USA/Africa Dialogue, No. 176: AIDS & Nevirapine

Thank you for your coverage on the AIDS drug Nevirapine. While the report
sheds some light on a very important discussion, please note that there is
much more to the Nevirapine story than current media outlets, including
yours, suggest. A body of well-referenced evidence indicates the most
compelling concern with Nevirapine is not the potential for drug resistance,
but the high incidence of severe and life-threatening effects. These serious
adverse events have been known for quite some time.

Three years ago, the US Centers for Disease Control issued warnings on short
course use of Nevirapine for healthcare workers after 22 medical
professionals treated with the drug suffered severe, life-threatening
hepatoxicity, including one case that required a liver transplant. (Reuters,
January 4, 2001) These dire drug reactions were emphasized again in a recent
issue of the science journal HIV Medicine which noted that more than
two-thirds of healthcare workers taking limited doses of Nevirapine
experience severe adverse events including liver failure. (Feldt, T et al,
HIV Medicine, 2004)

In 1998, high rates of severe hepatic and dermatological toxicities among
Nevirapine users-all life threatening and some fatal-led the European Agency
for the Evaluation of Medicinal Products EAEM) and Cananda's Therapeucic
Products Programme (TTP) to limit Nevirapine's use to only adults
demonstrating immunological deterioration. In 2000, both the EAEM and the
TTP issued special safety alerts on Nevirapine.

The US FDA approved Nevirapine only for administration among adults; it is
not licensed for use by pregnant women in the US, Europe, Canada or any
other industrialized nation. In fact, manufacturer Boehringer Ingleheim (BI)
withdrew its FDA application for single dose use of Nevirapine in expectant
mothers after failing to comply with FDA requests for original data from the
HIVNET 012 trial. In response to FDA inquiries, BI admitted they could
locate only 100 of the 645 medical case files in HIVNET012. Other alarming
irregularities with this trial continue to surface.

Speaking more directly to the topic of Nevirapine's use among expectant
mothers in Africa, although only healthy women were accepted into HIVNET
012, the single trial upon which such use of Nevirapine is based, 80%
experienced clinical or laboratory abnormalities while 7% of their infants
died after just one exposure of Nevirapine. Further, the women involved in
the trial were diagnosed HIV positive based on a single ELISA test, a
protocol that would constitute medical malpractice in the US. As you may
know, the ELISA test kit literature warns that pregnancy can cause false HIV
positive results.

I urge you to conduct further investigation into these and other disturbing
facts on Nevirapine and perhaps provide an answer to the pressing question
only touched upon in your coverage: If Nevirapine is not acceptable for
women and children in the US, what justifies its use among women and
children in Africa?

Please visit the following link to referenced data on Nevirapine
http://aras.ab.ca/haart.html#nevirapine

And please consider contacting Dr. Sam Mhlongo, Head of the Department of
Family Medicine and Primary Care at the Medical University of South Africa,
who in July of 2002 presented the Medicines Control Council in his country
with a fact sheet that raise serious questions about Nevirapine's efficacy
and safety. You may email Dr. Mhlongo <smmhlong@iafrica.com>

With thanks for your interest,

Christine Maggiore
Founder/Director, Alive & Well AIDS Alternatives
Tel 818-780-1875 Cell 818-430-7383 Email Christine@AliveandWell.org