Suicidal risk from TADS study was higher than it first appeared.

Completed suicides are a major cause of death in adolescents in Sweden. Forensic analysis of completed suicides in children and adolescents shows there is one completed suicide per 1000 children taking a selective serotonin re-uptake inhibitor (SSRI). In order to elucidate these events we undertook a study of the results and reporting of suicidal events in the Treatment of Adolescents with Depression Study (TADS). We conclude that a major, albeit underreported, finding in the TADS was the significant increase of suicidal events in the adolescents on antidepressant medication in comparison to the group on placebo medication. The proportions of suicidal events were 11% and 2.7% respectively. This increased risk of suicidal events might be related to the high incidence of medication with an SSRI in the group of completed suicides among Swedish adolescents.

Shooting the Messenger: The Case of ADHD.

Medicating ADHD is a controversial subject that was acutely inflamed in 1995 when high rates of ADHD diagnosis and treatment were documented in southeastern Virginia. Psychologists in southeastern Virginia formed a regional school health coalition to implement and evaluate interventions to address the problem. Other professionals with strong ties to the pharmaceutical industry launched ad hominem attacks on the coalition's research and work. These attacks contributed to the work being terminated in 2005. In the ensuing years, ADHD drug treatment continued to escalate. Today, the national rate of ADHD diagnosis exceeds all reasonable estimates of the disorder's true prevalence, with 14 % of American children being diagnosed before reaching young adulthood. Notable key opinion leaders continue to claim that there is no cause for concern, but with a message shift from "the prevalence is not too high" to "high prevalence is not too concerning." This paper provides an object lesson about how innovative research can be derailed to the detriment of sound medical and mental health care of children when industry interests are threatened. Tenure may be the only option for protecting innovative research from specious attacks. The authors offer a summary of the data on ADHD drug treatments, suggest judicious use of such treatments, and add their voices to others who are once again sounding a cautionary alarm.

Data based medicine and clinical judgement.

Randomized controlled trials (RCTs) are a useful tool to check the effectiveness of drugs but have come to shape the culture of medicine in a manner that increasingly compromises medical care. Dependence on RCT evidence is compromised by the well-known problems stemming non-publication of trials, lack of access to trial data, ghostwriting of those trials that are published and a variety of coding and other strategies to hide harms. But what is less appreciated is that whenever a drug and an illness can produce the same benefit or harm that the outcomes of RCTs can be profoundly misleading. This article gives examples of how RCTs can produce the wrong answer.

Relabeling the medications we call antidepressants.

This paper raises the question about whether the data on the medications we call antidepressants justify the label of antidepressant. The authors argue that a true antidepressant should be clearly superior to placebo, should offer a risk/benefit balance that exceeds that of alternative treatments, should not increase suicidality, should not increase anxiety and agitation, should not interfere with sexual functioning, and should not increase depression chronicity. Unfortunately, these medications appear to fall short on all of these dimensions. Many of the "side effects" of these medications have larger effect sizes than the antidepressant effect size. To call these medications antidepressants may make sense from a marketing standpoint but may be misleading from a scientific perspective. Consumers deserve a label that more accurately reflects the data on the largest effects and helps them understand the range of effects from these medications. In other words, it may make just as much sense to call these medications antiaphrodisiacs as antidepressants because the negative effects on libido and sexual functioning are so common. It can be argued that a misleading label may interfere with our commitment to informed consent. Therefore, it may be time to stop calling these medications antidepressants.

Does acceptance and relationship focused behavior therapy contribute to bupropion outcomes? A randomized controlled trial of functional analytic psychotherapy and acceptance and commitment therapy for smoking cessation.

This study evaluated a treatment combining bupropion with a novel acceptance and relationship focused behavioral intervention based on the acceptance and relationship context (ARC) model. Three hundred and three smokers from a community sample were randomly assigned to bupropion, a widely used smoking cessation medication, or bupropion plus functional analytic psychotherapy (FAP) and acceptance and commitment therapy (ACT). Objective measures of smoking outcomes and self-report measures of acceptance and relationship processes were taken at pretreatment, posttreatment, 6-month, and 1-year follow-up. The combined treatment was significantly better than bupropion alone at 1-year follow-up with 7-day point prevalence quit rates of 31.6% in the combined condition versus 17.5% in the medication-alone condition. Acceptance and the therapeutic relationship at posttreatment statistically mediated 12-month outcomes. Bupropion outcomes were enhanced with an acceptance and relationship focused behavioral treatment.

Bibliotherapy as a treatment for depression in primary care.

