DOJ Makes Novartis Pay $420 Million For Kiddy Kickback Scheme

I cringe when I see the growing list of pharmaceutical corporations that not only drugged kids for cash, but drugged the entire industry of child welfare to believe that it was a good thing for kids.

When you look at the national statistics, you will see a category labeled as " physical neglect".  Physical neglect has 12 codes assigned to break down the different categories for purposes of research studies.

There are two specific codes which address issues of medical neglect:

Refusal to allow or provide needed care for diagnosed condition or impairment.

Unwarranted delay or failure to seek needed care

TRANSLATION: When a parent refuses psychotropic medication to the child, this constitutes medical neglect, a reportable condition to increase the national statistics of child abuse and neglect, and grounds for removal.

This is a classic Title IV-E funding training technique (usually billing at the improper higher rate of 75%) where a Child Welfare Worker will use the tactic of performing an Axis III diagnosis, without medical license, to support the placement of the child in foster care and to automatically classify the child as special needs, accessing Targeted Case Management funding benefits called kiddy kickbacks.

Novartis resolves its own kiddy kickback liabilities, generated from Social Security dollars while the States child welfare systems continue its pattern of practice of promoting the drugging of children.

Trileptal is a commonly prescribed as a psychotropic drug for foster children.

Wolverine Human Services of Michigan uses this drug liberally with foster children.

Novartis Pharmaceuticals Corp. to Pay More Than $420 Million to Resolve Off-label Promotion and Kickback Allegations

WASHINGTON – Novartis Pharmaceuticals Corporation has agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products, the Justice Department announced today.


According to the agreement reached with the government, the East Hanover, N.J.-based company will plead guilty to a misdemeanor and pay a $185 million combined criminal fine and forfeiture for the off-label promotion of Trileptal in violation of the Food, Drug and Cosmetic Act. The Food and Drug Administration (FDA) approved Trileptal as an anti-epileptic drug, for the treatment of partial seizures, but not for any psychiatric, pain or other uses. Once a pharmaceutical is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as "unapproved" or "off-label" uses.
In addition to the criminal fine and forfeiture, Novartis has agreed to pay $237.5 million to resolve civil allegations under the False Claims Act that the company unlawfully marketed Trileptal and five other drugs, and thereby caused false claims to be submitted to government health care programs. Specifically, the civil settlement resolves allegations that Novartis illegally promoted Trileptal for a variety of uses, including psychiatric and pain uses, which were not medically accepted indications and therefore not covered by those programs. In addition, the agreement resolves allegations that the company paid kickbacks to health care professionals to induce them to prescribe Trileptal and five other drugs, Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The federal share of the civil settlement is $149,241,306, and the state Medicaid share of the civil settlement is $88,258,694.


"This resolution demonstrates the Department of Justice’s ongoing dedication to taking action against pharmaceutical fraud in all its forms," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "Unlawful off-label promotion and providing illegal inducements to health care professionals undermine the integrity of our health care system and we will continue to pursue these types of violations."


"Off-label marketing can undermine the doctor-patient relationship and adversely influence the clear judgment that a doctor’s patients have come to rely on and trust," said Zane D. Memeger, U.S. Attorney for the Eastern District of Pennsylvania. "Pharmaceutical companies have a legal obligation to promote the drugs they manufacture only for uses that the Food and Drug Administration has deemed are safe and effective. That legal obligation takes priority over a company’s bottom line. This prosecution demonstrates our continuing commitment to ensure that pharmaceutical companies comply with the law."


The civil settlement resolves four lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. The four cases are: U.S. ex rel. Austin v. Novartis Pharmaceuticals Corporation; U.S. ex rel. McKee v. Novartis Pharmaceuticals Corporation; U.S. ex rel. Copeland v. Novartis Pharmaceuticals Corporation; and U.S. ex rel. Garrity v. Novartis Pharmaceuticals Corporation. As part of today’s resolution, the whistleblowers, all former employees of Novartis, will receive payments totaling more than $25 million from the federal share of the civil recovery.


"This settlement represents a landmark victory in our district’s continuing battle against health care fraud. We intend to bring to justice any pharmaceutical company that attempts to cloud physicians’ medical judgment through kickback practices and illegal promotional activities," said A. Brian Albritton, U.S. Attorney for the Middle District of Florida.


Novartis also signed a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). The company is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of this CIA and subject to monetary penalties for less significant breaches. Among other things, the CIA requires the board of directors (or a committee of the board) to annually review the company’s compliance program with the help of an outside expert and certify its effectiveness; that certain senior executives annually certify that their departments or functional areas are compliant; that Novartis send doctors a letter notifying them about the settlement; and that the company posts on its website information about payments to doctors, such as honoraria, travel or lodging. The five-year agreement further requires the implementation of a compliance program addressing promotional activities.


"OIG will carefully monitor the Corporate Integrity Agreement to ensure that Novartis is more transparent in its business transactions, that its Board of Directors is held more accountable, and that the names of physicians receiving payments are publicly disclosed," said Department of Health and Human Services Inspector General Daniel R. Levinson. "The result will be stronger protections for patients and the nation's taxpayers."


The U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Justice Department’s Office of Consumer Litigation prosecuted the criminal case. The Justice Department’s Civil Division, the U.S. Attorney’s Office for the Eastern District of Pennsylvania, and the U.S. Attorney’s Office for the Middle District of Florida handled the civil lawsuit, with assistance from the National Association of Medicaid Fraud Control Units and the offices of various state attorneys general.


This settlement is part of the government’s emphasis on combating health care fraud and another step for the HEAT initiative, which was announced by Attorney General Eric Holder and HHS Secretary Kathleen Sebelius in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $3.445 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 have topped $4.595 billion.

HHS OIG Corporate Integrity Agreement with Novartis Pharmaceuticals Corporation

National Archive On Child Welfare Fraud

It is institutional reports like this that makes me wonder the abilities of the researchers to do basic review of the literature outside of the traditional academic journal articles.


There is no psychotropic medication oversight in foster care.  This one fact can easily be found just by subscribing to daily feeds of my site.


David Sessions did an expose on the issue of Psychiatric Drug Abuse in Foster Care Costs Government Billions, but this was before the Department of Justice and Department of Health and Human Services Office of Attorney General stepped in.


In this federal settlement agreement, Forest Pharmaceuticals agreed to pay $313 million for the wrongful and illegal marketing of Lexapro and Celexa to children.


Then there was the $2.3 Billion federal settlement with Pfizer for using children as lab rats and kiddy kickbacks.


I could continue providing evidence on the unregulated use of psychotropic medication in foster care, but I prefer to just refer you to the National Archive On Child Welfare Fraud.


What this report does successfully present is a quantitative formula to detect potential Medicaid fraud in child welfare.

