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

Death Studies

Volumn 40, Issue 2, 2016, Pages 113-120

  Hoerger, Michael ^a  

^a TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; NEW DRUG;

COMPASSIONATE USE; DOCTOR PATIENT RELATION; HEALTH CARE DELIVERY; HUMAN; LEGISLATION AND JURISPRUDENCE; MEDICAL INFORMATION; PATIENT CARE; PATIENT RIGHT;

ANTINEOPLASTIC AGENTS; COMPASSIONATE USE TRIALS; DRUGS, INVESTIGATIONAL; HEALTH COMMUNICATION; HEALTH SERVICES ACCESSIBILITY; HUMANS; PATIENT CARE; PATIENT RIGHTS; PHYSICIAN-PATIENT RELATIONS;

EID: 84957845046     PISSN: 07481187     EISSN: 10917683     Source Type: Journal    
DOI: 10.1080/07481187.2015.1077356     Document Type: Article

References (55)

1. American College of Surgeons. (2012). Cancer program standards 2012: Ensuring patient-centered care. V1.2.1. Retrieved from https://www.facs.org/~/media/files/quality%20programs/cancer/coc/programstandards2012.ashx
2. M.Andrews, (2014). Laws spreading that allow terminal patients access to experimental drugs. Retrieved from http://kaiserhealthnews.org/news/laws-spreading-that-allow-terminal-patients-access-to-experimental-drugs/
3. A.L.Back,, R.M.Arnold,, W.F.Baile,, K.A.Fryer-Edwards,, S.C.Alexander,, G.E.Barley,, … J.A.Tulsky, (2007). Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Archives of Internal Medicine, 167(5), 453–460. doi:10.1001/archinte.167.5.453
4. M.A.Bakitas,, T.D.Tosteson,, Z.Li,, K.D.Lyons,, J.G.Hull,, Z.Li,, … M.T.Hegel, (2015). Early Versus delayed initiation of concurrent palliative oncology care: Patient outcomes in the ENABLE III randomized controlled trial. Journal of Clinical Oncology, 33, 1438–1445. doi:10.1200/jco.2014.58.6362
5. C.B.Begg,, K.Kim,, & J.D.Neaton, (2014). “Right to try” laws. Clinical Trials, 11(5), 519–520. doi:10.1177/1740774514546574
6. V.Brower, (2014). Food and drug administration responds to pressure for expanded drug access. Journal of the National Cancer Institute, 106(6), dju171. doi:10.1093/jnci/dju171
7. A.Caplan,, & A.Bateman-House, (2014). Compassion for each individual’s own sake. The American Journal of Bioethics, 14(11), 16–17. doi:10.1080/15265161.2014.957622
8. A.Chapman, (2014). Proposal for patient obligations for access to unapproved medical interventions: Both too much and not enough. The American Journal of Bioethics, 14(11), 25–26. doi:10.1080/15265161.2014.957419
9. J.Coulehan, (2011). Deep hope: A song without words. Theoretical Medicine and Bioethics, 32(3), 143–160. doi:10.1007/s11017-011-9172-2
10. J.J.Darrow,, A.Sarpatwari,, J.Avorn,, & A.Kesselheim, (2015). Practical, legal, and ethical issues in expanded access to investigational drugs. The New England Journal of Medicine, 372(3), 279–286.
11. M.-J.Del Vecchio Good,, B.J.Good,, C.Schaffer,, & S.E.Lind, (1990). American oncology and the discourse on hope. Culture, Medicine and Psychiatry, 14(1), 59–79. doi:10.1007/bf00046704
12. R.M.Epstein,, & V.Entwistle, (2013). Capacity and shared decision-making in serious illness. In Palliative care and ethics: common ground and cutting edges, ed. T. E. Quill & F. G. Miller, 162–185. Oxford, UK: Oxford University Press.
13. R.M.Eveleigh,, E.Muskens,, H.van Ravesteijn,, I.van Dijk,, E.van Rijswijk,, & P.Lucassen, (2012). An overview of 19 instruments assessing the doctor-patient relationship: Different models or concepts are used. Journal of Clinical Epidemiology, 65(1), 10–15. doi:10.1016/j.jclinepi.2011.05.011
14. FDA. (2013). Guidance for industry: Expanded access to investigational drugs for treatment use: Qs and As. Rockville, MD: Author.
15. A.Gaffney, (2015). “Right to try” legislation tracker. Retrieved from http://www.raps.org/Regulatory-Focus/News/Databases/2015/05/01/21133/Right-to-Try-Legislation-Tracker/
16. J.Gerhart,, Y.Asvat,, E.Lattie,, S.O’Mahony,, P.Duberstein,, & M.Hoerger, (In press). Distress, delay of gratification and preference for palliative care in men with prostate cancer. Psycho-Oncology. doi:10.1002/pon.3822
17. D.Gesme, (2007). Should terminally ill patients have the right to take drugs that pass phase I testing? No. British Medical Journal, 335(7618), 479. doi:10.1136/bmj.39245.429525.ad
