Off-Label Use Of Risky Antipsychotic Drugs Raises Concerns

By Sandra G. Boodman

Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia.

"It's a total outrage," said Fugh-Berman, a physician who is an associate professor of pharmacology at Georgetown University. "These kids needed some basic sleep [advice], like reducing their intake of caffeine and alcohol, not a highly sedating drug."

Those Georgetown students exemplify a trend that alarms medical experts, policymakers and patient advocates: the skyrocketing increase in the off-label use of an expensive class of drugs called atypical antipsychotics. Until the past decade these 11 drugs, most approved in the 1990s, had been reserved for the approximately 3 percent of Americans with the most disabling mental illnesses, chiefly schizophrenia and bipolar disorder; more recently a few have been approved to treat severe depression.

But these days atypical antipsychotics -- the most popular are Seroquel, Zyprexa and Abilify -- are being prescribed by psychiatrists and primary-care doctors to treat a panoply of conditions for which they have not been approved, including anxiety, attention-deficit disorder, sleep difficulties, behavioral problems in toddlers and dementia. These new drugs account for more than 90 percent of the market and have eclipsed an older generation of antipsychotics. Two recent reports found that children and adolescents in foster care, some less than a year old, are taking more psychotropic drugs than other children, including those with the severest forms of mental illness.

In 2010 antipsychotic drugs racked up more than $16 billion in sales, according to IMS Health, a firm that tracks drug trends for the health-care industry. For the past three years they have ranked near or at the top of the best-selling classes of drugs, outstripping antidepressants and sometimes cholesterol medicines. A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million. And a recent report by pharmacy benefits manager Medco estimated that the prevalence of the drugs' use among adults ballooned more than 169 percent between 2001 and 2010.

Critics say the popularity of atypical antipsychotics reflects a combination of hype that the expensive medicines, which can cost $500 per month, are safer than the earlier generation of drugs; hope that they will work for a variety of ailments when other treatments have not; and aggressive marketing by drug companies to doctors and patients.

"Antipsychotics are overused, overpriced and oversold," said Allen Frances, former chair of psychiatry at Duke University School of Medicine, who headed the task force that wrote the DSM-IV, psychiatry's diagnostic bible. While judicious off-label use may be appropriate for those who have not responded to other treatments for, say, severe obsessive-compulsive disorder, Frances said the drugs, which are designed to calm patients and to moderate the hallucinations and delusions of psychosis, are being used "promiscuously, recklessly," often to control behavior and with little regard for their serious side effects. These include major, rapid weight gain -- 40 pounds is not uncommon -- Type 2 diabetes, breast development in boys, irreversible facial tics and, among the elderly, an increased risk of death.

The Latest Fad?

Doctors are allowed to prescribe drugs for unapproved uses, but companies are forbidden to promote them for such purposes. In the past few years major drugmakers have paid more than $2 billion to settle lawsuits brought by states and the federal government alleging illegal marketing; some cases are still being litigated, as are thousands of claims by patients. In 2009 Eli Lilly and Co. paid the federal government a record $1.4 billion to settle charges that it illegally marketed Zyprexa through, among other things, a "5 at 5 campaign" that urged nursing homes to administer 5 milligrams of the drug at 5 p.m. to induce sleep.

Wayne Blackmon, a psychiatrist and lawyer who teaches at George Washington University Law School, said he commonly sees patients taking more than one antipsychotic, which raises the risk of side effects. Blackmon regards them as the "drugs du jour," too often prescribed for "problems of living. Somehow doctors have gotten it into their heads that this is an acceptable use." Physicians, he said, have a financial incentive to prescribe drugs, widely regarded as a much quicker fix than a time-intensive
evaluation and nondrug treatments such as behavior therapy, which might not be covered by insurance.

In a series in the New York Review of Books last year, Marcia Angell, former editor in chief of the New England Journal of Medicine, argued that the apparent "raging epidemic of mental illness" partly reflects diagnosis creep: the expansion of the elastic boundaries that define mental illnesses to include more people, which enlarges the market for psychiatric drugs.

