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.”

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.

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.

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.

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/

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)

FDA Panel Throws Life Line to Antipsychotic Pushers

Evelyn Pringle June 15, 2009

On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics “won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients.”

“The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent,” says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.

“Rather than focus on protecting children’s safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children–thereby ensuring that far greater numbers of children will be victimized and die,” according to Sharav.

A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.

On November 17, 2008, on the popular Furious Seasons website, Philip Dawdy reported that Zyprexa had killed 3,455 people between 1997 and early 2008, based on a review of an FDA staff document with a summary of adverse events in the agency’s database.

From 1993 through the first three months of 2008, 1,207 children on Risperdal suffered serious adverse events, including 31 who died, according to a report in the November 18, 2008 New York Times.

The deaths included a 9-year-old child, receiving Risperdal for the unapproved use of ADHD, who suffered a stroke twelve days after starting the drug. At least 11 of the deaths were in children whose treatment was for an unapproved use.

In May 2009, CBS News reported that Risperdal was causing boys to grow breasts due to increased prolactin levels caused by the drug. The news segment featured a boy who was prescribed Risperdal for ADHD, and had to undergo a double mastectomy to remove the breasts.

Philadelphia attorney, Steve Sheller, represents six boys who developed breasts after taking Risperdal, in lawsuits against Johnson & Johnson. Two have had mastectomies.

On June 3, 2009, Medscape reported that findings presented at the American Psychiatric Association annual Meeting, on the preliminary results from the “Metabolic Effects of Antipsychotics in Children” study, “show that 12 weeks of initial antipsychotic treatment was associated with significant mean increases in overall adiposity and percentage of body fat, as well as a decrease in whole-body insulin sensitivity.”

“Further,” Medscape said, “the investigators found antipsychotic treatment was also linked to significant increases in body-mass index (BMI) percentile and fasting plasma triglyceride levels, both clinically available indicators of adverse metabolic changes associated with increased adiposity.”

In terms of live-long health issues: “This is a serious problem,” says Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and past president of the American College of Cardiology.

“The substantial increase in body fat and increased insulin resistance will almost certainly lead to a higher lifelong incidence of diabetes,” he warns.

“Diabetes is a major cause of heart attack, stroke, kidney failure, blindness, and limb amputation,” Dr Nissen points out.

In an April 2008, editorial, in Psychotherapy and Psychosomatics, titled, “Irrational Healers,” Dr David Healy, author of the new book, “Mania: A Short History of Bipolar Disorder,” writes:

“For fifty years, the antipsychotics were viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the trade-off between hazards and benefits justified treatment.”

“Yet now a new generation of possibly even more problematic antipsychotics is being given to preschoolers, in North America, on the basis that they might have a disorder that most of the rest of the world does not believe happens in children.”

“FDA officials are ignoring the real world tragedies–drug-induced deaths of children,” Sharav warns.

On June 6, 2009, the Topeca Capital Journal reported on the death of a Kansas toddler, Destiny Hager, and the confirmation by an autopsy that the child died of fecal impaction, after taking Seroquel and Geodon, with “antipsychotic drugs present in concentrations considered therapeutic in adults.”

Child psychiatrist, Vernon Kliewer, diagnosed Destiny with bipolar disorder and prescribed the drugs. State regulators recently “completed a two-year investigation of Kliewer that found the doctor violated Kansas law while treating Destiny and five other children,” the Journal reported.

A September 14, 2007 petition filed by the Kansas Board of Healing Arts, says Kliewer diagnosed Destiny with Bipolar Disorder in March 2006, at 3-years-old, and she died on April 4, 2006.

The petition contains 6 counts and details the prescribing of multiple drugs by Kliewer to six children including two more 3-year-olds, one 4-year-old and two 2-year-olds. In one case, he began treating a child at 2-years-old and between January 2003 and November 2006, prescribed a total of 9 drugs for the girl, including Risperdal, Abilify, Seroquel, and Geodon.

“The doctor negotiated a settlement in February with the Board of Healing Arts that didn’t require him to admit wrongdoing,” the Journal said. “He voluntarily stopped treating patients under age 6.”

