Registration standards reason behind potential de-registration of Nevirapine
Living with AIDS Programme 137

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‘€œIf the FDA wanted to visit the sites and to inspect the documentation they would have expected that the documentation for one patient would be all in one file. At the sites in Uganda it was found that that was not the case. Some documents were in one room. Some documents were in another room. Some of the documents were not properly legible, and so on. And that is the type of information that needed to be put in order in order to prepare for an FDA inspection.’€

That was the response of Kevin McKenna, Director of Technical Affairs and Strategic Product Development for Boehringer-Ingelheim, manufacturers of Nevirapine, in September last year. At the same time I interviewed Dr Edmund Tramont, Director of the National Institutes of Health’€™s Division of AIDS.

In the preface to the NIH’€™s final report on the review programme of the Uganda HIVNET-012 study, he wrote that ‘€œthe trial was conducted not only to determine the efficacy of Nevirapine, but also whether such an approach could work and be effective in a developing country.’€ The preface goes on to read that ‘€œat the outset it was never considered that such a trial ‘€“ the Uganda HIVNET-012 study – could be used as a

stand-alone pivotal trial for USA Food and Drug Authority licensure.’€

Dr Tramont explained what kind of data was needed by the FDA before it could register Nevirapine as a single intervention in the prevention of HIV transmission from mother to child.          

‘€œIt’€™s much more intensive gathering and recording of data that is necessary to address the Science. Therefore, since they don’€™t do the study they want the study reported to them in a very, very, compulsive standardised way.’€

Dr Tramont went on to explain that the FDA’€™s requirements had cost implications.

‘€œIt is appropriate for the United States to do that. The aspects of that is that it’€™s a lot more expensive. We are a very rich country. If Africa had to do that they wouldn’€™t have any money left over to do just ordinary care. So, the study was not conducted with that in mind. The study was conducted with Africa in mind.’€

Precious Matsoso, registrar of the Medicines Control Council in South Africa, refuses to accept that argument. Like the FDA, she deems it within the MCC’€™s right to demand access to information collected during the study for verification purposes.

We are looking at whether data was compromised, or not. Because, remember, if this was pivotal’€¦ I don’€™t know if I can use an example of accountants: When auditors go out there they have to ensure that the books are in order. They can’€™t go and say everything is okay and when there’€™s an audit they say, no, we are not so sure. We just have to satisfy ourselves that everything is in order.’€

It is important to underline that the MCC is questioning the approval of Nevirapine as a single agent in reducing the risk of HIV from mother to child. For this reason it has now requested the manufacturers of Nevirapine, Boehringer-Ingelheim, to provide information within 90 days of the efficacy of the drug when used on its own in preventing HIV from mother to child. But what is the rationale behind registering a drug for PMTCT and then possibly later, de-registering it, despite attestations that it is effective?

‘€œYes, we are mindful of that. We think that this is a responsible approach. All that we’€™re saying to Boehringer is: give us data. People have been saying we’€™ve used it; it works; we’€™ve said, no problem. But that’€™s not how the Medicines Control Council arrives at decisions. It’€™s not about emotions, it’€™s not about how people feel ‘€“ it’€™s about documented evidence, and this is what it’€™s all about, and if that is available, no problem, we’€™ll welcome that. This is why we’€™re giving the company an opportunity.’€


E-mail Khopotso Bodibe


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