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Texas AG suit over the drug Risperdal goes to trial Monday

Monday, January 9th, 2012

The Dallas Morning News
By Janet Elliott and Mark Curriden
January 8, 2012

AUSTIN — A routine inquiry a decade ago by an investigator for the Pennsylvania inspector general exposed a pattern in which pharmaceutical companies showered trips, meals and other perks on state officials in positions to influence which drugs would be used to treat patients under Medicaid.

The efforts appeared to have been particularly successful in Texas, which has one of the largest Medicaid populations.

In 2004, Allen Jones, a whistle-blower who worked with the Pennsylvania inspector general, filed suit alleging that pharmaceutical giant Johnson & Johnson improperly marketed its antipsychotic drug Risperdal for unapproved uses while funneling money to members of a state panel charged with recommending drug treatments for those in state health programs.

Two years later, Texas Attorney General Greg Abbott joined the lawsuit, seeking hundreds of millions of dollars in damages.

The case has been described by lawyers as the biggest lawsuit in Texas since the tobacco litigation in the 1990s. It goes to trial Monday in state court in Austin.

The high-stakes lawsuit alleging Medicaid fraud seeks $579 million in damages from Janssen, a division of New Jersey-based Johnson & Johnson, and penalties that could exceed an additional $500 million. The federal government will get half of any money recovered in the case, and Jones could receive between 10 and 25 percent.

The Texas case is separate from a reported $1 billion settlement reached just last week between Johnson & Johnson and others states over the marketing of Risperdal.

Risperdal was among antipsychotic drugs introduced in the 1990s. Initially approved for adults with schizophrenia, it soon became widely used in Texas mental hospitals and prisons for “off-label” uses, including for youths in the state’s foster care system.

“Not only was Risperdal not more effective, its risks were worse than its competitors and it was 45 times more expensive,” said Tom Melsheimer, a partner at Fish & Richardson in Dallas who represents the whistle-blower. “The company’s claim that its product was superior and its off-label promotional efforts were not supported by science.”

What did support Janssen’s promotional efforts were influential decision makers — including state employees, University of Texas faculty and mental health advocates — who received consulting fees, extravagant meals and travel accommodations, research funding and honoraria, according to the lawsuit.

Janssen denies that it misrepresented Risperdal and rejects allegations that its marketing efforts inflated the state’s spending on the drug. In court filings, the drug company points to the state’s continued use of Risperdal since joining the whistle-blower’s case in 2006.

Follow the money

In the 2010 fiscal year, Texas spent $15.016 million on Risperdal and $13.275 million on its generic equivalent for patients enrolled in Medicaid and the Children’s Health Insurance Program. The drugs cost an average of $229 per prescription, a 2006 Texas comptroller’s report said.

The program known as the Texas Medication Algorithm Project, or TMAP, started in the mid-1990s when state mental health officials contracted with the University of Texas and some of its professors to evaluate medications for treating mental illnesses and disorders.

Jones and the state allege that a process designed to be based on independent experts was co-opted by Janssen using false and misleading information, including ghostwritten articles and industry-funded studies, while playing down side effects, including weight gain and diabetes.

“Defendants thus ‘seeded the literature’ and increased the ‘noise level’ in the Texas health care community, including the Texas Medicaid community, with their false and misleading tale of Risperdal’s superiority to other antipsychotics and suitability for off-label use on vulnerable populations,” the state says in its most recent filing in the case.

Janssen is prepared to vigorously defend itself against these claims, spokeswoman Teresa Mueller said in emailed statement.

“We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication,” Mueller said. “If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action.”

Before the marketing blitz, the market was limited for Risperdal, Melsheimer said.

“Janssen determined in 1993 that the market for this drug was the 1 percent of adults with diagnosed schizophrenia, which was a $1 billion market,” he said. “So, the company created a new market for the drug. They created the perception that the drug was a breakthrough for expanded off-label treatments. As a result, the revenue generated by the sale of Risperdal jumped to $34 billion between 1997 and 2010.”

Fees, meals and trips

The most sensational allegations involve Janssen’s use of inducements, including consulting fees, meals, travel accommodations, research funding and honorariums. A key target was Dr. Steven Shon, medical director of the Texas Department of Mental Health and Mental Retardation. Records filed in the case show that Shon received $30,000 in fees and honoraria as a frequent speaker at Johnson & Johnson-sponsored events around the U.S.

David Rothman, a Columbia University professor who studies relations between medicine and the pharmaceutical industry, said in a report that Shon’s conduct was an “acute conflict of interest.” Shon, who resigned in October 2006, said in a deposition that he did not believe he influenced the placement of drugs on TMAP because he was an administrator and not a decision maker in the TMAP process.

Another potential witness in the case is M. Lynn Crismon, dean of the University of Texas College of Pharmacy. Crismon was a professor and member of the TMAP advisory panel in the mid-1990s when he “cultivated a financial relationship with J&J, accepting substantial fees and honoraria and soliciting research grants from the company,” according to Rothman’s report. “As a result, Dr. Crismon subverted the scientific integrity of his research and educational presentations, and biased his decision-making capacity as a member of TMAP.”

Crismon did not respond to a request for comment.

Jury selection is expected to take one day, with opening statements starting Tuesday. The trial could last four weeks.

Read article here: http://www.dallasnews.com/business/health-care/20120108-texas-ag-suit-over-the-drug-risperdal-goes-to-trial-monday.ece

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Tags: Allen Jones, antipsychotics, Janssen, Johnson & Johnson, M. Lynn Crismon, Pennsylvania inspector general, Risperdal, Steven Shon, Texas Department of Mental Health and Mental Retardation, Texas Medication Algorithm Project, TMAP, Tom Melsheimer, University of Texas College of Pharmacy, whistleblower
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7 Reasons America’s Mental Health Industry Is a Threat to Our Sanity

Friday, January 6th, 2012

Drug industry corruption, scientifically unreliable diagnoses and pseudoscientific research have compromised the values of the psychiatric profession.

Alternet
By Bruce E. Levine
January 6, 2012

Why do some of us become dissident mental health professionals?

The majority of psychiatrists, psychologists and other mental health professionals “go along to get along” and maintain a status quo that includes drug company corruption, pseudoscientific research and a “standard of care” that is routinely damaging and occasionally kills young children. If that sounds hyperbolic, then you probably have not heard of Rebecca Riley, and how the highest levels of psychiatry described her treatment as “appropriate and within responsible professional standards.”

When Rebecca Riley was 28 months old, based primarily on the complaints of her mother that she was “hyper” and had difficulty sleeping, psychiatrist Kayoko Kifuji, at the Tufts-New England Medical Center in Boston, Massachusetts, diagnosed Rebecca with attention deficit hyperactivity disorder (ADHD). Kifuji prescribed clonidine, a hypertensive drug with significant sedating properties, a drug Kifuji also prescribed to Rebecca’s older sister and brother. The goal of the Riley parents—obvious to many in their community and later to juries—was to attain psychiatric diagnoses for their children that would qualify them for disability payments and to sedate their children making them easy to manage.

By the time Rebecca was three years old, again based mainly on parental complaints, Kifuji had given Rebecca an additional diagnosis of bipolar disorder and prescribed two additional heavily sedating drugs, the antipsychotic Seroquel and the anticonvulsant Depakote.

At the age of four, Rebecca was dead.

At the time of her death, Rebecca had a life-threatening amount of clonidine—enough to kill her—in her body, according to the former director of the Massachusetts toxicology lab and the medical director of a regional poison control center. The medical examiner who performed the autopsy concluded that Rebecca died from intoxication of clonidine, Depakote and two over-the-counter cold and cough medicines that led to heart failure, lungs filled with bloody fluid, coma, and then death. Rebecca’s abusive parents went to prison for the over-drugging that led to their daughter’s death.

Kifuji’s fate? The psychiatric establishment rallied around Kifuji, enabling her to return to Tufts Medical Center practicing child psychiatry without any restrictions, penalties or supervision. After Rebecca’s death, Tufts-New England Medical Center defended Kifuji. A Tufts spokesperson told “60 Minutes” in 2009, “The care we provided was appropriate and within responsible professional standards.”

Apparently, psychiatric care that is considered appropriate and within responsible professional standards includes diagnoses of ADHD for a two-year-old and bipolar disorder for a three-year-old when the symptoms of those disorders are normal behaviors for those ages; prescribing three heavily sedating drugs that have not been approved by the FDA for child psychiatric treatment; ignoring the warnings from a school nurse about over-dosages for Rebecca; and making diagnoses based almost entirely on the reports of Rebecca’s mother, who herself was diagnosed with mental illness and heavily medicated to the point of falling asleep in Kifuji’s office.

