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Published by AAAS
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DUBIOUS DIAGNOSIS
A war on “prediabetes” has created millions of new patients
and a tempting opportunity for pharma. But how real is the condition?
T
he most common chronic disease
after obesity, afflicting 84 million
Americans and more than 1 billion
people worldwide, was born as a
public relations catchphrase. In
2001, the PR chief of the American
Diabetes Association (ADA) ap-
proached Richard Kahn, then the
group’s chief scientific and medical
officer, for help with a vexing problem, Kahn
recalls. ADA needed a pitch to persuade
complacent doctors and the public to take
seriously a slight elevation in blood glucose,
which might signal a heightened risk of type 2
diabetes. Raising the alarm wasn’t easy, given
the condition’s abstruse name, impaired glu-
cose tolerance, and lack of symptoms.
Kahn invited half a dozen diabetes thought
leaders to brainstorm at a National Institutes
of Health cafeteria in Bethesda, Maryland.
Surrounded by hungry federal employees,
many enjoying the kinds of fatty foods and
sugary drinks tied to the diabetes epidemic,
they landed on a then–little-used term that
seemed sure to scare patients and doctors
into action: prediabetes.
“We went back to the ADA office right after
lunch and started the change. Within a rela-
tively short period of time we … eliminated
‘impaired fasting glucose’ and ‘impaired glu-
cose tolerance’ and substituted ‘prediabetes’
in all of our literature,” Kahn says. Soon, the
term was enshrined in the Arlington, Vir-
ginia, group’s standards of care—widely re-
garded as the bible of diabetes. ADA and the
Centers for Disease Control and Prevention
(CDC) in Atlanta declared war against pre-
diabetes, with CDC diabetes prevention chief
Ann Albright, an ADA board member from
2005 to 2009, leading the charge. The two
groups labeled prediabetes a first step on the
road to diabetes, which can lead to amputa-
tions, blindness, and heart attacks.
In medicine, prevention is usually an
unalloyed good. But in this case, other dia-
betes specialists argue, medical and epidemio-
logical data give weak support, at most, for
increasingly dire prediabetes admonitions.
“Nobody really thought at the time, how
‘pre’ is prediabetes for all these people?” says
SCIENCE sciencemag.org
By Charles Piller;
Illustrations by Stephan Schmitz
Kahn, who left ADA in 2009 and is now at
the University of North Carolina in Chapel
Hill. The World Health Organization (WHO)
in Geneva, Switzerland, and other medi-
cal authorities have rejected prediabetes as
a diagnostic category because they are not
convinced that it routinely leads to diabetes
or that existing treatments do much good.
John Yudkin, a diabetes researcher and
emeritus professor of medicine at University
College London, describes the ominous warn-
ings about prediabetes from ADA and CDC
as “scaremongering.”
Yet ADA, a nonprofit that funds research,
issues treatment standards, and raises pub-
lic awareness, has gradually broadened its
definition of prediabetes to encompass more
people. “The public needs to know that right
now, in the United States … one out of three
may have some aspect of glucose abnor-
mality,” says William Cefalu, ADA’s current
chief scientific and medical officer. “A great
percentage … particularly in select ethnic
groups, may have an increased chance, or a
higher rate of progressing [to diabetes].”
CDC has followed ADA’s lead, because
“they set the primary standards of care in
the U.S.,” Albright wrote in a statement to
Science. (Albright declined interview re-
quests, and CDC would not permit Edward
Gregg, Albright’s top epidemiologist, to
comment for this story.) In the past, Albright
and CDC have said repeatedly that 15% to
30% of untreated prediabetes patients prog-
ress to diabetes within 5 years—a claim that
hospitals, professional organizations, and
local and state health departments have
embraced and publicized. She backed away
from that number in response to a ques-
tion from Science, saying, “We no longer
use that statement to characterize risk.”
Indeed, CDC’s own data show progression
from prediabetes to diabetes at less than 2%
per year, or less than 10% in 5 years. (Other
studies show even slower rates.)
