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Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

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Posted in: Chiropractic, Health Fraud, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Public Health, Science and the Media

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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.

At the end of Part 1, I wrote:

We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.

In his editorial for the JCO, Mark Levine made a different argument:

Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.

That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.

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Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

Background: the distinction between EBM and SBM

An important theme on the Science-Based Medicine blog, and the very reason for its name, has been its emphasis on examining all the evidence—not merely the results of clinical trials—for various claims, particularly for those that are implausible. We’ve discussed the distinction between Science-Based Medicine (SBM) and the more limited Evidence-Based Medicine (EBM) several times, for example here (I began my own discussion here and added a bit of formality here, here, and here). Let me summarize by quoting John Ioannidis:

…the probability that a research finding is indeed true depends on the prior probability of it being true (before doing the study), the statistical power of the study, and the level of statistical significance.

EBM, in a nutshell, ignores prior probability† (unless there is no other available evidence) and falls for the “p-value fallacy”; SBM does not. Please don’t bicker about this if you haven’t read the links above and some of their own references, particularly the EBM Levels of Evidence scheme and two articles by Steven Goodman (here and here). Also, note that it is not necessary to agree with Ioannidis that “most published research findings are false” to agree with his assertion, quoted above, about what determines the probability that a research finding is true.

The distinction between SBM and EBM has important implications for medical practice ethics, research ethics, human subject protections, allocation of scarce resources, epistemology in health care, public perceptions of medical knowledge and of the health professions, and more. EBM, as practiced in the 20 years of its formal existence, is poorly equipped to evaluate implausible claims because it fails to acknowledge that even if scientific plausibility is not sufficient to establish the validity of a new treatment, it is necessary for doing so.

Thus, in their recent foray into applying the tools of EBM to implausible health claims, government and academic investigators have made at least two, serious mistakes: first, they have subjected unwary subjects to dangerous but unnecessary trials in a quest for “evidence,” failing to realize that definitive evidence already exists; second, they have been largely incapable of pronouncing ineffective methods ineffective. At best, even after conducting predictably disconfirming trials of vanishingly unlikely claims, they have declared such methods merely “unproven,” almost always urging “further research.” That may be the proper EBM response, but it is a far cry from the reality. As I opined a couple of years ago, the founders of the EBM movement apparently “never saw ‘CAM’ coming.”

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

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Tai chi and fibromyalgia in the New England Journal of Medicine: An “alternative” frame succeeds

It never seems to fail. I go away for a few days, in this case to combine fun with pleasure and pleasure with fun by giving a talk to the Chicago Skeptics and at the same time meeting my brand new (well, by this time three weeks old) nephew for the first time, and something always happens. Before I get to what happened, I just want to point out that the talk actually went pretty darned well. I was utterly shocked that it was pretty much standing room only, with perhaps 50 people there to hear me. Honestly, don’t you people have anything better to do on a beautiful Saturday afternoon in August? But, seriously, the whole thing was a blast, and the assembled skeptics there didn’t even let me off the hook, as at least a couple of them asked some fairly challenging questions, one of which, I must admit, I wasn’t prepared for. In any case, my thanks go out to Dr. Jennifer Newport, skeptical Chicago pediatrician extraordinaire and organizer of my talk and the party at her apartment afterward. Between the two events she raised hundreds of dollars for the vaccination drive going on at DragonCon this weekend, Chicago Skeptics, the Women Thinking Free Foundation, and CFI-Chicago for inviting me and being such fantastic hosts.

Back to business. Science-based medicine (SBM) business, that is.

What happened while I was away could almost be characterized by the New England Journal of Medicine (NEJM) singing “Oops, I did it again.” Three weeks ago, the hallowed pages of the NEJM hosted a truly execrably credulous review article about acupuncture. So bad was the article that it “merited” the incredibly rare triple beat-down from this very blog, with posts by Steve Novella, the ever-irascible Mark Crislip, and myself in rapid succession applying the clue-by-four. As I was preparing to leave for Chicago on Thursday, I happened to look at the very latest issue of the NEJM hot off the presses, and what to my wondering (and watering–it is ragweed season) eyes should appear but an article reporting a study on the use of tai chi in treating fibromyalgia. Entitled A Randomized Trial of Tai Chi for Fibromyalgia, the study comes out of the Tufts University School of Medicine and the Newton-Wellesley Hospital in Boston and was carried out by a team led by Chenchen Wang, MD, MPH. Not surprisingly, the study has gotten a lot of play in the media, for example, in this story in the L.A. Times, which is at least reasonably restrained, probably because it an AP wire story by Marilynn Marchione, who has written some excellent articles about “alternative” medicine before. Even the usually reliable GoozNews seems smitten with this study beyond what it rates, characterizing it as “rare victory for the National Institute of Health’s National Center for Complementary and Alternative Medicine and Sen. Tom Harkin (D-IA), who routinely comes under fire for pushing funding for these types of studies.”

