Fwd: Psychiatrist who conducted drug trials on children who suicided gets Warning from FDA

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>>FDA spokespersons say the agency considers breaches of its regulations to be``very serious.'' Yet, even as the FDA warning letter to Dr. Punjwaninotes, ``we are concerned that the response is not adequate to preventfuture recurrence of the violation,'' the agency did not disbar him fromconducting further pediatric clinical trials.Who is accountable for the chemical torture of children who were subjectedto medical maltreatment that borders on criminal negligence?How many child casualties, and what level of professional negligence must bedocumented before a medical doctor's license to practice is revoked?<<Indeed!==========="VERACARE" <veracareMarch 16, 2010 9:17:07 AM HST"Infomail1 (AT) ahrp (DOT) org" <Infomail1Psychiatrist who conducted drug trials on children who suicided gets Warning from FDA ALLIANCE FOR HUMAN RESEARCH PROTECTIONA Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountabilityhttp://www.ahrp.org FYIIn 1997 Congress passed a law--FDA Modernization Act (FDAMA)--encouragingthe use of children as human subjects in drug trials. The law awards drugmanufacturers who test their patented drugs in children with an addition6-months of patent exclusivity--regardless, whether the drugs prove harmfulor beneficial for children.The consequences of that ill-advised law are documented in tales of horror.The Miami Herald reports about a psychiatrist who repeatedly put children'slives at risk in commercial psychotropic drug trials.One 7-year old child, Gabriel Myers, a child in foster care, who was"treated" by Dr. Sohail Punjwani, committed suicide by hanging himself witha shower cord."Before Gabriel's death, Punjwani had prescribed several powerful mentalhealth drugs -- some of which had not been approved by the FDA for use onchildren and had been linked to dangerous side effects, including anincreased risk of suicide among children."This boy's death prompted a yearlong investigation by a Department ofChildren & Families task force, as well as proposed legislation before theFlorida Senate.Dr. Punjwani who enrolled numerous children into drug trials, violatedmedical ethics, research protocols by overdosing the children, resulting inserious harm to the children. The FDA sent a warning letter to Dr. Punjwani, describing inhumanemaltreatment of children in the trials:Punjwani gave one child doses ``in excess of... specified limits.'' The girlwas ``overdosed'' on the drug for more than two weeks.The child was discontinued from the trial before it was completed, ``due toworsening auditory hallucinations that apparently caused the subject tolacerate her wrists.'' Another child, "Subject 1001" weighed 103 pounds: the child ``was overdosedon study medication for 20 consecutive days while participating in thestudy,'' the letter states. A child identified as ``Subject 1003,'' who was 15 at the time of thetrials, ``was overdosed on study medication for 21 consecutive days whileparticipating in the study.'' ``Subject 1004,'' a 16-year-old, ``received doses in excess of the maximumtarget dose for 3 consecutive days while participating.''A 10-year-old, identified as ``Subject 1007,'' was ``overdosed'' for nearlytwo weeks while on the study...According to the FDA letter, in one trial, six of seven children -- chosenat random -- who received one of the tested drugs in Punjwani's study, thedosage exceeded what was spelled out in the protocol.The FDA letter does not specify the names or types of drugs the doctor wastesting, and a spokeswoman for the FDA, Sandy Walsh, said "such details arekept confidential to protect drug companies."The Department of Children & Families Secretary George Sheldon, whoappointed a task force last year to study Gabriel's death, said Monday he isasking the FDA to compare a list of Florida foster children with lists ofchildren enrolled in Punjwani's clinical trials. Sheldon said he was actingon concerns that children in state care may have been involved in clinicaltrials, which is against state law.FDA spokespersons say the agency considers breaches of its regulations to be``very serious.'' Yet, even as the FDA warning letter to Dr. Punjwaninotes, ``we are concerned that the response is not adequate to preventfuture recurrence of the violation,'' the agency did not disbar him fromconducting further pediatric clinical trials. Who is accountable for the chemical torture of children who were subjectedto medical maltreatment that borders on criminal negligence?How many child casualties, and what level of professional negligence must bedocumented before a medical doctor's license to practice is revoked?Contact: Vera Hassner Sharavveracare212-595-8974http://www.miamiherald.com/2010/03/16/1531156/psychiatrist-gets-warning-from.htmlMiami HeraldMENTAL HEALTHPsychiatrist gets warning from FDAThe psychiatrist