Posts Tagged ‘Antidepressant’

Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

Tuesday, November 9th, 2010

Note from CCHR: Also see attorney Karen Barth Menzies interview on Paxil withdrawal effects and documents withheld from the public http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/3/Mpex0n0DXuc

Bloomberg News

by Jeff Feeley, November 9, 2010

GlaxoSmithKline Plc,  the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo officials had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about those deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements in the trial. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth- defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects his mother blamed on the drug.

$11.7 Billion in Sales

Glaxo officials contend Paxil played no role in Anna’s heart defects. They were most likely caused by genetics or the fact that her mother became pregnant late in life, Chilton Varner, a lawyer for the drugmaker, told jurors in her opening statement.

The deaths of Paxil animal test subjects had nothing “to do with Anna Blyth’s heart defects,” Varner said.

Approved in 1992 for U.S. use, Paxil generated about $793 million in sales in 2009, or about 1.8 percent of Glaxo’s total revenue. The company had $11.7 billion in U.S. Paxil sales over nine years starting in 1997, according to documents made public last year in a Pennsylvania trial over birth-defect claims.

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. The drugmaker said in May it plans to double revenue from India and China by 2015 as it cuts prices to match competitors in emerging markets.

The company has paid out more than $2 billion to resolve a wave of litigation over Paxil, including claims the anti- depressant caused suicides in some users and withdrawal symptoms. In July, Glaxo set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

Second Wave

After announcing its settlement of Paxil suits this summer, the company faced a second wave of suits over the drugs, said Carl Tobias, a University of Richmond law professor who teaches classes about mass-tort cases. That’s not unusual once a big- dollar settlement is on the table, he said.

“You’ll have plaintiffs lawyers who hope to get in on a settlement by going out and finding some new cases,” Tobias said. “Glaxo probably feels it had to litigate this case to send a signal that it’s not going to settle every one of these birth-defect cases, especially if they are weak.”

Sarah Alspach, a Glaxo spokeswoman, didn’t immediately return a call for comment on how many Paxil birth-defect cases remain outstanding.

In Anna’s case, the Summerville, South Carolina, resident had to undergo two rounds of open-heart surgery within nine months of her birth, Baden told jurors.

Her mother, Marsha Blyth, had taken Paxil for a short time during her pregnancy to deal with depression, Baden noted.

Glaxo’s Paxil warning label didn’t make it clear that offspring from animals on which the drug had been tested died, she said.

Read the rest of the article here: http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

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Former GSK lawyer indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug

Tuesday, November 9th, 2010

WZCO.Com, November 9, 2010

Ex-Glaxo lawyer indicted for role in U.S. drug probe

WASHINGTON (Reuters) – A former lawyer for pharmaceutical giant GlaxoSmithKline Plc has been indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug, the U.S. Justice Department said on Tuesday.

The lawyer, Lauren Stevens, was indicted on four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents related to Glaxo’s promotion of the drug for weight loss, which had not been approved by the Food and Drug Administration.

“Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations,” said Tony West, head of the Justice Department’s civil division.

The Justice Department did not name the drug or Glaxo, but the company confirmed she had worked in its legal department but retired. A legal directory described Stevens as a Glaxo vice president and associate general counsel.

A lawyer for Stevens was not immediately available for a comment.

The case emerged after the FDA sought information from Glaxo in 2002 about its promotion of the drug.

A Glaxo spokeswoman declined to comment about any FDA probe of marketing of its drug for an unapproved use.

Such charges against corporate executives in these kinds of instances are rare. Justice Department officials could not immediately recall a similar case in recent years.

Stevens knew the company had sponsored programs to promote the drug for unapproved uses, including payments to doctors to give hundreds of talks to other doctors, according to the indictment.

The indictment also accused Stevens of withholding slides that were used by doctors who were paid by Glaxo to promote the drug and that she prepared a memorandum about the benefits and risks of providing the information to the FDA.

The obstruction charges carries a maximum sentence of 20 years in prison, while each false statements charge has a maximum sentence of five years in prison.

