RCR Casebook: Conflicts of Interest
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Joanna, a psychiatrist, has a busy clinical practice. She is widely recognized as a leader in reducing the number of psychotic episodes that patients with schizophrenia experience. Her treatment modalities are largely informed by her research. She has performed numerous clinical trial studies combining various antipsychotic and other medications to achieve longer intervals without episodes. She has cultivated a trusting relationship with her patients as many have seen her for more than five years as she has provide hope and relief to a great number of them. | Therapeutic misconception occurs when an individual fails to appreciate the distinction between research and usual care. Clinical research strives to generate knowledge from systematic processes where clinical care focuses on meeting individual patients’ needs. -Appelbaum, PS et al., 2002 and Dunn, LB et al., 2006 |
Joanna is enrolling participants into a randomized placebo-controlled study with a promising new drug to treat schizophrenia. Although two other psychiatrists in her practice are referring patients to the study, she also decides to offer the protocol to patients in her practice that meet the inclusion criteria.
As part of the consent process, she explains to patients that there is a 50-50 chance whether they are placed in the group receiving the investigational drug or in the group that receives the placebo (sugar pill). She tells them that those who are given placebos will not be offered standard-of-care medicine so that important drug-placebo differences can be identified. Joanna also tells them that rational decision-making does not seem to be affected during short periods of medication-free intervals, according to the most recent research. She does acknowledge that studies have had mixed results about the increased risk of suicidality, however.
One of Joanna’s patients, a potential participant named Duncan, asks how long the study is supposed to last. Joanna knows that Duncan has failed other attempts of reducing the length and severity of his schizophrenic episodes. She also believes that he may be a good candidate for the study—as long as he’s not in the placebo group. There’s no guarantee that he’ll receive the treatment, or do well on it. If he doesn’t enroll, then his clinical care will go on uninterrupted. If he does enroll, this new experimental drug may be his best shot at receiving an effective treatment so that he can lead a more normal life.
Joanna asks if Duncan is interested. Duncan responds, “Whatever you think is best. You’re the doc.”
What should Joanna do?
Discussion Questions for the Facilitator
- How many different kinds of conflicts of interest does Joanna have?
- How concerned should she be that her patient(s) might not grasp the risks of participating in a drug trial?
- Do you think she should change anything about the informed consent process? Research protocol?
- In your own words, what is a therapeutic misconception?
- What do you think motivates patients like Duncan to respond “Whatever you think is best”?
- What are some responsible and creative ways to seek to solve this ethical problem?
- Should clinical researchers be allowed to enroll their own patients in a study? *
