Howie and Harlan are joined by Jerold Mande, a nutrition expert who has served in the FDA, where he led the graphic design of the Nutrition Facts label, and the USDA. Harlan reports on promising new therapies for sickle cell disease, high cholesterol, and hypertension; Howie reflects on the Thanksgiving holiday and the contributions of former First Lady Rosalynn Carter, who died this week.
Food and Health
Rosalynn Carter and Doing Good
Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.
Howard Forman: I’m Howie Forman. We’re physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare. We’re excited to welcome Professor Jerry Mande today. But first, we check in on current hot topics in healthcare. I know you have several items to talk about today, Harlan. Hit it.
Harlan Krumholz: Yeah. Thanks, Howie. I thought that folks might be interested in things that are going on in the gene editing world. What the heck is gene editing? People may have heard about this term CRISPR—there was this breakthrough where all of a sudden we were able to go into the genome, the inherited blueprint we have, and actually make edits, changes. We always thought that we’re stuck with what we inherited, but it turns out that we can actually make these changes. Folks also may have heard that just recently, regulators in the UK approved the very first CRISPR-based medicine that’s going to be available to treat sickle cell disease and beta thalassemia. In June, we heard a lot of updated results from some trials about lasting benefits of these treatments. UK has jumped ahead of United States and Europe in saying, “We’re going to move forward with this really the world’s first CRISPR treatment.”
Howard Forman: It’s more than just treatment though, right? I mean, presumably in the future, this is curative.
Harlan Krumholz: Exactly. For those listening, these are inherited conditions, sickle cell and beta thalassemia. They represent a defect in hemoglobin synthesis and gene, and they’re going to go in and fix it. This is authorized for patients who are at least 12 years old, and there’s so much harm that’s been caused by these mutations and so much suffering. This seems like it’s going to make a big difference and can be a really long-term fix for these genetic problems that really are at the root of the problem for these diseases. Now the FDA is set to rule on these in early December and in March for thalassemia. So we’re likely to see this also come into the U.S., but this is incredibly rapid science. I mean, from the time maybe a little more than a decade ago that these papers come out about this. By the way, papers weren’t even covered.
It wasn’t like front page of The New York Times. It was like a minor thing. They found an enzyme a way to snip this out and replace it in the DNA, and it seemed like it was an esoteric finding ends up becoming incredibly important, wins Nobel Prize, and now we’re already at the cusp of an approved drug just to show the speed that this is happening. Well, I was also just going to bring up this report that occurred at the American Heart Association just a couple of weeks ago. We’ve talked now before about the select trial that talked about the GLP-1 receptor agonists and the reduction. Well, there were a lot of other good science also at the American Heart meetings. One of them was a study that came out of a company called Verve, which was started by a scientist who was at Harvard, Kathiresan, who spun out a company that instead of focusing on rare diseases was going to focus on much more common condition, familial hypercholesterolemia.
It’s still a little bit rare, but many people have this, where their bad cholesterol, that LDL cholesterol is off the charts and these people have accelerated atherosclerosis. They get a lot of heart disease, many, shortens their lives, and the advent of the drugs to treat elevated cholesterol have been a boon to this group. But they still often have elevated levels that are hard to control, and they’re taking a lot of meds. The question was, “Could you go in and edit their genome and actually cure them of the condition?” This was the first in-human study they presented 10 patients, mean age about 54, 8 men, 2 women, from the UK and New Zealand. All of them had this and all of them had elevated cholesterol and many of them had preexisting severe coronary disease.
They presented this result that by giving them this treatment, they were able to markedly reduce their cholesterol levels. I mean, it worked. There was some question here about safety, and there were a couple of adverse events in the groups. It seemed like they probably were unrelated to the drug because of the timing of them and the way it worked. We’ll have to sort this out, but the big news to me was that if you think of it like Kitty Hawk, the plane flew. I mean they gave these people the medications. This is gene therapy for cholesterol, and the presumption is if you do it, then they won’t have to take these meds the rest of their life. Anyway, it’s very—
Howard Forman: The effect seemed durable, it seems, which is based on the premise that this sticks.
