[Senate Hearing 118-211]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 118-211

                 WHAT IS FUELING THE DIABETES EPIDEMIC?

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                                   ON

                    EXAMINING THE DIABETES EPIDEMIC

                               __________

                           DECEMBER 14, 2023

                               __________

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                                Pensions
                                
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                 BERNIE SANDERS (I), Vermont, Chairman
PATTY MURRAY, Washington             BILL CASSIDY, M.D., Louisiana, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  LISA MURKOWSKI, Alaska
MAGGIE HASSAN, New Hampshire         MIKE BRAUN, Indiana
TINA SMITH, Minnesota                ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            MITT ROMNEY, Utah
JOHN HICKENLOOPER, Colorado          TOMMY TUBERVILLE, Alabama
ED MARKEY, Massachusetts             MARKWAYNE MULLIN, Oklahoma
                                     TED BUDD, North Carolina

                Warren Gunnels, Majority Staff Director
              Bill Dauster, Majority Deputy Staff Director
                Amanda Lincoln, Minority Staff Director
           Danielle Janowski, Minority Deputy Staff Director
                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                      THURSDAY, DECEMBER 14, 2023

                                                                   Page

                           Committee Members

Sanders, Hon. Bernie, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Cassidy, Hon. Bill, Ranking Member, U.S. Senator from the State 
  of Louisiana, Opening statement................................     4

                               Witnesses

Gearhardt, Ashley, Ph.D., Professor of Psychology, University of 
  Michigan, Ann Arbor, MI........................................     6
    Prepared statement...........................................     8
    Summary statement............................................    15
Taillie, Lindsey Smith, Ph.D., Associate Professor, Department of 
  Nutrition, University of North Carolina, Chapel Hill, NC.......    15
    Prepared statement...........................................    17
    Summary statement............................................    23
Lipska, Kasia, M.D., M.H.S., Associate Professor of Medicine, 
  Yale School of Medicine, New Haven, CT.........................    24
    Prepared statement...........................................    26
    Summary statement............................................    29
Stanback, Natalie, Volunteer, JDRF, Lewisville, TX...............    30
    Prepared statement...........................................    31
    Summary statement............................................    32
Kowalski, Aaron J., Ph.D., Chief Executive Officer, JDRF, New 
  York, NY.......................................................    33
    Prepared statement...........................................    35
    Summary statement............................................    38

                          ADDITIONAL MATERIAL

Cassidy, Hon. Bill:
    Submitted on behalf of Hon. Susan Collins, Endocrine Society, 
      Statement for the Record...................................    57
Budd, Hon. Ted:
    Estimating the Cost of New Treatments for Diabetes and 
      Obesity, American Enterprise Institute.....................    59
Kaine, Hon. Tim:
    JDRF 2023 Children's Congress Scrapbook, Submitted for the 
      Record.....................................................    60

 
                 WHAT IS FUELING THE DIABETES EPIDEMIC?

                              ----------                              


                      Thursday, December 14, 2023

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.

    The Committee met, pursuant to notice, at 10:02 a.m., in 
room 430, Dirksen Senate Office Building, Hon. Bernard Sanders, 
Chairman of the Committee, presiding.

    Present: Senators Sanders [presiding], Casey, Baldwin, 
Kaine, Hassan, Smith, Hickenlooper, Cassidy, Collins, Braun, 
Marshall, and Budd.

                  OPENING STATEMENT OF SENATOR SANDERS

    The Chair. Senate Committee on Health, Education, Labor, 
and Pensions will come to order. Today, we are going to be 
discussing one of the major health crises in America, and that 
is the diabetes epidemic that is having a huge impact on our 
Country and an issue that must be addressed.

    Diabetes, as I think we all know, is not only a serious 
illness unto itself, but it is a contributing factor to heart 
disease, stroke, amputations, blindness, and kidney failure. 
Type 1 diabetes is a major problem that impacts over 1.4 
million Americans, and we are going to be discussing that issue 
today.

    My understanding is that Senator Cassidy has brought two 
witnesses who are extremely knowledgeable about type 1 
diabetes, and we look forward to hearing what they have to say. 
My focus is going to be on type 2 diabetes, which impacts about 
95 percent of Americans who have diabetes.

    There is obviously a whole lot that can be said about 
diabetes, but here are just a few of the questions that I hope 
we will dive into this morning. First, and maybe most 
importantly, why have we seen a huge increase in the number of 
people in America who have developed diabetes over the last 50 
years? What is going on? What has changed?

    I think that may be the most important question. Second, 
how is diabetes impacting our healthcare system? And I think we 
know some of those answers. Thirdly, given the huge number of 
people who are struggling with diabetes, how can we make the 
treatments, and there are some very effective treatments out 
there how do we make them available to everyone who needs them 
regardless of their income?

    Further, when we talk about the cost of treatments and 
diabetes, we are cognizant of the fact that Medicaid and 
Medicare and other public health programs spend huge amounts of 
money for those treatments, as do private health insurance 
companies. So how do we make sure that we don't bankrupt 
Medicare and Medicaid in the process of treating diabetes? 
First, the problem.

    Today in America, rather remarkably, we have over 35 
million Americans, that is over 10 percent of our population, 
who have type 2 diabetes. And the cost of treating that disease 
is absolutely staggering. According to the American Diabetes 
Association, the total cost of diabetes in the United States 
was nearly $413 billion last year, $413 billion, and that is up 
27 percent over the past 6 years.

    That amounts to about 10 percent of our overall health care 
costs. So, $1 out of every $10 spent on health care is dealing 
with diabetes. And when we talk about the type 2 diabetes 
epidemic and the huge increase in new cases, we must also talk 
about another epidemic, and that is the epidemic of obesity in 
America.

    Some 90 percent of people with type 2 diabetes are 
overweight or obese. These two epidemics go hand in hand. A key 
question that we must discuss. How did it happen, according to 
the CDC, that the rate of childhood obesity in America has 
tripled since the 1970's, tripled since the 1970's, and has 
gotten so bad that one out of every five children, and over 40 
percent of adults in our Country, today are now obese.

    Why is it that, according to the CDC, the number of 
children in America with type 2 diabetes is estimated to 
skyrocket by nearly 700 percent over the next 40 years unless 
we get a handle on that issue. Isn't that just an extraordinary 
number? The answers to those questions are not complicated. 
Difficult, but not complicated.

    For decades, in my view, we have allowed large corporations 
in the food and beverage industry to entice children to eat 
foods and beverages loaded up with sugar, salt, and saturated 
fat purposely designed to be overeaten. The situation has 
gotten so bad that most of what children in America eat today 
consist of unhealthy, ultra processed foods that doctors have 
told us lead to a higher risk of type 2 diabetes.

    Alarmingly, according to a recent study that will be 
discussed this morning, ultra-processed foods, which make up an 
incredible 73 percent of our Nation's food supply, can be as 
addicted--addictive, can be as addictive as alcohol and nearly 
as addictive as cigarettes.

    While diabetes and obesity rates in America soar, while we 
spend hundreds of billions of dollars to treat diabetes, the 
food and beverage industry spent $14 billion last year on 
advertising to make many of their unhealthy products appealing 
to the American consumer.

    Even worse, and I think really what gets to me, $2 billion 
of their advertising budget is used to directly market food 
predominantly high in sugar, salt, and saturated fat to our 
children in order to get them hooked on these products at an 
early age.

    How is that? According to the Rudd Center for Food Policy 
and Obesity, children and teens view about 4,000 food and 
beverage ads on television every year, an average of 10 
advertisements each day. Another study found that children who 
watch Nickelodeon and Nicktoons are exposed to over 10 
unhealthy food and beverage ads every hour, they're going after 
the children. Let me give you just one example.

    Last year, for example, Coca Cola spent $327 million on 
advertising in the United States alone. Not one of those ads 
will tell you that drinking one or two cans of Coke a day will 
increase your chances of getting type 2 diabetes by 26 percent. 
I didn't quite see that in those lovely ads that they do.

    Nor will their TV ads tell you that one 20 ounce bottle of 
Coke contains over 15 teaspoons of sugar, more than twice the 
recommended daily limit for kids under the age of 18. Nearly 30 
years ago, as I think we all know and the American people know, 
Congress had the extraordinary courage and it was not easy to 
take on the tobacco industry, whose products killed over 
400,000 Americans every year, including my father.

    Congress had the courage to do that then. Now is the time 
for us to seriously combat the type 2 diabetes and obesity 
epidemics in America. In order to do that, we must have the 
courage to take on the greed of the food and beverage industry, 
which every day is undermining the health and well-being of our 
children.

    As adults, as responsible people, as representatives of the 
American people, we have got to do that. And in my view, a good 
place to start would be to ban junk food ads targeted to 
children. Now, this is not a radical idea.

    The NIH has estimated that if the United States banned fast 
food advertising marketed to children, talking about kids, we 
could cut the childhood obesity rate in our Country by up to 18 
percent.

    In the 1980's, Quebec banned junk food advertising to 
children. Today, Quebec has the lowest childhood obesity rate 
in Canada and the highest consumption of fruits and vegetables 
of any province in their nation.

    Ireland, Sweden, South Korea, Taiwan, Spain, Portugal, and 
several other major countries throughout the world have either 
seriously restricted or banned junk food ads targeted to 
children.

    In addition to addressing the causes of type 2 diabetes, 
there is another important issue that we have got to address. 
We have got to make certain that the treatments available to 
people with diabetes are affordable for all Americans and are 
not bankrupting Federal health insurance programs or raising 
the cost of private insurance.

    The very good news is that a new class of treatments for 
diabetes and obesity like Ozempic and Mounjaro have the 
potential to be a game changer with respect to these major 
epidemics. According to clinical trials, these drugs, which 
suppress appetite, have been estimated to help people lose 15 
to 20 percent of their weight.

    That is the good news, and it is importantly good news. The 
bad news is that these drugs also have the potential to 
bankrupt Medicare and the American people. According to 
research published in the New England Journal of Medicine, if 
just 10 percent of people with obesity on Medicare took these 
drugs, it could cost Medicare up to $27 billion a year, driving 
Medicare premiums way, way up.

    Further, incredibly, these drugs, Ozempic and Mounjaro are 
up to 15 times more expensive in the United States than they 
are in other major countries. Let me repeat, these two 
important drugs, up to 15 times more expensive in the United 
States than in other countries. Ozempic, manufactured by Novo 
Nordisk, cost $12,000 a year in the United States. Do you know 
what it costs in Germany? $750 a year.

    Mounjaro, manufactured by Eli Lilly, costs $13,000 in the 
United States, costs $2,000 a year in the United Kingdom. 
Incredibly, it has been estimated that Eli Lilly, Novo Nordisk, 
and others in the pharmaceutical industry stand to make as much 
as $150 billion off of these drugs each and every year by 
charging us by far the highest prices in the world for their 
products.

    This is, to my mind, unacceptable for so many reasons, and 
that is why I am going to be introducing legislation which is 
very simple. It is legislation that says that here in the 
United States, we cannot continue to pay the highest prices in 
the world for prescription drugs. We should not be paying more 
than other major countries.

    If that bill were to be signed into law, we would lower the 
cost of prescription drugs in this country by 50 percent. So, 
that is where we are today. We have two issues. What is the 
cause of the epidemic, and how do we make sure that we have 
treatments available to all?

    I very much thank all of the panelists for being here. This 
is a very important issue and I look forward to this 
discussion.

    Senator Cassidy, the mic is yours.

                  OPENING STATEMENT OF SENATOR CASSIDY

    Senator Cassidy. Thank you, Chairman Sanders. The obesity 
epidemic is quite remarkable. And type 1 diabetes obviously not 
related to obesity, but nonetheless, part of that which we are 
addressing today.

    If you look at a kind of a map of the United States over 
the last three decades and the prevalence and incidence of 
diabetes, it just lights up. Goes bigger and more intense, 
etcetera, however you look at the map. So, it is a bipartisan 
issue. I am glad the Committee is addressing it.

    I will say, however, that the focus of the hearing has 
changed from our original agreement to explore the prevention, 
treatment, and management of diabetes from a clinical and 
public health perspective.

    Diet and access to healthy foods are important, but I will 
point out that corporate marketing practices to consumers and 
human nutrition are not the jurisdiction of this Committee. 
Those are on the Commerce and Agriculture.

    Food marketing is what this Committee will focus on today, 
but ideally, the Committee's time would be addressing issues 
over which we have legislative authority. If we have 
legislative authority, we can do something. If we have a 
hearing on something over which we have no legislative 
authority, we have a hearing.

    I will also point out, though, that our colleagues, Senator 
Susan Collins and Jeanne Shaheen have led the Special Diabetes 
Program Reauthorization, which the Committee did successfully 
vote out in June. When enacted, it will provide additional 
mandatory resources for diabetes research at NIH.

    I would also like, and that would be a good thing to have 
discuss today, how the NIH is using its discretionary funding, 
because that is something over which we do actually have 
jurisdiction. We should look at why NIH habitually under funds 
obesity research, despite it being the kind of foundation of 
why the rate of type 2 diabetes has gone up so dramatically, as 
well as, by the way, its impact upon many other medical 
conditions.

    It is important to explore the impact of recent medical 
advances upon the lives of diabetics. American medical 
innovation is saving countless lives. Diabetes is no different. 
Groundbreaking developments in diabetes management like the 
continuous glucose monitor, or CGM, increases patient adherence 
to treatment while improving quality of life for patients and 
peace of mind for parents and caretakers.

    We could familiarize ourselves more with that. I am a doc, 
but I wasn't aware of it. And then somebody says, oh, you look 
on your phone and you see what your diabetes is. It kind of 
really brings it home to the folks.

    It was quite remarkable. My internist friends explaining to 
me how this has been so positive of a change in terms of the 
management of diabetes. We can point out that even 10 years 
ago, parents were worried about their children developing 
diabetic shock.

    But now, with affordable CGMs and other innovative devices, 
blood glucose levels are monitored in real time, and these 
devastating occurrences, such as diabetic shock, are prevented.

    We need to continue to foster innovation and the solutions 
it creates. CGM are miracles to many now, but at some point it 
will become yesterday's news. We need the next miracles. 
Cellular treatments are on the horizon, and we have the 
potential to again revolutionize how Americans live with 
diabetes.

    I visited an outfit in Massachusetts, and they showed me 
this kind of twirling bath, and they said those are islet cells 
that can be gathered up and injected under someone's arm, and 
this is a technology that will be implemented. Quite 
remarkable. Again, we could have been discussing that today.

    The task of this Committee is to balance affordability with 
innovation. I accept the Chair's point. If there is an 
innovation that someone cannot afford, it is as if that 
innovation doesn't occur.

    I am with you on that. But we should again be discussing 
topics within the Committee's jurisdiction. That is what we 
have the responsibility to do. And if there is something that 
we can actually address, then consider legislation.

    I look forward to exploring the issues that we can address 
with our witnesses. With that, I yield.

    The Chair. Thank you very much, Senator Cassidy. Now we are 
going to hear from our very distinguished and knowledgeable 
witnesses, and we are delighted they are with us today. Our 
first witness will be Dr. Ashley Gearhardt, who is a Professor 
of Psychology and Clinical Science at the University of 
Michigan.

    Dr. Gearhardt's research focuses on the effects of poor 
nutrition on diabetes and obesity, and factors driving 
excessive consumption of unhealthy foods. Notably, she has 
published a recent study on how ultra-processed foods can be as 
addictive as nicotine and alcohol. Dr. Gearhardt, thanks so 
much for being with us.

STATEMENT OF ASHLEY GEARHARDT, PH.D., PROFESSOR OF PSYCHOLOGY, 
             UNIVERSITY OF MICHIGAN, ANN ARBOR, MI

    Dr. Gearhardt. Chairman Sanders, Ranking Member Cassidy, 
and distinguished Members of the Committee, thank you for the 
opportunity to participate in today's meeting.

    To begin, I will briefly review my qualifications to speak 
as an expert at this hearing. I received my Ph.D. in Clinical 
Psychology at Yale University with a focus on addictive 
disorders, obesity, and disordered eating.

    I am currently a Professor of Psychology and the Director 
of the Food and Addiction Science and Treatment Lab at the 
University of Michigan. I am also a licensed clinical 
psychologist. Through my clinical experiences, I have gained a 
firsthand understanding of how hard people are working to try 
and get control over their eating.

    I saw that even when people were faced with life 
threatening health conditions like diabetes and were very 
motivated to change, they still failed to do so. My research 
has been built on the parallels between what I observed in the 
clinic and my scientific training on how certain substances can 
trigger addictive processes.

    In my research I use multi-method approaches to explore the 
neuro-biological, psychological, and behavioral factors that 
contribute to compulsive overeating and its negative 
consequences like obesity and diabetes. The American food 
supply has changed dramatically over the last 40 years.

    The American diet is now composed mostly of ultra-processed 
foods. Ultra-processed foods are industrially manufactured 
products created by deconstructing foods from their component 
parts, modifying them, and combining them with a myriad of 
additives.

    The resulting ultra-processed foods contain little, if any, 
whole foods, and they are a major source of added sugars and 
saturated fats in our diets. The average American adult and 
child gets the majority of their calories from ultra-processed 
foods.

    Ultra-processed foods have been implicated in health 
conditions like depression and obesity across numerous studies. 
Based on analysis of 400,000 people, every 10 percent increase 
in ultra-processed food intake is associated with a 12 percent 
higher risk of type 2 diabetes.

    There are strong parallels between addictive substances and 
ultra-processed foods. Addictive substances are created through 
processing natural substances like fruits or leaves into new 
products that rapidly deliver a naturally high doses of 
reinforcing ingredients into the body like nicotine and 
cigarettes.

    Ultra-processed foods are similarly created by altering 
natural substances like fruits and grains into products that 
deliver a naturally high doses and combinations of 
carbohydrates and fats, which are then rapidly digested by our 
bodies.

    Additives further enhance the flavor and texture of these 
ultra-processed foods and make them shelf stable, accessible, 
and convenient. Basic neuroscience finds that ultra-processed 
foods high in carbohydrates and fats activate reward systems in 
the brain in an analogous manner to addictive substances like 
nicotine.

    Key signs of addiction occur in our intake of ultra-
processed foods. Systematic reviews of over 280 studies 
estimate that 14 percent of adults and 12 percent of children 
meet the criteria for an addictive disorder in their intake of 
ultra-processed foods.

    This includes losing control over intake, intense, almost 
irresistible cravings, and an inability to reduce intake 
despite serious negative consequences. This addictive pattern 
of ultra-processed food intake is associated with a more than 
five times greater occurrence of type 2 diabetes. I want to 
provide a representative quote from a research participant from 
my lab.

    She said, I can't even be in the same vicinity as a donut 
store or any type of donuts because I will finish a dozen all 
by myself, and I am a type 2 diabetic so that could kill me. I 
know that, and I know that I shouldn't be eating all of those. 
I shouldn't be eating one, let alone a whole dozen, but for 
some reason I just can't stop eating them.

    If addictive mechanisms are being triggered by ultra-
processed foods, this may be an overlooked reason why it can be 
challenging to reduce intake even in the face of health 
conditions like diabetes. There are also strong connections 
between the tobacco and processed food industries.

    From the 1980's to the late 2000, tobacco companies like 
R.J. Reynolds and Philip Morris became the biggest producers of 
processed food in the world. Internal tobacco industry 
documents demonstrate strategies designed to develop and sell 
cigarettes were applied to their processed food and beverage 
holdings, such as adding flavor enhancers developed for 
cigarettes into children's sugar sweetened beverages and 
increasing targeted marketing to children and racial ethnic 
minorities.

    Lessons learned from the tobacco epidemic can help guide 
solutions here. Investing in science to understand how ultra-
processed foods activate mechanisms of addiction and contribute 
to excessive intake is important.

    Multi-pronged approaches and a focus on prevention, 
particularly for youth, will be important for improving 
Americans' health. Thank you for your time.

    [The prepared statement of Dr. Gearhardt follows:]

                 prepared statement of ashley gearhardt
                              Introduction
    Chairman Sanders, Ranking Member Cassidy, and Distinguished Members 
of the Committee: thank you for the opportunity to participate in 
today's hearing. To begin, I will briefly review my qualifications to 
speak as an expert at today's hearing. I received my PhD in clinical 
psychology at Yale University with a focus on addictive disorders, 
obesity, and disordered eating. I have spent 11 years on the faculty at 
the University of Michigan. I am currently a professor of psychology 
and the director of the Food and Addiction Science Treatment laboratory 
at that institution. I am also a licensed clinical psychologist who has 
provided treatment to individuals with substance use disorders, 
obesity, and compulsive overeating.

    Through my clinical experiences, I have gained a firsthand 
understanding of how hard people are working to try and get control 
over their eating behavior. I saw that even when people were faced with 
life threatening health conditions, they often still failed to reduce 
their intake of highly palatable foods despite being motivated to 
change. My research has been built on the parallels between what I 
observed in the clinic and my scientific training on how certain 
substances can trigger addictive processes that keep people stuck in 
compulsive and destructive patterns of consumption. In my program of 
research, I use multi-method approaches to explore the neurobiological, 
psychological, and behavioral factors that contribute to compulsive 
overeating across the lifespan. I have published over 175 peer-reviewed 
articles, including in prestigious outlets like the JAMA Psychiatry and 
British Medical Journal.
            Ultra-Processed Foods Dominate the American Diet
    The modern American diet is now composed mostly of ultra-processed 
foods (1, 2), which are industrial formulations manufactured by 
deconstructing foods into their component parts, modifying them and 
recombining them with a myriad of additives (3-5). Common examples of 
ultra-processed foods are industrially created candy, sugar-sweetened 
carbonated beverages, instant noodles, frozen pizza, and salty snacks 
(4). Ultra-processed foods are a distinct category from minimally 
processed foods (e.g., fruit, vegetables) that have been washed, 
chopped, frozen, dried or fermented and processed culinary ingredients 
used for home cooking (e.g., butter, flour).

    Ultra-processed foods are a major source of added sugar and 
saturated fats in the American diet (6, 7). Most ultra-processed foods 
are considered hyper-palatable due to their unnaturally high level of 
palatability-inducing nutrients (fats, sugars, carbohydrates and/or 
sodium), which trigger reward signals and reduce sensitivity to satiety 
signals (1, 8). Ultra-processed foods also often contain flavor 
additives and texturizers that enhance taste and the feel of the 
product in the mouth (3-5). The preservatives in many ultra-processed 
foods allow them to stay shelf-stable and come in convenient ready-to-
heat or ready-to-eat packages (3-5). Epidemiological research estimates 
that the average American adult now gets the majority of their calories 
(57 percent) from ultra-processed foods while intake of nutrient-rich 
minimally processed foods like fruits, vegetables, and legumes is 
decreasing (2). This estimate is even higher for youth. From 1999 to 
2018, a global team of epidemiologists found that the percentage of 
energy consumed from ultra-processed foods increased from 61.4 percent 
to 67.0 percent in children 2 to 19 years old (9).

    A converging body of research highlights the potential 
ramifications of diets composed of high levels of ultra-processed foods 
(10). High levels of ultra-processed food intake have been implicated 
in an increased prevalence of health conditions like depression, heart 
disease, and obesity (10). In a controlled randomized crossover trial, 
a team of researchers at the National Institute of Health found that 
being given a diet high in ultra-processed foods relative to minimally 
processed foods over a 2-week period was associated with an increased 
daily intake of 500 calories and a two-pound weight gain (11). This 
occurred despite the ultra-processed and minimally processed meals 
being matched on the overall calories available to participants (11). 
Furthermore, a meta-analysis of over 400,000 participants found that 
every 10 percent increase in ultra-processed food intake was associated 
with a 12 percent higher risk of Type 2 diabetes (12). Thus, the high 
levels of ultra-processed food in the American diet are a major cause 
for concern and may be contributing to the obesity and diabetes 
epidemics.
   There are Strong Parallels between Addictive Substances and Ultra-
                            Processed Foods
    Most addictive substances are created by processing natural 
substances (e.g., fruit, leaves) into a new product that delivers a 
heighted dose of a reinforcing ingredient (e.g., ethanol, nicotine) 
into the body (13). Speed of absorption is also important and the more 
rapidly the reinforcing ingredient is absorbed the more likely the 
substance is to be addictive (14, 15). All addictive substances 
activate the mesolimbic dopamine system, which is key to the reward and 
motivational mechanisms that go awry in addiction (16, 17). For 
example, cigarettes are created by processing naturally occurring 
tobacco leaves through drying and curing into products that can be 
smoked to rapidly deliver high doses of nicotine into the body. The 
nicotine in cigarettes is further amplified by flavor enhancers, such 
as sugar, cocoa, and menthol, which create brand-specific taste and 
flavor profiles (18, 19). These tastes and flavors become repeatedly 
paired with the delivery of nicotine and become salient drivers of 
smoking behavior in their own right (18, 19). The cigarettes that 
result from this processing are highly addictive and can lead people to 
continue smoking even when facing life-threatening health conditions, 
like heart disease and lung cancer (20).

    Similarly, many ultra-processed foods are created by processing 
naturally occurring substances (e.g., fruits, grains, vegetables) into 
products that deliver unnaturally high doses of rapidly absorbed 
carbohydrates and/or fats. Refined carbohydrates, like sugar, and fat 
are highly reinforcing ingredients and they are effective at activating 
reward mechanisms in the brain (13, 21-23). While many minimally 
processed foods contain either carbohydrate (e.g., fruit) or fat (e.g., 
nuts, meat), the combination of both is rare in nature (21). In 
contrast, ultra-processed foods often deliver high levels of both 
refined carbohydrates and fats. This combination has a supra-additive 
effect in activating neural reward systems (22). Evidence exists that 
sugar, fat, and ultra-processed foods can activate mesolimbic dopamine 
in the brain at similar magnitudes as nicotine and ethanol (24-29). 
Additives further amplify ultra-processed foods by coupling industry 
created flavors and textures with the delivery of refined carbohydrates 
and added fats (4, 5). Thus, these ultra-processed foods with high 
levels of refined carbohydrates and fats are highly rewarding processed 
substances that share many commonalities with addictive substances like 
cigarettes (13).
                     Ultra-Processed Food Addiction
    A common set of diagnostic criteria are used to identify 
individuals who are experiencing clinically significant problems with 
addictive substances (see Table 1), including a loss of control over 
intake, intense cravings, and continue consumption despite physical or 
emotional problems (30). In 2008, my colleagues and I developed the 
Yale Food Addiction Scale, which applies these same criteria to the 
intake of ultra-processed foods (e.g., chocolate, soda, French fries, 
pizza) (31). The Yale Food Addiction Scale has been extensively 
validated and is a widely used measure in the field with over 1000 
citations and translations available in over a dozen languages (32). 
When we first began this research, the concept of ultra-processed foods 
was just emerging and investigations into what types of foods were 
consumed addictively was limited. Given the dearth of research at that 
time, we used the term ``food addiction'' to reflect meeting the 
diagnostic criteria for a substance use disorder in the realm of food 
intake. Since that time, it has become clear that not all foods are 
consumed addictively. Multiple studies have identified that people 
report consuming ultra-processed foods high in refined carbohydrates 
and/or fats in an addictive manner, but not minimally processed foods 
like fruits, vegetables, and legumes (33-35). Dietary intake studies 
confirm that individuals who meet ``food addiction'' consume higher 
levels of ultra-processed foods, but lower levels of minimally 
processed foods (36, 37). Thus, I will refer to the construct measured 
by the Yale Food Addiction Scale as ultra-processed food addiction in 
the remainder of my testimony.

    Although ultra-processed food addiction is not currently an 
officially recognized diagnosis by the American Psychiatric 
Association, the science on this topic has grown quickly. Systematic 
reviews of over 280 studies from 36 different countries estimate the 
prevalence of ultra-processed food addiction to be 14 percent in adults 
(38), which is similar to the prevalence of alcohol and tobacco use 
disorder (e.g., 14 percent for alcohol and 18 percent for tobacco) (39, 
40). The estimated prevalence of ultra-processed food addiction is 
twice as high (28 percent) in adults with obesity (38). Particularly 
relevant to the current hearing, ultra-processed food addiction has 
been associated with a more than five times greater likelihood of Type 
2 diabetes even when adjusting for sex and age (41).

    Below is a quote from a participant who was interviewed for a 
research study in my lab about their experience with ultra-processed 
food addiction.

    ``I can't even be in the same vicinity as [donut store] or any type 
of donuts, 'cause I will finish a dozen all by myself and I'm type 2 
diabetic. So, that could kill me, and I know that and I know that I 
shouldn't be eating all those. I shouldn't be eating one, let alone a 
whole dozen. But for some reason I just can't stop eating them.''

    In children, the estimated prevalence for ultra-processed food 
addiction based on a systematic review of the literature is 12 percent, 
which surpasses the prevalence of other substance addictions at this 
stage of development (42). Children are typically protected against 
exposure to addictive substances through policy initiatives (e.g., 
marketing restrictions, age limits on purchases), but exposure to 
ultra-processed foods for children in America is a daily occurrence 
(9). There is also evidence that ultra-processed food addiction is 
important for older Americans. In collaboration with Michigan Medicine, 
my lab recently conducted a study on ultra-processed food addiction in 
the National Poll of Healthy Aging. This is a nationally representative 
poll of over 2000 older adults between the ages of 50 and 80. In this 
poll, 13 percent of participants met the criteria for a clinically 
significant ultra-processed food addiction, which was associated with a 
greater likelihood of reporting being overweight and in poorer physical 
and mental health (43). Finally, individuals with food insecurity that 
lack adequate access to nutritious food are more than three times more 
likely to meet the criteria for ultra-processed food addiction with 
chips, soda, chocolate, pizza, and ice cream being identified as the 
most addictive foods (35).

    Taken together, this scientific body of evidence suggests that 
addictive processes play an important role in contributing to patterns 
of ultra-processed food intake implicated in poor health obesity, and 
diabetes (21, 44). If addictive mechanisms are being triggered by 
ultra-processed foods, this may be an overlooked reason why it can be 
challenging to reduce intake of ultra-processed foods even in the face 
of health conditions like diabetes.
 Connections between the Tobacco and Processed Food/Beverage Industries
    The industries that profit from tobacco and ultra-processed foods 
are inter-connected. In the 1970's and 1980's, the tobacco companies RJ 
Reynolds and Philip Morris bought processed food and beverage 
companies, including Kraft and General Foods (45, 46). When Philip 
Morris merged Kraft and General Foods in 1987, it became the largest 
processed food corporation in the world (45, 46). Although the tobacco 
industry sold off many of their holdings in this arena by the late 
2000's (45, 46), they had already impacted the nature of the American 
food supply. Internal tobacco industry documents demonstrate they took 
strategies designed to develop and sell cigarettes and applied them to 
their processed food and beverage products (45, 46). This includes 
putting flavor additives developed to enhance the palatability of 
cigarettes in their leading children's sugar-sweetened drinks and 
increasing marketing strategies that targeted children and racial/
ethnic minorities (45, 46). A recent study published in the journal 
Addiction found that between 1988 to 2001 products from tobacco-owned 
food companies were significantly more likely to have foods with hyper-
palatable combinations of carbohydrates, fat, and salt compared to 
foods from non-tobacco owned companies (47). However, by 2018, non-
tobacco owned food companies had increased their level of hyper-
palatable foods to levels that compared with tobacco-owned companies 
(47). This contributed to a modern food supply composed largely of 
ultra-processed, hyper-palatable foods (1). During this same time 
period, the amount of diabetes doubled (48) and the presence of 
moderate-to-high risk obesity tripled in America (49).
               What Can Be Done to Address this Problem?
    Tobacco also provides a point of reference on how we might reduce 
the costs associated with excessive intake of ultra-processed foods. 
Even when the health consequences of smoking became more evident, it 
took decades for their addictive nature to be acknowledged. Tobacco can 
look different than other addictive substances, as it does not induce a 
clear intoxication syndrome and is legal and accessible. In part, 
because of these differences, the addictive nature of tobacco products 
was hotly debated for decades despite thousands of tobacco-related 
deaths occurring each year (20, 50). Eventually, consensus was reached 
that tobacco products were addictive based in large part on scientific 
evidence on their highly reinforcing nature and their ability to 
trigger compulsive patterns of use (20). A similar debate now exists 
about the addictive nature of ultra-processed foods (13).

    Cigarettes are complex substances with up to 4000 different 
chemicals and even now the exact dose at which nicotine can trigger 
addiction in unknown (13). However, research has investigated how 
different aspects of cigarettes interact to increase their 
addictiveness. In addition to the dose of nicotine, additives and 
delivery mechanisms that speed up the absorption of nicotine appear to 
increase the addictiveness of cigarettes (18, 19, 51). Processes that 
enhance the taste and flavor of tobacco products (e.g., sugar, menthol, 
cocoa) have also been identified as important contributors to their 
addictive nature (18, 19). Investing in similar research to unpack how 
different aspects of ultra-processed foods interact to activate 
mechanisms of addiction and contribute to excessive patterns of intake 
will be important. This science could provide guidance to inform 
consumers about the risks associated with different types of ultra-
processed foods and could guide targets for different policy 
approaches.

    A wide range of potential approaches are available for 
consideration to reduce excessive intake of ultra-processed foods to 
improve the health of Americans. The history of addressing addiction 
epidemics also suggest that no singular approach will be sufficient to 
address complex public health like the obesity and diabetes epidemic. 
However, multi-pronged strategies have been effective in reducing the 
costs associated with addictive substances. In the context of tobacco, 
combining approaches like educational programs, labeling, economic 
incentives, age restrictions and marketing limitations helped 
drastically lower smoking rates in America (52-54). Countries, such as 
Chile and the United Kingdom, are instituting similar approaches to 
address the epidemic of diet-related disease, such as limiting 
marketing for less healthy foods to children. It is also not just 
people who experience clinically impairing levels of ultra-processed 
food addiction who would likely benefit. When addictive substances are 
inexpensive, easily accessible, and heavily marketed, many people 
without a clinical level of addiction are still prone to consume these 
substances excessively and experience problems in their mental or 
physical health. Thus, widespread use of addictive substances that stay 
below the clinical threshold for diagnosis can still pose a significant 
public health burden (55). On average, Americans experience between one 
to two symptoms of addiction in their intake of ultra-processed food, 
including intense cravings and an inability to cut down on intake 
despite a desire to do so (43, 56). Thus, many Americans would likely 
benefit from approaches to reduce the dominance of ultra-processed 
foods in the American food supply. Finally, another key point learned 
from the tobacco addiction epidemic is that prevention efforts can be 
far more cost effective than relying solely on treatment (57). 
Targeting prevention efforts on youth, especially, can be particularly 
helpful to shape lifelong health promoting behaviors (57).

    Eating is necessary for survival. We each make numerous food-
related decisions every day all while surrounded by grocery stores, 
restaurants, gas stations, convenience stores and marketing that 
promote ultra-processed foods. It is essential that we address the 
factors that contribute to obesity and diabetes and encourage an 
American food supply that promotes health, particularly for our 
children.

        TABLE 1. Diagnostic Criteria for Substance Use Disorders
------------------------------------------------------------------------
        DSM-5 Diagnostic Criteria for Substance Use Disorders(30)
-------------------------------------------------------------------------
Consumption of larger amounts and/or over longer time than intended
------------------------------------------------------------------------
        Persistent, unsuccessful attempts to cut down
------------------------------------------------------------------------
Significant time spent obtaining, using, or recovering from effects
------------------------------------------------------------------------
Cravings (i.e., intense almost irresistible urges for the substance)
------------------------------------------------------------------------
Interference with role obligations at work, school, or home
------------------------------------------------------------------------
         Use despite social or interpersonal problems
------------------------------------------------------------------------
             Important activities given up or reduced
------------------------------------------------------------------------
               Use in physically hazardous situations
------------------------------------------------------------------------
Continued use despite physical and/or psychological consequences
------------------------------------------------------------------------
Tolerance (i.e., needing more and more of the substance to get the
                                       desired effect)
------------------------------------------------------------------------
Withdrawal (i.e., experiencing psychological and/or physiological
                        symptoms when reducing intake)
------------------------------------------------------------------------
Individuals meet the diagnostic threshold for a substance use disorder
  in the Substance-Related and Addictive Disorders section of the
  Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition
  (DSM 5) by endorsing at least 2 of the symptoms above plus clinically
  significant functional impairment or distress(30). Severity of
  substance use disorders determined by the number of symptoms endorsed
  (mild 2-3 symptoms; moderate 4-5 symptoms; severe 6-11 symptoms).

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                                 ______
                                 
                [summary statement of ashley gearhardt]
    Ultra-Processed Foods Dominate the American Diet: The American diet 
is now composed mostly of ultra-processed foods, which are industrial 
formulations manufactured by deconstructing foods into their component 
parts, modifying them and recombining them with a myriad of additives. 
The average American now gets most of their calories from ultra-
processed foods and they are major sources of added sugar and saturated 
fats. Ultra-processed foods are implicated in health conditions like 
depression and obesity. Every 10 percent increase in ultra-processed 
food intake is associated with a 12 percent higher risk of Type 2 
diabetes.

    There are Strong Parallels between Addictive Substances and Ultra-
Processed Foods: Addictive substances are created through processing 
natural substances to rapidly deliver unnaturally high doses of 
reinforcing ingredients to the body. Ultra-processed foods are created 
by altering natural substances into products that deliver unnaturally 
high doses of carbohydrates and fat, which are rapidly absorbed. This 
activates the reward systems implicated in addiction. Additives further 
enhance the flavor and texture of these products.

    Key Signs of Addiction Occur in the Intake of Ultra-Processed Food: 
Systematic reviews of over 280 studies estimate that 14 percent of 
adults and 12 percent of children meet the criteria for an addictive 
disorder in their intake of ultra-processed foods. This prevalence is 
doubled in individuals with obesity. This addictive pattern of ultra-
processed food intake is associated with a more than five times greater 
likelihood of Type 2 diabetes. If addictive mechanisms are being 
triggered by ultra-processed foods, this may be an overlooked reason 
why it can be challenging to reduce their intake even in the face of 
health conditions like diabetes.

    There are Strong Connections between the Tobacco and Processed Food 
Industries: From the 1980's to the late 2000's, tobacco companies like 
RJ Reynolds and Philip Morris became the biggest producers of processed 
food in the world. Internal tobacco industry documents demonstrate 
strategies designed to develop and sell cigarettes were applied to 
processed food products, such as adding flavor additives developed for 
cigarettes into children's sugar-sweetened beverages and targeting 
children and racial/ethnic minorities in marketing.

    Lessons Learned from the Tobacco Epidemic Can Guide Solutions: 
Investing in science to understand how ultra-processed food activate 
mechanisms of addiction and contribute to excessive intake is 
important. Multi-pronged approaches and a focus on prevention, 
particularly for youth, will be important for improving American's 
health.
                                 ______
                                 
    The Chair. Thank you very much, Dr. Gearhardt. Our next 
witness will be Dr. Lindsey Smith Taillie, Associate Professor 
in the Department of Nutrition at the University of North 
Carolina at Chapel Hill.

    Dr. Taillie is a nutrition epidemiologist who evaluates 
food policies and the industry's influence on consumer choices. 
Dr. Taillie, thanks so much for being with us.

STATEMENT OF LINDSEY SMITH TAILLIE, PH.D., ASSOCIATE PROFESSOR, 
 DEPARTMENT OF NUTRITION, UNIVERSITY OF NORTH CAROLINA, CHAPEL 
                            HILL, NC

    Dr. Taillie. Chairman Sanders, Ranking Member Cassidy, and 
distinguished Members of the Committee, thank you for the 
opportunity to speak with you.

    My name is Lindsey Smith Taillie, and I am in nutrition 
epidemiologist who works in the U.S. and globally. My research 
focuses on understanding how the food industry and the food 
environment influences nutrition, particularly among kids, as 
well as what policies work to create healthier diets.

    In every country where I work, one thing is true, parents 
want to make healthy choices for their kids. However, the 
current food environment makes it nearly impossible. Diets are 
a major driver of obesity and type 2 diabetes, and this problem 
is especially alarming for kids. In the U.S., pediatric type 2 
diabetes has doubled over the last two decades.

    Healthier diets prevent diabetes and are more cost 
effective than medication. So why don't we change our diet? 
First, our food supply. Most of our packaged foods are ultra-
processed and nearly half are too high in added sugar, sodium, 
and saturated fat.

    Our food contains more sugar and sweeteners than other high 
income countries. We can't make healthy choices if healthy food 
is unavailable. Second, these products are aggressively 
marketed to children and disproportionately targeted to black 
and Hispanic youth. Food companies spend $14 billion a year on 
food advertising in the U.S., of which 80 percent is for 
unhealthy foods.

    Marketing is powerful. It makes kids want unhealthy foods, 
and it makes them consume more of them. Third, kids will get 
mostly ultra-processed foods at school. Unhealthy food 
marketing inside schools is also very common. This serves to 
hook kids on unhealthy foods at a very early age. It is also 
very hard for parents to know what is healthy versus unhealthy. 
Nutrition claims like 100 percent all natural are very common 
in our food supply and lend an aura of helpfulness even to 
unhealthy foods.

    Meanwhile, the Nutrition Facts panel provides useful 
information but can be hard to understand. Parents can't make 
informed choices without accessible information. Another major 
factor is price. Ultra-processed foods tend to be cheaper than 
healthy foods.

    Even though parents want to buy healthy foods, they buy 
ultra-processed because it is cheaper. Right now, the price of 
these unhealthy products does not reflect the health cost of 
consuming them. Last, the food industry has interfered with 
science and policy. Companies that pay to play by funding 
professional societies and research scientists to change the 
narrative about what causes obesity and diabetes.

    They also position themselves as part of the solution 
through voluntary initiatives, despite overwhelming scientific 
evidence that these programs are ineffective. So how can we fix 
this? We already have good data on what works. First, the U.S. 
should require clear nutrition labels on the front of food 
packages, a policy that the majority of Americans support 
across political parties.

    The FDA is currently researching front of package labels 
for the U.S. However, many of the designs that the FDA is 
focusing on are not based on the scientific evidence from the 
10 countries that have implemented these labels, nor the many 
experiments we have conducted in the U.S.

    For example, several of the proposed FDA labels include 
numbers or color schemes that research shows consumers do not 
understand. In contrast, simple nutrient warnings like those in 
Mexico and most of South America are well understood even by 
children. In addition, in countries with these labels, the food 
industry has cut sugar, sodium, and saturated fat with no 
adverse effect on the economy.

    The FDA needs to work closely with scientists to develop 
evidence backed labels that are easy to understand and clearly 
signal to consumers when products are unhealthy. Second, the 
U.S. should limit unhealthy food marketing to kids, much as it 
has for tobacco. Restricting where ads appear and the use of 
techniques like cartoons cut kids exposure and helps them 
develop healthy preferences.

    Also, companies should not be allowed to take tax 
deductions on what they spend on food advertising. Third, our 
kids deserve classrooms that are free from corporate food. We 
should restrict the marketing, promotion, and sale of ultra-
processed foods in schools, which global data show reduces 
their availability and improves children's diets.

    We also should use economic pressure to shift the food 
supply. Just like in tobacco, poor diets create massive health 
care burden and health costs in the U.S. And as in tobacco, 
taxes on the production of sugary drinks and ultra-processed 
foods would make food companies pay the true cost of these 
products.

    Global data show that these taxes spur companies to create 
healthier products and reduce the consumption of unhealthy 
foods. To further support diabetes prevention, revenue from 
these taxes could be used to fund fruits and vegetables 
subsidies for low income families. Last, we need more funding 
for nutrition research.

    Even though nutrition is the leading cause of obesity and 
diabetes, only a tiny fraction of the NIH budget goes toward 
nutrition. Additional research funding is critical to improving 
diets and preventing obesity and diabetes.

    In conclusion, kids should not be sick because of our food 
environment. Federal policy action is urgently needed to make 
the healthy choice the easy choice. Thank you.

    [The prepared statement of Dr. Taillie follows:]

              prepared statement of lindsey smith taillie
    Chairman Sanders, Ranking Member Cassidy, and Members of the 
Committee:

    My name is Lindsey Smith Taillie, and I am an associate professor 
of nutrition and nutrition epidemiologist. I appreciate the opportunity 
to speak with you today about my research on how the food industry and 
food environments influence nutrition, obesity, and type 2 diabetes, as 
well as policy actions that other countries are using to address these 
issues.