The Board placed Kliewer’s medical license on indefinite probation and ordered him to pay $13,079 to cover the investigation expenses, the Journal reported. Kliewer must also have another physician monitor his treatment of bipolar patients.

“Tragically, most physicians have not been trained or encouraged to think rationally about the hazards of monotherapy, let alone polypharmacy in children,” says Dr Grace Jackson, author of, “Rethinking Psychiatric Drugs: A Guide to Informed Consent, and the new book, “Drug Induced Dementia – a perfect crime.”

“Mental health professionals have an ethical duty to inform parents about the potential lethality of drug combinations,” she advises.

On June 5, 2009, Dawdy posted a link to the FDA’s briefing package on Furious Seasons, available to members of the advisory panel, and posted portions of the introduction by FDA psychiatry products chief, Thomas Laughren, including the following comments on side effects caused by the drugs:

“Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development,” Laughren noted.

In April 2009, Gabriel Meyers, a 7-year-old Florida boy, committed suicide by hanging in the bathroom of a foster care home. In the last few days of his life: “He was told his mother no longer had visitation rights, that he would probably be going back to Ohio, where he alleged he had been abused; the doctor changed his medication, he changed foster homes and he got a new counselor,” George Sheldon, secretary of the Department of Children and Families, stated in the May 12, 2009 St Petersburg Times.

In the year leading up to his suicide, Gabriel had been on the stimulant drugs Adderall and Vyvanse, the SSRI antidepressant Lexapro, Zyprexa, and Eli Lilly’s Symbyax, a drug containing both Zyprexa and Prozac, recently FDA approved for “treatment resistant” depression.

Gabriel was on Symbyax and Vyvanse when he died and neither prescription had been authorized by either his parents, or a court order signed by a judge, in violation of Florida law. He was listed as being on only Adderall in the Department of Children and Families’ database.

“On six separate occasions, Gabriel’s caseworker, Lawrence Chusid, documented that DCF had “parental consent” for the child’s medications,” according the May 9, 2009, St Petersburg Times

“But in the hundreds of records in Gabriel’s file released by DCF late last month, there is only one form signed by his mother, Candace, a blanket authorization for medical treatment for her son,” dated June 29, 2008, the Times reports.

The labeling on Prozac and Symbyax, contains a black box warning of an increased risk of suicide in children. Instead of discouraging the concomitant use of these two powerful medications, Lilly has encouraged such practices by “designing its own “combination” capsule which contains both Prozac and Zyprexa,” says attorney, Andy Vickery, of the Houston law firm, Vickery, Waldner & Mallia, who is involved in Zyprexa suicide litigation.

“The actual number and rate of completed suicides for patients in clinical trials on antipsychotic drugs, as submitted to the FDA, is higher on Zyprexa than on any of the other drugs in this class,” he reports.

“Specifically,” he says, “Lilly reported that, of 2500 patients on Zyprexa, there were 12 completed suicides, as compared to none on placebo.”

For several years, a system called the “Medicaid Drug Therapy Management Program,” was supposed to be monitoring the prescribing habits of doctors for children covered by Florida Medicaid. However, Gabriel’s shrink, Dr Sohail Punjwani, had been red-flagged as having “problematic” prescribing practices in every quarter since the monitoring began in 2006.

According to the Miami Herald: “Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.”

“The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children,” the Herald reported.

The doctor told the Herald that he did not even remember Gabriel. On May 12, 2009, the Herald reported that a “lawmaker who chairs a state Senate committee on children has asked the state to investigate the doctor who treated a foster child who killed himself.”

“In separate letters to the Florida Board of Medicine and the Agency for Health Care Administration, state Sen. Ronda R. Storms, a Brandon Republican who chairs the Children, Families and Elder Affairs Committee, requested investigations leading to a “full report,” according to the Herald.

Following Gabriel’s death, DCF Secretary Sheldon directed a review of the files for every Florida foster child to ensure that any child prescribed psychotropic drugs was accurately recorded in the Department’s system. He also directed a verification of the existence of a parental consent, or a court order signed by a judge, authorizing each child to receive such medication.

