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 CAM
Journal of Clinical Oncology editorial: “Compelling” evidence acupuncture “may be” effective for cancer related fatigue
Journal of Clinical Oncology (JCO) is a high impact journal (JIF > 16) that advertises itself as a “must read” for oncologists. Some cutting edge RCTs evaluating chemo and hormonal therapies have appeared there. But a past blog post gave dramatic examples of pseudoscience and plain nonsense to be found in JCO concerning psychoneuroimmunology (PNI) and, increasingly, integrative medicine and even integrations of integrative medicine and PNI. The prestige of JCO has made it a major focus for efforts to secure respectability and third-party payments for CAM treatments by promoting their scientific status and effectiveness.
Once articles are published in JCO, authors can escape critical commentary by simply refusing to respond, taking advantage of an editorial policy that requires a response in order for critical commentaries to be published. An author’s refusal to respond means criticism cannot be published.
Some of the most outrageous incursions of woo science into JCO are accompanied by editorials that enjoy further relaxation of any editorial restraint and peer review. Accompanying editorials are a form of privileged access publishing, often written by reviewers who have strongly recommended the article for publication, and having their own PNI and CAM studies to promote with citation in JCO.
Because of strict space limitations, controversial statements can simply be declared, rather than elaborated in arguments in which holes could be poked. A faux authority is created. Once claims make it into JCO, their sources are forgotten and only the appearance a “must read,” high impact journal is remembered. A shoddy form of scholarship becomes possible in which JCO can be cited for statements that would be recognized as ridiculous if accompanied by a citation of the origin in a CAM journal. And what readers track down and examine original sources for numbered citations, anyway?
Your health insurance plan probably covers anti-inflammatory drugs. But does it cover acupuncture treatments? Should it? Which health services deliver good value for money? Lest you think the debate is limited to the United States (which is an outlier when it comes to health spending), even countries with publicly-run healthcare systems are scrutinizing spending. Devoting dollars to one area (say, hospitals) is effectively a decision not to spend on something else, (perhaps public health programs). All systems, be they public or private, allocate funds in ways to spend money in the most efficient way possible. Thoughtful decisions require a consideration of both benefits and costs.
One of the consistent positions put forward by contributors to this blog is that all health interventions should be evaluated based on the same evidence standard. From this perspective, there is no distinct basket of products and services which are labelled “alternative”, “complementary” or more recently “integrative”. There are only treatments and interventions which have been evaluated to be effective, and those that have not. The idea that these two categories should both be considered valid approaches is a testament to promoters of complementary and alternative medicine (CAM), who, unable to meet the scientific standard, have argued (largely successfully) for different standards and special consideration — be it product regulation (e.g., supplements) or practitioner regulation.
Yet promoters of CAM seek the imprimatur of legitimacy conferred by the tools of science. And in an environment of economic restraint in health spending, they further recognize that showing economic value of CAM is important. Consequently they use the tools of economics to argue a perspective, rather than answer a question. And that’s the case with a recent paper I noticed was being touted by alternative medicine practitioners. Entitled, Are complementary therapies and integrative care cost-effective? A systematic review of economic evaluations, it attempts to summarize economic evaluations conducted on CAM treatments. Why a systematic review? One of the more effective tools for evaluating health outcomes, a systematic review seeks to analyze all published (and unpublished) information on a focused question, using a standardized, transparent approach to evidence analysis. When done well, systematic reviews can sift through thousands of clinical trials to answer focused questions in ways that are less biased than cherry-picking individual studies. The Cochrane Review’s systematic reviews form one of the more respected sources of objective information (with some caveats) on the efficacy of different health interventions. So there’s been interest in applying the techniques of systematic reviews to questions of economics, where both costs and effects must be measured. Economic evaluations at their core seek to measure the “bang for the buck” of different health interventions. The most accurate economic analyses are built into prospective clinical trials. These studies collect real-world costs and patient consequences, and then allow an accurate evaluation of value-for-money. These types of analyses are rare, however. Most economic evaluations involve modelling (a little to a lot) where health effects and related costs are estimated, to arrive at a calculation of value. Then there’s a discussion of whether that value calculation is “cost-effective”. It’s little wonder that many health professionals look suspiciously at economic analyses: the models are complicated and involve so many variables with subjective inputs that it can be difficult to sort out what the real effects are. Not surprisingly, most economic analyses suggest treatments are cost-effective. Before diving into the study, let’s consider the approach:
One of the points I’ve tried to emphasize through my contributions to Science-Based Medicine is that every treatment decision requires an evaluation of risks and benefits. No treatment is without some sort of risk. And a decision to decline treatment has its own risks. One of the challenges that I confront regularly as a pharmacist is helping patients understand a medication’s expected long-term benefits against the risks and side effects of treatment. This dialogue is most challenging with symptomless conditions like high blood pressure, where patients face the prospect of immediate side effects against the potential for long-term benefit. One’s willingness to accept side effects is influenced, in part, by and understanding of, and belief in, the overall goals of therapy. Side effects from blood-pressure medications can be unpleasant. But weighed against the reduced risk of catastrophic events like strokes, drug therapy may be more acceptable. Willingness to accept these tradeoffs varies dramatically by disease, and are strongly influenced by patient-specific factors. In general, the more serious the illness, the greater the willingness to accept the risks of treatment.
