South African Ruling Party in Online Newsletter Accuses U.S. of ‘Conspiracy’ in Nevirapine Trials

South Africa's ruling party, the African National Congress, in an article published on Friday on its Web site accused the United States of treating Africans like "guinea pigs" and "enter[ing] into a conspiracy" with a German pharmaceutical manufacturer to conceal potential adverse effects of the antiretroviral drug nevirapine, Reuters reports (Harrison, Reuters, 12/18). The article comes in response to recent controversy over NIH's research on the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to prevent vertical HIV transmission. The initial results from the research, which began in 1997, showed that the drug prevented HIV transmission to newborns in as many as half of the births. However, by early 2002, medical safety specialists, an auditor with NIH and the drug's manufacturer Boehringer Ingelheim all cited "widespread" problems with the research in Uganda -- including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research for 15 months from spring 2002 to summer 2003 to review the trial and take corrective steps. Last week, Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, admitted that he altered a safety report on the use of nevirapine in pregnant women to change its conclusions and remove negative information about the drug (Kaiser Daily HIV/AIDS Report, 12/17).

Criticism
The ANC said that President Bush and his administration must be "held accountable" for their lack of action regarding the drug's use in Africa (Reuters, 12/18). The article, which was unsigned, 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. In other words, [U.S. officials] 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" (Zavis, AP/Detroit News, 12/18). The article also "implied that there had been numerous deaths due to nevirapine that had been covered up by the U.S. authorities to promote their own ends," according to SAPA/News24.com (SAPA/News24.com, 12/18).

Reaction
According to London's Guardian, ANC's "bitter" letter has "renewed a long-simmering battle between" South African President Thabo Mbeki and HIV/AIDS advocates in the country. The letter also said that the South African HIV/AIDS treatment advocacy group Treatment Action Campaign is "part of a plot to market unsafe drugs" in the country and is "desperate to ensure that the truth does not undermine its drug marketing campaign," the Guardian reports. TAC Chair Zackie Achmat said that the organization has "demand[ed] an apology," according to the Guardian. "Several of us want to sue the ANC for defamation. We have to consider that very carefully, and we will put it to our executive committee for a decision in early January," Achmat wrote in an e-mail (Meldrum, Guardian, 12/20). TAC spokesperson Mark Heywood said that a 2002 South African Constitutional Court ruling requiring the government to provide medications to HIV-positive pregnant women to reduce the risk of vertical HIV transmission "did not bind the Health Department to the use of nevirapine and also paved the way for them to change their regimen as they saw fit." He added, "We always maintained that there were better regimens. At the time, our drug of choice was AZT. It was the South African government that decided to use nevirapine, largely on the basis of the Uganda trial." Achmat also accused Mbeki of writing the article, saying, "President Mbeki does not have the courage to publicly declare his views on HIV." ANC spokesperson Smuts Ngonyama denied that Mbeki was the author and said the article is an "opinion piece" from an unidentified party member (SAPA/News24.com, 12/18). A spokesperson for Mbeki declined to comment on the president's opinion of the ANC article.

U.S., Boehringer Ingelheim Response
The U.S. government had no immediate response to the ANC accusations, but NIAID on Friday in a statement on its Web site denied withholding from the White House information about the adverse effects of nevirapine. NIAID said NIH had not informed the president of "procedural problems" found during the trial "because they had no bearing on the safety and efficacy of single-dose nevirapine used to prevent mother-to-infant transmission" (Reuters, 12/18). NIAID also on Friday posted on its Web site a document containing questions and answers about the use of nevirapine and the recent press reports regarding the Ugandan trial (NIAID fact sheet, 12/17). Boehringer Ingelheim said the medicine is intended as a short-term treatment and no adverse effects had been found when it was used over the short term, according to Reuters (Reuters, 12/18).