PLACEBO PERFORMS AS WELL AS ANTIDEPRESSANT IN TREATING DEPRESSION

NIH study

 PLACEBO PERFORMS AS WELL AS ANTIDEPRESSANTS

THIS INFORMATION FIRST CAME TO LIGHT 5 YEARS AGO BUT FEW SEEM TO HAVE BEEN MADE AWARE, SO IN CASE YOU MISSED IT THIS INFORMATION DEFINITELY BARES REPEATING AND WE NEED YOU TO SHARE IT SO THAT OTHERS BECOME AWARE. WHAT IS LEFT OUT OF THE ARTICLE BELOW ON THIS NEW STUDY BY THE NATIONAL INSTITUTES OF HEALTH IS THAT UNLIKE AN ANTIDEPRESSANTS, A PLACEBO COSTS MUCH LESS, LACKS WITHDRAWAL SYNDROME, AND HAS FEWER SIDE EFFECTS OR AFTER EFFECTS!!!

Study: Placebo performs as well as antidepressant drugs in treating depression

by: Jonathan Benson,

(NaturalNews) The more that researchers truly study the effects of antidepressant drugs on depression patients, the more it becomes painfully obvious that these mind-altering medications are utterly useless. A new study conducted by the US National Institutes of Health (NIH) has revealed that antidepressant drugs work no better than talk therapy, placebo pills, or basically anything else, at relieving depression.

Funded in part by the drug industry, the new study follows the same pattern as several other recent studies that, even though they were not intended to do so, actually expose antidepressant drugs as a scam.

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

(Click link below to read full article) myscienceacademy.org/2013/01/09/study-placebo-performs-as-well-as-antidepressant-drugs-in-treating-depression/

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NEW STUDY: MORE FRUIT, MORE VEGGIES, MORE HAPPY

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In 1997 Dr. Canadace Pert Warned Us … 

Yet another reminder of what Dr. Candace Pert stated years ago (TIME Oct. 20, 1997). As she came out firmly against the SSRI antidepressants calling them “monsters.” She went on to say she wished she had never been involved with their birth & development. She further encouraged patients to look to diet & exercise as modalities to cure their depression.

“I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created 25 years ago. Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people in long-term use, which has become common practice despite the lack of safety studies.

“The public is being misinformed about the precision of these selective serotonin-uptake inhibitors when the medical profession oversimplifies their action in the brain and ignores the body as if it exists merely to carry the head around. In short, these molecules of emotion regulate every aspect of our physiology. A new paradigm has evolved, with implications that lifestyle changes such as diet and exercise can offer profound, safe and natural mood elevation.”

Those of you familiar with my work will not be the least bit surprised by the results of the following new study. For instance we have long known that antidepressants deplete both calcium & magnesium which is likely why so many Patients who have used antidepressants end up with the symptoms of fibromyalgia. The best way to rebuild those nutrients is by using dark leafy greens which are full of very easily digestible calcium & magnesium.

Fruits & veggies are filled with good healthy nutrition to build the body & brain rather than act as a stimulant as meat does.

Stimulant? Yes. When you introduce the DNA of an animal into your system the body looks at it no differently than it would any other foreign protein, such as an organ transplant…it immediately rushes to reject it recognizing it as not a part of your body makeup. In that rush to reject the foreign protein you get an adrenalin rush.

But what does adrenalin do? It pushes you beyond what energy level you actually have built with good nutrition in order to deal with a crisis situation. So what happens after the initial adrenalin high? You hit a low as the body is further depleted of critical nutrients.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin
Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD ”Help! I Can’t Get Off My Antidepressant!”

Too simplified? Just keep the thought in mind as you read through the following new research:

There are 3 or 4 excellent short videos with this article. I would encourage you to watch them all. And after you watch those videos here is another short video I just found with some really great ideas about eating more fruit & veggies:

http://www.eatingforenergy.ca/rawfood101/lesson1.html?id=2

 

NEW STUDY: MORE FRUIT, MORE VEGGIES, MORE HAPPY

THURSDAY, Oct. 11, 2012 — Feeling blue? Perhaps you need more reds, greens, and yellows in your diet. According to a new study from the University of Warwick and Dartmouth College, upping your fruit and veggie intake to seven servings daily from the typically recommended five servings promotes happiness and improved mental health.

Researchers studied the dietary habits of 80,000 people in Britain and surveyed participants on life satisfaction, mental well-being, history or presence of mental disorders, nervousness, feelings of depression, and personal self-reported health and happiness.

As subjects’ daily intake of fruits and vegetables increased, so did their sense of happiness and well-being. The dose-dependent pattern peaked at seven servings per day; eating more yielded no additional mood enhancement.

Though experts recommend five servings of fruits and vegetables per day for optimal health, the authors of the study report that 25 percent of British people consume one or no servings each day, and only a tenth of the entire British population meets the seven or more a day goal.

And according to the U.S. Centers for Disease Control and Prevention, only 14 percent of adult Americans eat enough fruits and vegetables, with 33 percent getting the recommended two or more daily servings of fruit, and 27 percent meeting the recommended three or more daily servings of vegetables.

“The statistical power of fruit and vegetables was a surprise. Diet has traditionally been ignored by well-being researchers,” says Sarah Stewart-Brown, MD, professor of public health at Warwick Medical School and study co-author. However, she stresses that there is still more to learn regarding the link between serving size and its effect on mood and well-being.

Last Updated: 10/11/2012
Last Reviewed: 1/1/1900

m.everydayhealth.com/diet-and-nutrition/1011/more-fruit-more-veggies-more-happy?xid=nl_everydayhealthdigestivehealth_20121015

About the Author: Ann Blake Tracy is the author of PROZAC: PANACEA OR PANDORA?, and the director of the International Coalition For Drug Awareness [www.drugawareness.org]. She has testified before the FDA and has testified as an expert in legal cases involving serotonergic medications since 1992.

BOOK: Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. SAFE WITHDRAWAL CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw from antidepressants & most psychiatric medications is saving lives! Both available at www.drugawareness.org

BOOK TESTIMONIALS:

“Very bold & informative”

“Priceless information that is giving me back to me”

“The absolute best reference for antidepressant drugs”

“Well documented & scientifically researched”

““I was stunned at the amount of research Ann Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

WITHDRAWAL HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambien. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for AnnTracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!” … Antoinette Beck

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BAN ON DRIVING FOR ANTIDEPRESSANT USERS? STUDY INDICATES 70% INCREASED RISK OF ACCIDENTS

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As usual early warnings about driving risks went unheeded.

FINALLY someone has done a study to investigate the problems with antidepressants & car accidents….and it only took 25 years since the drugs were introduced to get around to someone doing it! Let’s put it on record here that I approached a group focusing on prescription drug DUIs in 1991 asking them to seriously consider looking at the problems with Prozac & driving. Obviously it fell on deaf ears as so many other warnings I have given over the years.

When I first began interviewing patients about their reactions to the SSRI antidepressants in the early 90’s I stopped driving on freeways whenever possible. Why? Because patient after patient reported that although back then it was not allowed for pilots to fly planes while on SSRIs, they while on Prozac were:

#1 “flying their cars” down freeways,

#2 “having compulsions to ram other cars” as they drove the freeway, and

#3 “dreaming while driving” and having little recollection of how they got from Point A to Point B.

I also began watching my rear view mirror closely to make sure no one dreaming on Prozac had neglected to include my car in their dream so that they could react properly & allow for it being in front of them.  And  I began watching for cars coming at me going the wrong direction since so many attempted suicide reports came in of crossing into oncoming traffic & driving on the wrong side of the road to attempt suicide.

I would also encourage you to read the Road Rage document written by Rosie Meysenburg & posted in the mid 90’s on our www.drugawareness.org website.

From this recent study we learn:

“They have found that taking common antidepressants such as Prozac and Seroxat [Paxil] heightens the risk by 70 per cent.

AND in looking at drugs like Xanax, Valium, Ambien, & the newer atypical antipsychotics like Zyban, Abilify, Geodon, Risperdol, etc. the antidepressants are far worse: “Those taking a common group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) which include Prozac and Seroxat [Paxil] were 72 per cent more at risk.”

But what if someone had just started on an antidepressant?

According to the study: “Even patients who have only been on the pills for a few hours are far more likely to have a crash if they get behind the wheel.”

Now keep in mind that patients are told when they are given an antidepressant that it will take two weeks before the “beneficial” effects begin to appear. Bear in mind that the adverse effects DO NOT wait two weeks to appear. This is one example. The Paxil-induced murder/suicide case of Donald Schell is another glaring example after the jury ruled after hearing all the evidence (which few have ever heard), that taking only two Paxil pills over two days was the main cause of him shooting his wife, daughter, infant granddaughter, & himself. (Read more on this case called Tobin vs Glaxo Smith Kline at www.justiceseekers.com)

Two years ago I got a report out of Utah where the officer in a Ogden, Utah area reported that in a one month period he had 150 DUIs issued. ONE of those involved alcohol & all the rest were prescription drugs! But many remain unaware that you can face a DUI for driving while taking one of these medications. And now these researchers were so completely appalled by what they found in the way of impairment of driving skills by antidepressants that they are recommending that users be banned from driving!

Ban all antidepressant users from driving?

“Researchers say the study shows that doctors should be banning patients from getting behind the wheel as soon as they put them on a course of drugs.”

Now that would certainly clear up traffic congestion in Utah, Oregon, Washington, Michigan, Florida, & North Carolina – long known as hot spots for these meds! But the use of these drugs is so widespread at this point it would likely clear the traffic nationwide & if imposed in Australia, 25% of the Australian parliament would have to take a cab to work. I am sure far more American law makers would have to do the same!

What is even more frightening to consider is that truck drivers, bus drivers, taxi drivers, and now pilots are allowed to take these medications that severely impair driving skills.

Revisiting Princess Di’s Death

Remember that Princess Di’s driver, Henri Paul was on Prozac. When I saw his blood alcohol level of three times the legal limit coupled with the reports from his family that he was not a drinker yet was drinking hard enough to be on a medication like antabuse, I knew he had to be taking Prozac. It was the only thing that added up. (See my article on SSRIs & alcohol cravings as an excerpt from my book just below the book picture at www.drugawareness.org)

So I called the police in Paris & explained that Prozac was the only thing I knew that would cause someone to crave alcohol like that & raise the level of alcohol so high in a man who was reportedly a non-drinker. The following week the Paris police announced publicly that they had confirmed that Henri Paul was indeed on Prozac at the time of the crash that took the lives of Princess Di & Dodi Al-Fayed. This report only adds to my conclusion that Prozac was the main cause for their deaths with the chances of an accident being increased by 70% with Prozac alone & who knows by what percent with the alcohol cravings producing a synergistic effect between the alcohol & Prozac & forcing the blood alcohol content even higher than normal.

Was there a failure to warn by manufacturers? Without a doubt!

“Although some manufacturers put warning notices on boxes telling patients their judgment may be impaired, they don’t specifically tell them not to drive.
“But it is now thought that the same chemical changes that improve mood among those who take the pills also slows down reaction times.”

That last sentence should read: “But it is now thought that the same chemical changes that DESTROY mood among those who take the pills also slows down reaction times.” But if they have not yet read my book, Prozac: Panacea or Pandora? Our Serotonin Nightmare they likely are not yet aware of that fact either.

Read full article here: http://www.dailymail.co.uk/health/article-2202434/Taking-Prozac-Don-t-drive-Pills-raise-risk-having-accident-70.html#ixzz26ln3sPqE

About the Author: Ann Blake-Tracy is the author of PROZAC: PANACEA OR PANDORA?, and the director of the International Coalition For Drug Awareness [www.drugawareness.org]. She has testified before the FDA and testifies as an expert in legal cases involving serotonergic medications.

Ann Blake-Tracy, Executive Director,

International Coalition for Drug Awareness
www.drugawareness.org & www.SSRIstories.com
Author: “Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Safe Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

BOOK: Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. SAFE WITHDRAWAL CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw from antidepressants & most psychiatric medications is saving lives! Available at www.drugawareness.org

BOOK TESTIMONIALS:

“VERY BOLD AND INFORMATIVE”

“PRICELESS INFORMATION THAT IS GIVING ME BACK TO ME”

“THE ABSOLUTE BEST REFERENCE FOR ANTIDEPRESSANT DRUGS”

“WELL DOCUMENTED & SCIENTIFICALLY RESEARCHED”

“I was stunned at the amount of research Ann Blake-Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

WITHDRAWAL HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambien. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for Ann Blake-Tracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!” … Antoinette Beck

1,130 total views, 1 views today

STUDY: 75% OF THOSE TAKING ANTIPSYCHOTIC MEDS SHOW LOSS OF BRAIN MATTER!

