DONALD G. McNEIL Jr., writing for the New York Times,  "Furor in Africa Over Drug for Women With H.I.V." December 21, 2004


A series of articles critical of past trials of an
important AIDS drug has created a furor in Africa, causing
many public health experts to worry that some countries
will stop using the drug, which prevents mothers from
infecting their babies with the virus that causes AIDS.

Articles by The Associated Press last week detailing
allegations of incompetence and fraud in clinical trials of
the drug, nevirapine, have been interpreted overseas as an
attack on the drug itself, which has long been a part of
the arsenal of antiretrovirals.

On Friday, the National Institute for Allergy and
Infectious Diseases, an arm of the National Institutes of
Health, sharply criticized the articles, saying, "It is
conceivable that thousands of babies will become infected
with H.I.V. and die if single-dose nevirapine for
mother-to-infant H.I.V. prevention is withheld because of

The lead reporter on the series, John Solomon, referred
questions to an Associated Press spokesman, who said, "When
we discover information we think is important for people to
know, we investigate it thoroughly, write about it and
distribute it."

The articles were based on documents released by a clinical
trials expert who is fighting threats of dismissal by the
National Institutes of Health, which backed a trial of
nevirapine in Uganda in the 1990's and hired him in 2003 to
reassess its safety. The expert, Dr. Jonathan M. Fishbein,
said he felt that the trial was deficient, that department
officials had covered up the flaws, and that it was his
obligation to disclose such fraud.

The institutes have conceded that the trial had some sloppy
record-keeping, but said it still showed that nevirapine
was safe and that subsequent trials in other countries
confirmed that.

On Friday, South Africa's ruling party, the African
National Congress, citing the A.P. articles, accused "top
U.S. officials" of using Africans as guinea pigs and
conspiring with pharmaceutical executives "to tell lies to
promote the sales of nevirapine in Africa."

Zackie Achmat, a South African AIDS activist, said the
reaction by the government was "having a serious impact on
all our work - we're nearly back to square one."

On Thursday, the Rev. Jesse Jackson called the Bush
administration's 2002 decision to underwrite use of
nevirapine in Africa "a crime against humanity."

But groups treating AIDS patients in Africa, including the
Elizabeth Glaser Pediatric AIDS Foundation and Doctors
Without Borders, expressed alarm at the prospect of an
backlash against nevirapine.

They conceded that long-term use of the drug had risks,
like rashes and liver failure, but said that they had been
known for years and that short-term use was often the only
way to save a baby's life. "The truth about nevirapine is
getting widely misrepresented," said Rachel Cohen, a
medicine specialist at Doctors Without Borders, which is
treating about 23,000 Africans for H.I.V. and AIDS.

Most of the 38 million people infected with H.I.V.
worldwide live in very poor countries. More than half are
women, most of them of child-bearing age.

Nevirapine, sold in the United States under the name
Viramune, was approved by the Food and Drug Administration
in 1996 and is widely used in the daily triple-therapy drug
cocktails most AIDS patients take.

But in Africa, Ms. Cohen noted, women often seek medical
care only just before giving birth, and they often have
advanced AIDS. In such cases, it is too late to do anything
but give one dose of nevirapine to the mother and one to
the baby, which cuts the chance of infection by about half.
The two doses cost only $5.

Recent studies indicate that a mother who gets even one
dose of nevirapine is more likely to develop a
drug-resistant strain of the virus, which complicates any
subsequent treatment she gets.

For that reason, the World Health Organization prefers a
six-week course of AZT and nevirapine "when feasible," but
it costs about $40, so the single dose is still used when
it is the only chance to save a baby from infection.

The Associated Press series, which began Dec. 12, described
a dispute within the National Institutes of Health over the
recording of data in Uganda. A second article described the
death of a woman in a clinical trial in Tennessee when a
hospital gave her too much nevirapine.