Susan Mayne: Keeping Food Safe

Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.‌

Howard Forman: And I’m Howie Forman. We’re physicians and professors at Yale University and we’re trying to get closer to the truth about health and healthcare. Our guest today is Dr. Susan Mayne, but first we’re always checking in on the hot topics in health and healthcare. What do you have for us today, Harlan?‌

Harlan Krumholz: Hey, Howie, you know I had a lot to choose from today and I was going to bring in something that was really related to food in honor of having Susan as a guest. Well, you know I don’t like to gossip and I don’t like to speculate, but have you heard this that there’s been a bunch of study sections that have suddenly been canceled?‌

These study sections are what the NIH uses to evaluate grant applications. What happens is, somebody submits a grant application, it gets initially screened and then allocated to a committee that’s consisting of experts in that area who will assign that to some of their members and allow people to do deep dives into the proposal, look it over, and then they convene, and they talk about it, discuss it, rank it, rate it. And then that rating has a very important relationship to whether or not it will get funded. And this is a tried-and-true approach that NIH has taken. Many of us have bemoaned that it takes too much time, but it’s intended to establish the integrity of the process, to ensure that everyone gets a fair reading, and to bring in experts to help evaluate the quality of what’s being submitted.‌

It’s just been announced that the study sections that were scheduled toward the end of February and some meetings that were scheduled at the end of January have suddenly been canceled. This is quite interesting because sure, a new administration comes in and it’s a time for them to reset priorities, but I don’t think I’ve ever heard of this before, of putting a hold on the process.‌

Now, we’ve heard about this in other federal agencies where the administration is saying, “No new regs. No new policies. Give us a chance to come in and lead.” And that’s reasonable, but usually the grant process has a little bit of independence from the political process.‌

And I think it’s interesting because the nominee for the NIH, [Jay] Bhattacharya, and a lot of the discussion around the NIH has come to whether or not they should be resetting their funding priorities and whether or not they should be investing in some areas that have not historically been invested in and not investing in other areas and so forth.‌

And I think the presumption was that this might take some time for them to establish those priorities and to make public calls for grants and fix this up. This move, if true, it just recently reported, just reported actually within hours, that many of these study sections were canceled and not rescheduled.‌

Howard Forman: But in addition to that, Harlan, isn’t it also true that, I think a [National] Vaccine Advisory Committee meeting has now been canceled and as well, I believe, a meeting about—‌

Harlan Krumholz: It was reported by STAT that Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria—I’m not sure about the others, but this is just going to be something very interesting and important to watch. And many of our colleagues are going to be very much looking at this as well, that I’ve said this before, if I’m a medical school right now, if I’m a dean, I’m probably creating scenarios here.‌

It’s a lot of scenario planning for how things might change and be disrupted here because there seems to be a real interest in making large-scale changes at the NIH, across other agencies of course, as well. But this funding mechanisms that many academic centers depend on is maybe about to undergo quite a dramatic change. Hard to anticipate exactly what that is, but this move to cancel the meetings that evaluate grants that were submitted several months ago in anticipation and hopes of being evaluated soon and funding decisions coming after that, maybe that process may be slowed, reevaluated, and there could be change effort.‌

Howard Forman: And this comes up on the heel of an announcement yesterday that the Trump administration has canceled all public communications through February 1st around public health and healthcare. So there’s been a lot actually happening. We’re going to talk a little more about it in my segment later on about what the actions are, but these do compound on one another.‌

And as you’ve pointed out, even if this isn’t about a complete restructuring of how they fund things, it does gum up the works. And if you are a researcher who’s waiting for funding, this will slow it down.‌

Harlan Krumholz: Yeah, there are many people whose careers really are dependent on this mechanism. I’ve used this mechanism throughout my career, others, but there are people who may be at a critical juncture in their career where getting it or not getting it actually turns them one way or the other. It’s very fragile to be an academician these days, and this is going to be hard.‌

Another thing I heard, by the way, Howie, just to finish up the gossip part about this, is whether or not there’s a feeling that the traditional academic powerhouses, of which we’re at one, have gotten too much of the pie. And that there’s an interest, especially those in blue states, and there’s an interest in saying that we should be spreading around the federal research dollars more equitably.‌

And of course, that has a big implication at Yale, has implication at Stanford, Harvard, the traditional places. We’ve always bragged about, we’re number 2, 3, 4 in NIH funding among academic centers. That may make us a target going forward because rather than something to celebrate, it may be something that’s seen as a bug, not a feature.‌

