“Misinformed consent” rears its ugly head in Pediatrics

I’ve written about the concept of “misinformed” consent with respect to the anti-vaccine movement. To summarize, “misinformed consent” is a perversion of the concept of informed consent in which cranks claim to be championing true informed consent (and, by implication, that opponents have not) when in fact they are presenting a scientifically unsupportable assessment of the risks and benefits of an intervention. In the case of vaccines, anti-vaccine activists play up the risks of vaccines far beyond what science supports, attributing to them, for instance, risks of autism, autoimmune disease, and a veritable laundry list of diseases, conditions, and syndromes while at the same time downplaying the many, many benefits of vaccines. In other words, the “informed” in “informed consent” very much becomes “misinformed.”

Unfortunately, it’s not just the anti-vaccine movement that’s touting misinformed consent. it’s pretty much the entire “alternative medicine” movement. Worse, they’re even managing to promote their arguments in the very pages of influential peer-reviewed journals, such as Pediatrics. I’m referring to an article I came across in a recent issue of Pediatrics entitled Informed Consent: Advising Patients and Parents About Complementary and Alternative Medicine Therapies. One of the co-authors is Michael H. Cohen, JDA, MBA, who has been discussed over at Science-Based Medicine on more than one occasion and who maintains a blog (CAMLaw) that I check out from time to time that is unrelentingly hostile to science-based medicine and pro-woo. In this article, he and his co-authors advocate, in essence, using laws regarding informed consent to force doctors to “inform” their patients about “complementary and alternative medicine” (CAM) to pediatric patients, using the example of a child undergoing chemotherapy and suffering from nausea. The story is, from the beginning, slanted in the most heart-tugging, manipulative way that the lawyers can get away with in a peer-reviewed journal:

The parents of 6-year-old Jake, a young boy with medulloblastoma, are distressed by the nausea and vomiting he is suffering as a result of chemotherapy. His chemotherapy-induced nausea and vomiting (CINV) occur spontaneously and are also being triggered by sights, sounds, and smells for up to 2 weeks after a course of chemotherapy. His parents believe that this is preventing him from eating properly and that the psychological toll of the adverse effects of treatment are limiting his ability to combat the cancer. They ask Jake’s oncologist about other options to alleviate his nausea. He has tried dimenhydrinate and dexamethasone in addition to ondansetron, but like metoclopromide, they have not provided Jake with sufficient relief. Jake’s oncologist recommended that he continue with nabilone, a synthetic cannabinoid; however, Jake refuses to continue this drug, because it makes him feel dizzy and anxious. Disappointed, his parents resign themselves to the possibility that Jake might not find relief from his CINV.

While communicating online with other families of patients with cancer, Jake’s parents discover that a consensus panel through the US National Institutes of Health (NIH) has recognized the effectiveness of acupuncture for alleviating CINV.1,2They ask their oncologist about it, but his response is noncommittal. Jake’s parents take him out on intermittent passes from the hospital to an acupuncturist in the community. They are delighted to see that his nausea and vomiting are much improved after each acupuncture session. Jake begins to regain his appetite, gains weight, and generally has a better sense of well-being.

Jake’s parents are upset that their physician, whom they believe also had access to information outlining the potential benefits of acupuncture, did not tell them that it was potentially a safe and effective treatment option for CINV. When they describe their son’s improvements after acupuncture, their physician dismisses them as a “placebo effect.” Jake’s parents are concerned that the physician instead offered antiemetic medications that, from their point of view, only created more problems and unnecessary adverse effects

Of course, the physician is completely correct in describing the apparent response as almost certainly being placebo effect, but in the article the science-based view is presented as close-minded and biased, not to mention uncaring, with the physician in the vignette above (whether real or made up) coming across as either ignorant of something that might have alleviated the child’s suffering or uncaring in his dedication to science- and evidence-based medicine.

It’s pointed out that the law on informed consent varies in various states and nations, which is true enough. Some take a more patient-centered view of informed consent requiring physicians to disclose what a “reasonable” patient might want to know. Others take a more profession-centered view, mandating informing patients of what a reasonable health care professional would consider necessary to disclose. The authors then write:

…it has been suggested that when there is a genuine difference of opinion within the medical community and the treating physician does not support the alternative, there is still a duty to tell the patient about it and why the doctor considers it inappropriate.^25,28 Some cases have shown a narrower view, holding that the treating physician is only obligated to disclose options that in his or her reasonable medical judgment are appropriate for the patient.^31,32 This distinction may make little difference in practice because, as one court noted, when there is more than one medically reasonable treatment and the risk/benefit analysis engaged by the alternatives involves different considerations, then “a reasonable person would want to know about the alternatives and would want the assistance of the doctor’s risk/benefit analysis of the various possible treatments… .”

