April 14: the FDA announced that Coast IRB "has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company’s ability to protect human subjects participating in clinical trials."
The results suggest that the truth may have escaped the usual exclusion criteria. Underlying the commercial success of the new antipsychotics is evidence (usually suppressed) showing that these drugs are both harmful and ineffective even for their approved use.
It may come as a shock to some of you; but, Electroshock machines have never been tested for safety or efficacy.
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 New York Times reports that Federal prosecutors have issued a subpoena seeking information and all documents including transcripts of their testimony produced in litigation relating to three prominent Harvard researchers…
Another research scam uncovered by the GAO sting involved a "bogus IRB with a pet dog as its CEO."
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.
"Radical restructuring, not merger mania, is the need of our time." Dr. William Haseltine
Why is FDA Silent? Seroquel Victim Asked Judge to Unseal Documents for FDA Advisory