I’m less impressed. You’ll see what I mean in a few minutes, I hope. First, however, let’s look at the study itself.
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Posted in: Clinical Trials, Medical Academia, Science and the Media

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NCCAM Director Dr. Josephine Briggs and the American Association of Naturopathic Physicians

On Friday, one of my partners in crime here at Science-Based Medicine, Dr. Kimball Atwood, wrote an excellent Open Letter to Dr. Josephine Briggs. Dr. Briggs, as most regular readers of SBM know, is the Director of the National Center for Complementary and Alternative Medicine (NCCAM). As most regular readers of SBM also know, we at SBM have been quite critical of NCCAM for its funding of studies of dubious scientific value, including one that I mentioned quite early on in the history of this blog, in which an R21 grant was awarded to investigators at the University of Arizona for a project entitled Dilution and succussion in homeopathic remedy dose-response patterns. The purpose of this project was to compare the effectiveness of a homeopathic remedy at different dilutions. It even compared remedies that are succussed (vigorously shaken) at each dilution step against remedies that were merely stirred. Although this is merely the most egregious example I could find at the time, two years ago I did catalog many more examples, as well as the “educational” grants disbursed through NCCAM in order to teach (and, by doing so, promote) CAM.

Given NCCAM’s long history of promoting pseudoscience, we were all quite surprised when early this year we received an e-mail from Dr. Briggs herself inviting us to NCCAM to meet with her. Unfortunately, due to our work obligations, Steve Novella, Kimball Atwood, and I were not able to coordinate our schedules to travel to Bethesda and enter the heart of darkness itself until early April. Our conversation with Dr. Briggs and her staff was cordial and mutually respectful, as Steve Novella described, and we assured her that we understood that studies such as the one I mentioned above were funded before her tenure. At the same time we were a bit disappointed that Dr. Briggs appeared far too eager to dismiss such problems as being before her time. Still, we understood and approved of Dr. Briggs’ stated goal of making NCCAM more scientifically rigorous, even though we did point out that there is nothing done at NCCAM that couldn’t be done as well in the NIH’s structure before NCCAM existed.

Unfortunately, not too long before or after Dr. Briggs met with us, she also met with a group of homeopaths, leading us to worry that perhaps in her quest to appear “open-minded,” Dr. Briggs was being so open-minded that her brain was in acute danger of falling out, particularly after we saw her infamous “science must be neutral” director’s newsletter a month later, which Dr. Kimball skewered as part of his open letter and I recently used as an example of misinterpreting what scientific “neutrality” means during my talk at the SBM Workshop at TAM8 a couple of weeks ago. In fact, I now wonder if I missed a little gray matter oozing out of Dr. Briggs’ ears during the meeting even though I sat right next to her.

Unfortunately, Dr. Atwood’s open letter gives me even more reason to despair, because in it he pointed out that Dr. Briggs will be speaking at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP) from August 11-15 in Portland, OR. (One wonders if Mark Crislip would be willing to make an appearance there for a Very Special Episode of his Quackcast and thereby continue to expand his Internet empire. I realize that doing so would really be “taking one for the team,” but think of the blogging and podcast material!) Kimball’s explanation why this is disturbing is excellent and detailed, as usual, but one thing he didn’t do as much of as I would have is to go into a bit more detail of what sorts of dubious medical modalities and even outright quackery Dr. Briggs will be associating herself with by speaking at this particular convention. He probably didn’t feel the need, given that he referenced his two comprehensive deconstructions of the quackery that is naturopathy, but I’m not as well-versed in naturopathy as he is, and, I suspect, neither are you. Dr. Atwood didn’t need to delve into the woo that will be presented at the AANP. I do. That’s why I thought a bit of a survey of what will be presented at the conference was in order.
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Posted in: Homeopathy, Naturopathy, Politics and Regulation

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Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D.

Director, National Center for Complementary and Alternative Medicine

Dear Dr. Briggs,

As you know, we’ve met twice. The first time was at the Yale “Integrative Medicine” Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of having to appear ‘open-minded’ about nonsense.

More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you’ll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group—whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they’re “part of your education,” as my 91 y.o. mother used to say to me):

Naturopathy: A Critical Appraisal

Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth

The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one.

Thus the second article inevitably became the crash course—call it CAM for Smarties—that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents’ inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous ‘research’ (funded—unwittingly, I’m sure—by the NCCAM), bait-and-switch labeling of rational methods as “CAM,” vacuous assertions about ‘toxins’ and ”curing the underlying cause, not just suppressing the symptoms,” anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more.

