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Clinical trials in Madagascar :
past and today
Voahangy RasolofoUnité des Mycobactéries
Institut Pasteur de Madagascar
"Ethical Issues in Clinical Trials" European Commission Project “TBETHICS”
Institut Pasteur, Paris, October 29th-30th, 2003
since the creation of the Institut Pasteur de Madagascar at the end of the 19th century…
Evolution of the value senses and issues when considering clinical trials,
… to now
At the end of the 19th century,
1896 : Madagascar, French colony / Gal Galliéni urgent problem of smallpox and rabies
in the general interest,1898 : "Institut vaccinogène et antirabique de Tananarive"
Director : André Thiroux
1899 : "Institut Pasteur de Tananarive"
1900 : Delivery of smallpox vaccine…
… and rabies vaccine
Plague’s epidemic since 1921
1922 : Georges Girard,physician, scientific and humanist
1927 : "Institut Pasteur de Madagascar"
1946 : therapeutic regimen for plague WHO
1931 : Vaccine EV against plague (G. Girard and J. Robic)Efficacy in laboratory animalsHuman experimentation they inoculated themselves
1932 : Authorization / General Governor of the colonyVaccination campaign
Tuberculosis
1924 : BCG strain from Calmette
1926 : production of the BCG vaccinefirst vaccination of infants with BCG vaccine
1949 : treatment of pulmonary TB with streptomycin (18 patients)
1993 : production of BCG vaccinebrought to an end
New orientation of the IPM,
1961 : Agreement between IPM andMalagasy Republic
Public Health / coll. Ministry Health
1975 : IPM, in the International Networkof the Pasteur Institutes
From the independence of Madagascar,
In the 1990s,
In absence of any Ethical Committee, the Minister of Health issued with authorization for studies :
- treatment of chromomycosis- malaria / chloroquine- treatment of scalp pediculosis with different pediculicides/ "Comité Consultatif Français de Protection des Personnes dans la Recherche Médical" (Madagascar in the protocol)
- TB: ethambutol vs streptomycin(2EHRZ/HT vs 2SHRZ/HT)
At the end of 1990s,
- Several projects concerning therapeutic trial in human beings were submitted to the Ministry of Health
- Art. 17 and 19 of the Malagasy Constitution, recognize that each subject has a right to health, etc.
By decree n°5855/99-SAN of June 17, 1999, modified by the decree n°4583/2000-SAN of May 08, 2000,
Creation of the National Ethical Committee for Biomedical Researches
Internal Regulations of the NEC
-role and mission
-attributions
-functioning : compositionorganisationdeliberationmeeting (at least 1/year)legal
Appointment of the members by the Minister of Health
- Ministry Scientific Research- Ministry Law- Ministry of Health- Enseignement supérieur- Faculty of Medicine- Hospitals- Research institutes : IPM, CNARP, IMRA- “Comité National de Défense des Droits de l’Homme”- Dentists’ Association- Malagasy Medical Association- Chemists’ Association- Midwife- Catholic- Protestant
Institution / Projects
Ministry of Health
National Ethical Committee
Advice
Authorization
NEC operational since February, 2001
5 projects examined in 2001 :
-1 on schistosomiasis / Institut Pasteur de Madagascar
Since 2002, New President, New Government...and actually, restructuring of the NEC ,
- workshop for the members of the NEC- updating the functioning rules- guidelines for the NEC members
As a consequence, all projects are on holdIPM :malaria, tuberculosis…
1- tuberculosis (VACSIS / UE) : problem of the introduction of the HIV test in the protocol
and...
2- A serious problem that should be examined by the NEC
Country Z- disease X absent, but worrying it could be introduced-production of drug B, but no animal model proving its efficacy
Madagascar- disease X present- treatment (WHO) with drug A / good efficacy - Drug B not available
“Safety and efficacy of the drug B versus A for the treatment of the human disease X: to verify in Malagasy patients that drug B efficacy is not inferior to drug A“
Country Z / Project
Ministry of Health
National Ethical Committee
Advice
IPM as a collaborator
unfavourable
Country Z / Projects
Ministry of Health
National Ethical Committee
Advice
Authorization
IPM as a collaborator
unfavourable
In developing countries,
Political interests > ethics ?
But which solution to face this problem :
Conclusion,
Ethical issues in clinical trials in developing countries :
Human rights,consentcultural issuesetc.