When you pick up a bottle of supplements, should you trust what the label says? While there is the perception that supplements are effective and inherently safe, there are good reasons to be skeptical. Few supplements are backed by good evidence that show they work as claimed. The risks of supplements are often not well understood. And importantly, the entire process of manufacturing, distributing, and marketing supplements is subject to a completely different set of rules than for drugs. These products may sit on pharmacy shelves, side-by-side with bottles of Tylenol, but they are held to significantly lower safety and efficacy standards. So while the number of products for sale has grown dramatically, so has the challenge to identify supplements that are truly safe and effective. (more…)
Posts Tagged NCCAM
I don’t much like Senator Tom Harkin (D-IA), and, I daresay, neither do any of my fellow bloggers here.
The reason should be painfully obvious. Arguably, no single elected official currently serving today (or ever) has done more over a longer period of time to promote quackery in the United States. I make this harsh assessment because Senator Harkin was the legislator who created the National Center for Complementary and Alternative Medicine (NCCAM) and has been its most powerful patron, promoter, and protector. It’s a center in the National Institutes of Health (NIH) of which we at this blog have regularly been quite critical, right from the very beginning, when I pointed out how our taxpayer dollars were being wasted on pseudoscience and quackery, while Wally Sampson provided some perspective on how this situation came to be and I gave a bit of history of NCCAM. Since then, we’ve been hammering away at NCCAM as a blight on the the science of the NIH, whether intramural or extramural.
Three years ago, we even managed to attract the notice of Josephine Briggs, the current director of NCCAM, who invited us to Bethesda for a meeting. It was a very cordial meeting, as described by Steve Novella and myself. Unfortunately, in the name of “balance,” Dr. Briggs turned right around and met with a bunch of homeopaths and then drew a false equivalency between us “skeptics” and proponents of quackery as represented by the homeopaths. Clearly, she didn’t get it, or, if she did get it, her position was such that she couldn’t bite the hand that feeds NCCAM. A year after that, NCCAM published a five year strategic plan, which I characterized as “let’s do some rigorous science for a change,” given that that’s about all it said. It’s a nice sentiment. We’ll see if it actually happens, although I doubt that it will. Although studying herbs is nothing but a form of pharmacognosy (natural products pharmacology) and studying lifestyle interventions is science-based medicine, neither of them are actually “CAM” per se, because there is nothing “alternative” about them other than their having been co-opted as a “foot in the door” grafted onto the more serious woo. Like a stray limb grafted onto Frankenstein’s monster, they don’t belong and don’t fit.
But I digress. NCCAM has that effect on me.
A Congressional champion of quackery decides to quack no more (after 2014, anyway)
As hard as it is to believe, the Science-Based Medicine blog that you’re so eagerly reading is fast approaching its fifth anniversary of existence. The very first post here was a statement of purpose by Steve Novella on January 1, 2008, and my very first post was a somewhat rambling introduction that in retrospect is mildly embarrassing to me. It is what it is, however. The reason I mention this is because I want to take a trip down memory lane in order to follow up on one of my earliest posts for SBM, which was entitled The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Specifically, I want to follow up on one specific study I mentioned that was funded by NCCAM.
Even though I not-so-humbly think that, even nearly five years later, my original post is worth reading in its entirety (weighing in at only 3,394 words, it’s even rather short—for me, at least), I’ll spare you that and cut straight to the chase, the better to discuss the study. It is a study of homeopathy. Yes, in contrast to the protestations of Dr. Josephine Briggs, the current director of NCCAM, that NCCAM doesn’t fund studies of such pure pseudoscience as homeopathy anymore (although she does apparently meet with homeopaths for “balance”), prior to Dr. Briggs’ tenure NCCAM actually did fund studies of the magic water with mystical memory known as homeopathy. Two grants in particular I singled out for scorn. The principal investigator for both grants was Iris Bell, who is faculty at Andrew Weil’s center of woo at the University of Arizona. The first was an R21 grant for a project entitled Polysomnography in homeopathic remedy effects (NIH grant 1 R21 AT000388).
It’s one of the most common quackeries out there, used by a wide variety of practitioners for a wide variety of ailments blamed on “heavy metal toxicity.” Chelation therapy, which involves using chemicals that can bind to the metal ions and allow them to be excreted by the kidneys, is actually standard therapy for certain types of acute heavy metal poisoning, such as iron overload due to transfusion, aluminum overload due to hemodialysis, copper toxicity due to Wilson’s disease, acute heavy metal toxicity, and a handful of other indications.
