Eli Lilly Knew Prozac Causes Suicides, Violence - FDA Closed Both Eyes
Prozac, called fluoxetine by generic name, is a psychiatric drug prescribed to over 50 million people including millions of children. The drug was linked to increased suicides and violence as early as 1988, in a recently emerged document. Apparently the evaluation was known to Prozac's maker Eli Lilly as early as the 'eighties, but was never even given to the FDA.
This is the preoccupying picture that emerged just days ago, as the British Medical Journal passed on documents to the FDA which it had received by an anonymous whistleblower.
Can such a "head in the sand" policy be characterized as merely overzealous business practice, or is it an indication of something much more devastating? Eli Lilly is one of the multinational drug companies that have developed the "Texas Medication Algorithm Project", which is part of George Bush II's sweeping program to test kids at school as well as pregnant mothers for "psychiatric disorders". Prozac is one of the drugs that are to be given to kids who don't meet the evaluating personnel's standards of "normal" behaviour.
Eli Lilly is right where the important decisions are made. In July 2001, Gerald Radke, a former marketing director for Eli Lilly, became Deputy Director of Pennsylvania's Department of Public Welfare’s Office of Mental Health and Substance Abuse. Rathke, who is one of the major proponents of the universal testing and medication program, had previously been "on loan" to head a mental health advocacy group, NAMI or National Alliance for the Mentally Ill, which is funded by ... Eli Lilly and other pharmaceutical manufacturers.
When recently, antidepressant drugs received FDA mandated warning labels, Prozac wasn't on the list and indeed, in Europe the drug has been called "safe for children" for years. Recently, the whole FDA approval procedure for drugs has been questioned as being too industry friendly, and apparently with good reason. After recent revelations of heart attack risk for the users of several "new generation" painkillers - Vioxx, Bextra, Celebrex and others, the FDA's policy of sustaining the profits of pharmaceutical industry, in sharp contrast with its official mission of protecting patients from dangerous pharmaceutical drugs, has been publicly questioned.
Not only the drug approval process seems to be slanted in favor of industry. Even the food supply has been compromised with products such as artificial sweeteners and genetically modified plants, animals and bacteria that are by no means innocuous. While aspartame for instance has brought great profits to the industry, the FDA plain refuses to look at the numerous adverse reaction reports. FDA field agents are reported to block people from even reporting events, because "aspartame could not cause such a reaction".
The same is true for cholesterol lowering statin drugs, where apparently frequent reports of muscle pains, memory loss and other side effects just don't seem to make it into the FDA's system, despite being fairly widespread. The pains associated with statin drug use may even have led to the overuse of painkillers - those recently found to cause an increase of heart attacks.
Meanwhile, the FDA is complaining that it does not have sufficient means to control dangerous food supplements and is promoting stringent legislation on those nutrient rich products.
What has the world come to?
- - -
Journal hands over Prozac papers
Confidential papers on anti-depressant drug Prozac that went missing during a murder case have been handed to the US drug regulator by a UK medical journal.The documents, belonging to Eli Lilly, the makers of Prozac, included details of clinical trials of the drug, the British Medical Journal said.
The documents reportedly went missing after the relatives of the victims of Joseph Wesbecker started legal action.
Mr Wesbecker, who was on Prozac, shot eight people dead in 1989 in the US.
Another 12 people were injured during the shooting spree at a printing plant in Louisville, Kentucky.
Data
The 47-year-old then shot himself.
In 1994, the relatives brought a civil case against Eli Lilly.
The company subsequently won the case but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the BMJ reported.
Dr Richard Kalpit, the clinical reviewer at the US Food and Drug Administration, the US drugs regulator, who approved the drug, told the BMJ he was not given the data included in the documents.
"These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it."
Recent research has suggested children who use Prozac are at greater risk of suicide.
And earlier this month the Medicines and Healthcare Products Regulatory Authority said analysis of both published and unpublished data by experts on the Committee on Safety of Medicines showed "a modest increase in the risk of suicide from SSRIs [such as Prozac and Seroxat] compared to placebos [dummy pills]" in adults.
The FDA is now reviewing the papers, which were given to the BMJ by an anonymous source.
Confidential
BMJ deputy editor Dr Tony Delamothe said the journal had handed the confidential drug company documents to the FDA as it believed healthcare decisions need to be made using all the information available.
"The BMJ is committed to ensuring that results good, bad, or indifferent are reported."
A spokesman for Eli Lilly said it would not be appropriate to comment on the content of the papers as officials from the company have not seen them.
But he added: "Lilly is committed to the public disclosure of all clinical trial data to ensure that healthcare professionals and families have the information they need to make informed treatment decisions about Lilly medicines.
"Prozac has been prescribed for more than 50m people worldwide and is one of the most studied drugs in the history of medicine."
See also:
The Scotsman: US drug company knew that 'Prozac could lead to violence'Eli Lilly knew Prozac had 1200% higher suicide rate than other antidepressants
Psychiatrist: Company hid Prozac, suicide link
Prozac timeline
This is contained in a document filed in court in Forsyth v. Eli Lilly. Another confirmation that Eli Lilly knew very well about prozac's tendency to increase suicidality in patients taking the drug.March 24, 2005
Teen shooter was taking Prozac
By Ceci Connolly and Dana Hedgpeth - Washington Post
RED LAKE, Minn. – Two days after a shooting rampage on the Indian reservation in Red Lake left 10 dead, friends, relatives and neighbors of the teenage assailant began to sketch a portrait of a deeply disturbed youth who had been treated for depression in a psychiatric ward, lost several close family members, sketched gruesome scenes of armed warriors and had been removed from the school where he gunned down most of his victims Monday.Britain set for clash with Europe over ban on Prozac for under-18s
Europe's drugs watchdog has banned Prozac and other modern antidepressants for under-18s because of safety fears, putting it on a collision course with Britain's drugs regulator. Antidepressants increase suicidal thoughts and suicide attempts among children and adolescents, and should not be used to treat depression, the scientific panel of the European Medicines Agency (Emea) said. Including Prozac in the ban clashes with the stance taken by Britain's drugs regulator 16 months ago. Prozac is the only antidepressant that doctors can prescribe to children in Britain, following a safety review in 2003.FDA accused of suppressing drug safety information
Here's a report on the FDA that could only come from outside the United States. I'm reading to you from The Independent, a British newspaper, that says, "Vital data on prescription medication found in millions of British homes has been suppressed by the powerful U.S. drug regulators, even though the information could potentially save lives." An investigation by The Independent states that, under pressure from the pharmaceutical industry, the American Food and Drug Administration routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks.
posted by Sepp Hasslberger on Saturday January 1 2005
updated on Friday December 3 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2005/01/01/eli_lilly_knew_prozac_causes_suicides_violence_fda_closed_both_eyes.htm
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