Bad science & toxic politics; Misstep that ruined Ghana’s Ebola Vaccine Trial
Presumably, Ghana still awaits the verdict of its Parliament, almost four months after the legislature halted Ebola vaccine trials on the back of fears emanating from arguments of the Ghana Academy of Arts and Sciences (GAAS) that the vaccine trials amounted to importing Ebola Virus Disease (EVD) into Ebola-free Ghana!
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In spite of all the science to the contrary, the GAAS, led by its task force, took the position that “In Phase II Clinical Trials, patients are used as subjects. Ghana has not recorded cases of EVD. The trial being envisaged therefore necessitates either importing patients, who have had the disease or infecting volunteers, and thereby introducing Ebola into a hitherto Ebola-free Ghana.”
At the time, Prof. Fred Binka, Prof. Kwadwo Koram and Dr Kwaku Poku Asante — the Principal Investigators of the study — explained that “Ghana cannot be exposed to the Ebola virus from this study because the vaccine consists of envelopes made from parts of a common cold virus. Inside the envelopes, the genetic material that just codes for the Ebola viral coat has been placed. The Ebola genetic material contained in the investigational vaccine cannot cause someone to become infected with the Ebola virus. Trial participants that have received the investigational vaccines will develop antibodies against this genetic material, but this does not mean that they have been infected. The common cold virus cannot replicate.”
Cancelling our last trials
After multiple presentations to Parliament, multiple public fora to dispel fear and rumour, the jury is still out, with our leaders little realising that the horse of Ebola vaccine trial has long bolted from Ghana! In the words of the Principal Investigators, “We have cancelled two of the Ebola vaccine trials, and are about to cancel the last of the trials. Our colleagues in other African countries have recruited more than enough participants needed for the two trials, so the companies developing these vaccines have moved on. We are waiting for Parliament and the GAAS to make up their minds .The FDA refused to provide us with the permit to import the vaccines although we had approval for the protocol we submitted.”
In spite of the existence of a robust regulatory framework in Ghana for the conduct of scientific research, in spite of the extensive experience of the leading scientists in the conduct of vaccine trials, in spite of the continued absence of treatment for EVD globally, in spite of protocol reviews and approval at country level by the Ghana Food and Drugs Authority and the Ghana Health Service Ethics Committee and at the international level by the African Vaccine Regulatory Forum AVAREF, Ghana’s Parliamentarians, under the guidance of the Ghana Academy of Arts and Sciences, led us down this path.
As a result, Ghana, it appears, has earned the mockery of vaccinologists in the global community. The words of Dr Sodiomon Bienvenu SIRIMA, MD, PhD, a recognised Burkinabe Scientist come to play: “I’m very surprised by what I’m reading. I’m quite sure that there is confusion between the development plans of this viral disease vaccine with what some are used to seeing with the Malaria vaccine. With such a vision, I’m afraid that our region will not make any contribution in science. Please accept my sympathies.” Similar comments have been reviewed from scientists in Sierra Leone, Geneva, UK and USA.
Reflection
Recently, I requested the Principal Investigators to reflect on what could have been done differently at the point that the GAAS had questions on the conduct of the vaccine. In their view, the GAAS did not follow due process and hence “a few fellows who got their science wrong dragged the name of GAAS into the mud.” They explained further that the GAAS should have called a meeting of the Science division and made sure key people with different backgrounds were present to provide independent scientific opinions. This did not happen, apparently.
Secondly, Parliament could have done a much better job of exercising its oversight function. The matter could have been deliberated upon by the select Committee on Health to allow for a closer and more intense scrutiny instead of hurriedly escalating it to the floor of the house and subjecting it to premature open debate on the back of public fear and panic. Binka, Koram and Poku-Asante see the entire unfortunate episode as “a case of organised interests groups against individuals” like themselves and other scientists. Parliament could have taken the role of protecting the “interests of individuals against these powerful interest groups”
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Finally, there is no merit in the argument that Ghana lacks the capacity to conduct vaccine trials. The Principal Investigators point out that the successful evaluation of meningitis vaccines which are being used today and malaria vaccines which are being considered for malaria control show clearly that contrary to the GAAS assertion of no capacity, the capacity exists!
Going forward
Any key takeaway lessons. I asked the Director of Noguchi Memorial Institute for Medical Research, Prof. Kwadwo Koram; the Vice Chancellor of the University of Health and Allied Sciences (UHAS), Prof. Fred Binka, and Dr Kwaku Poku Asante of the Kintampo Health Research Centre.
Firstly, a group of Ghanaian scientists are considering forming a new scientific group or Academy of Medicine or Institute of Medicine whose membership will not be by invitation only but by application.
Secondly, the GAAS must be split into Sciences and Arts and the leading scientists of both arms encouraged to evaluate the scientific evidence before stating a position rather than “pursuing a scientific agenda in the Daily Graphic and not first in a peer reviewed journal such as the Ghana Medical Journal.”
Thirdly, the Act should be modified to allow scientists to educate the public in advance of the approval from the FDA. It would appear from the engagements with parliament that the law makers themselves did not know that the law forbade public education prior to official approval.
Fourthly, “We should not play politics with everything in this country!! The politics failed badly. We were simply trying to raise the academic image of our universities – Legon and UHAS – and research institutions –Kintampo. Even worse still, the entire principle of academic freedom was hijacked on the back of this bad science and toxic politics. Instead of a telephone call or a visit to find out what was going on, some political activists rushed to Accra to see the President and called a press conference without inviting us”, they lamented.
Finally, some in the press were also completely uninformed and succeeded in enhancing the national ridicule by publishing unverified facts.
“All the rubbish about $200million being shared in Ghana for the trials while a single cent had not been passed on to us because the trial was not yet approved! The sum quoted as the amount the company was investing in the development of the vaccine was laughable. How can a company pay $200million to recruit 36 participants into a trial?”
The Principal Investigators’ last reflection was that scientists like themselves must also not step back but confront those who are trying to peddle such falsehoods openly by using other stations or media to get their case across. This is because “We can only fool the people sometimes but cannot fool them all the time! The TRUTH always prevails however long it takes.”
In their view, 60 years after independence is long enough to work hard to find solutions to our problems.
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