Is it conceivable that a body grandiosely semi-labelling itself after an illustrious American name sake – the “Food and Drugs Administration” (FDA) -- has approved the testing of a vaccine against the apocalyptic pestilence, Ebola, and that “guinea pigs” for the vaccine were being recruited in the Volta Region with an inducement of two hundred cedis and a mobile phone?
The ethics underlying the testing of any drug stipulate that it must only be carried out on people who can give “informed consent” to such trials being undertaken on themselves. This means they must fully understand what it is they are doing, especially the risks involved.
It is also a requirement of simple common sense that the scientists involved do take the larger communities in which the testing is to be done into their confidence, by being absolutely transparent about the testing. For ignorance breeds fear, and fear breeds rumour and rumour feeds itself by exaggeration.
This is why the Ebola testing attempt has come a cropper in Ghana. Most Ghanaians knew absolutely nothing about the programme until Starr Fm radio station came into possession of information about it and dutifully shared its findings with the nation.
The radio station told its listeners that “officials of the University of Health and Allied Sciences in Ho” were “spearheading” the trial of an Ebola vaccine amongst its students.
A doctor quoted by the radio station was so insensitive that he mentioned two countries which no sane Ghanaian would touch with a bargepole at present: “The trial” [he said] "has been successful in Liberia and Guinea and other places.”
Documents cited by Starr FM indicated that “students [at Hohoe] “have been promised Gh ¢200 each and mobile phones. They will also receive other compensations, such as transport fares, among other [things], depending on how the trial goes.”
A student told the radio station: “I’m really scared and a lot of my colleagues are anxious too. Currently, they are compiling our names for the trial but we don’t know whether the vaccine is safe or not; whether we’ll contract the disease or otherwise. Nobody is explaining anything to us.”
Starr FM's hecks at the Food and Drugs Authority (FDA) confirmed that, “the national regulatory body is indeed testing the efficacy of the vaccine. 'Yes, we are testing the vaccine,' a spokesperson of the FDA, James Lartey, confirmed to Starr FM. Lartey said he was not in a position to disclose the stage of the test. But Starr FM was told that “another test” was “scheduled for Kintampo in the Brong Ahafo region.”
The Pro-Vice Chancellor of the University of Health and Allied Sciences, Professor Fred Binka, was quoted by the radio station as saying that the trials would “ inform” scientists on the effective results regarding the Ebola vaccine. They formed “part of preparations towards any case detection in Ghana” and had the “full backing of the World Health Organisation” (WHO), he claimed.
Starr FM named the antiviral vaccine as “Brincidofovir” and said it had been tested on Ebola patients on a voluntary basis in Liberia. A similar drug, “Ffavipiravir,” had been used in Guinea. It was, however, “unclear” which one was to be tested in Ghana. Starr FM quoted WHO figures as showing that “a total of 26,763 [Ebola] cases had been confirmed as of May 18, 2015, with 11,074 reported deaths in Sierra Leone, Liberia and Guinea.”
Naturally, the news about the vaccine trials has caused a sensation in Ghana. The Ghana Academy of Sciences has raised several technical questions about trials which need to concern us here. What we want to know is this: how could such a project have been ushered into Ghana, without the Ministry of Health, the FDA, the Ghana Academy of Sciences or any other relevant body, ever preparing the populace for its implementation? Do these institutions that are funded by taxpayers think that that the people of this country belong to those institutions, to be used in any way the institutions want?
Well, the Parliament of Ghana didn't think so. For once, the national interest seemed to have overridden party political interest in our Parliament, and an order went forth from the Speaker to suspend the trials, and requesting that the Minister of Health should come to the House to explain what was going on to MPs. Meanwhile, the Minister of Health himself issued an order for the testing to be stopped.
What happened next was instructive; some of the Ghanaians behind the project suddenly began to creep out of the woodwork.
The view of the Pro-Vice Chancellor of the University of Health and Allied Sciences, Professor Fred Binka, as reported earlier, was that the trials "formed part of preparations towards any case detection in Ghana". The trials had the “full backing” of the World Health Organisation, (WHO) he added.
Now, the question then is: has the University of Health and Allied Sciences obtained funds of any description from any organisation, be it a private company or an international agency, to collaborate with it on trials of the Ebola vaccine in Ghana?
Our Parliament must compel the Ministry responsible for the University to make the details of such funding public, if, indeed, such funding has occurred, or even been merely promised.
Another person who made unfortunately emotive statements on the issue was Professor Alex Dodoo, an “Associate Professor of the University of Ghana.” who is “with the WHO”.
