More on the Therapeutic Misconception

We've previously covered the therapeutic misconception (TM).  In an important article released in the latest PLoS Medicine, a group of distinguished scholars reported on their efforts to frame a useful definition of the therapeutic misconception.

The article was produced out of a workshop attended by some of the most influential theorists on the therapeutic misconception.  They report discordance in the literature regarding the proper definiton of the TM, and that such disagreement was reflected in the workshop itself.  To wit:

We considered whether the following question could be part of an instrument designed to measure TM:

“The purpose of the study is:

• (1) Only to help patients enrolled in the study, or
• (2) Both to help patients enrolled in the study and patients in the future, or
• (3) Only to help patients in the future”

There was consensus that answer (1) is incorrect and reflects misunderstanding of the purpose of research studies, but there was disagreement about whether the correct answer was (2) or (3). Those who argued that (3) is the only correct response believe that the purpose of a trial is to further science and help future patients, not to help the patients enrolled in the study. According to this argument, the purpose of an experimental intervention is not to provide treatment (i.e., clinical trials are not treatment). The presence of concomitant clinical care and the potential for benefit associated with trial participation should not be confused with the fundamentally scientific goals of clinical trials.

In contrast, advocates of (2) as the correct response believe that helping patients enrolled in a study can be a legitimate additional study purpose. This may be because research and clinical care procedures and activities overlap, or because administration of an experimental agent is seen both as a means to learn about its safety and efficacy and as an appropriate therapeutic option. This conceptual debate reveals the difficulty of applying general assessments to trials that employ very different study designs.

The latter response is unpersuasive to me.  The idea is certainly not that individual subjects never benefit from participating in clinical trials.  A generic participation benefit stemming from such participation, for example, is well-known.  From a medical humanities perspective, such a benefit is entirely unsurprising, as humans are social creatures and often make meaning in the face of illness by participating in all manner of practices (i.e., counseling, helping others, etc.).  However, it does not follow from this that the macro-level purpose of the study is to benefit the individual patient.  Not every patient who participates does enjoy the participation benefit, of course, nor is the primary objective of the vast majority of clinical trials to produce individual benefits for the subject.

That some subjects may in fact benefit is a fortunate byproduct of the clinical research process, but it would strain the premise, IMO, to conclude therefrom that a primary, macro-level objective of a study is to provide direct benefit for the individual patient connected to the particular intervention being evaluated.

In any case, the authors produce a definition of the TM that contains five components relating to (1) the scientific purpose (to produce generalizable knowledge); (2) the study procedures (that are often not necessary or even connected to clinical care); (3) the uncertainty of the risk-benefit ratio for experimental interventions; (4) the need for strict adherence to protocol (even where, e.g., CPGs might allow more flexible treatment protocols); and (5) the clinician is an investigator in context of the trial.

While I think these components are well-founded and go a significant way in illuminating some of the key features of the TM, I am too much a devotee of later Wittgenstein to feel comfortable with straining for definitions.  The effort to shed some light on conceptually cloudy aspects of the TM is surely well-advised, but I think the search for definitions of inherently ambiguous and malleable concepts is, as Wittgenstein warned, an attempt to open doors that are painted onto walls.

I concur that the notion of the TM is ambiguous, but nevertheless feel quite strongly that its constellation of meanings is decipherable to be germane to our practices.  As Wittgenstein argued, the fact that there is no logical connection between a rule and its definition hardly implies that our practices are not sensible.  IMO, we can make much of the concept of the TM in practice even without an unambiguous definition.  Indeed, I happen to think we can generate a very great deal more use out of the concept than we currently do.