Reposted from AFRO-NETS: http://www.afronets.org

Ethical concerns loom high in HIV drug trials in Nigeria
--------------------------------------------------------

A Nigerian non-governmental organization has concluded that ethical
concerns loom high in HIV drug trials in the country.

The Centre for the Right to Health (CRH), based in Lagos and Abuja,
Nigeria made this assertion in a recent report on the experiences of
People Living with HIV and AIDS (PLWHA) during recently conducted
drug trials.

The trials of various widely publicized cure claims by orthodox and
non-orthodox practitioners were mandated by the National Assembly of
Nigeria and conducted by the federally-owned Nigerian Institute of
Pharmaceutical Research and Development (NIPRD), during 2002.

The Centre initiated its field study following receipt of numerous
complaints from PLWHA regarding "procedures adopted during the drug
trials. Many [PLWHA] complained that they did not properly understand
what the trials were all about. Others complained of serious side ef-
fects to the herbal preparations and inability of the organizers to
provide care and treatment when they occurred", wrote Bede Eziefule,
Senior Program Officer of CRH ([email protected], March 1,
2003)

The objective of the CRH study, which was conducted in four major lo-
cations in Nigeria; Lagos, Abuja, Anambra and Enugu States, was "to
ascertain whether the human rights of participants were respected and
internationally recognized ethical principles for organizing drug
trials were adhered to".

During the research, officers of the trial agency - Nigerian Insti-
tute of Pharmaceutical Research and Development, National Action Com-
mittee on AIDS, principal investigators, claimants, people living
with HIV/AIDS and some other important stake holders were inter-
viewed.

Amazingly, the CRH study found that: "[Internationally accepted]
ethical standards required during drug trials had not been fully com-
plied with;... The consent of the participants at the trials was not
properly obtained;... No provisions were made for compensating par-
ticipants who suffered injury during the trial;... No proper provi-
sions were made for medical attention to those who suffered side ef-
fects during the drug trial;... Issues like setting up of ethical re-
view boards were not fully complied with."

In spite of a local capacity training workshop conducted in Abuja,
Nigeria in December 2001 by the Harvard Program on Ethical Issues in
International Health Research, these findings suggest that great ca-
pacity lapses still exist in local researchers and policy audiences
in Nigeria with regards to ethical issues in HIV research and drug
trials.

The Centre for the Right to Health offered the following recommenda-
tions in its report: "Individual's rights must be taken into consid-
eration when a drug trial is been organized.
* PLWHA should adequately be educated and well informed on the need
to partake in trials.
* Persons recruited for drug trial should be treated with human dig-
nity and adequate compensation provided to them."

Nigeria is Africa's most populous nation and according to UNAIDS
(http://www.who.int/emc-hiv/fact_sheets/pdfs/Nigeria_EN.pdf), was
home to 170,000 AIDS-related deaths, 1 million AIDS-related orphans
and 3.5 million adults and children living with HIV/AIDS between the
ages of 15 - 49 as at end 2001. The country was also recently identi-
fied by the US National Intelligence Council as one of five countries
in addition to Ethiopia, Russia, India, and China that would drive
the next wave of HIV infection world-wide.

A. Odutola
CHPSS, Lagos, Nigeria
mailto:[email protected]