We’ve considered it a feature because we’ve built a very strong institution that we believe can create strong lines of research and benefit society, and we’re proud of what we’ve been able to accomplish. We’re entering an uncertain time here with regard to how that may change, not just on merit but on other factors that might weigh into this.‌

You and I both talked about this on the program, that there was this one piece where it was said some metric of academic freedom was going to be used to determine NIH funding. It’s a very, very uncertain moment.‌

Howard Forman: It’s a very uncertain time, at the very least. I continue, and I’m not trying to defend anything that the new administration is doing, but in fairness, I do want to have grace and just wait until we get more information. What you’re saying is accurately reported, and it’s reported by very reliable sources, not just the communications that we’ve seen from colleagues. But at the same time, I’m hoping that in a few days there will be clarity and this will turn out to be a misunderstanding of one type.‌

Harlan Krumholz: It certainly could be. It just was the moment of the day, you asked me what was on my mind, I saw this, I go like, “Holy mackerel.”‌

Howard Forman: I’m glad you talked about it.‌

Harlan Krumholz: This is big news. But we are trying hard on this program to be fair and see how things unfold. We really are. And we’re just saying that, so we’re just waiting to see. But I’m just saying, this is big news, if true. It just reported out of STAT News, so we’ll see.‌

Howard Forman: No, I agree. And many of our colleagues on the remaining social media have been directly reporting what they’ve heard, so I think it is a big concern for scientists.‌

Harlan Krumholz: Yep. Okay, hey, let’s get on to our guest, Susan Mayne, big great interview today.‌

Howard Forman: Dr. Susan Mayne is an epidemiologist by training who has held leadership positions in both government and academia. She started her career at Yale School of Public Health and the Yale Cancer Center where she served as the C-E.A. Winslow Professor of Epidemiology and the Associate Director of the Yale Cancer Center, respectively. She then served as Director of the FDA Center for Food Safety and Applied Nutrition for eight years.‌

Under Dr. Mayne’s leadership, the FDA spearheaded many initiatives such as the Closer to Zero Act, the FDA Food Safety Modernization Act, and other successful projects to reduce trans fats and sodium. She recently returned to Yale, where she now serves as an adjunct professor of epidemiology. Dr. Mayne graduated from the University of Colorado with a BA in Chemistry.‌

She then went on to study at Cornell where she obtained her PhD in Nutritional Biochemistry. So first of all, I want to welcome you to the podcast. This could not be a better-timed presence at our podcast for this episode. We’re in the week of the new Trump administration. There have been a lot of announcements coming out of the FDA recently, and you are an expert on food and nutrition.‌

And I wanted to start off by saying that one of the reasons why we invited you on is that you helped me better understand about how the FDA plays a central role in food safety when we first discussed this a few months ago on an episode related to, I think, a listeria outbreak or one of the other recent outbreaks. So I want to just start off by asking you how did you get interested in nutrition and food safety?‌

Susan Mayne: A pleasure to be here with you. I’ve enjoyed listening to your podcast for quite some time, and it’s a real opportunity for me to share some of my knowledge on your podcast. So how did I get interested? It started early for me. I went to school at CU Boulder. CU Boulder has a huge culture of health, physical activity, nutrition. I was immersed in that culture and decided I wanted to spend my career studying nutrition.‌

So it started with that, and then it broadened to food safety. I was on the U.S. Food and Nutrition Board for seven years when I was at Yale, and they cover both food safety and nutrition issues. And I learned very quickly that it’s really impossible to separate food safety from nutrition. The two are intimately interrelated, and some of the learnings I had at FDA really reinforced that.‌

So I’m passionate about both areas. I spent most of my career doing research on nutrition and chronic disease prevention. So the timing of this podcast is very interesting for me as well, given the increased focus on chronic disease risk reduction and how the food supply can be an important component of how we can reduce chronic disease risk.‌

Harlan Krumholz: Gosh, I’ve got so many questions for you. Let me start with this one. So the Red Dye No. 3, I remember when I was in college, people were saying, “Don’t eat red M&Ms.” It was just this craziness around red dyes and all this stuff. And then I was surprised to see the news that we’re actually still using the dyes, because I haven’t been paying attention to this. So I think a lot of listeners might have, saw this come across the news. And can you help us understand what are the dyes that are being used in food? What did you guys just do? And why did you do it?‌