(Reporting by Jeremy Pelofsky; editing by Andre Grenon)

http://wkzo.com/news/articles/2010/nov/09/ex-glaxo-lawyer-indicted-for-role-in-us-drug-probe/

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Antidepressant Found ‘Ineffective and Potentially Harmful’

Monday, November 1st, 2010

The Epoch Times, November 1, 2010

by Dr. John Briffa

CLOSET SKELETONS: Of all the drug trials that have been done, how many more skeletons in the closet are there? (Photos.com)

If we wanted to find out if a drug or another treatment were any good, we would have to conduct some randomized controlled trials. This means individuals are randomly assigned to the drug being tested, a placebo, or another drug.

Neither the researchers nor the study participants know what’s being taken. Symptoms or other markers of health are monitored as well as side effects. After a period of time, the code is cracked, and we can learn who was taking what.

Now we can know if the drug being tested was more effective at helping people than the placebo and how safe it is. A few studies showing favorable results will usually get a drug passed as “fit for purpose.” This is how drugs end up getting licenses so that doctors can prescribe them to their patients.

Not so fast. While some (often the manufacturers) claim that there is a lot of research supporting a drug, it can sometimes be the case that the published research does not tell the full story.

Sometimes there exists other research that is not so supportive of the drug being tested—research that may not have seen the light of day. Drug companies want to publish supportive studies and shelve more-negative findings. There is an expression for this practice—publication bias.

Publication bias has gone on for decades but only relatively recently have some members of the scientific community taken steps to stamp it out. One huge step forward has been a decision in the United States for trials to be registered on a central database before or during a trial. That way the study has been logged, and if the results mysteriously fail to appear, then questions can be asked.

Not so long ago, trial results had to be forced out of the drug companies making the cholesterol-reducing agents simvastatin and ezetimibe. It took two years for the manufacturers to cough up their data after the conclusion of the study. Once the data came out, we learned why: This drug combo didn’t work to reduce signs of cardiovascular disease.

Subsequent studies have also proved negative. Not that long ago, such data would have been easily hidden, even from prying eyes. These days, drug companies don’t have things so easy.

Things are better now than they were. Now a natural question to ask is how many drugs earned their stripes based on publication bias? Some principled researchers are keen to answer this question by reassessing drugs using not only published data but also unpublished data.

An example of such a piece of work appeared online on Oct. 12 in the British Medical Journal. German researchers decided to assess unpublished and published data on the anti-depressant reboxetine, a relatively new type of antidepressant.

Reboxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI). This means it helps maintain brain levels of the chemical norepinephrine, which is believed to enhance mood. It is similar to the more commonly prescribed anti-depressants known as the selective serotonin reuptake inhibitors or SSRIs.

Previously published evidence showed that reboxetine was more effective in treating depression than placebo and was about as effective as the commonly prescribed SSRIs. It’s been licensed for use for depression in many European countries, including the U.K. and Germany, since 1997.

The researchers found that almost three-quarters of data on reboxetine was unpublished. This is disquieting in itself. And when they put this data into the mix, an altogether different picture emerged. When the totality of the evidence was assessed, it turns out that reboxetine was no better than placebo. Most researchers would summarize this by concluding that it doesn’t work.

Perhaps not surprisingly, reboxetine turns out to cause more harm than placebo and more adverse effects than the most-commonly prescribed SSRI (fluoxetine). The authors conclude that reboxetine is “an ineffective and potentially harmful antidepressant.” Yet here in Europe, it’s been licensed for more than a decade.

The authors of this re-analysis mention that here in the U.K., the National Institute of Health and Clinical Excellence (NICE) describes reboxetine as “superior to placebo and as effective as other antidepressants in the treatment of depression.” As the authors point out, “This conclusion can no longer be upheld.”

It is interesting to note that in the United States, reboxetine was originally licensed, but then its license was revoked. While it appears the U.S. authorities made the right decision, the discrepancy with some European countries suggest that the U.S. authorities had more data to go on or perhaps set different licensing criteria.

