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A Study of Binge Eating Disorder in the Context of Condition Branding
Jin Jung
Georgetown University
Abstract
Pharmaceutical companies expand their market through disease awareness
campaigns. Linking specific treatments to specific diseases is termed condition branding.
Continuing medical education (CME) is used to influence physicians’ perceptions of
diseases. We analyzed the themes, content, and funding of CME modules on binge eating
disorder (BED) to determine whether there was evidence of condition branding and to
attempt to reverse-engineer marketing messages for Vyvanse (lisdexamfetamine), a Shire
drug that is the only FDA-approved treatment for BED. The influence of Shire on CME
for BED is obvious. Although In doing so, Shire is violating the WHO standards of drug
advertisement and marketing.
Background
Pharmaceutical industries often expand the markets for their medications by
creating disorders. In doing so, they convince healthy people that they are sick. The act of
redefining normal human conditions or common symptoms as diseases is known as
disease mongering; selling sickness, or disease awareness. Moynihan defines selling
sickness as the act of “widening the boundaries of treatable illness in order to expand
markets for those who sell and deliver treatments”1. The pharmaceutical industry’s
marketing of diseases as well as drugs raises ethical concerns. Should pharmaceutical
companies create diagnoses or promote diseases? Many are concerned that marketing
compromises the ability of physicians to make unbiased and informed decisions that are
in the best interests of their patients.
Selling sickness to physicians
One of the most popular ways that pharmaceutical marketing influences
prescription practices of physicians is through continuing medical education (CME).
Physicians are required to take CME, and CME modules or events are often funded by
the pharmaceutical industry. Although the pharmaceutical industry claims that their
involvement with CME is purely for educational purposes, CME is actually an effective
marketing tool. Industry sponsors prepare teaching slides, may choose speakers, and pay
those speakers directly or indirectly. The role of industry in CME has led to questions
about the credibility of industry-sponsored information. A former editor of the New
England Journal of Medicine questioned the suitability of the pharmaceutical industry
taking roles in CME when they have an interest in selling their prescription drugs2.
Though the Accreditation Council for Continuing Medical Education (ACCME) issued
Standards for Commercial Support to limit roles of commercial interest in CME, this had
little impact on the ties between CME and industry3.
Selling sickness to the public
Besides establishing relationships with physicians, drug companies target
consumers through advertising, websites and disease awareness campaigns, which may
group common symptoms and link them to a condition name. Often, a branded condition
has an acronym (for example, GERD for gastroesophageal reflux disorder) so that
patients remember the condition more easily; acronym may also reduce stigma (or
example, ED, the acronym for erectile dysfunctionOne way to reach to the public is to
hire a celebrity. For example, Wyeth, a drug company responsible for selling menopausal
hormone replacement therapy, hired supermodel Lauren Hutton to raise awareness about
the dangers of menopause and the hope provided by Wyeth’s hormone pills. Drug
industries also partner with patient advocacy groups to raise awareness1. Pharmaceutical
companies promote designed disorders to raise the public awareness, but also to frighten
the public. Pharmaceutical companies create fear by exaggerating the prevalence of a
condition and implying that a condition, if untreated, could lead to a serious outcome.4
Furthermore, industry treats risk factors as diseases. For example, high blood pressure,
which can increase the chance of heart attacks and strokes, has successfully been cast as a
disease1. These are just few examples of how companies market diseases along with
medications to physicians or the public.
Condition Branding
Condition branding, a subset of disease mongering, associates a specific condition
with a specific treatment. An industry article states: “If you can define a particular
condition and its associated symptoms in the minds of physicians and patients, you can
also predicate the best treatment for that condition”5. Pharmaceutical companies invent
new diseases specifically to match their existing drugs. There is a host of examples of
condition branding: erectile dysfunction with Viagra; gastro-esophageal reflux disease
(GERD) with Nexium and Zantac; attention deficit hyperactivity disorder (ADHD) with
Adderall; osteopenia with Fosamax; and social anxiety disorder with Paxil. Condition
branding largely involves three strategies: “elevating the importance of an existing
condition”, “redefining an existing condition to reduce stigma”, and “developing a new
condition to build recognition for unmet market need”5.
GERD is an example of the first strategy: “elevating the importance of an existing
condition”. GlaxoSmithKline started associating GERD with gastroesophageal cancer.
GERD, essentially describing heartburn, became known as a disease that would cause
long-term consequences if not treated daily. An intermittent condition, thus effectively
became a chronic disorder. Another example of “redefining an existing condition” is
erectile dysfunction (ED), which is a more neutral term than “impotence”, which
connotes personal weakness and inability. The third strategy, “developing a new
condition to build recognition for unmet market need” is often used in psychological
disorders or conditions because these illnesses are never based on objective tests; an
example of an invented disease in this category would be social anxiety disorder.
Condition branding is especially popular in psychiatric disorders. Diagnostic
inflation is apparent in the expansion of acknowledged disorders in Diagnostic and
Statistical Manual of Mental Disorders (DSM), which is published by American
Psychiatric Association. It is essential to discuss the history of the DSM and the people
who create it. According to Decker, the author of The Making of DSM-III, the Board of
Trustees of the APA and Task Force members could not agree on the definition of
“mental disorder”.6 Without a clear definition of mental disorder, making a condition a
disorder became arbitrary. Furthermore, most of the DSM panel members have financial
associations with industry7. Thus, without a clear definition of mental disorder and in the
presence of financial conflicts of interest, biased decisions become inevitable.
It is important that the DSM recognizes a disease as a diagnosis because DSM is a
manual of mental health diagnoses and the source of codes used by physicians for
insurance reimbursement. Also, the Food and Drug Administration (FDA) is more likely
to approve a medication as a treatment for a specific disorder if a disease is recognized in
the DSM8. Therefore, the DSM became really important and popular to pharmaceutical
companies because getting a condition in the DSM became a common method of
expanding a psychological disorder. In result, pharmaceutical companies started
allocating a large sum of financial resources into marketing. For example, in 2004, the
budget for pharmaceutical promotion was $57.5 billion, which was twice as much as the
budget for research and development9.
Of all specialists, psychiatrists receive the most money from drug companies10.
