ACCORD Travesty

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I’m gonna get in trouble for this one. I got so outraged reading media reports on the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial that I may say some nasty and completely true things about the medical establishment.

I didn’t follow ACCORD when it started. I only started paying attention when the intensive blood sugar control arm was canceled. The more I found out about it, the angrier I got. I believe ACCORD is a great example of most of what is wrong with American medicine, and with the way our media covers it. I wrote about this in Chapter 4 of my book Diabetes: Sugar-coated Crisis. But this story is as bad as anything I cover in the book.

ACCORD is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), a government agency. All subjects in the trial have Type 2 diabetes and at least one other major cardiovascular risk factor. The idea was to see if heart attacks could be prevented in these patients through intensive drug therapy.

ACCORD has three “arms.”

There were two “blood sugar groups”: One aimed for an HbA1c of 7%, while the other, “intensive” group aimed for an HbA1c of less than 6%, which is considered the normal range.

There are two “blood pressure treatment groups”: One group aims for a systolic blood pressure of less than140 mm Hg, while the “intensive” group aims for less than 120 mm Hg.

And there are two lipid groups; both groups received cholesterol-lowering drugs called statins. The intensive-care group also received a fibrate drug to help lower triglycerides and raise HDL (“good”) cholesterol levels.

How did they lower these numbers?
From the beginning, ACCORD was a drug trial. The study called for participants to receive diet and exercise counseling if they wanted it, but set no guidelines for the counseling. There was no self-management group. It was all, repeat all, about the drugs.

Which drugs to use was up to the participating doctors, but many participants got pioglitazone (brand name Actos), rosiglitazone (Avandia), metformin, insulin, and others, in addition to whatever they were already taking for their heart problems, blood pressure, etc. This many drugs almost guarantees interactions and side effects.

In February, NHLBI stopped the intensive blood sugar control arm because more of the participants in that group were dying than in the normal care group.

Then came the outrageous part: NHLBI and media dummies came out saying that the intensive group’s blood sugars had been too low.

Of the media’s coverage, blogger Regina Wilshire wrote:

“Everyone seems to be bending over backward to say the intensive drug therapy…had nothing to do with the higher incidence of death in the trial…that it is the lowering of blood sugars to normal ranges that was the problem, not the means utilized to do it.”

Drug madness
Dr. Irl Hirsch, a diabetes researcher at the University of Washington, said in The New York Times that the study’s results would be hard to explain to some patients who have spent years getting and keeping their blood sugar down. “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.”

What kind of madness is this? You throw scads of drugs at sick people, treating only their numbers, not their bodies and lives as a whole. Then, when they die, you say it couldn’t have been the drugs. It must be the numbers. And you tell people with diabetes to get their blood sugars up.

You better believe that if ACCORD had shown a 10% decrease in cardiac deaths from intensive blood glucose management with drugs, those drugs would have become standard therapy for every person with Type 2 in the country. Nobody in the media would have said, “It wasn’t the drugs.” The drug companies would have made billions. That was the goal of the trial.

People are more than their lab numbers. Self-management, in which people can take charge of their own lives, has much more potential than intensive drug therapy. Drugs are OK, but they should be used cautiously, as part of a self-management approach that focuses on stress reduction, physical activity, healthy eating, and social support.

ACCORD and Iraq
The whole thing reminds me of the U.S. occupation of Iraq. Both were at least partly motivated by profit potential—in ACCORD, it was the drug companies, in Iraq, the military contractors and Halliburton.

In both cases, the media repeated exactly what the leaders said, whether it had any relationship to truth or even made any sense. From WMD to “The surge is working” to “We do not torture,” few in the media have challenged administration lies. From “Diabetes is all about lowering HbA1c” to “Heart disease is all about lowering cholesterol,” nobody questions medical statements that may have little evidence behind them.

Take-home message: Don’t believe what you read or hear in media, or from government or drug company spokespeople. My apologies if I went too far. Let us know what you think.

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