The push to diagnose and treat pre-
Published by AAAS
NEWS
diabetes has come at a cost. When told they
have the condition, many people face psycho-
logical and financial burdens trying to ad-
dress it. ADA, CDC, and other groups have
spent billions of dollars on research, educa-
tion, and health improvement programs—
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generally focused on weight loss and
exercise—that have generated lackluster re-
sults, according to critics. Kahn makes the
point with rhetorical bluntness: Spending
vast sums of public money on such preven-
tion programs “has nearly the same effect
as burning it in a fire … overall, [it’s] a ter-
rible waste of money.”
To lower blood sugar, ADA has increas-
ingly advocated more aggressive measures,
such as prescription drugs—a push that has
opened it to charges of conflicts of interest.
Science found that the group and its experts
who promote aggressive treatment of pre-
diabetes accept large amounts of funding
from diabetes drugmakers. So far, no drugs
have been approved specifically for pre-
diabetes, meaning that doctors are limited to
prescribing diabetes drugs or other medica-
tions “off label” to treat the condition. But
drug companies are testing dozens of drugs
aimed at prediabetes in hopes of tapping a
potential worldwide market of hundreds of
millions of people.
Given the avalanche of questionable
spending and the wave of anxiety it has un-
leashed, Kahn now says he rues the day he
helped promote the term prediabetes, calling
it “a big mistake.”
ACCIDENTAL AILMENT
ADA’s current definition of prediabetes was
born in 2009, after the group, along with
the European Association for the Study
of Diabetes (EASD) and the International
Diabetes Federation (IDF), convened an
expert committee to review research on a
diagnostic blood sugar test, A1c. It improves
on prior tests because it requires no fasting.
Hemoglobin A1c is a form of the red blood
cell protein bound to glucose; its level in-
dicates a person’s average blood sugar over
the preceding 3 months. The expert commit-
tee urged that people with A1c readings of
8 MARCH 2019 • VOL 363 ISSUE 6431 1027
 NEWS | F E AT U R E S

6% or higher should be considered for pre- few months gave Yuan empathy for her own Several companies target prediabetes
ventive interventions. But it unanimously patients who don’t take medicines as pre- patients for sales of continuous glucose
rejected the term prediabetes, saying it scribed. “On random days, I would get these monitors that attach to the body and trans-
implies that prediabetic patients eventually horrible side effects and feel really sick,” she mit data to smartphones. Market analysts
will get diabetes and everyone else won’t— says. Even on good days, the diagnosis added say makers of the devices—which can cost
“neither of which is the case.” a tinge of anxiety to her life. thousands of dollars annually—could add
ADA went in the opposite direction. It kept In interviews and public statements over 25 million customers in the next 12 years in
the term and ratcheted down its prediabetes many years, Albright has suggested such the United States alone, with prospects of a
A1c threshold from 6.1% to 5.7%—a move its anxiety is warranted. She has described much larger global market, including China.
two partners in the expert report never em- prediabetes as a runaway train. Patients are Simpler home glucose testers, such as those
braced. Evidence favored the lower figure, “walking toward the cliff’s edge,” she said used in finger sticks, are a razors-and-blades
Cefalu says, noting that prediabetes com- at a 2016 medical conference. The media proposition. A starter model costs just $11.55
prises a “continuum of risk,” with higher A1c has reported, widely and with little skepti- on Amazon, but requires branded test strips.
readings warranting more aggressive treat- cism, that prediabetes as defined by ADA Writing recently in Psychology Today, a phy-
sician and nutrition consultant
touted home glucose testing after
Alarming increase every meal as the top medical ne-
As the prediabetes definition has broadened, the number of potential patients in the United States has greatly increased, cessity for everybody—regardless
according to Centers for Disease Control and Prevention (CDC) estimates. Diabetes authorities such as the American of health or blood sugar status.
Diabetes Association (ADA) now list drug options for those patients. As the market expands, indi-

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vidual patients and society as
2004 2005 2010 a whole face a steep price tag.