Long before the Rebecca Riley tragedy hit the headlines, I was embarrassed by the mental health profession for seven major reasons:

1. Corruption by Big Pharma

How did it become within responsible professional standards for a two-year-old to get an ADHD diagnosis, for a three-year-old to get a bipolar diagnosis, and for toddlers to be prescribed multiple heavily sedating drugs? The short answer is drug company corruption of the mental health profession.

Congressional hearings in 2008 revealed that psychiatry’s “thought leaders” and major institutions are on the take from drug companies.

On June 8, 2008, the New York Times reported about psychiatrist Joseph Biederman: “A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007.”

Due in large part to Biederman’s influence, the number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003. Pediatrician and author Lawrence Diller notes about Biederman, “He single-handedly put pediatric bipolar disorder on the map.” In addition to his popularization of bipolar disorder for children, Biederman is one of the most significant forces behind the expanding numbers diagnosed with ADHD; and congressional investigators also discovered that Biederman conducted studies of Eli Lilly’s ADHD drug Strattera that were funded by National Institute of Health at the same time he was receiving money from Lilly.

Not only does the drug industry have influential psychiatrists such as Biederman in their pocket, virtually every major mental health institution is financially interconnected with Big Pharma. Congressional hearings also exposed the American Psychiatric Association psychiatry’s premier professional organization, as being on the take from drug companies. In 2006, the drug industry accounted for about 30 percent of the APA’s $62.5 million in financing. Most relevant here, the APA is the publisher of the psychiatric diagnostic bible, the Diagnostic and Statistical Manual of Mental Disorders (DSM), and thus the APA is the institution responsible for creating mental illnesses and disorders.

2. Invalid Illnesses and Disorders

Psychiatry’s first DSM (1952) and its DSM-II (1968) listed homosexuality as a mental illness. Only because of a fierce political fight waged in the 1970s by gay activists did the APA abolish homosexuality as an illness and eliminate it from its DSM-III (1980). Gay activists’ fight was not only a victory for themselves but a service for everyone else, as it made public the important scientific problem of psychiatric disorder invalidity. Specifically, are psychiatric disorders scientifically valid illnesses, or are they simply behaviors that create discomfort for some authorities at a given moment in time?

While psychiatry lost homosexuality as a mental illness in the 1980 DSM-III, the APA found other groups it could pathologize, groups that could not mobilize and resist, most notably children, who are now routinely given psychiatric diagnoses for behaviors that many of us view as normal for their ages.

Psychiatry sees it as within responsible professional standards to diagnose three-year-olds such as Rebecca Riley with bipolar disorder. The symptoms of bipolar disorder include irritable and rapidly changing moods, severe temper tantrums, defiance of authority, agitation and distractibility, sleeping too little or too much, poor judgment, impulsivity and grandiose beliefs.

Psychiatry also sees it as within responsible professional standards for Rebecca Riley to have been diagnosed at 28 months old with ADHD. The symptoms of ADHD are inattention (easily distracted and bored, difficulty organizing and completing tasks, losing things, not seeming to listen, not following instructions); hyperactivity (fidgeting, talking nonstop, having trouble sitting still, difficulty with quiet tasks), and impulsivity (impatience, blurting out inappropriate comments, interrupting conversations).

Today, children and teens are also diagnosed with oppositional defiant disorder (ODD), the symptoms of which include “often actively defies or refuses to comply with adult requests or rules,” and “often argues with adults.”

The standard for a medical disorder should not be whether or not an individual causes friction.

3. Scientifically Unreliable Diagnoses

Even if you believe that bipolar disorder for three-year-olds, ADHD for two-year-olds, ODD for teenagers, and all the other DSM diagnoses are valid disorders, there is still the scientific issue of diagnostic unreliability—the lack of diagnostic agreement among professionals examining the same person.

A generation ago, psychiatrists admitted that their diagnoses were unreliable and agreed that this was a major scientific problem. So in 1980, in an attempt to eliminate this embarrassment, they created the DSM-III with concrete behavioral checklists and formal decision-making rules, but they failed to correct the problem. Psychiatric diagnoses remain unreliable, but now psychiatry no longer talks about the unreliability problem.

If a measurement is a reliable one, then clinicians trained with it should be in high agreement on the diagnosis. A major 1992 study, conducted at six sites with 600 prospective patients, was done to examine the reliability of psychiatric diagnoses. Experienced mental health professionals were given extensive training in how to make accurate DSM diagnoses. Because of the extensive training, one would expect that diagnostic agreement would be much higher than in typical clinical settings. Herb Kutchins and Stuart Kirk summarize the study in Making Us Crazy (1997):

What this study demonstrated was that even when experienced clinicians with special training and supervision are asked to use DSM and make a diagnosis, they frequently disagree, even though the standards for defining agreement are very generous. . . . [For example,] if one of the two therapists made a diagnosis of Schizoid Personality Disorder and the other therapist selected Avoidant Personality Disorder, the therapists were judged to be in complete agreement of the diagnosis because they both found a personality disorder—even though they disagreed completely on which one! So even with this liberal definition of agreement, reliability using DSM is not very good.

Kutchins and Kirk conclude: “Mental health clinicians independently interviewing the same person in the community are as likely to agree as disagree that the person has a mental disorder and are as likely to agree as disagree on which of the over 300 DSM disorders is present.”

4. Biochemical Imbalance Mumbo Jumbo

Just as nothing was more important in selling the Iraq war in 2003 than the Bush administration’s certainty that Iraq possessed weapons of mass destruction, nothing has been more important in selling psychiatric drugs than psychiatry’s certainty of biochemical brain imbalances as the cause for mental illnesses.

Prior to psychiatry’s proclamation that depression was caused by too little of the neurotransmitter serotonin, few Americans were taking antidepressants. But by declaring that depression was caused by a serotonin imbalance analogous to diabetes and an insulin imbalance, depressed Americans became far more receptive to serotonin-enhancing drugs such as the “selective-serotonin-reuptake inhibitors” (SSRIs) Prozac, Paxil, and Zoloft.

SSRIs can make some depressed people feel better; however, alcohol makes some shy people less shy, but that’s not enough evidence to say that shyness is caused by an alcohol imbalance. The truth is—and scientists have known this for quite some time—that serotonin levels are not associated with depression.

Researchers have used a variety of methods to test the serotonin imbalance theory of depression, including comparing serotonin metabolites in depressed and nondepressed people, and depleting serotonin levels through a variety of means and then observing whether this resulted in depression. Elliot Valenstein, professor emeritus of psychology and neuroscience at the University of Michigan, reviewed the research in his book Blaming the Brain (1998) and reported that it is just as likely for people with normal serotonin levels to feel depressed as it is for people with abnormal serotonin levels, and that it is just as likely for people with abnormally high serotonin levels to feel depressed as it is for people with abnormally low serotonin levels. Valenstein concluded, “Furthermore, there is no convincing evidence that depressed people have a serotonin or norepinephrine deficiency.”

In 2002, the New York Times reported: “Researchers knew that antidepressants seemed to raise the brain’s levels of messenger chemicals called neurotransmitters, so they theorized that depression must result from a deficiency of these chemicals. Yet a multitude of studies failed to prove this precept.”

Yet even now, many psychiatrists and other mental health professionals continue to promulgate the serotonin imbalance theory of depression, and polls show that the majority of Americans continue to believe it.

5. Pseudoscientific Drug Effectiveness Research

There are multiple tricks that psychiatric drug manufacturers and their researcher psychiatrists and psychologists use to make their drugs look more effective than they really are. One of the most common depression measurements used by researchers paid by drug companies is the Hamilton Rating Scale for Depression. In the HRSD, researchers rate subjects, and the higher the point total, the more one is deemed to be suffering from depression. On the HRSD, there are three separate items about insomnia (early, middle and late) and one can receive up to six points for difficulty either falling or remaining asleep; however, there is only one suicide item, in which one is awarded only two points for wishing to be dead. The HRSD is heavily loaded with items that are most affected by drugs, and it is therefore especially damning for antidepressants that even with such measurement dice-loading, these drugs routinely fail to outperform placebos—even dice-loaded placebos.

Proper drug research requires that neither subject nor experimenter knows who is getting the drug and who is getting the placebo (a true double-blind control). Drug company antidepressant researchers use inactive placebos such as sugar pills (which don’t create side effects). Independent research on inactive placebos show that many subjects in antidepressant and other studies can guess if they are getting the actual drug or not, which changes their expectations and subverts the double-blind control. In order to make it more difficult to guess correctly, an active placebo (which creates side effects) should be used. In 2000, a Psychiatric Times article concluded: “In fact, when antidepressants are compared with active placebos, there appear to be no differences in clinical effectiveness.”

Dice-loading depression measurements and placebos are just two of many techniques drug company researchers use to make antidepressants look more effective than they really are. But even with such dice-loading, antidepressants have not fared well, at least when one examines all the studies.

