'Are You Sure You're Not Psychotic?' Asks Shameless Drug Company.

Commentary by Martha Rosenberg on OpEd News

If 100 million Americans have high cholesterol and only 8 million have schizophrenia or bipolar disorder, how can AstraZeneca's Seroquel not cholesterol pill Crestor be its second best selling pill?

Right after its number one pill, the Purple Performer Nexium?

Can anyone say disease mongering?

For years, AstraZeneca has tried to convince depressed people they are really bipolar and need to take the atypical antipsychotic Seroquel (quetiapine fumarate) which is only approved for schizophrenia or bipolar disorder.

"Is It Really Depression or Could It Be Bipolar Disorder?" trumpet the ads, urging unaware victims to take a Symptom Quiz and find out how sick they really are.

Full color spreads run in general interest magazines showing a rampaging woman her mouth contorted--think female Dark Knight--asking readers is this you?

"Are there periods of time when you have racing thoughts? Fly off the handle at little things? Spend out of control? Need less sleep? Feel irritable? You may need treatment for bipolar disorder."

Now the FDA says AstraZeneca can not--repeat not--market Seroquel for depression.

In December the FDA denied approval of Seroquel for major depressive disorder and asked the company instead for more information in a complete response letter (CRL).

Oops.

Of course to be AstraZeneca's number two pill, Seroquel must be used by more than the nation's schizophrenia and bipolar disorder patients who number only 8 million.

Almost half of Seroquel's 2006 sales were for off label uses says Bloomberg news including depression, autism and hyperactivity in adolescents and dementia, insomnia and Alzheimer's disease in the elderly.

Which wouldn't be so bad if Seroquel were safe.

But AstraZeneca faces nine thousand lawsuits--15,026 plaintiffs-- alleging the company failed to adequately warn patients about Seroquel side effects like severe weight gain, diabetes and pancreatitis.

Even as AstraZeneca vowed to defend the suits on their merits and not capitulate like Lilly with its $1.48 billion settlement with 32 states over similar drug Zyprexa this year, more bad ink spilled.

Documents surfaced in December that showed AstraZeneca knew as far back as 2000 about Seroquel's dangerous side effects at a pretrial hearing in a Tampa, Florida federal court for an upcoming Seroquel trial.

There was "reasonable evidence to suggest Seroquel therapy can cause" diabetes and related conditions wrote Wayne Geller, AstraZeneca's Global Safety Officer after analyzing available studies and internal trials says Bloomberg news.

Created in 1988 and approved for schizophrenia in 1997, Seroquel had an "efficient" journey from R&D to sales.

But in 2005 an article in the New England Journal of Medicine found Seroquel and other atypical antipsychotics except one had no advantage over the older antipsychotics like Haldol and Thorazine. Including the reduction in rigidity and tremors which was sold as their advantage over the old drugs!

The same year, an article in the British Medical Journal found Seroquel and a similar atypical antipsychotic were ineffective in reducing agitation among Alzheimer's patients and actually made cognitive functioning worse.

And in AstraZeneca's own clinical trials, 2.4 percent of people who began treatment with normal blood sugar became technically diabetic after 52 weeks on Seroquel plaintiff lawyer Paul Pennock testified at the Tampa pretrial hearing-- almost a 70 percent increase over those not taking the drug.

Nor can AstraZeneca claim it has marketed Seroquel legally and for approved uses only.

On Thursday, January 3, 2008, an AstraZeneca sales rep "made an unsolicited sales call to a physician at his office" and "stated that Seroquel was approved for treatment of Major Depressive Disorder (MDD)," charges a letter sent to James L. Gaskil, Pharm.D., Director of AstraZeneca's Promotional Regulatory Affairs from FDA Regulatory Review Officer Amy Toscano, Pharm.D. in December.

When the physician asked for written information, the rep sent a mailing with "information about Seroquel and Seroquel XR's use for MDD, and included summaries of eight clinical trials with referenced citations. This mailing was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative's statements," charges the FDA.

AstraZeneca reps were even coached to sell product using the A.A. Milne figures Tigger--bipolar!--and Eeyore--depressed!-- reports the pharma site Pharmalot.

The characterizations could come in handy.

In December AstraZeneca sought approval from the FDA for Nexium for the "overlooked GERD population" of "patients ages 0 to 1 year old."

"While some reflux and regurgitation are normal in infants and may not require medical treatment," says Marta Illueca, MD, AstraZeneca's Nexium Brand Medical Director, "Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants."

They may have bipolar disorder too.