    For the last decade, I have worked in the United States and many 
countries in Latin America, Africa, and Asia to research the design and 
test the effectiveness of food policies. Our goal has been to create a 
toolkit for what works to prevent the continued increase in diet-
related chronic diseases. Our premise, backed by scientific evidence, 
is that consumers want to make healthier choices, but that the current 
food environment makes it nearly impossible for them to do so.

    First, obesity and diabetes are pressing public health concerns. 
Twenty percent of our children have obesity, as do 42 percent of 
American adults (Hu & Staiano 2022; Li 2022). Obesity is linked to a 
plethora of adverse health effects, including sleep apnea, joint pain, 
cardiovascular disease, cancer, and type 2 diabetes (Wang 2019; Raud 
2020; Larsson 2019; Pati 2023; Klein 2022). Even more concerning, the 
incidence of type 2 diabetes among children has nearly doubled over the 
last 20 years (Wagenknecht 2023). These problems do not impact all 
Americans equally--Black and Hispanic children have been 
disproportionately affected, with steeper increases in both obesity and 
diabetes (Katz, Rodriguez & Knowles 2021). These health consequences 
are also very costly: Over $300 billion dollars is spent annually in 
the U.S. to treat diabetes, with an additional $100 billion spent on 
indirect costs like lower work productivity, unemployment due to 
chronic disability, and premature death (Parker 2023). About 67 percent 
of diabetes costs are paid by Medicare and Medicaid (U.S. Department of 
Health and Human Services 2021).

    Poor diets are the culprit of the obesity and type 2 diabetes 
epidemics. Americans are the world's leading consumers of sugary drinks 
and ultraprocessed foods. Put simply, ultraprocessed foods are what you 
might know as ``junk food:'' food that is industrially produced and 
often contains high levels of added sugar, sodium, and saturated fat, 
as well as additives, colorants, and preservatives. Currently, 
approximately half of American children and adults consume sugary 
drinks on a given day (Marriott 2019). Drinking sugary beverages 
promotes excess calorie intake, which leads to weight gain (Nguyen 
2023). Over time, the accumulation of fat can turn into non-alcoholic 
fatty liver disease, increase risk of diabetes, and raise the risk of 
heart disease (Qin 2020; Chen 2019; Yang 2022). Relevant to this 
hearing, obesity contributes to the development of type 2 diabetes by 
promoting insulin resistance, inflammation, and dysfunction of insulin-
producing cells (Kahn 2016; Luca & Olefsky 2008). In other words, 
excess fat disrupts our bodies' ability to produce and use insulin. 
Research also suggests that unhealthy diets can increase 
cardiometabolic risk through other mechanisms like altering the gut 
microbiome, disrupting hormonal signaling pathways, and affecting the 
brain's reward responses (Stanhope 2018).

    Ultraprocessed foods also pose a major threat to our health. A 
century ago, ultraprocessed foods did not exist. Now, 57 percent of 
calories consumed by U.S. adults and 67 percent of calories consumed by 
kids come from ultraprocessed foods (Juul 2022; Wang 2021), with 
consumption rising most rapidly among Black and Mexican youths (Wang 
2021). High consumption of ultraprocessed foods substantially increases 
risk of obesity (Moradi 2023; Lane 2020), metabolic syndrome (Lane 
2020), and cardiovascular disease (Suksatan 2022). The most compelling 
evidence to date comes from a rigorous randomized crossover trial 
conducted by Kevin Hall at the NIH (Hall 2021). In the study, 
participants were allowed to eat freely from nutrient-matched 
ultraprocessed vs. minimally processed menus for 2 weeks. The study 
found that during the ultraprocessed weeks, participants consumed 
roughly 500 more calories/day and gained 2.2 lbs (of mostly fat mass).

    Sugary drinks and ultraprocessed foods are designed for 
overconsumption, leading people to take in more calories than they want 
or realize. It is very easy to overconsume ultraprocessed foods because 
they are ``hyperpalatable,'' meaning they combine salty, sweet, and fat 
flavors in irresistible combinations not found in nature. They do not 
require much time or effort to prepare and are often eaten on the go or 
in front of a computer or TV, making it easy to eat or drink more than 
we realize. On a chemical level, ultraprocessed food ingredients are 
degraded to the point that they no longer give us feelings of fullness 
during digestion and send sugar and fat into our bloodstream more 
quickly.

    Improving diets could prevent and delay the onset of type 2 
diabetes in a way that is more effective and cheaper than medication 
(Lee 2019; CHOICES). The Diabetes Prevention Program clinical trial 
found better diets and physical activity reduced incidence of diabetes 
by 58 percent compared with a placebo, while metformin reduced 
incidence by 31 percent (Diab Prev Program Research Group 2002).

    Consumers want to make healthy choices. However, it is very 
difficult to eat healthy diets in the current American food environment 
for the following reasons:

          Food supply: The U.S. food supply is rife with 
        unhealthy foods: 50 percent of U.S. packaged foods in 2020 were 
        ultraprocessed, while 43 percent were high in sugar, sodium, or 
        saturated fat (under review). The U.S. has more sugar and non-
        caloric sweeteners in its packaged food supply compared to 
        other high-income, English-speaking countries (Dunford 2018), 
        and we consume on average 73 pounds of sugar, corn syrup, and 
        other sweeteners per year (USDA 2023). Product-for-product, our 
        food supply is sweeter: for example, the sugar content in 
        children's breakfast cereals is 10-20 percent higher than in 
        comparable countries (Chepulis 2019). The U.S. food supply is 
        also full of industrial food additives (e.g., colors, flavors, 
        flavor enhancers, emulsifiers, thickeners, and artificial 
        sweeteners)--ingredients which are added to make the products 
        more palatable and increase consumption. As of 2019, nearly 60 
        percent of U.S. consumer food purchases--and alarmingly, 73 
        percent of baby food purchases--contained additives (Dunford 
        2023).

          Food marketing: Sugary drinks and ultraprocessed 
        foods are aggressively marketed to children. Food companies 
        spend roughly $14 billion per year on food advertising in the 
        U.S., of which 80 percent is for unhealthy foods (Rudd Center 
        Food Marketing 2023). Companies target children with marketing 
        for unhealthy foods everywhere they live, learn, and play, 
        including on TV, social media, in product placement, at school, 
        and on their toys and clothing, and by using tactics like 
        licensed characters, A green and black television celebrities, 
        games, spokespeople, contests, and kids' clubs to attract their 
        attention. Targeted marketing to children is very common: every 
        day, U.S. children see an estimated 10 ads for unhealthy foods 
        on TV alone (Fleming-Milici 2017). Advertising to youth is 
        shifting from television to digital and mobile platforms, 
        including ads on social media, branded games and ordering apps, 
        and paid promotions from bloggers, influencers, and brand 
        Ambassadors--marketing that is often disguised as 
        entertainment. For example, teenagers see food marketing 189 
        times per week on social media apps--most for unhealthy foods 
        (Potvin Kent 2019). Children are uniquely vulnerable to the 
        impact of food marketing because of their inability to 
        recognize its persuasive intent (Harris 2009). This exposure to 
        unhealthy food and beverage advertisements increases youth's 
        preference, selection, and consumption of unhealthy foods 
        (Tsochantaridou 2023; Norman 2016).

           It is also very concerning that food companies target 
        unhealthy food marketing specifically to youth of color, who 
        are most at risk for diabetes. For example, fast food and 
        sugary drink ads appear at a higher rate on Spanish-language TV 
        than English language TV; schools with >60 percent Hispanic 
        populations have more outdoor food and beverage ads within a 
        half a mile of the school (CSPI 2023). Food companies target 
        children of color by designing specific products for them, 
        adapting pricing, advertising on specific channels or in places 
        in the community, using their own language and cultural 
        references, and personalizing digital advertisements. Companies 
        do this because children of color represent a rapidly growing 
        market with significant economic impact, have high levels of 
        media use, and are trend-setters for the general public. For 
        example, marketing campaigns targeting youth of color use 
        cause-related marketing like donations or collaborations with 
        non-profits. Coca Cola and Pepsi are responsible for the 
        majority of these marketing campaigns and they almost 
        exclusively promote unhealthy foods (Rudd Center Targeted 
        Marketing).

          Food prices: Cost drives food purchasing decisions, 
        and unhealthy foods tend to be cheaper than healthy foods. For 
        example, in New York City, the price per liter of sugary drinks 
        is higher than low-calorie drinks (Bragg 2022). In many parts 
        of the world, sugary drinks are cheaper than water (Blecher 
        2017); ultraprocessed foods also have lower per-calorie cost 
        and have faced slower price increases in recent years (Gupta 
        2019). Low-income people are more affected and report having to 
        purchase ultraprocessed foods and snacks vs. fruits and 
        vegetables due to price (Ravikumar 2022).

          Labeling: The current food labeling environment is 
        very confusing to consumers. Nutrition-related claims on food 
        packages are very common (Taillie 2018; USDA 2023); yet their 
        presence does not reliably indicate that a product is actually 
        healthy. For example, 97 percent of fruit drinks, the top-
        consumed sugary drink among kids, carry some type of claim like 
        ``100 percent Vitamin C'' or ``Natural'' (Duffy 2021). These 
        claims lead to the ``health halo'' effect, in which claims give 
        unhealthy products an aura of healthfulness, leading parents to 
        make less healthy choices (Hall 2023; Hall 2020). The Nutrition 
        Facts Panel got important updates in 2020, including the 
        requirement to disclose added sugar content. However, few 
        consumers consistently use these back-of-the package labels, 
        with low-income and low-educated populations less likely to use 
        them (Storz 2023). Moreover, people spend only seconds 
        selecting a food item, making it difficult to understand 
        complex, numeric information and make educated decisions.

          School foods: Kids consume about a third of their 
        daily calories at school; foods served and sold to children in 
        schools also affect lifetime food preferences. The Healthy, 
        Hunger Free Kids Act improved the nutritional quality of school 
        foods and helped prevent obesity among children in poverty, 
        with no difference in school meal participation (Johnson 2016; 
        Kenney 2020). However, our team's analyses of National Health 
        and Nutrition Survey data found that in 2015-2018, the majority 
        of calories kids consume at school comes from ultraprocessed 
        foods (Vatavuk, unpublished). Moreover, unhealthy food 
        marketing is highly prevalent in schools, with companies 
        providing school sports sponsorships, student incentives (e.g., 
        Pizza Hut's Book It program), branded fundraising and reward 
        programs (e.g., General Mill's Box Tops for Education; fast 
        food proceed donations), digital and physical advertisements, 
        and the sales of branded fast-food products (Harris 2014). In 
        addition, ``Smart Snacks,'' or packaged snacks that have been 
        reformulated to meet USDA school foods standards, are virtually 
        indistinguishable from the less healthy versions sold outside 
        of schools (Harris 2016). Thus, even these ``healthier'' snacks 
        serve as another form of marketing to get kids hooked on 
        specific brands, increasing their preferences and purchases.

          Food retail environment: Sugary drinks and 
        ultraprocessed foods are ubiquitous in all retail settings and 
        are often at checkouts, at endcaps of stores and are often 
        placed in locations and heights that children are more likely 
        to see and pester their parents to get. For example, a national 
        study found 91 percent of supermarkets carry candy at checkout 
        and 85 percent carry sugary drinks (Barker 2015).

          Corporate interference: To circumvent regulation, the 
        food industry has followed the tobacco industry playbook: 
        blaming personal responsibility, casting doubt on unfavorable 
        research, funding favorable research, coopting professional 
        organizations, lobbying, and arguing for self-regulation 
        (Stuckler & Nestle 2012). For example, the sugar and sugary 
        drinks industry has sought to shift the blame from sugar to fat 
        (Kearns 2016); created a shadow group to create allies in 
        academia and governments for pro-sugar policies, funded 
        physical activity research to change the narrative about what 
        causes obesity (Serodio 2018), and funded major nutrition and 
        health societies in exchange for influence over proceedings 
        (e.g., the American Academy of Nutrition and Dietetics) 
        (Gunnarsson 2022).

           The packaged food industry has proposed voluntary labeling 
        and marketing self-regulations in an attempt to circumvent 
        regulation. However, these initiatives have failed: they are 
        slow, ineffective, and contain many loopholes while allowing 
        companies to claim to be part of the solution (Boyland 2022). 
        Federal regulation is needed to create healthier food 
        environments. Many countries, particularly in Latin America, 
        have already begun taking action. Below, I outline evidence-
        based policy recommendations to promote healthier diets and 
        prevent diet-related diseases.
                          Key recommendations

         1. Require front-of-package labels on unhealthy foods.

        Since 2016, 10 countries have mandated front-of-package 
        nutrition labels on foods high in sugar, sodium, and saturated 
        fat, which includes all sugary drinks and most ultraprocessed 
        foods. Compared to other labeling systems, ``high-in'' labels 
        that signal when a product is high in unhealthy nutrients more 
        effectively empower consumers to avoid nutrients of concern 
        (Croker 2020). A simple black-and-white design grabs consumers' 
        attention and is easily understood, even by children and those 
        with limited English proficiency (Correa 2019; Hall 2021). 
        Chile was the first country to implement high-in labels, 
        leading to a 24 percent drop in sugary drink purchases and a 24 
        percent drop in purchases of foods carrying the labels (Taillie 
        2020, 2021). Chile's policy also incentivized the food industry 
        to cut sugar and sodium in the food supply (Reyes 2020), with 
        no adverse impacts on wages and employment (Paraje 2023). Many 
        countries have followed Chile's lead and implemented similar 
        warning label regulations--covering much of South America as 
        well as Mexico and Canada. The FDA is currently researching 
        front-of-package labeling options for the U.S. and plans to 
        issue a proposed regulation requiring new labels in June 2024. 
        FDA should consider that single-nutrient octagonal labels 
        maximize consumers' ability to quickly and accurately identify 
        unhealthy products, more so than labels with numerical 
        information requiring numeracy skills (Grummon 2019). Ample 
        experimental research in the U.S. already shows that warning 
        labels help consumers quickly identify unhealthy foods and make 
        healthier, informed choices (Musicus 2023; Taillie 2022). Using 
        evidence-supported visuals like icons or symbols further 
        increases comprehension (Hall 2021; Bopape 2021). Most 
        importantly, the FDA must ensure that progress toward clear, 
        informative labeling is led by governments and public health 
        experts, not commercial interests.

           1a. FOP labels should include visuals to increase 
        comprehension, use single-nutrient octagonal labels to maximize 
        consumers' ability to quickly and accurately identify products 
        high in nutrients of concern (including sugar), and avoid 
        including information about the percent of the daily value ( 
        percent DV).

           1b. Restaurants should require similar labels. In November 
        2023, New York City passed the ``Sweet Truth Act'' that will 
        require chains with 15 or more restaurants to use an added 
        sugar icon on their menus and menu boards to indicate a food or 
        drink item contains more than 50g of added sugar.

          2. Restrict food marketing to children

          Policies to reduce children's exposure to harmful food 
        marketing should protect children of all ages (up to age 18 
        years); use a strong, government-led nutrient profiling to 
        classify foods for restriction; be comprehensive enough to 
        minimize the risk of migration of marketing to other media or 
        to other age groups; and restrict the persuasive power of food 
        marketing (World Health Organization, 2023). Chile provides the 
        most compelling example of the impacts a strong marketing 
        policy. In 2016, Chile restricted the use of child-directed 
        appeals on products exceeding set nutrient thresholds, 
        restricted placement of ads in media with high child 
        viewership, and prohibited the sales and promotion of these 
        products in school. In 2018, they extended this regulation by 
        banning television advertisements on unhealthy food 
        advertisement between 6am-10pm. Together, these regulations 
        have worked in a relatively short amount of time to 
        dramatically reduce children's exposure to unhealthy food 
        marketing and lessen its persuasive appeal and power:

           In the first (and most lenient) year of the law, the 
        percentage of TV ads for foods and drinks high in energy, 
        saturated fats, sugars, or sodium dropped from 42 percent to 15 
        percent (Correa 2020).

           By 2019, Chile's marketing restrictions led to a 
        total drop of 73 percent in children's daily exposure to TV ads 
        for products high in calories, sugar, salt or saturated fat on 
        all TV and a 90 percent drop during children's programming 
        (Dillman Carpentier 2023). What's more, 67 percent fewer 
        unhealthy food ads on TV used child-directed creative content 
        such as cartoons, characters, toys, or contests, which are also 
        prohibited under the country's laws.

           The percentage of regulated cereals (typically high 
        in calories and/or sugar) with child-directed strategies 
        featured on their packages dropped from 43 percent to 15 
        percent in the first year of regulation (Mediano Stolze et al. 
        2019).

         3. Amend the tax code to remove the deductibility of expenses 
        associated with advertising and marketing foods and beverages 
        of poor nutritional quality to children.

         Food companies can deduct expenditures related to advertising 
        and marketing from their taxes. Through this process, the U.S. 
        government provides a subsidy for marketing unhealthy food and 
        drinks to children (Center for Science in the Public Interest 
        [CSPI] 2023). Removing the deductibility of advertising 
        expenses on sugary drinks and ultraprocessed foods would 
        incentivize companies to decrease unhealthy food marketing to 
        children and could raise $80 million in Federal revenue 
        annually (CSPI 2023).

         4. Implement taxes on sugary drinks and ultraprocessed foods 
        and subsidies on healthier foods.

         Tax policies would require legislative action and there have 
        been several bills introduced to the U.S. Congress in recent 
        years. We strongly recommend that a Federal tax on sugary 
        drinks as proposed in the 2021 ``SWEET Act'' Bill, which sets a 
        2-cents/ounce tax on ready-to-drink lower-sugar SSBs and a 3-
        cents/ounce tax on ready-to-drink high-sugar SSBs. Importantly, 
        it also proposes directing the resultant revenue toward public 
        health and health promotion objectives. Uses of the revenue 
        could include: improving school feeding programs and/or funding 
        expansion of healthy incentive programs to support low-income 
        families afford healthy foods as proposed in 2023 ``GusNIP 
        Expansion Act'' and the ``Opt for Health with SNAP (OH SNAP) 
        Close the Fruit and Vegetable Gap Act'' that were concurrently 
        introduced into the U.S. House of Representatives and Senate, 
        respectively. Dedicating the tax revenues toward lower-income 
        communities and families would enhance the equity potential, 
        with multiplier effects for the local economies of these 
        families, and address concerns around the income regressivity 
        of the tax. In a new modeling study, our team found that a tax 
        on sugary drinks following the SWEET Act would lower calories 
        purchased, while targeted subsidies would increase fruit, 
        vegetable, and healthier drink purchases without substantially 
        increasing calories (Pourya under review). A broader tax that 
        also includes ultra-processed foods along with targeted 
        subsidies for minimally processed foods could promote healthier 
        food choices among low-income households and could be budget 
        neutral for the Federal Government.

         U.S. and global data show that sugary drink taxes reduce 
        consumption (Andreyeva 2022; Teng 2019; Powell 2021), reduce 
        sugar content in the food supply (Dickson 2023), and result in 
        health benefits, including reduced pediatric hospital 
        admissions from dental caries (Rogers 2023), and decreased 
        prevalence of overweight and obesity, particularly where price 
        increases are steeper (Gracner 2022). Modeling studies have 
        predicted that in Mexico, where the first sugary drinks tax was 
        implemented, the tax will lead to a 2.5 percent reduction in 
        obesity prevalence and prevent 86 to 134 thousand cases of 
        diabetes a decade after the tax (Barrientos 2017). Fewer data 
        are available on foods taxes, but our research in Mexico found 
        that a modest 8 percent junk food tax reduced taxed food 
        purchases by ?5 percent (Batis 2016).

          5. Incorporate guidance on ultraprocessed foods into 
        dietary guidelines.

         Increasingly, other countries (most recently, Mexico) include 
        specific dietary guidance around the consumption of 
        ultraprocessed foods. The 2025 U.S. Dietary Guidelines Advisory 
        Committee is currently reviewing evidence on ultraprocessed 
        foods for the 2025 Dietary Guidelines. Inclusion of guidance on 
        ultraprocessed foods could help guide consumers and underpin 
        other policies, including school foods.

         6. Create healthier school environments.

        Schools should be a place where children can eat healthy foods 
        and learn good nutrition, free from the influence of corporate 
        marketing. Creating this environment will promote healthier 
        diets that track into adulthood.

           6a. Ideally, schools should not sell any foods that are high 
        in added sugar or any nutrient of concern (as identified by the 
        FOP warning labels in Recommendation 1). At a minimum, school 
        lunch standards should follow the Dietary Guidelines and ensure 
        that added sugars are limited to 10 percent of calories per 
        week. Schools should have product-based limits for high-sugar 
        foods, including grain-based desserts, breakfast cereals, 
        yogurts, and flavored milks, as well as other products like 
        condiments, toppings, and dressings. Schools should not offer 
        flavored sweetened milk, particularly among young children 
        (under grade 9). We applaud many of the USDA's proposed updates 
        to school nutrition standards which would address several of 
        these concerns. The USDA could go even further by considering a 
        policy like Brazil's, which requires that 75 percent of school 
        food procurement expenditures be used on fresh or minimally 
        processed foods, with only 20 percent allowed for purchasing 
        processed and ultraprocessed foods.

           6b. School food environments should be free from 
        advertising, promotions, and marketing of products high in 
        nutrients of concern. Again, Chile serves as an example: after 
        banning the sales and promotion of unhealthy foods in schools, 
        availability of unhealthy foods dropped from 97 percent of 
        foods and 76 percent of beverages to only 14 percent, with 
        concurrent reductions in calories, saturated fats, sodium, and 
        sugar available to purchase (Massri 2019). After the policies, 
        Chilean children consumed significantly less total sugar at 
        school (Fretes 2021).

         7. Increase nutrition funding.

        A major barrier to progress in using nutrition to prevent 
        diabetes is lack of scientific funding, which has remained flat 
        over decades (Fleischhacker 2020). The National Institutes of 
        Health only spends ?5 percent of its annual budget on 
        nutrition, with only 1.3 percent dedicated to understanding the 
        role of diet in preventing or treating disease. Increased 
        funding for nutrition science is critical for preventing 
        obesity, diabetes, and other diet-related chronic diseases.