This study was designed to determine whether a physician-delivered bibliotherapy prescription would compare favorably with the prevailing usual care treatment for depression in primary care (that often involves medication) and potentially offer an alternative. Six family physicians were trained to write and deliver prescriptions for cognitive-behavioral bibliotherapy. Thirty-eight patients were randomly assigned to receive either usual care or a behavioral prescription to read the self-help book, Feeling Good (Burns, D. D. (1999). Feeling good: The new mood therapy. New York: HarperCollins). The treatment groups did not differ in terms of overall outcome variables. Patients in both treatment groups reported statistically significant decreases in depression symptoms, decreases in dysfunctional attitudes, and increases in quality of life. Although not statistically significant, the mean net medical expenses in the behavioral prescription group were substantially less. This study provided empirical evidence that a behavioral prescription for Feeling Good may be as effective as standard care, which commonly involves an antidepressant prescription.

Treating depressed children with antidepressants: more harm than benefit?

Since the FDA held hearings in February 2004 on the safety of antidepressants in children, there has been a great deal of controversy regarding the use of antidepressants in children, culminating in the well publicized black box warnings about increased risk of suicidal behavior in children and young adults (up to age 25) caused by these medications. Using questions that a parent might ask, the current article attempts to summarize the efficacy and safety data on the use of antidepressants in children so that psychologists, with or without prescription privileges, may be able to inform parents of young patients about the science behind this treatment. This article is based on a presentation at the 2007 American Psychological Association conference by the author in acceptance of the 2006 APAHC Bud Orgel Award for Distinguished Achievement in Research. Much of the information described in this article is drawn from the recent APA Report of the Working Group on Psychoactive Medications for Children and Adolescents. (Brown et al. 2006; available at www.apa.org/pi/cyf/childmeds.pdf ) culminating in a book by the same authors (Brown et al., Childhood mental health disorders: Evidence base and contextual factors for psychosocial, psychopharmacological, and combined interventions 2007).

Corporate funding and conflicts of interest: a primer for psychologists.

A presidential task force on external funding was established by the American Psychological Association (APA) in 2003 to review APA policies, procedures, and practices regarding the acceptance of funding and support from private corporations for educational and training programs; continuing education offerings; research projects; publications; advertising; scientific and professional meetings and conferences; and consulting, practice, and advocacy relationships. This article, based on the Executive Summary of the APA Task Force on External Funding Final Report, presents the findings and unanimous recommendations of the task force in the areas of association income, annual convention, research and journals, continuing education, education, practice, and conflicts of interest and ethics. The task force concluded that it is important for both APA and individual psychologists to become familiar with the challenges that corporate funding can pose to their integrity. The nature and extent of those challenges led the task force to recommend that APA develop explicit policies, educational materials, and continuing education programs to preserve the independence of psychological science, practice, and education.

Suitability of bupropion SR for nicotine-dependent smokers: problems in a practice setting.

BACKGROUND: Bupropion SR (Zyban) has been shown in randomized controlled trials to be an efficacious pharmacological aid for smoking cessation; however, recent reports have raised serious concerns about the breadth of its applicability without complications or contraindications. METHODS: We examined this issue in a well-documented medical population, i.e. veterans volunteering to participate in a smoking cessation treatment research program involving the use of bupropion SR. RESULTS: Overall, 22% of the 78 subjects who met the study criteria were appropriate for and completed the course of medication. CONCLUSIONS: Thus, bupropion SR in nicotine-dependent veterans may not be broadly applicable when conservative prescribing guidelines are carefully followed.

Psychology in the prescription era: building a firewall between marketing and science.

The pharmaceutical industry has contributed to many life-saving innovations in medicine and has become one of the most successful industries in the world. As a result, pharmaceutical industry financial and marketing influences extend to federal regulatory agencies, professional organizations, medical journals, continuing medical education, scientific researchers, media experts, and consumer advocacy organizations. These extensive influences have created conflicts of interest that have undermined the credibility of medical research and education. As professional psychology pursues and achieves prescription privileges, it will likely be faced with increasing influences from the industry. To preserve the integrity of psychological science, the authors propose an aspirational "firewall" designed to separate industry marketing from the science of psychology.

Penetrating the blind in a study of an SSRI.

We assessed blind integrity in a double-blinded study comparing paroxetine 20 mg with inert placebo in 20 volunteer subjects who were attempting to stop using methamphetamines. At the end of the study, the blinded clinicians reviewed subject charts and attempted to identify the assigned conditions for the 13 subjects who completed two or more weeks of the study. The three subjects who completed the entire study also attempted to identify their conditions on a questionnaire. We conclude that the blind may unwittingly be broken when the treatments under study are placebo and the selective serotonin reuptake inhibitor (SSRI) paroxetine. The integrity of the blind should be tested in all double-blind SSRI studies.