Research ArticleOriginal Research

Marketing Messages in Continuing Medical Education (CME) Modules on Binge-Eating Disorder (BED)

Jinhyun Jung and Adriane Fugh-Berman
The Journal of the American Board of Family Medicine March 2020, 33 (2) 240-251; DOI: https://doi.org/10.3122/jabfm.2020.02.190129

Abstract

Background: In 2015, Vyvanse (lisdexamfetamine) became the first Food and Drug Administration (FDA)-approved treatment for binge-eating disorder (BED), a condition first recognized by the DSM–V in 2013. Because pharmaceutical companies use continuing medical education (CME) to help sell drugs, we explored possible bias in CME modules on BED.

Methods: We utilized a qualitative thematic analysis research approach to identify and classify patterns in CME activities focusing on BED.

Results: We identified 27 online CME activities on BED in 2015. All were funded by Shire, which manufactures lisdexamfetamine. Seven of 16 presenters disclosed financial ties with Shire. Twenty-nine slides recurred in at least 2 CME modules, and 12 slides were repeated in 5 or more modules. Diagnosis-related themes included: BED is a real, treatable disease; BED is highly prevalent but often missed; BED can occur in anyone; BED results in poor quality of life; many patients with BED are obese; and BED makes losing weight difficult. Treatment-related themes included: lisdexamfetamine is highly effective; topiramate is limited by substantial adverse effects; and other therapeutic options for BED are inferior to lisdexamfetamine because they do not cause weight loss. Although amphetamines can cause addiction, myocardial infarction, stroke, and death, no module mentioned these serious adverse effects.

Conclusions: It seems that CME is being used to promote lisdexamfetamine for weight loss (a contraindicated use) and to highlight benefits of lisdexamfetamine while underplaying the risks.

Most physicians are required to take continuing medical education (CME) courses for license renewal, and the quality of information provided affects patient care. Although most CME that physicians view is sponsored by the pharmaceutical industry, very few studies have examined commercial bias in sponsored CME.1 The few studies that do exist have found bias in favor of sponsors’ drugs,2⇓⇓⇓–6 raising the question of whether industry-funded CME compromises rather than promotes rational prescribing.

Pharmaceutical companies consider CME important for marketing7 and documents disclosed in litigation emphasize the importance of CME to marketing new drugs or new indications.8–9 Binge-eating disorder, first recognized by the DSM–V in 2013, may be an example of a disease created to sell a drug.10 A study of conflicts of interest among DSM task force and work group members involved in assessing new diagnoses, including binge-eating disorder, found that conflicts of interest regarding research and nonresearch relationships were common.11

Although binge eating is certainly an abnormal behavior that can be a symptom of stress, anxiety, depression, or obsessive-compulsive disorder, little evidence supports treating binge eating as a unique disease. In fact, binge-eating disorder has been cited as an example of pathologization of normative eating patterns.12⇓⇓⇓–16 In any case, therapy, especially cognitive behavioral therapy, has been shown to be an effective treatment for binge eating.17–18

In January 2015, Vyvanse (lisdexamfetamine) became the first drug approved for binge eating disorder. The drug was already popular; in 2014, lisdexamfetamine generated over a billion dollars of revenue.19

Lisdexamfetamine, which is simply dextroamphetamine attached to a lysine molecule that is cleaved off in the bloodstream,20 was first approved in 2007 for Attention-Deficit/Hyperactivity Disorder (ADHD). When the market exclusivity for that indication neared its expiration in February 2012, Shire decreased funding for educational modules on ADHD, while increasing educational grants for binge eating disorder.21 In the 18 months before approval of Vyvanse for binge-eating disorder (BED), Shire spent about US $4 million on increasing physician awareness of BED.21

Approval of a previously approved drug for a new indication extends market exclusivity by 3 years. The question of whether BED became a disease to sell a drug led us to investigate whether industry-funded CME on BED was used to promote lisdexamfetamine. We reviewed all Internet CME modules on BED available in 2015 to compare content and key messages between industry-funded and non-industry-funded modules.

