Ex FDA Chief Says J&J Broke The Law In Promoting Risperdal
By David Sell, Thursday, October 4, 2012
Former U.S. Food and Drug Administration Commissioner David Kessler, a pediatrician by training, said that Johnson & Johnson and its Janssen subsidiary broke the law in marketing its antipsychotic drug Risperdal for use in children and adolescents.
"In my opinion," Kessler wrote in a report submitted for a trial set to begin Oct. 9 in in Philadelphia's Court of Common Pleas, "Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act.
"The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning.
"The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning.
"The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning.
"Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."
Kessler served as FDA Commissioner from 2000 through 2007, under Presidents George H.W. Bush and Bill Clinton.
It probably won't shock anyone to know that J&J's attorneys in the lawsuit don't want Kessler saying anything on the witness stand in the suit, in which a Missouri mother sued on behalf of her 16-year old son who grew breasts after being prescribed Risperdal.
But the J&J attorneys in their motion to prevent Kessler from testifying focused on the relatively last-minute nature of the plaintiff's attorneys request to add Kessler to the witness list and the submission of Kessler's 92-page report, without letting them depose Kessler ahead of time.
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Kessler's report was posted to the Court of Common Pleas electronic docket system late Wednesday in four pieces, as part of the J&J motion to preclude him from testifying. The pieces are all PDFs and links are here, here, here and here.
Continue reading Mr Sell's report at Philly.com here.
Thank you Philly.com and Mr Sell
SFGATE.com has;
Sabin Russell, Chronicle Medical Writer
Published 4:00 a.m., Saturday, December 15, 2007
In light of the San Francisco Conspiracy with its non-existent Risperdal pushing Hospitals and Staffs, its Illuminati chaired UCSF Psychiatry Dept, and its SFGH being the Only 24hr/16hr PES in town, and its C&C MHB going deaf dumb and blind at City Hall just 6 months earlier, ..... you have to wonder, .....
SFGATE.com has coverage of Dr. Kessler leaving UCSF:
Dr. David Kessler, the head of the prestigious UCSF School of Medicine, has been fired for reasons the university refuses to disclose.
UCSF Chancellor Michael Bishop announced the departure this morning in a short e-mail to the campus faculty, saying Kessler has "left office," and thanking him for "his energetic service to the university and his substantial achievements on behalf of UCSF."
Kessler, the onetime commissioner of the Food and Drug Administration who became Dean of the UCSF School of Medicine in 2003, told The Chronicle today his dismissal followed years of discord over finances at the medical school.
Kessler said he was labeled a "whistleblower" by the University of California after he repeatedly sought to uncover what he called "financial irregularities that predated my appointment."
At the heart of the dispute, Kessler said, are tens of millions of dollars in funds that should have been in the Dean's office account prior to his starting the job, but have never been properly accounted for because of what he called "poor financial controls."
He was Dean of the Yale School of Medicine when he was recruited in 2003 to the $540,000 a year post as UCSF vice chancellor and medical school dean.
UCSF spokeswoman Corinna Kaarlela declined to comment on the firing, saying, "This is a personnel issue, and we cannot comment further," she said.
And Despite the Difficulty in bringing an AntiTrust Action against Government itself,
SFGATE.com has; (dateline September 13, 2008)
"If the state requires us to go out to rebid, we will go out to rebid," said Dr. Mitch Katz, director of the San Francisco Public Health Department. But he stressed that the state's ruling turns on "a very narrow legal question that's based on an esoteric statute. ... The (state's) letter itself is a little puzzling, so I'm having the city attorney review it."
- In a July 31 letter to Dr. John Brown, the city's emergency medical services director, California Emergency Medical Services Authority Director Steve Tharratt rescinded San Francisco's long-standing antitrust immunity in running its 911 ambulance operations and advised city officials to begin a competitive process. He made his ruling after the city submitted 127 pages of documents.
