FDA officials who continue to run its powerful center for drug evaluation (CDER) have once again shown bad faith by appointing financially compromised doctors to the Psychopharmacologic Drugs Advisory Committee (PDAC) advisory panel.
The State of Florida has established a pre-approval requirement to protect preschool children on Medicaid from being exposed to the hazardous effects of antipsychotic drugs. That step has prompted "a seismic change" in doctors’ inappropriate prescribing of antipsychotics for preschool children: the number of prescriptions for this age group has…
The most shocking disclosure is that Dr. Biederman’s study testing powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol,"
The most shocking disclosure: a Biederman study testing the use of powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol."
The disconnect provides further evidence of how the prescription drug industry can shape, revise or even conceal negative research findings that affect the way doctors prescribe.
Study 15 was pivotal to AstraZeneca gaining FDA approval to market Seroquel. The burial of negative data suggests that the approval process was tainted and the drug's license should be recalled.
Why is FDA Silent? Seroquel Victim Asked Judge to Unseal Documents for FDA Advisory
The unsealed documents reveal that AstraZeneca “buried” unfavorable studies that showed Seroquel posed a serious risk for diabetes.
A document filed in Federal District Court, Orlando Fla, by plaintiffs "in response to AstraZeneca’s motion to exclude evidence and argument about Dr. Macfadden’s personal relationships," sheds light on yet another facet of manipulation–sexual exploitation.
“Current users of typical and of atypical antipsychotic drugs had higher rates of sudden cardiac death than did nonusers of antipsychotic drugs.” NEJM 2009
"There is altogether too much secrecy in court cases that implicate public health."
A forceful editorial by the St. Petersburg Times cuts through the Bull: "There is altogether too much secrecy in court cases that implicate public health."
