Accra, April 23, GNA - Professor Nana Kofi Ayisi, Head of Vitrology, at the Noguchi Memorial Institute for Medical Research (NMIMR) has cautioned African governments to beware of the haste with which vaginal drugs are being developed in recent times with no pre-clinical studies.

He said, "Vaginal microbicides such as SAVVY and Carrageenan are being tried in Sub-Saharan Africa without any convincing pre-clinical scientific basis whatsoever and it is our women, the very people we are to defend, who are put at tremendous risk..."

Prof. Ayisi was speaking on the topic "Sex, Viruses and Grief: A Deadly Combination that poses the Greatest Threat to Human Health in the Twenty-First Century", During his inaugural lecture at the University of Ghana on Thursday.

He said SAVVY and Carrageenan were made to look very good drugs, but a careful analysis had indicated that these drugs produced mild protection and shown to be highly toxic.

"We must therefore not open the door wide for drugs with no proper pre-clinical data to pass through. If we do that, we would leave ourselves open for a future drug-related disaster of a magnitude greater than the thalidomide disaster".

Until recently, Prof Ayisi said the leading vaginal microbicides was Nanoxynol-9, but today it has been widely accepted that it enhances rather that prevents vaginal infections transmission of HIV. He said, surprisingly, it was only on January 2004 that Durex Consumer Products announced that it would stop to offer Nanoxynol-9 lubricated condoms for sale but the others had refused to discontinue.

Prof. Ayisi said Ghana, which was largely an end user of drugs developed elsewhere, it was absolutely necessary to develop the minimum capacity to evaluate the data on safety drugs before allowing their use. He said the devastating effects of some of the diseases in developing countries weaken their resolve in so many ways, to question critically the safety in human trials before they were launched.

'Our resolve is further undermined by negative publicity in the international media when we question efficacies and safety of drugs or vaccines as we have seen in relation to the Polio vaccine in Northern Nigeria and AIDS drugs in post apartheid South Africa," Prof. Ayisi said.

He said in developed countries, drug monitoring was efficient, therefore, those that turned out to be harmful during clinical usage were promptly withdrawn and victims of unintended side effects were adequately compensated. However, in developing countries, drug monitoring was poor and when harm was caused, a less robust legal system and limited financial resources of victims stand in the way of successful prosecution of international drug companies or their local agents. Prof Ayisi said the poor attention and low government expenditure on research and development, continued to weaken the rapid response capabilities and alertness in assessing drug safety before introduction.

23 April 04