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.


Vyšlo v časopise: An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med 13(3): e32767. doi:10.1371/journal.pmed.1001978
Kategorie: Policy Forum
prolekare.web.journal.doi_sk: 10.1371/journal.pmed.1001978

Souhrn

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.


Zdroje

1. Complaint, Amarin Pharma, Inc. v. U.S. FDA. No. 15–3588. (S.D.N.Y. 2015)

2. Opinion and Order, Amarin Pharma, Inc. v. FDA, No. 15–3588 (S.D.N.Y. Aug. 7, 2015)

3. Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and permitted statements about medications—Loosening the rules. New Engl J Med 2015;373: 967–973. doi: 10.1056/NEJMhle1506365 26332553

4. Pacira Pharmaceuticals, Inc., v. United States Food & Drug Administation. No. 15–7055 (S.D.N.Y. 2015).

5. Kapczynski A. Free speech and pharmaceutical regulation—fishy business. JAMA Intern Med 2016: doi: 10.1001/jamainternmed.2015.8155

6. Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR Study). American J Cardiol 2012;110:984–992.

7. Guyton JR, Slee AE, Anderson T, Fleg JL, Goldberg RB, Kashyap ML, Marcovina SM, Nash SD, O'Brien KD, Weintraub WS, Xu P. Relationship of lipoproteins to cardiovascular events: The AIM-HIGH Trial. J Am Coll Cardiol 2013; 62:1580–1584. doi: 10.1016/j.jacc.2013.07.023 23916935

8. HPS2-Thrive Collaborative Group and others. 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. Eur Heart J 2013;34:1279–1291. doi: 10.1093/eurheartj/eht055 23444397

9. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. New Engl J Med 2010;362:1563–1574. doi: 10.1056/NEJMoa1001282 20228404

10. Woodcock J. Letter to Amarin Pharma, Inc. June 5, 2015.

11. Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, Ward K, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013 Jan 1;1(1):CD004816.

12. Hiatt WR, Smith RJ. Assessing the clinical benefits of lipid-disorder drugs. New Engl J Med 2014;370:396–399. doi: 10.1056/NEJMp1313866 24476429

13. Krumholz HM. Biomarkers, risk factors, and risk clarifying the controversy about surrogate end points and clinical outcomes. Circ Cardiovasc Qual Outcomes 2015;8:457–459. 26349839

14. Nestel P, Clifton P, Colquhoun D, Noakes M, Mori TA, Sullivan D, Thomas B. Indications for Omega-3 Long Chain Polyunsaturated Fatty Acid in the Prevention and Treatment of Cardiovascular Disease. Heart Lung Circ 2015;24:769–779. doi: 10.1016/j.hlc.2015.03.020 25936871

15. Sharfstein JM, Charo A. The promotion of medical products in the 21st century: Off-label marketing and first amendment concerns. JAMA 2015;14:1–2.

16. Carpenter D. Reputation and power: Organizational image and pharmaceutical regulation at the FDA. Princeton: Princeton University Press; 2010.

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Interné lekárstvo

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PLOS Medicine


2016 Číslo 3
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