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FDA Sugar Labeling; Ca Surgery Results: It’s PodMed Double T!

PodMed Double T is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

This week’s topics include testing pregnant women and children for lead, health benefits of FDA labeling on sugar in foods, outcomes for cancer surgery, and live kidney donation complications.

Program notes:

0:58 FDA sugar labeling of foods and health

1:52 Could save 350,000 people from cardiovascular disease

2:50 What if they reformulated beverages?

3:50 Long time for FDA implementation

4:27 Safety in top ranked cancer hospitals and affiliates

5:28 As much as 100% higher

6:28 Experience of surgeon and team

7:10 Long term outcomes for live kidney donation

8:18 Most of the events not related to surgery

9:15 10,000 patients over a long period of time

10:00 Lead levels in children and pregnant women

11:15 Suggest that blood lead level in kids should be done?

12:31 Chelating agents associated with harms in kids

13:47 End


Elizabeth Tracey: What’s the cost effectiveness of the U.S. Food and Drug Administration (FDA) added sugar-labeling policy for improving diet and health?

Rick Lange, MD: Should we be looking at blood lead levels in children and pregnant women?

Elizabeth: What’s the long-term impact of donating a kidney?

Rick: And for people undergoing complex cancer surgery, is there a difference between the top-ranked hospitals and their affiliated hospitals?

Elizabeth: That’s what we’re talking about this week on PodMed TT, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a medical journalist at Johns Hopkins, and this will be posted on April 19th, 2019.

Rick: I’m Rick Lange, President of the Texas Tech University Health Sciences Center in El Paso, where I’m also Dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, how about if we start with this one that I rather awkwardly just read the title from — that’s in the journal Circulation. The title, again, is “Cost-Effectiveness of US FDA Added Sugar Labeling Policy For Improving diet and Health.” What’s interesting about this study — and the reason I did it that way — is that I’m not sure I could have phrased it any better; there are so many dependent clauses. But basically, what this is, is an analysis of a model for, “Hey, if we fully implemented FDA labeling with regard to adding sugar to foods, what would be the impact on health?”

We’ve got this micro-simulation model and it was used to estimate both cardiovascular disease and type 2 diabetes that would not occur if these sugar guidelines were fully implemented. It also looked at the quality-adjusted life-years (QALYs), policy costs, healthcare, informal care, and lost productivity. They said, “At the end of the day, if we fully implemented these policies, we could save 350,000+ folks from cardiovascular disease, almost 600,000 from developing diabetes, and a bunch of money — $31 billion in net healthcare costs or almost $62 billion in societal costs — by implementing these things.”

So I find it really interesting when I speculate on this because these sugar-labeling guidelines are already in place. But just recently, the FDA has announced that there is going to be another delay in mandatory participation — while some manufacturers are already voluntarily labeling added sugar on their products, they are not compelled to do so. And now the FDA has said [that] until 2020, it’s not going to be necessary.

Rick: The second part of the study was based upon that, what if they reformulated their particular beverage, and that is, lower the sugar content? The savings and the healthcare benefits you described, they are doubled if you reformulate based upon this information. This is a significant benefit, just in terms of healthcare, but also towards societal cost savings, and I was not aware that this small amount of information could have such substantial health benefits and cost savings as well.

Elizabeth: It’s very interesting. And it turns out that, of course, what happens is, when this labeling is there and consumers start to veer away, then manufacturers voluntarily will change formulations so they can regain their market share.

Rick: By the way, we see this in many of the fast food chains now where you can look at the caloric intake or the sugar intake. I do admit it really does alter what I’m going to order. I, like you, am disappointed in the fact that these aren’t being mandated for another year or two when there’s a clear benefit.

Elizabeth: That is definitely something about the FDA I would like to understand better, and I really, I do not. I would point also to regulation of nicotine and how long it’s taken for that to actually be fully implemented — it’s not, even at this point.