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Our most recent post was on the extreme increase in the use of antipsychotic medications – especially in children: Since 1993 use in children (who have no choice in the decision) skyrocketed by 800%, in teens by 500%, and in adults by 200%. Now a new study just out demonstrates brain damage in 75% of those who take these drugs!!

THE IMPACT UPON SOCIETY

Think it does not affect you because you are not on them? Better think again because we will all pay to care for those suffering brain damage from these drugs in higher taxes, higher insurance rates, disability payments, etc. and in reduced productivity & creativity via the contributions these people could have made to our society had their brains remained intact and functioning.

SEROTONIN-INDUCED OXYGEN DEPRIVATION

PRODUCING CELL DEATH

Of course my first question would be, “How many of those patients tested had previously been on antidepressants BEFORE they were given antipsychotics to treat their antidepressant-induced psychosis which antidepressants are so prone to produce?” Why would I want to know that? Because antidepressants ALSO decrease the blood flow to the brain as will any other drug that increases serotonin. The main function of serotonin is constriction of smooth muscle tissue such as the veins & arteries that carry oxygen to the brain.

CORKSCREW BRAIN CELLS FROM ANTIDEPRESSANTS

As early as a decade ago in February of 2000 Jefferson Medical College in Philadelphia published research indicating that several serotonergic medications within only four days use caused a shriviling up of brain cells or taking on of abnormal corkscrew shapes. (What a nice technical way to express that these drugs literally screw up the brain!) The drugs featured in this research were all serotonergic – the antidepressants Prozac and Zoloft, and the diet drugs Redux and Meridia which have now been pulled from the market due to the brain damage produced by these drugs (see below for that explanation).

BRAIN CELL DEATH? PERMANENT OR TEMPORARY?

The lead researcher in this study concluded: “We don’t know if results with four days of drug treatment are clinically significant,” Dr. Kalia says. “We don’t know if the cells are dying. That’s the key question. We need to do more studies to prove cell death. These effects may be transient and reversible. Or they may be permanent.” (Please see my comments below on the question of permanent damage or temporary.)

POPULAR DIET PILLS PULLED DUE TO BRAIN DAMAGE

Another piece of information few have is the fact that Fen-Phen & Redux were pulled from the market due to the massive brain damage they caused, not the heart valve damage or PPHN that so many assumed was the reason they were pulled from the market. Just two weeks before the removal of those drugs  from the market the National Institutes of Health (NIH) had finished an extensive study on Redux & brain damage which the manufacturer, Wyeth, was suppose to have completed as part of the drug’s approval a full year before.

The NIH study results demonstrated some of the most massive brain damage you could imagine! JAMA published the study August 27 1997, titled, “Brain serotonin neurotoxicity and primary pulmonary hypertension from fenfluramine and dexfenfluramine. A systematic review of the evidence.”

BRAIN SEROTONIN NEUROTOXICITY?!!

PLEASE note that term in discussing ANY drug that increases serotonin! Make the connection between elevated serotonin and neurotoxicity – brain damage!

Within a couple of weeks after pubication that NIH study the drugs were off the market! But tragically that left MANY patients in horrific cold turkey withdrawal which naturally resulted in many suicides, murder/suicides, and deep depression which most had never suffered from before taking these serotonergic diet pills. These cases went mostly unnoticed or recognized as related to the drugs or the cold turkey withdrawal from these drugs. At that point many of those patients ended up on antidepressants which helped to stop the withdrawal, but of course should be expected to continue the damage to the brain via the excess serotonin they too produce. This is an example of a dangerous senario all those on antidepressants need to be aware of – the potential abrupt withdrawal of the drugs they are taking being pulled with little to no warning.

IS THERE HOPE AFTER SUCH DAMAGE?

I have long contended that this brain damage does not have to be permanent. I do believe there is hope for recovery, but I think you have to work at it. Just stopping the drugs producing the damage is not enough. Please go to www.drugawareness.org/alternatives to see just how many options there are to restoring one’s health and brain function after the use of these drugs. You can even see brain scans before and after some of the treatments showing recovery.

I would also refer all to our website link to alternatives we have found to help and also to a special done by Dr. Sanjay Gupta from CNN, who, after interviewing with him I have much respect for as a brilliant and open minded scientist and good human being. The link to information on that special is located here: http://www.drugawareness.org/cnn-teen-in-coma-from-severe-brain-injury-recovers-with-alternatives/

Read the study on antipsychotics & brain damage, along with references here: www.sciencedirect.com/science/article/pii/S014976341200125X

Read article from Jefferson Medical College on corkscrew shaped brain cells here: http://www.antidepressantsfacts.com/Thomas-Jefferson-University-Hospital.htm

Read NIH study on Fen-Phen & Redux, Brain serotonin neurotoxicity and primary pulmonary hypertension from fenfluramine and dexfenfluramine. A systematic review of the evidence, here: http://www.ncbi.nlm.nih.gov/pubmed/9272900

 

Ann Blake-Tracy, Executive Director,

International Coalition for Drug Awareness

www.drugawareness.org & www.SSRIstories.com

Author: “Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the FullImpact of Antidepressants Upon Us & Our World” & Safe Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

BOOK:  Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. Find the book & the CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw from antidepressants & most psychiatric medications. Available at www.drugawareness.org

BOOK TESTIMONIALS:

“VERY BOLD AND INFORMATIVE”

“PRICELESS INFORMATION THAT IS GIVING ME BACK TO ME”

“THE ABSOLUTE BEST REFERENCE FOR ANTIDEPRESSANT DRUGS”

“WELL DOCUMENTED & SCIENTIFICALLY RESEARCHED”

“I was stunned at the amount of research Ann Blake-Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

WITHDRAWAL HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambian. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for Ann Blake-Tracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!

3,196 total views, 7 views today

STUDY: TAKING ANTIDEPRESSANTS NEARLY DOUBLES YOUR CHANCE OF RELAPSE

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Published in the journal, Frontiers of Evolutionary Psychology, (see article below)

I want to thank Dee Herron for bringing this article to our attention. It is beyond “difficult” to watch medical science slowly release one tiny bit of information at a time over many years on the dangers of antidepressants which you can get in one sitting from my book Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Knowing that all of this information was available when the book was first published in 1994 is testimony to the fact that this antidepressant nightmare will prove to be one of the biggest deceptions in medicine in history! Although the study referenced in this article came out last year, it bears repeating because too few are yet aware of this information & because it does not fully admit HOW antidepressants are doubling the chance of relapse or what it is about the chemical imbalance theory that is false.

Quote: “The result of the study, in a nutshell, was expressed by the lead author, Paul W. Andrews in Science Daily:

“We found that the more these drugs affect serotonin and other neurotransmitters in your brain—and that’s what they’re supposed to do—the greater your risk of relapse once you stop taking them…Our results suggest that when you try to go off the drugs, depression will bounce back. This can leave people stuck in a cycle where they need to keep taking anti-depressants to prevent a return of symptoms.”

First of all understanding that the Serotonin Theory is completely backwards is most critical in demonstrating how antidepressants actually CAUSE depression & suicide, etc., rather than cure these problems as we have been led to believe. When the SSRI antidepressants were introduced to the market we were told that serotonin is low in depression & we needed to raise serotonin levels in order to recover. Yet the fact is that serotonin is high in depression, rather than low, so as the drugs increase serotonin they produce a multitude of problems while worsening depression, anxiety, suicide, etc.! My book Prozac: Panacea or Pandora? – Our Serotonin Nightmare has 21 pages of references to back that statement up. In fact it was testimony to this major serotonin blunder – testimony given by the medical expert for the Paxil manufacturer that according to his serotonin research over many years demonstrated that impairing serotonin metabolism (serotonin reuptake) produces impulsive murder & impulsive suicide – that won the Donald Schell wrongful death case in that Paxil-induced mass murder/suicide in Wyoming in 2001! Ever wonder why the drug companies have never allowed another one of these cases to go to court? Well now you have a pretty good idea.

Now to address the statement by the lead researcher in this study “Our results suggest that when you try to go off the drugs, depression will bounce back. This can leave people stuck in a cycle where they need to keep taking anti-depressants to prevent a return of symptoms.”

First of all what he is talking about here is NOT “depression bouncing back” when someone attempts to go off their antidepressant. It is clearly drug withdrawal causing the depression in this withdrawal period! Those coming off the drugs very, very gradually, so as to avoid withdrawal, do not have a return of their symptoms. You can easily see it is withdrawal they are talking about when they say that the patient finds they need to keep taking antidepressants to prevent a return of symptoms. When you are in withdrawal from a drug be it caffeine, nicotine, whatever, what stops those withdrawal symptoms? Returning to taking the drug you are in withdrawal from! This is why people stay on antidepressants – they are hooked & cannot get off. And when they try they are told to do so too rapidly which forces them into this horrendous withdrawal, which most describe as a quick trip to hell, & they never want to try to come off again. This is how the drug makers have kept people on these drugs for years. They continue to tell them the withdrawal is a returning of their depression. NOT SO!!!

This article is more of a statement about how serious withdrawal with an antidepressant is rather than a statement about the doubling of the rate of relapse. These drugs produce withdrawal that patients say is worse than any street drug out there. This is why knowing HOW to withdraw safely & successfully is so important in order to be able to get off of these drugs & stay off them. My CD Help! I Can’t Get Off My Antidepressant! can be downloaded from our website for a mere $4.95 & is information EVERY home should have.

But, you say, you are not on these drugs so why would you need a copy? The answer is simple. There has never been a situation ever where the command to be your neighbor’s keeper has been more applicable! As an example go to our database of cases at www.SSRIstories.com & read the case of Officer Edward Lutes. In withdrawal from Luvox (the same antidepressant Columbine shooter Eric Harris was on) decorated officer Edward Lutes ran next door killing 2 neighbors, then to the next house killing 3 neighbors, then drove to the next city to make an attempt to kill his best friend the police chief before killing himself. I will take bets that ANYONE who knew Officer Lutes now wishes they had that information available to them to help him know how to withdraw safely.

As usual, this is only one of MANY examples I can refer you to in order to demonstrate the great importance of getting this information to those who need it. This is a public safely issue! Is it our responsibility? When no one else is taking responsibility who else is left but us? Someone has to warn. Someone has to work to stop this nightmare! I do not send you all of the cases. If I did you would be getting emails from me all day long. I am posting them now though on our website at www.drugawareness.org as quickly as I can. If you care to keep up with them you can find them there. As would be expected they are coming in at rates far greater than ever before.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.SSRIstories.com
Author: “Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Safe Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

Book Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. Find the book & the CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw at www.drugawareness.org

BOOK TESTIMONIALS:

“VERY BOLD AND INFORMATIVE”

“PRICELESS INFORMATION THAT IS GIVING ME BACK TO ME”

“THE ABSOLUTE BEST REFERENCE FOR ANTIDEPRESSANT DRUGS”

“WELL DOCUMENTED & SCIENTIFICALLY RESEARCHED”

“I was stunned at the amount of research Ann Blake-Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambian. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for Dr.Tracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!” … Antoinette Beck

Taking Antidepressants Nearly Doubles Your Chance of Relapse

Not only does this study demonstrate that antidepressants worsen the condition, it also shows that the underlying theory of a chemical imbalance is a bunch of hooey.

by Heidi Stevenson

21 July 2011

A new study demonstrates that using antidepressants nearly doubles the chance of suffering a major depressive relapse—and soon after discontinuing the drugs. This, of course, creates a vicious cycle that results in dependence on the drugs.

Published in the journal, Frontiers of Evolutionary Psychology, another highly signficant finding was made. Not only do antidepressants worsen the condition they’re meant to treat, the underlying theory that there is a chemical imbalance in the brain is pure nonsense. Antidepressants do not treat an imbalance. These drugs actually create it!

The Study

The study, entitled “Blue again: perturbational effects of antidepressants suggest monoaminergic homeostasis in major depression”, shows that these drugs interfere with the brain’s homeostasis. The meta-analysis discovered that people who don’t take any antidepressants have a 25% chance of relapsing, while those who do have a relapse rate of 42%.

