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Right-to-Try Laws: Hope, Hype, and Unintended Consequences

2015; American College of Physicians; Volume: 163; Issue: 10 Linguagem: Inglês

10.7326/m15-0148

1539-3704

Alison Bateman-House, Laura L. Kimberly, Barbara K. Redman, Nancy Neveloff Dubler, Arthur L. Caplan,

Pluripotent Stem Cells Research

Ideas and Opinions17 November 2015Right-to-Try Laws: Hope, Hype, and Unintended ConsequencesAlison Bateman-House, PhD, MPH, MA, Laura Kimberly, MSW, MBE, Barbara Redman, PhD, MBE, Nancy Dubler, LLB, and Arthur Caplan, PhDAlison Bateman-House, PhD, MPH, MAFrom New York University Langone Medical Center and Columbia University School of Social Work, New York, New York., Laura Kimberly, MSW, MBEFrom New York University Langone Medical Center and Columbia University School of Social Work, New York, New York., Barbara Redman, PhD, MBEFrom New York University Langone Medical Center and Columbia University School of Social Work, New York, New York., Nancy Dubler, LLBFrom New York University Langone Medical Center and Columbia University School of Social Work, New York, New York., and Arthur Caplan, PhDFrom New York University Langone Medical Center and Columbia University School of Social Work, New York, New York.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-0148 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail As of early September 2015, twenty-four states have "right-to-try" laws permitting terminally ill patients to request access to investigational drugs or devices that have not been approved by the U.S. Food and Drug Administration (FDA). Many other state legislatures are considering similar bills. However, right-to-try laws do nothing to significantly change patient access to investigational medical products. Worse, these laws may result in unintended negative consequences for patients and society.Right-to-try laws are based on model legislation promulgated by a libertarian think tank, the Goldwater Institute, and are promoted as helping terminally ill patients access investigational medical products (1). Such ...References1. Corieri C. Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of Their Treatment. Phoenix, AZ: Goldwater Institute; 2014. Accessed at http://goldwaterinstitute.org/en/work/topics/healthcare/right-to-try/everyone-deserves-right-try-empowering-terminally- on 24 March 2015. Google Scholar2. Gaffney A. From 100 Hours to 1: FDA Dramatically Simplifies Its Compassionate Use Process. Rockville, MD: Regulatory Affairs Professionals Society; 2015. Accessed at www.raps.org/Regulatory-Focus/News/2015/02/04/21243/From-100-Hours-to-1-FDA-Dramatically-Simplifies-its-Compassionate-Use-Process on 24 March 2015. Google Scholar3. Lowes R. FDA to Simplify 'Compassionate Use' Drug Applications. 4 February 2015. Accessed at www.medscape.com/viewarticle/839292 on 24 March 2015. Google Scholar4. Caplan AL, Bateman-House A. Should patients in need be given access to experimental drugs? [Editorial]. Expert Opin Pharmacother. 2015;16:1275-9. [PMID: 26001178] doi:10.1517/14656566.2015.1046837 CrossrefMedlineGoogle Scholar5. Caplan A, Levine B. Hope, hype and help: ethically assessing the growing market in stem cell therapies. Am J Bioeth. 2010;10:24-5. [PMID: 20461638] doi:10.1080/15265161.2010.481980 CrossrefMedlineGoogle Scholar6. Ginal J, Joshi J, Wright J, Buck K, Court L, Fields R, et al. House Bill 14-1281 of the General Assembly of the State of Colorado. Accessed at www.statebillinfo.com/bills/bills/14/1281_enr.pdf on 11 September 2015. Google Scholar7. Forbes JB. Man with ALS wants experimental drugs. St. Louis Post-Dispatch. 20 May 2015. Accessed at www.stltoday.com/gallery/news/multimedia/right-to-try-law-not-helping-st-louis-man-with/collection_0708ee3c-9c0a-5cdc-93fc-74e1a85a2938.html#0 on 7 June 2015. Google Scholar8. Farber D, Pinto PN, Caplan A, Bateman-House A. How State Right-to-Try Laws Create False Expectations [Blog]. Health Affairs Blog. 22 May 2015. Accessed at http://healthaffairs.org/blog/2015/05/22/how-state-right-to-try-laws-create-false-expectations on 7 June 2015. Google Scholar9. On "right to try" legislation [Blog]. Drug and Device Law. 23 October 2014. Accessed at http://druganddevicelaw.blogspot.com/2014/10/on-right-to-try-legislation.html on 23 March 2015. Google Scholar10. Gorski D. "Right to try" laws and Dallas Buyers' Club: great movie, terrible for patients and terrible policy [Blog]. Science-Based Medicine. 8 March 2014. Accessed at www.sciencebasedmedicine.org/right-to-try-laws-and-dallas-buyers-club-great-movie-terrible-public-policy on 24 March 2015. Google Scholar Author, Article, and Disclosure InformationAffiliations: From New York University Langone Medical Center and Columbia University School of Social Work, New York, New York.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0148.Corresponding Author: Alison Bateman-House, PhD, MPH, MA, Division of Medical Ethics, New York University Langone Medical Center, 227 East 30th Street, New York, NY 10016; e-mail, Alison.[email protected]org.Current Author Addresses: Drs. Bateman-House, Redman, and Caplan; Ms. Kimberly; and Ms. Dubler: Division of Medical Ethics, New York University Langone Medical Center, 227 East 30th Street, New York, NY 10016.Author Contributions: Conception and design: A. Bateman-House, L. Kimberly, B. Redman, N. Dubler, A. Caplan.Analysis and interpretation of the data: A. Bateman-House, L. Kimberly, A. Caplan.Drafting of the article: A. Bateman-House, L. Kimberly, B. Redman, N. Dubler, A. Caplan.Critical revision of the article for important intellectual content: A. Bateman-House, L. Kimberly, B. Redman, N. Dubler, A. Caplan.Final approval of the article: A. Bateman-House, L. Kimberly, B. Redman, N. Dubler, A. Caplan.Administrative, technical, or logistic support: A. Bateman-House.Collection and assembly of data: A. Bateman-House, L. Kimberly.This article was published online first at www.annals.org on 29 September 2015. 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