Such discrepancies and this flagrant example of publication bias do not instill confidence.

The good news is that at least some researchers are not content to do what paymasters in industry tell them to and genuinely appear to be seekers of the truth. I’d say we could expect many more skeletons to emerge from the closet over the coming years.

http://www.theepochtimes.com/n2/content/view/45212/

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Prescription for prestige—Drug firms’ speaking fees flow to Harvard doctors; concerns about influence prompt new restrictions

Tuesday, October 19th, 2010

The  Boston Globe,  October 19, 2010

Liz Kowalczyk

The Harvard brand, unrivaled in education, is also prized by the pharmaceutical industry as a powerful tool in promoting drugs. Its allure is evident in a new analysis of all publicly reported industry payments to physicians.

Doctors and researchers affiliated with Harvard Medical School collected 45 percent of the $6.3 million given to Massachusetts doctors in 2009 and 2010 by seven pharmaceutical companies that disclosed their payments for parts of those years. The money was mostly for talking to other physicians about the companies’ drugs and the diseases they treat, but also for consulting on research and marketing.

“Companies value the cachet that comes with the name of a prestigious institution,’’ said Dr. Paul Appelbaum, director of the Division of Law, Ethics and Psychiatry at Columbia University College of Physicians and Surgeons. “Even though the institutions themselves are not in any way endorsing the presentations, the aura carries over.’’

The proportion of money going to Harvard doctors underscores why the medical school and its affiliated hospitals, concerned that certain speaking fees can compromise the independence of doctors, are clamping down on such payments.

It is not clear yet whether these restrictions are slowing payments to Harvard doctors, because the data reported publicly are incomplete. But one company, Eli Lilly, gave 50 percent of its payments in 2009 to Harvard doctors and just 33 percent during the first three months of this year.

Many hospitals and medical schools continue to permit doctors to participate in company speakers bureaus, and even at medical centers that largely ban the practice, the analysis — by ProPublica, a nonprofit, online investigative reporting organization, and the Globe — found spotty enforcement.

Consulting with industry to develop new treatments is considered part of an academic physician’s role. But participating in speakers bureaus, while legal, is controversial. Bureau speakers typically show groups of doctors company-created or approved slide presentations about specific drugs or diseases treated by a company’s products. Many of these talks, often held at fancy restaurants, have been moved out of state, doctors said, since last year, when Massachusetts banned doctors from eating the free dinners.

Pharmaceutical companies defend speakers bureaus as an important tool for educating doctors and say industry naturally relies on physicians from top academic medical centers because their peers look up to them.

While some doctors who gave speeches once or twice during 2009 and 2010 earned $2,000 to $3,000, more than two dozen Massachusetts psychiatrists, endocrinologists, and other specialists who gave frequent talks brought in $40,000 to $100,000 and, in a few cases, more. Dr. Lawrence DuBuske, an allergy specialist, earned the most: $219,775. The Globe reported earlier this year that he resigned from Brigham and Women’s Hospital largely because of its new speaking ban.

Partners HealthCare, which includes the Brigham and Massachusetts General and McLean hospitals, halted their doctors’ promotional speaking appearances in January because of concern that they could be perceived as company salespeople and were helping to drive up use of expensive drugs.

Dr. Brent Forester, a geriatric psychiatrist at McLean, was one of the Massachusetts physicians paid the most last year, when he made $73,100 for giving nearly 40 talks for Eli Lilly to colleagues about the antipsychotic Zyprexa and the antidepressant Cymbalta over dinners in restaurants and in doctors offices. He has resigned from speakers bureaus to comply with the new rules, but said he “never felt like a spokesperson for the company at all.’’

“It was an opportunity to educate primary-care doctors about the treatment of psychiatric conditions,’’ Forester said.

Christopher Clark, who oversees compliance for Partners, said his staff searched drug company websites and identified 31 of its physicians who had been hired for speakers bureaus. All but two agreed to resign from the bureaus.