Not only do psychiatrists have the most ties with the industry, there are no objective tests
for diagnosing psychiatric disorders. Less than 30% of psychiatric patients in the United
States are severely ill8. More severe mental disorders are less likely to be treated than
milder disorders, so it is milder disorders that are most over-diagnosed. 8 Also, the
accuracy of claims made in the medical journal advertisements for psychiatric medication
were often not supported by the cited sources and were linked with sources that can no
longer be obtained11.
BED
Robert Spitzer first described the term binge eating disorder in 199012. It was
recognized in the DSM-5 in 2013. According to DSM, the criteria of binge eating
disorder are: 1) recurrent and persistent episodes of binge eating 2) binge eating episodes
associated with three or more of the following: eating much more rapidly than normal,
eating until feeling uncomfortably full, eating large amounts of food when not feeling
physically hungry, eating alone because of being embarrassed by how much one is eating,
feeling disgusted with oneself, depressed, or very guilty after overeating, 3) marked
distress regarding binge eating, and 4) absence of regular compensatory behaviors such
as purging. The DSM also defined the severity of the binge eating disorder based on the
number of episodes of binge eating.
However, some critics question whether binge eating disorder is a created
13
disease . Sarah Sorscher has already voiced in her letter that promoting Vyvanse for
binge eating disorder is another example of Shire’s disease-mongering campaign14. In
January of 2015, Vyvanse was approved for binge eating disorder. The same month,
Shire, the company that produces Vyvanse, began running ads featuring Monica Seles, a
retired professional tennis player, to talk about binge eating disorder.
Vyvanse is lisdexamfetamine, which is dextroamphetamine with a lysine group
attached. When consumed, the lysine group cleaves off in the bloodstream, leaving
dextroamphetamine15. Amphetamines are highly addictive and are a schedule II federally
controlled substance. Thus, Vyvanse has a high potential for abuse16. Furthermore,
adverse effects of Vyvanse include dry mouth, decreased appetite, insomnia, diarrhea,
nausea, increased blood pressure, anxiety, hyperhidrosis, increased heart rate, dyspnea,
agitation, and restlessness15. As was mentioned before, Vyvanse was approved in January
2015 to treat binge eating disorder. Vyvanse was first approved in 2007 for ADHD and it
is Shire’s blockbuster drug. In 2014, it generated over a billion-dollar revenue17.
There are a few indications that suggest that binge eating disorder might be
another example of condition branding. Currently, Vyvanse is the only drug approved to
treat binge eating disorder.
It is thought that Shire started to promote binge eating disorder to position
Vyvanse, previously approved to treat ADHD, as a treatment for binge eating disorder, in
order to extend the patent exclusivity for the drug. Patent exclusivity is a time period in
which the company has exclusive marketing rights for a drug18. It is common for
companies to extend patent exclusivity by getting the drug approved for a different
condition. When the Vyvanse patent exclusivity for ADHD neared its expiration in 2015
Shire gradually stopped funding educational grants on ADHD as. At the same time, Shire
spent more on educational grants for binge eating disorder18. The approval of Vyvanse
for binge eating disorder extended patent exclusivity by three years.
Understanding the history and prevalence of condition branding and looking at
the history of Vyvanse and marketing of binge eating disorder, the question of whether
binge eating disorder is an example of condition branding arises. If so, how did an
industry-invented condition become a medically accepted diagnosis? From my
preliminary research, I hypothesized that binge eating disorder was created to increase
the sale of Vyvanse when the drug was losing patent exclusivity for ADHD.
Significance
Binge eating disorder may not be a real disease. Binge eating is certainly an
abnormal behavior and is a real symptom of stress, anxiety, or depression19. Many
ordinary people are vulnerable to binge eating in times of stress and trauma. A real
symptom, however, is not necessarily a real disease. However, it is necessary to question
if binge eating disorder is a legitimate condition that needs medical attention. If it is not a
real disease, the diagnosis of binge eating disorder may be bad for the public health,
especially when an addictive amphetamine, Vyvanse, is the only treatment for it. When
binge eating stems from psychological issues, binge eating is best dealt with therapy for
longer and effective outcome. Treating a psychological problem with a pill that has
adverse effects is counterproductive and dangerous.
Furthermore, this research can help lead to measures to control diagnostic
inflation. The American population experiencing at least one disorder defined in DSM
jumped from 32% in 1980s to 47.4% in the 1990s. The fact that binge eating disorder
falls under psychiatric problem is concerning and could contribute to over-diagnosis.
Most women in American society are overly conscious about how much they eat. It is
almost the norm for women to be concerned with body image and feel shameful while
and after eating. Thus, mislabeling this common and expectable problem of binge eating
disorder could lead to “false-positive over-diagnosis and unnecessary overtreatment”8.
Inflation of diagnosis is problematic because it can lead to “trivialization of mental
disorder, misallocation of scarce resources, and reduction of the public’s commitment to
providing adequate care of the severely mentally ill”8.
Objectives
The main objective of this research is to analyze CME modules to see whether
they contain marketing messages that promote prescription of Vyvansee. To identify
marketing messages, it is necessary to determine if there are common themes and topics
across CME modules promoted by different number of speakers. Also in an attempt to
evaluate possible bias or lack of bias in CME modules, one of the objectives of this paper
is to compare the treatment options identified in CME modules with non-industry-funded
infomation. Furthermore, this study also seeks to determine if promotion of binge eating
disorder is used as a way to sell Vyvanse.
Methods
CME modules on BED were identified by searching “‘binge eating disorder’
CME” on Google. Using established narrative analysis techniques, common themes were
identified in the modules. After creating extensive notes on all modules, common themes
were identified. Additionally, slides that were duplicated in different presenters’ talks
were identified. Quotes reflecting specific themes were transcribed verbatim. Themes
were reviewed and refined with the faculty mentor.