The studies reviewed included virtually every permutation of antidepressant use: those who started on placebos and were switched to the real medications, those who started on real medications and were switched to placebos, those who took placebos throughout the studies, and those who took only placebos.

The authors looked at studies of four types of antidepressants; MAOIs (monoamine oxidase inhibitor), SSRIs (selective serotonin reuptake inhibitors), SNRIs (serotonin and norepinephrine reuptake inhibitors), and TCAs (tricyclics). Each of these affects at least one of the following: serotonin, norephinephrine, or dopamine. The specific drugs were:

MAOI: Phenelzine [Nardil] Selegiline [Carbex, Anipryl, L-deprenyl, Eldepryl, Emsam, Zelapar] [tranylcypromine-Parnate]

SNRI: Desvenlafaxine [Pristiq] Duloxetine [Cymbalta] Milnacipran [Savella] Venlafaxine [Effexor] [Mirtazapine-Remeron] [Tramadol-Ultram]

TCA: Amitriptyline [Elavil] Clomipramine [Anafranil] Desipramine [Norpramin] Imipramine [Tofranil] Nortriptyline [Pamelor, Aventyl] [Trazadone – Dezeryl]

SSRI: Citalopram [Celexa] Escitalopram [Lexapro] Fluoxetine [Prozac] Fluvoxamine [Luvox] Paroxetine [Paxil] Sertraline [Zoloft]

[Buspar] [Wellbutrin] [Zyban]

The result of the study, in a nutshell, was expressed by the lead author, Paul W. Andrews in Science Daily:

We found that the more these drugs affect serotonin and other neurotransmitters in your brain—and that’s what they’re supposed to do—the greater your risk of relapse once you stop taking them. All these drugs do reduce symptoms, probably to some degree, in the short-term. The trick is what happens in the long term. Our results suggest that when you try to go off the drugs, depression will bounce back. This can leave people stuck in a cycle where they need to keep taking anti-depressants to prevent a return of symptoms.

Antidepressant drugs may do a little bit to relieve symptoms, though note that Andrews is less than enthusiastic about that effect. However, they result in more depression, and that results in a vicious drug-taking cycle.

Is There a Positive Side to Depression?

We tend to think of negative emotions as being harmful. In today’s society, we’re expected to be happy and perky all the time. When we aren’t, we’re often treated as if we’re ill and should either just snap out of it or take drugs to somehow fix it. As anyone who’s been there, we can’t just flip a switch and be over it. But, as Andrews’ study documents, the drug-taking approach doesn’t work.

Andrews is inclined to believe that the symptoms of depression, such as tiredness, low appetite and sex drive, and loss of interest in associating with people, may be survival techniques for coping with stress. In other words, our bodies are simply forcing us to avoid more stress to give us a chance to resolve the problems we’re facing.

When we take drugs to avoid the feelings that go with depression, we’re working against our own nature. We’re literally avoiding the issue and thus destroying our ability to learn how to deal with our problems.

By taking antidepressant drugs, we avoid facing our problems. By not facing our problems, we never get a chance to heal. Instead, we end up stuck in a genuinely addictive cycle of drug-taking.

None of this even addresses the adverse effects of these drugs, which are significant. Truly, is there any upside to antidepressants? Any benefit they have is minimal. They double the depression relapse rate. They cause some horrible adverse effects, including violence and suicide. Dr. Peter Breggin documents that they cause brain damage and describes their effect as a chemical lobotomy.

But, it seems to me that the worst effect of all is that antidepressants destroy the opportunity to grow and become truly fulfilled human beings.

http://www.gaia-health.com/articles451/000491-antidepressants-double-relapse.shtml

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“Ann Blake-Tracy HAS BOLDY GONE WHERE FEW DARE TO TREAD!”…”BEST REFERENCE FOR ANTIDEPRESSANTS”…”BOLD & INFORMATIVE”… “PRICELESS”… “WELL DOCUMENTED”… “SCIENTIFICALLY RESEARCHED”… “WONDERFUL BOOK”

prozacbookcd[1]For over 20 years now I have run non-stop in this battle. So I have not slowed down to look much at what is going on around me as far as who has come on board to help or how the battle is going, etc. Of course I have done a quick scan of the whole situation occasionally, but that has been about it. So, the other day in searching for something else I ran across the following statements about my book & was both pleasantly surprised & humbled by what is said here which I have added to previous praise for the book. I thought I would share this with you so that you know a little more about the book that I so often forget to even mention and why so many who have read the book scold me for that forgetfulness as it has been such a help to them.

I do know how shocked I have been every time someone has said to me, “I would not be without your book…I keep it right next to my Bible as a reference!” or “Thank you! Your book saved my life!” Both statements I have heard many many times over the years. After spending so many years gathering the research it is heartwarming to hear such wonderful things being said about the work, especially after doctors trying to get me to break the book up into 15 books because they said there was too much information for one book & I could make so much money putting out many different books. They just did not understand you need to know this much to see completely what these drugs are doing…everything was much to important to leave out!

The latest edition of the book (Prozac: Panacea or Pandora? – Our Serotonin Nightmare in ebook format only at this point) is about the whole family of serotonergic antidepressants – the Prozac family of antidepressants, thus the title. The information in the book is centered around serotonin & the damage it can produce as these drugs inhibit the metabolism of serotonin. You can find additional information & excerpts from the book on our website at www.drugawareness.org. And the book, along with the CD on safe & successful withdrawal are available on the same website.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.drugawareness.org
Author: “Prozac: Panacea or Pandora? – Our Serotonin Nightmare” – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

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VERY IMPORTANT WORK!!!

“The work Dr. Ann Blake Tracy is doing is very important and she is truly a heroine.”… Dr. Candace Pert, Washington, DC

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ALWAYS ON MY NIGHTSTAND

I appreciate Prozac: Panacea or Pandora?  so much that I always keep it on my nightstand near my bed so it is at my fingertips as a reference whenever I need it! What incredible reference material! …Dr. John Lee

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A MONUMENT OF TENACITY AND LOVE

“Magnificent! This text is a monument to Ann Tracy’s tenacity and love for her fellow human beings.”… Dr. Paul Kennedy

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VERY BOLD AND INFORMATIVE

I was stunned at the amount of research Ann Blake-Tracy has done on this subject. Few researchers go to as much trouble agressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs. I had reactions to this class of drugs and I did exhaustive research, coming up with only bits and pieces of information trying to find out exactly what happened to me. All the doctors that I visited were ignorant to what was happening to me, but after reading the book and understanding exactly what happened, why it happened and knowing that I wasn’t alone with these “new” symptoms (She has personally interviewed hundereds, if not thousands of patients) I came to a realization that it was the drugs that caused those problems. She truly knows more about the subject of the effects of SSRIs on the human mind and body than any other doctor or researcher that I know of. I am looking forward to reading her next book. I know she is boldly continuing her research and has a book in the works.
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PRICELESS INFORMATION THAT IS GIVING ME BACK TO ME

Ann Blake-Tracy’s book is an objective presentation backed up by scientific studies that have been published in mainstream medical journals. “Prozac: Panacea or Pandora?” demonstrates the extreme dangers and ultimate ineffectiveness of SSRI’s and other antidepressants as well as the utter failure of the psychiatric/medical community to recognize these dangers. Also addressed is the unethical marketing practices that the pharmaceutical companies use to promote these drugs, how the drugs work and cause damage to the body, and what the side effects are and how they are caused by these drugs. Lastly, the book details how one can come off of these very addictive drugs. On a personal note, I’ve taken antidepressants for most of the last 18 years. I could relate to at least 90% of the information that was related in Ann Blake-Tracy’s book. Now as I follow Ann Blake-Tracy’s advice on how to slowly come off of these drugs, I’m finding that my physical, spiritual and psychological health is slowly improving. I am so grateful for this information.
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SSRI’s = DEATH OF SELF!

I was very impressed with the amount of research that went into this book. It has given me the courage to do something about the condition the SSRI’s have put me in. Yes, most every one who takes an SSRI at first thinks they are great. Then over the years as the dosages have to be increased (proves the addictive nature of these drugs) and the side affects mount, one slowly changes their mind (If they are still capable of having a coherent thought anymore!) about the so called miracle drug. Once a savior, then turns into a demon.

I personally have lost my sense of self. I have short term memory problems where once my memory was phenomenal. I talk contstantly and can not seem to stop due to the muddled state the SSRI has put my mind in. Maybe I don’t cry as much anymore but I don’t laugh much either. I used to have many friends and now, I am so different and have not clue 1 how to make a friend. Maybe I just don’t care. Drugged up I guess! People who know me now since the SSRI hell started really have no clue who I really am, this includes my own daughter. This saddens me. My entire personality has changed, some alternate being has take me over. I am easily confused and have trouble following a conversation.

As far as no lethal side effects how is suicide and murder and the lost of one’s own mind (death of self) for lethal side effects! And the loss of my ability to really love anyone or care about anything, I find to be lethal as well. I might be easier to live with becauce I get angry less and am less irritable and I don’t cry as much but at what cost? Just drug the patient and put them on a shelf and say they are cured cause they have lost the will and courage to stand up and shout, let me out of here, Zoloft has taken over. I am still under here, HELP!…

If you are depressed there are other answers out there other than SSRI’s. The liver being full of toxins is said to be a cause of depression. That is where I plan to focus my healing. It took me two years to slowing come off Valium and am currently withdrawing from Neuronin which is even a more addictive drug and is harder to come of. It will probably take at least 3 years to totally be free of it and then years to come off the Zoloft. Then I will be Free, except for the damage these drugs have done to my system. If I had it to do again I would have taken a diffent path.

Thanks for writing this valuable book, without it I may never have connected my dwindling health to the SSRI’s.
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DO NOT LISTEN TO DOCTORS! THIS BOOK SAVED MY LIFE!

… as long as people who have no experience being on any of these drugs, keep talking about how “safe” and “helpful” they are, the more people with think it is ok to take them. This book is well written, and deserves much praise. As someone trying to get off paxil, I can tell you it is the most hellish experience of my entire life. This book has given me hope, I no longer feel alone.
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THE ABSOLUTE BEST REFERENCE FOR ANTIDEPRESSANT DRUGS

We were looking for a book we could recommend to people [and patients] that had questions about what they were encountering with antidepressants. Ann Blake Tracy has compiled the research and named the dangers in such a way that anyone with questions about anti-depressant drugs could find the answers — without taking weeks in the process.
With the FDA reviewing the information that’s been WITHHELD by the pharmaceutical companies over the safety of these drugs, Tracy’s research is INVALUABLE in determining what happened — when — and why. This book is a must have for any one researching this issue whether for the purpose of writing about it or helping others — whether a patient or someone who has to deal with the patient. Finally the truth is out there. Finally the subject is getting the attention it deserves. Finally, the author of the book is testifying before the FDA on what ‘they’ knew and when ‘they’ knew it.

Wonderful book — Fantastic information.
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A BOOK FOR ANYONE WHO HAS EVER STRUGGLED WITH DEPRESSION

I would recommend this book as REQUIRED reading for every person who has ever struggled with depression or any other symptomology for which an antidepressant might be prescribed. I would also highly advocate this book as REQUIRED reading for every physician before being given license to dispense antidepressants.

Ann Tracy has boldly gone where few dare to tread…

Depression and other mental health ailments can be difficult to manage – nobody who has ever experienced chronic depression would deny this… There are a lot of theories as to the causes and cures of mental health problems, but too often a theory is presented as fact, and the public is being deceived. There is absolutely no biological basis to present depression, bi-polar disorder, or a host of other mental health problems as real diseases. One reader who rated the book claims he has a ‘serotonin deficiency’, and that the SSRIs correct this deficiency. I would be most interested in seeing the evidence, as there are no tests during life or even at autopsy that can measure any individual’s serotonin level. The first person who can present such evidence will be up for a Nobel prize in Biochemistry! This poor soul with a master’s degree has been sadly mislead as has most of the public. I invite all to do your own research. Ann Tracy’s comprehensive list of source references which are indexed in her book make this task quite simple. I applaud Ann Tracy for her courage and wisdom! If you’ve ever considered taking an antidepressant, please read this book! I’m sure you will think twice before taking your friendly Dr’s advice… and this book may well save your life!

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WELL DOCUMENTED, SCIENTIFICALLY RESEARCHED BOOK

This well documented book covers such diverse reactions to the SSRIs as: hypogylcemia, diabetes, REM sleep, sleep disorders, etc. Her bibliogrpahy and index are outstanding. A must read for those willing to reasearch what our “serotonin nightmare” is doing to our country. Never in history have so many people “adjusted” their serotonin without understanding the consequences of this action. I highly recommend this book.

