Medical Humanities Lexicon: Therapeutic Misconception

Today's long overdue entry in the Medical Humanities Lexicon is "therapeutic misconception."  This is a topic of particular interest of mine for a variety of reasons.  The phrase was, as far as I can tell, first used in 1982 by Paul Appelbaum et al., who along with Charles Lidz, has published some of the most important empirical studies of the phenomenon.  The therapeutic misconception refers to the general conflation of research with therapy.

Why are they distinct in some important senses? Why should they not be conflated?

They are distinct for a variety of reasons.  First, the objectives of each are entirely different.  The objective in biomedical research is to advance knowledge, or to test efficacy of a particular intervention.  The objective of therapy is to heal the illness sufferer.  In an important sense, there is a distinction between the expectations the participant brings to each encounter.  Whereas research is generally not conducted for the benefit of the individual participant, therapy that is not conducted for the benefit of the individual illness sufferer is ethically dubious, if not downright negligent. 

Biologics tested in clinical research, for example, are usually not proven to be therapeutic.  If they were so proven, they would almost by definition cease to be experimental in nature.  It is generally not reasonable for a participant in human subjects research to enter into the research expecting to receive direct therapeutic benefit from the intervention being evaluated.  In contrast, it is absolutely reasonable for an illness sufferer to enter into a physician-patient relationship expecting to receive direct therapeutic benefit from the intervention prescribed.

Second, interventions in research are generally not tailored to the individual subject.  Doing so would tend to undermine the validity of the study, because varying the experimental regimen from subject to subject would introduce a wide variety of confounders and result in diminished validity.  In contrast, interventions in therapy must be tailored to the individual subject -- dosage levels, frequency of usage, etc., etc.  Refusing to tailor therapeutic interventions is often derisively referred to as cookbook medicine, and is in some situations ethically inappropriate if not negligent.

Third, and related, in many placebo-controlled trials, would-be participants are often excluded because they suffer from illnesses that would skew the results of the study by introducing additional confounders.  In context of therapy, health care providers must often -- usually? -- treat and manage a variety of different illnesses and conditions in their patients.

There are myriad other reasons for drawing a macro-level distinction between research and therapy (the bibliography below provides a good starting point).  Here, I want to address some common objections to the claim, and then move on to discuss why the therapeutic misconception is so important and why its importance is often under-appreciated.

In response to the attempt to draw some meaningful distinction between research and therapy, many object that subjects do obtain benefit from participating in research.  There is the well-known participation benefit -- we know that illness sufferers, for example, generally do better when they participate in some kind of collective enterprise related to their illness, whether it is group counseling, advocacy, or biomedical research.  This is an important way of meaning-making, but I want to suggest, it is generic and is most assuredly not a phenomenon specific either to the particular clinical trial nor to the intervention being studied.  That is to say, the benefit inheres in the nature of human practices -- we are social beings, after all -- rather than the research itself.

Others sometimes point out that direct therapeutic benefit is typically expected from the experimental intervention in phase III trials.  There is reason to quibble with this, but even assuming it is correct, we know that the vast majority of biologics do not make it to phase III trials.  There is no reason to infer that analogous expectations of benefits are justifiable among this majority.

This, as far as it goes, is the therapeutic misconception.  Why and how is it relevant to the medical humanities? First, I am particularly interested in the therapeutic misconception both because of how pervasive it seems to be and of how poorly understood it is, by both lay and professional alike.  I cannot recount the number of times I have received blank looks from investigators and sponsors when I mention the therapeutic misconception, and my anecdotal impression is generally confirmed in the literature (that it is pervasive among investigators and sponsors, not simply laypersons).

I sometimes wonder if there is some kind of low-level collusion involved among many different kinds of stakeholders in the research enterprise to perpetuate the conflation of research with therapy.  Many believe that research is simply an extension of therapy -- when standard therapy fails, the patient is moved to experimental treatment simply as part of the standard of care.  My contention is surely not that such experiments should not be offered to the illness sufferer, but simply that the distinction between evidence-based therapy and experimental research should be communicated to the illness sufferer in an entirely transparent manner.

Second, there is an important ethical difference between biomedical research and biomedical therapy: the former is a roughly utilitarian enterprise, whereas the latter must be undertaken for the good of the particular patient.  Without turning this into a discourse on the merits of utilitarianism, there is sufficient reason to be concerned about the consequences, no pun intended, of utilitarian programs on the individuals involved in the program.  The sadly prevalent history of abuses in human subjects research in the 20th century confirms this presumption.

