Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

Reuters NewMedia - December 18, 2004
Rebecca Harrison

The African National Congress (ANC) said on its Web site U.S. health officials had "conspired" with German drug firm Boehringer Ingelheim to hide adverse effects of nevirapine when used to try to prevent mother-to-child HIV transmission.

Media reports have suggested tests on the drug's use with pregnant women in Uganda were flawed and that single-dose treatments of nevirapine could result in future drug resistance.

The United States has denied the charges and said while there were some procedural problems with the tests the results pointing to a dramatic reduction of HIV transmission were sound.

But the ANC issued a strong response late on Friday saying President Bush and his government, which distributed the drug across Africa in a high-profile gesture of support for the AIDS-ravaged continent, must be "held accountable" for inaction.

"(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," the ANC said in its weekly newsletter.

Quoting reports by the news agency Associated Press, which first ran the story, the ANC said top officials at the U.S. National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) had arranged to pull a U.S. application for the drug once concerns were raised.

"NO BEARING ON SAFETY"

The ANC quoted the report as saying the NIH knew about problems with the drug but did not tell the White House before Bush launched a plan to distribute the drug throughout Africa.

There was no immediate response from the U.S. government to the ANC charges.

But the U.S. National Institute for Allergy and Infectious Diseases (NIAID), a unit of the U.S. National Institutes of Health and which funded the study, denied in a statement on its Web site dated Dec. 17 that NIH officials chose not to inform the White House about safety issues concerning the drug.

NIAID said only procedural problems had been identified at the point the president was to announce his AIDS program.

"NIH officials did not directly inform the White House of these procedural problems identified in early 2002 because they had no bearing on the safety and efficacy of single-dose nevirapine used to prevent mother-to-infant transmission of HIV," NIAID said.

Privately-owned Boehringer Ingelheim said on Saturday nevirapine was not ideal but served a purpose in Africa and that no adverse effects had been recorded apart from when it was used as a long-term therapy, rather than a short-term treatment for pregnant women.

"Nevirapine is not the optimal solution, but it is working and there is no better help in very poor countries to prevent HIV-positive mothers passing the virus on to their children," a company spokesman said in Germany.

The company said on its Web site a 2002 audit of Ugandan site where the study occurred was sent to the NIH, Ugandan and U.S investigators "to encourage prompt correction of observed procedural deficiencies prior to the planned FDA audit."

FEAR OVER WRANGLING

It said the FDA audit was canceled because the Ugandan study could not correct the problems in time to satisfy a regulatory time frame, but that the overall conclusions regarding the safety of the drug "have remained intact."

The NIAID said it had asked the Institute of Medicine, a part of the U.S. National Academy of Sciences, to conduct an independent review of the study.

HIV/AIDS killed up to 2.2 million Africans last year and around two thirds of the 38 million people worldwide with AIDS live in sub-Saharan Africa, according to the United Nations. South Africa has the highest AIDS caseload in the world.

Doctors and AIDS activists in Africa have expressed concern that wrangling over nevirapine may prompt governments to halt the use of the antiretroviral drug, which is credited with protecting thousands of babies from infection.

South Africa President Thabo Mbeki's spokesman declined to comment on whether the ANC newsletter reflected the views of the president, who has been criticized for being too slow to respond to HIV/AIDS, which affects one in nine South Africans.

(Additional reporting by Frank Siebelt in Frankfurt)

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