Results
Google generated 13,800 hits. The first 200 results were reviewed. No unique
CME modules appeared after the 37th result. Twenty additional random pages were
checked; no additional CME’s were identified Twenty seven different CME modules
were identified and all of them were supported by Shire’s educational grant. There were
14 CME modules that were published before the approval of Vyvanse and there were 13
CME modules that were published after the approval of Vyvanse for binge eating
disorder. Of the 27 videos or text CME modules, there were 16 different presenters or
authors of the CME modules. Of the 16 presenters, six reported receiving a consulting fee
from Shire: Carlos Grilo, Susan McElroy, Paul Keck, Leslie Citrome, Susan Kornstein,
and Denis Wilfley. The most common speakers were Carlos Grilo, Tracy Cummings,
Paul Keck, and Susan McElroy (Table 1). To locate financial ties of these speakers with
Shire, I searched their names in Dollars for Docs, a database that collates information
form the CMS Open Payments, a repository of disclosure information on industry
payments to physicians. Most of these speakers were listed under dollars for docs except
Carlos Grilo and Denis Wilfley. Consulting fees from Shire to Carlos Grilo and Denis
Wilfley were discovered under the disclosure section in CME modules. Dollars for docs
showed that Susan McElroy received $12,944, Paul Keck received $11,441, Leslie
Citrome received $37,214 and Susan Kornstein received $39,496 for Vyvanse.
Furthermore, Susan McElroy, Paul Keck, Tracy Cummings, and Elizabeth Wassenaar are
all associated with Lindner Center of HOPE.
Table 1. Number of Appearances of Each Speaker in CME modules on BED
Speakers
Frequency
Carlos Grilo*
7
Susan McElroy*^
6
Paul Keck*^
5
Tracy Cummings^
4
Charles Vega
3
Angela Guarda
3
Janelle Coughlin
3
Nicholas Bello
3
Leslie Citrome*
2
Susan Kornstein*
2
Denis Wilfley*
2
Elizabeth Wassenaar^
1
Deidre Berens
1
Michael Pertschuk
1
Elizabeth Joy
1
James Mitchell
1
* Speakers with financial ties with Shire
^ Speakers associated with Lindner Center of HOPE
Repeated Slides
There were 31 different slides that were repeated throughout 27 CME modules.
The number of repeats ranged from 2 to 12. Some slides were repeated by many speakers
across many CME modules. Some repeated slides were used only by the staff associated
with Lindner Center of HOPE (Table 2). The content of the slides ranged from graphics,
data tables, and bullet points. In some cases, reference sources differed even though the
slides contained the same information.
Table 2. Repeated Slides by Speakers
Slide
number
Susan
McElroy
Paul Keck
Total
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
1
3
4
3
1
1
1
1
2
1
1
1
2
7
12
6
2
2
4
5
3
2
4
3
4
2
2
2
2
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
1
2
1
1
1
1
1
2
3
1
1
1
2
1
1
1
Tracy
Elizabeth
Carlos
Leslie
Cummings
Joy
Grilo
Citrome
Number of repeats by multiple people
1
2
1
6
1
3
1
1
1
2
3
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Number of repeats by staff at Lindner Center of HOPE
2
3
1
2
3
3
3
2
4
6
3
2
6
5
5
7
8
6
5
2
3
2
1
3
2
1
3
1
2
2
4
3
1
1
2
1
Themes and Quotes
The themes and the messages of the CME modules were similar across all CME
modules. While some reoccurring themes appeared in all CME modules, some themes
only appeared in CME modules that were published before and after the approval of
Vyvanse. Table 3 organizes themes that appeared in CME modules that were published
before the approval of Vyvanse, after the approval of Vyvanse, or both.
Table 3. Reoccurring Themes in CME modules on BED
Theme
Example
Many patients with BED
are obese.
“Overweight or obese binge eating disorder patients are
more likely to gain weights more rapidly”.
# of
modules
13
# of
speakers
9
BED results in poor
quality of life.
BED is not a character
flaw.
Probe patients about
BED because it is often
hidden behind
comorbidity and shame.
Lisdexamfetamine is
effective for BED.
Psychotherapy is not a
good BED treatment
because it does not
cause weight loss.
Topiramate is not a
good BED treatment
because it does not
cause weight loss.
All other
pharmacopherapy
options are not good
BED treatment because
they do not produce
weight loss.
BED can occur in
everyone regardless of
age, gender, and
ethnicity.
BED makes losing
weight difficult.
Treating BED will make
patient’s lives better.
The cause of BED is
related to
“Kids as young as 5 years old are already being
stigmatized for over weight. They have poor quality of
life. They rated as poor as children with cancer”.
“Binge eating disorder is not a sign of weakness or
character flaw. It is a medical condition”.
“Binge eating disorder is prevalent but often missed.
Therefore, patients should be assessed for binge eating
disorder and for frequent comorbidities, including
obesity, medical and metabolic problems, psychiatric
disorders, psychosocial function, and body image
particularly overvaluation of shape and weight”.
“It improved people's ability to inhibit their eating
behavior when they wanted to. The drug also reduced
hunger. And finally, lisdexamfetamine also reduced the
obsessive-compulsive features of binge eating. So people
spent less time thinking about eating or having urges to
binge eat, and they felt more in control of their eating
behavior”.
11
6
8
3
13
9
7
5
“How well do these [nonpharmacological treatments]
things work? Do they work on binge eating? Well yea,
they work very well on binge eating… but the problem is
that they don’t really result in weight loss”.
“One long-term study of topiramate had a duration of 42
weeks and showed continued improvement in binge
eating disorder and weight loss; however, the
discontinuation rate for adverse events in this stud was
high”.
“Other agents such as SSRIs or anti-depressants appear
to have some benefit for reducing BE but unfortunately
they do not produce any weight loss”.
5
4
6
4
8
5
“Unlike anorexia nervosa and bulimia, binge eating
disorder appears to affect me and women at similar rates
and has been identified across diverse community and
clinical samples, ethnicities, and racial backgrounds”.
“If you can stop binge eating, you can stabilize weight
gain”
12
5
4
4
“When you identify BED and treat this patient
effectively, the outcome can be outstanding, and you can
really make a strong difference in patients' lives by
preventing serious morbidity and just helping them to
live better, live happier, and be more in control of their
own lives”.
“Studies in humans and animal models suggest a role for
dopamine in the pathophysiology of BED”
2
2
4
3
hormonal/neuronal
problems (dopamine and
its role in rewarding
processing).
BED is a real and
“Treatments exist and include evidence-based forms of
treatable disease.
psychotherapy and medications”.
*see appendix A for entire list of quotes
5
2
Discussion
There are some indications that suggest bias from Shire in CME modules. Half of
the speakers have financial ties with Shire. The speakers who have financial ties tend to
appear more frequently in the CME modules (Table 1). Of the 16 speakers of CME
modules, four people are associated with Lindner Center of HOPE. The center received a
research payment of $53,000 and $72,000 in year 2013 and 2014, respectively, over the
course of five months from Shire.
