Expert Blog

The Good, The Bad, and the Ugly Part I: Why I’m not a Fan of the ADA/EASD’s 2012 Position Statement

John L. Leahy, MD
Endocrinologist
The highly awaited ADA/EASD statement on management of type 2 diabetes was published online April 19th, 2012.1 I feel like a curmudgeon,but as a general statement, I’m not a fan. In fact, I’m worried that at best it will have little impact, and at worst could be harmful.
 
My biggest surprise and disappointment is that the intent of the original ADA/EASD consensus statement to help providers be more effective clinicians through specific recommendations is hugely deemphasized. Instead, the document is now more of a general review, laying down principles with few specifics. In this, the first of two blogs, I’ll explain why, starting with a trip down memory lane.
 
First ADA/EASD Consensus Statement
 
The first ADA/EASD document on treating type 2 diabetes jointly appeared in the August 2006 issues of Diabetes Care and Diabetologia.2 It was historical, in that there had been significant tension between the organizations for years over issues such as the target A1c goal (6.5% in Europe and 7.0% in the U.S.) and different cultural approaches to health care. Magically, with this first consensus statement, the disagreement melted away.
 
The impact was immediate and significant. The document was well written and informative, with the right balance of background information and clinical pearls for the target audience. However, few read it. Instead, the treatment algorithm figure was shown at meeting after meeting and served as the only information about the paper and its recommendations for most providers. It was unwieldy and not visually pleasing. No one took full ownership to advocate and disseminate the recommendations, and the document rapidly became out-of-date as more diabetes medications came to market.
 
Second ADA/EASD Consensus Statement
 
An update appeared in January 2009,3 mostly by the same authors, with a similar writing style and intent. Unfortunately, although this was again a well-written document, it still featured a visually much less appealing algorithm figure. And, as before, the figure appeared at umpteen meetings and served as the only part of the document seen by most providers.
 
This time around the revised recommendations were not terribly well accepted by the diabetes specialty community, and at times there was open hostility. One issue was its failure to vary starting therapy for different levels of A1c—it was metformin for everyone—that flew in the face of the general belief that higher A1c patients needed multiple agents as initial therapy. In addition, focusing only on A1c goals challenged the belief of a particularly vocal group that postmeal hyperglycemia or glucose variability was most cardiotoxic.
 
Most attacked was the treatment algorithm itself, and consequently the algorithm figure, that divided second line therapy (i.e., after metformin) into validation tiers. Simply put, many had trouble believing that metformin followed by insulin or a sulfonylurea (50- to 90-year-old therapies) were the best we had, and should stand alone in the first tier. And the second tier was only pioglitazone or exenatide. What about DPP-4 inhibitors?
 
To be fair, the recommendations were often misrepresented. In actuality, the tiers were based on validation—how much information about efficacy and long-term safety was available for the different agents, an approach favoring drugs that had been used for decades, and excluding new drugs. However, it was rarely presented in that fashion. Instead the tiers were usually misdescribed as the most preferred versus less preferred therapy choices.
 
So the second version of the consensus statement was a harder sell, and felt inaccurate and dated as soon as it appeared. Compounding this were guidelines from other organizations (such as the AACE roadmap 4 and country-specific guidelines that appeared soon after) that were better accepted and felt more up-to-date. 
 
2012 ADA/EASD Position Statement
 
Rumors started a year ago that the ADA and EASD were working on an updated position statement they would take full ownership for. It’s now here, and, indeed, it opens with strong statements (frankly the strongest statements of the document) in support of a patient-centered approach. OK. But a well-known tough issue for healthcare providers regarding effective diabetes care is starting patients on injectables, not something they want to do. It often requires a strong and sometimes uncomfortable push from the healthcare provider to turn the patients into believers. This has been a major focus of fighting treatment inertia for nearly a decade—and it doesn’t come through in this document.
 
This opening is followed by superficial overviews of the goals of therapy, epidemiology and pathogenesis, and basic characteristics of the available therapies. Fine, but nothing surprising or terribly informative. I’m naïve enough to think most providers know enough of this already, so there’s little within these starting pages that will turn on many mental light bulbs.
 
I’m also a little turned off by the repeated statements about inability to make specific recommendations because of lack of adequate head-to-head long-term data for all of the available therapies. I know that’s true, but why write a position statement if you cannot make many recommendations? For instance, what to do after failing metformin? They say “With a distinct paucity of long-term comparative-effectiveness trials available, uniform recommendations on the best agent to be combined with metformin cannot be made.” So they say you can do anything: add a sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, or insulin, with the various drug characteristics, side effects, cost, and patient preference determining the choice. Accurate, but how does that really help? Who doesn’t know that? Plus the lack of specifics throughout the document steps back from the intent of the prior consensus statements to help general providers be more effective and is a major disappointment for me.
 
Regarding my feelings about specific statements and recommendations within the document, I will be publishing a companion blog next week, in which I pay homage to the Clint Eastwood's American Classic The Good, the Bad, and the Ugly.  In the meantime, here is a link to the 2012 Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) on Management of Hyperglycemia in Type 2 Diabetes.
 
