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Author: Sheila Matthews

Legislative Action Alert for May 20th – Connecticut

MONDAY – MAY 20th, HOUSE MEETS, MOMENT OF TRUTH

URGENT ACTION in Connecticut HOUSE OF REPRESENTATIVES!

Connecticut URGENT ACTION NEEDED! CALLS TO CT HOUSE OF REPRESENTATIVES. Two dangerous bills pass CT Senate move to House.

FIND YOUR REPRESENTATIVE: KILL THESE BILLS. LINK BELOW, Copy and paste and add or delete to our suggested letter.

http://www.cga.ct.gov/asp/menu/hlist.asp

FIRST BILL:

0652: AN ACT CONCERNING REFERRALS FROM THE DEPARTMENT OF CHILDREN AND FAMILIES TO THE BIRTH-TO-THREE PROGRAM.

To create a pilot program to refer children thirty-six months of age or younger who are the victims of substantiated abuse or neglect to the birth-to-three program.

DEAR REPRESENTATIVE:

I (your name) STRONGLY OPPOSE Senate bill 0652 and Senate bill 0833.

Senate bill 0652, places low income families and their babies that are mandated into the CT State Department of Children and Family Services “at risk” of being trafficked into to drug research and behavioral health research at Yale University.

The “Pilot” program has not been validated as effective or safe. This is “research” children from the department of children and families services are trapped within the State care system and do not have the “right to opt” out of these research “Pilot” programs.

The entire department of children and families services is run by behavioral health vendors who profit off the services given to children within the system. Currently, the only vendors allowed to identify children’s needs and to offer children services are that of psychiatry. This one vendor rule has no accountability for misdiagnosing or drugging children to death, which is part of the current crisis for children utilizing services by the State.

This bill would traffic children into the department of Psychiatry at YALE University under the term “pilot program” with no proven track record to support strong effective informed consent for participants nor gives participants the ability to refuse the services.

Therefore, I request you reject this bill and encourage the break up of the monopoly of service contractors servicing all children within State care. We urge you to watch the Diane Sawyer one year long investigation into the drugging of children within State care, whereas, data used for that investigation was provided through Ablechild from the Connecticut Department of Children and Family Services.

Second Bill for you to reject is Senate Bill 0833

AN ACT ADDRESSING THE MEDICAL NEEDS OF CHILDREN.

To provide the Department of Children and Families or other appointed guardian with the authority to meet the medical and educational needs of a child under an order of temporary care and custody.

Very simple, this bill strips away INFORMED CONSENT rights of children and families fighting to get their children out of state care, waiting for trials or placed in to State care for any other reason. This bill would allow the State to administer dangerous mind altering drugs to children while they are in “temporary” custody. This bill also goes as far as to allow the State to do “surgery” on children while in temporary custody of the State.

There are no legal protections for these children to file claims against the State for Malpractice or treatments that go wrong or were not needed. This allows the State to alter a child’s life while that child is only in temporary custody and rejecting the natural parents ability to participate in decision making in the best interest of the child they gave birth. There is no right to refuse. I strongly oppose this bill and urge you to as well.

http://www.cga.ct.gov/CGAPBTS.asp?selBillType=Bill&bill_num=SB00652
http://www.cga.ct.gov/CGAPBTS.asp?selBillType=Bill&bill_num=SB00833

Any questions please post below. We will gladly answer them right away! Phone calls would be great as well and use our letters above as talking points. These two bills are moving quickly. If you do nothing else today, make a call for the children trapped in Connecticut State care.

At this time we need people calling CT State House Members to kill these bills that traffic our children into dangerous and often deadly treatment plans.

Bill Status
www.cga.ct.gov

CDC’s Questionable Findings

Ablechild’s response to article in the Huffington Post, “Mental Disorders in Children: CDC Releases First-Ever Report”.

After reading the supplement report and an exhausting listing of subjective mental labels, their descriptions, and their definitions according to the industry that created them, studies them, and begs the government for funding of them; Ablechild found it stunning to see the doctor who penned the newly released “supplementary report”, Dr. Ruth Perou gives her opinion on the motives behind the CDC efforts.

“This is a deliberate effort by CDC to show mental health is a health issue. As with any health concern, the more attention we give to it, the better. It’s parents becoming aware of the facts and talking to a healthcare provider about how their child is learning, behaving, and playing with other kids,” Dr. Ruth Perou, the lead author of the study, told Reuters in an interview.

