Ebola vaccine development plan: Ethics, concerns and proposed measures

BMC Medical Ethics

Volumn 17, Issue 1, 2016, Pages

  Folayan, Morenike Oluwatoyin ^a   Yakubu, Aminu ^b   Haire, Bridget ^c   Peterson, Kristin ^d  

^a OBAFEMI AWOLOWO UNIVERSITY   (Nigeria)

^b Ministry of Federal Health Nigeria   (Nigeria)

^c UNIVERSITY OF NEW SOUTH WALES   (Australia)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Ebola; Healthcare workers; Myths; Public dialogue; Standard of care; TRIPS; Vaccine

Indexed keywords

VIRUS VACCINE;

DRUG DEVELOPMENT; EBOLAVIRUS; EMERGENCY; EPIDEMIC; ETHICS; EXPERIMENTAL THERAPY; HEALTH CARE PERSONNEL; HEMORRHAGIC FEVER, EBOLA; HUMAN; MEDICAL RESEARCH; PREVENTIVE HEALTH SERVICE; RESEARCH ETHICS; RESEARCH SUBJECT; STANDARDS; VACCINATION; VIROLOGY;

BIOMEDICAL RESEARCH; DRUG DISCOVERY; EBOLAVIRUS; EMERGENCIES; EPIDEMICS; ETHICS, RESEARCH; HEALTH PERSONNEL; HEMORRHAGIC FEVER, EBOLA; HUMANS; IMMUNIZATION PROGRAMS; RESEARCH SUBJECTS; THERAPIES, INVESTIGATIONAL; VACCINATION; VIRAL VACCINES;

EID: 84959537889     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/s12910-016-0094-4     Document Type: Article

References (72)