A red flag about medicating young children

A column from the Monadnock Ledger-Transcript by Bonnie Harris

World-renowned Harvard child psychiatrist and director of the research team at Mass General Hospital Dr. Joseph Biederman has been found by Sen. Chuck Grassley of Iowa to have failed to report millions of dollars he has received over the years from the drug companies that make the drugs he prescribes for ADHD and bipolar disorder. Biederman and his research team are responsible for putting the diagnosis of bipolar disorder, previously thought to start in young adulthood, on children as young as three.

The reported diagnosis of bipolar disorder grew 40-fold between 1994 and 2003. And that data is five years old. Biederman is the number-one influence on doctors nationwide who diagnose and medicate children with bipolar and attention-deficit disorder. Antipsychotic drugs previously prescribed for adults are now being given to children as young as three -- one of whom died at age 4 from an overdose her mother gave her desperately trying to control her behavior.

According to Medco, a pharmacy benefits manager, 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 who were younger than 6 years old. Biederman claims, "The average age of onset is about four .... It's solidly in the preschool years."

Another 3-year-old was reported by his mother to have violent and explosive outbursts. After a year of treatment, his mother says a psychiatrist told her he thought her son was bipolar. As the boy's mother reported, "He would tell us, you know, 'You donlove me.' ''You don't like me.' 'I don't like myself.' 'I hate myself.' 'I'm stupid.' 'Nobody likes me.' 'I wanna die.' Four-year-olds don't talk like that." After the boy was put on a fourth medication, the family decided that was enough and took their son to Seattle Children's Hospital, where they were told he was not bipolar. He now takes medication for hyperactivity and a sleep disorder. And he's learning to deal with his explosive moods through a behavioral program. The family claims there is no comparison to the child they are parenting today compared to the one diagnosed as bipolar.

Dr. John McClellan, familiar with this boy's case, says the children's psychiatric hospital he runs in the state of Washington is filled with kids who have been misdiagnosed as bipolar. He says it has become a catchall for aggressive and troubled children.

Please, let this report be a red flag to all who have children too quickly diagnosed with ADHD, bipolar disorder, oppositional defiant disorder and others.

A young child claiming that no one loves him, that he's stupid, hates himself, or wishes he could die is often a child who is crying out for acceptance and attention from the influential adults in his life who have yet to understand him and his problems. With that understanding, adjusted expectations, removal of damaging behavior modification techniques such as punishment, many children, even those with chemical imbalances and disorders, can have appropriate behavior without medication. So many children in today's world react strongly to being told what to do and how to do it, to feeling disrespected with regular criticism and punishment, to not fitting in to a schoolroom full of other children who seem to be able to "get it" more easily, to being easily overstimulated or misunderstood for the reasons beneath their behavior.

Children who feel misunderstood are capable of highly inappropriate behavior that is trying to signal their need. They don't know how to say "Hey, this isn't working. My needs are not getting met." So they act it out -- louder and more dramatically the longer the misunderstanding. One of the children diagnosed with bipolar disorder had a father who had been accused of abuse. This factor was not part of the equation of the diagnosis.

We must look to the reasons -- the root causes -- of why our children don't, won't or can't do what we ask. Diagnoses often feel validating and relieving when our attempts at control don't work to get our children to comply. We can shift the blame onto to "problem" and we don't have to change how we parent.

Let me be absolutely clear that I do not consider the parent to blame. It is the culture in which we live that does not support parents to support their children. We are still in a children-must-do-as-we-say mentality and if they don't -- well now we can medicate them and we don't have to deal with it. Let me also say that are many cases in which medication is helpful and necessary.

But please lets start to put more effort into understanding children, their temperaments, the reasons for their behavior, their need for acceptance and compassion, their desire to get it right and their frustrations when they can't.

Let's not medicate those frustrations before thorough evaluations can be conducted by several professionals looking at the behavior from different perspectives.

And please let's take some responsibility for what we, their parents and teachers, are presenting to our children that become triggers for disruptive behavior.

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Bonnie Harris, M.S.Ed,. is the director of Connective Parenting. Past columns can be found on her Web site, http://www.connectiveparenting.com. E-mail questions or topic requests to bh@bonnieharris.com.

Exposed: Harvard Shrink Gets Rich Labeling Kids Bipolar

A column by Bruce E. Levine, as seen on AlterNet

What Dick Cheney is to the U.S. invasion of Iraq, psychiatrist Joseph Biederman is to the explosion of psychiatric medications in American children. Recently, Biederman was nailed by congressional investigators and the New York Times for overestimating just how greedy an elite shrink is entitled to be. Beyond a peek into the corruption of psychiatry at its highest levels, the scandal is an opportunity to reconsider the Big Pharma financed view of why kids become disruptive and destructive.

