Will Another Blockbuster Drug Hit the Dust?
"The vote is an enormous blow to Avandia and GlaxoSmithKline. The vast majority of panel members voted either to withdraw the drug or to allow continued sales only if strict controls are added"
"The vote is an enormous blow to Avandia and GlaxoSmithKline. The vast majority of panel members voted either to withdraw the drug or to allow continued sales only if strict controls are added"
The dust-up involving Dr. Charles Nemeroff and Dr. Thomas Insell, director of NIMH shines a light on NIH leaders whose failure to enforce federal disclosure requirements is brushed off with excuses so untenable they have the ring of theater of the absurd.
"Dr. Nemeroff has become the poster child for what’s wrong with academic medicine in our country." Dr. Thomas Insell, Director of the NIMH, quietly helped him get a prized position at the University of Miami.
A stunning admission of failure by major drug manufacturers who market drugs for the treatment of Alzheimer’s. "We really believe drugs are failing because we honestly don’t understand the disease."
AHRP PROPOSAL:
Any FDA-approved drug, whose manufacturer has been found by a court of law or the Department of Justice–to have illegally marketed the drug by concealing risks or incidence of adverse effects, or making unsupported claims of clinical benefit–should be denied coverage by taxpayer funded insurance programs–including Medicaid, Medicare, VeteranstAffairs.
In response to yesterday’s AHRP Infomail (March 5) in which we informed readers that Dr. Gilbert Ross, the Medical Director of the American Council on Science and Helath (ACSH), the author of a WT OpEd (March 4, 2010), is a convicted felon, whose medical license was revoked after serving two years in prison for healthcare fraud:
In December, 2009, Bloomberg News published an investigative report by David Evans reported, "Big Pharma’s Crime Spree" documenting major court settlements: "Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies…
Ghostwritten journal reports masquerading as scientifically validated reports are a menace to public health.
Two high ranking FDA officials’ conflicts of interest have led one to resign, the other is under investigation by the Inspector General of the Department of Health and Human Services:
Medtronic acknowledged that some of the consulting payments occurred during the time that Dr. Kuklo, was shopping his favorable study of Medtronic’s Infuse bone-graft product to medical journals.
But FDA says keep taking the "medicines."
The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent.