bioethics: Case Discussion - Double Standard for an AIDS Drug

[innocentia.malope@nhls.ac.za]

>  * Is the opinion of the French AFSSAPS relevant to the decision of the
>African country's DRA?
>As an Southern African I feel this is one ethical step that needs to be
>considered and cleared before any major trials take place in a foreign
>country (esp african). No the french AFSSAPS dont have the right to
>interfere with African  (foreign)regulations. At first when the trial was
>done it should have been that if it works well with non life threatenning
>side effects...then it's application should be allowed to help the people.
>Let's face it Africa is facing this dillema. Thus we wouldnt like to be
>guinea pigs for trials done by foreignh countries that wont be useful to
>us...but still for HIV issues Southern africa is most affected and thus the
>best area for testing efficiency of emerging non harzardous drugs as they'll
>be targeted for us, not foreign countries with lesser prevalences.Thus the
>question is shouldn't any country that needs an african country
>collaboration on drug trials sign a contract that informs respect to the
>affected country?. i.e that is if the trial produces positive results...the
>country should be given the right to decide which measures to be taken
>regarding its registration and application to its nations. Ofcourse after
>following all the necessary confirmatory tests and considering the side
>effects.
>      * If so, was there an alternative action that the DRA could have taken?
>*       The DRA should have remonitored the drug itself before registering
>it. As a responsible organisation its obligation is to ensure the control of
>disease in their country but at the same time to exclude all the possible
>risks by themselves before believing in what others say. Yes we need help to
>control the dreadful HIV -AIDS syndrome. Yes we are desperate for help as we
>are affected by this dilemma...but ... but we dont need to be too desperate
>to end up endagering the same nation that puts its trust on us. Yes they
>have the anuthority to decide the best for their country...but then they
>need not neglect the fine prints...it is their responsibility to sit down
>and prove the efficiency of any drug before registering it...if all
>procedures are correctly followed then they have the outmost right to do
>what they do...but only if they themselves have done their own trials (even
>if only for a short term period).
>      * What was the role of WHO in this situation? Was it appropriate?
>*       WHO based its decision on the existing result of  the trial...as
>they said it was only meant to be an initial "dirty trial". There would have
>been nothing unethical in reevaluating the drug before its registration and
>use. A single trial will mostly have its set backs as proven by the french
>org...but if they can reasonably say they have considered that shortfall in
>their recommendation then okay. But let's face it any trial no matter how
>desperate we are...doesnt have to be endorsed to fasten things...no the
>reevaluation was necessary just for that short period and if it worked
>well... it will save most of us and it will give trust to our people. We
>believe in the WHO...and we dont want to end up thinking they are also in
>need to try to get short cut answers to this dillema...we can shorten trials
>but we need different opinions before deciding on sole trials... for the
>sake of our safety and to outdo the existing despair.... we need long term
>and lond lasting efficacy.
>      * What actions could have been taken by the partners involved to avoid
>such a situation?
>
>*       at first there was no good collaboration. Collaboration is greatly
>important as everyone at the end has the best interest for their
>territories. With such worlwide problems WHO should have facilitated the
>same trial in another country and waited for seven months to make a
>decisiosn. yes 7 months? most will ask more damage would have been
>done...but if therafter we are so sure we covered all the necessary
>procedures...we could all be helped confidently with less fear of
>detrimental results some time later.
>
>Ethical issues are very important and they should be thouroughly answered
>from the beggining and agreements on the authority of bodies be entered
>then. A lesson should be learned that mostly there are self interest in such
>trials and foreign bodies as they arenot directly affected they can be too
>harsh...but stilll affected countries shouldnt be too vulnerable. In short
>maybe mdiator bodies will be necessary in such issues to come up with the
>best posssible decision...we are dealing with human beings not animals.