Friday, February 15, 2008

ACCORD Study Halted? Welcome to the Program!

For the most part, I have remained pretty silent about the recent results from the failed ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, in part, because the results do not impact people with type 1 diabetes at all. However, to read the NIH's spin on the trial, see here.

Incidentally, I happen to agree with my friend Colleen who suggests that the naming of these studies to have an acronym that suggests something about the study has really gotten out of hand -- it's no longer cute anymore. She says that one of these days, she is going to pursue a diabetes study called FART, although she hasn't figured out what exactly that would study at this time, but her point is well-taken.

Anyway, today's New York Times features a story entitled "Diabetes Health Involves More Than Just Blood Sugar Levels, Doctors Say", which is pretty self-explanatory. The only question I have is why do they consider this news?

Before I get to my diatribe, let me just say that for those of us who live in New York City, we are routinely barraged with a commercial from the local cable provider, Time Warner Cable, but the entire debate brings to mind Time Warner's commercial, so I'll share the 30 second spot with you all here:



To everyone who was shocked by the results to the ACCORD trial, and most certainly, the U.S. Food and Drug Administration, and many clinicians out there, I say "get with the program".

The fact is that the medical profession has remained almost fixated exclusively on metabolic control since the conclusion of the Diabetes Complications and Control Trial (DCCT), as if nothing else mattered to the patient's or their health. In recent years, this issue has become so bad, that in the September 29, 2007 edition of The Lancet entitled "Patient-important outcomes in diabetes—time for consensus", the authors (largely from the Mayo Clinic) reported that a majority of diabetes clinical trials in the U.S. ignore virtually everything except glycemic control.

This is a HUGE problem, especially for the FDA who ignores everything but a medicine's impact on blood glucose levels (the FDA's stance has effectively been: Gastrointestinal side effects? Who cares ... Hypoglycemia? Who cares -- the only thing that seems to matter to our drug regulators is whether the drug lowers blood sugar levels). This applies to not only type 2 medicines (although there is far more research into these than there are for improvements on insulin) but also type 1 treatments and protocols. When I first called attention to this issue, I added that The Lancet article's authors wrote:

"Unfortunately, HbA1c loses its validity as a surrogate marker when patients have a constellation of metabolic abnormalities, when the most common complications are macrovascular, and when the treatments have multiple poorly understood effects."

These words were never more true today.

To that, I would say that the results from the ACCORD trial should bring far more attention to this matter. The fact is that the fixation on glycemic control above all else has been detrimental to patient health. Although many doctors consider the bigger picture, I have been calling for more attention to this issue for years. Now, apparently, I have a growing chorus of Johnny-Come-Latelies who are now claiming that there's more to diabetes treatment than glycemic control. Let me just add, that in my 2007 Year-End Review, I called attention to this very need. Now we need drug makers, doctors and the Food and Drug Administration to get with the program, too.

My hope is that the "shocking" findings in the ACCORD study have finally given some widespread, and badly-needed attention to this important patient need.

5 comments:

Anne said...

I wish they would study, for example, the effects of exercise on type 1 complications, aside from other variables such as A1c results.

Here's something you might find interesting: http://www.sciencedaily.com/releases/2008/02/080214092156.htm

Perhaps the sample group from ACCORD was too small. I've been advised since day 1 of diabetes to keep myself in good health otherwise. It seems pretty obvious that one would want to lower one's other risk factors for conditions such as heart disease, for example, by keeping blood pressure and cholesterol in check. Exercise and a decent diet have been by far the most important factors in me being able to do this.

Scott K. Johnson said...

Dude - sign me up for the FART study! Haha!! That's GREAT!!

My bet is that G-Money would be another great study participant...

:-)

islandinthenet.com said...

Scott,
Yesterday my endo used this study to "scold" me on the dangers of keeping my blood sugars too low.

Jenny said...

Scott,

ACCORD was so badly flawed as a study, that I don't think its results mean squat. They did not control for far too many variables, gave people a mess of drugs and started out with people who were already very ill with heart disease, fed them high carb diets and a variety of drugs known to worsen heart disease--Avandia and Sulfs and beta blockers which can be problematic especially if liver function is compromised as it might be with those TZDs, statins and fibrates all beind taken simultaneously.

The ADVANCE study which was longer and included twice as many subjects achieved the same blood sugar targets and showed NO increase in heart attack death.

Anonymous said...

Scott—

Anytime someone can label another person by using a number, a color, a gender or a lifestyle, the person so labeled is going to be put at a disadvantage. Studies like the one referenced make it rather easy for medical professionals—from the doctor to the lowliest person on his staff—to recognize a “non-compliant” diabetic. In fact, even your closest friends can look at you and label you for eating inappropriately (at least as they perceive ‘appropriately’).

The other day I had a follow-up appointment after cataract surgery. I was put on the routine ‘treadmill’ which always culminates with the question, “What was your blood sugar this morning . . . and at noontime?” This question is IRRELEVANT when they are looking at a lens which they implanted; but if anything goes wrong, and your blood sugar number is outside of normal, then the patient can be blamed for the failure.

The thousands of drugs which are currently in the marketplace have never been tested against each other, or in conjunction with each other. Only after patients die do we realize that, just possibly, drug interactions DO occur within the body, e.g. Heath Ledger is the most recent example. The FDA is only there to issue a new black box label AFTER someone times, focusing attention on the problem.

We need a new FART study for Failed Analog RDNA Trial. Comparing rDNA to natural (perfectly formed) insulins might be a real eye opener and expose the lies that have controlled our lives for 2 decades now.

--Brent