Posts Tagged ‘Paxil’

When Big Pharma Breaks the Law—Prosecute the CEO

Tuesday, October 19th, 2010

New Scientist

October 19, 2010

Avandia's manufacturer won't release all its documents about the drug (Image: Bloomberg/Getty)
(Image: Bloomberg/Getty)

Patient safety will remain at risk until big pharma’s top executives are brought to book for their companies’ actions, says Paul Thacker

THERE have been so many stories about pharmaceutical companies promoting the misuse or abuse of their drugs that the names seem to merge – Zyprexa, Seroquel, Paxil and more.

The latest case concerns GlaxoSmithKline’s Avandia (rosiglitazone), an anti-diabetes drug linked to heart attacks. Last month, the European Medicines Agency recommended its suspension from the market, while the US Food and Drug Administration made it all but impossible for doctors to write prescriptions for the drug.

With sales worth over $3 billion in 2006, Avandia was the world’s best-selling diabetes drug until May 2007, when The New England Journal of Medicine published a study linking it to heart attacks. Reporters circled, and the finance committee of the US Senate investigated, forcing GSK to hand over internal documents.

As the main investigator into Avandia for the Senate committee for the past three years, I looked closely at the documents. I was appalled. From 2000, GSK pulled out all the stops to keep the drug on the market. Not all studies were provided to regulators, and it intimidated a doctor who criticised the drug. Even though GSK is in the middle of multibillion-dollar lawsuits brought by thousands of patients, it still has hundreds of documents hidden from public view under court seal – a feature of the US system that leaves documents provided under discovery accessible only to the parties involved in the litigation.

How can we stop this? One way is to slash what pharma can spend on encouraging doctors to prescribe their drugs. Companies spend billions wining and dining doctors. For instance, Forest Laboratories’ 2004 marketing plan for its antidepressant Lexapro notes it planned to spend $34.7 million to pay doctors to give lectures to their peers, and $36 million on lunches for doctors to create “an extended amount of selling time for representatives”.

In legal settlements reached with the US government, several companies have been forced to publish databases listing monies they provide to doctors. A provision in the Health Reform Bill passed this year will from 2013 require companies to disclose payments above $10 made to doctors, and explain why. This will be available in a searchable public database.

This will help, and may shame doctors into not taking handouts, but we also need professional societies to tighten ethical requirements to stop doctors accepting pharma gifts.

A second route is to reform the continuing medical education (CME) courses doctors must take every year. Of the $2 billion spent on CME in the US, pharma funds almost half. Companies claim this has no influence on prescribing practices, but internal company documents made public by the Senate finance committee contradict this. For example, Forest Laboratories’ marketing material on Lexapro discussed how CME courses could be used to push sales of the drug.

Several universities have revised rules on industry funding. Stanford University in California now requires companies to pool their money and fund a number of activities instead of funding individual courses, as is still allowed in most medical schools. The Memorial Sloan-Kettering Cancer Center in New York has ended all commercial support for CME in 2007, without ill effects.

Third, we need to penalise executives when companies are caught committing illegal acts. Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.

Paul Thacker is an investigator at the Project On Government Oversight, a non-profit organisation exposing waste, fraud and abuse in federal government. He was congressional investigator for the US Senate’s finance committee, where he was Senator Chuck Grassley’s lead investigator on Avandia

Read the rest of the article here:  http://www.newscientist.com/article/mg20827826.900-when-big-pharma-breaks-the-law-prosecute-the-ceo.html

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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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Paxil Birth Defects Lawyers Site Offers News And Information About Antidepressant Heart Defects

Monday, September 27th, 2010
Quote startDespite evidence suggesting that Paxil could cause birth defects, Glaxo deliberately chose not to conduct studies that would have uncovered the true dangers of the drug.Quote end

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy. Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects.

PR WEB

September 27, 2010

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy.

Paxil is part of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). After it first went on the market in December 1992, Paxil has gone on to become one of the most widely prescribed drugs in the United States, with annual sales of $3.2 billion by 2002.

Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects. In December 2005, the Food and Drug Administration called for stronger birth defects warnings on the drug’s labeling after two studies found that Paxil doubles the risk of birth defects when taken by women during the first trimester of pregnancy. Most of these birth defects involved cases of atrial and ventricular septal defects (holes in the walls of the chambers of the heart).

Paxil has also been linked to an increased risk of birth defects when taken later in pregnancy. A 2006 study published in the New England Journal of Medicine found that women who take Paxil or similar antidepressants after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), a condition which causes breathing and circulation problems that may lead to hospitalization or death.

Taking Paxil during pregnancy may also be linked to a number of other serious heart defects in newborns, including cardiomyopathy, tricuspid stenosis, cleft mitral valves, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), bicuspid aortic valves or patent ductus arteriosus (PDA).

Documents uncovered in the ongoing litigation against GSK [Paxil] products liability litigation (MDL-1574)] have revealed that GlaxoSmithKline, the drug’s manufacturer, was aware of the potential link between the antidepressant and birth defects as early as 1980, but failed to recall the drug or properly warn about its dangers until these risks were made public by researchers.

“Despite evidence suggesting that Paxil could cause birth defects, GlaxoSmithKline deliberately chose not to conduct studies that would have uncovered the true dangers of the drug,” says David Friend of Hissey Kientz, LLP. “It is impossible to say how many lives were drastically altered because of the company’s failure to heed the advice of experts and investigate the link between Paxil and birth defects.”

Read the rest of the article here: http://www.prweb.com/releases/2010/09/prweb4565144.htm

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Making a Market in Antipsychotic Drugs: An Ironic Tragedy

Thursday, September 23rd, 2010

The Huffington Post

September 23, 2010

by Dr. Peter Breggin

Remember not so long ago when Prozac became the world’s largest selling medication of any kind, and then for years how Prozac, Paxil and Zoloft took over many of the top 10 spots? Remember the explanations at the time–that they were wonder drugs and that 15-50 percent or more of Americans would need them some time in their lives? To many people this seemed like a scientific breakthrough when in reality it was … a triumph of marketing.   Some studies suggest that the antidepressants are little or no more effective than a sugar pill and a lot more dangerous. Recent research examined all antidepressant studies submitted in recent years to FDA in regard to antidepressant efficacy and found that the drug performed no better than placebo except in “severely depressed patients,” reaching “clinical significance” only “at the upper end of the very severely depressed category.” Even then, the difference between the antidepressant and the placebo was “relatively small.”

In addition to being largely ineffective, the antidepressants can be very distressing to withdraw from, which keeps the market artificially inflated by people who would desperately like to stop but find the process too emotionally or physically painful. Often these individuals fail to realize that they are undergoing withdrawal and instead mistakenly conclude that they “need” the medication to control their original psychiatric problems.

Now look what have become the new top selling drugs in the world: antipsychotic drugs like Risperdal, Zyprexa, Abilify, Seroquel, Geodon and Invega. Although the FDA has been expanding the approved use of some of these drugs to some cases of autism, Tourettes and a variety of other problems, their original purpose and their main use in psychiatry until now has been largely confined to psychosis and acute mania. Psychosis and acute mania afflict a very small portion of the the population. Yet these drugs are now at the top of the list of most widely prescribed medications worldwide. How did these incredibly toxic chemicals become daily pharmacological mainstays for so many millions of children and adults? It’s time to face the truth that the prescription of psychiatric drugs is driven by marketing trends–and now for the first time by something even more dreadful and insidious than mere marketing.

To begin their market campaigns for the newer antipsychotic agents, the drug companies created the myth that these products were not as dangerous as the old antipsychotic drugs, which were becoming recognized as highly toxic. Especially hard to ignore, it was demonstrated that the old antipsychotics cause tardive dyskinesia, a disfiguring and sometimes disabling array of abnormal movements in 5-8 percent per year cumulative of otherwise healthy patients and more than 20 percent of older patients. But even the unproven and ultimately false claim that the newer drugs were safer could not make a huge market for them. Even if these were wonder drugs, they were wonderful for a relatively tiny percent of the population. The drug companies had to create a new patient population market and that market became “bipolar disorder.”

