AboutLawSuits.com – June 27, 2011

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.

The researchers also found that women who took any SSRI antidepressant during pregnancy were more than twice as likely to give birth to a child with a neural tube defect; 22 out of every 10,000 newborns, as compared to 9 out of every 10,000 newborns born to women who did not take any SSRI during pregnancy.

SSRIs are a relatively new class of antidepressants, which help reduce symptoms of depression by preventing certain nerve cells in the brain from re-absorbing the chemical serotonin. These drugs are commonly used by millions of Americans with depression.

Although the drugs have been found to cause fewer side effects than older anti-depressants, research has shown that users of the drugs could also face an increased risk of suicides, and use during pregnancy has been linked to a risk of birth defects, especially among users of Paxil.

Prozac (fluoxetine) is marketed by Eli Lilly and is approved for the treatment of depression, obsessive-compulsive disorder (OCD) and other psychiatric problems. In 2007 there were more than 22 million Prozac prescriptions in the United States.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

The company reportedly agreed to settle hundreds of Paxil heart birth defect lawsuits last year. The Paxil lawsuits were filed by parents who say that the use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) and other birth defects. The lawsuits claimed that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claimed that the company purposefully hid test results that would have revealed the side effects of Paxil and misled doctors.

http://www.aboutlawsuits.com/paxil-prozac-birth-defect-study-19139/

« Return to news items

News Feed

Related Posts

• UK Drug Regulatory Agency issues warning about potential birth defects from Prozac (1)
• With growing public awareness of antidepressant risks: Pro-pill website Web MD does damage control (1)
• Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System (0)
• Finally—An Official Admission: Psychiatric Drugs Cause Violent & Homicidal Behavior (0)
• Psychiatrist on Payroll of Glaxo Pleads Guilty to Research Fraud (4)

Note from CCHR: Due to the severe adverse reactions from psychiatric drugs finally becoming a matter of public knowledge, as well as studies proving psychiatric drugs are no more effective than placebo, the psychiatric drug lords have now come up with a more overtly drug dealer approach; prescribe patients lysergic acid diethylamide (LSD), Ketamine (An animal tranquilizer known as Special K on the the street) and psilocybin (mushrooms).

Medscape
By Deborah Brauser
August 25, 2010

Low doses of psychedelic drugs, including lysergic acid diethylamide (LSD), ketamine, and psilocybin, may reduce clinical symptoms in patients with depression, anxiety, obsession-compulsive disorders (OCDs), and chronic pain, without inducing depersonalization or hallucinations, according to a new Perspectives article published online August 18 in Nature Reviews Neuroscience.

The study authors note that this may be due to the drugs’ effect on patients’ altered brain circuits and neurotransmitter systems, including serotonin and glutamate systems, according to recent neuroimaging data.

“These findings raise the possibility that research into psychedelics might identify novel therapeutic mechanisms and approaches that are based on glutamate-driven neuroplasticity,” write Franz X. Vollenweider, MD, director of the Neuropsychopharmacology and Brain Imaging Research Unit at the University Hospital of Psychiatry in Zurich, Switzerland, and colleagues.

“These are serious, debilitating, life-shortening illnesses, and as the currently available treatments have high failure rates, psychedelics might offer alternative treatment strategies that could improve the well-being of patients and the associated economic burden on [them] and society,” they add.

Recent Research

Although research on psychedelics has been restricted for almost 40 years because of the drugs’ negative connotations, “recent advances in our understanding of the neurobiology of psychedelics” have led to renewed interest, write the study authors.

Read entire article here:  http://www.medscape.com/viewarticle/727438

« Return to news items

News Feed

Related Posts

• Leading psychologist says antidepressants no better than placebo—the difference is no suicidal side effects with placebo (1)
• Mental health services have become increasingly dominated by psychiatry’s ”medical model” (0)
• The Small Group of Thoughtful, Committed Citizens Has Been Drugged (0)
• Dealing With Depression Naturally (0)
• 1 million misdiagnosed ADHD children for $80B drug industry (0)

The Daily Mail
By Professor Irving Kirsch
August 3, 2010

We spend more than £250 m a year on antidepressants in the UK – and it’s a complete waste of money.

They are not much better than sugar pills, they have nasty side – effects, such as sexual dysfunction, and they increase young people’s risk of suicide.

