Monica Seles grunted her way to nine Grand Slam singles championships in the world of tennis. Now, the product she is endorsing is making some pharmaceutical and healthcare industry experts grunt in disapproval. Seles is a paid spokesperson for Vyvanse, a drug that acts as an amphetamine when consumed. That’s a concern for health officials. Amphetamines suppress appetite and have a history of abuse for treating obesity. Since it received FDA approval in January as a treatment for binge eating disorder (BED) —the first FDA-approved drug to market for moderate to severe binge eating—Seles has been recounting her struggles with binge eating even while she ruled women’s professional tennis. But many are critical of Vyvanse manufacturer Shire Pharmaceuticals, saying its product marketing is out of bounds. One of those is Dr. B. Timothy Walsh, professor of psychiatry at the New York State Psychiatric Institute at Columbia University.
Opening the Flood Gates
“Once a pharmaceutical company gets permission to advertise for it, it can often become quite widely prescribed, and even tend to be overprescribed, and that’s a worry,” Walsh told the New York Times. An estimated 2.8 million adults suffer from BED. Shire’s chief executive said he expected Vyvanse’s approval as a binge-eating treatment to add $200 million to $300 million in annual sales. Already, Vavanse is Shire’s top-selling drug for attention-deficit hyperactivity disorder (ADHD), bringing in almost $1.5 billion in 2014. Vyvanse’s preexisting approval by the FDA for treatment of ADHD is why its approval as a binge-eating solution took place so quickly, the FDA said. Drawing criticism is the way Shire marketed Vyvanse. Four days after getting government approval to treat binge eating, Shire launched “the first-ever, large scale national effort to raise awareness of BED,” according to a corporate news release. Seles appeared in ads and began a media tour that included appearances on “Good Morning America” and “The Dr. Oz Show.” Raising eyebrows has been a company website that:
- Explains how to raise the issue of binge eating with a doctor
- Provides sample opening lines to begin the discussion with the doctor
- Tells patients “don’t give up” if the doctor resists
- Tells patients how to find a new doctor if unsuccessful in securing a prescription
Nowhere on the website does Shire mention Vyvanse or its connection to the drug, but there’s only one pill for BED, and Shire has it. “I think educating patients is great and getting a disorder out in the open helps to remove shame and stigma,” said Dr. Michael Baron, medical director at The Ranch outside Nashville and board certified in addiction medicine and psychiatry. “A website that challenges a physician’s judgment and encourages changing doctors in order for a patient to get a prescription is maleficent. Most behavioral disorders can be treated with psychotherapy. To promote only one type of treatment, which is a high-risk medication, is atrocious.” Dr. Baron makes the case that a pill is not a long-term fix. “The first part of treatment is to remove the drug of choice,” in this case food, Dr. Baron said. “Amphetamines replace the drug of choice, similar to the maintenance program of using methadone to replace heroin. However, once the drug of choice is removed or the binge eating is stopped, psychotherapy, group therapy, 12-step therapy all are very important in providing support, motivation and education in making a change in one’s life. … Amphetamine does very little to make a sustained change. The risk of abuse is huge.”
Create Awareness, Sell a Solution
It is common for pharmaceutical companies to do what Shire is doing: Create an awareness of the problem (i.e., binge eating) before marketing a treatment. Binge eating was only accepted as its own disorder in 2013 by the American Psychiatric Association. Shire, located in Wayne, Pa., has a track record of creating markets for its products. According to The Times, it put ADHD on the medical map, then made billions from the sale of drugs such as Vyvanse and Adderall to treat it. The FDA cited Shire in 2011 for misleading advertising of Vyvanse, Adderall and other drugs. Late last year, the company paid $56.5 million to settle up with the government for violation of the False Claims Act. The feds claimed Shire downplayed Vyvanse’s potential for addiction and that Shire claimed its use would prevent car accidents, divorce, arrest and unemployment. The civil allegations—denied by Shire—stemmed from lawsuits filed by a former Shire executive and three former Shire sales representatives under the False Claims whistleblower provision, which permits private parties to sue for false claims on behalf of the government and share in any recovery. “Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient,” U.S. Atty. Zane David Memeger of the Eastern District of Pennsylvania said at the time.
High Potential for Abuse
Vyvanse is classified by the federal government as having a strong potential for abuse. Critics say using Vyvanse is trading one addiction for another. Binge eaters are emotional eaters who use foods to medicate, to numb their feelings. Dr. Pam Peeke, in her book The Hunger Fix, calls these comfort foods “hyperpalatables,” which are highly processed, carbohydrate-rich, sweetened junk food. We’re talking Twinkies, not broccoli or celery. “The potential for abuse and addiction is tremendous,” Dr. Baron said. “Patients who have BED use the hyperpalatable foods to activate the reward pathway which uses the dopamine as the principle neurotransmitter. Vyvanse increases dopamine in the reward area of the brain. In this respect, it is like replacing one drug, sugar, for another drug, amphetamine. The end result is an increase in dopamine. “If the patient that has BED has genetics that are favorable for developing addiction, then treating that patient with amphetamine will enhance addiction.”