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The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:

  • Explore complementary and alternative healing practices in the context of rigorous science.
  • Train complementary and alternative medicine researchers.
  • Disseminate authoritative information to the public and professionals.

If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.

Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.

Before I discuss the studies, it’s useful to explain briefly for the benefit of those not familiar with NIH grant mechanisms (in other words, the vast majority of our readers) just exactly what the alphabet-number soup describing the types of NIH grants means:

  • R01. The gold standard of NIH research awards, this mechanism describes investigator-initiated multiyear grants (usually four or five years) to study whatever the investigator wants to study, provided that he or she can convince a study section of the worth of the project and that the project is related to the program interests of one of the NIH Institutes. As such, they generally require a fairly large amount of preliminary data and a well-defined research plan to study a clear and scientifically reasonable and interesting hypothesis.
  • R21. These grants are usually one or two year exploratory rewards designed to investigate more risky hypotheses. As such, they require much less, if any, preliminary data.
  • P01 and P50. P-series awards are known and program project grants and are intended to fund large, multi-investigator projects (P01), often encompassing more than one institution, or research centers (P50).
  • K-awards. These awards are intended to fund the development of junior faculty and are also known as career development awards. The idea is that these awards, which require a mentor to support and guide the applicant, are supposed to be a bridge to independent funding.
  • Small Business Research Awards (R41, R42, R43, R44). These are granted to small businesses to fund the development of (usually) biotech and related projects.
  • T32. T32 and related grants fund training and fellowship programs. For example, my surgical oncology fellowship was funded by a T32 award, and our cancer institute has a T32 to fund medical oncology fellows who want to spend two years in the lab.

These by no means encompass all of the funding mechanisms of the NIH, but they are the most common and ubiquitous across Centers and Institutes. Now, let’s look at the breakdown for NCCAM:

Award Mechanism Number of NCCAM grants funded in FY2007
P01/P50

18

R01

60

R21

135

K- and F-series

69

T32

10

Misc. (F-, R-series)

45

It should also be noted that the NIH funds its grants by the fiscal year. Consequently, a five year grant is, in reality, made up of five one-year awards. The difference is that investigators do not have to compete for the renewal of their grants during the years encompassed by them. Rather, they simply have to submit progress reports, and, if reasonable progress is being made, the NIH will usually rubberstamp the renewal of the grants. These are called “noncompetitive renewals,” appropriately enough. The suffixes (-01, -02, -03, etc.) tell us which year of the grant is represented. At the end of the grant period, for R01 and other mechanism, (but not, for example, R21 grants, which are meant to be followed up by other mechanisms), the investigator can either submit a competitive renewal for a continuation of the grant or let the grant lapse.

We see from the above chart that NCCAM funded two new and nine ongoing P01 grants and 14 new and 47 ongoing R01 grants, but a more illuminating analysis comes when we look at the breakdown of general topics being covered in the P01, R01, R21, and training grants. I’m going to take the liberty of concentrating on studies of herbal remedies or dietary supplements or manipulations (mainly because these are the grants that could easily be funded by one of several other NIH Institutes), other modalities that are considered “alternative” for unclear reasons (such as studies of various light therapies on different diseases), studies of CAM usage (many of which seem designed to promote CAM usage), true “alternative therapies” (homeopathy, chiropractice, etc.), and then funding for training programs. A caveat is that not everyone will agree with which studies I chose for each group, but the relative numbers are such that minor quibbles on a few studies will not change the overall trend. Finally, I’m going to concentrate mainly on the R01, P01, and training mechanisms:

NCCAM grant topic Number of grants awarded
Herbs, supplements, dietary interventions

109

Modalities considered “CAM” for unclear reasons

12

CAM usage/promotion (not counting fellowships)

13

True “CAM” (chiropractic, craniosacral, prolotherapy, homeopathy, etc.)

61

Centers and fellowship programs

28

What we can see from this is that by far the largest category of NCCAM grants for research not related to small businesses is a topic that could just as easily be funded by numerous other Institutes or Centers within the NIH: the study of herbal remedies, which, when you come right down to it is nothing more than the study natural products, and studies of dietary manipulations to treat disease and improve health. If you peruse the list, you’ll see numerous studies of chromium supplementation, gingko bilova, saw palmetto, various dietary manipulations, and similar studies. Since when did the study of natural products and diet become “alternative”? There is no good reason why these sorts of proposals need a special “CAM” Center to fund them or why they could not be evaluated by the appropriate study sections in the appropriate disease-specific Institute of the NIH.