Methods

Online CME modules on BED were identified by searching the terms, “binge eating disorder,” combined with “CME” on Google. We limited our results to Web-based CME (in other words, we did not analyze live events). We utilized a qualitative thematic analysis research approach that enables the study of meanings. Using statements of belief, opinion, or putative fact as the units of analysis, thematic analysis is an inductive approach that is used to interpret text data through systematic identification and classification of themes or patterns. Thematic analysis requires identifying, recording, analyzing, and refining key narrative points, called “themes,” within a data set of spoken or written material. Our process involved multiple reviewings of modules; extraction and annotation of important teaching points (“themes”) that recurred in different modules; repeated refinement of the total list of themes across the data set, analysis of each theme’s overt and covert messages, and the use of verbatim quotes to illustrate our analysis.

Both authors viewed several CME activities and established preliminary themes. One author (JJ) reviewed all modules multiple times and took extensive notes, including verbatim quotes, on existing themes and new themes. Both authors added, deleted, and refined themes, based on their recurrence and expression in subsequent modules. Illustrative quotes in our table were selected based on clarity of statement or fluency of expression with respect to particular themes.

Financial conflicts of interest with Shire, the manufacturer of lisdexamfetamine, were identified through the disclosure sections of modules. In addition, all author/presenter names were searched in Dollars for Docs, a database that collates information reported to the Center for Medicare and Medicaid Services’ Open Payments, a repository of disclosure information on industry payments to physicians.

Results

A Google search for Web-based CME on BED generated 13,800 hits. The first 200 results were reviewed, and about 200 additional results on 20 random pages were checked. Twenty-seven22⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓–48 different video or text CME modules were identified. No new CME modules appeared after the 37th result; additional results identified in the 400 results reviewed were duplicates or irrelevant.

All CME modules were accredited by providers certified by the Accreditation Council for Continuing Medical Education. Nine modules were available on realcme.com, 7 on mycme.com, 4 on provaeducation.com, 3 on medscape.org, and 1 each on primed.com, healio.com, thedoctorschannel.com, and the Peerview Institute for Medical Education, respectively. Three of 922⇓–24 CME modules on BED at realcme.com were listed under weight management; 625⇓⇓⇓⇓–30 were listed under psychiatry.

No non-industry-funded CME modules were identified. Shire, the manufacturer of lisdexamfetamine, was the sole listed funder of the programs through educational grants. Fourteen CME modules were published before, and 13 after, the approval of lisdexamfetamine for BED. Sixteen different presenters or authors were identified in 27 CME modules. Eleven speakers presented in 2 or more modules (Speaker E spoke in 7 modules). Five speakers appeared in only 1 module each (Figure 1).

Figure 1.
Figure 1.

Number of slides repeated in different online activities on BED. Abbreviation: BED, Binge-Eating Disorder.

Of the 5 speakers who appeared in only a single module, none reported conflicts of interest with Shire. Seven of 16 presenters reported receiving consulting fees from Shire; these 7 speakers appeared in 2 to 7 modules. Speakers with financial ties appeared more frequently than speakers without ties. Four of 16 presenters (including speakers A, B, and C) were associated with the Lindner Center of HOPE, which received research payments of US $71,135 in 2013,49 US $164,592 in 201450 and US $134,137 in 201551 from Shire. -Two of the 4 authors (speakers A and B) associated with the Lindner Center of HOPE also had personal financial conflicts of interest with Shire.

Common Slides

Twenty-nine slides recurred in at least 2 CME modules. Eight slides were repeated in 5 or more modules (Figure 1). The content of repeated slides included graphics, data tables, and bulleted-list summaries. None of the identical tables or figures used by multiple speakers appeared in sources referenced on the slides. While several graphics used by multiple speakers were found in referenced sources, additional elements were added to the graphics and these alterations were identical in slides used by different speakers.

The most frequently repeated slide, illustrating the prevalence of BED by depicting faces superimposed over a map of the US, appeared in 11 different modules.