Susan Mayne: What did I just do? I was not at FDA when this was happening, but I can tell you what FDA has done.‌

Harlan Krumholz: Okay, thank you.‌

Susan Mayne: And I can share some perspective on that. First, you ask about what are the dyes that are used in food. Well, there are a number of different dyes that are used, and sometimes they use different names, what FDA refers to as FD&C, and then a color. So FD&C 3, for example, which is Red 3. That means that FDA has reviewed these dyes, these are chemicals. They review these dyes for safety.‌

The safety standard that FDA uses is a reasonable certainty of no harm. And so that’s how they review these dyes. And not only do they review them for safety, but they also certify these dyes. And that was work that was done in the center that I led, where they actually do chemical certification, purity testing to make sure that any dyes that are in use in the food supply or in the drug supply as well. The same dyes like Red 3 were also used in drugs. So they make sure that they’re safe and they’re lacking in impurities and they meet certification standards.‌

Harlan Krumholz: Just for example, what are they, example? What chemicals are used to give color to food? What is it?‌

Susan Mayne: They are synthetic, for the most part. These are synthetic colors. Like Red 3 is something called erythrosine.‌

Harlan Krumholz: Someone sits in a lab and just creates this out of a whole bunch of other elements to say like—‌

Susan Mayne: Correct.‌

Harlan Krumholz: Okay.‌

Susan Mayne: There’s also natural colors as well, and the food industry can use natural colors. But the reason the food industry has relied on these chemicals is that consumers have shown preference for them. And we can talk about that and what that means for going forward.‌

So what FDA did is within the last two weeks, they essentially put out an announcement that they were going to ban the use of Red 3, one of the red colors, there’s other ones that are still approved. But they’re going to ban the use of Red 3 in foods and drugs that are ingested.‌

And FDA was very clear in the announcement that they were not banning it because of a concern about safety. And the reason that they ended up taking this step to ban it is based on a legal issue, and that is called the Delaney Clause. And the Delaney Clause was passed by Congress in 1958, so more than 60 years ago.‌

And it basically said, if a chemical is found to cause cancer in man or animals, FDA must ban it. It doesn’t matter what the doses are, it doesn’t matter what the mechanisms are. It doesn’t matter if there are natural forms of the chemical in the U.S. food supply, Delaney says it must be banned.‌

So what FDA did is they reviewed all that scientific literature on Red 3 and said that Red 3 would be banned because it had been shown to cause cancer in animals, specifically male rats, at extremely high dose levels. FDA had said, “We don’t see any public health risk at the levels found in the U.S. food supply.”‌

So they didn’t ban it based upon health and safety, they banned it based upon a legal requirement to ban it. And they had received a citizen’s petition from some consumer groups that invoked Delaney. They said, “FDA, you need to ban this under the Delaney Clause.” So it’s an interesting situation where this action was taken not to protect human health according to the FDA, but because they had to, based upon administrative law.‌

Harlan Krumholz: That’s interesting. Wasn’t there something about red dye many years ago though, that people were talking about?‌

Susan Mayne: Red Dye No. 2.‌

Harlan Krumholz: Two. That was Red Dye No. 2?‌

Susan Mayne: There’s a couple of different dyes, different chemicals, and consumers often conflate them all together. You hear discussions about, well, dyes can affect behavior in children, but the question is these are all different chemicals and different potential modes of action. And so FDA says we need to consider these one at a time and be specific.‌

So they will look at the actual data involving individual chemicals and take public health action accordingly. So that’s what happened with Red 3. And the other thing I will add is that it was prioritized. People have asked me, “Why did this action take place right before the end of the administration?”‌

Part of the reason the action took place is it was prioritized because California had passed some laws that said certain ingredients could not be used in foods in the California food supply. And that included some of these colors.‌

So the food industry now had a very complicated scenario where their products could not be sold in the future in one state — but a very well populated state. And so you have this regulatory scenario where the products would have been legal across the U.S. but not legal in California.‌

So I’m sure that allowed additional prioritization on Red 3, given that you have this dichotomy where a chemical is allowed in the U.S. food supply, but not in one of the most populated states in the U.S.‌

Howard Forman: And this happened at around the same time that the FDA came out with their regulatory recommendations around the front-of-package labeling, which is something that you were involved in before you left service. Can you speak to that? Because I think it ties in really well with this whole idea of making America healthy or making America healthy again, depending on how you want to see it.‌