18. D.Goodman,, N.E.Morden,, C.-H.Chang,, E.S.Fisher,, & J.E.Wennberg, (2013). Trends in cancer care near the end of life: A Dartmouth atlas of health care brief. Retrieved from http://www.dartmouthatlas.org/downloads/reports/cancer_brief_090413.pdf
19. M.Goodman, (2014). Twitter storm forces Chimerix’s hand in compassionate use request. Nature Biotechnology, 32(6), 503–504. doi:10.1038/nbt0614-503
20. M.Hay,, D.W.Thomas,, J.L.Craighead,, C.Economides,, & J.Rosenthal, (2014). Clinical development success rates for investigational drugs. Nature Biotechnology, 32(1), 40–51. doi:10.1038/nbt.2786
21. M.Hoerger,, R.M.Epstein,, P.C.Winters,, K.Fiscella,, P.R.Duberstein,, R.Gramling,, … R.L.Kravitz, (2013). Values and options in cancer care (VOICE): Study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer, 13(1), 188. doi:10.1186/1471-2407-13-188
22. M.Hoerger,, E.Golden,, C.Rochefort,, K.Seibert,, S.Voorhees,, & L.Perry, (2015). Palliative care psychoeducational intervention for patients with metastatic cancer. Paper presented at the Association for Clinical and Translational Science, Washington, DC.
23. E.Horstmann,, M.S.McCabe,, L.Grochow,, S.Yamamoto,, L.Rubinstein,, T.Budd,, … C.Grady, (2005). Risks and benefits of phase 1 oncology trials, 1991 through 2002. New England Journal of Medicine, 352(9), 895–904. doi:10.1056/nejmsa042220
24. Institute of Medicine. (2013). Delivering high-quality cancer care: Charting a new course for a system in crisis. Washington, DC: National Academies Press.
25. Institute of Medicine. (2014). Dying in America: Improving quality and honoring individual preferences near the end of life. Washington, DC: The National Academies Press.
26. A.S.Kesselheim,, Y.T.Tan,, J.J.Darrow,, & J.Avorn, (2014). Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Affairs, 33(10), 1770–1778. doi:10.1377/hlthaff.2014.0529
27. E.B.Lamont,, & N.A.Christakis, (2001). Prognostic disclosure to patients with cancer near the end of life. Annals of Internal Medicine, 134(12), 1096–1105. doi:10.7326/0003-4819-134-12-200106190-00009
28. C.Le Tourneau,, J.J.Lee,, & L.L.Siu, (2009). Dose escalation methods in phase I cancer clinical trials. Journal of the National Cancer Institute, 101, 708–720. doi:10.1093/jnci/djp079
29. B.Lo,, T.E.Quill,, & J.Tulsky, (1999). Discussing palliative care with patients. Annals of Internal Medicine, 130, 744–749. doi:10.7326/0003-4819-130-9-199905040-00015
30. W.J.Mackillop,, W.E.Stewart,, A.D.Ginsburg,, & S.S.Stewart, (1988). Cancer patients’ perceptions of their disease and its treatment. British Journal of Cancer, 58(3), 355–358. doi:10.1038/bjc.1988.218
31. D.Magnus, (2014). Compassion and research in compassionate use. The American Journal of Bioethics, 14(11), 1–2. doi:10.1080/15265161.2014.969968
32. D.E.Meier, (2014). “I don’t want jenny to think I’m abandoning her”: Views on overtreatment. Health Affairs, 33(5), 895–898. doi:10.1377/hlthaff.2013.0517
33. N.E.Morden,, C.-H.Chang,, J.O.Jacobson,, E.M.Berke,, J.P.Bynum,, K.M.Murray,, & D.C.Goodman, (2012). End-of-life care for Medicare beneficiaries with cancer is highly intensive overall and varies widely. Health Affairs, 31(4), 786–796. doi:10.1377/hlthaff.2011.0650
34. National Cancer Institute. (2010). Common terminology criteria for adverse events (CTCAE), 2014. Retrieved from http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf
35. National Comprehensive Cancer Network. (2013). Clinical practice guidelines in oncology–palliative care. Version 2.2013. Fort Washington, PA: Author.
36. D.H.Novack,, R.Plumer,, R.L.Smith,, H.Ochitill,, G.R.Morrow,, & J.M.Bennett, (1979). Changes in physicians’ attitudes toward telling the cancer patient. Journal of the American Medical Association, 241(9), 897–900. doi:10.1001/jama.1979.03290350017012
37. B.Nyhan, (2010). Why the “death panel” myth wouldn’t die: Misinformation in the health care reform debate. The Forum, 8(1), Article 5.