The results of the review in a May 28, 2009 report indicate: “No record of consent or judicial order was found for 16.2% of the 2,669 children receiving psychotropic medication.”

On December 13, 2006, four-year-old Rebecca Riley died in a Hull, Massachusetts as a result of a drug overdose. At a mere 28-months-old, Dr Kayoko Kifuji, a psychiatrist at Tufts New England Medical Center in Boston, diagnosed Rebecca with ADHD and bipolar disorder, and subsequently prescribed, Seroquel, Depakote, an antiseizure drug, and clonidine, a blood pressure medication.

The medical examiner 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 police reports.

The legal filings show the two other Riley children, ages 6 and 11 at the time of Rebecca’s death, were also diagnosed with bipolar disorder and ADHD, by the same doctor, and kept on the same 3-drug cocktail for years.

Rebecca’s parent have been charged with murder under the theory that they overdosed the child in attempt to sedate her and she did not bring in government disability payments.

On February 7, 2007, the day after the parents pleaded not guilty to the charges, 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,” the Board’s February 7, 2007 press release stated.

In April 2008, attorney, Andrew Meyer Jr, filed a 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.

In an editorial titled, “How many more Rebecca Rileys?, in the January 9, 2009 Patriot Ledger, the author of, “From Difficult to Delightful in Just 30 Days,” Dr Jacob Azerrad, wrote: “To diagnose a 2-year-old as bipolar by adult standards is crazy.”

“A key issue is the misuse of psychiatric diagnostic labels to explain bad behavior in children,” he wrote. “This has resulted in the drugging of young children to a degree unprecedented in our history.”

“Our preschool children are far too young to defend themselves,” he said. “It’s up to parents to “say no to drugs” and teach their children that life is meant to be learned and experienced – it’s not just a pill to be swallowed.”

On March 5, 2009, Weymouth News reported that a “psychiatrist who prescribed drugs for the late Rebecca Riley, who was four at the time of her death, can be charged with malpractice.”

“A Suffolk County tribunal determined on March 5 that there was enough evidence to charge Dr. Kayoko Kifuji,” the News noted.

“Rebecca Riley’s doctor now the target of a grand jury,” was the headline in the May 1, 2009 Patriot Ledger. “Already the target of a civil medical malpractice lawsuit, the psychiatrist who prescribed the drugs that killed 4-year-old Rebecca Riley is now the subject of a grand jury criminal investigation,” reporter Lane Lambert wrote.

“If the grand jury does find the … psychiatrist criminally liable for Rebecca’s death, she could face involuntary-manslaughter charges,” Lambert noted.

Evidence of the grand jury investigation surfaced “amid fresh legal action in both the civil and criminal cases,” Lambert said. “Kifuji’s lawyers asked a Suffolk County judge to postpone her deposition in the civil case indefinitely, and close the entire court record to the public.”

Kifuji’s attorney “said a deposition would force the doctor to claim her Fifth Amendment right not to incriminate herself while the grand jury was looking at the case,” according to the report. The judge denied both motions, it noted.

An attorney for Rebecca estate said Kifuji is scheduled to give a deposition in the civil case on July 6, 2009, after the grand jury is finished. In the March 5, Weymouth News article, Kifuji’s attorney said the murder charges against the Rileys make it difficult to decide if she can be faulted for Rebecca’s death.

“This is not something bizarre that she (Kifuji) did,” he said. “A number of fine doctors feel this was appropriate.”

Back on September 30, 2007, Katie Couric interviewed Dr Joseph Biederman, whose research Dr Kifuji has said influenced her, in a 60 Minutes segment tiled “What Killed Rebecca Riley?”

When questioned about the rise in young children with bipolar disorder, Biederman told Couric: “The average age of onset is about four.”

“It’s solidly in the preschool years,” he stated.

The results of an investigation led by Senator Charles Grassley, on behalf of the Senate Finance Committee, revealed that between 2000 to 2007, Biederman earned at least $1.6 million from drug companies but failed to report at least $1.4 to Harvard University.