"You can't push a drug if people don't think they have a disease," said Fugh-Berman, who directs PharmedOut, a Georgetown program that educates doctors about drug marketing and promotion. "How do you normalize the use of antipsychotics? By using key opinion leaders to emphasize their use and through CMEs (continuing medical education) and ghost-written articles in medical journals," which, she said "affect the whole information stream."

James H. Scully Jr., medical director of the American Psychiatric Association, sees the situation differently. He agrees that misuse of the drugs is a problem and says that off-label prescribing should be based on some evidence of effectiveness. But Scully suggests that a key factor driving use of the drugs, in addition to "intense marketing and some effectiveness," is the growing number of non-psychiatrists prescribing them. Many lack the expertise and experience necessary to properly diagnose and treat mental health problems, he said.

Among psychiatrists, use of antipsychotics is rooted in a desire to heal, according to Scully. "All of the meds we use have their limits. If you're trying to help somebody, you think, 'What else might I be able to do for them?' "

Since 2005, antipsychotics have carried a black-box warning, the strongest possible, cautioning against their use in elderly patients with dementia, because the drugs increase the risk of death. In 2008 the Food and Drug Administration reiterated its earlier warning, noting that "antipsychotics are not indicated for the treatment of dementia-related psychosis." But experts say such use remains widespread.

In one Northern California nursing home in 2006 and 2007, 22 residents, many suffering from dementia, were given antipsychotics for the convenience of the staff or because the residents refused to go to the dining room. In some cases the drugs were forcibly injected, state officials said. Three residents died.

A 2011 report by the inspector general of the Department of Health and Human Services found that in a six-month period in 2007, 14 percent of nursing home residents were given antipsychotics. In one case a patient with an undetected urinary-tract infection was given the drugs to control agitation.

"The primary reason is that there's not enough staff," said Toby S. Edelman, senior policy attorney for the Center for Medicare Advocacy, a Washington-based nonprofit group, who recently testified about the problem before the Senate Special Committee on Aging. "If you can't tie people up, you give 'em a drug" she said, referring to restrictions on the use of physical restraints in nursing homes.

Drugs At 18 Months

Nursing home residents aren't the only ones gobbling antipsychotics.

Mark E. Helm, a Little Rock pediatrician who was a medical director of Arkansas's Medicaid evidence-based prescription drug program from 2004 to 2010, said he had seen 18-month-olds being given potent antipsychotic drugs for bipolar disorder, an illness he said rarely develops before adolescence. Antipsychotics, which he characterized as the fastest-growing and most expensive class of drugs covered by the state's Medicaid program, were typically prescribed to children to control disruptive
behavior, which often stemmed from their impoverished, chaotic or dysfunctional families, Helm said. "Sedation is the key reason these meds get used," he observed.

More than any other factor, experts agree, the explosive growth in the diagnosis of pediatric bipolar disorder has fueled antipsychotic use among children. Between 1994 and 2003, reported diagnoses increased 40-fold, from about 20,000 to approximately 800,000, according to Columbia University researchers.

That diagnosis, popularized by several prominent child psychiatrists in Boston who claimed that extreme irritability, inattention and mood swings were actually pediatric bipolar disorder that can occur before age 2, has undergone a reevaluation in recent years. The reasons include the highly publicized death of a 4-year-old girl in Massachusetts, who along with her two young siblings had been taking a cocktail of powerful drugs for several years to treat bipolar disorder; the revelation of more than $1 million in unreported drug company payments to the leading proponent of the diagnosis; and growing doubts about its validity.

Helm said that antipsychotics, which he believes have become more socially acceptable, serve another purpose: as a gateway to mental health services. "To get a child qualified for SSI disability, it is helpful to have a child on a medicine," he said, referring to the federal program that assists families of children who are disabled by illness.

Ask Your Doctor

Psychiatrist David J. Muzina, a national practice leader at pharmacy benefits manager Medco, said he believes direct-to-consumer advertising has helped fuel rising use of the drugs. As former director of the mood disorders center at the Cleveland Clinic, he encountered patients who asked for antipsychotics by name, citing a TV commercial or print ad.

