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.
“Current users of typical and of atypical antipsychotic drugs had higher rates of sudden cardiac death than did nonusers of antipsychotic drugs.” NEJM 2009
"It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine." Marcia Angell, MD
Complaint about a surge of FDA administrative approvals for expanded use of highly toxic antipsychotic drugs for children. Approvals were determined by Dr. Thomas Laughren after secret deliberations–without disclosure of scientific data, without an advisory panel or open public discussion.
Minnesota is the first of a handful of states to pass a law requiring drug manufacturers to disclose payments to doctors.
The re-prioritization of rapid approvals occurred at the expense of drug safety standards,
The shift from Hippocratic medicine grounded in the “do no harm” principle, to corporate medicine has severed the unique physician-patient relationship based on a tacit understanding that the physician’s reasoned therapeutic recommendations will be governed the patient’s best interest.
“To me one of the miracle of children’s brains is that we don’t see more harm from these treatments.”
The authors argue that recommendations for the expanded use of statins to stave off cardiovascular disease are NOT supported by the evidence.
Readers of the New England Journal of Medicine should be forewarned: The information in the pages of the NEJM is tainted by industry influence, its professional and scientific integrity are tainted.
Only if one assumes that the FDA sees the drug industry as its client can some sense be made of December 13th meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee in Silver Springs, Maryland.
Unssuccessful effort to engage debate within the community of the authorized clinical research gatekeepers charged with protecting the safety and welfare of the human subjects of research–i.e., members of institutional review boards (IRBs–REBs in Canada).
