FIVE WOMEN DIE DURING ANTI-AIDS DRUG TRIAL IN
Agence France Presse 5 April 2000
Cape Town, April 5 (AFP) - Five South African women have died
during an ongoing clinical trial of anti-retroviral AIDS drug
Nevirapine, Health Minister Manto Tshabalala-Msimang told
Two of the deaths were caused by hepatitis, while a link between
Nevirapine and the other three fatalities was "probable," the
A total of 510 pregnant women who are HIV-positive are on the
trial, which is being overseen by the country's Medicines Control
Tshabalala-Msimang said the deaths in the Nevirapine trial
underscored the need for caution.
"It would be immoral and unethical for government, despite the
numerous requests that we are receiving ... to attempt to make
policy decisions regarding the use of Nevirapine in our country,
until the full results of the clinical trails of the drug are
This would be in June or July, she added.
AIDS activists have called on government to make available either
Nevirapine or the more expensive drug AZT freely available to
pregnant women who are HIV positive to prevent mother-child
transmission of the disease.
But President Thabo Mbeki has banned the supply by the state of
AZT to pregnant women, partly because of cost, but also because
he maintains it could be dangerous for women's and babies'
health, although it is prescribed for pregnant women in many
Tshabalala-Msimang told parliament that based on results of the
Nevirapine trial so far, "there is a death rate of one percent
and a liver toxicity profile of 11 percent."
"These are serious findings," she said."As a result, the MCC has
halted any further recruitment of study subjects while full
reports are being compiled on all serious adverse events,
including the five deaths."
Nevirapine has been used in Uganda to reduce mother-child
transmission of HIV but, according to Tshabalala-Msimang, trials
in that country are still inconclusive.
Opposition parties called on the government not to halt the
Nevirapine trial, saying the drug had proved itself in clinical
trials in other countries to be at least as effective as AZT at a
fraction of the cost.
"There are so many advantages to using the drug," said Sandy
Kaylan of the main opposition Democratic Party.
"It is easy to administer ... and it is cheap," she said. "It
reduces transmission in early infancy. There is nothing immoral
in giving an HIV positive mother and her baby Nevirapine. You are
giving them hope."
Supporting her, Kobus Gous of the New National Party pointed out
that the clinical trial in question involved a "cocktail" of
anti-AIDS drugs and that it had not been shown conclusively that
Nevirapine caused the deaths.
Latest government figures show that 3.6 million South Africans --
nine percent of the population -- were HIV-positive in 1998.
Projections by the UN AIDS programme indicate that by 1999 that
figure will have risen to some 12.4 percent, or nearly five