Underreporting of Harms in Pharmaceutical Company-Sponsored Psychotropic Drug Research: The Need for Social Workers' Increased Involvement in Medication-Related Issues
Purpose: To examine the extent and quality of reporting of serious adverse events and psychiatric adverse events across Internet-registered clinical trial reports and peer-reviewed journal publications for popularly prescribed psychotropic medications. As social workers routinely work with medicated clients across a variety of practice settings, increased understanding of possible distortions of the drug treatment evidence base is essential for advancing roles as medication monitors and interdisciplinary collaborators and for ensuring the safety of medicated clients.
Methods: Internet-registered clinical trial reports and the first peer-reviewed journal publication associated with each report were retrieved for six psychotropic medications (Abilify, Geodon, Zyprexa, Strattera, Cymbalta, Zoloft). Data collection resulted in 142 pairs of online reports and print publications, reporting on more than 35,000 drug-treated participants. Three coders independently tallied the number and types of serious and psychiatric adverse events in each report and publication.
Results: Rates of serious adverse events ranged from a low of 0.6% in print publications of Strattera (2.1% in Strattera’s online reports) to a high of 10.5% in online reports of Geodon (7.3% in Geodon’s print publications). Across the six medications, only 28.5% of deaths appearing in online reports were also reported in print publications, as well as 30% of completed suicides, 25.8% of cases of suicidal ideation or suicide attempts, and 17.7% of cases of new or worsened psychiatric adverse events. On average, nearly half of online reports and print publications that reported the number of serious adverse events failed to describe the nature of the event.
Conclusions and Implications: Underreporting and selective reporting of serious and psychiatric adverse events was common in this sample of studies from six psychotropic medications. A lack of full and accurate reporting of possible drug harms in peer-reviewed literature - the primary outlet for disseminating drug research - damages the credibility of the evidence base and places treatment professionals in the precarious position of making benefit-to-risk assessments based on uncertain information. In light of this, the subjective experience of the medication consumer should be at the center of treatment decision-making. Social workers should help clients monitor the effects of medication, paying careful attention to the possibility of a drug-induced worsened psychiatric condition, elicit clients’ feelings and subjective perceptions of the medication experience, and collaborate with prescribers to improve rational treatment decision-making. Until the pharmaceutical industry is displaced as the primary stakeholder in mental health care, for example, through policies that remove control of research from drug manufacturers and support the expansion of psychosocial treatment alternatives, social workers should be critical consumers of drug information and vigilant in helping to ensure the safety of medicated clients.