Vyvanse for Binge Eating: Old Pill, New ‘Disease’

Health Letter, July 2015

By Sarah Sorscher, J.D., M.P.H.

In January, physicians and patients across the U.S. started seeing a new advertising campaign. The glossy ads show a woman sitting off-center before a gray background, hugging her knees and looking worried as a hamburger and soft drink sit untouched at her feet. Around her swirls a long, menacing spiral of doughnuts, pizza slices, French fries and other junk food. “Binge eating disorder (BED),” reads the caption. “Identifying and accurately diagnosing adults with BED is the first step to helping them.”

This marketing campaign, sponsored by pharmaceutical company Shire PLC, aims to teach physicians to diagnose BED as an eating disorder. The campaign has a website, BingeEatingDisorder.com, which provides information targeted at patients and a special presentation with further resources for health care providers.[1]

None of these advertising materials mention any drug, but Shire manufactures the only drug that is Food and Drug Administration (FDA) approved to treat binge eating: lisdexamfetamine (Vyvanse). This means every new diagnosis of BED brings Shire a potential new customer.

The Shire binge eating campaign represents one of the latest examples of a particularly insidious drug advertising practice, in which a drug manufacturer spends money promoting a disease to increase the number of people diagnosed with it — with the goal of ultimately selling the cure to the newly diagnosed.

Shire’s marketing campaign for binge eating is particularly ambitious. Binge eating was not even formally recognized as a distinct medical diagnosis when Shire began developing lisdexamfetamine for this condition in 2011, yet the company is now branding the condition as “the most common eating disorder in US adults,” affecting close to 3 million.[2]

The company stands to make enormous profits from this campaign. But what is good for Shire almost certainly will be bad for patients. Lisdexamfetamine is a potentially addictive amphetamine that reduces appetite at the expense of raising blood pressure and increasing heart rate, creating the potential for serious cardiovascular risks, including heart attack and stroke. For many, being diagnosed with BED will bring them one step closer to a dangerous treatment.

Evolution of an illness

Binge eating, or eating large amounts of food and feeling out of control while doing it, is not a new phenomenon; doctors have documented this practice for many years.[3] However, for most of the 20th century, this behavior was not recognized as a distinct medical disorder.[4]

In the early 1990s, a group of psychiatrists pushed unsuccessfully to have “binge eating disorder” recognized as a distinct medical diagnosis in the Diagnostic and Statistical Manual of Mental Disorders (DSM), which provides the standards used by psychiatrists to diagnose and treat mental health disorders. Such recognition would have led to broader recognition and diagnosis of the condition.[5] The effort, failed, however, with some critics arguing that binge eating was not well studied and including it as a medically recognized disorder could blur the line between normal overeating and a psychiatric illness.[6]

BED was not recognized as a distinct disorder until the DSM was revised again, in 2013.[7] Yet what constitutes binge eating disorder still is not entirely clear. Shire’s website describes “[r]egularly eating far more food than most adults would in a similar time period under similar circumstances” and “[f]eeling that one’s eating is out of control during a binge.” Eating fast, eating when not hungry, eating in secret and feeling bad about eating are all signs of the disorder, according to the website.[8] Unsurprisingly, this type of overeating and guilt is a common problem, particularly among people who are overweight or obese.[9]

Treatments for ‘BED’ and weight loss

Binge eating behavior and guilty feelings can be successfully treated through behavioral therapy.[10] But many patients who seek treatment for binge eating are overweight or obese,[11] and these patients generally want to do more than control their behavior and state of mind: They seek to lose weight and improve their overall health by doing so.[12]

For this reason, doctors have experimented for years, attempting to treat binge eaters with antidepressants, anti-epileptic drugs and weight loss drugs such as orlistat (Alli, Xenical) — none of which are FDA-approved to treat binge eating.[13] But even the most effective of these drugs produced only modest short-term results in most clinical trials: Generally, the average weight loss did not top 5 percent of the patient’s body weight, amounting to 10 pounds or less.[14] These weight loss strategies also had side effects. For example, orlistat can cause liver damage, renal failure and acute pancreatitis, in addition to a number of common, unpleasant gastrointestinal side effects.[15]