Susan Mayne: Happy to. So a little bit, what do we mean by front-of-pack nutrition labelings? So essentially, following the passage of the Nutrition Labeling and Education Act decades ago, FDA had the authority to mandate nutrition labeling on food packages. And that led to the iconic Nutrition Facts label.‌

And so that nutrition information is available on the back of the package. But what’s hard is when consumers are trying to make rapid decisions in the grocery store, to have to turn over those packages, compare them one at a time in order to make the healthiest food choices.‌

So many countries have been looking at the use of front-of-pack labeling, so essentially taking that nutrition information and moving it to the front of the package so that consumers can more quickly access that information. Research has shown that consumers can benefit from front-of-pack nutrition labeling.‌

So FDA, with support from National Academy of Sciences that had written a report recommending nutrition front-of-pack labeling, FDA moved forward on a path to try to mandate that. Now, FDA tried this once before, and the food industry essentially intervened and said, “We’re going to do it voluntarily.” And you may have seen something on the front of food packages called Facts Up Front.‌

If you look at certain packaged foods in your pantry, you will see some nutrition information. But what the consumer research has revealed is the Facts Up Front first is not the most useful and accessible information for consumers. Moreover, it’s not used on a large number of food products, so it’s very hard to compare.‌

So this was a voluntary system that was put in place by industry and the fact that so many products chose not to use the front-of-pack labeling put FDA on a path to mandate that. So in order for FDA to mandate that, they moved first to do consumer research, focus groups, on what might be most helpful for U.S. consumers. They did behavioral research involving nearly 10,000 study subjects to test different labeling schemes to see what would be most helpful and then move forward with a proposed rule. And this was a commitment that we made in the White House National Strategy on Hunger, Nutrition, and Health. The Biden/Harris administration said, “We are going to move forward on front-of-pack nutrition labeling for consumers.”‌

And then the future actions would be, after releasing this, is to take those public comments and then finalize a rule that would mandatorily require the food industry to use uniform front-of-pack nutrition labeling across the U.S. food supply.‌

Harlan Krumholz: I wanted to talk to you a little bit about dietary supplements. This really drives me crazy when I see all these advertisements on TV. I think the viewers get confused in the sense that there are all these regulations around drugs, and yet these dietary supplements can come on. So people are hearing about, for example, treatments for Alzheimer’s, wondering about them, and then this Prevagen commercial comes on again and again and again. And as you know that this... what is it, apoaequorin, the component of Prevagen is understood, this thing, protein from a jellyfish, is understood as a dietary supplement.‌

And so they can go out and make claims about this improving memory and supporting brain health and making it seem like a miracle drug, but it’s based on this Madison Memory Study that’s gotten a lot of criticism. It’s not a large-scale amount of evidence. We see cereal boxes that say, “This can improve your immune system.”‌

We see red beets product being promoted as, this is going to elevate your cardiovascular health, really strong promotions with authoritative statements. How did we get in this predicament? Can you explain just a little bit about how this works and what the Dietary Supplement Health and Education Act of 1994 actually did to enable people to produce something and make all these claims without really having to have strong evidence?‌

Susan Mayne: So I can speak broadly about claims, ’cause I worked on those a lot at FDA. I didn’t specifically work on dietary supplements, so I think I’ll avoid the topic of dietary supplements. But claims in general. What happens with claims is, you’re running into a situation where you want strong scientific evidence, but there are also issues involving the First Amendment.‌

And where this has become relevant is, for example, FDA may say that we’re uncomfortable with some of these claims, and Congress can say, “We’re going to require you to allow the food industry to put claims on there so if there is any evidence anywhere, not the totality of the evidence, it’s there is any evidence anywhere that these products may have this purported benefit or this purported function.”‌

And so that puts the regulators in a situation where they need to follow the laws that Congress passes. And that is true with some of these health claims. So speaking broadly about health claims, there were different categories of health claims that FDA has written a lot about. There are claims that require significant scientific agreement. Those are our highest-evidence claims.‌

There are claims that are qualified and they can be so qualified where they can say things like, “FDA has reviewed this evidence and there’s inconsistent scientific evidence that this may have this role.” And a company can choose to put that on a food package if they think it will help. And one of the frustrating things for me when I was at the FDA is I had to put staff working on those qualified health claims because we were required to by Congress.‌

At the same time, I personally think they have little value for public health. And so that’s one of the challenges. And I think it brings up the theme that the actions that FDA takes are determined by the laws that Congress passes and what the agency is authorized and charged to do.‌

