[Senate Hearing 118-211]
[From the U.S. Government Publishing Office]
S. Hrg. 118-211
WHAT IS FUELING THE DIABETES EPIDEMIC?
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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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Available via the World Wide Web: http://www.govinfo.gov
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54-524 PDF WASHINGTON : 2024
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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
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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?
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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.
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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
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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\
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\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
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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.
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\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.]
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