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| Category: Psychiatric Care |
Date published: February 13, 2009 |
Psychiatric Drugging of Children - Intolerable
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.
Evelyn Pringle
(This
report was written as part of the Pharmaceutical Litigation Roundup
series and sponsored by the Baum, Hedlund, Aristei & Goldman law
firm)
(Evelyn Pringle is a columnist for Scoop Independent News
and an investigative journalist focused on exposing corruption in
government and corporate America) |
[All work by author is copyright protected. If you would like to use this article, please contact the author for permission.]
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