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Release on binge-eating disorder study raises questions on commercial influence

Clinical trial examines safety, effectiveness of drug to treat binge eating disorder

Our Review Summary

monica-seles-vyvanse

Monica Seles is the face of an industry-sponsored campaign to raise awareness of binge-eating disorder.

A clinical trial in people diagnosed with binge-eating disorder found that a drug of the amphetamine class, also marketed for attention-deficit disorder, effectively decreased the number of days patients engaged in binge-eating as compared to placebo after 11 weeks of treatment. This news release overall does a good job communicating the findings, but skimps a bit on the limitations of the research and doesn’t address potential costs. And while it’s not a news release’s job to dig deep into the commercial background surrounding a study it’s reporting on, we think readers would be well served to understand that context — which we’ll help provide in this review.

 

Why This Matters

Binge-eating disorder became an official psychiatric diagnosis with the publication of DSM-V in 2013. It’s not just over-eating, but periods (at least 2 days/week for 6 months) of excessive eating with loss of control that causes psychological distress. It is associated with other psychiatric problems, especially depression and substance/drug abuse problems. The news release neglects to mention that people with depression were excluded from this study, as were people with recent substance abuse problems. This limits how broadly we can apply the findings, as the study authors point out. The short duration of the study, and the treatment of one symptom of a chronic and presumably complex psychiatric condition, also makes one wonder “why this matters” (other than to the company that wants to market the drug).

[Editor’s note: This review was completed in February while we were still developing and honing this news release review service. Although it’s a few months old, this review contains valuable information for those who write and consume health-related news releases, which is why we’re still publishing it.]

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release does not discuss costs for drug, lisdexamfetamine (Vyvanse), that is still under patent. All drugs of the amphetamine class suppress appetite, and those that are generically available might potentially give similar results. The companies that market those generic drugs, however, have little incentive to undertake the expensive testing involved to achieve an FDA approval, since many companies make the generics. That said, lisdexamfetamine is different from the other amphetamines in that it is released more slowly into the blood. Tests show the main neurotransmitter affected by these drugs, dopamine, is released more slowly and doesn’t get to as high a level, so this drug may have less potential for abuse and addiction problems.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

While some quantification is given for a secondary study outcome (the proportion who stopped binge-eating for four weeks), no specific numbers are given for the primary study outcome (binge-eating days per week). Since this was the main measure of the success of the study, we think this result should have been described more thoroughly.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

There is no information about possible harm. In general, we might expect a news release about this kind of study to include the most common side effects found at rates considerably higher than placebo. Here those side effects include insomnia, dry mouth, and nausea. The rate on insomnia, which occurred in 14-15% of patients on drugs and <2% on placebo, is especially cogent, as it’s a symptom that can really affect people’s lives.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

We’ll rate this satisfactory with some reservations. The description of evidence is good in that the release notes it is a randomized, placebo-controlled clinical trial. A limitation not mentioned is the short duration of the trial. In addition, there’s no discussion of the fact that patients with depression were excluded from the study. Since depression and binge eating are commonly found together, this limits how broadly we can apply the findings.

Does the news release commit disease-mongering?

Satisfactory

Although the news release is free of emotionally wrenching words or phrases, binge-eating disorder itself would be considered by some to be an example of disease mongering. It is essentially a problem of overeating, differentiated from other psychiatric eating disorders (anorexia and bulimia) by the lack of purging or fasting to compensate for the overeating. It was originally codified as a disorder worthy of further study in DSM-IV, by a work-group that was heavily involved with industry. DSM-V added it as an official diagnosis. The eating disorders work-group had become less conflicted, but still 50% of members reported COIs.

Given the nation’s obsession with weight and overeating, one can see how many people will be convinced they have this disorder. In the buildup to the drug’s expanded approval, drugmaker Shire played an active role marketing awareness of binge-eating disorder, as The New York Times reported.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

A pharmaceutical company is identified as the funder of this study in an editor’s note at the bottom of the release, and the release notes that the study authors also disclosed conflicts of interest. Also disclosed is the fact that the sponsor paid a communications company to write and edit the manuscript.

That’s sufficient for a Satisfactory rating, although we’d add that each of the study authors (except one, who works for another company) is heavily involved with industry above and beyond this particular study. The cumulative effects of these commercial aspects is worrisome: Where does one draw the line between experiment and “experimercial”?

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release identifies cognitive behavior therapy and psychotherapy as alternatives, but offers no comparison in outcomes other than to make the point that few health care providers use the behavioral alternatives.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release clearly indicates that the drug is already approved to treat other medical problems. It also indicates that the next step in making the drug available for the need at hand rests on “confirmation of these findings” in additional clinical trials. This release was issued in January 2015, and the drug has subsequently been approved for the treatment of binge-eating disorder.

Does the news release establish the true novelty of the approach?

Satisfactory

The release notes that at the time of its writing, no drug had yet been approved by the FDA for this problem.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

Contrary to sensationalizing this study, the news release offers a rather cautious summary of the research. Unfortunately, this caution seems to have come at the expense of readability. The release quotes extensively from the original study, with language that’s quite technical.

Total Score: 7 of 10 Satisfactory

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