Second class medicine for developing nations?
5 December 2002 23:00 GMT
by Vicki Brower
Available
drugs and diagnostics for diseases that plague developing nations
are "outrageously outdated," said Carol Nacy, Chief Executive
Officer of the Rockville, MD-based biotech company Sequella.
"Tuberculosis, at the turn of the millennium, is grievously out of
control," said Nacy, speaking at the Partnering for Global Health
Forum in Washington, D.C., an event jointly sponsored by the
Biotechnology Industry Organization (BIO) and the Bill and Melinda
Gates Foundation. "How would you feel if a doctor told you she'd
treat you with 50-year old medicine and 100-year-old diagnostics?
You would be outraged," she said.
Sequella is one of a handful of biopharmaceutical companies
that is focusing its drug development exclusively on global
infectious diseases. The five-year old company is beginning with
TB. Noting that in 2001, two to three million people worldwide
died from this disease, more than 100 million people were tested,
and almost 9 million were diagnosed with TB, Nacy observed that
for a small biotech company, tuberculosis represents both an
urgent global health crisis and an excellent business opportunity.
As a result of successful public and private partnering (with the
Gates Foundation and the National Institutes of Health, among
others), Sequella described the progress of five products through
its pipeline in five short years. It will begin Phase III testing
of a new rapid Patch Test for active TB early next year, a
therapeutic vaccine and the first of its new TB drugs will be in
trials in late 2003/early 2004.
Sequella has been testing its drugs and diagnostics for the
past four years in South Africa, an area extremely hard struck by
the epidemic. During that period, it has trained skilled lab
personnel and set up a clinical site where the epidemiology, human
genetics and molecular epidemiology of TB are being studied. The
team is currently preparing a site for Phase II and Phase III
clinical trials. Along the way the Sequella team has learned that
the need to create trust in the community through understanding -
not just its health problems, but also its politics and culture -
is as important as getting the science right.
Offering some historical perspective, Brian Greenwood of the
London School of Hygiene and Tropical Medicine noted that when he
began working in Nigeria on the prevention of meningococcal
disease in 1978, no studies were conducted with regulatory
oversight. The past 25 years has seen significant change: in East
Gambia, where he recently worked, there is now FDA approval for
trials and five ethics committees. In place, are a regulatory
presence, good clinical practices, and a serious effort to deal
with complex ethical issues, including informed consent and
medical care delivery post-trial. An ongoing issue is whether
trial participants will have access to the product being tested,
however. Moving forward, what is needed is more staff, more
patient education, additional training of ethics committees, and
more clinical trial centers.
While conditions have changed for the better in just the past
10 years in Ghana, serious challenges remain, said Fred Newton
Binka, executive director of the INDEPTH Network based at the
University of Ghana, a nongovernmental organization comprised of
28 demographic surveillance system field sites in 16 countries.
INDEPTH monitors 1.8 million people at a household-level as a
platform for the design and evaluation of healthcare innovations
and research studies.
Binka recounted experiences from trials in Ghana with vitamin A
supplementation, permethrin-impregnated nets for children's sleep
areas, intermittent treatment of malaria, rotavirus vaccine and
tafenoquine for malaria prevention. While the Ministry of Health
has forged links with universities and other partners to improve
research training and disease control, regulatory practices are
still thin or non-existent, there is a dearth of labs, good
clinical and lab practices practice are rudimentary or lacking,
and ethics boards are bare-bones, says Binka.
"There are serious inequalities in power and advantage in
conducting clinical research in developing countries," agreed
Sandy Thomas, director of the UK's Nuffield Council on Bioethics.
Last May, the Council published a critical report on research
ethics, which was precipitated by a controversial study published
three years ago in the New England Journal of Medicine on
the reduction of HIV transmission to infants by short-course AZT
therapy. Is it ethical to develop a second - inferior - standard
of care for developing countries because of a lack of resources,
Thomas asked.
The Nuffield report suggests a framework of duties and
responsibilities of those who design clinical trials for
developing nations, identifying minimum requirements to be met in
all circumstances. It encourages nations to set their own
priorities for health care, and to set up their own guidelines.
"The existing international - CIOMS and Helsinki - guidelines on
research ethics are ambiguous, too diverse, and need revision,"
she said.
The Council identified the key issues of informed consent,
standard of care (universal compared with what is available in a
particular region), post-trial access to drugs and diagnostics,
the ethical review of research, and the role of sponsors as
particularly pressing. It recommended that the universal standard
of care be offered to the control group after the trial; where not
appropriate, the minimum is the best treatment offered by the
national public health system. It also recommended that post-trial
access to all should be secured for effective interventions. In
spite of current pitfalls, "it is not only possible but absolutely
essential to do this research in developing countries," urged
Thomas.

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