Psychotropic Medication and Youth in Foster Care Report

Released: 9/23/2010 7:00 AM EDT
Source: Tufts University

Newswise — The Tufts Clinical and Translational Science Institute (CTSI) today issued a landmark report from a multi-state study on psychotropic medication oversight in foster care. Led by Laurel K. Leslie, MD, MPH at Tufts CTSI, Christopher Bellonci, MD at Tufts Medical Center and Justeen Hyde, PhD at Cambridge Health Alliance, the study examined state policies and practices in 47 states, including Massachusetts, and the District of Columbia regarding the use of medication for treating behavioral and mental health problems in foster care children and adolescents ages 2 to 21 years.

Over the past decade, psychotropic medication use in the general youth population has more than doubled. Estimated rates of psychotropic medication use in foster care youth, however, are much higher (ranging from 13-52%) than those in the general youth population (4%).

In 2008, President Bush signed into law the Fostering Connections to Success and Increasing Adoptions Act, which requires state child welfare agencies and Medicaid to provide ongoing oversight and coordination of medical and mental health services, including psychotropic medications, for youth in foster care. Since then, state child welfare agencies have been working to develop sound policies and practices for this population of kids.

The Tufts CTSI multi-state study, begun in 2009, concluded that while oversight of psychotropic medication is a high priority of the state child welfare agencies, there is also great variability among the state policies and practices governing such oversight. The Study Report calls for a national approach and resources for medication oversight for youth in foster care. A more detailed national look at which state policies and practices are the most effective for improving the mental health of these youth is also needed. Without a national approach, crossing a state border could mean the difference between a youth in foster care being appropriately treated with medications or not. The report also stresses the need for youth-serving organizations and state agencies to work together, and for more informed decision-making and appropriate medication monitoring for youth in foster care.

New study finds children labeled as ADHD may not be

Researchers Fail to Reveal Full Drug Pay

A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.

By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.
The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

In an e-mailed statement, Dr. Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.

John Burklow, a spokesman for the National Institutes of Health, said: “If there have been violations of N.I.H. policy — and if research integrity has been compromised — we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and N.I.H. will not tolerate it.”

The federal grants received by Drs. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital’s grants or even suspend them altogether.

Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.”

Ms. Kneller said the doctors had been referred to a university conflict committee for review.

Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings, and he placed the letters along with his comments in The Congressional Record.

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.

Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children’s lives over time, experts say.

In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.

To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.

The health institutes last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, health institutes officials have long insisted. So the government relies on universities.
Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.

“It’s really been an honor system thing,” said Dr. Robert Alpern, dean of Yale School of Medicine. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”

Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.

Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.

Mr. Grassley asked Harvard for the three researchers’ financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.

“Basically, these forms were a mess,” Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. “Over the last seven years, it looked like they had taken a couple hundred thousand dollars.”

Prompted by Mr. Grassley’s interest, Harvard asked the researchers to re-examine their disclosure reports.

In the new disclosures, the trio’s outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.

In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.

At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.

Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.

In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.

Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

Longtime critics of the group see its influence differently. “They have given the Harvard imprimatur to this commercial experimentation on children,” said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.

Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.
 
The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale — well below the 50 percent change that most researchers now use as the standard.

Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.
More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”

More Child Drug Fraud

Children's drug consumers sue J&J for fraud

This time, the lab rats had mommies and daddies to speak out.

Consumers are accusing Johnson & Johnson (NYSE: JNJ) of fraud and racketeering in a lawsuit stemming from its recent children's drug recall. The buyers of those recalled meds are demanding cash refunds--rather than coupons for replacement products--in five suits seeking class-action status in federal court in Chicago.
The complaints say that the company's coupon offer is "worthless" because J&J's McNeil Consumer Healthcare has stopped making the products (if only temporarily), and parents might not want to use J&J children's drugs when they do come back on the market.
The suits also manage to rope in that "phantom recall" of Motrin tablets. The consumers' suits allege that quietly retrieving the Motrin packets was a "cover up" by a "criminal enterprise," Bloomberg reports, justifying punitive damages for racketeering.
The company is due to file a manufacturing-overhaul plan to FDA this week.

Read more: Children's drug consumers sue J&J for fraud - FiercePharma http://www.fiercepharma.com/story/childrens-drug-consumers-sue-j-j-fraud/2010-07-12#ixzz0tdb2gyAK
Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma

Psych Evals On Fetus

It will not be long before Child Protective Services picks up on this as grounds for termination of parental rights. Wait, they already do.

Pre-Crime? Try Pre-Diagnose and Pre-Drug: Psychiatrists target infants as mental patients

By CCHR International
June 23, 2010

A new study, published in the American Journal of Psychiatry and headed by psychiatrist John H. Gilmore, professor of psychiatry and Director of the UNC Schizophrenia Research, claims to be able to detect “brain abnormalities associated with schizophrenia risk” in infants just a few weeks old. We would like to point out the obvious flaw in this bogus study; there is no medical/scientific test in existence that schizophrenia is a physical disease or brain abnormality to start with. There is not one chemical imbalance test, X-ray, MRI or any other test for schizophrenia, not one. So with no evidence of medical abnormality to start with, the “associated with schizophrenia risk” amounts to what George Orwell called Doublespeak (language that deliberately disguises, distorts, misleads)—it means nothing.

For decades, psychiatrists and Pharma have spouted lines to the press and public amounting to, “researchers now believe” they have medical evidence of schizophrenia as a physical/biological abnormality, or “new evidence suggests” evidence of schizophrenia as a real disease. But despite millions of dollars in research funds and countless tales of “belief” —no evidence to support the theory. One of the most common tricks employed by the Psycho/Pharmaceutical industry to mislead the public, legislators and the press, is to take X-rays or brain images of people who have been long-term users of antipsychotic drugs (known to cause brain atrophy/shrinkage) and then claim people with schizophrenia have smaller brains. They’ve spouted similar studies on kids with ADHD having smaller brains, but the bottom line to that study was that the kids with smaller brains, were…smaller kids. These are just a few of the many PR spins employed by Psycho/Pharma to try and maintain the “belief” in psychiatry, in their credibility as a science. As evidenced by the recent statement of psychiatrist Allen Frances, former DSM- IV Task Force Chairman, this belief is falling apart even within their own ranks, “There are no objective tests in psychiatry-no X-ray, laboratory, or exam finding that says definitively that someone does or does not have a mental disorder.” —Allen Frances (And Frances isn’t the only psychiatrist exposing the fraud of the biological brain disease model; click here for more.)

The logical question the press should be asking is what are the American Journal of Psychiatry and “the Director of UNC Schizophrenic Research” really after? What is their goal?

