The Ethics of Clinical Research
Authors: Robert I. Misbin
Journal: Annals of Internal Medicine (1999)

Letters2 February 1999The Ethics of Clinical ResearchRobert I. Misbin, MDRobert I. Misbin, MDRockville, MD 20851Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-130-3-199902020-00013 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The recommendation that “treatment should be implemented as early as possible” (1, 2) to prevent the vascular complications of diabetes seems inconsistent with Maggs and colleagues' study (3), in which they discontinued standard treatment to have patients participate in a placebo-controlled drug trial. This study design has been used widely, apparently with the approval of the U.S. Food and Drug Administration.Results of the complete trial were recently published (4). While receiving sulfonylureas, patients had a mean hemoglobin A1c level of 8.4%; in the placebo group, this increased to 10.7% after 6 months. Fasting serum glucose levels ...References1. The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. Diabetes. 1995; 44:968-83. Google Scholar2. Henry RR, Genuth S. Current recommendations about intensification of metabolic control in non–insulin-dependent diabetes mellitus. Ann Intern Med. 1996;124:175-7. LinkGoogle Scholar3. Maggs DG, Buchanan TA, Burant CF, Cline G, Gumbiner B, Hsueh WA, et al . Metabolic effects of troglitazone monotherapy in type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1998;128:176-85. LinkGoogle Scholar4. Fonseca VA, Valiquett TR, Huang SM, Ghazzi MN, Whitcomb RW. Troglitazone monotherapy improves glycemic control in patients with type 2 diabetes mellitis: a randomized, controlled study. J Clin Endocrinol Metab. 1998;83:3169-76. MedlineGoogle Scholar5. Misbin RI. Comment on the ethics of placebo-controlled trials in patients with type 2 diabetes mellitus [Letter]. J Clin Endocrinol Metab. [In press]. Google Scholar Author, Article, and Disclosure InformationAuthors: Robert I. Misbin, MDAffiliations: Rockville, MD 20851 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoMetabolic Effects of Troglitazone Monotherapy in Type 2 Diabetes Mellitus David G. Maggs , Thomas A. Buchanan , Charles F. Burant , Gary Cline , Barry Gumbiner , Willa A. Hsueh , Silvio Inzucchi , David Kelley , John Nolan , Jerrold M. Olefsky , Kenneth S. Polonsky , David Silver , Thomas R. Valiquett , and Gerald I. Shulman The Ethics of Clinical Research David G. Maggs , Gerald I. Shulman , and Thomas A. Buchanan Metrics 2 February 1999Volume 130, Issue 3Page: 241KeywordsClinical trialsDrugsFood and Drug AdministrationGlucoseHemoglobinHyperglycemiaPatientsResearch ethics ePublished: 15 August 2000 Issue Published: 2 February 1999 Copyright & PermissionsCopyright © 1999 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...