Category Archives: Youth Today

FDA Advisory Committee Okays Marketing Use of Three Psych Meds for Youth

Youth Today
Agency Itself Has Final Say on Approval
by John Kelly

An expert panel for the U.S. Food and Drug Administration (FDA) has approved the marketing of three psychotropic medications for use by mentally disturbed youth, a path of treatment that is already heavily relied upon by some child welfare and juvenile justice systems.

The Psychopharmacologic Drugs Advisory Committee said this month that it supports a request by the manufacturers of Zyprexa, Seroquel and Geodon to market the drugs as effective and acceptably safe for treatment of bipolar disorder and schizophrenia among youth.

The decision to approve the drugs now rests with the FDA, an action which some observers believe that approval could lead to more prescriptions for the drugs to youth.

Here are the three drugs up for discussion, their makers and the prescribed use for which the maker sought approval:

Zyprexa. Eli Lilly. “For the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.” Lilly agreed to pay the U.S. government $1.4 billion to settle criminal and civil cases regarding its promotion of Zyprexa for use with the elderly and children. Zyprexa is one of the three drugs that was prescribed to Gabriel Myers, a 7-year-old Florida foster child who is believed to have committed suicide. Myers’ death prompted the Florida Department of Children and Families to examine the use of psychotropic medication by children in the agency’s care.

Seroquel: AstroZeneca. “For the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age.”

Geodon: Pfizer. “For the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age.”

What Could Change

Doctors are not prohibited from prescribing the medications to youths now, but must do so off-label. Informal studies have yielded some positive results in youths, but the side effects of these three drugs and others in the “atypical antipsychotics” family include significant weight gain and Type II diabetes.

Official approval to market the drugs might ease concerns of state Medicaid and Medicare agencies about paying for the drugs, said David Cohen, a psychotherapist and professor at Florida International University.

“The bulk of sales [for psychotropic drugs] have been from government programs,” namely Medicaid and Medicare, Cohen said. It is possible that state Medicaid agencies, which are directly involved in expenditures for youths in the child welfare system, “will lessen their scrutiny of the drugs if they’re approved.”

“I believe the approval, should it officially come from the FDA, will counter the very recent drop in sales,” said Cohen.

Psychologist Ronald Brown, who made a statement to the committee on behalf of the American Psychological Association, indicated that an association working group on such drugs yielded little evidence that they were successful in treating youth, while there was little doubt that they carried significant risk of serious side effects. Brown did not ask the committee to reject the applications.

“Of the few pediatric studies that do exist, many include small samples sizes and attendant methodological weaknesses,” said Brown, the dean of public health at Temple University.

Speaking with health trade paper HealthDay before the committee voted, however, Brown said his own view was that the applications should not be approved.

“Particularly with children, when you don’t know, I don’t think you should approve it,” Brown said. “In this country, we are very overzealous to approve drugs. I think we need to be more conservative, particularly because this is a pediatric population.”

The use of psychotropic medications is high among youth involved in state systems such as child welfare and juvenile justice. About 14 percent of youth in foster care are prescribed a psychotropic medication, according to a policy paper written in 2006 by the Institute for Juvenile

Research at the University of Illinois at Chicago. But only 1 to 3 percent all youth suffer from bipolar disorder and schizophrenia, according to Dr. David Fassler, a clinical professor of psychiatry at the University of Vermont College of Medicine.

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FDA Committee to Rule on Psych Meds for Youths

Youth Today
by John Kelly

The Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee will vote next week on whether to allow three psychotropic medications to be marketed as effective and acceptably safe for youths with certain conditions.

Doctors have been prescribing all three to children for years, and many of them are youths who are known to child welfare and juvenile justice systems. About 14 percent of youth in foster care are prescribed a psychotropic medication, according to a policy paper written in 2006 by the Institute for Juvenile Research at the University of Illinois at Chicago. And any committee vote of confidence is unlikely to curb what many believe to be an overreliance on psychotropics in dealing with troubled youths.

