On 2002.03.21 23:41 TAC News Service wrote:

Government Creating Smokescreens and Red Herrings Over Nevirapine
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In a speech today in Alexandria, Johannesburg, the Minister of Health once
more called into question the safety and efficacy of Nevirapine. Yet again
she has done so without any scientific basis. The inflammatory nature of
her speech and the continued baseless attacks on life-saving medicines that
have been proven safe and effective are highly irresponsible. This is a
desperate attempt to create smokescreens and red herrings to divert public 
attention from her department's failure to accept the Pretoria High 
Court's decision on mother-to-child transmission prevention.


In her latest attempt to deny life-saving medicines, the Minister referred
to an application by Boehringer Ingelheim (BI) to the Food and Drug
Administration (FDA), the body responsible for registering medicines in the
United States. BI is the manufacturer of Nevirapine and they recently
applied to the FDA for approval for the use of Nevirapine for
mother-to-child transmission prevention in the United States. The FDA has
stringent requirements for registering medicines. BI had not met certain
administrative requirements of the regulatory body. When the FDA requested
this information from BI, the pharmaceutical company withdrew the
application until they have met these administrative requirements. The
safety and efficacy of Nevirapine were NOT questioned by the FDA. It must
be emphasised that the application was withdrawn entirely for 
administrative reasons. This is not unusual in the difficult FDA 
registration process.

With regard to the safety and efficacy of Nevirapine, the following should
be noted:

* The Medicines Control Council (MCC), the equivalent of the FDA in South
Africa, has approved Nevirapine for mother-to-child transmission
prevention. The MCC has a well-deserved reputation for caution and 
applying strict criteria to the registration of medicines.

* Nevirapine's safety and efficacy have been established by the HIVNET 012
trials which took place in Uganda. It has been shown to reduce HIV
transmission by nearly half. Not a single serious side-effect to mother or
child has been reported from this study. An 18 month follow-up of the
babies who came through this trial has confirmed that no serious side 
effects due to Nevirapine have occurred.

* Thousands of women and babies in poor countries such as Uganda and
Zimbabwe have been through Nevirapine-based mother-to-child transmission
prevention programmes. Not a single serious side effect has been reported
due to Nevirapine when it is used for this purpose.

We call on the World Health Organisation and UNAIDS to review all data
pertaining to the HIVNET 012 study  and to release a statement on the
safety and efficacy of Nevirapine.

We call on the Government, in particular the Minister of Health, to stop
confusing the public with baseless statements. We are perturbed that the
Government has become more concerned about saving face at having lost a
court battle it should not have fought than about saving the lives of
thousands of children.