--University of Arizona College of Pharmacy,
--Yale University School of Medicine
Telephone: (202) 248-2777
Career and Expertise:
Dr. David Gortler is a pharmacology expert/drug expert in the areas of atherosclerosis, atheroprogression, vascular inflammation, cholesterol metabolism, (pharmacology expertise includes: statins, statin side effects, lipid/ LDL/ HDL modulation, rhabdomyolysis, and obesity pharmacology). Dr. Gortler is proficient in the drug development process, the drug approval process, clinical trial design, evaluating drug safety, including evaluating the FDA's AERS and FAERS (Adverse Event Reporting System) database and is an FDA expert in the efficacy/safety review process and the FDA drug labeling process.
Among other FDA reviews, Prof. David Gortler was the lead medical officer, pharmacology expert/ drug expert and FDA expert responsible for reviewing and assessing the simvastatin side effects in Merck's SEARCH Trial: (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine). The Merck SEARCH Trial was an FDA safety and efficacy trial which compared the simvastatin side effects of simvastatin 80 mg and simvastatin 20 mg. As part of its safety arm, The Merck's SEARCH trial evaluated the muscle safety/ rhabdomyolysis and efficacy signals between simvastatin 80 mg and simvastatin 20 mg. The results of this trial were critical since simvastatin 80 mg is a commonly prescribed high-dose statin medication, and rhabdomyolysis is a statin side effect which occurs with all seven of the currently available statins approved by the FDA. Compared to all other statins, simvastatin 80 mg is the least expensive statin relative to its potency and therefore has the most statin side effects because of relative abundance of postmarketing FDA safety/ rhabdomyolysis and efficacy data, since its FDA approval in 1992. Of interesting note, drug-induced rhabdomyolysis was essentially non-existent prior to the advent of statin pharmacology. The Merck SEARCH trial completed approximately 12,000 patients over a 6.7 year period. Dr. David Gortler was the lead FDA expert and pharmacology expert/ drug expert given charge of writing the FDA safety review of the Merck SEARCH trial and presenting the simvastatin side effects, including the muscle safety/ rhabdomyolysis postmarketing and efficacy data findings. These data were presented by Prof. David Gortler to the entire FDA, including all officers in the FDA Immediate Office, at an official FDA Safety Regulatory Briefing.
Prior to his position as an FDA pharmacology expert/ drug expert Prof. Gortler was a Senior Medical Analyst and Medical Officer in the Division of Metabolism and Endocrinology (DMEP) at the FDA in the Office of New Drugs, (OND). Preceeding that, Dr. David Gortler was an Assistant Professor of Pharmacology at The Yale University School of Medicine, and prior to that he was an early-phase Investigational Medicine Scientist at Pfizer Inc in their metabolism and endocrinology group where he developed, designed and executed investigational medicine trials in atherosclerosis. Dr. David Gortler was one of the original 19 members that helped initiate Pfizer's research development program in HDL modulation and obesity.