Harlan Krumholz: There’ll have to be a much longer-term outcome. Anyway, this was one of the things, and I’ll just jump in on one other thing. I think it’s also very interesting is that there was yet another study coming out saying that we should really be treating people to much lower blood pressure levels. I’m a big advocate of this. There now have been four large trials that have come in and said that it’s not the 140/90 level. We should really be looking at 130. This trial that just came out at the American Heart was really trying to get people below 120. Again, marked benefits of lower blood pressure. I’m going to just pair that study with another one that came out that was looking at a subcutaneous injectable for treating hypertension. Again, there’s also innovation occurring in the treatment side such that it’s not about people taking pills, but people can now take... we’ll be able to take injections and we’re looking at whether that’s a better way to do it some people think eventually—
Howard Forman: Importantly, an injection every six months, not an injection every day or every week, but every six months, right?
Harlan Krumholz: Right. Exactly. Everyone thinking that, like, twice a year I can go into the doctor, I’ll get a shot. Then that’ll take care of the issues around remembering to take your pills and all that stuff.
Howard Forman: Compliance.
Harlan Krumholz: Anyway, a lot of innovation going on. I thought there was a lot of other good science there besides that around the treatment of obesity and things that are getting me excited anyway recently.
Howard Forman: That’s great stuff.
Harlan Krumholz: Good. Let’s get onto our interview with Jerry.
Howard Forman: Professor Jerry Mande is the CEO and the founder of Nourish Science, a nongovernmental organization working to create a more sustainable and equitable food system that promotes optimal health. Before bringing his political and policy acumen to bear to solve the current U.S. nutrition crisis with Nourish Science, Professor Mande served in senior policymaking positions for three presidential administrations at the U.S. Department of Agriculture, the Food and Drug Administration, and OSHA. Notably, Professor Mande served as senior advisor to the undersecretary of the USDA’s food, nutrition, and consumer services during the Obama administration and led the redesign of the nutrition facts label during the Bush administration.
In addition to his governmental work, he has held appointments at the Tufts Friedman School of Nutrition Science and Policy, the Yale School of Medicine, and The Harvard University’s T. H. Chan School of Public Health. He holds a BS in nutritional science from the University of Connecticut and an MPH from the University of North Carolina at Chapel Hill.
First, just welcoming you to the podcast. It’s obviously a really timely visit. I don’t think I know of anybody who has followed their interest in a theme for their entire career as specifically as you have doing nutrition science as an undergrad and really sticking to it your entire career, advising Senator Gore when he served in the Senate and continuing your service through that. But my first question, because we had Dawn Sherling on several months ago to talk about her feelings about ultra-processed food; we’ve obviously talked about anti-obesity drugs and anti-obesity surgery. Can you just tell us two or three ingredients that worry you the most and for which we don’t have a sufficient information right now or anything along those lines about why we need to do better and more science?
Jerold Mande: First point I’d make is just how sick we are as a country because of our food, which is really extraordinary. I think people somehow know that there’s a problem here, but I don’t think people really understand just how serious it is. Indeed, there’s been recent reporting in The Washington Post highlighting a phenomena that we’ve seen over the last couple of years that Americans are living a shorter lifespan, sicker lives than before, actually, lower than any other developed country right now. But what the Post found is it is chronic illness caused by our food, particularly obesity that’s driving it.
I think that’s the first thing and related to that, and part of that is how sick our kids are. So as you all know, being physicians, it used to be adult onset diabetes. Today, it’s type two because it’s become so common in children. As part of the Washington Post reporting, they did a whole story on fatty liver disease and kids, something that’s just even more unthinkable than type two diabetes. Then The New York Times had a magazine section on bariatric surgery, something you were talking about last week in teenagers. This is something that should have everyone’s attention not because of how sick we are, not because how relevant this sickness is. COVID, right? Two-thirds of COVID hospitalizations and maybe 800,000 deaths were not due to COVID alone, but to obesity, heart disease, hypertension, diabetes caused by our food.