    Ideally, multiple of these policies would be implemented together 
as a policy package. Our experiences with food policies implemented in 
many countries suggest an interactive and reinforcing effect. For 
example, front-of-package nutrition labels can be used to guide what is 
permissible to market and sell in schools, where children can further 
learn how to use the labels to tell what is healthy vs. not healthy. 
Together, these policies can create healthier food environments for 
children, promoting healthier dietary behaviors that track into 
adulthood and help prevent obesity, type 2 diabetes, and other diet-
related chronic diseases across the lifecycle.
                                 ______
                                 
              [summary statement of lindsey smith taillie]
    Why diet matters for type 2 diabetes prevention:

          The U.S. has an alarmingly high prevalence of obesity 
        and type 2 diabetes. The incidence of type 2 diabetes among 
        children has doubled over the last 20 years, with Black and 
        Hispanic children experiencing the fastest increases.

          Americans consume too much sugary drinks and 
        ultraprocessed foods. Often known as ``junk food,'' 
        ultraprocessed foods are industrially produced foods that 
        typically contain additives and high levels of added sugar, 
        sodium, saturated fat, and excessive calories. Nearly 2/3 of 
        kids' daily calories come from ultraprocessed foods, and the 
        steepest increases have occurred among Black and Hispanic 
        youth.

          Sugary drinks and ultraprocessed foods lead to weight 
        gain, which promotes diabetes. In an NIH trial, just 2 weeks on 
        an ultraprocessed food diet led people to consume ?500 more 
        calories per day and gain weight.

          Sugary drinks and ultraprocessed foods are designed 
        for overconsumption because they combine flavors, sugar, salt, 
        and fat in ways not found in nature; they are cheap; they are 
        convenient; and we digest them more quickly.

          Improving diet quality would prevent and delay onset 
        of type 2 diabetes and is more cost-effective than medication.

    The U.S. food environment makes it very difficult for Americans to 
make healthy choices.

          Food supply: The U.S. food supply contains more sugar 
        and sweeteners than other high-income countries. Fifty percent 
        of U.S. packaged foods are ultraprocessed and 43 percent are 
        high in sugar, sodium, or saturated fat.

          Food marketing: Unhealthy foods are widely and 
        aggressively marketed to kids, particularly youth of color. 
        Companies use tactics like licensed characters to appeal to 
        kids, and strategies like specialized product design, language 
        and cultural references, cause-related marketing, and 
        personalized digital advertisements to target youth of color. 
        Food marketing increases kids' desire for, purchases of, and 
        intake of unhealthy foods.

          Food labeling: The high prevalence of nutrition 
        claims in the U.S. packaged food supply makes it difficult for 
        consumers to tell when a product is unhealthy. For example, 
        claims like ``Natural'' on sugary fruit drinks mislead parents 
        into thinking that drinks don't contain added sugar when they 
        do. Although recent updates to the Nutrition Facts Panel, like 
        requiring information about added sugar, are applaudable, most 
        consumers do not always use the information and it is hard to 
        understand for consumers with low education levels.

          Food pricing: Sugary drinks and ultraprocessed foods 
        tend to be cheaper than minimally processed or whole foods. 
        Parents report wanting to buy healthy foods but being unable to 
        afford to.

          Retail environment: Sugary drinks and ultraprocessed 
        foods are ubiquitous in food stores and are often placed in the 
        checkout, end caps, and at locations and heights that kids are 
        more likely to see and pester their parents to get.

          School foods: The Healthy Hunger-Free Kids Act 
        improved school nutrition. However, most of the calories kids 
        consume at schools still come from ultraprocessed foods, and 
        unhealthy food marketing in schools is very common.

          Industry interference: The food industry has funded 
        professional societies and research scientists to change the 
        narrative on what causes obesity and type 2 diabetes, 
        preventing policy progress.

    What policies are needed based on global evidence.

          Front-of-package labels: Front-of-package nutrition 
        labels that are clear, grab attention, and are easy to 
        understand can help consumers make informed, healthier choices. 
        In 2016, Chile was the first of now 10 countries to implement 
        mandatory front-of-package nutrient warnings on unhealthy 
        foods. The policy incentivized the food industry to cut sugar, 
        sodium, and saturated fat in the food supply with no adverse 
        impact on wages or employment. The policy also reduced 
        unhealthy food purchases. The FDA is currently researching 
        front-of-package labels and should consider a design like 
        Chile's, which has been demonstrated in U.S. experimental 
        research to outperform other label types.

          Food marketing restrictions: Voluntary corporate 
        initiatives to restrict marketing are ineffective. Mandatory 
        restrictions on unhealthy food marketing to children--for 
        example, by limiting where ads appear or by reducing the use of 
        techniques like cartoons--would help children develop 
        preferences for healthy foods. In Chile, strong food marketing 
        restrictions cut children's exposure to unhealthy food 
        advertisements by 73 percent.

            An additional policy is the removal of tax deductions on 
        companies' advertising expenditures, which would make it more 
        expensive to advertise unhealthy foods to children, cut kids' 
        exposure, and also generate tax revenue for the government.

          Taxes: Global evidence from 50+ countries shows that 
        sugary drink and ultraprocessed food taxes incentivize 
        reformulation and reduce consumption. Revenue from taxes can be 
        used to fund public health programs to further type 2 diabetes 
        prevention, such as for fruit and vegetable subsidies for low-
        income families.

          Healthier school food environments: Schools should be 
        free from the marketing, promotion, and sales of sugary drinks 
        and ultraprocessed foods. Global evidence shows that 
        restricting the marketing, promotion, and sales of unhealthy 
        foods in schools reduces their availability and improves 
        children's diets.

          Increase funding for nutrition research: With only 
        1.3 percent of the NIH budget, more funding for nutrition 
        science is needed to improve diets and prevent obesity, type 2 
        diabetes, and other diet-related chronic diseases.

                                 ______
                                 
    The Chair. Thank you very much. Our next witness is Dr. 
Kasia Lipska, Associate Professor of Medicine at the Yale 
School of Medicine, and we thank her very much for being with 
us.

STATEMENT OF KASIA LIPSKA, M.D., M.H.S, ASSOCIATE PROFESSOR OF 
        MEDICINE, YALE SCHOOL OF MEDICINE, NEW HAVEN, CT

    Dr. Lipska. Thank you. Chairman Sanders and Ranking Member 
Cassidy, I am Dr. Kasia Lipska, Physician Scientist at the Yale 
School of Medicine. Thank you for the opportunity to present my 
testimony.

    As a clinician, I take care of patients who have--who 
already have developed diabetes. There are now over 35 million 
people with type 2 diabetes in our Country. Nearly one in every 
third older adults has diabetes.

    My focus with patients is to reduce the risk of 
complications of diabetes, such as heart attacks, strokes, 
amputations, kidney failure, and blindness. One of the biggest 
challenges in my clinical practice, including this past year, 
is still figuring out how to get my patients access to 
affordable treatment.

    Even the best medications cannot help patients if they 
cannot afford them. According to a national survey, in 2021, 16 
and a half percent of people with diabetes rationed their 
insulin because of cost.

    This is not just due to lack of insurance coverage. Among 
Medicare beneficiaries with diabetes, 1 in 10 reported 
skipping, delaying, or taking less medication to save money. 
There has been so much excitement about the new medications and 
type 2 diabetes and obesity.

    That is because some of the medications, including 
semaglutide or Ozempic, really seem to work. They not only help 
people lose weight, but also importantly reduce the risk of 
complications related to diabetes and obesity. But the price 
tags for these new medications are simply outrageous.

    Ozempic, the brand name for semaglutide approved for type 2 
diabetes and marketed by Novo Nordisk, has a U.S. list price of 
over $900 per month. Wegovy, the brand name for the same drug 
approved for obesity is $1,300 per month. If Medicare were to 
fully cover Wegovy for all of its beneficiaries with obesity 
for 1 year, we as American taxpayers would end up with a $268 
billion invoice.

    To give you some perspective, that is 70 percent of all the 
money that was spent on prescription drugs in the U.S. in 2021. 
And could we stop at 1 year? Probably not. What we know about 
semaglutide, and the related medications is that they work 
while people take them. However, as soon as they stop, their 
weight comes back.

    Patients are looking at a potentially lifelong treatment, 
and we could be facing the most expensive subscription service 
in the history of medicine. What can Congress do to fix this? 
Ozempic is priced at roughly $100 per month in Sweden and just 
$80 in Australia and France.

    That is 10 percent of what we are being asked to pay. One 
explanation is that those governments are negotiating prices 
directly with the pharmaceutical companies. That is not 
socialized medicine. That is smart negotiating. Price 
negotiation is critical, but I believe we must do more.

    Pharmaceutical companies have absolutely no restrictions on 
the launch prices of their products, nor is there any evidence 
that these prices are reflective of research and development 
costs. No amount of expert negotiation can bring down drug 
prices years later, when the launch price is sky high to begin 
with.

    We have to align the launch price with the drug's value, 
the cost to develop and manufacture the drug, and what patients 
can afford. This is a rational approach that is in place in 
many other developed countries. But I want to be clear here, 
medications alone cannot be the solution to the diabetes and 
obesity epidemics.

    We need to be more farsighted and strategic than that. 
Neither diabetes and obesity is a moral failure or a personal 
choice. Just telling people to eat less, exercise more is not 
going to solve the problem.

    Instead, we must address the upstream causes of obesity, 
like holding the food industry accountable, as my fellow 
experts have already made clear. The reality is that the drug 
industry is really good at pushing its solutions and its 
products. Drug companies are powerful, sometimes more powerful 
than governments.

    Novo Nordisk, which is based in Denmark, now has a market 
value that is bigger than its host nation's GDP. So, we must 
remember that drugs alone can't save us. They are only part of 
the solution.

    We can't simply prescribe our way out of this problem. And 
before we sign up for that never ending subscription service 
and spend trillions of dollars, let's be smart consumers and 
have the Government at the negotiating table right from the 
start.

    In closing, the bottom line is this, we have a food 
industry that profits from making people sick and a drug 
industry that profits from treating them. We must break that 
cycle. Thank you.

    [The prepared statement of Dr. Lipska follows:]

                   prepared statement of kasia lipska
    Chairman Sanders and Ranking Member Cassidy, I am Dr. Kasia Lipska, 
a physician scientist at the Yale School of Medicine in the Section of 
Endocrinology and Metabolism. Thank you for the opportunity to present 
my testimony. I am here in my personal capacity as an expert in 
endocrinology and practicing clinician, and I am not representing the 
Yale School of Medicine.

    My research has focused on the safety and effectiveness of 
medications to treat type 2 diabetes. I have evaluated trends in 
utilization of these medications over time and examined associated 
health outcomes. My overarching goal has been to generate evidence that 
patients and doctors can use to make decisions about what treatment is 
best for each individual. However, I realized that in my own practice, 
I was often forced to make decisions with my patients about 
medications--not based on scientific evidence about their safety and 
effectiveness--but rather on what options were affordable, even if 
those options were far from ideal. As a result, I expanded my research 
to consider cost-related barriers to treatment. In 2017, we conducted a 
survey in our Yale Diabetes Center and showed that 1 in 4 patients with 
diabetes, who were prescribed insulin, rationed this medication due to 
cost. \1\ I became involved in advocacy efforts for affordable insulin. 
In addition to writing editorial pieces in national media outlets such 
as the New York Times, \2\ and testifying before the House Energy & 
Commerce Committee on the human impact of rising insulin costs, \3\ I 
have worked closely with T1International, an advocacy organization that 
does not accept any money from the pharmaceutical industry or any other 
entity that might influence their ability to speak out freely.
---------------------------------------------------------------------------
    \1\  Herkert D, Vijayakumar P, Luo J, et al. Cost-Related Insulin 
Underuse Among Patients With Diabetes. JAMA internal medicine. 
2019;179(1):112-114.
    \2\  Lipska KJ. Break up the insulin racket. The New York Times, 
Opinion, February 20, 2016; Available at: https://www.nytimes.com/2016/
02/21/opinion/sunday/break-up-the-insulin-racket.html. Accessed July 
11, 2019.
    \3\  Lipska, KJ, Expert Witness Testimony for the House Committee 
on Energy & Commerce: ``Priced out of a lifesaving drug: The human 
impact of rising insulin costs;'' April 2d, 2019. Available at https://
energycommerce.house.gov/sites/democrats.energycommerce.house.gov/
files/documents/Testimony--Lipska--Insulin percent20Prices.pdf Accessed 
June 29, 2021.

    As a clinician, I take care of patients who have already developed 
diabetes. There are now over 38 million people with diabetes in our 
Country. Nearly 1 in every 3d older adults has diabetes. \4\
---------------------------------------------------------------------------
    \4\  Centers for Disease Control and Prevention, National Diabetes 
Statistics Report. Available at: https://www.cdc.gov/diabetes/data/
statistics-report/. Accessed on December 10, 2023.

    My focus with patients is to reduce the risk of complications of 
diabetes, such as heart attacks, strokes, amputations, kidney failure, 
and blindness. My clinic is in the Yale Diabetes Center in New Haven, 
CT where we serve over 3,000 patients with both type 1 and type 2 
diabetes. About a third of our patients are insured by Medicaid, a 
third by Medicare, and a third have commercial insurance. New Haven's 
age, education, and race/ethnicity demographics reflect those of our 
Nation. \5\ One of the biggest challenges in my clinical practice--
including this past year--is still figuring out how to get my patients 
access to affordable treatment. This is what it's like in my clinic. I 
saw a 71-year-old man who is a retired auto body mechanic for follow-up 
the other day. He has type 2 diabetes, obesity, fatty liver disease, 
and coronary heart disease. He was taking metformin for his diabetes, 
but his blood sugars were uncontrolled. I prescribed Ozempic 
(semaglutide) but he was not able to fill this due to cost. We tried 
the other medications in the same class, but those were also expensive. 
I switched to Jardiance (empagliflozin), a pill for type 2 diabetes 
that reduces the risk of cardiovascular complications, but he had to 
stop this as well because our 340B program no longer offers it at a 
discount. He ended up on glipizide, probably the worst possible choice 
for his type 2 diabetes. Glipizide is associated with a risk of low 
blood sugar reactions and tends to result in weight gain.
---------------------------------------------------------------------------
    \5\  'Normal America' Is Not A Small Town of White People. April 
28, 2016 available at: https://fivethirtyeight.com/features/normal-
america-is-not-a-small-town-of-white-people/. ``The metropolitan area 
that looks most like the U.S. is New Haven, Connecticut'' based on age, 
educational attainment, race, and ethnicity metrics.

    Even the best medications cannot help patients if they cannot 
afford them. According to a national survey, in 2021, 16.5 percent of 
people with diabetes rationed their insulin because of cost. \6\ This 
is not just due to lack of insurance coverage. Among Medicare 
beneficiaries with diabetes, 1 in 10 reported skipping, delaying, or 
taking less medication to save money. \7\ What's more, when patients 
fill their perscriptions and purchase the insulin that they need, this 
is often extremely costly for them. Using nationally representative 
data from 2017 and 2018, we found that 14.1 percent of Americans 
reached catastrophic levels of out-of-pocket spending on insulin, 
defined as spending more than 40 percent of their disposable family 
income on insulin alone. \8\
---------------------------------------------------------------------------
    \6\  Gaffney A, Himmelstein DU, Woolhandler S. Prevalence and 
Correlates of Patient Rationing of Insulin in the United States: A 
National Survey. Annals of internal medicine. 2022;175(11):1623-1626.
    \7\  Assistant Secretary for Planning and Evaluation (ASPE) Report, 
``Prescription Drug Affordability among Medicare Beneficiaries'', 
January 19, 2022, available at: https://aspe.hhs.gov/sites/default/
files/documents/1e2879846aa54939c56efeec9c6f96f0/prescription-drug-
affordability.pdf. Accessed on December 10, 2023.
    \8\  Bakkila BF, Basu S, Lipska KJ. Catastrophic Spending On 
Insulin In The United States, 2017-18. Health affairs (Project Hope). 
2022;41(7):1053-1060.

    There has been progress in making insulin affordable--in large part 
due to tireless advocacy efforts by many people living with the 
disease, including organizations like T1International, fighting for 
access to insulin for all. And progress has been made thanks to the 
many policies that you have proposed or passed into law to improve 
insulin affordability. But on the whole, insulin is still way too 
expensive. My patients continue to struggle to pay for this drug. Over 
a century ago, inventors of insulin gave their patent to the University 
of Toronto, for $1, so that humankind would have affordable access to 
the drug forever. \9\ Instead, drug companies have been very 
resourceful at controlling the market, gaming the patent system to 
block more affordable competitors, inflating their product prices ever 
since. And now that there are many new medications for diabetes, we 
must apply the lessons we learned from insulin to not make the same 
mistakes again.
---------------------------------------------------------------------------
    \9\  Bliss M. The discovery of insulin. Chicago: University of 
Chicago Press, 2013.

    There has been so much excitement about the new medications in type 
2 diabetes and obesity. That's because some of the medications, 
including semaglutide (marketed by Novo Nordisk as Ozempic for type 2 
diabetes and as Wegovy for obesity), really seem to work. They not only 
help people lose weight but also reduce the risk of complications 
related to diabetes and obesity.10,11 In recent trials, these 
medications reduced the risk of cardiovascular complications by 20-25 
percent. \10\, \11\
---------------------------------------------------------------------------
    \10\  Marso SP, Bain SC, Consoli A, et al. Semaglutide and 
Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 
2016.
    \11\  Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide 
and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 
2023.

    But the price tags for these new medications are outrageous. 
Ozempic, the brand name for semaglutide approved for type 2 diabetes, 
has a U.S. list price of over $900 per month. Wegovy, the brand name 
for the same drug approved for obesity, is $1,300 per month.12 If 
Medicare were to fully cover Wegovy for all of its beneficiaries with 
obesity, we as American taxpayers would end up with a $268 billion 
invoice. \12\ To give you some perspective, that's 70 percent of all 
the money that was spent on prescription drugs in the U.S. in 2021. 
\13\ And could we stop at 1 year? Probably not. What we know about 
semaglutide, and the related medications, is that they work while 
people take them. However, as soon as they stop, their weight comes 
back. \14\ So patients are looking at a potentially lifelong treatment 
and we could be facing the most expensive subscription service in the 
history of medicine.
---------------------------------------------------------------------------
    \12\  Baig K, Dusetzina SB, Kim DD, Leech AA. Medicare Part D 
Coverage of Antiobesity Medications--Challenges and Uncertainty Ahead. 
N Engl J Med. 2023;388(11):961-963.
    \13\  Centers for Medicare & Medicaid Services, National Health 
Expenditure Accounts, National Health Expenditures 2021 Highlights, 
available at: https://www.cms.gov/files/document/highlights.pdf. 
Accessed on December 10, 2023.
    \14\  Wilding JPH, Batterham RL, Davies M, et al. Weight regain and 
cardiometabolic effects after withdrawal of semaglutide: The STEP 1 
trial extension. Diabetes Obes Metab. 2022;24(8):1553-1564.

    How do we find a way to make these drugs affordable? We can't 
assume that this will simply get better with time, as patents expire 
after several years. There is just too much money on the table and the 
---------------------------------------------------------------------------
pharmaceutical industry is not about to walk away.

    What can Congress do to help patients like mine? Ozempic is priced 
at roughly $100 per month in Sweden and just $80 in Australia and 
France. \15\ That's 10 percent of what we are being asked to pay. One 
explanation is that those governments are negotiating prices directly 
with the pharmaceutical companies. \16\ That's not socialized medicine. 
That's smart negotiating. That's a group of people leveraging their 
buying power to get a good deal.
---------------------------------------------------------------------------
    \15\  Peterson Center on Healthcare-Kaiser Family Foundation , 
``How do prices of drugs for weight loss in the U.S. compare to peer 
nations' prices?'' Available at: https://www.healthsystemtracker.org/
brief/prices-of-drugs-for-weight-loss-in-the-us-and-peer-nations/ 
Accessed on December 10, 2023.
    \16\  Vokinger KN, Naci H. Negotiating Drug Prices in the U.S.-
Lessons From Europe. JAMA Health Forum. 2022;3(12):e224801.

    The Inflation Reduction Act already authorizes the Secretary of the 
Department of Health and Human Services (HHS) to negotiate prices with 
pharmaceutical companies under specific provisions, and for a limited 
set of drugs. Notably, 4 out of the 10 initial medications selected for 
negotiation are medications for type 2 diabetes. But neither 
semaglutide nor the related medications in the same class are currently 
on the list of these drugs. As a result, millions of Americans are 
being asked to pay an impossible price--almost $900 a month--to get 
treatment that has the potential to change their lives. Many simply 
can't. That money is needed to pay rent, buy groceries, or make a car 
payment. So they go without. I see these patients every week in my 
---------------------------------------------------------------------------
clinic.

    Price negotiation is critical, but I believe we must do more. 
Pharmaceutical companies have absolutely no restrictions on the 
``launch prices'' of their products, nor is there any evidence that 
these prices are reflective of research and development costs. \17\ No 
amount of expert negotiation can bring down drug prices years later 
when the launch price is anchored to be sky-high. We have to align the 
launch price with the drug's value, the costs to develop and 
manufacture the drug, and what patients can afford. This is a rational 
approach that is in place in many other developed countries.
---------------------------------------------------------------------------
    \17\  Wouters OJ, Berenbrok LA, He M, Li Y, Hernandez I. 
Association of Research and Development Investments With Treatment 
Costs for New Drugs Approved From 2009 to 2018. JAMA network open. 
2022;5(9):e2218623.

    But I want to be clear here: medications alone cannot be the 
solution to the diabetes and obesity epidemics. We need to be more far 
sighted and strategic than that. Neither diabetes nor obesity is a 
moral failure or a personal choice. Just telling people to eat less and 
exercise more is not going to solve the problem--that strategy has 
failed thus far. Instead, we must address the upstream causes of 
obesity on the systemic level, such as reducing food deserts and 
improving built environments. \18\ (As my fellow experts have already 
made clear.)
---------------------------------------------------------------------------
    \18\  Vandevijvere S, De Pauw R, Djojosoeparto S, et al. Upstream 
Determinants of Overweight and Obesity in Europe. Curr Obes Rep. 2023.

