Friday, November 23, 2007

Eleven States have now Sued Antipsychotic Makers - More Lawsuits to Come

Arkansas Attorney General Dustin McDaniel claims that Janssen engaged in a direct, illegal, nationwide program of promotion of the use of the antipsychotic drug Risperdal for non-medically necessary uses. McDaniel accused the companies of deceptive marketing practices that pushed doctors to prescribe Risperdal much more than necessary. The lawsuit also accuses drugmakers of not including warnings on Risperdal's bottle about adverse effects such as neurological problems, weight gain and diabetes.

For articles and lawsuits on all the state lawsuits filed so far, see here:

9 states have sued Eli Lilly regarding Zyprexa  - Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania,  South Carolina, Utah and West Virginia.
 states have sued Janssen regarding Risperdal  - Arkansas, Louisiana,  South Carolina, Texas and Pennsylvana
2 states have sued AstraZeneca regarding Seroquel  - Pennsylvania, South Carolina 

Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing

LITTLE ROCK (AP)--Drug companies improperly marketed an anti-psychotic drug, Arkansas Attorney General Dustin McDaniel claimed Tuesday as he asked a state judge to force the firms to repay millions shelled out by the state's Medicaid program for unnecessary prescriptions.

McDaniel filed a lawsuit in Pulaski County Circuit Court against Janssen Pharmaceutica Inc., Janssen LP and Johnson & Johnson Inc. (JNJ). In the filing, McDaniel said the companies "engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal for non-medically necessary uses."

New Brunswick, N.J.-based Johnson & Johnson is the parent company of both Janssen Pharmaceutica and Janssen LP.

The lawsuit did not specify how much the state is seeking, but McDaniel has estimated that the state's Medicaid program spent about $200 million over eight years to pay for prescriptions for Zyprexa, Seroquel and Risperdal. The lawsuit filed Tuesday focuses solely on Risperdal.

Gabe Holmstrom, a spokesman for McDaniel's office, said the state will file similar complaints about the marketing of the other drugs. McDaniel has said other companies that will be targeted include Eli Lilly and Co. (LLY) of Indianapolis and AstraZeneca PLC (AZN), a joint venture by a British firm and a Swedish firm.

McDaniel has said the drugs were prescribed for uses not approved by federal regulators or indicated in labeling. McDaniel accused the companies of deceptive marketing practices that pushed doctors to prescribe Risperdal much more than necessary.

The lawsuit also accuses drugmakers of not including warnings on Risperdal's bottle about adverse effects such as neurological problems, weight gain and diabetes.

Ambre Morley, a spokeswoman for Janssen, defended the company and said it fully disclosed all information about Risperdal to doctors and government agencies.  


Monday, November 19, 2007

Should You Medicate Your Child's Mind?

Pittsburgh Post Gazette
Bipolar kids or bad parents?
At the urging of parents, doctors are medicating far too many kids who just need a better upbringing, according to
Dr. Elizabeth J. Roberts  who is a child and adolescent psychiatrist and the author of "Should You Medicate Your Child's Mind?"  
Sunday, November 18, 2007

In September 2007, researchers at Columbia University reported that there had been a 40-fold increase in the number of children diagnosed with bipolar disorder from 1994 to 2003 -- an increase which has shown no signs of slowing.

Worse than the current frenzy to diagnose children with bipolar disorder is the practice of medicating kids as young as 2 with the kinds of psychiatric medications that were once prescribed only to psychotic adults. The shocking reality is that the use of these potent anti-psychotic drugs in children increased more than 500 percent between 1993 and 2002.

This dramatic rise in childhood bipolar disorder has spurred a raging debate in the mental health field. Some psychiatrists insist that this incredible increase is entirely due to the identification of mentally ill children who had been previously overlooked.

Yet a 4,000 percent increase in childhood mental illness, specifically bipolar disorder, is simply implausible and difficult to justify based solely on improved diagnostic techniques. To the contrary, in the 30-plus years that I have been treating, educating and caring for children -- half of that time as a child psychiatrist -- I have found that the approach to diagnostics in psychiatry clearly has deteriorated over time, not improved.

There was a time when doctors insisted on hours of evaluation with a child and his parents before venturing a psychiatric diagnosis or prescribing a medication. Today many of my colleagues brag that they can complete an initial assessment of a child and write a prescription in less than 20 minutes. Many parents have told me it took a previous doctor less than five minutes to diagnose and medicate their child.

