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.
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)