Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States

Stanford University, Palo Alto, California, United States
Archives of General Psychiatry (Impact Factor: 14.48). 04/2007; 64(4):466-72. DOI: 10.1001/archpsyc.64.4.466
Source: PubMed

ABSTRACT IMS Health Inc data presented by the Food and Drug Administration (FDA) on September 13 and 14, 2004, at a joint meeting of the Center for Drug Evaluation and Research's Psychopharmacologic Drugs Advisory Committee and the FDA's Pediatric Advisory Committee suggested that the number of children and teenagers who were prescribed antidepressants continued to increase in 2004, despite widespread publicity surrounding 2 FDA advisories regarding the potential for pediatric suicidality with selective serotonin reuptake inhibitor use. These results are contradictory to findings from the Medco Health Solutions, Inc, March 2004 analysis of pharmacy benefit claims and a separate subsequent analysis conducted by NDC Health using dispensing data from March 31, 2004, through June 30, 2005.
To investigate the contradictory findings and provide additional analyses on the prescribing trends of antidepressants across age groups and physician specialties in the United States.
Retail pharmacy prescription data and physician audit data were obtained from Verispan, a joint venture between Quintiles Transnational and McKesson. In addition to examining prescribing trends, a joinpoint regression analysis was conducted to identify the timing for significant changes in prescription use.
The analyses suggest that the number of children and teenagers who were prescribed antidepressants has decreased significantly (P = .02) in the wake of widespread publicity surrounding the FDA public health advisories. Another impact of the advisories seems to be a shift in care from "generalists" to psychiatric specialists when it comes to prescribing antidepressants to patients younger than 18 years. Finally, the analyses highlight a slight shift in prescribing toward the non-selective serotonin reuptake inhibitor bupropion hydrochloride, even though it carries the same FDA "black box" warning as the selective serotonin reuptake inhibitors.
The effect on antidepressant prescribing volume observed in our analysis of the Verispan data parallels earlier findings reported by Medco Health Solutions, Inc, and NDC Health that the FDA actions have had a significant effect on the prescribing of antidepressants to children and adolescents. Together, these findings underline the importance of presenting a fair balance within the media due to the significant reach of this channel among prescribing physicians.