According to JoyFM, Prof Dodoo “condemned” the reaction of Ghanaian politicians to the Ebola vaccine trial in Ghana. “People have gotten it so wrong and it is sad. It is sad for the country, it is sad for science” he said.
But I am sorry, Professor, you are the one who's got it wrong! Did you take it upon yourself, if you knew the project was of such great value to Ghana, to exchange ideas with our Parliamentarians and other opinion leaders, about its underlying benefits before it was commenced? Prof Dodoo, are you conversant with the provisions of what might be called Public Health Education 101?
Where else in the world, dear Professor, would anyone simply draw up a programme on a frightful disease like Ebola, take it secretly to a country (that has been fortunate enough to escape from a disease that has killed over 11,000 people in its neighbours) and expect its people to accept the programme without open, public discussion? Do you think the mere say-so of scientists should serve as the conclusive word on such a sensitive subject, when you know fully well that opinion on the subject is anything but unanimous in the scientific community itself?
You see, we do not live in an elite-governed fascist society, but in a fully democratic state, where it would be “so sad” if our elected representatives were to allow any institution or person to use the people as guinea pigs, without verifying the ethics associated with proposed research efforts.
May I remind you of the horrific Tuskegee Syphilis Experiment:
https://en.wikipedia.org/wiki/ Tuskegee_syphilis_experiment
conducted between 1932 and 1972 by the U.S. Public Health Service in Alabama, and for which a US President had to render an apology? And more recently, have you followed the reports that live anthrax viruses were transported in error across laboratories in the USA -- as well as to Australia and South Korea -- from state-of-the-art American institutions of research, where such dangerous instances of scientific carelssness are simply not supposed to happen?
MEANWHILE, HERE IS A STATEMENT ISSUED BY THE GHANA ACADEMY OF ARTS AND SCIENCES ON THE EBOLA TRIALS IN GHANA:
The Academy firmly believes that at this point, it is unsafe to undertake the trials in Ghana.
"The main concerns raised by the Technical Committee of the Academy relate to the following:
1. Major uncertainties about the nature and origins of the Ebola virus, including the circumstances of its appearance in Guinea,
2. Whether the Zaire strain of the virus, which is the one being used in the GSK vaccine to be tested in Ghana, is the strain responsible for the Ebola epidemics in Liberia, Mali, Nigeria, Senegal and Sierra Leone, and the identity and characteristics of other strains of the Ebola virus that might exist;
3. The use in the GSK/NIH vaccine of a gene particle of the wild species of the Zaire Ebola virus, rather than the gene particle of the Makona strain isolated in the epidemic in Guinea;
4. What pre-clinical animal experimentations had been carried out with a vaccine based on the Makona strain to establish evidence of safety, immunogenicity and protection;
5.What basis is there for expecting that immune responses generated against the wild type Zaire Ebola virus GSK vaccine formulation (construct), with a live non-replicating chimpanzee adenovirus carrying a gene from Zaire Ebola virus, would be effective against the Makona strain or any other Ebola virus species and strains;
6.After a test vaccine has been shown in the vaccinated individual to produce an immune response (immunogenicity), what guarantee would there be, in this instance, that the vaccine would offer protection against the full Zaire Ebola virus and other species and strains;
7.On the basis of research conducted so far towards vaccine development, what is the likelihood of the present construct of vaccines protecting communities against the rapid emergence of new, more virulent strains of the virus, as appears to have happened with the Makona: the risk of false confidence deriving from the use of a new vaccine must be noted;
8.What assurances do we have that the chimpanzee-derived live adenovirus vector used in the GSK vaccine construct, although non-replicating for now, will remain dormant and not itself cause a disease to compromise the health of the people of Ghana;
9. It is to be noted that the application for the GSK Ebola vaccine Phase II trial in Ghana includes children, even though the Phase I trial in the US, UK, Mali and Switzerland was limited to adults, raising the question of dosage profiles for children and other vulnerable groups in the Phase II trial;
10. What evidence is there of strict compliance with the International Committee on Harmonization Protocol Guidelines for Clinical Trials, including full “informed consent” by all volunteers.
It was confirmed at the above-mentioned meeting between the President and Technical Committee of the Ghana Academy of Arts and Sciences, and staff of the MOH, the Food and Drugs Authority (FDA) and its expert advisors, and the Principal Investigators in the GSK/NIH Phase II trial, that the processes for the approval of the Phase II clinical trial of the GSK Ebola Virus Disease test vaccine had not been concluded. Our firm understanding was that the approval process will continue to take into account the concerns and issues raised by the Academy.
In the course of the meeting, it was mentioned approval had already been given to an application for a separate Phase I trial in Hohoe, of a test vaccine
