Clinical Trials, how safe are we?

http://www.sun-sentinel.com/news/broward/fl-psychiatrist-boy-death-20100315,0,5700616.story


Broward psychiatrist gets harsh letter from FDA
Dr. Sohail Punjwani’s 7-year-old patient committed suicide in 2009
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By Carol Marbin Miller, The Miami Herald
9:34 p.m. EDT, March 15, 2010

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A South Florida psychiatrist who was treating a 7-year-old patient 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 overmedicated 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 pediatrict subjects to significant overdoses, which jeopardized the subjects' rights, safety and welfare," the letter says.

Punjwani did not return calls 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 overmedicated 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.

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