amanet-trust.org

[Godfrey Tangwa]

THE TROVAN TRIAL CASE STUDY: AFTER PROFITS OR TO SAVE LIVES?
(A la Recherche du profit ou pour sauver les vies? Etude de Cas de l’essai du Trovan:)

Tous les participants aux présents travaux de discussions ont unanimement reconnus que la présente recherche n’a pas respecté les règles éthiques et cela pour des raisons suivantes :

La recherche a été entreprise au cours d’une épidémie, et ceci pour des raisons d’opportunisme évidentes. La flambée d’une épidémie qui menace la vie est l’occasion de voler au secours des personnes en danger, et non pas une pour se précipiter à tester un nouveau médicament. Dans cette situation, l’exigence éthique est claire et il est de même de la motivation et de la réponse de la firme pharmaceutique, qui s’est dépêchée de tester son médicament. Cette attitude contraste avec celle de l’ONG « Médecins sans frontières » qui s’est précipitée simplement à aider les victimes. Ledit médicament aurait soit aidé certaines victimes, soit aidé à réduire le taux de mortalité tel que réclamé par la firme pharmaceutique dans sa défense, mais cela est bel et bien en deçà des principes éthiques.
En tant qu’un produit ad expérimentum, on ne saurait présumer de ses effets bienfaisants. Si les médicaments gratuits fournis par MSF pour sauver la situation ont paradoxalement causé quelques dommages, cela n’a en rien diminué le mérite éthique du geste.

L’essai clinique a été mené sur des enfants, lesquels constituent un groupe hautement vulnérable et dont la participation dans une étude requiert des précautions et des garanties spéciales. Pire, cette incorporation s’est faite sans un consentement éclairé préalable. Le consentement éclairé est l’acte nécessaire et absolu quoi que non suffisant pour une recherche impliquant les sujets humains. Dans le cas d’espèce, l’accord des parents ou de leurs tuteurs, en même temps que le consentement des enfants, était éthiquement nécessaire. La présence ou l’absence d’un comité d’éthique en pareille situation est, une fois de plus, en deçà des principes éthiques. Tous ceux qui menaient l’essai clinique en étaient bien conscients. D’ailleurs, la première chose qu’ils ont essayé de faire, dès la première alarme sur leur pratique était de forger des fiches de consentement

Les collaborateurs Nigérian de l’essai clinique ou médicamenteux partagent la lourde responsabilité du caractère non éthique de cette étude. Ils ont aidé et facilité l’exploitation de leur propre peuple lequel ils avaient l’impérieux devoir de protéger, pour des raisons qu’on peut juste spéculer.

Le Gouvernement Nigérian assume la plus grande responsabilité de cet essai non éthique, en dépit du fait qu’il est maintenant le plaignant légal contre cet essai devant la justice. La première partie prenante, le gardien et le contrôleur des recherches entreprises et financées par l’extérieur est bel et bien le Gouvernement de tout pays délivrant les visas à l’équipe de recherche et autorisant la mise en œuvre de leurs activités sur son territoire.

Enfin, il faut remarquer que la manière dont l’étude était présentée était sujette à induire des préjugés, ou à étouffer des considérations de quelques natures que ce soit. La présentation disjonctive et bi-focale du sous titre de l’étude : THE TROVAN TRAIL CASE STUDY : AFTER PROFITS OR TO SAVE LIVES ? Laisse l’impression que les personnes appelées à étudier le cas étaient invitées à se positionner sur l’un des volets de la disjonction. Or il n’est nullement question de se prononcer ni pour l’une, ni pour l’autre alternative, encore moins pour les deux. Il est souhaitable que les études futures ne soient plus intitulées de manière à orienter, ou à anticiper sur les discussions, ou les possibles positions qui pourront être prises sur un sujet donné.




Godfrey B. Tangwa, PHD
(Bioéthicien)


THE TROVAN TRIAL CASE STUDY: AFTER PROFITS OR TO SAVE LIVES?



All contributors to the above case study discussion were unanimous that the study was unethical, and rightly so for the following reasons:

The study was carried out during an epidemic for evidently opportunistic reasons. The outbreak of a life-threatening epidemic is the occasion to rush to the rescue of endangered victims, not the occasion to rush to test a new drug. The ethical imperative in that situation was quite clear and the motivation and response of the drug company which rushed to test its potential drug can be contrasted with that of the NGO, Medicins Sans Frontieres, which rushed in simply to help the victims. The candidate drug might have helped some of the victims or it might have helped lower the mortality rate of the epidemic, as claimed by the drug company in its defense, but that is well beside the ethical point. Being an investigational product, such allegedly good effects of the candidate drug could not have been foreseen, let alone intended. If the free drug provided by MSF to salvage the situation had unforeseeably caused some harm, that would not have detracted from the ethically meritorious character of the gesture.


