Journalist Philip Dawdy, author of the mental health news blog Furious Seasons has made numerous attempts to interview Thomas Laughren MD, director of the FDA's psychiatry products division.
The FDA has made a statement that it supports the Childhood/pediatric Bipolar diagnosis, yet the diagnosis is not in the DSM, and more importantly, the medications that are used for treatment have not had any long term studies done to show safety for use in children. Risperdal and Abilify have only recently been approved by the FDA for children, yet the long term effects are not known.
How this agency can possibly say that a diagnosis is official based on KOL's (key opinion leaders, such as Joseph Biederman et al) is beyond me.
I did a little bit of research on Thomas Laughren and here's a few things I've located for interest:(Dawdy's article below)
Furious Seasons: FDA Director won't answer questions re: childhood bipolar.
Dawdy received this email from an FDA spokeswoman:
"It is the FDA's position that there may be some debate in the psychiatric community about the prevalence of pediatric bipolar disorder, but not about its validity as a diagnosis. As noted in our recent email exchange, the FDA does accept the validity of pediatric bipolar disorder."-Sandy Walsh
To accept the "validity" of "pediatric bipolar disorder", appears one-sided and dangerous thinking, in my opinion this is a public safety issue concerning children under age 10.
Antipsychotics have black box warnings for diabetes and other numerous dangerous side effects and as a parent who watched her child at age 11 suffer the consequences of the acceptance of childhood bipolar disorder for the last decade--I think Sandy Walsh needs to hear from me regarding that statement. I wonder if she knows about Rebecca Riley? age 4 dead from Depakote, Seroquel and more, diagnosed at age 2.
--
Ghostwriting
AHRP-FDA Official Dr.Thomas Laughren ghostwritten articles.
"We also informed Dr. von Eschenbach that the Alliance for Human Research Protection has located at least three (apparently) ghostwritten articles to which the name of Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products, CDER, is penned."
"Dr. Laughren has lent his name repeatedly to industry-sponsored reports promoting a commercially-driven public health policy aimed at increasing the use of highly toxic drugs that now carry Black Box warnings about risks of suicidal behavior (SSRIs) and premature death (antipsychotics)."
--
Child and Adolescent Bipolar Foundation
C.A.B.F
Some very familiar names are in the list of names to cite from this article: including Martha Hellander,past President of C.A.B.F,(several have been at one time associated with CABF in a professional advisory capacity) and other KOL researchers that created the pediatric bipolar disorder theory:
Peter S. Jensen, MD,
Robert L. Findling, MD,
Roger E. Meyer, MD,
Joseph Calabrese, MD,
Melissa P. DelBello, MD,
Graham Emslie, MD,
Laurie Flynn,
Frederick Goodwin, MD,
Martha Hellander,
Robert Kowatch, MD,
Vivek Kusumakar, MD,
Thomas Laughren, MD,
Ellen Leibenluft, MD,
James McCracken, MD,
Editha Nottelmann, PhD,
Daniel Pine, MD,
Gary Sachs, MD,
David Shaffer, MD,
Renee Simar, PhD,
Michael Strober, PhD,
Elizabeth B. Weller, MD,
Janet Wozniak, MD,
Eric A. Youngstrom, PhD
Journal of Child and Adolescent Psychopharmacology
Methodological Issues and Controversies in Clinical Trials with Child and Adolescent Patients with Bipolar Disorder: Report of a Consensus Conference-Abstract 2003
"Objective: To achieve consensus among researchers, pharmaceutical industry representatives, federal regulatory agency staff, and family advocates on a template for clinical trials of acute mania/bipolar disorder in children and adolescents."
"Method: The American Academy of Child and Adolescent Psychiatry, in collaboration with Best Practice, convened a group of experts from the key stakeholder communities (including adult psychiatrists with expertise in bipolar disorder) and assigned them to workgroups to examine core methodological issues surrounding the design of clinical trials and, ultimately, to generate a consensus statement encompassing: (1) inclusion/exclusion criteria, (2) investigator training needs and site selection, (3) assessment and outcome measures, (4) protocol design and ethical issues unique to trials involving children/adolescents, and (5) regulatory agency perspectives on these deliberations."
"Results: Conference participants reached agreement on 18 broad methodological questions. Key points of consensus were to assign priority to placebo-controlled studies of acute manic episodes in children and adolescents aged 10-17 years, who may or may not be hospitalized, and who may or may not suffer from common comorbid psychiatric disorders; to require that specialist diagnostic "gatekeepers" screen youths' eligibility to participate in trials; to monitor interviewer and rater competency over the course of the trial using agreed upon standards; and to develop new tools for assessment, including scales to measure aggression/rage and cognitive function, while using the best available instruments (e.g., Young Mania Rating Scale) in the interim.
Conclusions: Methodologically rigorous, large-scale clinical trials of treatment of acute mania are urgently needed to provide information regarding the safety and efficacy, in youth, of diverse agents with potential mood-stabilizing properties."
THE FINE PRINT:
This conference was convened by the American Academy of Child and Adolescent Psychiatry and funded by Best Practice with partial financial support from unrestricted grants from the following companies:
ABBOTT PHARMACEUTICALS,BRISTOL-MEYERS SQUIBB,GLAXOSMITHKLINE,JANSSEN PHARMACEUTICA,JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT,ELI LILLY, NOVARTIS,PFIZER AND SOLVAY PHARMACEUTICALS.
The article has a disclaimer that Dr.Laughren with the FDA was made on private capacity and intent to connect to the FDA should not be inferred. With those researchers and pharmaceutical companies in the background-- does it make you wonder how influential they are/were toward the FDA?
Why else would the FDA call pediatric bipolar disorder VALID?
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