Mea culpa to the max. I completely forgot that today is my day to post on SBM, so I’m going to have to cheat a little. Here is a link to a recent article by yours truly that appeared on Virtual Mentor, an online ethics journal published by the AMA with major input from medical students. Note that I didn’t write the initial scenario; that was provided to me for my comments. The contents for the entire issue, titled “Complementary and Alternative Therapies—Medicine’s Response,” are here. Check out some of the other contributors (I was unaware of who they would be when I agreed to write my piece).
Posts Tagged placebo
Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month I blogged about the frequency of placebo prescribing by physicians. I admitted my personal discomfort, stating I’d refuse to dispense any prescription that would require me to deceive the patient. The discussion continued in the comments, where opinions seemed to range from (I’m paraphrasing) “autonomy, shmatonomy, placebos works” to the more critical who likened placebo use to “treating adults like children.” Harriet Hall noted, “We should have rules but we should be willing to break them when it would be kinder to the patient, and would do no harm.” And on reflection, Harriet’s perspective was one that I could see myself accepting should I be in a situation like the one she described. It’s far easier to be dogmatic when you don’t have a patient standing in front of you. But the comments led me to consider possible situations where a placebo might actually be the most desirable treatment option. If I find some, should I be as dogmatic about homeopathy as I am about other placebos?
Nicely, Kevin Smith, writing in the journal Bioethics, examines the ethics of placebos, based on an analysis of homeopathy. Homeopathy is the ultimate placebo in routine use — most remedies contain only sugar and water, lacking a single molecule of any potentially medicinal ingredient. Smith’s paper, Against Homeopathy — A Utilitarian Perspective, is sadly behind a paywall. So I’ll try to summarize his analysis, and add my perspective as a health care worker who regularly encounters homeopathy.
Among the many incredible speakers and events at TAM9 there will be a Science-Based Medicine workshop and an SBM panel discussion. The prominence of SBM at TAM9 partly reflects the new collaboration between SBM and the James Randi Educational Foundation (JREF), who organizes TAM.
The SBM website is now a joint project of the New England Skeptical Society (who founded SBM) and the JREF – two non-profit educational organizations dedicated to promoting the public understanding of science. I am delighted that the JREF is making SBM a priority, and we all look forward to working closely with them in promoting high standards of science in medicine and improved public understanding of the relationship between science and the practice of medicine.
As part of this new relationship I have accepted a position at the JREF of Senior Fellow and Director of their Science-Based Medicine project.
This essay is the latest in the series indexed at the bottom.* It follows several (nos. 10-14) that responded to a critique by statistician Stephen Simon, who had taken issue with our asserting an important distinction between Science-Based Medicine (SBM) and Evidence-Based Medicine (EBM). (Dr. Gorski also posted a response to Dr. Simon’s critique). A quick-if-incomplete Review can be found here.
One of Dr. Simon’s points was this:
I am as harshly critical of the hierarchy of evidence as anyone. I see this as something that will self-correct over time, and I see people within EBM working both formally and informally to replace the rigid hierarchy with something that places each research study in context. I’m staying with EBM because I believe that people who practice EBM thoughtfully do consider mechanisms carefully. That includes the Cochrane Collaboration.
To which I responded:
We don’t see much evidence that people at the highest levels of EBM, eg, Sackett’s Center for EBM or Cochrane, are “working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”
Well, perhaps I shouldn’t have been so quick to quip—or perhaps that was exactly what the doctor ordered, as will become clear—because on March 5th, nearly four months after writing those words, I received this email from Karianne Hammerstrøm, the Trials Search Coordinator and Managing Editor for The Campbell Collaboration, which lists Cochrane as one of its partners and which, together with the Norwegian Knowledge Centre for the Health Services, is a source of systematic reviews:
It has long been recognized that there are substantial multifactorial placebo effects that create real and illusory improvements in response to even an inactive treatment. There is a tendency, however (especially in popular discussion), to oversimplify placebo effects – to treat them as one mind-over-matter effect for all outcomes. Meanwhile researchers are elucidating the many mechanisms that go into measured placebo effects, and the differing magnitude of placebo effects for different outcomes.
