In a previous post, we looked at how so-called “complementary and alternative medicine” (or “CAM”) might fit into the definition of “essential health benefits,” which must be covered by insurers pursuant to the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA”). In another, we contemplated what it might mean for insurers to “discriminate” against CAM providers, which is prohibited by the ACA. In both posts, the conclusion reached was that these provisions of Obamacare might not incorporate CAM practices into health care at the level CAM providers were hoping for. Here again we examine how the great expectations of CAM promoters may not be met in health care reform.
This time, we take a look at some additional provisions of the ACA that CAM lobbyists and their friends in Congress managed to insert into the healthcare overhaul. Of course, whether the ACA is around for much longer will depend on the outcome of the November elections, although Gov. Romney’s promise to “repeal Obamacare” if elected president will happen only if his party wins a majority in both the House of Representatives and Senate. (more…)
I’ll begin with the possibly shocking admission that I’m a strong supporter of the collection of ideas and techniques known as evidence-based medicine (EBM). I’m even the current President of the Evidence-Based Veterinary Medicine Association (EBVMA). This may seem a bit heretical in this context, since EBM takes a lot of heat in this blog. But as Dr. Atwood has said, “we at SBM are in total agreement…that EBM “should not be without consideration of prior probability, laws of physics, or plain common sense,” and that SBM and EBM should not only be mutually inclusive, they should be synonymous.” So I have hope that by emphasizing the distinction between SBM and EBM and the limitations of EBM, we can engender the kind of changes in approach needed to address those limitations and eliminate the need for the distinction. One way of doing this is to critically evaluate the misuses of EBM in support of alternative therapies.
One of the highest levels of evidence in the hierarchy of evidence-based medicine is the systematic review. Unlike narrative reviews, in which an author selects those studies they consider relevant and then summarizes what they think the studies mean, which is a process subject to a high risk of bias, a systematic review identifies randomized controlled clinical trials according to an explicit and objective set of criteria established ahead of time. Predetermined criteria are also used to grade the studies evaluated by quality so any relationship between how well studies are conducted and the results can be identified. Done well, a systematic review gives a good sense of the balance of the evidence for a specific medical question.
Unfortunately, poorly done systematic reviews can create an strong but inaccurate impression that there is high-level, high-quality evidence in favor of a hypothesis when there really isn’t. Reviews of acupuncture research illustrate this quite well.
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 somecaveats) 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:
David Gorski recently pointed out that Science Based Medicine is going on five years. Amazing. That there would be so much to write about day after day comes as a surprise to me. Somehow I vaguely thought that ‘controversies’ would be resolved. Pick a SCAM, contrast the SCAM with reality as best we understand it, and, once the SCAM was found wanting, it would be abandoned. Why would rational, thoughtful people persist in the pursuit of irrational behavior, contradicted by the universe?
Ha. More the fool me. I would never have guessed that these SCAMs are harder to kill than Dracula (at least one version of Dracula). Stake them and back they come*.
I have tried to avoid repeating repeating information found in prior posts by myself and others, in part because I am lazy and in part because, well, I have said it before. Just look it up. I have come to realize (all too slowly) that each blog entry should be self contained and that much of the old material is lost in the corn maze (an punning homophone) that is WordPress. Reading my second favorite computer reinforces the realization that each post often needs to be an island universe, complete in itself.
Supporters of science-based medicine have expressed concern over this provision in the Patient Protection and Affordable Care Act (“Obamacare,” or the “ACA.”):
SEC. 2706. NON-DISCRIMINATION IN HEALTH CARE.
(a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.
Section 2706 (now codified as 42 U.S.C. Sec. 300gg-5) goes into effect in 2014 and covers virtually all individual and group insurance market policies, although it is not clear whether it will apply to existing policies “grandfathered” in 2010 by the ACA.
Section 2706 was not part of the U.S House of Representatives version of the ACA but was included in the Senate version (which ultimately passed) under the guidance of (surprise!) Sen. Tom Harkin (D-Iowa). It was heavily lobbied by the American Chiropractic Association and other “CAM” providers, as well as some “conventional” providers like nurse anesthetists and optometrists. The legislative history (reports, committee minutes, floor debates and the like which precede a vote on a bill) indicates it was specifically included to prevent discrimination against CAM providers. This is of obvious concern to anyone who supports science-based, or for that matter evidence-based, medicine, as there is nothing to indicate that scientific plausibility or evidence (or the lack thereof) actually affects CAM practices. It should also concern insurers and those who pay for insurance (employers and individuals) to the extent it might require payment for CAM treatments, as ineffective treatments will negatively affect their bottom line. The U.S. Departments of Health and Human Services (HHS) and Labor and the Treasury Department, which are charged with issuing regulations implementing the ACA, have not yet promulgated regulations for Section 2706. The American Medical Association House of Delegates has already passed a resolution seeking its repeal.
