Publication And Disclosure Issues In Antidepressant Pediatric Clinical Trials

Publication and disclosure issues in antidepressant pediatric clinical trials : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, second session, September 9, 2004.

Witnesses: Joseph Camardo, Sr. V.P., Wyeth Pharmaceuticals; Cathryn Clary, U.S. Medical, Psychiatry & Neurology, Pfizer, Inc.; Ronald Davis, member, ARA Board of Trustees; Richard Gorman, American Academy of Pediatrics; John Hayes, Product Team Leader, Eli Lilly Co.; Caroline Loew, V.P., Scientific & Regulatory Affairs, PhRMA; Ronald Marcus, Neuroscience Global Clinical Development, Bristol-Myers, Squibb Co.; Larry Olanoff, Exec. V.P., Scientific Affairs, Forest Labs., Inc.; Patrick Osinsky, General Counsel, Organon USA; David Wheadon, Sr. V.P., Regulatory Affairs, GlaxoSmithKline; & Janet Woodcock, Dep. Comm. for Operations, FDA. Additional material: FDA, letter to John Eingell; & FDA, response. Illustrations.

As the mental health reporter for the Boston Globe, Alison Bass's front-page reporting on conflicts of interest in medical research stunned readers, and her series on sexual misconduct among psychiatrists earned a Pulitzer Prize nomination. Now she turns her investigative skills to a controversial case that exposed the increased suicide rates among adolescents taking antidepressants such as Paxil, Prozac, and Zoloft. Side Effects tells the tale of a gutsy assistant attorney general who, along with an unlikely whistle-blower at an Ivy League university, uncovered evidence of deception behind one of the most successful drug campaigns in history. Paxil was the world's bestselling antidepressant in 2002. Pediatric prescriptions soared, even though there was no proof that the drug performed any better than sugar pills in treating children and adolescents, and the real risks the drugs posed were withheld from the public. The New York State Attorney General's office brought an unprecedented lawsuit against giant manufacturer GlaxoSmithKline, the maker of Paxil, for consumer fraud. The successful suit launched a tidal wave of protest that changed the way drugs are tested, sold, and marketed in this country. With meticulous research, Alison Bass shows us the underbelly of the pharmaceutical industry. She lays bare the unhealthy ties between the medical establishment, big pharma, and the FDA—relationships that place vulnerable children and adults at risk every day.

Pediatric Anxiety Disorders provides a critical, updated and comprehensive overview of anxiety disorders in children and adolescents based on the current state of empirical research. The book provides specific clinical recommendations which integrate new knowledge from neuroscience and innovative delivery formats for interventions. This is the first reference to examine anxiety diagnoses in accordance with the latest edition of the DSM-5, including childhood onset disorders, such as Separation Anxiety Disorder, Selective Mutism, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia and Generalized Anxiety Disorder. The book assists clinicians in critically appraising the certainty of the evidence-base and the strength of clinical recommendations. Uses the latest edition of the Diagnostic and Statistical Manual of Mental Disorders, the DSM-5 Includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in assessing guideline development Focuses on advances in etiology, assessment and treatment Presents new advances in our understanding of the brain behind fear and anxiety Uses a stepped care approach to treatment

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.