An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion

Spencer Phillips Hey and Aaron Kesselheim propose that informativeness—asserting scientific facts—rather than truthfulness ought to be the standard for regulating commercial speech about pharmaceuticals.

[1]  G. Lippi,et al.  Statins for Primary Prevention of Cardiovascular Disease. , 2017, Trends in pharmacological sciences.

[2]  A. Kapczynski.  Free Speech and Pharmaceutical Regulation -- Fishy Business. , 2016, JAMA internal medicine.

[3]  J. Sharfstein,et al.  The Promotion of Medical Products in the 21st Century: Off-label Marketing and First Amendment Concerns. , 2015, Journal of the American Medical Association (JAMA).

[4]  A. Kesselheim,et al.  Forbidden and Permitted Statements about Medications--Loosening the Rules. , 2015, The New England journal of medicine.

[5]  H. Krumholz.  Biomarkers, Risk Factors, and Risk: Clarifying the Controversy About Surrogate End Points and Clinical Outcomes. , 2015, Circulation. Cardiovascular quality and outcomes.

[6]  M. Noakes,et al.  Indications for Omega-3 Long Chain Polyunsaturated Fatty Acid in the Prevention and Treatment of Cardiovascular Disease. , 2015, Heart, lung & circulation.

[7]  Daniel Carpenter,et al.  Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA , 2014 .

[8]  W. Hiatt,et al.  Assessing the clinical benefits of lipid-disorder drugs. , 2014, The New England journal of medicine.

[9]  J. Fleg,et al.  Relationship of lipoproteins to cardiovascular events: the AIM-HIGH Trial (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides and Impact on Global Health Outcomes). , 2013, Journal of the American College of Cardiology.

[10]  M. Landray,et al.  HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment , 2013, European heart journal.

[11]  C. Ballantyne,et al.  Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). , 2012, The American journal of cardiology.

[12]  Lukasz Januszkiewicz.  [The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus]. , 2010, Kardiologia polska.

[13]  John B Buse,et al.  Effects of combination lipid therapy in type 2 diabetes mellitus. , 2010, The New England journal of medicine.