For generations, it was called gluttony.
Then, for research purposes, it was labeled binge-eating disorder in the Diagnosis and Statistical Manual of Mental Disorders (DSM), but not many people noticed.
Then, in 2013, it went prime time.
That was when the American Psychiatric Association formally labeled it as a mental disorder . The APA decision also changed the definition psychiatrists used to diagnose it.
New Status, New Definition
Previously, someone had to have out of control eating episodes at least twice a week for a period of 6 months. The new criteria said the episodes only had to occur once a week for 3 months.
What followed were assertions that up to 8.5 million American adults have the condition; the approval of a drug — an amphetamine — to treat it; and a marketing campaign complete with a celebrity spokesperson, former tennis star Monica Seles.
But not everyone agreed and some doctors argue that it is not a disease at all, but simply an unhealthy habit.
What’s more, those skeptics say, the number of people said to have the condition is inflated and many will be diagnosed and over treated with drugs that can cause serious side effects.
Allen Frances, MD, the former chairman of psychiatry at Duke University, called binge-eating disorder a “fake diagnosis.”
Frances was chairman of the task force that, in 1994, produced the fourth edition of the DSM. That’s when binge eating disorder was listed as a condition for research purposes.
He’s a critic of the change made in 2013 edition of DSM that elevated its status and broaden its definition.
“It is a behavior that many people have,” he said. “We shouldn’t be turning everyday behaviors into mental disorders.”
Experts say a simple change in the manual can mean several things.
First, in can create — overnight — a lucrative new market for drug companies.
It can make it easier to get insurance coverage for drugs to treat the newly identified condition. And, they say, it can add urgency for the FDA to approve new products to treat it.
And Now the Treatment …
In 2015, the FDA approved the first drug for the condition — Vyvanse (Lisdexamfetamine dimesylate), an amphetamine already in use to treat attention deficit hyperactivity disorder (ADHD).
“Generally, the landscape has changed from a climate of wondering whether this unusual pattern of eating was a valid mental disorder to a discussion of how to best understand the causes of and develop treatments for this common and impairing condition,” said James Hudson, MD, a professor of psychiatry at Harvard.
Hudson was the lead author a 2007 study that estimated nearly 7 million Americans had the condition under the old definition. The number was based on a large national household survey conducted by non-physicians between 2001 and 2003.
The survey has not been updated using the new definition.
The Office of Women’s Health in the U.S. Dept. of Health and Human Services estimates 4 million Americans have it.
The number was higher — 8.5 million — in a CME course was funded by Shire, the company that markets Vyvanse.
In an email, Carlos Grilo, PhD, professor of psychiatry and psychology at Yale and faculty chair for the online course, said that number was a “very reasonable estimate (perhaps too conservative).”
Grilo, who said he had received consultant fees from Shire, said the estimate was based on the new definition; the increased incidence of obesity; and a greater willingness of people to disclose they have the problem.
Psychiatrist B. Timothy Walsh, MD, who chaired the working group that created the new definition, said that one problem is psychiatry does not have physical tests that can confirm a diagnosis.
For instance, in a suspected heart attack an EKG can confirm the diagnosis. With binge-eating disorder, doctors must rely on what the patient tells them.
“I wish there was a blood test for binge-eating disorder,” said Walsh, a professor psychiatry at Columbia University.
Even some of those who support the new definition, such as Walsh, express concerns about the long-term safety of Vyvanse.
And an FDA review of the drug prior to approval did raise several concerns, including concerns about cardiovascular safety and a worry that some obese patients may use the drug for weight loss, an indication that is not FDA approved.
Vyvanse is know to cause spikes in blood pressure but no long term studies have been conducted to test the cardiovascular safety of the drug.
The pivotal trials for approval were short and people who were at increased risk for heart problems, including those with high blood pressure and diabetes were excluded.
There also are questions about how well it actually works.
The FDA decision was based on data from two 12-week placebo-controlled trials in patients who had, on average, nearly 5 binge-eating days per week. In those trials, the drug reduced the binge-eating days by 3.9 per week.
But a placebo also seemed effective, reducing the binge-eating days by about 2.5 per week .
Because the drug is an amphetamine its label carries an FDA warning about its potential for dependence and abuse.
Moreover, side-effects include psychotic and manic symptoms.
In an email, Shire spokesman Charlie Catalano said Vyvanse was proven to be effective when used as prescribed by a licensed, trained healthcare professional.
Catalano added that patients with binge eating disorder “have very real medical needs.”
