By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New Jersey – Drinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

Oklahoma – Kaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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Pharmalot
By Ed Silverman
July 19, 2010

Last year, a 7-year-old foster boy named Gabriel Myers committed suicide in Florida and, after reams of publicity and hand-wringing over the use of psychotropic medications in such children, a state task force recommended, among other things, that children never be allowed to participate in a clinical trial designed to evaluate new psychotropic meds or whether such drugs approved for adults should be given to children.

The move was prompted, in part, because a Florida psychiatrist, Sohail Punjwani, who treated the boy before he committed suicide, received an FDA warning letter for failing “to protect the rights, safety and welfare” of children enrolled in clinical trials (back story). Before the suicide, the psychiatrist prescribed to kids several drugs, some of which weren’t approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children (back story).

As part of the follow-up, George Sheldon, who head’s Florida’s Department of Children and Families, wrote FDA commish Margaret Hamburg for info about any foster children who might have participated in clinical trials for psychotropic meds (read the letter) and asked the FDA to forbid foster kids from participating in these trials. Last month, the agency wrote back to say the agency does not agree with a “blanket prohibition” on enrolling foster children. Why? Such a policy fails to account for the greater risk of off-label prescribing and research involving children can yield benefits that cannot be obtained by tracking usage in adults, Jill Warner, acting associate commissioner for the FDA’s Special Medical Programs, wrote back (see here). Drugmakers, by the way, also have something at stake – they receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials.

We asked Florida officials if they are rethinking their position. The answer? No way. The state is resolute.

Read entire article:  http://www.pharmalot.com/2010/07/florida-tells-fda-no-children-in-psychotropic-trials/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot

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The Market Oracle
By Michael Stathis
April 15, 2010

Is there any reason why Pfizer shares are down today?

Just yesterday, shares were trading at ~ $17.30. Today, with the DJIA up by 0.7%, Pfizer is down by nearly 1%.

A clue to this sell-off MIGHT be due to the anticipation by investors of increasing pressure to change the way drugs are prescribed. This could also trigger several lawsuits down the road.

Recently, another study was published in the Journal of the American Medical Association discussing elevated suicide risks associated with the use of anticonvulsant drugs. Anticonvulsants have been approved by the FDA for people diagnosed with epilepsy.

Of course, this is not the first study showing anticonvulsants raised the risk of suicide.

In 2008, the FDA required all anticonvulsant drugs to have a warning label that disclosed a two-fold increased risk of suicide. However, warning labels are rarely effective. They simply enable drug companies to continue to sell what many experts feel to be dangerous drugs, while having the safeguard of a disclaimer.

When patients receive a prescription for a drug to address a medical condition, they assume it’s a safe drug; otherwise, it wouldn’t be approved for use. And their doctor certainly wouldn’t prescribe it if it weren’t safe, would he?

According to DEA and FDA regulations, physicians are free to prescribe any drug for any condition they see fit, known as off-label use. As a result of off-label usage, anticonvulsants are prescribed for many different medical conditions like bipolar disorder, pain and migraine headaches. As you might imagine, in some cases, off-label use has accounted for a big chunk of drug sales.

The class of drugs prescribed most by physicians for off-label uses are the antipsychotics (Prozac, Xanax, Zyprexa, etc). The FDA has approved these drugs to treat a variety of neurologic conditions such as depression and bipolar disease. However, drug companies have used many methods to get physicians to prescribe them for a wide range of off-label uses.

Read entire article:  http://www.marketoracle.co.uk/Article18652.html

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CBS4.com
By Lisa Cilli
April 13, 2010

Florida lawmakers are scheduled to discuss a measure Tuesday designed to curb the prescription of mental-health drugs to children in state care. Senate Bill 2718, also known as the Gabriel Myers Bill, would allow officials to more closely monitor the powerful psychiatric drugs dispensed to Florida foster care children.

The proposal is largely based on the findings of a task force formed after Gabriel locked himself in a bathroom and hung himself with a shower cord last April in his Margate foster home. Gabriel was on Seroquel, used to treat bipolar disorder, and other psychiatric drugs linked by federal regulators to potentially dangerous side effects, including suicide, but the risks may not have been adequately communicated to his foster parents. The drugs are not approved for use by young children. But doctors often prescribe them ‘off-label,’ for purposes for which the drugs have not been approved.

Sen. Ronda Storms (R)-Brandon, who filed the bill, said prescribed drugs have replaced talk therapy and are over-prescribed to subdue unruly children.