For example, placebo effects for pain appear to be maximal, while placebo effects for outcomes like cancer survival appear to be minimal.
A recent study sheds additional light on the expectation placebo effect for pain. The effect is, not surprisingly, substantial. However it does not extrapolate to placebo effects for outcomes other than pain, and the results of this very study give some indication why. From the abstract:
The effect of a fixed concentration of the μ-opioid agonist remifentanil on constant heat pain was assessed under three experimental conditions using a within-subject design: with no expectation of analgesia, with expectancy of a positive analgesic effect, and with negative expectancy of analgesia (that is, expectation of hyperalgesia or exacerbation of pain).
What they found was that the positive expectation group reported twice the analgesic effect as the no expectation group, and the negative expectation group reported no analgesic effect. This is a dramatic effect, but not surprising.
Melanie Thernstrom has written a superb book based on a historical, philosophical, and scientific review of pain: The Pain Chronicles: Cures, Myths, Mysteries, Prayers, Diaries, Brain Scans, Healing, and the Science of Suffering. Herself a victim of chronic pain, she brings a personal perspective to the subject and also includes informative vignettes of doctors and patients she encountered at the many pain clinics she visited in her investigations. She shows that medical treatment of pain is suboptimal because most doctors have not yet incorporated recent scientific discoveries into their thinking, discoveries indicating that chronic pain is a disease in its own right, a state of pathological pain sensitivity.
Chronic pain often outlives its original causes, worsens over time, and takes on a puzzling life of its own… there is increasing evidence that over time, untreated pain eventually rewrites the central nervous system, causing pathological changes to the brain and spinal cord, and that these in turn cause greater pain. Even more disturbingly, recent evidence suggests that prolonged pain actually damages parts of the brain, including those involved in cognition. (more…)
NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski. 😉
On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”
Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”
A “Patient-Centered Extremist”
If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:
It’s boring to try to ferret out reliable health information from dry medical journals. It’s easier and more fun to watch a movie. A new movie promises to change the way you think about your health. To bring you breakthroughs that will transform your understanding of how to get well and stay well. To share the discoveries of leading researchers and health practitioners about miracle cures that traditional medicine can’t explain.
If this makes your baloney detector light up, good for you!
The Living Matrix: A Film on the New Science of Healing is an atrociously bad movie that falls squarely in the tradition of What the Bleep Do We Know? In his book Nonsense on Stilts, Massimo Pigliucci characterized the “Bleep” movie as “one of the most spectacular examples of a horribly tangled mess of science and nonsense,” and this new movie is more of the same. Bleep was just silly, but The Living Matrix is potentially dangerous because it might persuade patients to make poor decisions about their medical care. (more…)
In part 2 of the Science-Based Medicine 101 series we take a look at the second pillar of good science: plausibility. This blog post was written for a lay audience so more advanced readers will need to indulge me here…
I really enjoy sci-fi action movies. I love the convincing special effects and the fact that heroes can accomplish the physically impossible without skipping a beat. Implausible events unfurl with convincing reality, and you never know what might happen with the plot.
I also enjoy the TV show, America’s Funniest Home Videos, for different reasons. The mundane nature of actual reality, and the often predictable, but hilarious mistakes made by those I relate to result in some pretty hearty laughs.
But there is a big difference between these two forms of entertainment: science-fiction requires the suspension of belief in plausibility, while home videos are based on plausible outcomes. When it comes to medical research, though, plausibility can mean the difference between science fiction and reality.
Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.
As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.
For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients? It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:
“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”
Moreover, a recent article in the New England Journal of Medicine concludes:
“Outside the setting of clinical trials, there is no justification for the use of placebos.”
However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.
The authors note:
“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”
How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?