Drug companies try to ensure that those studies showing antidepressants to be no more effective than placebos are not published; however, all studies must be submitted to the FDA. So independent researcher Irving Kirsch and his research team at the University of Connecticut used the Freedom of Information Act to gain access to all data, and analyzed 47 studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Kirsch discovered that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo (and in the trials where the antidepressant did outperform the placebo, the advantage was slight).

6. Psychotropic Drug Hypocrisy

Chemists consider psychiatric prescription drugs and illegal mood-altering drugs all to be psychotropic or psychoactive drugs. Cocaine and ADHD drugs such as Adderall and other amphetamines affect the neurotransmitters dopamine, serotonin, and norepinephrine; and antidepressants used in combination also affect the same neurotransmitters. Not only are prescription psychotropics and illegal psychotropics chemically similar, they are used by people for similar reasons, including taking the edge off their discomfort so they can function. The hypocrisy surrounding illegal and prescription psychotropic drugs is harmful to society in at least two ways.

At one level, because people are being misinformed about the realities of prescription psychotropic drugs, they are more likely to gulp them down and to give them to their children. This has helped create a tragic phenomenon detailed by investigative reporter Robert Whitaker in his book Anatomy of an Epidemic (2010). Psychiatric drug use turning mild and episodic conditions into severe and chronic ones has helped create a huge increase of Americans with severe mental illness, especially among children.

At a second level, this psychiatric-illegal psychotropic drug hypocrisy allows for unfair criminalizing and incarceration of people using illegal psychotropics.

7. Diversion from Societal, Cultural and Political Sources of Misery

When we hear the words disorder, disease or illness, we think of an individual in need of treatment, not of a troubled society in need of transformation. Mental illness expansionism diverts us from examining a dehumanizing society.

In addition to pathologizing normal behavior, the mental health profession also diverts us from examining a society that creates the ingredients—helplessness, hopelessness, passivity, boredom, fear, and isolation—that cause emotional difficulties. We are diverted from the reality that many emotional problems are natural human reactions to loss in our society of autonomy and community. Thus, the mental health profession not only has financial value for drug companies but it has political value for those at the top of societal hierarchies who want to retain the status quo.

Today, a handful of dissident mental health professionals do challenge and resist their profession’s dehumanizing standard practices. I know several of these dissidents, and they are the only psychiatrists, psychologists and mental health professionals that I have any respect for.

Read article here: http://www.alternet.org/story/153634/7_reasons_america%27s_mental_health_industry_is_a_threat_to_our_sanity/

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Tags: ADHD, American Psychiatric Association, antidepressants, antipsychotics, APA, big pharma, biochemical imbalance, Bruce E. Levine, Diagnostic and Statistical Manual of mental disorders, Drug industry corruption, dsm, Elliot Valenstein, Hamilton Rating Scale for Depression, joseph biederman, Kayoko Kifuji, pathologizing normal behavior, placebos, pseudoscientific research, psychiatric drugs, psychiatrists, scientifically unreliable diagnoses, SSRIs
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J&J to Agree to $1B Accord in Risperdal Probe

Thursday, January 5th, 2012

Bloomberg News – January 5, 2012

By Margaret Cronin Fisk, Jef Feeley and David Voreacos

Johnson & Johnson will pay more than $1 billion to the U.S. and most states to resolve a civil investigation into marketing of the antipsychotic Risperdal, according to people familiar with the matter.

J&J, the world’s largest health products company, reached an accord last week with the U.S. attorney in Philadelphia, according to the people, who weren’t authorized to speak about the matter. It doesn’t resolve negotiations over a possible criminal plea, they said.

The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J has said in Securities and Exchange Commission filings. The company said it has been in negotiations with the U.S. to settle this investigation.

J&J, based in New Brunswick, New Jersey, disclosed in August that it reached an agreement to settle a misdemeanor criminal charge related to Risperdal marketing. The company is in negotiations to pay about $400 million more to settle this portion of the investigation, one of the people said.

“We’re not going to comment on rumor or speculation,” Teresa Mueller, a J&J spokeswoman, said in a phone interview.

Company officials said in an SEC filing in May that they had reserved funds to resolve the government’s claims over Risperdal marketing. The company didn’t say how much had been set aside. The drugmaker said in an August filing it added an unspecified amount to the reserve to cover criminal penalties.

Accord Announcement

When the final settlement will be announced isn’t clear. The Justice Department typically announces civil and criminal resolutions at the same time in corporate cases.

A majority of U.S. states will join the settlement, the people said. Which ones will accept the final agreement hasn’t been determined, they said. Each state can decide whether to join the federal government’s settlement or pursue its own case.

Typically, states with cases in court continue to pursue their own. Texas alone is asking for more than $1 billion in a case that goes to trial next week.

J&J and its Janssen unit have been sued by 12 states, including Texas, South Carolina and Louisiana, over Risperdal marketing. The attorneys general of the other states “have indicated a potential interest in pursuing similar litigation against” Janssen, J&J said in its quarterly SEC filing in November.

A jury in Louisiana, weighing only the claim that the company downplayed the drug’s risks, awarded that state $257.7 million in 2010. A South Carolina judge last year ordered J&J to pay $327 million over Risperdal sold in the state.

Texas Suit

The Texas lawsuit, which involves additional allegations including off-label marketing, goes to trial next week.

“Discussions have been ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act related to the promotion of Risperdal,” J&J said in its August SEC filing. “Certain issues remain open before a settlement can be finalized.”

“The ultimate resolution of the above criminal and these civil matters is not expected to have a material adverse effect on the company’s financial position,” J&J officials said in the filing.

The agreement in principle on the criminal charge is “pursuant to a single misdemeanor violation of the Food, Drug and Cosmetic Act,” the company said.

Risperdal is a member of a class of drugs, known as atypical antipsychotics, that includes Indianapolis-based Eli Lilly & Co.’s Zyprexa and London-based AstraZeneca Plc’s Seroquel.

Lilly, AstraZeneca and two other J&J competitors making these drugs have paid $2.7 billion to resolve government marketing claims, particularly that the companies pushed the drugs for unapproved uses.

Lilly paid more than $1.7 billion to resolve state and federal investigations over Zyprexa and AstraZeneca Plc has paid almost $590 million. Pfizer paid $301 million for its drug Geodon.

–With assistance from Alex Nussbaum in New York. Editors: Charles Carter, John Pickering

http://www.bloomberg.com/news/2012-01-05/j-j-to-agree-to-1b-accord-in-risperdal-probe.html

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Tags: $1 billion, antipsychotic, drug, J&J, Johnson and Johnson, Risperdal
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Chinese citizens sent to mental hospitals to quiet dissent

Thursday, December 29th, 2011

USA Today – December 29, 2011

By Calum MacLeod

“I have no home or family, I have been detained and tortured by illegal medical treatment,” Wu says. “They have destroyed the latter half of my life. Until the people who illegally handled my case are punished, I won’t close my eyes, even in death.”

ZHENGZHOU, China – The electric acupuncture needles stung her scalp, and the drugs bloated her weight, gave her heart palpitations and brought on premature menopause.

But Wu Chunxia consented to the treatments at the psychiatric hospital because if she didn’t, she knew she would be strapped to her bed and left vulnerable to assaults from violent inmates.

“It was worse than hell in there,” says Wu, 37, of the Henan provincial psychiatric hospital in Xinxiang. “I feared I would be strangled at night by other patients.”

Wu was not at the hospital for reasons of mental health. She was committed there in 2008 by the Chinese government for 132 days as punishment for protesting about local injustice to higher authorities.

The Communist Party does not acknowledge its mental facilities are used to silence critics, but according to numerous human rights groups and Chinese dissidents, China’s Communist-led government has for decades incarcerated healthy people in mental wards to suppress dissent. In the past two years, wrongful confinement cases have sharply increased, says Liu Feiyue of Civil Rights and Livelihood Watch, a human-rights organization based in Suzhou.

The rise in confinements is greatest among petitioners — the ordinary people who complain about local problems, he says. Committing them to mental hospitals is a “quick, convenient and very effective” method for the government to silence criticism.

Now some Chinese officials are pushing back against the political confinements. Prodded by academics, activists and former patients, China’s National People’s Congress is discussing what would be the country’s first ever mental health law.

Minister of Health Chen Zhu told the standing committee of the Congress in October that the new law will curb the abuse of involuntary hospitalization and better protect the rights of the mentally ill. Chen blamed “procedural failings” for cases of forcible treatment that were challenged by victims and families.

Despite several shortcomings, the draft legislation represents both a legal and social milestone for the world’s most populous country, says Wang Yue, a psychiatry professor at Peking University.

“Only once a society develops to a certain level does it pay more attention to mental health and forced hospitalization,” says Wang, who alludes to wrongful confinements in mental wards in the U.S. in the early 1900s, though such cases were not attempts by the government to silence political opponents.

“In China, we have long had the principle of big government and small society, and only now are we moving toward judicial supervision and a society ruled by law,” he says. “We must solve the problem of treating those mental patients who need treatment and not hospitalizing people who don’t.”