And so in some cases, the agency may be doing things that may not be their preference, and that includes actions taken under the Dietary Supplement Health and Education Act. But Congress sets the rules, the federal agencies deploy the resources that Congress gives them to execute that portfolio of work. And that’s how things go.‌

And I think we should talk about the resources, ’cause I highlighted a little bit about the authorities and what Congress has asked the FDA to do. And the resources, we should talk about that as well.‌

Harlan Krumholz: Well, go ahead. Obviously there’s an issue here about the disconnect between the vast responsibilities and the amount of funding that’s provided to pursue those.‌

Susan Mayne: There is, and I knew when I went to the FDA that the food side of FDA was quite underfunded. I didn’t fully appreciate just how challenging it was until I got in there and worked with all the different offices and saw their budget asks and what we had available. So just a few statistics that may help your viewers. The food side of FDA has a very, very large mandate, and that is, they oversee 80% of the U.S. food supply, just generally speaking, 80%. The other 20% is overseen by USDA. That’s primarily meat and poultry products. FDA is responsible for over 275,000 food manufacturing facilities, and half of them are across the border. These are overseas food manufacturers.‌

FDA is also responsible for produce safety. Thirty-five thousand produce farms, it’s estimated FDA is responsible for. And with the budget that we had just generally for all of that work: food safety, nutrition, all the work FDA does, it was the same budget that the U.S. Department of Agriculture had for their 20% of the food supply. So FDA is very, very constrained.‌

The number of people that we have available is determined in large part by the resources that Congress would give us. And so you asked about dietary supplements. There’s a line item in the congressional spending bill, what they call the Appropriations Bill, that directs FDA how to spend their resources.‌

So I knew how much money I had to spend on nutrition, how much I had to spend on cosmetics, how much I had to spend on food safety, chemical food safety, food ingredients. It’s authorized, determined by Congress what that appropriate funding will look like.‌

You asked about dietary supplements. We had an office that had been stood up for up to 50 employees. It was never resourced to have more than 25 people. So we had 25 people to oversee tens of billions of dollars in the dietary supplement industry. Nutrition is another area. I’ve always been passionate about nutrition.‌

I was somewhat shocked when I arrived at the FDA that the nutrition side of our budget amounted to 5%. So 5% of the center’s budget, not the FDA’s budget, 5% of the center’s budget was allotted for nutrition. We did some analyses showing the return on investment for spending resourcing actions in nutrition. It’s about $120 for every dollar we spent. Those would be the returns.‌

But despite that, I really struggled to increase the funding for nutrition. I managed to budget up from 5% of the center’s budget to 7% in my time at FDA. But it’s significantly underfunded compared to what I would really like to see resourced at the FDA.‌

Howard Forman: As I mentioned at the beginning, one of the reasons why you and I first talked about the FDA’s role in food is that you helped me understand about how the FDA works with the CDC to investigate food outbreaks. Can you comment a little about that, how the collaboration works and how genomic analysis has changed the game for our ability to track outbreaks?‌

Susan Mayne: I’d be happy to. It’s a great story, actually. A few things just to think about before we get into the outbreak. I want to say that food is not reviewed in a pre-market way, it’s post-market. FDA doesn’t approve foods before they come to the market like they do medical products and drugs.‌

So what that means is, it’s really industry’s obligation to make safe food. And FDA has done a lot to help industry make the safest food possible. But if industry fails to do that, FDA’s post-market function is critically important to get the unsafe food off the market as quickly as possible.‌

Sometimes that’s just food testing, and the FDA does significant testing. They find pathogens in food, they recall the foods. But if people are getting sick and we have outbreaks, it’s even more urgent, ’cause we know that this is a pathogen that is making consumers sick.‌

So what happens is, it starts with the people who’ve gotten sick, and that’s the CDC’s role, is to try to pull together a case series or a cluster of people who all have the same illness. And in the past, we might know that we had people, for example, with listeria infections, but we didn’t know if they were all related together or not.‌

And so what science has done is, it’s allowed us to look at the molecular analysis of the pathogen, the bug that made people sick, and actually pull together cases that we know must have consumed a related source, that they had a single source because they all have the exact same pathogen. So that’s done by molecular analysis.‌

Then FDA’s role, and this was work that was developed at the center that I led, is to do those pathogen analyses in foods, in food environments, in manufacturing facilities. If they do an inspection and they find concerning conditions, they can test that and they can find listeria.‌

