Questionable advertising of psychotropic medications and disease mongering.
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Biomedical subjects
Publications and source records attributed to Jonathan Leo.
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The recent announcement by the Food and Drug Administration (FDA) requiring pharmaceutical companies to warn patients about the increased likelihood of suicidal thoughts when taking antidepressants was largely due to the recent availability of data that had gone unreported in the original research reports. The current article is a summary of the comparison between the published literature and the recently released data available on the FDA web site, with a focus on Prozac, Paxil, and Zoloft. The discrepancies between the two versions suggest that the scientific community was not given enough information in the published medical literature to make adequately informed decisions about the optimal method for treating emotionally distressed children. There are many voices that want to blame the FDA for its role in the widespread use of these medications. The current article focuses on the role that academic medicine played in the process whereby these medications became so widely accepted.
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When researchers design an experiment to compare a given medication to another medication, a behavioral therapy, or a placebo, the experiment often involves numerous comparisons. For instance, there may be several different evaluation methods, raters, and time points. Although scientifically justified, such comparisons can be abused in the interests of drug marketing. This article provides two recent examples of such questionable practices. The first involves the case of the arthritis drug celecoxib (Celebrex), where the study lasted 12 months but the authors only presented 6 months of data. The second case involves the NIMH Multimodal Treatment Study (MTA) study evaluating the efficacy of stimulant medication for attention-deficit hyperactivity disorder where ratings made by several groups are reported in contradictory fashion. The MTA authors have not clarified the confusion, at least in print, suggesting that the actual findings of the study may have played little role in the authors' reported conclusions.
This article presents eight commentaries on a case study published in the journal Pediatrics in 2001. The case study, introduced in Pediatrics to highlight the issue of adolescents' compliance with drug treatment in a "high-prevalence neurobehavioral condition," briefly describes an adolescent boy who announces that he no longer needs the methylphenidate he was prescribed for ADHD and had been taking for the last five years. We invited experienced professionals from the disciplines of psychiatry, psychology, counseling, education, and occupational therapy to comment on the case and make recommendations to the adolescent boy in the case study, his family, and professionals. Their commentaries highlight issues rarely discussed in the mainstream literature, including: the extent to which ADHD is erroneously portrayed and vigorously managed as a disease; the lack of validity of the ADHD construct in adolescence; the widespread use of stimulants as performance-enhancing drugs; the need to respect an adolescent's gut instinct and developing decisions; the importance of family dynamics in ADHD-like situations; the need to ease stimulant withdrawal effects; and the human rights of children prescribed psychotropic drugs.