Concern over high medication rate among foster kids – Review of kids’ psych drugs urged

Atlanta Journal-Constitution
By April Hunt

While in foster care, Giovan Bazan, now 20, says he was put on Ritalin, anti-depressants and sleeping pills. At 18, he elected to stop all drugs, and says he learned he didn't need them.

Giovan Bazan was 6 when a doctor first gave him medicine to treat his diagnosis of hyperactivity.

Bazan admits he was unruly at the time. Perhaps it was because the only parent he had ever known, his foster mother since he was an infant, had just died.

No one asked about that. Nor did anyone check years later to see that he was on a double dose of Ritalin when another physician, seeing a boy so mellowed out that he barely reacted, prescribed an antidepressant. “They start you on one thing for a problem, then the side effects mean you need a new medicine,” Bazan said. “As a foster kid, I’d go between all these doctors, caseworkers, therapists, and [it] seemed like every time there was a new drug to try me on.”

When he turned 18, Bazan elected to stop all medications. It turned out he didn’t need any of them.

Now, the Georgia House is weighing an idea to better track the psychotropic drugs foster children take at a far greater rate than other kids.

House Bill 23 hits a rare political sweet spot. The proposal to create an independent clinic review of the drugs foster children are given has support from Democrats and Republicans because of its efforts to protect the vulnerable — and projections that it will save the state millions of dollars. The state spends $7.87 million per year in Medicaid funds on those mind-altering drugs for foster kids. “This is an idea I’m very open and willing to have a discussion about,” said Speaker David Ralston, R-Blue Ridge, adding his main concern is the cost of the review.

The issue is a national one. Only half of state child welfare systems — not including Georgia — have a policy to review usage of mind-altering drugs, even though as many as 52 percent of kids in foster care are taking them.

By comparison, about 4 percent of the general youth population is on the medications, according to a 2010 Tufts Clinical and Translational Science Institute study.

“These drugs are not something you take like an aspirin,” said state Rep. Judy Manning, a Marietta Republican and chairwoman of the House Children & Youth Committee who is co-sponsoring HB 23 with Rep. Mary Margaret Oliver, D-Decatur.

“We want to monitor it and make sure the treatment is correct,” she said. “You don’t want a tragedy.”

Lack of oversight can prove deadly. Gabriel Myers, a 7-year-old foster child in Florida, hanged himself in 2009 while taking three powerful psychotropic medications, none of which had been approved for use in children.

There have been no similar high-profile cases in Georgia. Still, one in three foster 
children on Medicaid was 
prescribed mind-altering psychotropic drugs last year, according to a January report from the state Department of Community Health. More than half of them were on a daily cocktail of more than two of the drugs — some of which lack approval for treatment in children.

Oliver argues that both the cost and number of foster children on such drugs will drop if her proposal succeeds.

Her plan calls for an independent review to kick in on red-flag cases in the system, such as when a very young child is prescribed drugs for mental health or when a youngster is on multiple medications at once.

It would be up to the Human Services or Behavioral Health departments to decide what would flag cases and how to best manage the independent psychiatrists who would monitor them.

Oliver said private foundations have expressed interest in funding the idea as a national pilot program.

“Foster children are more traumatized, for horrible reasons, and that’s why their medical care has to be better,” Oliver said. “I am excited about the number of stakeholders who want to work on solving this problem with us.”

The issue may extend to lack of oversight on what drugs foster kids are being prescribed and taking. A 2010 investigation by The Atlanta Journal-Constitution revealed several companies operating foster care homes in the state had repeatedly used psychotropic medications to “subdue” children.

“Medications dispersed often aren’t to help the child with their problems but to make the child more docile for the caregivers,” said Richard Wexler, who heads the National Coalition for Child Protection and Reform. “And the paradox of child welfare care has always been the worst thing for the kids is what costs the most.”

That seems to have been the case for Bazan. Now 20, he can recall a brief period in high school when prescriptions had run out and his foster mother didn’t keep him on the stew of mind-altering drugs.