As we have exposed in the article “Australian Psychiatrist Patrick McGorry Wants His Pre-Drugging Agenda to Go Global” there is a concerted push being headed by Australian psychiatrist Patrick McGorry and other pharmaceutically funded psychiatrists for the global implementation of a new mental health paradigm; preventative mental health, i.e., pre-diagnosing (diagnosing children before they develop a “mental disorder”) and pre-drugging children ( before they show “signs” of the mental disorder). There is an obvious push for the same pre-diagnosing and pre-drugging agenda with this latest study, which claims ”major cases of schizophrenia are usually not diagnosed until a person begins witnessing its related symptoms like delusions and hallucinations as a teenager or adult . However, by that time, the disease [notice the term disease despite no medical evidence of disease] crosses the stage of preliminary treatment and is difficult to treat.” In other words, if we wait to administer drugs to them it may be too late. That along with Gilmore’s statement, “It allows us to start thinking about how we can identify kids at risk for schizophrenia very early and whether there are things that we can do very early on to lessen the risk.” This is the pre-diagnosing, pre-drugging agenda being pushed and the new “preventative” model of mental health that is more akin to a Brave New World than anything previously witnessed. And this latest “study” tells us infants are also on the agenda.

And finally, to psychiatrist and lead study author John H. Gilmore, we think you should take a lesson from the former National Institute of Mental Health (NIMH) Chief of the Center for Studies in Schizophrenia, the late Loren R. Mosher, M.D. who stated in his letter of resignation to the American Psychiatric Association, “The fact that there is no evidence confirming the brain disease attribution is, at this point, irrelevant. What we are dealing with here is fashion, politics and money. This level of intellectual/scientific dishonesty is just too egregious for me to continue to support my membership…After nearly three decades as a member it is with a mixture of pleasure and disappointment that I submit this letter of resignation from the American Psychiatric Association. The major reason for this is my belief I am actually resigning from the American Psychopharmacological Association. Luckily, the organization’s true identify requires no change in the acronym…”

To read more from Loren Mosher, including his two-year outcome study treating patients diagnosed “schizophrenic” without the use of drugs, his vehement stance against the biological psychiatric model of “disease” and more, click here.

To read the latest bogus psychiatric study, click here.

Here is the John Gilmore's letter to the editor:

The authors report no financial relationships with commercial interests.
This letter (doi: 10.1176/appi.ajp.2010.10010105) was accepted for publication in March 2010.

Dr. Gilmore Replies
To the Editor: I thank Drs. Read and Bentall for their interest
in my editorial comments about brain development and the causes of schizophrenia. I am pleased they are in agreement with the overall argument made. They rightly point out that risk factors across the entire range of prenatal and postnatal development ultimately contribute to schizophrenia and call our attention to the literature regarding early childhood adversity. As they note, hypothalamic-pituitary-adrenal axis alterations and epigenetic regulation are likely candidate mechanisms that deserve study. Their discussion of the potential role of environmental enrichment is very important, since we realize that it may be difficult to prevent many of the multiple causes of schizophrenia but may be possible to identify and modify developmental trajectories of risk.

JOHN H. GILMORE, M.D.
Chapel Hill, N.C. 

The actual article addresses of the lack research on the effect of maternal psychiatric medication on fetal health during pregnancy and the possibility of brain imaging for pregnancy management and fetal development.

Psychotropic Drug Abuse in Foster Care

This is a well written article, but there is a variable to this equation that was not mentioned, and that is the States administrative "revenue-maximization schemes" that allow this to happen, and continue.

Psychotropic Drug Abuse in Foster Care Costs Government Billions

David Sessions

Seven-year-old Gabriel Meyers didn't want soup for lunch one Thursday in April, 2009. When his 23-year-old foster brother sent Gabriel to his room for dumping his soup in the trash, Gabriel threatened to kill himself. He kicked his toys around his room, then locked himself in the bathroom.

Police reports say Gabriel was home sick that day from his elementary school in Margate, Fla., under the care of Miguel Gould, his foster father's son. Around 1:00 p.m., city police responded to Gould's frantic 911 call and found Gabriel had hanged himself.

A troubled child who had previously suffered from neglect, sexual assault, and abusive parenting, Gabriel spent the previous year shuttling among several foster parents while taking a constellation of antipsychotic medicines, including Lexapro and Vyvanse, to control his depression and attention deficit hyperactivity disorder. Like most children in Florida state foster care, Medicaid paid Gabriel's medical expenses.

Just one month before his suicide, Gabriel's doctor prescribed him Symbyax, an anti-depressant restricted for treatment of children. The medication's FDA-required label features a warning that use of the drug by children or teenagers can lead to suicide.

Symbyax does not meet criteria established by Congress for Medicaid reimbursement., so it is illegal for Medicaid to pay for a prescription of the drug to a child. Sohail Punjwani, the doctor who prescribed Gabriel's Symbyax, received a stern letter from the FDA about his history of over-prescribing mental health drugs.

According to a number of foster care experts who spoke with Politics Daily, children in foster care, who are typically concurrently enrolled in Medicaid, are three or four more times as likely to be on antipsychotic medications than other children on Medicaid. Alarmingly, many of these drugs are medically prohibited for minors and dangerous to the children taking them. Often young patients under state supervision are also prescribed three or four high-risk drugs at a time -- all paid for by Medicaid.

State foster care programs and child protective services have had mixed success addressing the pervasiveness of dosing their clients with prescription psychotropic drugs. Using federal Medicaid monies to purchase dangerous prohibited prescriptions for children, which cost the government up to $600 per dose, is technically a violation of the law.

Now, the Senate Subcommittee on Oversight of Government Management, chaired by Democratic Sen. Daniel Akaka of Hawaii, has asked the Government Accountability Office to look into the drugging of foster care children. The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage. The GAO is collecting data from Oregon, Massachusetts, Florida, Maryland, Minnesota, and Texas, to search for patterns of abuse. This effort marks the first time suspicion of Medicaid fraud related to psychotropic drugs has been examined at the federal level. According to Senate staffers working on the investigation, the committee will likely hold hearings on the matter later this year.

Psychotropic medications, also called "antipsychotics," act on the central nervous system and alter brain function, mood and consciousness. The GAO investigation is chiefly focused on anti-depressants, widely used in foster care in dangerous combinations, and for so-called "off-label" uses to treat symptoms for which they have not been medically approved. Antipsychotic medications have been a factor in a number of children's deaths.

Statistics on psychotropic drugs in foster care have until now come out in scattered reports, mostly from investigations of foster care failures by individual states. For example, in 2003 a Florida Statewide Advocacy Council study found that 55 percent of Florida's foster children were being administered psychotropic medications. Forty percent of them had no record of a psychiatric evaluation. Another Florida report also indicated anti-psychotic medication use increased an astounding 528 percent from 2000 to 2005.

A Texas state study in 2004 revealed that 34.7 percent of Texas foster children were prescribed at least one antipsychotic drug -- and 174 children in the care of the state aged 6-12 were taking five or more psychotropic medications at once.

Last April, an investigation by the Atlanta Journal-Constitution exposed several companies operating foster care homes in Georgia repeatedly used antipsychotic medications to "subdue" children in their care. Despite being cited repeatedly, none of the agencies were fined more than $500.