Then there are a number of other studies (you may disagree with me about the specific studies chosen) that examine physical treatments that are considered “alternative” for unclear reasons, studies such as near infrared therapy or the effects of blue light on alertness. There’s no reason why such these studies need to be under the rubric of “alternative” or “complementary” medicine, either. These are the same sorts of studies that “conventional” physicians have been doing for decades. Indeed, when it comes to natural products and herbal remedies, I suspect some pharmacologists, dieticians, and medicinal chemists probably look at NCCAM as easy money (or, in this disastrously tight NIH funding environment, at least less torture to get) if they just slap together a project to study the most popular herb du jour. Finally, there are the 28 grants funding either fellowships or large collaborative CAM centers or projects and 13 funding studies that either examine CAM usage or seem custom-made to promote CAM usage, such as this study of the effect of increased coverage of CAM therapies by insurance companies.

That just leaves approximately 61 P01- , R01, or R21-level grants that seem to look at therapies that might truly be called “CAM” (at least by NCCAM’s definition). These are, not surprisingly, weighted towards acupuncture or accupressure (17 grants), mind-body interactions (15, with a huge emphasis on “mindfulness,” a distinctly religious concept), and then assorted miscellaneous CAM therapies that constitute a grab-bag of mostly unrelated modalities. There are also some rather disturbing grants here, a few of which look as though they couldn’t get through an Institutional Review Board (IRB) review. For example, there is actually a grant to fund the study of acupuncture for acute spinal cord injury. I wish I were joking. It even pulls the usual acupuncture trick of including electrical stimulation (which, by the way, is not acupuncture, but rather transcutaneous electric nerve stimulation, a decidedly conventional therapy that has been well-studied to treat chronic pain) as part of it.

Worst of all, there are two grants to study arguably the most scientifically implausible of all CAM modalities, homeopathy. For instance, there is an R21 grant funding a study called Polysomnography in Homeopathic Remedy Effects. Yes, you have it right. Your tax dollars are going to fund at least a study this year on homeopathic remedies (a.k.a. water). But it’s even worse than that. There was actually awarded an R21 grant to study homeopathic dilution and succussion and how they affect the dose-response curve of homepathic remedies. This latter grant actually proposes to study whether succussion (the vigorous shaking done with each homeopathic dilution) that, claim homeopaths, is necessary to “potentize” their remedies affects the dose-response characteristics of homeopathic remedies up to 30C dilution (30 times 100-fold, or a dilution factor of 1 x 10-60). This is a dilution factor many orders of magnitude larger than Avagaddro’s number, which is makes a 30C homeopathic remedy nothing but water. Period. In fact, the investigators are actually going to compare stirring with succussion to see whether succussion, as homepaths claim, improves the dose-response curve. It beggars the imagination that such a project was actually seriously considered and then scored highly by a study section. There can also be found grants studying seriously dubious modalities such as craniosacral therapy, prolotherapy, and even qi gong for treating cocaine addicition. Truly, it’s like studying whether eye of newt or pixie dust is more efficacious in curing cancer!

Here’s another thing to consider: An NIH-funded grant is the pinnacle of external funding mechanisms to universities, largely because the government gives the universities additional “indirect costs” of around 50 cents on the dollar to administer the grants and maintain their infrastructure. In the eyes of universities (and probably the public) it doesn’t matter whether that grant came from NCCAM, the NCI, NHLBI, NIAA, NIDDK, or whatever. Universities will be just as happy if investigators get grants from NCCAM as from any other agency within the NIH. More insidious still are the grants to fund fellowship and training programs. It’s easy enough to laugh at grants being offered to study whether homeopathic succussion does anything other than aerate the solution, but when I see how much NCCAM is laying out for the promotion of non-evidence-based medicine through “education” grants, I find it truly disturbing. There are grants to fund fellowships in CAM at the University of North Carolina Chapel Hill, the Weill Medical College of Cornell University, the University of Virginia, Harvard University, the University of Arizona, Oregon Health and Science University, UCSF, and a naturopathic college (Bastyr University). Most of these centers are not there to look at CAM from a truly scientific or skeptical viewpoint. Most are run by believers, and their NIH-funded existence lends a patina of undeserved scientific credibility to the enterprises, particularly since most of them are housed in academic medical centers.

As two of my co-bloggers Wally Sampson and Kimball Atwood IV have pointed out, NCCAM was created not because of any groundswell of support from the scientific community. Rather, it was CAM-friendly legislators who foisted it upon the NIH and made sure that its budget skyrocketed–at least until the recent flattening and decline of the NIH budget put the brakes on. It doesn’t seem to matter if a bona fide scientist is placed in charge, either. For example, Dr. Stephen Strauss was the Director of NCCAM from 1999 to just last year, and he was a hardcore scientist who promised to “explore CAM healing practices in the context of rigorous science, to educate and train CAM researchers and to disseminate authoritative information about CAM to the public.” Yet that is not what has happened. Recently, it was announced that Dr. Strauss’ replacement would be Josephine Briggs, MD, another accomplished researcher with a strong CV making similar promises. Can she deliver on them?

