Articles

Posts Tagged paternalism

Beyond Informed Consent: Shared Decision-Making

Happy New Year to all our readers! Today marks the completion of 5 years of SBM and the beginning of year 6. My contributions, at one a week, have now reached a total of 260. My first post on this blog, 5 years ago, was a review of an important book about science and alternative medicine, Snake Oil ScienceThis year I’d like to start with an important book about communicating medical science to patients, Critical Decisions,  by Peter A. Ubel, M.D.

I was wrong about informed consent. I thought informed consent was a matter of explaining the risks and benefits of treatments to patients so they could decide what they wanted to do.  That was naïve, simplistic, and misguided. Ubel’s book has radically changed my thinking about how doctors should interact with patients.

Paternalism in medicine is dead. Patient autonomy rules. We respect the right of patients to determine their own treatments, even if their choices seem unwise to us. Patients should do what they want. But there’s a problem: patients may not know what they really want. Emotions and unconscious and irrational forces influence their medical decisions. Preferences can change from one moment to the next, and they can shift with subtle changes in how treatments are described and how the issues are framed. Doctors need to develop a better understanding of what is going on in their patients’ minds, of how the way they present treatment options can inadvertently influence patients, and of how they can participate with patients in a process of shared decision-making. It’s possible to provide direction without paternalism. (more…)

Posted in: Book & movie reviews, Medical Ethics

Leave a Comment (17) →

Does thinking make it so? CAM placebo fantasy versus scientific reality

Last week, I discussed a rather execrable study. Actually, the study itself wasn’t so execrable, at least not in its design, which was a fairly straightforward three-arm randomized clinical trial. Rather it was the interpretation of the study’s results that was execrable. In brief, the authors tested an “energy healing” modality known as “energy chelation” versus a placebo (sham “energy chelation”) and found, as is so often the case in studies of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) that both modalities did better than no treatment on the primary outcomes but that the “real” treatment (if one can call energy chelation “real treatment”) produced outcomes that were statistically indistinguishable from the “sham” treatment. Not surprisingly, the next move on the part of the researchers was to do a bunch of comparisons, and, as is so often the case (particularly when one fails to correct statistically for multiple comparisons), they found a couple of secondary endpoints with barely statistically significant differences and trumpeted them as meaning that their “energy chelation therapy” has “significant promise for reducing fatigue.” They then argued that the study was also ” designed to examine nonspecific and placebo elements that may drive responses.”

Which brings us to the “power” of placebo.

As I was contemplating what I wanted to discuss this week, I thought about the study that Drs. Coyne, Johansen, and I objected to, but then I also thought about Dr. Crislip’s post last week and post I did about a month ago in which I noticed how lately CAM apologists seem to be—shall we say?—retooling their message in the wake of negative trial after negative trial of their implausible treatments. Gone (mostly) are claims of powerful specific effects and efficacy from treatments such as various “energy healing” modalities, acupuncture, homeopathy, and the like themselves, to be replaced by claims that physicians should embrace CAM because it’s “harnessing the power of placebo” to produce “powerful mind-body healing.” It’s a powerful message that has sucked in people who normally would be considered skeptics, such as Michael Specter, who, as I described, apparently bought into the message sufficiently that when Ted Kaptchuk was making the media round right before the holidays he happily published a fairly credulous interview with him entitled, The Power of Nothing: Could Studying the Placebo Effect Change the Way We Think About Medicine? (My answer: Very likely no.) Even Ira Flatow of Science Friday fell hard for Kaptchuk’s message, declaring at the beginning of the interview that Kaptchuk’s irritable bowel syndrome study is evidence that “placebos work even when patients are in on the secret.” (It’s not.)

That skeptics and scientists find the idea that the mind has the power to heal the body, often referred to as “self-healing” or “mind-body healing,” so seductive should probably not be surprising. After all, who wouldn’t want to be able to cure themselves simply by willing it to be so? It’s a concept that, like so many concepts in CAM, goes far back into ancient times and stretches forward to today in ideas like The Secret, which goes quite a bit beyond the whole idea of “mind-body healing” or healing yourself because you wish it to be so, and declares that you can have virtually anything you want simply by thinking the right thoughts. In fact, to me it appears that the “powerful placebo” is being drafted in the service of supporting what are, at their core, mystical beliefs far more than science. I’d like to elaborate on that idea a bit more than I did last time I discussed this isssue, where I concluded by writing:

In the end, all too much of the rebranding of CAM as placebo and the selling of placebos as some sort of powerful “mind-body healing” strikes me as being much like The Secret, in which wishing makes it so.

Let’s take a look at just how far this goes.
(more…)

Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Religion

Leave a Comment (23) →

Double-Talk And Paternalism

One of the more frustrating things about practitioners who promote unsafe and scientifically discredited medical practices is their tendency to change their message for different audiences. One day they’ll tell you that they espouse only evidence-based practices and the next they’ll be promoting snake oil. This double talk is hard to combat, since to disprove them one would essentially have to provide a video of their contradictory remarks.

One day I participated in a series of business meetings with a CAM practitioner in attendance (he was an MD who graduated from UCSF). During one meeting he boldly proclaimed his support of scientifically rigorous research, and praised the Cochrane Collaborative’s efforts to provide systematic reviews of the evidence (or lack thereof) for various practices.

Several hours later we were sitting together in another meeting in which I objected to the publication of a consumer article that would assist parents of children with autism in finding a DAN! practitioner who could provide chelation therapy to their children. I explained that there was no evidence for the efficacy of such treatments, and plenty of evidence for their harm (including the death of at least one child that I’d read about in the news). I suggested that an article describing these dangers might be in order, but that an article encouraging chelation use for autism was simply unethical and I would not allow it to be published.

Instead of agreeing with me, the CAM MD suggested that I was being “narrow” and that I should allow consumers to “explore all their options.” I was stunned. This was the same person who had just said that he fully supported scientific inquiry. So I asked him how he could say that he supported evidence-based medicine, and then turn around and ignore evidence at will – even at the peril of human life.

His response dumbfounded me:

“I am just as comfortable practicing within an evidence-based framework as I am outside it.”
(more…)

Posted in: General, Public Health, Science and Medicine

Leave a Comment (19) →

Placebo Therapies: Are They Ethical?

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?
(more…)

Posted in: General, Medical Ethics, Science and Medicine

Leave a Comment (27) →

Paternalism Revisited

Paternalism is out of fashion. Doctors used to have a parent-child relationship with their patients: they concealed the truth if they thought it was in the patient’s best interest, they dictated the treatment and did not have to justify it to the patient. “You have to take this pill because I’m the expert and I know what’s best; don’t ask questions.” Sort of like “You have to go to bed now – because I said so and because I’m the mommy.”

Some time in the 20th century we evolved to a different doctor-patient relationship, an adult-adult one in which the doctor shared expert knowledge and information with the patient and they cooperated to decide on the best treatment plan. The principle of patient autonomy became paramount and the patient gave informed consent to the chosen treatment.

It is generally accepted that this is all for the good. But is it really? In his book Intern: A Doctor’s Initiation, Sandeep Jauhar says, “Over time, my views on informed consent have evolved. I no longer view paternalism as suspiciously as I once did. I now believe that it can be a core component of good medical care.” (more…)

Posted in: Medical Ethics

Leave a Comment (27) →