Harvard Medical School itself is also prohibiting participation in speakers bureaus, effective early next year. Consulting payments will still be allowed, with certain restrictions, but will have to be disclosed to Harvard, which has been under pressure from Senator Charles Grassley of Iowa to better monitor its faculty’s relationships with industry.

“We must ensure the integrity and objectivity of all our activities,’’ said Gretchen Brodnicki, the medical school’s dean for faculty research and integrity, who added that the Harvard faculty is huge, about 24 percent of the state’s doctors.

The data on physician payments was compiled from the websites of Eli Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Merck & Co., Cephalon, and the Johnson & Johnson companies by ProPublica and analyzed for Massachusetts by the Globe.

Companies reported paying about 470 Massachusetts doctors, about 200 of them Harvard faculty, a small percentage of the physicians statewide and of those affiliated with the university.

Most drug companies, however, have not publicly reported payments. The ones that have posted the information report different types of payments for different time periods, so it is not possible to draw definitive conclusions about how many doctors received payments and how much individual doctors earned.

Read the rest of this article here:  http://www.boston.com/news/health/articles/2010/10/19/mass_doctors_earn_drug_firms_dollars/?page=full

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Author of ‘Sex, Lies and Pharmaceuticals’ Criticizes ‘Hypoactive Sexual Desire Disorder’

Wednesday, October 13th, 2010

Wall Street Journal

by Alicia Mundy
October 13, 2010
Is female sexual dysfunction a medical condition?

Drug companies have sure been trying to make you think so, says researcher and journalist Ray Moynihan in his new book, “Sex, Lies and Pharmaceuticals.” So far, though, their efforts to get anything approved by the FDA to treat hypoactive sexual desire disorder, to use industry lingo, have been for naught.

Most recently, Boehringer Ingelheim stopped the development of flibanserin, which was intended to boost sex drive in women and was originally studied as an antidepressant. An FDA advisory panel rejected the drug in June after the formal FDA review criticized data on the drug’s ability to increase libido. The German pharma company said the decision to cease development was “not made lightly,” and that it continues to believe in the benefits the drug “would have for women suffering with HSDD.”

“It’s quite significant that [Boehringer] abandoned that after so much hype,” Moynihan tells the Health Blog.

He and his co-author Barbara Mintzes argue in their book that HSDD is largely a creation of the pharma industry. They write that 1990s research claiming that about 43% of women suffer from the disorder sprang from a questionnaire that grouped all sexual desire issues together, without regard to severity, frequency or whether the source was emotional or physical.

Moynihan lambastes drug-industry-financed patient advocacy groups, medical associations and “key opinion leaders” for a global marketing strategy aimed at convincing doctors and regulators that female sexual dysfunction was a medical condition in need of a pharmaceutical treatment.

Read the rest of the article here: http://blogs.wsj.com/health/2010/10/13/author-of-sex-lies-and-pharmaceuticals-criticizes-hypoactive-sexual-desire-disorder/

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I lost ten years of my life as a middle class, NHS sponsored drug addict…

Monday, October 11th, 2010

( NHS—National Health Services)

The Daily Mail, UK

By Philip Robinson
October 12,  2010

Philip Robinson was 25 when he went to his GP with mild depression. The pills he was prescribed changed his life, turning him into a ‘zombie-like’ addict — just one of the 1.5 ­million Britons whose lives have been ruined by prescription drugs. Here, with extraordinary candour, he reveals how he battled to get his life back.

The problem began when I got married. ­Uncertain about the commitment I had just made and torn between wanting to leave my wife and not wanting to hurt her, I started to drink.

I wasn’t desperately depressed, nor was I drinking myself to oblivion. In fact, compared with my fellow journalists on the lads’ magazine Loaded, where I worked at the time, my drinking wasn’t a problem; I was just going through a low point.

It was 1998. I was 25 years old, and had been married for just a year when I went for the doctor’s appointment that would drive me to the edge of insanity and rob me of the next ten years of my life.

