doctors and scientists in general

    They do?

  28. #29 Kimball Atwood
    March 21, 2009

    …rather than explaining what you mean, you sling your jargon…

    When the Science-Based Medicine blog began, I posted a series on homeopathy followed by a series on prior probability that explained, in detail and with as little technical language as could reasonably be used, the issue at hand. The series begins here:

    http://www.sciencebasedmedicine.org/?p=11

    For links to the rest, look here:

    http://www.sciencebasedmedicine.org/?author=6&paged=6

    ……………….

    If subjects are recruited from those who would otherwise use the quack therapy, then randomizing patients to quack therapy or placebo could be justified.

    Orac is correct: this scheme does not render the trial ethical. For a primer on human studies ethics applied to trials of implausible claims, look here:

    http://www.csicop.org/si/2003-09/alternative-medicine.html

  29. #30 Gaiamuse
    March 31, 2009

    Gentlemen, Gentlemen — you seem to totally ignore the evidence that many people FEEL better using alternative remedies, whereas they sometimes don’t when using allopathic remedies. If this is all placebo effect, they why are you not seriously studying placebos?

    Moreover, I am surprised that you rail against acupuncture as “useless.” Acupuncture has now been proven in several studies to be effective for certain kinds of pain and conditions, and not for others. Why are you ignoring those studies?

    If you would begin to focus on people as opposed to test results: get doctors to ask their patients how they are feeling — as opposed to concentrating on their blood studies — you might begin to understand what is going on.

    Allopathic remedies sometimes carry drastic side effects that feel– if they are not actually – worse than the disease (how many times have I heard the term “liver damage” in a contra-indication for a drug?) I have rarely heard of someone’s liver failing from a herb – if it had, it would be banner headlines.

    Moreover, holistic practitioners who recommend these protocols and treatments often treat their patients as “whole” beings — physical, emotional and mental — which helps their patients “heal” – which is what patients are looking for. Doctors are trained to ignore and indeed discard the other severe effects — emotional and effects that illness may have on their patients. And it makes people feel worse.

    Listen up! People are talking by using these remedies…and they have volumes to say — so don’t ignore it.

  30. #31 Chris
    March 31, 2009

    Gaiamuse said “Gentlemen, Gentlemen — you seem to totally ignore the evidence that many people FEEL better using alternative remedies, whereas they sometimes don’t when using allopathic remedies. If this is all placebo effect, they why are you not seriously studying placebos?”

    Um… are you seriously only addressing those people who have posted here with a Y-chromosome?

    Actually, silly person, placebos have been studied. Dan Ariely of Duke University published a study that showed more expensive placebos work better than cheaper placebos. He was very proud of the award he got for that paper:
    http://improbable.com/ig/winners/#ig2008 (his book was also a good read).

    And you continue to dig deeper with this: “Allopathic remedies sometimes carry drastic side effects that feel”

    First off, there is no such thing as “allopathic” remedies. There is medicine that works, and other stuff. Allopathy was a word made up by Samual Hahnemann to describe anything that was not homeopathy:
    http://skepdic.com/allopathy.html

    Digging deeper with “Doctors are trained to ignore and indeed discard the other severe effects — emotional and effects that illness may have on their patients. And it makes people feel worse.”

    You are just making stuff up without any evidence. Let me introduce you to the concept of the family practice doctor trying to work within the limits of insurance. Actually most good doctors do take in the “whole” person. A general practitioner will know the patient, and the type known as a “family doctor” also knows the whole family. I am at my limit of two URLs, but I suggest you bring up your concerns at the ScienceBasedMedicine blog. You will find real family doctors (Harriet Hall), specialists like Steven Novella and even a medical student (Tim Kreider).

    Actually, we have listened, and researched and actually read the pertinent literature. Something you seem to have neglected to do. For a first step you should read the book “Snake Oil Science” by R. Barker Bausell. It includes lots on acupuncture, and even a guide on how to chose an alternative health care provider. When you are done with that I suggest you also read “Trick or Treatment” by Ernst and Singh.

