patrick.net

As Shire introduces an ambitious campaign to promote Vyvanse but also to raise awareness about the disorder, some are saying the company is going too far to market a drug, a type of amphetamine, that is classified by the federal government as having a high potential for abuse. Shire’s track record is adding to the worry: The company helped put another once-stigmatized condition — attention deficit hyperactivity disorder — on the medical map and made billions of dollars from the sale of drugs, like Vyvanse and Adderall, to treat it. In recent years, federal officials have cited the company for inappropriately marketing Vyvanse and other A.D.H.D. drugs.

In addition, some drug safety experts questioned why the Food and Drug Administration so swiftly approved the drug for binge eating — seeking little outside input — despite the fact that, for decades, amphetamines, which suppress the appetite, were widely abused as a treatment for obesity.

Vyvanse is Shire’s top-selling drug, bringing in close to $1.5 billion in sales in 2014. Shire’s chief executive, Dr. Flemming Ornskov, recently said he expected the binge-eating approval to eventually contribute between $200 million and $300 million to annual sales of Vyvanse.

In 2011, the F.D.A. cited Shire, which is based in Dublin, for misleading advertising, and last fall the company paid $56.5 million to settle federal charges that it improperly promoted Vyvanse, Adderall and other drugs. Among the allegations, which Shire denied, was that the company played down Vyvanse’s addiction potential and said it would prevent car accidents, divorce, arrests and unemployment.

56.5 million in fines and zero convictions....cost of doing business.

http://www.nytimes.com/2015/02/25/business/shire-maker-of-binge-eating-drug-vyvanse-first-marketed-the-disease.html