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. Continue reading →
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.” Continue reading →
Pfizer, the world’s largest drug manufacturer has the dubious distinction of being a corporate "repeat offender…" Continue reading →
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 . . . Continue reading →
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. Continue reading →
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.
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is . . . Continue reading →