Fellow students noticed the no-nonsense boy was suddenly joking around and friendly.

“When I was off the medicines, everyone kept asking me why I was so happy,” Bazan said. “There was a real difference.”

The medications quickly 
returned, however. But Bazan said they didn’t help with the loss he felt over the death of 
his first foster mother or his feelings of being unwanted 
and under attack in the foster home he repeatedly ran away from.

He spent time in Department of Juvenile Justice facilities, where the medications kept coming, sometimes provoking seizures because some of them didn’t mix.

No one, he said, ever asked about his feelings. “They would have gotten a better response if someone had just taken a look at what was really going on in my life,” he said.

Bazan did that himself when he quit all medications cold turkey at age 18. But the years of medication already have hurt his future: His plan to enter the military to pay for college is blocked by the diagnosis of hyperactivity. He is ineligible to serve.

Bazan now works part time at the Division of Family and Children Services, acting as 
a liaison with community 
organizations and state agencies.

He also has started his own security company to provide nighttime patrols at his church in DeKalb County and others.

His goal is to get a full-time job with DFCS and persuade Gov. Nathan Deal to appoint him to the Georgia National Guard. With that, he could pay for college.

First, though, he is sharing his story in the hope that lawmakers and others will see him as a cautionary tale for what can happen when someone isn’t monitoring care of foster kids.

“I ask them, ‘Would you give all these people carte blanche with your kids, without any scrutiny of their medical history and a review of their life?’” Bazan said. “We’re just children. Someone has to look out for us. We need the same care and attention you give your own children.”

So much bluster, but foster kids’ drug nightmare continues

Miami Herald
By Fred Grimm
Gabriel Myers died for nothing.

His shocking death supposedly galvanized Florida. It would mean something, this suicide of a foster kid who had been drugged into nether-consciousness with antidepressants and antipsychotics never intended for any child, much less a 7-year-old.

A new law would be crafted. State-sponsored zombification of foster kids would be stanched. Something would be done.

More like nothing.

“I was shocked. I was devastated,” said Mez Pierre, a young survivor of the unrestrained psychotropic regimes used to addle Florida foster kids.

THE PERPLEXING PUSHBACK

Pierre, 23, joined a number of child advocates, state officials, political leaders and judges in the Gabriel Myers Work Group formed by the Department of Children & Families. They met a dozen times over the past year, exploring legislative fixes for this stunning propensity to subdue foster children with adult-strength pharmaceuticals.

The group was born out of our collective shame. Gabriel Myers had been addled with Lexapro, Zyprexa and Symbyax — a drug cocktail no real parent would countenance. On April 15, 2010, Gabriel locked himself in the bathroom of his Margate foster home, coiled a shower hose around his neck and shocked Florida into . . . nothing.

The widely supported bill designed to regulate the drugging of foster kids disappeared in the House of Representatives this week. Medical and drug-industry lobbyists, and a single powerful legislator, Rep. Paige Kreegel, chairman of the Health Care Services Policy Committee, managed to waylay the bill.

Bernard P. Perlmutter, director of the University of Miami’s Children & Youth Law Clinic, was surprised that “pushback came from doctors and psychiatrists, since the bill did little more than codify existing medical ethics standards and laws regarding consent from a child’s parents or judge, and assent from the child, before psychotropic medication could be administered.”

Kreegel feigned unfamiliarity with Myers’ case. “I am shocked that the chairman never heard about Gabriel Myers, especially after the months of work by a task force of leading experts and then work by the Senate,” said Broward child advocate Andrea Moore. “Unfortunately, we know there are other children who have been harmed by the unfettered use of these drugs as chemical restraints. If a highly publicized death is not enough to galvanize the Legislature, I do not know what will do it.”

SPIRITS IN SHACKLES

Mez Pierre now understands Florida’s priorities: Doctors matter. But foster children . . .

“They sent foster kids a message.” he said.

“You’re just not important enough to protect.”

Pierre, 23, grew up in so-called “therapeutic” foster homes from age 5 to 18, shuffling from one zombie warehouse to another, where psychotropic drugs left him perpetually listless, filled his head with strange, often suicidal thoughts and caused serious physical side effects.

