nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
See here for more discussion.

Saturday, October 2, 2010

Is It Ethical For Physicians To Stand Mute On Unproven Alternative Medicine? A Personal View.

 
Is it unethical for physicians to acquiesce in unproven therapy...in particular, alternative medicine?

This post needs an introduction.  I originally wrote what follows for publication in an online journal.  While blogs tend to have more opinion content, I occasionally do more technical pieces for different venues.

In this case, I asked myself the question in bold above.  Physicians often have patients who want to try therapies or herbals for which we have no solid evidence of benefit, and in some cases, whether they are truly harmless.  Is it ethical to say nothing, not dissuade, or avoid pointing out that--at this point--there is no verifiable benefit?  In summary, is it ethical to permit unproven therapy?

Ten years back, I did graduate study in philosophy and taught medical ethics.  It occurred to me that the same ethical arguments that were effective against the use of placebo (which is also of no known utility) might also apply to alternative therapies.  What emerged is not a knock-down argument against physicians allowing patients to pursue homeopathy, naturopathy, and the like...but I think it's a worthy attempt.

Hence, the somewhat long, if (I hope) interesting, post that follows.  Reader warning:  it's different from what you usually see on Nostrums.
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The Ethics of Permitting Unproven Therapy



I just finished R. Barker Bausell's excellent book Snake Oil Science. Bausell makes the case that the placebo phenomenon “holds the key to answering this book's pivotal question: whether or not CAM therapies work;” i.e., the placebo effect just is the genesis of symptom relief from complementary and alternative medicine (CAM)...and other therapies I'll lump together as “unproven.” I won't follow his argument in detail in this post (Chapter 8 of the book is compelling, and worth the price of the book); it's enough for my purposes that there be a close enough relationship between why both seem to work, and that both share a lack of scientific evidence for a disease-specific causal relationship to the benefit they offer. I'll explore in this post whether these shared features create an ethical problem for the physician who thinks placebos should not be used but will permit--or acquiesce in--patients using CAM.

What follows won't offer a firm conclusion, but it makes some assumptions. (1) There is no definitive randomized double-blinded placebo-controlled study of CAM demonstrating positive results. (2) The benefit of CAM is indistinguishable from that of placebo. (3) Intentional uninformed use of placebo is harmful and unethical. (4) There is little distinction between intending harm and permitting harm.

While many would agree with all four, each could be argued.

As a clinician,my experience of placebo is its use in well-controlled studies. I can't recall intentionally prescribing a useless treatment deceitfully with the hope of gaining ground against a medical condition for which other active therapies had proven ineffective. I have engaged in “empiric” antibiotic use, but for the last two decades have rarely been tempted to risk adverse drug reactions or treatment failure when it was likely that giving an antibiotic would serve only the placebo effect of giving the patient a sense of having been treated with something powerful.

However, this type of placebo effect is not my concern here. I want to focus on the use of so-called harmless substances where the physician has no good options for active therapeutic benefit...that is, the sugar pill, or the inert capsule. This use of placebo has a long history. For most of the last 2,000 years the use of substances that had no active ingredient was unintentional, because physicians had no evidence that nostrums and potions were not working. But the intentional use of a substance known to lack specific pharmacological effect lasted well into the modern era... until some began to question whether using placebos, despite providing measurable symptom relief, was ethical. Due in no small part to an article by philosopher Sissela Bok, (“The Ethics of Giving Placebos,” Scientific American 231, 1974: 17-23), the practice has largely disappeared. The AMA's code of ethics states that
In the clinical setting, the use of a placebo without the patient’s knowledge may undermine trust, compromise the patient-physician relationship, and result in medical harm to the patient.
With that introduction, I want to ask this question: if prescribing a placebo is unethical, how is it ethical to permit a patient--uninformed by evidence--to engage in an unproven CAM therapy? In what way is that less of a moral deceit than prescribing a sugar pill? When we acquiesce in our patients' adoption of cleansing diets and homeopathy, are we doing anything less deceitful? Many clinicians have tried to adopt a middle way, an open-mindedness to patient's needs that avoids the extreme of being “so open-minded your brains fall out.” In the words of one practitioner (link) who reflected on this:
When it comes to CAM , I’ve learned to support my patients in their choices while tempering their enthusiasm from time to time with evidence of harm or sometimes just plain old common sense. For Jenny, since she wasn’t on any medications or recreational drugs and was careful to follow a healthy diet, I told her that as long as she didn’t overdo it, a little taste of her own fresh urine every morning wasn’t likely to cause her any harm. I’ve adjusted to the new climate in healthcare, and my mind is open but balanced — without any need to pick my brain up off the floor. http://www.physicianspractice.com/index/fuseaction/articles.details/articleID/1455.htm)
I suspect many of us don't try to “talk patients out of it.” Patients who sing the praises of chiropractic get no advice from me, unless they ask what I think. This middle way may be our best ethical approach, but it leaves the question unanswered: if you accept the parallel operation and impact of placebo therapy and CAM, why is the first unethical, and not the second?

