The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

World Experts Demand End to Child Drugging in the US – Part I

Evelyn Pringle October 25, 2007

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.

The main topics of debate included the recommendations by the NFC to screen public school children in all 50 states with a program called TeenScreen and the implementation in many states of programs modeled after TMAP (Texas Medication Algorithm Project), a treatment plan that mandates the use of the new expensive psychiatric drugs with all patients diagnosed with mental disorders who are covered by public health care programs such as Medicaid.

The new generation of antidepressant drugs include Prozac and Cymbalta by Eli Lilly; Paxil marketed by GlaxoSmithKline; Zoloft by Pfizer; Celexa and Lexapro from Forest Laboratories; Effexor by Wyeth, as well as generic versions sold by Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

The new generation of atypical antipsychotics include Zyprexa by Eli Lilly; Risperdal marketed by Janssen Pharmaceuticals, a subdivision of Johnson & Johnson; Abilify by Bristol-Myers Squibb; Clozaril sold by Novartis, and Geodon by Pfizer.

Many of the presentations at the conference focused on the pharmaceutical industry’s role in the invention of both TMAP and TeenScreen and the many financial ties between the drug makers, the Bush administration, a group of psychiatrists, and state policy makers largely credited with the creation and promotion of these two programs.

Minnesota Pediatrician Dr Karen Effrem produced a briefing booklet and CD entitled, “The Dangers of Universal Mental Health Screening,” which is available at the ICSPP web site at http://www.icspp.org/.

During her presentation, Dr Effrem explained the history of TMAP and TeenScreen, a 52-question computerized self-administered questionnaire that takes 10 minutes to complete and was developed by Columbia University Children’s Psychiatric Center.

“The New Freedom Commission, TMAP and TeenScreen,” Dr Effrem notes, “appear to be a blatant political/pharmaceutical company alliances that promote medication, and more precisely, more expensive antidepressants and antipsychotics, which are at best of questionable benefit and come with deadly side effects.”

During the portion on TeenSceen, Dr Effrem cited one study which found an 82% false-positive rate in students screened, meaning that if 100 students were tested, 82 were wrongly flagged as having some mental disorder. “TeenScreen’s extremely high false-positive rate makes the test virtually useless as a diagnostic instrument,” she stated.

According to Dr Effrem, it is “difficult, if not impossible” to diagnose young children accurately, due to very rapid developmental changes. “Often, adult signs and symptoms of mental disorders in adults are characteristics of normal development in children and adolescents,” she explains.

Since the arrival of selective serotonin reuptake inhibitors antidepressants (SSRI’s) and atypical antipsychotics on the market, countless studies have shown the so-called “wonder drugs” to be ineffective and harmful to children. But for years, drug companies have manipulated data, suppressed negative clinical trials and published only the studies that showed positive results.

The truth is that the mass drugging of the entire population in the US with SSRI’s has accomplished nothing when it comes to reducing suicidality. According to a June 2005 study, primarily funded by the National Institute of Mental Health, in the Journal of the American Medical Association, although people who were likely to attempt suicide were far more likely to be treated with antidepressants in 2001-2003, the rates for suicide attempts, gestures and ideation remained basically unchanged for over a decade.

To reach their conclusions, the researchers analyzed a survey of close to 10,000 adults and compared it to a similar survey conduced 10 years earlier for the years 1990-1992.

The prescribing rates for psychiatric drugs increased every year during that time period. On January 13, 2005, WebMD reported a government study that reviewed the patterns of treatment from the mid-1990’s to 2001, and found more Americans than ever were being treated for depression, substance abuse and mental disorders but that the treatment was most often limited to drugs alone.

The cost of mental health drugs rose 20% each year, and according to study, about 80% of the increase could be explained by the increased prescribing of antidepressants and atypical antipsychotics.

A “Myth and Fact Sheet” presented at the conference reports that, in 2003, more money was spent on psychiatric drugs for children than on antibiotics and asthma medications.

By tugging at the heartstrings of parents in claiming TeenScreen is a suicide prevention tool, the drug profiteers have managed to set up the bogus screening program in towns and cities all across America, and the promoters never seem to tire of using the line that suicide is the third leading cause of death in teens and adolescents in the US. However, experts explain that the rate of suicide remains high on the list only because persons in this age group seldom die of any causes.

During his presentation at the conference, neurologist Dr Fred Baughman, a recognized authority on psychotropic drugs and author of “The ADHD Fraud,” stated: “Psychiatry and the pharmaceutical industry married and launched the joint market strategy of calling all emotional and behavioral problems ‘brain diseases’, due to ‘chemical imbalances’, needing ‘chemical balancers’ – pills.”

“Every time parents are lead to believe that their child’s emotional or behavioral problems are a ‘disease’ due to an abnormality in the brain,” Dr Baughman says, “they are lied to.”

He discussed the overdose death of 4-year-old Rebecca Riley in December 2006, who was diagnosed with ADHD and Bipolar Disorder when she was only 2-and-a half-years old. She was kept on a cocktail of 3 psychiatric drugs, none of which were FDA approved alone for a child her age, much less together, until the time of her death.

The title of his presentation was, “Who Killed Rebecca Riley,” and Dr Baughman placed the blame squarely on the gang of industry shills who are largely credited with the invention and promotion of ADHD and Bipolar Disorders in small children, including among others, Dr Joseph Biederman, Dr Steven Hyman, Dr Jerome Groopman and Dr David Shaffer, the brainchild credited with inventing TeenScreen.

The Fact Sheet reports a 2006 review of the FDA’s MedWatch adverse event database, which found 45 deaths in children due to toxicity of antipsychotics.

Dr Baughman calls the use of the “chemical imbalance theory,” the “biggest health care fraud” and “mass character assassination” in human history, and says it must be abolished.
Dr Dominick Riccio, executive director of the ICSPP, also weighed in on the “chemical imbalance” theory and said that child drugging in the US is based on a “hypotheses with no validity,” propagandized by the pharmaceutical industry.

He warned that there is absolutely no scientific evidence to validate the “chemical imbalance” used to justify the drugging of America’s “most precious commodity,” and “if we continue to damage our children, there will be hell to pay down the line.”

Dr Riccio called for “integrity” in the psychiatric profession and told professionals in attendance, “if you do not understand child development, you should not work with children.”

Washington psychiatrist, Dr Joseph Tarantolo, warned that the new selective serotonin reuptake inhibitor antidepressants are not “selective,” “the drugs are cannons,” he said.
He also explained that the “so-called” antipsychotic drugs do not affect psychosis, “they deaden a person’s response to life.”

According to Dr Tarantolo, because the drugging began 10 or 15 years ago, “we are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs.”

He says an epidemic is defined as 1% of the population and warns that there will be far more than 1% injured by these drugs.

The bribing of prescribing doctors in the field of psychiatry is rampant. A June 26, 2007, report by the Attorney General of Vermont of payments made to doctors by drug companies during the period July 1, 2005 through June 30, 2006, shows that, by category, psychiatrists were the largest beneficiaries, and 11 psychiatrists received a combined total of $502,612.02, or more than 22% of the overall total of all payments.

For the past 4 years, psychiatric drug makers have remained high on the list of the top 10 spenders in Vermont, with Paxil maker Glaxo holding the number one position in both 2003 and 2004.

An analysis of Minnesota disclosure records by the consumer watchdog group Public Citizen, reported by the Pioneer Press, found a similar windfall for shrinks in that state between 2002 and 2006, with psychiatrists receiving combined payments of $7.38 million.

However, the drug maker’s off-label sales of antipsychotics are now under fire due to the greed involved in the billings submitted for Medicaid patients. In September 2007, Arkansas became the latest state to sue the drug makers when it announced the filing of a lawsuit against Lilly, Janssen and AstraZeneca for “improper and unlawful marketing,” of their drugs and concealing the serious health risks associated with their use.

The Medicaid fraud lawsuits seek to recover not only the money paid for the antipsychotics but also the cost of medical care for all the patients who were injured by the drugs known to cause drastic weight gain, abnormal blood sugars and diabetes.

The bribing of shrinks may be coming to an end as well because, in addition to Medicaid fraud lawsuits, states are also going after the prescribers. On August 16, 2006, the Houston Chronicle reported that five doctors in Texas were notified that they needed to return the Medicaid money paid for drugs they prescribed as part of a two-year effort to better regulate how children are prescribed psychiatric drugs in that state.

The Chronicle reported that a review of a two-month period of Medicaid records in 2004 determined that over 63,000 foster children were on stimulants, antipsychotics or antidepressants, with nearly one-third of the kids taking drugs from more than one of the three classes at the same time and that doctors had filed 114,315 claims worth over $17 million.

The experts at the ICSPP conference reported that the over-prescribing of attention deficit drugs is also out of control, even after the new warnings were issued. The ICSPP Fact Sheet notes that the new labeling changes for ADHD medications include: “Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.”

“Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional can be caused by stimulants at usual doses,” the warning also notes.

Psychiatrist Dr Grace Jackson, author of “Rethinking Psychiatric Drugs,” says the fact that cardiovascular risks are associated with ADHD drugs is not news. “As early as 1977,” she says, “research documented the cell changes associated with heart muscle enlargement in a chronic consumer of Ritalin.”

“The connection between stimulants, cardiovascular disability, and death has long been documented in the medical literature,” she states.

However, no slow down in prescribing rates for these drugs is likely. In 2005, according to a December 15, 2006, report by Research and Markets, the value of the ADHD market was $2.6 billion, and it is now the 9th largest segment of the CNS market with growth of 8% year-on-year. Approximately 90% of global sales were derived from the US in 2005, and by 2012, global sales are forecast to reach $4.3 billion.

In February 2007, the FDA finally directed the drug makers to develop Patient Medication Guides to inform patients about the adverse effects of Adderall, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Metadate CD, Methylin, Ritalin and Strattera.

