HIV Prevention

Government: unconvinced about safety & efficacy of Nevirapine

“Public pressure for a cure and for quick solutions, while understandable, could contribute to hasty decisions to assuage the sentiments of the public with extremely negative consequences.” – Affidavit from Dr Ayanda Ntsaluba, Director General of Health

“Public pressure for a cure and for quick solutions, while understandable, could contribute to hasty decisions to assuage the sentiments of the public with extremely negative consequences.” – Affidavit from Dr Ayanda Ntsaluba, Director General of Health.

Government argues that TAC is trying to get the courts to change the policy embarked on by the health minister. It submits that it is not the role of the courts to make policy decisions.

Government also argues, principally through an affidavit by Ntsaluba, that it is not violating the Constitution. It states that it has the duty to balance a number of complicated factors, including fiscal and operational issues, before taking action.

Ntsaluba says TAC’s proposed solutions are impractical. They “ignore the vital infrastructural and operational considerations which accompany treatment with nevirapine, such as voluntary counselling and testing and the monitoring and evaluation of the mother and child to ensure effectiveness and to alert to the development of resistant viral strains which may lead to other public health crises”.

Government argues that it is justified in introducing a mother-to-child transmission (MTCT) programme through its 18-site “Research and Training Programme” as not enough is known about various aspects of the use of Nevirapine.

The Medicines Control Council (MCC) registered nevirapine, based only on the Ugandan study of the efficacy of the drug in preventing MTCT, notes government. The MCC regarded the South African (SAINT) study of the drug’s efficacy in MTCT, (on which TAC’s case relies in part) to be inconclusive on the question of the efficacy of Nevirapine in reducing the risk of MTCT.

There is not enough research on whether a child who had nevirapine at birth will be HIV-negative at the age of two, as HIV can be transmitted by breastfeeding. The government papers note that a Ugandan study evaluating the efficacy of nevirapine beyond 18 months showed that nevirapine would only save 10 out of every 100 babies born to HIV-positive mothers.

The Research and Training Programme aims to discover what it would take to sustain the benefits of using nevirapine at birth.

Simply allowing doctors in public hospitals the right to dispense nevirapine at their own discretion is not a solution, adds Ntsaluba. Hospitals may lack services such as counselling services and the supply of breast milk substitutes. In addition, if doctors could prescribe whatever drugs they wanted, this could have serious budgetary implcations.

His affidavit is supported by affidavits from eight provincial heads of health; Dr Nono Simelela (Manager of the National AIDS Programme); Dr Lindiwe Makubalo (Chief Director for Health Surveillance, Monitoring and Evaluation) and the Medicines Control Council.

About the author

Kerry Cullinan

Kerry Cullinan is the Managing Editor at Health-e News Service. Follow her on Twitter @kerrycullinan11