According to child care experts and assessments by both advocacy groups and state government agencies, many states lack efficient records management and adequate oversight of foster care, contributing to pervasive lack of medical continuity for the children. Social workers have oversized caseloads of foster children, who are often shunted between families and prescribed antipsychotics from doctors unfamiliar with their medical histories. Without a case history, experts and foster care alumni say, doctors are more likely to add medications than take them away, resulting in record numbers of children dispensed several antipsychotic medications at once. In many cases, the drugs are prescribed off-label to kids with behavior problems.

Julie Zito is a professor of pharmacology at the University of Maryland who conducted a 2008 study of the Texas foster care system that found 41 percent of the children prescribed psych drugs received three different medications. She told Politics Daily what little research has been done suggests children in foster families are rarely assessed properly, a failure leading to serious effects. There has been no research on multiple-drug regimens, professor Zito explained, and "blitzes" of medication have become a pervasive way of dealing with behavior problems in foster care. "We've expanded the medication practice in response to children not getting better," she said, and children who fail to improve, "are getting more medication."

Pharmaceutical companies manufacturing psychotropic drugs have played a major role in encouraging their increased use on foster care clients. Drug companies participate in aggressive marketing, conduct misleading research about efficacy and safety, and in some cases, "bribe" psychiatrists to prescribe their drugs, according to Zito and Jim Gottstein, an Alaska lawyer and founder of the Law Project for Psychiatric Rights, who has mounted several lawsuits against pharmaceutical corporations.

For example, last year the St. Petersburg Times reported that a psychiatrist in Jacksonville, Fla., was paid for speaking engagements to encourage her to prescribe Seroquel, a drug used to treat bipolar disorder and schizophrenia, and a neurologist in Tampa received free trips to Spain and Scotland from AstraZeneca, the drug's British manufacturer, for her innumerable prescriptions of the drug for headaches. Seroquel is the top-selling antipsychotic drug in the U.S., with over $4 billion per year in worldwide sales. AstraZeneca recently paid $520 million to settle lawsuits -- some brought by doctors who had been offered swag in exchange for prescriptions -- over its illegal promotion of off-label uses for Seroquel.

According to Jim Gottstein, the increase of antipsychotic use in foster care amounts to "drug companies sacrificing children's lives on the altar of corporate profits." Gottstein recently filed a citizen's suit on behalf of the state of Alaska against several doctors, drug companies, and insurance companies, claiming that they knowingly promoted Medicaid fraud.

Reform Attempts

In response to the devastating study of the Texas system in 2004, that state's top health agency introduced a new set of guidelines stressing specific treatment goals for medication and "informed consent" of parents and guardians. That effort led to decreased use of psychotropic drugs relative to the number of children enrolled in foster care from 2002 to 2009, according to data from the Texas Health and Human Services Commission.

In May 2005, Florida expanded foster parents' rights to reject psychotropic treatment for the children in their care. Four years later, however, a review found that the new requirements were being flauted, and the panel that investigated Gabriel Meyers' suicide concluded that every level of the Florida system had missed "warning signs" that Gabriel's care was inadequate. Thirteen percent of Florida foster children were on one or more psychotropic drug, and 16 percent of those were not approved by parents or guardians.

In 2008, Rep. Jim McDermott (D-Wash.), the only psychiatrist in Congress, introduced a bill titled Invest in KIDS Act, which included stronger oversight for prescription medications in foster care. McDermott held a hearing on psychotropic drugs' use in foster care, but the bill died in committee. Near the end of George W. Bush's second term, Congress passed a law co-sponsored by McDermott that included increased oversight for "mental health" in foster care, but did not specifically mention psychotropic drugs.

"Some children in foster care may need and benefit from psychotropic medication," McDermott told Politics Daily. "But these drugs should not be used as a shortcut to treat foster children when more effective treatments, including counseling, might provide long-term benefits."

Federal and state agencies have pursued drug companies that illegally market their drugs for off-label uses, a practice that experts say heavily contributes to the overuse of psychotropic drugs in foster care.

Last year, a Justice Department action against Pfizer led to a $2.3 billion settlement, the largest in the department's history. Companies convicted of major health fraud are barred from participating in Medicaid and Medicare. But worrying that a conviction would cause Pfizer to fail and cost its employees their jobs, the government allowed Pfizer's shell company, which exists solely to plead guilty in lawsuits, to be charged instead, and the drug company paid a fine. Pfizer maintains that it did not break the law.

In 2006, the New York Times obtained a batch of internal documents that showed Eli Lilly, the maker of Zyprexa, a medication approved exclusively for treating the severe mental illnesses of schizophrenia and bi-polar disorder, was suppressing information on the drug's harmful side effects and advertising it illegally. Lilly paid $62 million to settle lawsuits with 32 states and the District of Columbia, and agreed to ensure that its marketing complied with the law.

How to Fix It

The problems that lead to psychotropic drug abuse in foster care are complex and deeply entrenched, but activists and advocates have proposed a number of solutions for limiting the overuse of anti-psychotics. Foster care experts, including a current task force of the American Academy of Pediatrics, believe that getting foster children a "medical home" -- one physician who manages their care over the long term and has access to relevant records -- would reduce the over-prescription of antipsychotic medications.

"Having a drug to take the edge off the pain and fear and sadness saved my life a time or two, but it's not a lifestyle." said Misty Stenslie, a former foster child who is currently the deputy director of Foster Care Alumni of America. Children under the protection of government agencies deserve the assurance of safe and decent health care. Especially, as Stenslie points out, "We can't give kids what they really need, and that's a family and love."

Cuomo Kicks Kids to the Side of His Political Campaign Road

As promised, here is the actual New York Kiddy Kickbacks complaint.

What should be noted is that, even though the State had been put on formal notice on numerous occasions, detailing the levels of violations and abuse, Attorney General Andrew Cuomo did absolutely nothing to help these children, many of whom should never have been placed in these residential institutions.

In addition, General Cuomo has not, even to this day, lifted a finger to aggressively recoup the false claims of Medicaid fraud.

Sadly enough, this continues to happen every day across the nation, and States Attorney Generals are kicking kids to the side of the political campaign road in favor of a successful bid for Governor.

Legal Aid v. Carrion.New Yo... by Beverly Tran on Scribd

How Would You Feel?

Suicide Among Youth Within Residential Group Facilities and Single Family Foster Homes

Recent years, researchers admit high rates of suicides among youth within the foster care system. Researchers explain that suicides are caused by social and emotional conditions rather than a mental disease. Furthermore, it is often associated with hundreds of suicides and suicide attempts. “Researchers discovered attention problems and aggressive or delinquent behavior in 40 per cent of children aged five to 17 who were in home-based foster care, up to eight times more than in the general school-age population” (Gough 2007)....more...