I realize that Steve blogged about this study earlier in the week, but since I also commented on this particular study as my not-so-super-secret alter ego, I figured it rated a place on SBM as well. I emphasized different aspects of the study and tried to quantify exactly why, under even the most charitable interpretation of the study possible, the effects are not clinically significant. Besides, if the level of comments and e-mails is any indication, there is sufficient interest in this particular study to rate a second post.
Not suprisingly, this study is about about acupuncture. Well, it’s not exactly a study, it’s a meta-analysis that aggregates a whole lot of acupuncture studies in which this most popular of woos is administered to patients with chronic pain from a variety of causes. It’s also being promoted all over the place with painfully credulous headlines like: (more…)
The [California Department of Consumer Affairs'] use of the term “endorsement” is inaccurate, may confuse the public, and may lead the public to falsely conclude that NIH has made certain efficacy and/or safety conclusions regarding acupuncture. Further, consensus conference reports are not a policy statement of NIH or the Federal Government… NIH asks that you correct these two points of information in your booklet and on your website.
— Jack Killen, MD, Deputy Director, NCCAM, NIH
I have to praise the Deputy Director of the National Center for Complementary and Alternative Medicine (NCCAM), Jack Killen, for asking the State of California to remove a couple of false claims in a “Consumer’s Guide” on acupuncture.
Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.
News reports generally reflect this conclusion – acupuncture works, but mostly (although not entirely) through placebo effect, but that’s OK.
I took a close look at the study and find that the authors display considerable pro-acupuncture bias in their analysis and discussion. They clearly want acupuncture to work. That aside, the data are simply not compelling, and the authors, in my opinion, grossly overcall the results, which are compatible with the conclusion that there are no specific effects to acupuncture beyond placebo.
[o]nce considered archaic and obsolete, Oriental Medicine has greatly benefited from the postmodern attitudes towards science and knowledge. This is because postmodernists consider the ‘truth’ as being relative to one’s viewpoint or stance. They do not see science as a superior process of acquiring knowledge, but as a ‘belief system,’ a ‘language game,’ which does not give more access to truth than other conceptual constructs.
This “postmodern fallacy,” he continued,
has allowed the return of mass professional delusions under the label of Chinese, Oriental or Asian Medicine. As an unfortunate byproduct, dangerous and outdated therapies have been legitimized, and quacks and charlatans can overtly defraud those who cannot distinguish scientific medicine from lore and fantasy.
There is probably no better example of this “unfortunate byproduct” than the state acupuncture and oriental medicine practice acts. These laws have indeed legitimized dangerous and outdated therapies, allowing quacks and charlatans to defraud the public.
Editor’s Note:Dr. Gorski was on a rare vacation last week, recharging his batteries. As a result, there is no new material by him this week. Fortunately, Ben Kavoussi was ready with another in his series of posts on traditional Chinese medicine. Dr. Gorski will return next week; that is, if he doesn’t return even sooner because he can’t stand to be away from SBM for two whole weeks.
The established laws of nature do not support Oriental Medicine’s claim of Yin and Yang and Five-Phases Theory. Oriental Medicine’s main theory was constructed when our civilization had limited methods to understand our surroundings, and as such, it is only an ancient illusion.1
— Yong-Sang Yoo, MD, PhD, Chairman of the Committee for Medical Unification, Korean Medical Association, 2010
Yong-Sang Yoo is one of the strong and growing voices in Korea that is calling for an end to the national insurance coverage for Oriental Medicine.
Similarly, Professor Zhang Gongyao of the Central South China University petitioned the central government of China in 2006 to abolish support for Oriental Medicine because it has “no clear understanding of the human body, of the functions of medicines and their links to disease. It is more like a boat without a compass: it may reach the shore finally but it’s all up to luck.”2 Zhang Gongyao and fellow critics have consequently blasted China’s traditional medicine as an often ineffective, even dangerous derivative of witchcraft that relies on untested concoctions and obscure ingredients to trick patients, and employs a host of excuses if the treatments do not work.3
Bloodletting is used in Oriental Medicine to relieve excess “heat,” meaning fever, sore throat, joint pain, muscle sprain, as well as inflammation. It is often practiced in unsanitary conditions.
A Product of Archaic Thinking
The arguments of Yong-Sang Yoo and Zhang Gongyao are reminiscent of those of William R. Morse, Dean of Medical School at West China Union University, who wrote in 1934 that China’s traditional medicine was a “weird medley of philosophy, religion, superstition, magic, alchemy, astrology, feng shui, divination, sorcery, demonology and quackery.” Morse added that Chinese diagnostic methods “border on the ridiculous and possibly cross the line into absurdity.” Harvey J. Howard — a Dean at the Peking Union Medical College — also wrote in 1934 that “the great majority of these Chinese medicines reminds one of the list of remedies suggested by the third witch in Shakespeare’s Hamlet.”4