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Is FDA Bipolar or Complicit in Legitimizing Illegal Marketing?
Monday, 08 June 2009
The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent. FDA officials are ignoring the real world tragedies--drug-induced deaths of children. Unfortunately for the children, child psychiatrists in particular are noted for irresponsibly prescribing high doses of the most toxic drugs in pharmacopoeia for young children who do not have a valid medical condition, much less a life-threatening illness that would justify the magnitude and scope of risks posed by these drugs, singly and in untested combinations.
The latest child casualty reported by the press, is four-year-old, Destiny Hager, who was prescribed two highly toxic antipsychotic drugs--quetiapine (Seroquel) and ziprasidone (Geodon)--since age three.
The Topeca Capital Journal reports that an X-ray revealed the child's colon was blocked - a known side effect of Seroquel and Geodon.
An autopsy confirmed that the child died of fecal impaction and had "antipsychotic drugs present in concentrations considered therapeutic in adults." Destiny Hager weighed 38 lbs.
This week, on June 9-10, an FDA advisory panel will be considering applications for expanded approval of highly toxic antipsychotics for use in children aged 10 to 17. The drugs under consideration are: Seroquel (AstraZeneca), Zyprexa (Eli Lilly) and Geodon (Pfizer).
Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die.
FDA has already approved Johnson & Johnson's antipsychotic Risperdal for use as a chemical restraint to curb aggression in autistic children without a public hearing--and despite the J & J's withdrawal of its application in the UK, after the British panel required rigorous medical monitoring of children prescribed risperdone (Risperdal). FDA officials have also approved
(aripiprazole) (Abilify), manufactured by Otsuka Pharmaceutical and Bristol-Myers Squibb (BMS) to treat manic and mixed episodes associated with bipolar I disorder in pediatric patients ages 10-17.
It should be underscored that the diagnoses, schizophrenia and bipolar in children are highly controversial--indeed, pediatric bipolar is not recognized elsewhere in the world and there is evidence uncovered during litigation by the US Attorney strongly suggesting that prominent US academic child psychiatrists promoted both the diagnoses and antipsychotic drugs while receiving considerable cash payments from these drugs' manufacturers.
[Below, an EXCELLENT Op Ed in NEWS BLAZE cites some of the recently uncovered corrupt practices that should have precluded FDA from even considering expanding market approval for these drugs.]
Most troubling are confirmatory preliminary scientific findings about the rapid onset of severe hazards these drugs pose for children. Alarmed by their findings, researchers reported them at the American Psychiatric Association meeting (below)
Beyond acute weight gain, the researchers reported: "Atypical Antipsychotics Linked to Rapid, Adverse Metabolic Changes in Children." In just 12 weeks "the entire group of children exposed to one of the antipsychotic drugs exhibit "striking changes in [metabolic] parameters." "These preliminary results suggest that weight gain is associated with a significant decrease in insulin sensitivity."
Reuters and The Wall Street Journal quote from a May 8 memo to the advisory committee by Dr. Thomas Laughren, the agency's director of the FDA's psychiatric product division: "We generally are in agreement that the
sponsors have provided adequate support to suggest effectiveness."
While acknowledging that the risks posed by these drugs are "of particular concern in pediatric patients because of the life-long nature of these disorders." Dr. Laughren couched his directive to the advisory committee in "forked tongue" fashion acknowledging concern for safety issues, but hedging on the lack of proof of efficacy. He retreated from evidence for concern by claiming the risks for children appeared "to be qualitatively similar to those observed" with adults.
If approved, these exceedingly toxic drugs will be widely prescribed for children whose misbehavior will condemn them to the drugs' irreversible hazards.
Question: What are FDA's medical, scientific, or moral standards for considering approval of demonstrably toxic drugs for use in otherwise physically healthy children who would be irreparably harmed by these drugs?
A concern not acknowledged by the FDA nor ever considered by psychopharmacologic advisory panels is the fact that there is a cumulative incremental danger posed by these drugs' multiple severe, adverse, disabling, life-shortening health hazards--including diabetes, metabolic syndrome, and cardiovascular disease and sudden death.
The negative risk / benefit ratio is acknowledged by Dr.Thomas Insel, Director of the National Institute of Mental Health, who recommends precaution:
"With current antipsychotics you risk either metabolic side effects or neurological side effects. With current antipsychotics you risk either metabolic side effects or neurological side effects. Sometimes these potentially serious risks are worth the benefit, but in children the balance needs to favor minimizing risks."
Question: What are FDA's medical, scientific, or moral standards (if any) for considering approval of demonstrably toxic drugs whose hazards are disabling and life-shortening, for use in otherwise physically healthy children who would be irreparably harmed ?
Posted by Vera Hassner Sharav
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