Africans Irate Over U.S. AIDS Drug

Aids in Africa
President Thabo Mbeki's African National Congress party carried an article in its online journal Friday accusing top U.S. officials of treating Africans like guinea pigs and telling lies to promote the sales of a key AIDS drug.

The article, published in ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld concerns about a key nevirapine study before President Bush launched a 2002 plan to distribute the drug in Africa to protect newborns from catching HIV from their infected mothers.

In the United States, the Rev. Jesse Jackson called for a U.S. congressional investigation into the report and he demanded nevirapine no longer be distributed in Africa.

"This was not a thoughtful and reasonable decision, but a crime against humanity," he said Thursday in Chicago. "Research standards and drug quality that are unacceptable in the U.S. and other Western countries must never be pushed onto Africa."

Documents obtained by AP show Dr. Edmund C. Tramont, chief of the National Institutes of Health's AIDS division, rewrote an NIH report to omit negative conclusions about the safety and conduct of a U.S.-funded drug trial in Uganda, and later ordered the research to continue over the objections of his staff.

"In other words they entered into a conspiracy with a pharmaceutical company to tell lies to promote the sales of nevirapine in Africa, with absolutely no consideration of the health impact of those lies on the lives of millions of Africans," the article said.

"Dr. Tramont was happy that the peoples of Africa should be used as guinea pigs, given a drug he knew very well should not be prescribed," the article added.

Smuts Ngonyama, an ANC spokesman and editor of the journal, said the article was an opinion piece by a member and didn't reflect official party policy. He wouldn't identify the author.

Dr. H. Clifford Lane, the NIH's No. 2 infectious disease specialist and one of Tramont's bosses, has said an internal review cleared Tramont of scientific misconduct.

He said Tramont changed the report because he was more experienced than his safety experts and had an "honest difference of opinion." Tramont has also argued that Africans with an AIDS crisis deserved some leniency in meeting tough U.S. safety standards.

Some 70 percent of the 45 million people worldwide infected with HIV live in sub-Saharan Africa.

Studies have shown that a single dose of nevirapine to an infected woman during labor and another dose to her newborn baby can reduce the chances of HIV transmission by up to 50 percent. Nevirapine is also used in combination with other drugs to prolong the lives of AIDS patients.

Subsequent research has confirmed the safety and efficacy of nevirapine in protecting newborns, according to the World Health Organization. But there is evidence that women who receive a single dose during pregnancy can develop resistance to the drug that can compromise their own future AIDS treatment.

WHO recommends nevirapine be used in combination with other drugs where possible — a strategy that has reduced transmission to less than 1 percent in wealthier countries. But it says resistance concerns must be weighed against the simplicity and practicality of administering a single dose of nevirapine in impoverished African countries.

Doctors and AIDS activists in Africa are worried governments may halt use of single-dose nevirapine, which has protected thousands of babies from HIV infection in reaction to the concerns about the drug's testing and effect on pregnant women.

In July, South Africa's Medicines Control Council recommended that nevirapine only be used in combination with other drugs because of the resistance concerns.

The Health Department this week welcomed U.S. criticism of the Uganda study, saying it echoes its own worries about the safety of nevirapine..

AIDS activists in South Africa accused the Health Department and ruling party officials of putting out misleading statements that can frighten patients off their treatment.

"The criticisms leveled by the parties involved in the NIH news story ... do not provide evidence questioning the safety or efficacy of short-course nevirapine," said the Treatment Action Campaign, which has led efforts to increase access to anti-retrovirals in South Africa.

"There is to date not a single life-threatening adverse event associated with this regimen which is widely used in the developing world."

Mbeki's government has been criticized for its sluggish response to the AIDS pandemic, which is killing at least 600 South Africans a day, according to U.N. figures.

The government refused to provide single-dose nevirapine at more than 18 pilot sights until it was ordered to expand the program to all infected pregnant women by the Constitutional Court in 2003.