Posts Tagged ‘Paxil’

Paxil Class Action Moves on in Canada as Lawsuits Still Filed in U.S.

Wednesday, January 2nd, 2013

The Legal Examiner
By Steve Thomas
January 2, 2013

Click image to read all drug warnings, studies and side effects reported to the FDA on the antidepressant drug Paxil

GlaxoSmithKline, maker of the selective serotonin reuptake inhibitor Paxil, is mired in a class action lawsuit in Canada that alleges the antidepressant caused birth defects in children whose expectant mothers took the drug without the corporation’s adequate warning of the heightened risks. A British Columbia judge permitted the class action.

This is the sort of thing that cost the manufacturer legal and financial setbacks in the U.S. The corporation spent millions on legal defense and paid millions in compensation awarded in Paxil lawsuits based on similar causes of action. The pharmaceutical litigation team at Reich & Binstock represents Paxil victims. The damage to children and to families frankly defies description, but the recovery of damages, including exorbitant medical costs, is welcome relief. Reich & Binstock’s personal injury attorneys are proud and fulfilled to help victims receive the justice they deserve.

Apparently, the Canadian mothers took the drug before warnings existed about the heightened risks of Paxil birth defects, such as a rare heart and lung condition known as persistent pulmonary hypertension — risks that the manufacturer should have known and had a duty to provide. Certainly bewildered women of childbearing age, who were taking either Paxil or another SSRI for that matter, wish they had known.

Imagine how they felt when their newborns were diagnosed with serious heart and lung conditions and then they learned that they and their babies were unwitting Paxil casualties. Put yourself upon careful reflection in such a mother’s shoes for a moment, as best you can.

The U.S. Food and Drug Administration in July 2006 updated its prescribing information for Paxil and for other SSRIs, including, Celexa, Fluvoxamine, Lexapro, Prozac, Symbyax and Zoloft. Those medications are in the same boat, and thank goodness there is a judicial process to redress the injuries associated with taking those drugs.

The FDA’s safety alert was based on a study that showed “infants born to mothers who took selective serotonin reuptake inhibitors after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension than infants born to mothers who did not take antidepressants during pregnancy. The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1,000 live births. Neonatal PPHN is associated with significant morbidity and mortality.”

Read full article here:  http://houston.legalexaminer.com/fda-and-prescription-drugs/paxil-class-action-moves-on-in-canada-as-lawsuits-still-filed-in-us.aspx?googleid=306286

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Paxil Class-Action Lawsuit—Lawyer estimates 200 Canadian children born with heart defects due to Mother’s taking Paxil

Thursday, December 6th, 2012

December 5, 2012

 

Click image for warnings/studies on Paxil

VANCOUVER – A British Columbia mother whose daughter was born with a hole in her heart after taking prescribed anti-depressants during pregnancy will lead a class-action lawsuit against a pharmaceutical giant.

A B.C. Supreme Court judge has ruled that representative plaintiff Faith Gibson can proceed with her lawsuit against the maker of Paxil, GlaxoSmithKline Inc., alleging the drug causes birth defects.

“We estimate there are more than 200 children across Canada who were born with cardiovascular defects because their mothers were on Paxil during pregnancy,” said David Klein, one of the lawyers representing Gibson.

“The information from GlaxoSmithKline was totally inadequate with respect to using the drug while pregnant.”

Gibson’s daughter, Meah Bartram, was born just two weeks before the company sent a letter to doctors in September 2005 warning that taking the drug during pregnancy could increase the chances of cardiovascular defects.

Click image for warnings/studies on antidepressants and birth defects

The cautionary letter cited early results of a study that found “ventricular septal defects” were possible in women who had taken Paxil during pregnancy. It suggested doctors heed that information when considering using it to treat pregnant women.

From the time the product was made available in Canada in 1993, it bore a generic product label that noted it should not be used during pregnancy “unless the potential benefit to the patient outweighs the possible risk factors.”

In winter 2006, the company amended the product label to much more thoroughly outline the potential problems that might arise.

“The plaintiffs allege that GSK knew or ought to have known of the risk before then,” says the court ruling released on Dec. 4.

Klein said that prior to the label change, there were reports of birth defects in smaller case studies, as well as in studies on similar products.

“It’s been known for decades,” he argued. “The warnings could have and should have been much stronger.”

Read the rest of the article here

 

 

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Doctors’ warning to women: Don’t take antidepressants during pregnancy

Monday, November 12th, 2012

NaturalNews.com
By Jonathan Benson
November 12, 2012

(NaturalNews) Autism, birth defects, persistent pulmonary hypertension of the newborn (PPHN) — these are among the many serious health conditions newborn babies face whose mothers take selective serotonin reuptake inhibitors (SSRIs) and certain other antidepressant drugs during pregnancy. The side effects of SSRIs are so serious for pregnant women, in fact, that two prominent doctors recently came forward with warnings to pregnant women against taking the drugs, which can cause potentially deadly complications for both unborn babies and their mothers.