New research shows they don’t even work on the brain in the way we thought they did.

For years we were told depression was caused by low levels of a brain chemical called serotonin, and that antidepressants worked by boosting it.

But an Australian study published in the Archives of General Psychiatry shows that rather than low levels, depressed people might have double the normal amount in some parts of their brains.

Many people were surprised by these new findings, but I wasn’t.

I’ve been studying antidepressants for more than a decade, and I knew that if they worked at all, it wasn’t by changing brain chemistry.

The major reason you feel better when taking an antidepressant – maybe the only reason – is the placebo effect.

When I first published a paper back in 1998 saying that antidepressant drugs such as Prozac and Seroxat were not much better than a placebo, almost everyone thought it couldn’t be true.

There was so much evidence they worked. Thousands of people claimed the drugs had turned their lives round.

My colleagues said that I must have made a mistake: either I had looked at the wrong data, or I hadn’t analysed it properly.

In fact, what I’d done was to look at the research on antidepressants in a different way from everyone else.

Other researchers were concentrating on how much better the drugs were than a placebo.

What I was interested in was finding out how strong the placebo effect was in treating depression.

I compared the placebo effect to having no treatment at all – no one had done that before.

We already knew that placebos could have a powerful effect in conditions such as pain, angina, ulcers and asthma.

Depression was an obvious next step, because when you are depressed you lose hope, and placebos give you hope.

But I was flabbergasted by just how big the placebo effect was.

Read entire article here:  http://www.dailymail.co.uk/health/article-1299791/Why-antidepressants-simply-confidence-trick-A-leading-psychologist-claims-taking-sugar-pills-work-just-well.html?ito=feeds-newsxml

« Return to news items

News Feed

Related Posts

• Public reports reveal psychiatric drugs linked to 64% of all suicides in Sweden (1)
• The Small Group of Thoughtful, Committed Citizens Has Been Drugged (0)
• The Globe and Mail — “Is Depression a Disease? Big Pharma says yes, but others aren’t so sure” (1)
• Psychiatric Drugs, Violence and Suicide (8)
• Can Prozac Cause Kids to Kill? A Canadian Judge Has Ruled it Can (2)

« Return to news items

News Feed

Related Posts

• Psychiatric Meds 101: A Surprising Discovery – Your Own Personal Hell (15)
• Can Prozac Cause Kids to Kill? A Canadian Judge Has Ruled it Can (2)
• Medscape – Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children (4)
• “Drugged Warriors: Sharp Rise in U.S. Military Psychiatric Drug Use and Suicides” by Psychologist Bruce Levine (1)
• 7 Reasons America’s Mental Health Industry Is a Threat to Our Sanity (0)

Scoop Independent News
By Evelyn Pringle
July 14, 2010

The SSRI antidepressant makers are desperate to find new customers, so they recently have been focusing on capturing groups for which the drugs were usually considered off limits. The latest marketing coup managed to open up sales to roughly 614,000 American pilots.

Under a new policy announced on April 5, 2010, pilots diagnosed with depression can seek permission from the Federal Aviation Administration to take one of four SSRIs, including Eli Lilly’s Prozac, Pfizer’s Zoloft, and Forest Laboratories’ Celexa and Lexapro.

“The FAA should reverse its ruling before it’s too late and hundreds of lives are lost when a pilot becomes impulsive, suicidal or violent–or just loses his sharpness–under the influence of antidepressant medication,” said SSRI expert, Dr Peter Breggin, in an April 19, 2010 Huffington Post commentary.

The Citizens Commission on Human Rights is also calling on the FAA to rethink allowing pilots to take SSRI in light of a new report issued last month by the National Transportation Safety Board, on a February 1, 2008 plane crash in North Carolina, by a crazy acting pilot on Zoloft, that killed all six persons on board

The report said the pilot failed to maintain control of the plane during instrument flying conditions and “deliberately descended below the minimum descent altitude.” The plane stalled and crashed while circling after an aborted landing.

“Review of the cockpit voice recorder (CVR) audio revealed that the pilot had displayed some non-professional behavior before initiating the approach,” the NTSB reported.

The CVR recorded the pilot singing: “Save my life I’m going down for the last time,” before beginning a commentary in which he told passengers: “If anybody back there believes in the good Lord, I believe now would be a good time to hit your knees.”

