bioethics: Case Discussion- Double Standards on Clinical Trials

[biotronics1@hotmail.com]

> >  * 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.