Complaining to higher authorities

The number of wrongful confinements has risen because the number of Chinese who demand justice for personal matters has grown, Liu Feiyue says. They are reviving an ancient Chinese system of seeking redress by taking a complaint directly to higher authorities. They are determined, often desperate, he says, and thus troublesome to the authorities who are well aware their careers can be ruined by disquiet.

Xu Wu, 43, a former security guard, had grown suicidal after four years of incarceration, including electric shock treatment, for petitioning authorities about a wage dispute with his employer. In April, after watching a film in which kung fu star Jet Li escapes from jail, Xu copied Li’s moves by loosening his cell bars over three nights and escaped from the mental hospital in the Yangtze River port Wuhan.

He fled by train to Guangzhou, 600 miles south, where a hospital test concluded he was sane. He was seized eight days later by plainclothes Wuhan police outside the Guangzhou television station where he had just described his plight on-air. Media coverage, including video of his re-capture, helped secure Xu’s release on June 10, the same day the initial draft law was released for public comment.

He has read it and is pessimistic about its effectiveness. “I hope the new law will help other patients, but it will be hard to implement, like all laws in China,” Xu says.

His lawyer sounds more optimistic.

“The law will reduce the abuse of power and the confinement of healthy people,” says Huang Xuetao, director of the Equity & Justice Initiative, a non-profit based in Shenzhen, south China. She welcomes the revisions adopted in the latest October draft, including removal of the catch-all “risk of public disorder” reason for involuntary hospitalization, but urges further revision before the law is finalized sometime in 2012.

Last month, with the help of Equity & Justice, Xu Wu and four fellow victims of forced hospitalization appealed to the National People’s Congress for patients to be permitted to enlist outside representatives to help appeal their diagnosis and confinement.

In China, only the person or organization that applied for a patient’s forced commitment can apply for his or her release.

“The ideal would be for every involuntary hospitalization case to be examined and verified by judicial authorities, as happens in some U.S. states,” Huang says. “But in China at present, that’s just not realistic.”

Persistence pays off sometimes

Wu Chunxia won her release from the psychiatric hospital in Xinxiang by threatening suicide and persistently demanding her case be investigated, she says. Now she is battling for justice and compensation both through China’s courts, despite their lack of independence from the Communist Party, and the more traditional route of petitioning higher authorities, the very act that, while legal, got her detained in the first place.

She has had some success. Officials revoked the police decisions to punish her petitioning first by detaining her, then by committing her to a labor camp, a decision later changed to confinement in the mental hospital. The policeman who handled her case, Zhang Xiaodong, told USA TODAY he doesn’t know Wu. But earlier this month, in an interview with Southern Metropolitan News, Zhang blamed his treatment of Wu on orders from the local political-legal committee, a Communist Party group that guides judicial work. Committee secretary Li Zongxi declined to comment.

Corruption plays a major role

Rights activist Liu says officials commit troublemakers to mental hospitals because the process is secretive and, unlike the courts, requires no evidence of wrongdoing. He says the full extent of wrongful confinement in recent years far exceeds the 1,000 cases his group has compiled in a database since 2009.

Corruption also plays a major role. Unethical doctors and hospital administrators can benefit financially by allowing police to turn hospitals into “black jails,” Liu says.

For these reasons, Liu says the new law will remain “just a piece of paper” until China undertakes “systematic change, to a society that genuinely respects law and human rights.”

Even accepting the current draft over nothing may be a devil’s bargain, warns Nicholas Bequelin, a Hong Kong-based researcher for Human Rights Watch. “A bad law will entrench bad practices and would extend too much the power of public security officials to detain people on the basis of their political opinion or other irrelevant aspects,” he says.

China has failed to adopt the international norms for mental health law set out in the United Nations Convention on Rights of Persons with Disabilities, despite its ratification by Beijing, Bequelin says. The draft lacks provision for people to be assisted by lawyers and fails to prohibit the “political use of psychiatry,” he says.

Wu Chunxia is encouraged by the pending legislation. “It shows more attention paid to human rights in China,” she says. “I hope the law stops normal people suffering the persecution I had.”

Two years after Wu filed a suit against both the hospital and the neighborhood officials who committed her, a court in nearby Shenqiu County held its first hearing in October. Now she is petitioning the provincial court to speed the process and asking police to investigate the policeman Zhang Xiaodong.

http://www.usatoday.com/news/world/story/2011-12-28/china-mental-hospitals/52260592/1

Watch: G Edward Griffin on Psychiatry and Politics as a form of Government Control:

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Psychiatry’s Flawed Tool: A book full of subjective checklists—the Diagnostic and Statistical Manual of Mental Disorders

Thursday, December 29th, 2011

First Things – December 29, 2011
by Joe Carter

Photo: Garry Mcleod; Origami: Robert Lang

Someday our grandchildren’s grandchildren are going to sitting in college classroom learning about the early 21st century and wonder how a society so seemingly advanced could have such primitive ideas about mental health.They will no doubt be shocked and appalled that our major diagnostic tool for psychiatry is a book full of subjective checklists—the Diagnostic and Statistical Manual of Mental Disorders (DSM versions I-IV).

I became all too familiar with the DSM in my college days, first as a psychology major and then as a behavioral science major (I switched because I believed behavioral science would be more scientifically rigorous. It wasn’t.) I was constantly shocked that such an utterly absurd book could be considered our primary mental health tool. The diagnostic criteria is often so vague that it is virtually impossible to determine if a patient truly has a mental disorder. Yet almost every diagnosis in America is made based on comparing a patient against the DSM’s checklist of “symptoms.”

Part of the reason the DSM is so flawed is because it is highly politicized. For example, homosexuality was classified in DSM as a sexual disorder until the 1970s. And until 1987, “ego-dystonic homosexuality” was still classified as a pathology. These “mental disorders” were later removed, not because of a change in empirical data (since there is none) but because of the protest of gay rights groups. I agree with the gay rights activists on this one: homosexuality should have never been classified as a mental disorder. But this example shows that the judgments made by psychiatrists are often highly subjective and are rooted more in speculative theories than in scientific fact. (Keep in mind that this is the same profession that, for almost a century, believed the Freudian idea that holding your feces in as an infant affected your personality as an adult.)

Such criticisms against the DSM have been made for decades (mostly by cranks like me) but they are gaining a new hearing because of who is now making them: Allen Frances, lead editor of the DSV-IV. As Frances says, “there is no definition of a mental disorder. It’s [BS]. I mean, you just can’t define it.” As Wired magazine notes:

Some of this disputatiousness is the hazard of any professional specialty. But when psychiatrists say, as they have during each of these fights, that the success or failure of their efforts could sink the whole profession, they aren’t just scoring rhetorical points. The authority of any doctor depends on their ability to name a patient’s suffering. For patients to accept a diagnosis, they must believe that doctors know—in the same way that physicists know about gravity or biologists about mitosis—that their disease exists and that they have it. But this kind of certainty has eluded psychiatry, and every fight over nomenclature threatens to undermine the legitimacy of the profession by revealing its dirty secret: that for all their confident pronouncements, psychiatrists can’t rigorously differentiate illness from everyday suffering. This is why, as one psychiatrist wrote after the APA voted homosexuality out of the DSM, “there is a terrible sense of shame among psychiatrists, always wanting to show that our diagnoses are as good as the scientific ones used in real medicine.”

Since 1980, when the DSM-III was published, psychiatrists have tried to solve this problem by using what is called descriptive diagnosis: a checklist approach, whereby illnesses are defined wholly by the symptoms patients present. The main virtue of descriptive psychiatry is that it doesn’t rely on unprovable notions about the nature and causes of mental illness, as the Freudian theories behind all those “neuroses” had done. Two doctors who observe a patient carefully and consult the DSM’s criteria lists usually won’t disagree on the diagnosis—something that was embarrassingly common before 1980. But descriptive psychiatry also has a major problem: Its diagnoses are nothing more than groupings of symptoms. If, during a two-week period, you have five of the nine symptoms of depression listed in the DSM, then you have “major depression,” no matter your circumstances or your own perception of your troubles. “No one should be proud that we have a descriptive system,” Frances tells me. “The fact that we do only reveals our limitations.” Instead of curing the profession’s own malady, descriptive psychiatry has just covered it up.

Read more . . .

http://www.firstthings.com/blogs/firstthoughts/2011/12/29/psychiatrys-flawed-tool/

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Therapists revolt against psychiatry’s bible

Wednesday, December 28th, 2011

Mental health professionals say new diagnoses will lead to overmedication

Salon Magazine, December 27, 2011

by Rob Waters

“epidemics of over-diagnosis in child psychiatry” have caused "huge numbers of children to be unnecessarily labeled with attention deficit disorder and bipolar disorder and treated with medications."