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OCT. 1998 NOTE FROM A BRITISH NURSE

“I started having bad reactions… Oct ‘96 1 found Prozac to be causing joint and muscle pain itself I also became concerned that I was developing signs of Cushing’s Syndrome. . . I was very pro-Prozac until last October and wouldn’t have listened to anything said
against it until I got problems (thought it was saving my life, while all the time it was insidiously and slowly killing me!) When I first heard about your book on the Internet I was interested but quite skeptical. However, since reading it and having suffered so many problems with Prozac, I have come to the conclusion that the book is brilliant, and a life-line as far as I am concerned. I tried to fault the research and reasoning, but could not and still can t. I would like to extend my thanks to you for your heroic stance on this enormously important issue. I have tremendous respect and admiration for your hard work, determination and courage in pursuing this subject so vigorously, against so much powerful opposition for the benefit of people like me. Your integrity puts many, if not most doctors and psychiatrists to shame. It is reassuring to find that there are a few people in the world who are prepared to fight for the truth for the benefit of mankind.”

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INCREDIBLE COMPILATION OF MEDICAL DATA

“PROZAC: PANACEA OR PANDORA? is an incredible compilation of medical data that will lay the
groundwork to educate other professionals and the general public about the new SSRI antidepressants –
Prozac, Zoloft, Paxil, Luvox, Effexor and Serzone.”… Jeff Wise, psychologist, Salt Lake County Drug
and Alcohol Abuse
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NO OTHER BOOK WITH MORE INFORMATION OR WELL DOCUMENTED

“In 15 years of reading books on drugs I have never read a book with more information or so well
documented as PROZAC: PANACEA OR PANDORA?.. . Dr. Kevin Millet, Bountiful, UT

 

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IF YOU CAN ONLY AFFORD TO GET ONE BOOK THIS IS THE ONE!

“You have no idea how helpful and reassuring I have found your book Prozac, Panacea or Pandora has become like a bible to me. I could not put it down when I started reading it. I would like you to know how much comfort I have gained as a result of your work and that! have recommended it to all my helpline clients in the hove that it will give them the same reassurance that I got. I always say to people that if you can only afford to get one book, Dr. Ann Blake Tracy’s book is the one I would recommend as it covers everything.

I have your book, I have all Peter Breggin‘s books and I have Gleninullen‘s book amongst many others. But yours was the one that helped me because it reflected your efforts in carefully researching the information; you listed many medical reference sources which made it easier for the reader to follow up on any aspects they wanted to learn more about and yours is my number one choice when it comes to recommended books.”. . . Ramo Kabbini, head of UK Prozac Survivor’s Group

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PROZAC: PANACEA OR PANDORA? LITERALLY SAVED MY LIFE!

“PROZAC: PANACEA OR PANDORA? literally saved my life, and if I’d known about it a year earlier, could have saved me untold grief and agony as well. It is the only collated, comprehensive source I know of for this information, and is a much-needed counterbalance to popular books like LISTENING TO PROZAC, which either ignore the issue of serious adverse reactions, or wrongly attribute all reports of such reactions to ‘propaganda from the Church of Scientlogy’. It is also a far more complete treatment of the subject than the books of Peter Breg gin. It was like the light at the end of the tunnel; this book described everything that had happened to me in great detail, gave scientific reasons why it happened, backed it all up with solid research, included testimonials fromn hundreds of others in the same situation, it immaculately details, explains, and refers one to the latest research on a whole hornet’s nest of ‘atypical’ side-and/or after-effects fromn the use of these antidepressants. It also contains information on how to reduce the severity of problems encountered while starting on or going
off these meds.”

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AN ANSWER TO EVERY QUESTION

“PROZAC: PANACEA OR PANDORA? has not left one question about these drugs unanswered! Ann Tracy has covered them all.”. . . Margaret McCaffery, N. Y. (lost her daughter, a neurosurgeon, in a Prozac suicide)

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INTERNATIONAL COALITION FOR DRUG AWARENESS
www.drugawareness.org
The International Coalition for Drug Awareness is a private, non-profit group of physicians, researchers, journalists and concerned citizens.

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Kauffman Study – (SSRI) Drugs: More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

SSRI Bombshell by Joel M. Kauffman, Ph.D. Tuesday, March 31st, 2009

Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks Than Benefits?

Joel M. Kauffman, Ph.D.

ABSTRACT

Anecdotal reports have suggested that selective serotonin reuptake inhibitors (SSRIs) may cause suicidal or violent behavior in some patients. Because of the publicity surrounding certain events, and the numerous lawsuits that have been filed, a review of benefits and risks is needed.

At most 30% of patients receive a benefit from SSRIs beyond the large placebo effect in certain mental conditions, especially depression, according to a recent meta-analysis of published trials. An equally recent meta-analysis of all SSRI trials submitted to the FDA showed a small benefit for the severely depressed patients only. Many early unpublished trials did not show any benefit. Adverse effects are common, occurring in up to 75% of subjects.

Severe adverse effects may be underreported.

Meta- analyses of controlled trials did not include any actual suicides or murders, but only suicidality, some finding, in 1991 and 2007, no evidence even of suicidality.

Other meta-analyses using many of the same trials found that suicidality doubled to 1 in 500 on SSRIs compared with placebo or non-SSRI antidepressants, but did not include any actual suicides or murders. The trial designs were devised by SSRI makers to prevent reports of suicides, by eliminating subjects with the slightest trace of suicidal tendencies. Retrospective studies by others showed actual suicides on SSRIs with a relative risk (RR) of 2–3 compared with non-SSRI antidepressants, with an increased incidence of 123/100,000. Lower doses than the smallest available ones were found to maintain benefits in a majority of patients while reducing risks.

table_03_zoloftbusted1

[PLEASE NOTE THAT THE SSRISTORIES DATABASE REFERRED TO BY DR. KAUFFMAN IN THIS STUDY IS NO LONGER POSTED AT THE URL LISTED ABOVE BUT HAS BEEN MOVED TO THE URL www.ssristories.NET ]

No causal connection between SSRIs and suicide and/or violence has been proved; neither has it been ruled out. Physicians need to be vigilant, and aware of legal precedents that may subject them to enhanced liability when prescribing these drugs. The Genesis of SSRIs Fluoxetine (Prozac in the U.S., see Table 1), introduced in 1988 to combat depression, was the fourth selective serotonin reuptake inhibitor (SSRI) on the U.S. market, after being seriously considered by Eli Lilly as an antihypertensive drug. Unlike the earlier “tricyclics” (amitripyline, clomipramine, dothiepin, imipramine, etc.) and other drug classes, SSRIs acted on the brain to raise levels of the neurotransmitter serotonin without raising the levels of norepinephrine. This was thought to be a benefit in treatment of depression, and later anxiety, panic, social phobia, obsessive- compulsive disorder (OCD) , and many other conditions. The SSRIs listed in Table 1 are among the most frequently prescribed in the U.S., and compete with the five non- SSRIs shown, and others.

ssri-drug-table1

Benefits of SSRIs

A prominent recent meta-analysis of Bridge et al. included 27 trials of SSRIs for three defined mental conditions: major depressive disorder (MDD), OCD, and non-OCD anxiety disorders. Benefits, compared with placebo, were found to be highly statistically significant. For MDD, data from 13 trials showed benefit in 61% vs. 50% on placebo, a gain of 11% absolute (NNT=10), <0.001 for all ages of participants. For OCD, data from six trials showed benefit in 52% vs. 32% on placebo, a gain of 20% absolute (NNT=5), <0.001 for all ages. For non-OCD anxiety, data from 6 trials showed benefit in 69% vs. 39% on placebo, a gain of 30% absolute (NNT=3), <0.001 for all ages. These results represent the maximum expectation of benefit from SSRIs since 22 of the 27 trials were financially supported by SSRI makers, and thus subject to the routinely positive bias of industry-sponsored clinical trials. Jay S. Cohen, M.D., author of the 2001 book , wrote that half his patients did well on fluoxetine, but he noted a high incidence (50%) with side-effects. Cohen also cited a pre-approval study showing that the standard 20 mg per day starting dose helped 65% of patients, while 5 mg helped 54%, so Cohen became one of the pioneers in using lower doses before Lilly made them available. The 1996 entry for paroxetine, at least, confirmed that the 17 most common side-effects were dose-dependent.

In four observational cohort studies of four common SSRIs reported by physicians as part of the prescription-event monitoring program in the UK, with more than 10,000 patients in each drug group, only 36% of the physicians reported fluvoxamine as effective, compared with 60% for fluoxetine, sertraline, and paroxetine. These possible benefit rates, which include the placebo effect, parallel the percentage of patients remaining on the drug for 2 months.

See: Over Dose: the Case Against the Drug Companies

An old trial of placebo for anxious and depressed subjects reduced distress in 43%. Three meta-analyses of the antidepressant literature that appeared in the 1990s independently concluded that two-thirds of the effectiveness attributed to SSRIs is actually placebo effect. In a series of nine controlled studies on hospitalized patients with depression, 57% of those given placebo showed improvement in 2–6 weeks. A 1998 meta-analysis of 47 trials on antidepressant medication including SSRIs indicated that 75% of the response to them was duplicated by placebo. This meta-analysis was criticized on several grounds. Therefore, Irving Kirsch, Ph.D., of the University of Connecticut, with other authors, obtained data submitted to the FDA on every placebo-controlled clinical trial on the six most widely used SSRIs, and published a meta-analysis on 47 trials, finding a small, clinically insignificant effect.

This work was updated in 2008:

Analyses of datasets including unpublished as well as published clinical trials reveal smaller effects that fall well below recommended criteria for clinical effectiveness. Specifically, a meta-analysis of clinical trial data submitted to the U.S. Food and Drug Administration (FDA) revealed a mean drug–placebo difference in improvement scores of 1.80 points on the Hamilton Rating Scale of Depression (HRSD), whereas the National Institute for Clinical Excellence (NICE) used a drug–placebo difference of three points as a criterion for clinical significance when establishing guidelines for the treatment of depression in the United Kingdom. Kirsch et al. concluded that the updated findings from 35 carefully vetted trials suggest that, compared with placebo, the four new- generation antidepressants ( fluoxetine, venlfaxine, nefazodone, and paroxetine) do not produce clinically significant improvements in depression in patients who initially have moderate or even severe depression.

They show statistically significant but clinically minor effects only in the most severely depressed patients. Moreover, the significance of the effect probably is based on a decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new- generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective. In addition, they write that the decreased placebo response in extremely depressed patients, combined with a response to antidepressants comparable to that of less severely depressed patients, is a potentially important insight that should be investigated further.

Even these unimpressive findings exaggerated the benefits of antidepressants. In three fluoxetine trials and in the three sertraline trials for which data were reported, the protocol allowed replacement of patients who, in the investigators’ judgment, were not improving after 2 weeks. The trials also included a 1–2 week washout period, during which patients were given a placebo prior to randomization. Those whose scores improved 20% or more were excluded from the study. In 25 trials, the use of other psychoactive medication was reported. In most trials, a chloral hydrate sedative was permitted in doses ranging from 500 mg to 2,000 mg per day. Other psychoactive medication was usually prohibited but still reported as having been taken in several trials.

Perhaps such considerations led David Healy, M.D., an SSRI expert, to his conclusion that “…these drugs do not convincingly work….” His evidence came from early unpublished clinical trials whose results were revealed to him at FDA hearings. For fluoxetine, Healy noted four trials with a positive result and four without. For sertraline, only one of five early studies showed benefit. Because of the huge placebo effect, 32–75%, most physicians unfamiliar with the studies revealing this effect are likely, in my opinion, to say that one-third to two-thirds of their patients are improved on SSRIs. This would also explain Dr. Jay S. Cohen’s findings on lower doses of fluoxetine.

SSRIs reportedly interact with 40 other drugs to cause “serotonin syndrome.”

This presents as twitching, tremors, rigidity, fever, confusion, or agitation. Serotonin/norepinephrine reuptake inhibitors (SNRIs) also may cause serotonin syndrome by interactions. Most tricyclic depressants do not have these interactions, with the exception of amitriptyline.

