Kudos to the Ghana Academy of Arts and Sciences

If there is a dangerous person in the world, it is an “educated person” who behaves like an illiterate. This is because when one is dealing with an illiterate person, one lowers one’s expectations considerably and makes allowances for the opportunities the illiterate person has not been given to extend his or her horions.

But when in dealing with an “educated person”, one makes a whole lot of assumptions, some of which may not relate to reality but are crafted by the prejudices which one’s own background has created in one.

But if what might be paradoxically termed an “educated illiterate” is dangerous, then a scientist who is not “educated” is diabolical.

An “uneducated scientist?” Is such a human contraption possible? I am afraid it is. For you can put instruments and chemicals and pages of text before a student, teach him or her to make experiments and evaluate the results, and at the end of the “course”, award a degree to the person. But if you do not add values to the scientific knowledge you have imparted, you may have created a monster.

Such a monster was a South African scientist called Dr Wouther Basson, whose scientific practices were so misanthropic that he was nicknamed as “Dr Death”. In short, what he did was, among other things, to supply a “lethal triple cocktail of powerful muscle relaxants” which were used during Operation Duel (the systematic elimination of SWAPO prisoners of war captured in Namibia.) One group thus eliminated consisted of 200 SWAPO prisoners.

Now, you ask why I am telling you this. The answer is that some scientists in Ghana appear to have pulled a fast one on Ghanaians. They have agreed to use Ghana as a testing ground for a vaccine that is being developed against one of the molest deadly diseases in the world, Ebola.

The agreement is with a giant pharmaceutical company called GlaxoSmithKline.

The trials came to public knowledge only because one of our radio stations, Starr FM, was given information about it and broadcast it.

The information has now been confirmed by the MP for West Dayi (the relevant constituency) Mr Loh, who told Radio Gold that some of his constituents had complained that they had been given the vaccine, and that they had been suffering from aches and pains and other ill-effects.

Now, no-one is claiming that research into diseases should not be carried out in Ghana. What is unconscienable is that when such tests are done here, the ethics governing them should NOT be fully observed. In particular, the people on whom the vaccine is tested should do so voluntarily; should be fully told of the risks involved so that they can give what is called “informed consent”, and should not be influenced in their decision by psychological or financial pressures of any sort.

But in this instance, StarrFM has revealed that the participants in the trial were each offered GH¢200 plus a cell phone.

Like so much else in Ghana – look at the fact that a Government White paper has been published on the findings of the investigation into the World Cup scandal of 2014, without the main Report being published!) there is a lack of transparency on this Ebola vaccine issue.

One Minister said on Joy FM that Ghana decided to take part in the trial because the vaccine had also been tested in Tanzania and Ghana did not want to give the impression that it did not want to co-operate in finding a vaccine that could defeat a disease that the whole world was worried about. Was he implying that his own colleague, the Minister of Health, was wrong to stop the trial of the vaccine?

What other countries are doing is not the issue. The issue is whether the right thing has been done in Ghana. In any case, the Minister should kindly note that Tanzania became independent in 1961 – a full two years after Ghana had set up an Academy of Arts and Sciences to give informed advice to the people and Government of Ghana on issues of science!

Well, the Academy has now risen to its responsibilities and published a full statement on the Ebola vaccine trials. The statement needs very little or no comment.

It recalls that in January 2015, the Academy became aware, from a newspaper report, that a clinical trial for an Ebola Virus Disease (EVD) vaccine was due to start in Ghana before the end of March 2015. (Note well that the Academy learnt of such a major development from a newspaper report. The question is why? Who was hiding what from the Academy?)

Anyway, the Academy set up a five-person Technical Committee, made up of Fellows of the Academy, to undertake an urgent review of the matter and report to the Academy. In its preliminary report, the Committee noted that the proposal before the Food and Drugs Authority (FDA) was for a Phase II clinical trial of an Ebola Virus Disease (EVD) vaccine, developed by GlaxoSmithKline and the US National Institutes of Health (NIH).

But, the Technical Committee advised, “such an undertaking must be preceded by a thorough evaluation of the available data, and the application subjected to the appropriate procedures.”

On the basis of its preliminary investigation and study, the Committee recommended a second look at the design of the study; a review of the basis for the selection of Ebola-unaffected countries like Ghana; and – because some Ghanaians have anti-bodies to the [Ebola] adenovirus – a fuller understanding of the adenovirus vector used in the development of the test vaccine.

The statement went on: “In discharge of the Academy’s mandate to provide independent science-based advice for policy making, the Council of the Academy asked the President of the Academy to bring these concerns urgently to the attention of the Minister of Health.

“After some delay, the Minister of Health convened a meeting on June 03, 2015, at which the concerns and issues raised by the Academy were discussed with the technical staff of the Ministry of Health, the Food and Drugs Authority and its expert advisors, as well as the Principal Investigators in the GSK/NIH Phase II trials”.

The main concerns raised by the Technical Committee of the Academy related to, among others, 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, was the strain responsible for the Ebola epidemics in Liberia, Mali, Nigeria, Senegal and Sierra Leone.

“What assurances do we have that the chimpanzee-derived live adenovirus vector used in the GSK vaccine construct, although non-replicating for now, would remain dormant and not itself cause a disease to compromise the health of the people of Ghana?” the Committee wanted to know.

Perhaps most important, the Committee also asked: “What evidence is there of strict compliance with the The International Committee on Harmonization Protocol Guidelines for Clinical Trials, including full “informed consent” by all volunteers?

The Academy of Arts and Sciences statement disclosed that “It was confirmed at the above-mentioned meeting between the President [of the GAAS] 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 would continue to take into account the concerns and issues raised by the Academy.”

Yet, in the course of the meeting, it was let slip that “approval had already been given to an application for a separate Phase I trial in Hohoe, of a test vaccine with a different construct from the GSK test vaccine, which latter had been the focus of concern of the Academy.

This came as a shock to the Academy representatives at the meeting, as nothing had been said anywhere previously about a separate Phase I clinical trial application, let alone its approval! “The Academy’s representatives therefore refused to discuss that matter,” the statement further revealed.

The Academy’s statement warned that the Phase I trial of the GSK vaccine in Europe produced an adverse event, namely, prolonged bleeding, in 10% –15% of the vaccinated population. This was a serious adverse event that called for extreme caution in approving clinical trials, both Phase I and Phase II, in Ghana.

“Moreover,” the GAAS further warned, “it is the case that those vaccinated at Phase I and Phase II may be shedding the adenovirus vector into the surrounding community. In the absence of a map of adenovirus prevalence in the trial sites, there is a high risk of an ‘escape virus’ merging with the endemic adenoviruses to create more virulent strains.

For that reason alone it is important that the exposed communities and, indeed, the general public be adequately informed of such trials and their benefits and risks.

In conclusion, the Ghana Academy of Arts and Sciences stated that it “ wishes to state its firm position that, subject to satisfactory answers to the issues it has raised, and considering the gaps in our knowledge and state of preparedness, it would be unsafe to undertake the proposed EVD vaccine clinical trials in Ghana.”

And there you have it!

Cameron Duodu

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