They would then subject that to whole genome sequencing that could uniquely identify these pathogens. And then NIH’s role is to host all of that scientific data in publicly accessible information in real time.‌

So what that means is you can say, “Okay, we’ve got a cluster of listeria cases from five different states. We’ve got five people, they all have the same pathogen. Where have we seen this before? Have we seen this in a food? Have we seen this in a food manufacturing facility? Have we seen this in a farm?” And really make those linkages much more quickly than ever we could have done in the past.‌

So I like to draw the analogy, it’s like the Hubble telescope compared to the past technologies to investigate foodborne illnesses. And what we’ve seen is that we’re detecting more outbreaks than we did in the past, but those outbreaks are much smaller.‌

And I was shocked that in many cases we were able to solve outbreaks with as few as three people with the same illness and get back to the source and get that removed from the market. So those are your public health agencies—CDC, FDA, NIH—working together to really remove those unsafe foods from the market as quickly as possible.‌

Harlan Krumholz: That’s terrific. We’re getting to the end here. I have one more thing to ask you before we finish. You were working on this Closer to Zero initiative, and many people listening may be surprised to hear that our food may even have some arsenic, lead, cadmium, mercury. And I think people may be thinking, “Closer to Zero, you’re trying to get rid of these environmental contaminants. What the heck are they doing in our food in the first place?” And especially since, as I was reading about this in preparation for your coming here, that we have inorganic arsenic in infant rice cereal, which, that may be an important source of iron, but if it’s actually giving our babies arsenic, that doesn’t sound like a good thing.‌

So how does this happen that actually these contaminants come in there? And is it a big deal to get rid of them by the industry? How do we get in this predicament? And what are you trying to do about it?‌

Susan Mayne: It’s a great question. So these compounds that you highlighted, the reason FDA is concerned about them especially is they affect infant neurodevelopment. So our priority in looking at these toxic elements is really focusing in on sources for infants and young children, where the public health effects are most important.‌

And you are correct that these things are in our environment. They’re in the soil, they’re in the water, they’re in the air. Some of them are naturally there because of things like volcanic activity, but others are there because of human intervention in the past, and a good example for that is lead.‌

Lead was widespread in the soil when we used leaded gasoline, as an example, and leaded paints and these environmental sources that led to soil contamination. Through public health efforts, that lead has been cut down in the soil quite dramatically, and that has reduced quite dramatically infant exposures to lead, but they’re still there. And so what more can FDA do?‌

Inorganic arsenic is a great example. It’s naturally in the soil. It’s also there because of arsenical pesticide use in the past. So how do we try to get the cleanest food to our infants and young children? And that was the task we were given. So, because our resources were limited, we started in a risk-based framework, tried to figure out, where are the most important dietary sources of these toxic elements for babies and young children?‌

And the first one is infant rice cereal. And that is because it is the predominant source of inorganic arsenic in the diets of infants and young children. So we started with that and said, “Well, how can we do that? How can we get down the levels?” Rice is a grain that takes up arsenic based upon attributes of the grain.‌

So what we did is we worked with the industry very carefully, and we relied on the data and what was known about the variability in arsenic in different sources of rice. And what we were able to do is to say, “Different types of rice genotypes take it up different amounts. We want the food industry, the baby food industry to source the lowest inorganic arsenic rice they can find into the baby food market.”‌

The baby food market uses about 1% of the rice in this country. So we created what are called action levels for industry, and we said, “We want you to meet these. We want you to be bringing down inorganic arsenic levels in infant food to help protect the health of our infants.”‌

So with that one action where we worked with the industry and put out an action level for inorganic arsenic, we were able to reduce infant exposure to inorganic arsenic by about 30%. So it can be done, but it’s a complicated subject because it is naturally occurring. And what we learned is that many consumers did not understand that.‌

Many consumers thought that the infant food industry was adding these things into their food, and many consumers said, “Well, I’ll make it myself.” The problem with that, as research has shown, is you don’t get lower levels if you make it by yourself. And in fact, you could end up getting higher levels because the industry is testing every one of the ingredients that they’re putting into the baby food.‌

So it’s a complicated scenario, but it shows where science and data can lead to improvements in public health, but there’s also a critical need to communicate with consumers so they understand what’s happening in this particular space.‌

