Concerns over Vyvanse marketing: NYT

A New York Times report from Tuesday cited concerns from drug safety experts that Shire's ADHD drug Vyvanse, which was recently approved for binge-eating disorder, is susceptible to being overmarketed and, subsequently, overprescribed in its new indication.

The Times cites Shire's previous success with putting attention-deficit/hyperactivity disorder “on the medical map” and profiting greatly from it, as well as the lawsuits levied against the Dublin-based drugmaker for illegally marketing the drug.

Shire paid $56 million in September to resolve civil litigation related to Adderall XR and Vyvanse. The litigation alleged, among other things, that “Shire sales representatives and other agents allegedly made false and misleading statements about the efficacy and ‘abuseability' of Vyvanse to state Medicaid formulary committees and to individual physicians,” according to the Department of Justice.

The Times wrote that drug safety experts wondered why the FDA had given the drug priority review and why the agency had sought little outside output related to the drug's approval, especially given amphetamines' likelihood for abuse. An FDA spokesperson responded to the Gray Lady by saying that Vyvanse received an accelerated approval timeline because no other drugs were approved to treat the disorder.

Dr. Andrew Kolodny, chief medical officer for a drug treatment organization Phoenix House, told the NYT that “we had a horrible experience with amphetamines in this country, so the fact that this would just get rushed through without even bringing it before an advisory committee is especially concerning.” The newspaper also brings up what has become a common industry practice—spreading awareness about a disorder or disease, such as through unbranded disease awareness campaigns, prior to pushing advertising about the medication directly, noting, a Shire company website that makes no mention of Vyvanse.

Monica Seles, a retired tennis player and paid Shire spokesperson for Vyvanse's latest indication, has been featured on talk shows and in People magazine, sharing her own experiences with the disorder.  

Correction: An earlier version of this article's title wrongly suggested expert concerns only pertained to the marketing of Vyvanse.