Once much rarer than schizophrenia, bipolar disorder would soon become one of the most common diagnoses made in medicine and psychiatry. Indeed, while ordinary folks used to talk about their biochemical imbalances and depression, now they’ve upgraded to having bipolar disorder.

Lithium, once the magic bullet without side effects for bipolar disorder–then called manic-depressive disorder–had turned out to be a severe central nervous system toxin that over the years ruins mental function while also producing thyroid disorders, kidney failure and a host of other serious problems. The discrediting of lithium created a new niche for antipsychotic drugs–to be used as “mood stabilizers” for people with severe ups and downs. But it was a relatively smalll niche to begin with.

Where would all the new bipolar patients come from? Many of them would come from the fertile imagination of drug company sponsored psychiatrists who found bipolar disorder in everything from toddlers with temper tantrums to adults with bursts of energy followed by a natural period of feeling fatigued. Leaders in child psychiatry like Harvard’s Joseph Biederman were literally paid under the table to push antipsychotic medications for bipolar disorder in children. A recent study showed that children labeled bipolar actually receive more adult antipsychotic drugs than adults labeled bipolar . Another recent study covering 2000-2002 showed that 18 percent of child visits to a psychiatrist included antipsychotic treatment, and 92 percent of those were for the newer so-called second generation drugs. It took a great deal of marketing to convince physicians that these relatively untried and highly toxic antipsychotic drugs are that safe and effective in children.

But even marketing bipolar disorder to the professions and the public was insufficient to create a huge enough market to satisfy the drug companies. Here’s where the irony of ironies came into play. The newer antidepressants–once the leading drugs in the world–frequently cause mania. They do so in millions of patients, children and adults alike, every year. These once most popular drugs in the world by causing mania made and continue to make the market for the next wave of most popular drugs–the antipsychotic drugs being used as mood stabilizers.

How common is antidepressant-induced mania? Very common. Several studies have found that 6 to 8 percent of patients exposed to antidepressants will develop a manic disorder. One research study, for example, found in a retrospective study that Paxil produced mania in 8.6 percent of patients exposed. Other studies find the rates as high as 17 percent And if a person has already shown a manic tendency or has experienced a manic-like episode, antidepressants will push one-quarter to one-third into new manias (For a review, see P. Breggin, Brain-Disabling Treatments in Psychiatry, 2008, pp. 157-165) . Yet misguided psychiatrists commonly give antidepressants to patients diagnosed with bipolar disorder. The result? Millions of people suffer from medication-induced mania and other expressions of what I call “medication madness.”

When I took my psychiatric residency at Harvard in Boston and at SUNY in Syracuse in the early 1960s, we never saw or diagnosed bipolar disorder in children. In my four years of training, I saw one 19-year-old in a manic state and a few adults. When a person was admitted in a manic condition talking a mile a minute, imagining grand things about themselves, making outrageous plans, bursting with anger and energy, unable to sleep and otherwise euphoric, the condition was so unusual that we would hold grand rounds, a medical show-and-tell, to discuss the patient.

Now psychiatric wards are filled with patients having their second and third or umpteenth manic episode and every psychiatrist’s day is filled with patients diagnosed bipolar. It’s mostly about antidepressant-induced mania. Every single child I have evaluated who has suffered what looks like a manic episode has been taking stimulants or antidepressants, both of which cause mania. At least 9 out of 10 adults I’ve seen in the last two decades who have suffered emotional episodes that could be diagnosed as mania had them in direct response to stimulants or antidepressants–mostly the newer antidepressants starting with Prozac.

In the official diagnostic system, these are not cases of bipolar mania but cases of medication induced mood disorder with manic features; but they are almost always mistakenly called bipolar disorder in order to avoid identifying the drug and the prescriber as the causative agents.

For those who want further details, I have reviewed all the studies mentioned in this report in my medical book, “Brain-Disabling Treatments in Psychiatry, Second Edition” (2008). In my popular book, “Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime” (2008), I have provided dozens of in-depth illustrations of lives ruined by psychiatric drugs, especially the newer antidepressants.

