CLINICAL TRIALS, CONFIDENTIALITY, AND THE STOCK MARKET. Aggressive, unscrupulous stock analysts have been posing as physicians and even enrolling in clinical trials in order to attain fragments of “inside information” about the progress of clinical trials, reports The Wall Street Journal (8 Aug 2002). Analysts posing as physicians have pretended to have a patient to refer to a clinical trial and use the opportunity to question the PI as to how the trial seems to be progressing. Analysts enrolling in clinical trials have lied about their medical problems in hopes of learning about Serious Adverse Events affecting fellow study participants. In other cases, stock analysts hire consultant physicians ($300 to $5000 for a phone interview) in hopes of getting the physician to accidentally disclose information not otherwise to be made public because of confidentiality agreements between PIs and sponsors. These unethical actions may lead to unfavorable reports on a particular biotechnology stock and primarily enrich short-sellers. Worse, however, is that fragments of information do not accurately indicate how an investigational therapy is performing overall.
 

ACADEMIC HEALTH CENTER BEGINS NEW IND/IDE ASSISTANCE PROGRAM. The AHC is pleased to announce the IND/IDE Assistance Program, a new program for faculty investigators who also serve as the sponsor of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA. Few, if any, other universities provide similar support for the development of new therapeutic agents by its faculty. Harvey M. Arbit, Pharm.D., M.B.A., will be the director of this new program, which is available to all AHC faculty at no charge. Dr. Arbit has extensive experience in drug development, clinical research, and regulatory affairs at several pharmaceutical companies.
Faculty should contact Dr. Arbit for assistance with preparing new IND or IDE applications or for assistance in maintaining existing INDs and IDEs. He can be reached at 625-0930, at arbit002@umn.edu, or in Room 507 Children’s Rehabilitation Center after August 26, 2002.