On June 8, 2008, the New York Times reported the following about Joseph Biederman: "A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful anti-psychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given congressional investigators."

Due in part to Biederman's influence, the number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003, and as Bloomberg News reported (September 2007), "The expanded use of bipolar as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for anti-psychotic drugs."

Pediatrician and author Lawrence Diller notes about Biederman, "He single-handedly put pediatric bipolar disorder on the map." Biederman has been in a position to convince many doctors to diagnose bipolar disorder in children and to medicate them with anti-psychotic drugs. In addition to being a professor at Harvard, Biederman is also chief of research in pediatric psychopharmacology at the Massachusetts General Hospital, which publishes more than 30 papers yearly on psychiatric disorders. And Biederman himself has authored and co-authored approximately 500 articles, 70 book chapters, and more than 450 scientific abstracts, as well as being on the editorial board of many professional journals.

Biederman (and two of his colleagues in the psychiatry department at Harvard Medical School who received an additional $2.6 million from drug companies from 2000 to 2007), by failing to report income from drug companies while at the same time receiving federal funds from the National Institutes of Health (NIH), violated rules designed to police conflicts of interest, according to Sen. Charles Grassley, R-Iowa. Grassley concluded, "Obviously, if a researcher is taking money from a drug company while also receiving federal dollars to research that company's product, then there is a conflict of interest." In one example, Biederman neglected to report his 2001 income from Johnson & Johnson (makers of the anti-psychotic drug Risperdal); Johnson & Johnson reported to Grassley that it had paid Biederman $58,169 in 2001.

In addition to his popularization of bipolar disorder for children, Biederman is one of the most significant forces behind the commonplace diagnosis of attention deficit hyperactivity disorder. Congressional investigators also found that Biederman conducted studies of Eli Lilly's attention deficit hyperactivity disorder drug Strattera that were funded by NIH at the same time he was receiving money from Lilly that exceeded the maximum amount permitted.

NIH rules state that researchers cannot take more than $20,000 in payments from a drug company whose drug they are funded by NIH to research and that researchers must disclose any payment received from a drug company of $10,000 or more. Apparently, for drug researchers taking federal funding from NIH, there is no law against being on the take from drug companies, but there are rules against greed.

Mental health treatment in the United States is now a multibillion-dollar industry, and all the rules of industrial complexes apply. Not only does Big Pharma have influential psychiatrists such as Biederman in their pocket, virtually every mental health institution from which doctors, the press, and the general public receive their mental health information is financially interconnected with Big Pharma. The American Psychiatric Association, psychiatry's professional organization, is hugely dependent on drug company grants, and this is also true for the National Alliance for the Mentally Ill and other so-called consumer organizations. Harvard and other prestigious university psychiatry departments take millions of dollars from drug companies, and the National Institute of Mental Health funds researchers who are financially connected with drug companies.

The corporate media, dependent on drug company advertising, occasionally reports on egregious scandals, but the corporate media is generally timid in reporting the big picture of how drug companies spread around millions of dollars to make billions of dollars.

There are certainly many troubled and disruptive American children who are sometimes extremely destructive to themselves or others. However, any attempt to understand these kids will be corrupted by financial dependency on drug companies, which have a vested interest in viewing all attentional, emotional, and behavioral difficulties as diseases that can be fixed with drugs.

There are several commonsense nondisease reasons why children become troubled and behave disruptively and destructively. For more than two decades, I have worked with annoying, disruptive, and destructive children. Many of these children had been previously diagnosed with attention deficit hyperactivity disorder, oppositional defiant disorder, bipolar disorder, and other serious psychiatric diagnoses, and they were routinely given a variety of drug combinations. Their parents most often reported that drugs were prescribed after being questioned by doctors about symptoms but without any exploration of reasons as to why their children were behaving as they did.

In America's assembly-line medicine, drug prescriptions are routinely written without any exploration of commonsense reasons as to why a child might be behaving problematically. Is the child resentful over a perceived injustice? Is the child experiencing deep emotional pain? Is the child simply bored? Does the child feel powerless? Does the child have low self-worth because a lack of life skills and thus behaves immaturely so no expectations are placed on him or her? Is the child starving for attention? Has the child lost respect for his or her parents because these adults have not acted like adults? Has the child's basic physical needs -- such as proper nutrition, physical activity, or sleep -- not been met? Routinely, few if any of these areas are explored before a prescription is written.