Fifteen of 29 slides common to multiple presentations were repeated by 2 different speakers, 11 slides by 3 different speakers, and 3 slides by 4 different speakers. Slide 4 was used by 2 different speakers who presented within the same CME module.31 Four modules25⇓–27,32 utilized 2 speakers in discussion; in these cases, the slide was attributed only to 1 primary speaker. Three slides that were used by 4 different speakers discussed DSM-5 criteria for the diagnosis of BED, the prevalence of BED, and characteristics of binge eating. Thirteen of 29 slides were repeated only by staff associated with Lindner Center of HOPE (Figure 1).

Common Themes

Twelve major themes, present in all modules, were identified:

  1. BED is highly prevalent but often a missed diagnosis; clinicians must elicit the diagnosis by questioning patients closely.

  2. BED can occur in everyone regardless of age, gender, ethnicity, or weight.

  3. BED results in poor quality of life.

  4. BED is associated with many other disorders, including obesity, depression, anxiety, substance use disorders, diabetes, dyslipidemia, and metabolic syndrome.

  5. Many patients with BED are obese.

  6. BED makes losing weight difficult.

  7. BED is not a character flaw.

  8. BED is related to dopamine dysfunction.

  9. BED is a real, treatable disease, and treatment improves lives.

  10. Lisdexamfetamine is highly effective for BED.

  11. Topiramate may be effective but its use is limited by substantial adverse effects.

  12. Other therapeutic options for BED are inferior to lisdexamfetamine because they do not cause weight loss.

See Table 1 for examples of statements from different modules related to each theme.

View this table:
Table 1.

Themes with Examples of Quotes

Marketing Messages

Both explicit and implicit marketing messages supporting lisdexamfetamine were identified in these modules. Explicit marketing messages in these modules included the positioning of lisdexamfetamine as a safe, very effective treatment for BED; the positioning of topiramate, serotonin reuptake inhibitors (SSRIs), and other pharmacologic therapies as unsafe, and the framing of psychotherapy as effective but difficult to access. The primary implicit marketing messages in these modules were that BED is associated with obesity, and that lisdexamfetamine was superior to other therapies because only lisdexamfetamine caused weight loss.

None of the 27 modules reviewed mentioned that lisdexamfetamine is an amphetamine with a high potential for abuse. No module mentioned any serious adverse effects of lisdexamfetamine, which include sudden death, stroke, myocardial infarction, hypertension, tachycardia, psychosis, manic symptoms, growth suppression, and peripheral vasculopathy.20

In these modules, lisdexamfetamine appeared safe. A typical statement regarding side effects was that the “safety profile was very similar to use of lisdexamfetamine for ADHD, which is usually very well tolerated.”31 Activities that mentioned any adverse effects at all mentioned only decreased appetite, dry mouth, headache, and insomnia.

Lisdexamfetamine was presented as a highly effective drug for BED, even in modules released before approval for BED. For example, a speaker in 1 module dated before approval of lisdexamfetamine for BED stated: “lisdexamfetamine has more recently been studied with very positive results … the result has been so positive.”33 Another stated: “We don’t get results like this in many studies. This is incredibly positive data.”32

Besides lisdexamfetamine, speakers presented all other therapies for treating BED and obesity in a negative light, including topiramate, zonisamide (an anticonvulsant), duloxetine and other SSRIs, antiobesity medications, and psychological therapies.

Topiramate was highlighted for negative attention. For example, 1 speaker stated: “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.”34 Another stated that: “Studies of topiramate have reported superiority over placebo with regard to reductions in binge frequency and weight loss. Topiramate is associated with side effects (eg, paresthesias, dry mouth, headache, dyspepsia, and cognitive impairment) that may have contributed to high dropout rates in some trials. It should be noted that topiramate is considered pregnancy category D and has been associated with increased risk for fetal defects.”22

Cognitive behavioral therapies (CBT) and psychotherapy were presented as effective but difficult to access. For example, 1 presenter stated that psychotherapy is “not commonly available.”35 The same module stated that: “identify[ing] someone who really knows manual-based approaches such as CBT are hard to find.”35