1. Polesky A, Bhatia G. Ebola hemorrhagic fever in the era of bioterrorism. Semin Respir Infect. 2003;18:206-15.
2. th November 2014.
3. Lamontagne F, Clément C, Fletcher T, Jacob ST, Fischer 2nd WA, Fowler RA. Doing today's work superbly well - treating Ebola with current tools. N Engl J Med. 2014;371:1565-6.
4. Chertow DS, Kleine C, Edwards JK, Scaini R, Giuliani R, Sprecher A. Ebola virus disease in West Africa - clinical manifestations and management. N Engl J Med. 2014;371:2054-7.
5. Schieffelin JS, Shaffer JG, Goba A, Gbakie M, Gire SK, Colubri A, et al. Clinical illness and outcomes in patients with Ebola in Sierra Leone. N Engl J Med. 2014;371:2092-100.
6. Ansumana R, Jacobsen KH, Sahr F, Idris M, Bangura H, Boie-Jalloh M, et al. Ebola in Freetown area, Sierra Leone - a case study of 581 patients. N Engl J Med. 2015;372:587-8.
7. Bah EI, Lamah MC, Fletcher T, Jacob ST, Brett-Major DM, Sall AA, et al. Clinical presentation of patients with Ebola virus disease in Conakry, Guinea. N Engl J Med. 2015;372:40-7.
8. Decker BK, Sevransky JE, Barrett K, Davey RT, Chertow DS. Preparing for critical care services to patients with Ebola. Ann Intern Med. 2014;161:831-2.
9. Kreuels B, Wichmann D, Emmerich P, Schmidt-Chanasit J, de Heer G, Kluge S, et al. A case of severe Ebola virus infection complicated by gram-negative septicemia. N Engl J Med. 2014;371:2394-401.
10. O'Hare B. Weak health systems and Ebola. Lancet Glob Health. 2015;3:e71-2.
11. Gostin LO. Ebola: Towards an International Health Systems Fund. Lancet. 2014;384(9951):e49-51.
12. nd April, 2015.
13. nd April, 2015.
14. Sayegh J: Ebola and the Health Care Crisis in Liberia. Cultural Anthropology Online 2014; 7th October 2014. http://www.culanth.org/fieldsights/595-ebola-and-the-health-care-crisis-in-liberia. Accessed 22nd April, 2015
15. nd April, 2015.
16. Cox E, Borio L, Temple R. Evaluating Ebola Therapies - the case for RCTs. N Engl Med. 2014;371(25):2350-2351.
17. Cohen J, Kupferschmidt K. Infectious Diseases. Ebola vaccine trials raise ethical issues. Science. 2014;346:289-90.
18. Bellan SE, Pulliam JR, Dushoff J, Meyers LA. Ebola virus vaccine trials: The ethical mandate for a therapeutic safety net. BMJ. 2014;349:7518s.
19. Kanapathipillai R, HenaoRestrepo AM, Fast P, Wood D, Dye C, Kieny MP, et al. Ebola vaccine: An urgent international priority. N Engl J Med. 2014;371:2249-51.
20. Rid A, Emanuel EJ. Ethical considerations of experimental interventions in the Ebola outbreak. Lancet. 2014;384:1896-9.
21. Hayden EC. Ethical dilemma for Ebola trials: Public-health officials split on use of control groups in tests of experimental treatments. Nature. 2014;515:177-8.
22. Adebamowo C, Bah-Sow O, Binka F, Bruzzone R, Caplan A, Delfraissy JF, et al. Randomised controlled trials for Ebola: Practical and ethical issues. Lancet. 2014;384:1423-4.
23. Dawson L. Not All RCTs are created equal: Lessons from early AIDS trials. Am J Bioeth. 2015;15:45-7.
24. Caplan AL. Morality in a time of Ebola. Lancet. 2015;385(9971):e16-7.
25. Caplan AL, Plunkett C, Levin B. Selecting the right tool for the job. Am J Bioeth. 2015;15(4):4-10.
26. Folayan MO, Haire B, Peterson K, Yakubu A, Brown B. Stakeholder engagement and Ebola Virus Disease therapy research. BMC Public Health (in Press).
27. Henao-Restrepo AM, Longini IM, Egger M, Dean NE, Edmunds WJ, Camacho A, et al. Efficacyand effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: Interim results from the Guinea ring vaccination cluster-randomised trial. Lancet. 2015;386:857.
28. th November 2014.
29. th November 2014.
30. th November 2014.
31. th November 2014.
32. th November 2014.
33. Friedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-5.
34. Satalkar P, Elger BE, Shaw DM: Prioritising healthcare workers for Ebola treatment: Treating those at greatest risk to confer greatest benefit. Dev World Bioeth 2015, 8731. doi:10.1111/dewb.12079
35. Macklin R. The Ethics of the Ebola Outbreak: Who Should Receive Experimental Treatment? http://www.huffingtonpost.com/ruth-macklin/the-ethics-of-the-ebola-o-b-5698128.html. Accessed 19tn April, 2015.
36. Degeling C, Johnson J, Mayes C. Impure politics and pure science: Efficacious Ebola medications are only a palliation and not a cure for structural disadvantage. Am J Bioeth. 2015;15:43-5.