Anyone who’s ever tried to get reimbursed by a health insurance company after seeing a psychiatrist or psychotherapist, or taking a child or teenager to one, has no doubt noticed the incomprehensible numbers that appear on the clinician’s statement, perhaps preceding some slightly less imponderable phrase.

Maybe you are a 296.22 (major depressive disorder, single episode, mild) or a 300.00 (anxiety disorder NOS–not otherwise specified). Hopefully, you are not a 301.83 (borderline personality disorder). Your kid might be a 313.81 (oppositional defiant disorder) or, more likely, a 314.01 (attention deficit hyperactivity disorder, predominantly hyperactive-impulsive type).

Since 1952, a tome called the Diagnostic and Statistical Manual of Mental Disorders, better known as the DSM, has been reducing to a few digits the psychological malady said to afflict a patient. This bible of mental health treatment, published by the American Psychiatric Association (APA), provides a list and description of every mental health condition known to—or invented by—psychiatry, from histrionic personality disorder (301.50) to transvestic fetishism (302.3).

Over the decades, the manual, adapted from a guide for mental diseases developed by Army and Navy psychiatrists, has ballooned. The number of listed disorders tripled to nearly 300. A few have been discredited and dumped along the way. Most famous were battles over the inclusion of homosexuality. Successive iterations of the manual listed homosexuality as a “sociopathic personality disturbance,” then modified that to describe a more limited “sexual orientation disturbance” among people who were “in conflict with” their attraction to people of the same sex. That was later replaced by a disorder called “ego-dystonic homosexuality,” applied to those whose homosexual arousal was a source of distress. That item was dropped in the DSM-III-R, published in 1987.

The great book’s coming edition, the DSM-5, is slated for publication in May 2013. As the task force producing it has posted drafts on its website, an undercurrent of dissatisfaction has exploded into a full-scale revolt by members of U.S. and British psychological and counseling organizations. The chief complaint is that the newest version will lower the criteria needed to diagnose some conditions, creating “subthreshold” disorders, and generally making it easier for healthcare professionals to label a person with a psychiatric disorder and medicate him or her.

The latest rebellion against the DSM-5 began with a salvo from across the Atlantic. In June, a special committee of the British Psychological Society complained in a letter to the APA that “clients and the general public are negatively affected by the continued and continuous medicalisation of their natural and normal responses to their experiences.” The committee criticized the proposed creation of an “attenuated psychosis syndrome”—a sort of poor-man’s psychosis with less severe symptoms—“as an opportunity to stigmatize eccentric people.” They also objected to a proposed reduction in the number of symptoms needed to diagnose adolescents with attention deficit disorder (ADD) because it might increase diagnoses and the use of meds.

Then David Elkins, professor emeritus at Pepperdine University and president of the Society for Humanistic Psychology, a division of the American Psychological Association, formed a committee to discuss similar objections and draft a petition enumerating them. In October, he posted the petition online. “I figured we’d get a couple hundred signatures,’’ Elkins said.

The response stunned him and his colleagues. The petition attracted more than 6,000 signatures in three weeks; as of mid-December it had topped 9,300 signatories and garnered the endorsement of 35 organizations. On Nov. 8, American Counseling Association president Don Locke jumped in with a letter to the APA objecting to the “incomplete or insufficient empirical evidence” underlying the proposed revisions and expressing “uncertainty about the quality and credibility” of the DSM-5.

“This has become a grassroots movement among mental health professionals, who are saying we already have a national problem with overmedication of children and the elderly, and we don’t want to exacerbate that,” says Elkins.

For many critics, Exhibit A is childhood ADD. As the disorder describing fidgety, easily distracted kids morphed from “hyperkinetic reaction of childhood” to the current “attention deficit hyperactivity disorder,” the number of children given the diagnosis exploded, fueling, by one account, a 700 percent increase in the use of Ritalin and other stimulants in the 1990s. Diagnosis requires checking six of nine boxes from a list of symptoms that include “often does not seem to listen when spoken to directly” and “often fidgets with hands or feet or squirms in seat.” Sound familiar, parents?

Two other newly proposed disorders singled out as problematic in the petition are “mild neurocognitive disorder” in the elderly and “disruptive mood dysregulation disorder” in children and adolescents. Both lack a solid basis in research and may fuel the use of powerful antipsychotic medications, which cause weight gain, diabetes and a host of other metabolic problems, the petition says.

“We are gravely concerned that if this is published as is in 2013, it will create false epidemics where hundreds of thousands of children and the elderly who really are normal will be diagnosed with a mental disorder and given powerful psychiatric medications that have dangerous side effects,” Elkins says. “That is not tolerable.”

David Kupfer, the University of Pittsburgh psychiatrist who chairs the task force overseeing the manual’s preparation, says he expects the final number of disorders included in the DSM-5 to be about the same as in the current book. He says he welcomes the criticism and that nothing is final. The task force has been testing proposed new diagnoses in 2,300 patients at seven adult treatment centers and four adolescent centers that are acting as field-test sites, he says.

“There’s a myth that all the decisions have been made, when in fact, all the decisions haven’t been made,” he says. “Just because [things have] been proposed doesn’t necessarily mean they’ll end up in the DSM-5. If they don’t achieve a level of reliability, clinician acceptability, and utility, it’s unlikely they’ll go forward.”

The most surprising critic of the DSM is a one-time pillar of the psychiatric establishment. Allen Frances, professor emeritus at Duke University, chaired the task force that created the DSM-4. Now he’s railing against both the process and proposed content of the new DSM in blogs on the website for Psychology Today that blast the new revision as “untested” and “unscientific.”

Psychiatric diagnoses are loose enough already, Frances told me, and that laxity has led to “epidemics of over-diagnosis in child psychiatry” causing huge numbers of children to be unnecessarily labeled with attention deficit disorder and bipolar disorder and treated with medications.

“DSM has to be a safe, reliable and credible guide to current clinical practice,” he says. “It can’t be an untested program for future research.’’

The user revolt against the DSM-5 has emerged as a major challenge to the document, Frances says, and its future is looking unclear. He and Elkins are proposing that an independent committee of experts review the proposed draft and make recommendations.

The fight over the DSM-5 pits some of the greatest minds and biggest egos in the world of psychiatry, but it’s more than a battle among 301.81s (narcissistic personality disorder). For people seeking help for life’s problems who don’t want to be labeled mentally ill or have their treatment limited to medication, and for clinicians who want to help people without reducing them to a category, the stakes are high.

http://www.salon.com/2011/12/27/therapists_revolt_against_psychiatrys_bible/singleton/

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Pharmageddon: America’s bitter pill — U.S. is world’s biggest user of psychotropic drugs

Tuesday, December 27th, 2011

Russia Today – December 27, 2011

The United States has a passion for pills, being the world’s biggest users of psychotropic drugs, consuming 60 per cent of them. And pharmaceutical firms are keen to keep cashing in on the multibillion-dollar market, even if it costs people’s health.

America is regarded as a country with a prodigious appetite for consumption. Today, a widespread fondness for pharmaceuticals has turned the US into a nation of pill-poppers.

With over $14 billion in annual sales, antipsychotics remain the top-selling therapeutic class of prescription drugs in the US.

Dr. Harriet Fraad believes Big Pharma has manufactured a climate of insanity by manipulating and even creating illness for capital gain.

“One of the things that drives Big Pharma is to find a diagnosis that is very vague, so that everybody can fall into that,” she told RT. “Everybody is sad sometimes. There are good reasons. The point is to market pharmaceuticals. And the advertising strategy is to have vague diagnosis and then find wiggle room so that they apply to everyone.”

The US is the only Western country that allows direct-to-consumer advertising of prescription drugs. For example, an ad for Attention Deficit Hyperactivity Disorder warns that untreated patients will likely end up divorced. Another commercial promises to make you happier, but side-effects may include dry mouth, insomnia, sexual dysfunction, diarrhea, nausea and sleepiness.”

Critics also say Big Pharma uses its financial muscle to ply doctors with gifts, cash kick-backs and research funding in exchange for endorsing or prescribing the latest and most lucrative drugs.

Harriet Fraad says there is a whole network of doctors hustling these drugs.

“If a patient comes in with a knee injury and says, ‘I’m so sad.’ Oh, are you depressed? Hey write a prescription! They’re given out like M&Ms.”

Last year, prescription drug abuse became the number one cause of accidental death, with more than 30,000 Americans overdosing.

For instance, Seroquel, medication for bi-polar disorder, generated $4.4 billion in sales last year.Listing all its side-effects requires 49 seconds of air-time.

The number of children consuming antipsychotic medication has doubled in the past decade. Millions of American adolescents are taking drugs like Adderall, doled out by doctors to treat hyperactivity.

Author of Surviving America’s Depression Epidemic, psychologist Bruce Levine, told RT that, “All these drugs are very similar to illicit or illegal drugs, except they’re more dangerous. Marijuana is a little safer. But kids have no choice.”