Read the rest of the article here http://www.huffingtonpost.com/dr-peter-breggin/making-a-market-in-antips_b_720861.html

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Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

Thursday, September 9th, 2010

BNET

By Jim Edwards

Dr. Joan Luby, the preschool depression researcher at the center of a New York Times article that failed to mention her past research was funded by Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently testing the antipsychotic Risperdal on autistic children aged 30 months to 5 years old, according to the ClinicalTrials.gov database. Although the study is not funded by Janssen, the unit of J&J that makes Risperdal, it nonetheless typifies a new field of drug research: The use of mood-altering pharmaceuticals on the very, very young.

The NYT piece investigated the development of preschool depression as a diagnosis. Slate, like me, found it surprising that the author did not believe Big Pharma’s interest in the field was relevant. Minyanville thought the same thing. Such research is controversial. In November 2008, the FDA said antipsychotic drugs were over-used in children and that more should be done to discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in children, according to this press release — is just one researcher looking at extending the use of antipsychotics to very young kids. Here’s a study on Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on kids aged 6 and up. GlaxoSmithKline (GSK) is currently testing Paxil on 7-year-olds despite that medicine’s well-document propensity to trigger suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold: First, many of these products are not approved for use in children. Risperdal — the product in the Luby study of 30-month olds — is only approved for use in autistic children older than 5; and for schizophrenics older than 13. Eli Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone below the age of 13.

Read the rest of this article here http://www.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychotic-medicines-for-preschoolers/5624?tag=content;drawer-container

To see what side effects doctors, pharmacists,  health care providers and consumers have reported to the US FDA regarding antipsychotics and antidepressants on children (including 0-1 year olds) search CCHR’s decrypted FDA Medwatch reports here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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Psychotropic Drugs, Our Children and Our Pill-Crazed Society

Wednesday, September 8th, 2010

The Huffington Post
By Dr. Ronald Ricker and Dr. Venus Nicolino
September 8, 2010

Today, the use of psychoactive drugs by children (6-17) is all too common, relied on far too much and growing at an alarming rate. It all started in the ’70s.

Memorialized in 1966 by the Rolling Stones’ “Mothers Little Helpers,” it was at that time that our society took the first steps at becoming “Pill Crazy.” Valium and Librium and Quaaludes were “Mother’s Little Helpers. The first drugs to enter the stage. If you couldn’t stand Johnny, your friends, your husband, in-laws, etc, tranquilizers smoothed you out, made you tranquil. Not surprisingly, in the 70s, the consumption of these tranquilizers, once discovered and available, skyrocketed. Anxiety was the popular diagnosis. Antidepressants were beginning to raise their heads as well. Their popularity at that time, however, was muted by the fact that they didn’t work well, and also sported many side effects, some of which were very annoying and occasionally dangerous. And, no one knew what was just around the corner.

Prozac

Prozac was first marketed in 1987. It was a totally new type of antidepressant, which seemed to work and had far less side effects. What had been a stream of tranquilizers became a tsunami of Prozac’s and tranquilizers. Other ‘Prozac’s’ entered the scene–Zoloft, Celexa, Paxil and Luvox, all vying to take part of Prozac’s market share. Promotion of these drugs by drug manufacturers exploded. Where there had been a surge in the diagnosis of anxiety, now the diagnosis of the decade was ‘depression.’ Housewives by the droves needed and demanded antidepressants and even more tranquilizers. If one was good, two must be better. The pill craze was on.

Diagnoses started to morph. The more the diagnoses, the more opportunities to sell drugs. Anxiety became anxiety neurosis, panic disorder, panic attacks, etc. ‘Depression,’ as a diagnosis, was of course and remains very popular. However, many patients don’t and didn’t like that diagnosis–perhaps it sounded too much like a disease. So a new depression explanation and diagnosis emerged–’chemical imbalance,’ which sounded more sheik and less like a disease and, of course, yielded more customers.