However, experts say children are being damaged by ADHD drugs in ways that will never show up in a pamphlet. According to child psychiatrist Dr Stefan Kruszewski, “children who are medicated early do not learn to develop coping strategies that work as they move through different developmental stages.”

“We are encouraging a generation of youngsters to grow up relying on psychiatric drugs rather than on themselves and other human resources,” says Dr Peter Breggin, ICSPP founder and author of, “Talking Back to Ritalin.”

“In the long run, we are giving our children a very bad lesson,” he warns, “that drugs are the answer to emotional problems.”

“The problem with the diagnostic assessment of ADHD,” Dr Kruszewski explains, “is that the prescreening statement is so inclusive that virtually every child meets prescreening criteria and therefore every child, under prevailing treatment modalities, becomes eligible for ‘chronic’ medication therapies.”

He also points out that, once children are screened, “they become ‘eligible’ for additional screening for conditions such as social anxiety, bipolar disorder, and obsessive-compulsive disorder, and too often end up on even more drugs.”

Dr David Stein, author of, “Unraveling the ADD/ADHD Fiasco,” also warns that stimulant drugs are “near the top of the heap of potentially addictive drugs.”

He says there is no way of pinpointing which children are at risk of becoming addicted, and “psychiatry has an extremely poor track record for treating addiction problems.”

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, front groups, Kifuji, NAMI, NFC, Spitzer, SSRIs, TeenScreen

It’s Time To Sue Doctors Who Prescribe Drugs Off-Label – Part I

Evelyn Pringle August 15, 2007

Critics say the tens of thousands of lawsuits filed against the drug giants have had little impact when it comes to dismantling the off-label drug marketing schemes and therefore, there needs to be an all out campaign of highly publicized lawsuits filed against the doctors serving as middle man pushers, one by one by one.

It is illegal for a drug company to promote a drug for uses not listed on the FDA-approved label for the simple reason that the drug maker has not successfully proven to the FDA that the drug is safe or effective for uses not listed on the label.

However, because of a legal loophole wider than a barn door, doctors have the authority to prescribe a drug for an unapproved use if they believe a patient would benefit, which means all a drug maker has to do is find doctors willing to promote the off-label uses and deny the drug company’s involvement in the scheme.

And recent studies on prescribing habits have shown that the drug companies have found thousands of doctors all across the US in every field of medicine more than willing to participate in drugging for profit schemes by writing prescriptions that result in fees paid for monthly office visits that require no more than a few minutes of the doctor’s time.

Critics says the first round of lawsuits should be filed against the quacks involved in prescribing psychiatric drugs to millions of children who are now stigmatized for life by a label of mental illness and will face a life-time of discrimination in finding jobs and obtaining health insurance due to a trail of medical records showing a history of taking drugs used to treat the most severe mental illnesses of major depression, bipolar disorder and schizophrenia.

Critics point out that doctors in fields of medicine that have never before involved the diagnosing and treatment of mental illness would never have come up with the idea to prescribe psychiatric drugs off-label to children without the illegal prompting from the drug makers.

For example, on June 20, 2004, the Florida Sun-Sentinel reported that a review of Medicaid records in that state found doctors with specialties in dermatology, nutrition, anesthesiology, ophthalmology, allergy, radiology, plastic surgery, hematology, obstetrics, pathology, diabetes, rheumatology, and hand surgery wrote prescriptions for psychotropic drugs for children aged 12 and younger between September 2002 to September 2003.

In record numbers, children are being fed powerful psychiatric drugs, often in combination with each other, including selective serotonin reuptake inhibitor antidepressants like Paxil, Cymbalta, Lexapro, Celexa, Prozac, and Zoloft and the new generation of “atypical” antipsychotics, such as Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify.

Children are also receiving drugs for ADHD in record numbers including the stimulants Adderall, Dexedrine and Ritalin, often combined with drugs approved only to treat adults with epilepsy such as Depakote and Neurontin.

Experts say its not uncommon to see children on an SSRI, an antipsychotic, a stimulant drug, and a sleeping medication all at the same time. Neurologist, Dr Fred Baughman, author of, The ADHD Fraud, warns that multiple drugs are being prescribed together in combinations that are lacking of any scientific basis.

Most critics say the ever-expanding list of invented disorders is the driving force behind this mass-drugging for profit. “While the drug companies certainly are getting rich providing mind-altering drugs for psychiatry’s made-up mental disorders, the fault for the fraud of psychiatric diagnosing lies with the psychiatric community,” says investigative journalist, Kelly Patricia O’Meara, author of “PSYCHED OUT: How Psychiatry Sells Mental Illness and Pushes Pills That Kill”.

Harvard Instructor Dr John Abramson, author of, “Overdosed America,” calls it a “progressive medicalization” of undesirable behavior in children. “We have seen this in the enormous proliferation of stimulant medication use,” he notes, “far out of proportion to use in other countries.”

Now the diagnosis of bipolar disorder in children is rising in parallel, he says, and clearly it is the drug industry driving this medicalization to sell more products.

Other experts agree. On February 15, 2007, the New York Times reported comments by Dr Bessel van der Kolk, a professor of psychiatry at Boston University who also treats children at a trauma clinic. “Most of the patients I see who have been misdiagnosed,” she said, “have been told they have bipolar disorder.”

“The diagnosis is made with no understanding of the context of their life,” she said. “Then they’re put on these devastating medications and condemned to a life as a psychiatry patient.”

Former Clinical Director of Kingsboro Psychiatric Center in Brooklyn, Dr Nathaniel Lehrman also says, “relying on medication as the definitive treatment of psychiatric complaints, rather than addressing their real causes in patients’ lives, is responsible for the gross overuse of psychiatric medications, especially among children.”

He is especially critical of the ADHD diagnosis. “Its “symptoms” acting impulsively; easy distractibility; interrupting others; constant fidgeting or moving; and difficulty in paying attention, waiting one’s turn, planning ahead, following instructions, or meeting deadlines, can be found in any of us,” Dr Lehrman points out.

A study in the August 3, 2004 Archives of Pediatric Adolescent Medicine reported that the rate of antipsychotics use by children covered by a public health care program in Tennessee had nearly doubled between 1996 and 2001, and had increased 61% with preschoolers.

A review of Medicaid records in Ohio for the month of July 2004, found 18 newborn to 3 year-old babies had been prescribed antipsychotics and 28 more in the same age group were on antidepressants, according to the April 25, 2005 Columbus Dispatch.

According to the December 2006 Special Report entitled, “Foster Children – Texas Health Care Claims Study,” in 2004, psychotropic drugs accounted for more than 76% of the cost of all medications prescribed to foster children in Texas on Medicaid.

Of all drugs prescribed, the study found antidepressants, antipsychotics and stimulants were the most frequently prescribed and half of the children in a sample of 472, received 3 or more drugs from different classes at the same time and 27.5% received 4 or more, with antidepressants and antipsychotics being the two most commonly prescribed together.

The same year, Texas also spent nearly $4.8 million on nearly 43,000 anticonvulsants used as mood stabilizers for about 4,500 foster children, including 133 aged four and younger, as well as close to $4.5 million on 45,318 stimulant prescriptions for more than 6,500 foster children including nearly 200 who were aged 4 and under.

There were also nearly 2,500 prescriptions written for hypnotic/sedative drugs for about 1,000 foster children, including 232 four and younger to treat anxiety or sleep disorders.

In addition, more than 400 of the foster children were prescribed antidyskinetics drugs to control side effects caused by the antipsychotics which included tremors, tics, dystonia, dyskinesia and tardive dyskinesia.

Last year in Florida, Medicaid records show that more than 1,100 children 6 and under were prescribed antipsychotics at a cost to Medicaid of nearly $1,800 per child and most were prescribed to treat mood disorders, depression, anxiety or ADHD. In addition, 367 Florida toddlers 3 and under were prescribed ADHD drugs in 2006.

The debate about the over-drugging of children has been festering behind the scenes for a decade, but the all-out war between medical professionals recently exposed in the media is the result of the widespread outrage over the highly publicized overdose death of the 4-year-old toddler, Rebecca Riley in Hull, Massachusetts in December 2006.

The outrage began when the police investigation revealed that Rebecca was given the diagnoses of ADHD and bipolar disorder by Dr Kayoko Kifuji, at the Tufts-New England Medical Center, when she was only 2 and half-years-old and placed on a 3-drug cocktail of Clonidine, a drug approved to treat adults with high blood pressure, Depakote an antiseizure drug approved to treat adults with epilepsy, and Seroquel, approved to treat adults with schizophrenia or the mania of bipolar disorder.

Investigators also reported that Dr Kifuji had diagnosed Rebecca’s 6-year-old sister and 11-year-old brother with the same disorders and kept them on the same 3-drug cocktail even longer than Rebecca. The mother and father were also diagnosed mentally ill and the whole family was covered by Medicaid, according to police reports.

In a June 17, 2007 report in the Boston Globe, reporter Scott Allen discussed Rebecca’s death and the rising dissent within the medical profession. Under the headline, “Backlash on bipolar diagnoses in children,” he noted that psychiatrist, Dr Joseph Biederman of Massachusetts General Hospital, “could be credited more than any other” for convincing Americans that even small children can develop bipolar disorder.

“From his perch as one of the world’s most influential child psychiatrists,” Mr Allen wrote, “Biederman has spread far and wide his conviction that the emotional roller coaster of bipolar disorder can start “from the moment the child opened his eyes” at birth.”

Critics also identify Dr Janet Wozniak, director of the Pediatric Bipolar Disorder Research Program at Massachusetts General, as a researcher who has worked side by side with Dr Biederman to promote the bipolar diagnosis for children.