How would you feel if someone snatched you from the family you love and locked you up for no reason, only to be beaten and overmedicated with mind altering, suicidal-side-effect psychotropic medications that you will never see your family again and will grow up to face the possibility of homelessness, unemployment, and incarceration with daily induced sessions of individual therapy? 

Please keep in mind that the drugs and counseling noted above is all funded through Targeted Case Management, Medicaid.

The best part of this article is what is not included, and that is major universities do not include such data in its research and publications...Cornell.  

Wouldn't want to bite the hand that feeds you. 

Florida Fails Drugging Children Legislation

There is a reason why this bill failed and it has nothing to do with ensuring tighter controls on administering psychotropic drugs to foster children. It has to do with Medicaid fraud.

If it is found that the psychotropic drugs were wrongfully administered to foster children, then, the state would be obligated to enforce Medicaid fraud statutes, both federal and state, jeopardizing the state's Federal Financial Participation Rate due to non-compliance.

Other component that have flown under the radar are the use of antipsychotropic medications and clinical testing on foster children. As it stands, there is no mandate for parental authorization, as the children are under the auspices of the state. This means, the parental authority is the state, and that is an inherent conflict of interest as the state would be left to self-prosecute.

Daytona Beach News Journal
DCF tightening medicine rules
By DEBORAH CIRCELLI
May 14, 2010
DAYTONA BEACH — A bill that would have ensured tighter controls on administering psychotropic drugs to foster children failed to pass this legislative session, but the head of the state Department of Children & Families is moving forward with rules he says will ensure children are safe.

George Sheldon, secretary for the state Department of Children  Families, (left) who was in town Thursday afternoon to attend community meetings on the department’s future strategic plan, said the bill not passing was a “major failure” on the part of the Legislature.

A work group made 90 recommendations following the April 2009 death of a South Florida foster child, Gabriel Myers, 7, who was prescribed several mind-altering drugs and hanged himself in his foster home.

Some of the recommendations included hiring a chief medical officer to monitor the prescribing of such medications, which Sheldon plans to move forward with using other funds.

By July 1, he said, operating procedures also will be in place to ensure every child on psychotropic medications has a guardian; to prohibit any foster child from being a part of any clinical trials; and to make sure every child is informed of the side effects, to name a few.

Psychotropic medications are drugs used for psychiatric reasons such as mood stabilizers, stimulants and drugs for attention-deficit hyperactivity disorder.

A database also will be in place to allow DCF to monitor any “red flag” cases where a child is on more than two psychotropic medications at the same time, he said.

“I’m unwilling to have Gabriel Myers’ death be in vain,” Sheldon said in an interview Thursday.
Sen. Evelyn Lynn, R-Ormond Beach, who was honored at a community meeting Thursday for her work over the years for social services, said she was “very disappointed” the bill did not pass and that it “is an issue that must be dealt with in our state.”

The work group criticized DCF in the review of Gabriel’s death and raised concerns in some cases that the drugs have been used to control foster children’s behaviors.

Statewide as of May 7, according to DCF records, 14.6 percent or 2,724 foster children are on one or more prescriptions for psychotropic medications, with 122 or 14.8 percent locally.

Bill Babiez, CEO of Community Partnership for Children, the local foster care agency for the state, said local initiatives include hiring a specialist to make sure parental consents are in place when a doctor prescribes psychotropic medications.

“We don’t want to miss a beat on this issue. It is too critical to the life of a child,” Babiez said.

Feds Recovery $4 Billion in Fraud in 2009

Last year, the Federal government recovered more than $4 billion in health care fraud. It may not seem much, but when you consider it was only a few agents in a handful of cities and a few bold individuals who brought forth qui tams under the False Claims Act, it is quite significant.

Here are highlights of some of my favorite child welfare schemes of 2009:

• In Mississippi a Psychologist conspired with others to submit false and misleading patient diagnosis to the Social Security Administration in order to assist many of his patients to obtain disability benefits. Once a patient was approved for disability benefits, Medicare was billed, claiming that he was providing psychological health care services to patients on a weekly or semi-weekly basis, when in fact, he was treating these patients only a few times a year, if at all.

TRANSLATION: Psychologists label foster kids with made up disorders like Separation Anxiety, Bi-polar, ADHD, Defiance and Depression, prescribe heavy doses of unnecessary medication,  then submit false reports to the court to keep the kids in foster care longer, and do not provide any services that are billed to Medicaid.

• In Michigan and New York, the States claimed Medicaid reimbursements for outpatient expenditures for drug products that were not eligible for Medicaid coverage because they were dispensed after their termination dates or less than effective. In addition, the States claimed for drug products that were not approved by Medicaid.

TRANSLATION: Child welfare psychological services provided foster children with large doses of out-dated and unnecessary medication to keep them in the system longer and billed Medicaid.

• Pennsylvania did not comply with federal and state mandates in Targeted Case Management by billing for service unsupported by case records or insufficiently documented.

TRANSLATION: Judges were sending kids to jail and foster care for, for no reason, got kiddy kickbacks and billing Medicaid.
DHHS and DOJ Annual Health Care Fraud and Abuse Control Program Annual Report for FY 2009

The one thing that should be noted is the States Medicaid Fraud Units had absolutely nothing to do with recoveries because of the inherent conflicts of interest in child welfare.

"Criminals have concluded that health care fraud is a safe bet. It is
imperative that we change the calculus," said Daniel R. Levinson,
Inspector General for the Department of Health and Human Services.

Florida Kills Another Child Lab Rat

Another child dies in clinical trials of medication that has been found to have been wrongfully and illegally marketed with research from a university that promotes overmedication, unnecessary medication an using children as lab rats, paid by the same pharmaceutical company that drugs children strictly corporate profit.

Despite the dangers of these drugs, the universities continue to teach the practice and encourage the policies of using poor and disabled children as lab rats.

Florida Attorney General Bill McCollum has presented himself as a squamulous laggard in the execution of his fiduciary duties of office to protect children and the citizens of the state. General McCollum woefully administers the Medicaid Fraud Control Unit by using taxpayer dollars to cover up and maintain the status quo of human trafficking under the guise of child welfare.

Miami Herald
Florida suspends Miami psychiatrist in boy’s overdose death

State health administrators have suspended the license of a Miami psychiatrist who treated a disabled preteen boy who died of overmedication.
BY CAROL MARBIN MILLER

May 13, 2010

State regulators have suspended the license of a South Florida psychiatrist who has treated hundreds of poor and disabled children, saying Dr. Steven L. Kaplan poses “an immediate, serious danger to the health, safely, or welfare of the public.

In an emergency order, Florida Surgeon General Ana M. Viamonte Ros issued an emergency suspension of Kaplan’s license, saying Kaplan committed “medical malpractice” in his treatment of 12-year-old Denis Maltez, a boy with autism who medical examiners ruled died of an overdose of mental health drugs.