Really?  Ablechild takes issue with her statement and reminds her that the CDC’s mission is not to be the marketing arm for the psychiatric industry, but to collect data to reduce disease.  The CDC including “mental illnesses” into their data collection arena isn’t something Ablechild would normally agree with since the diagnostic process is subjective in nature and they are not diseases.  As you see from the entire introduction and report itself,  it blathers on about surveys and questionnaires, and we can all agree that diseases are not diagnosed by questionnaires and surveys.   Even the NIMH in April came out with a statement invalidating the DSM (Diagnostic Statistical Manual) symptom based model as being unscientific.  However, considering the CDC’s recent release of the skyrocketing numbers of children diagnosed with ADHD (up 53% in the past decade) we can surmise that this serves as an alarming warning of the dangers that this presents to our children’s health and safety.

Ablechild does support the NVDRS (which is completely ignored by Dr. Ruth Perou) which is a state-based surveillance system that links data from law enforcement, coroners and medical examiners, vital statistics, and crime laboratories to assist participating states in designing and implementing tailored prevention and intervention efforts. An incident-based, relational database collects and stores the data and is available free of charge from the NVDRS Web-based Injury Statistics Query and Reporting System (WISQARS). http://www.cdc.gov/ncipc/wisqars/NVDRS/About-NVDRS.htm#disclaimer .

Ablechild supports this new National Violence Data Reporting System.  This system has the potential to collect data of psychiatric drugs and their link to increased risk of suicide and violence among users.  This is evidence-based and the public needs to ensure that this system is not only set up to capture the data but is accurately maintained and supported by professionals.

 

http://www.cdc.gov/ncipc/wisqars/NVDRS/About-NVDRS.htm#disclaimer

In Wake of Sandy Hook, Parent’s Rights Organization Holds Community Forum on Violence Prevention

On Monday, May 13th from 6-8pm at the Edmond Town Hall in Newtown, CT, a national parent right organization is holding a violence prevention forum which is open to the public. It will tackle difficult questions that today’s media hasn’t addressed, which deals with the growing number of school related acts of violence being linked to psychiatric drugs known to have deadly side effects.

In a major effort to educate the public on the importance of linking data together regarding 31 school shootings and/or school-related acts of violence and their association with psychiatric drugs, a national parent rights organization, Ablechild will host a forum on mental health and the importance of informed consent. The forum scheduled for Monday, May 13th in Newtown will be filmed, and will tackle hard questions that have been ignored by mainstream media, despite the fact that there are 22 international regulatory agency warnings that have been issues on psychiatric drugs citing effects of mania, hostility, aggression, violence and even homicidal ideation.

Ablechild has a pending APPEAL in the State of Connecticut for the release of the medical and toxicology records of the latest school shooter in the mass murder suicides that are plaguing our nation. Ablechild will host an open discussion on mental health, informed consent, bridging the data to save lives with an open community discussion. The forum will be filmed to share with other communities.

“This can happen anywhere and will sadly happen again if we don’t start linking the data together in an intelligent and meaningful way to protect public safety,” says Ablechild board member, Michael Montanaro, orthodontist with offices in Bridgeport, New Canaan, Shelton, and Westport, Connecticut. “During my recent visit to Newtown, it took my breath away to think of the human loss. This forum will help explain to this hard-hit community the importance of collecting the right information to help prevent senseless acts of violence in our communities.”

This friendly forum will allow for a calm, intelligent discussion to exchange knowledge on mental health safety and inspire educated action. As seating is limited, please RSVP in advance to Ablechild volunteer,

Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Bob Fiddaman and Sheila Matthews
sheila@ablechild.org
(203) 594-1700

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 Connecticu 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 itsDCF 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 pscyhotropic 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.

Federal Court Decision May Place More Children At Risk

Sheila Matthews
National Vice President
www.ablechild.org
sheila@ablechild.org
(203) 966-8419

Last month, in Juan F., et al. v. M. Jodi Rell, et al., the United States District Court in the District of Connecticut held that Connecticut’s Department of Family Services (“DCF”) could not suspend new intakes of children into its Voluntary Services Program (the “Program”). According to the Court, the decision to suspend new intakes would unilaterally cut off the service lifeline for vulnerable, at-risk children. The Court explained that any suspension of intakes would leave children at imminent risk of irreparable harm, and place the defendants in violation of their settlement obligations. Ironically, a point often forgotten, is the fact that the original plaintiff/child in the case, Juan F., died while under State care.

