In part 1 of this exclusive interview from AACE 2016, Dr. Claude Lardinois discusses amputations and SGLT-2s, and genetic risk factors for cardiovascular issues in diabetes patients.
I think smoking is a huge factor in amputations. In fact, I personally think that in my practice anyway, 90% of the patients that have amputations are the ones that continue to smoke.
Joy Pape: So, how do you teach your patients about foot care and preventing amputations?
Dr. Lardinois: We have a policy that you have to get your shoes and socks off immediately when you get in the room.So we inspect the feet every time we see the patients. When I have patients that are smokers, I look at their leg and I’m checking for sensory and that and I say, do you like your legs?
Well of course, Dr. Lardinois, I like my legs. Well if you keep smoking, you’re not going to have your legs. I say, do you know what a black and decker is? Well yeah. We might as well do a black and decker right now. Because that’s what’s going to end up happening if you keep smoking.
I’m amazed because I’ve actually had patients that have quit smoking. I just saw one of my patients not too long ago, and the nurse said your black and decker’s here today. She laughed, she said you got me to quit smoking, because you emphasized to me the importance of my legs.
Joy Pape: This could be very interesting. You might come up with some very interesting ways of getting people motivated to manage their diabetes better. Something else we were talking about earlier [was] about cardiovascular disease. Or just managing diabetes and the topic of genetics. Tell me more.
Dr. Lardinois: Let’s talk about diabetes and cardiovascular disease, because if you look at patients with diabetes and patients without diabetes, the only difference is one has an elevated blood sugar, the other does not.
So, intuitively, the thought process was, particularly from the ADA, is if you lower the glucose to normal, your heart disease will go away. Doesn’t happen. You still have heart disease, because it turns out it’s not the glucose, it’s that you have insulin resistance.
I’ve been accused by my colleagues that I’m really not an endocrinologist, I’m a cardiologist disguised as an endocrinologist, because I really don’t get too hung up about the blood sugar. I don’t have to have it 6.5 or 7. I tell my patients, you are going to die of heart disease.
So what are the factors that make the most difference in cardiovascular disease?
Blood pressure. I’m a very big believer in blood pressure control. Lower is better. Again, you have to be careful in some elderly patients.
But cholesterol is very important, measuring albumin in your urine is very important. So these are all factors, but even after we do that, we’re still evaluating people as a group, not as an individual. That’s where the genetics come in.
There are certain genetic tests that everybody should have done, whether you have diabetes or not. Some of those are Apo-E [tests].
Apo-E is a very important gene that really determines what type of nutritional recommendations you’re going to make for your patient. If you’re a 2-2 or a 2-3, or if you’re a 3-3 or a 3-4, it’s going to vary on what the nutritional recommendations are.
Another thing is, we always talk about alcohol as being good for you — modest alcohol consumption. If you’re an Apo-E 4 and 25% of the population has either 3-4 or 4-4, alcohol actually makes your cholesterol worse and it increases cancer, particularly breast cancer in women. Some of my colleagues say I’m not going to measure my Apo-E 4, because I like alcohol. You’re going to tell me I can’t drink anymore. But we have to explain to those patients that they really have to limit their alcohol to one drink a day. So that’s very important nutritional information, right from the start, that you would never get by just following the standard guidelines.
There’s other genetic markers. There’s actually a statin marker — a lot of controversy behind it. But I stand firm that there’s a certain gene that we have called KIF6, and if you don’t have the variant, the studies with two of the cholesterol drugs weren’t very compelling, that they lowered LDL, but they didn’t reduce heart disease. So I tell a lot, if you don’t know what your KIF6 variant is, which most doctors don’t (I know mine), you have to be very discretionary in which statin you prescribe.
Then there’s other genes that you could also look at. One is haptoglobin; haptoglobin is how we carry our oxygen around. It turns out that there’s three different haptoglobins, 1-1, 1-2, and 2-2. Well, patients with type 2 diabetes who have 2-2, have a 45 percent increased cardiovascular event rate.