Positive bias towards Vyvanse
There is an obvious positive bias toward Vyvanse in Shire-funded CME modules.
Industry-funded speakers and authors promote lisdexamfetamine as an effective
treatment for BED while criticizing other forms of treatment. The speakers criticize
topiramate, SSRIs, anti-obesity medication, zonisamide, and duloxetine for various
reasons. Some atherapies re criticized because they do not improve binge-eating
frequencies, which is a good reason to dismiss them because the goal of the treatment for
BED should be to reduce the binge eating frequencies. However, most of these
pharmacotherapy options show improvements in binge eating frequencies. These drugs
are then criticized for lack of weight improvement, high discontinuation rates, and
adverse effects. For example, Susan Kornstein states, “One long term study of topiramate
had a duration of 42 weeks and showed continued improvement in binge eating disorder
and weight loss; however, the discontinuation rate for adverse events in this study was
high”
On the other hand, Vyvanse is praised for its effectiveness in treating binge eating
disorder and weight management. For example, Tracy Cummings says
“lisdexamfetamine has more recently been studied with very positive results… the result
has been so positive. It’s moved on in positive phase 2 studies has been reported in 2012
to meet the primary endpoint, which is very exciting for those of us in realms of treating
BED”. The tone of the voice that she uses when introducing lisdexamfetamine is very
different from when she talks about other therapy options. Furthermore, only mild side
effects of lisdexamfetamine are presented to the audience, suggesting that
lisdexamfetamine is completely safe.
There are a total of 31 different slides that are repeated throughout 26 CME
modules. These repeated slides suggest that Shire has a promotional slide deck that is
distributed to speakers in order to get across certain messages. Most of these repeated
slides focus on exploring pros and cons of specific drugs and comparing
pharmacotherapy and psychotherapy. If the slides do not focus on treatment options, they
focus on promoting a high frequency of BED diagnoses.
The topics that are found in these repeated slides seem to work in favor of Shire.
Urging the physicians to diagnose more patients with BED would lead to high number of
prescription for Vyvanse. Comparing treatment options to favor Vyvanse helps with
Vyvanse sales. Speakers appear to be using a slide deck that Shire had provided them;
one indication is hat some of the identical graphics that different speakers used are not
directly from the sources that they reference. Several summaries of key study findings
were identical. It is very unlikely that multiple people would summarize the information
in a study in same table or figures. Furthermore, some slides have different sources
referenced; yet these speakers were able to come up with same bullet points verbatim.
Lastly, the themes identified in CME modules that were published before and
after the approval of Vyvanse seem to be orchestrated differently. Most of the themes
identified are repeated in all CME modules but there are a few themes that appear only in
the CME modules that were published before the approval of Vyvanse. Conversely, there
are themes that only started to appear after Vyvanse got approved. Before the approval of
Vyvanse for BED, it was imperative that condition of BED is portrayed as a detrimental
condition in order to convince people that treatment for BED is important. The themes
that appear only in the CME modules that were published before the approval of Vyvanse
indeed dealt with the nature of the condition. They stress that BED makes losing weight
difficult and that treatment of BED is necessary because it makes patients’ lives much
better. Once Vyvanse was approved for BED, it was important to convince the
prescribers that BED is a real disease in order to promote diagnoses of BED. Again, the
themes that appeared in CME modules only after the approval of Vyvanse were focused
on telling the physicians that BED is a real and treatable disease and that the cause of
BED is related to neurotransmitter imbalances that can only be treated with a drug.
Problems with themes found in CME modules
The speakers of CME modules do not provide entire information. For example,
one of the common themes found in CME modules is that LDX is safer than other drugs.
The only side effects that they mention of LDX are decreased appetite, dry mouth,
headache, and insomnia. These side effects make Vyvanse harmless and best choice of all
pharmacotherapies. However, Vyvanse has adverse effects of death, stroke, anxiety, and
heart attacks. These adverse effects are very serious and it is important that consumers
and physicians are informed of these side effects along with the mild side effects that
were presented in the CME modules. Thus, by avoiding to present entire scope of adverse
effects, the messages in CME modules put Vyvanse in a really positive light.
Throughout the CME modules, the idea that psychotherapy is not a good
treatment is promoted. James Mitchell attacks psychotherapy as “not commonly
available” and “identify[ing] someone who really knows manual based approaches such
as CBTs are hard to find”. In some cases, psychotherapy is criticized because it doesn’t “t
really result in weight loss”. However, these claims are contradictory to many articles
found in psychiatry journals. Many psychiatric journals have been promoting the
effectiveness and success of cognitive behavioral therapies for eating disorder like nonpurging bulimics20.
Furthermore, the main concern for psychologists for patients with eating disorders
is treating self-esteem and body image21. However, the speakers of the CME modules are
more concerned with weight loss. For example, when speakers criticize behavioral
therapies because of lack of weight loss, they are communicating that they are not really
concerned with psychological harm. Rather, they are concerned with weight loss. It is
odd that CME modules supported by Shire would criticize psychotherapy, which is
widely accepted treatment for eating disorders in psychiatry journals, because it does not
lead to “meaningful weight loss”.
Violation of WHO standards
According to the World Health Organization, “all promotion-making claims
concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced,
up-to-date, capable of substantiation and in good taste… Comparison of products should
be factual, fair and capable of substantiation”. The contents of the CME modules for
BED were not fair, accurate, reliable, or balanced. It was clear that the speakers were
promoting Vyvanse over all other treatment options even when psychotherapy is well
supported in the field of psychology. The speakers fail to mention harmful effects of
Vyvanse, while they listed many risks for other pharmacotherapies. Not only do the CME
modules for BED violate standards limiting commercial messages in CME, but they also
violate the WHO standards of promotion and advertisements3,22.
Condition branding is clear in these CME modules
All of the main strategies of condition branding are fulfilled in these modules. The
strategies of “elevating the importance of an existing condition is clearly demonstrated by
the speakers’ repeated assertions that BED impairs peoples’ lives. For example, Paul
Keck states, “Many people with binge eating disorder have additional thoughts about the
behavior and these thoughts can be very distracting and it impairs people’s ability to
function optimally”. In another example, Carlos Grilo says, “with all patients with binge
eating disorder, there is an increased risk for them to suffer psychological distress,
interpersonal problems, and some role impairments. There have been some reports on
elevated suicidality”. The purpose of these remarks is to convey that BED diminishes
quality of life and to imply that treating binge eating will improve quality of life.
