Did any of you catch this excellent article in the New York Times last week: Diabetes Case Shows Pitfalls of Treatment Guidelines? I was surprised to see very little blog chatter on it. It’s a fascinating summary of the recent controversy over national blood sugar guidelines, sparked primarily by the ACCORD study that scared everybody off tight glucose control last summer.
The article explains how the benchmark for aggressive control of blood sugar was abruptly withdrawn, amidst fear that “lowering glucose too quickly or too much in some patients could harm or even kill them.” I’ve published quite a bit about experts’ counter-opinions here, namely that too-tight control is certainly ill-advised for some patients, who are very high risk for heart disease, and taking a host of other meds, etc. It’s just a damn shame that the media frenzy over this study shot out so many erroneous messages (see here).
The plot thickens:
This latest NYT article introduces two new sticky issues to the debate, namely Conflict of Interest, and the definition of “Good Evidence.”
Critics suggest that pharmaceutical companies influenced the low A1c guideline so they could sell more of their glucose-lowering drugs. It seems that the standards committee, the National Committee for Quality Assurance, indeed received about $3 million, or 10 percent of its revenue, last year from drug and medical device makers. Hmm.
“The main problem is that many guidelines are based not on rigorous studies like clinical trials but on weaker types of medical evidence,” the article notes. The implication is that trying to bring the average diabetic’s A1c level down to that of a person without diabetes can be potentially dangerous, and hasn’t been studied enough with the right populations and methodologies.
Now in place is “a more a more nuanced guideline that, among other things, exempts patients over 55 years old with heart or cardiovascular problems.”
For my part, I have two takeaways here:
1) More oversight of Pharma’s role? Due to the way our system is historically and financially organized, conflict of interest is an ongoing, deeply embedded issue in medical research here. Pharma companies’ involvement is not going to disappear any time soon. So rather than even attempting to chase them out, I wonder if these standards organizations could also be responsible for setting up strict guidelines on study methodology, to protect against “drug bias” by sponsoring organizations?
2) Watch those messages! As a person with diabetes, who now is in contact with scores of Type 2 patients who know very little about how to stay healthy with this disease, this whole issue still makes me want to scream! Unfortunately, the mainstream media message heard across the country here was “tight blood glucose control is now proven to be ‘bad for you.’” How do you explain to somebody with an A1c of 10 or higher that it’s not only safe, but imperative to their health to lower their glucose levels ASAP?
We’ve got your “Good Evidence” right here…
The one element that is missing from the entire conversation is that at present, there is a lot of discussion about “comparative effectiveness” in medicine, mainly as a method of managing costs. Diabetes is one of the primary targets for such programs, but policy-makers naively use only a reduction in HbAc1c as the evaluation as to whether a treatment is therefore “successful”. As we all know, good diabetes care involves much more than lowering HbA1c, which IS NOT a guaranteed surrogate for improved patient outcomes (even if the FDA has historically used that as the ONLY criteria for evaluating diabetes treatments … which is a BIG mistake). Decisions cannot be made in a vacuum and policy-makers need to acknowledge that medical treatment is more than just numbers, it involves the entire patient. For example, it is not healthy to reduce HbA1c if that means a corresponding jump in severe hypoglycemic episodes, as the cost savings might instead be consumed by paramedic treatments. The same goes for diabetes and depression, as cost-savings achieved could be eaten up by expenses for depression treatments. Medicine cannot be evaluated by such statistical measures, and the sooner policy-makers realize this, the closer we’ll be to meaningful reform.
Healthy people wake up in the morning with 60-90 mg/dl, have a reading of around 120 mg/dl about an hour after some high carb input, hardly ever up to 140, and are back to around 80 mg/dl 2 hours after eating.
Diagnosed D-people wake up with 126 and more and produce such a high and lasting spike after the input of 75g of carbs that they read 201 and more 2 hours after drinking.
