![]() I am currently President of RCN Associates, Inc., an independent consulting firm in global drug safety, postmarketing surveillance, pharmacoepidemiology, therapeutic risk management, regulatory strategy, drug abuse liability assessments, Good Pharmacovigilance Practices (GPVP), forensic epidemiology, and regulatory affairs. Public Health Service in February 1998 with the rank of Captain (06). ![]() #TERAWELL DESIGN DOLL MODEL DISAPPEARS FULL#In my most recent FDA position as Associate Director (Epidemiology), I lead the re-engineering of the post-marketing surveillance program for human drugs, including utilization of relevant international harmonization initiatives, a comprehensive regulations rewrite, full process re-engineering, and the construction of a new computer system (“AERS”) for spontaneous adverse drug reactions. I conducted my thesis research, “Psychotropic drugs, psychiatric disease and automobile crashes: a case-control study in 1300 females” at the Mayo Clinic.Īt the FDA, I held multiple positions of increasing responsibility and scope in new drug review, epidemiology, and post-marketing surveillance, with an intervening stint to found and direct the Center for Drug's Staff College. in epidemiology from the University of Minnesota. While on active duty, I completed both a Master's in Science (in the Administration of Science & Technology) from George Washington University, and a Ph.D. I continued with the FDA for more than 20 years thereafter. I transferred to the Food & Drug Administration's (FDA) Division of Neuropharmacological Drug Products in 1977. Public Health Service, and served as the clinical pharmacy liaison to the Neurology Institute at the National Institute of Health (NIH). In 1975, I accepted a commission in the U.S. in pharmacy from Long Island University's Brooklyn College of Pharmacy in 1974, then completed an American Society of Hospital Pharmacist (ASHP) accredited Residency in Hospital and Clinical Pharmacy at the University of Connecticut Health Center. I am a clinical pharmacist by background and initial training. The report I submit today is based upon materials that I have reviewed. My opinions are contained in my report presented below. Pustejovsky and in my opinion, agree that Ms. Pustejovsky has been diagnosed with tardive dyskinesia by her physician. Pustejovsky was given the generic metoclopramide drug manufactured by Pliva, who is a defendant in this action. It is further my understanding from the prescription records, that Ms. Pustejovsky was prescribed and ingested the prescription drug, metoclopramide. Thank you for requesting my opinions in Martha Pustejovksy's case. Nelson, Ph.D., FISPE of RCN Associates, Inc., 160 Main Street, Suite 1740, Stouchsburg, PA 19567, cellular phone 44. ![]() Wyeth, et al Northern District of Texas, Fort Worth Division Case No.: 4:07-CV-103-YĪs you know, my name is Robert C. Technorati Tags: Reglan Lawsuit, Metoclopramide, Metoclopramide lawsuit, Reglan The most common form of TD presents as orofacial stereotypy (i.e., involuntary, repetitive oral facial and lingual movements that resemble chewing, lip smacking, tongue protrusion), at times associated with choreatic movements (i.e., brief, irregular contractions that are not repetitive or rhythmic, but appear to flow from one muscle to the next) of the extremities and trunk (Jimenez-Jimenez, 1997).Īpparently, movement disorders have been known side effects of Reglan and Metoclopramide for over thirty years. The term “Tardive Dyskinesia” is used to describe all persistent, occasionally reversible, abnormal movements caused by prolonged exposure to dopamine antagonists. My testimony will include discussion regarding enumerable published reports, that have been accumulating since 1978, that evidence that CAPs are strongly associated with Tardive Dyskinesia (hereafter TD) when given at sufficient dose for a sufficiently long duration (i.e., duration of exposure is a major risk factor for CAP-induced TD). This lengthy report explains the regulatory and clinical history of Reglan and Metoclopramide, including their association with movement disorders:
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