Amphetamine of the Year
Some doctors are afraid Vyvanse, originally prescribed for ADHD, will be abused now that it's also being used to treat binge eating disorder.
Procuring amphetamines for recreation or studying used to take skills. You had to ingratiate yourself to someone with a hook-up, or convincingly affect ADD or ADHD in order to land a coveted Adderall 'scrip.
If you want a speedy prescription drug in 2015, however, there is now something new you can fake: binge eating disorder (BED).
Earlier this year, Vyvanse, a drug similar to Adderall and originally approved to treat ADHD, was approved to treat BED. The approval came after Vyvanse was evaluated under the FDA's priority review program, designed for drugs that are "intended to treat a serious disease or condition and may provide a significant improvement over available therapy" and fill a void in the market. Because there are no other pharmacological therapies approved for BED, Vyvanse qualified for the fast track.
The approval immediately set off alarm bells in the medical community. Many doctors are concerned that the FDA approval was based only on two 12-week studies. (Dr. Barry K. Herman, a senior medical director at Shire, noted two additional studies are forthcoming, including a long-term maintenance of efficacy study.) The fear is that having an amphetamine on the market for an eating disorder will ignite a diet pill craze reminiscent of the one that swept the country in the 60s, or the Fen-Phen crisis of the 90s.
"I feared it would be a backdoor excuse for drug companies to promote stimulant diet pills."
Medical professionals are also polarized on the question of whether binge eating disorder is a disease at all. BED was only officially recognized in 2013 in the Diagnostic Statistical Manual of Mental Disorders, 5th Edition, also known as the DSM-5. It is characterized by the following criteria:
- Recurrent and persistent episodes of binge eating
- Binge eating episodes are 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
- Marked distress regarding binge eating
- Absence of regular compensatory behaviors (such as purging).
"I tried (and failed) to persuade the DSM 5 group that BED was a premature and dangerous idea precisely because I feared it would be a backdoor excuse for drug companies to promote stimulant diet pills," Dr. Frances Allen, a psychiatrist and frequent critic of the DSM-5, told Motherboard in an email. He has had particular concerns about the new criteria for diagnosing eating disorders. "The rushed approval of Vyvanse realizes my worst fears," he said.
"With these diagnostic criteria [for BED], there is huge potential for a false positive. Do a lot of people struggle with binge-eating? Absolutely. Are all of these people actually ill? That is the major question around this diagnosis and the Vyvanse treatment," said Lisa Cosgrove, a professor and clinical Psychologist at the University of Massachusetts, Boston.
Vyvanse is hardly a novelty in the drug marketplace where amphetamines have been available for several decades.
First patented in the 1920s, and marketed as the first anti-depressant starting in the 30s and 40s, amphetamines found popularity as a weight loss drug in the mid-century. By 1945, close to half a million American civilians were taking amphetamines for both psychiatric indications and for weight loss.
Drugs like Dexamyl that combined both amphetamine and barbiturate become popular with housewives and teens alike by the 1960s, part of a selection of prescriptions that were being widely abused for everything from weight loss and mood enhancement to more explicit desire to get high.
The side effects, which included sleeplessness, psychosis, and paranoia, were generating enough concern that by 1972, the FDA was introducing more limits on amphetamine production and distribution until 1979, when amphetamines were banned for use in diet aids.
Amphetamines remain available for other indications like ADHD, however, making drugs like Adderall hugely popular and highly susceptible to abuse and addiction. In contrast to Adderall, Vyvanse has a lower risk of dependence and abuse because of its particular pharmacokinetic and pharmacodynamic profile. But "less addictive than Adderall" is hardly a high standard. Herman at Shire told Motherboard via email, "Before taking Vyvanse, patients should tell the doctor if they have ever abused or been dependent on alcohol, prescription medicines or street drugs." As a Schedule II controlled substance, patients are still at risk of dependence and an incentive to abuse for weight loss.
On the other side of this equation, however, are the doctors and patients who recalled absolutely debilitating encounters with binge-eating disorder and are delighted about Vyvanse as a treatment option.
Dr. Jim Greenblatt is chief medical officer with Walden Behavioral Care, where he has treated many BED patients with debilitating symptoms. "BED is not regular overeating, it is mindless consumption of food. The shame and guilt is profound and pervasive," Greenblatt told Motherboard in a phone call.
Patients reported similar distress about their binge-eating. "Rationally I didn't want to eat but at a certain point, my body went into overdrive and said, 'No you have to eat that.' It was a really dysfunctional relationship with food that took over my life," said Jamie [name has been changed] a 26-year-old Vyvanse user, in a phone call with Motherboard.
"Even before the Vyvanse approval, people came in looking for stimulants and appetite suppressants," Greenblatt said when asked about the possibility for abuse. "I worry about untrained physicians dishing it out too quickly but most of them know how to use it."