I’m talking just the health and suffering. There’s the economic costs which are extraordinary, so much medical debt is due to our poor diets. Then even military readiness. Eight hundred former admirals and generals’ mission readiness. The number one issue and threat to our military is childhood obesity.
Harlan Krumholz: I was wondering, Jerry, whether some of this is also contributing to marked disparities. I mean, I think back 20, 30 years ago, there was a lot about food that I think was contributing to poor health writ large, the way people were eating and so forth. But then there’s been a divergence where people of means can have access to fresh vegetables and healthy foods and are moving in a direction towards healthier diets. But then largely there are food deserts or the highly processed food is cheaper, easier to access, and more affordable for many families. So I just wonder your thoughts about whether this is also contributing to the fact that you’ve got this one group who are eating very healthy, paying a lot of attention, but it’s costing them more.
You go to Whole Foods, you can’t even afford, not that they just only have healthy food, but many of the places people are going to maintain a vegetarian diet can be more expensive. Then it can be for alternatives depending on what your access to food is. What are your thoughts about that with regard to are we really reaching the populations that need healthy food? I mean, are we making it accessible and affordable?
Jerold Mande: Those are great points. Two in particular I’ll highlight. First, you’re absolutely right, poverty overall, but even more than that is a big factor here. It’s not just also the cost of the food. Indeed, when we were at USDA, people often say that produce is going to cost more. Those were earlier studies before I was at USDA, which were studies on the cost of food per 100 calories. When you look at food per 100 calories, produce was one of the most expensive foods and McDonald’s was one of the cheapest. But when you look at it at volume, which is how our stomachs are filled, produce in season is actually one of the cheapest foods. So it is cost, but not in the way you were saying, it’s time is cost. When you buy that produce, then you need to make it into a meal.
There is where the problem really lies in that for people of middle income even—certainly, people of low income—the time necessary to prepare a meal from healthier food is considerable. That raises the other really important point you made, ultra-processed food, and going back to a point that Howie made earlier, the additives may play a really key role, not in the sense that recently when we banned certain additives of fear that it might cause cancer, not that. It’s that companies are designing food to be over-eaten, and that’s really at the root of our obesity epidemic.
Howard Forman: That’s where I really.... I’m still curious to know are there specific ingredients, just use examples. Harlan and I talked about erythritol a few months ago. There are other sugar alcohols that people have been concerned about. There are other emulsifiers that Dawn Sherling talked about. I’m curious from you, since you are so steeped in this area, you understand this area. Are there specific ingredients that our listeners should care about when they look at a package, or is it just the fact about how it’s made that gives you the greatest concern?
Jerold Mande: I think how it’s made gives me the greatest concern than any one chemical. I got interested in this whole field back when I was a student, when FDA banned essentially red M&M’s by banning red dye number two because of the risk of cancer. Even then, what struck me about that is I read some about it and it’s unclear whether someone ever got cancer in the U.S. due to red M&M or red dye number two, but yet even then, maybe a third of cancer deaths have been associated with our diet. There seems to be a mismatch. It goes back to this nutritionism mindset, this reductionist approach where people look at things. I get it. Scientists, we’ve all trained that way. What is it that we reduced down?
I just think we haven’t done enough of the science in nutrition to figure out what it reduces to. There are tens of thousands of compounds in food. There are 100 or 200 that we understand that we think of as nutrients, but all of those are probably important, all of the 10,000-plus chemicals, and we just don’t study it to understand it.
Harlan Krumholz: Be clear what an ultra-processed food is.
Jerold Mande: Well, it’s difficult because we’re using their definition where they say the easiest way to think about it is if you pick up the package and there’s a list of ingredients you don’t really recognize, or another way is this is just something you couldn’t prepare in your kitchen. But I think the way to think about it, these are foods that are designed by food companies, but they’re designed using a lot of processing and additives that are designed so the food is overeaten. I think that is the most important point.