    The reality is that the drug industry is really good at pushing its 
solutions and its products. Drug companies are powerful, sometimes more 
powerful than governments. Novo Nordisk, which is based in Denmark, now 
has a market value that is bigger than its host nation's GDP. \19\ And 
so, perhaps inevitably, the path of least resistance will be for us to 
prescribe our way out of this problem. So I leave with you two 
thoughts:
---------------------------------------------------------------------------
    \19\  Bloomberg News, ``Novo's Value Surpasses Denmark GDP After 
Obesity Drug Boost'', available at: https://www.bloomberg.com/news/
articles/2023--08--09/wegovy-pushes-novo-nordisk-nvo-market-value-
above-denmark-gdp. Accessed on December 10, 2023.

        [1] drugs alone can't save us, they're only part of the 
---------------------------------------------------------------------------
        solution; and

        [2] before we sign up for that never-ending ``subscription 
        service,'' and spend trillions of dollars, let's be smart 
        consumers and have the government at the negotiating table, 
        right from the start. Every extra dollar spent on these 
        exorbitantly priced drugs is another dollar not available to 
        address the systemic issues contributing to diabetes and 
        obesity in the first place.

                                 ______
                                 
                  [summary statement of kasia lipska]
    Even the best medications cannot help patients if they cannot 
afford them. According to a national survey, in 2021, 16.5 percent of 
people with diabetes rationed their insulin because of cost. This is 
not just due to lack of insurance coverage. Among Medicare 
beneficiaries with diabetes, 1 in 10 reported skipping, delaying, or 
taking less medication to save money.

    There has been so much excitement about the new medications in type 
2 diabetes and obesity. That's because some of the medications, 
including semaglutide, really seem to work. They not only help people 
lose weight but also reduce the risk of complications related to 
diabetes and obesity.

    But the price tags for these new medications are outrageous. 
Ozempic, the brand name for semaglutide approved for type 2 diabetes, 
has a U.S. list price of over $900 per month. Wegovy, the brand name 
for the same drug approved for obesity is $1,300 per month. If Medicare 
were to fully cover Wegovy for all of its beneficiaries with obesity, 
we as American taxpayers would end up with a $268 billion invoice. To 
give you some perspective, that's 70 percent of all the money that was 
spent on prescription drugs in the U.S. in 2021. And could we stop at 1 
year? Probably not. What we know about semaglutide, and the related 
medications, is that they work while people take them. However, as soon 
as they stop, their weight comes back. So we could be looking at 
lifelong treatment here and then we're potentially talking about the 
most expensive subscription service in the history of medicine.

    How do we find a way to make these drugs affordable? Ozempic is 
priced at roughly $100 per month in Sweden and just $80 in Australia 
and France. That's 10 percent of what we are being asked to pay. One 
explanation is that those governments are negotiating prices directly 
with the pharmaceutical companies. That's not socialized medicine. 
That's smart negotiating. That's a group of people leveraging their 
buying power to get a good deal.

    Price negotiation is critical, but I believe we must do more. 
Pharmaceutical companies have absolutely no restrictions on the 
``launch prices'' of their products. No amount of expert negotiation 
can bring down drug prices when the launch price is sky-high. We have 
to align the launch price with the drug's value, the costs to develop 
and manufacture the drug, and what patients can afford. This is a 
rational approach that is in place in many other developed countries.

    But I want to be clear here: medications alone cannot be the 
solution to the diabetes and obesity twin epidemics. We need to be more 
far sighted and strategic than that. Neither diabetes nor obesity is a 
moral failure or a personal choice. Just telling people to eat less and 
exercise more is not going to solve the problem--that strategy has 
failed thus far. Instead, we must address the upstream causes of 
obesity on the systemic level, such as reducing food deserts and 
improving built environments.

    The reality is that the drug industry is really good at pushing its 
solutions and its products. And so, perhaps inevitably, the path of 
least resistance will be for us to prescribe our way out of this 
problem. So I leave with you two thoughts: [1] drugs alone can't save 
us, they're only part of the solution; and [2] before we sign up for 
that never-ending ``subscription service,'' and spend trillions of 
dollars, let's be smart consumers and have the government at the 
negotiating table, right from the start. Every extra dollar spent on 
these exorbitantly priced drugs is another dollar not available to 
address the systemic issues contributing to diabetes and obesity in the 
first place.
                                 ______
                                 
    The Chair. Thank you very much.

    Senator Cassidy, want to introduce your witnesses?

    Senator Cassidy. Yes, thank you, Mr. Chairman. Pleased to 
first introduce Mrs. Natalie Stanback, a mother to a type 1 
diabetes patient. Mrs. Stanback provides an insightful, 
personal perspective on the issues of children with type 1 
diabetes and their parents' encounter.

    In 2015, Mrs. Stanback's daughter Nadia was diagnosed with 
type 1 diabetes, and apparently her family has a strong family 
history of type 1 diabetes, unrelated to obesity. Natalie 
volunteers with JDRF, the Juvenile Diabetes Research 
Foundation, to advocate for type 1 diabetes research. Earlier 
this year, she served as chair of the JDRF's children's 
Congress.

    She lives in Texas with her husband and three kids. Thank 
you for joining us. I look forward to your testimony.

 STATEMENT OF NATALIE STANBACK, VOLUNTEER, JDRF, LEWISVILLE, TX

    Mrs. Stanback. Chairman Sanders, Ranking Member Dr. 
Cassidy, Members of the Committee, thank you for inviting me to 
testify today. I am here because unfortunately, I am deeply 
familiar with the many challenges presented by type 1 diabetes, 
or T1D.

    I do not have this disease, but my 11 year old daughter 
Nadia does, and she lives with it. My brother died from 
complications of T1D when he was only 38 years old, so you can 
imagine the fear that I felt when Nadia was diagnosed at the 
age of three. It was overwhelming, to say the least.

    Nadia does not know life without diabetes. We are blessed 
to have access to the best medical care, which helps her live 
the life she wants to live. She has an insulin pump and a 
continuous glucose monitor. She plays soccer and runs track. 
She looks like a normal kid, and in most ways she is.

    But diabetes is always there, 365 days a year, 24/7. This 
disease is hard, and it is cumbersome. We are an emotionally 
positive family, glass half full, but this disease is still 
hard on all of us, but especially it is hard on Nadia. She 
can't eat without calculating how many carbohydrates are in the 
food so that she can dose the correct amount of insulin.

    Her blood sugar levels can go low during soccer games, 
which forces her to sit out, and then treat it, and then get 
back in the game if there is still time. She has to deal with 
the needles necessary to change insulin pump infusionsites and 
glucose monitoring sensors in a way that many adults would and 
still do struggle with.

    Then prescriptions and doctor's appointments must be 
diligently managed. My daughter is brave. She is responsible 
and she is miraculous, but it is still so very hard every day, 
not just for her, but for all those around her.

    Her siblings, extended family members, teachers, coaches, 
friends, friends' parents, everyone needs to understand Nadia's 
needs and how they can help, especially in the case of an 
emergency. It takes a village to raise a child. It takes a city 
to raise a child with diabetes. I know that the Members of this 
Committee are aware of the realities of diabetes and have 
championed this cause for years.

    I am grateful. I was honored to chair JDRF's children's 
Congress this past summer, and I know the amazing delegates and 
guardians you all met are so grateful too. Having you as 
champions has helped us get to where we are today.

    In fact, SPD supported research directly contributed to the 
development of the incredible devices that Nadia relies on 
every day. They could still be--they could still be years in 
the future, if not for the support of the SPD.

    What my daughter and what every parent of a child with 
diabetes needs, and what every person affected with diabetes 
needs is a cure. Something that removes the thousands of 
medical decisions we must make every day so that we can focus 
on everything else in life.

    For my daughter, that would mean focusing on scoring goals 
on the soccer field and doing well in school, not whether she 
will go dangerously low or high in blood sugar in the process. 
Research can make that happen.

    The STP has been foundational to nearly every advance in 
pursuit of that ultimate goal, which is cures. I am excited 
about the progress in therapies to delay T1D onset and those at 
risk of developing the disease.

    Anyone who is able to take advantage of delaying T1D onset 
is receiving an incredible gift, time without T1D. I wish that 
Nadia could have had that opportunity. I do believe that 
someday Nadia will receive that ultimate gift, life without 
T1D. We have made incredible progress toward curing T1D through 
cell therapies.

    This research is happening right now. I do not know when 
she will receive that gift. No one does. But I do know the best 
way to bring that day closer is long term, sustained funding 
for the special diabetes program. This research must continue. 
As a mom, I do not want my daughter to face a lifetime with 
diabetes.

    With STP funded research, I no cures are possible. I know a 
life free of insulin pumps and monitors and the looming threat 
of complications is on the horizon, but only if the brilliant 
minds who have gotten us this far have the resources they need 
to get us across that finish line. And until then, we need 
affordable insulin.

    The Insulin Act would help us make that more of a reality, 
so I urge you for your support. Thank you so very much for your 
time, and I look forward to your questions.

    [The prepared statement of Mrs. Stanback follows:]

                 prepared statement of natalie stanback
    Chairman Sanders, Ranking Member Dr. Cassidy, Members of the 
Committee--thank you for inviting me to testify today. I'm here 
because, unfortunately, I'm deeply familiar with the many challenges 
presented by type 1 diabetes--T1D. I don't have this disease, but my 
eleven-year-old daughter, Nadia, lives with it.

    My brother died from complications from T1D when he was only 24 
years old so you can imagine the fear I felt when Nadia was diagnosed 
at the age of 3. It was overwhelming.

    Nadia doesn't know life without diabetes. We are blessed to have 
access to the best medical care, which helps her live the life she 
wants to live. She has an insulin pump and a continuous glucose 
monitor. She plays soccer and runs track. She looks like a normal kid, 
and, in most ways, she is.

    But diabetes is always there 365 days a year 24/7. This disease is 
hard. We're a very emotionally positive family--definitely glass half 
full. But this disease is hard. On all of us, but especially Natalie. 
She can't eat without calculating how many carbohydrates are in the 
food to dose the correct amount of insulin. Her blood sugar level can 
get low during soccer games, which forces her to sit out, treat it, and 
then get back in the game if there's still time. She has to deal with 
the needles necessary to change insulin pump infusionsites and glucose 
monitoring sensors in a way many adults would struggle with. And 
prescriptions and doctor appointments must be diligently managed.

    My daughter is brave, responsible--she is miraculous. But it is 
still so very hard, every day. And not just for her, but for all those 
around her.

    Her siblings, extended family members, teachers, coaches, friends, 
friends' parents--everyone needs to understand Nadia's needs and how 
they can help, especially in case of an emergency.

    If it takes a village to raise a child, it takes a city to raise a 
child with diabetes.

    I know that the Members of this Committee are aware of the 
realities of diabetes and have championed this cause for years. I am 
grateful. I was honored to chair JDRF's Children's Congress this past 
summer and I know the amazing delegates and guardians you met are 
grateful, too.

    Having you as champions has helped us get to where we are today. In 
fact, SPD-supported research directly contributed to the development of 
the incredible devices that Nadia relies on every day. They could still 
be years in the future if not for the support of the SDP.

    What my daughter, what every parent of a child with diabetes needs, 
and every person affected by diabetes needs is a cure. Something that 
removes the thousands of medical decisions we must make every day so 
that we can focus on everything else in life. For my daughter, that 
would mean focusing on scoring goals on the soccer field and doing well 
in school, not whether she will get dangerously low or high blood sugar 
in the process.

    Research can make that happen. The SDP has been foundational to 
nearly every advance in pursuit of that ultimate goal: cures.

    I am excited about the progress in therapies to delay T1D onset in 
those at risk of developing the disease. Anyone who is able to take 
advantage of delaying T1D onset is receiving an incredible gift--time 
without T1D. I wish that Nadia could have had that opportunity.

    I do believe that, someday, Nadia will receive the ultimate gift--
life without T1D. We have made incredible progress toward curing T1D 
through cell therapies. This research is happening right now. I don't 
know when she will get that gift--no one does--but I do know the best 
way to bring that day closer is long-term, sustained funding of the 
Special Diabetes Program. This research must continue.

    As a mom, I don't want my daughter to face a lifetime with 
diabetes. With SDP-funded research, I know cures are possible. I know a 
life free of insulin pumps and monitors and the looming threat of 
complications is on the horizon--but only if the brilliant minds who 
have gotten us this far have the resources, they need to get us across 
the finish line.

    Until then, we need affordable insulin. The INSULIN Act would help 
make that more of a reality. I urge your support.

    Thank you very much for your time and I look forward to your 
questions.
                                 ______
                                 
                [summary statement of natalie stanback]
    Chairman Sanders, Ranking Member Dr. Cassidy, Members of the 
Committee--thank you for inviting me to testify today. I am here 
because, unfortunately, I am deeply familiar with the many challenges 
presented by type 1 diabetes--T1D. I do not have this disease, but my 
eleven-year-old daughter, Nadia, lives with it.

    My brother died from complications from T1D when he was only 24 
years old so you can imagine the fear I felt when Nadia was diagnosed 
at the age of 3. It was overwhelming.

    Nadia does not know life without diabetes. We are blessed to have 
access to the best medical care, which helps her live the life she 
wants to live. She has an insulin pump and a continuous glucose 
monitor. She plays soccer and runs track. She looks like a normal kid, 
and, in most ways, she is.

    But diabetes is always there 365 days a year 24/7. This disease is 
hard.

    My daughter is brave, responsible--she is miraculous. But it is 
still so extremely hard, every day. And not just for her, but for all 
those around her. Her siblings, extended family members, teachers, 
coaches, friends, friends' parents--everyone needs to understand 
Nadia's needs and how they can help, especially in case of an 
emergency. If it takes a village to raise a child, it takes a city to 
raise a child with diabetes. I know that the Members of this Committee 
are aware of the realities of diabetes and have championed this cause 
for years. I am grateful. I was honored to chair JDRF's Children's 
Congress this past summer and I know the amazing delegates and 
guardians you met are grateful, too.

    Having you as champions has helped us get to where we are today. In 
fact, SPD-supported research directly contributed to the development of 
the incredible devices that Nadia relies on every day. They could still 
be years in the future if not for the support of the SDP.

    What my daughter, what every parent of a child with diabetes needs, 
and every person affected by diabetes needs is a cure. Something that 
removes the thousands of medical decisions we must make every day so 
that we can focus on everything else in life. For my daughter, which 
would mean focusing on scoring goals on the soccer field and doing well 
in school, not whether she will get dangerously low or high blood sugar 
in the process.

    Research can make that happen.

    As a mom, I do not want my daughter to face a lifetime with 
diabetes. With SDP-funded research, I know cures are possible. I know a 
life free of insulin pumps and monitors and the looming threat of 
complications is on the horizon--but only if the brilliant minds who 
have gotten us this far have the resources, they need to get us across 
the finish line.

    Until then, we need affordable insulin. The INSULIN Act would help 
make that more of a reality. I urge your support.

    Thank you very much for your time and I look forward to your 
questions.

                                 ______
                                 
    Senator Cassidy. And now I have the privilege of 
introducing the next witness, Dr. Aaron Kowalski, the Chief 
Executive Officer and President of JDRF. In his role as CEO and 
President of JDRF, Dr. Kowalski is responsible for advancing 
and funding type 1 diabetes research by working closely with 
academics and the type 1 diabetes community.

    He is also a scientist, and I am told, and this is 
apparently not HIPPA protected, you also have type 1 diabetes. 
I always got to throw that in there, Dr. Kowalski, and make 
sure I don't get busted.

    Dr. Kowalski has authored a number of type 1 diabetes 
research articles focusing upon diabetes standards of care and 
the artificial pancreas. He has a doctorate in microbiology and 
molecular genetics from Rutgers. I look forward to your 
testimony, sir. Thank you for joining us.

STATEMENT OF AARON J. KOWALSKI, PH.D., CHIEF EXECUTIVE OFFICER, 
                       JDRF, NEW YORK, NY

    Dr. Kowalski. Thank you. Chairman Sanders, Ranking Member 
Dr. Cassidy, Members of the Committee, thank you so much for 
inviting me to testify and your interest in diabetes. I am Dr. 
Aaron Kowalski, CEO of JDRF, the leading global not for profit 
focused on type 1 diabetes.

    As a scientist by training, and Dr. Cassidy, as a person 
living with type 1 diabetes, I am honored to work for JDRF for 
the past 19 years, 4 of which in my current role. I would like 
to start with a thank you.

    Because of your incredible bipartisan support and 
leadership, and the steadfast leadership of the Senate Diabetes 
Caucus Co-Chair Senator Collins, who just had to leave, 
unfortunately, and Senator Shaheen, the Special Diabetes 
Program, the STP, and the Special Diabetes Program for Indians, 
the STPI, are making a tremendous difference in the lives of 
people with diabetes and for their, our hope for the future.

    These programs have helped fundamentally change what it 
means to live with type 1 diabetes and have put new life 
changing therapies in our hands and have brought us closer to 
cures.

    JDRF and our countless volunteers are so grateful for the 
Committee--that the Committee recognizes the importance of 
building on this progress with the approval of S. 1855, the 
Special Diabetes Program Reauthorization Act.

    We thank you, and we continue to work with your colleagues 
to ensure the 2-year $170 million per year for each program is 
enacted. Let me highlight for you a few of the many exciting 
breakthroughs that have resulted in the investment in the STP 
that gives us so much hope for a brighter future.

    Because of STP funding, we have a new therapy approved, the 
first ever what we would call disease modifying therapy, it is 
called Tzield, that delays the onset of type 1 diabetes and the 
need for insulin for nearly 3 years.

    This is a landmark, first time in 100 years we have ever 
changed the course of type 1. Other such therapies are 
advancing in the research pipeline. This is huge progress. 
Delaying the onset has a tremendous impact on the daily lives 
of people at risk for type 1, their families, and the overall 
health care system.

    To take full advantage of Tzield and therapies on the 
horizon, we need to ensure widespread screening for the risk 
factors that trigger type 1. In June, the FDA approved the 
first ever cell therapy for adults with type 1, those who are 
unable to maintain average blood glucose levels due to severe 
episodes of hypoglycemia.

    This therapy will allow some patients to live without 
external insulin for several years. This therapy could also 
have promise for the estimated 8 million people T2D, type 2, 
who also rely on insulin administration every single day. This 
would not have happened without STP funding.

    Another game changer for people with diabetes is technology 
to better manage blood sugar levels. I and many others with 
type 1 wear an artificial pancreas system or AP systems. It 
consists of an insulin pump, a continuous glucose monitor, and 
a computer program called an algorithm that allows the pump and 
the CGM to communicate with each other and give the right 
amount of insulin at the right time.

    AP systems aren't perfect. They don't replace what you lost 
when you developed type 1 diabetes, but they do make life 
better. Better blood sugar control and easier diabetes 
management. Several systems are on the market now and next gen 
systems are in the research pipeline.

    Individuals with type 2 are also benefiting from these 
technologies. Many now use CGM to gain valuable information 
about how their food, exercise, stress, and other factors 
impact their lives, and help them better manage their blood 
sugar levels to improve their health. Just this last week, the 
ADA standards of care were updated to reflect the importance of 
diabetes devices and recommended them to patients right away 
when they are diagnosed.

    Continued support of the STP will enable several long term 
T1D oriented research programs and clinical trial networks to 
continue their important work. It will enable researchers to 
explore new opportunities.

    For example, highly beneficial SGLT inhibitors, drugs that 
lower blood sugar by preventing kidneys from re-absorbing 
glucose are approved type 2, but not for people with type 1.

    We need to develop strategies to ensure these drugs can be 
safely used by type 1 people, which could reduce the costly and 
devastating impact of heart and kidney disease. Research for 
both type 1 and type 2 is critical to gain further 
understanding, advanced therapies, find cures, and JDRF and 
others are significantly investing in this research.

    But absent Government support and investment, these 
advancements will slow. The cost of diabetes will rise. We need 
Congress to move swiftly and enact the STP and STPI funding 
contained in S. 1855.

    Until cures, we need affordable insulin for all those who 
need it to live. JDRF supports the bipartisan Insulin Act of 
2023, led by Senators Collins and Shaheen, and calls on 
Congress to support its enactment.

    Thank you again for this opportunity to testify and I look 
forward to your questions.

    [The prepared statement of Dr. Kowalski follows:]

                prepared statement of aaron j. kowalski
    Chairman Sanders, Ranking Member Dr. Cassidy, and Members of the 
Committee, I am Dr. Aaron J. Kowalski, Chief Executive Officer for 
JDRF, the leading global organization harnessing the power of research, 
advocacy, and community engagement to advance life-changing 
breakthroughs for type 1 diabetes--T1D. As a scientist by training, a 
person living with T1D, and someone with a brother with T1D, I have 
been honored to work for JDRF and to represent individuals and families 
impacted by T1D for the past 19 years, four of which have been in my 
current role.

    I am also honored to testify and appreciate the Committee's focus 
on diabetes. I would like to start with a thank you. Because of your 
bipartisan leadership and support, and the steadfast leadership of 
Senate Diabetes Caucus Co-Chairs, Senators Susan Collins and Jeanne 
Shaheen, the Special Diabetes Program and the Special Diabetes Program 
for Indians (SDPI) are making a tremendous difference in the lives of 
people with diabetes and their hope for the future. These programs have 
helped to fundamentally change what it means to live with diabetes, 
have put new life-changing therapies in our hands, and have brought us 
closer to cures.

    JDRF and our countless volunteers are grateful the Committee 
recognizes the importance of maintaining this momentum and building 
upon this progress with the approval of S. 1855, the Special Diabetes 
Program Reauthorization Act of 2023. We thank you and continue to work 
with your colleagues to ensure the 2-year, $170 million per year for 
each program, is enacted.
               Diabetes--A Costly and Burdensome Disease
    Far too many people are aware of ``diabetes'' but do not know the 
difference between type 1 diabetes (T1D) and type 2 diabetes (T2D). T1D 
is an autoimmune disease in which a person's pancreas stops producing 
insulin, a hormone that enables a person to utilize energy from food. 
The condition lasts a lifetime, and people with T1D must take insulin 
to live. T2D is a metabolic disease. With T2D, the body still produces 
insulin but cannot use it effectively.