On February 26, 2009, Biederman was questioned under oath in a deposition for litigation titled, In re Risperdal/Seroquel/Zyprexa Litigation, Case Code 274, Alma Avila as next fried of Amber Avila versus Johnson & Johnson Company et al, in the Superior Court of New Jersey, Middlesex County.

At one point, when questioned about his participation in medical education events as a paid speaker, he blamed a decline in invitations to speak over the past year on Grassley’s investigation and inferred that the investigation was brought on by media hype over Rebecca’s death.

When asked if he had any idea why he received fewer invitations, Biederman said: “There has been some accusations by Senator Grassley about issues of conflict of interest; and while the investigation is going on, I agreed not to speak.”

“What is the nature of Senator Grassley’s investigation of you?” attorney, Fletch Trammell, asked.

“Senator Grassley read, there was an article in The Boston Globe about a little girl in town that the parents are accused of first-degree murder,” Biederman noted.

“In fact, you may have seen it,” he told the attorney.

“The accusation has been upgraded from second-degree to first-degree murder,” he pointed out.

“But because the child was diagnosed with bipolar illness, it captured the imagination of the media and there was an article in The Boston Globe that talked about the diagnosis and how controversial that is and particularly as it pertains to preschoolers,” Biederman continued.

“And in the article the reporter got — I sent my standard disclosure forms, so he wrote that I have extensive relationships with fifteen or so pharmaceutical companies,” he stated.

“So Senator Grassley wrote a letter to the institution, to Harvard and Mass. General, asking for details,” he said. “And that has been the cascade of events.”

“So Senator Grassley became interested in you because of these people who were accused of killing their kid?” the attorney asked Biederman.

“Senator Grassley claims to be interested in issues of conflict of interest and is interested in making sure that the universities have tight conflict-of-interest rules,” Biederman said. “I have no dispute with that.”

“What interactions have you had with Senator Grassley or his staff?” the attorney asked.

“None,” Biederman stated. “Senator Grassley’s interactions are with Mass. General and with Harvard, not with me directly.”

Biederman said the hospital was paying a law firm to represent him in the matter of Grassley’s investigation and for the deposition.

He acknowledged having a professional relationship with Janssen, Eli Lilly, Bristol-Myers Squibb, AstraZeneca and Pfizer, the makers of atypical antipsychotics. “I have a professional relationship with dozens of manufacturers,” Biederman said.

“In the course of carrying out these relationships with all these drug manufacturers, does the relationship always involve them giving you money?” the attorney asked.

“Most of the time,” Biederman replied.

On March 27, 2009, the New York Times reported that, “Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.”

The researchers, Doctors Joseph Biederman, Thomas Spencer and Timothy Wilens – “are named in the subpoena, which was sent … to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines,” the Times noted.

Up until June 10, the researchers and doctors in the field of psychiatry identified by Grassley’s investigation included Charles Nemeroff from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford University; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, “Infinite Minds,” broadcast for years by National Pubic Radio.

But on June 10, the name Zachary Stowe was added to the list, with a Wall Street Journal headline: “Emory Psychiatrist Cited in Conflicts of Interest.”

“Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women,” the Journal wrote.

Stowe is the director of the “Women’s Mental Health Program” at Emory. Its website says the focus his “clinical research is the use of psychotropic medications during pregnancy and lactation, the psychobiology of mood disorders during pregnancy and the postpartum period, and the impact of maternal mental illness on fetal and neonatal exposures.”

The latest off-label marketing scheme in the works involves federal legislation expected to come up for a vote soon in the US Senate called the Mothers Act. This one involves a plan to screen all pregnant women for a long list of pregnancy related “mood” and “anxiety” disorders.

After covering the Pharma’s off-label marketing schemes using mental illness screening scams since mid-2004, beginning with TeenScreen, the Mothers Act is no different than the others, aside from the fact that a whole new treatment industry was built up around it, and more profiteers are involved. But then, Pharma could hardly expect to keep selling drugs through middle-man pushers forever, while keeping the massive profits to itself.

Amy Philo, the leader of “Unite for Life,” a coalition of 50 groups against the bill, warns that the Mother’s Act is: “Trolling for Mental Patients in a Maternity Ward Near You.”