Dr. Adam Urato, an obstetrician and Chairman of the Department of Obstetrics and Gynecology at MetroWest Medical Center in Framingham, Massachusetts, and his colleague Dr. Alice Domar, a psychologist and assistant professor at Harvard Medical Center, conducted a systematic review of available literature on antidepressant use during pregnancy, which they published in the journal Human Reproduction. They found that, based on the science, antidepressants provide no benefits for pregnant women, but present a whole lot of potential complications.

Besides their uselessness, antidepressants were found to put unborn babies at serious risk of developing a myriad health conditions, including but not limited to heart defects, anencephaly, cleft lip and palate, PPHN, and respiratory distress. In regards to PPHN, an unborn baby’s risk of developing the condition is six times higher when the mother takes SSRIs compared to babies born to mothers who do not take SSRIs, according to the U.S. National Institutes of Health (NIH).

“Study after study shows increased rates of newborn complications in those babies who were exposed to SSRIs in utero,” said Dr. Urato to the U.K.’s Telegraph about the findings. “The (U.S. Food and Drug Administration) and Health Canada have put out warnings specifically regarding this issue,” he added, referencing a 2005 warning put out by the FDA that said taking SSRIs made with paroxetine, which includes the drug Paxil, during the first trimester of pregnancy could cause birth defects or heart problems.

According to the authors, at least 40 different published studies link SSRI use during pregnancy to premature birth, which in and of itself is linked to a bounty of illnesses and health conditions. And as far as the mother is concerned, taking SSRIs during pregnancy can cause her to develop high blood pressure, liver problems, and stroke, and may even result in a stillbirth.

“Antidepressant use during pregnancy is associated with increased risks of miscarriage, birth defects, preterm birth, newborn behavioral syndrome, (PPHN), and possible longer term neurobehavioral effects,” wrote the authors in their study. “There is no evidence of improved pregnancy outcomes with antidepressant use.”

 

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Two Soldiers Prescribed 54 Drugs: Military Mental Health “Treatment” Becomes Frankenpharmacy

Tuesday, October 30th, 2012

The mental health watchdog Citizens Commission on Human Rights (CCHR) announces the second in a four-part series by award-winning investigative journalist Kelly Patricia O’Meara exploring the epidemic of suicides in the military and the correlation to dramatic increases in psychiatric drug prescriptions to treat the emotional scars of battle. The second installment covers psycho-pharma’s disastrous chemical experimentation within the military ending in sudden unexplained deaths, including those of Marine corporal Andrew White and Senior Airman Anthony Mena who were prescribed a total of  54 drugs between them, including Seroquel, Effexor, Paxil, Prozac, Remeron, Wellbutrin, Xanax, Zoloft, Ativan, Celexa, Cymbalta, Depakote, Haldol, Klonopin, Lexapro, Lithium, Lunesta, Compazine, Desyrel, Trileptal, and Valium.

by Kelly Patricia O’Meara
October 30, 2012

The devastating adverse effects mind-altering psychiatric drugs may be having on the nation’s military troops are best summed up by Mary Shelley’s Dr. Frankenstein, writing “nothing is so painful to the human mind as a great and sudden change.”

Just as the fictional character, Dr. Frankenstein, turned to experiments in the laboratory to create life with fantastically horrific results, the psychiatric community, along with its pharmaceutical sidekicks, has turned to modern day chemical concoctions to alter the human mind.  The result is what many believe is a growing number of equally hideous results culminating in senseless deaths, tormented lives and grief-stricken families.

The nation’s military troops are taking their lives at record numbers and seemingly healthy soldiers are dying from sudden unexplained deaths. That’s a fact. The data are clear, yet, despite growing evidence pointing to the enemy among us, the monstrous psycho-pharmacological experiment continues  (see Part 1: Psychiatric Drugs and War: A Suicide Mission).

To truly understand the madness that has become the military’s mental health services, one only need review a few cases before the horror of these unorthodox and destructive psycho-pharmacological experiments is exposed. Marine corporal Andrew White and Senior Airman Anthony Mena are just two examples of psycho-pharma’s disastrous chemical experimentation.

Marine Corporal Andrew White was prescribed 19 drugs in less than one year

White was a healthy 23-year-old, gung-ho Marine returning from a nine-month tour in Iraq, who, like so many of his brothers in arms, suffered from the seemingly normal stresses of war – insomnia, nightmares and restlessness. The young corporal turned to the military’s mental health system for help. Within a few short months White became unrecognizable to his family.

According to Andrew’s mother, Shirley White, “he couldn’t function.” White, explains, “he was a Zombie… it was like we were caring for an elderly person.”  White’s sudden and shocking decline began shortly after beginning a multi-drug treatment.

