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.
FDA Scientists Collide with FDA Managers Re: Safety Issues
Since 1995 FDA scientists have been at odds against FDA managers who routinely override sientists’ safety concerns to approve dubious prescription drugs.
FDA: This Agency Can Be Dangerous_Marcia Angell
"… the basic missions of industry and regulators are different, and inherently somewhat adversarial, no matter how pleasant the relationship…"
12-Year Old Denis Matez: Dead of Psych Drug Cocktail Rx by Psychiatrist
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.
FDA Acknowledges Caving to Influence Peddling–ReGen / ECT
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’s $2.3 Billion Settlement Leaves Victims in the lurch
Pfizer, the world’s largest drug manufacturer has the dubious distinction of being a corporate "repeat offender…"
Florida Antipsychotic Pre-Approval Requirement Protects PreschoolChildren
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…
Letter of Complaint to FDA Commissioner, 2007
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.
FDA Proposals Fail to Ensure Independent Drug Safety Assessment
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).
Eli Lilly Lies About Zyprexa_NYT Editorial Calls for CongressionalHearings
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?
Texas Attorney General Joins Whistleblower Lawsuit against J & J
Two ground breaking legal actions in Texas to rein in out of control psychotropic drug prescribing will have nationwide reverberations.
Infomail Archive 2004
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 This Drug Right? Dec 29: Bill would shield…