So again, that’s why I think with cardiology, we have these studies, even if we aggressively treat their lipids, we still have this 30% residual. Well, I don’t think that residual is cholesterol. I think it’s haptoglobin, APO-E, maybe the statin that you’re prescribing; other factors, albumin in the urine.
I think albumin in the urine is a powerful risk factor for heart disease. But unfortunately the FDA doesn’t see it as a good primary endpoint. I think until they do that, and actually establish a primary endpoint for that, we will never get a valuable answer. There’s no question about albumin in the urine. People think it’s just the kidney, albumin in the urine is the kidney telling you, you have endothelial disease. That you are leaking albumin throughout your entire body. That albumin drives cardiovascular disease. Big time.
Joy Pape: So, do you refer your patients for genetic counseling? If this is the way you practice, how do you learn more about their profile?
Dr. Lardinois: Right now it’s been kind of challenging. The diabetes [practice] I was in, they were not all that receptive. Change is always hard to do. So I actually worked with two of my former medical students, who are now practicing physicians in Reno. There’s a concierge service. I helped them set-up a genetic thing, so if patients do want to come in, they pay cash now. It’s only $1000 for the genetic testing. You do a treadmill which is $1100, and that doesn’t tell me anything. I think treadmills are kind of useless. I went 16 minutes on the treadmill, and I’ve got heart disease. I went 16 minutes. Well they’d tell me I’m just fine. Well, I’d be dead now. That’s what happened to the guy on Meet the Press. He had a treadmill [test] and three days later he was dead. What was his name? I’ll think of it in a second. [ed. note: Tim Russert.] Right now, it’s been hard to get it implemented, and I’m moving to a different position in a different hospital and maybe I can get involved with a cardiologist and get this up and running. I do think there’s basic genetic testing that should be implemented in the management of everybody with any disease, and it’s not that expensive.
Joy Pape: So we talk about patient education and people making changes. Behavior change. So how did it work? How does it work if your patients find they have this certain gene and they need to cut down on their drinking? Have you had any experience with that?
Dr. Lardinois: Oh yeah, some of them aren’t really happy with that. But I say, I provide you a service. I’m not your mom or your dad and I provide you a service and I say based on this information, you should reduce your alcohol consumption to one drink a week.
Joy Pape: Is it effective?
Dr. Lardinois: In some people it is. I think 70% of patients will follow along with you, but I think 30% no matter what you do [won’t]. There’s patients that I say [to], I feel sorry, I feel bad today. They say why? You came in, I gave you these recommendations three months ago, you didn’t do any of them. Your A1C, your blood pressure, your cholesterol, your kidney test is all the same. I’m going to have to charge you $75 for this. We live in Nevada, you could go to a nice big buffet with your whole family for $75. So I feel kind of bad, I’m taking their money away because why did they even bother to come? They didn’t do anything.
Joy Pape: Well, I’m sure glad you came today. I think it’s obvious why you got this award that you’ll be getting tonight. So congratulations and thank you.
Dr. Lardinois: Just one other point I’d like to share that I think is important. One of the things I try to do is, I work with the VA to try to set up ways to get doctors to better manage their [patients’] diabetes. I actually came up with this thing called PENTAD. I published it in Archives of Family Medicine. It was very short. Just a little card, a pocket card. The P stood for Proteinuria, which would be albumin. The E stood for Eyes. Make sure you have your patients get their eye exam. N was necklace or bracelet. Make sure they have a bracelet. T was toes, check the toes. The A was A1C. And then you say well it’s PENTAD, you have the D, so what’s the D? I said that you Document in the chart that you did the PENTA. I was very successful. It worked very well. I was going through some old papers of mine and I came up and had a few of my PENTAD cards left that I did. I did camps for kids with diabetes for 18 years and I think Lilly or somebody nicely made these PENTAD cards, so we just gave them out to everybody.
Joy Pape: It’s great to have those memory tags, something to remember.
Dr. Lardinois: We actually had a stamp. We had a stamp at the VA where we just stamped the PENTAD in and you could just write it in. That improved compliance tremendously, because it’s a reminder.
Joy Pape: I know it’s something I’ll use. Thank you so much.