How, then, is it possible that in 2007 doctors are now able to identify hundreds of thousands of previously missed cases of bipolar disorder in children by reducing the time they spend with patients from multiple hours to just a few minutes?

On the other hand, there simply is no possible way that the number of children who actually have bipolar disorder has increased from approximately 20,000 to 800,000 in a nine-year period. Yet the arguments of skeptics are being dismissed by academics in psychiatry. Research psychiatrists appear to be more invested in defending their research conclusions -- funded by pharmaceutical companies -- than engaging in a meaningful discussion to examine these preposterous demographics.

What I find more astounding than the claim that there are 800,000 American children with bipolar disorder is the fact that there are that many children whose conduct is so aberrant that their parents are seeking psychiatric treatment for them.

The symptoms, which are regarded as evidence of bipolar disorder, usually are what most people recognize as ordinary belligerence. Children who have anger outbursts, who refuse to go to bed, who are moody and self-centered under the current standard of care in child psychiatry are being diagnosed with bipolar disorder. To most rational human beings, these behaviors describe an ill-mannered, immature and poorly disciplined child. Nonetheless, the temper tantrums of belligerent children are increasingly being characterized by doctors as the mood swings of bipolar disorder.

The over-indulgent parenting practices of the past 20 years have created a generation of dysfunctional children who are becoming increasingly more entitled, defiant and oppositional. In a poll by Associated Press-Ipsos, 93 percent of people surveyed said that today's parents are not doing a good job when it comes to teaching their kids to behave. According to Dan Kindlon, a Harvard psychologist, 50 percent of the parents he interviewed described themselves as more permissive than their parents had been.

The permissive parents of spoiled children seek refuge from blame by using the excuse that their child's angry outbursts are the result of a chemical imbalance. Since a psychiatric condition is completely beyond a parent's control, a diagnosis of bipolar disorder is the perfect alibi. Once a child has been diagnosed with bipolar disorder, a parent feels absolved of guilt or responsibility for the child's misbehavior and therefore, the parents' discipline practices cannot be called into question.

Parents looking for a psychiatric explanation for their child's misbehavior will find an abundance of support in the media and on the Web for the conclusion that their child's temper tantrums are due to a psychiatric disease rather than the result of bad parenting. Psychiatrists, for their part, are more than willing to accept, without question, the assessment offered by a parent. Doctors have found it easier and less contentious to comply with a parent's wish to have their child diagnosed with a psychiatric condition than to confront the parent with the notion that their own weak parenting is the root cause of the child's aberrant behavior.

Using the diagnosis of bipolar disorder, doctors then justify the sedation of these children with powerful psychiatric drugs. Even though some children treated with anti-psychotics may be temporarily sedated, their belligerent attitude continues unchanged. Of the many children I treat every year who had been previously diagnosed with bipolar disorder, not one of them stopped throwing tantrums after being treated with psychiatric medications. Yet doctors continue to misdiagnose and overmedicate children to appease frustrated parents in spite of the many serious, permanent or even lethal side effects.

Tragically, as in the death of Rebecca Riley, her parents administered the multiple medications prescribed by their psychiatrist for Rebecca's "bipolar disorder" until the meds killed her. A few weeks ago, in an interview on 60 Minutes, Rebecca's mother told Katie Couric that she now believes that her four-year-old daughter had been misdiagnosed, had never been bipolar, and that Rebecca was simply mischievous.

When it comes to misdiagnosing and overmedicating children, doctors have an unwitting, though not unwilling, accomplice -- the parent. Ultimately, it is the parent who is the gatekeeper for their child's health-care delivery. It is the parent who pursues psychiatric treatment for their child, fills the prescriptions and administers the medications. Parents have a duty to protect their children from the folly of this disastrous approach to childhood behavior problems.

Instead of grooming, feeding and educating the next generation of Americans to be the fittest, brightest, most competent contributors on the planet, we have indulged, placated and spoiled our children into dysfunctional misfits. We are teaching our children to use a psychiatric diagnosis to excuse their antisocial behaviors. This will inevitably lead to a greater reliance on psychiatric medications, which unfortunately do not endow an individual with improved self-control or maturity.