Not far behind ‘chemical imbalance’ came ‘mood disorder,’ a special type of depression, also called bipolar disorder. There are people who actually have a bipolar disorder and require numerous special medications for treatment. These medications, mood stabilizers, antidepressants, and second generation antipsychotics are far more dangerous medications than Prozac and tranquilizers. Further, there are also many people who are said to have ‘bipolar disorder’ who don’t. Often these patients are those who were said to be depressed yet don’t get better with standard antidepressants. They get all the special and dangerous medications (the number of which is multiplying geometrically) and have the additional advantage of being able to excuse pretty much anything they do as a result of their ‘mood disorder.’

This pretty well takes us through the ’90s. But here come our children. How did our children get sucked into all this? Our pill craze was and is a huge part. Parents and physicians often subscribe to this theory, that there is a pill for everything. Mommy says Johnnie is depressed, doctor agrees, Johnnie doesn’t. Guess who wins? Certainly not Johnny. Guess what Johnnie gets? A pill, usually an SSRI, which he may end up taking for a long time. Assuming Johnnie takes three years of SSRI therapy, his diagnosis is changed 25 percent of the time, usually to the much more serious diagnosis, bipolar disorder. His medications are changed to a much more serious and dangerous types. If Johnny takes an SSRI for six years the chances of his diagnosis changing to bipolar increases to 50 percent. So do his meds.

There’s yet another and newer mine field for Johnnie to negotiate, new in the last two decades. Let’s say Johnnie fidgets in his seat, doesn’t listen to the teacher, hates to read, and talks to his neighbor all the time. Guess what. Johnnie is diagnosed with ADHD (attention deficit hyperactivity disorder) and given another serious type of drug, a stimulant–usually Ritalin or a form of speed (one example being Adderall). Did you know that Adderall is 100 percent speed? We know speed kills but give it to our children. Think about that. Speed kills and we give speed to our children, masked as Adderall.  Astounding.

Read entire article here:  http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/psychotropic-drugs-our-ch_b_680488.html

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Treatment for PTSD may be killing veterans

Wednesday, September 1st, 2010

War in Context

by News Source on August 31, 2010

Associated Press reports:

Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate.

In White’s case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

“He was told if he had trouble sleeping he could take another (Seroquel) pill,” said his father, Stan White, a retired high school principal.

Activist, Vince Boehm, communicated with the Whites and told Beyond Meds:

Stan and Shirley White lost two sons to war. Robert White, a staff sergeant, was killed in Afghanistan in 2005, when his Humvee was hit by a rocket-propelled grenade. But the death of Robert’s younger brother Andrew, who survived Iraq only to succumb to a different battle, is in some ways “harder to accept” says his father.

Struggling with PTSD compounded by grief over the death of his brother, Andrew sought help from VA doctors. Their first line of defense was to prescribe him 20 mg of Paxil, 4 mg of Klonopin and 50 mg of Seroquel. These medications helped at first, but later proved ineffective. Instead of changing the course of treatment, the doctors responded by continually increasing his dosage until the Seroquel alone reached a whopping 1600 mg per day. Within weeks of Andrew’s death, three more young West Virginia veterans died while being treated for PTSD with the same drugs, prompting Stan and Shirley White to begin a mission to find out what the deaths have in common.

Earlier this year, Martha Rosenberg reported on the same deadly cocktail being used to treat PTSD:

Sgt. Eric Layne’s death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was “suffering from incontinence, severe depression [and] continuous headaches,” according to his widow, Janette Layne.

Soon he had tremors. ” … [H]is breathing was labored [and] he had developed sleep apnea,” Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

Read the rest of this article here: http://warincontext.org/2010/08/31/treatment-for-ptsd-may-be-killing-veterans/

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The Over-Prescribing of Psychoactive Drugs to Children: A Scourge of Our Times

Wednesday, September 1st, 2010

The Huffington Post

September 1, 2010

by Dr. Ronald Ricker and Dr. Venus Nicolino

Today, the administration of psychoactive drugs to children (6-17) is all too common and growing at an alarming rate. These drugs often cause the opposite of the intended effect, often condemning children to a life of misery and ill health. The prescription of these drugs is said to treat “chemical imbalances” which were said to cause ADHD, Depression and Bi-polar disorder. It turns out, however, that what we were calling “disease-causing chemical imbalances,” is simply incorrect . The sad irony is, the inappropriate use of these medications is in fact creating different chemical imbalances, which do cause mental disorders, many of which are both life-long and debilitating.