Read part 2.
Feature
We know about the issue of slowed metabolism after weight loss due to the lean muscle mass loss that goes along with fat loss. This is one reason why higher protein/low carb diets work better than low fat diets; because muscle mass is maintained better. Well, new information from Diabetes in Control backs up what some of us know intuitively or may have experienced personally….
Diabetes Diet 
I’m delighted that The BMJ has stood by this article and decided against retraction. Two outside reviewers judged that the criticisms of the piece did not merit its retraction, and in the end, the corrections made by The BMJ do not, in my view, materially undermine any of the article’s key claims. This article therefore stands as one of the most serious ever, peer-reviewed critiques of the expert report for the US Dietary Guidelines for Americans (DGAs).
The importance of the DGAs, and therefore of this article, should not be understated (and indeed was recognized by many in the mainstream media when the article was published). The DGAs have long been considered the “gold standard,” informing the US food supply, military rations, US government feeding assistance programs such as the National School Lunch Program which are, altogether, consumed by 1 in 4 Americans each month, as well as the guidelines of professional societies and governments around the world, and eating habits generally.
Yet rates of obesity began to shoot upwards in the very year, 1980, that the DGAs were introduced, and the diabetes epidemic began soon thereafter. A critically important yet little understood issue is why the DGAs have failed, so spectacularly, to safeguard health from the very nutrition-related diseases that they were supposed to prevent.
In documenting fundamental failures in the science behind the DGAs, this article offers new insights; It establishes that a vast amount of nutrition science funded by the National Institutes of Health and other governments worldwide has, for decades, been systematically ignored or dismissed, and that therefore, that the DGAs are not based on a comprehensive reviews of the most rigorous science. Incorporating this long-ignored relevant science would likely lead to fundamentally different DGAs and could very well be an important step in infusing them with the power to better fight the nutrition-related diseases.
A fundamental question is why 170+ researchers (including all the 2015 DGA committee members, or “DGAC”), organized by the advocacy group, the Center for Science in the Public Interest (CSPI), would sign a letter asking for retraction. After all, in the weeks following publication, any person had the opportunity to submit a “Rapid Response” to the article, and both CSPI and the DGAC did so, alleging many errors. I responded to them all in my Rapid Response. This is the normal post-publication process.
Yet after all this, CSPI returned for a second round of criticisms, recycling two of the issues (CSPI points #3 and #10) that I had already addressed in my Rapid Response (and which had required no correction), adding another 9 (one of which, #4, contained no challenge of fact), and demanding that based on these alleged errors, the article be retracted. CSPI then circulated this letter widely to colleagues and asked them to sign on.
This lack of substance in the retraction effort seems to point to the reality that it was first and foremost an act of advocacy—a heavy handed attempt to silence arguments with which CSPI, a longtime supporter of the Dietary Guidelines and its allies disagree.[ footnote 1] And this applies not just to the retraction letter but to other CSPI efforts to stifle alternative viewpoints. Earlier this year, for example, I was dis-invited from the National Food Policy Conference after CSPI, together with the USDA official in charge of the Dietary Guidelines, threatened to withdraw if I were included, details of which are reported here and which a Spiked columnist called an act of “censorship.”
It’s important to note that I am not the only person disturbed by the lack of rigorous science underpinning our dietary guidelines. Numerous scientists around the world have expressed concern about the science. And indeed, this consternation is shared by no less than the US Congress, which held a hearing on Oct 7, 2015 to address its serious doubts about the DGAs. Such was this concern that last year that Congress mandated the first-ever major peer-review of the DGAs, by the National Academy of Medicine. Congress appropriated $1 million for this review, and it additionally stipulated that all members of the 2015 DGA committee recuse themselves from the process.
What is the dangerous information challenging the DGAs that cannot be heard on a conference panel nor published in a peer-reviewed journal?