A review of medical records documented that “from December 4, 2006 through December 31, 2007, the pilot had filled 6 prescriptions for 30 tablets of 50 mg sertraline (Zoloft),” the report said.

The records indicated that he had been treated previously with two other antidepressant medications for “anxiety and depression” and a history of “impatience” and “compulsiveness,” the NTSB noted.

An investigation of another plane crash, resulting in two fatalities in Kingsport, Tennessee, in August 2003, found Zoloft in the blood and liver of a private flight instructor, according to an accident report by the NTSB.

In the policy statement published in the Federal Register, the FAA seems to justify the use of these drugs via the fully debunked “chemical imbalance in the brain” theory when writing: “All these medications are SSRIs, antidepressants that help restore the balance of serotonin, a naturally occurring chemical substance found in the brain.”

“Increasingly accepted and prevalently used, these four antidepressants may be used safely in appropriate cases with proper oversight and have fewer side effects than previous generations of antidepressants,” the FAA wrote, with no citation to any scientific paper to back up this assertion.

In fact, the current labels on SSRIs warn that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

“Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence,” according to Dr Breggin.

CCHR has set up a great website with a one-of-a-kind search engine that allows the public and officials to access the database on side effects reported to the FDA on SSRIs, and every other psychiatric drug. The site also has a search engine to access all the International warnings and studies on psychiatric drugs which have been summarized so they are easy to understand, even to a lay person.

Input Only From the Choir

On April 6, 2010, Bob Fiddaman, author of the long-running popular website and blog, “Seroxat Sufferers,” sent a request to the FAA, under the Freedom of Information Act, seeking information on the change in policy.

In the Federal Register, the FAA claims it came to its decision after “careful consideration.” However, in the 58 pages of documents sent to Fiddaman on June 9, 2010 (and kindly shared with this author), there is no mention of consultations with any of the prominent SSRI experts who may have offered a contrary view. Like Peter Breggin for instance.

The FAA’s response to Fiddaman shows the agency has been discussing the policy change since at least 2008. In response to a request for “minutes of meetings where the change in the policy was on the agenda,” as well as a list of “members present and a declaration of interests of each of the members,” the FAA sent a copy of a July 18, 2008, Memorandum, with a summary from one consultants meeting. Three outside experts attended but there were no declarations of interests, or lack thereof, by anyone at the meeting.

The summary noted that the consultants “unanimously agreed that the concept of allowing certain airmen taking antidepressant medication was reasonable and safe.” But the “unanimous consensus” was that only Prozac and Zoloft “were appropriate medications due to the longevity of their use and overall safety.”

“They also felt that only these two should be considered initially, and no other medications considered at this time,” the summary reported.

In responding to the question of whether the new policy would apply to Air Traffic Controllers, the FAA said the “new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.”

In response to a request for any information “given to FAA from outside parties that relate to the FAA’S recent change in policy regarding pilots on antidepressant medication,” the FAA sent copies of documents received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army.

“In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain,” the response said. “We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.”

The documents Fiddaman received show consideration of a 2003 study of aviation accidents that found SSRIs in 61 pilot fatalities between 1990-2001, in which the psychological condition and/or the drug use was determined to be the cause, or a factor in 16 of the accidents, or 31%.

However, there was no mention of a later November 2006 study titled, “Pilot Medical History and Medications Found in Post Mortem Specimens for Aviation Accidents,” led by Dennis Canfield, from the FAA’s Civil Aerospace Medical Institute, in the “Aviation, Space, and Environmental Medicine” journal.

For this study, toxicological evaluations were performed on 4,143 pilots involved in fatal aviation accidents during the period between January 1, 1993, through December 31, 2003, to identify all pilots found positive for medications used to treat cardiovascular, psychological, or neurological conditions.

The evaluations found one-hundred dead pilots with SSRIs in their systems including forty with Prozac, twenty-six with Zoloft, twenty-one with Paxil, and thirteen with Celexa.

Less than a month after the new policy was announced, in “Aviation International News,” on May 1, 2010, Matt Thurber reported that in a review of 127 accidents in the NTSB database since 1991, containing the word “antidepressant,” only three were nonfatal.

“In 124 of those accidents, 211 people were killed,” Thurber said. “In accident after accident, antidepressants … were found in the tissues of dead pilots, and the pilots had falsified their medical certificate applications to show that they had never been treated for psychiatric problems.”