It’s highly unlikely.

Here’s why. First, she has only minimal control over who is appointed to the two councils charged with advising the Director on matters related to research funding and clinical trials, and, in any case, the Council is mandated to be constituted as follows:

Of the 18 appointed members, 12 shall be selected from among the leading representatives of the health and scientific disciplines (including not less that 2 individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the NCCAM, particularly representatives of the health and scientific disciplines in the area of complementary and alternative medicine. Nine of the members shall be practitioners licensed in one or more of the major systems with which the Center is involved.

In other words, they must be CAM practitioners and “leaders” in the field. It’s unlikely that such a group will support rigorous science that might threaten their livelihood, and indeed they don’t. In fact, its stated mission notwithstanding, NCCAM was never originally intended as a means of rigorously investigating CAM therapies but was rather as a government agency to give these therapies the patina of credibility and respectability that they can’t earn through the science. Dr. Strauss may have tried to do what he said he would do during his tenure, but it clearly just didn’t work. He couldn’t change NCCAM. Moreover, no matter what he did, he couldn’t win either way. On the one hand, he was criticized by scientists and physicians who support science- and evidence-based medicine (like me) for allowing highly dubious studies to be funded, while on the other hand he was castigated for being too scientifically rigorous and not being a CAM practitioner because CAM advocates didn’t like his emphasis on determining whether their therapies worked or not. The same thing appears to be true of Dr. Briggs. Indeed, I found an open letter to Dr. Briggs from a CAM supporter that is most revealing, from which I draw a key excerpt:

Your predecessor, Stephen Straus, MD, also had no experience in complementary and alternative medicine. He told the New York Times during his tenure that he had no plans to experiment. I always thought that an odd waste of human imagination. This is not cancer, or renal failure we’re typically talking about. These are therapies and approaches which many view as particularly valuable for creating health and vitality – often altering the course of disease, or a person’s experience of disease, in doing so. Why spend 7 years as an “investigator” and never personally investigate?

Now, a decade later, the NIH has done it again. Director Zerhouni appointed you, despite the fact that you too have no visible professional experience in the field that you were selected to lead. Of your 125 publications, none appear to touch on the kinds of interventions which will be on your desk at your new job.

The writer of this letter, John Weeks, then tries to give Dr. Briggs some advice, most importantly to “go get yourself some experience of complementary, alternative and integrative practices.” He then goes on a rant against NCCAM for, in essence, not being friendly enough to the CAM practices he supports because it does not spend as much as he would like on “whole systems” and “whole practice” approaches. Even worse, from his perspective, NCCAM actually is out of compliance with the mandate that 50% of NACCAM members be licensed in the specialties studied by NCCAM in that only 25% are so licensed. (Actually, if true, this was the only heartening information I found during my research). Mr. Weeks goes on:

I spoke with a conventional academic medicine colleague and researcher yesterday who is a close NCCAM watcher. He said he was “flabbergasted – not in a positive way” by your appointment. His gut feeling was that “the appointment makes it very clear that the NIH wants to bury NCCAM.” He wondered why you took the job, given your career path. Did you just want to be on the NIH director’s Council? Is it, for you, merely a step in dirty water, a post in Siberia on a career path which you hope will veer back into other zones more prestigious in your view – a plum position in Moscow? – as soon as possible?

My colleague told me he believes that, with all of the momentum in recent years, and the increased interest among employers and consumers, the field of integrative medicine is going to keep growing. The question on the table, he believes, is “whether NCCAM will provide leadership or become irrelevant.”

What this letter encapsulates to me is the attitude of CAM advocates towards NCCAM. They don’t want truly rigorous scientific studies to determine if these therapies work. They want studies that assume that these therapies work and then simply look at utilization and cost-effectiveness. They want funding of fellowships in CAM (taught, of course, by true believers). In brief, they want CAM promotion.

This is why we can only hope that the NIH really is trying to bury NCCAM. There’s nothing that NCCAM does, other than its advocacy for CAM therapies in academic medicine, that couldn’t be done as well or much better by other Institutes and Centers of the NIH appropriate to each question. This is particularly true for the study of herbal remedies and dietary interventions, neither of which are “alternative” except when claims are made that diet or herbs can, for example, cure cancer.  Unfortunately, as protected as it is by powerful legislators, the best we can hope for is a career scientist like Dr. Briggs trying to slow NCCAM’s descent into pseudoscience. It can’t last forever, though. Sooner or later a true believer will be appointed Director at NCCAM. It’s virtually inevitable. The only thing keeping that from happening, I’d guess, is that the most prominent CAM practitioners (like Andrew Weil, for instance) make far too much money to be easily willing to take a huge pay cut to work for NCCAM. When that day comes, any pretense of rigorous science taking into account scientific plausibility will fly out the window.

