In part two of Dr Lardinois’ interview for Diabetes in Control we learn more often overlooked points regarding albumin.
The Role of Albumin in Heart Disease
In part 2 of this exclusive interview from AACE 2016, Dr. Claude Lardinois discusses why albumin is a driver of cardiovascular disease.
Steve Freed: I woke up with a nightmare and I said to myself (and it goes to what you’ve been saying) microalbumin in the urine can actually be an indicator for heart disease, diabetes, and kidney failure.
Dr. Lardinois: And congestive heart failure too.
Steve Freed: I was told by a doctor that 10% of the population has some form of kidney issues and that if we prevent one person from going on dialysis, that’s a quarter of a million dollars over their lifetime. Just one person. I said to myself. Well, wait a second, we have microalbumin tests right now. I looked into it and you can perform a microalbumin test with blood, you can also do a dip stick in your office. But there is no FDA approved test for home use to detect microalbumin. Now if you remember, we had colon cancer tests where you put a piece of feces in the mail, and we found all these people and we saved millions and millions of dollars.
Dr. Lardinois: I would say two things: one is, I would discontinue using the term microalbumin. Now the reason I say that is I’ve actually asked students or residents what microalbumin is, and do you know what they think it is? It’s a smaller molecule of albumin. It’s a small albumin molecule. There’s a small albumin and a big albumin. Well, there’s not! It’s just albumin, period.
Steve Freed: So I said to myself, let me investigate this. So I went out and I found overseas a test that’s like a pregnancy test. A plastic container, put two drops of urine in it. If the red line comes up, you’ve got “albumin” in the urine. Obviously if you’re lifting weights, you might have albumin in the urine. If you have a cold, you might have albumin in your urine. So I asked the doctor, he said you know I tried this about 20 years ago, and what they discovered was it was too costly. Well, I found a way to get this thing made for less than a dollar. It has to get FDA approved. My thought is you can send these out and I would send two, maybe even three tests out, and if one was positive, you do another one in a week and if that was positive, you can do another one. If you get two positives then you need to contact your physician and have them do further testing. Because you could be at risk. I know I can’t say that you’re diagnosed. All I can say is you’re at risk and more tests have to be done and you need to contact your physician. Send this out to the self-insured companies that have 10,000 employees, send it out with your tax refund, if the check is no good.
Dr. Lardinois: I’ll share with you, I’ve got a couple of very important things. You said something about nightmares though?
Steve Freed: Well I had a nightmare because of all these people I have to talk to, this doctor and I said a quarter of a million dollars.
Dr. Lardinois: You don’t have diabetes do you?
Steve Freed: No, it’s in my family.
Dr. Lardinois: Because what I tell you is that I tell people that a nightmare or a bad dream is a hypoglycemic reaction. When you said that, I used to do camps for kids and there were kids that would have a 400 blood sugar in the morning and everybody thought they didn’t take their insulin. They had too much insulin and they rebounded. Here’s the issue with albumin…. Albumin in the urine. What do they tell you your albumin in the urine should be? Less than 30. Where did that number come from?
Steve Freed: The albumin test is greater than 20.
Dr. Lardinois: That’s because you have to correct for grams of protein so it actually becomes 30. It’s 20 mg but when you correct for creatinine it’s actually 30. That number of 30 was generated by the nephrologists. What they showed was that if you had less than 30 mg of albumin in your urine, your chances of going onto end stage renal disease was zero, almost zero. If you had between 30 and 300, that’s where they came up with the term microalbumin. It really wasn’t microalbumin, it was just albumin in the 30 to 300 range. You had a small percentage of going into end stage renal disease. If you had more than 300 in your urine, I tell my patients, you better start learning the word nephrologist. Not endocrinologist, because you’re going to do that. But I can tell you, the true value, the goal for albumin in the urine is 7.5 in women and 4 in men.
Steve Freed: You say 4 and 7, what does that mean?
Dr. Lardinois: I’m saying instead of 30 it should be 7.5 for you [Joy], and 4 for you [Steve]. There are studies now, and I will show this data, that once your albumin in the urine is more than 5 mg per gram of creatinine, your mortality starts to go up. When you get to 30, you’ve already doubled your mortality. So you’re twice as likely to die if you have a 30 as a 5, but everybody says it’s normal because you’re less than 30. The other thing they don’t take into account, but I’ve learned from a couple nephrologists here, that they actually are addressing now is you [Steve] versus her, because you have a bigger muscle mass than she does. You’re going to have a seriously lower creatinine because it’s an albumin to creatinine ratio, because you have a bigger creatinine, your numbers actually are going to be lower. But when you correct it for lean body mass, your numbers should be lower, so yours should be 4 and hers is 7.5. But I’m going to do a whole hour on that.
Steve Freed: So what do you think of that? I’ve already got a lab, we’re working on it, we’re putting it together, we’re putting together a business plan to develop this and get it FDA approved.
Dr. Lardinois: I think it would be a great idea, but I’m hoping that the FDA and that societies will stop looking at 30 as the normal.
Steve Freed: Where can I get this information?
Dr. Lardinois: Which information?
Steve Freed: That 30 is not normal.
Dr. Lardinois: I can give you all the information you want. I can send you the talk I gave in Hawaii and it’s going to be similar in December, but obviously I’ve got some new information just in the last couple weeks. I always update my presentations.
Steve Freed: I’d like to transcribe it so I can hand it to the National Kidney Foundation.
Dr. Lardinois: I’ve been very adamant. I’ve not got anywhere with it. Even some of them say, what are you talking about, let’s do a physician paper. I said ok fine, but your blood pressure, lipids, continuous glucose monitoring. Why don’t you actually do one on albumin? In fact I even said I would be happy to even chair it, if you were willing to do it, because I think it’s something that’s really important. The problem with albumin right now, is we’ve never designed any good control studies, so all the data we have is observational. Observational studies, that’s the problem with nutrition. All of them are observational studies, and that’s been flawed. So that’s prevented us. Until the FDA will accept albumin as a legitimate marker, and say, ok, we must get below 7.5 in you, we must get below 4 in you, let’s see what happens? I’ll guarantee you, I’m from Nevada but I don’t spend money at the casinos, but I would [spend] some serious money on that. I’ll bet you, I’ll bet $25,000 that if you did a clinical study and you got it below 7.5 in women and 4 in men, you would save a lot of lives.
Steve Freed: That’s going to take time to show.
Dr. Lardinois: Exactly, but they’ve got studies where they’ve done it, but they didn’t want it. It wasn’t part of the end point. But they’ve got studies like Life study which shows normal albuminuria and the death rates up 200% with a “normal” albuminuria. I’ll be happy to send you that.
Diabetes in Control will continue to provide updates as more information becomes available.
Claude K. Lardinois, M.D., FACP, FACE, MACN, is a professor of medicine at the University of Nevada School of Medicine and a member of the graduate faculty for Nevada Studies in Nutrition at the University of Nevada, Reno.
Portions of this interview transcript have been edited for brevity and clarity.
Feature
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.