FDA Warned Psychiatrist Over Foster Kids In Trials
7 CommentsBy Ed Silverman // March 17th, 2010 // 7:14 am
A Florida psychiatrist who treated a 7-year-old foster child before the boy committed suicide last year received an FDA warning letter for failing “to protect the rights, safety and welfare” of children enrolled in clinical trials, The Miami Herald reports. The Feb. 4 letter said Sohail Punjwani overmedicated children who were enrolled in clinical trials for undisclosed drugs.
One girl, the letter said, slashed her wrists while hallucinating. And a 13-year-old, “experienced sedation and dizziness during the study,” according to the letter, which goes on to say 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 states. Punjwani did not return calls from the paper.
The letter mailed to Punjwani doesn’t specify names or types of drugs that were tested and an FDA spokeswoman tells the paper such details are kept confidential to protect the drugmakers. However, she adds the agency doesn’t issue such warning letters often, and considers breaches to be “very serious.”
Punjwani treated 7-year-old Gabriel Myers when the boy hanged himself with a shower cord in a foster home, the Herald writes. The boy’s death prompted a probe by a Department of Children & Families task force and proposed legislation before the Florida Senate. Before Gabriel’s death, Punjwani prescribed several mental health 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. Punjwani also was sued last summer by a woman who claims her 16-year-old son died after being overmedicated with several mental health drugs at a Fort Lauderdale psychiatric hospital.
Last year, the paper writes, the Florida Department of Children & Families Secretary George Sheldon appointed a task force to study Myers’ death and asked the FDA to compare a list of Florida foster children with lists of children enrolled in Punjwani’s clinical trials. Why? Sheldon tells the paper that children in state care may have been involved in clinical trials, which is against state law.
Vera Sharav of the Alliance for Human Research Protection, who has been critical of industry marketing and testing of psychotropic meds, says the incident reflects what she calls the “ill-advised” decision to allow drugmakers to gain additional six-month patent exclusivity for running clinical trials with children.
pharmavet
South Florida is notorious for clinical investigators ignoring the rights of patients. You have the perfect storm: a large indigent population of Hispanic and other minorities and greedy investigators trying to make a fast buck off these poor folks. I personally witnessed the debacle that was South Florida Bioavailability Clinic (SFBC), that was closed down several years ago because of numerous violations of both patients’ rights and a number of other factors.
http://www.floridatrend.com/print_article.asp?aID=46147
Lisa Van Syckel
The Psychiatrist should be stripped of his license. The FDA should have released the name of the corporate sponsor, and the study medication. Was the study medication an antipsychotic, and if so, was this study used to win FDA approval?
Im sure this case isnt an isolated incident!
JaT
We know some people that looked into bringing in a foster child who was deemed to be a difficult child. They got a package describing what classes they would have to take and that there is an emergency intervention number that could be called, what kind of doctors the child would be required to see, how often, etc, etc..
What kept them from going forth was the drugs. There was no way to avoid participating in the psychotropic drug program. They wanted to help to bring this child to a more normal state and felt that the drugs were going to interfere and they couldn’t bring themselves to do it.
So they asked if there were any of these kids that did not have the same medication requirement. All being “difficult children” the answer was no. Not from that agency anyway.
This is a great way to make a buck if you are willing to participate in the dispensing of medications. So much for quality foster parents- as they were not in it for the money.
JaT
BTW, this was not in Florida.
M Helm, MD
This stuff breaks my heart every day. It is great to start with protections for children enrolled (legally or not) in clinical trials. What about the kids who are not in trials whose parents/guardians have never seen an informed consent document, and don’t know that for the most part they are subjecting their child to an uncontrolled experiment on a very young and vulnerable human being.
I would bet the medication used in the study in question was an antipsychotic. I don’t think duloxetine or desvenlafaxine have been around long enough to justify trying for the 6 month exclusivity extension.
If you ask the good child and adolescent psychiatrists, they will admit that overmedication is common. My preferred referral docs in CAP spend more time taking kids OFF medications than putting them on meds. Sometimes this just means cutting the kids back from three (sometimes competing) meds to one.
There is lots of inappropriate treatment of childhood behavior with medications. The best response to behavior problems in children tends to be a behavioral solution - especially in younger children (for proof, just watch SuperNanny). Funny enough, mood problems in children tend to respond quite well to non-pharmacologic interventions too, though OCD can still be troubling.
It is hard to imagine what could drive a 7 year-old to suicide. Easier to imagine with a teen, but still just as tragic.
JaT, I think your friends are exactly right, and Florida is not the worst state regarding psychotropic medication use in children. They just have better reporting.
AmyG
Punjwani is in deep. Investigations by various agencies and at least one lawsuit.
Lisa Van Syckel
Justice for these children, Would be to throw this creep in a 6 by 6 jail cell..