Viamonte Ros’ order comes three weeks after another state department, the Agency for Health Care Administration, booted Kaplan from the state Medicaid program, the insurer for needy and disabled children that had paid many of Kaplan’s bills. Kaplan’s termination from the Medicaid program is effective May 17.
Denis Maltez, left, poses for a picture in the park. 

Kaplan, who has yet to file a response to the suspension, did not return three calls Wednesday from a Herald reporter seeking comment. It’s unclear how long the suspension would span.

The suspension of Kaplan’s license takes effect immediately. Kaplan has 30 days to appeal the order, said Eulinda Smith, a Department of Health spokeswoman, and the department has 20 days to initiate disciplinary proceedings by filing a complaint with a Board of Medicine probable-cause panel — which must make a recommendation for discipline to be imposed.

“Dr. Kaplan’s actions in treating Patient DM demonstrate his inability and/or unwillingness to practice medicine in such a way that adequately protects patients who may not be able to protect themselves,” the suspension order states.

The order adds: “Dr. Kaplan’s actions demonstrate such general lack of medical judgment and understanding of his role as a physician that the safety of the public cannot be ensured by any means other than the suspension of Dr. Kaplan’s license.”

Kaplan was the subject of a front-page story in The Miami Herald on April 19 that focused on the May 23, 2007, death of Denis, who weighed 70 pounds but had been prescribed the maximum adult doses of two powerful anti-psychotic drugs.

The Herald reported that the psychiatrist had for years ignored warnings — both in writing and during office visits from state regulators — that his excessive prescribing of psychiatric drugs to children was potentially dangerous.

Kaplan “said he did not find the time to deal with non-important things such as paperwork,” an expert from the University of South Florida sent to Kaplan’s office on May 15, 2009, wrote in a report. “He said he had been practicing long enough to know how to treat his patients and was tired of being told what to do.”

Viamonte Ros’ May 7 order deals primarily with Kaplan’s treatment of Denis, whose autism sometimes resulted in disruptive outbursts. Acting on the advice of state disability administrators, Denis’ mother, Martha Quesada, placed him in a Miami group home called Rainbow Ranch — which regulators shut down in 2007.

According to the order, executed by the state Department of Health:

• Kaplan failed to perform a physical examination of the boy, failed to develop a treatment plan, failed to document the boy’s mental health history and did not conduct a psychiatric assessment.

• Kaplan “made no attempt” to verify information given to him by Rainbow Ranch’s owner that Denis had been abandoned by his mother, and never sought her consent to treat the boy. “Dr. Kaplan unreasonably relied solely on the reports of a virtually unknown non-health care provider for information regarding [Denis'] complex condition and care.”

• Kaplan did not perform blood tests to ensure that Denis was not being harmed by the mental health drugs he prescribed — assuming, instead, that the tests were being done by Denis’ pediatrician. The pediatrician saw Denis only twice a year, and the necessary blood work was never done.

• Though reviewers with the University of South Florida warned Kaplan on July 24, 2006, that his prescribing of mental-health drugs to four children, including Denis, was problematic, “Kaplan did not respond to the notice, nor did he follow-up with [Denis] through laboratory testing, communication with [Denis'] former psychiatrists, or further assessment.”

• Kaplan insisted that he saw Denis in his office on a couple of occasions, but he had no records to document the office visits.

“Dr. Kaplan fell below the standard of care when when he documented only two visits of this patient over a year’s course of treatment,” the order says, noting that Kaplan had, on one occasion in January 2007, written 11 refills for mental-health drugs for Denis.

The Department of Health began an investigation of Kaplan in November 2009, when the agency received a complaint that his treatment of Denis fell “below the standard of care.” Details of the investigation were forwarded to an unnamed department medical expert for review, the order says.

The expert, the order says, agreed that Kaplan’s treatment fell below accepted practices in a host of areas, including record-keeping, conducting a physical exam, medication prescribing, diagnosis and patient care.

“A review of [Denis'] Rainbow Ranch records demonstrates that DM was being mismanaged physically at the ranch, and if Dr. Kaplan had engaged in appropriate and close follow up, it would be reasonable to infer that Dr. Kaplan would have noticed and reported it,” the order states.

Quoting from the agency’s expert, the report added: “A patient that is as medically and psychiatrically complicated as this patient needed to be followed.”

“Dr. Kaplan has demonstrated a disregard for the duties and responsibilities imposed upon a physician practicing in the state of Florida and for the health and welfare of Patient DM,” the order says.

“Dr. Kaplan’s conduct constitutes a breach of the trust and confidence that the state of Florida placed in him by issuing him a license to practice medicine.”

“This breach is particularly compelling in Dr. Kaplan’s case because his failure to meet the standard of care and failureto adequately document justification for his treatment occurred while practicing medicine and treating a vulnerable patient who did not have the ability to ensure his own well-being.”

Call Bill McCollum and tell him to start doing his job to protect children and end Medicaid Fraud in child welfare.

To report fraud or abuse, individuals may use the statewide hotline number or contact the Medicaid Fraud Control Unit nearest them. The statewide hotline number is 1-866-966-7226

• Tallahassee (850) 414-3300
  
• Orlando (407) 999-5588
  
• Tampa (813) 287-7940
  
• Ft. Lauderdale (954) 712-4600
  
• Miami (305) 377-5441
  
• Jacksonville (904)-858-6919
  
• West Palm Beach (561) 837-5000
  
• Pensacola (850) 595-6057

The hearing impaired may now report Medicaid Provider Fraud Monday through Friday, 7:30 a.m. to 4:30 p.m., by contacting the Medicaid Fraud Control Unit at (850) 414-3935 (voice/TTY) or through the Florida Relay at 1-800-955-8771 (TTY)

Florida Finds Psychiatric Hospital Unsafe For Kids

Bradenton Herald
State slams Manatee Palms psychiatric hospital
Agency: Psychiatric hospital unsafe, poorly managed
By TIMOTHY R. WOLFRUM

May 6, 2010

MANATEE — The state of Florida has barred a Manatee County psychiatric hospital for young people from accepting new admissions after an investigation found unsafe conditions and “a variety of failures” in administrative procedures.

The Agency for Health Care Administration executed an emergency order of moratorium for Manatee Palms Youth Services, 4480 51st St. W., on April 16, according to state records. The order prohibits Manatee Palms from accepting new patients or readmitting previous patients.

The moratorium stems from complaint investigations AHCA filed on Feb. 25 and March 4 concerning patient care and safety at Manatee Palms. On two occasions, patients complaining of injuries that turned out to be fractured bones, were forced to wait several hours before diagnosis and treatment. Another patient with a history of self-injury cut himself or herself with glass during a game of kickball in the gymnasium.

Agency investigators later visited the hospital and found corrective actions proposed by Manatee Palms had not been taken, the order said.

“The Respondent’s Facility currently suffers from substandard conditions and deficient practices with respect to its operating standards and program standards that are severe enough that they pose an immediate threat to the health and safety of the Facility’s clients,” the order read.

