AFRICA: Furor in Africa over Drug for Women with HIV

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

AFRICA: Furor in Africa over Drug for Women with HIV

New York Times (12.21.04) - Tuesday, December 21, 2004
Donald G. McNeil Jr.

Many public-health experts are worried that some countries in Africa will stop using nevirapine to prevent mother-to-baby HIV transmission in the wake of a series of Associated Press articles critical of trials of the drug. AP's articles, which allege incompetence and fraud in trials of the drug, are being seen overseas as an attack on nevirapine itself.

The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, on Friday sharply criticized AP's series: "It is conceivable that thousands of babies will become infected with HIV and die if single-dose nevirapine for mother-to-infant HIV prevention is withheld because of misinformation."

The articles are based on documents supplied by Dr. Jonathan Fishbein, a clinical trials expert hired by NIH in 2003 to reassess a US-backed 1990s trial of nevirapine in Uganda. Fishbein said department officials had covered up the trial's deficiencies and it was his obligation to report such fraud. Fishbein is fighting threats of dismissal from NIH; it has acknowledged some poor record-keeping in the trial but said the results still showed nevirapine is safe and that subsequent trials elsewhere have confirmed this.

The Elizabeth Glaser Pediatric AIDS Foundation and Doctors Without Borders, which treat patients in Africa, fear a backlash against nevirapine.

DWB's Rachel Cohen, a medicine specialist, said African women with AIDS often seek care only just before giving birth, when their disease is typically advanced and it is too late to do anything but administer single-dose nevirapine to the mother and baby, which cuts the risk of transmission by about 50 percent. The two doses cost about $5.

As some studies have shown the single dose can lead to the development of drug-resistant virus in the mother, the World Health Organization endorses a six-week regimen of AZT and nevirapine "when feasible." But as this costs about $40, the single dose of nevirapine is still used when it offers the only chance to prevent transmission to the infant.
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