Academic journal article The Hastings Center Report

The Therapeutic Misconception at 25: Treatment, Research, and Confusion

Academic journal article The Hastings Center Report

The Therapeutic Misconception at 25: Treatment, Research, and Confusion

Article excerpt

"Therapeutic misconception" has been misconstrued, and some of the newer, mistaken interpretations are troublesome. They exaggerate the distinction between research and treatment, revealing problems in the foundations of research ethics and possibly weakening informed consent.

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Years ago, a friend of mine who sits on an institutional review board was diagnosed with cancer. When her oncologist invited her to participate in a randomized controlled trial studying two approved therapies, she enrolled. She is well versed in the research ethics literature, and she knows what ethicists mean by "therapeutic misconception"--namely (and roughly), the phenomenon of conflating research and therapy. She also knew--although she was somewhat troubled by the fact--that participation in the study required her to forgo a treatment that she would have preferred to receive simultaneously. And years later, she knows that the study failed to demonstrate the superiority of the arm to which she was assigned. Yet if you ask her whether she was receiving treatment for her cancer while on protocol, she will unhesitatingly answer in the affirmative.

In the past half decade, this view has suffered a bruising, partly because of the ever-broadening interpretation of the concept of "therapeutic misconception." This expansion has largely been salutary for the ethics of clinical trials. Fields like gene transfer have long been faulted for inflating medical benefits and exploiting therapeutic misconceptions; that researchers running gene transfer protocols have responded to the phenomenon, and informed consent guidelines have changed, is evidence that the concept has stimulated important reflection. (1)

However, like "paradigm," "empowerment," and "social capital," the concept of therapeutic misconception is showing signs of wear typical of concepts that are developed in one context and generalized to others. Some flawed interpretations are merely annoying. But others are more worrying because they reveal unrest about one of research ethics' foundational issues: how to demarcate the boundary between research and care.

This year marks the twenty-fifth anniversary of the seminal article that first introduced the "therapeutic misconception." In what follows, I describe the therapeutic misconception's evolution and argue that recent interpretations of the concept might weaken aspects of informed consent and exaggerate the distinction between therapy and treatment, thereby eroding human protections.

The Rise of the Therapeutic Misconception

The problem of therapeutic misconception was first articulated by Paul Appelbaum and colleagues in 1982 and introduced to the wider bioethical community in 1987 (I will call the idea as presented in the 1987 publication simply the "original formulation"). (2) In studies of psychiatric drugs, Appelbaum and colleagues noticed that research subjects frequently misinterpreted the risks and benefits of participation because they failed to appreciate how various research procedures interfered with their care. For example, after being told that investigators would randomize participants to a placebo arm, prospective subjects continued to believe that the investigator would assign them to whichever arm best suited their medical needs. "To maintain a therapeutic misconception," wrote Appelbaum et al., "is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself." (3)

Although the term was used sporadically throughout the early 1990s, it lay more or less dormant until a revival in 2000, when its meaning, and influence, significantly expanded. The reasons for this sudden expansion are not clearly attributable to any single factor, but do present an interesting sociological question. The original formulation had discussed only randomized controlled trials; now the phenomenon was generalized to phase I oncology and other kinds of studies. …

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