100 ADA broadens CDC adopts ADA keeps prediabetes
prediabetes broadened label, further broadens
In 2014, failing to note its own
Prediabetes
defnition ADA standard. defnition using “A1c” role in widening the patient

CREDITS: (GRAPHIC) N. DESAI/SCIENCE; (DATA) AMERICAN DIABETES ASSOCIATION; U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION; D. NATHAN, DIABETES CARE, 32, 1327, (2009)
75 based on blood test. pool, ADA warned of “alarm-
Millions of people

fasting blood 2011 ing” U.S. prediabetes spending,

sugar test.
50
25
0 costs are substantial and rising.
2001 2003 2007
ADA begins Prediabetes ADA begins to
to call slightly frst mentioned recommend
elevated in ADA metformin for
blood sugar treatment some prediabetes
“prediabetes.” standards. patients.
ment. ADA’s new A1c standard, combined
with its adoption of a similarly broad stan-
dard on a different blood sugar test a few
years earlier, created about 72 million poten-
tial new prediabetes patients in the United
States alone—and could create hundreds of
millions more if embraced worldwide.
One of those Americans was Nance Yuan,
a surgical resident in Los Angeles, Califor-
nia. In 2018, amid a demanding career, Yuan
decided to freeze some of her eggs in case
she wanted to have a baby later. A blood
test before the procedure led to unwelcome
news: prediabetes. Her result was border-
line, so normally she would have been urged
simply to improve her diet and to exercise
more. But in light of her egg harvesting
plans, Yuan’s gynecologist also prescribed
metformin, a drug often given to patients
with full-blown diabetes.
“It was a little bit of a shock,” says the
slim, 34-year-old physician. “I think of met-
formin as something that middle-aged obese
patients are on.” Using the drug for just a
CDC adopts broadened
ADA defnition of
prediabetes.
2009 2013
International ADA begins
experts reject to suggest
prediabetes label other diabetes can also be
as scientifcally drugs for
unsound. prediabetes.
and CDC is a serious health threat. Even
Nutrition Action, a popular newsletter that
debunks outlandish health claims, depicted
diabetes as the tip of an iceberg with the
prediabetes behemoth lurking below.
The broadened definition of prediabetes
has triggered far-reaching changes in the
medical landscape. CDC’s budget for dia-
betes prevention jumped from $66 million
in 2010 to $173 million in 2017—a 123% rise,
in constant dollars. (At the same time, the
agency’s cancer prevention budget plum-
meted.) Many people diagnosed with pre-
diabetes visit doctors more often for blood
sugar tests and advice on diet and exercise.
And a major marketing opportunity has
opened up. Companies have pressured the
Food and Drug Administration (FDA) for a
seal of approval on foods or supplements—
such as coffee, dairy products, and sugar
substitutes—that they say can help prevent
diabetes. A cottage industry of specialty fit-
ness coaches emerged to serve a multitude
of worried prediabetes patients.
estimated at $44 billion in 2012
(the most recent year for which
Diabetes data are available)—about 1.6%
of all health care costs and 74%
higher than in 2007. Even if that
is an exaggeration, as some say,
Cefalu says lower-cost inter-
2019 ventions are needed, but he de-
ADA says
weight loss drugs scribes many current programs
as cost-effective, and a medical
considered for and moral necessity. In a recent
prediabetes.
article about diabetes prevention,
he invoked Winston Churchill’s
wartime pronouncement: “It is no use say-
ing, ‘We are doing our best.’ You have got to
succeed in doing what is necessary.”
SCIENTIFIC CONFLICTS
Many scientists, however, question the need
to identify and treat prediabetes as ADA de-
fines it. All endorse healthy diets and regular
exercise and say substantially elevated glu-
cose levels can lead to diabetes. But research-
ers diverge over crucial questions: How often
and how quickly does prediabetes progress to
diabetes? Does prediabetes itself cause harm,
particularly when a person’s average glucose
levels are at the low end of the test result
spectrum as defined by ADA?
On one side are CDC and ADA, powerful
financial gatekeepers and opinion leaders.