Under the guise of treating childhood bipolar disorder, the spoiling of American children not only undermines their healthy social development, but it also puts them at great risk for the serious medical complications inherent in the use of psychiatric medications, including death. 


Psych Drugs may be killing thousands of Elderly

St. Petersburg Times

 Dementia relief, with a huge side effect

The off-label use of some drugs is helping elderly patients, but may be killing thousands.

November 18, 2007

Two years ago, federal regulators sounded a dire warning: Elderly people with dementia who take drugs like Seroquel, Risperdal and Zyprexa could suffer the ultimate side effect.

They could die.

Yet today, about one in four nursing home residents still take these antipsychotic drugs. Sales to the elderly continue to rise, generating a total of $13-billion in revenues for their manufacturers this year.

The disconnect between government warnings about the increased risk of death and physician prescribing practices led a prominent Food and Drug Administration safety expert to make a stunning estimate.

Dr. David Graham, who had blown the whistle on the dangers of Vioxx, was back before a congressional panel in February. He testified that Zyprexa and other antipsychotics kill about 15,000 nursing home residents each year.

His pronouncement did not spark any followup investigations; it did not prompt government-sponsored research for safer alternatives. Instead, there was resounding silence.

* * *

Why was there no outrage?

Barbara Hengstebeck, executive director of the Tallahassee-based Coalition to Protect America's Elders, thinks she knows.

"A lot of people feel like the elderly in nursing homes are expendable," she said. "They're old anyway, they have dementia anyway, they're of no value to society. So what's the big deal? That's a sad commentary."

More here:

Monday, November 12, 2007

Again, Higher Mortality with Antipsychotics in Patients with Dementia - Journal Watch (General)

Snake oil salesman deserve more respect than these guys as at least snake oil produced just as good a result without driving the patient to violence or suicide. The deception is what irks me as they simply lied about any effectiveness from the start and hid the negative results. Is there a handcuff shortage or what! That is what these con men deserve.

Again, Higher Mortality with Antipsychotics in Patients with Dementia

Both conventional and atypical antipsychotics were associated with higher mortality.

Although antipsychotic drugs are prescribed widely to control neuropsychiatric symptoms in patients with dementia, recent studies suggest questionable efficacy (Journal Watch Oct 11 2006) and an association with increased mortality (Journal Watch Psychiatry Nov 2 2005). This retrospective cohort study compared mortality rates in patients with dementia who received antipsychotic drugs and those who received psychiatric medications other than antipsychotics.

Using a U.S. Veterans Affairs database, researchers identified 10,615 patients who began outpatient treatment with psychiatric medication following a dementia diagnosis. One-year mortality was 25% in users of conventional antipsychotics, 23% in users of atypical antipsychotics, 15% in users of other psychiatric drugs (e.g., antidepressants and anxiolytics/hypnotics), and 18% in a cohort of dementia patients who did not take psychiatric medication. After adjustment for medical comorbidities, mortality was significantly higher in patients who took antipsychotics (conventional or atypical) than in patients who took psychiatric drugs other than antipsychotics. Mortality in the non-antipsychotic medication group was similar to that in the no-medication group.

Comment: Once again, use of antipsychotic drugs was associated with increased mortality in patients with dementia. Although confounding could account for these results, statistical adjustment for confounding variables was extensive, and patients who received antipsychotics actually had slightly less measured medical comorbidity than those who received other drugs. Thus, this study gives us yet another reason to avoid antipsychotic drugs in demented patients.

Allan S. Brett, MD

ADHD Drugs Ineffective Over The Long Term

Apart from being ineffective over the long term, ADHD (attention deficit/hyperactivity disorder) drugs may also undermine your child's physical growth, a BBC television program, Panorama, has revealed. Scientists seem to be saying that claims made about ADHD drugs some years ago were overstated.

A long-term monitoring program involving 600 kids across the United States since the beginning of the 1990s was shown in the TV program - with some of its results. It is called the Multimodal Treatment Study of Children with ADHD. The study concluded that over the long term, such ADHD drugs as Concerta and Ritalin have no demonstrable benefit for children - long term means after three years of taking the drug(s).

The use of ADHD drugs in much of the developed world has doubled over the last five years - many say it has become a cure-all for bad behavior.

In 1999 studies had claimed that a one-year course of ADHD medication is more effective for a child with ADHD than behavioral therapy. These studies had a strong influence on how doctors would treat their patients. According to Professor William Pelham, University of Buffalo, USA, the findings were exaggerated.