In a controlled trial of paroxetine vs. clomipramine sponsored by GlaxoSmithKline, 75% of the subjects had an adverse effect on paroxetine, 21% had a severe adverse effect, and 13% committed a suicidal act (1 in 8). The 1996 entry for paroxetine lists 17 side-effects with an incidence of ≥ 5% for approved doses.

They are: asthenia, sweating, constipation, decreased appetite, diarrhea (up to 15%), dry mouth (up to 21%), nausea (up to 36%), anxiety, dizziness, nervousness, paresthesia, somnolence (up to 22%), tremor (up to 15%), blurred vision, abnormal ejaculation, impotence, and other male genital disorders. Fully 31 additional side effects with an incidence at least 1% greater than placebo were listed, including uncontrollable yawning.

Murder, suicide, and suicidality were NOT [emphasis added] included.

Nor were they on comparable lists for fluvoxamine, or sertraline. For fluvoxamine, suicide were separately listed as “infrequent.”

For fluoxetine, suicidal ideation was listed as a voluntary report not proved to be drug related. For sertraline, suicidal ideation and attempt were listed separately as “infrequent.”

The entry for venlafaxine was: “…the possibility of a suicide attempt is inherent in depression.” Not found in the was weight gain, which Cohen lists as a serious side effect.

Typical dropout rates in recent trials are claimed to be 5% (see below), but these must be short trials, or trials with a run-in period. In a meta-analysis of 62 earlier trials with a total of 6,000 subjects, the mean total dropout rate and the proportion of dropouts due to side effects appear comparable to results in general practice: total dropout rates of between 30% and 70% have been reported by 6 weeks, of which some 30%–40% are attributed to side effects and the rest to failure of treatment. Early findings of severe adverse effects by SSRI makers came to light only after the class was established. Of 53 healthy volunteer studies on fluoxetine, the results of only 12 were openly reported.

From 35 healthy volunteer studies on paroxetine, pre-launch, the results of only 14 appeared. From 35 pre-launch healthy volunteer studies on sertraline, only seven appeared. Among the unpublished trials, there was one in which all volunteers dropped out because of agitation (akathisia). In published work on sertraline, data excluded material on behavioral toxicity, including at least one suicide of a Adverse Effects of healthy volunteer, and in a different trial, 2 of 20 volunteers became intensely suicidal. This last is consistent with the dropout rate of 5% for agitation alone in actual trials. It is also consistent with Lilly’s animal studies, in which previously friendly cats treated with fluoxetine started growling and hissing—an unheeded warning.

Just a year after fluoxetine was introduced, Bill Forsyth of Maui, Hawaii, had taken it for only 12 days when he committed one of the first murder/suicides attributed to any SSRI.

In the same year Joseph Wesbecker killed eight others and himself in a Louisville, Ky., printing plant where he worked, after 4 weeks on fluoxetine. Yet as early as 1986, clinical trials showed a rate of 12.5 suicides per 1,000 subjects on fluoxetine vs. 3.8 on older non-SSRIs vs. 2.5 on placebo! An internal 1985 Lilly document found even worse results and said that benefits were less than risks. Such documents were released into the public domain by Lilly as part of the settlement in the Wesbecker case. Fifteen more “anecdotes” of murder/suicide, three with sertraline, were listed by DeGrandpre.

Lilly’s denials of a link to murder/suicide on national television and elsewhere cited a sponsored meta-analysis in in 1991, which exonerated fluoxetine as a cause of suicidal acts or thoughts without even mentioning actual murder or suicide. This study included only 3,067 patients of the 26,000 in the clinical trials it utilized. None of the trials had a declared endpoint of suicidality.

Some of the trials had been rejected by the FDA. No mention was made that Lilly had had benzodiazepines co-prescribed to minimizethe agitation that had been recognized with fluoxetine alone. The 5% dropout rate for anxiety and agitation (akathisia) would have taken out the most likely candidates for suicide. Nevertheless, the 1991 study had its intended effect. For example, in 2006 a 900-page tome entitled , which was aimed at attorneys, cited this study, and failed lawsuits concerning SSRIs. The 2007 meta-analysis by Bridge et al. may be influenced by indirect conflicts of interest that are hard to prove based on the financial disclosures.

Their paper pooled excess risk above placebo for “suicidal ideation/suicide attempt” from 27 trials. The excess risk was said to be 0.7% and statistically significant across all indications, but significant within each indication. Of the 27 trials, only five were sponsored by the drug maker, and one of these, the 2004 Treatment for Adolescents with Depression (TADS) study of fluoxetine, had the highest rate of suicidality—7% above placebo. Most of the same trials were used in a meta-analysis by the FDA, which found a statistically significant excess risk of 2% (4% vs. 2% on placebo, 1 in 50 more). Bridge et al. used a random-effects calculation, while the FDA used a fixed-effects calculation.

In commenting on the negative findings, Bridge et al. write: “No study [in our meta-analysis] was designed to examine suicidal ideation/suicide attempt as a study outcome, and in fact most trials were conducted in patients who had been carefully screened to exclude youths at risk.” No actual murders or suicides associated with SSRI use were reported. Did the designs of the studies preclude detection or reporting?

The Bridge meta-analysis was not just a vindication of SSRIs, as communicated to the by Gilbert Ross, M.D., Medical Director of the American Council on Science & Health. Ross went further, commenting that the FDA “Black Box warning” (see below) was counterproductive because it was discouraging the use of antidepressants! Ross speculated that the lethal rampage of the Virginia Tech shooter might have resulted from premature cessation of medications.

SSRIs in general have long lifetimes in the body. Fluoxetine and its active metabolite in particular have a half-life of 16 days, according to the 1996 . In a reexamination of trials in which suicides or attempts during the inadequate washout period were not blamed on the drug, it was shown that the relative risk (RR) of suicidal acts ranged from 3 for sertraline to 10 for fluoxetine.

A concurrent meta-analysis of 24 trials by Kaizar et al. utilized Bayesian statistics, a valid choice, in my opinion, because data do not have to follow a Gaussian or normal curve to yield valid results, and this method can be used to revise probabilities to determine whether a specific effect was due to a specific cause. They found an association between SSRI use and suicidality with odds ratios of 2.3 (95% confidence interval [CI] 1.3-3.8), when the diagnosis was MDD, not OCD, anxiety, nor ADHD. Non-SSRI antidepressants were said to have no association with suicide. This supports the FDA’s findings and requirement, as of October, 2004, for a Black Box warning for all SSRIs, to monitor children and adolescents for suicidality. Kaizar et al. were concerned that there were no completed suicides among 4,487 subjects in the trials; that the trial times were too short at median length of 8 weeks; and that in 10 of the 12 MDD studies, Again, there was no citation of actual suicides associated with SSRIs and no citation of Healy’s work.

Healy reviewed epidemiologic studies that have been cited to exonerate SSRIs. One was analyzed by Healy to show a threefold increase in suicidality compared with other antidepressants.While “treatment-related activation” has been considered primarily with regard to suicidality, it can lead to harm to others as well as to self. Healy summarized data on “hostile episodes” provided by GlaxoSmithKline from placebo-controlled trials with paroxetine in subjects of all ages: 9,219 on paroxetine and 6,455 on placebo. The rubric of “hostility” was used in the trial to code for aggression and violence, including homicide, homicidal acts, and homicidal ideation, as well as aggressive events and “conduct disorders.” No homicides were reported from these trials.

Overall, during both therapy and withdrawal, the RR was 2.1 for hostile events. In children with OCD the RR was 17. Separately, in healthy volunteer studies, hostile events occurred in 3 of 271 subjects on paroxetine vs. none of 138 on placebo. In trials of sertraline on depressed children submitted by Pfizer, 8 of 189 subjects discontinued for aggression, agitation, or hyperkinesis (a coding term for akathisia), compared with 0 of 184 on placebo. In clinical practice, the term akathisia has been restricted to demonstrable motor restlessness, but if that is the only effect, it would have been called dyskinesia according to Healy, who cites four studies linking akathisia to both suicide and homicide.

Actual suicides were combined with suicide attempts in a 2005 meta-analysis of 702 trials of SSRIs vs. either placebo or an active non-SSRI control. Studies were rejected if the citation was a review, a result of duplicate publication, too short, crossover, or had no reporting of actual or attempted suicide. The studies meeting the criteria included 88,000 patients. For attempted suicide, the RR was 2.3 for SSRIs vs. placebo (95% CI, 1.14-4.55). The number needed to treat to harm (sometimes called the “reverse NNT”) was 1 in 684. There was no difference in actual suicide. Of the 702 trials, 104 failed to report adverse events below a certain pre-set limit of 3%, 5%, or 10% of patients. Only 493 trials reported dropout rates, with a mean of 29%, and the mean follow-up time was only 11 weeks. Thus, there was clearly gross underreporting of adverse effects. PDR children and adolescents with an elevated baseline risk of suicide were excluded.

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 9

More importantly, because actual suicides are involved, Healy cited a study by Donovan et al. that demonstrated a RR=3.4 ( <0.01) for SSRIs compared with all non-SSRI antidepressants involving 222 actual suicides, of which 41 were among patients who had an SSRI within a month of their suicide. Also the British Drug Safety Research Unit recorded more than 110 suicides in 50,000 patients taking an SSRI, an incidence of 219/100,000 compared with 96/100,000 for the non-SSRI mirtazepine (Remeron), an increase of 123/100,000, or 1 in 813 (Table 2). Thus the RR for actual suicide in patients taking SSRIs was 2.3 (or 2.8 for paroxetine). Even here, though, no murders were listed.

In another study cited by Healy, Jick et al. reported 143 actual suicides among 172,598 patients taking antidepressants. The relative risk of suicide in patients taking fluoxetine was 2.1, compared with those taking the tricyclic antidepressant dothiepin. The risk was not age-dependent. SSRI makers keep insisting that there will be more suicides if SSRIs are used as frequently as now. But the RR of 2–3 shown in studies is a number that the number of suicides that may have been prevented, so SSRI use is associated with more suicides, not fewer.

The International Coalition for Drug Awareness in cooperation with the Prozac Survivors Support Group has produced a website on which about 1,600 violent incidents associated with SSRI use are described ( www.ssristories.net ). The first column on the type of incident (murder, school shooting, etc.) is a hot link to a publicly available description of the incident, typically a local newspaper article. A selection of 10 entries (rows) is presented here as Table 3. About 360 suicides are tallied as well as about 400 murder incidents, many of which were multiple murders, each linked to 26 not net includesSSRIs Provide 1,600 Anecdotes of Violence SSRI use (Rosie Meysenburg, personal communication, 2008 .

As the number of “anecdotes” exceeds 1,600—hardly a small number—the association of SSRIs with murder/suicide, often combined, must be taken seriously. The SSRI website was searched to find combined murder/suicide incidents attributed to a specific SSRI. There were three for fluvoxamine, four for citalopram, 10 each for paroxetine and sertraline, and 31 for fluoxetine. Where the studies above substantiated suicide from SSRI use, the total on the SSRI website of 48 simultaneous murder/suicide incidents associated with SSRI use ties together SSRIs and murder. Since there were about two murders per suicide, we may infer that the murder rate on SSRIs could be about 250/100,000. Since no clinical trial involving multiple homicides is ever likely to be run, no firmer evidence is likely to be found. Healy noted that much of the evidence for suicide and murder came from the efforts of journalists and lawyers.
Note that the website carries a prominent warning that “withdrawal can often be more dangerous than continuing on a medication.” Nine violent events cited elsewhere—seven court cases of homicide (one attempted) and two assaults—were associated with specific SSRIs: three with paroxetine, three with sertraline, two with fluoxetine, and one with venlafaxine. Skeptics have cast doubt on whether the prescribed SSRIs were actually taken, especially since many medical records of juveniles were sealed. In the Columbine, Colo., shootings the toxicology report showed “therapeutic” levels of fluvoxamine in one of the shooters. The Red Lake, Minn., shooter had fluoxetine found, according to news items referenced on the website.

A 2004 editorial in by Simon Wessely, M.D., a spokes- man for Eli Lilly, and Robert Kerwin, Ph.D, cited only a single paper by Healy as a source of claims of suicidality that have found a receptive media audience. Tellingly, the only study described at length is by Jick et al. on the correlation of SSRI use and “attempted suicide,” in which the rates on dothiepin, amitriptyline, fluoxetine and paroxetine were not statistically different. Actual suicides in this study (seven on SSRIs) were not mentioned by Wessely and Kerwin, nor were the 143 suicides in Jick’s earlier paper. Jick et al. have been supported partially by GlaxoSmithKline and Pfizer. No study that reported actual suicides on SSRIs was described in detail, let alone refuted. Wessely and Kerwin wrote: “The problem is that depression is unequivocally and substantially associated with suicide and self-harm.” True, but this not the truth.