Howard Forman: More than, I think, probably close to 15 years ago, in that range, our former dean, David Kessler, former FDA commissioner, wrote a book about why we overeat and how you can stop overeating. In some ways, it was targeted at the audience trying to get them to change their behavior. But there was this also underlying premise, if I recall correctly, about how food companies, it’s not necessarily emulsifiers or specific ingredients, but salt and high-fructose corn syrup alone contribute so much to our natural insatiable appetite. We pick up a bag of chips and we just can’t stop eating. We pick up a sweet candy bar and we have too many in Oreos and so on, and everybody has their favorite vice in that way. What can we do on a population health, on a public health basis to start to impact that we shouldn’t be able to accept or be complacent about where we are? What can we do?
Jerold Mande: This is what food companies are taking advantage of and what their science is focused on. It’s the craving that’s there for these foods that affects most people because of the way our brains are. You’re absolutely right at one of the leading ingredients they use, in that respect, is sweetness. I’m using the word “sweetness,” it is important because when companies switch from added sugars to non-nutritive sweeteners, they’re still pushing that sweetener button in the brain that’s wired in for 150,000 years in terms of getting the energy we need. They’re abusing it. It’s okay to have it there, but not the way they’re using it that drives people to crave the foods.
The other question, of course, what can we do about it? We have a plan. The first thing is the government needs to update its strategy and its mission in this space. It’s been just making sure there are healthy options or there’s education or information. The child obesity problem is so severe in our country at the moment. We should set a goal for our country to ensure that every child reaches the age 18 at a healthy weight and in good metabolic health. Now the good news is we’ve demonstrated already we have the tools where we could make the progress on child obesity we made what childhood smoking. As you both know and you mentioned the former dean, David Kessler, when he was at FDA, we took on smoking and tobacco and kids. At the time, 25% of high school seniors smoke. The latest data is just out. It’s less than 2% today. We need to make a similar serious concerted effort around childhood obesity, and we can do that.
Harlan Krumholz: One thing I wanted to bring up, Jerry, why we have you is, people may not know just what a key role you played in the FDA labeling of food. I remember you telling me about this both getting it done and the design of the label and making it readable and understandable to average lay folks who may not have been sophisticated about these labels. I think that was a tremendous contribution. But one of the disappointments to me is the lack of evidence that this labeling, which I think is important, has actually made an impact. I just wonder how you reconcile what I thought was a tremendous educational public health initiative, which is to educate us about the food we’re eating, but the disconnect between maybe its impact on how people eat. Maybe it’s just because of the neuromarketing. It’s hard to overcome all these other factors that you’re describing, but what would it be that would be required for this information to actually help people make wiser choices?
Jerold Mande: Well, I share very clearly both those feelings you described, Harlan. It’s the project I worked on. I’m maybe most proud and having been able to design that label that’s so ubiquitous. But then I’ve stayed on it and looked at the data, and I agree with you, it hasn’t had the impact we thought it would have. The key to the design is that it would not just nudge consumers to make healthier choice, but it’s really power. 100% percent of who reads the label—maybe half of consumers at best; the companies whose product you put the label on, 100% of them read the label. The hope of a label is to nudge them to redesign their products. What’s happened, what we didn’t expect is that this ultra-processing I’m talking about, but I’ll call this bag of tricks that companies have with additives and processing.
We thought, “Well, gee, we’d put information on the label about fat and they would put healthier oils or something in, or we put added sugars and they would stop putting in the added sugars.” Well, to an extent, but what we missed is, well, what do they replace it with? This is where the FDA has failed dramatically. FDA was created more than a hundred years ago by Harvey Wiley, a chemist at USDA at the time. He was just worried that processed food was making us sick. It was a new industry. People were first eating it, and processed food companies were relying on chemical companies to help them figure out how to make products that tasted good, were affordable, convenient. It turned out that those chemicals and those foods were making people sick. Well, you fast-forward today, back then it was one of the 10 leading causes of death. Today, it’s number one.
Yet the FDA is doing absolutely nothing about it. Let me say what that means. The FDA has a billion-dollar food budget. They’re spending every penny of that on making sure that E. coli, Salmonella don’t make us sick. We need to do that. There are 1,400 deaths a year that FDA and USDA are trying to prevent. We need to prevent every one of them, especially in infants, just a horrible, horrible illness. But there are more deaths in that every day from these chronic food illnesses that our companies are causing as well, and the agency is spending nothing and doing nothing about it. The only thing it has in place is, as you said, is this label we developed. Here’s the problem and here’s what FDA needs to do. Labeling can be part of it, but companies... The agency has to say, well, when companies change the design of the food, how are they redesigning it?