Posted in: Basic Science, Clinical Trials, Medical Academia, Politics and Regulation, Science and Medicine

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53 thoughts on “The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

  1. skidoo says:

    Thanks for this detailed analysis of the scam that is NCCAM. Fascinating insight into the cogs and flywheels and gyrations and the resulting hemorrhaging resources.

    Thanks also for so clearly highlighting the ridiculously unwarranted inclusion of modalities that may actually have some plausible mechanism (however slim) with those that fall unequivocally in the, erm, “alternative” category.

    What the hell is wrong with plain old medicine? Oh, that’s right. It’s hard.

  2. Joe says:

    As a practical matter, I thought it made sense to include herbs under CAM. The basis for most herbal recommendations is testimonial, and herbalist forays into research are usually deeply flawed. On top of that, clinical trials are often doomed to failure (http://scienceblogs.com/terrasig/2007/07/another_botanical_clinical_tri.php) because nobody knows what, if anything, is active in the herb.

    “Tyler’s Honest Herbal” (by the late, Varro Tyler) makes it clear that most attempts to chemically standardize herbal preps arbitrarily center on some prominent or characteristic compound in the plant. One might as well standardize an herbal prep based on the cellulose present. A case in point is the Artemisia species that produce the antimalarial, artemisinin. The plant only produces the drug under certain conditions. One could find a powerful effect in a pilot study, only to have it disappear when a full clinical trial is conducted with a new batch of the herb. Once the active compound is identified, the herb is just a contaminated dosage form.

    Finally, herbalists indulge in the post-hoc rationalizations characteristic of pseudo-science. As I recall, the first high-quality test of echinacea provided it in tablet (or capsule form). The herbalists cried “of course it failed, we always supply it as a liquid.” Then, a high-quality study using it in liquid-form failed, and the herbalists asked “but, who prepared the liquid?”

  3. apteryx says:

    Joe, your assumption that a plant has only one active molecule (“the active compound”) that can be isolated and concentrated without reducing activity or safety is oversimplified. For some plants it may be true (quinine), but for others it clearly is not (hawthorn). The same is true for food plants; there is a long sad history of assumptions that only the molecules whose identity and function were already known to science were nutritionally important. The question of whether any one newly isolated molecule is better or worse than the original extract is for each molecule an individual testable hypothesis that needs to be tested. Botanical studies need to be funded by NCCAM because most NIH funding panels only want to study isolated molecules, whereas if you wish to know whether a crude extract benefits its users, studying isolated molecules tells you nothing.

    Are you able to provide a citation for the “high-quality study” of liquid echinacea you mention? I would like to know which study you are referring to.

  4. Joe says:

    Apteryx,

    Sure: “An Evaluation of Echinacea angustifolia in Experimental Rhinovirus Infections” Turner, Ronald B.; Bauer, Rudolf; Woelkart, Karin; Hulsey, Thomas C.; Gangemi, J. David. NEJM Volume 353(4), 28 July 2005, pp 341-348.

    Apteryx wrote “your assumption that a plant has only one active molecule (”the active compound”) that can be isolated and concentrated without reducing activity or safety is oversimplified.” The comments section is no place for a treatise on natural products, so I provided the streamlined version. Certainly, one can find multiple, useful compounds in one source. When fractionating an herbal mix, all the activity is discoverable.

    Apteryx wrote “Botanical studies need to be funded by NCCAM because most NIH funding panels only want to study isolated molecules, …” There is good reason for that. Do not make the mistake that NIH ignores combinations, they just need justification.

    Apteryx wrote “… whereas if you wish to know whether a crude extract benefits its users, …” One does a screen, or a pilot, study and then tries to identify the active components.

    Apteryx wrote “… studying isolated molecules tells you nothing.” That is wrong.

    Apteryx wrote “… there is a long sad history of assumptions that only the molecules whose identity and function were already known to science ..” I never recommended studying only known compounds; I advocate basic research on any compound.

  5. apteryx says:

    Joe,

    I believe there has been one decent-quality, essentially negative trial of liquid echinacea, to stack up against a number of positive trials — but Turner et al. ain’t it! Yes, the paper is nicely written up to get a high Jadad score, chatting about assessment of blinding and so on. Unfortunately, the test substance used was garbage. Firstly, they did phytochemical analysis on their product, and it contained NO detectable echinacoside, a putative active ingredient that is expected to be present at 0.4-1.7%. Since they don’t say anything about where they got this echinacea root, I see no proof it was even the right species. If they had really wanted to give this plant every chance to demonstrate efficacy, they would have thrown the material out and bought a new batch that contained echinacoside. Secondly, as echinacea is not a very potent plant, a fairly high dose is traditionally used. The authoritative World Health Organization monograph recommends 3 grams per day. Turner et al. gave the equivalent of 300 mg 3 times per day, or 900 mg, which is to say 30% of the recommended dose. Use garbage material and give less than a third of the traditional dose, and it’s no surprise if you don’t find a significant benefit. (Their later responses to criticism seemed to make it clear that that was fine with them.)

