Medication discontinuation and symptom provocation in research: a consumer and family perspective

Research involving symptom provocation and medication discontinuation, although common throughout medicine, raises some significant issues for consumers and family members facing severe mental illnesses. Reasons for our attention to these research approaches include the apparent prevalence of this research; the prospect of significant distress, illness, or disability, especially in the event of medication discontinuation; questions about the scientific strength of at least some challenge studies; the changing nature and pressures on research, including its "deinstitutionalization," and the increasing role of private funders; early evidence of consumer concerns about medication discontinuation; the possibility of long-term damage as a result of delayed treatment; concerns about subject recruitment methods and the adequacy of informed consent for these studies; and the lack of data concerning consumer experience and outcome from this research. Because research involving symptom provocation and medication discontinuation can present significant risks to the consumer participating in the study, we must take steps to make sure of the following: that the use of this research methodology be minimized as much as possible; that it meets the very highest standards of scientific merit and necessity; that it includes the strongest possible protections for human subjects, including optimal informed consent about the nature and risks of the study and communication with care-giving family members and others; that in discontinuation studies research protocols precisely spell out in advance the clinical situations that will trigger intervention and what the intervention will be, and furthermore, that discontinuation studies should assure adequate clinical monitoring for early identification and treatment of signs of clinical distress or deterioration; and that researchers should begin systematically collecting and publishing information on the outcomes for and experiences of consumers in these types of studies. Enhanced oversight of these research protocols, by funders and IRBs is essential. Finally, our consideration of these issues has raised concerns for us about recruitment methods, which warrant examination; and we would like to see attention to placebo control use, insofar as it is necessary to show new medications are effective.