The use of placebo in a trial of rectal artesunate as initial treatment for severe malaria patients en route to referral clinics: Ethical issues

Journal of Medical Ethics

Volumn 36, Issue 2, 2010, Pages 116-120

  Kitua, Andrew ^a   Folb, Peter ^b   Warsame, Marian ^a   Binka, Fred ^c   Faiz, Abul ^d   Ribeiro, Isabela ^e   Peto, Tom ^f   Gyapong, John ^g   Yunus, Emran Bin ^h   Rahman, Ridwan ⁱ   Baiden, Frank ^j   Clerk, Christine ^k   Mrango, Zakayo ^l   Makasi, Charles ^l   Kimbute, Omari ^l   Hossain, Amir ^h   Samad, Rasheda ^h   Gomes, Melba ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

^b SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^c UNIVERSITY OF GHANA   (Ghana)

^d SIR SALIMULLAH MEDICAL COLLEGE   (Bangladesh)

^e DNDi   (Brazil)

^f LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^g Health Research Unit Ghana Health Service   (Ghana)

^h CHITTAGONG MEDICAL COLLEGE   (Bangladesh)

ⁱ Shaheed Suhrawardy Medical College   (Bangladesh)

^j KINTAMPO HEALTH RESEARCH CENTRE   (Ghana)

^k Dodowa Health Research Centre   (Ghana)

^l NATIONAL INSTITUTE OF MEDICAL RESEARCH   (Tanzania)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; ARTESUNATE; PLACEBO;

ARTICLE; ETHICS; HEALTH; HEALTH CARE DELIVERY; HUMAN; MALARIA; PATIENT COMPLIANCE; PATIENT REFERRAL; RANDOMIZED CONTROLLED TRIAL; RECTAL DRUG ADMINISTRATION; SUPPOSITORY;

ADMINISTRATION, RECTAL; ANTIMALARIALS; ARTEMISININS; HEALTH SERVICES ACCESSIBILITY; HUMANS; MALARIA; MEDICATION ADHERENCE; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFERRAL AND CONSULTATION; RURAL HEALTH; SUPPOSITORIES;

EID: 77952484082     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2009.030874     Document Type: Article

References (43)