Pfizer, America’s most profitable multinational pharmaceutical company makes anti-depressants not only for people, but also for animals. In 2009, the pharmaceutical giant paid $2.3 billion to settle civil and criminal allegations over illegally marketing one of its drugs. It was the largest healthcare fraud settlement and criminal fine in US history. That being said, the fine amounted to less than three weeks of Pfizer’s drug sales.

“The money is so huge that the fines are immaterial. They’re not thinking about the social effects of what they’re doing. They’re thinking about the profits they accrue,” says psychotherapist Harriet Fraad.

The pharmaceutical industry remains the most profitable business in the US. More success and financial gain for the companies will always remain possible as long as more Americans are encouraged to take drugs.

http://rt.com/news/us-prescription-drugs-abuse-715/

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The Psychiatric Drugging of America’s Foster Children by Psychiatrist Peter Breggin

Thursday, December 22nd, 2011

The Huffington Post – December 22, 2011

Remember that many of these children will be waking up on Christmas morning to count out their multiple mind-altering psychiatric drugs that they have been prescribed by psychiatrists and other prescribers hired by the states in which they reside and paid for by tax dollars. These kids don't need psychiatric drugs, they need human "angels" to rescue them from a system that is stacked against their well-being.

The most vulnerable among us are the littlest victims. Young children, torn from their birth families through various, often unspeakable tragedies. These children end up in state supervised foster care and too often are passed from hand to hand, house to house. There were approximately 662,000 children in foster care in the United States in 2010.

Now there is a Government Accounting Office (GAO) report confirming that foster children in five states — Florida, Massachusetts, Michigan, Oregon and Texas — are receiving shocking amounts of psychiatric drugs. In the words of ABC News, they are “being prescribed psychiatric medications at doses higher than the maximum levels approved by the Food and Drug Administration (FDA) in these five states alone. And hundreds of foster children received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together.” The ABC News report shows one 7-year-old holding a bag filled with 13 psychiatric medications that she had taken.

During the FDA drug-approval process, the maximum dose of a drug is determined by giving that drug by itself without any other psychoactive substances. When two or more psychiatric drugs are given together, each at its maximum dose, toxic levels of exposure can occur. In addition, some of these children are being given higher than the FDA-approved dose of individual drugs.

One young child interviewed by ABC News described the effect of the antidepressant and antipsychotic drugs he was taking: “They made me feel like I had a thousand bricks on my head.” Another child said, “Some of the medications were for ADHD but I’m not ADHD, I’m just naughty.” A teen in foster care on multiple psychiatric drugs told ABC News she felt like a “guinea pig.”

Foster children are provided government insurance in the form of Medicaid that includes “mental health” services such as psychiatric evaluations and prescription drug coverage. Individual states administer Medicaid and the U.S. Department of Health and Human Services is responsible for overseeing the state programs.

In the states surveyed by the GAO, children in Massachusetts fared worst. Thirty-nine percent of the foster care children aged 0-17 on Medicaid were prescribed at least one psychiatric drug. By comparison, 10 percent of non-foster care children in Massachusetts were prescribed at least one psychotropic medication under Medicaid. It’s serious enough when 10 percent of non-foster care children from our poorer communities are receiving psychiatric drugs; it’s even more tragic when 39 percent of our most poor and abandoned children are being inundated with these drugs.

Other states in the GAO study had total numbers of foster care children on Medicaid being prescribed at least one psychiatric drug: Oregon — 19.7 percent; Texas — 32.2 percent; Florida — 22 percent; and Michigan — 21 percent. The statistics reported are eye-opening, and it is worthwhile to see the full GAO report. In Texas, for instance, 9.1 percent of foster care children aged 0-5 years old are on at least one psychiatric drug, and 58.2 percent of foster care children aged 13-17 years old are on at least one psychiatric drug. Massachussetts has 53.4 percent of foster care children aged 13-17 on at least one psychiatric drug, and almost 5 percent of foster children aged 0-5 are on at least one psychiatric drug.

Is this widespread psychiatric drugging medically appropriate or indicated? Absolutely not. First of all, these are young children, even infants, who have already been through extremely traumatic experiences. All of them have been taken from their homes and most of them will not have had a stable replacement home. Beyond that, one can only imagine their horrendous living conditions prior to being removed from their families of origin. These children do not need psychoactive substances — they need the best human, caring services that our society can provide. The drugs may make them temporarily more docile, but by disrupting and suppressing normal brain function and development, they add new stressors to their lives and prevent them from adapting and growing as best as possible.

ABC News reports, “Of all the psychiatric medications, antipsychotics are, by far, the most prescribed, especially for foster children. Foster children are given anti-psychotics at a rate nine times higher than children not in foster care, according to a 2010 16-state analysis by Rutgers University of nearly 300,000 foster children.”

These antipsychotic drugs — including Abilify, Risperdal, Seroquel and Zyprexa — can lead to obesity, elevated blood sugar and diabetes, pancreatitis, cardiovascular abnormalities and a disfiguring and sometimes disabling movement disorder called tardive dyskinesia. It’s been suggested they could shorten lifespan by up to 25 years in patients exposed to them for decades. Evidence is accumulating that they can also lead to shrinkage of the brain in those patients exposed to them for years.

Why are these highly-toxic drugs being given to so many children in foster care? The antipsychotic drugs can suppress the highest centers of the brain — the frontal lobes — leading to indifference and apathy, which makes the children more docile and easier to manage. The use of multiple psychiatry drugs (polydrug therapy) produces similar effects. In the extreme, these children become zombie-like.

The newer antidepressant drugs such as Prozac, Paxil, Zoloft, Cymbalta, Lexapro, Wellbutrin, Effexor and Pristiq and have been shown to cause an increase in suicidal behavior in children. In addition, as the FDA-approved label and medication guides for these drugs confirm, they also can cause a general worsening of the individual’s condition, including depression, anxiety, hostility, aggression, impulsivity and mania. Many studies also suggest that a high percentage of children are driven into abnormal mental states by these drugs. When a child develops any one of these adverse reactions they are likely to have additional psychiatric drugs added to their drug cocktail rather than being carefully withdrawn from the offending substances.

As ABC News documented with one mother, parents or foster parents who object to the prescriptions of mind-altering psychiatric drugs for their young children are likely to be threatened with removal of the child from their care. In a separate case in Detroit, a child who was on Medicaid due to physical disability was taken off her mind-altering psychiatric drug by her mother when she displayed adverse effects.

The prescribing clinic called child welfare services and reported the mother. Welfare services removed the child from her mother’s care for a time. Fortunately, this child was later returned by court order to her mother and criminal charges against the mother were dismissed.

But word gets around. Complain about your child being placed on drugs and social services may intervene.

A mother in Millbrook, NY, was charged with medical neglect for not continuing her 4th grade son on a cocktail of psychiatric medications that was making him angry and listless. Off the drugs his energy returned and his mood improved, but public school officials kicked the boy out of school and reported the mother. The mother prevailed and was exonerated of “medical neglect” charges. Her son attended a private school and thrived. He is now a grown man and responsible citizen. His mother explained, “Kids don’t need drugs, they need individualized education and better family life. The priorities are all screwed up.”

In two of the ABC news foster care cases, the clinics that were authorized to deliver services to the children were also promoting themselves as being research facilities for “CNS Conditions” (central nervous system conditions, a misnomer for psychiatric conditions.) As research facilities those clinics have ties with pharmaceutical companies.

And what about the drug companies? Are they doing all they can to prevent the inappropriate use of their products? To the contrary, several of the largest drug companies have paid billions to settle claims they illegally marketed antipsychotics to children and other off-label populations, such as the elderly.

What is being done to these children should be viewed as chemical battery and child abuse. The misguided parents and foster parents are not the perpetrators. The psychopharmaceutical complex is the perpetrator, including the drug companies, the federal government and organized medicine and psychiatry.

The drugging of America’s children raise many issues including parental rights, children’s rights, child safety, off-label prescribing of the drugs and fraud and malpractice on the part of the researchers, psychiatrists and other prescribers. Most tragic is the silence! The stifled voices of victimized children and the self-serving silence of health professionals throughout the country who fail to take a public stand against the escalating drugging of our children.

Drugging traumatized foster children shoves them under society’s rug and is in no way therapeutic for the child. There are humane and effective approaches to helping our most vulnerable children. First, they need to be protected from predatory psychiatrists and other prescribers. Second, they need improved social services that could keep many of them in their homes or provide better assistance, training and supervision to improved foster care homes. When they inevitably become emotionally distressed and at times behaviorally disturbing, they do not need chemical readjustments of their brains — they need better attention from adults in the form of improved home-life or foster care, improved educational opportunities and psychosocial therapies aimed at helping them overcome and move beyond the trauma and stress they have endured and continue to endure as children and youth.