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Available from: Charles B Nemeroff, Sep 25, 2015
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    • "The steep rise in prescriptions of antidepressants, most notably SSRIs, for US youth in the five years prior to 2004 is well documented (Chen & Toh, 2011; Olfson, Marcus, & Druss, 2008; Zito, 2002). As might be expected, studies evaluating the impact of FDA warnings (Libby et al., 2007; Nemeroff et al., 2007; Olfson et al., 2008; Pamer et al., 2010) found marked differences between forecasted and actual rates following the black box advisory. These investigations did not find a significant decrease in prescription rates but rather a reduction in prescription growth. "
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    ABSTRACT: The purpose of this review is to assess whether evidence supports a favorable risk/benefit profile for pediatric antidepressant use and reconsideration of the black box. The review examines studies post-black box purporting to show declines in pediatric antidepressant use and rising youth suicide, summarizes evidence for efficacy and safety of pediatric antidepressants, and discusses irregularities in recent meta-analyses of fluoxetine for youth. Pediatric antidepressant prescription did not significantly decline post-black box and youth suicide has risen only in recent years. Recent meta-analyses fail to undermine evidence that antidepressants are associated with increased risk of suicidality in youth. First line prescription of antidepressants for youth is not advisable. The black box and international warnings on pediatric use of antidepressants are warranted. Wider availability of psychosocial options for depressed youth is recommended.
    Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent 08/2013; 22(3):240-6.
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    • "Importantly, faster rate of response in the acute phase of treatment is associated with more complete improvement, with those responding to treatment within the first four weeks being more likely to achieve remission after 12 weeks of treatment (Brent et al., 2008; Tao et al., 2009). The major concern for the findings for both depressed adults and juveniles is that the medications are not without risk, remain a major health cost, and their use have declined due to warnings and side effects (Kratochvil et al., 2006), with a resultant increase in suicides (Nemeroff et al., 2007; Olfson et al., 2006). "
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    ABSTRACT: The Depressed Adolescents Treated with Exercise (DATE) study evaluated a standardized aerobic exercise protocol to treat non-medicated adolescents that met DSM-IV-TR criteria for major depressive disorder. From an initial screen of 90 individuals, 30 adolescents aged 12e18 years were randomized to either vigorous exercise (EXER) (>12 kg/kcal/week [KKW]) or a control stretching (STRETCH) activity (<4 KKW) for 12 weeks. The primary outcome measure was the blinded clinician rating of the Children's Depression Rating Scale e Revised (CDRS-R) to assess depression severity and Actical (KKW) accelerometer 24hr/ 7days a week to assess energy expenditure and adherence. Follow-up evaluations occurred at weeks 26 and 52. The EXER group averaged 77% adherence and the STRETCH group 81% for meeting weekly target goals for the 12 week intervention based on weekly sessions completed and meeting KKW requirements. There was a significant increase in overall weekly KKW expenditures (p < .001) for both groups with the EXER group doubling the STRETCH group in weekly energy expenditure. Depressive symptoms were significantly reduced from baseline for both groups with the EXER group improving more rapidly than STRETCH after six weeks (p < .016) and nine weeks (p < .001). Both groups continued to improve such that there were no group differences after 12 weeks (p ¼ .07). By week 12, the exercise group had a 100% response rate (86% remission), whereas the stretch group response rate was 67% (50% remission) (p ¼ .02). Both groups had improvements in multiple areas of psychosocial functioning related to school and relationships with parents and peers. Anthropometry reflected decreased waist, hip and thigh measurements (p ¼ .02), more so for females than males (p ¼ .05), but there were no weight changes for either gender. The EXER group sustained 100% remission at week 26 and 52. The STRETCH group had 80% response and 70% remission rates at week 26 and by week 52 only one had not fully responded. The study provides support for the use of exercise as a non-medication intervention for adolescents with major depressive disorders when good adherence and energy expenditure (KKW) are achieved.
    Mental Health and Physical Activity 06/2013; 6(2):119-131. DOI:10.1016/j.mhpa.2013.06.006
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    • "Despite evidence that acceptability is linked to utilization and outcomes, few quantitative studies have examined the acceptability of treatments for depression (Banken & Wilson, 1992; Cooper et al., 2003; Hall & Robertson, 1998; Tarnowski, Simonian, Bekeny, & Park, 1992) and none have sampled adolescents. Given the recent controversy surrounding selective serotonin reuptake inhibitors (SSRIs) and fluctuations in the rates of antidepressant use among youth (e.g., Katz et al., 2008; Nemeroff et al., 2007), it is important to understand consumer perspectives on depression treatments in order to maximize their effectiveness. Adolescents are unique consumers in that they may have the cognitive capacity to evaluate the risks and benefits of treatment, yet their consent is not legally required. "
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    ABSTRACT: An efficacious treatment is diminished in value if consumers do not seek it out and adhere to it, making treatment acceptability an important predictor of the effectiveness of treatment. This study examined the acceptability of treatments for depression to 67 female high school students. All participants read a vignette describing a depressed adolescent and rated the acceptability of four single treatments for depression (cognitive-behavioral therapy, interpersonal therapy, family therapy, and pharmacotherapy) and three treatment combinations. Psychotherapy approaches were generally more acceptable to adolescents than combinations of psychotherapy and pharmacotherapy; and, pharmacotherapy used alone was not acceptable. For interpersonal therapy and family therapy only, treatment acceptability was related to perceived causes of depression. Across all treatments, acceptability was not associated with symptom severity. Implications for increasing the utilization of mental health services in this population are discussed.
    Journal of Adolescence 05/2012; 35(5):1237-45. DOI:10.1016/j.adolescence.2012.04.007 · 2.05 Impact Factor
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