The strategy of “redefining an existing condition to reduce stigma” is also obvious
when the speakers emphasize that BED is not a character flaw. Susan McElroy says,
“BED is not a sign of weakness or character flaw. It is a medical condition”. Over and
over again, these speakers stress that BED is not a personal failure or character flaw, but
that it is a medical condition. In doing so, they are able to reduce stigma. Another way
that the speakers reduce stigma is by stating that BED is caused by dopamine
dysfunction. Although a connection between dopamine and BED has not been proven,
multiple speakers mention it frequently, perhaps to convince physicians that BED is a
biological problem. By making BED a biological problem, the effectiveness of
psychological treatment – or simple willpower - is undermined .
The last strategy of “developing unmet market need” is achieved by stating that
BED is under-diagnosed and that it is prevalent. The speakers repeat multiple times that
BED occurs in everyone regardless of age, gender, weight, and ethnicity. Carlos Grilo
stated, “so that gives you a sense that BED is prevalent. It is found in men, it’s found in
women, it’s found across ethic and racial minority groups. BED can occur, it has been
mentioned, in people of any size, weight, and shape”. On top of promoting the idea that
BED could occur in everyone, the speakers emphasize that BED is under-diagnosed.
Through these two tactics, they are able to achieve a sense that the medical need for a
large proportion of the population is unmet.
Vyvanse is being promoted as a diet drug
Vyvanse is not any different from dextroamphetamine (Dexedrine) because when
lisdexamfetamine is absorbed from the gastrointestinal tract, it is converted to
dextroamphetamine in the blood (Shire, 2015). Amphetamine was widely prescribed in
the 1940s to the 1970s to overweight people to suppress appetite23. However, there was
an epidemic of people abusing the drugs. Thus, companies stopped selling amphetamines
as diet pills and FDA restricted the use of amphetamines. Consequently, there are many
concerns that approving Vyvanse, an amphetamine, for binge eating disorder will lead to
prescribing Vyvanse as a diet pill for people without binge eating disorder24. It is very
evident from the CME modules that binge eating disorder is constantly linked to weight
gain, and Vyvanse, but not other treatments, are linked to weight loss.
In realcme.com, six of the CME modules pertaining to BED were listed under
psychiatry while three of the CME modules were listed under weight management. This
categorization links BED treatment to weight loss.
Furthermore, the theme of “many patients with BED are obese” is repeated 16
among 8 speakers. For example, Carlos Grilo states, “binge eating disorder is associated
with severe obesity”. Another example is by Susan McElroy when she says, “Most
people presenting for treatment for binge eating disorder are obese”. Although they stress
that not all patients with BED are obese, every CME modules covers the topics of obesity
and metabolic syndrome. With this theme being promoted all the time, Vyvanse becomes
a treatment for obesity, not for binge eating disorder.
Besides linking BED with weight gain, the speakers also stress the importance of
losing weight. Weight loss becomes as important as treating psychological problems.
Most other pharmacotherapy options are dismissed because of the sole reason for not
producing weight loss. As James Mitchells states, “weight issue is very important”.
In many modules, Vyvanse is promoted as causing weight loss while other BED therapies
are criticized for showing lack of weight loss.
Problems of Disease Inflation
With the approval of Vyvanse for BED and the official recognition of BED in
DSM-5, we need to examine the dangers to public health. Disease inflation lowers the
threshold for being sick and expands the eligible market for drugs. The administration of
potentdrugs ato those who are less sick can be problematic. In this case, giving a
addictive amphetamine to patients with a mild eating disorder adversely affects, l the
benefit to harm ratio.
The availability of Vyvanse as an illegally marketed diet pill makes it inevitable
that consumers will demand Vyvanse. The approval of Vyvanse for BED contributes to
the medicalization of normal life. Condition branding turns healthy people into patients
and causes harm. When people are convinced that normal symptoms are diseases that are
treatable, they take dangerous drugs25. In doing so, they put their health at risk. If drugs
were harmless, condition branding would not be concerning but no drug is completely
benign. Furthermore, with the possible danger of using Vyvanse as a diet pill, it is
inevitable that the demands for Vyvanse would be popular, especially in the United
States, where being thin is idolized.
Strengths and weaknesses of this research
This unique mixed-methodology study combines qualitative research techniques
with aspects of investigative reporting. The unique strength of qualitative research is the
ability to study meanings. The proposed method allows deeper understanding of how
binge eating disorder arose in the context of medical culture. A weakness of this research
is the lack of access to Shire’s internal communications. The nature of this research is
essentially investigative journalism; we have attempted to reverse-engineer the marketing
messages associated with this drug. It is impossible to confirm the marketing messages
associated with Vyvanse without access to Shire’s internal communications. Because
Vyvanse was approved for binge eating disorder very recently, it is difficult to assess the
impacts of this promotional campaign on the sales of Vyvanse.
Conclusion
Based on the contents in the CME modules, it is likely that Shire used CME to
market Vyvanse to physicians. It is very clear that Vyvanse is favored above all other
treatment options, thus linking BED with Vyvanse, a successful example of condition
branding. Favorable bias towards Vyvanse is unavoidable when Shire funds all the CME
modules for BED and half of the speakers have ties with Shire. Shire’s control over
content is apparent in slides that are duplicated in numerous talks by different speakers.
The majority of the content of the CME modules emphasized obesity rather than the
psychological impact of BED. Considering that the speakers view the weight loss
component as the most important criterion for effective treatment, it is likely that Shire is
indirectly promoting Vyvanse as a weight loss agent. Use of amphetamine, an addictive
drug with serious side effects, as a diet pill is dangerous and such use would be unlikely
to be approved by the FDA. Shire’s CME modules may skirt laws against off-label
promotion.
Our study shows that CME is being used to promote Vyvanse as a diet pill.
Shire’s actions are unethical and possibly illegal.
Acknowledgement
I would like to thank my faculty mentor, Dr. Adrian Fugh-Berman, for her guidance.