    As a general principle, when a botanical trial is positive, the anti-herb lobby asserts that since botanicals are variable, the results apply only to the single product (or even the single long-gone batch!) used in the trial, and offer nothing at all to support the efficacy of all the other products used throughout history or available today. Yet when a trial is negative, we are told that those negative results apply to all possible products derived from that plant — and the question of whether the test material was of ideal or even average quality is never asked. Had Turner et al done a fair trial, and had they found positive results, how broadly would you be willing to apply them?

    For your information, it is not always possible to identify all the activity in a botanical extract by fractionating it. If molecules in different fractions interact synergistically, e.g., an antibiotic and a compound that interferes with bacterial resistance to the antibiotic, the summed activity of all the fractions will be less than the activity of the whole extract. That’s just in bioassays; the presence of multiple slightly different antioxidants or antibacterial compounds may have long-term value in vivo (if it could not, why would the plant go to the metabolic effort of making whole suites of compounds?). If you have a plant like hawthorn with perhaps dozens of bioactive compounds in each of several classes (and therefore fractions), it is simply too complex to turn into a synthesized patentable product, except by arbitrarily deciding which beneficial molecules you will keep and which you will throw out; when you do that, if you find that the product is less efficacious or more toxic, don’t blame the plant!

    The study of an isolated molecule will never allow you to pass judgement upon the potential value of a traditional food or medicinal product. Every plant contains molecules that will generate impressive bioactivities in lab studies, and molecules that could be toxic at sufficiently high concentrations. Judging a plant by its individual molecules will generate endless false promises of benefit (if curcumin may treat cystic fibrosis, does eating curry do so?) and endless false threats of harm (one group has tried to impugn ginger for containing a mutagenic compound, although whole ginger extract is antimutagenic). It will also underestimate the value of plants whose activity is not attributable to so few compounds that their individual and combined activities can be manageably (or affordably) studied. Reductionist studies have value for elucidating novel biochemical interactions, and certainly for developing new drugs. But if you really want to know whether or not chamomile tea will settle your stomach, as has been claimed for millennia, sooner or later you have to give people chamomile tea – not azulene.

  6. Simon says:

    Just as an aside, as we’re talking about plant products being used to treat animal diseases- Does anyone know of any animal derived chemicals being used to treat plant infections? I realise that this is less likely than the reverse as plants tend (in my limited understanding of botany) to produce simple organics to combat infection while animals have far more multi-faceted immune systems, but I would be surprised if it was an entirely one way field. Answers on a postcard.

  7. Wallace Sampson says:

    Ateryx and other herb advocates note:

    Joe is correct. The proposition that combinations of plant materials, mostly unknown, have some unknown synergistic activity or a multilicity of activities that provide a more “natural” aproach to therapeutics (because we evolved using those natural substances) is flawed beyond resolution.

    That may apply to foods, but not to theraeutic materials.

    As Joe pointed out, artemisinin’s antimalarial varies in the artemis plant. All chemically active plant components vary in concentration depending on a multilicity of factors. So one has introduced not just the variability of one presumed component, but a variety of alterations – some decrease, and some components increase.

    Sectarian herbalists criticize use of multiple pharmaceuticals. What does one call the multiplicity of chemicals in herbs?

    Polypharmacy in both cases. But with pharmeceuticals, one knows what one is taking from one day to the next.

  8. apteryx wrote: “But if you really want to know whether or not chamomile tea will settle your stomach, as has been claimed for millennia, sooner or later you have to give people chamomile tea – not azulene.”

    If you really want to know if chamomile tea settles stomachs, you are going to have to start by identifying the source of the plant that many actually believe calms their stomachs and then test it using double-blind clinical trials. If the results are positive, it will be a first step that should lead to an attempt to cultivate the plant in a way that consistently gives the same results when tested objectively.

    However, most “dietary supplements” are not sold as botanicals. They are processed into liquids and pills. So if someone actually does good studies showing that a botanical offers benefits and wants to process it as an extract or pill, he will then have to repeat double-blind clinical trials using the extracts or pills he has made from the botanicals that objective tests have conistently shown offered benefits.

    It is the manufacturers who will have to do these tests for the products that they sell. Otherwise as apteryx has pointed out no one will believe the results of the studies. They will believe that the wrong product was tested. Of course, until scientists with no financial interest in the products consistently reproduce manufacturers studies, few will believe them.