Every CME module covered obesity and metabolic syndrome. Thirteen modules with 8 different speakers associated binge-eating disorder with weight gain or obesity.22,23,29,31,33⇓⇓⇓⇓⇓⇓⇓⇓–42 Messages linking obesity to BED included: “BED is associated with severe obesity.”31 “Most people presenting for treatment for BED are obese.”36 BED “is frequently associated with other medical and psychological comorbidities, including obesity.”38

Speakers also stressed the importance of losing weight. A typical statement was, “The weight issue is very important.”35 Speakers regularly mentioned that lisdexamfetamine caused weight loss,31,34,35,42 and 9 modules noted that pharmacologic and nonpharmacologic therapies for BED other than lisdexamfetamine are ineffective for weight loss.22,28,31⇓⇓⇓–35,37,43 Modules stated, for example, that psychotherapy does not “really result in weight loss”35 or does not lead to “meaningful weight loss”.28 Other examples include:

“… there is no change in BMI with duloxetine”32

“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”43

“Chronic use of SSRIs is associated with weight gain”.35

See Table 1 for more examples of statements related to each theme.

Condition Branding Binge-Eating Disorder

Industry sponsorship affects prescribing; 1 study52 of 160 German physicians found that physicians who avoided sponsored CME prescribed more generic and fewer branded drugs than physicians who participated in sponsored CME.

CME is particularly important for disease awareness, or “condition branding,” a marketing technique in which a company creates, adopts, or redefines a condition and then develops perceptions of that condition along with marketing a treatment.53 Examples include premenstrual dysphoric disorder, depicted as a more serious form of premenstrual syndrome to sell Sarafem (fluoxetine), which was repackaged Prozac (fluoxetine).4 Social anxiety disorder was created to create a marketing niche for Paxil (paroxetine), a serotonin reuptake inhibitor that entered a market crowded with related drugs for depression.53⇓–55 Hypoactive Sexual Desire Disorder (HSDD) was created to sell a medication that purportedly boosted libido in women.4

Psychiatric disorders are particularly fertile ground for condition branding, because no lab or imaging tests can confirm psychiatric diagnoses. According to an industry article, condition branding is characterized by “[E]levating the importance of an existing condition and “developing unmet market need.”55 Statements supporting the first condition include:

“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”44

“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”.27

Statements supporting “developing unmet market need” include many claims that BED is highly prevalent, underdiagnosed, and can occur in everyone regardless of age, gender, weight, and ethnicity. For example, 1 speaker stated that BED “…is found in men, it is found in women, it is found across ethnic and racial minority groups” and can occur “…in people of any size, weight, and shape.”31

BED was included in appendix B (“Criteria Sets and Axes Provided for Further Study”) of the DSM–IV, published in 1994.56 However, it was diagnosable only using the catch-all category of “eating disorder not otherwise specified.” In DSM–5, the American Psychiatric Association (APA) officially included BED and also loosened the frequency and duration criteria: while DSM–IV required symptoms to occur at least 2 days a week for 6 months, DSM–5 required only 1 day a week for 3 months. Current DSM criteria for binge eating disorder are 1) recurrent and persistent episodes of binge eating, 2) binge eating episodes associated with 3 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 1 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. Severity of the disorder is based on the number of episodes of binge eating.57

Discussion

These modules create a sense of urgency regarding an invented “unmet medical need.” Linking BED to other conditions increases the population eligible for treatment. It is implied that treating BED will help other psychologic disorders, although it is far more likely that treating anxiety or depression will help binge-eating symptoms than that treating BED will mitigate psychologic symptoms.

Although we sought to determine whether industry-funded CME was used to promote binge eating disorder, we discovered that CME is being used to position lisdexamfetamine as a diet pill. Although lisdexamfetamine was approved to treat BED, it has never been approved by the Food and Drug Administration (FDA) for weight loss. In fact, use for weight loss is specifically contraindicated on the label.20

The indirect promotion of lisdexamfetamine as a diet pill was obvious in the CME modules we analyzed. Although speakers never specifically recommended lisdexamfetamine as a weight loss drug, speakers regularly noted that lisdexamfetamine caused weight loss, while dismissing other options because they do not cause weight loss. Although lisdexamfetamine has never been approved for weight loss, some CME modules on BED were listed under weight management on CME portals.

