Part I: Binge Eating Disorder & Conflict of Interest

I will now wade into the muck that is the inclusion of binge eating disorder (BED) as a standalone eating disorder within the Diagnostic and Statistical Manual for Mental Disorders Version 5 (DSM-5). There will be two posts necessary to address this topic.

Part I:   Conflict of Interest
Part II:  What Does BED Really Look Like?

Prior to the release of the DSM-5, BED was not categorized as a standalone eating disorder. In fact, the symptoms of BED were recognized as extremely rare and indicative of underlying psychopathologies, rather than symptomatic of a standalone eating disorder. i

All that changed with DSM-5 but not because the scientific literature had actually now confirmed that BED is a standalone eating disorder and not just a suite of symptoms that could occur for some with serious mental disorders such as schizophrenia, various personality disorders and/or bipolar disorder.

To set the stage for why this happened despite the absence of strong corroborating scientific evidence, I will use my own direct experience as an example of how conflict of interest really works.

As you all know, I attended the UCSD Eating Disorder Conference last year in San Diego. I had an opportunity to meet and chat with Dr. Stephen Wonderlich, one of twelve members to sit on the eating disorders work group for the development of the DSM-5. I also chatted with the chair of that group, Dr. Tim Walsh.

Most of us likely have a sense of what constitutes a conflict of interest as being all about the money: you are essentially paid to use your position of influence to benefit the person or entities that “bought” you.

The American Psychiatric Association (APA) went to some trouble in the development of the DSM-5 to create much more rigor around how financial conflict-of-interest (FCOI) would be managed when it came to both task force and work group members. The individuals had to submit a retrospective 3-year FCOI statement; they could not accept more that $10,000 (USD) from industry sources; and they could not hold more than $50,000 (USD) in pharmaceutical stock during their time on the task force or work group in question. ii

In the following rigorous review, Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5, the researchers made the following conclusions:

“In all but 1 trial, FCOIs were found between DSM-5 panel members and the pharmaceutical companies that manufactured the drugs that were being tested for the new DSM disorders. The financial associations of panel members included research grants, consultation, honoraria, speakers bureau participation, and/or stock. Seven out of the 10 patented drugs included in the trials either are currently or have been blockbusters for their manufacturers. (A blockbuster drug is defined as a drug that earns over USD 1 billion in revenue in 1 year)…Our data show that there are financial ties between some DSM panel members and pharmaceutical companies that have a vested interest in finding a new indication for their drugs. A new indication allows the drug manufacturer to obtain an additional 3 years of exclusivity for that drug.” iii

Most importantly, binge eating disorder was specifically included within the above-quoted review of tripartite conflicts of interest. It is worth a read. Many of you will have noticed the recent direct-to-consumer advertising blitz by Shire Pharmaceutical for its lisdexamfetamine, brand name Vyvanse (an amphetamine-based drug) for treating BED. It is a perfect example of an extension of patent for this new indication (BED) for a drug formerly approved for the treatment of attention deficit (hyperactivity) disorder (ADHD).

The current definition of binge eating disorder is considered so vague as to render it extremely vulnerable to diagnostic inflation. In fact the former president of the APA, Dr. Paul Appelbaum had this observation to make on the topic of DSM-5 revisions:

“The flexible boundaries of many psychiatric diagnostic categories, in the absence of definitive diagnostic tests, may encourage expansive definitions of affected populations and create opportunities for industry to promote treatments for people who would not previously have been seen as having a disorder.” iv

The psychiatrist who chaired the DSM-IV development, Dr. Allen Frances, is even more blunt on the issues surrounding the inclusion of BED as a standalone disorder within the DSM-5:

“… DSM-5 had radically lowered the bar for including new diagnoses, giving its experts free rein to promote their pets. The few, largely uninformative studies that would have badly flunked the DSM-IV test breezed through DSM-5.

The head of the DSM-5 Eating Disorders Workgroup is a smart, honest, and decent man who had the same role in DSM-IV. When I repeatedly warned that he was creating a target for diet pill disease mongering, he replied that his job was just to judge the science. Any possible misuse of BED was an "educational issue."