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Appendix A
Many patients with BED are obese
 “There may be many reasons why patients continue to gain weight despite
ongoing weight-loss efforts. Two common nonmedical reasons include readiness
and binge eating. Obese patients may not be ready to commit to weight loss lack
of readiness is very common and can be assessed using methods to establish
readiness for change. The presence of binge eating episodes can lead to weight
gain, even when patients engage in food restriction during the rest of the day.”
 “Overweight or obese BED patients are more likely to gain weights more
rapidly.”
 “Let me talk about a clinical case study: Sally, a White 40 year old woman, who
is not losing weight despite being on repeated diets. That alone should clue us in
that we need to ask about eating behaviors.”
 “It is frequently associated with other medical and psychological co-morbidities,
including obesity.”
 “BED is associated with severe obesity.”
 “Recent substantial weight gains, history of weight fluctuation or current reports
of inability to lose weight those are things that need to be monitored and looked at
for possible medical reasons as well as they signal for presence of this behavior in
psychiatry problem.”
 “Weight issue is very important.”
 “Most people presenting for treatment for BED are obese.”
 “Studies reveal overlaps among appetitive traits that likely increase risk for binge
eating symptoms and excess weight gain… In this sense, the disorder is a
biologically based subtype of obesity. The proneness to bingeing behaviors can
lead to hyper-reactivity to the hedonic properties of food.”
 “Patients with binge eating disorder ten to be overweight, but certainly not all
people with obesity feel a loss of control while eating or consume significant
amounts of food over a short time period.”
 “We will be talking a lot about the connection between obesity and binge eating
along with BED.”
 “Most patients with BED are obese.”
 “When you are looking at targets for BED treatment wise, you are wanting to
look at few areas … and excess adiposity or the weight.”
 “One of the interesting things is that BED does not automatically equate to
obesity, but it definitely increases the risk of obesity -- by about 75% in 1 large
study.”
 “I think there are clear red flags that determine when we definitely should ask
about binge eating -- most importantly, whenever somebody presents with a
weight problem.”
 “It is associated with increased risk for obesity. Therefore medical problems
associated with obesity. So clear medical management pressing need for these
patients.”
BED results in poor quality of life

“People may develop obesity, including severe obesity and possibly metabolic
syndrome, and then binge eating disorder is associated with reduced quality of life
and impairment in functioning that is actually comparable to that seen in people
with bulimia nervosa.”
 “The quality of life is impaired.”
 “Many people with BED have additional thoughts about the behavior and these
thoughts can be very distracting and it impair people’s ability to function
optimally.”
 “With all patients with BED, there is an increased risk for them to suffer
psychological distress, interpersonal problems, and some role impairments. There
has been some reports on elevated suicidality.”
 “Patients with this disorder may have greater impairment and poorer physical
health, for example, worsened metabolic profiles, more rapid weight gain, and a
worse response to weight loss treatment.”
 “Beyond obesity, medical concerns such as metabolic syndrome and diabetes are
also frequently associated with BED, leading to a reduced quality of life and
impairment in functioning.”
 “Kids as young as 5 years old are already being stigmatized for over weight. They
have poor quality of life. They rated as poor as children with cancer.”
 “People may develop obesity, including severe obesity and possibly metabolic
syndrome, and then binge eating disorder is associated with reduced quality of life
and impairment in functioning that is actually comparable to that seen in people
with bulimia nervosa.”
 “BED is a disorder that affects everyone that causes a lot of suffering across many
different groups of people.”
 “Beyond obesity, medical concerns such as metabolic syndrome and diabetes are
also frequently associated with BED, leading to a reduced quality of life and
impairment in functioning.”
 “It is also important to realize that ED is associated with distress, reduced quality
of life, and role impairment comparable to that seen with bulimia nervosa.”
BED is not a character flaw.
 “BED is not a sign of weakness or character flaw. It is a medical condition.”
 “Educate the patient about BED that it is a medical condition. It is not something
that they are choosing to do or is a character flaw.”
 “It is not a character fault of hers -- it is not that she is a bad person or that she has
done something wrong -- but that this is a real disease.”
 “We have both alluded to it with our cases and throughout this conversation, but I
believe we must convince our patients that this is a disease; this not a character
flaw. It is a real disorder for which we have multiple treatments that can be
effective.”
 “It is not a character flaw. It is not a personal failure.”
 “I also tell them that binge eating disorder is a distinct medical condition that's
classified in the DSM-5, and this can help patients realize that they have a
disorder rather than a personal weakness.”

“And when communicating with binge eating patients, it is crucial to have a
nonjudgmental demeanor and to emphasize that the disease is not their fault and
to highlight that they are not alone with this condition.”
 “We need to provide patients with education. Not only with information but with
validation. How common it is and that it is not a character flaw.”
 “BED is a diagnosable psychiatric disorder. This is a serious and formal disorder.
It is not about willpower.”
 “Binge eating, patients just lack will power. That’s all it takes. No, bed is a
diagnosable psychiatric disorder. This is a serious mental and behavioral problem.
It is not about weakness or it is not about lack of will power. This is a diagnosable
problem. It is a diagnosable disorder.”
Probe patients about BED because it is often hidden behind comorbidity and shame.
 “BED hide within previously diagnosed condition.”
 “Again, patients will not call in with their primary concern. Instead, use tools to
BED hiding under emotionally destroyed person.”
 “Pushing a little further can elicit diagnosis for BED.”
 “These patients often present for weight loss programs or with other
comorbidities, such as depression, anxiety, or substance use, but the eating
disorder frequently goes undiagnosed.”
 “BED is prevalent but often missed. Therefore, patients should be assessed for
binge eating disorder and for frequent comorbidities, including obesity, medical
and metabolic problems, psychiatric disorders, psychosocial function, and body
image particularly overvaluation of shape and weight.”
 “That it is a hidden disorder that people do not report because they feel such
shame, or they do not even know they are doing it.”
 “I think when you find that hidden disorder, the patients do think, “Finally,
somebody has brought this up.” They feel like the bond is that much stronger
between you and them.”
 “That open-ended question can lead to the diagnosis of BED”  CME 10 and 11
emphasizes open-ended questions
 “Just go one step further and ask that question about uncontrolled eating, and
many times you will have a revelation at that patient visit.”
 “Maybe more helpful clinically to probe a little bit – to proceed little bit. And ask
or proceed along these lines. Ask Kendra, tell me little bit about the eating at
night.”