Furthermore, it is now clear that often we are diagnosing ordinary childhood and adolescent behavior as mental disorders (Wait, children are supposed to be bursting with energy? It’s normal for a teenager to be moody and aloof?). This diagnosing is not only based on this idea of “chemical imbalances,” but also a general and pervasive notion that every non-acceptable behavior is due to a mental illness. And last, but certainly not least, the prescribing of these medications by doctors is based on the disinformation provided them by the FDA, drug manufactures and often fraudulent studies, all in the name of making money, on the backs of our children.

In a recent lecture, respected journalist, writer and Nobel Prize Nominee, Robert Whitaker (PBS, Boston, June 15, 2010) highlighted not only the appallingly unscientific methodology used in the development, prescription and use of psychotropic drugs in school-aged children, but also how hopelessly corrupt and failed the systems that should be regulating the safety of medicines are in this country.

Unfortunately, many drug companies exist for one reason: to make money. As such, the people who run these companies have developed a worldview bereft of any more notion of ethics or morality than British Petroleum. Some drug companies’ success is not based on a drug’s usefulness or the safety of its products, but whether it makes money. The path to more money is simple: find new uses for their old drugs, invent new drugs and find new markets for both new and old drugs. Unfortunately, children are today’s newest market.

The FDA requires a “Successful Drug Trial” to approve new medications. “Trial” is often a misnomer, as the word implies some notion of impartiality and unknown outcome. These “trials” often are more like kangaroo courts. In one “trial,” in this case to prove the usefulness of Prozac, corruption and dishonesty were the rule. Children who responded to placebos were removed from the data, as were negative responders to the actual drug. This meant that the only children who were left in the study group were so-called “positive responders.” And, even then, the researchers and doctors, whose “research” funding was provided by the makers of Prozac, were the very ones to decide which subjects, if any, actually did respond “positively” to the drug. This, of course, is a massive conflict of interest. The doctors, researchers and drug companies all want the same thing — FDA approval and to make more money.

In a 2004 article published in perhaps the most prestigious British medical journal, Lancet, said the trial studies used to provide proof of the usefulness of anti-depressant drugs in children, were “nothing but fraudulent.” Following that assessment, all anti-depressants but Prozac were banned in the UK for use on children. (The fact that Prozac was not banned was based on very dubious, some say dishonest, research as documented above).

The true damage caused by the use of anti-depressant drugs like Paxil, Zoloft, Prozac, etc. (AKA of SSRI’s: Selective serotonin reuptake inhibitors) by school-aged children is only found by legitimate, longer studies, like those that continued from 17 months to six years. In one study, 25 percent of children who had been on SSRI’s for three years were re-diagnosed with the much more serious disorder of Bi-polar disease. This number increased to 50 percent after six years of SSRI use. Long-term use of new anti-psychotics may lead to even greater problems than the initial disease. Diabetes, morbid obesity and early death have all been linked to the use of these drugs. And, as written by us in a previous blog both short and long term use of stimulant drugs such as Adderall), have numerous serious side effects.

Read the rest of this article here: http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/the-prescribing-of-psycho_b_665838.html

Note: To view all international drug regulatory warnings and studies on psychiatric drugs including those issued specifically for children,visit CCHR’s psychiatric drug search engine here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Also see this video – Drugging Our Children: Side Effects – http://www.cchrint.org/videos/

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Psychiatrist pleads guilty to 15 counts of fraud in Paxil clinical trials for kids

Friday, August 20th, 2010

CNBC

Associated Press

NEW ORLEANS – A 58-year-old psychiatrist involved in two clinical trials evaluating the drug Paxil’s safety and effectiveness in children and adolescents has pleaded guilty to 15 federal counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with those clinical trials.

Dr. Maria Carmen Palazzo was a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline. Prosecutors say that during those studies she included psychiatric diagnoses inconsistent with patients’ psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and reported symptoms she knew the study subject did not demonstrate.

Read the rest of this article here:  http://www.cnbc.com/id/38783181

Read more about Maria Carmen Palazzo here: http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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