That a committee was asked to rule on the issue is itself a statement on the controversial nature of the issue. The FDA is not required to seek committee approval to accept a pharmaceutical company’s application.

“When an advisory committee is convened, it usually means the evidence is not so clear,” said David Cohen, a psychotherapist and professor at Florida International University. Committees are called in when “other issues need to be considered, or the consequences are so weighty.”

The three drugs up for discussion, their makers and their prescribed uses:

-Zyprexa, Eli Lilly: “for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.” Lilly agreed to pay the U.S. government $1.4 billion to settle criminal and civil cases regarding its promotion of Zyprexa for use with the elderly and children. The drug’s side effects include significant weigh gain and diabetes. Zyprexa is one of the three drugs that was prescribed to Gabriel Myers, the 7-year-old Florida foster child who is believed to have committed suicide. Myers’ death has prompted the Florida Department of Children and Families to examine the use of psychotropic medication by children in the agency’s care.

-Seroquel, AstroZeneca, “for the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age.”

-Geodon, Pfizer, “for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age.”

In November 2008, the FDA’s pediatric advisory committee surprised the agency when it unanimously rejected a proposal that the FDA routinely monitor Zyprexa and another drug, Risperdal. The meeting was supposed to be a routine review of the pediatric safety of the drugs.

Cohen would like to see this committee act in a similar manner. Medicaid agencies are leery of the costs associated with the drugs, he said, and “This hearing is a desperate attempt to legitimize” the use of these drugs on children, Cohen said. A favorable ruling for the drugs’ manufacturers “would take lot of heat off” of them.

Notice of the meeting is available here http://edocket.access.gpo.gov/2009/E9-10451.htm on the Federal Register website.

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Foster Children Medicated Without Consent

Youth Today
by Jamaal Abdul-Alim, John Kelly

Nearly one in six children in the Florida foster care system who had been prescribed psychotropic medication were given the drugs without parental consent or authorization from a judge, despite the state’s increased scrutiny of the drugs’ use.

That is among the preliminary findings of a review released Wednesday by the Florida Department of Children and Family Services. The review was ordered following the apparent suicide on April 16 of 7-year-old Gabriel Myers, who had been prescribed psychotropic drugs without informed parental consent or a judge’s order while foster care system. Gabriel reportedly hung himself on a shower rod.

The review by the Florida DCF, using data from its Florida Safe Families Network (FSFN), found that of the 2,669 children in Florida’s foster care system who were prescribed psychotropic drugs, there was no record of consent or a judicial order in 433 cases. The statistics did not specify the ages of the children for whom there was no consent on record.

“It’s inconceivable to me, with all the attention focused on psychotropics, that the system doesn’t have this right yet,” Florida DCF Secretary George Sheldon said yesterday when asked how so many children in foster care could be prescribed the drugs without proper authorization.

A 2005 law requires an agency to obtain the consent of a parent or judge before giving mind-altering medications to foster children. Consent is necessary for each prescription.

“I don’t think there’s any excuse,” Sheldon said.

He vowed to take swift action on the 433 cases in which there is no record of parental consent or a judicial order, explaining that there are plans to bring all of the cases into compliance with the law and to get the cases reviewed by a judge by June 5.

Number Disputes

The majority of youths without consent for their prescriptions were served by private agencies that have carried out most child welfare services in the state since the officials began privatizing the system in the early 2000s.

Sheldon conceded during yesterday’s telephone news conference that the private agencies managing the cases where youth may have been prescribed the drugs illegally could face contract reviews or termination, and the caseworkers involved could face disciplinary action..

“Stay tuned,” Sheldon said, explaining that for the time being, he is more concerned with getting agencies and caseworkers to cooperate and produce reliable information on the extent of the problem of wrongful use of psychotropic drugs for children in state care.

