ETHIC IN AFRICA (SECOND PART)

ETHICAL PRINCIPLES

Bioethical principles as well moral ones are universal. Their relevance and validity transcends cultures. They have a special status that rationally makes them more compelling and imposing than laws, customs, traditions and social practices. Ethical norms and rules that derive from universal ethical principles can be recognised and distinguished from unethical rules and norms by an implicit ethical necessity. These rules are however not hard and fast. They can be sensibly violated under certain clear circumstances if need be. Moreover, to be applied in a given context, they need to be adapted to the form, the colour and the scope of the context.

Any medical study or intervention in which humans are involved must be conducted in abidance by four essential ethical principles:  the respect for the human being, beneficial action, harmlessness and equity.  A conscientious preparation for scientific projects should take these principles into account. According to circumstances, the expression of principles and the value attached to them may differ and their sound implementation could have various consequences and lead to dissimilar decisions or actions.

The respect for the individual in bioethics or health ethics encapsulates two basic ethical notions: 1- the autonomy: every -one who is able to set their own objective should be considered with the respect due to their self determination capacity. The protection of the people whose autonomy is breached or diminished requires that people under dependency or those who are vulnerable be protected against any abuses or prejudice.

The beneficial action is the obligation for every ethical theory to maximise individual advantages and to minimise the possibility to be a nuisance or to commit mistakes. Norms which derive from these principles require that research hazards be reasonable with regards to expected gains. Such research should be well conceived and researchers should have the necessary qualifications to carry out the work as well as to respect the integrity of humans on whom this research is conducted.   

The notion of harmlessness which also means « not to hurt » is a key principle of traditional medical ethics. The aim is to protect the individual who is being taken care of from any harmful action. 

The notion of equity requires that all similar cases be given equal consideration and dissimilar cases be given an attention which takes their divergence into account. Applied to people under dependency or vulnerable ones, this principle rests on rules of distributive law. Distributive law applies within a community and among communities. Paupers should not bear a disproportioned share of the burden of a treatment if all the members will benefit from it. This applies to research on AIDS for example. Are these principles respected in Africa?

EXAMPLES OF CASES WHEN ETHICAL PRINCIPLES ARE VIOLATED

In Africa, medical and pharmaceutical rules are those of the colonial era and seem obsolete or outdated. Hazards linked to the non respect of these ethical principles are so high that more laboratories tend to conduct their guinea pig experiment in the African continent. In fact the cost is five times lower than in developed countries. Furthermore, epidemiological conditions in Africa seem to be more suitable to the realisation of tests: higher frequency of diseases, particularly those which are infectious, and the existence of symptoms yet to be weakened by repeated and intensive healthcare. Finally, it is easy to convince patients in utmost despair because of the poor coverage of health facilities.

In such a context, it is easy to bypass ethical principles. In Nigeria, for instance, when carrying out the clinical tests of the Trovan ®, (a vaccine) neither the Nigerian authorities nor the ethics committee were officially consulted on how to inform the families and obtain their consent. Similarly, from July 2004 to January 2005 when testing Tenofovir ®, an antiviral drug, on about 400 Cameroonian sex workers, ethical principles were violated.  This molecule reduces the transmission of the Ape Immunodeficiency Virus, the equivalent of HIV in Apes. The manufacturer wanted to test its effectiveness on Humans and sampled people with risky lifestyles: the prostitutes from countries with a high infection rate since the probability to contract AIDs there was high as well. Many of the sampled sex workers could not read documents in English and thought that they were being vaccinated. It is most often the duty of ethics committee as recommended by the World Medical Association in their 1964 Helsinki declaration to examine the experimentation procedures before the testing; to check their relevance and their applicability in the social and economic context of the area where the study will be conducted. We could mention here that in the last ten years these committees have progressively being put in place in Africa even though they are yet to be provided with the required competence and means. 

Some flaws

The clinical testing of the Trovan ® could be justified since it was necessary to test its effectiveness on an great number of patients, that is, 200 children in Nigeria. However those who were carrying the test felt concerned neither about the cost of the drug nor about the possibilities for its sales in the absence of any social security agreement to pay medical expenses or to reimburse expenses incurred, and hence of the virtual impossibility to use the drug in Africa. This was a serious violation of the ethical code.  