Whatever your instinct at this point, Dr. Bok's comments shed more light on the comparison.
The common practice of prescribing placebos to unwitting patients illustrates the two miscalculations so common to minor forms of deceit: ignoring possible harm and failing to see how gestures assumed to be trivial build up into collectively undesirable practices. (from Lying:Moral Choice in Public and Private Life, pg 61-68)
Take ignoring possible harm first. Bok says (paraphrasing for CAM), to the extent that the evidence-based physician allows a patient to engage in unproven therapy--without first ascertaining the underlying problem--significant disease can be overlooked. In practice, directly overlooking a disease is uncommon. More common would be a failure to understand the underlying reason a patient would consider an unproven therapy; understanding that need could be invaluable to future treatment.

Further, as Bok goes on to point out for placebos, the beneficial effect of CAM can be short-lived, and the patient may lurch from one New Age therapy to another as each loses its impact. Finally, as Bausell points out in his book, the natural history of chronic disease-- which promotes treatment-seeking behavior when symptoms are worst, but would have improved soon anyway--is indistinguishable from therapeutic benefit to the patient. This clouds the perceived benefit from the useless--and invariably expensive—CAM treatment. Patients are left believing the CAM therapy (that operates like placebo) has worked.

As regards Bok's second miscalculation, the growth of “collectively undesirable practices,” we're there. Every day a new therapy appears in print, based on some object's imagined influence on health. If the new therapy survives allegations of acute injury, then it graduates to full CAM adoption without further inquiry.

My current favorite is Earthing: the Most Important Health Discovery Ever? It's #4 on Amazon's CAM bestseller list. The publisher's blurb says
Few people know it, but the ground provides a subtle electric signal that maintains health and governs the intricate mechanisms that make our bodies work-just like plugging a lamp into a power socket makes it light up. Modern lifestyle, including the widespread use of insulative rubber or plastic-soled shoes, has disconnected us from this energy and, of course, we no longer sleep on the ground as we did in times past.
The number of fantastic therapies is growing faster than patients can launch into them, lose interest, and drive on to the next. In the minds of some, physician acceptance that there can be other non-evidence-based alternatives is instrumental to that growth. Others have written that the promise of modern medicine was its own worst enemy; as the diseases that historically plagued humanity were conquered, people came to expect the same success with the chronic diseases of a longer-lived population. And that promise has not been fulfilled. Chronic disease is mitigated, temporarily, at best by science-based medicine. In common sense language, the more we promote magic pills, the more the public comes to expect them, and if they can't get them from us, they'll try elsewhere.

In summary, CAM does harm for the same reasons that placebos do harm.

I think applying Bok's reasoning regarding placebo forms a moral basis for actively resisting CAM therapies. Absent this resistance, the number of these counter-intuitive and implausible treatment modalities will grow unimpeded by critical review.

I've left to last an important distinction between placebo and CAM that some would argue undermines the clinical parallel between placebo and CAM. In the placebo effect, there is direct physician intent to deceive, however worthy the motive. In CAM, the patient intends the activity and the physician's role is passive acquiescence. Is there an ethical distinction here? Two influential works that argue “no” are Shelly Kagan's The Limits of Morality (1991), and Samuel Scheffler's The Rejection of Consequentialism (1994).

Philosophers have argued about moral duty of this type for ages. Rather than this become a lecture on ethical theory, my dumbed-down version is this: some would argue that “intent” is the more important part of an act with moral content. Others would say that the “outcome” is more important. That's my mickey mouse distinction between deontologic and utilitarian theory.

My reading of Bausell and Bok is that, like with placebo, permitting unproven therapy is a form of deceit; an abdication of responsibility to truthfulness that could undermine trust and lead to harm, either by overlooking an underlying medical issue or by contributing to new, collectively undesirable practices. In practice this would mean clinicians should intervene even in those situations where the patient chooses the harmless “sugar pill” variety of CAM.

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Doc D
 

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