Sure, it’s easier to give them drugs. But has anybody noticed — it doesn’t help them in the long run. Exposure to psychiatric drugs in childhood is dangerous and over time can be damaging, disabling and even deadly.

No agencies and no associations — not NIMH, the American Medical Association, the American Psychiatric Association, the American Psychological Association, and the many other mental health associations — are willing to call a halt to the massive tidal wave of mind altering psychiatric drugs being thrown at America’s children. Several states, including Florida, Louisiana and New York have expelled “high prescribing” doctors from Medicaid but this is like nipping off the top of the iceberg. The primary problem remains: Placing children on psychiatric drugs instead of offering genuine help.

Dr. Robert Nelson, M.D., Ph.D. of the FDA Office of Pediatric Therapeutics, squirmed when challenged by Diane Sawyer in the ABC foster child series, but said the FDA had no plans to strengthen their warnings about psychiatric drugs and children.

The GAO, while courageously illuminating the great number of foster children on psychiatric drugs as well as the seriousness of children being exposed to multiple psychiatric drugs, falls far short of calling for the curtailment of the drugging of American children.

Twenty-five years ago, a tiny fraction of children were prescribed psychiatric medications, and that was largely confined to stimulants. In the early 1990s we were blowing the whistle on the increasing attention psychiatry was paying to children. I wrote an op-ed piece in the Wall Street Journal in 1989 and spoke frequently through the media about how children being blamed and diagnosed for problems in families, schools and in society. From 1990 to 1995 the increased prescribing of psychotropic drugs for preschoolers had begun.

What is to be done?

It is time for state attorney generals to launch full-scale investigations into the practices of these Medicaid psychiatrists. When appropriate, they should be charged with battery and with fraud, and sued for malpractice. But the psychiatrists are largely responding to the campaigns conducted by the psychopharmaceutical complex.The entire system, from the drug companies and insurance companies to the medical and psychiatric associations, and also the researchers and universities, need to be investigated for participating in this widespread medical abuse of children.

This Christmas, as many of us gather around a Christmas tree watching the children in our families wake up with shining eyes and happy laughter… remember. Remember that there were approximately 662,000 children in foster care in the United States in 2010.

Remember that many of these children will be waking up on Christmas morning to count out their multiple mind-altering psychiatric drugs that they have been prescribed by psychiatrists and other prescribers hired by the states in which they reside and paid for by tax dollars. These kids don’t need psychiatric drugs, they need human “angels” to rescue them from a system that is stacked against their well-being.

Only an outraged citizenry will change this. Write your Congressional representatives and senators. Write your state representatives and senators. Write your state attorney general’s office requesting a full investigation in your state of the crisis with foster children and psychiatric drugs. If you are a parent or a foster parent being pressured to keep your child on psychiatric drugs, call your local paper, referencing the ABC News investigation. If you are a reporter, plan a local series on this issue. If you are a teacher, a social worker or professional in the Medicaid system, consider becoming a whistleblower against the chemical assault of these children. If you are a medical professional learn how to help children safely taper off their psychiatric drugs while assisting their families in obtaining more useful services. Always remember that withdrawal from psychiatric drugs can be hazardous and needs to be done carefully with experienced clinical supervision.

It’s the Christmas season. Let’s not forget the kids who are so drugged their eyes cannot sparkle anymore. Become one of their real-life angels.

Peter R. Breggin, M.D. is a Harvard-trained psychiatrist and former full-time consultant with NIMH who is in private practice in Ithaca, New York. Dr. Breggin is the author of more than twenty books including the bestseller Talking Back to Prozac and the medical book Brain-Disabling Treatments in Psychiatry, Second Edition. His most recent book is Medication Madness, the Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime. He is also the author of dozens of peer-reviewed scientific articles, many in the field of psychopharmacology. On April 13-15, 2012 in Syracuse, New York, the annual conference of Dr. Breggin’s 501c3 nonprofit international organization, The Center for the Study of Empathic Therapy, will present a panel of lawyers, experts, survivors and families concerning antidepressant-induced violence and crime. Conference information is available on www.EmpathicTherapy.org.

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Prozac is now a defense for murder, writes Australian Member of Parliament Martin Whitely

Wednesday, December 21st, 2011

For the first time in criminal history, a murder was attributed to an anti-depressant drug. (Photo Credit -The Daily Telegraph)

Perth Now – December 21, 2011

FIRST it was ADHD drugs, then organ donation, now WA Labor MP Martin Whitely is hoping to get some action on the fatal risks of antidepressant drugs, such as Prozac, to children.

Anti-depressant manufacturers warn that products such as Prozac should not be given to children, because of the potentially tragic consequences, but they are prescribed every day to Australian kids.

Some anti-depressants, prescribed to help lift people out of a depressive state, actually have the opposite effect and make things worse.

This is what happened, with fatal results, in the case of a 16-year-old boy in Canada who stabbed a friend to death.

For the first time in criminal history, a murder was attributed to an anti-depressant drug.

In the finding, handed down on the 16th of September 2011, a Canadian Judge said a 16-year-old boy, who stabbed his brother’s friend in the stomach, would not have committed the offence had he not been treated with the drug Prozac (a brand of Fluoxetine).

The judge accepted the evidence of psychiatrist, Dr Peter Breggin, who told the court the boy’s symptoms were consistent with a Prozac-Induced Mood Disorder with Manic Features.

In delivering his decision the judge stated, “his basic normalcy now further confirms he no longer poses a risk of violence to anyone and that his mental deterioration and resulting violence would not have taken place without exposure to Prozac”.

The boy, who had no history of violence, had been taking Prozac for three months, during which his parents observed a marked deterioration in his behaviour and mood, which included acts of violence and self-harm where previously no such signs existed.

His alarmed parents returned to his doctor for advice, but instead of taking him off Prozac or reducing his dosage, his doctor increased the dose, obviously believing more of what appeared to be causing these dangerous behaviours, would solve the problem.

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and is approved for use in Australia for the treatment of depression, obsessive compulsive disorder and premenstrual dysphoric disorder.

However, it is routinely prescribed ‘off label’ for a range of other conditions including panic and eating disorders.

Australian Government Department of Health and Ageing figures revealed that in the 2008 financial year, 110,848 Australians received Fluoxetine scripts that were subsidised via the Pharmaceutical Benefits Scheme.

Concerns about possible aggression and manic side effects of Prozac were first raised in Australia in the New South Wales parliament in 1995, just five years after the release of the drug in Australia.

Since 2007, the US Food and Drug Administration has labelled SSRI antidepressants including Prozac with the highest possible ‘black box’ warning stating:

“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, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric.”

The US Black Box warning was followed by similar warnings in Australia. The evidence that led to these warnings came from, ‘pooled analyses of short-term placebo-controlled trials of anti-depressant drugs (SSRIs and others)’ which ‘showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents [by 100%], and young adults ages 18-24 (by 50 per cent) with major depressive disorder (MDD) and other psychiatric disorders.’ The fact that SSRI antidepressants like Prozac are supposed to manage severe depression in young people but increase the risk of suicidality poses obvious questions.

Over a 10 year period, up until 30 June 2011, more than 40 adverse events of self-harm and violence, including suicides, homicides and suicidal or homicidal ideation, for Fluoxetine were reported to the Australian Therapeutic Drugs Administration (examples are listed below).

Hundreds of reports were recorded by the TGA for other antidepressants however, it is impossible to know the true number of actual events, as the voluntary nature of the reporting system means only a fraction of actual incidents gets reported.

Despite the fact that the manufacturers advise that Prozac and other SSRI antidepressants are ‘not recommended for use in children and adolescents under 18 years of age’ they are frequently prescribed ‘off label’ to even very young children.

Data provided by the Commonwealth Department of Health revealed that in the 2007-8 financial year 3,752 Australian children 15-years-old or younger (863 were 10 or younger, 117 were six or younger) were prescribed Pharmaceutical Benefits Scheme-funded Fluoxetine.

Furthermore all the expense and risks of adverse side effects may be for little or no benefit. The efficacy of antidepressants are being questioned – with some high profile, mainstream critics, arguing that placebos are just as effective and much safer in treating moderate depression.

One such critic, Marcia Angell, MD, Senior Lecturer on Social Medicine at Harvard Medical School and former Editor-in-Chief of The New England Journal of Medicine, contends; ‘that clinical trials have failed to find antidepressants effective at all in mild to moderate depression; that many psychiatric drugs have devastating adverse effects, especially in children and when used long-term; and that despite the risks and uncertain benefits, use of psychiatric drugs is soaring and the heavy reliance on drugs diverts resources better spent on improving treatment’.

In summary, taxpayers are subsidising the ‘off label’ use by children and adolescents of antidepressants, with questionable efficacy, that double their risk of suicidality. This invites some obvious questions: Is this the best way to spend our taxes? And more importantly, is this the best way to help troubled young people?

