In Opposition to Liberty: We Need a “Sovereign” to Govern Drug Claims
Authors: Jerry Avorn
Journal: Annals of Internal Medicine (2015)

Ideas and Opinions4 August 2015In Opposition to Liberty: We Need a “Sovereign” to Govern Drug ClaimsJerry Avorn, MDJerry Avorn, MDFrom Harvard Medical School and Brigham & Women's Hospital, Boston, Massachusetts.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-1429 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Hobbes had it right. The 17th-century political philosopher explained that civilization requires individuals to willingly transfer some of their freedom to a Sovereign who can use that power to organize society through the consent of the governed (1). Without this basic tradeoff, Hobbes argued, existence would be a struggle of “all against all,” resulting in life that is “solitary, poor, nasty, brutish, and short.” Hobbes' work helped inspire the Declaration of Independence and the Constitution. Now the latter document is being used to threaten a central aspect of medical practice that is rooted in this “consent-of-the-governed” concept.During the summer ...References1. Hobbes T. Leviathan. London: Andrew Crooke; 1651. Google Scholar2. Clarke T. Under Pressure, FDA to Hold Public Meeting on Off-Label Use. Accessed at www.reuters.com/article/2015/05/07/us-fda-pharmaceuticals-constitution-idUSKBN0NS00F20150507 on 6 May 2015. Google Scholar3. Carpenter D. Reputation and Power. Princeton, NJ: Princeton Univ Pr; 2010. Google Scholar4. Higgins JP, Green S, eds. Cochrane Handbook for Systematic Reviews of Intervention. West Sussex, UK: J Wiley; 2008. Google Scholar5. Avorn J. Healing the overwhelmed physician. New York Times. 12 June 2013:A27. Google Scholar6. Avorn J, Kesselheim AS. The 21st Century Cures Act—will it take us back in time? N Engl J Med. 2015 June 3 [Epub ahead of print]. [PMID: 26039522] CrossrefMedlineGoogle Scholar7. Alosa Foundation. Accessed at www.AlosaFoundation.org on 23 June 2015.32. Google Scholar8. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics—comparison of three regulatory agencies. N Engl J Med. 2012;366:2284-93. [PMID: 22591257] doi:10.1056/NEJMsa1200223 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Harvard Medical School and Brigham & Women's Hospital, Boston, Massachusetts.Disclosures: The author has disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1429.Corresponding Author: Jerry Avorn, MD, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, [email protected]harvard.edu.Author Contributions: Conception and design: J. Avorn.Drafting of the article: J. Avorn.Final approval of the article: J. Avorn.This article was published online first at www.annals.org on 30 June 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 4 August 2015Volume 163, Issue 3Page: 229-230KeywordsDrug safetyDrugsFood and Drug AdministrationHealth promotionInformation storage and retrievalInternetLegislationObservational studiesPatient advocacySafety ePublished: 4 August 2015 Issue Published: 4 August 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...