On June 19, 2007, pediatrician, Dr Lawrence Diller, author of “Should I Medicate My Child,” publicly denounced their research and what he called “misguided standards of care” in an editorial in the Boston Globe and informed the world that he had recently done “the nearly unthinkable” at a medical conference on bipoloar disorder in children.

“I charged another doctor,” he stated, “with moral responsibility in the death last December of Rebecca Riley, a 4-year-old girl from Hull.”

He acknowledged that he understood the risks of naming names. “Yet I felt compelled,” he said, “to name Joseph Biederman, head of the Massachusetts General Hospital’s Pediatric Psychopharmacology clinic, as morally culpable in providing the “science” that allowed Rebecca to die.”

According to Dr Diller, Dr Biederman shocked the child psychiatric world in 1996 by announcing that nearly a quarter of the kids he was treating for attention deficit disorder also met his criteria for bipolar disorder. “Up until then,” he says, “bipolar disorder was rarely diagnosed in teenagers and unheard of in prepubertal children.”

Dr Diller says there are thousands of potential Rebecca Rileys being treated with multiple psychiatric drugs because Dr Biederman has said it’s OK and necessary.

Critics say the tens of thousands of lawsuits filed against the drug giants have had little impact when it comes to dismantling the off-label drug marketing schemes and therefore, there needs to be an all out campaign of highly publicized lawsuits filed against the doctors serving as middle man pushers, one by one by one.

It is illegal for a drug company to promote a drug for uses not listed on the FDA-approved label for the simple reason that the drug maker has not successfully proven to the FDA that the drug is safe or effective for uses not listed on the label.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, Kifuji, KOL, SSRIs

It’s Time To Sue Doctors Who Prescribe Drugs Off-Label – Part II

Evelyn Pringle August 17, 2007

Experts say the serious side effects associated with the use of the 3-drug cocktail of Seroquel, Depakote and Clonidine prescribed to Rebecca Riley when she was 2 and a half-years-old that resulted in her slow and torturous death two and a-half-years later should be known to all prescribing doctors by now.

According to police reports, Rebecca was under the care of Dr Kayoko Kifuji, at the Tufts-New England Medical Center, and her mother said Dr Kifuji prescribed Depakote to control Rebecca’s mood, at a dose of 3 capsules in the morning and 3 capsules at night, administered by breaking the capsules open and sprinkling the contents on her tongue.

She said Seroquel was prescribed to help calm Rebecca and to help her stay asleep and she received 25 mg in the morning and 175 mg at night. Clonidine was also prescribed to help her calm down and sleep and was given at a dose of .1 mg tablets, divided in half so that Rebecca took a half tablet in the morning, a half tablet at noon, a half tablet at 3:00 pm and two full tablets at bedtime, according to the police report.

Experts say this combination of drugs has never even been studied in animals much less humans. As far back as September 2003, University of Maryland researcher Julie Magno Zito, said in an interview with Mother Jones Magazine, that she was surprised to discover that the new antipsychotics were being used to treat kids who “act out,” and was also worried about Clonidine, a blood pressure drug that was being given to children with ADHD, and even to “sleep resistant” babies, she said.

Clonidine is among the top 5 psychotropic drugs used with children, Dr Zito said, and yet, “no one is tracking what effect it may have on a child’s cardiovascular system to take a drug that speeds up the heart, often along with one that slows it down,” she warned.

Poison centers nationwide are receiving increasing reports of children suffering toxic effects from Clonidine, according to a University of Maryland School of Pharmacy study. “This is a really potent drug that can have an adverse effect at a dose as small as one pill,” says the study’s author Wendy Klein-Schwartz.

The new “atypical” antipsychotics include AstraZeneca’s Seroquel, Eli Lilly’s Zyprexa, Abilify by Bristol-Myers Squibb, Johnson & Johnson’s Risperdal and Geodon by Pfizer.

According to Scott Allen’s report in the June 17, 2007, Boston Globe, “Psychiatrists used to regard bipolar disorder as a disease that begins in young adulthood, but now some diagnose it in children scarcely out of diapers, treating them with powerful antipsychotic medications based on Biederman’s work.”

In 2001, he says, the Massachusetts General researchers published what he refers to as another “enormously influential” study in the Journal of Child and Adolescent Psychopharmacology which included 23 children who were diagnosed with bipolar disorder and given Zyprexa for 8 weeks.

The researchers reported that Zyprexa lessened the outbreaks of aggression but the children typically gained more than 10 pounds, according to Mr Allen. He says this study went on to become one of the most frequently quoted articles in the history of the Journal.

Rebecca’s death is not a rare occurrence for children on these drugs. A May 10, 2007, report in the New York Times said in 2006 alone, the FDA received reports of at least 29 children dying and at least 165 more reports of other serious side effects in children where an antipsychotic was listed as the “primary suspect.”

Neurologist Dr Fred Baughman, author of “The ADHD Fraud,” blames Rebecca’s doctor and says misdiagnosing patients for profit is criminal. “As a neurologist,” he say, “it was my duty to diagnose the neurological consequences of these drugs and only one to 2% of all antipsychotics prescribed might be justifiable, if that.”

He points out that Rebecca’s death was not the result of science gone wrong. “It was flatly, plainly, criminal,” he says, “and the criminals must be indicted, tried and sentenced.”

In an affidavit filed in Rebecca’s case, a state trooper reported that no testing was conducted to make the diagnosis of attention deficit and bipolar disorders and that Dr Kayoko Kifuji, at the Tufts-New England Medical Center, said she based her diagnoses on the “family mental illness history” as described by the mother and “Rebecca’s behavior” as described by the mother and “briefly observed” by Dr Kifuji during office visits, which “occurred from every two weeks to every other month and Rebecca’s two older siblings were also seen,” the trooper states.

The police reports describe kids who were drugged into oblivion. The neighbors said the Riley children were “zomebielike” and “robotic” and the staff at Rebecca’s school said she was like a “floppy doll,” with tremors so bad that she could barely stand up.

The reports reveal that Rebecca’s teacher had repeatedly contacted the school nurse because she was so concerned over her flat affect and shakiness since the spring of 2006.

The school principal told police that she had to assist Rebecca with getting off the bus and walking up the stairs into the school several times because the child was shaking so much that she afraid she would fall and also reported that Rebecca’s face and hands were notably swollen and puffy, the reports says.

The trooper’s affidavit notes that Dr Kifuji had received several calls from a therapist and the nurse at Rebecca’s school saying they were concerned about her medication and the serious side effects they were observing.

A teacher and the nurse told police that Rebecca had a constant need to urinate but would void very little and was so weak that she could often not zip up her pants when she was done and that Dr Kifuji said the constant need to urinate was caused by the medication. They also told police that they had not observed any behaviors in Rebecca that would indicate that she had ADHD or bipolar disorder.

In a June 19, 2007, editorial in the Globe, pediatrician Dr Lawrence Diller said Rebecca’s death was the last straw and it was time to direct the blame where it belongs. “Biederman and his colleagues at Harvard,” he wrote, “are the professionals most responsible for developing and promoting those standards of care — which include diagnosing preschool children as young as 2 with bipolar disorder and treating them with multiple medications.”

“Supported by millions of dollars of drug industry promotional funding,” he says, “Biederman and his colleagues circle the globe offering professional medical “education” for their singular point of view.”

Dr Diller’s claim that doctors are influenced by research at Mass General certainly holds true in Rebecca’s case, because Dr Kifuji said she was influenced by the work of the Dr Biederman, according to Mr Allen’s report. In fact, her attorney, J W Carney Jr, is quoted in the Globe as stating, “They are by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar.”

However, if these researchers are indeed the “leading lights,” recent reports in the media about the money flowing to Dr Biederman and Mass General indicate that the drug companies are paying the electric bills.

According Mr Allen’s report, Dr Biederman has received research grants from 15 drug makers and serves as a paid speaker or adviser to seven, including Zyprexa maker Eli Lilly and Risperdal maker Janssen.

And in May, 2007, Lilly released a report, no doubt prompted by the investigation by the Senate Finance Committee into the “educational grants,” involved in the off-label marketing of Zyprexa, that lists the money that Lilly paid out during the first 3 months of 2007, and the largest grant of $825,000 went to Mass General’s psychiatry department.

A report in the August 4, 2007, New York Times identifies Dr Melissa DelBello, of the University of Cincinnati, as having a role in fueling the widespread use of antipsychotics by touting studies funded by AstraZeneca which the Times says were “inconclusive, but she has described them as demonstrating that Seroquel is effective in some children.”

When the Times asked Dr DelBellow how much she was paid by AstraZeneca to help market Seroquel, she said, “Trust me, I don’t make very much.”

The Senate Finance Committee is investigating the payments by drug companies to doctors and researchers like Dr DelBello and this month, Senator Charles Grassley (R-Iowa), introduced legislation that would require drug makers to disclose all payments made to doctors who bill the Medicare and Medicaid programs for services.

In his speech on the Senate floor, Senator Grassley listed Dr DelBellow as an example of why the legislation is necessary. After reading the Times article where she said she did not make much, Senator Grassley checked out her disclosure forms at the University and found that she had received $100,000 from AstraZeneca in 2003, and $80,000 in 2004. She also consults for 7 other drug makers, according to the Times on August 4, 2007.

Rebecca’s parents have been charged with murder and accused of overmedicating their daughter to sedate her in the 2 days before her death. However, the official autopsy report says Rebecca died of the “combined effects” of the drugs, and that her lungs and heart were damaged by “prolonged abuse of these prescription drugs, rather than one incident.”

At the time of her death, there were also over-the-counter cold medicines in Rebecca’s body including Children’s Tylenol Cough and Runny Nose, which contain acetaminophen, dextromethorphan and chlorpheniramine and a highly respected expert on psychiatric drugs, Dr Grace Jackson, author of Rethinking Psychiatric Drugs, says Rebecca most likely died as a result of a largely unrecognized condition called serotonin syndrome caused by the many different drugs in her system.