 “I believe BED is at the core of this patient's other health complaints.”
 “Another important group of patients to assess for binge eating is people with
medical complications of obesity such as diabetes, dyslipidemia, even metabolic
syndrome, especially when that particular medical problem has been difficult to
control… Then, there are psychological clues for when we should screen for
BED.”
 “Subjects showed increased frequency of anxiety disorders, substance-related
disorders, depressive symptoms, trait anxiety, and higher external and emotional
eating scores than subjects without BED.”

“When you ask these questions to people with binge eating disorder, they often
resonate, and people will answer affirmatively when they're specifically probed
about their symptoms.”
 “Binge eating symptoms are extremely embarrassing to patients. They feel guilty
about them. They feel like it's a choice. They feel it's a weakness.”
 “Most clinicians in psychiatric space probably have a number of patients with
BED who have presented them with comorbidity depression or anxiety and
questions about binge eating has never come up.”
 “Unfortunately, busy clinicians often do not recognize the signs of eating
disorders, such as BED, in their patients, and due to associated feelings of shame
and embarrassment or poor awareness of the condition, most affected patients will
not self-identify to seek treatment for BED.”
 “Patients with BED often display discomfort, shame, or guilt regarding their
weight and eating behavior. Many patients with BED are secretive about their
binge eating and attempt to conceal their behaviors.”
 “As noted, mood and anxiety disorders are commonly comorbid with BED, and
Gary presented with features that may suggest depression. Presentations that
suggest depression or anxiety should increase suspicion for BED.”
 “It's very important to remember that BED often co-occurs with other psychiatric
and medical disorders, in particular, mood disorders, and that includes both
depressive and bipolar disorders, anxiety disorders, substance use disorders,
impulse control disorders, including attention-deficit/[hyperactivity] disorder, and
BED also co- occurs with obesity, and that includes severe obesity, as well as
possibly metabolic syndrome.”
 “Those with BED has significantly elevated psychiatry comorbidity.”
 “BED is associated with a huge amounts of co-morbidities.”
Lisdexamfetamine is effective for BED.
 “This medication (LDX) is really getting positive results.”
 “We don’t get results like this in many studies. This is an credibly positive data.”
 “Like lisdexamfetamine has more recently been studied with very positive
results… the result has been so positive. It’s moved on in positive phase 2 studies
has been reported in 2012 to meet the primary endpoint, which is very exciting for
those of us in realms of treating BED.”
 “Both of these studies showed VERY positive results for LDX for BED.”
 “Although no medication currently has FDA approval for BED. There are
promising new treatments on horizon such as LDX and others in development.”
 “Once you move up to 50, 70mg [of LDX], then you see very impressive results.”
 “Adverse effects [of LDX] have been comparable to those in ADHD use.”
 “It improved people's ability to inhibit their eating behavior when they wanted to.
The drug also reduced hunger. And finally, lisdexamfetamine also reduced the
obsessive-compulsive features of binge eating. So people spent less time thinking
about eating or having urges to binge eat, and they felt more in control of their
eating behavior.”
 “We can learn to prescribe drugs in a couple of hours. We can sit down and read
about it and figure it out.”

“Self help is commonly available and it is not difficult to do. Pharmacotherapies
are widely available and they are not difficult to use. Because of this, this seems
to be a very good model for treating BED… if they are not successful you can
think about adding structured psychotherapy at that point. This seems to be the
most cost effective way of approaching BED.”
 “Lastly, amphetamine pro-drug, LDX, is the only agent to my knowledge with
FDA indication for moderate to severe BED.”
 “Safety profile was very similar to use of LDX for ADHD, which is usually very
well tolerated.”
Psychotherapy is not a good BED treatment because it does not cause weight loss.
 “Psychological therapies, however, do not produce weight loss without a
complementary weight-reduction or anti-obesity intervention.”
 “Specialized psychoterhapies are generally not effective for weight and obesity.”
 “Unfortunately, CBT and some of other psychological treatments that are
available in special centers the do not seem to produce weight loss unless, of
course, there is complementary weight loss intervention or anti-obesity
medication or anti-obesity intervention provided in adjunct.”
 “Are there proven psychotherapies? Yea but they are not commonly available.”
 “If you want to use psychotherapist to treat BED you need to identify someone
who really knows manual based approaches such as CBTs. Frankly, they are hard
to find. And they are difficult to learn. To learn to do manual based psychotherapy
takes months and to be good at it takes years.”
 “Help manuals alone or with guidance from therapies may benefit some people
with BED but should be only considered as first step in treatment. But not
probably effective for many people… They don’t produce clinically meaningful
or sustain weight loss.”
 “How well do these [nonpharmacological treatments] things work? Do they work
on binge eating? Well yea, they work very well on binge eating… but the problem
is that they don’t really result in weight loss.”
Topiramate is not a good BED treatment because it does not cause weight loss.
 “One long-term study of topiramate had a duration of 42 weeks and showed
continued improvement in BED and weight loss; however, the discontinuation
rate for adverse events in this stud was high.”
 “You can compare that for example down to the topiramate, which is in fact the
most studied medication in BED. And you can see that it has been shown to be
effective in both binge eating episodes as well as weight loss. The downside being
some high discontinuation rates due to side effects.”
 “Topiramate is effective but it is off label.”
 “Topiramate have been shown to be effective but complicated by high
discontinuation rate and side effects.”
 “Studies of topiramate have reported superiority over placebo with regard to
reductions in bigne frequency and weight loss. Topiramate is associated with side
effects (eg, parathesias, dry mouth, headache, dyspepsia, and cognitive
impairment) that may have contributed to high drop out rates in some trials. It
should be noted that topiramate is considered pregnancy category D and ahs been
associated with increased risk for fetal defects.”

“A number of antiepileptics have been studied in binge eating disorder, and in
particular, topiramate has been shown to be effective for reducing binge eating
and also effective for weight loss, but there are high discontinuation rates with the
compound because of side effects.”
 “Main problem [of topiramate] was that side effects were significantly a problem.”
All other pharmacopherapy options are not good BED treatment because they do
not produce weight loss.
 “Again there is no change in BMI with duloxetine.”
 “In anti-depressant realm, there has been some modest effect on binge eating
episodes, but no significant effect on weight loss itself.”
 “Similarly, you will see effectiveness that was shown from the sibutramene.