Back from the brink: Philip with wife Anna and their children

Back from the brink: Philip with wife Anna and their children. He became hooked on tranquillisers prescribed to beat mild depression

I was told, in the nicest ­possible way, that I was a depressed ­alcoholic. I was so shocked I gave up drinking immediately. I have not touched a drop since.

Then the doctor prescribed 90 Valium pills and a bottle of beta blockers to help with stress, and recommended I visit a psychiatrist in Harley Street.

I can still remember looking at the bottle in disbelief. I’d seen people thrown out of nightclubs for possessing two of these pills. The doctor had just given me 90!

What I didn’t realise at the time was that antidepressants and tranquillisers create long-term users. Thanks to the pills that my doctor had just handed over like Smarties, I was already on the road to what is known as ‘involuntary tranquilliser addiction’.

Put simply, this is where people seeking short-term help for ­anxiety end up hooked on ­powerful mood-altering drugs, sometimes for life. I had just been turned into a middle-class, NHS-­sponsored junkie, one of the 1.5 million Britons addicted to prescribed medication.

It comes at a price for the NHS, too: the health service spends £3 billion a year on tranquillisers and antidepressants alone.

Even back then I was shocked to be given so many drugs by the NHS. I remember one colleague noting the number of pills I was packing away in the course of day and telling me to take half. But, as far as I was ­concerned, I’d obtained these drugs from the doctor, and ­doctor knows best.

In Harley Street I was given my first supply of anti-­depressants and told that I was simply ­suffering from anxiety and depression.

After a few months I was no better. In fact, I was miserable, and seemed to be experiencing new nervous symptoms. In hindsight I was probably suffering side-effects from the drugs.

‘My wife became accustomed to my ever-changing personality, which altered according to whichever pills were being tried out on me by my ­psychiatrist’

Over the next few years, Anna, my wife, became accustomed to my ever-changing personality, which altered according to whichever pills and dosages were being tried out on me by my ­psychiatrist in Harley Street.

Despite the side-effects, Anna and I both trusted the doctors and I tested a host of antidepressants and mood-altering pills, trying to find the right combination that would cure my depression and give me back my life.

I remember these pills mostly for their side-effects. In one instance, I was offered a choice of two pills: one would make me fat, the other would give me a sexual dysfunction. I chose the weight gain.

Another course of pills made me vomit violently if I took them on an empty stomach.

Feeling increasingly depressed, dislocated, and paranoid, I was starting to lose sight of who I was. I began to display the symptoms of someone who was genuinely mentally ill and I took to ­sleeping all day, unable to get out of bed.

I left full-time work to recover at home and retreated from all but two or three of my friends. Anna loyally stood by me, even though I was growing more angry, depressed and unstable.

I had also become hooked on Valium. If I ran out of pills and the doctors’ surgery was closed, I would go to the hospital for an emergency prescription or face cold turkey.

Unlike illegal drugs, pres­cription drugs are incredibly convenient. You can unscrew the lid while walking for the bus, take a couple of neatly pressed, official-looking pills — medicine — and slip into a metaphorical side room. Tranquilliser users watch life though a chink in a pharmaceutical ­curtain, unable to participate in their own existence.

Philip in the grip of addiction when son Oscar was aged one: He struggled to cope with the pressures of marriage and fatherhood but his prescribed medication was more curse than cure

Philip in the grip of addiction when son Oscar was aged one: He struggled to cope with the pressures of marriage and fatherhood but his prescribed medication was more curse than cure

Five years after my first ­prescription, it seemed there wasn’t an antidepressant in the world that worked on my brain, yet my Harley Street doctor seemed determined that there was a pharmaceutical answer to my problem.

I was depressed, but Anna and I did have some moments of ­happiness and normality. We had moved into a new house and Anna was pregnant with our first child. I felt that this was my side of the arrangement, my duty, and that I owed her a child.

I loved her, but I was pretending to be a normal dutiful caring husband when, in reality, I was little more than a waxwork.

My state worsened when I was put on a powerful (and expensive) anti-epileptic drug called Depakote. Depakote is so toxic that it requires a blood test to be taken first.

