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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. References 1. Moynihan, R., Health, I., and Henry, D. (2002). Selling sickness: The pharmaceutical industry and disease mongering. British Medical Journal. 324, 886-891. 2. Relman, A.S. (2001). Separating Continuing Medical Education From Pharmaceutical Marketing. JAMA. 285(15), 2009-2012. 3. Podolsky, S.H., Greene, J.A. (2008). A Historical Perspective of Pharmaceutical Promotion and Physician Education. JAMA. 300(7), 831-833. 4. Angelmar, R., Angelmar, S., Kane, L. (2007). Building Strong Condition Brands. Journal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing. 7(4), 341-351. 5. Parry, V. (2003). The art of branding a condition. Medical Marketing and Media. 38(5), 43-49. Retrieved from https://sdsuwriting.pbworks.com/f/Parry+art+of+branding+a+condition.pdf. 6. Decker, H. (2013). The making of DSM-III: A diagnostic manual's conquest of American psychiatry. New York: Oxford University Press. 7. Cosgrove, L., Krimsky, S. (2012). A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists. PLoS Med. 9(3). 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Polivy J., Herman, C.P. (2002). Causes of eating disorders. Annual Review of Psychology. 53: 187-213. 20. Hom, P.H., Giles, T.R. (1991). Performance-based intervention for non-purging bulimia: Some implications for the treatment of binge eating and obesity. Psychology & Health. 5(3): 183-191. 21. Martijin, C., Alleva, J.M., Jansen, A. (2014). Improving body satisfaction. European Psychologists. 20(1): 62-71. http://www.latimes.com/health/la-hebinge23-2009nov23-story.html. 22. World Health Organization (1994). Essential Drug Monitor No. 017. World Health Organization. http://apps.who.int/medicinedocs/en/m/abstract/Js21079en/. 23. Rasmussen, N. (2008). America’s First Amphetamine Epidemic 1929–1971: A Quantitative and Qualitative Retrospective With Implications for the Present. American Journal of Public Health, 98(6), 974–985. http://doi.org/10.2105/AJPH.2007.110593. 24. Kirkey, S. (2015, April 24). U.S. Drug Regulators Approve First Pill To Treat Binge Eating, Let the Debate Begin. National Post. Retrieved from http://news.nationalpost.com/health/u-s-drug-regulators-approve-first-pill-to-treatbinge-eating-let-the-debate-begin. 25. Mercola, J. (2010, Oct. 29). How to Brand a Disease – and Sell a Cure. Mercola.com. Retrieved from http://articles.mercola.com/sites/articles/archive/2010/10/29/disease-branding-forthe-sake-of-drug-marketing.aspx. 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.”