Some states are attempting to rein in their use and cut escalating costs. Texas has announced it will not allow a child younger than 3 to receive antipsychotics without authorization from the state. Arkansas now requires parents to give informed consent before a child receives an anti-psychotic drug. The federal Centers for Medicare and Medicaid Services announced it is summoning state officials to a meeting this summer to address the use of antipsychotics in foster care. And Sens. Herb Kohl (D-Wis.) and Charles E. Grassley (R-Iowa) introduced legislation that would require doctors who prescribe antipsychotics off-label to nursing home patients to complete forms certifying that they are appropriate.

Medco is asking doctors to document that they have performed diabetes tests in patients taking the drugs. "Our intention here is to get doctors to reexamine prescriptions," Muzina said.

"In the short term, I don't see a change in this trend unless external forces intervene."

Source http://www.kaiserhealthnews.org/Stories/2012/March/13/off-label-use-of-risky-antipsychotic-drugs.aspx

Petition To Stop Drugging Of Children In Foster Care

Stop Over-prescription of Psychotropic Drugs for Foster Children

Target: U.S. Congress

Goal: Investigate and stop over-prescription of antipsychotic drugs to foster children.

Recent studies show a disturbing over-prescription of antipsychotic drugs for children in foster care. Foster children often receive more than one prescription of powerful psychotropic drugs like Seroquel and Zyprexa, drugs used to treat severe bipolar disorder and schizophrenia in adults. Tell Congress to investigate these dangerous and irresponsible medical practices and illegal use of Medicaid funds to pay for them.

Studies exposing the disturbing trends of over-prescription of psychotropic drugs began in the early 2000s. For example, a 2003 study in Florida found that 55% of foster children in the state had been prescribed psychotropic drugs, 40% of them without even receiving a psychiatric evaluation. A 2004 study in Texas found that 34.7% of foster children in the state were receiving one or more anti-psychotic drug.

The problem is that drugs like Zyprexa or Seroquel which were designed for serious psychiatric conditions in adults are being prescribed for foster children with behavioral problems. Combining one or more of these medications is even more dangerous, as these medications can be known to cause depression in young children. That’s what happened in the case of Gabriel Meyers, a nine year old foster child taking Symbyax, an anti-depressant not meant for children, who killed himself in 2009 after an altercation with his foster brother. Gabriel’s doctor was cited by the FDA for over-prescribing the drug.

Medicaid pays for the medical treatment of foster children but there are supposed to be guidelines in place that prevent Medicaid from paying for these prescriptions that are not meant for children. What is occurring is a costly abuse of government money with fatal consequences.

Recent studies still show that foster children are receiving dangerous cocktails of psychotropic drugs at alarming rates. Senator Tom Carper has asked the General Accountability to look into this shocking disregard for children’s health and abuse of government funds. Sign the petition and demand that Congress addresses this problem now.

Sign the Petition by clicking HERE

Drugs Used for Psychotics Go to Youths in Foster Care

Blogger note:
This article states that psych doctors get very little money for drugging children in foster care but what it fails to report is that the states make money by drugging the children in state care. They get this extra money by giving the children the title of "special needs." States collect more money for special needs children from the federal government than they do for children that are not special needs. That is why states usually use their own psyc doctors and will not seek a second opinion in coming up with diagnoses that require these drugs. Independent doctors are less likely to agree with the use of psychotropic and antipsychotics for children.
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Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters on Medicaid, a new study suggests.

The report, published Monday in the journal Pediatrics, is the first to investigate how often youngsters in foster care are given two antipsychotic drugs at once, the authors said. The drugs include Risperdal, Seroquel and Zyprexa — among other so-called major tranquilizers — which were developed for schizophrenia but are now used as all-purpose drugs for almost any psychiatric symptoms.

“The kids in foster care may come from bad homes, but they do not have the sort of complex medical issues that those in the disabled population do,” said Susan dosReis, an associate professor in the University of Maryland School of Pharmacy and the lead author.