My personal interest in chelation therapy developed out of its use by unscrupulous practitioners who blamed autism on the mercury-containing thimerosal preservative that used to be in many childhood vaccines until 2001 but has since all but disappeared from such vaccines except for one vaccine (the flu vaccine, for which a thimerosal-free alternative is available) and in trace amounts in some other vaccines. Mercury became a convenient bogeyman to add to the list of “toxins” antivaccinationists hype in vaccines. In fact, my very first post after I introduced myself on this very blog discussed the idea that mercury in vaccines was a significant cause of autism and autism spectrum disorders, and I’ve periodically written about such things ever since, in particular the bad science of Mark and David Geier, whose idea that chemical castration of children with Lupron “works” against “mercury-induced” autism is based on a chemically ridiculous idea that somehow testosterone binds mercury and makes it harder to chelate. Unfortunately, this particular autism quackery has real consequences and has been responsible for the death of a child.
Chelation isn’t just for autism, however. Despite many practitioners advertising it for autism, cancer (often with dubious studies that I might have to take a look at), Alzheimer’s disease (which Hugh Fudenberg has blamed on the flu vaccine, a claim parroted by Bill Maher, of course!), and just about every ailment under the sun, it’s easy to forget that the original use for chelation therapy promoted by “alternative medicine” practitioners was for cardiovascular disease. When it is used for coronary artery disease or autism, on a strictly stoichiometric and pharmacological basis, it is extremely implausible. Moreover, it is not without potential complications, including renal damage and cardiac arrhythmias due to sudden drops in calcium levels. Such arrhythmias can and have led to death in children, and in adults complications such as renal failure and death.
The ill-advised, NIH-sponsored Trial to Assess Chelation Therapy (TACT) is finally over. 839 human subjects were randomized to receive Na2EDTA infusions; 869 were randomized to receive placebo infusions. The results were announced at this weekend’s American Heart Association meeting in Los Angeles. In summary, the TACT authors report a slight advantage for chelation over placebo in the “primary composite endpoint,” a combination of five separate outcomes: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina:
Although that result may seem intriguing, it becomes less so when the data are examined more carefully. First, it barely achieved the pre-ordained level of statistical significance, which was P=.036. Second, none of the individual components of the composite endpoint achieved statistical significance, and most of the absolute difference was in coronary revascularization–which is puzzling:
I don’t know how I’ve missed this, given that it’s been in existence now for a month and a half, but I have. Regular readers (and even fairly recent readers, given that I write about this topic relatively frequently) know that I’m not a big fan of the National Center for Complementary and Alternative Medicine (NCCAM). (Come to think of it, neither is anyone else writing for this blog.) Just search this blog for “NCCAM” if you don’t believe me. I’ve explained the reasons many times, but the CliffsNotes version is that NCCAM is an enormous waste of taxpayer money, dedicated as it is to the study of modalities that are at best highly implausible and at worst break well-established laws of physics (i.e., “energy healing”). I do concede that, since the latest NCCAM director (Dr. Josephine Briggs) took over, there has been a noticeable attempt to bring more scientific rigor to NCCAM, and to some extent Dr. Briggs has succeeded. At the very least she is a legitimate scientist with an impressive pre-NCCAM track record, and I do fear who will succeed her when she moves on or retires given that there is enormous pressure from the CAM community to appoint one of their own as director.
Unfortunately, as rigorous a scientist as Dr. Briggs was in her former life, since coming to NCCAM she has gradually been assimilated into the culture of the place. Indeed, although it is good that NCCAM has backed away from studying woo like homeopathy and distance healing, the co-optation of science-based modalities such as exercise, diet, and natural products pharmacology has continued apace. Worse, the recently released five year strategic plan for NCCAM admitted that the science funded by NCCAM in the past was crap and, in essence, promised to do some real science for a change. That’s why on occasion I’ve jokingly said that we should take off and nuke NCCAM from orbit. It’s the only way to be sure. On the other hand, no doubt someone would think I seriously mean that we should nuke NCCAM. Of course, I’d never advocate that! NCCAM is located right smack dab in the middle of the NIH campus. The collateral damage would be unacceptable.
Voodoo science is a sort of background noise, annoying but rarely rising to a level that seriously interferes with genuine scientific discourse… The more serious threat is to the public, which is not often in a position to judge which claims are real and which are voodoo. Those who are fortunate enough to have chosen science as a career have an obligation to inform the public about voodoo science.
– Robert L. Park, PhD, 20001
Imagine you are an ordinary person with limited knowledge of science and medicine, and you see this 2010 video on tai chi and qi gong by the National Center for Complementary and Alternative Medicine (NCCAM) — one of the agencies that make up the National Institutes of Health (NIH). I am certain that the solemn voice of the Director of NCCAM, Dr. Josephine Briggs, talking about “rigorous scientific research” and “accurate, authoritative information on complementary and alternative medicine,” will leave you with a strong sense of confidence in her message.