One of the most common reasons that children behave problematically is that well-meaning parents are having difficulty relating to their child's personality. Perhaps the parents are, by nature, compliant and conformist, and their child has a nonconformist and rebellious temperament. Good parents feel guilty when they have difficulty relating to their child, but all of us -- including doctors -- are human, and we all need to admit our limitations. The reality is that children who feel that nobody "gets them" are more likely to be troubled and disruptive. In another era, if a parent had difficulty relating to his or her child, there would more likely be at least one grandparent, uncle, aunt, friend, or other adult in the community who could easily relate. In our increasingly disconnected society (see Robert Putnam's Bowling Alone for a detailed picture of the destruction of American community), there are increasing numbers of children without even one adult who they believe relates to them.

Moreover, as society demands increasing machinelike efficiency, more of us -- children and adults -- will not be able to fit in; but a corporate media cannot confront a corporate culture that produces widespread painful alienation, which in turn creates a variety of attentional, emotional and behavioral problems. The corporate media may at times report on egregious corruption of an individual or an institution, but it does not ask this question: In an increasingly homogenized and standardized society, should we drug those who do not neatly fit in -- or should we consider transforming such a society?

60 Minutes Report: Who Killed Rebecca Riley?

Last night 60 Minutes broadcast a report on the death of Rebecca Riley, and on the storm of controversy that has resulted when it was found out that the 4 year old died as a result of an overdose of psychiatric medication for bipolar disorder, the disease formerly known as Manic Depression.

Bipolar disorder in a 4 year? Are the psychs crazy? In my opinion, yes they are.

The full 15 minute report is available on the website, including streaming video through CBS's own Flash player and a transcript. It is too long to provide in full here. Instead, we can provide some snippets that we find interesting.

"According to the medical examiner, her heart and lungs were damaged, and this was due to prolonged abuse of these prescription drugs, rather than one incident. Prolonged abuse of these prescription drugs," Couric remarks.

"Yes. And the doctor had Rebecca on .35 milligrams, daily, for months. And I didn't know anything about dosages. How much was fatal," Riley says.

The medical examiner ruled that Rebecca died of a drug overdose from a mix of medications. And that the amount of Clonidine alone would have been fatal.

Today, awaiting trial, Carolyn Riley says she now knows more about bipolar disorder than she ever did when her daughter was alive.

Asked if she thinks Rebecca was really bipolar, Riley says, "Probably not."

"What do you think was wrong with her, now?" Couric asks.

"I don't know," she says. "Maybe she was just hyper for her age."

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The prosecutor alleged at their arraignment in February that they were overdosing Rebecca by repeatedly giving her more medication than she was prescribed. "It was used on Rebecca, her sister and her brother for one simple purpose by these defendants: to knock them out and make them sleep," the prosecutor claimed.

But the Rileys claim that they were following doctor's orders. 60 Minutes wanted to talk to the psychiatrist, Dr. Kayoko Kifuji, but she declined. Instead 60 Minutes got a statement from her hospital: "The care we provided was appropriate and within responsible professional standards."

60 Minutes did obtain a copy of Rebecca's medical records. In them, Dr. Kifuji notes Rebecca's increased risk of mental illness because of her family history. She diagnosed Rebecca after Carolyn said her daughter was - quote - "driving me crazy" and her mood switches within a minute. She would eventually prescribe the preschooler more than ten pills a day.

Riley says she did feel that that was a lot of pills for a little girl, but she says she went ahead and gave Rebecca the prescriptions. "I trusted the doctor," she says.

Dr. Kifuji has stopped practicing, pending a ruling by the state medical board. But her lawyer has said she was just practicing mainstream psychiatry. It's now estimated that nearly one million children like Rebecca Riley have been diagnosed with bipolar disorder, or manic depression. And while some psychiatrists told 60 Minutes that early diagnosis is saving lives, a growing number of doctors say it is being over-diagnosed.

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Dr. John McClellan [...] says the children's psychiatric hospital he runs in Washington state is filled with kids who have been misdiagnosed as bipolar. He says it has become a catchall for aggressive and troubled children.

"I think it's a problem to label kids with a major adult psychiatric disorder when they're five years old or when they're three years old," Dr. McClellan says. "Little kids are not adults. And little kids do things that if an adult did them, it would be evidence of a mental health problem."

"Having said that, if someone is bipolar and it presents later in life, doesn't it make sense that these issues exist really from birth?" Couric asks.

"No, that does make sense," McClellan says. "The problem is symptoms like irritability or recklessness or high energy when you're an eight-year-old don't necessarily predict in the long run developing bipolar disorder. Some might. Do you expose all those kids to medications to prevent the one kid that's going to get it?"

Maybe we need to ask if psychiatry kills. After all, the psychiatrist is not being investigated by law enforcement, and maybe psychiatrists should be, especially when there is a death involved. The death of a child.