38. B.E.Osta,, J.L.Palmer,, T.Paraskevopoulos,, B.-L.Pei,, L.E.Roberts,, V.A.Poulter,, … E.Bruera, (2008). Interval between first palliative care consult and death in patients diagnosed with advanced cancer at a comprehensive cancer center. Journal of Palliative Medicine, 11(1), 51–57. doi:10.1089/jpm.2007.0103
39. R.B.Parikh,, R.A.Kirch,, T.J.Smith,, & J.S.Temel, (2013). Early specialty palliative care: Translating data in oncology into practice. New England Journal of Medicine, 369(24), 2347–2351. doi:10.1056/nejmsb1305469
40. S.M.Parker,, J.M.Clayton,, K.Hancock,, S.Walder,, P.N.Butow,, S.Carrick,, … M.H.N.Tattersall, (2007). A systematic review of prognostic/end-of-life communication with adults in advanced stages of a life-limiting illness: Patient/caregiver preferences for the content, style, and timing of information. Journal of Pain and Symptom Management, 34, 81–93. doi:10.1016/j.jpainsymman.2006.09.035
41. J.Rabourn,, & R.S.Bedlack, (2014). SAPs: A different perspective. The American Journal of Bioethics, 14(11), 19–20. doi:10.1080/15265161.2014.957621
42. M.Roth-Cline,, & R.Nelson, (2014). FDA implementation of the expanded access program in the United States. The American Journal of Bioethics, 14(11), 17–19. doi:10.1080/15265161.2014.957418
43. K.Servick, (2014). “Right to try” laws bypass FDA for last-ditch treatments. Science, 344(6190), 1329. doi:10.1126/science.344.6190.1329
44. T.J.Smith,, S.Temin,, E.R.Alesi,, A.P.Abernethy,, T.A.Balboni,, E.M.Basch,, … J.H.Von Roenn, (2012). American society of clinical oncology provisional clinical opinion: The integration of palliative care into standard oncology care. Journal of Clinical Oncology, 30(8), 880–887. doi:10.1200/jco.2011.38.5161
45. D.P.Sulmasy,, A.B.Astrow,, M.K.He,, D.M.Seils,, N.J.Meropol,, E.Micco,, & K.P.Weinfurt, (2010). The culture of faith and hope. Cancer, 116(15), 3702–3711.
46. J.S.Temel,, J.A.Greer,, A.Muzikansky,, E.R.Gallagher,, S.Admane,, V.A.Jackson,, … T.J.Lynch, (2010). Early palliative care for patients with metastatic non-small-cell lung cancer. New England Journal of Medicine, 363, 733–742.
47. A.-M.The,, T.Hak,, G.Koëter,, & G.van der Wal, (2000). Collusion in doctor-patient communication about imminent death: An ethnographic study. British Medical Journal, 321(7273), 1376–1381. doi:10.1136/bmj.321.7273.1376
48. M.J.Walker,, W.A.Rogers,, & V.Entwistle, (2014). Ethical justifications for access to unapproved medical interventions: An argument for (limited) patient obligations. The American Journal of Bioethics, 14(11), 3–15. doi:10.1080/15265161.2014.957416
49. J.C.Weeks,, P.J.Catalano,, A.Cronin,, M.D.Finkelman,, J.W.Mack,, N.L.Keating,, & D.Schrag, (2012). Patients’ expectations about effects of chemotherapy for advanced cancer. New England Journal of Medicine, 367(17), 1616–1625.
50. J.C.Weeks,, E.F.Cook,, S.J.O’Day,, L.M.Peterson,, N.Wenger,, D.Reding,, … R.S.Phillips, (1998). Relationship between cancer patients’ predictions of prognosis and their treatment preferences. Journal of the American Medical Association, 279, 1709–1714. doi:10.1001/jama.279.21.1709
51. P.Wicks,, & J.Heywood, (2014). Data donation could power the learning health care system, including special access programs. The American Journal of Bioethics, 14(11), 27–29. doi:10.1001/jama.279.21.1709
52. J.H.Wolf,, & K.S.Wolf, (2013). The Lake Wobegon effect: Are all cancer patients above average? Milbank Quarterly, 91(4), 690–728. doi:10.1111/1468-0009.12030
53. A.A.Wright,, B.Zhang,, A.Ray,, J.W.Mack,, E.Trice,, T.Balboni,, … H.G.Prigerson, (2008). Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. Journal of the American Medical Association, 300, 1665–1673. doi:10.1001/jama.300.14.1665
54. C.Zimmermann,, R.Riechelmann,, M.Krzyzanowska,, G.Rodin,, & I.Tannock, (2008). Effectiveness of specialized palliative care: A systematic review. Journal of the American Medical Association, 299(14), 1698–1709. doi:10.1001/jama.299.14.1698
55. C.Zimmermann,, N.Swami,, M.Krzyzanowska,, B.Hannon,, N.Leighl,, A.Oza,, … C.Lo, (2014). Early palliative care for patients with advanced cancer: A cluster-randomised controlled trial. The Lancet, 383, 1721–1730. doi:10.1016/s0140-6736(13)62416-2