  9. Joe says:

    NCCAM certainly should be closed. However, the problem is (as it has been from the start) political, not scientific. We will have to lobby Congress. History does not give us much encouragement- a couple years ago an attempt to bring “supplements” under tighter control ended when their patron (Sen. O. Hatch, R, UT) said “No” and that was the end of that. Sen. Harkin (D, IA) is still a formidable ally for quackery (as is Rep. Dan, the loose cannon, Burton (R. IN)).

    The numbers, laid out by D. Gorski are compelling to us. To members of Congress, they are merely numbers. In a book “Parkinson’s Law” written in the 1960s, this was explained. Ask the City Council to approve $20 for the City Hall coffee fund- that is pocket money (of no consequence) and it is approved. Ask them to set spend $10,000 to repave a driveway, and there is a long debate because some members know an outfit that will do the job for $9,000 (this approximates a major, household budget item). Ask them for $10 million to improve the sewage plant, and it sails through like the coffee money ($10 milllion is an unimaginable amount) despite the fact that a 10% cut would save a lot more than it would on the paving job.

    Going back to the the NCCAM, an early director of the (preceding) OAM tried to make it rigorous and Harkin held the whole NIH budget hostage till that idea was dropped. I have little confidence in what a new director can accomplish.

  10. David Gorski says:

    I agree that the problem is political and that NCCAM was never meant to be a center to investigate so-called CAM in a scientifically rigorous fashion. It was always intended from the beginning by Harkin et al to be an agency that would promote CAM, to give it a gloss of scientific respectability that it can’t earn through science. Harkin realized that if the NIH funded CAM research that universities would be more than happy to jump on board, thanks to the indirect costs they reap from any federal grant investigators receive. That was Harkin’s genius, coupled with the knowledge that it’s almost impossible to shut down a government agency once formed.

    That is why I’m quite pessimistic that the new Director will be able to do anything to “fix” NCCAM, no matter how good her intentions may be now. For one thing, unless its charter were to be radically revised, NCCAM can’t be “fixed” to make it more on par with other NIH Institutes and Centers. Moreover, if she goes too far in demanding scientific rigor and accountability that include estimates of prior probability based on science in deciding what grants to fund, it’s a good bet that Harkin (and other CAM-friendly legislators like Dan Burton) won’t wait long to bring the budgetary and legislative hammer down. I did not exaggerate when I predicted that it is only a matter of time before an Andrew Weil-like “researcher” is appointed as Director of NCCAM. I still predict that it will happen one day, as that’s what NCCAM’s constituency wants. At that point, NCCAM will then cease even to have any pretense of being dedicated to the science of CAM therapies.

  11. apteryx says:

    Dr. Sampson writes:

    “Joe is correct. The proposition that combinations of plant materials, mostly unknown, have some unknown synergistic activity or a multilicity of activities that provide a more “natural” aproach to therapeutics (because we evolved using those natural substances) is flawed beyond resolution.

    “That may apply to foods, but not to theraeutic materials.”

    Dr. Sampson, you are a recognized expert, if one with a recognized ax to grind, but in this instance you are not making sense. Are you willing to acknowledge the now enormous weight of evidence that better diets improve long-term health, beyond the avoidance of scurvy and beriberi? If so, you are admitting that the myriad known and unknown vitamins, fatty acids, flavonoids, antioxidants, etc., in plant foods combine to prevent or mitigate various “Western diseases” in a way that supplements made from isolated active compounds cannot, which is certainly a significant bioactivity. How can you then deny any possibility that similar fatty acids, flavonoids, antioxidants, etc. in plants labeled “medicinal” can combine to provide health benefits?

    Furthermore, how do you find a meaningful division between “foods” and medicinal plants, or “therapeutic materials”? Many food plants (flaxseed, ginger, turmeric, bilberry jam, cranberry juice, and green tea, to name a few) are also medicinal plants and vice versa. Do the hundreds of phytochemicals in ginger contribute to good health when it is used as a stir-fry vegetable, but suddenly become inactive when it is taken as a tea or capsule? Those who want to discourage if not stamp out citizens’ use of bioactive plants are treading on thin nutritional ice, because every food plant that can reduce your risk of some disease is a bioactive plant, if not a medicinal plant, as is every herb and spice. Give them all up, and you would be left with what we might call the Bland Cancer-Promoting Diet. (Also known, come to think of it, as “English cuisine.”)

  12. David Gorski says:

    Are you willing to acknowledge the now enormous weight of evidence that better diets improve long-term health, beyond the avoidance of scurvy and beriberi?

    Are you willing to explain to me why the study of dietary interventions for the improvement of health should in any way be considered “alternative”?

    If we as a scientific community do not pay sufficient attention to diet, the answer is to raise awareness. Sequestering NIH funding for dietary research in a scientific ghetto (NCCAM) is not the way to improve its respectability and increase rigorous scientific research about the effects of diet on health and disease.