“If you’ve never been “Teen Screened” in high school, quizzed by a college counselor about your potential perfectionism, mood swings, or alcohol use- or told you might go crazy if you don’t start taking drug x, consider yourself among the fortunate, fading few,” Amy advises.

“Imagine yourself pushing a baby into the world in a hospital somewhere in America,” Amy says, “only to be greeted by a friendly, neighborhood-psychological-screener the very moment baby begins munching down on his first meal.”

“Would either of you like a DSM-IV Mental Disorder diagnosis code with that milk?”

With no psychiatric drugs FDA approved as safe for use by pregnant and nursing mothers and doctors rightfully reluctant to prescribe any drugs harmful to the fetus, a new customer recruitment scheme was needed and the Mothers Act fit the bill.

Opposition to the Act stems from the certainty that it will lead to more forced drugging of infants with no voice of their own to prevent it, with antidepressants, antipsychotics, and antiseizure drugs that cause birth defects, a withdrawal syndrome and many other serious health problems, through pregnant and nursing mothers.

The Act is modeled after a mandatory screening law enacted in New Jersey, the home state of the bill’s main sponsor, Senator Robert Menendez, and also the home state for many drug companies. Attempts to pass the federal version have failed for the past 8 years.

The postpartum websites strung out all over the internet to promote the bill, many run by people benefiting financially from the new treatment industry they created, argue that the Act does not call for mandatory screening, without mentioning that the screening language was removed last year due to strong opposition.

“There is NO MANDATED screening,” Susan Stone wrote in a blog on the website for her treatment center, PerinatalPro, on May 29, 2009.

On May 12, 2009, the Herald News reported that the Act “lacks one vote for approval” in the US Senate, citing a speech made by Menendez, during a press conference. Menendez told the Herald that the national bill would not mandate screening. “Hopefully, states would adopt screening,” he said.

This statement, in May of this year, clearly shows that the goal of passing the federal legislation is to set the stage for states to pass mandatory screening laws, like the one in New Jersey.

A June 16, 2006, press release, by Menendez and Senator Richard Durbin, announcing the bill stated, the “Act was introduced in response to a recently passed, first-of-its-kind New Jersey law requiring doctors and nurses to educate and screen expectant mothers about PPD.”

The Theraurus on my computer lists “require,” as an alternate word for “mandatory.”

On June 8, 2009, New Jersey.com, ran the headline: “E-mail: Drug lobbyist targeted Menendez to help with importation bill,” and reported that the subject line of the email said: “URGENT”

The email called for New Jersey drug companies to ask Menendez to be their champion on an amendment that would effectively kill any attempt to allow cheaper drugs to be imported from other countries, according to the report.

“We need to locate a Democratic lead cosponsor for the second degree amendment,” the e-mail said.

“Can … [Johnson & Johnson], Merck, Novartis, Pfizer and the other New Jersey companies coordinate and contact Senator Menendez’s office and ask him to take the lead?”

The strategy to pursue Menendez became known when the email from the Pharmaceutical Research and Manufacturers of America, the industry trade group, ended up with Senator John McCain, a drug importation advocate. “And McCain read it on the Senate floor – twice,” the article notes.

“Menendez’s office said that while he supports the drug companies’ position, he did not act as their champion,” according to New Jersey.com.

The Mothers Act refers to “entities,” as being eligible for grants and participating in research and the development of screening methods and treatments and delivery.

The bill states: “The Secretary may make grants to eligible entities for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with a postpartum condition and their families.”

Under definitions, it says the term ‘eligible entity’– “means a public or nonprofit private entity;” and “includes a State or local government, public-private partnership, recipient of a grant under section 330H (relating to the Healthy Start Initiative), public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, public housing primary care center, or homeless health center.”

“Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing,” according to Kelly Patricia O’Meara in May 7, 2009 article, “Stress Testing the Mothers Act.”

“Where is the guarantee that the “entities” are not pharmaceutical front-men?”, she writes.

“Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse,” O’Meara points out.