References
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Comments

Submitted by Irl Hirsch on

I agree the initial ADA/EASD statement on this topic was "historic". But here we are, years later, more confused due to more organizations all over the world with different recommendations made even more confusing by the explosion of new agents. While it is true these agents are not available everywhere, wouldn't it make sense to take the lead from the initial ADA/EASD statement and instead have a representative at the table from IDF, AAFP, ACP, Canadian Diabetes Association, British Diabetes Association, etc? We would only require one representative from each organization. The data for these statements are the same for everyone. Why can't we make this less confusing for the providers caring for the patients instead of us debating whose recommendations are best?

Submitted by Jeff Unger MD on

Sorry, Jack, I actually appreciate the patient-centered approach. Basically stated, give me a patient with an A1C of 8 %. Then, based on everything else I know about this patient including his weight, blood pressure, lipid panel, kidney function, family history of diabetes and complications, work history, cultural and financial barriers, activity level, cardiac history, age, list of medical comorbidities including mental illness, cancer, sleep apnea, sexual dysfunction, Parkinson's disease, and anything else you can throw into the diagnostic soup that we see every day in primary care, let's pick the therapy which is most likely to match that patient's needs.

We've got stuff that gives you gas, stuff that makes you constipated, meds that might reduce cancer risk, drugs which increase cancer risk, drugs you can inject, stuff you can swallow, and experimental depot meds you can house in your skin for weeks. Hey, for those that like to take chances, I've got something that can kill the beta cells and maybe get you retired sooner rather than later. However, if you love your beta cells, I can help you keep them strong. If you're skinny I've got something that can make you swell. If you're fat, I can fix that too. For those of you that love the surgical option, guess what...if you pit surgery vs medical treatment for diabetes remission guess who's going to win? The surgeon??? You've got to be kidding.

So give the PCP his due, Jack. Let's lay it all out on the table for everyone of our patients and help them decide what might be their best option. If things don't work out so well, we'll try again in 3 months or so. For those patients who tried surgery, well, they may be the biggest winners of all!

Jeff Unger, MD

Submitted by Jack Leahy on

Jeff, you know I basically agree. But also you are a smart up to date diabetes doctor. Change the patient to an A1c of 9 or 10%. The list of reasonable meds start to shorten (a lot). I wish the new guidelines built in expected efficacy as strongly as patient centered decisions. I still see too many patients on 3 or 4 OHAs with A1c of 9-11% who are referred to me, with the first statement "I don't want insulin". I want the document to improve DM care in the US and around the world. I just don't see that.

The position statements are okay. Though I like to go for the patient centered approach. We should always recognize the individuality of the patients - the gamut of disease load, associated risk factors, and above all, the differing sensitivity to the drugs including insulin. Added to this, each patient follows a unique life style and his or her specific eating habits. Further, targets may differ in patients.

Albeit, general statements are a sort of guide to keep in mind, though not to follow necessarily in strict sense. Medical practice though based on science and research, has always been an art and I think will remain so. I agree with Dr John L. Leahy when he states that he is not a fan of ADA/EASD statement on management of type 2 diabetes.

Dr Vinod Nikhra, MD
New Delhi, India
www.vinodnikhra.com

Submitted by Jack Leahy on

Thank you Vinod for the thoughtful comment. You and Jeff Unger countered with positives of the patient centered approach. In principle I agree - it's a bit presumptuous for health care providers to make such important decisions in a vacuum. Also there are lots of choices in the market place. And patients are often knowledgeable (thank God for the Internet) and should have a strong say in their health care. I'm good with all that.

But there is another issue for me and it drives my negativity. It implies that health care providers and patients are up to date to weigh the treatment choices and make an informed choice. True for some - you and Dr. Unger - but not for many others. Primary care is full of algorithms and treatment guidelines, some good and some lousy. But all are geared on laying out what is effective versus less effective treatment decisions. That's what the original ADA/EASD consensus statements tried to do with some success. I don't see the same here. And remember the document is from the most important worldwide diabetes organizations, and is closely scrutinized and analyzed around the world for what constitutes today's best diabetes care. I just don't see that here.

Thanks for the comment.

Submitted by Jeff Unger MD on

Just another thought about guidelines, Jack. Do you think it might be wise for AACE or the ADA to consider publishing expert opinion guidelines on managing Type 1 diabetes? I would like to have so guidance on perhaps salvaging beta cells in newly dxd T1DM patients. How aggressive should our management be early on vs. treating patients who have had the disorder for many years and are complication free such as those Joslin Gold Medalist Patients? I saw a patient the other day from Kaiser (I am not a Kaiser provider), 29 years old, newly diagnosed T1DM, initial RBS 600 + and A1C of 12 .8 %. 2 months ago Kaiser placed him on OADs and 5 units of NPH. Patient continues to loose weight and has been to the ER 3 times in past 3 weeks for dehydration. I believe that beta cell preservation might be a worthy target for patients with T1DM, T2DM and MODY but intensification early on is the key. We have NO guidelines on how best to intensify our T1DM patients. I think this might be something that could be worth while in the very near future. Thanks. Jeff

Submitted by Nadeem Tahir-Kheli on

I am amazed that the algorithms published by ADA/AACE are recommending using Metformin alone for three months prior to moving on two agents or addition of Insulin. In the written script there is mention of earlier initiation of Insulin/versus two drug therapy for elevated HBAIC yet the algorithms are practically saying see the patient back in three months and then recheck a HBAIC. How can they justify waiting three months and not making medication/Insulin adjustments earlier to get patients at goal??

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