A new indication for an old pill

Lisdexamfetamine is a type of amphetamine,[16] a class of stimulants that have long been known to promote weight loss but also release dopamine in the brain, creating a sense of pleasure that can lead to addiction.[17] Amphetamines were widely consumed for weight loss from the 1940s until the 1970s, when federal narcotic authorities and the FDA introduced stricter prescribing and marketing controls to address the drugs’ addiction potential.[18]

Until this year, lisdexamfetamine was FDA-approved only for attention deficit/hyperactivity disorder (ADHD).[19] Had Shire sought to have this amphetamine approved as a weight-loss drug instead of a “cure” for binge eating, it would have faced significant challenges. The FDA has become particularly cautious about approving new weight loss treatments after the weight loss drugs fenfluramine, dexfenfluramine and sibutramine were linked to increased risk of cardiovascular problems (such as heart attack, stroke and heart valve disease) and removed from the market.[20],[21] To address potential risks for new weight loss products, the FDA now generally requires long-term studies of safety and effectiveness. It recently approved two weight loss drugs, lorcaserin (Belviq) and phentermine-topiramate (Qsymia), after manufacturers conducted safety and effectiveness trials lasting one or two years.[22],[23],[24]

Lisdexamfetamine has been linked to sudden death, stroke and heart attack in adults and children.[25] Given these heart and blood clotting-related risks, the drug would likely have fared poorly in long-term cardiovascular safety studies. Rather than attempt to overcome these high hurdles, Shire chose to develop lisdexamfetamine for binge eating disorder.[26] This choice paid off: Despite the fact that binge eating, like obesity, is a long-term condition that likely requires long-term treatment, the FDA approved lisdexamfetamine based on just 12 weeks of testing in placebo-controlled trials.[27] Patients with existing cardiovascular problems, which tend to be common among obese patients, were excluded from clinical testing. This omission made it even less likely that high numbers of cardiovascular side effects would occur during clinical testing and potentially prevent the new indication from being approved.[28]

Lisdexamfetamine did reduce binge eating in clinical trials, at least for the 12 weeks subjects were taking the drug.[29] It also led to an average short-term weight loss of about 5 or 6 percent of total body weight.[30] (The FDA has ordered a postmarket study on “longer-term” effectiveness, but the details of this study have not been announced.)[31]

But the drug also significantly increased blood pressure and heart rate, indicators of potential increased cardiovascular risk.[32] Subjects taking the drug also experienced fainting and a certain pattern of tingling sensations, which are both side effects related to the cardiovascular system.[33]

These signs and symptoms were troubling to FDA officials, but there were few serious adverse events during testing, probably because the trials were of short duration and enrolled only relatively healthy patients.[34] This made it difficult for FDA officials to draw firm conclusions.[35]

Rather than deny approval and require further testing for cardiovascular safety, the FDA approved lisdexamfetamine for the new use, with label warnings that the drug has a high potential for addiction and causes cardiovascular side effects.[36] Shire is not allowed to promote the drug for weight loss.[37] Yet this distinction is likely to mean little in clinical practice, as overweight and obese patients seeking treatment for binge eating generally desire drug treatment to lose weight and achieve overall health, not simply to control the sense of unhappiness they feel about their behavior.[38]

Selling sickness

This is not the first time Shire has focused on selling a disease. The company has faced criticism in the past for spending heavily to promote “awareness” of ADHD in order to promote sales of Adderall XR, Vyvanse and Daytrana, Shire-owned drugs approved to treat ADHD.[39] The campaign has been wildly successful: The number of children on medication for ADHD has reached 3.5 million, more than five times the number of children taking drugs for the condition in 1990.[40] Shire’s own ADHD drugs achieved blockbuster status, with lisdexamfetamine alone bringing in close to $1.5 billion in sales in 2014.[41]