1. White NJ. The treatment of malaria. N Engl J Med 1996;335:800-6.
2. World Health Organization. Guidelines for the treatment of malaria. 2006 edn. Geneva: World Health Organization, 2006. http://www.who.int/malaria/publications/atoz/9241546948/en/index.html.
3. Bourel P, Souvestre R. A particular nervous traumatology: lesions of sciatic nerve by quinine intragluteal injections. Med Trop (Mars) 1982;42:209-13.
4. Barennes H. Intramuscular injections in Sub-saharan African children, apropos of a frequently misunderstood pathology: the complications related to intramuscular quinine injections. Bull Soc Pathol Exot 1999;92:33-7.
5. Rasamoelisoa JM, Tovone XG, Rakotavao E, et al. Acute flaccid paralysis after drug injection: a case report in the pediatric service of the Befelatanana Hospital Center in Antananarivo. Arch Inst Pasteur Madagascar 2000;66:58-60.
6. Yen LM, Dao LM, Son LH, et al. Role of quinine in the high mortality of intramuscular injection tetanus. Lancet 1994;344:786-7.
7. Boumandouki P, Kounkou RY, Teke-Bagamboula NJ, et al. Intramuscular injections of quinine and tetanus at the Centre Hospitalier Universitaire of Brazzaville, Congo. Bull Soc Pathol Exot 2008;101:298-300.
8. Barnes KI, Mwenechanya J, Tembo M, et al. Efficacy of rectal artesunate in the initial treatment of moderately severe malaria in African children and adults. Lancet 2004;363:1598-605.
9. Montanari RM, Bangali AM, Talukder KR, et al. Three case definitions of malaria and their effect on diagnosis, treatment and surveillance in Cox's Bazar district, Bangladesh. Bull World Health Organ 2001;79:648-56.
10. Yunus EB, Faiz MA, Rahman M, et al. Malaria Research Group. Study to document pre admission risk factors for development of severe malaria and the spectrum of it and the outcome in different categories of hospitals in malaria endemic zone of Bangladesh. J Bang Coll Phys Surg 2004;22:83-8.
11. Cockcroft A, Andersson N, Milne D, et al. What did the public think of health services reform in Bangladesh? Three national community-based surveys 1999e2003. Health Res Policy Syst 2007;5:1.
12. Hill Z, Kendall C, Arthur P, et al. Recognizing childhood illnesses and their traditional explanations: exploring options for care-seeking interventions in the context of the IMCI strategy in rural Ghana. Trop Med Int Health 2003;8:668-76.
13. Ministry of Health. Ministry of Health, Adult Morbidity and Mortality Project. The policy implications of adult morbidity and mortality: end of phase 1 report. Dar es Salaam, Tanzania: United Republic of Tanzania, 1997. Ministry of Health, Dar es Salaam, Tanzania, August 1997; 1997.
14. Makemba AM, Winch PJ, Makame VM, et al. Treatment practices for degedege, a locally recognized febrile illness and implications for strategies to decrease mortality from severe malaria in Bagamoyo District, Tanzania. Trop Med Int Health 1996;1:305-13.
15. Warsame M, Kimbute O, Machinda Z, et al. Recognition, perceptions and treatment practices for severe malaria in rural Tanzania: implications for accessing rectal artesunate as a pre-referral. PLoS One 2007;2:e149.
16. Gomes M, Faiz MA, Gyapong JO, et al. Pre-referral rectal artesunate to prevent death and disability in severe malaria: A placebo-controlled trial. Lancet 2009;373:557-66.
17. Li GQ. Clinical studies on treatment of cerebral malaria with qinghaosu and its derivatives. Clinical trials on Qinghaosu and its derivatives. J Tradit Chin Med 1990;2:125-30.
18. Rothman KJ. Declaration of Helsinki should be strengthened. BMJ 2000;321:442-5.
19. Stang A, Hense HW, Jöckel KH, et al. Is it always unethical to use a placebo in a clinical trial? PLoS Med 2005;3:-72.
20. McCloskey RV, Straube RC, Sanders C, et al. Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. CHESS Trial Study Group. Ann Int Med 1994;121:1-5.
21. Eisenberger MA, Blumenstein BA, Crawford ED, et al. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med 1998;339:1036-42.
22. Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991;324:781-8.
23. Baron JA, Sandler RS, Bresalier RS, et al. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet 2008;372:1756-64.
24. Ehni H-G, Wiesing U. International ethical regulations on placebo-use in clinical trials: a comparative analysis. Bioethics 2008;22:64-74.
25. World Medical Association. Declaration of Helsinki. 2008. http://www.wma.net/en/30publications/10policies/b3/index.html.
26. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. CIOMS, 2002. http://www.cioms.ch/frame_guidelines_nov_2002.htm.
27. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997;337:853-6.
28. Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997;337:847-9.
29. Garrattini S, Bertele V, Li Bassi L. How can research ethics committees protect patients better? BMJ 2003;326:1199-201.
30. Sperling RS, Shapiro DE, Coombs RW, et al. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus Type 1 from mother to infant. N Engl J Med 1996;335:1621-9.
31. Whalen CC, Johnson JL, Okwera A, et al. A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. Uganda-Case Western Reserve University Research Collaboration. N Engl J Med 1997;337:801-8.
32. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997;337:1003-5.
33. Williams JN. The ethics of placebo-controlled trials in developing countries to prevent mother-to-child transmission of HIV. Ann Acad Med Singapore 2000;29:557-62.
34. Benatar SR, Singer PA. A new look at international research ethics. BMJ 2000;321:824-6.
35. Macklin R. Double standards in medical research in developing countries. Cambridge: Cambridge University Press, 2004.
36. World Health Organization. Guidelines for good clinical practice for trials on pharmaceutical products. WHO Technical Report Series, No 850, 1995, Annex 3 World Health Organization, Geneva. http://apps.who.int/medicinedocs/en/d/Jwhozip13e/.
37. European Forum for Good Clinical Practice (EFGCP). Guidelines and recommendations for European Ethics Committees. EFGCP, Leuven, Belgium. 1997. http://www.efgcp.be/Downloads/EFGCP%20Guidelines%20and%20Recommendations%20for%20EEC.pdf.
38. Medical Research Council (UK) (MRC). Guidelines for good clinical practice in clinical trials. MRC, London. 1998. http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002416.
39. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1.
40. Bloom B. The highest attainable standard: Ethical issues in AIDS vaccines. Science 1998;279:186-8.
41. Benatar SR. Reflections and recommendations on research ethics in developing countries. Soc Sci Med 2002;54:1131-41.
42. Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics. BMJ 2001;322:747-8.
43. Krishna S, Planche T, Agbenyega T, et al. Bioavailability and preliminary clinical efficacy of intrarectal artesunate in Ghanaian children with moderate malaria. Antimicrob Agents Chemother 2001;45:509-16.