As concerns the tests administered in Cameroon, there seems to have been no concerns on the relevance of Tenofovir ® in Africa. In fact, if the clinical testing proves that the HIV transmission can be blocked by the Tenofovir ®, this medicine will be proposed as prophylactic treatment against AIDS. Is such a target reachable in a continent where the treatment of patients and the availability of cheap condoms already face so many hindrances? The question deserved to be asked since the experience of prophylactic treatment against malaria has shown that it is a utopia to think that one could spend huge amount of money to buy an expensive treatment, especially if one knows that one is in sound health.  That could be the reason why some people believed that clinical testing was administered in southern states, particularly on prostitutes because it was an easy and cheap way to have a fast and conclusive proof of its effectiveness.  Is this not anotherviolation of ethical principles?

One has the impression that strategic imperialism is being put in place in order to impose specific rules upon the poor without asking for their consent. One would hardly agree with Mr Philippe Kourilsky, the General Manager of the Pasteur Institute of Paris who asserted that a sort of ideological imperialism was being put in place in order to spread rules that only apply to the wealthy to those who cannot assume them.  Those who set rules are not well placed to indicate who can assume them or not. Not long ago, pertinent reactions were recorded from people who asserted that what had taken place in Nigeria as concerns the DT Polio vaccine should not be repeated. The Cameroonian minister of health, André Mama Fouda, declared that in Cameroon a combined injectable vaccine had been homologated since 2006 under the appellation DultavaxR.  That vaccine is not sponsored by any health programmes.

In France, the pharmaceutical firm, SANOFI Pasteur MSD, decided to call off the distribution of the DT POLIO vaccine and to bring the remaining stocks back to their laboratories because of the numerous cases of allergy in children vaccinated from the beginning of the year 2008 onwards. The worse was avoided thanks to these two measures.

PROPOSALS

It would seem necessary for Africans themselves to master how to administer clinical testing in order to address specific public health needs in the continent. This issue seems to be of utmost importance as the tests could also be carried out on traditional medicines which are cheaper and likely to be more accepted by the population. The clinical testing could prove the harmlessness and the efficiency of medicines that can valorise the national assets. This could lead to the emergence of a home pharmaceutical business. The African plants which are anti infectious, anti inflammatory or diuretic, could be used against infections, rheumatisms, hypertension or heart condition and line up behind the now famous example of quinine made from quinquina.

Medicines tested in Africa should correspond to the needs of the continents. They should go along with specific criteria determined by their future use: effectiveness and harmlessness in relation to the inadequate local chemical watch, easy use of the drug (easy to prescribe, to consume and to store). All this will ease the distribution and the adhesion of patients to the treatment; hence solving the flaws of the health system. The drugs will be more available. Most importantly, there is need to boost the capacity of the local authorities to make decisions, achieve and keep an eagle eye on the health system in order to make it possible to enjoy full independence as far as clinical studies are concerned.

In African countries, legal texts governing health sectors are either non existent or not enforced. It istime such a loophole was closed. These professions are insufficiently provided with regulatory textsas concernsthe preciseconception of proper ethicalor deontological texts. Besides, these countries don’t have a customary tradition that could make up for the absence of such texts. A sound and relevant juridical framework is henceforth necessary if these problems are to be tackled. This framework should take all the aspects into account, the definition of ethical and deontological norms should be included therewith. It should be drafted through a participatory approach. It should, above all, be based on rules to be promoted; the text should be made into a law, not a simple regulatory by-law.

AN  EXEMPLE OF  MEDICAL ASSISTANCE

Javier Lozano Cardinal Barragan had this to say : « in Africa… the church implements religious educational programmes to train social, religious and health workers to sensitize the populations , give humanitarian assistance to sick people at home and in hospitals. » He went on saying that “we fight against stigmatization, we facilitate diagnostics, counselling and reconciliation. We provide antiretroviral drugs, medicines to prevent mother to child transmission”. The Dominican health Centre (CHD) Saint Martin de Porres in  Yaoundé, Cameroon, managed by Sister Christine medical doctor, is an example of the implementation of these actions as it is among the 27% of catholic health centres in the world which give health care to AIDS patients and others.

Apart from the 120 sick people who are daily taken care of, the CHD provides its personnel, youth, families, and sick people with quality training. As soon as people become aware that they are HIV positive theydevelop identity breaches which installgaps in their capacities to connectwith others. The HIV positive patient should face the psycho social difficulties linked to his or her health status. At this level the CHD helps them to better understand their new status and to shoulder the new condition by accepting to undergo the antiviral treatment and committing themselves to lead a positive existence that is, without considering the situation as desperate. The CHD focuses its pastoral of health on the Good Samaritan gospel (Luke 10, 20). This text highlights the paradigm of merciful love which goes beyond human barriers.