On January 19, 2012 60 minutes aired a program on the SSRI antidepressants. CBS featured the work of Irving Kirsch, whose work demonstrated effectively that in clinical trials, including the trials used to obtain FDA approval, the SSRI 'antidepressants' were not statistically more effective than placebo. Jonathan Leo and Jeffrey Lacasse in their blog on the Mad in America website, 'Rethinking the Broken Brain,' write about how this "dirty little secret" received a public airing (so to speak) and was presented as 'news' e.g. new information, even though it has been known for years. It is not 'news,' nor is it recently discovered information about these drugs. Kirsch's conclusions are drawn from a meta-analysis of the data submitted to the FDA to gain the drugs approval, as well as after approval clinical trials.
The drug was not FDA approved when
Traci Johnson killed herself.
The FDA approved Cymbalta to treat depression in August 2004
Eli Lilly conducted the clinical trials for duloxetine, which they called, Cymbalta, for use as an antidepressant; and Yentreve, for treating urinary incontinence simultaneously, with Cymbalta receiving FDA approval first.
Jeanne Lenzer reports via Slate Magazine:
"By the end of that year, Cymbalta sales topped $61.3 million. In January 2005, as Cymbalta sales climbed to $106.8 million for the first quarter, Lilly announced that it was withdrawing its application for Yentreve. Then it cited the trade-secret rule in refusing to disclose why the drug did not win approval."
The so-called, "Trade Secret" is dirty, but is no little secret; just dirty rotten.
More than a dozen bodies were buried in order to enable
Eli Lilly to claim Cymbalta is safer and more efficacious than it is...
more from Slate:
"Over four months beginning in January, I filed several Freedom of Information Act requests on behalf of the Independent on Sunday, a British newspaper, for all safety data related to Cymbalta and Yentreve. I received a database that included 41 deaths and 13 suicides among patients taking Cymbalta. Missing from the database was any record of Johnson, or at least four other volunteers known to have committed suicide while taking Cymbalta for depression." read here
This is the legal definition of fraud:
"A false representation of a matter of fact—whether by words or by conduct, by false or misleading allegations, or by concealment of what should have been disclosed—that deceives and is intended to deceive another so that the individual will act upon it to her or his legal injury."
The certain required features:
"Fraud must be proved by showing that the defendant's actions involved five separate elements: (1) a false statement of a material fact,(2) knowledge on the part of the defendant that the statement is untrue, (3) intent on the part of the defendant to deceive the alleged victim, (4) justifiable reliance by the alleged victim on the statement, and (5) injury to the alleged victim as a result." via The Free Dictionary
NPR had a program about another 'secret' the FDA, the American Psychiatric Association, and the American Academy of Child and Adolescent Psychiatry have been keeping for the pharmaceutical industry: the 'serotonin metaphor.' This supposed 'metaphor' is referring to the claim that depression is caused by a serotonin imbalance...The claim that depression is caused by a chemical imbalance of any kind is not based on any facts, it is a claim made so patients believe that depression is a medical condition caused by a chemical imbalance, which requires antidepressant drugs to 'correct the imbalance." It is told to gain 'treatment compliance.'
The definition of metaphor:
A figure of speech in which an implied comparison is made between two unlike things that actually have something in common. Adjective: metaphorical. A metaphor expresses the unfamiliar in terms of the familiar. ex. "Love is a rose"
via Mad in America Rethinking the Broken Brain:
"Revising the History of the Serotonin Theory of Depression?" a couple of excerpts:
"What if research has indicated for decades that the serotonin theory is false, yet psychiatrists told their patients the serotonin story anyway? What would this mean?"
“By 1970…[George] Ashcroft had concluded that, whatever was wrong in depression, it was not lowered serotonin.” [D. Healy, Let Them Eat Prozac]
“Although it is often stated with great confidence that depressed people have a serotonin or norepinephrine deficiency, the evidence actually contradicts these claims.” [Neuroscientist Elliot Valenstein, 1998, in Blaming the Brain]
“In truth, the "chemical imbalance" notion was always a kind of urban legend- never a theory seriously propounded by well-informed psychiatrists.” Ronald Pies, M.D., Editor of Psychiatric Times, in 2011
read here
It has been known for decades depression is not caused by a chemical imbalance of serotonin, or any other neurotransmitter. Unless the word 'metaphor' is a euphemism for telling a lie in order to successfully convince people to take their "prescribed treatment," e.g. manipulate a patient's beliefs about a psychiatric diagnosis, with the intent of altering their behavior to ensure 'treatment compliance.' This so-called 'metaphor' has been effectively used as a tool in perpetrating consumer medical fraud. Stating depression is due to a 'chemical imbalance' is no 'metaphor.'
via Phil Lawrence, NUMB a documentary director on youtube:
Vera Sharav speaking at a Press Conference prior to the 2006 FDA Advisory Committee Public Hearing on the connection between antidepressants and suicidal thoughts and actions. The press conference was put together by the family of Woody Witczak.
Vera Hassner Sharav, M.L.S.
Vera Sharav, a professional law librarian turned public advocate for human rights, is the founder and president of the Alliance for Human Research Protection (AHRP) which serves as an information resource, a public interest watchdog, and a catalyst for public debate whose goal is to unlock the walls of secrecy in biomedical research and to bring accountability to that endeavor.
She has earned the respect and admiration of a distinguished network of physicians and scientists including those who have agreed to serve on the Medico-Scientific Advisory Committee for a publicity campaign aimed at providing credible information to consumers about the undisclosed risks of widely and inappropriately prescribed psychotropic drugs whose hidden hazards pose severe, irreparable risks of harm.
Ms. Sharav has developed a database to track ethical violations in research and failure to disclose drug hazards. Her advocacy efforts include: suspension of EPA pesticide experiment (CHEERS) on children (2005); federal investigations on the use of children in foster care in experimental AIDS drug and vaccine trials (2004); suspension of smallpox vaccine on children (2002); suspension of "violence prediction" experiment exposing 6-11 year old NYC boys to fenfluramine (1998); organized testimonies by victims of unethical research before the National Bioethics Advisory Committee (1997). These testimonies led to a prize-winning series in the Boston Globe, "Doing Harm: Research on the Mentally Ill" (1998), the shut down of 29 clinical trials at the National Institute of Mental Health (1999), culminating in the prize-winning book by Robert Whitaker, Mad in America (2001).
Mrs. Sharav served on the Children’s Workgroup of the National Human Research Advisory Committee (2001-2002); she has testified before national policy advisory panels including: the Institute of Medicine (against prisoner experiments (2005); against human pesticide experiments (2002); FDA hearings on antidepressants and the risk of suicide (2004 and 2006), the National Bioethics Advisory Committee (1997), military ethics forums and academic forums, and consumer advocacy forums (2006). Among her recent publications: Screening for Mental Illness: The Merger of Eugenics and the Drug Industry, Ethical Human Psychology and Psychiatry (2005); Conflicts of Interest in Biomedical Research Harm Children With and Without Disabilities,"Journal of Disability Policy Studies (2004); "The Impact of FDAMA on the recruitment of children for research," EHPP (2003); "Children in Clinical Research: A Conflict of Moral Values," American Journal of Bioethics (2003); The ethics of conducting psychosis-inducing experiments," Accountability in Research (1999).
via the FDA: Guidance Drug Safety Information
FDA’s Communication to the Public an excerpt:
snake oil image from businesspundit.com
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