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Posted in: Homeopathy, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine, Science and the Media, Vaccines

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Doctor’s Data Sues Quackwatch

A few weeks ago I posted an article about bogus diagnostic tests. I cited Doctor’s Data, Inc. (DDI), as “a company with a long history of dubious offerings.” I also wrote:

You can’t help but have noticed that many of the links in this post are to articles on Quackwatch. That’s because the site is chock full of useful information about bogus tests, far more than can be found elsewhere. There you will find a more comprehensive list of bogus tests than I’ve mentioned here, and a larger list of laboratories peddling them. You’ll also find an article on “Dubious Genetic Testing” co-authored by the Quackwatch founder, Stephen Barrett, and our own Harriet Hall, and an article about bogus “biomedical treatments” for autism showing that—surprise!—Doctor’s Data and Genova Diagnostics are major players there, too.

I stand by all of those statements. It turns out that Doctor’s Data is not pleased that Dr. Barrett has so thoroughly blown the company’s cover.

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Posted in: Health Fraud, Politics and Regulation, Science and Medicine, Science and the Media

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Cancer Treatment Centers of America and “naturopathic oncology”

EDITOR’S NOTICE: NOTE THE DISCLAIMER.

On “wholistic” medicine

If there’s one aspect of so-called “alternative medicine” and “complementary and alternative medicine” (CAM) is that its practitioners tout as being a huge advantage over what they often refer to sneeringly as “conventional” or “scientific” medicine is that — or so its practitioners claim — alt-med treats the “whole patient,” that it’s “wholistic” in a way that the evil reductionist “Western” science-based medicine can’t be. Supposedly, we reductionistic, unimaginative physicians only focus on disease and ignore the “whole patient.” Of course, to me this claim is belied by the hectoring to which my own primary care physician has subjected me about my horrible diet and lack of exercise on pretty much every visit I’ve had with her, but then maybe she’s an anomaly, along with Dr. Lipson on this very blog and pretty much every other primary care doctor I’ve ever dealt with. Anecdotal experience, I know, but since alt-med mavens appear to value anecdotal evidence above pretty much all else I thought it appropriate to mention here. Also belying the claim of alt-med practitioners that they “individualize” treatments to their patients in a way that science-based medicine does not is the maddening tendency of various alt-med modalities to settle on just One True Cause of All Disease, be it liver flukes as the One True Cause of Cancer, heavy metal toxicity as the One True Cause of cancer, autism, and various other diseases, or “allergies,” acid, or obstruction of the flow of qi as the One True Cause of All Disease.

Given the claim of “wholism” that is such an advertising gimmick among many of the varieties of woo, I’m always interested when I see evidence that alt-med is imitating its envied and disliked reductionistic competition. True, this is nothing new, given how alt-med has tried to seek legitimacy by taking on the mantle of science-based medicine wherever it can. Examples include the National Center for Complementary and Alternative Medicine (NCCAM), various organizations that try to confer legitimacy to pseudoscience by providing “certification” in various flavors of woo, and moves to push state medical boards to go further than that and confer legally protected status to practitioners by actually licensing them. This latter tactic has been very successful in that many states now license acupuncturists, while some states even license naturopaths and “homeopathic physicians,” the latter of which I find quite amusing because the term perfectly encapsulates what must remain of such a physician’s medical training after being diluted to 30C with woo. The only difference is that, unlike what is claimed with homeopathy, diluting MD medical knowledge with woo does not make it stronger. In terms of naturopathy, though, one of the most alarming aspects of the infiltration of naturopaths into the health care system is that some states in the U.S. and provinces in Canada are seriously considering allowing them to prescribe real pharmaceutical medications, even though they lack the training and knowledge to use such drugs safely.

Imagine my combination of bemusement and alarm, then, when I learned of a new specialty of pseudoscience, namely the field of naturopathic oncology.

Be afraid. Be very afraid. (I know I was when I first encountered this specialty.)
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Posted in: Cancer, Chiropractic, Homeopathy, Science and Medicine

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Another overhyped acupuncture study misinterpreted

acupinhead

Perhaps the most heavily studied of “alternative medicine” modalities is acupuncture. Although it’s hard to be sure as to the reason, I tend to speculate that part of the appeal to trying to do research in this area is because acupuncture is among the most popular of actual “alt-med” modalities, as opposed to science-based medical modalities co-opted by believers in alt-med and rebranded as “alternative” (diet and exercise, for instance, to which is all too often added the consumption of huge quantities of unproven nutritional supplments) or activities that make people feel better, whether they’re healthy or ill (massage, for instance). In contrast, acupuncture involves actually sticking needles into the skin. Never mind that the rationale for acupuncture, namely “redirecting” the flow of the “life energy” known as qi when it is blocked by sticking needles in “meridians” like some electrodes in some imaginary qi battery, is pure bunkum, as we’ve pointed out here at SBM time and time again. Somehow the image of needles sticking out of the skin, apparently painlessly and making some extreme acupuncture practices resemble Pinhead from the Hellraiser movie series, seems “sexy” as far as “alternative” therapies go, particularly since it’s “Eastern” as opposed to that reductionistically evil “Western medicine,” and, as we all know at SBM, “Western” is bad and “Eastern” is good.