This leads to the third point, which is that many scholars, including me, suspect that one of the primary factors in unethical human subjects research is the therapeutic misconception.  If, after all, the protocol can be perceived as therapeutic, risk-benefit ratios that would seem impermissible for research can theoretically and historically be permitted.  It is, I suggest, no accident that Joachim Mrugowsky, a Nazi doctor who was executed in 1948 after the Nuremberg Trials, remarked in an introduction to a German volume on medical ethics that because the results of the research were for the benefit of the Volk, the National Socialist part had succeeded in breaking down the boundary between research and therapy (Lifton 2000, 32).

Please do not accuse me of violating Godwin's Law, as it would be ill-advised to discuss anything relating to the history and ethics of human subjects research without examining Nazi attitudes to such research (which is most assuredly not to exculpate other Western researchers, including Americans -- quite the contrary, as I and many others have written on this).  Nevertheless, I continue to believe that comprehending on the macro level that there exists a meaningful distinction between research and therapy is crucial.

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Bibliography

Franklin G. Miller and Howard Brody, "A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials," Hastings Center Report 33, no. 3 (2003): 19-28.

Howard Brody and Franklin G. Miller, "The Clinician-Investigator: Unavoidable but Manageable Tension," Kennedy Institute of Ethics Journal 113, no. 4 (2003): 329-346.

Alex John London, "Two Dogmas of Research Ethics and the Integrative Approach to Human Subjects Research," Journal of Medicine and Philosophy 32 (2007): 99-116.

W. Glannon, "Phase I Oncology Trials: Why the "Therapeutic Misconception Will Not Go Away," Journal of Medical Ethics 32 (2006): 252-255.

P.S. Appelbaum, L. Roth, C.W. Lidz, "The Therapeutic Misconception: Informed Consent in Psychiatric Research," International Journal of Law and Psychiatry 5 (1982): 319-29.

P.S. Applebaum, C.W. Lidz, T. Grisso, "Therapeutic Misconception in Clinical Research: Frequency and Risk Factors," IRB 26 (2004): 1-8; "Correction and Clarification," IRB 26, no. 5 (2004): 18.

N. King, "Defining and Describing Benefit Appropriately in Clinical Trials," Journal of Law, Medicine & Ethics 28 (2000): 332-43.

Michael Bamberg and Nancy Budwig, "Therapeutic Misconceptions: When the Voices of Caring and Research are Misconstrued as the Voice of Curing," Ethics & Behavior 2, no. 3 (1992): 165-184.

Comments

[Patrick S. O'Donnell]

Well, I do look forward to these lexicon entries and this one was certainly worth the wait. I like the careful and articulate distinction between medical research and therapy. I wonder how much doctors who see their profession as resting, in the end or at bottom, on the (anticipated, eventual...) success of scientific research see themselves as involved in a scientific enterprise that aims for a kind of objectivity inappropriate for the therapeutic situation (I would not therefore characterize the therapeutic situation as wholly subjective). For example, as Kathryn Montgomery reminds us, "Physicians draw on their diagnostic skills and clinical experience as well as scientific information and clinical research when they exercise clinical judgment." This often leads, she argues, to the misdescription of medicine as a science (something 'medical humanities folks' are constitutionally disposed to recognize and appreciate) inasmuch as clinical practice in general and clinical judgment in particular is reliant on something as elusive and circumstantial as Aristotelian phronesis or practical reasoning, however much it draws from the fund of science and technical knowledge: "Physical symptoms are read narratively, contextually, and interpreted in cultural systems. A physician's diagnosis is a plot summary of a pathophysiological sequence of events. The lump is there. It is a sign, caught *in media res*, a clue to a natural history that is unfolding. Science describes and explains it and determines what can be done about it. But the importance of that lump, the acts its discovery entails, and what those acts will mean are social and cultural matters." And the consequent danger: "...[M]edicine's status in society depends in large part on the scientific character of much of its information. To claim to be a scientist in our culture is to stake out authority and power. But physicians suffer the ill effects of this hubris: as patients and as citizens, we expect them to be far more certain than either their practice or the biology on which it is based can warrant, and, for many reasons, they are likely to take these expectations for their own. Malpractice suits that arise more from anger over misplaced expectations and perceived neglect than from genuine mistakes are the result." No matter how successful evidence-based medicine proves to be, it "will not turn medicine into a science." The quotes are from Montgomery's How Docotrs Think: Clinical Judgment and the Practice of Medicine, 2006).

[Daniel Goldberg]

Hey Patrick,

Thanks for the insight. Kathryn Montgomery's book is excellent, and I am somewhat surprised it has seemed to be swallowed up by Groopman's similarly titled book, esp. b/c I think the former is a much thicker analysis.