The authors note that neither Canadian nor U.S. legal scholars have been able to identify a case where physicians or other “conventional” health care providers have been found liable for not informing a patient about CAM or not advising a patient to undertake CAM. I was actually relieved to learn this, because, given the tone of the article up to this point I was expecting that the authors would have dredged up at least one such case. It is also noted, however (and rather ominously), that:

…disclosure obligations evolve over time. As the evidence for a particular therapy (whether conventional or CAM) grows and it becomes more accepted in the medical literature, clinicians’ duty to disclose information about them can be expected to expand accordingly as well.

What follows next is a group of lawyers, bioethicists, and woo-friendly physicians laboring mightily to argue that there is a real effect of acupuncture on chemotherapy-induced nausea and vomiting that is anything more than placebo. They cite a 14-year-old NIH Consensus Statement on Acupuncture that is exhibit A in the deficiencies of evidence-based medicine and how it doesn’t take into account basic science and prior plausibility, relegating them to the lowest rung of the evidence hierarchy. As I’ve explained (as have others), this problem comes into play for extremely implausible medical treatments like homeopathy and, yes, acupuncture. They then cite the most recent Cochrane Review on CINV, which is actually far less glowing about the potential usefulness of acupuncture than the NIH consensus statement was.

It’s actually a fairly useful Cochrane Review in that the systematic review and meta-analysis, if anything, was far less supportive of acupuncture for CINV than this Pediatrics article suggests. If you look at the pooled numbers, the first thing you will notice is that the effect sizes reported tend to be all very small, with 95% confidence intervals that barely miss overlapping 1.0 for effect sizes and lots of p-values of 0.04; i.e., barely reaching statistical significance. In the case of such results, I always question whether “statistically significant” actually equals “biologically significant” or “clinically significant.” Given the effect sizes noted, I remain…skeptical. At best. And that doesn’t even take into consideration the extreme biological implausibility of acupuncture, particularly for conditions other than pain. One can’t also help but notice that the general quality of the studies pooled is pretty poor. Several of them don’t even include a sham acupuncture control group, for instance. In the acupressure studies, most did not include a placebo control. Taken in its entirety, this Cochrane review is relatively unconvincing. And, of course, it calls, as nearly all of these Cochrane reviews do, that “more research is needed.”

There is a very clear agenda behind papers like this, and that agenda has nothing to do with science. The agenda to which I refer that these CAM advocates are promoting is no less than using the law to provide legitimacy to various implausible CAM modalities that science has not provided. The strategy is explicit, too. It isn’t hidden. It isn’t even all that disguised. They want nothing less than to use the laws regarding informed consent to force physicians to have to “disclose” various CAM therapies to patients. The next step will be to mandate referrals. Indeed, in a companion article by the same authors in the same issue of Pediatrics (which I might just blog tomorrow) in the same issue of Pediatrics implies just that.

Of course, readers of this article probably have no idea what Michael Cohen’s true agenda is. As Kimball Atwood has pointed out, Cohen was very involved in the American Association for Health Freedom, a group dedicated to convincing the government to legitimize various implausible medical claims through political influence rather than science. Indeed, some of Cohen’s other writings are downright scary, such as this essay entitled What is the Matrix? A Radical Look at Medico-Legal Reform, in which he likens health care law and health care to the Matrix. For example, get a load of this passage:

Controlling fraudulent practitioners is seen as a public good, therefore licensure and credentialing rules, prohibitions against fraud, and the like are seen as virtuous, light-bearing beacons in the social order rather than as manifestations of evil. Yet the dark forces of fear, jealousy, and control often govern licensing laws and bodies; this includes intra-professional turf battles, legislative line-drawing in scope of practice conflicts, and medical boards’ attempts to revoke licensure and discipline practitioners for deviating from conventionally agreed norms. The godly art of medicine and the best intentions of honest caregivers can be obscured if not buried by the maze of legal rules governing the profession and the ever-present fear of professional liability.

This maze is the Matrix. The Matrix controls healing.

Health and healing can involve the highest of which a human being is capable. Near-death experiences, encounters with angels, and events that touch the individual’s interior castle and border on mysticism-hese experience manifest ‘light,’ in the sense of coming closer to that which is Supreme at the edges of our consciousness. How would an enlightened civilization, composed of enlightened citizens, govern its own evolutionary movement toward the highest possible level of healing? What role would law play? Would the absence of regulation, instead of its pervasiveness, bring peace-a kind of regulatory lacuna? Would legal structures be able to handle the notion that healing involves mind, body, emotions, and spirit, but also such other dimensions of the human experience as inter-species communication and greater sense of earth-consciousness (Gaia)?

Wow.

Unfortunately, Michael Cohen has managed in a short ten years to go from writing bizarre passages like the one cited above (which, trust me, was not taken out of context, as you can determine for yourself if you don’t believe me) to coauthoring articles like the one in Pediatrics that I’ve been discussing. His intent is clear. He wants to use the concept of informed consent as a bludgeon to force practitioners to offer CAM therapies to their patients as an “alternative.” At its core, this strategy is nothing more than the same strategy that anti-vaccine activists have been using. It’s more “misinformed consent.”