  31. #32 Gaiamuse
    March 31, 2009

    You could all be gentlemen and so could I — it was just a euphemism.

    Stop looking at studies and start talking to people — listen to real live humans and ask them why they take herbs, go to acupuncturists, visit holistic practitioners. Ask people you know. They will answer you. Are they all crazy? Stupid? Discarding anecdotal evidence is unwise in this case — since people are embracing alternative medicine in larger and larger numbers and there must be some reason for it. Are you interested in solving the problem? Or do you just want to prove me wrong?

    Hint: There are two sides of our brain. They seem to be about the same size, but many scientific researchers seem to allow only a left sided approach. And many people are dissatisfied with that approach. Do you think that the right side of your brain is a useless appendage for getting information and making decisions about our lives?

    Last, I didn’t insult you. I simply mentioned what I have observed in listening to people who are having problems with the traditional medical system. You replied with an attack and insulted me. Go ahead. Put down anybody who doesn’t agree with you. Well done, you may win and yet somehow you’ve alienated another human in the name of science. And there are growing numbers of those people every day. What a great success.

  32. #33 Chris
    April 1, 2009

    Gaiamuse said “You could all be gentlemen and so could I — it was just a euphemism.”

    Sexist idiot.

    Digging deeper continued with “Stop looking at studies and start talking to people — listen to real live humans and ask them why they take herbs, go to acupuncturists, visit holistic practitioners.”

    That is what the studies do, you idiot. The plural of anecdote is not data! Try to actually read the literature, or at a minimum the books I listed. Come back when you have some actual substance to contribute. Maybe those of us who lack the Y-chromosome will acknowledge your contributions if they had actual evidence. Until then, you are just idiotic noise.

  33. #34 Henry
    April 17, 2009

    Lee is basically a troll in disguise, so let me just make sevreal points clear:

    –All “new” scientific theoris must be altered to the point that can explain BOTH previous observations and new observations, and none of the alternative medicine under the current research has this kind of potential. For example, how the hell does body-spirit relationship cures anything? The current observation states that spirit does not exist at all, or at least has no effect on the objective level. There really isn’t no way to cooperate both sides in this case, so one must be completely wrong, and there is no reason for me to believe that the modern science can be defeated by a mere religious concept, and if you spend time on studying ANY alternative medicine, you will face the same dellima: You really cannot cooperate the theories behind ANY alternative medicine with the current scientic theories, and one side always has to be destoryed at the end, and there are many good reasons that modern science would be the winner.

    Remember, science is constanly revised, but a complete revolution cannot occur, because NO observation can contradict to each other. You cannot say qi exists, and does not exist at the same time, for example.

    –Rarely we fund a research project that can go for almost 2 decades without any credible result. I don’t know why we should be easy on alternative medicine. Double standard is the most dangerous enemy of science and the hub of superstition.

    –As Orac has pointed out, whether NCCAM is meant to support pseudoscience or not, obvious the supporters of alternative medicine are. They view science as evil and destory their spiritual dreams and believe that one day there will be a superior law that overshadow the authority of modern science and scientific method, and they are waiting for the right time to revolt. It is better to shut down NCCAM and cut their hope completely before this happens and we all go back to Dark Age.

  34. #35 Henry
    April 17, 2009

    “Are they all crazy? Stupid? Discarding anecdotal evidence is unwise in this case — since people are embracing alternative medicine in larger and larger numbers and there must be some reason for it. Are you interested in solving the problem?”

    Anyone who uses their cultural background to reject modern science (those people probably account the vast majority of the CAM fans) and have deep belief in any New Age concept, should be called crazy, stupid, foolish, etc etc.

    And of course I am interested in solving the problem. The solutions are right there: Shutting down NCCAM so the cultists lose their hope in the revival of Dark Age; then we give them proper education so they can improve their life quality correctly with science.

    Actually protests against alternative in Korea, India and China (in China, traditional Chinese medicine is _constitutionally_ protected) are rising, too. One day there should be a worldwide alliance that work together on removing alternative medicine completely from the face of the earth.

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