A number of providers said that at least some of the 433 cases simply lack a paper trail; consent was given, but it was not properly documented.

Officials for Miami-based Our Kids, which the report stated had 62 youths prescribed medication with proper authorization, told Youth Today that notification of a change in prescription sometimes makes it into the state database before consent has been sought. In some cases, when youth run away from care or initially refuse to take medication, the agency stops seeking consent since the drug is not being administered, said clinical services director Michelle Montero.

Eckerd Youth Alternatives, a lead agency in Florida’s Suncoast Region, had 78 no-consent cases according to the report. A spokeswoman for the agency said that when it reviewed every single child in its care over the past two weeks, it identified 25 children that fit into the no-consent category.

Eckerd spokeswoman Karen Bonsignori believes the discrepancy of 53 cases likely is due to incomplete reporting of consensual prescriptions on the part of the group Eckerd subcontracts with to provide case management. Eckerd will be entering information into FSFN from now on, Bonsignori said.

Sheldon conceded that the review’s findings may be flawed and there are efforts under way to validate the findings.

“We have to get the database in better shape,” Sheldon said.

Causes and Solutions

How did the actual no-consent cases happen? A primary cause cited by lead agencies is that mental health developments in a child’s life can occur more frequently than visits with lead agency staff do.

“A kid can see one doctor, then move to another doctor,” said Hillsborough Kids CEO Jeff Rainey, whose organization did not have consent for 52 of the psychotropically medicated youths in its care. “Sometimes the medications get changed. There’s a catch-up factor.”

Foster parents are supposed to let agencies know if a child is prescribed psychotropic medication as part of the bilateral agreement they have with lead agencies, said Gregory Kurth, executive director of Family Services of Metro Orlando (FSMO), which the DCF report said had 63 children on prescribed medication without consent. “That may not necessarily happen every time.”

Rainey concedes that none of these factors is an excuse. “It’s a complex process,” he said, “but at the end of day it’s our responsibility.”

The Gainesville-based Partnership for Strong Families (PSF) had only one child with a non-consent prescription. PSF President Shawn Salamida said his organization has been diligent about monitoring for changes in medication for children in its care.

PSF pulls reports directly from a the Florida Safe Families Network’s statewide database and cross checks it with its own records. “That tells us which kids are on psychotropics. We review that list…to make sure we’re in compliance.”

Salamida said the organization also holds frequent “staffings,” regular reviews of cases that bring together caseworkers, quality management staff, attorneys and parents in some situations.

The lead agency that managed Myers case, ChildNet, said it “is one of the few Community Based Care lead agencies throughout the state that has internal policies and procedures in place to document and monitor use of psychotropic medications. Our policy and procedures were in place since our inception in 2005.”

Sheldon stressed that it’s important for parental consent to be actual informed consent rather than on paper only. In the case of Gabriel Myers, for instance, Gabriel’s mother signed a blank consent form when she was high on drugs, Sheldon said.

“It’s not just enough to get a signed parental consent form,” Sheldon said. “It must clearly be informed. That means the parent is clearly explained the use of psychotropics.”

Gabriel, who had been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) had been prescribed Vyvanse in December 2008. In the weeks leading up to his death, he had also been prescribed Lexapro, which was later discontinued and replaced with Symbyax.

Asked for his own views on the use of psychotropic drugs, Sheldon said: “I’m not a psychiatrist, and I’m not anti-medication. But I have serious questions when it comes to the administration of psychotropic drugs to children. I think it should be done as a last resort” and then only when reviewed by medical professionals.

At Family Services of Metro Orlando, Kurth is considering using a medical consultant to review any prescription for psychotropics made for one of its children. He does not intend to become a final say on the drugs, but thinks a consultant can make sure doctors have considered every option and asked every question before resorting to serious medication.

More info on the Myers case: http://www.dcf.state.fl.us/admin/GMWorkgroup/index.shtml

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