So the fascination with acupuncture remains, so much so that an inordinate amount of research dollars are spent on studying it. Unfortunately, that money is largely wasted. As Steve Novella has pointed out, in general in medicine (at least these days), the trajectory of research is usually from bench research to animal models to small scale, less rigorous, pilot studies in humans to large scale, rigorously designed studies using many subjects. True, this order doesn’t always hold. For instance, if physicians make a compelling observation “at the bedside” of response to therapy or how a disease progresses, frequently, after making closer observations to confirm the initial observation, researchers will jump back to animal models and bench top research to try to figure out what’s going on. For such a progression to be useful, though, scientists have to be sure that the phenomenon in human patients under study actually exists.

Unfortunately, in acupuncture, the evidence is still unconvincing that there is any “there” there in that acupuncture effects appear to be no greater than placebo effects. As larger, more well designed studies using real placebo or sham acupuncture techniques, have increasingly shown that acupuncture does not function any better than placebo in human beings (and sometimes even worse), acupuncturists and acupuncture believers have been reversing the usual order of things, doing smaller studies and “pragmatic” (i.e., uncontrolled) clinical trials, where the placebo effect is not controlled for. Never mind that it doesn’t matter where the needles are placed (thus blowing the whole “meridian” idea out of the water) or even if the needles puncture the skin. Toothpicks work just as well as needles. Also never mind that the mythology of acupuncture as having been routinely practiced for over two thousand years (or, sometimes, four thousand years, is largely a creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4). Unfortunately, even the National Center for Complementary and Alternative Medicine (NCCAM) falls for this mythology.

Every so often, I’m amazed when an acupuncture study ends up in a high impact journal like Nature Neuroscience. Of course, when I read such articles, virtually inevitably I discover that what is being studied is not really “acupuncture” per se, but rather sticking needles into either people or animals. Sometimes, “electroacupuncture” (which is in reality not acupuncture at all, given that there was no source of electricity hundreds of years ago in China when acupuncture was supposedly invented) is misrepresented as acupuncture. Since a bunch of readers, both here and at my other blog, have deluged my mail box with this particular study, I felt obligated to have a look at it, even if Steve Novella has already weighed in with his excellent deconstruction. This particular study is especially annoying, because it’s been hyped to the nth degree, and even some news sources where the reporters should know better have fallen for it.
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Posted in: Acupuncture, Science and the Media

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Potential New Mechanism of Pain Relief Discovered

The development of drugs and other treatments for specific symptoms or conditions relies heavily on either serendipity (the chance finding of a beneficial effect) or on an understanding of underlying mechanisms. In pain, for example, there are limited ways in which we can block pain signals – such as activating opiate receptors or inhibiting prostaglandins. There are only so many ways in which you can interact with these systems. The discovery of a novel mechanism of modulating pain is therefore most welcome, and has the potential of leading to entirely new treatments that may have better side-effect profiles than existing treatments and also have additive clinical effects.

A recent study by Nana Goldman et. al., published in Nature Neuroscience, adds to our understanding of pain relief by identifying the role of adenosine in reducing pain activity in the peripheral nervous system. The researchers, in a nice series of experiments, demonstrated that producing a local painful stimulus in mice causes the local release of ATP (adenosine triphosphate) that peaks at about 30 minutes. This correlates with a decreased pain response in the mice. Further, if drugs are given that prolong the effect of adenosine, the analgesic effect itself is prolonged.

Also, if drugs are given that activate the adenosine A1 receptor, the observed analgesic effect is replicated. When these experiments are replicated in knockout mice that do not have the gene for the adenosine A1 receptor, there is no observed analgesic effect.

Together these experiments are fairly solid evidence that local pain results in the local release of adenosine that in turn binds to the adenosine A1 receptor inhibiting the pain response. This is potentially very exciting – it should lead to further investigation of the adenosine A1 receptor and the effects of activating and inhibiting it. This may lead to the development of drugs or other interventions that activate these receptors and may ultimately be a very useful addition to our ability to treat acute and chronic pain.

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Posted in: Acupuncture, Neuroscience/Mental Health

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