February 6, 2008

My Take on ACCORD

I've heard from quite a few people today asking me what I think of the news that the ACCORD study seems to have found a connection between lowering the A1c below 7% and having cardiac patients die more frequently.

Deaths Partially Halt Diabetes Study

I'd like to see a more detailed report on the actual findings than what is currently appearing in the press,There is very little information here about what were the actual protocols used in this study. Follow up releases include claims supplied by the maker of Avandia that the study did not connect the excess deaths with the use of Avandia or "any drug."

But the little I could find about how this study was designed suggests that it may be impossible to tease out what really caused the excess deaths, because the study participants were given not only a wide variety of blood sugar lowering drugs, but also an aggressive blood pressure lowering drug regimen, and they were put on the aggressive combination of fibrates with statins to lower their LDL.

Here's the NIH description of the study:NIH Study Will Test Best Ways to Lower Risk of Heart Disease and Stroke in Adults with Type 2 Diabetes.

Clearly the participants in this study were ALL taking a large number drugs which were interacting like crazy with each other in a large number of possible combinations, any one of which might be causing the excess deaths.

For example, we recently learned that lowering LDL by combining a statin with another LDL lowering agent may thicken plaque, as that is what happened when Zetia was added to a statin. We also know that for people with compromised liver function the Beta Blockers used to lower blood sugar can actually be toxic (that information is in the prescribing information) and that both statins and TZDs can each affect liver function. What happens to the liver when both kinds of drugs are prescribed at once along with fibrates may never have been studied before.

The glaring omission in this study is this: There was no control group which lowered their A1c without the use of drugs. All the participants were taking drugs, lots of them. So we have no true way of knowing if it was the lowered blood sugar or the drugs causing the excess mortality. This really is a shame as many of you reading this are people diagnosed with diabetes who have lowered your blood sugars below 7% using carb restriction and exercise alone. So there is no reason that such a control group could not have been included.

But this study only involved people taking drugs, so we can be pretty sure that the people with lower blood sugars in this study took MORE drugs than those with higher blood sugars and that it is likely that it is some effect of the interactions of these drugs to blame if, as is claimed in the GlaxoSmithKline press release the data could not point to a clear connection between ONE drug and the excess deaths.

If we ever get access to more data I'll be sure to let you know what it tells us. We all have learned by now that what the headlines tell us a study shows is often NOT what the study actually shows, and that will probably be the case here.

My own experience after almost ten years of keeping my A1c in the 5% range is that despite doctors spending an unholy amount of their time and my money trying to prove that I must have heart disease since I have diabetes and eat a low carb/high fat diet, I've come up clean on the scans, treadmill tests, monitoring, and everything else they could throw at me.


Anna said...

Have you had one of those EBT CT heart scans that measures coronary plaque (via calcium deposits) and gives a score based on age, gender, andis used ot track progression or regression over time)? If so, do you mind commenting on them? I have been reading the Track Your Plaque book by Dr. William Davis and was thinking about getting them done for both myself and my husband.

Jenny said...


I had an ultrasound carotid scan. My feeling about Dr. Davis' kind of scan is that I'm already doing the things a person can do to improve their cardiovascular health, so there is no need to get obsessive about measuring plaque, especially with repeated x-ray scans.

I have a concern about x-ray exposure, being a cancer survivor, and I've already had a lot of it, including a CAT scan in the past few years.

The benefit of that kind of test is that it can motivate a person to make lifestyle changes. But I've already made the kinds of changes that Dr. Davis promotes.

And my risk is very low given my age, blood sugar, HDL, lipid ratios, and family history. And I also have very low APO(b), too.

I'd be a bit more into Dr. Davis if his whole online presence wasn't so oriented towards money-making.

His business model seems to be to put out free articles that frighten people into paying him for the information about what they can do about the the things he's frightened them about. I have mixed feelings about that. And because he charges for his information I don't have a clear idea of what it is. It does seem to send a lot of patients to his scanning clinic.

Tim said...

Good post, thanks :-)

And I was just going to email to ask what you thought of this study :-)

Anne said...

I took a look at the description of the study on the NIH site. There was not a mention of diet or exercise.

Found this in a Canadian article: "Gerstein noted that even though there was a higher rate of deaths in the aggressive treatment arm, rates of death in these high-risk patients were well below those of similar people in the general population who were not part of the study." http://canadianpress.google.com/article/ALeqM5hBJg_ftvOHmFzxPo-ripkSeAcGGQ

Here is a link to the article in the NEJM that is mentioned where intensive intervention did reduce cardiovascular events.

I would like to read the complete NEJM article and see the full protocol of the ACCORD study.

Right now I am working hard with low carb diet and exercise to get my BG under control. I have a feeling if diet was used in these studies, it was a low fat diet.


Red Sphynx said...

EBCT vs Ultrasound: There an
excellent thread at TheHeart.Org (registration is free.) William Blanchard is a cardiologist who uses the same approach as Bill Davis (but without the book and the website and the newsletter.) D Hackam is another cardiologist who champions the use of ultrasonography instead. They have an interesting, cordial back and forth about the advantages of each. Both of them would rather track plaque via some kind of imaging than go in and stent.

Bill Davis pops in towards the end.
I learned a lot from this thread. RTWT.

Adam Becker Sr

Nicky said...

It seems to have been the ADA diet, too, Jenny - so they fed them shed-loads of carbs, medicated them to hell and gone, and wondered why they had a problem...

Anonymous said...

Sounds like a poorly designed study to be frank, if you can't get any possible answers because of all the variables.

According to Dr Davis (the website Dr) CT heart scans make very little profit, especially compared with angiography. And there is little chance of profit from follow up procedures such as stents. IMHO

baji said...

After reading yours i am worried about my doctor, currently iam on lisinopril and vytorin, and my LDL went from 155 to 50 in a month and for last 3 month its 50. And told the lisinopril the blood presser drug was to reduce the plaque build-up.
Do i have to change my doctor!!

Jenny said...


We can't draw any conclusions until we see the details of the study from which the conclusions were drawn.

In her blog today Gretchen Becker cites another new study that found HUGE health improvements in people lowering A1c.

Lisinopril is supposedly one of the good drugs for people with diabetes. I wouldn't worry about it.

The effects of statins and the importance of lowering LDL is controversial and there are a lot of opinions about it. If you haven't read Gary Taubes' Good Calories Bad Calories, I'd advise doing so. You'll learn a lot about why LDL was demonized and why it may not be what you have to obsess about.