Is the redesign better than what it was before? What the history has shown is the redesign is not better and has even been worse in some cases. So the agency needs to set guardrails for companies around the design of these ultra-processed foods. Use its authority. Good news is, we don’t need a new law. The Harvey Wiley statute says, “Our food can’t make us sick.” The agency has all the authority it needs. The standard in the statute is “may be injurious to health.” That is the standard that all of these additives need to pass. They’re clearly injurious to health. All of the sickness that you see as a cardiologist, cancer patients, a third of cancer patients—this is being caused by our food. The agency has the authority, as does the USDA. They need to start regulating it so that when companies—then the label encourages them to reformulate, we can be assured the reformulation results in a healthier product.
Howard Forman: We’re on the cusp of Thanksgiving, and this is our Thanksgiving episode. It’s a day when people do indulge. What’s your favorite Thanksgiving food? What are you looking forward to?
Jerold Mande: Man, the whole meal. It is a time where food is at the center. I think this is also a point I want to make, which is the most important thing about food is it should be delicious. People should think about it that way. The problem isn’t that food is too delicious. It’s that, in fact, pretty much if you’re cooking your Thanksgiving dinner yourself, I think you’re fine. I think the thing you need to worry about is all of these highly processed foods that companies are designed to be overeaten.
Harlan Krumholz: One final question here at the end, just because I think people might be interested, since you’re such an expert in this area. What’s your diet?
Jerold Mande: I do eat a diet that I think everyone should eat it. First, again, the most important thing in my diet is delicious. So that comes up first. But my diet is what people have described. I say a pescatarian, Mediterranean diet. I do eat meat occasionally, but I eat mostly a plant-based diet. You mentioned the food label, which I was proud to do at FDA when I was at USDA, we did the MyPlate that I helped oversee as well and developed that. I remember Tom Vilsack, who was the secretary, he had agreed with us at this pyramid, that maybe your listeners don’t even remember anymore, was really confusing. He had no idea what it meant. So we talked about, well, we could redesign that. He’s the secretary. We could come up with a new icon for the dietary guidelines.
We came up with MyPlate, and this is radio or podcast, so it’s hard for people to visualize. If they haven’t, they should look it up. But when we showed it to Vilsack, he got it right away. His remark was, “My plate looks nothing like that.” The plate is for those who don’t know it, when they look it up, it’s half your plate is fruits and vegetables. The protein is really a side dish. It’s not the main dish if you’re eating particularly an animal-based protein and the grains need to be whole grains.
Harlan Krumholz: Will you have turkey on Thanksgiving?
Jerold Mande: Absolutely. Yeah. Turkey’s great.
Howard Forman: Well, look, we want to wish you and everyone in your family a very happy Thanksgiving. Thanks for joining us this week on the podcast. I certainly hope that what you’re saying and what you’re pushing for is heard by both our government as well as our listeners and others.
Harlan Krumholz: Yeah. What a great episode. Much love to you and Elizabeth and the boys, and have a great holiday, and it’s great to see you, Jerry.
Jerold Mande: Yeah. Well, thank you all so much for this opportunity. It was a delight to spend time with you again and talk about public health, the most important issue and my great passion.
Harlan Krumholz: Hey, that was terrific. Jerry’s a good friend of ours and—
Howard Forman: It was fun.
Harlan Krumholz: ...tons of knowledge about nutrition and really interesting. But anyway, Howie, we’re on the cusp of Thanksgiving. Any thoughts for this week?