However this medication has been withdrawn from the market.”
 “However, noncompleter rates were high in both the zonisamide (60%) and
placebo (40%) groups.”
 “Discontinuation rates were greater in the placebo group (29%) than in the orlistat
group (11%).”
 “Overall, studies of SSRIs in BED have reported greater reductions in binge
eating compared to placebo, although weight reduction was modest in most trials.
A meta-analysis of studies of antidepressant udse for BED reported significantly
higher binge eating remission rates compared to placebo. However, not all results
support the efficacy of SSRIs in BED. In one study comparing fluoxetine to CBT
or both together, CBT alone was superior to fluoxetine alone, and addition of the
SSRI did not improve outcomes over CBT alone.”
 “More limited evidences describes similar outcomes with zonisamide, including
greater reductions in binge frequency and body weight compared to placebo, as
well as high rates of discontinuation.”
 “So antidepressants have been shown to be somewhat or modestly effective for
reducing binge eating over the short term, but they're not usually associated with
significant weight loss. And also there have been no long-term studies to see
whether or not the modest effect on binge eating can be maintained over the longterm.”
 “The anti-obesity medication, sibutramine, has been studied in several
randomized controlled trials in people with binge eating disorder, where it's been
shown to be effective for reducing binge eating behavior and also effective for
weight loss. But this compound has been withdrawn from the market because of
safety concerns.”
 “The anti-obesity agent, orlistat, has been studied in binge eating disorder as well,
but the results have been mixed. It's really not clear whether or not this compound
reduces binge eating behavior, and in some studies, there was weight loss and
other studies there wasn't. And again, there's a high discontinuation rate with this
drug because of side effects.”
 “Other agents such as SSRIs or anti-depressants appear to have some benefit for
reducing BE but unfortunately they do not produce any weight loss.”
 “Chronic use of SSRIs is associated with weight gain.”
 “These [referring to drugs other than LDX] do have effects on binge eating and on
weight but the problem is, as you know as well, they are difficult to use.”

“Anti- depressants have been studied. Their overall effect on BE has been modest.
They do not significantly produce weight loss and their tolerability varies among
different types of anti-depressants.”
 “Lipase inhibitors or orlistat have been looked at. But you would not predict that
this drug would do much of anything since it doesn’t actually act on the brain to
affect compulsive behavior. It just prevents fat absorption. It does produce weight
loss but no significantly effect on BE. It is typically not tolerated – well tolerated.”
BED can occur in everyone regardless of age, gender, and ethnicity.
 “Research has documented that binge eating is more common than previously
recognized, occurring in 2.6% of US adults, in both men and women, and in
members of all ethnic/racial groups.”
 “BED is most prevalent eating disorders in males.”
 “BED does affect women more than men like anorexia and bulimia nervosa also.
But of the eating disorders, BED occurs more in men.”
 “BED occurs across all age groups and across ethnic and racial groups.”
 “BED is a disorder that affects everyone. It causes a lot of suffering across many
groups of people.”
 “It is a common problem for both men and women.”
 “Unlike anorexia nervosa and bulimia, BED appears to affect me and women at
similar rates and has been identified across diverse community and clinical
samples, ethnicities, and racial backgrounds.”
 “Like other eating disorders, binge eating disorder affects women more often than
men, but binge eating disorder is more common in men than other eating
disorders.”
 “BED often presents in young-to-middle adulthood, but children and adolescents
get the condition, and many patients will tell you, ‘I’ve been binging for as long
as I can remember.’”
 “BED is found both in men and women.”
 “Rates of BED are comparable across all ethnic samples.”
 “It’s important to keep in mind that BED occurs in all weight categories.”
 “BED is comparable across racial/ethic groups. So please don’t miss. Look for it
in everyone.”
 “You may be surprised to hear that almost half are male and actually the gender
distribution is far less skewed with BED than it is with anorexia nervosa and
bulimia nervosa, where it sees to occur more commonly among female.”
 “It is important to recognize that BED is found both in women and men.”
 “BED occurs across all weight categories.”
 “BED is found across all weight, age categories, as well as all ethnic and racial
groups in united states.”
 “Unlike the other eating disorders, particularly anorexia nervosa, we see much
less gender disparity.”
 “An important finding and again this goes against the clinical law, is that BED
particularly, in contrast anorexia nervosa, is very comparable and evenly
distributed across racial and ethnic minority groups in United States.”
 “BED is common across all weight categories.”

“So that gives you a sense that BED is prevalent. It is found in men, it’s found in
women, it’s found in across ethic and racial minority groups.”
 “BED can occur, it has been mentioned, in people of any size, weight, and shape.”
BED makes losing weight difficult.
 “If you can stop binge eating, you can stabilize weight gain.”
 “There is the weight piece. We want to decrease weight gain and perhaps promote
some weight loss.”
 “These red flags include the presence of excess weight or obesity; a history of
weight fluctuations, rapid weight gain, and difficulty losing weight.”
 “Going with obesity, there is a higher risk of metabolic syndrome associated with
BED.”
Treating BED will make patient’s lives better.
 “There are also some great self-help books out there so that they gain more of an
understanding of the disorder and they get more empowered in the management
of their own lives. Many times when they do that, it is not just the binge eating
that improves, and it is not even the other chronic medical conditions.”
 “When you identify BED and treat this patient effectively, the outcome can be
outstanding, and you can really make a strong difference in patients' lives by
preventing serious morbidity and just helping them to live better, live happier, and
be more in control of their own lives.”
The cause of BED is related to hormonal/neuronal problems.
 “BED is associated with dopamine dysfunction while controlling for obesity.”
 “Studies in humans and animal models suggest a role for dopamine in the
pathophysiology of BED.”
 “Basic research into the neurobiological mechanisms of BED has implicated
different neurotransmitters and systems, with varying degrees of evidence.
Potentially involved neurotransmitter systems include, among others: dopamine.”
 “It has been demonstrated that repeated stimulation of dopamine-containing
neurons in the mid brain that project to the striatum is associated with the
development and maintenance of binge eating.”
BED is a real and treatable disease.
 “BED is a diagnosable and treatable disorder.”
 “Treatments exist and include evidence-based forms of psychotherapy and
medications.”
 “BED is a diagnosable disorder and a treatable disorder.”
 “BED is treatable.”