“In this case,” Dr Jackson says, “the primary culprits were dextromethorphan and chlorpheniramine, an antihistamine which also boosts serotonin levels.”

“It is probably quite likely,” she explains, “that the family had not been warned by any doctor or pharmacist that this combination of medications could cause death – particularly, in a toddler.”

In the days before Rebecca died, observations reported to investigators describe behaviors common with serotonin syndrome including that she appeared dazed and disorientated and became incoherent and would not respond to her own name.

Through their attorneys, the parents have accused Dr Kifuji of over-prescribing and the doctor’s license has been suspended while the state’s medical board investigates the case.

After Rebecca’s death, the Massachusetts Department of Social Services sought an independent opinion from doctors at Children’s Hospital in Boston for her brother and sister and determined that their medication needed to be changed.

According to Mr Allen, state officials have also stepped up a review of 8,343 more children on Medicaid in Massachusetts who are on antipsychotics to determine whether the treatment is appropriate.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, Kifuji, KOL, SSRIs

Activists Take on Eli Lilly Over Sale of Zyprexa

Evelyn Pringle February 27, 2007

On February 23, 2007, a new grass roots advocacy group issued a press release to rally support for attorney, Jim Gottstein, in his legal battle with Eli Lilly over his role in providing secret company documents obtained in litigation to the media to alert the public about the health risks associated with Zyprexa that were kept hidden since the mid-90s.

In turning the document over to the press, Mr Gottstein’s goal was also to alert the public about Lilly’s illegal off-label marketing schemes aimed at getting doctors to prescribe Zyprexa, a drug FDA approved only for adult patients with schizophrenia or bipolar disorder, to patients of all ages for uses that were not approved as safe and effective.

Although a doctor may prescribe a drug for an unapproved use, it is illegal for Lilly to promote Zyprexa for an off-label use. The illegal marketing in this case includes influencing doctors to prescribe the drug to millions of consumers for conditions not listed on the label, prescribing Zyprexa in combination with other drugs or for a longer duration than recommended, and prescribing a drug for children that was only approved for adults.

Activists say most consumers are not even aware that it is legal for a doctor to prescribe a drug for an off-label use and take for granted that a prescribed drug picked up at a pharmacy is approved to treat their condition and their children.

The recent overdose death of 4-year-old, Rebecca Riley, in Massachusetts, demonstrates the dire need to educate the public about the practice of prescribing drugs for unapproved uses and the dangers of prescribing drugs like Zyprexa to children.

At 2-and-a-half-years-old, Rebecca was diagnosed with attention deficit disorder and bipolar disorder and was prescribed Zyprexa’s atypical cousin, Seroquel, along with Clonidine, an adult high blood pressure drug, and Depakote, a drug approved to treat adults with epilepsy. None of these drugs were approved for children and they were prescribed in a combination that has never been tested even with adults.

From age 2 on, Rebecca remained on this daily drug off-label concoction until she was found dead on the floor in her parent’s home on December 13, 2006. The autopsy report stated that she died of the “combined effects” of the drugs and that her lungs and heart were damaged by “prolonged abuse of these prescription drugs, rather than one incident.”

Experts say, this case reinforces the assertion that judges have got to quit allowing drug makers to seal documents with court orders that show the side effects of drugs and the illegal conduct of promoting the sale of drugs for unapproved uses.

With the Zyprexa documents, as soon as the New York Times began running articles about Lilly’s off-label marketing scheme and the side effects of Zyprexa, Lilly went to court and got the judge in the underlying litigation to issue a permanent injunction against Mr Gottstein, and other persons who obtained the documents from Mr Gottstein, ordering them to return the documents to the court.

However, after a couple months of legal wrangling, the court recognized that it could not restrain the world because the documents were all over the internet and lifted the part of the injunction that enjoined certain web sites from revealing the documents.

One of the documents that Lilly fought to keep secret, is a November 12, 1999, letter from a psychiatrist at the Ventura County Behavioral Health Department, Dr Albert Marrero, to Lilly’s medical director, and describes the blood sugar problems occurring specifically with Zyprexa patients stating: “We have had eight patients out of possibly thirty-five patients on Zyprexa show up with high blood sugars.”

Dr Marrero further informed Lilly that, “Two patients had to be hospitalized due to out of control diabetes….We have certainly never seen this with Haldol, Navane, Risperdal and others to this extent.”

And yet, despite this clearly stated notification of these serious adverse events in 1999, Lilly did not revise the labeling on Zyprexa to include a warning about high blood sugar and diabetes until the fall of 2003, and then it was only because the FDA said do it.

With the health risks of Zyprexa concealed for all that time, doctors were led to believe Lilly sales representatives who said they could safely prescribe Zyprexa and Lilly gained millions of new customers.

With this in mind, the new advocacy group has launched, “The Just Say “Know” to Prescription Drugs Campaign,” with a goal of getting one million people to stop and reevaluate the medications they are taking. It is also supporting Mr Gottstein in his battle with Eli Lilly over the release of the Zyprexa documents.

“If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it,” says Dr Greg Tefft, co-founder of the Just Say “Know” Campaign. “We’re talking 20 million people potentially at risk and more being added daily,” he says.

But instead of focusing on Lilly or the judge who suppressed the documents, the Campaign says, it will educate the public about off-label prescribing and what consumers can do to protect themselves against unwittingly taking Zyprexa, or other drugs, without knowledge of the side effects or that the drugs are not approved for their condition.

“We are convinced that the way to solve this problem is to work the demand side of the market,” Dr Tefft said. “We are going directly to consumers and encouraging them to know what they are taking.”

To that end, a Zyprexa radio series, hosted by Dr Dominick Riccio, Chairman of the Campaign, and Dr Laurence Simon, provides information to consumers about the drug. The official web site for the Campaign is http://justsayknow.kpncradio.com

This group has a lofty goal because the off-label sale of Zyprexa has literally been unstoppable so far. Throughout years of litigation, while settling out of court with an estimated 26,000 Zyprexa victims, Lilly has been successful in keeping the company’s off-label marketing schemes sealed under the ruse that they contain trade secrets and confidential information.

Mr Gottstein obtained the documents from Dr David Egilman, who had discovered that Lilly had failed to disclose Zyprexa’s link to rapid weight gain, high blood sugar levels, and diabetes, while he was serving as an expert witness in the underlying litigation.

It’s likely that Dr Egilman also knew that by settling the second batch of Zyprexa lawsuits out of court, that Lilly planned to go right on concealing the information.

The men had every reason to believe that the off-label prescribing would continue because even after paying over $1 billion in settlements, Zyprexa was still Lilly’s top-selling product with sales of more than $4 billion in 2006.

The story behind Rebecca Riley’s death, gives a clear picture of how blatant the off-label marketing scams have become. After she died, investigators discovered that her 2 siblings, ages 6 and 11, were also fed the same 3 drug cocktail every day and that the parents were on psychiatric medications as well.

Which means, if not for the disruption by Rebecca’s untimely death, this family represented five steady customers for the “mental health industry,” with 100% of the costs for doctor’s visits and prescriptions paid for by public health care programs.

Psychotropic drug expert, Dr Ann Blake Tracy, Director, International Coalition for Drug Awareness, and author of “Prozac: Panacea or Pandora?,” says, “this is what is referred to as the “Family Discount,” when everyone in the family is drugged.”

And this is the type of tragedy she worries about, Dr Tracy says. “The parents unable to function, the children acting up and unable to function – all due to the effects of the drugs.”

She states that she would not be surprised to learn that the mother was on psychiatric drugs while she carried Rebecca which also may have caused problems for the child.

One of the world’s leading experts pharmacology experts, former Secretary of the British Association for Psychopharmacology, Dr David Healy, also maintains that there is no justification for giving these drugs a 2-year-old and “certainly not for the combinations mentioned here,” he states.

Testing a 2-year-old for these mental disorders, he says, can not be done.

Rebecca’s parents have been charged with first-degree murder for the overdose death of a child, but many legal experts and advocacy groups say the main perpetrator is still on the loose. That being the psychiatrist with the prescription pad, Dr Kayoko Kifuji of Tufts-New England Medical Center, who diagnosed these kids with bipolar disorder and ADHD, and prescribed the drugs for all 3 children.

Attorney, Ted Chabasinski, who works on cases involving psychiatric drugs, says he is shocked that the parents are charged with the death, “while the psychiatrist who prescribed the drugs that killed her will probably never be held accountable.”

“The prosecutor makes much of the fact that the parents gave drugs to their daughter that were not approved for use in children,” he points out, “but it is the doctor, not the parents, who is responsible for that.”

Mr Chabasinski says the drug company executives, and the psychiatrists who collude with them, are criminally responsible for Rebecca’s death. “This is an example,” he states, “of how the drug industry and the psychiatric profession are out of control.”

Houston Attorney, Andy Vickery, has been representing persons harmed by psychiatric drugs for many years and he also finds this story “appalling.”

He states that the father seems to be a bad actor and he may have purposely overdosed the child, but says, “he isn’t the one that started her on the psychoative medications and someone needs to do something to hold the prescribing physician accountable.”

David Oaks, director of MindFreedom, an international human rights organization, also believes the psychiatrist should be charged with criminal negligence. “It’s revealing,” he notes, “that the criminal justice system has so far targeted the parents and not the psychiatrist.”

MindFreedom is calling for criminal penalties against physicians for this level of abuse, Mr Oaks says, because it may be the only way to change their behavior.