The Court ultimately concluded that children accepted into the Program must be accepted by the State because these “at-risk” children were part of the original settlement in the lawsuit. AbleChild addressed the flawed intake methods in a friend of the court brief. The concern of AbleChild is that many of the children identified for the Program are not “at-risk.” The real danger is that some of these children, who are not “at-risk,” will now be put into harm’s way by taking them away from their families without cause and forcing them to ingest dangerous psychotropic
medications.

Unfortunately, in trying to help more “at risk” children, the Court ignored the State’s current intake methods for determining which children are truly “at risk.” Often times, the State concludes a child is “at risk” without any justification. Children are taken away from their families on the basis of a single phone call into a “hotline” and even without the filing of a police incident report. When this happens, innocent children are unjustly put at risk, and the child’s family is forced to prove to a court that their child is not in danger.

AbleChild appreciates the Court’s concern regarding the well-being of all of Connecticut’s children; however, AbleChild also recognizes that children who enter DCF, regardless of whether the children are “at-risk,” are typically diagnosed with a mental illness and treated with psychotropic drugs. Ablechild believes the parties, and the Court, should make a commitment to first insuring that no child is unnecessarily taken away from their family.

ABLECHILD SAYS THAT MISDIAGNOSIS OF A MILLION CHILDREN UNJUSTIFIABLE AND URGES PARENTS TO GAIN RISKS OF TESTING, LABELING AND DRUGGING

Diane Nahabedian
dianenahabedian@yahoo.com
(617) 943-3732

Over 4.5 million children nationwide have been diagnosed with attention deficit hyperactivity disorder or ADHD according to a study says an article “Youngest in Class get ADHD Label” published this week in USA Today . Nearly 1 million children may have been misdiagnosed because they were the youngest in their class.

Sheila Matthews, co-founder of AbleChild in Connecticut says, “it is unjustifiable to misdiagnose a million children with ADHD. Psychiatry claims ADHD is a serious disease like cancer, and our schools have become a marketing distribution channel for this false data. The “experts” have compared ADHD to having diabetes and touts the cure as the need for powerful dangerous mind altering drugs. Imagine if a million children were diagnosed with cancer or diabetes and underwent needless treatments. Ablechild wants to know what compensation is planned for these children and their families? In addition, when is the psychiatric industry going to tell the truth about ADHD to parents, and the fact that the diagnosis is not based in any real science, and is not a disease like cancer or a condition like diabetes. It is subjective!”

Patricia Weathers, another co-founder of AbleChild, who has testified before a Congressional subcommittee regarding the use of drugs in the schools explains, “when parents are confronted by a teacher or school psychologist regarding issues like ADHD they often feel frightened and alone, and pressured to drug their children. Frequently, parents recognize their child’s challenging behavior as normal, and may not want to subject their child to the serious risks caused by psychotropic drugs.” Weathers herself was threatened with child protective services as a result of a charge of medical neglect waged at her by her son’s school when she took him off psychiatric drugs that caused him a wide array of side effects.

Matthews and Weathers continuously urge all parents to remember that they are their child’s best advocate, and know their own child best. “We urge all parents to gain an understanding of the real risks of psychological and behavioral testing, labeling and drugging,’ says Matthews.

Unfortunately, school officials place tremendous pressure on parents to not only allow the school to conduct psychological testing on their children but to drug them as well. Parents may not realize that these tests are being used many times as the sole basis for the diagnosis of behavioral issues.

AbleChild, a 501C3 established in the state of New York, works with a team of parents, educators, attorneys and non-pharmaceutical-associated psychologists and psychiatrists who all have experience with the risks of psychotropic drugs and non-drug alternatives. AbleChild is a clearinghouse for objective information regarding ADD, ADHD, and other behavioral issues. All services that they render are free to the public.

The parents who founded this extraordinary organization and all those who work with it have personally suffered battles with their schools to have their children tested and drugged.

