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.”
This month PLoS editors called for a zero tolerance policy: calling upon journals to identify and retract ghostwritten articles and banish their authors from publishing in their journal.
"How can they call this America, the land of the free?" she asked. "Where are my parental rights?"
What possible risk/ benefit standard can justify giving an inadequately studied vaccine whose risks include serious, permanent adverse effects–including death– to millions of girls and women–who will likely never get cervical cancer?
Today’s New York Times reports (below) that "court documents provide a paper trail showing that Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing."
ACRE’s mission is to persuade physicians that MORE rather than less industry involvement in Continuing Medical Education programs is good for patients–much as industry’s "Harry and Louise" ads were aimed at convincing the public that universal healthcare was BAD for them.
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.
Two news reports: Alaska Supreme Court decision and a JAMA report confirms that risk of violence among schizophrenia patients "was mostly confined to patients with substance abuse comorbidity."
AHRP proposes a multi-disciplinary team of independent scientists to review ALL of Dr. Joseph Biederman’s publications and supporting documents, including: research protocols, consent forms, and the original (of course, anonymized) data sets with associated code books for all pediatric studies.
The FDA expanded approval process for toxic drugs is unaffected by evidence uncovered by the US Justice Department showing the studies to be flawed, if not fraudulent.
Dr. Peter Slavin, president of Mass. General Hospital: "We don’t want our faculty being on the road as hired guns."
