AIDS DRUG DEFENDED AFTER U.S. ORDERS
By Maggie Fox
Reuters 22 March 2002
Washington -- Researchers rushed on Friday to defend
an important drug that fights the AIDS virus, saying
they feared a U.S. government review of African trials of the drug
would give South Africa's government an excuse to reject it.
Nevirapine is one of the standard drugs used in cocktails that can
suppress the virus. It can also help protect newborns from catching the
virus from their mothers.
But South African President Thabo Mbeki has questioned whether
HIV actually causes AIDS and has moved slowly in
allowing the use of HIV drugs in his country, although South Africa has
the highest rate of HIV infection in the world.
A single Nevirapine pill given to the mother, and a single dose given to
the baby at birth, can cut the cases of mother-to-child transmission of
the AIDS virus in half.
Studies that demonstrated this were done in Uganda in 1999 by
researchers at Johns Hopkins University, the U.S. National Institute of
Allergies and infectious Diseases (NIAID) and Ugandan researchers.
When the results came out, the German manufacturer of the drug,
Boehringer Ingelheim, said it would make it available free in developing
countries, where most of the 40 million people infected with HIV live,
to prevent mother-to-child transmission.
It applied for approval from the U.S. Food and Drug Administration to market Nevirapine for this purpose in the United
Sold under the name Viramune, the drug is already widely prescribed
for adults and children, and doctors are free to prescribe it any way
they wish. But FDA approval is needed for the company to actively
promote the drug for use in preventing mother-to-child transmission in
the United States.
When scientists started going through the data from the 1999 trial done
in Uganda, some "procedural" problems were found, Boehringer and
the NIAID said.
The NIAID told the FDA, which started an investigation.
Drug is Safe and Works Well, Experts Say
The company, government researchers and the FDA itself stressed that
Nevirapine is considered safe and useful. "The issues with this study in
no way affect the safety and efficacy of the product as currently labeled
in the United States," an FDA spokesman said.
But, he added, "FDA believes that these problems are potentially quite
serious. We can't say how they will affect the conclusions of the study."
South Africa's Medicines Control Council said on Thursday it would
consider reviewing the drug in the light of the FDA's findings. This
immediately raised hackles among AIDS activists and researchers.
"I am concerned that people would take this information and misuse it
and not look at exactly what this all means," Sandy Thurman, who
advised former president Bill Clinton on AIDS and who is now
president of the International AIDS Trust, said in a telephone interview.
"The bottom line is we have 600,000 children born every year in Africa
to HIV-infected mothers. If we err on the side of caution at this time,
we lose literally thousands, if not hundreds of thousands, of lives in the
Johns Hopkins spokeswoman Joann Rodgers said the FDA concerns
involve paperwork and documentation, not the actual findings from the
"One of the things they always require are access to primary records,"
she said. "These records were often difficult to obtain. This is not
unusual for research done in developing countries. These records
sometimes are in cardboard boxes with no alphabetization, no names
on them," she said.
"There is no evidence of any underreported deaths or of deaths or
harm to mothers or babies that could be attributed to the drugs used in
The company said it was in the meantime withdrawing its application to
label the drug for use in preventing mother-to-child transmission in the
United States -- labeling which, is approved, would give it a six-month
extension on its patent for Nevirapine.