  13. BlazingDragon says:

    This was pretty depressing to read. All that money being wasted on junk. Studying herbal extracts should be done, but I agree that they should be studied by other aspects of NIH. Other truly alternative modalities should not be given this awful patina of scientific validity by being funded, indirectly, by the NIH.

    apteryx, it is entirely possible to fractionate a plant into a single fraction that contains >90% of the putative active ingredients. It all depends on how one does the fractionation. You also left out that you can fractionate in several different ways, get rid of the carrier material, then combine the different fractions in a known ratio and test them to get all of the “active ingredients.” Good science could even tease out that a plant contains an antibiotic substance + a substance that neutralizes a resistance mechanism (if single fractions don’t work, but the whole plant consistently does, just keep looking at combinations of fractions until one finds the “right” combination).

  14. BlazingDragon says:

    apteryx wrote:

    “Dr. Sampson, you are a recognized expert, if one with a recognized ax to grind, but in this instance you are not making sense. Are you willing to acknowledge the now enormous weight of evidence that better diets improve long-term health, beyond the avoidance of scurvy and beriberi?”

    Uhm, this invalidates your argument completely…. scurvy is curable by a single, easily isolated and synthesized molecule (vitamin C) and beriberi is due to the lack of a simple, easily isolated and synthesized molecule (vitamin B1). You don’t need complicated herbal extracts with “synergistic” components to cure either of these conditions…. you also left out rickets, which is caused by a lack of single substance (vitamin D). Science has even figured out which form of D is “better” (D2 vs. D3), although both will work.

  15. apteryx says:

    BlazingDragon,

    Uhm… you missed my point completely, and indeed reversed it. Acute deficiency diseases caused by the lack of single molecules in the diet can be corrected by the consumption of single-molecule supplements. Dr. Sampson will not doubt the etiology of these diseases, whereas his view of the relevance of diet to more complex chronic diseases remains to be heard; that’s the meaning of the word “beyond.” These conditions have no bearing on the question of health effects caused by interaction among multiple molecules, which is why I did not wish to discuss them in detail, e.g., by providing a comprehensive list.

    The situation I refer to is the one where we know that people who eat many plant species have lower rates of degenerative diseases than people who eat the “Western diet” of meat, white bread, and worse. People who consume the diets containing more vitamin C, vitamin B1, vitamin D (also from sun exposure), lycopene, etc. are less likely to get cancer. But if people take vitamin C supplements, or lycopene supplements, or any other single molecule however essential, they do not see a protective effect similar to that of the whole foods. Conclusion: chronic disease is not due to a subclinical deficiency of any one essential molecule, which can be separated out from the “carrier material” of our foods and put in a capsule, while the rest is tossed in the garbage. Where food is concerned, the “carrier material” IS the medicine.

  16. pmoran says:

    David, it is reasonable to assume that after fifteen years and the expenditure of a billion dollars, the most important and credible “alternative” medical claims will have been examined.

    Will a follow-up article reveal what has been added to medical knowledge?

  17. BlazingDragon says:

    apteryx,

    Do any “whole food” diet studies control for the fact that the people who eat “whole foods” take better care of themselves? Get more exercise? In other words, things that are already proven by science-based medicine to improve health? To make your point real, two sets of people would have to be matched for age, pre-existing conditions, etc. etc., then be given a whole host of herbal extract-derived products thought to improve health (each as a pure substance) vs. people getting the same dose of the substance through “whole foods,” while controlling dietary intake of overall fiber, carbs, fats, protein, etc. In other words, a damned difficult (and expensive study). If a study controlling all other variables that might affect health and well-being is not conducted as I described, all you are left with is a correlation, NOT causation. Sometimes correlation = causation, sometimes not.

    Of course, it always makes sense to eat less processed foods (usually lower in fat, salt, sugar, things that are known to be “bad” for you by conventional medicine). But you can’t jump to such conclusions that “whole foods” are better than single substances, or that most herbal extracts are “good for you” and “prevent disease.”

    Also, I don’t know if you’ve made your point or not… scurvy used to be the bane of existence. I’ll bet all kinds of “humors” and “vapors” and “evil spirits” were blamed for it, until people found out it was a simple, single substance. Some people still claim that “natural” vitamin C is superior to “artificial” (i.e. synthesized and purified as a single substance) vitamin C. Both will prevent scurvy. Any other health benefits of “natural” vitamin C must be pretty small because they still are not obvious in controlled studies.

