bioethics: Case Discussion

[bioethics@hsphsun2.harvard.edu]

>Double standards or no standards at all in research ethics today ?
>
>Dear Colleagues,
>It is indeed unfortunate that we keep hearing of such cases of 
>questionable ethical
>practices. Following comments are made:
>
>* Is the opinion of the French AFSSAPS relevant to the decision of the
>African country's DRA?
>It appears that French AFSSAPS wants the African country's DRE authority 
>not to lincense
>the drug based on the fact that it is not licensed in France, due to 
>reasons of failure to
>meet tyhe requirement of good clinical practice. If that is the case than 
>this is
>relevant, reasonable and ethical. What is not good for me is not good for 
>others!
>
>  * If so, was there an alternative action that the DRA could have taken?
>DRA need to study the results of the trial carefully and see whether 
>objections raised by
>French AFSSAPS are valid. It is the ethical responsibilty of DRA to 
>licence those drugs
>which have been shown to be effective and safe. It should not allow their 
>people to be
>used as either guinea pigs nor a market to make profits!
>
>What was the role of WHO in this situation? Was it appropriate?
>The pressure from international community particularly WHO is 
>questionable. What personal
>interest do they have? It seems they thought the drug to be very effective 
>and should be
>used but than why not pressurize the French Government do market it in 
>their country? If
>there are concerns about the safety and efficacy than why not recommend 
>and support
>further trials?  Clearly the role of WHO seems inappropriate!
>What actions could have been taken by the partners involved to avoid
>such a situation?
>It seems that some vested interest want the drug to be marketed right 
>away. There is
>clearly a need for further wait till such time that the researchers are 
>satisfied and can
>convince those in countries with strict drug safety regulation to approve 
>its use in their
>countries! Why conduct trials on people from a developing country and not 
>in the country
>of the research institute? Is it not the misuse of vulnerable populations? 
>Either the
>trial should have been conducted in France or otherwise the benefit of 
>reserach should
>have been clearly considered for the population of country where research 
>was allowed in
>the first place!
>These are my thoughts from what I have understood. It is clearly a case of 
>double
>standards. The drug is not good enough to be marketed in France but very 
>much so for a
>poor developing African country!
>
>Dr. Waris Qidwai
>Associate Professor, Family Medicine
>Aga Khan University
>Karachi