This didn't make sense then and the careless FDA approval has since given him buyer’s remorse. The science was weak. The risk’s as clear as the nose on your face. The 'education' would mostly be done by drug companies to enhance profits, not help patients.” v

I have just finished watching the first season on Netflix of the show Sense8, written and largely directed by the Wachowski’s, the originators of the Matrix movie trilogy. Without giving hopefully too much away, there is a character in the series that has the ability to experience all of your thoughts and feelings directly if you look him in the eye. The other characters are advised at all cost to avoid looking him in the eye otherwise they risk the safety of everyone. Bear with me on this analogy for a moment.

It might surprise many of you for me to admit that I have a conflict-of-interest when it comes to the inclusion of BED in the DSM-5. No, it’s not because I have BED. And it’s most certainly not that I receive money, sponsorship, speaking engagements or research funding from interested pharmaceutical companies. I am most certainly not a key opinion leader for any drug company out there, and I own absolutely no pharmaceutical stock (or any stock for that matter).

My conflict of interest is that I have met and chatted with both Drs. Tim Walsh and Stephen Wonderlich, and I liked them both very much. Both of them struck me as tremendously hard working, humble and dedicated researcher/clinicians. These guys and their equally impressive colleagues have likely improved the lives of thousands of patients throughout their respective careers.

Is much of their research work funded by pharmaceuticals? Well probably, but these days how else can you get research to happen? Are they perhaps key opinion leaders or on the speaking engagement circuit? Do they hold stock in said companies? I don’t know, but surely they would maintain their ethical distance such that they can provide objective and unadulterated scientific data no matter whether those affiliations are present or not.

And that is exactly the thought process that renders a conflict of interest insurmountable for almost all human beings. Look them in the eye, and you cannot maintain your ethical distance and if you think you can, you are even more likely to go astray.

I kid you not that as soon as I returned from the conference and re-read my passages on BED in the upcoming Patient Handbook I am writing, I had an overwhelming urge to rewrite it to make it just a bit less unforgiving.

It’s not the flow of money that’s really the issue here, although it most certainly greases the wheels. The real issue is that you (as the DSM eating disorder work group member) meet that hard working, empathetic and kind pharmaceutical representative (detailer) and you get to know him or her. You get to know the entire pharmaceutical conference organizing team who makes sure your slide deck is already loaded and your hotel room is “just-so”. You joke around with them before your presentation. You have interesting, intellectual and engaging discussions with your research counterparts who are employed by these pharmaceutical companies. And those stock options have put your daughter through college and she’s landed her dream job. You have looked them all in the eye.

So as it was for me meeting these hard working researcher/clinicians, so it is for them with all the pharmaceutical company human interactions they experience.

Dr. Carl Elliott, professor in the Center for Bioethics, University of Minnesota, in his book White Coat, Black Hat: Adventures on the Dark Side of Medicine made the following astute observation:

"The best mark is often a person to whom the possibility of a con never occurs, simply because he thinks he is too smart to be tricked. Medical practice is like this. Many doctors know nothing about advertising, salesmanship, or public relations. They believe these are jobs for people who could not get into medical school. This is probably why they are so easily fooled." vi

I’m not too smart to avoid being tricked (obviously) and I will try mightily to overcome my conflict of interest to provide objective and neutral observations on BED. But let’s face it, I am secretly rooting for BED to be a real standalone eating disorder even as I know the science doesn’t support that. So filter what comes in Part II  of this series with that in mind.

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i Stunkard, A. J., & Allison, K. C. (2003). Binge eating disorder: disorder or marker?. International Journal of Eating Disorders, 34(S1), S107-S116.

ii Cosgrove, L., Krimsky, S., Wheeler, E. E., Kaitz, J., Greenspan, S. B., & DiPentima, N. L. (2014). Tripartite conflicts of interest and high stakes patent extensions in the DSM-5. Psychotherapy and psychosomatics, 83(2), 106-113.

iii ibid.

iv Appelbaum, P. S., & Gold, A. (2010). Psychiatrists’ relationships with industry: the principal-agent problem. Harvard review of psychiatry, 18(5), 255-265.

v http://www.huffingtonpost.com/allen-frances/binge-eating-disorder_b_6856636.html

vi Elliott, C. (2010). White coat, black hat: adventures on the dark side of medicine. Beacon Press.