HEALTH AND HUMAN RIGHTS
engaging in risky sexual behaviour.
Similar strategies will be developed for
all HVTN sites.
HVTN’s decision to provide antiretrovirals might set a precedent for
HIV-1 vaccine trials in developing
countries. However, the decision may
not be relevant for other HIV-1 prevention research, which might not
require the capacity needed to support
antiretroviral delivery, or involve follow-up of disease progression.
One research organisation cannot
reverse global inequities in HIV-1
care, but researchers from wealthy
countries who work with resourcepoor countries have an obligation to
try to narrow the equity gap. HIV-1
vaccine researchers can work with
communities to develop, implement,
and assess high-quality treatment
models for participants in research
programmes, and encourage the development of sustainable community
access to good quality HIV-1 care.
1
HVTN is supported by NIAID of NIH. Ethics
discussions were also supported by the NIH
Fogarty International Center.
4
2
3
*Daniel W Fitzgerald, Jean William Pape,
Judith N Wasserheit, George W Counts,
Lawrence Corey
5
The HIV Vaccine Trials Network (HVTN),
Seattle, WA 98109, USA
(e-mail: [email protected])
UNAIDS. Ethical considerations in HIV
preventive vaccine research. Geneva:
UNAIDS, 2000.
WHO. Scaling up antiretroviral therapy in
resource limited settings. Geneva: World
Health Organization, 2002.
CIOMS. International ethical
guidelines for biomedical research
involving human subjects. Geneva:
CIOMS, 2002.
Amara RR, Villinger F, Altman JD, et al.
Control of a mucosal challenge and
prevention of AIDS by a multiprotein
DNA/MVA vaccine. Science 2001; 292:
69–74.
Barouch DH, Kunstman J, Kuroda MJ,
et al. Eventual AIDS vaccine failure in a
rhesus monkey by viral escape from
cytotoxic T lymphocytes. Nature 2002;
415: 335–39.
HIV-1 care in resource-poor settings: a view from Haiti
hen asked, “Have you no
morals?” Alfred Doolittle, in
George Bernard Shaw’s Pygmalion,
answered: “Can’t afford them, governor. Neither could you if you was as
poor as me.”1 The modern concept of
human rights underpins a moral society and holds governments responsible
for fulfilling these rights. From
informed consent to the right to
privacy, civil and political rights have
dominated the human rights focus of
the HIV-1 epidemic. Yet, the
economic and social rights of people
with HIV-1 infection, in particular the
rights to health care and to share in
scientific advances, are glaringly disparate between rich and poor countries. This disparity has become the
focus of debate in transnational HIV-1
vaccine research.
Haiti, whose yearly health budget is
$US15 million, less than $2 per person
per year, is one of the sites for the HIV
Vaccine Trials Network (see page
993). Health care and HIV-1 treatment
will be guaranteed to trial participants.
Yet, Haiti’s public-health infrastructure
cannot provide even basic medical care
for the rest of the population. How can
governments as poor as Haiti’s fulfil the
right to health care without external
help?
The Global Fund to Fight AIDS,
Tuberculosis and Malaria is the first
international fund with which antiretrovirals can be purchased. With help
from the Haitian Ministry of Public
Health, money from the fund has been
used to provide HIV-1 prevention and
treatment throughout Haiti: in Port au
Prince at GHESKIO centres, and in
central Haiti by Partners In Health’s
HIV Equity Initiative (HEI).
Providing a comprehensive HIV-1
treatment programme has necessitated
revitalising the public-health infrastructure, and improving the delivery of
essentials such as vaccination, sanitation, and clean water. For example, the
Clinique San Michel in Boucan Carre
serves a rural population of 40 000.
Because of the financial crisis in Haiti,
the clinic was in disrepair, poorly
stocked, and inadequately staffed (figure 1). During the past 10 years, fewer
than ten patients per day were seen and
no testing or treatment for HIV-1 or
tuberculosis offered. Early in 2003,
HEI stocked the clinic with essential
medicines, hired and trained health
workers to do active case finding, and
increased wages to prevent the drain of
staff from this rural area to Port au
Prince. After 6 months, the clinic sees
more than 150 patients for general
medical care daily (figure 2), does more
than 100 HIV-1 tests per month, and
treats about 100 patients for tuberculosis. Thus, improving basic health care
has been a building block in expanding
HIV-1 prevention and treatment.
Certainly, the search for a vaccine is
of urgent importance. Yet the achievements of the first two decades of HIV-1
research, in particular HAART, have
not been shared with resource-poor
countries. Not only are poor governments unable to provide HAART, but
also the public-health community has
opposed provision because of cost and
perceived competition with resources
for HIV-1 prevention.2
In 1998, in rural Haiti, we began
providing HAART to a few patients
with advanced AIDS. This effort was
met with scepticism because of cost
and the perceived lack of evidence that
such therapy would be feasible,
sustainable, or effective in resourcepoor settings.3,4 Access to HAART has
now been scaled up, and should cover
all central Haiti and Port au Prince in
Figure 1: Clinique San Michel, January, 2003
994
Copyright 2002 © Partners In Health
Copyright 2002 © Partners In Health
W
Figure 2: Clinique San Michel, July, 2003
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Copyright 2002 © Partners In Health
HEALTH AND HUMAN RIGHTS
Figure 3: Before initiation of HAART
Figure 4: After 1 year of HAART
the next 5 years. A patient in rural
Haiti comments: “I was a walking
skeleton before I began therapy. I was
afraid to go out of my house and no
one would buy things from my shop.
