Maria Carmen Palazzo, M.D., PhD., MMM, will soon have some numbers to add to the letters behind her name as she likely will find herself behind bars for Medicare Fraud and for criminal failure as a clinical investigator to maintain records of clinical drug studies. The New Orleans psychiatrist contracted with SmithKline Beecham to participate in clinical drug studies related the safety of Paxil in the treatment of children and adolescents with major depressive disorders and obsessive compulsive disorders. She failed to comply with the study protocols and failed to personally review all of the information in the patient charts. She apparently accepted about $5000.00 per study, for some patients at least who were never diagnosed with the conditions.
Last January a federal district court sentenced Dr. Palazzo to 87 months in prison and assessed restitution at $655,000.00 for Medicare Fraud, but the court had earlier dismissed additional criminal claims arising out of her failure to maintain records for criminal trials as required by 21 U.S.C. § 331 and 355(i) and 21 C.F.R. §312.62. Dr. Palazzo argued that the statutory delegation of authority by the Congress to the FDA lacked sufficient standards for the FDA to promulgate regulations imposing criminal liability on clinical investigators for failure to maintain drug trial records. On February 6, 2009, the Fifth Circuit Court of Appeals in United States v. Palazzo, No. 07-31119, issued its opinion which had little difficulty in finding sufficient guidance in the delegation by the Congress. Presumably Dr. Palazzo will find lots of opportunity to apply her skills in her extended stay as a guest of the government.
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