June 24, 2008

A Giant Step Backwards: Misinterpreting ACCORD Harms People with Diabetes

The fallout from the ACCORD study continues, and it is going to cause a lot of unnecessary kidney failure and neuropathy.

If you'll remember, ACCORD was the study where they took people who had diabetes and preexisting heart disease , put them on every drug possible, including Avandia, Actos, Byetta and Insulin, encouraged them to eat a high carb/low fat diet and discovered that there were a very small number of so-called "excess deaths" in the group who achieved blood sugars nearer 6.5% compared to those who aimed for the old 7.0% ADA target.

The take home message from this for doctors was that lowering the A1c kills people with diabetes.

A second study, ADVANCE, which involved a lot more people with diabetes and lasted longer--a study which did NOT use Avandia, Actos, or Byetta found NO such excess deaths in the group that lowered their A1c. Not only that, but the group in the ADVANCE study that achieved the 6.5% A1cs had 21% less kidney disease--a major finding given how many type 2s end up on dialysis.

Clearly the problem illuminated in ACCORD was not that lowering A1c kills people with diabetes but that the combination of drugs given to people with diabetes to lower their blood sugar along with the high carbohydrate diet was not safe for people with preexisting heart disease.

The lack of excess deaths and the decrease in kidney disease found in the ADVANCE study should have in itself been reason to advise lowering the blood sugar targets for all people with diabetes using a protocol similar to that used in ADVANCE--which was one that did not use the newer, possibly more dangerous diabetes drugs. Ideally more scientific effort would now be put into analyzing the differences between the two studies to determine why ACCORD showed those excess cardiac deaths and the larger, longer ADVANCE study did not.

My guess is that the ACCORD population was sicker to start with--i.e. their diabetes was of much longer standing at the time the study began, that their diets were probably higher in carbs, trans fat, and junk food (ACCORD was an American study while ADVANCE was not), and that the addition of Avandia and Actos to their protocols--both known to be cardiotoxic--was probably more significant than the drug company funded researchers revealed.

Whatever the explanation, if your doctor tells you to RAISE your A1c to "be safe"--which I am hearing from my correspondents is becoming horrifyingly common-- remind him or her that:

1. There is NO study about the safety of lowering A1c using a low carb diet rather than using dangerous drugs like Actos and Avandia with the high carb/low fat diet that was used in ACCORD. All early indications from small studies are that lowering blood sugar by lowering carb intake improves all cardiovascular markers and does not worsen heart disease.

2. ADVANCE showed decisively that lowering A1c prevents kidney disease.

3. ADVANCE lasted longer and involved more people with diabetes than ACCORD and found NO increase in cardiac deaths.

There's a petition you can fill out addressing the NIH's dangerous issuing of a warning about the dangers of lowering A1c based on the ACCORD findings. You will find it here:

Petition: NIH must acknowledge existing science

Don't hold your breath expecting this to change anything.


Anonymous said...

Thanks for the good info, Jenny.
I signed the petition & do hope it helps. I do believe with activists like yourself, petitions and anything else available, we will be able to make changes.
Keep up the good work!

Anne said...

I filled out the petition too. Keep doing what you are doing.

Hope you are healing well.

Anonymous said...

Thanks for the updates & comments, but a small group of patients in ADVANCE is on TZD. (16.8% of patients in intensive arm & 10.9% standard arm).

Alcinda (Cindy) Moore said...

Thanks for the post Jenny!! I linked to your post and the petition on my blog. ALL OF US that have blogs should post on this and include a link to the petition!