Kaiser Daily HIV/AIDS Report Date: Sun, 18 Jun 2000
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SOUTH AFRICA: ANTIRETROVIRAL USE DURING LABOR WOULD REDUCE NEW AIDS
CASES WITHOUT STRAINING BUDGET
South Africa could prevent 110,000 new AIDS cases over the next five
years by providing all pregnant women with antiretroviral medicine
during labour, according to a study published in this week's issue of
The Lancet. The effort would cost less than one-thousandth of a per-
cent of South Africa's national health spending and increase the
country's predicted life expectancy in 2005 from 46.6 years to 47.5
years if all women were treated, the study found. "There is actually
a measurable demographic benefit from this kind of intervention,"
lead researcher Evan Wood of St. Paul's Hospital in Vancouver, Can-
ada, said. While programs to prevent mother-to-infant HIV transmis-
sion appear cost-effective, Wood noted that treating just 25% of
those already infected with HIV would siphon off 13% of total health
spending in South Africa. The prediction assumed that a triple cock-
tail would cost US$ 8 per day per patient; each year of life "gained"
over the next five years would carry a price tag of US$ 15,000. By
contrast, treating all pregnant women with antiretrovirals would cost
US $19 per year of life gained, well below the US$ 50 considered
cost-effective for health care interventions in developing countries
(Brown, Washington Post, 6/16). According to BBC News, growing inter-
national pressure to provide HIV treatment for less developed coun-
tries where the virus has become a major health epidemic (BBC News,
6/16).
SPERMICIDE: MANUFACTURER OF ADVANTAGE S FACES LAWSUIT, ETHICS
QUESTIONS
After its Advantage S vaginal spermicide "unexpectedly" failed to re-
duce HIV rates among African and Asian female prostitutes in a five-
year clinical trial, Miami-based Columbia Laboratories' shareholders
are suing the company, charging that insiders sold more than US$ 1
million in stock at inflated prices before the test results were an-
nounced, the Wall Street Journal reports. In March, the company an-
nounced that a "preliminary peek" at the study's data indicated posi-
tive findings of the spermicide's efficacy at protecting women from
HIV. But when researchers broke the study's code last week to assess
the complete results, they discovered that the women who received the
placebo actually had lower rates of HIV, and those that received Ad-
vantage S had higher infection rates. "I spent the next day making
sure there were no errors with all the different languages and par-
ticipants, and we made sure everything was correct. People said yeah,
it truly didn't work," William Bologna, Columbia's president and CEO,
said, adding, "Flabbergasted is the only word I can use."
TRIAL ETHICS DEBATED The company's research methods have raised seri-
ous ethical concerns. The study, conducted between 1996 and May 2000,
enrolled 700 women working as prostitutes in South Africa, Ivory
Coast, Thailand and Benin; half received a placebo and half were
given the Advantage S spermicide. All were given condoms and encour-
aged to use them. While considered unreliable subjects, the company
chose sex workers for two reasons: A result could be achieved quickly
because the women were being exposed to the virus at high rates, and
researchers believed they had a greater say in what types of contra-
ception were used. "Testing these products in real world situations,
where we depend so heavily on the compliance of participants, is very
complicated," Zeta Rosenberg, scientific director of HIV prevention
trials at Family Health International, said. Some researchers ques-
tioned the effect of condom use on the study's findings, suggesting
that "condoms may have clouded the results by adding another product
that could be responsible for blocking HIV infection." But Rosenberg
said, "It would be unethical not to advise the women to use condoms
because that would be leaving those using a placebo totally unpro-
tected." Researchers are now reviewing the study's design to deter-
mine whether something affected the findings that may have implica-
tions for further research (Brannigan/Carrns, Wall Street Journal,
6/16).
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