Howard Forman: Well, that’s terrific. I want to thank you for joining us, and really, at a time when people have great uncertainty about our institutions and public health, you give me a lot of reassurance that our government works together collaboratively and is actually making a lot of progress on behalf of consumers. So thank you so much for everything that you have done.‌

Harlan Krumholz: And expertise matters, Howie. Expertise matters, right?‌

Howard Forman: Yes, it certainly does.‌

Harlan Krumholz: Thank you so much, Susan.‌

Susan Mayne: Expertise and data. Everything we did required good robust data, and so that’s what really was critical for me as a decision-maker.‌

Harlan Krumholz: That’s great.‌

Howard Forman: Well, we thank you for your service.‌

Harlan Krumholz: And welcome back to Yale. We’re so happy to have you.‌

Susan Mayne: Thank you. Good to be with you.‌

Harlan Krumholz: Well, that was a terrific interview. I think we could have gone on with her for a long time.‌

Howard Forman: Oh, she’s great.‌

Harlan Krumholz: There’s so much interesting stuff around food and regulation, but hey, let’s get to one of my favorite parts of the show.‌

Howard Forman: Thanks.‌

Harlan Krumholz: Howie Forman, what’s on your mind?‌

Howard Forman: There you go. So I’ll give you a quick update on the Trump administration. And by the way, both parties have a habit of producing—‌

Harlan Krumholz: We’re nonpartisan, right?‌

Howard Forman: No, no, exactly.‌

Harlan Krumholz: Just the facts.‌

Howard Forman: That’s what I’m saying.‌

Harlan Krumholz: Just facts.‌

Howard Forman: Both parties have a habit of producing executive auditors on day one, and many of these are just fulfilling campaign promises.‌

Harlan Krumholz: Often not as many as you’ve seen recently.‌

Howard Forman: Yeah, but nonetheless, they still do it. And executive orders are far less durable or effective than enacting a law, and often they’re subject to judicial reviews. So I’m just going to review a few of them and give people an idea of what’s going on in the healthcare space.‌

So number one, Biden had extended open enrollment periods and offered additional funds in order to enroll individuals in the Affordable Care Act exchanges, what people call the Obamacare exchanges, and achieved record enrollment. Twenty-four million people are on these exchanges now. So Trump has reversed these two offerings, and one might expect that over the next year we’ll see lower enrollment because of that. But we’ll see.‌

Harlan Krumholz: Can you just explain that to me? What are these offerings you’re talking about? What exactly did he reverse?‌

Howard Forman: The two biggest things is that there were longer periods of time for you to enroll. If you lost track and you forgot to enroll, he gave you an extension for it. And the other was that he gave dollars to the states to market and help people get enrolled. And now not giving those dollars to the states would be expected to have less than an effect. So that’s a material thing. Small effect, but nonetheless, material.‌

The second thing, also, not a huge thing, but there were three different efforts sponsored by the Center for Medicare and Medicaid Innovation inside the Center for Medicare and Medicaid Services to test novel pricing for drugs through Medicare, and these were also withdrawn. And we can go into them, but they get a little too complicated, but they’re nice experiments to see what might help get prices down over time and help with cost containment without—‌

Harlan Krumholz: So can I just ask you quickly on the rationale here? So you basically provide fewer options for people by cutting off this extension. You stop an experiment about lower drug prices. There are lots of things this administration’s interested in, I never heard them campaign on that. How does that align with what their priorities are?‌

Howard Forman: If I had to guess, I would say it’s a libertarian impulse to say, “Listen, we’re giving you every opportunity to take this. We don’t have to hand-feed it to you.”‌

Harlan Krumholz: And what about the drug pricing? Why cut off an experiment like that?‌

Howard Forman: So my guess, again there, this is speculation, is that they feel like this was set up to come up with conclusions about how to get to lower prices through Medicare. And they’re more inclined toward the pharmaceutical industry right now and want to start off from scratch with their own ideas about how they might hold down drug prices. I’m being as generous as I can with how I interpret that.‌

Harlan Krumholz: Okay. Okay, keep going. What else?‌

Howard Forman: Sure. There were several COVID policies that were revoked. But most of these were from four years ago, so I’m not even sure they were meaningful. I think it was just wiping the slate clean from a period that Trump was not happy about.‌

Harlan Krumholz: What’s one example?‌

Howard Forman: Oh, I don’t know. They were helping to support the distribution of, I think, drug tests, things like that. It was not—‌

