bioethics: Case Discussion - Double Standard for an AIDS Drug

[ajafarey@hsph.harvard.edu]

>It is great to have hsphsun2.harvard.edu back on air!
>
>It appears that Viraret was good enough for AFSSAPS/French researchers to use
>as an innovative regiment on the subjects but was not good enough as a 
>regimen
>on the same population.
>
>I think it is important to know the nature of the infringement of the Good
>Clinical Practice that have occurred in the trial. Obviously if the DRA
>discovers significant problems with the study, licensing should not go
>forward. If however the issues are not significant as compared to the
>potential benefit for the community, the licensing should go on. It is clear
>that the drug will be of significant benefit for the community which is in
>immediate need of it, more so than the sponsoring country. I feel that the
>local licensing agency, the DRA should take a stand basing its decision on 
>its
>own needs and limitations rather than follow blindly the dictates of the
>AFSSAPS. Why should the DRA be subject to the norms of another country?
>
>The WHO in putting its weight behind licensing seems to be satisfied by the
>results of the trial. But WHO backed programs are also not above and beyond
>controversy, the latest Three by Five program for AIDS treatment is one
>example. I think irrespective of what any international agency or foreign
>authority has to say, it is the local DRA that has to analyze the concerns
>brought forward by the AFSSAPS, look at them in their own context and weigh
>the benefits versus the risks and decide independently about licensing or not.
>
>What may be unacceptable for one person may not necessarily be unacceptable
>for another person. We have to keep ethics within the realm of reality.
>
>Aamir Jafarey
>Ethics Fellow,
>Harvard School of Public Health


*****
Susie Welty
Program Manager
Program on Ethical Issues in International Health Research
Department of Population and International Health
Building I -- Room 1104
Harvard School of Public Health
665 Huntington Avenue
Boston, MA  02115

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