As I’ve described before, consumers may have completely different risk perspectives when it comes to drug therapies and (so-called) complementary and alternative medicine (CAM). For some, there is a clear delineation between the two: drugs are artificial, harsh, and dangerous. Supplements, herbs and anything deemed “alternative”, however, are natural, safe, and effective. When we talk about drugs, we use scientific terms – discussing the probability of effectiveness or harm, and describing both. With CAM, no tentativeness or balance may be used. Specific treatment claims may not be backed up by any supporting evidence at all. On several occasions patients with serious medical conditions have told me that they are refusing all drug treatments, describing them as ineffective or too toxic. Many are attracted to the the simple promises of CAM, instead. Now I’m not arguing that drug treatment is always necessary for ever illness. For some conditions where lifestyle changes can obviate the need for drug treatments, declining treatment this may be a reasonable approach – it’s a kick in the pants to improve one’s lifestyle. Saying “no” may also be reasonable where the benefits from treatment are expected to be modest, yet the adverse effects from treatments are substantial. These scenarios are not uncommon in the palliative care setting. But in some circumstances, there’s a clear medical requirement for drug treatment – yet treatment is declined. This approach is particularly frustrating in situations where patients face very serious illnesses that are potentially curable. This week is the World Cancer Congress in Montreal and on Monday there were calls for patients to beware of fake cancer cures, ranging from laetrile, to coffee enemas, to juicing, and mistletoe. What are the consequences of using alternative treatments, instead of science-based care, for cancer? There are several studies and a recent publication that can help answer that question. (more…)
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.
I know a woman who is a survivor of colorectal cancer. At one point, doctors had given up hope and put her in hospice, but she failed to die as predicted and was eventually discharged. She continues to suffer intractable symptoms of pain with alternating diarrhea and constipation. I don’t have access to her medical records, but she tells me her doctors have talked about irritable bowel syndrome (IBS) and have also suggested that the heavy doses of radiation used to treat her cancer may have caused permanent damage to her colon. Whatever the cause, her symptoms have seriously interfered with her mobility and her quality of life. Her health care providers have recently recommended questionable treatments in what I think can be construed as using CAM as a dumping ground for difficult patients.
Colonoscopy hadn’t shown any obstruction, but one of her doctors had hypothesized that her symptoms might be due to impaired bowel motility in the irradiated area. She was desperate enough to consider surgery if there was a chance that bowel resection or colostomy might improve her symptoms. She belongs to a large, well-known HMO with a good reputation. She asked her primary HMO physician who thought the idea was plausible and referred her to a surgeon. The first surgeon said surgery was not indicated and referred her to another surgeon on staff. In addition to being board certified in general surgery, the second surgeon was allegedly board certified in something related to CAM (my friend can’t remember his exact words and has been unable to verify any such credentials online).
The surgeon recommended acupuncture, not once but twice. My friend’s husband (who teaches statistics at a nearby community college) told the surgeon that he was fascinated by the challenges of double-blinded studies of acupuncture and that he was aware of no benefits beyond the placebo level. The surgeon then retreated a little and suggested that the primary benefit of acupuncture in treating IBS was the “relaxation” effect.
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.