    Today, more than 37 million Americans have diabetes and 96 million 
have prediabetes. \1\ Of those with diabetes, JDRF estimates that 1.4 
million people have T1D. Diabetes affects people of all ages and races 
across the country. The complications that result from the condition 
are significant--ranging from heart disease and strokes to lower-limb 
amputations--and reduce life expectancy by at least 10 years in people 
with diabetes compared to people without diabetes. As a result of the 
breadth and impact, the total annual cost for diabetes in 2022 was 
$412.9B, including $306.6B in direct medical costs and $106.3B in 
indirect costs. \2\
---------------------------------------------------------------------------
    \1\  Centers for Disease Control and Prevention. National Diabetes 
Statistics Report website. https://www.cdc.gov/diabetes/data/
statistics-report/index.html. Accessed July 6, 2023.
    \2\  American Diabetes Association. New American Diabetes 
Association Report Finds Annual Costs of Diabetes to be $412.9 Billion. 
https://diabetes.org/newsroom/press-releases/new-american-diabetes-
association-report-finds-annual-costs-diabetes-be (2023)

    Research for both T1D and T2D is critical to gain further 
understanding, advance therapies, and find cures for both conditions. 
JDRF and others are investing significantly in research, but absent 
additional investments the advances will slow significantly, while the 
costs of diabetes continue to rise exponentially.
              JDRF--Partnering with the Federal Government
    Before I share some of the exciting breakthroughs resulting from 
the SDP, I want Congress to know that JDRF's private funding works hand 
in hand with SDP funding to ensure that the most important and 
promising research projects have the support they need. JDRF 
accelerates the path to cures by raising funds and allocating them to 
T1D research and therapy development, as well as by leveraging our 
expertise and leadership to bring in additional funding and supporters.

    I am proud to say that JDRF has invested more than $2.5 billion in 
research funding since our founding in 1970. And through direct 
research investments and partnerships within the public and private 
sectors, including through the SDP, we helped raise $473 million for 
T1D research and therapy development in JDRF's 2022 fiscal year. 
Investments from the JDRF T1D Fund, which is a separate mission-driven 
venture philanthropy fund focused on equity investments in companies 
developing life-changing T1D products, is a part of this total. This 
partnership between the public and private sectors is what it takes to 
deliver major advances for T1D research.
        The Special Diabetes Program--Accelerating Breakthroughs
    There has been tremendous progress that gives us hope for a 
brighter future. Here are some examples of the advancements that are 
exciting to the T1D community where the SDP played a role.

          First Disease-Modifying Therapy Brought to Market

        The SDP enabled the creation of TrialNet, the largest clinical 
        network for T1D. TrialNet conducted the clinical trials that 
        led to the November 2022 U.S. Food and Drug Administration 
        (FDA) approval of Tzield, the first disease-modifying therapy 
        for individuals at-risk for developing T1D. This therapy can 
        delay T1D onset for almost 3 years; other therapies to delay 
        and prevent onset are advancing in the research pipeline.

        A delay in the onset of T1D has a tremendous impact on the 
        daily lives of people at risk for T1D, their families, and the 
        overall healthcare system. It frees them from the constant 
        burden and stress of blood glucose monitoring and insulin 
        administration. It frees them from the worry and fear of short-
        and long-term complications, while giving them the opportunity 
        to learn more about disease management. And it enables one to 
        avoid the medical emergency that often accompanies a T1D 
        diagnosis. This is both clinically and emotionally meaningful.

        With a therapy to delayT1D onset and others on the horizon, 
        screening for the risk factors that trigger T1D is even more 
        important. TrialNet has a screening program for those with a 
        direct relative who has T1D; however, anyone who tests positive 
        for risk factors may be eligible to enroll in a clinical trial. 
        JDRF launched T1Detect, a community-based education and 
        awareness program to expand screening to the general 
        population. JDRF is also studying the age or ages when 
        screening should be done. We know the need to focus on 
        screening is great and look forward to talking with you further 
        about it.

          Advances in Cell Therapies

        Another recent exciting development in diabetes research is the 
        June 2023 FDA approval of the first cell therapy for adults 
        with T1D. The approval is specifically for adults unable to 
        maintain average blood glucose levels due to repeated severe 
        episodes of low blood glucose levels or hypoglycemia. This 
        therapy, with the use of immunosuppression, takes deceased 
        donor islets and places them into people with T1D. This is an 
        important first for the diabetes community, as it is a therapy 
        that allows some patients to go without any injected or infused 
        insulin for several years. This therapy could also have promise 
        for the estimated eight million Americans with T2D who rely on 
        insulin administration every day. Clinical trial data resulting 
        from the SDP-supported Clinical Islet Transplantation 
        Consortium contributed to this pivotal step toward identifying 
        cures.

          Artificial Pancreas Systems

        Yet another area of progress that is a real game changer for 
        people with T1D is technology to better manage blood glucose 
        levels. An artificial pancreas (AP) system consists of an 
        insulin pump, a continuous glucose monitor (CGM), and a 
        computer program called an algorithm that allows the pump and 
        CGM to communicate with each other to give the right amount of 
        insulin at the right time--much like the pancreas does in 
        people without T1D. AP systems are not perfect, but they allow 
        people to think about their diabetes a little less and have 
        better blood glucose control, which improves the quality of 
        life of those impacted by T1D and helps to mitigate costly and 
        burdensome long-term diabetes-related complications. I was very 
        involved in the development of AP systems and the approval 
        process, and I'm thrilled to see the benefits that have 
        resulted for myself, my brother who also lives with T1D, and 
        the entire diabetes community.

        SDP-funded research laid the early groundwork for developing AP 
        systems. In fact, SDP funds contributed to the first fully 
        automated insulin-dosing system being made available to 
        patients in 2017, five to 7 years earlier than expected. 
        Positive results from SDP-supported clinical trials since then 
        have led to other FDA-approved systems and next-generation AP 
        devices that have outperformed first-generation devices in 
        children, adolescents, and young adults.

        Individuals with T2D and athletes are also benefiting from some 
        of this research. Many are now using CGMs to better monitor 
        their blood glucose levels; gain valuable information about how 
        food, exercise, stress, and other factors impact their levels; 
        and better manage their levels for improved health or peak 
        performance.

  The Special Diabetes Program for Indians (SDPI)--Making a Difference
    The SDP's sister program, the SDPI, is also demonstrating 
significant progress toward the prevention and treatment of T2D in 
American Indian and Alaska Native communities, which are impacted 
disproportionally by the disease. The SDPI serves 780,000 American 
Indians and Alaska Natives across 302 programs in 35 states. The 
program focuses on community-directed approaches that are culturally 
based.

    Since the beginning of the SDPI, blood glucose levels have 
decreased by 11 percent, average LDL cholesterol risk factors have 
reduced by 25 percent, diabetes-related kidney disease has been cut by 
more than half, fewer people are developing diabetes, and primary 
prevention and weight management programs for Native youth have 
increased. That's amazing. These successes will continue, and even 
greater progress will be made with the continued Federal investment 
contained in S. 1855.
             Future Opportunities--Building on the Momentum
    While the opportunities before us are abundant, here are a few 
examples in need of funding with the next SDP renewal.

          Fund Long-Term Research Programs and Clinical Trials

        Continued support of the SDP would keep several long-term T1D-
        oriented research programs and clinical trial networks running 
        strong, enabling them to continue their work which has yielded 
        so many exciting and promising discoveries. For example, The 
        Environmental Determinants of Diabetes in the Young (TEDDY) 
        study of 8,600 children, enrolled at birth and being followed 
        until they are 15 years old, seeks to understand which 
        environmental factors trigger or protect against T1D onset. 
        Information on diet, infections, and other exposures is being 
        analyzed from children who are progressing toward--or now 
        have--full T1D onset. Results to date indicate that there are 
        multiple pathways leading to T1D. Further investigation is 
        needed to develop strategies to prevent the onset of the 
        disease, ranging from a vaccine to specific dietary changes. 
        The data collected from this study could also benefit other 
        autoimmune diseases, such as celiac disease.

          Protect Heart and Kidney Health for Those with T1D

        SGLT inhibitors, such as Invokana, Farxiga and Jardiance, 
        protect heart and kidney health for people with type 2 diabetes 
        but are not yet FDA approved for people with T1D. There is an 
        immediate need to develop evidence-based strategies to ensure 
        these drugs can be used safely by people with T1D, which could 
        significantly reduce costly and devastating impacts of heart 
        and kidney disease.

        A recent study shows that for the current population living 
        with T1D, lowering End Stage Renal Disease rates by 50 percent 
        is expected to generate Medicare savings that build over time. 
        At the 10-year mark, the cumulative savings to Medicare are 
        $5.1 billion. By the 25-year mark, Medicare savings reach $13.6 
        billion \3\. These savings estimates do not incorporate 
        individuals who will be diagnosed in the future and therefore 
        are conservative.
---------------------------------------------------------------------------
    \3\  Winn, A, Skandari, R, O'Grady, M, and Huang, E. ``Potential 
Medicare Savings of Reduced End Stage Renal Disease in Patients with 
Diabetes,'' May 2023. Unpublished white paper.

---------------------------------------------------------------------------
          Investigate Cardiovascular Disease in People with T1D

    Cardiovascular disease (CVD) in people with T1D is not as well 
studied as in people with T2D, even though it is a major cause of death 
in people with T1D. There is a major unmet need to identify the 
mechanisms that promote earlier development of CVD in people with T1D, 
to learn and develop new interventions to prevent and treat it.
         Long-term, Uninterrupted SDP Support--A Critical Need
    The critical research supported by the SDP requires lengthy periods 
to achieve optimal results. A long-term reauthorization would allow the 
National Institute of Diabetes and Digestive and Kidney Diseases to 
carefully plan the use of funds, which are directed toward new and 
ongoing clinical trials that take multiple years to complete.

    Technology development also takes time. The noteworthy progress in 
developing artificial pancreas and other glucose management 
technologies has been spurred by long-term SDP support, as I noted 
earlier. For the scientists who conduct the research, long-term, 
sustained funding is incredibly important. With the uncertainty of 
sustained funding, they may pursue other research opportunities 
elsewhere. The assurance of long-term funding is also important to 
attract new talent to this field and to maintain a pipeline of future 
generations of scientists to conduct T1D research.

    Again, I thank you Chairman Sanders, Ranking Member Dr. Cassidy, 
and Members of this Committee for advancing S. 1855--bipartisan 
legislation led by Senators Susan Collins and Jeanne Shaheen to renew 
the SDP and SDPI. I urge Congress to move swiftly and enact the 2-year, 
$170 million per year reauthorization for both programs so we can keep 
this exciting and life-changing momentum going.
              Insulin Affordability--Also a Critical Need
    While the focus of my remarks is on the SDP and SDPI, it is 
important to note that people with diabetes need access to affordable 
insulin until we have cures. I appreciate the Committee's interest in 
addressing this issue, as we all know the current drug pricing system 
does not work for countless people who need insulin to survive. 
Progress has been made but we need to take the next step. JDRF urges 
Congress to pass the bipartisan INSULIN Act of 2023, led by Senators 
Susan Collins and Jeanne Shaheen, which establishes a $35 per month 
insulin copay cap for people with commercial insurance and includes 
other provisions that would make insulin more affordable for everyone, 
regardless of insurance status.

    Thank you again for the opportunity to testify. I look forward to 
answering your questions.
                                 ______
                                 
                [summary statement of aaron j. kowalski]
    Thank you. Because of your bipartisan leadership and support, and 
the steadfast leadership of Senate Diabetes Caucus Co-Chairs, Senators 
Collins and Shaheen, the Special Diabetes Program--SDP--and the Special 
Diabetes Program for Indians--SDPI--are making a tremendous difference 
in the lives of people with diabetes and their hope for the future. 
These programs have helped to fundamentally change what it means to 
live with diabetes, have put new life-changing therapies in our hands, 
and have brought us closer to cures.

    JDRF and our countless volunteers are grateful the Committee 
recognizes the importance of building on this progress with the 
approval of S. 1855, the Special Diabetes Program Reauthorization Act. 
We thank you and continue to work with your colleagues to ensure the 2-
year, $170 million per year for each program, is enacted.

    Here are a few of the many exciting breakthroughs resulting from 
the SDP:

    A new FDA approved therapy--Tzield can delay T1D onset--and the 
need for insulin--for nearly 3 years. Other such therapies are in the 
pipeline. This has a huge impact on the lives of people at risk for T1D 
and the overall healthcare system. To take advantage such therapies, we 
must ensure widespread screening for risk factors that trigger T1D.

    In June, the FDA approved the first cell therapy for adults with 
T1D who are unable to maintain average blood glucose levels due to 
severe hypoglycemia. This therapy allows some patients to live without 
external insulin for several years and could have promise for the 
estimated eight million Americans with T2D who rely on insulin 
administration every day.

    Several artificial pancreas (AP) systems are on the market and next 
generation systems are in the pipeline. They're not perfect, but they 
typically result in better blood glucose control. Individuals with T2D 
are also benefiting--many now use CGMs to gain valuable information 
about how food, exercise, and other factors impact their levels; and 
better manage their blood glucose levels.

    Continued SDP support will enable several long-term T1D-oriented 
research programs and clinical trial networks to continue their 
important work. And it will enable researchers to explore new 
opportunities. For example, highly beneficial SGLT inhibitors--drugs 
that lower blood sugar by preventing the kidneys from reabsorbing 
glucose--are approved for T2D are not yet approved for people with T1D. 
We need to develop strategies to ensure these drugs can safely be used 
by people with T1D, which could reduce the costly and devastating 
impacts of heart and kidney disease.

    Research for both T1D and T2D is critical to gain further 
understanding, advance therapies, and find cures for both conditions. 
JDRF and others are investing significantly in research, but absent 
additional government investments the advances will slow significantly, 
while the costs of diabetes continue to rise exponentially.

    We need Congress to move swiftly to enact the SDP and SDPI funding, 
as contained in S. 1855. And until there are cures, we need affordable 
insulin for all who need it to live. JDRF supports the bipartisan 
INSULIN Act of 2023, led by Senators Collins and Shaheen, and calls on 
Congress to support its enactment.

    Thank you.

                                 ______
                                 
    The Chair. Thank you very much, Dr. Kowalski. This familiar 
product is a 20 ounce bottle of Coke. Contains over 15 
teaspoons of sugar, more than twice the recommended daily limit 
for kids under the age of 18.

    This is a 12 ounce can of Coke, and according to the Center 
for Science in the Public Interest, people who drink one or two 
cans of Coke a day, ``have a 26 percent greater risk of 
developing type 2 diabetes than people who rarely consume such 
drinks. And the risks are even greater for young adults.?

    Dr. Taillie, do you believe that Coca Cola and companies 
that make similar products should be marketing these products 
to children? Should there be labels on products like Coke 
warning people that regularly consuming sugary drinks 
substantially increases their chances of getting type 2 
diabetes? Dr. Taillie.

    Dr. Taillie. We know that food marketing is very effective 
for kids, and over 50 percent of our kids are still drinking 
products like Coke on a daily basis. That consumption has gone 
down over recent years, but still remains far too high.

    These kids are being marketed products like Coke in many 
different ways. Increasingly, this is proliferating on social 
media and online, where kids aren't even able to identify it as 
advertising.

    Kids are seeing nearly 200 ads a week for products like 
Coke. And so, this is really getting into their heads and 
creating these strong preferences for these products at a very 
early age.

    In terms of clear labeling, we have a lot of data, both 
from experiments that we have done here in the U.S. and from 
global evidence from countries that have implemented these 
labels that these labels help people really clearly see when 
they are looking at the package that this is unhealthy.

    Coke is a product that is more clear. More consumers know 
that sodas are unhealthy. But when we think about fruit drinks, 
those are the products that kids consume the most. Those are 
products that parents think are healthy. Those are confusing 
products, and they still contain a lot of sugar.

    Warnings--warning labels would really help parents 
understand that better.

    The Chair. Apologize for cutting you off. We don't have a 
lot of time. I want to go to Dr. Gearhardt.

    According to your testimony, the food and beverage industry 
has used some of the same tactics as the tobacco industry to 
get our kids addicted to ultra-processed foods that are high in 
sugar, salt, and saturated fat.

    Is that correct? Are we seeing products sold to kids 
similar to the style used by the tobacco companies?

    Dr. Gearhardt. Yes. So, there is documented evidence, given 
the intertwined histories between the tobacco industries and 
the processed food industries that these strategies used to 
sell, create market cigarettes were applied very intentionally 
to improve the profit margins of especially children's sugar 
sweetened beverages.

    We know that our brains were never developed to handle this 
level of food reward, the amounts of sugar, how rapidly they 
are being delivered into the body. That these are really 
effective at engaging the core nerve circuitry of addiction.

    The Chair. Thank you. Dr. Lipska, Ozempic costs about 
$12,000 per year in the United States, but just $2,000 here in 
Canada and $750 in Germany. What do these very high prices mean 
for your patients? Do you think your patients would be living 
healthier lives if we can make these drugs more affordable?

    Dr. Lipska. Mr. Chairman, absolutely. These prices are, as 
I said, outrageous. And what happens is that patients cannot 
afford those medications and so they go without. And we know 
these medications have effects in terms of reducing the risk of 
heart disease. When people go without, they are at risk for 
these complications. They would be healthier if they were able 
to afford them.

    The Chair. Would I be correct in saying not only do people 
suffer and die unnecessarily, but the cost to the health care 
system increases? If I can't give you a drug, you end up in the 
hospital. Am I correct in that?

    Dr. Lipska. Absolutely. Absolutely correct.

    The Chair. Okay.

    Senator Cassidy.

    Senator Cassidy. I am going to defer to Senator Marshall. 
But before I do so, I would like to have unanimous consent--
Senator Collins had to leave for a just called Committee 
hearing. She asked that I submit for the record testimony from 
the Endocrine Society. I ask for unanimous consent to do so.

    The Chair. Without objection.

    [The following information can be found on page 57 in 
Additional Material:]

    Senator Cassidy. With that, I defer to Senator Marshall.

    Senator Marshall. Yes. Thank you. Ranking Member and thank 
you, Chairman. I sit here in this Committee hearing in my head 
is just spinning. Been on this Committee for 3 years and I am 
not sure we have made any meaningful impact yet on diabetes.

    A huge epidemic, as we already know this. Through these 
opportunities to attack the nutrition standpoint, the education 
standpoint, it is time to stop studying it and forming 
committees.

    It is time to move forward with action. I think we all 
understand the cost of prescription drugs is part of the 
challenge here. It is interesting to me that in 2022, Americans 
spent $633 billion on prescriptions, $633 billion. Almost $500 
billion of that went through the hands of our pharmacy benefit 
managers.

    $5 out of $6 that Americans spend on prescription drugs go 
through the hands of pharmacy benefit managers. And of course, 
there is kickbacks. They give some of that money back to 
Medicare and insurance providers, and we have no idea who and 
how much those are going to.

    But in case you are feeling sorry for the PBMs, they had a 
profits of $27 billion in 2022. $27 billion was their profit 
margin. Three PBMs are now ranked 4, 5, and 12 on the Fortune 
500 list. So, as I look to solving this problem of prescription 
drugs to treat diabetes, I tried to figure out where is the 
biggest bang for the buck without destroying innovation.

    I keep coming back to these pharmacy benefit managers. We 
have done incredible work so far to address this problem, but 
our work is not finished. We have sponsored the Drug Act, which 
is a bipartisan, bicameral legislation that would delink 
administrative fees paid to PBMs from the price of prescription 
drugs.

    Rather than paying a percentage of the drug, that there 
would be a flat fee. Obviously, the PBMs are motivated to the 
higher the drug costs, the more they are going to benefit when 
they get a percentage of that. We have had great colleagues 
here with Senators Kaine and Braun, and we withdrew our 
amendment because it didn't have a CBO score at the time.

    But this remains my top priority. We had the CBO estimate. 
Guess what? This is going to save the Federal deficit by $654 
million if it is fitted into the PBM Reform Act. Senator 
Collins said this legislation is literally right on the money, 
and certainly Senator Collins has been my mentor in trying to 
figure out what to do with diabetes here in many ways.

    The underlying issue is that PBMs favor higher priced brand 
insulin over insulin biosimilars. We had hoped the biosimilars 
coming to market would help drive this down, but it remains a 
challenge.

    This legislation eliminates the perverse incentives of PBMs 
to block access to affordable insulin, biosimilars, and generic 
drugs. Is there anybody on the panel that would disagree that 
by limit--by delinking this would help drive down the price. 
Does anyone disagree with that? Okay.

    I just hope to have a commitment from our folks, from this 
Committee that we have continued to work on this and that 
somehow we could add this delinking amendment and get it as 
part of the package to move forward to actually impact the 
challenges that we have here already. I guess I got a minute 
and a half left.

    Let's talk about education and nutrition. I will defend 
Coke and Pepsi for a second. They are going a lot to other more 
healthy drinks. I see them out there. And more and more, I see 
young people probably better so than people my age group making 
healthier choices. Does anybody have any comments on how we can 
promote that education in a better way?

    Dr. Taillie. Sure. I mean, I think education is really 
important and we could do better in our schools by requiring 
nutrition education, which I believe is not currently required. 
But we also know that education isn't enough because there are 
all of these other forces around marketing and pricing, and 
really the confusing food labeling that makes it complicated.

    When you are looking at that product, that sugary drink, 
and it tells you that it has got 100 percent vitamin C, it can 
still be hard to understand just how much sugar it has. So, 
there are other things that we could be doing besides education 
that would help people make healthier choices. Because we know 
people want to do that. It is just currently hard to do that 
even when they have education.

    Senator Marshall. Okay, thank you so much. I yield back.

    The Chair. Let me just briefly respond to Senator Marshall. 
I think you are aware that I consider the high cost of 
prescription drugs to be one of the great crises facing our 
healthcare system.

    We are going to have to take on 1,800 well-paid lobbyists 
from the pharmaceutical industry here and all of the campaign 
contributions that they make. This ain't easy. But I think for 
the sake of diabetes and so many other illnesses, it should be 
a major priority of this Committee, and I look forward to 
working with you to make that happen.

    Senator Hassan, I believe, is next.

    Senator Hassan. Thank you, Mr. Chair and Ranking Member 
Cassidy for this hearing. Thank you to our witnesses for being 
here today. Really helpful testimony. I want to start with a 
question to you, Dr. Lipska.

    Last year, three major insulin companies announced that 
they would limit the cost of insulin to $35 a month for all 
patients. However, we have heard that patients may not actually 
be getting that discount at the pharmacy counter. In August, 
Senator Smith and I wrote a letter to Eli Lilly, Novo Nordisk, 
and Sanofi asking how their companies will ensure that patients 
can get insulin at this lower price.

