The trials and tribulations of the University Group Diabetes Program 1: the trial and the controversies

The University Group Diabetes Program was an investigator-initiated secondary prevention trial funded by grants from the National Institute of Arthritis & Metabolic Diseases. Its purpose was to assess whether any of the commonly used agents for people with type 2 diabetes were useful in preventing morbidity associated with the condition. The trial started in 1960 (first patient enrolled February 1961) and ended in 1981 (last follow-up examination done August 1975). The first publication of results came in 1970 and was prompted by a decision to stop using tolbutamide (Orinase ) in the trial because of evidence of ill-effects. In all, the study produced eight major publications. Before the smoke settled, there were Congressional hearings, audits, court cases and a request under the Freedom of Information Act for raw data from the trial which eventually wound its way to the U.S. Supreme Court. As prevention trials go, the University Group Diabetes Program was relatively small – only 1027 patients about evenly divided across five treatment groups – but what it lacked in size it made up by being in the forefront of secondary prevention trials. In the end, the principal trouble with the trial was that it produced results the world did not want to hear. When that happens, the assumption is that there is something wrong with you and your trial because, surely, the world cannot be wrong. The controversy surrounding the University Group Diabetes Program has been covered by Harry Marks, initially in his doctoral thesis, subsequently in his book The progress of experiment: Science and therapeutic reform in the United States, 1900–1990. Details of the study and the controversy are featured in Chapters 7 and 49, respectively, of the first and second editions of my textbooks, in Chapter 5 of Aaron Mauck’s PhD dissertation, in Chapter 4 of Jeremy Greene’s book, Prescribing by Numbers, and in a paper by Blackburn and Jacobs. See also trialsmeinertsway.com for a detailed account of the trials and tribulations of the University Group Diabetes Program and UGDPmorabilia.htm for University Group Diabetes Program memorabilia. This essay is from the perspective of an investigator in the Coordinating Center (deputy director) of the trial.