Table 2. Suicides Related to SSRIs or Mirtazapine

table_02_zoloftbusted1

The legal defense by Lilly, repeated by the media and others, is that any suicides are caused by the condition, depression, not by their drug—whether the violence is associated with short-term drug use, long-term drug use, increased doses, withdrawal, or rechallenge. There is no website, as far as I know, for violent acts committed by persons who never received SSRIs, or for total violent acts; hence the denominator for violent acts is not known. Also unknown is the fraction of potentially violent persons who are treated with SSRIs, or of persons treated with SSRIs who are potentially violent. The published studies on actual suicide, however, compare patients on SSRIs with similar patients on non- SSRI antidepressants or placebo. Children diagnosed with OCD, not depression, also became suicidal on SSRIs, as did healthy volunteers.

Actual two- to threefold increases in suicide rates have been demonstrated as well as they could be. How else could such effects be demonstrated? Who would submit, and what institutional review board or human subjects committee would approve a study explicitly designed to show whether assaultive, homicidal, or other violent behavior increases in subjects prescribed the study drug?

Denial by SSRI makers of culpability for these risks continues to this day. Whether physicians’ acting on the Black Box warnings of 2004 and 2007 for all SSRIs will diminish the incidence of murders and suicides is not yet known. Following the introduction of fluoxetine in 1988, only a year passed before an early user committed multiple murders and suicide; many other examples followed. More than 200 lawsuits have been begun by users of SSRIs and victims’ families charging wrongful death or failure to warn; these have had mixed outcomes. There is now legal precedent for SSRIs as a cause of murder, and the maker of the SSRI is potentially liable for damages, according to David Healy.

Eli Lilly responded with total denial to the lawsuits claiming a link between fluoxetine and violence. Several claims were settled out of court with secret details and no admission of guilt. The Australian David Hawkins was freed from a murder charge by a finding of temporary insanity caused by using sertraline. Tim Tobin of Wyoming won $6.4 million from SmithKline Beecham when a jury found that a murder/suicide committed by Donald Schell was attributable to use of paroxetine. There are four other homicide cases in which the SSRI was deemed to have contributed, resulting in a suspended sentence in one case and an insanity verdict in another.

One case of homicide, with a guilty verdict and a life sentence, followed a judicial ruling that akathisia was associated with SSRI use, but that a causal relationship with homicide could not be argued; thus the link of an SSRI with homicide was disallowed. This was in direct conflict with the findings of the four trials cited above. The SSRI website was searched to find murders related to a specific SSRI whose perpetrators were acquitted based on temporary SSRI-induced insanity. There were two cases with sertraline, four cases with paroxetine, and four cases with fluoxetine. So a precedent has been established for legal recognition that an SSRI can be a cause for murder, and that the drug maker can be found liable for damages. The notices of suicidality for the SSRIs found in the PDR or package inserts before 2004 did not really warn of actual suicide or murder.

200 SSRI-related Lawsuits

The Black Box warning of 2004 about possible suicide in children under 18 years of age did not cover adults or murder at any age, so potential liability for the SSRI makers still exists. In 2007 the warning was extended to persons under age 25 years. David Healy was quoted as saying that the warning was overdue, and that the risk was not likely to disappear above age 25. This was shown by the trials from GlaxoSmithKline on paroxetine cited above.

Antidepressants are extraordinarily difficult to assess for risks or benefits in trials. At most, 11%–30% of patients with depression or related conditions who take SSRIs actually benefited beyond the placebo effect on normal doses. Of the perceived benefit, 32%–67% can be attributed to the placebo effect. Adverse effects, mostly dose-dependent, will appear in up to 75% of patients on normal doses. Of these, studies suggest that suicidality will be observed in an additional 2%–13% (1 in 50 to 1 in 9) of patients on normal doses, beyond what is seen on placebo or many non-SSRI antidepressant drugs. This is sufficiently frequent that a typical prescribing physician should observe examples in routine practice.

The actual suicide rate could be about 123/100,000 (1 in 813) higher in patients on SSRIs than in those on tricyclics or placebo. Studies show that many more suicides are on normal doses of SSRIs beyond what is seen on placebo or many non-SSRI antidepressant drugs. Available data suggest that actual murders may be committed at about the rate of 250/100,000 (1 in 400) SSRI-treated patients beyond what is seen on placebo or many non-SSRI antidepressantdrugs, and that many more murders will be attempted on normal doses as well. While correlation does not prove causation, and results of court trials are not medical science, the data for suicide are solid, and the association of murder with suicide is very suggestive. Now that there is a stronger Black Box warning, physicians who ignore it may be liable for damages; the warning primarily protects the manufacturers of SSRIs. There is obviously great peril in drawing conclusions about causat i on from press report s or court decisions.

While manufacturers have a vested interest in exonerating their drugs, plaintiffs have an interest in blaming it, and defendants in exonerating themselves. We need careful, independent analysis of existing study data. In addition to randomized controlled trials, evidence from basic science ( neuropharmacology) and challenge/dechallenge/rechallenge investigations needs to be sought. Both the public and individual patients are imperiled by an incorrect answer to the pressing questions about these widely prescribed drugs. Future studies may show lower levels of murder and suicide with close supervision, and with better matching of this drug type to patient type.

Conclusionsattemptedsimultaneous
Joel M. Kauffman, Ph.D.

Acknowledgements:
Joel M. Kauffman, Ph.D., professor of chemistry emeritus at the
University of the Sciences, 600 S. 43rd St., Philadelphia, PA 19104-4495,
Contact: kauffman@bee.net.

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Frances E. H. Pane edited the manuscript. David Moncrief piqued my interest by providing a review copy of by Richard DeGrandpre.
The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 11
Potential conflicts of interest: The author has neither a financial interest in any drug mentioned, nor in any alternate treatments for treating any mental illness.

REFERENCES
DeGrandpre R.,Durham, N.C.: Duke University Press; 2006.

The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture.
Bridge JA, Iyengar S, Salary CB, et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment. 2007;297:1683-1696.

Jørgensen AW, Hilden J, Gøtzsche PC. Cochrane reviews compared
with industry supported meta-analyses and other meta-analyses of
the same drugs: systematic review. doi:10.1136/bmj.38973.
444699.0B (publ Oct 2006).

Cohen JS. New York, N.Y.: Tarcher/Putnam; 2001.

Mackay FJ, Dunn NR, Wilton LV, et al. A comparison of fluvoxamine, fluoxetine, sertraline and paroxetine examined by observational cohort studies. 1997;6:235-246.

Park L, Covi L. Nonblind placebo trial. 1965;336-345.

Cole JO. Therapeutic efficiency of antidepressant drugs: a review. 1964;190:124-131.

Kirsch I, Moore TJ, Scoboria A, et al. The emperor’s new drugs: an analysis of antidepressant medication data submitted to the U. S. Food and Drug Administration. 2002;5(1):23-33.

Kirsch I, Deacon BJ, Huedo-Medina TB, et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. 2008;5(2):e45. doi:10.1371/journal.pmed.0050045.

Healy D. One flew over the conflict of interest nest. 2007;6(1):26-27.

Healy D. New York, N.Y.: New York University Press; 2004.

Healy D. FDA Psychopharmacologic Drugs Advisory Committee hearings. Available at:: www.healyprozac.com/PDAC. Accessed May 13, 2007.

Wolfe SM, ed. SSRIs can have dangerous interactions with other drugs. 2008;14(1):2-5. www.citizen.org/hrg/. Accessed Feb 4, 2009.

JAMA BMJ, Over Dose: The Case Against the Drug Companies.
Pharmacoepidemiol Drug Safety Arch Gen Psychiatry

JAMA
Prevention & Treatment
PLoS Medicine
World Psychiatry
Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression.
Worst Pills Best Pills News

Braconnier A, Le Coent R, Cohen D. Paroxetine versus clomipramine in adolescents with severe major depression: a double-blind, randomized, multicenter trial. 2003;42:22-29.

Anderson IM, Tomenson BM. Treatment discontinuation with selective serotonin reuptake inhibitors compared with tricyclic antidepressants: a meta-analysis. 1995;310:1433-1438.

Healy D. Lines of evidence on the risks of suicide with selective serotonin reuptake inhibitors. 2003:72:71-79.

Healy D, Herxheimer A, Menkes DB. Antidepressants and violence: problems at the interface of medicine and law.
2006;3(9):1478-1487.

Beasley CM, Dornseif BE, Bosomworth JC. Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression. 1991;303:685-692.

Cohen H. Antidepressants: clinical use and litigation. In: 2nd ed. O’Donnell JT, ed. Tucson, Ariz.: Lawyers & Judges Publ.Co; 2006:379-390.

Ross G. Black Box backfire. Apr 21, 2007.

Donovan S, Clayton A, Beeharry M, et al. Deliberate self-harm and antidepressant drugs. 2000;177:551-556.

Kai zar EE, Gr eenhouse JB, Sel t man H, Kel l eher K . Do antidepressants cause suicidality in children? A Bayesian meta-analysis. 2006;3:73-98.

Berenson ML, Levine DM.. 7th ed. Upper Saddle River, N.J.: Prentilee-Hall; 1998:213-217.

Healy D, Whitaker C. Antidepressants and suicide: risk-benefit conundrums. 2003;28:331-337.

Fergusson D, Doucette S, Glass KC, et al. Association between suicide attempts and selective serotonin reuptake inhibitors.2005;330:396-402.

Donovan S, Kelleher MJ, Lambourn J, Foster T. The occurrence of suicide following the prescription of antidepressant drugs.1999;5:181-192.

Jick SS, Dean AD, Jick H. Antidepressants and suicide.1995;310:215-218.

Wessely S, Kerwin R. Suicide risk and SSRIs. 2004;292:379-381.

Jick H, Kaye JA, Jick SS. Antidepressants and the risk of suicidal behaviors. 2004;292:338-343.

Carey B. FDA expands suicide warning on drugs. ,May 3, 2007:A17.

J Am Acad Child Psychiatry BMJPsychother PsychosomPLoS Med
BMJ

Drug Injury:Liability, Analysis and Prevention.

Wall Street Journal,Br J Psychiatry Clinical Trials

Basic Business Statistics: Concepts and Applications J Psychiatry Neuroscience

New York Times:Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

USA Trade Name Generic Name:
SSRIs
Celexa
Luvox
Paxil
Prozac
Zoloft
non-SSRIs
Effexor
Remeron
Serzone
Wellbutrin
(UK)
citalopram
fluvoxamine
paroxetine
fluoxetine
sertraline
venlafaxine
mirtazapine
nefazodone
bupropion
dothiepin USA Trade Name Generic Name
SSRIs
Celexa
Luvox
Paxil
Prozac
Zoloft
non-SSRIs
Effexor
Remeron
Serzone
Wellbutrin
(UK)
citalopram
fluvoxamine
paroxetine
fluoxetine
sertraline
venlafaxine
mirtazapine
nefazodone
bupropion
dothiepin

Physicians Desk Reference (PDR)
Joel M. Kauffman, Ph.D.
Table 1. Commonly Prescribed SSRIs and Other Antidepressants Selective Serotonin Reuptake Inhibitor (SSRI) Drugs:
More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 7 Physicians Desk Reference (PDR)
Joel M. Kauffman, Ph.D.
Table 1. Commonly Prescribed SSRIs and Other Antidepressants Selective Serotonin Reuptake Inhibitor (SSRI) Drugs:
More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 7

JAMAwhole12,69210,98313,74112,73450,15013,554

10 dead, 7 wounded: dosage increased one week before rampage
15 year old shoots two teachers, killing one: then kills himself
Columbine High School: 15 dead, 24 wounded
Four dead, twenty injured after Prozac withdrawal
Teen shoots at two students: kills his father
Jury finds Paxil was cause of murder-suicide
Man cleared of charges due to Paxil withdrawal defense
Not guilty by reason of Prozac induced insanity: mother kills daughter
Nine dead, 12 wounded in workplace shooting
11 year old hangs himself: lawsuit

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

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SSRI Medications

Below is a the drug manufactures BEST GUESS as to how SSRI antidepressants work in your brain. They fully admit that they really don’t know how they work. However, we maintain that the positive effects that patients report come from the stimulant, amphetamine-like, nature of these mind-altering drugs.