ADA journals are the field’s most influen-
tial, and the two organizations fund much
of the nation’s research and programs on
diabetes prevention. On the other side are
public health and primary care authorities,
including WHO, the U.K. National Institute

1028 8 MARCH 2019 • VOL 363 ISSUE 6431 sciencemag.org SCIENCE

Published by AAAS
for Health and Care Excellence, EASD, and
IDF. Those groups either do not use or do not
emphasize the term prediabetes, and they
normally advise treatment only when blood
sugar levels approach those of frank diabetes.
Researchers skeptical of the ADA defini-
tion point to a comprehensive 2018 review of
103 studies by the Cochrane Library in Lon-
don, which showed that most people who
qualify as prediabetic never progress to dia-
betes over any period studied. People who do
progress usually start out at the higher end of
the ADA prediabetes test range. The review
also noted that studies of people labeled pre-
diabetic often fail to account for weight, age,
and physical activity, which can all affect glu-
cose, as can daily stress, inflammation, and
other factors. According to the review, up to
59% of prediabetes patients returned to nor-
mal glycemic values over 1 to 11 years with no
treatment whatsoever.
“Doctors should be careful about treating
prediabetes because we are not sure whether
this will result in more benefit than harm,”
the Cochrane authors concluded, “especially
when done on a global scale.”
Kahn adds that even people whose ele-
vated blood sugar does lead to diabetes prog-
ress slowly. “If you screen for diabetes every
3 to 5 years, you’re fine,” he says. Prediabetes
itself does not raise the risk of cardiovascular
disease or other complications of diabetes,
says former ADA President Mayer Davidson,
a physician now at Charles R. Drew Univer-
sity of Medicine and Science in Los Angeles.
To support the value of aggressive treat-
ment, ADA and CDC cite a landmark clinical
trial of prediabetes, the Diabetes Prevention
Program Outcomes Study (DPPOS), which
began in 2002 and is still collecting data.
Sponsored by the National Institute of Dia-
betes and Digestive and Kidney Diseases and
conducted by researchers at 25 centers across
the nation, it included nearly 3000 predia-
betic subjects randomly separated into three
groups. One received intensive diet and exer-
cise interventions, one took metformin, and a
control group got neither. Fewer people in the
treatment groups progressed to diabetes over
6 years—5.3% per year in the lifestyle group
and 6.4% for the metformin group, compared
with 7.8% in the control group, DPPOS scien-
tists reported in 2009 in The Lancet.
The study’s patients were selected on the
basis of a glucose tolerance test, now rarely
used, whose results are inconsistent with
those of today’s more common A1c. On av-
erage, the people studied were less healthy
than most people within ADA’s broad defi-
nition of prediabetes—obese, with blood
glucose levels near the cusp of diabetes.
The sample also skewed to ethnicities
more prone to diabetes. To critics such as
Yudkin, those features of the study raise
SCIENCE sciencemag.org
doubts about whether its results justify treat-
ing everyone diagnosed with prediabetes.
David Nathan, a diabetes specialist at
Harvard Medical School in Boston and chair
of the DPPOS research group, explained to
Science that the researchers chose a rela-
tively high-risk cohort “so we could study
a manageable/affordable-sized population
over a realistic period of time.” The data,
he added, showed treatment benefits across
all ethnicities.
Yet 38% of the lifestyle treatment group
failed to maintain the strict regimen after just
6 months. That outcome was despite costly,
intensive medical, psychological, and exer-
cise support, which community-based pro-
grams can’t provide. Henry Kahn (no relation
to Richard Kahn), a former CDC physician
who retired from Albright’s staff in 2018, says
the DPPOS demonstrated “efficacy—I won’t
say ‘effectiveness’—to delay diabetes through
very intensive and expensive education for a
“Doctors should be
careful about
treating prediabetes
because we are not
sure whether this will
result in more
benefit than harm.”
Cochrane Library
selected group.” He says the relevance of the
DPPOS findings to the real world is unclear.
Richard Kahn goes further. “There’s never
been a study to show that a population can
lose sufficient weight and keep it off over
more than a few years in order to prevent
diabetes over the long run. Never. Not one.”
