bioethics: Case Discussion- Double Standards on Clinical Trials

["Ishrat Waheed" <biotronics1@hotmail.com>]

 From the moderator: I previously posted a response under Dr. Waheed's name 
that was not his response. I apologize for the "mix-up" and am posting his 
response below.

Sir/Madam:

I appreciate your bringing a critical bioethical case ( Double standards 
for an AIDS Drug) to the discussion forum.
The case in point strikes a raw nerve in every conscientious biomedical 
researcher.  I find it deeply alarming that vested commercial interests and 
precarious clinical practices so often take precedence over the sanctity of 
human life especially if it involves poor and underdeveloped nations where 
the standards and costs of conducting such trials are practically 
non-existent.  This is a classic example of the cheap human guinea pig 
culture that has persisted in vaccine and drug related clinical "mistrials" 
over the years.  Following issues are under review.

1-     Conducting clinical trials in poor underdeveloped countries.

2-     The IND game for rapid commercializing of new drugs for life 
threatening illnesses.

3-     Role of local DRAs.

4-     Role of WHO in new drug approval and marketing.

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Answers to the Qs.



*   Is the opinion of the French AFSSAPS relevant to the decision of the 
African

country's DRA?

-  Yes the East African DRA's decision to consider French monitoring 
agency's reported lapse in GCP is relevant.  Home govt.'s health agency is 
responsible for making sure that the proposed drug is safe to use both in 
short term as well as in long term studies especially when it involves 
materno-fetal transmission which may compromise the growth and development 
of the child later on.



* If so, was there an alternative action that the DRA could have taken?

-     DRA could have approved the drug for investigational purposes only, 
i.e., in compliance with GCP and GMP.  It would have eliminated the market 
monopoly by the drug manufacturer and would have made the drug available 
free of cost to the trial participants.



* What was the role of WHO in this situation? Was it appropriate?

-     WHO seems to have jumped the gun in this case.  It should have looked 
at the facts more rationally and responsibly before letting another 
developing country turn into a human laboratory for epidemiology and 
pharmacology studies.



* What actions could have been taken by the partners involved to avoid such 
a situation?



-     Partners involved:

The French Manufacturer/Sponsor

South African Trial Site

French Monitoring Agency

WHO/Drug Approving Body

East African Govt.



It is in almost all cases, the responsibility of all parties involved in 
the drug development process to comply with regulatory requirements and 
bioethical concerns.  In the end, major responsibility lies with;

1-     The trial monitor.

2-     The drug approving agency.

3-     Local regulatory bodies.

Thus, the French AFSSAPS, WHO and the East African DRA should have looked 
at the clinical data more stringently as it ought to be for investigational 
new drugs, fast- tracked for licensing.

WHO could also have sponsored an independent short term study of its own, 
allowing the French AFSSAPS to monitor the trial with the consent of the 
East African DRA to compare the results with that of  the South African 
study site before final approval.



Regards
Ishrat Waheed, Phil, PhD.
Project Director,
Toxicology and Pharmaceutical development
Montreal, Canada