South Africa rebukes U.S. health officials for promoting AIDS drug in Africa
By ALEXANDRA ZAVIS / Associated Press

Saturday, December 18, 2004

JOHANNESBURG, South Africa --

President Thabo Mbeki's ruling party published a stinging attack Friday on top U.S. health officials, accusing them of treating Africans like "guinea pigs" and lying to promote a key AIDS drug.

The criticism reinforces fears of doctors and activists that new questions about the testing of nevirapine could halt use of the drug that's credited with protecting thousands of African babies from catching HIV from their 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 nevirapine study before President 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 worried about record-keeping problems, violations of federal patient 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 African National Congress 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 United States, the Rev. Jesse Jackson called for a U.S. congressional investigation 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.

Activists in South Africa accused the Health Department and ruling party officials of putting out misleading statements that could frighten patients off their treatment, and worried that governments may now halt use of single-dose nevirapine before alternatives are available.

"NIH may be guilty of a cover up of bad (research) protocols, in which case we would be the first to want them held accountable," said Zackie Achmat, head of the Treatment Action Campaign. "But there is no doubt in my mind about the safety of nevirapine."

Achmat also accused Mbeki of hiding behind an anonymous article. Some 70 percent of the 45 million people worldwide infected with HIV live in sub-Saharan Africa.

[A very different view, describing problems with nevirapine, can be found at the two following references:1. "The Trouble with nevirapine", by Anthony Brink;    2. "PERTH GROUP PRESENTATION ON NEVIRAPINE", by Dr. Valendar Turner   (This information, in italics, was not part of the Detroit News article).]

Studies have shown that a single dose of nevirapine to an infected woman during labor and another dose to her newborn 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, the World Health Organization says. But there's evidence pregnant women who receive a single dose can develop resistance to the drug that can compromise their future AIDS treatment.

A study in Uganda found that 20 percent of pregnant women and 46 percent of their babies developed resistance to nevirapine after taking one dose, a health official said. Scientists don't know the possible long-term effects on the women, said Dr. Philippa Musoke.

"Resistance does occur, but it fades after one year," Musoke said, adding that Uganda will continue distributing the drug "for the time being until we get an alternative."

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 practicality of administering a single dose of nevirapine in impoverished African countries.

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.

The original story, describing how officials withheld criticism of a nevirapine study, was by John Solomon of AP, on December 14, 2004.