Gojka Roglic, a physician responsible for
WHO’s diabetes program, says ADA’s pre-
diabetes definition sharply increases the
number of people said to be at risk despite
the lack of “a preventive intervention that
has been shown to work for people identi-
fied by these criteria.”
Cefalu acknowledges that “it’s a differ-
ent approach in the real world. There’s a
lot of additional hurdles—social-economic
concerns, finances, adherence, compliance.”
But he and Albright told Science the DPPOS
showed that, in principle, lifestyle changes
can delay or prevent diabetes. “We need to
find ways to ensure that these programs can
be [successful],” Cefalu says.
The DPPOS has yet to report whether life-
Published by AAAS
style changes or metformin reduced heart
disease and stroke—key complications of
full-blown diabetes—but those interven-
tions have had no impact on mortality.
Women in the control group did have more
microvascular changes—seen in tiny blood
vessels—which can eventually damage eyes,
kidneys, and nerves, than those in the life-
style intervention group. But that effect
was barely statistically significant, and the
opposite pattern emerged in men. “If after
15 years of follow-up, the rate of eye, kidney,
and nerve damage is exactly the same in all
three groups,” Yudkin says, “then there are
2000 people being treated with no benefit.”
Cefalu says that in other studies, research-
ers have found a relationship between hav-
ing an average blood glucose level within the
ADA prediabetes range and cardiovascular
disease many years later. But many of the
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studies were observational, based on medical
records, and such studies are generally con-
sidered weaker than controlled trials such as
the DPPOS. Most of the studies did not show
harm at statistically significant levels.
Cefalu and Albright cited another paper—
a long-term Chinese study of people diag-
nosed with prediabetes published in 2014 in
The Lancet—that Albright said “showed life-
style changes improved cardiovascular out-
comes.” After 23 years, the study researchers
found fewer deaths overall and fewer deaths
from cardiovascular causes than in the con-
trol group. But the study was small, just
577 people, and the benefit was marginally
significant and seen only for women.
DRUG OPTIONS
While the scientific dispute simmers, drug
companies are racing to fill the demand cre-
ated by ADA’s prediabetes definition. The
federal registry ClinicalTrials.gov lists human
tests for more than 100 drugs, supplements,
and other prediabetes remedies, including
devices such as gastric bands. Drugmakers,
ADA, and others have funded trials for at least
10 classes of drugs.
So far, FDA has approved no drug or
device for prediabetes. Approval timelines
remain hazy because the agency has yet to
define clear therapeutic goals, says Todd
Hobbs, U.S. medical officer for Novo Nord-
isk, a leading diabetes drugmaker based in
Bagsværd, Denmark. “Is it delaying of pa-
tients who have normal glucose from devel-
oping prediabetes? … Is it a lower percentage
of people who have prediabetes going on to
develop type 2 diabetes in a defined period
of time?” he asks. Hobbs says FDA eventu-
ally will pick some criteria. Prediabetes “is
already an important issue, and the obesity
epidemic is clearly driving this,” he says. “It
will certainly only increase in focus.”
Meanwhile, doctors can treat prediabetes
8 MARCH 2019 • VOL 363 ISSUE 6431 1029
NEWS | F E AT U R E S
with a rising number of drugs prescribed
off label—most approved for diabetes or
obesity. In 2007, ADA began to recommend
metformin as a relatively safe, inexpensive,
long-term option for prediabetes patients
with other risk factors for diabetes, such as
obesity. Then, in 2013, ADA joined other ad-
vocates of aggressive diabetes prevention in
listing more powerful, costlier drug options.
Cefalu says ADA still discourages using
any drug except metformin for prediabetes.
But since 2013, ADA standards of care have
consistently listed a variety of diabetes and
obesity drugs that it says may decrease the
incidence of diabetes among prediabetics.
ADA urges doctors to consider “cost, side
1030 8 MARCH 2019 • VOL 363 ISSUE 6431
effects, and lack of persistence in effect”
but does not advise against prescribing the
drugs, as it did in the past.
Some physicians are trying new drug op-
tions on ADA’s list. For example, a 2018 ob-
servational study in The Lancet looked at
222 prediabetes patients in a Southern Cali-
fornia community medical practice who
tested, on average, at the very low end of
ADA’s A1c scale—barely prediabetic. They
were given a cocktail of either two or three
diabetes drugs. On average, their blood sugar
decreased slightly.