Rick: Wish I had an answer for that Elizabeth. My role in the FDA is limited to looking at cardiovascular devices, so I have no insight into this. But what I would call upon manufacturers is, if it’s not mandated, let’s do it voluntarily.

Elizabeth: I wonder if they could cease that and actually advertise the fact that they are looking out for health and they are already trying to change formulations to benefit people’s health.

Rick: Advocating on their social responsibility and taking advantage of it, and I couldn’t agree more.

Elizabeth: Let us turn to which of your favorites would you like this week.

Rick: Let’s talk about this differential safety between top-ranked cancer hospitals and their affiliates for people undergoing complex cancer surgery. We have, for example, things like U.S. News & World Report that rank them, so we can pick those top cancer hospitals, and many times now they’re associated with community hospitals or other affiliated hospitals that share their name. The question is, are the outcomes as good for these complex cancer surgeries?

That’s what these investigators addressed. They looked at 59 different top-ranked hospitals and their affiliates, 343 different affiliates, and almost 30,000 patients that underwent complex cancer surgery, about 60% of them at the mother hospital and about 40% at the affiliate hospitals. They looked at 90-day mortality.

What they discovered was that the likelihood of surviving complex cancer surgery was greater at the top-ranked cancer hospitals compared with the affiliated hospitals. On average, it was about 40% higher, but in some cases for some surgeries, it was as much as 100% higher. Then when they looked at the different networks, they determined that in 85% of those networks this was in fact the case — the mother hospital had better outcomes than the affiliated hospitals.

Elizabeth: Clearly saying to consumers, when they are selecting these things, they ought to select the mother ship rather than going to one of the affiliates. This, of course, is in JAMA Network Open, and I’m not really terribly surprised by this. I think we’ve circled around these kinds of outcomes for a long time.

Some of the factors, of course, that are just so very important [include] how often do you do a certain procedure. For some of these complex cancer surgeries — and I would point to things like Whipple operations — they are exceedingly complex, and so doing them more and more often is really going to involve having those people come to you when that surgery needs to take place. And the other thing is the team, and how experienced is the team, and we’ve also talked about many studies that point to that as being really important in [the] outcome.

Rick: For our listeners that may not be familiar, the Whipple procedure is done on people that have pancreatic cancer. So Elizabeth, on the one hand, you say you’re not terribly surprised by these results. I have two responses. First of all, nobody has ever looked at it before and there is the assumption that by the affiliate assuming the other hospital’s name, the results would be equivalent.

Other studies have shown that somewhere between 1/3 and 1/2 of patients who would otherwise have gone to the bigger hospital will change their mind and go to the affiliated hospital just because it shares the same name. So that’s why I thought this particular study was important for our listeners to understand.

Elizabeth: Good information for people to have. Let’s turn from here to another study that’s in JAMA Network Open. This is one that came over the transom for me with a lot of interest because we just did [it] at Hopkins, of course, this historic HIV-to-HIV kidney transplantation. Some of the questions that surrounded that for the woman who donated her kidney were, gosh, if you have HIV, is there going to be a problem for you in the long haul because you’ve given up one of your kidneys? And it’s been a recurring issue with regard to living kidney donation.

In this study, they took a look at just shy of 10,000 living kidney donors for whom the data was complete and available. Almost 15% of them did have a post-donation event. Those four most common events were the development of high blood pressure — and that happened in just over 8% of the folks — diabetes development in just over 2%, proteinuria in just shy of 2%, and a postoperative ileus — which I’m a little bit less concerned, at least in the long haul, about that one — in 1.5%.

They also discerned that most of these events that occurred more than 2 years after donation were nonsurgical and could occur up to 40 years after somebody donates. And so the conclusion clearly is just when somebody has donated a kidney and we think they’ve gotten over it, and it’s all fine, and things are all functional, that these people need to continue to be looked at fairly carefully.

