Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Associated Press - December 17, 2004
The article reinforces the fears of doctors and activists that new questions about the testing of nevirapine could halt use of a drug credited with protecting thousands of African babies from catching HIV from their infected mothers.
The article, published in the online journal ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld criticism of a key nevirapine study before President George W. Bush launched a 2002 plan to distribute the drug in 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 way a U.S.-funded drug trial was conducted in Uganda, and later ordered the research to continue over the objections of his staff. Tramont's staff was worried about record-keeping problems, violations of federal patient safety safeguards and other issues at the Uganda research site.
"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 said. "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."
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.
In the U.S>, the Rev. Jesse Jackson called for a U.S. congressional investigation into the report and demanded nevirapine no longer be distributed in Africa.
"This was not a thoughtful and reasonable decision, but a crime against humanity," Jackson 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."
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 in the midst of an AIDS crisis deserved some leniency in meeting tough U.S. safety standards.
Some 70% 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% in wealthier countries. But it says resistance concerns must be weighed against the practicality of administering a single dose of nevirapine in impoverished African countries.
Doctors and AIDS activists in Africa are worried governments may now halt use of single-dose nevirapine before alternatives are available.
"It's an issue affecting people's lives," said Dr. Saul Onyango, who was involved in the testing in Uganda. "A lot of damage has already been done."
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. concerns about the quality of nevirapine research in Uganda, saying it supported its cautious attitude to the drug.
Until this year, Mbeki's government refused to provide anti-retroviral drugs through the public health system, citing safety and cost concerns. A coalition of doctors and AIDS activists won a 2002 Constitutional Court order requiring the government to immediately expand a pilot nevirapine program to all infected pregnant women.
Activists accused the Health Department and ruling party officials this week of putting out misleading statements that could 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," the Treatment Action Campaign said in a statement. "There is to date not a single life-threatening adverse event associated with this regimen which is widely used in the developing world."
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