Pelham says he believes the beneficial impact of medication in the first study was exaggerated. It had been thought that kids would have better outcomes if they were medicated for longer - however, it is not the case, there were no beneficial effects at all.

ADHD medications also stunt a child's growth, he/she runs a very high risk of losing height and weight, compared to children who do not take the medication.

Pelham said "In the short run they will help the child behave better, in the long run it won't. And that information should be made very clear to parents."

According to Pelham, behavioral therapy and a simple diet of Omega-3 may help a child as a first move.

Ritalin of no long-term benefit, study finds

Research released today raises questions about the long-term effectiveness of drugs used to treat attention deficit hyperactivity disorder (ADHD).

A team of American scientists conducting the Multimodal Treatment Study of Children with ADHD (MTA) has found that while drugs such as Ritalin and Concerta can work well in the short term, over a three-year period they brought about no demonstrable improvement in children's behaviour. They also found the drugs could stunt growth. 

More here:

Wednesday, November 07, 2007

The Psychoanalyst and "Public Relations"

How to make the population wholly reactive and screw everybody: 101


1 Hour, 6 Minutes well spent.


Monday, November 05, 2007

Cymbalta Causes Suicide

Cymbalta Causes Suicide

October 16, 2007

By Sach Oliver

People of all ages should be carefully monitored, particularly when starting Cymbalta or any other antidepressant treatment. The FDA recently issued a new warning about suicidal thinking in adults taking antidepressants and the FDA specifically singled out Cymbalta. If you, your family member, or a friend is taking Cymbalta, please be careful.

Cymbalta's generic name is duloxetine. The FDA singled out Cymbalta because it has a higher than expected rate of suicide attempts. Cymbalta is made by Eli Lilly. Eli Lilly has a clinic at Indiana University Medical Center in Indianapolis. Traci Johnson, who did not suffer from depression, volunteered for trial testing of Cymbalta. As a result of Cymbalta, Traci hung herself in one of the clinic's showers. Traci was the fifth patient to commit suicide after taking Cymbalta in clinical trials. For heaven sakes, please do not volunteer for any clinical testing involving Cymbalta.

Why do you think Eli Lilly pushes this drug onto so many doctors and then onto the patients? Some analysts believe that Cymbalta will generate revenue up to $3 billion by 2009. This is why every night while watching TV you see dozens of Cymbalta commercials.

Our firm is handling Cymbalta suicide cases. Not until after meeting the families of the Cymbalta victims did I immediately call my own family to make certain they were not taking Cymbalta. My heart stopped to learn that several of my own family members had taken Cymbalta and no one had warned them about the consequences. Please, before even thinking of taking Cymbalta, research the drug thoroughly and make certain the patient is closely monitored

Provigil Warnings / Weight Control in Kids / Cancer & Psychosocial Needs

The last sentence shouldn't stop the shrinks. "Finally, the label reminds providers that Provigil is not approved for use in children for any indication."

Physician's First Watch for October 25, 2007
David G. Fairchild, MD, MPH, Editor-in-Chief

Warnings Added to Provigil Label

Simple Measures Help Prevent Excess Weight Gain in Kids

Panel Devises Plan for Meeting Psychosocial Needs of Cancer Patients

Warnings Added to Provigil Label

Warnings about the potential for serious rashes and psychiatric symptoms have been added to the prescribing information for the wakefulness-promoting agent Provigil (modafinil), the FDA has announced.

Although rare, serious rashes — including Stevens-Johnson syndrome, toxic epidermal necrolysis, and rash with eosinophilia and systemic symptoms — have been reported in children and adults on the drug. In addition, multiorgan hypersensitivity reactions have occurred.

Some patients also report experiencing anxiety, mania, hallucinations, and suicidality on the drug. Thus, "caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania," the label states.

Finally, the label reminds providers that Provigil is not approved for use in children for any indication.

FDA alert (Free)

Provigil label (Free PDF)

Authorities say Pittsburg woman committed suicide - fluoxetine (Prozac) and benzodiazpines (Valium-Xanax type drug) + meth

Published October 25, 2007 09:08 pm - COLUMBUS, Kan. — A Cherokee County Sheriff’s Department investigation has concluded that a Pittsburg woman who was found dead May 21 in her car near Weir shot herself, chief Detective Doug Wydick said Wednesday.