Harlan Krumholz: Stuff that wasn’t relevant anymore.‌

Howard Forman: Not relevant anymore, at least, yeah.‌

Harlan Krumholz: Okay.‌

Howard Forman: This is probably one of the most important ones, and that is he reversed several measures that were intended to protect transgender and LGBTQ individuals, including stating that there are only two genders and no longer can one indicate X on their passport as a neutral gender, and immediately shut down all federal diversity efforts. So that was a big one, and that does have health care impact.‌

And then the last one, which is the one that most people have heard about by now, is that Trump signaled his intention, our intention as a nation to withdraw from the World Health Organization. Now, we fund roughly 15% of the budget for the World Health Organization, so this is no small change for them.‌

Harlan Krumholz: What’s it like? $1.2 billion or something?‌

Howard Forman: That’s the upper limit. And a lot of that money that we give is actually voluntary contributions. And so for instance, in 2020, he had already pulled back on the voluntary contributions.‌

We have a fixed contribution that is our membership fee, and then the majority of the money that we give to the World Health Organization is voluntary. In other words, this money for Ebola or this money for AIDS treatment in sub-Saharan Africa. So we get to pick and choose things that we want to support.‌

Harlan Krumholz: And didn’t he threaten this before?‌

Howard Forman: Absolutely. This is a continuation of his preexisting policy.‌

Harlan Krumholz: And what about USAID? Does that money have anything to do with this?‌

Howard Forman: This is not part of that. No, that’s a separate program.‌

Harlan Krumholz: It’s separate program. PEPFAR, all that stuff is separate?‌

Howard Forman: That’s right. But that has to be renewed by Congress. We’re going to come back to that again. That still is at great risk.‌

Harlan Krumholz: And for everyone, this is the program, for example, that was working on HIV in Africa and that George Bush—‌

Howard Forman: Exactly. And enormously successful. So that still is at risk, but that’s not what he’s talking about now. And look, I think withdrawing from the World Health Organization would be a big mistake. I’m not an expert on this, so I’ve looked to a lot of our colleagues who are experts on public health and global health. With regard to the World Health Organization, they universally have criticism of the World Health Organization, but they also universally think that it’s far better for us to reform the organization from within than for us to be a non-member organization. We were a founding member of this, and being from the outside.‌

And look, I want to be optimistic here and think that Trump is doing this to begin a negotiation with the World Health Organization about how it has to function in the future. And if that’s the case, then so be it. But it would be a huge mistake if we do functionally withdraw by the end of next year.‌

Harlan Krumholz: And what would we want to negotiate with them? What would be the kind of thing you’d want out of that?‌

Howard Forman: I think they were very disappointed in how the investigation and communications occurred over China, so that was more of the more acute events going on. And I think that people feel that the organization has been, at times, hijacked by political considerations rather than pure science considerations.‌

And that the organization should be serving global health as a primary function and not member states as a primary function. And right now, that’s the trade-off. It’s a membership organization, and you could either serve the greater global good, or you could be serving the members and being very sensitive to their concerns. And I think they’re concerned that that is not the right approach.‌

Harlan Krumholz: I see. Wow, it’s really interesting. We’re going to have to continue to track this. So much happening so fast, which it’s really great to hear your summary. You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.‌

Howard Forman: So how did we do? To give us your feedback or to keep the conversation going, email us at health.veritas@yale.edu or follow us on any of social media, LinkedIn, Bluesky to the top of the list right now.‌

Harlan Krumholz: And we want to hear your feedback, questions, experiences. Howie, I had a phone call this week from a friend of ours who was talking about what you talked about last week, and we don’t expect people to agree all the time with what we say—‌

Howard Forman: That’s for sure.‌

Harlan Krumholz: ... but it was really great to get that kind of engagement and interest.‌

Howard Forman: No, I think you and I agree that we have some of the most engaged listeners, and we appreciate them all.‌

Harlan Krumholz: That was great to hear that. So great encouragement out to all of you. We love hearing from you. And also, if you rank us, it helps people find us, so that’d be terrific.‌

Howard Forman: And if you have questions about the MBA for Executives program at the Yale School of Management, 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 and the Yale School of Public Health. Thanks to our researchers, Inès Gilles, Sophia Stumpf, Tobias Liu, and to our producer, Miranda Shafer. They are all amazing, terrific, and help us do a great job every week. Talk to you soon, Howie.‌

Howard Forman: Thanks very much, Harlan. Talk to you soon.‌