Literature DB >> 26313583

Right-to-try laws and individual patient "compassionate use" of experimental oncology medications: A call for improved provider-patient communication.

Michael Hoerger1.   

Abstract

The U.S. Food and Drug Administration's Expanded Access program allows patients with life-threatening diagnoses, such as advanced cancer, to use experimental medications without participating in clinical research (colloquially, "Compassionate Use"). Sixteen U.S. states recently passed "right-to-try" legislation aimed at promoting Expanded Access. Acknowledging popular support, Expanded Access could undermine clinical trials that benefit public health. Moreover, existing norms in oncologic care, for example, often lead patients to pursue intense treatments near the end of life, at the expense of palliation, and improved communication about the risks and benefits of Expanded Access would more often discourage its use.

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Year:  2015        PMID: 26313583      PMCID: PMC4816436          DOI: 10.1080/07481187.2015.1077356

Source DB:  PubMed          Journal:  Death Stud        ISSN: 0748-1187


  43 in total

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Authors:  Camilla Zimmermann; Rachel Riechelmann; Monika Krzyzanowska; Gary Rodin; Ian Tannock
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2.  SAPs: a different perspective.

Authors:  Jess Rabourn; Richard S Bedlack
Journal:  Am J Bioeth       Date:  2014       Impact factor: 11.229

3.  Compassion for each individual's own sake.

Authors:  Arthur Caplan; Alison Bateman-House
Journal:  Am J Bioeth       Date:  2014       Impact factor: 11.229

4.  FDA implementation of the expanded access program in the United States.

Authors:  Michelle Roth-Cline; Robert Nelson
Journal:  Am J Bioeth       Date:  2014       Impact factor: 11.229

5.  Data donation could power the learning health care system, including special access programs.

Authors:  P Wicks; J A Heywood
Journal:  Am J Bioeth       Date:  2014       Impact factor: 11.229

6.  Proposal for patient obligations for access to unapproved medical interventions: both too much and not enough.

Authors:  Audrey Chapman
Journal:  Am J Bioeth       Date:  2014       Impact factor: 11.229

7.  Practical, legal, and ethical issues in expanded access to investigational drugs.

Authors:  Jonathan J Darrow; Ameet Sarpatwari; Jerry Avorn; Aaron S Kesselheim
Journal:  N Engl J Med       Date:  2015-01-15       Impact factor: 91.245

8.  Prognostic disclosure to patients with cancer near the end of life.

Authors:  E B Lamont; N A Christakis
Journal:  Ann Intern Med       Date:  2001-06-19       Impact factor: 25.391

9.  Distress, delay of gratification and preference for palliative care in men with prostate cancer.

Authors:  James Gerhart; Yasmin Asvat; Emily Lattie; Sean O'Mahony; Paul Duberstein; Michael Hoerger
Journal:  Psychooncology       Date:  2015-04-21       Impact factor: 3.894

10.  Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial.

Authors:  Marie A Bakitas; Tor D Tosteson; Zhigang Li; Kathleen D Lyons; Jay G Hull; Zhongze Li; J Nicholas Dionne-Odom; Jennifer Frost; Konstantin H Dragnev; Mark T Hegel; Andres Azuero; Tim A Ahles
Journal:  J Clin Oncol       Date:  2015-03-23       Impact factor: 44.544

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  4 in total

1.  RxLegal: A Rapid Review of Right-To-Try.

Authors:  Michael Gabay
Journal:  Hosp Pharm       Date:  2018-06-20

2.  What do patients with unmet medical needs want? A qualitative study of patients' views and experiences with expanded access to unapproved, investigational treatments in the Netherlands.

Authors:  Eline M Bunnik; Nikkie Aarts
Journal:  BMC Med Ethics       Date:  2019-11-09       Impact factor: 2.652

3.  Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology.

Authors:  David S Shulman; Lulla V Kiwinda; Stacey Edwards; Catherine M Clinton; Sarah Hunt; Lianne Greenspan; Kristen D Lawler; Gregory Reaman; Hasan Al-Sayegh; Kira Bona; Allison F O'Neill; Suzanne Shusterman; Katherine A Janeway; Andrew E Place; Susan N Chi; Clement Ma; Steven G DuBois
Journal:  Cancer Med       Date:  2021-03-09       Impact factor: 4.711

4.  Going "social" to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access.

Authors:  Tim K Mackey; Virginia J Schoenfeld
Journal:  BMC Med       Date:  2016-02-02       Impact factor: 8.775

  4 in total

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