Any drug for prediabetes would likely
have to be taken for years, perhaps a life-
time, so such modest benefits must be
Published by AAAS
weighed against the potential harms of
continual treatment. And several pre-
diabetes options described by ADA and oth-
ers present serious hazards. Pioglitazone, a
drug to lower blood sugar developed by the
Tokyo-based Takeda Pharmaceutical Com-
pany under the brand name Actos, carries
on its label a “black box” side effect warn-
ing of the risk of congestive heart failure.
The drug can also raise the risk of bone
fractures and cancer. Exenatide (branded
Bydureon by Cambridge, U.K.–based Astra-
Zeneca), which reduces blood glucose and
suppresses appetite, has a black box warn-
ing for thyroid cancer. Liraglutide (sold as
Victoza by Novo Nordisk) also carries warn-
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ILLUSTRATION: STEPHAN SCHMITZ
sciencemag.org SCIENCE
ings of potentially lethal side effects.
Yudkin says the growing emphasis on
drugs for prediabetes reflects in part a false
sense of urgency about its health risks.
WHO’s Roglic also doubts that the benefits
of taking a diabetes drug for prediabetes out-
weigh the risks. “It seems counterintuitive
to take a medicine in order to prevent some-
thing for which you would take that medi-
cine. The reasoning is a bit twisted.”
FINANCIAL CONFLICTS
The push for drug treatments for pre-
diabetes takes place in an environment rife
with financial conflicts of interest. For years,
ethicists have criticized ADA for financial de-
pendence on diabetes drugmakers. In recent
years, ADA says, it has received $18 million to
$27 million annually from drug companies,
including many donations of $500,000 to
$1 million per year. The group also gets up to
$500,000 annually from each of more than
a dozen other firms in the diabetes and pre-
diabetes markets, including makers of con-
sumer and medical products, testing labs,
insurance companies, and drug retailers.
The American College of Physicians re-
cently reviewed the diabetes and prediabetes
treatment guidelines from several authori-
ties and assessed each for financial conflicts
of interest with drug companies. It rated
ADA’s conflicts as among the most extreme.
An ADA representative wrote in an email to
Science that its funders have no influence
over “the final outcome” of ADA’s work.
Many prominent physicians who now rec-
ommend drugs for prediabetes also received
large payments in recent years from compa-
nies whose sales could be affected by such
endorsements. Science documented some
of that compensation by examining data
from mid-2013 through 2017 in Open Pay-
ments, a federal database that tracks money
that drug- or devicemakers give to clini-
cal professionals for consulting, teaching
fees, travel, and other purposes. The data-
base also shows funds funneled through
their institutions for research.
Ralph DeFronzo, an endocrinologist at the
University of Texas Health Science Center in
San Antonio and a co-author of treatment
guidelines for the American Association of
Clinical Endocrinologists (AACE) and the
American College of Endocrinology (ACE), is
one of the most influential diabetes research-
ers. His papers discussing wider use of drugs
for prediabetes—including the Southern
California study in The Lancet—have been
cited more than 3000 times. DeFronzo got
about $5 million from diabetes drugmakers,
including $1.3 million in fees paid directly to
him for consulting, advice, and travel. About
half of the total was for work associated with
drugs he has cited as effective for some pre-
SCIENCE sciencemag.org
diabetes patients, such as pioglitazone, ex-
enatide, and liraglutide. DeFronzo declined
to comment about whether those earnings
might have influenced his views.
Many physicians who wrote the 2018 ADA
standards of care for prediabetes, which rec-
ommend that doctors consider prescribing
those same three drugs, also received large
sums from drugmakers. Seven of the 14 ADA
experts got between $41,000 and $6.8 mil-
lion between mid-2013 and 2017 from makers
of diabetes drugs or candidate prediabetes
medicines or devices. The payments covered
consulting, travel, and research and included
an average of $276,000 for personal fees.