* A sample from the Adverse Drug Reactions Committee (ADRAC) adverse event reports for Fluoxetine Hydrochloride:

A 54 year old woman attempted suicide. She was also suffering from mania and a confusional state.

A 36 year old woman “attempted suicide”.

A 36 year old woman was admitted to intensive care in a coma following a suicide attempt.

A 51 year old woman “had sudden urge to murder someone”.

A 37 year old woman was admitted to a psychiatric hospital suffering from “suicidal ideation, nausea, trembling, feelings of despair, anxiety, paranoia and fear”.

A 16 year old boy suffering from agitation and auditory hallucinations heard voices “telling him to kill his mother, father, sister and himself”.

A 45 year old man “became obsessively suicidal and cut his throat” 3/7 days after Prozac was stopped.

A 17 year old girl “became manic half an hour after commencing antidepressant.”

A 40 year old patient “experienced trembling, cramps, heard voices and had suicidal ideation.”

A patient of unrecorded gender and age experienced “homicidal and suicidal ideation.”

A patient of unrecorded gender and age attempted suicide after experiencing suicidal ideation.

A 44 year old patient “experienced akathisia, suicidal ideation and suicide attempt.”

A patient of unrecorded gender and age experienced “suicidal violence” and “aggression.”

A patient of unrecorded gender and age experienced “suicidal ideation.”

A patient of unrecorded gender and age experienced “suicidal ideation and “suicide attempt.”

A 50 year old patient experienced “suicidal ideation, suicide attempt and akathisia.”

A 37 year old patient attempted suicide.

A patient of unrecorded gender and age experienced “suicidal ideation and suicide attempt.”

A patient of unrecorded gender and age made a suicide attempt and was violent.

A 16 year old girl “attempted to hang herself with television cord from curtain rail in hospital bedroom. Nurse said she found her at the last moment.”

A 16year old girl “ingested 40 Panadol tablets. Also frequent self-harming.”

A 16 year old girl “attempted suicide by ingestion of 80 Panadol, 20 Panadeine, 7 Olanzapine.”

A 29 year old patient “developed acute suicidal akathisia” and made a suicide attempt.

A 73 year old patient “experienced homicidal ideation and made a suicide attempt.”

A 60 year old woman “experienced suicidal ideation, suicide attempt and homicidal ideation – she attempted to kill her parents.”

A 69 year old patient “experienced suicidal ideation and was very anxious.”

A 16 year old girl attempted to “strangle herself with and IPod cord in the bathroom of the hospital. Agitation. She ran around crying and banging her fists of the walls and windows begging to be let out. … it lasted about 10 minutes before I could settle her.”

A patient of unrecorded gender and age “took a fistful of sleeping pills.”

A 35 year old patient “murdered his wife whilst on Prozac. He had also experienced suicidal thoughts.”

A female patient of unrecorded age “became seriously depressed, complained of headaches, and clenching jaw, was unable to sleep and started to self-harm. She began to have suicidal thoughts, was hyperventilating, agoraphobic, had five suicide attempts, was confused, tearful, phobic, aggressive, experienced akathisia and suspected serotonin syndrome. She experienced weird dreams, was impulsive, light headed, had numbness and tingling limbs and committed suicide by hanging on 11 September 2000 on the second attempt.”

A 50 year old woman “became more depressed whilst taking Prozac. She wanted to throw herself off a train or bus, had difficulty sleeping, was pacing and restless, had voice hallucinations, would look in the mirror and see a different person, had murderous thoughts, stiff legs, was hot a lot, felt she was in a delirium, could not concentrate, was angry, had numbness in her hands and pins and needles a lot in her body.”

A 19 year old male “had thoughts about killing himself which made him violent, tried to hit someone else, tried to hit a security guard with feelings of killing and tried to do physical damage. Tried to hurt himself and had thoughts of hurting other people. He was walking faster than normal. Experienced aggression, insomnia and was feeling high on Prozac. Also felt anxious and put on more than 20kg.”

A male of unreported age “experienced severe depression, cognitive impairment and was acutely suicidal.”

A 16 year old girl was “cutting herself, throwing herself against the walls while an inpatient”. She “intentionally overdosed on Fluroxetine” and “developed severe levels of aggression and violence.”

A 14 year old boy experienced “suicidal ideation.”

A female of unreported age “experienced suicidal ideation”.

A 16 year old girl experienced “excessive bleeding, psychosis, high blood pressure, severe diarrhea, sweating, tremors, violent, aggressive and suicidal behavior, serotonin syndrome.”

A 14 year old male experienced “severely increased suicidal ideation in two days with high level of intent and plan to jump in front of train. Previously no suicidal ideation and settled spontaneously within four days of ceasing Fluoxetine”.

A female patient experienced a “sudden and marked increase in hostility and verbal abuse of others and describes intrusive suicidal ideation. Seems agitated and restless”.

A 32 year old woman experienced “audio hallucinations, bright and blurred vision, made everything sound louder, constipation, increased suicidal thoughts and increased anxiety”

http://www.perthnow.com.au/news/western-australia/prozac-is-now-a-defence-for-murder/story-e6frg13u-1226227796937

Note from CCHR International: CCHR is the only organization to have decrypted the US FDAs Medwatch reports on adverse reactions to psychiatric drugs and compiled them in an easy to search database. This database is provided here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

CCHR has also compiled all international drug warnings and studies on psychiatric drugs here http://www.cchrint.org/psychdrugdangers/drug_warnings.php

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Tags: ADHD Drugs, Adverse reactions, aggression, agitation, Antidepressant, anxiety, Australia, black box warning, children, Defense, drugs, homicides, hostility, mania, murder, overdose, panic attacks, Peter Breggin, prozac, psychiatric, SSRI antidepressants, suicidality, suicides, TGA, tragic, US FDA, violence
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Record Breaking $327 Million Verdict Upheld Against Manufacturer of Antipsychotic Risperdal—Request for New Trial Denied

Wednesday, December 21st, 2011

PR Newswire – December 21, 2011

(Click image for international warnings on antipsychotic drugs) The "dear doctor" letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal.

The jury verdict in the case of State of South Carolina versus Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson, Inc. has been upheld and requests for a new trial denied, affirming groundbreaking $327 million in civil penalties against the manufacturers of the drug Risperdal.

Circuit Court Judge Roger Couch announced the rulings on December 20 through two written orders. One order denies the defendant’s motion for judgment notwithstanding the verdict or, in the alternative, for a new trial; the second order denies the defendant’s motion to alter or amend the judgment and/or for a new trial. John B. White, Jr. and Donald C. Coggins, Jr. of Harrison, White, Smith & Coggins, P.C., a Spartanburg-based law firm, along with John Simmons of the Simmons Law Firm, a Columbia-based law firm, and Bailey Perrin Bailey, a Texas based law firm represented South Carolina in the case.

“We are obviously very pleased with Judge Couch’s decision and his careful consideration of this matter,” stated John B. White, Jr. one of the attorneys representing the state in the case. “The verdict handed down by the jury is just and speaks the truth. The damages awarded further substantiated the level of deception Janssen used in business practices in our state. Once again, we have sent a clear message to drug companies that deceptive business practices will not be tolerated in South Carolina.”

On March 22, 2011 a jury in the Spartanburg Court of Common Pleas found that New Jersey-based Janssen willfully violated the South Carolina Unfair Trade Practices Act by engaging in unfair or deceptive acts or practices in the conduct of any trade or commerce in the “dear doctor” letter of November 10, 2003 and the drug label (package insert). This decision represents the first jury verdict that finds the defendant violated unfair trade practices since the inception of its pharmaceutical product. The “dear doctor” letter, sent to more than 7,000 doctors across South Carolina, and the package insert were found to be misleading about the safety and effectiveness of the antipsychotic drug Risperdal. Risperdal was introduced by Janssen in 1994 and by 2005, generated annual revenues in excess of $3.5 billion.

On June 3, 2011 civil penalties amounting to $327,073,700 were ordered by Circuit Court Judge Roger Couch based upon violations found with the drug labels and “dear doctor” letters. Regarding the drug label violations, the judge ruled that 509,499 package inserts were distributed with sample boxes, and levied $300 per violation for a total drug label awarded damages of $152,849,700. Regarding the “dear doctor” letter violations, the judge ruled that 7,184 letters were mailed and 36,372 were provided during sales calls, and levied $4000 per violation for a total “dear doctor” letter awarded damages of $174,224,000.

The combination of the drug label and letter damages of $327,073,700 amounts to the highest verdict brought against Janssen for the drug Risperdal.

http://www.marketwatch.com/story/record-breaking-327-million-verdict-upheld-in-janssen-case-and-request-for-new-trial-denied-2011-12-21

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Tags: $327 million, agitation, antipsychotic, anxiety, Cardiac arrest, dear doctor, Janssen Pharmaceuticals, judge, Risperdal, settlement, side effects, South Carolina
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