I am not epileptic, but the pill is commonly given to severely ill ­people who are bipolar. As far as I knew, I had not been diagnosed with either illness.

‘I’d gone to my doctor initially to seek help because I was a young man, overwhelmed by the responsibility of marriage. At what point did I acquire severe mental health issues?’

I got my blood tests done and took Depakote alongside Effexor (an antidepressant), Valium (a tranquilliser) and Zopiclone (a sleeping pill). All I required was a pair of baggy trousers and green face paint and I could have ­doubled up as a zombie.

I found myself unable to laugh, or smile, or cry. I was taking more and more Valium to cope with mood swings related to ­taking ­Valium. I was by now taking double or triple my original ­prescribed dose.

An additional problem was that heavy doses of tranquillisers slow your breathing and suppress your gag reflex.

One night, after approximately 70mgs and some sleeping pills, I woke up aware that I was about to swallow my tongue, which had lolled back into my throat, almost creating an airtight seal. Fortunately, I had enough air in my lungs to cough it out. I remember not feeling concerned at the time.

As the Depakote established itself in my brain, I became cold and detached. I had ‘decided’ to live nocturnally, as this was optimum for my writing. I wanted peace and quiet. I avoided my young family, content with silence and the sound of blood pulsing in my ears.

After a few months of this weird, living death I was incapable of understanding or empathising with other peoples’ emotions. None of it seemed relevant.

The tipping point came when I visited my GP to speak about my continuing prescriptions. She clicked through my records on her screen and casually noted that I should continue my medication because I was listed as being on my local council’s Severe Mental Health Register.

Severe Mental Health Register? I left the appointment consumed by a sense of tragedy.

I’d gone to my doctor initially to seek help because I was a young man, overwhelmed and confused by the responsibility of marriage. At what point did I acquire severe mental health issues?

When did I become a threat to myself and others? I’m a threat to an open packet of chocolate biscuits, but not much else. I had found rock bottom.

Deep down, I knew that I couldn’t be bipolar and I had not been diagnosed as such. I was a happy child from a lovely family. My upbringing was so great that when I described it to psychologists, they seemed to be convinced I was making it up to conceal my inner torment.

I realised the only way to find out who I really was would be to get my brain chemistry back to how it was when I could last remember feeling normal. Back to before I ever saw a doctor or even had a drink.

I needed to be a kid again. I went back to see the doctor a ­couple of weeks later and told her that I had made the decision to come off the pills.

She wasn’t so sure and warned that my mental health might well collapse if I stopped taking the drugs and that there was a risk of hospitalisation. I wasn’t offered any help or advice.

Despite this prophecy of doom hanging over me, I found dropping the ­bipolar pills to be a slow, but relatively easy process. About a month after I stopped taking them, the world seemed brighter and I started to write again and feel alive.

I filled up notepads with ideas, and Anna noticed that I was more engaged with life, she could see my old self coming back.

A couple of months later, only ­Valium remained. I had now been on these mood-altering tranquillisers for ten years and lowering the dose was an agonising battle. Each milligram I took out of my bloodstream was paid for by huge ebbs and flows in my sanity levels.

Over the next two years, I threw myself into bout after bout of ­Valium withdrawal, lowering the dose each time and enduring what felt like a three month-long Mad Hatter’s tea party in my head.

Read the rest of this article here: http://www.dailymail.co.uk/health/article-1319716/I-lost-years-life-middle-class-NHS-sponsored-drug-addict-.html?ito=feeds-newsxml

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Doctor: Paxil “Especially Notorious” for Causing Withdrawal

Monday, October 11th, 2010

Note from CCHR: To see the 42 international warnings/studies on Paxil visit our psychiatric drug side effects search engine http://www.cchrint.org/psychdrugdangers/drug_warnings.php or watch this video on Paxil causing addiction/withdrawal featuring attorney Karen Barth Menzies http://www.youtube.com/watch?v=Mpex0n0DXuc

Lawyers and Settlements

October 9, 2010

Atlanta, GA: There are a number of Paxil side effects associated with the antidepressant, and some patients continue to experience these effects even after discontinuing use of the drug.