Among the first of the VA’s pharmacological concoctions in March of 2007, White was prescribed Seroquel, or “Serokill” as it is being referred of late, a powerful antipsychotic approved by the Food and Drug Administration (FDA) to treat Bi-polar disorder and Schizophrenia, along with the antidepressant, Paxil.  These mind-altering psychiatric drugs made up the first “sudden change” to White’s mind.

The off-label prescription of Seroquel (AstraZeneca) carries with it the following adverse reactions: irregular heartbeat, hallucinations, mood changes, panic attacks, insomnia, restlessness and suicidal thoughts or actions. These are just a few of the more than one hundred possible side effects.

The second part of White’s prescribed pharmacological cocktail was the antidepressant, Paxil, an SSRI approved by the FDA to treat symptoms of PTSD, which also carries its own lengthy list of severe side effects, including restlessness, insomnia and irregular heartbeat—the very symptoms for which White had sought treatment.

Given that Seroquel was not approved to treat White’s symptoms, and it carried with it all the possible severe side effects White actually complained of, one has to wonder why it was chosen as part of the VA’s mind-altering cocktail. The answer may lie in the cozy relationship between top staff at the VA and the pharmaceutical industry.

Matthew J. Friedman, the executive director of the Department of Veterans Affairs National Center for PTSD, and Professor of Psychiatry and Pharmacology at Dartmouth Medical School, was on the payroll of AstraZeneca, the maker of Seroquel.  And, while a consultant to AstraZeneca, Friedman was one of four authors of the American Psychiatric Association’s 2009 Practice Guide for the Treatment of Patients with Acute Stress Disorder and PTSD.[1] Additionally, as a proponent of SSRI medications to treat PTSD, Friedman also sat on the PTSD Scientific Advisory Boards for GlaxoSmithKline and Pfizer—the makers of the antidepressants Paxil and Zoloft.[2]

Despite Dr. Friedman’s belief that cocktails of mind-altering drugs will “help” those suffering from combat related symptoms, White’s symptoms not only persisted but worsened, and VA,  military and civilian psychiatrists returned to their laboratories, ever convinced the next multi-drug elixir would elicit remarkable results.

Apparently the physicians and psychiatrists caring for White worked from some twisted, mad scientist laboratory mentality that if-this-cocktail-of-five-mind-altering-drugs-doesn’t-work-let’s-try-upping-the-dosage-and-adding-drugs-we-haven’t-tried.  One “sudden change” to another.  The problem is the more drugs that were mixed, matched and increased, the worse White’s symptoms became.

And what was the explanation White’s parents were provided when they questioned Andrew’s doctors about his deteriorating health?  “We asked his doctors,” says his mother, “but they just said ‘it takes time (for the pills to work).’”

Click image to view increasing dosages of drugs prescribed to Andrew White.

But time ran out for White when, eleven months after beginning his first cocktail of mind-altering drugs, he died in his sleep from what the medical examiner ruled an “accidental overdose of medication.”  After reviewing White’s list of prescribed mind-altering drugs, some may seriously wonder if “accident” is a grotesquely distorted word for negligent or, perhaps, criminal?  (See complete list of drugs White had been taking here.)

Since taking his first multi-drug cocktail to the date of his death, White had been prescribed no less than nineteen different drugs with many at ever-increasing dosages, including antidepressants, antipsychotics, anti-anxiety, pain killers and antibiotics.  The prescribed drugs Methadone, Oxycodone, Paxil and Seroquel were found in his system at the time of death.

Perhaps more shocking is that White had been prescribed 1600mg of Seroquel—more than double the maximum recommended dose for someone “schizophrenic” or “psychotic.” White was neither of these and, yet, the dosage of Seroquel climbed from 20mg to 1600mg over an eleven month period.

Shirley and Stan White can’t prove it, but they believe it was the cocktail of the high level of Seroquel and another, or several, of the drugs White had been prescribed that caused their son’s death. Given the changes that have occurred in the military and VA’s prescribing, there may be some truth to these suspicions.

In 2009, the FDA expressed worries about Seroquel and, in 2011, the federal agency issued new warnings for the antipsychotic as it “may be associated with sudden cardiac arrest…in some who took high doses of Seroquel.” Additionally the concerns about Seroquel, and the sudden unexplained deaths within the military, have not been ignored by the top brass at the Pentagon.  In March of this year, U.S. Central Command removed Seroquel from the “approved” formulary, but there’s no guarantee that it won’t still be prescribed.

White’s parents believe this is a good first step, but more needs to be done to stop the chemical experimentation on the troops.  “Andrew’s real problems,” says Shirley White, “did not start until after he was medicated.”  Too many other parents mimic Shirley White’s sentiments, including Pat Mena who suddenly lost her son, Anthony, in July of 2009.