The implication, Dr. dosReis and other experts said: Doctors are treating foster children’s behavioral problems with the same powerful drugs given to people with schizophrenia and severe bipolar disorder. “We simply don’t have evidence to support this kind of use, especially in young children,” Dr. dosReis said.

In recent years, doctors and policy makers have grown concerned about high rates of overall psychiatric drug use in the foster care system, the government-financed program that provides temporary living arrangements for 400,000 to 500,000 children and adolescents. Previous studies have found that children in foster care receive psychiatric medications at about twice the rate among children outside the system.

The new study focused on one of the most powerful classes of drugs, antipsychotics. It found that about 2 percent of foster children took at least one such drug, even though schizophrenia and bipolar disorder, for which the drugs are approved, are extremely rare in young children.

“It’s a significant and important finding, and it should prompt states to improve the quality of care in this area,” said Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University who did not contribute to the research.

In the study, mental health researchers analyzed 2003 Medicaid records of 637,924 minors from an unidentified mid-Atlantic state who were either in foster care, getting disability benefits for a diagnosis like severe autism or bipolar disorder, or in a program called Temporary Assistance for Needy Families. All of these programs draw on Medicaid financing. The investigators found that 16,969, or about 3 percent of the total, had received at least one prescription for an antipsychotic drug.

Yet among these, it was the foster children who most often got more than one such prescription at the same time: 9.2 percent, versus 6.8 percent among the children on disability, and just 2.5 percent of those in the needy families program.

Antipsychotic drugs, the authors said, also cause rapid weight gain and increase the risk for metabolic problems in many people, an effect that may be amplified by the use of two at once.

Doctors who treat such children are aware of the trade-offs and often prescribe lower doses of the medications as a result. And when they add a second such drug, it is often to counteract side effects of the first medication.

Still, the relatively high rates of these drug combinations in such a young and vulnerable group have prompted policy makers across the country to take notice. A consortium of 16 states, in collaboration with Rutgers University, has drawn up guidelines to improve care for foster children and others dependent on state aid.

“The psychiatrists who are treating these kids on the front lines are not doing it for money; there are very low reimbursement rates from Medicaid,” said Dr. Ramesh Raghavan, a mental health services researcher at Washington University in St. Louis. “There’s enormous anguish because everyone knows that this is not what we should be doing for these kids. We as a society simply haven’t made the investment in psychosocial treatments, and so we are forced to rely on psychotropic drugs to carry the burden.”

http://www.nytimes.com/2011/11/21/health/research/study-finds-foster-children-often-given-antipsychosis-drugs.html?_r=1

"Off-label" Use of Antipsychotic Drugs for Some Conditions Not Supported by Evidence

Blog Authors Note:
When children in foster care are put on psychotropics for various "mental health" and/or "behavioral disorders," most of the time, that use is "off label." These are horribly powerful drugs that basically create a chemical lobotmy. We feel that you should protect your children from these drugs at all costs, even if it means that you have to get an injunction against the state to do so. That is why the following article struck us as important to post.
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"Off-label" Use of Antipsychotic Drugs for Some Conditions Not Supported by Evidence
Press Release Date: September 27, 2011

There is little evidence to support the use of atypical antipsychotic drugs for some treatments other than their officially approved purposes, even though many clinicians continue to commonly prescribe these drugs for so-called "off label" uses, according to a new report from the U.S. Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ). An article based on information in the report will be published in the September 28 issue of the Journal of the American Medical Association.

The report finds that atypical antipsychotic medications—approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia, bipolar disorder and, in some cases, depression—are commonly prescribed to treat other behavioral conditions.

The report, which is an update of a 2007 report, found some evidence to support the off-label use of atypical antipsychotic medications. Evidence was strongest, for example, for the off-label use of risperidone, olanzapine and aripiprazole to treat symptoms of dementia; quetiapine to treat generalized anxiety disorder; and risperidone to treat obsessive-compulsive disorder.

However, evidence was lacking to justify the use of these and other atypical antipsychotic drugs to treat substance abuse problems, eating disorders or insomnia, the report noted. Atypical antipsychotic medications have been linked to some harms, including a small increased risk of death in elderly patients with dementia, according to the report.

