The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

SSRIs are Actually Depressants… The Big Suicide Loophole

Breggin says it best, so for now my comments are unnecessary.

http://www.breggin.com/AntidepressantSuicideLoophole.html

The Big Suicide Loophole in Antidepressant Drug Safety Studies
By
Peter R. Breggin, M.D.
On December 13, 2006 the FDA’s Psychopharmaceutical Drugs Advisory Committee (PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.
Now the agency has given advanced notice of its new findings—antidepressants, all of them according to the FDA, cause increased suicidality in young adults. Suicide occurs more than twice as much on antidepressants than on sugar pills in individuals under age 25.
First the agency admits that antidepressants cause suicidality in children. Now the agency admits the drugs cause the same disasters in young adults. Meanwhile, an independent review of all antidepressant trials submitted to the FDA has shown that the drugs are no better than placebo.[i] America’s drug watchdog needs to come clean. It’s been approving depressants as antidepressants.
The Largest Loop Hole
But it gets worse. The primary data on suicidality has been generated in short-term controlled clinical trials planned by drug companies, carried out by drug company hacks, and evaluated by drug company employees at corporate headquarters. If that kind of carefully cultivated evaluation bears such bad fruit, imagine what the real data must show.
Since I first began working as a medical expert in product liability cases way back in the early 1990s, I’ve spent innumerable hours culling the sealed data contained within the files of companies like GlaxoSmithKline and Eli Lilly. Among other things, I long ago found evidence that Paxil and Prozac cause suicidality in adults. These discoveries then led to settlements in product liability suits brought against the two companies brought by surviving family members. I’ve also communicated my conclusions in books like Talking Back to Prozac and the Antidepressant Fact Book and in scientific articles but the primary data until recently remained sealed.
Drug company groomed data creates the biggest loophole in the FDA’s evaluations of drug safety. In May 2006 GSK published a Dear Healthcare Provider letter admitting that Paxil causes suicidality in depressed adults, but even that data was diluted before it was processed. The real picture is even worse.
Paxil Suicide Data Sealed in Company Files
I recently published analyses of previously sealed GSK data on Paxil suicide in the peer-reviewed journal Ethical Human Psychology and Psychiatry. I combed the data out of GSK files during a several-day investigation of the company’s Paxil records. My original medical-legal report recently became unsealed and provided the basis for the published reports.
The first report shows how GSK omitted some suicides and suicide attempts from their tables and from the data sent to the FDA.[ii] The second shows how the company hid data on Paxil-induced akathisia (psychomotor restlessness) and its relationship to suicidality.[iii] The third shows how the company hid the basic concept of activation or stimulation that recently became a central part of the newly mandated antidepressant labels.[iv] [Go to Breggin Selected Scientific Papers for Paxil Special Reports 1 through 3]
Prozac Suicide Data Sealed in Company Files
The sealed Prozac data from Eli Lilly also came from my investigations of the company as a medical expert in product liability suits. BMJ (The British Medical Journal) recently obtained the sealed documents from an anonymous source and released them to the FDA and the U.S. Congress. The documents are contained in four Lilly PDFs that can be downloaded from my professional website [http://www.breggin.com/].v]
Lilly PDFs 1 to 3 show that the drug company knew in 1985 that patients taking Prozac had a 12 to1 increase in suicide attempts compared to placebo or to an older antidepressant. This original data and the analyses were never shown to the FDA until the BMJ recently forwarded them to the agency. The FDA has never responded. [Go to Lilly PDF 1] [Go to Lilly PDF 2] [Go to Lilly PDF 3]
Lilly PDF 4 contains several studies. Most important, two in-house memoranda show that Eli Lilly was purposely hiding suicide attempts and suicide ideation by coding them under false categories, such as “depression” and “no drug effect” (pages 3 and 4 of Lilly PDF 4). Eli Lilly employee Claude Bouchy expressed shame about going along with this fraudulent practice: “I do not think I could explain to the BGA [the German regulatory agency], to a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicide ideation.” [Go to Lilly PDF 4] The data used to evaluate antidepressant-induced suicidality in adults is not reliable. This is a fact the FDA has yet to face. The data has been pruned, culled and manipulated by the drug companies before being tabulated and released. The FDA must send investigators into the original drug company files to search and analyze the primary sources of data, much as I have done as a medical expert in product liability suits against drug companies. I will be happy to share my knowledge with FDA officials on how to conduct these searches and analyses.
[i] Kirsch, I. and Sapirstein, G. (1998). Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention & Treatment, 1, Article 0002a, 16 pages, posted June 26, 1998. http://www.journals.apa.org.
[ii] Breggin, P. (2006a). Court filing makes public my previously suppressed analysis of Paxil’s effects. Ethical Human Psychology and Psychiatry, 8, 77-84, 2006. Available on http://www.breggin.com.
[iii] Breggin, P. (2006b). How GlaxoSmithKline suppressed data on Paxil-induced akathisia: Implications for suicide and violence. Ethical Human Psychology and Psychiatry, 8, 91-100.
[iv] Breggin, P. (2006c) Drug company suppressed data on paroxetine-induced stimulation: Implications for violence and suicide. Ethical Human Psychology and Psychiatry, 8, 255-263.
[v] Lilly Documents, Folders 1-4 (2006). Dr. Breggin analyzes Eli Lilly Prozac-induced suicide and violence documents now in possession of the British Medical Journal (BMJ). http://www.breggin.com/. Retrieved December 10, 2006.
Go to Scientific Papers of Peter R. Breggin, MD
HomeBooksBiographyResumeContact Dr. Breggin
Peter R. Breggin, MD101 East State Street, # 112 Ithaca, New York 14850 By Appointment Only Phone 607 272 5328 Fax 607 272 5329