Learn the truth about these drugs in “Prozac: Panacea or Pandora?”

What you need to know about serotonin-enhancing medications

Selective Serotonin Reuptake Inhibitors do exactly that: Inhibit the reuptake of serotonin, thus leaving excess serotonin which allows this stimulation to continue. It has long been known that inhibiting the reuptake of serotonin will produce depression, suicide, violence, psychosis, mania, cravings for alcohol and other drugs, reckless driving, etc. [See full list of reactions below]

The most popular drugs that produce this reuptake of serotonin are:

SSRI Antidepressants: Prozac, Serafem, Zoloft, Paxil, Luvox, Celexa, Lexapro

SNRI Antidepressants: Effexor, Remeron, Serzone, Cymbalta

Atypical Antipsychotics: Zyprexa, Geodon, Abilify, Seroquel, Risperdal

Weight Loss Medications: Fen-Phen, Redux, Meridia

Pain Killers: (Any opium or heroin derivative) Morphine, OxyContin, Ultram, Tramadol, Percocet, Percodan, Lortab, Demerol, Darvon or Darvocet, Codeine, Buprenex, Dilaudid, Talwin, Stadol, Vicodin, Duragesic Patches, Fentanyl Transdermal, Methadone, Dextromethorphan (commonly used in cough syrups), etc.

WARNING: Anesthetics can also fall into this group as well as drugs used for other purposes. Always check to see what the mechanism of action is in a drug before combining it with another serotonergic agent or using it soon after the use of a serotonergic agent because the combination of two can cause the potentially fatal reaction known as Serotonin Syndrome. As the main function of serotonin is constriction of smooth muscle tissue, Serotonin Syndrome produces death via multiple organ failure.

“Psychedelic agents mimic the effects of serotonin.”

The brain chemical these drugs increase, serotonin, is the same brain chemical that LSD, PCP and other psychedelic drugs mimic in order to produce their hallucinogenic effects. And remember that psychedelic agents are “a class of compounds with no demonstrated therapeutic use, a history of extensive abuse, and the ability to provoke psychosis. Yet many brain researchers value the psychedelic agents above any of the other psychoactive drugs” because “the research into psychedelic drugs has already enriched our understanding of how the brain regulates behavior.” (Dr. Solomon Snyder, DRUGS AND THE BRAIN). Just how much will these brain researchers learn from our experience with these drugs designed to specifically increase serotonin, the same brain chemical the psychedelic agents mimic to produce their effects?

We know that these drugs interfere with serotonin metabolism (demonstrated by levels of the serotonin metabolite 5HIAA). It is not serotonin that is low in these disorders, it is this by-product 5HIAA, which indicates the level of serotonin metabolism, that is low in depression, suicide, etc. Yet as serotonin (5HT) goes up serotonin metabolism (5HIAA) generally comes down. We already have studies demonstrating at what percentage each of these drugs increase 5HT and decrease 5HIAA. Here are the results of elevated levels of serotonin (5HT) and decreased levels of serotonin metabolism (5HIAA):

Elevated 5HT (serotonin) levels:

  1. schizophrenia, psychosis, mania, etc.
  2. mood disorders (depression, anxiety, etc.)
  3. organic brain disease – especially mental retardation at a greater incident rate in children
  4. autism (a self-centered or self-focused mental state with no basis in reality)
  5. Alzheimer’s disease
  6. old age
  7. anorexia
  8. constriction of the blood vessels
  9. blood clotting
  10. constriction of bronchials and other physical effects

Lower 5HIAA (serotonin metabolism) levels:

  1. suicide (especially violent suicide)
  2. arson
  3. violent crime
  4. insomnia
  5. depression
  6. alcohol abuse
  7. impulsive acts with no concern for punishment
  8. reckless driving
  9. dependence upon various substances
  10. bulimia
  11. multiple suicide attempts
  12. hostility and more contact with police
  13. exhibitionism
  14. arguments with spouses, friends and relatives
  15. obsessive compulsive behavior
  16. impaired employment due to hostility, etc.

All are exactly what patients and their families have continued to report to be their experience on these drugs since Prozac was introduced! These individuals are frantically searching for answers while this research sits right under our noses. Although this is a totally different picture than pharmaceutical marketing departments would have us believe, marketing claims and reality rarely have much in common.

Researchers tell us that five, ten or twenty years later it is not uncommon to find we have another thalidomide on our hands. Raising 5HT (serotonin) and lowering 5HIAA (serotonin metabolism) in such a high number of people can produce very serious, extensive and long term problems for all of society. Even more frightening for the future of our society is the rapidly rising and widely accepted practice of prescribing these drugs to small children and adolescents. This crucial medical research must be addressed openly, without delay, rather than remain buried in seldom read medical research documents as has been the case in the past with other mind-altering medications, once thought to be safe, which were subsequently prohibited by law.

[SOURCE: PROZAC: PANACEA OR PANDORA?, BY ANN BLAKE TRACY]

  • Adverse SSRI Reactions
  • Prozac Package Insert
  • Hyperserotonemia
  • Serotonin Syndrome

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CELEXA: Youth in India Dies During Clinical Trial

Paragraph 10 reads: “Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram [Celexa] by the Sun Pharma Advanced Research Centre in Vadodara. ”

http://www.himalmag.com/Bodies-for-hire;-The-outsourcing-of-clinical-trials_nw3213.html

Bodies for hire; The outsourcing of clinical trials August 2009
By: Sandhya Srinivasan

Medical testing by Western countries is having a staggering impact on India, if only we were to care to pay attention. And the government’s own policies are encouraging this.

Karen Haydock
In November 2008, the Hindustan Times’ LiveMint broke the story of an infant in Bangalore having died after being administered a vaccine in a drugs trial. The Drugs Controller-General of India (DCGI), Dr Surinder Singh, halted the testing, reportedly the first time that the office of the DCGI had taken such action. The trial, for a new pneumonia vaccine, was being conducted by a Hyderabad-based contracted research organisation, GVK Biotech, for the US-based multinational Wyeth Pharmaceuticals. The infant had been recruited from St. John’s Medical College, a reputed private medical institution in Bangalore.

GVK’s spokesperson claimed that the vaccine had nothing to do with the death, as the child had received an approved and widely used vaccine – not the experimental product. However, the DCGI’s investigation revealed that the infant had a heart condition, and that the trial had been meant to be conducted only on healthy babies. According to C M Gulhati, editor of the Monthly Index of Medical Specialities, India and a Delhi-based expert on clinical-trial regulations, the investigation revealed a number of other irregularities as well: the informed-consent document had not been signed before the child was recruited; and the St John’s ethics committee had not been properly constituted, as it was not chaired by an external member to ensure independent functioning.

Yet the infant’s death was not an aberration. In December 2008, 25-year-old K Surender, of Hyderabad, died in a ‘bioequivalence’ trial of a blood-pressure drug, felodipine. Bioequivalence trials test generic versions of drugs to ensure that they are as effective as the original, and involve administering the drug and then monitoring the individual through blood tests and other investigations. These tests are conducted on healthy people who are paid for their participation. The Hyderabad trial also happened to be run by GVK Biotech, which subsequently issued a statement that Surender had simultaneously been part of many bioequivalence studies, with GVK as well as other contracted research organisations. This multiple trial participation could have accounted for his death, argued the company.

Such an explanation is unconvincing. If Surender had taken part in many trials, it would only have been for the money, which would amount to an inducement according to national and international ethical guidelines for research – an inducement that might have made him overlook the risks of the trials. And, in any case, why did the company let him take part in the felodipine trial when it was aware that he had taken part in many others? The answer to this question lies in the compulsions of the global pharmaceutical industry. The GVK trials are among the increasing number of international clinical trials that are taking place in India – and the concerns that they raise will come up increasingly frequently in the future. The reports of various government and private bodies put the potential of the clinical-trial industry into billions of dollars, though the method of calculating these numbers is not available. One market-research company, Frost and Sullivan, reportedly estimates a USD two billion turnover by 2010.

Marcin Bondarowicz
The growth of the outsourced clinical-trial industry in India followed changes in the law in January 2005 that encourage clinical research in India. The most important of these was an amendment to the Drugs and Cosmetics Rules, permitting clinical trials in India to be carried out at the same time that they are done in other countries, rather than waiting until the results of drug trials in other countries were made public. Previously, this ‘phase lag’ had ensured that India was of no interest to big pharmaceutical companies to test their drugs. At that time, Phase II trials were permitted in India only after the results of a Phase III trial abroad were declared. And Phase I trials of foreign drugs were simply not permitted. (Phase I or safety trials are done on healthy ‘volunteers’, Phase II trials look at the drug’s safety and effectiveness on patients, and Phase III trials also look at safety and effectiveness, but in large numbers of patients.) It should be noted, though, that an exception was made for drugs deemed of importance to India. While the Drugs and Cosmetics Rules do not specify, such drugs would probably include the HIV vaccine.

This changed in January 2005, and India is now prominently on the radar screen of the international pharmaceutical industry in terms of clinical trials, given its vast population of potential trial subjects. As of today, the bulk of clinical trials are still located in rich countries. To illustrate, as of 19 July 2009, the US government clinical-trial database lists a total of 76,018 trials, of which 44,758 have sites in North America and 17,878 have sites in Europe – accounting for the bulk of trials. In contrast, only 1021 clinical trials have sites in India, in addition to 122 in Pakistan, 61 in Bangladesh and 12 each in Nepal and Sri Lanka.

However, the number of trials in India is growing fast. Figures given by the DCGI’s office show that the number of newly approved trials every year went from 100 in 2005, when the new rules kicked in, to about 500 in 2008. What is of concern here is that many of the trials that come to countries such as India are likely to be those rejected as unethical in Western countries. As trials shift to countries such as India, there has been an international debate on ethical concerns of the outsourcing boom. This debate has been partly responsible for amendments in the World Medical Association’s Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects” in 1996, 2000 and in October 2008. Drug regulators in Europe and the US require that clinical trials submitted to them adhere to the Declaration.

Some of these changes have dealt with placebos or ‘sugar pills’. The October 2008 revision took a strong stance against the use of a placebo in a trial when a treatment exists. Clinical trials compare the effect of an experimental drug to an existing drug. If there is no drug for the condition, the experimental drug may be compared to a placebo. Using a placebo when a treatment exists deprives the trial participant of effective treatment. The ethical guidelines of the Indian Council of Medical Research and the World Medical Association’s Declaration of Helsinki both forbid the use of a placebo when an effective treatment exists, with certain specific exceptions. While both of these documents have been a bit ambiguous in the past, the 2008 revision of the Helsinki Declaration is clear: placebos can be used only when absolutely methodologically necessary, and when the risk to the participant is low. This revision was reportedly preceded by behind-the-scenes lobbying by the drug industry to permit greater use of placebo controls.

In the same month that the revised Declaration was announced, the US Food and Drug Administration (FDA) amended its own requirements for clinical trials. While placebos are rarely necessary, regulatory bodies such as the FDA require placebo-controlled trials to give marketing approval to new drugs. Yet as of October 2008, trials conducted for FDA approval no longer had to adhere to the Declaration of Helsinki – an internationally accepted document, but not binding unless incorporated into national regulations. The FDA would continue to require placebo controls, and no one was going to tell them otherwise.

Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram by the Sun Pharma Advanced Research Centre in Vadodara.

Certain types of trials are more likely to be conducted in India and other countries where regulatory and monitoring mechanisms are weak, or regulators are too willing to please drug companies. The use of placebos is a good example, as it is not difficult to conduct placebo trials in India. In 2005-06, Indian patients with schizophrenia were taken off their regular medication and given either a new, ‘extended-release’ formulation of an approved drug (quetiapine, marketed by AstraZeneca) or a placebo, to compare the time it took for people in each group to have a relapse attack of schizophrenia. The trial was conducted by a Contract Research Organisation (CRO) called Quintiles, in India as well as a number of countries in Eastern Europe. One patient (not in India) who was on the placebo committed suicide. Experts are unanimous in their view that a placebo was methodologically unnecessary in that trial, as the new formulation could have been compared to the existing ‘immediate-release’ drug. But the European regulators required a placebo-controlled trial, noted Irene Schipper and Francis Weyzig of the Dutch research organisation Centre for Research on Multinational Corporations, in a 2008 report. They also argued that placebo-controlled trials for severe conditions, which put the participants at greater risk, are more likely to be conducted in developing countries.