who treated the Broward foster child who killed himselflast year is now in hot water with the FDA.BY CAROL MARBIN MILLERMarch 16, 2010A South Florida psychiatrist who was treating a 7-year-old foster childbefore the boy committed suicide last year has received a warning fromfederal drug regulators who say he failed ``to protect the rights, safetyand welfare'' of children enrolled in clinical drug trials.In a strongly worded letter dated Feb. 4, regulators at the U.S. Food andDrug Administration said Dr. Sohail Punjwani over-medicated children whowere enrolled in clinical trials for undisclosed drugs. One girl, the lettersaid, slashed her wrists while hallucinating.Another, a 13-year-old, ``experienced sedation and dizziness during thestudy,'' the letter said. The warning letter, a harsh and rare form of discipline by the agency, saysPunjwani failed to ``adhere to the applicable statutory requirements and FDAregulations governing the conduct of clinical investigations.''``Your failure to conduct the requisite safety measures contributed to theunnecessary exposure of pediatric subjects to significant overdoses, whichjeopardized 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 SouthFlorida, was treating 7-year-old Gabriel Myers when the boy hanged himselfwith a shower cord in a Margate foster home. The boy's death prompted ayearlong probe by a Department of Children & Families task force, as well asproposed legislation before the Florida Senate.Before Gabriel's death, Punjwani had prescribed several powerful mentalhealth drugs -- some of which had not been approved by the FDA for use onchildren and had been linked to dangerous side effects, including anincreased 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 ofmental health drugs at a Fort Lauderdale psychiatric hospital.The letter mailed to Punjwani does not specify the names or types of drugsthe doctor was testing, and a spokeswoman for the FDA, Sandy Walsh, saidsuch details are kept confidential to protect drug companies.Walsh said the FDA does not send out such warning letters often, and theagency considers breaches of its regulations to be ``very serious.'' Theletter was signed by Leslie K. Ball, a doctor who heads the complianceoffice 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, largelydue to ethical concerns over using kids as test subjects. More recently,however, Congress passed laws to encourage pharmaceutical companies to testtheir drugs for safety and efficacy with children by extending patents ondrugs approved for adults.In a trial for one drug that was not identified, Punjwani gave one childdosages ``in excess of... specified limits,'' the letter says.The child was discontinued from the trial before it was completed, theletter says, ``due to worsening auditory hallucinations that apparentlycaused the subject to lacerate her wrists.'' The girl was ``overdosed'' onthe drug for more than two weeks.The letter says Punjwani submitted a corrective action plan to the FDA andrevised his procedures to better protect his research subjects from dosingmissteps. ``However,'' the letter says, ``we are concerned that the responseis not adequate to prevent future recurrence of the violation.''The clinical trials for a different drug were to adhere to a series ofprotocols that specified what dosage of the drug was to be used, dependingon 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'sstudy, the dosage exceeded what was spelled out in the protocol.One child who weighed 103 pounds, for example, ``was overdosed on studymedication for 20 consecutive days while participating in the study,'' theletter states. The child is identified only as ``Subject 1001.''A child identified as ``Subject 1003,'' who was 15 at the time of thetrials, ``was overdosed on study medication for 21 consecutive days whileparticipating in the study,'' the letter says. ``Subject 1004,'' a16-year-old, ``received doses in excess of the maximum target dose for 3consecutive days while participating,'' the letter says.A 10-year-old, identified as ``Subject 1007,'' was ``overdosed'' for nearlytwo weeks while on the study, the letter states.Department of Children & Families Secretary George Sheldon, who appointed atask force last year to study Gabriel's death, said Monday he is asking theFDA to compare a list of Florida foster children with lists ofchildrenenrolled in Punjwani's clinical trials. Sheldon said he was acting onconcerns that children in state care may have been involved in clinicaltrials, which is against state law.The FDA letter, Sheldon said, ``raises clear ethical issues and judgmentissues that we need to clearly understand.'' If foster kids were enrolled inclinical trials, he said, ``we will need to take it to another level.'' FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit._____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. 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