July 10, 2002
Fifty-two programs in 28 African countries have been approved and received nevirapine (Viramune) through Boehringer-Ingelheim's (BI) donation program (VDP) for the prevention of mother-to-child transmission of HIV. The numbers in the abstract book and poster did not match, hence, I am using the data from the actual poster.
Programs interested in participating must contact the VDP administrator through an interactive Web site -- which could be a problem for countries with limited internet access. Information is then collected on how the drug will be procured, stored and used. To date, 92,509 mother-child pairs have been approved in over 12 months.
At first glance, this seems like a truly altruistic program. But when one starts to explore the implications of this program, some ethical concerns are raised. The purpose of this poster was to detail the feasibility of program implementation. However, after discussion with a BI representative, he said he hoped other countries would review and sign up for this program. One of the disturbing aspects is that BI is not gathering outcomes. Much like when you donate to a thrift shop and you have no idea what happens to your donation. Here it is up to the individual government or non-governmental organization or other agency to follow up for outcomes.
Although this program is "under review" there was no outcome data available. Yet over 92,000 mothers have been approved to receive drug. I think before companies start shipping mass quantities of any drug there should be provisions made to make sure that the women who are receiving this drug are in fact HIV positive, for instance. There should also be some laboratory monitoring -- especially for hepatoxicity and follow up on the infant's status.
Other considerations will be the emergence of NNRTI resistance and development of adverse events in those women who subsequently receive nevirapine again. Although I understand this can be quite difficult in countries with little infrastructure -- and the intent is that follow-up will occur -- I question the value of implementing such a mass drug donation until those processes are in place.
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