Howard Forman: Yeah. We lost First Lady Rosalynn Carter this week at the age of 96—77 years married to President Jimmy Carter, and she was a trailblazer, and by all accounts, an amazing woman, mother, wife, leader. Most people know that she did devote much of her professional efforts to advancing mental health and well-being starting in the early 1970s when her husband was governor of Georgia. I remember sitting just a few feet from her in the Senate dining room about 20 years ago, along with Mike Wallace of CBS fame and others in support of mental health parity legislation that took Congress too long to pass and still has not accomplished all that it can do. I just have enormous admiration for Mrs. Carter and so many others who have sought to elevate our discourse and destigmatize a group of diseases that are so very prevalent in our midst and that we have returned to on this podcast numerous times.
You asked me any thoughts on Thanksgiving. You may think this is a non sequitur, but it’s not. The holidays are a time of great joy and happiness is also a spike in depression and related ailments. I want to encourage your listeners to do good for others while they do good for themselves. There is enormous evidence that altruism or other regarding behaviors as you might describe it, delivers physical and mental benefits to the altruist. They live longer and healthier lives. Simple acts of kindness can bring benefits to you and to those you help. Give thanks, help your neighbor, offer friendship, or a simple visit to someone who’s alone, or do an organized community service activity. Do it for others; do it for you.
On this Thanksgiving, I want to offer my sincere thanks this holiday season to my parents, my daughters, the rest of my family, and all the friends that I love and appreciate. To you, Harlan, a friend, collaborator, mentor, role model for 28 years, I want to just thank you so much for all of that and for this podcast. Thanks to our amazing listeners, I can’t thank them enough for their advice, their feedback, their suggestions, and their support.
Harlan Krumholz: Well, I don’t think I can match that eloquence, Howie. I’m extraordinarily grateful to you, and it is a time I think for us to be able to sit back and reflect on how other things that make us fortunate, how fortunate many of us are, and it really is in those relationships that we can make relationships with our family, our friends, our colleagues... they both enrich life, but increasingly the evidence is that it helps us live healthier lives as well and certainly more meaningful lives. Your words are, I think, so important, well taken and appreciated. Thanks to Miranda Shafer, Ines Gilles, Sophia Stumpf, the people that work with us that make this podcast possible.
Howard Forman: 100%.
Harlan Krumholz: Yeah, our listeners and everyone all around. Thank you so much.
Howard Forman: I mean, it is a valid point. The number of people that have come to help us with this podcast from our communities in the med school, the School of Public Health, the School of Management are too numerous to count, but they are no less important.
Harlan Krumholz: Anyway, deep gratitude to you all. You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.
Howard Forman: How did we do? To give us your feedback or to keep the conversation going, I’m going to recommend you reach out to us at email@example.com. But you can also find us on social media, including what used to be called Twitter.
Harlan Krumholz: Yeah, I always say this. Every week it becomes harder and harder, but I’m still hanging in there just because of the community that I have is so great.
Howard Forman: Although I will say our LinkedIn followers are amazing. I mean, I feel much better about our LinkedIn profile and followership and the comments that people leave have been really very fulfilling.
Harlan Krumholz: Yeah. Anyway, at X, I’m @H-M-K-Y-A-L-E. That’s @hmkyale.
Howard Forman: I’m @thehowie. That’s @T-H-E-H-O-W-I-E. Aside from Twitter and our podcast, I’m fortunate to be the faculty director of the healthcare track, founder of the MBA for Executives program at the Yale School of Management. Feel free to reach out via email for more information or check out our website at som.yale.edu/emba.
Harlan Krumholz: Health & Veritas is produced with the Yale School of Management, Yale School of Public Health, and I want to say I am now a part of the Yale School of Management with the official appointment.
Howard Forman: You are. Congratulations. It’s not a small thing, I thought about mentioning it. I’m happy you did. There are very, very few people at this university with a dual appointment or with a joint appointment at the School of Management, and you are among the rare few. Congratulations.
Harlan Krumholz: I’m happy to join you as being someone at the Yale School of Medicine, the Yale School of Public Health, and the Yale School of Management.
Howard Forman: 100%.
Harlan Krumholz: I’m thrilled by that. As I’ve said, we’re so grateful to Ines and Sophia and to Miranda. We hope that they have a wonderful Thanksgiving. Talk to you soon, Howie.
Howard Forman: Thanks very much, Harlan. Talk to you soon.