The brutal effects ended when he left foster care at age 18 and quit the psychotropics. Without the pills, the supposedly unruly young man has finished three years at Broward College. “But what happened to me, what happened to Gabriel, it’s still going on,” Pierre said.

And all the work group meetings. All the talk. All the work. As if foster kids mattered.

It came to nothing.

Foster kids lose

Miami Herald
OUR OPINION: Still subject to over use of psycho-tropic drugs

State Sen. Rhonda Storms, a Valrico Republican, put up a Herculean fight on behalf of Florida’s foster kids this week, but a powerful bloc of doctors and psychiatrists defeated her in the Florida House.

The House leadership could have prevented this travesty. Instead, it caved to Florida’s powerful medical lobby and sacrificed some of the state’s most vulnerable residents.

The battle was over use of psycho-tropic drugs on youth in state care. After the 2009 suicide of 7-year-old foster child Gabriel Myers in Margate, the Department of Children & Families hired former Florida Department of Law Enforcement Deputy Commissioner Jim Sewell to investigate how drugs are used to control unruly foster kids.

Mr. Sewell pulled no punches in his report. Foster parents and doctors often resort to strong anti-depressants to keep children with emotional problems in line. Treatment of their underlying psychological problems take second place to keeping them drugged up.

Gabriel had been prescribed several such drugs before he hung himself, including anti-depressants linked to an increased risk of suicide among children.

The DCF sought better oversight of how doctors prescribe psychiatric drugs to foster children. The bill, sponsored by Sen. Storms, would have required doctors to seek the “assent” of older foster kids before they could be medicated and upheld current law requiring doctors to get consent from a parent or a judge in most cases before using drugs.

That’s reasonable — and, more important, in the child’s best interests. But physicians fought, saying they didn’t want government telling them what to do. Republican state Rep. Paige Kreegel, a Punta Gorda doctor, blocked the bill from even being heard in the House, though it had passed easily in the Senate.

Sen. Storms tried every legislative maneuver available to get around Rep. Kreegel, but the physicians won the day, and Florida’s foster children are worse off for it.

DCF ought to seek another way to control use of these medications until reason prevails in the House.

Drug’s use again in spotlight

Miami Herald
The mother of a Broward teen who died in 2003 believes it was because of an anti-psychotic drug he should not have been prescribed.
BY NIRVI SHAH

A Broward doctor reprimanded by the Food and Drug Administration for his drug-prescribing practices is facing accusations in a civil suit that he caused the death of a Weston teen after prescribing an anti-psychotic drug not approved for use in adolescents.

Norma Tringali of Tamarac believes the drug Seroquel, which Dr. Sohail Punjwani prescribed to her son Emilio, played a role in his death seven years ago. Punjwani is the same physician who was treating 7-year-old foster child Gabriel Myers before he committed suicide last year.

Earlier this week, pharmaceutical giant AstraZeneca agreed to pay state and federal government agencies $520 million to settle an investigation into the company’s marketing practices, which the Department of Justice said encouraged doctors to use Seroquel for young and elderly people for indications not approved by the FDA.

The settlement will yield about $8.5 million for Florida, split between the state’s Medicaid program, general revenue fund and a reward program for reporting Medicaid fraud.

Tringali’s case against Punjwani is expected to go to trial later this year.

All the other doctors and institutions named in the suit have settled with Emilio’s family, said her lawyer, Michael Freedland.

In the meantime, for Tringali, the civil penalty AstraZeneca has said it will pay provides some resolution.

“That is the thing — that is the answer,” Tringali said, through tears. “Emilio was taking something recommended for adults, not kids.”

Punjwani and his attorneys did not return several phone calls seeking comment.

After a year in Punjwani’s care, Emilio, who played water polo, had a heart attack and died. He was a junior at Piper High School in Sunrise. The lawsuit alleges that Punjwani’s care “deviated and departed from the prevailing professional standard of care exercised” by most doctors.

It goes on to say that Punjwani failed to monitor the effects of a combination of anti-psychotic drugs on Emilio’s heart, failed to perform regular cardiac testing and failed to consult with a cardiologist or other doctor with more experience with the heart-related side effects of anti-psychotic drugs, among other things.

But it is not certain whether the settlement will have a direct effect on the suit against Punjwani, said Tringali’s lawyer, Weston attorney Michael Freedland.

“She was always convinced that these drugs caused his death,” Freedland said of Emilio’s mother. “For her this settlement was some kind of vindication in a sense. It doesn’t necessarily relate to the exact same issue.”

Freedland’s office was simultaneously working on Tringali’s case and the whistleblower case that led to this week’s settlement with AstraZeneca. But rules about whistleblower suits meant they could not share anything about that case with Tringali until the settlement became public this week.

Punjwani was reprimanded by the FDA because he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.

“Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects’ rights, safety and welfare,” the FDA wrote.

Early last year, drugmaker Eli Lilly pleaded guilty to illegally marketing the anti-psychotic drug Zyprexa for unapproved uses. Freedland’s firm also worked on that case, which netted a $1.42 billion settlement.

“The issue relates to these drugs,” Freedland said. “The way Dr. Punjwani treated Emilio Villamar and the manner in which these drugs were prescribed is a picture of everything that’s wrong with this industry and the relationship between doctors and pharmaceutical companies.”

The settlement says that AstraZeneca targeted its illegal marketing of Seroquel at doctors who do not typically treat schizophrenia or bipolar disorder, including physicians who treat older patients, young patients and primary care doctors and to psychiatrists and other physicians for uses that were not approved by the FDA as safe and effective.

The civil penalty will repay Medicaid, Medicare and other programs that were billed for the drug, although it was being prescribed incorrectly.

In a statement, AstraZeneca said under the agreement, it still denies the allegations.

However, the international company, with U.S. headquarters in Delaware, entered into a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services that will last for five years.

Effort to protect children from overmedication fails

Miami Herald
The product of state child welfare administrators’ half-year of soul-searching, a bill to protect foster kids from powerful mental health drugs is killed by doctors.
BY CAROL MARBIN MILLER AND MARC CAPUTO
April 30, 2010

TALLAHASSEE — When a heavily medicated foster child died of an apparent suicide, the response seemed obvious: Better oversight of the way doctors prescribe psychiatric drugs to children in state care.

But in the waning days of Florida’s 60-day lawmaking session, what looked like common-sense regulation to some has no chance of passing, a victim of conflicting ideologies and the power of doctors and psychiatrists in the Capitol who don’t want government telling them what to do.

The bill, sponsored in the Senate by Sen. Ronda Storms, a Valrico Republican, would have required doctors to seek the “assent” of older foster kids before they could be medicated, and upheld provisions of current law that require doctors to gain consent from a parent or judge in most cases before a foster child could be drugged.

“I’m extremely disappointed,” said Jim Sewell, a former lawman who headed up a six-month investigation for the Department of Children & Families into the April 16, 2009, death of 7-year-old Gabriel Myers. “For all of us, this was a real involvement of the heart, and to see it not get codified into law was a big disappointment.”

Sewell, a former Florida Department of Law Enforcement deputy commissioner who is now special assistant to DCF Secretary George Sheldon, presided over a series of public hearings on Gabriel’s death, and published a surprisingly frank report last November. Gabriel had been prescribed several mental-health drugs in the months before his death, including anti-depressants linked to an increased risk of suicide among children. Sewell’s report contained a host of recommendations for changes in state law — many of which were in the bill.

Among other things, the bill would have banned children in state care from being enrolled in clinical drug trials — a provision that gained momentum last month when Gabriel’s psychiatrist, Dr. Sohail Punjwani, received a stern warning from federal regulators over his conduct in a drug trial for an undisclosed psychiatric drug.

The measure flew through the Senate with unanimous votes in every committee. But in the House, Rep. Paige Kreegel, a physician, refused to even hear the bill in his Health Care Services Policy Committee.

“I don’t feel right now that we are in definite need of any additional regulation in the state,” said Kreegel, a Punta Gorda Republican. “There’s all kinds of regulation.”

Kreegel said he didn’t know the particular facts behind the case of Gabriel Myers — who authorities say hanged himself with a shower cord in the bathroom of his Margate foster home. But he said Storms’ legislation would effectively have stopped psychiatrists from prescribing medicine to needy children.

Kreegel called some of Storms’ statements about out-of-control doctors “baloney.” Storms was outraged that Kreegel was able to kill the bill — which was one of DCF’s highest legislative priorities.

“How can anyone be against protecting children?” Storms said.

Storms spent a feverish week trying to get around Kreegel’s procedural maneuver. She amended her bill onto a must-pass piece of legislation governing DCF. Then she persuaded Senate leaders to make the issue part of budget negotiations.

Among other moves, Storms passed around a Miami Herald story showing a Miami doctor had ignored scores of letters — and three office visits — from state health regulators who warned his mental health drug prescribing practices were potentially dangerous. One of the doctor’s patients, a disabled 12-year-old, died of complications from over-medication.

But the House balked at every turn.

Sen. Nan Rich from Weston, who will become the ranking Democrat next year, said the Houses’s failure to take up the bill will allow future child welfare administrators to “once again fall back into the path of least resistence” by using mental health drugs as a chemical restraint on unruly foster kids.

Amendment to bill targeting foster kids’ medication draws fire

Miami Herald
Critics are questioning an amendment to a bill designed to protect foster children from being inappropriately medicated with mental-health drugs.
BY CAROL MARBIN MILLER

One of the largest providers of inpatient psychiatric care for Florida foster kids successfully pushed for an amendment to a bill that will make it easier for group homes and treatment centers to begin medicating foster children without the consent of a parent or judge.

Psychiatric Solutions, which operates 13 residential treatment programs in Florida, including three in Broward County, proposed an amendment to state Sen. Ronda Storms’ bill that will allow the company, and others like it, to administer mental-health drugs to young foster children for three days without the consent of a parent or judge. The legislation was prompted by the 2009 death of a 7-year-old Margate foster child, Gabriel Myers.

CONSENT NEEDED

Under current law, and under the bill that Storms, a Valrico Republican, proposed, children younger than age 11 in the care of the Department of Children & Families cannot be given psychiatric drugs without the consent of a parent, or a state judge in cases where the child’s parents have lost their parental rights.

In her bill, Storms proposes that caregivers for foster children must present a “compelling government interest” that medication is in the “child’s best interest.” The bill requires DCF to get an independent review in order to medicate children younger than 11.

In an e-mail to DCF’s legislative affairs director, Jim R. Henry, the director of Manatee Palms Youth Services, which is owned by Psychiatric Solutions, suggests that the state has, by definition, a compelling interest in allowing children to be medicated at treatment centers, since the kids already are presumed to be mentally ill.

Jeff Turiczek, who runs Manatee Palms, wrote in a March 26 e-mail that the amendment “basically [makes] the case that by the admissions requirements into those facilities the compelling governmental interest has been met.” In other words, a child entering a treatment center or therapeutic group home already has been diagnosed with a mental illness, and therefore may need to be medicated. Turiczek did not return calls seeking comment.

Storms said Friday she did not amend her bill to benefit the company. “It is true lobbyists come to see me,” Storms said. “No one said, hey will you do this from PsychSolutions, or whatever. I’m not trying to do it for any singe entity’s benefit. I am saying I want to fend off as much of the opposition as I can, so it gets through.”

Storms’ bill requires that doctors receive informed consent from a parent or guardian before administering mental-health drugs.

But the bill, as amended by Storms on Tuesday, makes exceptions: Doctors may begin the use of psychiatric drugs, without consent or a court order, if a child is in a mental hospital, a crisis stabilization unit, a residential treatment center or therapeutic group home. In such settings, DCF must seek a court order to administer the drugs within three days of beginning the medication.

Critics of the amendment note that children in such institutional settings are the most at risk of being inappropriately medicated.

In May 2009, during DCF’s investigation into the use of psychotropic drugs, the agency reported that 26 percent of children in group homes or other institutional settings were being given mental-health drugs, compared to 21 percent of children in foster homes and 4 percent of children living with relatives.

Jim Sewell, a special assistant to DCF Secretary George Sheldon who chaired a task force last year that looked into the use of mental-health drugs among foster kids, said supporters of the amendment had not spoken to him about it. “It was kind of a surprise,” he said.

“The language can be better, a lot of us believe. But rule-making authority will enable us to put things in place that ensure the protection of kids,” Sewell said.

Another member of the Gabriel Myers Work Group has expressed misgivings about the amendment. Gabriel died a year ago Friday after hanging himself in a foster home shower. He had been prescribed several mental-health drugs in the months before his death, including anti-depressants linked to an increased risk of suicide among children.

“The fact that a child needs residential treatment is not per se sufficient to say they need medication,” said Robin Rosenberg of Florida’s Children First. “I think there is too much potential for abuse.”

PROTECTING KIDS

Storms, who has been extremely vocal about her concern that doctors are relying far too heavily on drugs to manage troubled foster kids without first attempting other methods, said doctors still will have to seek consent from a judge. Storms said the bill will better protect children than current law.

She said she added the amendment to drum up more support for the bill, as she had received a number of calls from concerned treatment centers that they would not be able to medicate if a child were pulling out their hair, cutting themselves, or banging their head on a table without end.

Miami Herald staff writer Robert Samuels contributed to this report.

Vigil will be held in memory of boy

St. Petersburg Times
CLEARWATER
Times staff

One of four statewide candlelight vigils in memory of 7-year-old Gabriel Myers, a foster child in state care who reportedly hanged himself while on three powerful psychotropic medicines, will be held from 7 to 8:30 p.m. Friday on the bike walk of the Memorial Bridge in downtown Clearwater. Hosted locally by Dr. Elizabeth Young, Pamela Seefield and the Citizens Commission on Human Rights of Florida, the vigil will also address issues related to the right to informed consent. State Rep. Kevin Ambler, R-Tampa, will speak. For more information, call (727) 442-8820.

In wake of child’s suicide, Legislature moves to limit foster care’s reliance on psychiatric drugs

St. Petersburg Times
By Cristina Silva, Times Staff Writer

TALLAHASSEE — A year after a 7-year-old boy heavily medicated on powerful psychiatric drugs hanged himself in his Margate foster home, lawmakers are pushing to reform state medical requirements for foster children.

The Senate’s Children, Families, and Elder Affairs Committee unanimously approved a measure Thursday designed to curb the prescription of mental-health drugs to children in state care.

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

The measure (SB2718 and HB1567) would also give children some say in the drugs they take.

“We are not just going to medicate them until they turn 18 and then dump them into adulthood,” said sponsor Sen. Ronda Storms, R-Brandon, chairwoman of the Children, Families, and Elder Affairs Committee.

The state’s growing use of adult medication on emotionally and mentally troubled children has sparked debate for years.

Multiple state studies show child-welfare doctors and case managers routinely failed to follow legally required treatment plans or properly document when and why drugs were given to foster children, creating a network of youth sedated by “chemical straitjackets,” Storms said.

The death of Gabriel Myers in April further revealed the shortcomings of 2005 legislation that required more information sharing, parental involvement and second-party review of doctors’ prescriptions for the youngest children.

Because foster children are often cared for by multiple service contractors, communication lapses and fragmented mental health care are still rampant, a recent state report on Myers’ death determined.
“Our response to him was to medicate him, and medicate him, and medicate him,” Storms said.

Under the bill, proposed medical treatment plans must be explained to a child and the child must consent to the treatment in many cases before taking the drugs.

“What this means is less medication and more behavior analysis so that they are not just sedated little zombies,” said Jan Montgomery, president of the Florida Association for Behavior Analysis, which would train legal guardians to observe and treat behavioral problems.

Still, Montgomery said she did not expect a sudden culture shift, given failed past efforts to track foster children’s medical records.

“It’s going to be a slow slide toward what we are hoping is the right way,” Montgomery said.

Bills worry child advocates

Daytona Beach News Journal
By DEBORAH CIRCELLI

DAYTONA BEACH — While social service agencies brace for more cuts this legislative session, many are following dozens of bills dealing with everything from giving foster children psychotropic medications to better screening of employees who work with vulnerable children and adults.

Improvements in background screenings for state-regulated jobs passed the Florida House on Thursday, but will still need approval in the Senate and by the governor. Owning a gun also won’t prevent someone from adopting a child, based on a bill approved in both chambers Thursday.

Local child-welfare officials are also watching what new guidelines will be passed dealing with prescribing psychotropic medications to foster children after the April 2009 death of a South Florida 7-year-old foster child, Gabriel Myers. Gabriel was prescribed several mind-altering drugs and hanged himself in his foster home. Locally, about 120 or 14.4 percent of foster children in out-of-home care such as foster homes, group homes or living with relatives are on psychotropic medications.

Former foster youth receiving a monthly stipend by the state for living expenses while they continue their education could also see their money cut in half.

A House bill (HB 5305) would place a cap of $675 on how much former foster youth could receive each month for living expenses while continuing their education. About 70 youth locally are receiving about $1,200 a month. Another committee bill (SB7066) would require an audit of the program to track how youth are doing and spending the funds.

State and local advocates fear cutting funds will lead to youth dropping out of high school or college and becoming homeless.

“I think it would be extremely difficult for them to make it,” said Bill Babiez, CEO of Community Partnership for Children, the local foster care agency for the state.

Some other bills being followed by social service agencies include:

• BACKGROUND SCREENINGS (SB1520/HB7069): Enhances screenings for groups working with vulnerable adults and children. Some areas would include Guardian Ad Litem, nursing homes, foster homes, mental health personnel, home health agency personnel and people working with the developmentally disabled. The bill passed unanimously in the House. Fingerprints for various groups would be submitted electronically and retained by the state Department of Law Enforcement.

• FIREARMS/ADOPTIONS (SB530/HB0315): Prohibits an agency from denying a person the ability to adopt because they lawfully possess a firearm. The Legislature adopted the bill Thursday — including a 112-0 vote in the House and 38-2 in the Senate — and Gov. Charlie Crist said he supports it.

• ADOPTION (SB102/HB0003): Repeals law that currently prohibits someone who is homosexual from adopting.

• ATTORNEY REPRESENTATION FOR FOSTER CHILDREN (SB1860/HB7075): Appoints attorneys for foster children in certain cases such as if they’ve been in care for 18 months and their parents’ rights have not been terminated, or if a child asks for an attorney and the court agrees. Also, in cases where psychotropic medications are prescribed and the child objects or the court is concerned.

• INCREASED SERVER PENALTIES/OPEN HOUSE PARTIES (SB1068/SB1066/HB0033): Enhances penalties for people serving alcohol to someone under 21, including someone hosting an open house party where drugs or alcohol are possessed or consumed by minors. As opposed to 60 days in jail and a fine not to exceed $500, a person could get a one-year sentence and $1,000 fine, which is a first-degree misdemeanor, for selling or delivering alcohol to a minor within one year of a prior conviction.

• MENTAL HEALTH, CRIME REDUCTION AND TREATMENT ACT (SB1140/HB 1189): Provides more substance abuse and mental health services in the community such as crisis intervention teams and mental health courts. The legislation would reduce the number of people with mental illnesses or substance abuse disorders from being in the criminal justice system. Chet Bell, CEO of Stewart-Marchman-Act Behavioral Healthcare, said, “We want mental illness among nonviolent offenders to be treated as a health issue, not a criminal justice issue,”

• INTELLECTUAL DISABILITIES (SB1388): Would replace the word “mental retardation” in current legislation to “intellectual disability.” Barry Pollack, president & CEO of United Cerebral Palsy of East Central Florida in Daytona Beach, said, “Our society has turned the word ‘retardation’ and variations of the word into a socially unacceptable label with very negative characterizations.” Other bills dealing with rights of people with disabilities include increased training requirements for people teaching children with disabilities.

