In part 5, the conclusion of this Exclusive Interview, Stanley Schwartz talks with Diabetes in Control Publisher Steve Freed during the AACE 2018 convention in Boston about the studies that could make a more accurate and effective set of new diabetes guidelines and process of care.
Stanley Schwartz, MD, FACP, FACE is an Emeritus Associate Professor of Medicine at the University of Pennsylvania.
Transcript of this video segment:
Freed: Recently, the American College of Physicians came out with the statement saying that the A1C is okay if it’s between 7% and 8%. After AACE and how many years American Diabetes — even American Diabetes Association is learning that normal is good. That having an A1C, that is not considered in the diabetic range for a normal person who doesn’t have diabetes, is a good thing. And yet this organization, I don’t know, they took it upon themselves to come out with this statement that really doesn’t make any sense. At least from the studies that have come — in the hundreds of thousands of studies that have come saying that normal is good. And they come out and say that 7% – 8% is okay.
Schwartz: So, simple statement is it’s the most horrible recommendation I have seen come from a traditional medical organization through my 40 years of medicine. Just horrible. Historically, I know — I believe I know where it came from. And let’s start with the fact that even though they question it, there should be no doubt that the higher the sugar the greater the risk of damage to tissues. We know what normal is. We know what abnormal is. And that damages tissues in many patients, not every single one. And we even have — and by the way, the final clinical thing there were the old Pirart studies out of Belgium, who, no ifs, ands, or buts, that was the marker that actually was the best argument for Keen’s issue about diabetes and complications. So, there should be no doubt about the fact that the high sugars markedly increase sources of diabetic complications. And then, now I’m giving you the high level historical approach– then you had, you’ll excuse the expression and I’ll apologize to the viewers out there, this horrible thing called evidence-based medicine. Evidence-based medicine as it’s used in the US and really across the world in the past 50 years, I think has destroyed medicine. Because it says if there’s no evidence, my translation is, keep doing the lousy thing you’ve been doing for so many years. My personal bias is, you should be using evidence-based practice. Evidence-based practice, I learned when I went to medical school. It’s if there’s evidence, I’m going to use it. And maybe that’s what they were trying to say with evidence-based medicine. But evidence-based practice says, “We use it as, if there’s evidence, we’ll use it. If there’s no evidence, I’ll understand the disease. I’ll read the primary data, around drugs, around conditions, and then make a logical decision.” So, what American College of Physician said was the evidence may not be as precise as a pure scientist working with mice and tissues might like about the relationship of sugar to complications. I think it’s good enough they said, “Oh, it’s not quite precise.” And by the way, when we tested that, ACCORD, VADT, ADVANCE trials, we saw no benefit. So, there must be something wrong. Now, their interpretation was, “Well, let’s ignore how it happened,” but there was really no good benefit, right, but that’s a misstatement for multiple reasons. The single most important reason is those studies had high risk of hypoglycemia and they had high risk of weight gain. And no surprise then that there were adverse cardiovascular events with those elements in those three studies. So, that’s what they saw and said, “Well, we’re in an evidenced-based medical construct, not perfectly sure that sugar is related, and by the way, you had complications. So, we’ll accept seven to eight.” So, I think they had the wrong clinical approach to the data that they had available to them. So, my interpretation is that the data is more than sufficient: sugar is related to complications. The problem with the studies was that they didn’t have the right tools to try to bring the patient down, so they got into trouble with the hyperglycemia weight gain. Guess what? My approach which I gave you earlier was, “I’m not using sulfonylureas, I’m avoiding Insulin in 90% of my patients,” so I should be able to get wonderful control and reduce complications if you use the right drugs, right. And don’t engender the hypoglycemia. So, they were so worried about the hypoglycemic risk that they’re making the wrong clinical decisions overall. What is needed is not what’s being now done by the NIH. There’s a study. I actually forget the name of the study. They’re comparing individual agents and say, “This one might be a little better than that one,” point one or point two. But the right study is a process of care, sort of what they use in ACCORD but without sulfonylureas at all, and insulin as a last alternative. And if they did three or four drugs, right, non-hypoglycemic, no weight gain, and use that as a way to take care of diabetes, I submit to you that you’re going to see clear benefit. And we have the inference from separate studies with GLP-1s, separate studies with SGLT2 inhibitors, separate studies with bromocriptine. Guess what? If you use those in combinations, right, you might get a supra- or additional effect with each and to enable to show a reduction of cardiovascular outcomes, reduction with even complications. If you did that kind of study, instead of the one they’re using now and instead of the ACCORD study [in which you] use your own drugs, hypoglycemic agents, and we could easily prove that there’s value. But ACP just misinterpreted the data they had and were not thinking in evidence-based practice mode. They were using the old and, to me, illogical evidence-based — I mean, if the patient sitting in front of you doesn’t fit the patients that were in the studies, then what do you do? So, you need a process of care now. And the process of care says, “Use the evidence that’s available and then be logical based on interpretation of all the other data and come out with the conclusion that I’ve given you.” Don’t use hypoglycemic agents, avoid weight gain, and the current medicines will be more sufficient. And you will be able to prove as my logical conclusion, my evidence-based practice approach to care patients with diabetes.
Freed: I want to thank you for your time. It’s very interesting, educational. And looking forward to talking to you again at ADA coming up next month.
Schwartz: Wonderful! Thank you so much for having me.