15 December 2004
The Department of Health has noted a report that top U.S. Health Officials were warned that research on the key drug, Nevirapine was flawed and may have underreported severe reactions including deaths, but the officials chose not to inform the House White.
As Government and as a Department, we have repeatedly underscored the importance of looking at interventions such as those aimed at reducing the risk of mother to child transmission of HIV in a comprehensive manner. That includes pharmacovigilance and the reporting of serious Adverse Events. We are continuing to work with the relevant institutions to establish the facts and to find medical alternative to Nevirapine.
If you recall that is part of the reasons the Uganda based HIVNET 012 protocol was first piloted in South Africa. That decision was made so as to allow us to gather our own evidence regarding the use of Nevirapine in monotherapy.
Most unfortunately a court order issued to us by the Constitutional Court did not allow us to proceed in a more cautioned manner. As the general public will also recall we appealed the court's decision on two occasions but were ultimately compelled to abide by the ruling.
It however remains crucial that information regarding the safety of medicines is made public to comply with regulatory and legislative requirements around administration and management.
Not only so that Governments and regulatory bodies can pronounce themselves better in questions such as the one you are raising but more importantly so that such information can (as required) be included in the package insert of the said drugs since this is information owed to the public to protect the very health and lives we have pledged to work for as health professionals. These are indeed priceless.
Background:
The Medicines Control Council (MCC) recommended in June this year that a combination of anti-retrovirals be used instead of a single dose of Nevirapine (monotherapy) to reduce the mother of child transmission of HIV. MCC was concerned that a regimen of single dose Nevirapine could cause resistance in HIV infected mothers and infants.
The MCC's findings were in line with the World Health Organisation's (WHO's) recommendation, which stated that combination therapy using both AZT and Nevirapine is the preferred approach (to monotherapy) to reduce the mother to child transmission of HIV.
The MCC did not recommend that the use of Nevirapine be stopped altogether, but that it should be used in combination with other drugs, because it was showing a significant resistance of up to 50%. This means that the South African Government's policy to reduce the risk of mother to child transmission of HIV remains unchanged.
The Department of Health will continue providing Nevirapine as monotherapy (a single drug) to mothers and babies at public health facilities until new approach has been decided upon.
The Department of Health remains committed to provide quality health care and safe treatment to all South Africans
Issued by: Department of Health
Contact: Charity Bhengu 073 268 7132