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Knowledge – The Anti-Drug

Plato wrote an essay called “The Cave.” A man lives in a cave his whole life, and one day the entrance to the cave is opened and a bright light shines in. He leaves the cave, and is at first completely blinded by the bright light. But after his eyes have had time to adjust, he sees the world as it really is for the first time. Life is brand new outside the cave; the darkness which he had been living in his whole life is no longer limiting his vision.

Are you as aware as you should be? The saying goes, if you’re not outraged, you’re not paying attention. Can you see what is going on around you and the way that people are manipulating others? Or do you take things for granted because they are the status quo? I sincerely hope you will choose to step out of the cave and see what a wonderful thing life can be when you work with your body and spirit, instead of suppressing it with drugs or shock or even unnecessary surgery. I hope that your perspective will be a light to guide others to the truth. We must shine that light for all to see. We must also show others the ways that they are being trapped in darkness.

Some people like to say that we don’t know why things happen, that everything happens for a reason, and it’s all part of a master plan. The plan is compared to a painting that God is working on, or a rug that he is weaving. The thread of our life may not make much sense the way it is being worked in the moment, but if you get some perspective you can see why it was twisted or bent in such a way. A dot of paint on a canvas may not make sense, but when you get back far enough to see the big picture, it’s very clear what the story is.

God is not the only one working on a rug. In case you haven’t noticed, there are some very powerful people in our world trying to work their magic. Usually this means they are trying to get the most money. But what will money do for them anyway? Life is fleeting, and you can’t take possessions with you.

If you have faith in a life after death perhaps you can grasp the idea that what is most important while we are alive is fulfilling our purpose rather than filling our pocketbooks.

Two years ago I had my first baby. The birth was the beginning of an experience I had not planned on. I wanted an unmedicated birth, but wound up with just about every drug and procedure available short of a c-section. After the birth I was crying a lot because I wasn’t dealing well with the challenges that I was facing. When my son nearly choked to death from trying to vomit some formula that he couldn’t digest, I became intensely frightened for his life. Feeding him was the only way to keep him alive but I was afraid to feed him because I was afraid he would choke again. I saw my doctor after having a panic attack, and he gave me Zoloft.

Today I help spread awareness about the harm that drugs like Zoloft can do. I met many people online who, like me, experienced psychotic effects from SSRIs or other meds. Now I know why that happens. It is definitely the drugs and not the person. I am thankful that I have survived that ordeal, not only for myself and my children, but also so that I can hopefully help to prevent the same thing, or something much worse, happening to someone else. Perhaps this is the reason that I went through the horrible pain of months of drug-induced psychosis. Perhaps the sacrifices my family made, and the risks we were exposed to were for a good reason in the end. Perhaps it was part of a larger plan.

Many groups have formed, and many survivors have been desperately trying to get the message out to as many people as possible. It is time for us to unite together to fight the massive machine of drug company influence in our society.

There are many issues facing us that need our action. I see them as opportunities. Together we can research, publicize, counsel, heal, and lobby for important changes in our country and the world. The impact we have will affect many lives.

People who doubt our stories, research, or points of view should realize that everything we say is out of a genuine desire to help others, not from greed like that of a giant pharmaceutical company or an industry that capitalizes on illnesses or weaknesses without offering any real solution. Skeptics should seriously question any of their defense arguments if they happen to be almost verbatim compared to those written in drug company manuals, advertisements, and official statements.

Please join the movement against harmful drugging and mistreatment of human beings. Help create a better future by uniting together for this worthwhile cause – bringing awareness to the risks of using psychiatric drugs or electroshock.

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