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FDA Pediatric Ethics Committee (inaugural meeting) will consider whether the scientific merit of a proposed NIH study outweighs the risk of administering dextroamphetamine to healthy children. Dexamphetamine is an addictive drug of abuse: it is linked to cardiovascular and central nervous system adverse effects. See: http://www.healthyplace.com/medications/dextroamphetamine.htm#adverse
This proposed trial is the latest example of medical abuse. It is a barometer of the prevailing culture in psychiatry and at the National Institute of Mental Health. It is immoral to entertain conducting an experiment that exposes healthy, but helpless children to the hazards of amphetamines. Those who propose it, have no regard for children's rights and welfare. Such experiments are proliferating since the enactment of federal laws that encourage the testing of drugs in children. The FDA Modernization Act (1997) and Best Pharmaceuticals for Children Act (2002) provide lucrative 6 month patent extension rights to companies that test their drugs in children-whether the drugs are beneficial or harmful for children.
Sept. 13-14: a follow-up to the Feb 2 meeting will review FDA Analysis Of Antidepressant Pediatric Suicidality Data. Of concern is the process by which the FDA is selecting a new panel of experts to replace the Feb 2 panel-a panel that had urged the FDA to issue immediate stronger warnings to the public.
Eli Lilly is the latest drug company to announce plans to disclose trial data on the website. As the Wall Street Journal correctly observes, recent drug company "pledges" for "broader disclosure" of clinical trial data are meant "to quell the furor" about concealed evidence of drug-related harm. But public furor is unlikely to recede in the absence of enforced, mandatory, full and explicit disclosure.
As long as the drug industry controls the trial data and voluntarily reports--or conceals--the post-marketing adverse event data, the reports are not trustworthy. If public officials, who have been entrusted with oversight authority over the drug industry, betray their public trust and serve that industry's interests, public furor is unlikely to be quelled. FDA's failure to disclose severe adverse drug effects to physicians and patients, its delaying tactics and continued suppression of the agency's own expert medical officer's report and recommendations are a demonstration of bad faith. The suppressed report is posted on the AHRP website as a public service at: http://www.ahrp.org/risks/SSRImosholder/index.html
FDA's record leads to suspicions that FDA officials cannot be trusted to select objective experts for the new Pediatric Advisory Committee. What safeguards are there to prevent the FDA from appointing panelists with financial ties to drug manufacturers?
Congressional committees have also fallen prey to drug industry influence. A July 20 hearing of the House Oversight and Investigations subcommittee--"Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials"--was scuttled when Cong. James Greenwood, the committee chairman, accepted a job offer by a pharmaceutical /biotech trade association. The hearing has scheduled a hearing Sept. 9, at 11:00 AM.
The original (July 20) hearing had all the makings of breaking the silence about undisclosed hazardous side-effects linked to antidepressant drugs. Seven representatives of the major pharmaceutical companies, and a representative of the drug trade organization, PhRMA, were scheduled to testify under oath about their concealment of safety and efficacy data. Also scheduled to testify on July 20, was Dr. Robert Temple, Associate Director for Medical Policy, Food and Drug Administration.
* The FDA Hearing will be held at the Holiday Inn in Bethesda, Maryland. For those wishing to speak, call Anuja Patel to register: 301-827-6790. To submit a written report, call 800-741-8138 ex. 301-451-2544 or go to www.fda.gov, scroll down the page about half way and click References, then go to Dockets.
Contact: Vera Hassner Sharav Tel: 212-595-8974 e-mail: veracare@ahrp.org
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FDA's analysis of independently reviewed pediatric suicidality data for antidepressants will be discussed Sept. 13 & 14 during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the newly formed Pediatric Advisory Committee.
The meeting is being held as a follow-up to a Feb. 2 meeting where advisory committee members expressed concern about the high degree of variability and lack of categorization of events believed to be suicide related.
FDA's preliminary review of over 4,000 pediatric patients from clinical trials of several antidepressants identified 109 cases as "possibly suicide related."
Since the Feb. 2 meeting, "experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and FDA has conducted an analysis of these data," a Federal Register notice slated for publication Aug. 4 states.
The Columbia group employed a standardized methodology to categorize events into "suicidal," "non-suicidal," and "indeterminate." The suicidal category has three subdivisions: "suicide attempt," "suicidal ideation," and "suicidal behavior without injury."
"The committees will consider the results of FDA's analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients," the Federal Register notice reports.
Also on the agenda for the two-day meeting is discussion of further research needed to address questions of pediatric suicidality with antidepressant use. FDA's conduct with regard to the pediatric data remains under investigation by the Senate Finance Committee. The investigation was recently expanded with an inquiry regarding the relationship between CDER's Office of New Drugs and Office of Drug Safety.
In the wake of the investigation, eight out of 10 of the selective serotonin reuptake inhibitors have added class warnings on suicidality to labeling. Pfizer is negotiating language for Zoloft; Solvay's Luvox was withdrawn in 2002.
The Sept. 13-14 meeting will be the first meeting of the full Pediatric Advisory Committee. The Pediatric Ethics Subcommittee will meet Sept. 10 to discuss a study protocol for dextroamphetamine; a full committee review will follow Sept. 15.
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