“Again,” says Matthews, “drugging a child today may result in serious consequences for that child’s future health.” Weathers adds, “if any parent is confronted with the issue of ADD, ADHD, or other behavioral issues that affect their child, please call us. We will give information that can help each parent make an informed decision. We are not a medical group, but a group of concerned parents who want everyone to make healthy decisions for the children they love.”

Please visit AbleChild at www. ablechild.org and become a friend on our Facebook page, or call us at 203-594-1700.

Senator Grassley Seeks Data From Drugmakers on Treatment of Whistleblowers

Jul 1, 2010
By David Voreacos

U.S. Senator Charles Grassley asked 16 drugmakers, including Pfizer Inc., AstraZeneca Plc and Eli Lilly & Co., to reveal how they treat whistleblowers who file complaints under the False Claims Act.

Grassley, an Iowa Republican, sent letters June 28 that posed eight questions such as how companies notify employees of the law, how they treat whistleblowers and what changes they have made in response to a 2009 law extending anti-retaliation protections. Grassley’s office provided copies of the letters.

The False Claims Act lets private citizens sue on behalf of the government and share in any recovery. Whistleblowers were paid $2.39 billion from 1987 to 2009, or 16 percent of the $15.19 billion collected in False Claims lawsuits in which the U.S. government joined the case, according to the Justice Department.

“What measures does Pfizer have in place to ensure fair treatment to those filing complaints?” Grassley wrote to Chief Executive Officer Jeffrey Kindler. “Of employees who have filed complaints, have any complained of unfair treatment and/or retaliation after the filing of the complaint?”

The False Claims Act was passed by Congress in 1863 and strengthened three times since 1986. Citizens file so-called qui tam cases that remain sealed from public view as the Justice Department investigates the claims and decides whether to join the suit. Twenty-five U.S. state shave their own versions of the law.

Large Settlements

Drugmakers have reached some of the largest settlements in recent years. Pfizer agreed to pay $2.3 billion over improper drug marketing, Lilly paid more than $1.6 billion to settle claims over its marketing of the drug Zyprexa, and AstraZeneca paid $520 million over marketing of its drug Seroquel.

Chris Loder, a spokesman for New York-based Pfizer, the world’s biggest drugmaker, said the company is responding to the letter and “shares the senator’s desire to detect and report any false claims that may lead to unnecessary costs to our health-care system.”

Pfizer, he said, has invested “substantial resources” to “create a compliance program that consists of mandatory training for every one of our employees, proactive monitoring and surveillance, and strict enforcement of all federal and state health-care laws.”

The company also has a chief compliance officer reporting to the CEO, a corporate compliance committee, a code of conduct, a compliance hotline and extensive procedures to investigate and remediate possible non-compliance, he said.

Anonymous Reports

Tony Jewell, a U.S. spokesman for London-based AstraZeneca, the U.K.’s second-largest drugmaker, said the company encourages its employees to report any instances of misconduct through various channels, including anonymously.

“We respond to all complaints of wrongdoing through prompt investigations and appropriate remedial action,” he said. “Retaliation of any kind is explicitly prohibited under our policies.”

Edward Sagebiel, a spokesman for Indianapolis-based Lilly, confirmed that the company received the senator’s letter.

“We will be cooperating fully with this request for information,” he said.

Grassley was a sponsor of the Fraud Enforcement and Recovery Act passed last year, which restored powers under the False Claims Act that had been narrowed by court rulings. The new law limited the ability of companies to avoid liability under the False Claims Act and made it easier for the Justice Department to issue civil investigative demands, a type of subpoena power, in pursuing cases.

‘Public Responsibility’

“My appeal to drugmakers is based on the fact that they have a public responsibility to safeguard the tax dollars that pay for their products, and promoting a culture where those who speak up about possible fraud are rewarded rather than retaliated against is one way to fulfill that responsibility,” Grassley said in a statement. “There can never be too many taxpayer watchdogs, so I see this letter as an opportunity to foster a mindset that recognizes the value of whistleblowers and the duty these companies have to act honestly when seeking taxpayer dollars.”

Whistleblowers are routinely exposed to retaliation and blackballing from their industries, said Patrick Burns, a spokesman for Taxpayers Against Fraud, a Washington non-profit advocate for the False Claims Act.