Rick: I think your point is well-taken. This is educational. What it doesn’t do is it doesn’t compare to the general population. So you identified — you’re right, if you look for up to 40 years after someone’s donated a kidney, some will develop diabetes and some will develop hypertension. But if you look at the general population, that’s true as well. What I do think this does is it provides some reassuring information that 85% of individuals who donated a kidney really don’t have significant events afterwards. One of the major benefits is it has a large number of patients — 10,000 patients — followed over a long period of time.

Elizabeth: Yeah. I think the one thing is you’re exactly right. I’m not surprised by the development of diabetes or the proteinuria. The high blood pressure, of course, is something that we can definitely deal with. In fact, that does happen in 8+% of people who donate a kidney. Maybe increased vigilance is important.

Rick: I agree with you for anybody that’s donated a kidney. But I would say, just, in general, anybody that’s aging — and that would include everybody that’s listening to us, by the way — needs to have follow-up for routine preventive things. As you mentioned, these things didn’t occur within a short period of time after the kidney donation. These occurred 2 to 40 years later, which indicates to me this is just some of the chronic health issues that we all need to be vigilant about.

Elizabeth: Speaking of vigilance then, let’s turn to the Journal of the American Medical Association and the USPSTF — the U.S. Preventive Services Task Force — taking a look at screening for elevated blood levels of lead in childhood and pregnancy.

Rick: This was an update because the USPSTF had addressed this issue in 2006. Blood lead levels, if they are elevated, can affect the neuropsychiatric component of someone’s health. They can affect [the] kidneys. In women, they can affect pregnancy in terms of the fetus and in terms of the mother. What they concluded, in short, after looking at all the additional studies over the last 13 years was, “We still don’t have enough information to suggest that this is beneficial.”

This is an important nuance. What the USPSTF does is, in a very rigorous way, look at all the data, and does the data inform us of whether any particular practice is going to help prevent disease? This doesn’t say we shouldn’t do it. What it says is, “We don’t have enough information to know whether we should or we shouldn’t.” So this calls for an opportunity to investigate this a little bit more fully.

Elizabeth: I think one of their conclusions, the one that screening questionnaires were not accurate for identifying children with elevated blood levels, is important also. And I guess one question I would have about that is, does that suggest that we ought to do a blood lead level in kids as a routine part of just “well care”?

Rick: What I will tell you is that there are other organizations that have recommendations based upon this. So while the screening questionnaire is not very helpful, doing things from a small amount of blood that is a little fingerstick is very accurate.

What populations should we consider it in? Well, the American Academy of Pediatrics suggests that it should be done in Medicaid patients — that’s because we know it’s related to socioeconomic status — and high-risk populations such as immigrants, international adoptees, and targeted screening for children between 1 and 2 years of age who live in communities where more than 25% of the housing was built before 1960, because it is more likely to have lead paint. Or if we know that there’s an area endemic where children are more likely to have an elevated — that is more than 5 mcg/dL — concentration in that area. Also, kids that live in or visit a home or childcare facility that has a lead hazard.

What about in pregnant women? Well, the American College of Obstetrics and Gynecology recommends we screen women that might be in some of these high-risk areas, and if they are, those women should probably have blood levels detected as well.

Elizabeth: Then that brings me to the other conclusion that was a part of this report, which is that chelating agents that are used to actually reduce those blood lead levels were associated with significant harms in children.

Rick: Right. It’s interesting because the chelating agents that one typically gives, it can lower the blood lead levels. The question is does it have a long-term beneficial effect 4, 5, or 6 years down the road? And they weren’t able to demonstrate that. Again, it’s a gap in our knowledge.

What I would say, though, is if you’ve identified an individual that has high blood levels of lead, one of [the] things we need to do is we need to determine what the cause is and remove that cause. So that information, although it may not lead to chelation therapy being beneficial, can lead to other modifying behaviors that will lower the blood lead levels, and that is important.

Elizabeth: So I think for right now, I guess, what I would say is the take-home for people who may be listening if they’re concerned about it, if they feel that they are in a risk group, that they ought to probably be tested.

Rick: That can be done with as little as a drop of blood from a fingerstick.

Elizabeth: On that note, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.