Senior Airman Anthony Mena was prescribed 35 drugs over an 18 month period

Twenty-three-year old Anthony (Tony) Mena did two tours in Iraq as part of  Kirtland Air Force Base’s 377th Security Forces Squadron.  Like so many others returning from combat, Mena suffered from insomnia, restlessness and nightmares—and like White, Mena received treatment from military, VA and civilian doctors.

Mena also complained of severe back pain and was routinely told by the military and VA doctors that it was “all in his head.”  As it turned out, it actually was “all in his back” and when Mena was referred for help outside the military establishment,  a very real medical condition was diagnosed by a civilian doctor.

By this time, however, Mena already had become a victim of the military’s mental health mind-altering multi-drug approach to treatment.  Between January of 2008 and his death in July 2009, Mena had been prescribed no less than 35 prescription drugs, including numerous antidepressants, pain killers, tranquilizers and muscle relaxers.

The toxicology report revealed that Mena had nine different prescription medications in his system at the time of his sudden death – Xanax, Ambien, Dilaudid, Fentanyl, Paxil, Remeron, Skelaxin and Desyrel.  Despite the numerous combinations of mind-altering drugs prescribed to Mena, he did not get “better” but, rather, became another psycho-pharma experiment gone deadly wrong.  (See complete list of drugs Andrew had been taking here.)

Click image to view increasing dosages of drugs prescribed to Anthony Mena.

According to Tony’s mother, Pat Mena, “Tony didn’t die from PTSD, he died from the combination—cocktail—of the drugs they gave him. Tony never got better and they tried almost every antidepressant on the market.” “None of the drugs,” explains Mena, “helped my son and that’s what I’d tell his doctors. I’d say ‘you gave him a tranquilizer and I don’t see him calm, you gave him an antidepressant and I don’t see him happy and he’d take pain killers and he still had pain.’”

Like Stan and Shirley White, Tony’s parents repeatedly questioned doctors about the number of drugs their son was taking and were continually assured  that the treatment “takes time.”  But, like White, time ran out for Senior Airman Anthony Mena, and no crazed combination of psycho-pharma’s multi-drug concoctions can turn back the clock.

Andrew White and Anthony Mena have become part of ever-increasing numbers of young, seemingly healthy soldiers who survived the horrors of war only to return home to fight, and lose, their toughest battle.  Their deaths were not suicides. Rather, they are among a growing list of sudden deaths among military personnel, which many believe is due to sudden cardiac arrest brought on by the drug cocktails being prescribed.  Fred Baughman Jr., MD has been researching these questionable deaths and believes the few that are known are just the “tip of the iceberg.”

There have been a number of peer-reviewed papers regarding the  increased risks of sudden cardiac arrest deaths associated with antipsychotics and antidepressants.  Baughman looked into the fatal heart attacks of four soldiers who died in their sleep.  All four soldiers were given Seroquel, Paxil and Klonopin for treatment of PTSD—all in their twenties, no signs of suicide or drug overdose. According to Baughman, “antipsychotics and antidepressants alone or in combination, are known to cause Sudden Cardiac Death [SCD].”

“The drugging in the military doesn’t make any sense,” says Baughman. “When we get information from the families,” explains Baughman, “we’re finding that these guys are on five to fifteen different drugs at any one time.  If these soldiers are dying from these drugs and the military is refusing to cut back on the drugs, this is scandalous.  I think they are just calling these sudden cardiac arrests suicides and I don’t think we’ve begun to see the true numbers.”

Baughman continues to research SCD data and is working with families whose sons and daughters have fallen victim to the multi-drug cocktail experiment.  “The military,” says Baughman, “has to come clean on these deaths.” The families of the fallen also want answers and are working to bring the issue to the forefront.

Both the White and Mena families feel a responsibility to their sons to warn others about their experiences within the military mental health system.  With the hope that the story of Tony’s downward spiral will help others, Pat Mena has written a book titled, You’ll Be Fine, Darling: Struggling With PTSD After Trauma of War.  The Whites are vocal opponents of the excessive drugging and  have lobbied Congress about the dangers of the psychiatric medications being prescribed to the nation’s troops.

One can only admire the courage of these families and hope that with their voices fighting on their behalf, other warriors will be spared the nightmare that is this horrific pharmacological experiment. The military is a powerful family and they take care of their own.

Perhaps it is time for them to sever their ties to the psycho-pharma community, reconsider the benefit of modern day pharmacological experimentation and heed the dire warning to Mary Shelley’s, Dr. Frankenstein… “You have created a monster, and it will destroy you.”