Authorities say Pittsburg woman committed suicide

By Roger McKinney

COLUMBUS, Kan. — A Cherokee County Sheriff’s Department investigation has concluded that a Pittsburg woman who was found dead May 21 in her car near Weir shot herself, chief Detective Doug Wydick said Wednesday.

Janet McMurray’s autopsy, on file in the Cherokee County District Court clerk’s office, stated McMurray died of a single gunshot wound to her chest. The bullet went through her body and entered the car seat behind her.

The autopsy was performed by Dr. Erik Mitchell, with Frontier Forensics, Topeka, on May 22. His final report was filed Aug. 30.

Mitchell wrote that he had received information from investigators that McMurray was found dead in her vehicle and had partially wrapped herself in a blue tarp. A gun was found inside the car. He wrote that notes were found indicating that she had self-destructive thoughts and that she was on methamphetamines and benzodiazepines, a sedative.

Mitchell wrote that her body remained partially encased in the blue, plastic tarp when the autopsy began. She was wearing a wrist band labeled “admit one.”

The toxicology report notes that McMurray’s blood contained fluoxetine, an antidepressant, at a higher concentration than is used for standard therapeutic treatment and was at the lower border range for fluoxetine-induced deaths.

The concentration of methamphetamines in her blood was in the range where death can occur, according to the report.

Drugging Our Poor

"The increasing correlation between psychiatric visits and medicated
therapy may call into question whether mental screening actually
benefits the public. In 2002, the Journal of the American Academy Child
& Adolescent Psychiatry (JAACAP) reported that 9 of 10 children referred
to a psychiatrist received psychotropic medications as part of their
treatment. Dr. Peter Breggin, psychiatrist and founder of ICSPP,
asserted that psychotropic drugs are insufficient treatment because they
"deaden the person's response to life. That is not dealing with
psychosis. Psychosis has to do with a very complex way of thinking."

"TeenScreen's earlier reliance on passive parental consent, the
program's high rate of false positives, and concerns about privacy
invasion have caused many groups to publicly denounce its policies."

Sunday, November 04, 2007

LA TIMES - DSM Psych - "We don't know what we're doing"


Fine-tuning diagnostic labels for kids

November 5, 2007

A project that could help rewrite psychiatrists' diagnostic guidebook is underway at UCLA. The work, launched this summer by the National Institutes of Health, aims to put the diagnosis of several major psychiatric conditions -- including attention deficit hyperactivity disorder, bipolar disorder and schizophrenia -- on a more rigorous footing by identifying and mapping the biological processes that may link these diseases or distinguish them from one another.

Under the $22.5-million project, UCLA neuroscientists expect to explore how weakness in two cognitive skills -- working memory (sometimes called short-term memory) and impulse control -- may better identify people who have, or are developing, psychiatric disease. If clinicians can test patients for such measurable deficits, they might one day abandon the imprecise diagnostic labels and the trial-and-error medication decisions that characterize psychiatry today, says UCLA neuroscientist Robert Bilder, who leads the project.

Until then, it's hard to know whether mental-health professionals are overdiagnosing or underdiagnosing psychiatric disorders in kids or adults, Bilder says. Instead, he says, "there's an implicit misdiagnosis, since we don't know what we're doing."

-- Melissa Healy

Friday, November 02, 2007

Experts demand end to child drugging...

Washington, DC: On October 12, 2007, experts in the field of psychiatry and child development from all over the world arrived in Washington to attend the annual conference of the International Center for the Study of Psychiatry and Psychology. This year's conference focused on one specific goal - to end the mass-prescribing of psychiatric drugs to children.

In addition to the seminars and presentations by psychiatric experts and academics, other presenters and speakers at the conference varied from patients and leaders of patient advocacy groups to social workers, nurses, educators, authors and lawmakers.

The conference included presentations on the serious health risks associated with the new generation of psychiatric drugs now commonly prescribed to children, including attention deficit medications, antidepressant drugs and atypical antipsychotics.

Much of the outrage expressed by speakers and attendees alike stemmed from the recommendation by the Bush Administration's New Freedom Commission on Mental Health to conduct "universal" mental illness screening of all Americans from the age of "0" on up to the oldest living citizen.

More here: