Posts Tagged ‘George Sheldon’

Following 7-year-old’s psychiatric drug-induced suicide—Florida bans foster children from clinical drug trials

Wednesday, August 11th, 2010

Education News
By Pareesha Narang
August 9, 2010

Sixteen months after 7-year-old Gabriel Myers committed suicide while taking psychotropic drugs, the state of Florida has banned allowing any children in the state’s custody from participating in clinical drug trials.

It is unclear if Gabriel was involved in any clinical trials. The doctor who prescribed the medicines to him was conducting clinical trials involving psychotropic drops and the Food and Drug Administration sent him a warning letter earlier this year about overdosing children who were involved in those trials.

The Florida ban was imposed  after the state tried to find out from the FDA if Gabriel or any other foster care child in Florida was a participant in such trials, and the FDA said it could not disclose such information and that mostly they know participants by only coded identifiers.

Though Florida officials had suggested that, under such circumstances, the Federal Food and Drug Administration ban all foster care children from participating in such trials, the agency refused, saying the children might benefit from the drugs.

In a letter last month,  George Sheldon, secretary of the state’s Department of Children and Families (DCF), announced that regardless of the FDA’s stance the state, using “administrative procedures,” was precluding children in state care from participating in such trials.

“Children who come into our care are often the victims of abuse, neglect, and abandonment,” Sheldon said in the letter. “It is therefore imperative that the state do all in its power to stabilize their environment, to protect them from further trauma, and to foster their successful growth into adulthood.”…

Before he hanged himself in his foster home, Gabriel had been taking different drugs for a variety of psychological problems – and some of the drugs were not approved for use in children.  Some of these drugs, including Lexapro, Vyvanse and Symbyax, had “black box” warnings cautioning dangerous side effects such as suicidal thoughts.

Read entire article here:  http://www.educationnews.org/educationnewstoday/97911.html

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Death of 7-year old prompts Florida officials to ask FDA to forbid allowing foster kids as guinea pigs in drug trials

Monday, July 19th, 2010

Pharmalot
By Ed Silverman
July 19, 2010

Last year, a 7-year-old foster boy named Gabriel Myers committed suicide in Florida and, after reams of publicity and hand-wringing over the use of psychotropic medications in such children, a state task force recommended, among other things, that children never be allowed to participate in a clinical trial designed to evaluate new psychotropic meds or whether such drugs approved for adults should be given to children.

The move was prompted, in part, because a Florida psychiatrist, Sohail Punjwani, who treated the boy before he committed suicide, received an FDA warning letter for failing “to protect the rights, safety and welfare” of children enrolled in clinical trials (back story). Before the suicide, the psychiatrist prescribed to kids several drugs, some of which weren’t approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children (back story).

As part of the follow-up, George Sheldon, who head’s Florida’s Department of Children and Families, wrote FDA commish Margaret Hamburg for info about any foster children who might have participated in clinical trials for psychotropic meds (read the letter) and asked the FDA to forbid foster kids from participating in these trials. Last month, the agency wrote back to say the agency does not agree with a “blanket prohibition” on enrolling foster children. Why? Such a policy fails to account for the greater risk of off-label prescribing and research involving children can yield benefits that cannot be obtained by tracking usage in adults, Jill Warner, acting associate commissioner for the FDA’s Special Medical Programs, wrote back (see here). Drugmakers, by the way, also have something at stake – they receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials.

We asked Florida officials if they are rethinking their position. The answer? No way. The state is resolute.

Read entire article:  http://www.pharmalot.com/2010/07/florida-tells-fda-no-children-in-psychotropic-trials/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot

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