Kelly Patricia O’Meara is an award winning investigative reporter for the Washington Times, Insight Magazine, penning dozens of articles exposing the fraud of psychiatric diagnosis and the dangers of the psychiatric drugs – including her ground-breaking 1999 cover story, Guns & Doses, exposing the link between psychiatric drugs and acts of senseless violence.  She is also the author of the highly acclaimed book, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills that Kill.  Prior to working as an investigative journalist, O’Meara spent sixteen years on Capitol Hill as a congressional staffer to four Members of Congress. She holds a B.S. in Political Science from the University of Maryland.

                                                                                           

[1] David M. Benedek, M.D.; Matthew J. Friedman, M.D., Ph.D.; Douglas Zatzick, M.D.; Robert J. Ursano, M.D., “Guideline Watch (March 2009): Practice Guideline for the Treatment of Patients With Acute Stress Disorder and Posttraumatic Stress Disorder,” APA Practice Guidelines, PsychiatryOnline, http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1682793.

[2] Matthew J. Friedman, MD, PhD, “Pharmacologic Management of Posttraumatic Stress Disorder,” Primary Psychiatry, 2003;10(8):66-68, pp. 71, http://www.primarypsychiatry.com/aspx/article_pf.aspx?articleid=1237.

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Boom in Suicides—Government Addresses Suicides Without Looking at Suicide-Linked Drugs

Wednesday, September 12th, 2012

Counter Punch—September 12, 2012

by Martha Rosenberg

It would be laughable if it weren’t tragic. This week Surgeon General Regina Benjamin introduced a plan to stem the nation’s growing suicide rate without addressing the nation’s growing use of suicide-linked drugs.

Antidepressants like Prozac and Paxil, antipsychotics like Seroquel and Zyprexa and anti-seizure drugs like Lyrica and Neurontin are all linked to suicide in published reports and in FDA warnings. (Almost 5,000 newspaper reports link antidepressants to suicide, homicide and bizarre behavior.) Asthma drugs like Singulair, antismoking drugs like Chantix, acne drugs like Accutane and the still-in-use malaria drug Lariam, are also linked to suicide.

The US’s suicide rate has risen to 38,000 a year, says USA Today, after falling in the 1990s. The rise correlates with the debut of direct-to-consumer drug advertising in the late 1990s, the approval of many drugs with suicide links and more people taking psychoactive drugs for lifestyle problems.

Dr. Benjamin announced that federal grants totaling $55 million will save 20,000 lives in the next five years through suicide hotlines, more mental health workers in the VA, better depression screening and Facebook tracking of suicidal messages. Nowhere, including in the suicide-racked military, does she suggest looking at the overmedication which has gone hand-in-hand with the deaths. And on which the government is spending a lot more than $55 million.

Click image to read summary of all antidepressant warnings by international drug regulatory agencies, published studies and side effects reported to the US FDA’s Medwatch database

Suicide increased more than 150 percent in the Army and more than 50 percent in the Marine Corps between 2001 to 2009, reported Military Times displaying graphs of the suicide and prescription drug increases, in a print edition, that are similar enough to be laid over one another. One in six service members was on a psychoactive drug in 2010 and “many troops are taking more than one kind, mixing several pills in daily ‘cocktails’ for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches–despite minimal clinical research testing such combinations,” said Military Times.

Eighty-nine percent of troops with posttraumatic stress disorder (PTSD) are now given psychoactive drugs and between 2005 and 2009, half of all TRICARE (the military health plan) prescriptions for people between 18 and 34 were for antidepressants. During the same time period, epilepsy drugs like Topamax and Neurontin, increasingly given off-label for mental conditions, increased 56 percent, reports Military Times. In 2008, 578,000 epilepsy pills and 89,000 antipsychotics were prescribed to deploying troops. What?

Nor is the suicide rate going down as troops withdraw from Iraq and Afghanistan. In   July, 2012, there were 38 Army suicides says USA Today and in July of 2011, there were 32. According to the Army’s in-depth Health Promotion, Risk Reduction and Suicide Prevention Report in 2010, 36 percent of the troops who killed themselves had never even deployed.

Click image to read summary of all international drug regulatory warnings, studies and antipsychotic drug side effects reported to the US FDA’s Medwatch database

Why are such drugs, which affect reaction time, motor skills, coordination, attention and memory even allowed during active duty? And why are they prescribed to soldiers who are at the exact age–young adults–that is most at risk for suicide according to warning labels?

Nor are troops the only cash cows for Big Pharma. One in four women are on psychoactive drugs according to published reports and millions of children are on psychoactive drugs, especially poor children and those with disability status.

When the FDA first put suicide warnings on antidepressants for young people in the mid 2000s, Big Pharma linked psychiatrists like Charles Nemeroff argued that suicides would go up if doctors and patients were scared off by the black box warnings. Though the argument was absurd–is the nation fat because fen-phen was withdrawn?–the theory got play in the mainstream and medical press until it was proven wrong.

Yet as the Surgeon General and HHS proved this week, the government is still in denial about suicide and the elephant in the room called Big Pharma. Instead of spending millions on counselors, crisis lines, and “awareness campaigns” why doesn’t it look at the millions it’s spending on suicide-linked drugs?