Vera Sharav, the Director of the Alliance for Human Research Protections, also believes that the only way to stop the prescribing assault on children is to put the professionals who prescribe the toxic drug cocktails on trial in open court. “Let the public bear witness,” she states, “to the proceedings that will demonstrate the absence of scientific-medical evidence to support the widespread misprescribing of harmful drugs for children.”

Kelly Patricia O’Meara, author of, “Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill,” says the most important issue raised in the media is the response by the psychiatrist who prescribed the drugs. “Given the known adverse reactions to many of these drugs, and that they are not approved for children,” she also says, “the psychiatrist needs to be held responsible.”

As for the behaviors of family members described in the media, Ms O’Meara says, the prescription drugs they were taking could have caused many of the same. “Hostile, violent behavior,” she says, “is a possible side effect of many of the mind-altering drugs.”

Dr Healy also notes that it is at least possible that some of the alleged behaviors of the parents could be caused by the drugs they were on. As far as drugging the whole Riley family, he says, there is no mental illness that effects an entire families.

The off-label drugging of the Riley children is not an isolated incident. None of the atypicals drugs are approved for children, yet on May 11, 2006, the Associated Press reported that the number of prescriptions written for children had increased 73% over a four year period, according to Medco Health Solutions, a pharmacy benefits manager.

In addition to Zyprexa, the other atypicals in the same class include Seroquel (AstraZeneca) the drug given to the Riley children, Abilify (Bristol-Myers Squibb); Risperdal (Johnson & Johnson); Geodon (Pfizer); and Clozril (Novartis).

Dr Timothy Scott, author of, “America Fooled: The Truth about Antidepressants, Antipsychotics and How We’ve Been Deceived, reports a 2005 study that found there are approximately 30,000 children under 5 on these drugs.

Overall, child neurologist, Dr Fred Baughman, author of “The ADHD Fraud: How Psychiatry Makes “Patients” of Normal Children,” reports that 10 million of the 50 million school children in the nation are on one or more psychiatric drugs and states: “This is death by psychiatry.”

Along with Lilly, many of the above drug makers are currently under investigation by Federal and state law enforcement agencies for promoting the atypicals for off-label use. Lawsuits have also been filed to recover the money paid by public health care programs for the actual purchase of the drugs, as well as the cost of medical treatment for patients who developed diabetes and other health problems as a result of taking them.

While Mr Gottstein and Dr Egilman may have set themselves up for big trouble by releasing the Zyprexa documents to the press; in light of the harm to the public from off-label prescribing, evidenced well by the Riley case, drastic measures were called for and they obviously believed the risks were worth taking.

According to Dr Lawrence Diller, a behavioral-developmental pediatrician, and author of “The Last Normal Child,” and A Prescription for Disaster: “The extensive prescription of these medications for children, without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties.”

“Catastrophic side effects,” he says, “may be rare, but they become predictable when we treat so many children with so many drugs.”

As for Lilly, the company has billions of reasons to keep the documents buried because they prove beyond any doubt that the company knew about the health problems caused by Zyprexa and intentionally kept the information hidden while it influenced doctors to write off-label prescriptions for million of consumers in the name of the almighty dollar.

Filed under: 2007, antipsychotics, Eli Lilly, Kifuji, Zyprexa

Lilly Makes Billions Off Zyprexa While Approved for Schizophrenia Only

Evelyn Pringle November 15, 2007

For the first four years Zyprexa was sold in the US, the promotion of the drug for any use other than adult schizophrenia was illegal. When the FDA approves a drug for a specific use, it can only be marketed for that use. Eli Lilly gained approval for schizophrenia in 1996 and the drug was not approved to treat bipolar disorder until 2000.

Zyprexa belongs to a class of drugs known as “atypical” antipsychotics, which arrived on the market in the US beginning in 1993. Other drugs in this class include Seroquel, sold by AstraZeneca, Risperdal marketed by Johnson & Johnson subsidiary Janssen, Geodon, sold by Pfizer, Abilify, from Bristol-Myers Squibb and Clozaril manufactured by Novartis.

Schizophrenia is considered the most severe of all mental illnesses and is said to occur in only about 1% of the population. The definition of the disorder in the Diagnostic and Statistical Manual of Mental Disorders, IV, reads as follows:

Schizophrenia is a disorder that lasts for at least 6 months and includes at least 1 month of active-phase symptoms (i.e. two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, negative symptoms.)

Experts say it would be highly unlikely that a competent psychiatrist could misdiagnosis this condition because the symptoms are so extreme and distinct.

Once a drug is approved to treat one condition, it is legal for doctors to prescribe the drug for other uses. These unapproved uses are referred to as “off-label,” and can mean prescribing a drug for a longer duration than specified, at a different dose, in combination with other drugs, or with a different patient population than listed on the label.

The Food, Drug, and Cosmetic Act prohibits companies from promoting a drug for uses other than those approved and the Federal Anti-Kickback Statute prohibits companies from providing remuneration to induce or reward doctors for prescribing products for beneficiaries of Federally funded health care programs such as Medicare and Medicaid.

Accordingly, during the first four years that Zyprexa was sold in the US, Lilly sales representatives were not allowed to discuss any use other than adult schizophrenia and discussions of other uses were not allowed in any company funded event. Lilly itself noted at a July 20, 1995 presentation that the market for Zyprexa was limited the year before it was approved, estimating the total schizophrenia market to be only about $1 billion.

However, the drug was Lilly’s best selling product by 2000, with worldwide sales of $2.35 billion, according to Lilly’s 2001 Annual Report filed on January 28, 2002.

Zyprexa was approved for adults with bipolar disorder in 2000 and US sales rose 23% over 1999, to $1.69 billion in 2000. The next year, it became Lilly’s first product to have sales in excess of $3 billion worldwide, and US sales rose 29% to $2.18 billion, according to the Report.

Experts say there is no way that Zyprexa could have become Lilly’s most widely prescribed drug in the US without influencing doctors to prescribe the drug off-label. For instance, even though Zyprexa was approved to treat the manic phase of bipolar disorder only, which is typically brief, patients were kept on the drug for years.

According to Ellen Liversidge, her son was prescribed Zypexa for bipolar disorder and he remained on the drug for two years, during which time he gained about 100 pounds, until he went into a coma and died of profound hyperglycemia on October 5, 2002.

Ms Liversidge says she later learned that other countries had required Lilly to add warnings about the risk of drastic weight gain, hyperglycemia, and diabetes to the label of Zyprexa in the spring of 2002, months before her son died.

On February 12, 2006, due to increased antipsychotic use, the Florida Agency for Health Care Administration announced a plan to study their use by children in the Florida Medicaid program. The agency stated in a press release that close to 18,000 children took antipsychotics in 2005 and more than 475,000 prescriptions were written in the past 5 years.

On October 7, 2007 the AHCA released a report entitled, “The Use of Antipsychotic Medications with Children,” that said pediatric use of antipsychotics increased in the late 1990s and early 2000s after a decline in the 1980s and stable use in the early 1990s. The increases were largely attributed to the arrival of the atypicals, starting in 1993.

The report noted that both commercial and Medicaid populations experienced increased use and that one study documented a 75% increase in the commercially insured population of 0-17 years from 1997 to 2001, and another study of use in the commercial managed care population from 1996 to 2001 found a 127% increase among children aged 0 to18.

The study found that antipsychotic use in the Medicaid populations in the late 1990s was already 3-4 times higher than commercial populations but also grew in the early 2000s. In Texas, prescription rates for kids rose 141% between 1996 and 2001 and in another program in the Midwest, usage grew 304% over the same time period, the report stated.

The authors said the analyses reveals that the drugs are used to treat a broad spectrum of disorders, and some of these disorders, such as attention deficit hyperactivity disorder and major depression, “clearly do not call for antipsychotic treatment.”

The study found that in the 0 to 5 age group, 53.8% of the antipsychotics were prescribed for ADHD and in the age group 6 to 12, 48% were prescribed for ADHD.

The report noted that the use of antipsychotics with children under 6 is generally not recommended and “should be considered only in very rare circumstances.”

The authors pointed out that the risk associated with the increased use would be significant even if the medications were prescribed for indications approved for adults since most would agree that in this context children can not be considered “little adults.”

But the medications are now being used to treat a broad spectrum of disorders never anticipated or approved for adult use and we “therefore lack even the adult analogy in trying to estimate safety, tolerability and effectiveness of antipsychotic agents in the pediatric population,” the authors wrote.

A September 2007 study in the Archives of General Psychiatry, reported that the number of children in the US diagnosed with bipolar disorder had increased from about 20,000 in 1994 to roughly 800,000 in 2003.

One of the world’s leading experts on psychopharmacology, UK psychiatrist and professor, Dr David Healy, author of, “The Latest Mania: Selling Bipolar Disorder,” says bipolar disorder in children is all but unrecognized outside the US and it is unlikely that a significant proportion of these children would actually meet the DSM criteria for the disorder.

A group of researchers that Dr Healy credits with turning American children into profit centers via the pediatric diagnosis of bipolar disorder is led by psychiatrist, Dr Joseph Biederman, at Massachusetts General Hospital in Boston.

According to Dr Healy, Massachusetts General conducted clinical trials with Zyprexa and Risperdal in children as young as four, and recruited participants by running TV ads featuring clinicians and parents informing other parents that difficult and aggressive behavior in children aged four and up might be caused by bipolar disorder.

“This does more than recruit patients with a clear disorder,” Dr Healy notes, “it suggests that everyday behavioral difficulties may be better seen in terms of a disorder.”

He explains that it would be all but impossible in a short-term trial of sedative drugs in pediatric states characterized by overactivity to not show some behavioral changes that could be regarded as beneficial, so the outcomes of the trials would naturally appear to validate the bipolar diagnosis and increase the prescribing of drugs.