FDA warns psychiatrist who treated dead foster child

Miami Herald
BY CAROL MARBIN MILLER

MENTAL HEALTH
FDA warns psychiatrist who treated dead foster child
The psychiatrist who treated the Broward foster child who killed himself last year is now in hot water with the FDA.

A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.

In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.

Another, a 13-year-old, “experienced sedation and dizziness during the study,” the letter said.

The warning letter, a harsh and rare form of discipline by the agency, says Punjwani failed to “adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.”

“Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects’ rights, safety and welfare,” the letter says.

Punjwani did not return calls from The Miami Herald seeking comment.

Punjwani, who practices in Tamarac and has offices elsewhere in South Florida, was treating 7-year-old Gabriel Myers when the boy hanged himself with a shower cord in a Margate foster home. The boy’s death prompted a yearlong probe by a Department of Children & Families task force, as well as proposed legislation before the Florida Senate.

Before Gabriel’s death, Punjwani had prescribed several powerful mental health drugs — some of which had not been approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children.

Punjwani also was sued last summer by a Tamarac mother who claims her son, 16-year-old Emilio Villamar, died after being over-medicated with a group of mental health drugs at a Fort Lauderdale psychiatric hospital.

The letter mailed to Punjwani does not specify the names or types of drugs the doctor was testing, and a spokeswoman for the FDA, Sandy Walsh, said such details are kept confidential to protect drug companies.

Walsh said the FDA does not send out such warning letters often, and the agency considers breaches of its regulations to be “very serious.” The letter was signed by Leslie K. Ball, a doctor who heads the compliance office of the Division of Scientific Investigations, and Constance Cullity, a doctor who is also a compliance officer.

For years, drug makers did not study most medications on children, largely due to ethical concerns over using kids as test subjects. More recently, however, Congress passed laws to encourage pharmaceutical companies to test their drugs for safety and efficacy with children by extending patents on drugs approved for adults.

In a trial for one drug that was not identified, Punjwani gave one child dosages “in excess of… specified limits,” the letter says.

The child was discontinued from the trial before it was completed, the letter says, “due to worsening auditory hallucinations that apparently caused the subject to lacerate her wrists.” The girl was “overdosed” on the drug for more than two weeks.

The letter says Punjwani submitted a corrective action plan to the FDA and revised his procedures to better protect his research subjects from dosing missteps. “However,” the letter says, “we are concerned that the response is not adequate to prevent future recurrence of the violation.”

The clinical trials for a different drug were to adhere to a series of protocols that specified what dosage of the drug was to be used, depending on the child’s weight, the letter states. But for six of seven children — chosen at random — who received one of the tested drugs in Punjwani’s study, the dosage exceeded what was spelled out in the protocol.

One child who weighed 103 pounds, for example, “was overdosed on study medication for 20 consecutive days while participating in the study,” the letter states. The child is identified only as “Subject 1001.”

A child identified as “Subject 1003,” who was 15 at the time of the trials, “was overdosed on study medication for 21 consecutive days while participating in the study,” the letter says. “Subject 1004,” a 16-year-old, “received doses in excess of the maximum target dose for 3 consecutive days while participating,” the letter says.

A 10-year-old, identified as “Subject 1007,” was “overdosed” for nearly two weeks while on the study, the letter states.

Department of Children & Families Secretary George Sheldon, who appointed a task force last year to study Gabriel’s death, said Monday he is asking the FDA to compare a list of Florida foster children with lists ofchildren enrolled in Punjwani’s clinical trials. Sheldon said he was acting on concerns that children in state care may have been involved in clinical trials, which is against state law.

The FDA letter, Sheldon said, “raises clear ethical issues and judgment issues that we need to clearly understand.” If foster kids were enrolled in clinical trials, he said, “we will need to take it to another level.”