The drug trial was carried out on children, a highly vulnerable group, whose participation in research requires special precautions and safeguards; moreover, this was done without any informed consent. Informed consent is the absolutely necessary though by no means sufficient condition for ethical research on human subjects. In this case, both the proxy consent of the parents or guardians of each child together with the assent of the child was ethically necessary. The presence or absence of an ethics review committee in that situation is, again, beside the ethical point. All those involved with the trial were quite aware of this, as the first thing they tried to do when the whistle was blown on the trial was to attempt forging consent forms.


The Nigerian collaborators of the drug trial share the heavy responsibility of its unethical nature. They helped to facilitate the exploitation of their own people whom they should have been protecting, for reasons that can only be speculated about.


The Nigerian government bears the heaviest responsibility for the unethical trial, in spite of the fact that it is now a legal complainant against the trials in the courts. The first stake holder and first gate-keeper or control for externally propelled research is the government of any country which issues visas to the research teams and authorizes their activity within its area of jurisdiction.


Lastly, it should be remarked that the way the case study was presented was liable to induce prejudice or to foreclose other possible considerations. The bi-focal disjunctive on the subtitle of the case: THE TROVAN TRIAL CASE STUDY: AFTER PROFITS OR TO SAVE LIVES? seems to leave the impression that discussants were being called upon to position themselves on either side of the disjunction, whereas neither or both might have been the case. It seems desirable that future cases should starkly be stated without any attempt at anticipating the discussion or the possible positions that might be taken on the issue.





Godfrey B. Tangwa, PhD

(Ethicist)

[adugyasidennis]

Having concluded with these remarks, i pray we get a channel to make decision makers aware to help formulate certain policies. Thanks to those whp made us aware of this study
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dennis adu-gyasi

[Bulus Adzu]

The remarks made on 'The Trovan Trial' is very interesting both in content and substance. However, the various contributions made will only make sense if similar scenario is not repeated elsewhere. A concrete position have to put in place or else such unfortunate event can again happened even in the very Kano where the incident took place. The scientific will to resist might be there, but is the political will on ground?

Bulus Adzu
Abuja, Nigeria.

[Aderemi]

This discussion has afforded many with clearer picture of the event. I'm sure Clinical Research Community in Nigeria has also learnt a great lesson from the incident. Beyond the hues and cry for justice and compensation going on in some quarters, all efforts should be made to standardise clinical trial in the contry. A gain from the Trovan episode is the strenthening of Ethics Committee at institutional and National levels. Regulatory agencies (especially National Food Drug Adminisration And Control) should be more pro active and exercise its authority in timely fashion. I don't think it is wise to have a repeat experience of the Trovan Trial.
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Dr. Aderemi Olusola Taiwo
Chief Operating Officer,
Healthy Life For All Foundation,
Idi Ape Avenue, Ibadan Nigeria.

[tkihdzee@yahoo.com]

I am highly impressed by the depth and the expanse of this discussion. Such a well thought out job cannot go without an impact. Those in authority and decision-making will be highly influenced by the ideas exchanged in this forum and it will positively influence the ethical standards in health research in Africa. We need to take giant strides. those amongst us who parade the corridors of authority and decision-making should reflect this ideas in such areas. They should prove themselves as worthy ambassadors of the forum if such abuses must be stopped. Thanks!

TANAYEN Julius Kihdzee
Uganda
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TANAYEN J.K.

[tatahgg@yahoo.co.uk]

The Trovan Trial team might have had the aim of saving lives but their approach was wrong. The fact that the parents of the kids were illitrates does not mean they were not capable of understanding the aim of the study and to decide if they wanted their children to be subjects. At least the team worked with local nurses and other health personnel who spoke the local language and could explain to these parents. Also, having started the study without approval from the ERC/IRB is wrong. The team also left the scene when the epidemic was not yet over. This means they did not care what happened to the subjects after their study. This is also wrong. Firm decisions should therefore be made in order that this does not repeat itself anywhere else.
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HEALTH IS WEALTH

[Iriemenam]

The conclusion is very right. At last, Pfizer has agreed to pay $75m settlement to Kano State. One major question remains - will the individuals/families affected recieve their compensation?

Read more: http://news.bbc.co.uk/2/hi/africa/8177388.stm

[Seth]