As for the recent claims that child suicide rates have significantly increased since the FDA added warnings about an increased risk of suicide to the labels of the selective serotonin reuptake inhibitor antidepressants (SSRIs), Dr Healy says if suicide rates have increased at all, it is most likely due to doctors switching children from SSRIs to antipsychotics.

In the last two or three years, he explains, drug companies have marketed bipolar disorder by claiming that the problems from SSRIs were the result of patients being misdiagnosed as depressed when they should have been diagnosed as bipolar and given antipsychotics.

However, Dr Healy says, “the antipsychotics have just as great an increase in suicide risk as SSRIs, if not greater.”

Many experts are now blaming the Biederman gang for the death of 4-year-old Rebecca Riley, who was diagnosed with bipolar disorder and ADHD at the age of 2-and-a half. Her doctor, Dr Kayoko Kifuji, a psychiatrist at Tufts New England Medical Center in Boston, kept her on a 3-drug cocktail that included an atypical, an anti-seizure medication and a drug approved to treat adults with high blood pressure, until her death in December 2006.

In a June 19, 2007, editorial in the Boston Globe, pediatrician Dr Lawrence Diller wrote, “Biederman and his colleagues at Harvard are the professionals most responsible for developing and promoting those standards of care — which include diagnosing preschool children as young as 2 with bipolar disorder and treating them with multiple medications.”

At the October 13, 2007 conference of the International Center for the Study of Psychiatry and Psychology, Dr Fred Baughman, author of, “The ADHD Fraud,” and a well-recognized expert on psychiatric drugs, discussed the death of the 4-year-old in a presentation titled, “Who killed Rebecca Riley?”

The answer, according to Dr Baughman and many other experts in the field of psychiatry and child development at the conference, is the Biederman gang, due to its promotion of a diagnosis for attention deficit and bipolar disorder in children as young as infants.

Dr Baughman says the aim of the “psycho-pharmaceutical cartel” in the 1990s was not to increase the market for psychiatric drugs, “it was to invent a market out of thin air.”

About a month before Rebecca’s death, on November 23, 2006, Dr Biederman defended the prescribing of multiple drugs to children in the New York Times by comparing it to doctors prescribing multiple drugs to treat heart disease, diabetes, cancer and aids.

“Child psychiatry is not any different,” he said. “These drugs have revolutionized how we treat severe psychopathology in children.”

A report in the June 17, 2007 Boston Globe by Scott Allen, revealed that Dr Biederman has received research grants from 15 drug makers and serves as a paid speaker or adviser to seven, including Lilly and Risperdal maker Janssen.

Dr Kifuji is apparently a fan of the Biederman gang, judging by Mr Allen’s report, in which her attorney, J W Carney Jr, states, “They are by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar.”

The legal filings in Rebecca’s case show that Dr Kifuji also diagnosed the other two Riley children, ages 6 and 11, with ADHD and bipolar disorder and placed them on the same drug cocktail, with the cost of all mental health services and drugs covered by Medicaid.

Former Federal fraud investigator, Allan Jones, says the atypical makers were able to turn the schizophrenia drugs into cash cows by influencing the doctors and state officials involved in the approval of formularies that specify the drugs that can be used by persons covered by public health care programs.

Each state has an approved formulary and “before a drug can be prescribed for a patient on Medicaid it has to be on the list,” he explains.

Evidence to support this claim came on August 21, 2007, when the Associated Press reported that drug companies had spent a lot of money on two members of the Minnesota panels who helped select the drugs covered by Medicaid. Dr John Simon earned $354,700 from drug makers between 2004 to 2006, and Robert Straka, a University of Minnesota pharmacy professor, was paid $78,000 while he served on the panel, the AP said.

And on August 27, 2007 the Pioneer Press reported that Dr Simon earned the most money from Lilly, “whose antipsychotic drug Zyprexa is the most costly each year for Minnesota’s fee-for-service health program for the poor and disabled.”

Lilly’s financial disclosure records show payments to Dr Simon of $91,854.95 in 2004 alone. On October 17, 2007, the Associated Press reported that he had quite the panel.

The corruption of advisory committees has led to criminal charges against a state official who was fired in Pennsylvania. On November 21, 2006, Steven Fiorello, the Director of the Pharmacy Services, and chairman of the formulary committee, was charged with one count of conflict of interest for accepting money from drug companies and one count of failing to disclose income on Statements of Financial Interests.

“Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals – decisions which guided more than $9 million in annual drug purchases,” the state’s Attorney General said in a press release.

While he was helping to guide the purchases, the press release stated, “he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board.”

In October 2006, a state official in Texas, Dr Steven Shon, was fired after the state’s attorney general found that Janssen had improperly influenced him to place Risperdal on the state formulary, while he was receiving money from Janssen.

According to Lilly’s August 6, 2007 second quarter SEC filing, the California Attorney General’s Office has subpoenaed documents related to Lilly’s “efforts to obtain and maintain Zyprexa’s status on the formulary, the marketing and promotion of Zyprexa, and the remuneration of health care providers.”

Lilly’s off-label marketing of Zyprexa has come under scrutiny in the past several years, in large part, because lawmakers and law enforcement agencies became suspicious about the skyrocketing costs of a drug approved to treat such limited conditions being prescribed to so many patients in public health care programs.

According to Lilly’s SEC report, Medicaid fraud lawsuits filed against Lilly thus far include the states of Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia. Arkansas is the latest state to file a lawsuit.

The Medicaid fraud allegations include that Lilly illegally marketed Zyprexa for off-label uses while concealing the serious health risks associated with the drug, and most specifically high blood sugar levels, extreme weight gain and diabetes.

The lawsuits seek to recover not only the money paid to purchase Zyprexa for patients on Medicaid but also for the medical care of persons injured by the drug. Mississippi alleges that about 10% of the Medicaid patients who took Zyprexa in that state have developed diabetes which will require life-long care.

Montana’s lawsuit alleges that Lilly gave kickbacks to doctors, promoted Zyprexa as a sedative in nursing homes, and created a 280-person sales force to promote the drug exclusively for off-label uses, specifically in long-term care facilities.

The West Virginia complaint alleges that Lilly promoted Zyprexa for off-label conditions including anxiety, sleep disruption, mood swings, attention deficit and dementia and “benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs.”

In private litigation, since June 2005 Lilly has entered into settlements with approximately 30,200 claimants in the US for about $1.2 billion and there were still about 350 lawsuits covering about 540 claims pending in the US at the time of the August 2007 filing.

However, off-label prescribing has obviously not ceased because in 2006, Zyprexa sales were $4.3 billion and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to Lilly’s SEC filing.

Additional lawsuits are now being filed on behalf of suicide attempt survivors and the family members of suicide victims who died while taking Zyprexa. They allege that Lilly knew about the increased risk of suicide associated with the drug but failed to warn the public while it widely promoted the Zyprexa for off-label uses.

An August 2002 analysis of clinical trial data on drugs approved by the FDA between 1985 and 2000, by Dr Arif Khan of the Northwest Clinical Research Center in Bellevue Washington, found the rate of completed suicides in the antipsychotic trials to be 752 per 100,000, an astronomical number considering that the suicide rate is only 11 per 100,000 for persons in the general population.

Families seeking legal advice regarding Zyprexa related suicide can contact the Baum, Hedlund, Aristei & Goldman Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/

Filed under: 'ADHD', 2007, antipsychotics, Eli Lilly, Kifuji, Zyprexa

Psychiatric Drugging of Children Intolerable

Evelyn Pringle February 2009

On September 2, 2008, the Law Project for Psychiatric Rights filed what is sure to become a landmark case against the State of Alaska aimed at stopping the over prescribing of psychiatric drugs to children covered by public health care programs in that state.

“The massive over-drugging of America’s youth is an unfolding national horror,” says attorney Jim Gottstein, the leader of the Law Project.

The lawsuit seeks an injunction to stop Alaska from authorizing or paying for psychotropic drugs prescribed to children in foster care or children covered by Medicaid “without safeguards being in place to make sure proper decision making occurs.”

Specifically, the complaint is asking for a court order prohibiting the State from giving or paying for these drugs unless and until: (i) evidence-based psychosocial interventions have been exhausted, (ii) rationally anticipated benefits of psychotropic drug treatment outweigh the risks, (iii) the person or entity authorizing administration of the drug(s) is fully informed, and (iv) close monitoring of, and appropriate means of responding to, treatment emergent effects are in place.

“The corrupt influence of the pharmaceutical industry in illegally promoting much of this drugging has been well established,” Mr Gottstein says, “yet the state continues to inflict great harm on the children it has taken away from their families by giving them these drugs.”

“It is absurd to think all these children have a mental illness,” he states. “They are being drugged because they are upset and bothering people.”

“Because decisions to administer medication to children are not made by the children themselves, the administration of psychotropic drugs is involuntary,” Mr Gottstein explains.

Under the Alaska Constitution, he says, involuntary administration of such drugs infringes upon fundamental rights and the state must have a compelling state interest in doing so. They must be in the best interest of the children and there must be no less intrusive alternatives, the lawsuit notes.

Governor Sarah Palin is named as a defendant in the lawsuit because she is ultimately responsible for the protection of children as Governor of Alaska. “I doubt anyone on the Governor’s staff has even let her know about the problem despite my trying to bring it to her attention ever since she took office,” Mr Gottstein notes.

In fact, as far back as March 14, 2007, he emailed Governor Palin about children in custody in other states dying from the administration of psychotropic drugs, and stated:

“The massive over-drugging of America’s children and youth is a titanic health catastrophe caused by the government’s failure to protect its most precious citizens, who rely on the adults in their lives to shield them from harm, not inflict it upon them. Perhaps the worst of all is the State inflicting this harm on children and youth it has taken from their homes “for their own good.”