More information about overmedication of troops and suicide-linked drugs is found in Martha Rosenberg’s recently published Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health.

Martha Rosenberg’s is an investigative health reporter. Her first book,  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, has just been released by Prometheus books.

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Feds Say Dr. Drew Was Paid By Glaxo To Talk Up Antidepressant

Tuesday, July 3rd, 2012

Forbes
By Matthew Herper – July 2, 2012

Dr. Drew Pinsky (Photo credit: Randy Stewart)

Part of the case made by U.S. prosecutors that led to GlaxoSmithKline’s $3 billion settlement today is that the company used a network of paid experts, speaking to doctors and to the press, to promote uses of its drugs that had not been approved by the Food and Drug Administration. According to the Department of Justice’s complaint, one of those paid experts was celebrity physician Dr. Drew Pinsky, then the host of the radio show Loveline, which was also being broadcast on MTV. Pinsky has gone on to host Celebrity Rehab, Dr. Drew on HLN, and Dr. Drew’s Lifechangers on the CW.

The government alleges that Pinsky was paid a total of $275,000 over just two months – March and April 1999 – to deliver messages about Wellbutrin SR, a Glaxo antidepressant, “in settings where it did not appear that Dr. Pinsky was speaking for GSK.”

As an exhibit to the complaint, the prosecutors  include invoices from Cooney Waters, a public relations firm, to GlaxoSmithKline for Pinsky’s services as a spokesperson. They also include a transcript of Pinsky’s appearance on David Essel – Alive!, another national radio program. As part of the $3 billion settlement announced today, Glaxo agreed to pay $727 million in criminal fines for its marketing of Wellbutrin SR and Paxil, another antidepressant.

One difference between Glaxo’s Wellbutrin SR and other antidepressants is that it may not decrease libido and may actually boost sex drive. (The drug’s package insert lists both “decreased libido” and “increased libido” as potential side effects.) Most common antidepressants, like Eli Lilly’s Prozac, Pfizer’s Zoloft, and Glaxo’s own Paxil, all of which are known as selective serotonin reuptake inhibitors (SSRIs), tend decrease sex drive. But Glaxo had no FDA approval for promoting Wellbutrin as having fewer sexual side effects. So it allegedly paid speakers, like Pinksy, who spoke about how, in his clinical practice, he used Wellbutrin SR in patients who suffered low sex drive on other drugs.

According to the transcript, the Essel show began with a clip from a woman who said she had 60 orgasms in a row, “just nonstop.” When asked if this was even possible, Pinsky replied, “Oh yeah. For some women. What I think she was amazed about was it just suddenly started and that kind of thing most typically happens from medication, frankly.” He then segues into saying that that is what he is on the show to talk about. Soon he’s talking about how Wellbutrin (he also mentions the generic name, bupropion) is the medicine he’s had the most experience with in his practice when it comes to avoiding the sexual side effects of antidepressants. “It actually is the one we advocate, one of the things we suggest people do if they’re getting a decrease in their libido or decrease in their arousal which typically occurs in the serotonin re-uptake inhibitor medication.”

 

The section of the government's complaint that details Glaxo's relationship with Dr. Drew. (Click to enlarge)

A note from the PR firm accompanying the transcript says: “During the fifteen-minute segment, Dr. Pinsky communicated key campaign messages.” The spot is almost a textbook for the way drug companies have used speakers to promote medicines. Everything Pinksy says is reasonable – anecdotally, Wellbutrin does seem to have few sexual side effects. But Pinsky’s comments has the effect of giving air time to a use of a medicine that Glaxo was not supposed to promote.

Dr. Drew wasn’t alone. He’s one of a long list of experts listed in the complaint that the government says were paid by Glaxo as part of its promotional efforts. Requests for comment were sent to a manager for Pinsky, a publicist who had represented him, and through his HLN web site, but were not immediately returned.

The documents:

The complaint

A transcript of Dr. Drew’s appearance on a radio show

Invoices to Glaxo from the public relations firm Cooney Waters for paying Dr. Drew’s speaking fees.

Other documents included in the DOJ’s complaint

Read article here:  http://www.forbes.com/sites/matthewherper/2012/07/02/feds-say-dr-drew-was-paid-by-glaxo-to-talk-up-antidepressant/

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GlaxoSmithKline settles healthcare fraud case for $3 billion

Monday, July 2nd, 2012

Reuters
Reporting by David Ingram and Kate Holton – July 2, 2012

(Reuters) – GlaxoSmithKline Plc has agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle the largest case of healthcare fraud in U.S. history.

The settlement includes $1 billion in criminal fines and $2 billion in civil fines in connection with the sale of the drug company’s Paxil, Wellbutrin and Avandia products, according to filings in federal court on Monday.