Manatee Palms is a 60-bed psychiatric treatment facility that accepts children and adolescents ages 6 to 17. It is classified as a specialty hospital by the state. Its state license expires Aug. 6, according to the AHCA website.

Kim Smoak, a field operations supervisor at AHCA, said Manatee Palms submitted a plan of correction Monday. The agency will review the plan and, if it’s approved, monitor its implementation, she said.

Smoak said there is no timetable for the moratorium to be lifted, and that Manatee Palms can continue to treat its current patient population under monitoring by AHCA staff.

Manatee Palms Chief Executive Officer Jeff Turiczek did not return a message left for him Wednesday. Brian Fulton, a spokesman for Manatee Palms’ parent company, Psychiatric Solutions Inc., issued a statement.

“Manatee Palms Youth Services is committed to providing the highest quality care to our patients in a safe environment,” the statement said. “We are cooperating fully with the state of Florida and the Florida Agency for Health Care Administration in order to continue to meet and exceed the quality standards our patients and community expect from us.”

It is not clear whether the moratorium will affect the opening of Manatee Palms’ new therapeutic group homes at 1324 37th Ave. E. The first two of five 12-bed homes were scheduled to open later this month, pending licensing from the state fire marshal and AHCA. Neither Smoak nor Fulton would comment on the group homes’ status.

AHCA investigated Manatee Palms’ hospital facility after receiving the following complaints, according to state records:

On Feb. 10, a patient with an “impulsivity/self harm” diagnosis cut himself or herself six times with a piece of broken light bulb during a game of kickball in the facility’s gymnasium despite a hospital policy that required a staff member to be “within arm’s length” of such patients at all times. The cuts were not considered serious.

n On Feb. 16, a patient was placed in physical restraints from 7:26 p.m. to 7:29 p.m. after an altercation with staff members. The patient complained of shoulder pain at 9:30 p.m. but wasn’t seen by a physician until 9:50 a.m. the next day. The patient was diagnosed with a fracture of the left clavicle.

n On Feb. 20, a patient complained of wrist pain after an altercation with another patient and a staff member at 10:05 a.m. A physician ordered an X-ray at about 10:30 a.m., but no X-ray was taken until 7 p.m. The X-ray showed fractures to the patient’s radius and ulna.

AHCA cited Manatee Palms in all three instances and gave the hospital 10 days to make corrective actions to its policies.

But between March 1 and April 13, the state found 14 incidents that involved issues addressed in the previous citations. Nine of those incidents had not been investigated or addressed according to Manatee Palms policy or state law, according to the moratorium order.

“The deficiencies here are widespread, involve a number of clients that occurred over a period of time, and involve a variety of failures,” the order said.

On May 4, 2007, AHCA placed a moratorium on new admissions at Manatee Palms and temporarily suspended its license because of similar issues. The state and Manatee Palms administration later came to a settlement agreement, and the suspension and moratorium were lifted on Nov. 9, 2007. Manatee Palms paid a $12,000 fine as part of the settlement, according to state records.

Florida Drugs Another Child To Death

The higher the dosage, the more the money. Just another example how children in foster care are lab rats

Health News Florida
‘Emergency’ action took 4 yrs.
By Carol Gentry

May 10, 2010

Four years ago, the Department of Health was warned that psychiatrist Steven L. Kaplan was dangerously overmedicating children, state records show. DOH got around to filing an “emergency” suspension of Kaplan last week, three years too late for one little boy.

The emergency suspension order by State Surgeon General Ana Viamonte Ros released late Friday makes no reference to the warnings about Kaplan that it received from the Agency for Health Care Administration’s Medicaid unit in May 2006. The order says it received a complaint about Kaplan in November 2009 and began its investigation at that time.

The DOH’s emergency order does not name the patient beyond his initials, but the circumstances make clear it was Denis Maltez, an autistic boy who lived in a state-licensed group home for foster children called Rainbow Ranch. He was Kaplan’s patient for a year before dying at age 12.

As the Miami Herald reported last month, three agencies — AHCA, the Department of Children and Families, and the Agency for Persons With Disabilities — all voiced concerns about Kaplan’s prescribing practices for years but no action took place as Kaplan continued to prescribe for hundreds of children in foster care.

The state Medicaid program acted only after the Herald report, removing Kaplan as a provider effective next week.

The Herald report, based on documents that became public in a lawsuit, indicates that DOH knew about Kaplan in 2008 but didn’t act. It turns out that DOH knew about Kaplan much sooner than that — a year before Denis died.

Records provided by AHCA show that the Medicaid Program Integrity Office notified the DOH Division of Medical Quality Assurance in writing on May 12, 2006 about problems with Kaplan’s “prescribing habits” as they pertained to “antipsychotic medications for Medicaid recipients/patients.”

A low-level staffer at DOH wrote back on May 26, 2006 asking for medical records, consultants’ reports and any other documents that would be helpful.

Tiffany Vause, a spokeswoman for AHCA, told Health News Florida last week that those records and reports were provided at the time.

However, it was a full year later –only a few days before Denis died, in fact — that a medical malpractice investigator for DOH notified AHCA that an investigation had been initiated.

The complaint was dismissed a year later, apparently, although none of that is mentioned in the emergency order.

DOH does not discuss complaints in which no “probable cause” is found by a committee of the Board of Medicine. Officials at DOH say the law does not permit them to do so.

A phone call to Kaplan’s office upon the release of the suspension order was not returned. Health News Florida has asked DOH to explain how the agency will justify issuing an “emergency” suspension order on events that occurred in 2006.

Babies Prescribed Psychotropic Drugs.

And we are off!  It looks like we have another organization speaking out in celebration of National Child Abuse Propaganda Month!  The trend of diagnosing. medicating and clinically testing babies needs to abruptly end.

Psychiatric Drugging Of Infants And Toddlers In The US - Part I

By Evelyn Pringle

19 April, 2010
Countercurrents.org

The United States has become the psychiatric drugging capital of the world for kids with children being medicated at a younger and younger age. Medicaid records in some states show infants less than a year old on drugs for mental disorders.

The use of powerful antipsychotics with privately insured children, aged 2 through 5 in the US, doubled between 1999 and 2007, according to a study of data on more than one million children with private health insurance in the January, 2010, "Journal of the American Academy of Child & Adolescent Psychiatry."

The number of children in this age group diagnosed with bipolar disorder also doubled over the last decade, Reuters reported.

Of antipsychotic-treated children in the 2007 study sample, the most common diagnoses were pervasive developmental disorder or mental retardation (28.2%), ADHD (23.7%), and disruptive behavior disorder (12.9%).

The study reported that fewer than half of drug treated children received a mental health assessment (40.8%), a psychotherapy visit (41.4%), or a visit with a psychiatrist (42.6%) during the year of antipsychotic use.

