The World Health Organization (WHO) approved Viramune, an anti-AIDS drug, on Thursday, despite warnings from the US Food and Drug Administration (FDA) that the medicine could cause liver damage.
The benefits outweigh side effects
The WHO said it would not change its policy on Viramune because the advantages from the drug outweighed any side effects that might be caused by the drug. Viramune, also known generically as Nevirapine, is an anti-AIDS drug produced by Boehringer Ingelheim, Germany's top drugmaker in terms of sales.
Boehringer provides the drug free of charge to poor countries as an antiretroviral which prevents mother-to-child transmission of HIV, and said they will not stop this practice.
On Wednesday the FDA revised the side effects warnings and said doctors should weigh benefits and risks before prescribing Viranume. The drug has been linked to some deaths, including those of pregnant women.
Viramune is offered free in some developing countries through a "Viramune donation program" run by Boehringer as a way to prevent HIV transmission from mother-to-child. It is also part of a subsidized anti-AIDS cocktail used as a continuous therapy.
A spokeswoman for Boehringer said they do not expect any major changes on their sales or from doctors as a result of the warning from the FDA. And there will be no influence on the donation program or the continuing supply of the drug to developing countries at reduced prices.
Controversy from South Africa
In South Africa, Viramune is a sensitive issue. South Africa has the world's highest caseload of HIV and AIDS. The country has about 5 million infected people, out of a population of 45 million. Activists estimate about 600 people die daily from HIV and AIDS-related disease.
South African health officials and activists involved in the fight against AIDS have stood by Viramune. However, the ruling political party, the African National Congress (ANC), said the FDA warning about the drug proved its concerns about using Viramune were valid.
Last month the ANC sparked controversy by accusing US officials and Boehringer of hiding the side effects of Viramune. The charges were disputed by US authorities.
The FDA said cases of liver damage that produce rashes, fever or other symptoms were more common with Viramune than with other anti-AIDS drugs. It says no serious liver toxicity or deaths had been reported when a single dose was given to prevent mother-to-child transmission of the HIV virus.
In 2003 Viramune had sales of over €300 million, making it Boehringer's sixth-biggest drug.
Zackie Achmat, the head of the South Africa's leading AIDS lobby is himself on antiretroviral treatment and agrees with an official from Doctors Without Borders, who said no drug is perfect. Achmat says the FDA findings are nothing new and that all antiretroviral drugs are known to have side effects, including liver damage.