via
Hooked: Ethics, Medicine, and Pharma:
July 3, 2012
a couple of excerpts:
"Thanks to the U.S. Justice Dept. complaint in the suit recently settled by GlaxoSmithKline for a record $3B:http://www.justice.gov/opa/documents/gsk/us-complaint.pdf
--we can follow the history of this study in more detail, based on the internal GSK documents discovered during the proceedings, and see just how the data were manipulated for marketing purposes."
--we can follow the history of this study in more detail, based on the internal GSK documents discovered during the proceedings, and see just how the data were manipulated for marketing purposes."
"More important, the 11 patients with serious adverse reactions due to Paxil, and the 5 of them with specifically suicidal or agitated symptoms, magically disappeared. In the revised manuscript the investigators suddenly decided that only one of the reactions (headache) was actually caused by Paxil, and the other bad outcomes were unrelated to the drug. When the FDA got its hands on the raw data from 329, it eventually determined that 10 of 93 patients taking Paxil had experienced a potentially suicidal reaction--a far different and scarier picture than that portrayed in any of the drafts or in the final manuscript." read here
via Pharmalot:
Brown University, A Paxil Study And Retractions
By Ed Silverman // February 6th, 2012 // 10:52 am
a couple excerpts:
"The Department of Health & Human Services, by the way, was also reluctant to pursue the matter. In a letter last November to Jureidini, John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity at the HHS, noted that Paxil effectiveness was “apparently exaggerated.” But he went on to say that his office was unable to pursue an investigation due to the statute of limitations."
"Due to the statute, “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct… Further, given the significant lapse of time between the time the study was conducted and concerns raised, the likelihood of being able to conduct a fair and objective review, given the inevitable difficulties in locating records and relying on memories of events well over 10 years ago, seems remote” (here is the letter). Say Jureidini: “We are a bit stuck about where to take it from here.” read here
"Due to the statute, “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct… Further, given the significant lapse of time between the time the study was conducted and concerns raised, the likelihood of being able to conduct a fair and objective review, given the inevitable difficulties in locating records and relying on memories of events well over 10 years ago, seems remote” (here is the letter). Say Jureidini: “We are a bit stuck about where to take it from here.” read here
Thank you Evelyn Pringle for listing all the dirty dogs who put their names on Study 329:
"Give credit where credit is due. In alphabetical order, the full list of authors who signed on to the ghostwritten and fraudulent Paxil Study 329 includes: Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Martin Keller, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan,, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller, Nancy Winters"
I wonder, if John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity has any idea what integrity is. Or if he is aware there are no limits to how many will be harmed or killed because of people who have been promoted to a position that is above their level of incompetence.
People were not warned of the risks, children and adults have died and have killed others, babies have been born with serious defects and many have died soon after they were born; all for the love of money. That these horrible things have happened as a direct result of the failures of people who work for the American people; or more accurately, collect a paycheck that is funded by the American people. In reality, public servants have performed their jobs as if their primary duty was to ensure that marketing campaigns, illegal marketing included, are extremely profitable. The means being unethical, illegal or deadly was of no consequence, as long as the ends were attained.
Every one of the doctors named above knew of the risks, it is safe to assume they did not care that people would die because of their subterfuge. They received their paychecks for aiding and abetting a massive fraud that was perpetrated on vulnerable people; a fraud that has caused the deaths of patients; were uninformed so unaware of the risks they faced. The fraud was enormously profitable, in no small part due to the ongoing efforts of psychiatrists who are members of the American Academy of Child and Adolescent Psychiatry, and the American Psychiatric Association; and the cooperation of public servants who work at the FDA, Health and Human Services, and the Centers for Medicare and Medicaid without these public servants' cooperation and abdication of their ethical duty the fraud could not have been perpetrated so successfully, nor could it continue unabated as it has.
Unfortunately, so do the drug-induced homicides and suicides...
Paxil gif: jeaniejinx photobucket
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