The report, a comparative effectiveness review prepared for AHRQ's Effective Health Care Program by the Southern California Evidence-based Practice Center, based at the RAND Corporation, is available at http://www.effectivehealthcare.ahrq.gov.

"While atypical antipsychotic medications are not for everyone, many patients who suffer from psychiatric conditions have found these drugs to be very helpful," said AHRQ Director Carolyn M. Clancy, M.D. "However, their off-label use, while in some cases beneficial, is of concern because we just don't know enough about their effectiveness and safety for multiple behavioral conditions. This report will give clinicians and patients additional information they can use to make the best possible decisions."

Antipsychotic drugs are commonly divided into two classes, reflecting two waves of development: conventional (or "first generation") and atypical (or "second generation"). Currently, nine atypical antipsychotic drugs have been approved by the FDA: aripiprazole, asenapine, clozapine, iloperidone, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone.

The report's authors also cautioned against assuming that all atypical antipsychotic drugs are similar, because they vary in effectiveness and side effects.

The report, Off-Label Use of Atypical Antipsychotics: An Update, is the latest comparative effectiveness review from AHRQ's Effective Health Care Program. The Effective Health Care Program helps patients, doctors, nurses, pharmacists and others choose the most effective treatments by sponsoring the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. More information about the program can be found at http://www.effectivehealthcare.ahrq.gov.

For more information, please contact AHRQ Public Affairs: (301) 427-1892 or (301) 427-1998.

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Internet Citation:

"Off-label" Use of Antipsychotic Drugs for Some Conditions Not Supported by Evidence. Press Release, September 27, 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2011/ehcofflabelpr.htm

Source http://www.ahrq.gov/news/press/pr2011/ehcofflabelpr.htm

52% of foster kids are prescribed psych drugs—One of them is fighting back

By CCHR Int - Original Article 06-23-2011

At just 6 years of age, still grieving over the death of the only mother he’d ever known, his foster mother, Giovan Bazan received the first of many psychiatric “diagnoses” and drugs that would plague him for the next twelve years of his life. Moved from foster home to foster home, orphanages and other modes of state care, Giovan was stigmatized with a plethora of psychiatric diagnoses and drugs until the age of 18, when he could finally make his own medical decisions and quit. Now a child advocate working part time at the Division of Family and Children Services (DFCS) in Georgia, Giovan is on a mission: To get a full-time job with DFCS and help enact laws to combat the wholesale labeling and drugging of foster children. In the video below, Giovan tells his story and why he decided to fight back against the abuse of kids in foster care.


Foster kids—often removed from family homes because of abuse—are further abused when they are prescribed psychotropic drugs under state care. Many of these children are on cocktails of prescribed drugs, including antipsychotics and antidepressants with documented side effects of diabetes, stroke, mania, psychosis, tumors, coma, suicide and death.

Yet, the rates with which these children are being given drugs has been increasing. The antipsychotic use rate among foster kids increased by 5.6% between 2004 and 2007 (from 11.7 percent to 12.4 percent). Another study in Pediatrics, revealed that youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate more than 3 times that of Medicaid-insured youth who qualify by low family income.

Only half of state child welfare systems have a policy to review usage of these drugs, and those are weak policies at that.

The psychiatric drugging of foster kids has caused so much concern nationally that in July 2010, the Government Accountability Office (GAO) started an investigation into the use of these drugs in foster care, as they are widely used in dangerous combinations, and for so-called “off-label” uses to treat symptoms for which they have not been medically approved. The GAO is looking into the estimated hundreds of millions of dollars of fraud arising from this and is collecting and analyzing data from Florida, Maryland, Massachusetts, Minnesota, Oregon and Texas.

The Medication Of Foster Children

Jan. 7, 2011

A recent 16-state study from Rutgers University on the use of antipsychotics in children and adolescents covered by Medicaid found that foster children received antipsychotic medications at a rate almost nine times that of other children covered by Medicaid.

Here is a PBS video about children in foster care being drugged.

Watch the full episode. See more Need To Know.