Sun, Dec 19, 2004 - Page 6 News List

Africans `guinea pigs' for new drugs, Mbeki says

EXPERIMENT?The South Africa president said Africans were given a new AIDS drug that has yet to be tested, but US doctors and drug companies say there's nothing to fear


President Thabo Mbeki's ruling party published a stinging attack on top US 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 Friday in the online journal ANC Today, was responding to reports this week that US health officials withheld criticism of a nevirapine study before US President George W. Bush launched a 2002 plan to distribute the drug in Africa.

Documents show Dr Edmund Tramont, chief of the National Institutes of Health's AIDS division, rewrote an NIH report to omit negative conclusions about the way a US-funded drug trial was conducted in Uganda, and later ordered the research to continue over the objections of his staff. Tramont's staff complained 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.

Leading AIDS activist Zackie Achmat accused Mbeki of hiding behind an anonymous article, saying, "President Mbeki does not have the courage to publicly declare his views on HIV."

In the US, the Reverend Jesse Jackson called for a US 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 US and other Western countries must never be pushed onto Africa."

Dr 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 US 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 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's evidence women who receive a single dose during pregnancy can develop resistance to the drug that can compromise their future AIDS treatment.

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