Mr Gottstein concluded by asking her to, “Please correct this situation.” On February 4, 2008, he wrote to Governor Palin again, in hopes of avoiding a lawsuit, and sent copies to the Attorney General and others, conveying scientific evidence regarding the harm being done by the over-prescribing of psychotropic drugs to children, and stated in part:

“Children and youth are virtually always forced to take these drugs because, with rare exception, it is not their choice. PsychRights believes the children and youth, themselves, have the legal right to not be subject to such harmful treatment at the hands of the State of Alaska.

“We are therefore evaluating what legal remedies might be available to them. However, instead of going down that route, it would be my great preference to be able to work together to solve this problem. It is for this reason that I am reaching out to you again on this issue.”

“Fewer than ten percent of psychotropic drugs are FDA-approved for any psychiatric use in children and youth,” the lawsuit alleges.

In the February 2009 New York Review, former New England Journal of Medicine editor and Senior Lecturer in Social Medicine at Harvard Medical School, Dr Marcia Angell, wrote:

“Although it is illegal to promote drugs for use in children if the FDA has not approved them for that use, the law is frequently circumvented by disguising marketing as education or research. Eli Lilly recently agreed to pay $1.4 billion to settle civil and criminal charges of marketing the anti-psychotic drug Zyprexa for uses not approved by the FDA (known as “off-label” uses). Zyprexa, which has serious side effects, is one of the drugs frequently used off-label to treat children diagnosed with bipolar disorder.”

She went on to state: “Unlike migraines or shyness, hypertension or high cholesterol can be defined by an objective measurement–a blood pressure or cholesterol level. One can dispute the threshold chosen as abnormal, but the measurement is easily verifiable. The fact that psychiatric conditions are not objectively verifiable underscores the necessity for both diagnosis and treatment to be as impartial as possible. That is why conflicts of interest are more serious in this field than in most others.”

Mr Gottstein’s complaint lays out the evidence of harm to children caused by psychiatric drugs as documented by a program titled, “Critical Risk Rx, A Critical Curriculum on Psychotropic Medications,” designed by a team led by Dr David Cohen, a Professor at Florida International University.

The purpose of the “Critical Think Rx” program is to promote critical thinking skills about psychiatric medication issues related to the authorization of the administration of psychotropic drugs to young patients. The program was developed under a grant from the Attorneys General Consumer and Prescriber Grant Program through the multi-state settlement with Pfizer of consumer fraud claims regarding the off-label promotion of Neurontin, one of the anti-seizure drugs marketed as a mood stabilizer.

Critical Think Rx is funded at the Florida International University, and is the only project targeting non-medically trained professionals in child welfare and mental health. All investigators and consultants involved in the program have agreed to forego pharmaceutical industry funding for the duration of the project in order to maintain complete independence.

The “best practices” recommended in the lawsuit were assembled by the Critical Think team and have been proven effective, Mr Gottstein advises.

Major turning point

December 13, 2006 will probably go down in history as the day the nation awoke to the unthinkable truth that children as young as toddlers were being labeled mentally ill and drugged for profit.

On that day, a little 4-year-old girl named Rebecca Riley died of an overdose after being diagnosed with ADHD and bipolar disorder by Dr Kayoko Kifuji, at Tufts New England Medical Center in Boston, and placed on a three-drug cocktail.

The legal filings in the criminal case that followed this tragedy show the other two Riley children, ages 6 and 11 at the time of Rebecca’s death, were also diagnosed with bipolar disorder and ADHD, and had been on the same three-drug cocktail for years, with all costs for Dr Kifuji’s services and the drug prescriptions billed to Medicaid.

When investigators interviewed Dr Kifuji, she said Rebecca had been a patient since August 2004. She had based her diagnoses of the 28-month-old child on the “family mental illness history” as described by the mother, and “Rebecca’s behavior” as described by the mother and “briefly observed” by Dr Kifuji during office visits, which “occurred from every two weeks to every other month and Rebecca’s two older siblings were also seen,” according to an affidavit filed by State Police Officer, Anna Brooks on February 5, 2007.

The filing shows that Dr Kifuji prescribed Depakote, an anti-seizure drug; Seroquel, an antipsychotic, and Clonidine, a blood pressure medication. None of these drugs were approved for pediatric use, together or alone, for any condition.

The parents, Carolyn and Michael Riley, were originally charged with first degree murder and accused of having Rebecca diagnosed mentally unstable to collect Social Security disability benefits and of intentionally giving her too much medication to cause her death. However, a Massachusetts judge has since lowered the charges to second-degree murder due to a finding of insufficient evidence of premeditation.

The prosecutor appealed the judge’s ruling. However, the problem with the prosecution’s theory is that, without a willing accomplice like Dr Kifuji, the Rileys’ could not have set up this type of scheme.

When interviewed by police, Carolyn Riley described the daily regimen of giving the drugs to Rebecca. She said the child was prescribed 125mg Depakote sprinkle capsules to control her mood, with 3 in the morning and 3 at night. She would administer the drug by breaking the capsules open and sprinkling the contents on Rebecca’s tongue, she said.

Seroquel was prescribed to help Rebecca calm down and stay asleep. She received 25 mg in the morning and 175 mg at night. Carolyn said Dr Kifuji also prescribed Clonidine tablets that dissolved instantly to help Rebecca calm down and sleep. She was given .1 mg tablets, which her mother would divide in half, so that Rebecca took a half tablet in the morning, a half at noon, another half tablet at 3:00 pm and two full tablets at bedtime.

In visualizing this child’s drugging procedure, it’s important to remember that the same medications also had to be doled out to the other two children every day.

Abundance of red flags

According to police reports, all three Riley children were visibly over-drugged. The neighbors described them as “zomebielike” and “robotic,” and staff at Rebecca’s preschool said she was like a “floppy doll,” with tremors so bad that she could barely stand up at times.

The filings show Rebecca’s teacher was repeatedly contacting the school nurse due to concerns over the child’s flat affect and shakiness dating back to the spring of 2006.

The school principal reported that she had to help Rebecca get off the bus and walk up the stairs several times because the child was shaking so badly and that her face and hands were notably swollen and puffy.

The preschool staff told investigators that Rebecca was lethargic and listless every day when she arrived at school in the fall of 2006, but seemed to come alive at about two o’clock in the afternoon when the mediation wore off.

They recounted that Rebecca had a constant need to urinate but would void very little and was so weak that she could often not pull up her pants. They told police that Dr Kifuji said the need to urinate was caused by the medication.

The school nurse told investigators that she had informed Dr Kifuji that school personnel had never observed any behaviors in Rebecca consistent with a diagnosis of ADHD or bipolar disorder that would justify prescribing the three drugs.

Police interviewed a social worker who attempted to provide therapy to Rebecca and her sister once a week at their home from May 2006 through July 2006. The social worker was also concerned about the types of drugs and the amounts prescribed to Rebecca because “she found it unusual in her experience, especially since she did not observe any behavior consistent with the diagnosis,” the filing states.

She recalled that both girls were frequently asleep when she arrived and she had “repeatedly urged Carolyn Riley to speak with Dr. Kifuji about lowering the dosage and variety of medication that Rebecca and her sister were on,” it notes.

The social worker stated that “she never observed any aberrant behavior in Rebecca and really wanted to reduce her medication so they could work on her alleged issues and/or see evidence of the illness(es),” according to the filing.

She produced notes from a phone call to Dr Kifuji on May 24, 2006, in which she told the doctor about the side effects of the drugs and noted, Dr Kifuji “… also has concerns. Feels children require too much medication, did not want to give them that much but Mom kept saying children weren’t sleeping, was hoping prescribing Depakote and then keep medications down…”

The medical examiner, Dr Elizabeth Bundock, told investigators that the amount of Clonidine alone in Rebecca’s system was fatal. “She further noted that Rebecca’s heart and lungs were damaged and found that this was due to prolonged abuse of these prescription drugs, rather than one incident,” according to the filing.

In dying of an overdose of Clonidine, Dr Bundock stated that Rebecca would have died a slow and painful death:

“Her heart would not have pumped fast enough to circulate blood into her lungs and other major organs, causing these organs to slowly shut down. Her lungs would have gradually filled with fluid, resulting in pulmonary edema and congestive heart failure. The symptoms of pulmonary edema and congestive heart failure would include, pale, cool, clammy skin, a cough, uncontrollable at times, which would sound sharp.”

“Towards the end of her life, Rebecca would probably have become incoherent as her organs began to shut down, her skin would have been pale and she would eventually lose consciousness.”

“Rebecca would have become restless, uneasy and agitated towards the end of her life as she felt her lungs filling up, she would be gasping or breathing heavy and would sound like her chest was congested. Eventually she would die.”

In the days before her death, relatives told investigators that Rebecca was vomiting, and would not eat or sleep, and became so disoriented and incoherent that she would not even answer to her own name.

The social worker told investigators that she had filed two complaints with the Department of Social Services in 2006. The first based on her observations that Carolyn was neglecting her children and “appeared heavily drugged and unable to respond.” And a second after Rebecca’s sister disclosed that Michael Riley had hit her.

Carolyn’s brother and his girlfriend told investigators that they saw Michael grab Rebecca’s brother by the neck and bang his head against the window of a pickup truck “in an apparent uncontrollable rage,” the police affidavit reports.

Carolyn obtained a restraining order against Michael in October 2006, but allowed it to lapse a few weeks later.

At the time of Rebecca’s death, Michael was not supposed to be living in the home. He was indicted in September 2005 on charges of sexual assault against Carolyn’s 13-year-old daughter from a previous relationship and giving pornography to a child. He is now serving a 2 1/2-year prison sentence after being convicted on the charge of providing obscene material to the child in November 2007, according to the November 22, 2007 Patriot Ledger.

The Department of Social Services removed the two older Riley children from the home when Rebecca died and placed them in foster care.

