The World Health Organization (WHO) is perhaps the most important agency of the United Nations with a global mandate whose importance is evident and acknowledged by all and sundry. All around the world, ministries of public health, healthcare providers and medical researchers listen to the WHO and sometimes obey its recommendations like dummies. For these reasons, the WHO needs to be not only highly professional in its actions and pronouncements but also transparently fair to all the different global communities and competing interests in global health.
Since the outbreak of the Ebola virus disease (EVD) in parts of West Africa in December 2013, the WHO has shown appropriate concern and involvement in saving the lives of victims, bringing the spread under control and finding a solution to the disease, even if some of its actions had been a little tardy. Two important releases of the WHO on Ebola had caught my attention, the first of which I applauded and the second of which I critiqued.
On 12 August 2014, the WHO had 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 was justifiable by the fact and to the extent that the situation in question was that of a deadly and highly infectious epidemic with no known, let alone available, cure. The context was a purely therapeutic one with all efforts directed at saving human lives in imminent danger of death. We applauded this WHO release and the Cameroon Bioethics Initiative (CAMBIN) which I chair posted a statement on its website (www.cambin.org) on 29 September to that effect.
Subsequently, the WHO published another release, 29-30 September, 2014 [http://www.who.int/immunization/diseases/ebola/WHO_consultation_ebola_sep2014/en/] “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.
We expressed our concerns against this development in the same statement referenced above and attempted to propose conditions under which, in our view, clinical trials could be carried out on the Ebola virus in the following words. “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,…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, … (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.
Now on July 31 2015, a ground-breaking publication [“Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial”] was made in the very influential journal, THE LANCET (www.thelancet.com) , copyrighted by the WHO, with some of its high officials as co-principal investigators/co-authors. The announcement of this publication in newspapers, radio and television was accompanied by hyperbole quite uncharacteristic of the scientific domain: “spectacular”, “first time ever”, “100% effective”, “game changer”.
The successful molecule, hurriedly tested on Africans in Guinea, had originally not been developed or prepared against the Ebola virus but rather as an anti-bioterrorism product for North Americans, which had been subjected to non-human animal tests but not yet human tests. The following preliminary questions thus naturally arise:
- Was the WHO statement on clinical trials for Ebola of September 2014 tailor-made to ensure tests in humans of this particular candidate vaccine?
- Was this not an opportunistic trial reminiscent of the TROVAN trials in northern Nigeria in 1996?
- As an agency of the United Nations with oversight for global health, is it right for the WHO itself to engage directly in commercial drug discovery, development and clinical tests, while at the same time issuing guidelines and directives on how these should properly and ethically be done?