Wednesday, October 24, 2007


Mulago HIV debacle and the Nazi trials
October 23, 2007
The protagonists of the practice of subjecting human beings to drug related clinical trials or experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study.

But what the campaigners of drug related clinical trials on human beings don’t want to tell the unsuspecting public is the fact that these processes are flawed in many ways and some border on criminality.

For instance, in the recently failed HIV/Aids trials where an undisclosed number of Ugandan women were exposed to the dreaded HIV virus, the researchers and their European/ American backers refused to provide even mundane details about the fate of the vulnerable women who participated in the botched project.

They evoke the legally challengeable disclaimer clauses and the secretive nature of the contracts which the trial subjects sign. This is not any better than the days of the brutal dictator Hitler who called upon the Nazi physicians to help justify his policies of racial hatred with a ‘scientific’ rationale (racial hygiene).

There is need that before human beings are subjected to medical trials certain basic principles should be observed in order to satisfy moral, ethical and legal concepts.
The Nuremberg Code was a response to the horrors of the Nazi experimentation in the concentration death camps where the prisoner subjects were subjected to deadly medical experiments without their consent. The code has 10 provisions , two of which are designed to protect the rights of subjects of human experimentation and the eight others geared at protecting their welfare.

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him make an understanding and enlightened decision.

The latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected and the effects upon his health or person which may possibly come from his participation in the experiment.

The law is to the effect that the duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. In this case the Ugandan researchers who participated in the failed trials have a legal duty to tell the Ugandan public what exactly went wrong and the mitigating measures that have been put in place to secure the lives of the people who participated in the trials. This is a personal duty and responsibility which may not be delegated to another with impunity.

International and local human rights principles also provide that clinical experiments involving human beings should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

In fact , no experiment should be so conducted where there is reason to believe that death or disabling injury (like in the case of the failed HIV/Aids trials) will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

Much as section 40 of the National Drug Policy and Authority Act bars any person(s) from carrying out clinical trials in respect of any drug without a certificate issued by the National Drug Authority, the law is not comprehensive enough to capture the complex human rights concerns.

The National Drug Authority has come on record to state that they have drafted a new set of guidelines for the conduct of drug related clinical trials although they are not yet approved. The hope is that the NDA’s proposed legal framework will address the human rights concerns to ensure that no human subject participates in such trials unless there is a justifiable case for success.
The writer is a journalist and advocate
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