Read the rest of this article here:  http://www.scoop.co.nz/stories/HL1007/S00116.htm

Read FOIA documents here: http://fiddaman.blogspot.com/p/faa-respond-to-freedom-of-information.html

« Return to news items

News Feed

Related Posts

• The FAA will Allow Antidepressant Popping Pilots and their Lethal Side Effects in an Unfriendly Sky (2)
• Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System (0)
• The FAA better rethink allowing pilots to take antidepressants; New report says pilot in 2008 plane crash was on Zoloft (0)
• The Huffington Post: “Pilots Taking Antidepressants? The FAA Is Risking Our Lives” (1)
• Can Prozac Cause Kids to Kill? A Canadian Judge Has Ruled it Can (2)

Public reports reveal psychiatric drugs linked to 64% of all suicides in Sweden

The One Click Group
By Janne Larsson
June 29, 2010

This unique report presents data about the preceding psychiatric drug treatment for all persons who committed suicide in Sweden 2007. The conclusion is that a large percentage of the persons who committed suicide had received extensive treatment with psychiatric drugs within a year of and close to the suicide.
Public reports reveal psychiatric drugs linked to 64% of all suicides in Sweden.

This is a report about suicides committed in Sweden (with around 9 million citizens) in 2007 and the psychiatric drug treatment that preceded these suicides.

The report has three main parts:

• It gives unique data about all suicides committed in 2007 and the psychiatric drugs that the persons received within a year of the suicide.

• It compares these data with autopsy reports about psychiatric drugs found in the blood (of 98%) of all the persons who committed suicide in 2007.

• It gives extensive information about the psychiatric drug treatment given within a year to the subgroup of persons who committed suicide in 2007 and then were reported to the National Board of Health and Welfare by reason of law 3 – one third of all suicides committed that year.

The data presented on these pages should have been published by the responsible national authorities.

A large percentage of the persons who committed suicide in Sweden in 2007 had received extensive treatment with psychiatric drugs within a year of their suicide.

The idea that persons who are depressed are suffering from “chemical imbalances” and are deficient in the substance serotonin has been marketed by the pharmaceutical companies selling antidepressants (in the class of antidepressant drugs called Selective Serotonin Reuptake Inhibitors, SSRIs, such as Prozac, Paxil/Seroxat, Zoloft) for more than a decade. The intensive marketing has led persons to believe that their low mood is a deficiency disease – and that it is vital to supply the substance that corrects this deficiency – the antidepressant drug.

But there is no scientific evidence that a low mood is caused by a ”chemical imbalance” in the brain. The hypothesis has been rejected with the following words by one of the most well known names in the field, Dr. David Healy,“The serotonin theory of depression is comparable to the masturbatory theory of insanity.”

The Swedish medical agencies and their psychiatric consultants have used old data from forensic toxicological screenings to mislead the public and to heavily increase the use of antidepressants and other psychiatric drugs.

The most important information in this area is the patients’ medical history; the treatment history. Antidepressants, neuroleptics and other psychiatric drugs may cause harmful changes in the brain and these brain dysfunctions do not vanish when the drugs are discontinued – in many cases they cause chronic dysfunction to the brain, exemplified by the known neurological harm caused by neuroleptics. Many patients also get serious withdrawal reactions; reactions that can be so severe that they can lead to suicide.

Better sources of information are the unpublished clinical trials of psychiatric drugs done by pharmaceutical companies, and the important studies done by independent researchers. A number of these studies show that antidepressants and neuroleptics increase the risk of suicidal behaviour and directly cause effects that lead to suicide.

Download and read the full report here; http://www.theoneclickgroup.co.uk/documents/ME-CFS_docs/Psychiatric%20Drugs%20&%20Suicide,%20Sweden%202007.pdf

« Return to news items

News Feed

Related Posts

• Leading psychologist says antidepressants no better than placebo—the difference is no suicidal side effects with placebo (1)
• The Small Group of Thoughtful, Committed Citizens Has Been Drugged (0)
• Panel to Examine Murder and Suicide Associated With Antidepressants (0)
• Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System (0)
• Psychiatric Meds 101: A Surprising Discovery – Your Own Personal Hell (15)

Big Pharma says yes, but others aren’t so sure

The Globe and Mail
By Leah McLaren
June 18, 2010

“It’s all in your head” isn’t something a chronically depressed person likes to hear. In the age of Prozac, when adjusting your serotonin level is as normal as checking the oil in your car, it seems unhelpful to suggest that someone might think their way into – or out of – a disease of the mind.