The Bravewell Collaborative maps the state of “integrative medicine” in the U.S., or: Survey says, “Hop on the bandwagon of ‘integrative medicine’!” (2012 Edition)
Earlier today, Steve discussed a new report hot off the presses (metaphorically speaking, given that it’s been published online) from the Bravewell Collaborative. Naturally, given the importance of the issue, I couldn’t resist jumping in myself, but before you read the blather I have to lay down, you really should read what Steve wrote about it. It’s that good. (Also, he’s our fearless leader, and I wouldn’t want him to be…unhappy about my having muscled in on his usual day to post.) Have you read it? Good. Now we can begin…
One of the most common (and potent) strategies used by promoters of “complementary and alternative medicine” (CAM)–or, as its proponents like to call it these days, “integrative medicine” (IM)–to convince the public and physicians either to use it (or at least to remain a shruggie about it) is in essence an argumentum ad populum; i.e., an appeal to popularity. Specifically, CAM/IM apologists like to use the variant of argumentum ad populum known as the “bandwagon effect,” in which they try to persuade patients and physicians that they should get with the CAM/IM program because, in essence, everyone else is doing it and it’s sweeping the nation in much the same way New Coke did in the 1980s. (Admittedly, CAM/IM apologists are, unfortunately, much better at sales than Coca-Cola was.) Not coincidentally, this is one type of method of persuasion much favored by Madison Avenue when selling cars, clothing, music, movies, food, beer, and nearly every other product–like Coca-Cola. I say “not coincidentally” because what CAM proponents are doing, more than anything else, is selling a lifestyle, a brand, a belief system, and, of course, many, many products whose value reminds me, more than anything else, of the aforementioned New Coke. In using this appeal to popularity, CAM/IM proponents try to portray stodgy physicians (you know, like pretty much every one of us at this blog) who insist on plausibility, science, and evidence to support the use of drugs and treatments as hopelessly behind the times, dogmatic, out of touch, and in general no fun to be around at all, particularly at parties.
“Obama Promises $156 Million to Alzheimer’s…But where will the money come from?” That’s easy: the NCCAM!
The quoted language above is part of the headline of this story in today’s The Scientist:
Citing the rising tide of Americans with Alzheimer’s—projections suggest 10 million people will be afflicted by 2050—the Obama administration and top National Institutes of Health officials are taking action. On February 7, they announced that they will add an additional $80 million to the 2013 NIH budget for the Alzheimer’s research program.
The problem is that there ain’t no such thing as a free lunch:
However, Richard Hodes, director of the NIH’s National Institute on Aging, told Nature that the 2013 dollars still have to be approved by Congress in the next budget and, if not, existing programs may need to be cut. And this year’s $50 million is likely to bump other projects, perhaps at NIH’s National Human Genome Research Institute. “If there’s a finite budget anywhere, once there’s more of something, there is less of something else,” he said.
Often such budget compromises are difficult, because there is no ready way to choose between two or more competing recipients of taxpayers’ money, each of which might be comparably worthy. Thus it is with a great sense of relief that in this case, we in the biomedical community can assure President Obama that no such dilemma exists. This is one of those occasional decisions that requires no hair-pulling whatsoever. The obvious solution is to defund the National Center for Complementary and Alternative Medicine (NCCAM), which, at about $130 million/yr, would solve the problem of funding Alzheimer’s research and take the heat off other worthy programs such as those mentioned by Richard Hodes.
Dr. Ian Gawler, a veterinarian, suffered from osteogenic sarcoma (a form of bone cancer) of the right leg when he was 24 in 1975. Treatment of the cancer required amputation of the right leg. After completing treatment he was found to have lumps in his groin. His oncologist at the time was confident this was local spread from the original cancer, which is highly aggressive. Gawler later developed lung and other lesions as well, and was given 6 months to live due to his metastatic disease.
Gawler decided to embark on an alternative treatment regimen, involving coffee enemas, a vegetarian diet, and meditation. Eventually he was completely cured of his terminal metastatic cancer. He has since become Australia’s most famous cancer survivor, promoting his alternative approach to cancer treatment, has published five books, and now runs the Gawler Foundation.
At least, that is the story he believes. There is one major problem with this medical tale, however – while the original cancer was confirmed by biopsy, the subsequent lesions were not. His oncologist at the time, Dr. John Doyle, assumed the new lesions were metastatic disease and never performed a biopsy. It was highly probable – the timing and the location of the new lumps following a highly aggressive cancer. But even a diagnosis that is 95% likely will be wrong in 1 patient out of 20 – which means a working physician will have patients with the 5% diagnosis about once a week. The standard of practice today would be to do a biopsy to get tissue confirmation of the diagnosis, and rule out the less likely alternatives.