    The responses from the companies confirm that many patients 
have to navigate a complex system of manufacturer coupons and 
online applications in order to access low cost insulin. While 
these programs allow drug makers to say that their insulin is 
low cost, it can be really nearly impossible for patients to 
navigate.

    What are you hearing from your patients about the 
affordability of insulin and other diabetes medications?

    Dr. Lipska. Thank you for this question. It is so 
important, and this is why I am here. I heard that the 
companies announced their cuts. I heard them give you their 
word, right, and my patients are not getting $35 insulin.

    I thought initially, maybe they are doing something wrong. 
Let me try it. Let me try to print out the coupon. I asked my 
nurses in the Yale Diabetes Center, are you paying $35? Are you 
commercially insured? Are you getting this deal?

    No, they are not either. So, I don't know. The system is 
really--it is really difficult to navigate, that is true. But 
we are savvy at the Yale Diabetes Center, and we can't get that 
deal.

    Senator Hassan. Well, that is very helpful and something 
that we all need to follow-up on, obviously. And I appreciate 
your work in this area. Dr. Kowalski, I wanted to turn to you 
and thank you and the JDRF for the important work you are doing 
to advance breakthrough treatments, and 1 day, a cure for type 
1 diabetes.

    In particular, you mentioned some of these clinical trials 
on one type of cell therapy, and Dr. Cassidy did too, called 
islet therapy, has been really promising. This therapy, along 
with bio-fabrication, is being researched and developed in New 
Hampshire.

    I would invite the Chair and Ranking Member to New 
Hampshire to see our bio-fabrication center and could remove 
the need for insulin injections for some patients. Dr. 
Kowalski, I would like you to speak to the impact that this 
breakthrough therapy could have on patients with diabetes.

    I would also like the Chair and Ranking Member to consider 
follow-up hearings or work on making sure that the FDA has the 
approval pathways they need for some of this groundbreaking 
research.

    Dr. Kowalski. Excellent. Thank you for the question, 
Senator Hassan. And I was fortunate to be in Portsmouth at a 
groundbreaking for a cell manufacturing facility that Vertex is 
building. Cell therapies have the potential for me to take off 
my pump, and it gives me incredible excitement.

    For years I mentioned cell therapies have provided a 
pathway to the cures, but they have required somebody to donate 
a pancreas upon death. We now have the ability to make insulin 
producing cells from stem cells.

    The 8 million people in the United States on insulin could 
benefit from these tremendous advancements. And Senator 
Marshall said the Committee hasn't made an impact. They have, 
you have. The advancements funded by STP to have brought us to 
the cusp. We are in human trials right now. People are coming 
off insulin.

    The first patient has been off insulin for 2 years now. It 
is absolutely amazing. So, the continued support here is to 
drive this toward what we are calling it, an immunosuppression 
free version, and that is where further research is needed.

    But the potential is massive. I truly believe I will be 
cured in my lifetime, as well my brother, who lives with type 1 
diabetes, and this funding is critical to get us there.

    Senator Hassan. Thank you. One more question for you, Dr. 
Lipska, before my time is up. As we have heard today, new 
evidence shows that some diabetes drugs such as Ozempic appear 
to improve other conditions, such as obesity and heart disease.

    However, with higher demand for these medications, I am 
hearing from constituents with diabetes who are experiencing 
really long delays to get their prescriptions filled. So, how 
can Congress ensure that all populations that can benefit from 
this medication have access to it?

    Dr. Lipska. That is a very important question. Yes, I am 
seeing patients, my patients who come in previously well-
controlled, uncontrolled diabetes because they are not able to 
access their medication. So, the supply issue is important, but 
there is also really important shortages because of the price.

    Senator Hassan. Right.

    Dr. Lipska. And I think that is where this Committee can 
really help to ensure that patients can afford these drugs, 
which are transformative, but not if you cannot take it.

    Senator Hassan. Thank you very much. I yield, Mr. Chair.

    The Chair. Senator Cassidy.

    Senator Cassidy. I will defer to Senator Budd.

    Senator Budd. Thank the Ranking Member. Thank the Chair, 
and the witnesses for being here today, including, I think, one 
from North Carolina.

    Glad to have you all here. So, back in November, so not too 
long ago, The Wall Street Journal reported on a phenomenon 
where pharmacy benefit managers, PBMs, they favor drugs with 
higher list prices.

    I think Senator Marshall mentioned this phenomenon. For 
example, one particular brand of insulin sells at $274 per 
vial, while an unbranded counterpart sells at only $25 per 
vial. Now, according to the Wall Street Journal, half as many 
Americans have insurance coverage for the less expensive 
product, as for the higher priced brand, which accounts for 
about 61 percent of the prescriptions.

    Now, this is important because the PBMs that are in there, 
they preferred coverage for the higher priced medications 
because they are reimbursed on percentage of the list price. 
So, the proposal that Senator Marshall discussed on delinking 
PBM reimbursement from the list price, I think that would go a 
long way in realigning incentives to best serve the interest of 
the patients.

    Now, a paper published by the American Enterprise Institute 
makes clear that the list price, and I believe the Chair 
mentioned list prices when he was referring to some anti-
obesity drugs that were $12,000 or so, but I don't think the 
list price is really the best way to look at that, and that is 
not the best indicator of their true cost.

    Specifically, the study reveals that the rebates that 
manufacturers pay to those PBMs on anti-obesity medication can 
be as high as 80 percent of the list price. So, I ask unanimous 
consent to submit the paper for record.

    The Chair. Without objection.

    [The following information can be found on page 59 in 
Additional Material:]

    Senator Budd. Thank you, Chairman. Thank you. So, the 
question. Dr. Kowalski--again, thank you for being here. And 
again, I appreciate your presence in my State of North 
Carolina. You are making an impact there and a lot of friends 
affected by this in similar situation to you.

    Natalie, thank you for sharing the story of your daughter, 
Nadia. So, the insulin of 100 years ago, they are not the same 
insulin that patients are utilizing today, as I understand. 
There have been countless innovations with insulin, auto 
injectors, longer lasting insulin, and some of the references 
you mentioned.

    Dr. Kowalski, could you speak to how public, private 
partnerships have contributed to some of these advancements?

    Dr. Kowalski. No, this has been an incredibly important 
field. When my brother was diagnosed in 1977 and I was 
diagnosed in 1984, we used to count pig insulin. It was really, 
really difficult to manage, incredibly unpredictable.

    We have seen advancement over advancements in insulin, 
making insulin easier to use, more effective, and driving 
better outcomes. Today's insulins are not good enough, and I 
think this is the balance between innovation and access. JDRF 
believes we need to continue to innovate in better and better 
insulins.

    For example, we have funded what are called glucose 
responsive insulins that would only work when your body needs 
them. These would be transformative. That said, an insulin that 
is generic and off the patent for many years needs to be 
accessible.

    No one with type 1 diabetes should go without insulin. You 
die. If you took away my insulin pump, I would die within a 
week. So, this rationing of insulin is an unacceptable outcome 
in the United States of America.

    This is a balance that we need to strike. But the 
advancements that continue are critically important. We know 
the average person with diabetes right now in the United States 
is not achieving their goals. We need to do better.

    Senator Budd. Appreciate you being here. I yield the floor.

    The Chair. Thank you, Senator Budd.

    Senator Smith.

    Senator Smith. Thank you, Chair. Thanks very much for this 
hearing, and thanks to all of you for being here. I want to 
just put a note on what Senator Hassan was asking about related 
to how people can get access to this, what seems like mythical 
$35 insulin.

    I hear from Minnesotans every single day who tell me that 
they are rationing this medicine that keeps them alive. And 
then we have these big companies come in and tell us, oh, it's 
not us. We are doing everything that we possibly can. We are 
trying to--we are making our products available. And I don't 
believe it. I don't think that is what is happening.

    Mr. Chair, I think that this is completely unacceptable and 
obviously it just pisses me off. I really appreciate your 
testimony about how food is being engineered by these big food 
companies to be addictive and the impact that has on people's 
health, their physical health, their mental health. It is 
pervasive.

    I also have been really encouraged by some of the 
preliminary results that we are seeing for around enrolling 
diabetic or pre-diabetic patients in food as medicine 
initiatives. On the other hand, when you actually are consuming 
real food, it has a big impact on the quality of your health.

    These studies, as I understand it, are showing decreases in 
A1C levels, increases in food security, and improvements in 
self-management of diabetes. So, Dr. Taillie and Dr. Gearhardt, 
could you talk a little bit about this? What is the potential 
of this?

    What is the correlation between access to healthy foods and 
the risk of diabetes, and what should we be doing to take down 
some of the barriers that make it difficult for providers to 
support that kind of therapy?

    Dr. Gearhardt. Thank you so much for this really important 
question. We are actually doing work in my lab right now taking 
our food as medicine perspective. We have funding from the 
Eisenberg Family Depression Center at the University of 
Michigan.

    Again, I am seeing as a clinical psychologist just this 
huge mental health epidemic in adolescents and teens. And we 
know that the majority of teens, teens are maybe getting more 
calories from ultra-processed foods than any other 
developmental stage young children or adults.

    Yet we are seeing that when you can move people to real, 
nourishing whole foods, that it doesn't just help improve their 
physical health, but their mental well-being. And so, we are 
actually doing a trial to work with a company Fresh and Lean, 
to deliver affordable, convenient, minimally processed, ready 
to go meal packages for people as a potential treatment for 
depression.

    I think we need to think not just about cost and protecting 
against marketing, but part of what ultra-processed foods do is 
they are super convenient. They have been designed so you can 
just pour in your mouth while you are driving your car--and 
cheap. And so, thinking about ways to make nutritious 
nourishing food convenient, accessible, and affordable so it 
can compete with these hyper palatable foods is key.

    Senator Smith. Thank you.

    Dr. Taillie. The food is medicine data so far are very 
promising. It shows that it reduces food insecurity, increases 
intake of fruits and vegetables, and reduces A1C, so that is 
great. From a prevention perspective though, it means that 
somebody still has to get sick and access the health care 
system in order to get those prescriptions. And in an ideal 
world, we would see that people had access to those foods as 
part of their daily lives before they develop obesity or 
diabetes.

    Senator Smith. I really appreciate that. And it gets to a 
whole other realm of questions that we could be asking if we 
were on the Ag Committee around challenges with concentration 
in the food sector, what that means for how people can get 
food, food deserts in rural communities and urban communities, 
particularly black and brown communities. There is a lot of 
work to be done there.

    I want to just follow-up on this for a minute more. We know 
that American Indian and Alaska Native adults are much more 
likely than white adults to be diagnosed with diabetes. And we 
also know that the Special Diabetes Program for Native People, 
which funds community based initiatives, provides access to 
people to traditional food, native food is really effective 
because it incorporates traditional practices and traditional 
foods in combination with clinical interventions.

    It seems like there is a correlation between what we are 
talking about here. Maybe, I just have a few seconds more, Dr. 
Lipska. Would you like to talk a bit about why this kind of 
program can be so effective?

    Dr. Lipska. Absolutely. I actually spent some time working 
on the Navajo reservation, so I am very familiar with the 
setting and the rates of diabetes. You know, we have to tailor 
the foods, so they are culturally appropriate for our patients, 
and we have to--but I just want to say, I think we have to go 
really way upstream--I know we are out of time--with these 
interventions because it is much harder to intervene, as you 
said, once people already have prediabetes or obesity.

    Senator Smith. Thank you very much. Thanks, Mr. Chair.

    The Chair. Thank you.

    Senator Cassidy.

    Senator Cassidy. Senator Braun, would you like to go?

    Senator Braun. Thank you. I am ready. This has been a 
subject of interest for me way before I got to the U.S. Senate. 
When you are talking about diabetes, drugs, prevention, and 
remediation, I wrestled with it to where I was at the point of 
frustration.

    There was nothing that you couldn't generally solve in 
running a business other than health care, which generally 
ended up how lucky you were that it was only going up 5 to 10 
percent each year.

    When we were at the point where I could really do something 
about it large enough to self-insure, did three simple things. 
No. 1, I realized none of my employees were health care 
consumers.

    They were the inelastic demands of remediation, generally 
wanting the plan to pay for everything. And in the same way, if 
your private plan doesn't pay for it, people look to Government 
to do it. It has created a system that has given us a bizarre 
kind of cross purpose where it doesn't jibe with what works in 
most other markets. What I did, they became health care 
consumers.

    I gave them every wellness tool, including a free biometric 
screening. I didn't coddle them. You were going to pay more if 
you wouldn't take that. And you know what it has done? It has 
lowered health care costs. Not--we have been doing that 15 
years and have not had a premium increase.

    I would like Dr. Lipska and maybe Dr. Kowalski, how much of 
what we are talking about here is part of a broken system that 
is now driven mostly by huge hospitals that love opaqueness, no 
transparency, and insurance companies that have gone way beyond 
indemnification to where they are in on everything, and they 
grab roughly 15 percent of the health care dollar that is 
purely administrative.

    We are talking about things, I think, on the side of how 
you fix diabetes and other chronic ailments. What about fixing 
the system itself? I would love for you, Dr. Lipska, to weigh 
in, and then Dr. Kowalski.

    Dr. Lipska. Thank you for that question. I agree with you 
that our system is broken.

    In terms of how do we fix this for diabetes in particular, 
to prevent diabetes, to prevent obesity, I think we--the health 
care system needs to serve the needs of the patients who 
develop these conditions, but I think we have to, again, go 
upstream from the health care system in order to prevent people 
from getting sick in the first place.

    I think that is critical. That is going to save us money 
and in the long run to keep people healthy. And I think that is 
upstream from the health care system.

    Dr. Kowalski. So, I will just make a quick statement 
because I am going to come in with a research perspective. But 
start by saying we are talking a lot about obesity and diet, 
that being obese does not mean you are going to get diabetes.

    Sometimes I worry we stigmatize people with type 2 diabetes 
by saying, and some of our colleagues said this, but you just 
stop eating and you will get diabetes. This is a genetically 
inherited disease, so----

    Senator Braun. And I know that. I am asking about the 
framework within which you would like to see that we address it 
and many other things.

    Dr. Kowalski. Absolutely. So, when we think at JDRF, our 
mission statement is accelerating life changing breakthroughs 
to cure, prevent better treat T1D and its complications.

    I always take those words very literally and significantly, 
meaning your life has not changed if you don't have access to 
better care. And if the system provides barriers, as Senator 
Sanders said, to drugs that could improve your care and your 
life and your health, then we haven't succeeded in our mission.

    Senator Braun. And I agree with that. And I think that is a 
particularity that will weigh in to be helpful. Let me tell you 
what I think is a solution to this and the extremely high cost 
of health care, access and all of it. And proud to say that 
later today, Senator Sanders and I will be introducing a bill 
called the Healthcare Price Transparency Act.

    I have been working on this for the 5-years I have been in 
the Senate, and I think it is the umbrella that finally takes 
us to solutions for this and many other things. Briefly, let me 
tell you what some of the things it is going to do. It is going 
to require machine readable files of all negotiated rates and 
cash prices between plans and providers, not estimates.

    It is going to require pricing data standards, including 
all billing codes for services. It is going to require actual 
prices for 300 shoppable services, with all services by 2025. 
It is going to require a testing by executives that all prices 
are accurate and complete.

    It is going to prevent preemption of state price 
transparency rules, codify the transparency coverage rule, and 
it is going to provide group health plans the right to access, 
audit, and review claims and counter data.

    Thank you, Senator Sanders and Senator Smith for being on 
it. I hope to get all Republicans and Democrats on a bill that 
will fix many aspects of health care.

    The Chair. Thank you, Senator Braun.

    Senator Hickenlooper.

    Senator Hickenlooper. Thank you, Mr. Chair. I thank all of 
you for being here. I have got a few questions, so I am going 
to hope you can be very concise. This morning, we have 
discussed what more we need to do to address upstream causes of 
obesity that are leading to higher rates of diabetes in our 
Country.

    It is particularly important that we think about what we 
can do early on to ensure a fewer of our kids end up with type 
2 diabetes. In addition to nutrition, one major tool, which has 
been talked about somewhat, to improve overall health and 
wellness is access to green spaces and outdoor activity.

    Green spaces and getting kids into outdoor recreation can 
help promote the kind of lifestyle that keeps kids healthy. One 
in three Americans, including 28 million children, don't have 
access to green space within a half a mile. We are working on 
legislation to create a Federal Office of Outdoor Recreation, 
which will help ensure equitable access to recreation in all 
communities.

    Let's start with Dr. Gearhardt and Dr. Taillie. Can you 
discuss the benefit that physical activity with healthy eating, 
along with healthy eating, can have in delaying or preventing 
the onset of type 2 diabetes?

    Dr. Gearhardt. So, we see that physical activity and nature 
can play a big role in our overall mental health and well-
being. We do see that the role of nutrition and diet can kind 
of swamp some of those effects.

    But I think you are right that it has really got to be 
multi-pronged and multifaceted, and we need to take holistic 
views, but also invest our energy and resources where it is 
going to make the biggest bang for our buck.

    Dr. Taillie. Yes, to build on that. The diabetes prevention 
program showed that the combination of physical activity and 
diet changes were tremendously effective at preventing type 2 
diabetes.

    But at the same time, going back to Senator Sanders showing 
us that can of Coke, we know that it is really, really easy to 
drink a can of Coke, and that would require exercising, running 
a mile and a half to offset that can of Coke.

    It is really important to, in my view, really prioritize 
nutrition coupled, of course, with physical activity to promote 
overall fitness.

    Senator Hickenlooper. Great. Thank you so much. Community 
health centers place an emphasis on integrated care models, 
take a comprehensive approach to patient care, focusing not 
only on treatment but prevention, nutrition, exercise, other 
social determinants of health.

    We have seen some compelling data on this Committee that 
shows community health centers are more successful at helping 
patients with hypertension and diabetes control these issues, 
which really is remarkable because community health centers are 
more and more dealing with complex chronic conditions.

    Dr. Lipska, what can other health care providers learn from 
community health centers and their approach to caring for a 
diabetes patients?

    Dr. Lipska. Thank you. And I think it has to do a lot with 
the fact that community health centers take that holistic 
population view as opposed to the rest of health care, which 
often takes care of the patient in front of you, bill for the 
service, and then that is it, right.

    I think that if we have these systems where you are 
responsible for the care of the population of patients, you are 
going to put more emphasis on prevention of disease rather than 
just treatment of complications when they occur. So, I think we 
can all learn a lot from that. I think that they are doing a 
great job.

    Senator Hickenlooper. I agree. Just one other point on 
that, or separate from that, is consuming these ultra-processed 
foods like sugary drinks and all these things you have been--we 
have been talking about are also connected with higher rates of 
dementia in later in life. I didn't know whether you or any of 
the others would like to comment on that.

    Dr. Gearhardt. Yes, there has been some people have even 
started to think a little bit of Alzheimer's and dementia as 
type 3 diabetes. It has been discussed a bit.

    I could say we have done research with the National Poll 
and Healthy Aging at the University of Michigan that found in 
older adults, 13 percent endorsed clinically significant signs 
of addiction in their intake of ultra-processed foods, and that 
was associated with higher mental health, physical 
difficulties, and overall tendency to have a lower quality of 
life.

    I think older adults are a really key population whose 
increase of ultra-processed foods has been increasing 
remarkably over the last couple of decades.

    Senator Hickenlooper. Got it. Great. Thank you. And just 
very quickly, Ms. Stanback, the National Institute of Diabetes 
and Digestive and Kidney Diseases at NIH funds this critical 
research across the country.

    University of Colorado, a Denver diabetes research center 
with this important support, is spearheading research into type 
1 and type 2 diabetes. They also run a program to recruit young 
faculty into diabetes related research.

    Your experience, first with your brother and then with your 
daughter Nadia, highlights the importance of prioritizing 
research and making sure future scientists are focusing on 
treatment. How have the recent medical breakthroughs, even over 
the course of Nadya's life, changed her experience of living 
with type 1?

    Mrs. Stanback. Peace of mind. A lot of us are talking about 
the pharmacy, pharmaceuticals and the medicines that help 
people with type 1 diabetes, but it also presents a very 
mental--a serious mental burden that presents in the form of 
burnout and other things that are detrimental to the health of 
people living with type 1 diabetes.

    Her insulin pump and the CGM gives not only her but me also 
peace of mind and being able to manage the cumbersome disease.

    Senator Hickenlooper. All right. Thank you. Thank you all. 
Appreciate you spending time to be here. I yield back to the 
Chair.

    The Chair. Thank you.

    Senator Cassidy.

    Senator Cassidy. We have 5 minutes, so if I interrupt you, 
I am not being rude--or maybe I am being rude, but that is the 
reason.

    [Laughter.]

    Senator Cassidy. Dr. Kowalski, you mentioned risk factors 
for type 1 diabetes, but what is there besides genetics? What 
are the risk factors? Are there other risk factors that we 
don't know about?

    Dr. Kowalski. Well, I think you are--so you are hearing 
that in both forms of diabetes, there is----

    Senator Cassidy. Just type 1.

    Dr. Kowalski. Okay, but it is genetics and an environmental 
factor. And if we could find that environmental factor, we 
could stop this disease.

    Senator Cassidy. So, when you mentioned that we need to 
focus upon the research, it is just that this has to be 
developed. It is not that we know it now. You said that we need 
to study those who have the risk factors, but the principal 
risk factor would be like Ms. Stanback's family. My gosh, maybe 
yours because you mentioned your brother having it.

    Dr. Kowalski. Yes. No, no, there is definitely a genetic 
component to type 1 diabetes. We know that well. But if you 
have an identical twin, it is not 100 percent that the second 
twin, if the first one develops it, will get it.

    We have, for example, the STP funding a very, very 
important study called Teddy that tracks from in utero to 
adulthood children at high risk. And we are looking at 
environmental factors that could be triggering the disease. 
That will stop----

    Senator Cassidy. Let me interrupt you. I graduated from med 
school in 1983, and they have been talking about it since `83. 
So, obviously it is pretty difficult to tease out what those 
environmental factors are.

    Dr. Kowalski. Very difficult, but we do have a number of 
candidates that are moving into human clinical trials, and we 
believe that we will get there.

    Senator Cassidy. That is fantastic. Ms. Stanback, Dr. 
Lipska mentioned that in her clinic, the workers there have a 
hard time getting $35 insulin. We know, we are told up here, 
but we often don't know what we know.