Doctor: Paxil "Especially Notorious" for Causing WithdrawalDr. Charles Raison, an associate professor at Emory University, wrote in response to a reader’s question on CNN that about 20 percent of patients experience withdrawal symptoms when they stop taking antidepressants.

Raison says that the common symptoms of antidepressant withdrawal include dizziness, anxiety, sensory disturbances and flu-like symptoms.

According to Raison, coming off the medication slowly is important.

“The trick to lowering your chances of having these symptoms is to reduce the dose of the antidepressant as slowly as possible,” he writes. “For people who are really sensitive it can take months to get off an antidepressant slowly enough to avoid withdrawal symptoms.”

Raison also said that Paxil is “especially notorious for causing withdrawal problems” because of its short half-life in the body.

Paxil is also associated with a number of side effects for those currently taking the medication, including birth defects and depression.

Read the rest of the article here http://www.lawyersandsettlements.com/articles/15134/paxil-birth-defects-side-effects-pph-7.html

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Hundreds of U.S. Pilots Treated for Drug Abuse and Psychiatric Disorders, Review Finds

Wednesday, September 15th, 2010

Note From CCHR: If the fact that commercial airline pilots are now allowed to fly while under the influence on antidepressants and antipsychotic drugs doesn’t send off any alarm bells, then perhaps you should take two minutes and try this— go to this link http://www.cchrint.org/psychdrugdangers/drug_warnings.php and in the Search box (with the red text) simply type in the word suicide and scroll down the page to quickly look over the results.   Then search  aggression,  hallucinations, violence and psychosis.   By reversing their previous ruling and now allowing commercial airline pilots to fly under the influence of these drugs, the FAA is playing a game of Russian Roulette with all of us.

FoxNews.com

Published September 15, 2010

By Jessica Heslam

Boston Herald

Hundreds of commercial and private U.S. pilots have been diagnosed and treated for a broad array of serious psychiatric and medical conditions, including schizophrenia, attempted suicide, sexual deviance, alcoholism and drug abuse, a Herald review has found.

The review comes in the wake of a chilling episode at Logan International Airport four months ago involving a distraught JetBlue [JBLU] pilot who threatened to “harm himself in spectacular fashion” an hour before takeoff – an incident that sent shudders through airline passengers across the country.

Medical record data from 2008, 2009 and 2010 provided by the Federal Aviation Administration under a public records request show:

– 15 pilots – including one from Massachusetts – have been treated for or diagnosed with schizophrenia.

– Another 292 pilots have attempted suicide, including five Bay Staters.

– 2,700 pilots have been treated for alcohol abuse, including 34 from Massachusetts, and another 1,253 have been diagnosed as alcoholics – including 20 Bay Staters.

– 1,377 pilots have been treated for drug abuse – 23 from Massachusetts – and another 94 for drug dependence.

Read the rest of this article here:  http://www.foxnews.com/us/2010/09/15/hundreds-pilots-treated-drug-abuse-psychiatric-disorders-review-finds/?test=latestnews

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Forest Labs will pay $313 mil to settle criminal &civil charges that it improperly marketed antidepressants for use in children & distributed unapproved thyroid drug

Wednesday, September 15th, 2010

The Wall Street Journal by Brent Kendall

WASHINGTON (Dow Jones)–Forest Laboratories Inc. (FRX) will pay $313 million to settle criminal and civil charges that it improperly marketed antidepressants for use in children and distributed an unapproved thyroid drug, the Justice Department announced Wednesday.

The New York-based drug maker had previously announced a settlement in principle with the department, and said in July that the full cost of the pact would be covered by a reserve it had created.

The department said a Forest Labs subsidiary, Forest Pharmaceuticals Inc., would plead guilty to a felony charge of obstruction of justice, and misdemeanor charges related to the distribution of the thyroid drug Levothroid, which at the time was an unapproved new drug, and the illegal promotion of the antidepressant Celexa for use in treating children and adolescents.