“The goal for companies is to isolate, humiliate, and terminate,” Burns said. “They want to send a signal to anyone else in the company that this is what happens to you — you will lose your job, you may lose your house, you may end up with a dissolved marriage.”

The Justice Department is investigating almost 1,000 whistleblower cases filed under seal, Assistant Attorney General Tony West said in an interview on June 3.

In the letters, Grassley, the ranking Republican member of the Senate Finance Committee, said he expects written responses to his questions by July 20.

The Washington Times: Mental health Trojan horse, It’s enough to make anyone sick

December 31, 2009
By Richard E. Vatz and Jeffrey A. Schaler

The vast majority of Americans are unaware of most of what is included in the Senate and House health care reform bills as they head for reconciliation in the House-Senate Conference. They will be in for a big surprise concerning parity mental health care coverage, covering mental problems comparably to physical problems. In addition, the arguments supporting the changes, rarely made public in order to avoid rigorous debate, have revealed the shifting grounds supporting parity.

Health and Human Services Secretary Kathleen Sebelius spoke on Dec. 16 to a friendly crowd of health care providers and others at Sheppard Pratt Health System near Baltimore, a location for a broad array of psychiatric services, concerning mental health coverage, and, according to reports, she defended the expansion of such coverage with all of the familiar shibboleths.

She argued, consistent with the administration’s claim that expanding health care in general to 30 million or more citizens would actually save us money, that the vastly increased mental health parity program would additionally, as the Baltimore Sun reported her message, “improve care for millions of Americans who do not get all the mental health services they need.”

In the speech, Ms. Sebelius said, “One in 5 Americans will have a mental health illness this year and almost half will have a mental illness in their lifetimes. Yet 10 million people didn’t get the mental health care they needed last year, and 20 million didn’t get substance abuse services.”

Ms. Sebelius proclaimed her own false analogy of mental health to physical health by saying, “If 10 [million] or 20 million Americans were walking around bleeding, we’d have alarm bells going off.”

But if mental heath professions’ own estimates of the current number of people who are mentally ill are correct, Ms. Sebelius is way off in her calculations. As Mark Twain quipped, “There are lies, damned lies and statistics.”

The American Psychiatric Association (APA) claims that more than 50 percent of Americans are mentally ill in their lifetime – and recent APA studies dwarf that statistic. Moreover, the problems that qualify as “mental disorders,” all those listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), are virtually without limit.

Significantly, the new coverage of mental illness covers a vast array of the “worried well,” who have no neurological or mental disorders but simply have problems in living. Support for mental health parity in the new health reform bills relies on the public’s false inference that the prototypical mental disorder is dementia or some other organically based brain disease, which constitute only a tiny percentage and atypical sampling of the hundreds of “mental disorders” listed in DSM-IV.

Typically, psychiatrists label those unhappy people they concede have no physical illness as having “social anxiety disorder” or some other equally benign “disorder.” Such people can be in costly, insurance-covered therapy indefinitely. As one psychologist told us, “Anyone who comes in with any problem can be diagnosed as having ‘adjustment disorder.’ ” (e.g., “with anxiety,” DSM-IV Code 309.24).

There are many such diagnoses of easily applicable disorders, including “antisocial personality disorder” (DSM-IV Code 301.7), “avoidant personality disorder” (DSM-IV Code 301.82), and others vague enough to be applied to almost anyone. This is one of the reasons that the American Psychiatric Association claims that in a lifetime far more than a majority of citizens will suffer from a mental disorder, and the estimates are increasing.

In the December 2008 APA’s Archives of General Psychiatry, there is a report that “almost half of college-aged individuals had a psychiatric disorder in the past year [emphasis added],” and this includes heavy drinking, categorized as “alcohol use disorder” (DSM-IV Code 305.00).

When everyone is sick, what is normal? “What is healthy?”
On one strategy to deal with these issues, perhaps Ms. Sebelius and mental health skeptics can agree: It is high time to let a national debate begin – before mental health parity becomes part of universal national health care insurance.

Richard E. Vatz, a professor at Towson University, is associate psychology editor of USA Today Magazine. Jeffrey A. Schaler, a professor at American University, is executive editor of Current Psychology and author of “Addiction Is a Choice” (Open Court Publishing Co., 1999).