  18. apteryx says:

    Are you aware that you have a tendency to put words in the mouths of those with whom you disagree? You might want to watch that. It should have been clear from context that “whole foods” meant “intact foods,” as opposed to isolated molecules, not as opposed to processed foods. But while we are on the subject, since you seem to deny that eating a traditional human diet improves health, most of the evidence for this does not come from within-culture studies (since the few Americans who eat well probably do also exercise more) but from between-culture studies, or studies of foreigners who start developing diabetes and heart disease as soon as they start eating American-style. It may well be that just about everyone in every non-Western culture on Earth “gets more exercise,” but I doubt that they “take better care of themselves” by your standards, as many of them cannot afford much Western medicine, and – oops! – frequently use traditional herbal medicine as their primary health care.

    You’re rather confusing me with the talk about scurvy. Your point, that other health benefits of vitamin C are not seen in controlled studies, was first my point: even though the presence of this molecule in the diet is essential to life, it is not the sole molecule in those plants that contributes to good health, nor is any other vitamin. If it were, supplement consumers would enjoy the same level of risk reduction as fruit and vegetable consumers, and studies have found otherwise. There is not likely to be a single yet-unidentified magic bullet that prevents the Western diseases in all of the world’s disparate healthy diets, some of which have few if any species in common. How many different valuable compounds must a plant contain before it becomes more rational to eat it than to try to take it as pills?

  19. BlazingDragon says:

    You continue to miss the point: Unless all other variables between “fruit and vegetable” consumers and “vitamin” consumers (of let’s say, vitamin C) are well-controlled, the conclusion that fruit-and-vegetable eaters are healthier than vitamin consumers is worthless. Fruits and vegetables have more fiber too, and fiber has been shown to have positive effects on health by good ol’ science. People who eat more fruits and vegetables are probably “full” and don’t eat as much junk food either, which is another variable that would confound the claims you make of “whole foods.”

    Show me the study where people have controlled for all other variables known to positively affect health, one that isolates as many known influences on health and tries very hard to spot the difference between getting vitamin C from a pill vs. fruits and vegetables, then we can talk. Until then, your claims are just that… claims.

    If the effect of other molecules were as large as you claim it is, it would have been spotted in studies already.

    As for people who eat “western” diets vs. traditional diets: When people start to consume “western” diets, they stop eating things that are known to be good for them in scientific studies (filling up on fruits and vegetables with fiber, eating less sodium, fat, etc.) and begin to eat more total calories, more fat, more sodium, etc. All of these things have been established to be good/bad by modern medicine.

    You are taking a simple observation (that things such as fruits and vegetables are good for you) and coming up with ludicrous reasons as to why they are good for you, rather than looking at the obvious reasons (fruits and vegetables mean you get more vitamins, more fiber, and cannot eat as much “junk” because fruits and vegetables are “filling” foods).

  20. Aaron S. says:

    “Are you willing to acknowledge the now enormous weight of evidence that better diets improve long-term health, beyond the avoidance of scurvy and beriberi?…combine to prevent or mitigate various “Western diseases” in a way that supplements made from isolated active compounds cannot”

    Non-sequitur. What diet does “eating many plant species” consist of? What is the “Western diet”.

    Even once defined, the number of variables becomes too high to make such a specific conclusion based on a dichotomy of vague categories. Even if one was better than the other, what does that say about individual compounds? Who knows? More specific studies would be needed. As BlazingDragon said, you will find that they contain useful compounds. If only part of the compound is absorbed, and if must appear in a certain structure, then pills/tablets/whatever can do the same. If it is more economical to just grind parts of plants for the pill/tablet/whatever, then fine.

    Either way, natural or artificial, they are just chemicals. There can be no A Priori distinction that says “natural”/”plants” are better than “artifical/supplements”. Therefore, there must be scientific evidence, and comparing two vague diet dichotomies is not it.

  21. Joe says:

    I wrote “[H]erbalists indulge in the post-hoc rationalizations characteristic of pseudo-science. {snip} [A] high-quality study using [echinacea] in liquid-form failed, and the herbalists asked “but, who prepared the liquid?””

    Apteryx wrote ” {snip} Unfortunately, the test substance used was garbage. {snip} I see no proof it was even the right species. {snip} The authoritative World Health Organization monograph recommends 3 grams per day. Turner et al. gave the equivalent of 300 mg 3 times per day, or 900 mg, which is to say 30% of the recommended dose.”

    QED. The herb never fails in the study, the study always fails the herb.

    Apteryx wrote “… Firstly, they did phytochemical analysis on their product, and it contained NO detectable echinacoside, a putative active ingredient {snip}”

    “The, late, Varro Tyler- Purdue University Distinguished Professor of Pharmacognosy- wrote:
    “Echinacoside [not] involved in [activity]. Why standardize an herb to a meaningless compound?”

    Why, indeed … But, Apteryx, if you think you know what ingredients ARE active, by all means test them.

    Apteryx wrote “For your information, it is not always possible to identify all the activity in a botanical extract by fractionating it.”

    For your information, my colleagues and I are more clever than you give us credit for. I repeat: all the activity in a plant is discoverable.

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