When I first heard of the English(my mother tongue is German) term of tight control I thought it meant just lowering the spikes. But it does not! Tight control means that the whole bg-curve of the day gets lowered by X numbers of mg/dl. That is the spikes as well as the valleys! With spikes at 300 and valleys at 100 the lowering of the curve by 50 will get the spikes down to a still far too high 250 and the valleys far too low to a jittering 50 mg/dl. Let that person go for a walk when he is still around 100 and he’s sure to get into real trouble. Sorry, that’s no control at all, that is a total conceptual mishap
A friend of mine was diagnosed with an A1c of 11plus a forthinght before Easter. As he dreaded the perspective of being put on sugar meds after the hollydays I told him to buy a meter and strips and to have a try [url=http://www.phlaunt.com/diabetes/14045524.php]the Jenny way[/url]. He did and a month later alsmost all of his readings were below 150 and none above 200. The A1c was 5.8 last week and that is what I would call real good and tight, if you want to, control. And that way can be extended by the careful personal (not just thrice daily!) use of bg-lowering meds up to insulin as more and more beta cells might drop out. The facilitation of healthy D-ways like the one of my friend’s would be what I would expect from a real good diabetes educator.
OT? I don’t think so. It’s all about avoiding costs. Tight control cannot do it because it’s direct costs are too high. Slight control cannot do it becaus it only shifts costs from the primary field of diabetes to the secondary field of its complications. The healthy bg way has been doing it silently for about two decades as every single person you want to pick out of their growing numbers on that way would prove.
@Hans: Eating 75g of carbohydrate in ANY meal is a irresponsible on ANY diet – diabetic or not.
I get up with at breakfast with a BG close to 100, max out 2.5 hour later at below 150, and will in the 80s just before my next meal. My A1C: under 6.
Maybe I’m atypical or maybe I am just taking responsibility for my health.
My A1c is under 6 too, but Khurt, I don’t have euglycemic numbers like you have. I still have higher than idea post-prandial readings on my meter. I aim to reduce, as much as possible, the amount of time spent at those high numbers. If I have a high number, I correct it immediately.
I am all for taking responsibility for my T1 diabetes and overall health. I don’t understand people who let their A1c ride a “little bit” high and don’t expect to pay the consequences. Our bodies don’t like hyperglycemia. We should strive to stay as close to the non-diabetic zone as possible at all times. Smart diabetics understand this, and they are smarter and more informed than the medical community in many, many aspects.
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Just to reply to Kurt’s statement that, “@Hans: Eating 75g of carbohydrate in ANY meal is a irresponsible on ANY diet – diabetic or not.”
I understand that many diabetics adhere to low carb regimens; however, definitely not all, and in fact many health experts don’t recommend low carb (not saying they’re right or wrong, but it’s up for debate clearly). The point is that it’s a bit absurd to make a sweeping statement that 75g of carb in any meail is irresponsible on any diet. As a type one diabetic who is trying to go with a moderate carb approach and is 220 pounds (100 Kg), I’d say that 75 g is at the top of what I’d have for a dinner, but by no means some crazy number that no person should ever have.
Those 75g of carbs are the standard helping you get with the oral glucose tolerance test (OGTT), a standard test for Diabetes.
In my view the amount of carbs I can eat per meal is limited by my ability to keep my postprandial bg curve within the healthy range below 140-120-100 mg/dl 1-2-3 hours after the input – and by my BMI
I’ve read several reports linking low blood sugar events to a higher risk of alzheimers. I fear Alzheimers more than heart disease. So I do what I can to not have a low blood sugar event. If that means AIC’s in the 7′s…so be it. Almost 10 years in the 7′s an absolutely no evidence of any harm.
I read that the Blood sugar levels in the human body must be maintained in a fairly fine range to maintain health.
Your article is more helpful. Thanks for sharing it.
@Nancy: if that was so, Alzheimers would have been a major type1 complication before the widespread advent of the meter in the 90s of the last century.
Hans: Wasn’t it more common prior to meters, to be hyperglycemic? Didn’t the addition of meters allow tighter control and thus more low events? I didn’t make up the Alzheimer study. It is what it is. The study showed that the more low events a person had the stronger the Alzheimers link.
As history shows the meter was originally developed for emergency room use to distinguish unconscious hypos from unconscious drunks at a finger’s prick without the help of a lab. So the events must have been quite numerous and certainly enough to establish a correllation with if not a link to Alzheimers.