Deputy U.S. Attorney General James Cole said at a news conference in Washington that the settlement “is unprecedented in both size and scope.”

As part of the settlement, GlaxoSmithKline agreed to strict oversight of its sales force by the U.S. government to prevent the use of kickbacks or other prohibited practices.

GSK said in a statement it would pay the fines through existing cash resources. The company announced a $3 billion charge in November related to legal claims.

Chief Executive Andrew Witty said GSK’s U.S. unit has “fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct.”

http://www.reuters.com/article/2012/07/02/us-glaxo-settlement-idUSBRE8610S720120702

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Canadian judge rules antidepressants like Prozac can cause children to commit murder

Monday, December 19th, 2011

NaturalNews – Dec 19, 2011

By Jonathan Benson

11 recent school shooters were under the influence of psychiatric drugs

The use of antidepressant and psychiatric drugs, particularly among children, is an extremely risky activity that could have fatal consequences for both the individuals that use them, as well as their friends and family. According to the National Post, a Canadian judge recently ruled that the extreme mind-altering effects of the antidepressant drug Prozac were in large part responsible for causing a 15-year-old boy to thrust a nine-inch kitchen knife into one of his closest friends.

Though the Winnipeg boy that committed the heinous crime had allegedly abused prescription drugs and “experimented” with cocaine long prior to the incident, he had never had a violent or aggressive personality about him, according to reports. It was only when he began taking Prozac, the very thing doctors had given him as a so-called “solution” to his previous illicit drug problems, that he began to rapidly go off the deep end.

“He had become irritable, restless, agitated, aggressive and unclear in his thinking,” said Justice Robert Heinrichs of the Manitoba Justice Department, who ruled on the case. “It was while in that state he overreacted in an impulsive, explosive and violent way. Now that his body and mind are free and clear of any effects of Prozac, he is simply not the same youth in behavior or character.”

What the judge appears to be implying here is that Prozac is directly responsible for altering the brain of a user and causing them to think irrationally, which in turn can cause them to harm themselves or others. In other words, if it were not for the use of this mind-warping drug, the murderer in this case most likely would never have dreamed of slaughtering one of his best friends.

Judge Heinrichs ultimately determined that, because of the drug’s involvement, the boy who murdered his friend would not be tried in an adult court. Even though the boy pleaded guilty to second-degree murder, the judge only added a ten-month sentence on top of the two years that the boy had already spent in jail pending the trial — and there will apparently be no appeal, which is a first in any North American court.

In a similar outcome back in 2001, a Wyoming jury ruled that the antidepressant drug Paxil had caused a man to murder his wife, daughter, and granddaughter, after which he killed himself. And one of the mass-murderers in the infamous Columbine High School shooting, Eric Harris, had allegedly been taking the antidepressant drug Luvox at the time that he participated in the tragedy (http://www.naturalnews.com/019342.html).

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With growing public awareness of antidepressant risks: Pro-pill website Web MD does damage control

Monday, October 24th, 2011

OpEdNews – October 24, 2011

by Martha Rosenberg

WebMD, the gigantic, pro-pill web site whose original partner was Eli Lilly, is doing damage control for SSRI antidepressants.

There was a day when it seemed like everyone was on antidepressant “happy pills” like Prozac, Paxil and Zoloft. But then the pendulum began to swing. Patients objected to the weight gain and feelings of not being “themselves,” sexual side effects and the withdrawal symptoms. There were even reports and warnings about suicide and other “neuropsychiatric” effects.

Now, WebMD, the gigantic, pro-pill web site whose original partner was Eli Lilly, is doing damage control for SSRI antidepressants. New articles, sounding like they’re from crib makers or cantaloupe growers, urge patients not to panic or quit taking their pills just because of things they read.

Don’t believe all the hooey about antidepressants turning “you into a zombie,” ruining your sex life or costing too much, says an article called Fears and Facts About Antidepressants on WedMD. And don’t be impatient!   “ If the first antidepressant medication doesn’t help, the second or third often will . Most people eventually find one that works for them.” Ka-ching.   Don’t listen to all that suicide talk either!   “Switching to a different antidepressant may help,” say the damage control articles.

Is your fear of becoming a drug lifer keeping you from antidepressants, asks another WebMD article called What’s Stopping You from Seeing a Doctor About Depression? “If you do need a medication, it most likely won’t be for life,” says the article. Just until the patent runs out?

Do you think you can ignore your depression and it will go away?   “Waiting for depression to simply pass can be harmful,” because “depression that goes untreated may become more severe,” say the WebMD articles–rewriting medical practice itself since depression has never been a progressive disease but is actually self limiting.