37. Scoones I, Forster P. One world, one health? Rural 21. 2009;43:22-4.
38. Folayan MO, Haire B. Prioritization of healthcare workers for experimental Ebola therapeutic would exacerbate existing inequalities; DWB (in Press).
39. Yakubu A, Folayan MO, Sani-Gwarzo N, Nguku P, Peterson K, Brandon B. The Ebola outbreak in Western Africa-ethical obligations for care. J Med Ethics 2014, September 9, 10.1136/medethics-2014-102434.
40. Breman JG, Johnson KM. Ebola then and now. N Engl J Med. 2014;371:1663-6.
41. Guimard Y, Bwaka MA, Colebunders R, Calain P, Massamba M, De Roo A, et al. Organization of patient care during the Ebola hemorrhagic fever epidemic in Kikwit, Democratic Republic of the Congo, 1995. J Infect Dis. 1999;179:S268-73.
42. Lipsitch M, Longini IM. Vaccine testing Ebola and beyond. Science. 2015;348:46-8.
43. nd April, 2015.
44. Daniels N. Justice, health and healthcare. Am J Bioeth. 2001;1(2):2-16.
45. Edmond MB, Diekema DJ, Rerencevich N. Ebola Virus Disease and the need for new personal protection equipment. JAMA. 2014;312:2495-6.
46. Shuchman M. Sierra Leone doctors call for better Ebola care for colleagues. Lancet. 2014;384:e67.
47. Kass N. Ebola, ethics, and public health: What next. Ann Intern Med. 2014;161:744-5.
48. th November 2014.
49. Molyneux CS, Geissler PW. Ethics and the ethnography of medical research in Africa. Soc Sci Med. 2008;67:685-95.
50. Zvonareva O, Engel N, Ross E, Berghmans R, Dhai A, Krumeich A. Engaging diverse social and cultural worlds: Perspectives on benefits in international clinical research from South African communities. Dev World Bioeth. 2015;15:8-17.
51. UNAIDS/WHO. Ethical considerations in biomedical HIV prevention trials. UNAIDS/WHO guidance document. http://www.unaids.org/sites/default/files/en/media/unaids/contentassets/documents/unaidspublication/2012/jc1399-ethical-considerations-en.pdf. Accessed 19th April, 2015.
52. Miller L, Folayan M, Allman D, Nkala B, Kasirye LM, Mingote LR, et al. How ethical is your clinical trial? Int J ClinPract. 2010;64:1179-82.
53. Etokidem AJ. Wondifon: Myths and misconceptions as barriers to uptake of immunization. Vaccine Vaccination. 2013;4:7.
54. DeStefano F, Chen RT. Autism and measles-mumps-rubella vaccination: Controversy laid to rest? CNS Drugs. 2001;15:831-7.
55. th April, 2015.
56. Kochhar S, Rath B, Seeber LD, Rundblad G, Khamesipour A, Ali M. Introducing new vaccines in developing countries. Expert Rev Vaccines. 2013;12:1465-78.
57. Braka F, Asiimwe D, Soud F, Lewis RF, Makumbi I, Gust D. A qualitative analysis of vaccine safety perceptions and concerns among caretakers in Uganda. Matern Child Health J. 2012;16:1045-52.
58. Chakrapani V, Newman PA, Singhal N, Jerajani J, Shunmugam M. Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India: A social ecological approach. PLoS One. 2012;7:e51080.
59. nd April, 2015.
60. Reno W. Ironies of post-cold war structural adjustment in Sierra Leone. Rev Afr Polit Econ. 1996;23(67):7-18.
61. Outram Q. Its terminal either way: An analysis of armed conflict in Liberia 1989-1996. Rev Afr Polit Econ. 1997;24(73):355-71.
62. th November 2014.
63. Torjesen I. Two doctors die from Ebola and lives of others under threat in West Africa. BMJ. 2014;349:4895.
64. Franco E, Bagnato B, Marino MG, Meleleo C, Serino L, Zaratti L. Hepatitis B: Epidemiology and prevention in developing countries. World J Hepatol. 2012;4:74-80.
65. World Medical Association. Declaration of Helsinki. 2008.
66. CIOMS. International ethical guidelines for biomedical research involving human subjects. 2002.
67. Milstien J, Kaddar M. Managing the effects of TRIPS on availability of priority vaccines. Bull World Health Organ. 2006;84:360-5.
68. th November 2014.
69. th November 2014.
70. Danzon PM, Towse A. Differential pricing for pharmaceuticals: Reconciling access, R&D and patents. Int J Health Care Finance Econ. 2003;3:183-205.
71. Lopert R, Lang DL, Hill SR, Henry DA. Differential pricing of drugs: A role for cost-effectiveness analysis? Lancet. 2002;359:2105-7.
72. Nasiru SG, Aliyu GG, Gasasira A, Aliyu MH, Zubair M, Mandawari SU, et al. Breaking community barriers to polio vaccination in Northern Nigeria: The impact of a grass roots mobilization campaign (Majigi). Pathog Glob Health. 2012;106:166-71.