University of Minnesota

“If It Isn’t Fun.” – The University Group Diabetes Program (UGDP)

If “Diet-Heart” were my first exposure to clinical trial design and procedure, my first active participation was with UGDP. This multicenter study was the first major trial on the effectiveness of oral hypoglycemic agents versus insulin or placebo on vascular complications in adult-onset, non-insulin-dependent diabetes. I was drafted by Chris Klimt, Curt Meinert, and Jake Bearman at Minnesota to classify the study ECGs, but this soon developed into a broader involvement with clinical end-points for the trial. This exposed me to design issues, in particular “data and safety monitoring,” which impinged in turn on criteria for stopping a trial early. And it dumped me headlong into my first major polemic, with Alvin Feinstein of Yale.

Feinstein, a brilliant clinical investigator, was an industry consultant who, with no direct evidence, charged Minnesota with shenanigans in data analysis at the Coordinating Center and ECG Center. The trial outcome, showing that oral agents were no more effective than diet or diet and insulin in preventing complications of diabetes, had vastly annoyed the makers of oral hypoglycemic medications and a large segment of diabetologists clearly vested in them. His shocking and personal attack was my first exposure to the power of an industry to discredit a whole trial, and individuals in it, without evidence. I was impressed with the arrogance and deviousness of bright folks who have a suspicious nature and are on a well-paid mission.

Klimt and Co., the UGDP investigators, fought back successfully on principle, legally defending their decision not to release study data to Feinstein and parties vested in such a mission. Klimt’s combative attitude, on the other hand, probably heightened suspicion among the opposing camp of diabetologists and pharmaceutical companies. A vicious editorial campaign ensued that managed to discredit the study among a large segment of the diabetes community and served to divert attention from the prime study finding, that probably no treatment by the oral hypoglycemics of that day was more effective than diet and a standard insulin dosage in reducing diabetic complications.

The UGDP polemic was not to be our last confrontation with Dr. Feinstein. He became a perennial gadfly and the darling of industry and others attacking clinical trials in which the hypotheses at the outset or the end results did not suit them.

Unfortunately, I never explored the major issue for which I originally signed on to the UGDP, the prognostic power of the ECG in diabetics. But that’s another story.

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