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Ebola Epidemic: the WHO gets it right, then wrong

Saturday 18 October 2014

The EBOLA virus epidemic (EVE) has continued ravaging West Africa, with nearly 4,000 deaths already as of October 2014, and is threatening to migrate to other regions of the world. Shortly after the outbreak of the epidemic, the World Health Organization (WHO) convened a consultation meeting of ethicists, other experts and stakeholders, on 11 August 2014, “to consider and assess the ethical implications for clinical decision-making of the potential use of unregistered interventions”. On 12 August 2014, the WHO released a short statement captioned “Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD): Summary of the panel discussion” which generally was well received and appreciated around the world.

The consultation panel had reached the consensus that, “in the particular circumstances of this outbreak, and provided certain conditions are met”…, “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention”. This recommendation is justifiable by the fact and to the extent that the situation in question is that of a deadly and highly infectious epidemic with no known, let alone available, cure. The context is a purely therapeutic one with all efforts directed at saving human lives in imminent periculo mortis.

Subsequently, the WHO has published another release, 29-30 September, 2014 [http://www.who.int/immunization/dis...] “WHO Consultation on Phase 2 clinical trials for Ebola”, being the result of “an expert consultation to assess the state of the art work to test and eventually license candidate Ebola vaccines” in which “more than 70 experts, including many from affected countries in West Africa… Ebola virus disease (experts), manufacturers, regulators from Africa, Europe and USA, those with expertise in vaccine science, clinical trials and clinical management of patients” took part. This panel considered and apparently approved urgently carrying out clinical tests on humans of some candidate Ebola vaccines in the development pipeline, including Chimpanzee adenovirus serotype 3 (Chad 3) by Glaxo Smith Kline + others and Recombinant vesicular stomatitis virus (rVSV) vaccine by a consortium involving Canadian Public Health plus others.

Biomedical clinical trials would normally pass through 4 distinct phases: Phase 1 trials (on 20-80 people) to evaluate safety and dosage; Phase 2 (several hundreds of people) to determine efficacy and further evaluate safety; then Phase 3 (several thousands of people) to investigate efficacy by comparison with other standard experimental interventions as well as to monitor adverse effects; and finally Phase 4, conducted after the intervention has been marketed, to monitor effectiveness in the general population and to collect information about adverse effects associated with widespread use. But in this case of the Ebola disease, it is envisaged by the expert consultants and WHO, “before going straight into very vulnerable people in African countries” to test “in a few hundred volunteers” whether it is safe and induces antibodies. It is hoped to have these results before the end of 2014 and, ceteris paribus, to “start using the intervention in affected countries in January 2015”.

This is a highly ambitious project, maybe consistent with the challenge at hand. But it is not an ethically justifiable proposal. The Ebola virus epidemic (EVE) as distinguished from the Ebola virus disease (EVD) as such is still raging unabated and threatening to migrate from its epicenter in West Africa to other regions of the world. All reports coming out from West Africa describe an overwhelmingly desperate and chaotic situation. How would anybody go there with an aim and intention, let alone with a clinical research project, whose immediate purpose is anything other than containing the spread of the epidemic and helping to save the lives of those in imminent danger of death? How would one go about asking for, let alone obtaining, the informed consent of participants in such a research project? It should be recalled that the problem with the TROVAN trial by Pfizer in northern Nigeria about two decades ago now was not that such an experimental intervention should not have been tested but that Pfizer chose opportunistically to conduct the test during a meningitis epidemic and, moreover, with forged informed consent forms, which was another but different issue.

It is evident that, in the current situation in West Africa, any attempted testing of an investigative substance would be up against an insurmountable therapeutic misconception and illusion. Besides, one of the proposed candidate vaccines to be tested belongs to a powerful pharmaceutical company with a reputation for controversial drug trials involving a legion of unethical practices. Also, no mention is made in the WHO statement of post trial access to any successful vaccine or treatment that may eventually result from the trial, from which it can be deduced, in the light of past experience, that whatever vaccine or medicine results from the trials will be priced beyond the means of those who helped to make it possible.

The WHO got it right the first time regarding the use of unproven interventions in attempt to save lives, and the Cameroon Bioethics Initiative (CAMBIN) which I lead endorsed the WHO position in a statement published on its website (www.cambin.org) on 29 September 2014 but, this time around, regarding clinical testing of experimental substances, CAMBIN is unable to endorse the WHO release.

If clinical tests on any candidate vaccine or medicine for Ebola are to be carried out, after the current epidemic has been brought under reasonable control, of course, (in Nigeria it has been brought under control without the use of any medicine beside oral hydration) the following would seem recommendable:

Let the Phase 1 and 2 of such trials (expedited or not) be carried out on well-informed volunteers from amongst research scientists, members of ethics review committees, medical personnel including doctors, nurses, laboratory technicians etc., personnel of pharmaceutical companies, civil servants especially in the Ministries of Health and Scientific Research, University teachers, government ministers, members of parliament, experts in all domains. In my layman’s view, these initial two phases of the trial would not last less than 12-18 months. For to take such a putative experimental substance which has previously only been tested in non-human animals requires appropriate caution. One cannot start celebrating safety and efficacy only a couple of weeks after surviving the test and not contracting the Ebola virus whose incubation period is said to be three weeks. There is need to observe possible effects for at least a couple of months.

Phase 3 and 4 can then go “straight into very vulnerable people in African countries” as envisaged by the WHO and its expert consultants, while every effort is made to avoid exploiting the desperately poor, ignorant or ill who have been the guinea pigs of medical research, the unacknowledged heroes/heroines of the great advancement of Allopathic Western medicine in the past century.

Godfrey B. Tangwa, PhD (aka GOBATA)

(Philosopher and Bioethicist)

Yaounde, 09/10/2014

- See more at: http://www.gobata.com/2014/10/ebola...

See online: Ebola Epidemic: the WHO gets it right, then wrong