Guillermo Umpierrez, who served on the
ADA standards panel and is an endocrino-
logist at Emory University in Atlanta (he
was also a member of the AACE-ACE panel),
received the most during that period, ac-
cording to Open Payments: $6.8 million—
including about $123,000 in consulting and
travel fees. About $5.3 million came from
the makers of drugs in the classes that ADA
“I just don’t think
we [prevent diabetes]
by making every
healthy person a patient.”
Victor Montori, Mayo Clinic
now recommends as options for prediabetes,
for research or consulting on drugs in those
classes. Umpierrez told Science that he plans
to dispute some figures in Open Payments,
which has sometimes included errors, but he
gave no details. Umpierrez said drug com-
pany payments did not influence him.
ADA says it does not regard as conflicts of
interest any drugmaker-provided research
funding, funds received before the year its
guidelines were written, or payments under
$10,000. Even by those narrow criteria, 41%
of the authors of its standards of care during
the past 5 years were conflicted, according
to ADA. The group can require such panel-
ists to recuse themselves from discussion or
voting, but in the past 2 years, none did so.
John Ioannidis, a physician and expert on
evidence-based medicine at Stanford Univer-
sity in Palo Alto, California, calls prediabetes
a classic example of how clinical guidelines
from groups such as ADA can escalate costs
to society, to the benefit of specialty practi-
tioners and drug companies. “You have a
combination of two forces. One is to expand
the definition of disease and to get more
people classified as being sick or in need of
treatment. And second, direct endorsement
Published by AAAS
of specific interventions that [guideline au-
thors] have direct conflicts of interest with,”
he says. “It’s really very worrisome.”
ADA’s expanded prediabetes definition
is a financial win for physicians, companies
that conduct lab tests, drug companies, de-
vice and app developers, clinics, and hospi-
tals, says Victor Montori, a diabetes clinician
at the Mayo Clinic in Rochester, Minnesota.
“The people who lose are the people who go
from being a healthy person to being a pa-
tient. Now, they have the sick role. They have
to go for checkups and tests and treatments,”
often at considerable expense.
Yuan, the surgical resident, had her eggs
frozen after a few months of prediabetes
treatment. With great relief, she stopped tak-
ing metformin—which several diabetes and
fertility experts say was overtreatment in her
situation. But the prediabetes diagnosis and
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prescription remain on her medical record,
which could affect her future insurance pre-
miums. Other people given a prediabetes di-
agnosis face greater challenges: For example,
according to a recent study, Medicare reim-
burses just a small fraction of costs for its
own diabetes prevention program.
The insurance problem is one sign of what
happens when a borderline medical test re-
sult becomes “medicalized,” turning many
basically healthy people into stressed-out pa-
tients, critics of ADA’s prediabetes definition
say. “Seventy to 80% of them are never going
to get diabetes, so is it unnecessary stress?”
asks Davidson, the former ADA president.
Many public health organizations believe a
mainly clinical approach to diabetes preven-
tion is ineffective. WHO, for example, favors
societywide solutions, which aim to address
the health impacts of social stratification
and failures of urban planning. It endorses
laws that help reduce consumption of sugary
drinks and unhealthy foods.
A 2011 study in JAMA examined health
outcomes in women living in stressful, low-
income housing projects who had been
randomized into three groups: One got a
voucher for better housing and help moving,
one a voucher for moving to any area without
help, and a control group got neither. Women
who got the most housing assistance suffered
the least obesity and diabetes—over 20 years,
about 15% had become diabetic, compared
with 20% in the control group.
“None of those people got advice on lifestyle
changes. None got advice on dietary changes
or activities. None got diabetes drugs,” Mon-
tori says. Diabetes can and should be pre-
vented, he says. “I just don’t think we do that
by making every healthy person a patient.” j
Jia You and Meagan Weiland contributed
reporting. This story was supported by the
Science Fund for Investigative Reporting.
8 MARCH 2019 • VOL 363 ISSUE 6431 1031
Dubious diagnosis
Charles Piller

Science 363 (6431), 1026-1031.

DOI: 10.1126/science.363.6431.1026

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