Safety Issues: FDA Scientists Collide with FDA Managers
Since 1995 FDA scientists have been at odds against FDA managers who routinely override sientists’ safety concerns to approve dubious prescription drugs.
Since 1995 FDA scientists have been at odds against FDA managers who routinely override sientists’ safety concerns to approve dubious prescription drugs.
Since 1995 FDA scientists have been at odds against FDA managers who routinely override sientists’ safety concerns to approve dubious prescription drugs.
"… the basic missions of industry and regulators are different, and inherently somewhat adversarial, no matter how pleasant the relationship…"
Twelve-year old, Denis Matez (weighing 68 lbs) is a human casualty of psychotropic drug "overmedication"– a notorious psychiatrist entrusted with the care of 800 Florida children in Florida foster care prescribed lethal mega doses for unapproved uses.
Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner, acknowledged: “The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions.”
Pfizer, the world’s largest drug manufacturer has the dubious distinction of being a corporate "repeat offender…"
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…
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.
In essence FDA proposals merely change the seating arrangement on the deck of the sinking Titanic. Eli Lilly announced that it intends to seek FDA approval for a long-lasting injectable form of Zyprexa (taken once a month).
The question is: will Eli Lilly succeed, once again, to divert public attention from the revelations contained in its internal documents about the company's illegal marketing practices and its failure to warn about lethal risks posed by its product?
Two ground breaking legal actions in Texas to rein in out of control psychotropic drug prescribing will have nationwide reverberations.
British Medical Journal: Something is rotten at the heart of FDA / Glaxo faces class action suit Sun, 5 Dec 2004 “Something is rotten at the heart of the FDA.” That’s the opening of an editorial in the British Medical Journal. [1] Indeed, there is something rotten at the heart…