Trials in government hospitals in India can also be of special concern. In one trial, 290 people who had been hospitalised because they were having a severe attack of acute mania were given either a drug (risperidone, marketed by Johnson & Johnson) or a placebo. The idea, of course, was to examine how many people recovered with the drug, and how many with the placebo. This subjected seriously ill people to harm. The majority of patients in this India-only trial, also conducted by Quintiles, were recruited from government hospitals where, according to the principal investigator of the trial, the most seriously ill patients could be found. It is also where patients can be recruited easily, because trial participation ensures a hospital bed and free, quality treatment.

Another concern about trials in government hospitals is that they are conducted on poor people who may have no access to the drugs tested on them after the trial is over. In August 2008, the media reported that 49 children died in 42 clinical trials that were conducted over two and a half years in the Department of Paediatrics at the All India Institute of Medical Sciences (AIIMS) in Delhi. An investigation ordered by the National Human Rights Commission concluded that the trials were conducted properly: the children in the trials were seriously ill, and all the deaths occurred because of the serious illnesses, not the treatments. However, the committee’s report left many questions unanswered. What, for instance, was the purpose of these trials? Would they help other poor children in India?

One of these trials tested the blood-pressure drug valsartan, supplied by its manufacturer Novartis. Paediatric hypertension is indeed a serious condition, but companies conduct paediatric trials for various reasons, including to get information for the benefit of doctors who prescribe the drug to children. Another reason is because the US FDA extends a drug’s exclusive marketing rights when it is tested on children; this provision is meant to encourage research on children who are otherwise prescribed drugs based on the results of research on adults. However, companies also use this clause to maximise their profits. Another trial was linked to gene-activated human glucocerebrosidase, a treatment for Gaucher’s disease, a serious genetic condition in which a fatty substance (lipid) gets deposited in cells and specific organs. The drug for this trial was provided by the US-based Shire Human Genetic Therapies. Will the drug be made available in India once it is proved effective? Both the Helsinki Declaration and the ICMR’s guidelines emphasise that a community on which a drug is tested should have access to the drugs, if proven effective, once the trial is over. Unfortunately, this is rarely the case. Although all of the new drugs being tested in India will indeed be available in India, this will be at prices unaffordable to the very people who agree to have them tested on their bodies.

More generally, but of no less concern, AIIMS has stated that the trials did not “target” children from poor backgrounds. But there is no need to target poor people at AIIMS – they constitute the majority of patients at this government referral hospital. The simple fact is that the vast majority of people seeking care at the AIIMS centre would be there because they cannot afford treatment elsewhere.

Body market
The pharmaceutical industry depends on constantly getting new drugs into the market. New drugs include new uses for old drugs (a cancer drug that can also be used for infertility?) or ‘improved’ or ‘me-too’ versions of older drugs (all those antacids, blood-pressure and cholesterol-lowering drugs, anti-depressants or antibiotics). These drugs must be tested on human beings before they can go into the market. Permission has to be obtained, patients have to be recruited, trials carried out and the results filed – all at top speed, because time is money.

This is where the Contract Research Organisation – the CRO, such as GVK Biotech referred to earlier – steps in. The CRO undertakes all aspects of the process involved in getting regulatory clearance: getting the necessary permissions, tying up with doctors and hospitals to recruit patients on whom the drugs are to be tested, analysing the data that emerges from the trials, monitoring the trial to make sure that the information collected meets standards, putting together reports and even ghostwriting articles for publication in medical journals. Of course, the most important aspects of all this is the recruitment of patients. The best place to recruit patients for, say, a diabetes-drug trial, is a country with a large diabetic population. And diabetics who have not received treatment make better trial subjects, as the results of drugs tested on them will not be ‘contaminated’ with the results of drugs that they have already used.

Clinical trials in developing countries depend not only on physical infrastructure – hospitals and laboratories – and trained human power. They also depend on drug companies getting access to bodies on which they can test their drugs. So, CROs in India market Indian bodies. In a 2006 advertisement on their website (which has since been removed), a CRO named Igate advertised the ‘India advantage’ as “40 million asthmatics, about 34 million diabetics, 8-10 million people HIV positive, 8 million epileptic patients, 3 million cancer patients.”

CROs in India all claim to have ‘access’ to patients with various health problems for which drugs can be tested. For instance, a research group called Veeda claims to have “access to vast patient populations and has specific expertise in recruiting patients with cardiovascular disease, oncology, diabetes, renal disease”. The CRO Quintiles India once boasted that, for a paediatric-flu-vaccine trial, it recruited 201 one- to three-year-olds from three sites in India in just six days. What kind of network does Quintiles have, and what kind of influence does it have with the medical profession, that it can round up 200 children and convince their parents to let them get an experimental flu shot – all in just six days flat?

It seems that at least some of this is able to take place through wilful misinformation. Spectrum Clinical Research specialises in recruiting patients, collecting patients through networks of private clinics, hospitals, specialists and family physicians. It also runs ‘awareness campaigns’ – for instance, a “white ribbon initiative” on osteoporosis, co-organised with the women’s magazine Femina of the Times of India stable, collected data on 2000 patients with osteoporosis. Another campaign, this time to “defeat diabetes”, collected data on 1000 patients with diabetes. In these ways, people who think they are joining patient-support groups are actually being tracked so they can potentially be put on a trial.

Behind a veil
Other than the boasts of CROs, there is little information available on the hundreds of clinical trials being conducted in India. This is despite the evidence that many of these trials are conducted for the benefit of international drug companies, at unacceptable cost to the local population; that trial subjects could be put at risk; that subjects often have not given their informed consent to participate; that they might be provided care that is of lower quality than if they had been recruited for a trial in the West; that injuries during a trial might not be investigated thoroughly, and that those injured may not receive treatment of the highest standard, or even compensation; and that drugs that are tested are often too expensive for people who need them in India.

The only institution to have direct power over the conduct of a trial is the ethics committee (EC). Research institutions appoint their own institutional ethics committee to conduct an ethics review of all research proposals from within the institution. Independent or freelance ethics committees undertake ethics review for a fee, from anyone who applies – usually the CRO or drug company who coordinates the trial at a number of small nursing homes or private clinics, which don’t have their own ethics committee. The EC is a collection of specialists from various fields who review trial documents, including the trial design, the manner in which subjects are recruited, the patient information sheet and the informed-consent form, and approve or reject the application. These committees also have the authority to investigate a trial, and even to stop it if they feel that something is not right.

Ethicist Amar Jesani points out that ethics committees have a lot of power, as the DCGI requires that all trials be passed by such an appointed group. In fact, the DCGI only requires approval by an ethics committee, since it does not monitor the actual conduct of the trial – it does not check that informed consent is taken, that the investigators do their job correctly, that subjects are not harmed, and so on. Thus, says Jesani, it is the ethics committee, not the DCGI, that is the real regulator of clinical trials.

Yet the effectiveness of an ethics committee depends entirely on the setting in which it functions. Important factors, for instance, include the institution that funds the committee’s work or that determines its level of independence, the training of its members, and their competence in terms of doing a proper ethics review. Likewise ‘independent’ or freelance ethics committees are more accountable to the companies that pay for their services. Even the patient information sheet and informed-consent document are treated as confidential documents by the ethics committee – and, of course, the trial’s sponsor. These contain the information on the purpose of the trial, its risks and benefits, and an assurance that a patient’s treatment will not be jeopardised by refusal to participate, or withdrawal from a trial. There is nothing here of proprietary value – on the contrary, everything in these documents is of public interest, and they should be available to the public. Ethics committees are also often poorly educated in their responsibilities.

The reports of people dying in trials are likely to be merely the tip of the proverbial iceberg. And many more are likely to suffer an injury related to the trial drug, injuries that require treatment and that could result in temporary or permanent disability. Indian guidelines require that trial participants be compensated for injuries suffered during research. However, a study by Urmila Thatte and others in a 2009 issue of the UK-based Journal of Medical Ethics found that many trial investigators as well as ethics committee members are not even aware of this requirement. The guidelines of trial sponsors – such as drug companies – provide for medical treatment of any participant who suffers a trial-related injury, or reimbursement of their medical costs. However, Thatte and her colleagues found that none of the companies sponsoring trials, or ethics committees reviewing their trials, had a policy of compensation for trial-related disability or death. Yet for ethics committees to be a law unto themselves is hardly surprising, given the overall environment of lax regulation and monitoring.

Now, the FDA’s decision to do away with the Declaration of Helsinki will create a dilemma for the DCGI. If CROs in India are to follow the FDA requirements – such as using a placebo even when it is not absolutely necessary, and when it might put subjects at risk – they will be violating Indian regulations, which require that the Declaration of Helsinki be followed. The latest revision of the Declaration is quite clear that the placebo may be used in very few circumstances. At the moment, however, the DCGI’s record – permitting a number of unethical trials – suggests that his office places greater value on the potential financial returns of clinical trial outsourcing than on protecting the people who take part in drug trials in India.

Sandhya Srinivasan is a Bombay-based journalist specialising in public health and development issues. She is executive editor of the Indian Journal of Medical Ethics.

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Study Links Older Bipolar Drug to Fewer Suicides

9/17/2003 • Study Links Older Bipolar Drug to Fewer Suicides

Dr. Frederick K. Goodwin, senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center

Journal of the American Medical Association

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

9/17/2003

Study Links Older Bipolar Drug to Fewer Suicides

http://www.nytimes.com/2003/09/17/health/17SUIC.html

Dr. Frederick K. Goodwin, senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center

Journal of the American Medical Association

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

Lithium, an old and inexpensive drug that has fallen out of favor with many psychiatrists, is better than the most commonly prescribed drug, Depakote, at preventing suicide in people who have manic-depressive illness, researchers are reporting.

People with the illness, also called bipolar disorder, swing back and forth between bleak spells of depression and periods of high excitability that may run the gamut from euphoria to rage. From 1.3 percent to 1.5 percent of people in the United States suffer from bipolar disorder, and their risk of committing suicide is estimated to be 10 to 20 times that of the rest of the population.

Perhaps because patients are more likely to seek medical help when they are depressed than when they are manic, the disorder is often misdiagnosed at first as depression alone, but antidepressants are not the correct treatment for bipolar disorder and may in fact make it worse.

The new study, published today in The Journal of the American Medical Association, found that patients taking Depakote were 2.7 times as likely to kill themselves as those taking lithium. Earlier studies by others had also found that lithium could prevent suicide, but today’s report is the first to compare suicide and attempted suicide rates in lithium and Depakote users. The study was based on medical records of 20,638 patients aged 14 and older in Washington State and California who were treated from 1994 to 2001.

Solvay Pharmaceuticals, a maker of lithium, paid for the study, but did not influence the findings or the way they were reported, the authors said.

The study included 53 actual suicides and 383 attempted suicides that led to hospitalization. But the researchers, as well as Depakote’s manufacturer, cautioned that because this study was based only on patients’ records, it was not conclusive.

Precisely how lithium might prevent suicide is not known, although it is believed to help regulate levels of serotonin, a brain chemical that influences mood.

“Lithium is clearly being underutilized,” said Dr. Frederick K. Goodwin, the senior author of the study and director of the psychopharmacology research center at George Washington University Medical Center. The drug can save lives, he said, adding, “The real tragedy is that a lot of young psychiatrists have never learned to use lithium.”

Lithium, which can smooth out the highs and the lows of bipolar disorder, was first used in the 1950’s, and in the 1970’s was the first drug to be designated a “mood stabilizer” by the Food and Drug Administration. But the drug has been around for so long that its patent has expired and generic versions exist, meaning that lithium cannot generate substantial earnings for industry, Dr. Goodwin said. Drug companies promote newer, more profitable drugs like Depakote.

Some difficult cases referred to Dr. Goodwin turn out to be people who have never taken lithium because their psychiatrists, often under 40, never thought of prescribing it. But Dr. Goodwin also emphasized that lithium did not work for everyone and that other drugs like Depakote were also needed.

Dr. John Leonard, a spokesman for Abbott Laboratories, the maker of Depakote, questioned the findings. Dr. Leonard said that studies looking back at patients’ records were inherently flawed and not as reliable as studies in which patients were randomly assigned by researchers to take one drug or the other. He said conclusions could not be drawn from the data, and doctors should not base treatment decisions on it.

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