The important thing, say the articles, is to never stop your meds. “Stopping medication abruptly may.. cause depression to return,” and can cause side effects, say the articles. Worse–”prescription abandonment”–people who discover what a drug costs and leave it at the pharmacy or quit drugs because of their effects– costs Pharma lots of money! Pharma even has programs now that send Big Brother nurses to people’s homes, through their pharmacies, to make sure people are taking their meds.

 One antidepressant with a big PR problem is Eli Lilly’s Cymbalta. It’s linked to the deaths of   Traci Johnson, a healthy 19-year-old who hung herself on the Lilly campus during clinical trials in 2004, and Carol Anne Gotbaum, daughter-in-law of former New York City Public Advocate Betsy Gotbaum who died in police custody at Phoenix’s Sky Harbor airport in 2007.

Cymbalta is noted in the scientific literature for producing suicidal side effects in people with no mental health history. A 37-year-old man described in the Journal of Clinical Psychopharmacology with a stable marriage and employment and no history of mental problems tried to kill himself with carbon monoxide two months after taking Cymbalta for back pain. A 63-year-old man, also with no mental health history, became suicidal on the drug after two weeks.

“There is an emergence of suicidality in apparently nonsuicidal patients after starting or increasing Duloxetine [Cymbalta] reads an article in Clinical Practice and Epidemiology in Mental Health.”

But now, Cymbalta is being promoted as a pain drug of choice like it’s not a repurposed antidepressant with antidepressant side effects. Last year it was approved for chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, and it was already approved for fibromyalgia and diabetic nerve pain.

A Cymbalta ad in October’s New England Journal of Medicine , says “Today a non-NSAID [non- aspirin or ibuprofen] non-narcotic, once daily analgesic FDA approved for 3 indications across 4 different chronic pain conditions can be found in 1 med.” Sounds as safe Vioxx.

http://www.opednews.com/articles/Should-You-Take-A-Psychiat-by-Martha-Rosenberg-111023-164.html

Martha Rosenberg’s first book , Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, will be published by Prometheus Books in 2012.

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PEOPLE’S PHARMACY:Can drugs cause violent behavior?

Thursday, July 21st, 2011

Tuscaloosa News – July 21, 2011

PEOPLE’S PHARMACY

Americans revere personal responsibility. It resonates with our respect for accountability and frontier justice. That may explain why we have a hard time believing that medications could alter people’s personalities or lead them to behave badly.

Violence as a drug side effect seems preposterous to patients, pharmacists, physicians and even juries. Trying to use the “Prozac defense” to justify killing or hurting someone is often met with scorn.

Although drug-induced hostility or aggression has not been well-studied, a surprising number of medications come with precautions about violent acts.

Antidepressant prescribing information, for example, warns physicians that, “All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior.” Drugs such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil) and sertraline (Zoloft) carry warnings about aggressiveness, agitation, hostility, impulsivity and irritability.

The stop-smoking medication varenicline (Chantix) also comes with warnings about agitation, hostility, depressed mood and changes in behavior. The trouble with such warnings is that people don’t imagine that these bad things could happen to them. But many readers have shared scary stories about Chantix and violence. Here is one:

“I started taking Chantix early in January 2011 because I promised my son I’d quit. After about two weeks on the drug, my husband and I got into a disagreement, and I ended up giving him a black eye and busting out his tooth. Rage and panic attacks were occurring every day, so I quit taking Chantix.

“I figured it was just the stress of having to live with my in-laws, so I stayed off it until I left my husband and got my own place with my son. I’ve now been taking Chantix for about two weeks, and I’m having emotional outbursts and extreme rage again. I have no stress in my life right now, so it can’t be anything else but the drug.

“I’ve researched this, and apparently Chantix is at the top of a list of drugs that cause violent behavior. Chantix worked very well for a friend of mine to help her stop smoking, but now I wonder if it contributed to her breakup with her fiance.”

Other readers have shared stories of people who had no history of aggressiveness, violence or mental-health problems going berserk while taking Chantix. One man beat his wife and called police but had no recollection of the incident.

A recent article in the European Journal of Clinical Pharmacology (online, June 7, 2011) “confirms the risk of violence associated with benzodiazepines and related drugs (zopiclone and zolpidem). … Physical aggressiveness, rapes, impulsive decision making and violence have been reported, as have autoaggressiveness and suicide.”

Benzodiazepines are anti-anxiety agents such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium) and lorazepam (Ativan). Eszopiclone and zolpidem are popular prescription sleep aids. Americans need to know how prescribed drugs might affect their behavior. Only then can they take responsibility for their actions.

http://www.tuscaloosanews.com/article/20110721/NEWS/110719697/1005/sitemaps04?p=2&tc=pg

(Note from CCHR:  Our psychiatric drug database, comprised of international drug regulatory agency warnings and clinical studies,  contains 19 warnings of psychiatric drugs causing violence, aggression and hostility -  type in aggression in the red search box – or suicide which has 66 warnings)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php )

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