And yet depression is all in our heads. Where else would it be? The real question, still hotly debated in the scientific community, is whether its cause is chemical and ultimately curable (good news for Big Pharma) or something far more complex (good news for poets and pot-smoking students of existential philosophy).

There is no doubt that depression exists. Inexplicable sadness – or “melancholia,” as it was historically known – has been with us since Hippocrates conceived his famous oath. But a groundbreaking new study has found that not only is depression affected by the way we think about it, so too is its cure.

Last week Irving Kirsch, a professor at the University of Hull in the U.K., presented a study that found Prozac and its ilk are no more effective than placebos in treating depression. In his view, there is no substantial link between serotonin – the brain chemical that antidepressants are supposed to regulate – and chronic depression.

It’s a controversial study – one that many members of the psychiatric community reject out of hand – but it also raises a nagging question about depression: How did it come to be recognized as a disease in the first place?

Like Hirsch, psychologist and writer Gary Greenberg is part of a growing number of psychiatric professionals who have begun to publicly question the underpinnings of popular thinking on depression.

Read entire article:  http://www.theglobeandmail.com/life/style/is-depression-a-disease/article1609422/

« Return to news items

News Feed

Related Posts

• Depression? Don’t believe it —Big Pharma has gained an ever greater hold over our mental & emotional lives (0)
• The Small Group of Thoughtful, Committed Citizens Has Been Drugged (0)
• Leading psychologist says antidepressants no better than placebo—the difference is no suicidal side effects with placebo (1)
• SSRIs Render Unfriendly Skies—FOIA documents reveal what FAA failed to consider in allowing pilots on antidepressants to fly (0)
• The Drugging of America (0)

The Brooklyn Rail
By Kaitlin Bell
February 2010

Gary Greenberg opens his new history of depression with a riveting tale of scientific ingenuity. A young, unknown marine biologist with an interest in mussels happens to discover the neurotransmitter serotonin and helps spur the antidepressant revolution. Lest we get too excited, though, Greenberg deflates our hopes just a few pages in.  Great science stories involve chance discoveries that change our everyday lives, he says—but this is not the kind of story he is going to tell.

Instead, the story that dominates Manufacturing Depression: The Secret History of a Disease is of scientific exuberance run amok, of coincidences and hasty conclusions, of a lust for money and for control over what Greenberg aptly describes as the landscape of mental suffering. Greenberg is outraged that “the depression doctors,” as he ominously terms them, have cornered the market on Americans’ internal anguish and have managed to convince millions of people that their unhappiness is actually a disease with a simple cause—a chemical imbalance—and a magic-bullet cure. It’s especially infuriating because this notion isn’t based in fact; it’s just a story we have allowed the medical establishment to tell us. There is no biochemical marker for depression, no good way to tell who is and who isn’t depressed. The tools doctors use to diagnose depression, as well as the other varieties of mental illness, are based on symptoms alone—whether someone is eating or sleeping more or less than usual, for example, or suffering from excessive guilt, or engaging in too much self-criticism.  Most of what’s diagnosed as depression is, in other words, nothing more than the name our society gives to a particular kind of emotional and mental suffering considered worthy of fixing.

In one sense, Greenberg has reclaimed the narrative very effectively. He has produced a tightly woven history showing that the medical establishment, despite claims to the contrary, knows almost nothing about the causes of depression from a scientific, biochemical, or neurological perspective.

Read entire article:  http://www.brooklynrail.org/2010/02/express/a-frustrating-mess

« Return to news items

News Feed

Related Posts

• The Globe and Mail — “Is Depression a Disease? Big Pharma says yes, but others aren’t so sure” (1)
• The New York Times on Psychiatric Disorders, “Not Diseases, but Categories of Suffering” (0)
• Paxil and Prozac Linked to Risk of Heart Birth Defects (0)
• New antidepressant warning – Prozac and other drugs raise risk of heart attack and stroke (1)
• Profiting from mental ill-health (1)