In addition, despite the fine-print and the disclaimer, the appearance of Dr. Briggs in the video could be broadly viewed as a sign of tacit endorsement. Often, the very fact that a treatment is associated with the government is already a de facto stamp of approval and a warranty of efficacy. For instance, the publication below by the California Department of Consumer Affairs states that the NIH formally “endorses” acupuncture, simply because in 1997, a panel of scientists assessed its use and effectiveness for a variety of conditions. Since 1997 the scientific review of acupuncture by NIH has become synonymous with its endorsement, despite the fact that as a federal research agency, the NIH does not endorse any product, service, or treatment.
In October 26, 2011, a few weeks after Steve Jobs’ death, Josephine Briggs decided to do something she has never done before: she put an explicit disclaimer on her blog:
When making treatment decisions, unproven “alternative medicine” approaches should not replace conventional medical care approaches known to be useful or helpful. Simply put, the evidence is not there (emphasis added).2
Three paragraphs down the page, she goes on — with a candor rarely seen from her — that given the recent news about Steve Jobs’ choices for cancer treatment, all health decisions “should be guided by the best available evidence.”
Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.
Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.
“NCCAM officials have spent $375,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer.”
The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.
Two weeks ago I promised that I would discuss the Marino Center for Integrative Health, identified in the recent Bravewell report as having a “hospital affiliation” with the Newton-Wellesley Hospital (NWH) in Newton, Massachusetts, which is where I work. I also promised in that post that I’d provide examples of ‘integrative medicine’ practitioners offering false information about the methods that they endorse. I’d previously made that assertion here, and Jann Bellamy subsequently discussed its legal and ethical implications here. The Marino Center is a wellspring of such examples.
A Misleading ‘Affiliation’
Let’s quickly dispel the “hospital affiliation” claim. According to the Marino Center website:
Hospital AffiliationsIn support of our services and to ensure that our patients have access to exceptional tertiary care, the Marino Center maintains deeply established relationships and affiliations for referrals and admitting privileges with major medical facilities in the Boston area.
The Marino Center:
- Is a proud member of the Partners Healthcare family
- Is affiliated with Newton Wellesley Hospital
- Makes referrals to Mass General Hospital, Dana Farber, Children’s Hospital and more
Well, it wouldn’t surprise me if the Marino Center is a ‘member’ of the Partners Healthcare family, which includes not only the Newton-Wellesley Hospital, but lesser known entities such as the Massachusetts General Hospital and the Brigham and Women’s Hospital. After all, there are already unfortunate pseudomedical schemes involving Partners entities, such as the Osher Center for Complementary and Integrative Medical Therapies and, even under my own roof (I shudder as I write this), a Reiki Workshop. Nevertheless, it’s telling, I hope, that not only does the Marino Center fail to appear under any list of Partners affiliates, Community Health Partnerships, Wellness, Prevention, or any other conceivable category, but it fails to yield a single ‘hit’ when entered as a search term on the Partners website (the term ‘integrative’ yields seven hits, but none appears to be about ‘CAM,’ except possibly for an RSS feed that I’ve no patience to peruse. Is it possible that Partners is embarrassed by the Osher Center? I hope that, too).
I’ve previously asserted that the NWH is not affiliated with the Marino Center, other than that some Marino Center physicians have been—against my judgment, not that I was consulted—granted hospital staff privileges. I made this assertion in my original Bravewell post a couple of weeks ago, after having questioned the NWH Chief Medical Officer, Dr. Les Selbovitz, who verified it; nothing on the NWH website suggests otherwise.
I’ve no reason to doubt the Marino Center’s third bullet above, “makes referrals to Mass General Hospital,” etc., but this is something that any physician can do, regardless of affiliation. I suspect that if there were an ‘integrative hospital‘ in Boston, reason forbid, the Marino Center would make referrals to it.
False and Misleading Information about ‘Services’
Let’s get to the meat of the problem.
This is yet another response to the recent “Integrative Medicine in America” report published by the Bravewell Collaborative. Drs. Novella and Gorski have already given that report its due, so I won’t repeat the background information. Inevitably, I’ll cover some of the same points, but I’ll also try to emphasize a few that stand out to me. Most of these have been discussed on SBM over the years, but bear repeating from time to time. Let’s begin with:
If it Ducks like a Quack…
Misleading language is the sine qua non of ‘integrative medicine’ (IM) and its various synonyms. The term itself is a euphemism, intended to distract the reader from first noticing the quackery that is its distinguishing characteristic. As previously explained, Bravewell darlings Andrew Weil and Ralph Snyderman, quack pitchmen extraordinaires, recognized nearly 10 years ago that if you really want to sell the product, you should dress it up in ways that appeal to a broad market.
Let’s see how this is done in the latest report. Here is the very first sentence:
The impetus for developing and implementing integrative medicine strategies is rooted in the desire to improve patient care.
Who would disagree with improving patient care? (Try not to notice the begged question). Here’s the next paragraph (emphasis added): (more…)