A binge-eating disorder diagnosis relies on self-reported behaviors. Though Vyvanse does not have the reported euphoria of Adderall or its substantial loss of appetite, it remains a potent and desirable stimulant for those seeking weight loss. Two-thirds of BED sufferers are reportedly overweight, so it makes sense that some might seek out a weight loss drug even if they do not meet the binge-eating disorder criteria.
The studies that the FDA reviewed noted a mean weight loss with the group taking Vyvanse as opposed to a placebo, and there were signs of marked loss in appetite as well. The nearly impossible thing to untangle is whether the weight loss was a result of healthier habits due to cessation in bingeing because of chemical level changes in the body that stopped the impulse to binge when not hungry—or if it was just a trusty case of amphetamines doing their appetite-killing magic.
A binge-eating disorder diagnosis relies on self-reported behaviors
Pro-anorexia (also called "ana") communities online that trade in eating disorder tips and tricks have a wide range of conversations about Vyvanse and other stimulants, ranging from how they were prescribed it, to how it compares to Adderall at killing appetite and how to prevent dependence. "Vyvanse= adderall but better, and a smoother ride, in my opinion," one user wrote on the forum myproana.com. "I just get it from a friend. Mainly because it will allow me to go days without eating without even feeling hungry or feeling hunger pangs."
Taking too much Vyvanse on an empty stomach causes nausea, the user continued, and "I will become super overtired because I'll be up for more than 24 hours at a time." This prompted a long discussion about using Vyvanse for weight loss, addiction, and side effects.
Jamie noted that working in the fashion industry has exposed her to many colleagues asking about getting Vyvanse to lose weight. She hopes, however, that the addiction profile screening she had to go through to get her prescription will stop the drug from getting into the wrong hands.
Bingeeatingdisorder.com is a website operated by Shire, the pharmaceutical company that makes and markets Vyvanse, to provide information and tools to better understand if patients have BED. A close reading of the site, however, looks like more of a how-to guide on getting a doctor to diagnose a patient with BED.
The BED Symptom Checklist starts with the qualifying question, "During the last 3 months, did you have any episodes of excessive overeating (i.e., eating significantly more than what most people would eat in a similar period of time)?" If you answer "Yes," visitors move onto the next questions to determine the severity of their BED. Subtle, charming inquiries like, "During your episodes of excessive overeating, how often were you embarrassed by how much you ate?" and "During your episodes of excessive overeating, how often did you feel disgusted with yourself or guilty afterward?" follow. But in a culture where people (and women especially) are taught to feel that any over-indulgence ought to be a source of embarrassment and disgust, the checklist seems rigged after the first question to make sure that everyone gets a diagnosis in the end.
Our culture's disdain for people whose bodies do not fit strict guidelines makes it difficult to identify truly pathological eating behaviors
One section reads, "Binge Eating Disorder (B.E.D.) is a relatively new distinct disorder. So some health care providers may be thinking about more common issues. Don't be discouraged." The text continues, "If you still feel your concerns weren't addressed, don't give up. Health care providers are accustomed to being asked for referrals. Don't be afraid to ask for a referral to a doctor or other health care professional who specializes in eating disorders." Under the mantle of empowering patients, Shire essentially encourages them to shop for doctors until they can get the diagnosis they want. A disclaimer on the site reads, "While Shire US Inc. makes reasonable efforts to include accurate, up-to-date information on the site, Shire US Inc. makes no warranties or representations as to its accuracy. Shire US Inc. assumes no liability for any errors or omissions in the content of the site."
"What makes psychiatry more vulnerable than other medical specialties to industry influence is absence of biological markers for the DSM diagnoses. There's no blood test, or scanning technique, such as an MRI," Cosgrove said. "When clinicians make a psychiatric diagnosis they rely completely on their judgment. For example, the DSM has criteria for all of the disorders but will use terms like 'often'—terms like that leave lots of wiggle room and open the door for over diagnosis."
In a culture that abhors the overweight and what it perceives as their excessive consumption, many are quick to write off BED as the excuse of those would be called gluttons in another decade and admonish them for trying to take weight loss shortcuts with amphetamines. There is real and profound suffering here, however, and the impulse to take amphetamines to mitigate the consequences is understandable.
"You have to be extremely sensitive to the fact that there are people who are really suffering severe and debilitating symptoms from a condition," said Ray Moynihan, a senior research fellow at Bond University in Australia and the author of Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients. "But when we put so much energy into medicalizing normality, it takes resources and attention and care away from people who are seriously ill."
Our culture's reflexive disdain for people whose bodies do not fit strict guidelines makes it difficult to disentangle truly pathological eating behaviors from normal behaviors that people have been socialized to see as aberrations worthy of shame. We should be sympathetic to these struggles and receptive to treatments that might alleviate suffering, but we should also make an effort to recognize that popular expectations for body shapes and eating are a kind of social sickness. We'll need something more than a new drug to rid ourselves of its most debilitating symptoms.
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