The scientific method is defined as “the process of observing, asking questions, and seeking answers through tests and experiments” That definition applies whether you are talking about electronics, biology, or medicine. An example may help you understand how this principle works. The cardiometabolic team that I worked with had 180 patients in the ACCORD trial. It is a good example of the scientific method in medicine.
Observation
An elevated blood sugar defines diabetes. Diabetes leads to heart attacks and strokes which cause the deaths of most diabetics.
Question
Since diabetes is a disease defined by sugar elevation, does lowering the sugar to near normal by any means reduce the number of heart attacks, strokes, and deaths?
The Experiment
In this experiment, 10,251 patients were randomly assigned to aggressive glucose lowering to near normal (hemoglobin A1c less than 6) or less aggressive glucose lowering (hemoglobin A1c of 7 to 7.9). While lowering the sugar made sense, aggressively lowering the glucose to near normal killed more people. “At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group.” After three and a half years, there was no difference in heart attack and stroke and more people died. Trials like this have a data monitoring and safety committee that can see the data. They stopped the trial early because the intensive treatment arm had more death.
That was a horrible result for the diabetic research community, but that is the way science works. You observe, formulate a hypothesis (near normal sugar is protective), and then you test the hypothesis. The patients are assigned randomly. The patients and researchers cannot know how the study is going until the study ends and the assignment of patients is revealed. The ACCORD trial is a landmark trial because it proved lowering the sugar by any means available does not reduce heart attack, stroke, or death. The Steno 2 trial had a similar sugar target, but it lowered the glucose using a protocol that started with metformin treatment in obese patients. It specified certain medications for cholesterol and blood pressure management. It dramatically reduced heart attack, stroke, and death.
The Lesson
Reducing the sugar is important, but the way you lower the sugar is equally important. It is just as important to lower the blood pressure and cholesterol using best practice approaches. People died in both groups but the scientific method identifies the treatment approach that provides the most protection. Because this trial did not work, medical researchers have learned much more about the molecular biology and epigenetics that lead to complications in type 2 diabetes and there are other treatments. Medical approaches that make sense and seem to work may prove to be harmful in clinical trials.
The obsession with normalized glucose and ignoring the devastating impact of hyperinsulinemia is the fundamental failure of the diabetic industry. This is a well-known fact now, unfortunately.
Why have you removed all references to MCG TECHNOLOGY, Bill?