ACCORD Trial Mess

From the New York Times,

...a major federal study of more than 10,000 middle-aged and older people with Type 2 diabetes has found that lowering blood sugar actually increased their risk of death, researchers reported Wednesday.

It's hard to make heads or tails of what happened as the actual data has not been released - we're left to read through press reports and information provided by the NIH to try to determine what went wrong in the trial. Everyone seems to be bending over backward to get the message across that the intensive drug therapy - a large number of pharamaceuticals taken together - had nothing to do with the higher incidence of death in the trial.

But one must really wonder!

Speculation abounds, but that hasn't stopped some from foisting out the idea that it is the lowering of blood sugars to normal ranges that was the problem, not the means utilized to do it.

Dr. Irl Hirsch, a diabetes researcher at the University of Washington, said the study’s results would be hard to explain to some patients who have spent years and made an enormous effort, through diet and medication, getting and keeping their blood sugar down.

They will not want to relax their vigilance, he said.“It will be similar to what many women felt when they heard the news about estrogen,” Dr. Hirsch said. “Telling these patients to get their blood sugar up will be very difficult.”

Call me crazy, but didn't this study throw every pharmacuetical intervention at these folks?

Perhaps the problem wasn't the lowered blood sugars, but toxicity and side-effects from massive drug therapy to acheive a lower blood sugar level?

“Many were taking four or five shots of insulin a day,” he said. “Some were using insulin pumps. Some were monitoring their blood sugar seven or eight times a day.”

They also took pills to lower their blood sugar, in addition to the pills they took for other medical conditions and to lower their blood pressure and cholesterol. They also came to a medical clinic every two months and had frequent telephone conversations with clinic staff.

What this trial lacked was a control group utilizing an effective, non-pharmaceutical approach - a carbohydrate restricted diet - to lower blood sugars and A1c, which would have resulted in less medication, not more to achieve glycemic control.

If and when the data is published, I'll update - but for now think it highly irresponsible of anyone to speculate that it was simply the lowering of blood sugars that caused the problem given the wide variety and large number of medications used to intensively reduce blood sugars; and worse is to suggest that those with type 2 raise their blood glucose levels!