    You are the person who has been kind of living with this. 
So, what is your experience in terms of--and I ask this not 
knowing the answer, what is your experience in terms of getting 
affordable insulin?

    Mrs. Stanback. Our insulin is only affordable because we 
are paying top tier for our private insurance. But I have also 
not seen it----

    Senator Cassidy. Let me ask you, do you have any insight 
into what your pharmacy benefit manager--because we have been 
told pharmacy benefit managers deliberately do not take the low 
cost insulin but rather get the higher cost insulin because 
frankly, the PBMs allegedly make more money by costing you more 
money. Do you have any insight into that?

    Mrs. Stanback. I don't I just know that we selected the 
highest tier of the insurance provided by my employer to make 
sure that we cannot have any ambitions when it comes to choice 
or selection of insulin.

    Senator Cassidy. That is great. And Dr. Lipska, do y'all 
have any insight into what Yale does for its PBMs? Because 
again, this does come up continuously and this is the big rub. 
Eli Lilly says, hey, listen, we are given it for $35. Yes, 
there is a tax, there is a dispensing fee, but our cost is $35.

    The PBMs allegedly are saying, no, we are going to give you 
the top dollar and we are not going to take this one. Do you 
have any--when you inquire about this, do you know whether that 
extra cost being paid is due to the PBM or to the drug company?

    Dr. Lipska. That is a great question. I don't know. I 
honestly haven't been able to get to the bottom of why this 
happens because it is so difficult.

    Senator Cassidy. So, let me ask then, and this may come to 
you, it is my understanding that on some of these processed 
foods, it is fructose more than glucose or sucrose, which is 
the problem.

    That fructose is more quickly absorbed and causes a greater 
sugar high and kind of the greater sugar low, so therefore you 
want another hit. Now, again, I haven't looked at this for some 
time, but is that still kind of the thought?

    Dr. Lipska. Yes, I think--I don't know if the other 
panelists want to answer that as well since, again, I treat 
diabetes, but I am familiar with some of that research and I 
understand that is true, that fructose does activate those 
rewards systems.

    Senator Cassidy. Could one of you all answer that quickly, 
please?

    Dr. Taillie. That is true. But the high fructose corn syrup 
that we are consuming is actually very similar to sugar, from a 
chemical composition perspective.

    Senator Cassidy. The fructose?

    Dr. Taillie. The main--yes.

    Senator Cassidy. Yes, but the fructose is more quickly 
absorbed.

    Dr. Taillie. The main issue is also that we are consuming 
it via liquid forms, which means that it is much more rapidly 
digested. And that is true for ultra-processed foods as well. 
The way that those foods are made means that they are 
metabolized much more rapidly.

    Senator Cassidy. I get that, yes--the more fiber, the apple 
juice is absorbed more rapidly than applesauce, which is more 
rapidly than an apple.

    Dr. Taillie. Exactly.

    Senator Cassidy. More fiber is slower absorption. But 
fructose is the independent factor, and it does seem like 
fructose is a particular issue here, I will just point that 
out. Ms. Stanback, coming back to you.

    Again, we have had these kind of conversations as regards 
PBMs. When you change insurance companies, because periodically 
employers do, are they making you go through a prior 
authorization process for whatever your daughter's currently 
on?

    The brand new one, no, this didn't work before, but you got 
to go through it once more just to satisfy our requirements?

    Mrs. Stanback. No, not with our private insurance. It is 
through my employer.

    Senator Cassidy. Do you have a big employer or a small 
employer?

    Mrs. Stanback. It is fairly large.

    Senator Cassidy. Do you mind telling us?

    Mrs. Stanback. I work for AMN Healthcare, medical staffing.

    Senator Cassidy. Yes. That is a pretty big company. Okay, 
well, I am almost out of time, but I thank you all.

    The Chair. Thank you.

    Senator Kaine.

    Senator Kaine. Thank you, Chair Sanders. And great hearing, 
great witnesses. I would like to put an unusual document into 
the record. It is a JDRF 2023 children's Congress scrapbook.

    A bunch of students in Virginia who have diabetes told 
their stories and they are Emory Ellis, Maddie Hawkins, Riley 
Kitts, Karson Owen, Jack Samples, Jane Vanden Eykel. I think 
these are worthy testimony.

    I just want to read one that was interesting from Maddie 
Hawkins. She is in a family where mom, dad and her brother, the 
mother doesn't have diabetes, all the others have type 1 
diabetes.

    Listen to this. My dad was diagnosed with diabetes before I 
was even born and my brother diagnosed in 2020, so it is always 
crazy at my house. There is always some alarm going off, always 
someone who needs to treat their blood sugar. My mom's goal in 
life is for all of us to have the same blood sugar at the same 
time, but that hasn't happened yet. Still, at the end of the 
day, sharing diabetes creates a sense of camaraderie.

    Then there is a picture of the dad and the two kids who 
share this camaraderie because they have diabetes. I would just 
like to put that into the record.

    The Chair. Without objection.

    [The following information can be found on page 60 in 
Additional Material:]

    Senator Kaine. And focusing on young people, during the 
height of the pandemic, Congress provided schools with a lot of 
flexibilities around meals.

    One in five kids in the U.S. live without constant access 
to adequate food, and this temporary expansion during COVID 
allowed students, especially those in high need areas, to have 
much more access to meals that were nutritious.

    Now, the pandemic era policies in several states have 
enacted legislation allowing for universal free school meals. 
In Virginia, there are currently about 511 schools that have 
adopted the community eligibility provision where eligible 
schools can offer meals at no cost to all students.

    I am heartened to see this uptick in the CEP in my home 
state. Dr. Taillie, what impact does the nutritional value of 
school lunches have on students health, and what can Congress 
do to improve health outcomes for kids?

    Dr. Taillie. School foods are probably the No. 1 way that 
we could promote healthier diets among kids and ultimately 
prevent diabetes. Kids consume a third of their daily calories 
in school, so this is incredibly important.

    Universal school meals are critical because it ensures that 
all kids have access to food. We know that adequate nutrition 
is not only important for health and growth, but it promotes 
learning outcomes.

    It also means that kids are stigmatized for receiving when 
only some kids get this benefit. So, in addition to universal 
school meals, as I said in my testimony, really making sure 
that our schools are free from corporate food marketing, ultra-
processed foods, sugary drinks.

    The marketing and advertisement and sales of those products 
to our kids is currently a major problem, and so reducing or 
eliminating that would make huge progress.

    Senator Kaine. Let me ask another question. I have heard an 
interesting policy debate, and the question is should SNAP 
benefits be usable to purchase unhealthy and ultra-processed 
foods? Those who say yes say you shouldn't have a separate 
standard for people using a SNAP benefit--pardon, person using 
dollars and cents.

    Those who say that SNAP benefits shouldn't be used, say why 
would we want to pay tax dollars to enable people to purchase 
foods that make them sick or kill them? And if SNAP benefits 
weren't usable for unhealthy foods, the food retailers and 
grocery stores that are in neighborhoods where there is a high 
percentage of SNAP recipients would have more of a motive to 
offer more healthy food options. What do you all think about 
that debate?

    Dr. Taillie. Yes, I can weigh in on this. I have tried to 
do research in the past on this and wasn't able to receive 
funding. I think it is really important to make sure that 
people who are using SNAP have dignity and choice.

    At the same time, when we think about restricting, I think 
the clear place where we would start with that is around sugary 
drinks. I think there is an argument to be made that those may 
not even be considered as foods.

    They provide no nutritional value. And the health harms are 
so very clear that SNAP is currently not allowed to use for 
like hot meals or alcohol or things like that, and I could see 
putting sugary drinks into that category.

    Senator Kaine. Are thoughts from other panelists?

    Dr. Gearhardt. I think the problem is that those foods are 
also--the unhealthy foods are also cheaper, right. So, then 
your SNAP benefit is going to go potentially a longer way--if 
you can make those foods, the healthy foods, more affordable, 
that would make it easier.

    Dr. Taillie. And beyond restricting, the double up box 
program is a really effective strategy to instead of saying, 
well, you can't buy this, to incentivize people to buy fruits 
and vegetables by giving them more money to do that.

    Senator Kaine. Thank you. Mr. Chairman, last I will 
mention, which isn't really a question, is I know we are 
talking about doing work on the Older Americans Act next year, 
and I think there is a lot in this space that really we could 
do as part of a reauthorization of the Older Americans Act that 
has been touched on in the testimony earlier and look forward 
to working with you on that.

    The Chair. I agree. Okay, Senator Casey.

    Senator Casey. Thank you, Mr. Chairman. I want to thank the 
panel. And sorry I wasn't here earlier. We had an Aging 
Committee hearing that I was Chairing that overlapped. So, we 
have your testimony, and I am--I know that Sara and my team has 
been here for the whole hearing.

    I wanted to thank the witnesses for your testimony, 
bringing both experience and expertise to these issues. And I 
know the hearing touched on a number of critical issues 
relating to diabetes and including the high cost of insulin.

    I was one of the, many were co-sponsors of Senator 
Warnock's bill that proposed a cap on co-payments for insulin 
in the commercial market at $35 bucks a month. That was similar 
to what we passed and the Inflation Reduction Act for Medicare 
Part D beneficiaries. So, I just have two questions, Dr. 
Kowalski, and I will start with you.

    Type 1 diabetes is often perceived as a disease of children 
and young adults, but as health care for people living with 
diabetes has improved, it is truly a disease that can affect 
people a much longer time period throughout their lives, as you 
know. Are there specific challenges or factors we should 
consider with respect to older adults with type 1 diabetes? 
That is the first part of the question.

    Then second, are there medical issues that need more 
research or policy changes specific to the needs of older 
adults that you would recommend?

    Dr. Kowalski. Well, the great news is people with Type 1 
diabetes are living longer. When I was diagnosed, we were told 
we were to have significant reduction in lifespan. And my 
brother and I fortunately are doing well, and many people.

    That said, we know that older adults are particularly 
susceptible to severe hypoglycemia, hypoglycemia unawareness, 
which kind of called for because falls and broken bones.

    Unfortunately, broken bones are another issue in older 
adults with diabetes. So, that is an area. Reducing 
hypoglycemia is a big, big priority. As we drive better glucose 
control, we know that complications of diabetes that have been 
mentioned by a number of panelists, heart and kidney in 
particularly, are forestalled but don't go away.

    The risk of long term kidney disease, which is a major 
driver of CMF's cost, is another area where we are making 
progress. We have mentioned the benefits of these new drugs. 
GLP, SGLP inhibitors can reduce diabetic kidney disease and 
cardiovascular disease, a particular problem in older adults 
for type 1 and type 2 diabetes. So, this is an opportunity to 
reduce costs and improve care.

    Senator Casey. Thanks very much, Dr. Taillie--did I 
pronounce it right? Nutrition for children is obviously 
fundamental, as so many have made reference to. I introduced a 
bill that focused on what I believe are what should be the five 
freedoms for children.

    One of them is a freedom from hunger, in addition to health 
care and education, and so much else that we want to provide 
our kids.

    At the end of your written testimony, I think it is on page 
six, you mention the need for more research into nutrition 
science. What are some of the current gaps in our knowledge 
about nutrition, especially as it relates to kids?

    Dr. Taillie. One of the gaps that we have been talking a 
lot about is the fact that we still don't have a really good 
understanding for the biological mechanisms of how ultra-
processed foods work. They are such complex substances.

    Kevin Hall at DNH did a wonderful trial that was the first 
step in showing this, but there have been no additional studies 
to replicate that, to look at this issue in kids, and to really 
go further--to really isolate what those effects are.

    I think that would be the first piece of this. And then the 
second piece is understanding from a population level 
perspective, we are not thinking about how to treat these kids, 
we are trying to think about what policies work more broadly to 
prevent hunger and also promote healthy diets, because those 
things often kind of go hand-in-hand.

    We have a lot of kids who are hungry and also consuming 
diets that are really high in sugary drinks and ultra-processed 
foods.

    Senator Casey. Thanks very much. Thanks, Mr. Chairman.

    The Chair. Senator Cassidy, you want a brief closing 
remark?

    Senator Cassidy. Yes. Dr. Kowalski, I know you would agree 
with me totally, but just for the record, you mentioned that 
obesity does not necessarily lead to type 2 diabetes, but let's 
not imply that obesity does not have other problems associated 
with it.

    Hip replacements, joint replacements, heart disease, 
hypertension, gallstones, what was mentioned earlier about 
Alzheimer's, on and on and on. And so, I am a big proponent for 
obesity research.

    If the metabolic syndrome is almost always triggered by 
obesity, and I used to tell my medical students it is a hydra 
headed monster, and diabetes is one of those but there is many 
others as well.

    I think we need to be asking the NIH and CDC to focus more 
attention upon obesity in of itself. And I know you agree with 
that, but just for the record.

    Dr. Kowalski. I agree.

    The Chair. That was a brief remark. Good. Let me thank all 
of our witnesses. I thought a very informative hearing, and I 
thank all of you for being here.

    We have touched on a lot of issues the need for more 
research in type 1 diabetes and the need to address the crisis, 
and our kids becoming too heavy and the foods that they are 
eating, what they are drinking, and the need for affordable 
treatments.

    We covered a lot of territory that I hope this Committee 
will effectively deal with but thank you all very much for 
being here. And with that, this is the end of our hearing 
today, and I--for any Senators who wish to ask additional 
questions, questions for the record will be due in 10 business 
days, December 29th at 5.00 p.m.

    The Committee stands adjourned. Thank you all.

                          ADDITIONAL MATERIAL

                           endocrine society
    The Endocrine Society thanks the Senate Health, Education, Labor, 
and Pensions (HELP) Committee for conducting this hearing on the 
diabetes epidemic. We appreciate that the Committee is examining this 
critical issue, which impacts millions of people across the country. 
The Endocrine Society is the world's largest and oldest Society 
representing clinicians and scientists working to treat and research 
endocrine diseases and disorders. Founded in 1916, the Society 
represents approximately 18,000 physicians and scientists engaged in 
the management and research of endocrine disorders. Our membership 
includes over 11,000 clinicians who are on the front lines in treating 
diabetes and obesity, which are two of the most common chronic 
illnesses in the United States. Our member researchers are making 
significant contributions to the advancement of knowledge in diabetes 
research, prevention, and treatment and we have prioritized these 
issues in our policy work.

    There is a diabetes crisis in America requiring immediate attention 
by Congress. Diabetes affects over 38 million people in the United 
States, which represents 11.6 percent of the U.S. population, and this 
number continues to increase at an alarming rate. The prevalence rate 
is even more alarming when broken down by race, ethnicity, and age. 
Approximately 29.2 percent of people over the age of 65 have diabetes; 
16 percent of American Indian and Alaska Natives; 12.5 percent of 
African Americans; and 10.3 percent of Hispanic Americans have 
diabetes. No part of the country is immune from diabetes and many of 
the states represented by Members of this Committee are significantly 
impacted by this disease. Despite the fact that we know how to 
effectively treat and manage diabetes, prevent type 2 diabetes, and 
delay the onset of type 1 diabetes the number of people with diabetes 
continues to rise and people living with diabetes continue to 
experience barriers to access to care and affordability of the 
medicines they require. The Endocrine Society urges the Senate HELP 
Committee to support and advance the following bipartisan legislation 
to address the diabetes crisis in our Country today: Reauthorization of 
the Special Diabetes Program, passage of the INSULIN Act, and passage 
of the Treat & Reduce Obesity Act.
                        Special Diabetes Program
    The Special Diabetes Program (SDP) is a Federal program comprised 
of two components: the Special Diabetes Program for Type 1 Diabetes and 
the Special Diabetes Program for Indians (SDPI). Congress created these 
programs in 1997 to advance research for type 1 diabetes at the 
National Institute of Diabetes and Digestive and Kidney Disorders 
(NIDDK) and to provide type 2 treatment and education programs for 
American Indians and Alaska Natives (AI/AN). SDP continues to receive 
strong bipartisan support because of the program's many successes. It 
has delivered groundbreaking research on the artificial pancreas, which 
has led to the development of commercial devices; research that has 
resulted in the FDA approval of the first drug that can delay the onset 
of type 1 diabetes; and the first cellular therapy to treat adults with 
type 1 diabetes who have reoccurring episodes of dangerously low blood 
glucose levels. SDP is currently operating on a short-term extension 
which expires on January 19th. Short-term extensions are extremely 
harmful to the Program and make it difficult for researchers to map out 
long-term plans for their research. It also puts the important 
education and treatment programs for AI/AN communities in jeopardy. We 
urge Congress to reauthorize SDP through the end of 2025 at $170 
million per-program, per-year, which is a 13 percent increase in 
current funding. We were glad to see that the HELP Committee approved 
S. 1855, the Special Diabetes Program Reauthorization Act in a 
bipartisan fashion and we urge the Senate to reauthorize SDP before the 
program expires on January 19, 2024.
                         Insulin Affordability
    As you know, insulin is a life-saving medication for many people 
living with diabetes. Unfortunately, despite being over 100 years old, 
insulin is a medication that continues to be unaffordable for many who 
rely on it. While the Endocrine Society hears from our members about 
many different clinical and research issues, the rising out-of-pocket 
cost of insulin is one causing the greatest concern for our patients. 
We urge the Senate to pass S. 1269, the INSULIN Act of 2023, which is 
bipartisan legislation that would improve insulin affordability and 
access for the more than 7 million people nationwide who rely on this 
medication to manage their diabetes. This legislation, introduced by 
Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), the co-Chairs 
of the Senate Diabetes Caucus, includes several policies to make 
insulin more affordable. It would expand the $35 insulin co-pay cap, 
currently available for people on Medicare, to the private insurance 
market which would ensure that people on private health plans would pay 
no more than $35 per month for their insulin. The legislation would 
also ensure that people who rely on insulin are able to share in 
insulin rebates and discounts which often go to pharmacy benefit 
managers and private insurers. Finally, the legislation would promote 
competition by encouraging the approval of more generic and biosimilar 
insulins.
                                Obesity
    While the primary focus of this briefing is on diabetes, it is also 
important for the Committee to recognize obesity, which is related to 
diabetes and another costly chronic disease impacting millions of 
Americans. As you know, people living with obesity are at increased 
risk of developing type 2 diabetes and many other complications. We are 
alarmed by the increased prevalence of obesity across the country. Over 
42 percent of all U.S. adults and over 19 percent of children are 
estimated to have obesity in the United States. Obesity has a 
significant impact on economic costs accounting for $170 billion in 
higher medical costs each year. It has also impacted our Nation's 
military readiness and national security. Just over 1 in 3 young adults 
between the ages of 17 and 24 are too heavy to serve in our military. 
The management of obesity includes a range of options including 
lifestyle intervention and pharmacotherapy. Unfortunately, there are 
restrictions currently in place which prevent millions of Americans 
from accessing obesity treatment and care. Most notably, Medicare is 
currently prohibited by statute from covering FDA approved anti-obesity 
medications. Research shows that adding pharmacotherapy for weight 
management results in increased weight loss and overall improved 
health. Because Medicare is unable to cover these medications, which 
are scientifically proven to be effective, many private insurers also 
do not cover them because Medicare often sets the standard on what is 
covered. We urge the Senate to pass S. 2407, the Treat and Reduce 
Obesity Act (TROA), which would allow Medicare to cover FDA approved 
anti-obesity medications and also make it easier for Medicare 
beneficiaries to access Intensive Behavioral Therapy (IBT), which is an 
effective lifestyle intervention for obesity. We encourage you to work 
with your colleagues on the Finance Committee to advance this important 
legislation.

    We commend the Committee for taking time to discuss this critically 
important issue of diabetes and the impact it has on millions of 
Americans. We urge you to work swiftly to pass bipartisan legislation 
that prioritizes the groundbreaking research that continues to be done 
and ensures access and affordability for people living with diabetes 
and obesity. Our patients living with diabetes cannot wait longer. The 
Endocrine Society would like to work with you by providing information, 
having our member diabetes experts be a resource to you, and sharing 
our recommendations as you consider how to address this important 
public health issue. Please do not hesitate to contact Rob Goldsmith, 
Director of Advocacy and Policy, at [email protected] for more 
details.
                                 ______
                                 
     estimating the cost of new treatments for diabetes and obesity
    The rising popularity of drugs to treat obesity and diabetes, 
including Ozempic, has focused attention on their costs. However, 
existing research has incompletely characterized prices by focusing on 
only discounted list prices. We estimate that net prices received by 
drugmakers are 48-78 percent lower than list prices. In effect, we 
document a large difference between net payments to manufacturers and 
the prices faced by some consumers who pay list prices, even after we 
adjust for currently available coupons from manufacturers. We conclude 
by highlighting uncertainty surrounding future prices of drugs in this 
class and policy implications.

    The introduction of glucagon-like pcptide-1 agonists (CLP-1s), 
which include drugs such as Ozempic, represents a milestone in the 
treatment of diabetes and obesity. Clinical evidence suggests that 
diabetes products can help control blood sugar among diabetics, lower 
weight, reduce cardiovascular events and ease symptoms of heart 
failure. \1\
---------------------------------------------------------------------------
    \1\  For a discussion of evidence on glucagon-like peptide-1 
agonists (GLP-1s), see Herman (2023). For recent evidence on 
semaglutide's effect on major adverse cardiovascular events, see Novo 
Nordisk (2023). For recent evidence on semaglutide's effect on heart 
failure, see Kosiborod et al. (2023).

    With mounting evidence of clinical benefit, these drugs have 
attracted understandable levels of policy attention, much of it focused 
on their cost. Recent projections suggest revenue for GLP-1s could 
---------------------------------------------------------------------------
reach $100 billion annually over the next decade (Erman 2023).

    The majority of news coverage and research on these drugs has 
focused on their publicly available list price. \2\ While list prices 
arc relevant for some patients, prior research has shown that this is 
often a highly incomplete summary of typical transaction prices in the 
U.S. This reflects the relatively opaque use of ``rebates'' and other 
discounts, which alter the prices paid for branded drug products.
---------------------------------------------------------------------------
    \2\  For example, see Amin et al. (2023) and Cirruzzo and Leonard 
(2023).

    In this report, we aim to characterize the prices of these drugs 
more completely. In doing so, we hope to give researchers, 
policymakers, and journalists a fuller and more accurate understanding 
of these products' current costs.
                                 ______
                                 
                                 
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    [Whereupon, at 11:39 a.m., the hearing was adjourned.]

                                  [all]