"Antipsychotics, which are being widely and irresponsibly prescribed for American children--mostly as chemical restraints--are shown to be causing irreparable harm," warned Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a February 26, 2010 InfoMail.

"These drugs have measurable severe hazardous effects on vital biological systems, including: cardiovascular adverse effects that result in shortening lives; metabolic adverse effects that induce diabetes and the metabolic syndrome," she wrote. "Long-term use of antipsychotics has been shown to result in metabolic syndrome in 40% to 50% of patients."

The lead researcher on the study above, Columbia University psychiatry professor Mark Olfson, told Reuters that about 1.5% of all privately insured children between the ages of 2 and 5, or one in 70, received some type of psychiatric drug in 2007, be it an antipsychotic, a mood stabilizer, a stimulant or an antidepressant.

Psychiatric drugs bathe the brains of growing children with agents that threaten the normal development of the brain, according to Dr Peter Breggin, founder of the International Center for the Study of Psychiatry and Psychology (ICSPP), and author of about 20 books, including "Medication Madness."

The drugs themselves are causing severe disorders in millions of children in the US, he warns. "Substances like antidepressants, stimulants, mood stabilizers, and antipsychotic drugs cause severe, and potentially permanent, biochemical imbalances."

American Phenomenon

A number of presentations at the annual meeting of the American Psychiatric Association in May 2009, addressed the diagnosis of bipolar disorder, including one titled, "Pediatric Bipolar Disorder: A Critical Look at an American Phenomenon," at which Dr Peter Parry, a consultant child & adolescent psychiatrist, and senior lecturer at Flinders University in Australia, presented a survey on, "Australian and New Zealand's Child and Adolescent Psychiatrists' Views on Bipolar Disorder Prevalence and on Rates of Pediatric Bipolar Disorder in the USA."

Dr Parry and his colleagues conducted a survey of child and adolescent psychiatrists in Australia and New Zealand. Of the 199 psychiatrists who responded to the survey, 90.5% thought pediatric bipolar disorder was overdiagnosed in the US.

In an October 1, 2009 article titled, "Medicating Our Children," Dr Parry reports that since "the mid-1990s in the USA, some researchers have claimed that Paediatric Bipolar Disorder (PBD) frequently starts prior to puberty."

One of PBD's main proponents, Harvard University's Professor Joseph Biederman, stating onset "is squarely in the preschooler age group," he notes.

Parry explains that "PBD has been created by moving the diagnostic goalposts away from traditional concepts of bipolar disorder."

"In children," he says, "episodes were redefined to last hours instead of days or weeks and, instead of manic elation, severe anger in children sufficed as mania."

"Unlike diagnoses like ADHD or depression, or simply accepting a child has serious emotional and behavioural problems in reaction to various stressors, PBD implies a lifelong severe mental illness requiring of strong psychiatric medication," Parry warns.

"In the USA," he says, "the public is furthermore exposed to direct pharmaceutical advertising that can feed the natural desire parents of distressed and aggressive children have for a quick solution by suggesting a simple medication fix."

"The medicating of America's children has become intensely controversial, highlighted by the tragic case of Rebecca Riley, a four-year-old Boston girl diagnosed at 28 months old with ADHD and PBD," he points out.

On April 7, 2009, the author of the book, "Shyness: How Normal Behavior Became a Sickness," Christopher Lane, featured an interview on his Psychology Today blog, "Side Effects," with journalist, Philip Dawdy, the creator of the popular website, Furious Seasons, and discussed the rising number of children being diagnosed with bipolar disorder.

"As for bipolar disorder in kids (meaning pre-teens and younger), it's simply not an issue in the rest of the world," Dawdy told Lane. "The bipolar child is a purely American phenomenon."

"The pharma companies and the Harvard crew worked hand-in-hand to bring America a generation of ADHD kids and bipolar children, and their profound influence can be seen in the millions of children and teens who now carry lifetime diagnoses and take gobs of psychotropic drugs each day, often to their detriment," he advised.

Lane asked for Dawdy's opinion on a recent report in the St Petersburg Times that found 23 infants less than one-year-old had been prescribed antipsychotics in Florida in 2007, as well as the drug overdose death of 4-year-old Rebecca Riley in Massachusetts. "How is it possible for psychiatrists to continue prescribing to infants in such numbers without more oversight?" Lane asked.

"What's gone on with antipsychotics prescribed to infants and toddlers is simply inexplicable to me," Dawdy said. "The drugs are known to cause huge problems in adults, so why the heck would a doctor give them to little kids, especially infants? It boggles my small mind."

"I'm no fan of bans or restrictions," he told Lane, "but this does strike me as a situation where there needs to be a serious rethinking of what we are doing—and maybe there should be a ban on the use of these drugs in kids under, say, 6 years of age."

An October 2007 report by the University of South Florida found the most common diagnosis for antipsychotic use with children in Florida’s Medicaid program, between July and December 2005, was ADHD. Roughly 54%, or 1,372 cases, involved prescriptions for children five and under and the total number of antipsychotic users in this young age group was 2,549, with all disorders combined, according to the report.

Increased Prescribing to Poor Children

Federally funded research published online in December, 2009, revealed that children covered by Medicaid were prescribed antipsychotics at a rate four time higher than children with private insurance. The data showed that more than 4% of children in Medicaid fee-for-service programs received antipsychotics, compared to less than 1% of privately insured youth. The study found Medicaid kids were more likely to receive antipsychotics for unapproved uses such as ADHD and conduct disorders than privately insured children.

The researchers examined records for children in seven states for the years 2001 and 2004, chosen as representative of the US Medicaid population. But more recent data through 2007 indicates that the disparity has remained, said Stephen Crystal, a Rutgers professor who led the study, according to the December 11, 2009, New York Times.

Antipsychotics were the top selling class of drugs in both 2008 and 2009. With sales of $14.6 billion in 2009, they brought in more than the $13.6 billion earned by both heart burn and cholesterol medications. Antidepressants ranked fourth with sales of $9.9 billion, according to data by IMS Health. In 2008, the drug makers took in $11.3 billion from antiseizure drugs and $4.8 billion from ADHD drugs.

In a new book titled, "Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America," Robert Whitaker reports that the number of children on government disability rolls due to severe mental illness has increased more than 35-fold since 1987.

The book explores the question of whether the epidemic rise in people disabled by mental illness, among all age groups in the US over the past 20 years, could have been fueled by a drug-based paradigm of care.

It also explores what is happening to children over the long-term who are placed on psychiatric drugs. "Once again, science tells a very clear story, and, as you might imagine, it is one that — when you think of the millions of children so affected — makes you want to weep," Whitaker stated in a March 26, 2010, notice for the book's release on the Beyond Meds Website.

(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)

(This report is one of a series of articles focused on the rising rates of psychiatric drugging in the US and is sponsored by the International Center for the Study of Psychiatry and Psychology)