THE head of family medicine at Medunsa is sceptical about the existence of HIV and appears to believe that the use of the ”notoriously toxic” anti-retroviral drug nevirapine is part of a campaign to maximise corporate profits, according to an affidavit he prepared for the Constitutional Court last week.
In his affidavit Professor Sam Mhlongo also revealed that he had advised Minister of Health Manto Tshabalala-Msimang on how to respond to news that the manufacturer of nevirapine, Boehringer Ingelheim, had withdrawn from registering the drug for mother-to-child transmission with the Food and Drug Administration (FDA)in the United States.
Mhlongo said he had drafted a letter for Tshabalala-Msimang to send to the Medicines Control Council (MCC), the independent body responsible for registering and monitoring the safety of all drugs sold in South Africa. ”With this [the Constitutional Court] appeal just a couple of weeks away & I proposed to First Respondent that she establish the MCC’s intentions in the light of the American developments, and I provided her with a suggested draft letter of enquiry last week, but time didn’t allow the execution of this proposal.”
Mhlongo unsuccessfully tried to present his dissident Aids views to the Constitutional Court, which was hearing the government’s appeal against an earlier high court ruling that it must provide nevirapine to HIV-positive pregnant women where resources existed.
The Medunsa professor was seeking to put forward his views that nevirapine is a toxic drug that could poison mothers and their babies, and which would not be used in the First World.
He says: ”It is incredible to contemplate that a notoriously very toxic drug, approved as a therapeutic agent in the First World on a provisional basis only & should be judicially prescribed in our developing country for an indication not licensed anywhere else in the First World.”
Pregnant women with HIV in the First World are usually on some form of chronic anti-retroviral treatment throughout their pregnancy and labour. This renders redundant the quick nevirapine regime, involving a single dose to the mother during labour, and a weight-related dose to the child within three days of birth. The regime is used in developing countries where women do not have access to general anti-retroviral therapy.
In the US this course of nevirapine is given to HIV-positive pregnant women in or close to labour, where it is too late to use more comprehensive programmes to cut the chances that the newborn will be infected.
Mhlongo’s affidavit provides another interesting insight into the world of Aids dissidents, similar to that given by the now notorious ”Castro Hlongwane” document, which effectively called Aids a racist plot.
Mhlongo questions the existence of the virus that causes Aids, saying that that HIV has ”never in the history of the Aids era been isolated by the classical procedure for the isolation of viruses, namely by purification and electron micrograph verification. The specificity of such tests for the presence of the putative virus is consequently unknown.”
On the FDA’s halting of the registration of nevirapine because of problems with the reporting of the study’s results, Mhlongo says: ”I had expect-ed the MCC at least to temporarily suspend its provisional license to BI for the supply of nevirapine to HIV-positive pregnant women and their neonates, pending clarification, but to my surprise, it has not so acted.”
The surprise is in itself surprising given that there is no indication that the problems besetting the specific nevirapine registration with the FDA relate to safety of the drug. All indications are that it relates to issues with paperwork for the notoriously pedantic and rigid FDA approval.
Although nevirapine was registered for mother-to-child transmission on the basis of the Ugandan study, Hivnet 012, its use has been validated in the field and in other trials.
Five major international health bodies, including the World Health Organisation, the joint UN initiative on Aids, had said that there were no questions about the safety and efficacy of nevirapine for mother-to-child transmission.