The proposed law would require the state Department of Children and Families to assign volunteer guardians to oversee each child’s mental health care. It prohibits foster children from being the subject of clinical drug trials and raises the age at which children are allowed to take these drugs from 6 to 11 in many cases.

Read entire article:  http://cbs4.com/local/florida.legislators.legislation.2.1629212.html

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Sharp Rise in U. S. Military Psychiatric Drug Use and Suicides

CounterPunch
By Bruce E. Levine
April 2, 2010

One in six service members is now taking at least one psychiatric drug, according to the Navy Times, with many soldiers taking “drug cocktail” combinations. Soldiers and military healthcare providers told the Military Times that psychiatric drugs are “being prescribed, consumed, shared and traded in combat zones.”

The Navy Times reporters Andrew Tilghman and Brendan McGarry also noted that there has been a large increase in military suicides. From 2001 to 2009, the Army’s official suicide rate increased from 9 per 100,000 soldiers to 23 per 100,000. During that same period, the Marine Corps suicide rate increased from 16.7 per 100,000 soldiers to 24 per 100,000.

A Military Times investigation of records obtained from the Defense Logistics Agency revealed that the DLA spent $1.1 billion on psychiatric and pain medications from 2001 to 2009, and that there was a 76 percent increase in psychiatric drugs. DLA records show:

• Antipsychotic drugs spiked most dramatically — orders jumping by more than 200 percent.

• Orders for anti-anxiety drugs and sleeping pills such as Valium and Ambien increased 170 percent.

• Orders for antiepileptic drugs (also known as anticonvulsants) such as Depakote, routinely used as psychiatric medications, increased 70 percent.

• Antidepressants showed a 40 percent increase.

Investigators found that antipsychotic and antiepileptic drugs, approved for bipolar disorder and schizophrenia, are now commonly used to treat post-traumatic stress disorder (PTSD) symptoms such as nightmares, nervousness, and anger outbursts. The use of antipsychotic drugs for non-psychotic conditions such as PTSD is called “off-label” prescribing. The general public is also subject to off-label prescribing, which is considered legal.

Read entire article:  http://www.counterpunch.org/levine04022010.html

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CBSNews.com
By Edecio Martinez
March 17, 2010

The apparent suicide of 7-year-old boy Gabriel Myers, who was taking several psychiatric medications, has led to the introduction of a bill in the Florida legislature, which would assure that powerful mental health drugs dispensed to Florida foster care children would be more closely monitored.

The proposal is largely based on the findings of a task force formed after Gabriel locked himself in a bathroom and hung himself with a shower cord last April.

Gabriel was on Seroquel – used to treat bipolar disorder – and other psychiatric drugs linked by federal regulators to potentially dangerous side effects, including suicide, but the risks may not have been adequately communicated to his foster parents.

The drugs are not approved for use by young children. But doctors often prescribe them ‘off-label,’ for purposes for which the drugs have not been approved.

Sen. Ronda Storms said prescribed drugs have replaced talk therapy and are over-prescribed to subdue unruly children. The measure would require an independent review before psychiatric drugs can be administered to children 10 or younger.

Read entire article:  http://www.cbsnews.com/8301-504083_162-20000546-504083.html

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Geoff Leisik
Deseret News
November 11, 2009

Pharmaceutical giant Eli Lilly and Co. has agreed to pay $24 million to settle a lawsuit filed by the Utah Attorney General’s Office.

Attorney General Mark Shurtleff sued the company after a nearly four-year investigation revealed that Lilly concealed its knowledge of significant weight gain and obesity associated with the anti-psychotic medication Zyprexa. Investigators also showed that Lilly’s sales representatives illegally promoted the drug for uses not approved by the U.S. Food and Drug Administration.

“We’re not just asking them for money. We want their bad conduct to stop,” Shurtleff said Wednesday while announcing the settlement.

“As part of the settlement agreement, there are corporate integrity responsibilities and remedial provisions that will continue to be monitored by the court to stop (Lilly’s) harmful behavior.”

Zyprexa is approved for the treatment of schizophrenia and certain types of bipolar disorder in adults. But authorities say that in 1999, Lilly’s marketing arm that focuses on doctors who treat the elderly began encouraging physicians to prescribe the drug for dementia, Alzheimer’s disease, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. Lilly also trained its sales teams to avoid discussions with health-care professionals about the weight gain side effect, investigators said.

Read entire article: http://www.deseretnews.com/article/705343716/Firm-to-pay-Utah-24M-in-settlement.html

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