The major findings of this article are that:
1. The DGAC’s finding that the evidence of a “strong” link between saturated fats and heart disease was not clearly supported by the evidence cited. (Note that as of last year, the Heart and Stroke Foundation of Canada no longer limits saturated fats. Note, also, that Frank Hu, the Harvard epidemiologist in charge of the DGAC review on saturated fats, was an energetic promoter of the retraction letter against my article that critiqued his review, according to emails obtained through FOIA requests);
2. Successive DGA committees have for decades ignored or dismissed a large body of rigorous (randomized controlled trial) literature on the low-fat diet, on more than 50K subjects, collectively finding that this diet is ineffective for fighting obesity, diabetes, heart disease or any kind of cancer;
3. Although the DGAs have for decades recommended avoiding saturated fats and cholesterol to prevent heart disease, no DGA committee has ever directly reviewed the enormous body of rigorous (government-funded, randomized controlled trials) evidence, testing more than 25,000 people, on this hypothesis. Many reviews of this data have concluded that saturated fats have no effect on cardiovascular mortality;
4. The DGAC ignored a large body of scientific literature on low-carbohydrate diets (including several “long term” trials, of 2-years duration) demonstrating that these diets are safe and highly effective for combatting obesity, diabetes, and heart disease;
5. The Nutrition Evidence Library (NEL) set up by USDA to do systematic reviews of the science did not meet its own standards for its review of saturated fats in 2010;
6. Although the DGAC is supposed to consult the NEL to conduct systematic reviews of the science, the 2015 DGAC did so for only 67% of the questions that required systematic reviews;
7. For a number of key reviews, the 2015 DGAC relied on work done in part by the American Heart Association and the American College of Cardiology, which are private associations supported by industry and therefore have a potential conflict of interest;
8. The DGAs, for the first time, introduce the “vegetarian diet” as one of its three, recommended “Dietary Patterns,” yet a NEL review of this diet concluded that the evidence for this its disease-fighting powers is only “limited,” which is the lowest rank of evidence assigned for available data;
9. The DGA’s three recommended “Dietary Patterns” are supported by only limited evidence. The NEL review found only “limited” or “insufficient” evidence that the diets could combat diabetes and only “moderate” evidence that the diets can help people lose weight. The report also gave a strong rating to the evidence that its recommended diets can fight heart disease, yet here, several studies are presented, but none unambiguously supports this claim. In conclusion, the quantity of recommended diets are supported by a small quantity of rigorous evidence that only marginally supports claims that these diets can promote better health than alternatives;
10. The DGA process does not require committee members to disclose conflicts of interest and also that, for the first time, the committee chair came not from a university but from industry;
11. The 2015 DGAC conducted a number of reviews in ways that were not systematic. This allowed for the potential introduction of bias (e.g., cherry picking of the evidence).
This last claim, on the systematic nature of the DGAC reviews, is the subject of the corrections published in The BMJ this week, and refer to CSPI points #1, #2, #7, and #8 (two of which are statements in the text and two of which are in the supporting tables). I am grateful to have had the opportunity to work with The BMJ on developing this notice.
The BMJ has placed a word limit on my response. For the rest of this comment, please see: http://thebigfatsurprise.com/comment-bmj-correction-notice/
Footnote 1
CSPI has fought for decades to eliminate saturated fats from the American food supply (so much so, that throughout the late 1980s, CSPI advocated for replacing saturated fats with trans fats and succeeded in driving up consumption of trans fats to historic levels, as described in The Big Fat Surprise, pp.227-228). CSPI has also long advocated for shifting away from animal foods containing saturated fats, towards a plant-based diet based on grains and industrial vegetable oils. The researchers who joined CSPI in signing the letter are largely adherents to this view; many have participated in generating the science that has been used to support the hypothesis that fat and cholesterol cause heart disease, and it is upon this hypothesis that the Guidelines have been based.
Competing interests: I have read and understood BMJ policy on declaration of interests and declare that I am the author of The Big Fat Surprise (Simon & Schuster, 2014), on the history, science, and politics of dietary fat recommendations. I have received modest honorariums for presenting my research findings presented in the book to a variety of groups related to the medical, restaurant, financial, meat, and dairy industries. I am also a board member of a non-profit organization, the Nutrition Coalition, dedicated to ensuring that nutrition policy is based on rigorous science.