Those “dangerous drugs” that you decry are being pushed because most people are extremely resistant to lifestyle changes; the GP charges the same fee if he is telling us to drop fifty pounds by eating less and exercising more, or for telling us to take this little pill.

Oh, and despite all the hue and cry in this thread, you should note that the absolute incidence of major adverse effects is extremely low.

Cheers,
Felix.

I believe an A1C of 8 correlates to an average glucose of 180, not 210. Shooting for an average of less than 180 (A1C less than doesn’t seem unreasonable, especially given the lack of evidence that tight control matters for Type II DM.

As for those who see the devil, or worse yet, the pharma industry, behind every corner, I have four letters: DCCT.

Claiming that a “binary” standard (above vs. below an HgbA1c of 7.0%) is in and of itself bad is a strawman argument; the actual standard is “as low as it can be pushed while avoiding excessive hypoglycaemic events”. 7.0% is just a convenient number that, in my experience, can be attained by even a mildly motivated patient.

And while getting a patient’s HgbA1c from 14% down to 11% may be an accomplishment, I say that it is not a reason to call for one’s laurel wreath: initial gains are always easiest, and 11% is still a catastrophically high average BG.

I wonder whether the proponents of such elevated BGs are paid off by the immunosuppressant divisions of the pharma companies!

(And if the last paragraph sounded ridiculous to you: It is. But no more so than the aspersions cast on doctors who actually try to guide their patients to better health instead of less rapid disease progression.)

Cheers,
Felix.

An a1c of 8% equates to an average glucose of nearly 210. I really don’t feel that’s what we should be aiming for to improve outcomes.

If OA’s are a problem, instead of just going to maxes one 3 of those, why not add insulin sooner?

To illustrate by example the case of guidelines for TZD use in heart failure which have been endorsed by major medical societies AHA/ADA and widely disseminated which say that TZDs can be used in low dose in Stage I and II HF but contraindicated in Stage III and Stage IV.

- Clinical evidence–More than 1000 spontaneous reports of HF with TZDs even in people without HF submitted to FDA AERS

- TZDS contraindicated in all Stages of HF in Europe since approval.

-The current blackbox in the US based on spontaneous reports of AERS, despite our Meta-analysis of RCTs presented at SGIM and published in Diabetes Care submitted to FDA as well as the current paper in JAMA which shows HF in all stages with evidence from RCTS states ” TZDs contraindicated in symptomatic HF and in Stage III and Stage IV>?”

- It leaves Stage One and Stage 2 ambigous. Is this an attempt to expand the indication for this class.

-What evidence is the FDA and ADA/AHA looking at?

Note : I have no sources of funding.

It wasn’t so long ago we were reading stuff like this:

http://medrants.com/index.php/archives/2942

When I looked at the evidence regarding tight control of A1C and outcomes, through a critical reading of the UKPDS studies, I was quite surprised. I encourage you to read these two papers from the BMJ.

http://www.bmj.com/cgi/content/full/320/7251/1720

http://www.bmj.com/cgi/content/full/328/7440/E280

Incidentally, the microvascular improvement you cite was primarily due to a difference in the rates of photocoagulation for retinopathy. This was unblinded, so there may have been a bias to treat those with higher A1Cs, thinking it may be more “important” for those patients. (Even if you think this is important, note this is a disease oriented outcome, not a POEM.)

I personally find it amazing (and unfortunate) that the UKPDS evidence has been used to justify tight control based on A1C values.

As the author of the commentary that first ran on Marketplace and then was reproduced in longer form in the SGIM Forum (and I will quote a bit here), I’ll pitch in my 2 cents.

As a matter of quality of care, the use of a binary standard of 7% was rejected (everyone hear that REJECTED) by the panel of experts convened by the National Commission for Quality Assurance, and indeed that same standard was also REJECTED by the Veterans Health Administration. The scientific rejection of that standard is a matter of public record and open to all, just by reading the statement of that panel online at:

http://www.nationaldiabetesalliance.org/

Experts like those on the Technical Expert Panel of the Diabetes Quality Alliance and the Veterans Health Administration judged that there could be adverse consequences to the use of an absolutist binary standard like 7%.

Is that counterintuitive?

One of the most important problems is that while reducing HgbA1c is generally a good thing (no matter where you start out), a binary standard of 7% sets up peculiar incentives that run contrary to where we stand to do the most good for our patients. I will simply paraphrase my argument here, which summarizes the arguments elaborated by many others in addition to myself:

The doctor who brings a very challenging diabetic patient’s hemoglobin A1c from 14% to 11% has done such a patient enormous good, far more absolute good than reducing a mild diabetic from 7.5% to 6.9%. However, a single binary standard ignores the former and rewards the latter. In fact, with a binary standard like 7% the best thing a doctor can do is test a lot to diagnose and care for mild diabetics, preferably middle-class people with good insurance to cover medication expenses. The one thing that will hurt that doctor’s quality rating is to take care of the true “difficult patients”, the challenging ones, the poor ones with lousy insurance, where getting from 15% to 12% would be an absolute triumph and objectively does far more good for kidneys and eyes. The latter patients will count AGAINST the doctor’s quality rating, however, because they enter the doctor’s denominator (i.e. diabetics) but don’t count as successful. Anyone can read the relevant analyses in an article by Vijay et al. Annals of Internal Medicine; 1997: 127:788-95. I am aware of current articles in press that will review these same issues in detail (not by me).

So I am just one primary care doctor trying to point out the utter perversity of the binary standard that has been enshrined by some major quality organizations that happen to receive lots of money from the pharmaceutical industry.

Helping the patient who has the greatest need, and who stands to benefit the most from help, is precisely what the 7% binary standard discourages.

Is there anything more paradoxical than a quality standard that punishes doctors who try to help the patients who most need our help?

On the other hand the standard does encourage writing 1, 2, or even 3 prescriptions for costly glucose reducing drugs in a desparate attempt to reach the standard, even for patients where the balance of cost, convenience, risk and benefits may be quite a bit more complicated that “7% or bust.”

The question should be how major organizations would have chosen an absolutist binary 7% standard, despite the scientific recommendations of the majority of their OWN scientific expert panels.

I don’t fully know that part, but some of it is alluded to an article in the American Journal of Managed Care at http://www.ajmc.com/Article.cfm?Menu=1&ID=3291

(NO subscription required).

All of the major organizations that influence policy see themselves as existing to serve the public good, obviously. But there is no reason to assume that any one of us is exempt from scrutiny for potential conflict, we all know that good intentions have paved many a hellish road.

So let’s not forget that the 7% standard was first aggressively promulgated in 2002 by pharmaceutical firms (see http://www.diabetesmonitor.com/dma1ci.htm), just as the scientific experts were beginning to argue that this was in fact not a good idea.

Speaking for myself, I serve on the Board of a service-learning organization that received a big grant from Merck. I can and should be subject to scrutiny too.

I don’t know how to fully disentangle the conflicts that beset us, but I do feel that every organization that influences the health of millions of Americans should strive for complete transparency on who interprets the medical evidence, and what procedures were followed, and where the monetary industries may lie.

Stefan Kertesz, MD