Drug Makers Are Advocacy Group’s Biggest Donors

By Gardiner Harris, New York Times
October 21, 2009

nytimes-pillsDrug Makers Are Advocacy Groups’s Biggest DonorsWASHINGTON — A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations. Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

“For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,” Mr. Fitzpatrick said.

He promised that the industry’s share of the organization’s fund-raising would drop “significantly” next year.

“I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,” Mr. Fitzpatrick said. “It’s simply not true.”
Mr. Fitzpatrick said Mr. Grassley’s scrutiny, which he described as understandable given the attention paid to potential conflicts of interest in medicine, had led his organization to begin posting on its Web site the names of companies that donate $5,000 or more. And he predicted that other patient and disease advocacy groups would be prodded by Mr. Grassley’s investigation to do the same.

“Everyone I talk to wants to have more balanced fund-raising,” Mr. Fitzpatrick said. In a statement, Mr. Grassley praised the alliance for its disclosures. “It’d be good for the system for other patient groups to do what NAMI has done,” he said.

Mr. Grassley’s scrutiny has been unnerving for patient and disease advocacy groups, which are often filled with sincere people who are either afflicted with serious illnesses themselves or have family members who have been affected. Many join the groups in the hope of making sense of their misfortune by helping to find a cure or raising awareness of a disease’s risks and frequency.

Drug makers are natural allies in these pursuits since cures may come out of corporate laboratories and the industry’s money can help finance public service campaigns and fund-raising dinners. But industry critics have long derided some patient organizations as little more than front groups devoted to lobbying on issues that affect industry profits, and few have come under more scrutiny for industry ties than the mental health alliance.

For years, the alliance has fought states’ legislative efforts to limit doctors’ freedom to prescribe drugs, no matter how expensive, to treat mental illness in patients who rely on government health care programs like Medicaid. Some of these medicines routinely top the list of the most expensive drugs that states buy for their poorest patients.

Mr. Fitzpatrick defended these lobbying efforts, saying they were just one of many the organization routinely undertook. The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

“For the past five years, Bristol-Myers has sponsored this dinner at the highest level,” Dr. Feinstein said. He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that “now, more than ever, our enduring relationship with NAMI must remain strong.”

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits. The documents show, for example, that the alliance’s leaders, including Mr. Fitzpatrick, met with AstraZeneca sales executives on Dec. 16, 2003.

Slides from a presentation delivered by the salesmen show that the company urged the alliance to resist state efforts to limit access to mental health drugs.

“Solutions: Play Hard Ball,” one slide was titled. “Hold policy makers accountable for their decisions in media and in election,” it continued.

The alliance’s own slides concluded by saying, “We appreciate AstraZeneca’s strong support of NAMI.” Mr. Fitzpatrick said that the alliance frequently had such meetings and that the organization would fight for better access to mental health drugs “even if we had no relationship with pharmaceutical companies.”

Tony Jewell, an AstraZeneca spokesman, said that the company was “committed to improving health through partnerships with nonprofit organizations” and that “includes striving to ensure people can access our medicines through formularies managed by state Medicaid agencies.”

Stimulants for ADHD Shown to Cause Sudden Death in Children

By Dr. Peter Breggin
June 17, 2009

A new study, published Monday in the American Journal of Psychiatry, confirms what I’ve been warning about for years in my scientific books and articles. The stimulants used to treat children for so-called ADHD can cause sudden cardiac arrest and death in kids. The study was published by the journal online in advance of regular publication in the near future. On Monday, I had the opportunity to comment on the study on Good Morning America. Here is more detail.

The stimulant group of drugs includes amphetamines like Adderall and Dexedrine and methylphenidate products such as Ritalin, Concerta, and Focalin. The study focused on Ritalin because at the time it was more commonly used than the amphetamines, although amphetamines are probably even more toxic to the heart.

The results of the study were as dramatic as they are tragic. Children and youth age 7 to 19 taking prescribed Ritalin for ADHD were four to five times more likely to die of sudden unexplained cardiac arrest than other children who were not taking Ritalin.

Despite these ominous results, the study was skewed to hide just how many children die of sudden death when taking Ritalin. The study relied heavily on identifying cases through toxicology reports at autopsy. But autopsy studies for the detection of these controlled substances are geared to detect more massive doses from addiction and overdose. They are not sensitive enough to detect many cases of routine prescription use. As a result, many stimulant-caused deaths were probably missed.