Besides promoting lisdexamfetamine for weight loss, a contraindicated use, the fact that lisdexamfetamine was presented as an effective treatment for BED before the drug’s approval for BED also represents promoting an unapproved use.

The repetition of many novel slides by many different speakers in different “educational” modules suggests the use of a company-created promotional slide deck. Companies often distribute a set of slides to paid speakers to convey specific marketing messages (see supplemental material for repeated slides). Although speakers who work together (presumably the case at Lindner Center of HOPE) may well share slides, it is implausible that speakers at different sites independently developed identical slides.

Lisdexamfetamine is presented as a safe therapy in these CME modules. Serious harms associated with lisdexamfetamine were minimized or omitted in every module. The claim that lisdexamfetamine is safer than other drugs used for BED is not backed by evidence.

Widely prescribed between the 1940s and the 1970s as a weight loss drug, amphetamines caused an epidemic of stimulant abuse, and the FDA subsequently prohibited the use of amphetamines for weight loss.58 The fen-phen fiasco in the 1990s, during which many people developed irreversible pulmonary hypertension from a combination of phentermine (an amphetamine) and fenfluramine (a serotonergic drug subsequently removed from the market in 1997) created an unfriendly regulatory atmosphere for weight loss drugs, especially those containing amphetamines. The regulatory atmosphere may be changing: in 2012, Qsymia, a combination of phentermine and topiramate (an anticonvulsant), became the first antiobesity drug to be approved in 12 years.59

Nonetheless, lisdexamfetamine has never been approved by the FDA as a weight loss drug. The CME modules analyzed seem to be part of an off-label marketing campaign to market lisdexamfetamine as a diet drug.

Limitations

Using a thematic analysis approach, we attempted to reverse-engineer a list of marketing messages associated with lisdexamfetamine. However, marketing messages are proprietary information and we cannot confirm the accuracy of specific planned marketing messages without access to Shire’s internal communications. We were also unable to assess the success or failure of this promotional campaign on the sales of lisdexamfetamine.

Conclusion

Our study adds to the growing literature showing that industry-funded CME contains marketing messages that favor sponsors’ drugs. Our analysis of CME modules on BED, all which were solely funded by the manufacturers of lisdexamfetamine, reveal many marketing messages that advantage lisdexamfetamine over other treatment options, even psychotherapy, arguably the best and certainly the safest option. The omission of life-threatening adverse effects of lisdexamfetamine from every module may give physicians a distorted sense of the risk-benefit ratio of using lisdexamfetamine. Shire seems to be using CME to promote lisdexamfetamine as a weight-loss agent, an off-label claim.

Many aspects of these modules violate standards against commercial bias in CME. This raises serious questions about the ability of CME accreditors and the Accreditation Council on Continuing Medical Education to detect and neutralize commercial bias in CME. Subtle marketing messages may escape detection by CME accreditors and audiences, and these messages may powerfully influence therapeutic choices. The current accreditation system is inadequate. Physicians and other prescribers should avoid industry-funded continuing education, which is really marketing masquerading as education. Industry-funded CME is a form of promotion and should be regulated as marketing.

Acknowledgments

The authors wish to thank Alycia Hogenmiller and Sophie Krensky for help with manuscript preparation.

Notes

  • Disclosures: JJ has no conflicts of interest. AFB directs PharmedOut, a Georgetown University Medical Center project that encourages rational prescribing. AFB also has a contract with the George Washington Milken Institute School of Public Health to analyze pharmaceutical marketing data from Washington DC. AFB is also a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices.

  • Conflicts of interest: JJ has no conflicts. AFB is a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing.

  • This article was externally peer reviewed.

  • Funding: None.

  • To see this article online, please go to: http://jabfm.org/content/33/2/240.full.

  • Received for publication April 7, 2019.
  • Revision received September 27, 2019.
  • Accepted for publication October 1, 2019.

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