The Act also calls for a “a coordinated national campaign to increase the awareness and knowledge of postpartum conditions.” Activities under such a campaign may– “include public service announcements through television, radio, and other means;” which will basically provide the new pregnancy-related treatment industry with a tax-payer funded mass advertising campaign.

It would be interesting to know whether “entities” would include the treatment centers owned by Susan Stone and Karen Kleiman, and whether their programs would be eligible for funding. At the “Postpartum Stress Center,” Kleiman teaches seminars for professional training with ads on her website and the heading: “Become an Expert in the Treatment of Postpartum Mood Disorders.”

The first sentence in “Highlights” for this training states: “This is a crash course on diagnosis, screening, assessment, treatment options.” The fee is $750 for a 10-hour course, but they do throw in a book titled, “The Postpartum Stress Center’s Guide to Enhancing your PPD Private Practice: A checklist for successful practice,” for the $750.

For this gig alone, Karen could make $7,500 per seminar by simply recruiting 10 trainees. Nearly all the websites pitch in to promote conferences and seminars, so rounding up 10, or even 20, trainees would likely not be too difficult.

The website shows 4 seminars a year, meaning Karen could earn roughly $30,000 for 40 hours of teaching people how to “Become an Expert.” And if she could round up 20 trainees per class, she could make $60,000 a year, putting her up there with all the other highly paid speakers within the new industry.

In her May 29, 2009 blog, Susan mentions how the Act might help fund “inpatient maternal mental health” programs all across the US. “Just this morning,” she says, “I completed an interview with Parenting Magazine, which plans to feature an article about the nation’s first inpatient maternal mental health unit at UNC, Chapel Hill, NC, as well as focus on the federal legislation and how this bill might help fund other such programs across the country.”

Many sites provide links to “experts” and treatment programs. For instance, Katherine Stone runs “Postpartum Progress,” and in December 2008, she had links to the “Top Women’s PPMD Treatment Programs & Specialists.”

The first program on the list was Dr Stowe’s at Emory, which primarily focuses on “the evaluation and treatment of emotional disorders during pregnancy and the postpartum period,” the website states.

In 2008, Dr Stowe was the primary investigator of an National Institutes of Health grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to Grassley’s June 2, 2009 letter to the president of Emory.

During a 2008 deposition in a Paxil birth defect case, Stowe said that around “80% of his Emory salary ($187,000) comes from his NIH grants,” the letter notes. His total Emory salary was $232,000.

In 2007, Paxil maker, GlaxoSmithKline, paid Stowe $154,400 for 57 promotional talks. He also received $99,300 in the first ten months of 2008 for 38 promotional talks for antidepressant drugs, according to Grassley.

Stowe’s undisclosed income above was from one drug maker. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth. He has served on advisory boards for Wyeth, Bristol-Myers Squibb, and Glaxo, and he has served on speaker’s bureaus and/or received honoraria from Lilly, Glaxo, Pfizer, and Wyeth.

Dr Jeffrey Newport is the associate director of Emory’s Women’s Program. Newport was also an author on the “Antipsychotic,” study. He has received research support from Lilly, Glaxo, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according to the disclosures.

On June 14, 2007, Katherine Stone posted a blog with the headline: “Upcoming Event in Asheville Features My Psychiatrist!”, in an evening for prescribing clinicians called “Postpartum Mood Disorders: A Systemic Approach to Biopsychosocial Treatment.”

“The key speaker will be Dr. Jeffrey Newport, associate director of the Emory Women’s Mental Health Program here in Atlanta and also my psychiatrist!!!!”, she said. “I have firsthand knowledge that Dr. Newport rocks.”

An online announcement shows Dr Stowe gave a seminar titled, “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The moderator for the seminar was Charles Nemeroff, who earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to Grassley.

On July 23, 2008, an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and PostPartum,” was available on Medscape. The Medscape website stated, “This article is temporarily unavailable,” on March 17, 2009.

Nemeroff stepped down as chair of the psychiatry department in 2008 after an Emory found he had failed to report more than $800,000 from Glaxo from 2000 to 2006. “That matter is now being probed by the inspector general for the U.S. Department of Health and Human Services,” according to the Wall Street Journal.