Also, the study excluded a large number of sudden deaths if the children had even the slightest evidence of pre-existing heart disease. They excluded these children even when the coroner thought that heart disease played no role in the death. For example, if a child was taking stimulants and had minimal heart disease, such as a slightly enlarged heart, the researchers didn’t include the case as a possible death due to the stimulant. They also did not count children who were severely obese, anorexic, or asthmatic. But all of these children, especially ones with undetected heart disease, are much more highly at risk for of stimulant-induced sudden death. They even excluded children whose parents had some forms of heart disease.

It’s as if they did not want to confirm the obvious—that an examination of children with heart disease and related disorders would swell the numbers of those killed by Ritalin. In fact, the current FDA approved label specifically mentions the risk of cardiac sudden death when Ritalin is given to children with heart conditions.

Unconscionable, the study researchers were trying not to prove that stimulants cause sudden death in children. They made the findings despite their own attempts to avoid it. I was not surprised to find that some of the researchers for this study are among the biggest advocates of psychiatric medications for children.

Sudden cardiac death in children is rare, probably occurring—as the study notes—in a slightly little less than 1 in 100,000 children. But we need to take a few other facts into account. First, the rate is going to be much higher in children taking stimulant drugs. Not just the four or five times higher found in this study, but many more times higher when vulnerable children are included such as those with undetected heart disease, severe obesity, asthma, or anorexia. Second, stimulant drugs are one of the few causes of cardiac death in otherwise normal children, making it impossible to detect the risk before it happens.

There is also evidence from studies of stimulant addicts and case reports that stimulant drugs can cause heart disease, including inflammation and scarring. When drugs like Ritalin and Adderall are prescribed in routine pediatric doses, they commonly cause hypertension, which can lead to an enlarged heart. Yet children with even slightly enlarged hearts were excluded from the study. So the researchers ended up excluding any children with enlarged hearts caused by the stimulant treatment itself.

The same is true in regard to anorexia. Stimulants commonly cause anorexia. The researchers therefore excluded cases of stimulant-induced death in anorexic patients when the anorexia itself could have been caused by the stimulant.

Meanwhile the psychiatric establishment—represented by American Psychiatric Association, NIMH and drug companies–has been quick to dismiss the importance of the study. Instead, they should be emphasizing that the study detected the risk even though the highest risk patients were excluded, including some who were displaying toxic stimulant effects such as heart disease and anorexia.

Meanwhile, it’s hard to imagine a greater tragedy for the surviving family than the unexpected death of a child from taking a medication prescribed by a doctor. I’ve been involved as a medical expert or consultant for families in several tragic cases of stimulant-induced cardiac death. I’ve also been an expert in cases of suicide in children caused by stimulants. These tragic deaths are always heartbreaking. Years afterward, the emotional wounds remain as raw as ever for their parents and brothers and sisters. The family’s trust for doctors and the healthcare system can be forever shattered.

Yet the answer to this problem is simple. Don’t give stimulants to children. There are far better non-drug ways to deal with so-called ADHD. ADHD is defined as involving hyperactivity, inattention, and impulsivity. These are not diseases—they are disciplinary and educational problems. Very often these children improve dramatically when parents develop a more consistent, rational and loving plan for discipline. Sometimes the problem completely disappears when the child is assigned a better teacher.

At times the child diagnosed with ADHD is simply a little delayed in learning self-discipline or finding the motivation to study. Often something is distressing the youngster, such as peer ridicule and abuse. Or the child may be especially full of life and need more opportunity to run, to play, and to be creative.

Whatever these children need, they don’t need toxic drugs that can lead to drug addiction, cause psychosis and depression, stunt growth, impair brain function, and even cause sudden cardiac arrest. I describe and document all of these adverse stimulant effects, and many more, in my medical book, Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock, and the Psychopharmaceutical Complex, Second Edition (2008).

Our children don’t need drugs—they need us to protect them from misguided health professionals while we make every effort to meet their real needs in our families and schools. It’s time for all of us to retake responsibility for our children.

Dr. Breggin’s latest book is Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (St. Martin’s, 2008). It is now in paperback.

Dr. Breggin’s website is www.breggin.com
Email: psychiatricdrugfacts@hotmail.com