Shire’s current strategy for binge eating includes hiring tennis star Monica Seles to draw attention to the disease. Seles says she engaged in guilty, secretive binges for years as a professional athlete.[42] The tennis star was paid by Shire to tour television talk shows, including “The Dr. Oz Show” and “Good Morning America,” in the month following approval of lisdexamfetamine.[43]

Research has shown that receiving a medical diagnosis for a condition makes it more likely that a patient (or their caregiver) will choose drug treatment.[44] Shire’s campaign takes advantage of this likelihood by promoting binge eating as a medical disorder: “B.E.D. is a real medical condition,” reads the main page of BingeEatingDisorder.com, which also offers detailed instructions to patients on how to draw attention to their condition during a doctor’s visit.

It is too soon to tell whether Shire’s disease-mongering campaign to increase the market of potential customers with BED will be successful in boosting sales of lisdexamfetamine. Yet this drug may soon have competition: Liraglutide (Saxenda) and naltrexone-bupropion (Contrave), two other drugs currently approved by the FDA for weight loss, already are being tested for binge eating disorder.[45],[46]

Public Citizen’s Health Research Group has the same advice for binge eating drugs as it does for pills marketed more explicitly to promote weight loss: Do not use these drugs. Time and again, weight loss drugs have been shown to lack important long-term benefits and carry serious and unpleasant side effects. Marketing these drugs for binge eating does not render these drugs effective and safe for widespread use.[47]


References

[1] Shire Pharmaceuticals. Binge eating disorder in adults. BingeEatingDisorder.com. February 2015. https://www.bingeeatingdisorder.com/hcp/. Accessed June 3, 2015.

[2] Shire Pharmaceuticals. What is binge eating disorder (B.E.D.)? BingeEatingDisorder.com. http://www.bingeeatingdisorder.com/what-is-BED.aspx. Accessed June 3, 2015.

[3] Spitzer RL, Stunkard A, Yanovski S, et al. Binge eating disorder should be included in the DSM-IV: A reply to Fairburn et al.’s ‘The classification of recurrent overeating: The binge eating disorder proposal.’ Int J Eat Disord. 1993;13 (2):161-169.

[4] Spitzer R. Nonpurging bulimia nervosa and binge eating disorder. Am J Psychiatry. 1991;148:8.

[5] Ibid.

[6] Fairburn CG, Welch SL, Hay PJ. The classification of recurrent overeating: The ‘binge eating disorder’ proposal. Int J Eat Disord. 1993;13(2):155-159.

[7] Amianto F, Ottone L, Abbate Daga G, Fassino S. Binge-eating disorder diagnosis and treatment: A recap in front of DSM-5. BMC Psychiatry. 2015;15:70.

[8] Shire Pharmaceuticals. What B.E.D. looks like in adults. BingeEatingDisorder.com. http://www.bingeeatingdisorder.com/what-is-BED.aspx. Accessed June 3, 2015.

[9] Brownley KA, Peat CM, La Via M, Bulik CM. Pharmacological approaches to the management of binge eating disorder. Drugs. 2015;75:9-32.

[10] Ibid.

[11] Zwaan M. Binge eating disorder and obesity. Int J Obesity. 2001;25(Suppl 1):S51-S55.

[12] Brownley KA, Peat CM, La Via M, Bulik CM. Pharmacological approaches to the management of binge eating disorder. Drugs. 2015;75:9-32.

[13] Ibid.

[14] Ibid.

[15] Diet and exercise: Still the best medicine for losing weight or keeping fit. Worst Pills, Best Pills News. October 2012. http://www.worstpills.org/member/newsletter.cfm?n_id=817. Accessed June 3, 2015.

[16] Food and Drug Administration. Medical review: lisdexamfetamine dimesylate (Vyvanse). NDA#: 21-977/S037. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s037. Approval date: 1/30/2015.

[17] Bray GA. Medical treatment of obesity: The past, the present and the future. Best Pract Res Clin Gastroenterol. 2014;28(4):665-84.