But now I am fine again. My wife has
returned to me and my children are
not ashamed to be seen with me. I can
work again”, (figures 3 and 4).
Governments are the guarantors of
human rights, but it is only with
international assistance that the government of Haiti has been able to
begin to address the right to health.
The Global Fund is the first step
towards a worldwide responsibility to
fulfil this right. However, the fund
lacks support from donors and will
not meet its financial needs for the
third round of proposals.5 If the
medical community is to use data
generated in high-burden and
vulnerable populations to develop an
HIV-1 vaccine, we must ensure that
the global community will help
governments fulfil the right to health
and share the fruits of research with
the world’s poorest communities.
Joia S Mukherjee
Partners In Health, Division of Social Medicine
and Health Inequalities, Harvard Medical
School, Boston, MA 02115, USA
(e-mail: [email protected])
1
2
3
4
5
Shaw B. Pygmalion. New York: Brentano,
1916.
Marseille E, Hofmann PB, Kahn JG. HIV
prevention before HAART in sub-Saharan
Africa. Lancet 2002; 359: 1851–56.
Farmer P, Léandre F, Mukherjee JS.
Bull World Health Organ 2001; 79:
1145–51.
Gilks C, AbouZahr C, Türmen T.
HAART in Haiti—evidence needed.
Bull World Health Organ 2001; 79: 1154–55.
Fund the Fund. The current funding crisis.
http://www.fundthefund.org/crisis.html
(accessed July, 2003).
Not if but how? Caring for HIV-1 vaccine trial participants in South Africa
t a national health research ethics
meeting in South Africa in
February, 2003, it was proposed that
participants who became HIV-1
infected during HIV-1 vaccine trials
should have access to high quality
HIV-1 treatment, and moreover, that
this should be financed by trial sponsor
agencies. Ethics arguments for sponsor
financing have been described (CS,
unpublished data); the challenge now
is logistical. Establishing a national
mechanism to manage treatment and
care for more than 10 years after a trial
ends is a complex task, especially in
resource-poor settings. We propose a
way to do this in South Africa.
Our solution is for the government
to establish a trust fund, nationally
operated by a managed health-care
service provider. Volunteers who
become infected during trials could
access a national network of doctors
for HIV-1-related treatment and care.
Issuing volunteers with an identity
card specifying a telephone helpline
number that they could call, irrespective of their location in South Africa,
would enable them to move around
the country without prejudicing access
to medical care.
Treatment and care would be
financed by sponsor agencies, but this
would be the limit of their long-term
responsibilities. Sponsors would
commit a fixed amount of money per
A
infected volunteer per year to cover
these costs for at least 10 years.
This mechanism would not constitute a broad medical aid—ie, infected
volunteers would receive regular
HIV-1-related care, such as viral load
monitoring and CD4 cell counts, and
vaccinations and access to antiretrovirals as stipulated by South African
HIV Clinicians Society treatment
guidelines. However, should volunteers develop the complications of later
stages of AIDS, such as tuberculosis or
meningitis, they would be referred for
treatment in the public sector.
All laboratory and clinical data
obtained by the managed health-care
provider from infected volunteers
would be collated on a central national
database and, with the informed consent of volunteers, could be accessed
by the investigator team and sponsors
to track the progress of trial participants. So far, one potential managed
health-care provider has volunteered
to provide this service, as part of their
corporate responsibility programme,
and certain international agencies have
agreed in principle to the mechanism.
Our proposal would allow trial
sponsors in South Africa to operate
within a higher than routinely available
standard of care framework, using a
defined national mechanism. It would
ensure that volunteers in all trials
receive similar treatment, that service
provision is the responsibility of
national providers of health care rather
than of researchers, and would enable
a positive public-private partnership.
This approach is possible in South
Africa because of national privatesector managed health-care capacity,
but may not suit low-income countries
without such infrastructure. The
mechanism does not redress inequities
in HIV-1 treatment between public
and private sectors, and until there is
universal access to antiretroviral
treatment programmes, might even
introduce inequalities between volunteers in HIV-1 vaccine trials and those
in other HIV-1 preventive trials
and other community members.
Therefore, researchers should attempt
to build heath-care service delivery
capacity at trial-linked community
centres, and ensure that the whole
community benefits.1 Our proposal is a
practical attempt to address the
challenges of long-term, high-quality
treatment provision.
We thank Prof S Benatar for his advice.
*T Tucker, C Slack
*South African AIDS Vaccine Initiative, PO Box
19070, Tygerberg 7505, South Africa (TT);
HIV/AIDS Vaccines Ethics Group, University of
Natal, Pietermaritzburg, South Africa (CS)
(e-mail: [email protected])
1
Benatar SR, Singer PA. A new look at
international research ethics. BMJ 2000; 32:
824–27.
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