Betrayal of innocence

Rebecca was betrayed on many different fronts. She was betrayed by a doctor who diagnosed her with mental disorders without doing anything about her real-life situation — a dysfunctional family. Instead, Dr Kifuji took the “”easy road”” out and simply drugged her to death. Drug companies also betrayed Rebecca by pushing their medications to achieve maximum profits, hiring “opinion leaders” to promote not only the drugs, but the fabricated “disorders” they say require medications.

“Promoting the idea that bipolar is a genetic disorder is causing extreme harm to lots of little children like Rebecca,” warns the director of Mindfreedom International, David Oaks.

In this case, he says, “the evidence seems to point towards her and her siblings having been abused and misdiagnosed as bipolar, considering that reports were filed against the father for child abuse.”

Mr Oaks faults the psychiatrist, “for failing to recognize that, when all of the children in a family exhibit a particular behavior, that it may not be because of some unproven genetic theory but because of the well proven idea that humans respond to the treatment they receive from other humans.”

“The bipolar diagnosis in young children is an absurdity and its drug cocktail treatment, an obscenity, when they prematurely close the door to otherwise potentially profound changes in family behavior,” says Dr Lawrence Diller, the author of “The Last Normal Child.”

Creation of life-long customers

The Riley family is a truly tragic example of how the psycho-pharmaceutical complex operates. The mental health professional provides each member with a diagnosis of a mental disorder serious enough to warrant a finding of disability, which makes them eligible for all pubic assistance programs, including medical coverage for office visits and drugs, and a family of life-long customers is created.

Michael and Carolyn were both unemployed, collected welfare, received disability benefits and lived in subsidized housing, according to a March 26, 2007 Associated Press report. “Michael Riley claimed to suffer from bipolar disorder and a rage disorder,” and “his wife told police she suffered from depression and anxiety,” the newspaper noted.

The drug companies alone were raking in close to three grand a month by drugging the three children in this one family alone. According to Drug Store.com, the price of Catapres (clonidine) is $303 for 180 2m tablets. One hundred tablets of 100mg Seroquel sells for $388, and 100mg pills of Dapakote cost $289 per hundred. Multiply the $3,000 by the 28 months that passed since Rebecca joined her siblings in the daily drugging regime and the total comes to about $84,000.

Police reports note that Dr Kifuji saw all three children together in office calls — how much she was billing Medicaid for those visits, God only knows. Carolyn told police that she was taking Paxil for depression and anxiety and was also on prescription medication for migraines. Paxil costs $309 for ninety 30mg tablets at Drug Store.com.

Child drugging patterns

“There seems to be a clear correlation between the class of medication on patent and the diagnoses employed in psychiatry,” according to child and adolescent psychiatrist, Dr Peter Parry, senior lecturer at Flinders University in Australia.

In the 1980s, and especially the 1990s, he notes, when the new SSRIs (selective serotonin reuptake inhibitor antidepressants) were the basis of the drug company profits and shareholder value, “we had an epidemic of ‘depression’ and an explosion of antidepressant prescribing.”

Since the late 1990s, with SSRIs having some problems with suicidality and also coming off patent, he points out, “we have the emergence of a `bipolar spectrum disorders’ epidemic including treating pediatric bipolar disorder with antipsychotics and anticonvulsants rebadged as mood stabilizers.”

The reports on Texas foster children covering the past several years provide support for this theory. For instance, the top five most commonly prescribed psychotropic drugs to Texas foster children in 2007, were Ritalin, Risperdal, Clonidine, Seroquel, and Adderall. These five alone accounted for half of the $37.9 million spent on psychiatric drugs for foster children in 2007, according to a report in the August 17, 2008 Dallas Morning News.

The list for the top 10 diagnoses for children ages 6 to 12 in 2005, shows bipolar disorder was diagnosed more often than depression. Likewise, of the top ten drugs prescribed to this age group, Risperdal and Seroquel combined beat out the two antidepressants on the list by more than two to one. There were 1,669 prescriptions for Risperdal and 1,103 for Seroquel, compared to 701 for Zoloft and 712 for Trazodone.

In fact, the only drug prescribed more often than Risperdal was Ritalin. The antipsychotic Abilify also made the top ten list with 667 prescriptions.

In the three-year old toddler group, 25 were diagnosed bipolar and 23 with depression. Combined, Risperdal and Seroquel, were prescribed 115 times, compared to 23 prescriptions for Mirtazepine (generic Remeron), the only antidepressant on the list. Risperdal also rated second highest in this age group, behind Clonidine.

Among the youngest children, age 0 to 2, prescriptions for Risperdal and Seroquel had a combined total of 28, compared to 8 for Mirtazepine.

The promotion of drugging “bipolar children,” has been enormously successful, says Dr Peter Breggin, author of the new book, Medication Madness.

Before the 1990s, doctors hardly ever diagnosed kids with bipolar. In fact, Dr Breggin does not recall hearing of the diagnosis being given to children prior to the 1990s.

He points out that a recent survey showed a 40-fold increase in children being diagnosed with bipolar disorder between 1994 and 2003. The survey also found that 90.6 percent of the children were receiving psychiatric medications, including 60.3 percent on mood stabilizers like Depakote and 47.7 percent on antipsychotics like Risperdal and Zyprexa, with most kids on combinations, he reports.

“The advantages to the drug companies are obvious,” Dr Breggin says. “If children get several drugs at once, several dozen over their childhoods, they transform from being patients into cash cows for psychiatry.”

Side Effects of Drugs Commonly Prescribed to Children, such as the Riley Children

The Drugs.com website reports that the more common side effects of Clonidine include: dizziness, drowsiness, fatigue, weakness, sedation, agitation, nervousness, nausea, and vomiting.

The side effects listed by Drugs.com for Depakote sprinkle capsules include: dizziness; drowsiness, change in appetite, nausea, vomiting and trouble sleeping.

The site warns to seek medical attention right away if any of these “SEVERE side effects” occur when using Depakote sprinkle capsules:

“Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); … changes in behavior; … confusion; … difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; … lack of energy; loss of appetite; loss of coordination; … memory loss; mental or mood changes; … severe or persistent nausea, vomiting, … tremor; … unusual weakness; …”

The FDA’s information sheet on Depakote has a back box warning for “Hepatotoxicity.” “Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting,” the warning states.

“Patients should be monitored closely for appearance of these symptoms,” the label warns. “Liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months.”

According to Pennsylvania psychiatrist, Dr Stefan Kruszewski, “Depakote is prescribed to many children for off-label uses such as mood disorders, anxiety, agitation, aggression.”

“We can anticipate a series of tragic outcomes from Depakote’s massive overuse,” he says. “We can expect to see many patients with anemias, hepatic disease, diabetes type II, pancreatitis and other serious systemic and neurological dysfunctions.”

Some of the “less serious side effects” of Seroquel listed by Drugs.com include: dizziness, drowsiness, or weakness, anxiety, agitation, and nausea and vomiting.

The drug’s label contains a black box warning for Tardive Dyskinesia, which states: “A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.”

There is no known treatment for this disorder and the label warns that “Seroquel should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia,” and further states:

“Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.”

“In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.”

“Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Seroquel,” the warning label states.

“Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness,” it notes.

The safety and effectiveness of Seroquel for treating bipolar disorder even in adults has not been tested in trials longer than 12 weeks, according to the labeling information. “The physician who elects to use Seroquel for extended periods in bipolar disorder should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient,” the label warns.

“The safety and effectiveness of Seroquel in pediatric patients have not been established,” it says. “Anyone considering the use of Seroquel in a child or adolescent must balance the potential risks with the clinical need.”

In the Riley case, the police reports do not indicate whether Dr Kifuji ever ordered any medical testing for the children to check for potential harm caused by the three drugs.

Overdue lawsuit filed

On April 3, 2008, Boston attorney, Andrew Meyer Jr, filed a medical malpractice lawsuit against Dr Kifuji on behalf of Rebecca’s estate. “This child was subject to mostly telephone prescriptions and a slipshod diagnosis,” he told the Boston Globe on April 4, 2008.

“They made her a 4-year-old zombie,” he said. “We don’t believe that she did suffer from bipolar or that this was the appropriate medication.”

Mr Meyer contends that even if a jury finds Rebecca’s parents guilty of murder, it does not alleviate Dr Kifuji of liability. “The primary responsibility falls on this doctor,” he told the Globe.

“The failure of this doctor to respond to the warnings she was given and to thoroughly investigate the symptoms that her medication was causing ended with this very sad result here of a young girl dying,” he said.

The lawsuit seeks unspecified damages for the wrongful death and pain and suffering endured by Rebecca, as well as the loss suffered by her brother and sister, who are in foster care and have been named beneficiaries of her estate, the Globe reports.

On February 7, 2007, the day after Michael and Carolyn pleaded not guilty to murdering Rebecca, Dr. Kifuji entered into a voluntary agreement with the Massachusetts Board of Registration in Medicine to not practice medicine pending an investigation.

“The Agreement entered into by Dr. Kifuji will remain in effect until further order of the Board,” according to a February 7, 2007 press release by the Board.

Youngest victims

The Los Angeles based Baum, Hedlund, Aristei & Goldman law firm is handling lawsuits on behalf of the youngest victims of the psychiatric drugging era, representing families of infants born with serious birth defects due to prescribing of the drugs to pregnant women.

The firm has also handled many lawsuits across the country involving children and adolescents who have committed suicide or attempted suicide on Paxil, including a nationwide class action involving the false and misleading promotion of the drug as safe and effective despite evidence to the contrary.

(This report was written as part of the Pharmaceutical Litigation Roundup series and sponsored by the Baum, Hedlund, Aristei & Goldman law firm)

Filed under: 'ADHD', 2009, anticonvulsants, antipsychotics, Baum, Breggin, drugging children, Kifuji, SSRIs

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