[18] Rasmussen N. America’s first amphetamine epidemic 1929-1971: A quantitative and qualitative retrospective with implications for the present. Am J Public Health. 2008;98(6):974-985. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2377281/. Accessed June 3, 2015.

[19] Food and Drug Administration. Label: Lisdexamfetamine dimesylate (VYVANSE). 11/2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021977s033lbl.pdf. Accessed June 3, 2015.

[20] Bray GA, Medical treatment of obesity: The past, the present and the future. Best Pract Res Clin Gastroenterol. 2014;28(4):665-84.

[21] Food and Drug Administration. Medications target long-term weight control. June 17, 2012. http://www.fda.gov/forconsumers/consumerupdates/ucm312380.htm. Accessed June 3, 2015.

[22] Food and Drug Administration. Medical review: Lisdexamfetamine dimesylate (Vyvanse). NDA#: 21-977/S037. Approval Date: 1/30/2015.

[23] National Library of Medicine. Belviq – lorcaserin hydrochloride hemihydrate tablet. DailyMed. Updated December 2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7cbbb12f-760d-487d-b789- ae2d52a3e01f. Accessed June 3, 2015.

[24] National Library of Medicine. Qsymia – phentermine hydrochloride and topiramate capsule, extended release. DailyMed. Updated September 2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40dd5602-53da-45ac-bb4b- 15789aba40f9. Accessed June 3, 2015.

[25] DailyMed. Drug Label: Vyvanse – lisdexamfetamine dimesylate capsule. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=704e4378-ca83-445c-8b45 -3cfa51c1ecad. Accessed June 23, 2015.

[26] Food and Drug Administration. Medical review: lisdexamfetamine dimesylate (Vyvanse). NDA#: 21-977/S037. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021977Orig1s037. Approval date: 1/30/2015.

[27] Ibid.

[28] Ibid.

[29] Ibid.

[30] Ibid.

[31] Ibid.

[32] Ibid.

[33] Ibid.

[34] Ibid.

[35] Ibid.

[36] Ibid.

[37] Ibid.

[38] Brownley KA, Peat CM, La Via M, Bulik CM. Pharmacological approaches to the management of binge eating disorder. Drugs. 2015;75:9-32.

[39] Schwarz A. The selling of attention deficit disorder. The New York Times. December 14, 2013. http://www.nytimes.com/2013/12/15/health/the-selling-of-attention-deficit-disorder.html. Accessed June 3, 2015.

[40] Ibid.

[41] Thomas K. Shire, maker of binge-eating drug Vyvanse, first marketed the disease. The New York Times. February 24, 2015. http://www.nytimes.com/2014/06/03/upshot/calling-an-ordinary-health-prob…. Accessed June 3, 2015.

[42] Ibid

[43] Ibid

[44] Carroll A. Calling an ordinary health problem a disease leads to bigger problems. The New York Times. June 2, 2014. http://www.nytimes.com/2014/06/03/upshot/calling-an-ordinary-health-problem-a-disease-leads-to-bigger-problems.html?ref=todayspaper&_r=1&abt=0002&abg=1. Accessed June 3, 2015.

[45] U.S. National Institutes of Health. Treatment of binge eating disorder in obesity: Naltrexone/bupropion combination versus placebo. Clinicaltrials.gov. Verified December 2014. https://clinicaltrials.gov/show/NCT02317744. Accessed June 3, 2015.

[46] Robert SA, Rohana AG, Shah SA, et al. Improvement in binge eating in non-diabetic obese individuals after 3 months of treatment with liraglutide — a pilot study. Obes Res Clin Pract. April 10, 2015. pii: S1871-403X(15)00037-X. doi: 10.1016/j.orcp.2015.03.005. [Epub ahead of print]

[47] Diet and exercise: Still the best medicine for losing weight or keeping fit. Worst Pills, Best Pills News. October 2012. http://www.worstpills.org/member/newsletter.cfm?n_id=817. Accessed June 3, 2015.