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FDA slams FL doc; state doesn’t

By Carol Gentry
3/16/2010 © Health News Florida

The FDA  has issued a rare and blistering warning letter against a Broward psychiatrist, saying he significantly over-dosed several children enrolled in a clinical trial of psychiatric medications in 2006. Yet the state lists the doctor with a "clear, active" license. Yet the Florida Department of Health lists that doctor with a "clear, active" medical license. 

DOH has no pending administrative complaints against Dr. Sohail Punjwani, said Deputy Press Secretary Eulinda Smith. The DOH license lookup site offers no indication there has been any discipline in the past. 

DOH keeps its records secret by law until and unless a committee of a professional board finds there is "probable cause" that a violation of the practice act has occurred. So it is impossible to know whether Punjwani was investigated and cleared by state authorities -- in which case, the records will remain forever secret -- or whether the agency failed to investigate him despite a well-publicized suicide of a foster child he was treating last year.

Gabriel Myers, a 7-year-old foster child, killed himself in April 2009 while under treatment from Punjwani. It emerged later that Gabriel had been taking several psychiatric drugs that were not approved for children.

The Department of Children and Families studied the case for a year and came up with guidelines and proposed legislation being considered this session. For more details, see the DCF report and other materials.

Punjwani is also being sued in the death of teen-ager Emilio Villamar. His mother Norma Tringali told reporters last year that the doctor gave her son, who was diagnosed with bi-polar disorder, drugs that were not approved for kids.

The FDA letter echoes that accusation, saying Punjwani failed to abide by the law and FDA regulations on clinical trials in 2006 and”failed to protect the rights, safety and welfare of subjects.”

The letter says that in June and July of 2006, children were subjected to “significant overdoses and resultant adverse events,” including one girl who suffered hallucinations and cut her wrists, apparently not fatally. The letter doesn’t specify how many children participated in the drug trial but mentions seven, referring to them by number rather than name.

Punjwani apparently discovered his overdosing error in July 2006, according to the letter. He told the FDA that he thought all the pills in the blister packs were 20 mg., when in fact some were much stronger.  As a result, some of the children received doses more than double what was intended.

The FDA did not accept Punjwani’s explanation as sufficient, the letter shows, saying he was in charge and should have been checking patients more carefully.

The letter says the sponsor of the drug trial, which is not identified, closed down Punjwani’s participation in early 2007 because of the dosing errors and delays in resolving questions. Punjwani failed to report this to the Institutional Review Board that supervised the trial, the FDA letter says.

The Miami Herald reported today that DCF Secretary George Sheldon will provide FDA a list of foster children and ask the agency to determine whether any of those who were mentioned in the FDA letter were wards of the state.  

Meanwhile, as of today, Punjwani had a “clear, active” medical license in Florida according to the state’s Medical Quality Assurance web site. It shows that he has not been subjected to discipline by the Board of Medicine.

The state does not indicate on that site when a practitioner has a pending complaint, even those that are public records awaiting final action. To find out, citizens must contact DOH itself.

Upon doing so this morning, Health News Florida learned that there are no pending complaints against Punjwani.

The state site lists Punjwani as having practice addresses in Hialeah, Pembroke Pines and North Miami Beach in addition to a main address in Lauderhill. According to his profile he has privileges at three hospitals in Broward.

His profile on the state web site says he is a 1985 graduate of the Dow Medical College at the University of Karachi in Pakistan and that he completed a residency at University of Miami/Jackson in child and adolescent psychiatry in 1992.

The state site says Punjwani has board-certification in both adult psychiatry and child and adolescent psychiatry. He is listed as medical director of Compass Health Systems on that practice’s Web site. (Health News Florida left a message requesting to speak to Punjwani).

The FDA warning letter to Punjwani was issued Feb. 4 by Leslie K. Ball, M.D., director of the Division of Scientific Investigations in the FDA’s Center for Drug Evaluation and Research. 

--Carol Gentry, Editor, can be reached at 727-410-3266 or by e-mail.