The settlement also covers civil charges that Forest improperly promoted Celexa and another antidepressant, Lexapro, for pediatric use, which had not been approved by the Food and Drug Administration. Forest’s improper promotion campaign took place from 1998 until at least 2005, the department alleged.

It alleged that Forest misled doctors and consumers by failing to disclose a European medical study that determined Celexa was ineffective for pediatric use.

The civil case included other allegations that Forest paid kickbacks to encourage doctors to prescribe the antidepressants.

The Food and Drug Administration approved Lexapro last year for use in adolescents 12-17 years of age. That approval came after the time period covered by the legal case.

On the Levothroid charges, prosecutors said Forest Pharmaceuticals began distributing the thyroid drug in the early 1990s without first obtaining FDA approval. They said the subsidiary made a deliberate decision to continue distributing the unapproved drug in quantities far beyond what the FDA allowed during a phase-down period.

Prosecutors also said the company submitted inaccurate information to the FDA in its new drug application for Levothroid and obstructed an FDA regulatory inspection.

“Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the FDA and the American public,” Carmen Ortiz, the U.S. Attorney for Massachusetts, said in a statement.

Forest Chief Executive Howard Solomon said in a statement that the company was pleased to bring closure to the long-running investigation.

“We remain dedicated to ensuring that we operate in full compliance with all laws and regulations, and that our employees uphold the highest principles of integrity, honesty and ethics,” Solomon said.

While the Forest Pharmaceuticals subsidiary pleaded guilty to the criminal charges, Forest Labs said it denies the allegations being made in connection to the civil case.

As part of the settlement, Forest will pay a $150 million criminal fine and forfeit another $14 million in assets.

The company will pay roughly $149 million to settle the civil case.

It also entered into a five-year corporate integrity agreement that requires the drug maker to implement a compliance program and post information on its website about payments to doctors, such as honoraria, travel or lodging.

Lexapro is the company’s main money maker, with sales of $2.3 billion in fiscal year 2010.

Read the rest of the article here:  http://online.wsj.com/article/BT-CO-20100915-713619.html

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MomLogic.com “Babies on Antipsychotics?…Why would anyone put a BABY on antipsychotic meds?!”

Thursday, September 9th, 2010

MomLogic.com
By Vivian Manning Schaffel
September 9, 2010

Last week, the New York Times ran a sad yet compelling story about a boy named Kyle, who at 18 months was put on antipsychotic drugs to quell severe temper tantrums.

By the time he was 3, the poor kid had been diagnosed with autism, bipolar disorder, hyperactivity, insomnia and “oppositional defiant disorder” (um, isn’t that a fancy phrase for “normal toddler behavior”?). He was on the antipsychotic Risperdal, the antidepressant Prozac, two sleeping medicines and a pill for attention-deficit disorder.

Did you read that?! Prozac! Sleeping pills!

The side effects had Kyle “drooling” and “overweight,” but his mom likened the worst side effect to a coma. “I didn’t have my son,” she said. “It’s like, you’d look into his eyes and you would just see blankness.”

Fast-forward to the present, and you meet a very different kid. Kyle is 6, in first grade and doing very well in school. He’s off the drugs (except for Vyvanese for ADD), and as it turns out, never should have been on all those drugs in the first place.

In fact, the article pointed out that more and more doctors are writing stronger scripts for younger and younger children, citing a 2009 Food and Drug Administration report which stated that over half a million children and adolescents in America are now taking antipsychotic drugs. Yet some doctors warn of the considerable developmental and physical risks these strong drugs pose to younger children, and say that research has not deemed these meds safe for this age group.

Another disturbing nugget of info: A Rutgers University study found that children from low-income families, like Kyle, are four times more likely to receive antipsychotic medicines than children whose parents are privately insured. Why? Because medicating these children is cheaper than asking them to participate in family therapy.

Read entire article here:  http://www.momlogic.com/2010/09/babies_on_antipsychotics.php

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