Some Questions and Answers
1. What accounts for our deep seated skepticism?
Do you remember the public fear that the wave of spread of Ebola in neighboring countries caused in Ghana, does the thought of Ghana experiencing Ebola still not send chilling tremors down your spine?. Do you remember how tense we were as we followed the massive body counts that this dreadful virus left in its wake? Some of us virtually bathed hand sanitizers, a doctor friend of mine politely refused shaking my hand at the airport when I bumped into him and forgot the “no handshake rule”, I was quite embarrassed, but understood. We were left trembling when the virus reached Nigeria, pastors called for national prayers to avert the evil disease, education intensified, we clenched our fist in doubtful hope that we don’t face this nuclear bomb of a virus. Luckily for us we have been spared so far. Then the news broke that our Food and Drugs Authority (FDA) had approved an international pharmaceutical company to run clinical trials for an Ebola vaccine here in Ghana.
One would have thought we would heave a sigh of relief that at least a lasting solution was in sight. The story was remarkably different. There have been calls by politicians, political parties, individuals and some bodies condemning the scheduled clinical trials in the Volta Region. This culminated in a heated session in parliament where the honorable law makers minced no words in condemning the trials. Parliament through the speaker called for a suspension of the trials which has been upheld by the Ministry of Health. It is shocking to me, that a people who were so scared of a problem, can all turn away from the potential solution to such problem, even when it keeps staring us in the face.
This situation has kept me wondering about the role of the FDA. This institution was mandated by the Public Health Act of 2012 to deal with all issues of clinical trials in Ghana. I concur with the Research Coordinator at the Noguchi Memorial Institute for Medical Research, Susan Adu Amankwa that parliament has been disappointing in their understanding the very Act they enacted. Even more disappointing in my opinion is the seeming lack of understanding of the scientific facts about clinical trials and vaccination.
A member of parliament regrettably remarked that Ghana had been spared from Ebola by God, hence clinical trials for a vaccine in Ghana was unnecessary. I am yet to understand the reasoning behind this kind of analogy I listened to an honourable member remark that introducing the vaccine into the volunteers was tantamount to introducing the Ebola Virus into Ghana.
2. What are vaccines and how do they work?
Vaccines are typically made of either the weakened or killed version of a disease causing organism, its toxins or proteins so that the body of a host (human) can recognize and form antibodies against. Therefore in the event the real microorganism beckons, the body’s immune system will repel it. In other words, vaccines sensitize our bodies to “remember” and fight specific disease causing organisms. Trying a vaccine is thus not even remotely close to infecting people with a virus. The vaccines against poliomyelitis, tuberculosis, tetanus among others are all based on this same scientific innovation. When has vaccination against polio ever given a child polio?
3. How will clinical trial of an Ebola vaccine work?
Clinical trials are highly structured with specific goals in mind. In the case of Ebola, a simple explanation will be that, a vaccine is introduced into the body of a healthy person, and that fellow is observed for possible effects or interactions with other variables already determined and measured. After a specified period of time, a sample is obtained and tested for antibodies, immune response and of course the performance of the sample against the real virus. All further testing are done outside the person’s body in a laboratory using a sample obtained after vaccination. Indeed there are about 4 main phases of clinical trials some of which will eventually include actual Ebola patients to test dosage ranges and performance in the body. These are supposed to be done with high ethical standards and patient safety as the watchword.
4. What is the mandate of the Food and Drugs Authority (FDA)?
The recent developments makes one wonder the role of the FDA is, and whether or not it is proper for parliament to usurp the authority vested in the FDA in calling for a suspension of the planned clinical trials. What then becomes of the functions of the authority as the body mandated to oversee clinical trials in this country? On what real scientific basis is parliament calling for a suspension of the trials other than mere sentiments and political flavourings?. In a case of this nature, parliament, in my opinion, if indeed they have a business interfering with the mandate of the FDA need technical advice to inform their decision and not the kind of political interference we are currently seeing. In any case the FDA has come out to assure us the trials were safe and they have gone through the process with a fine toothed comb since November last year, the Noguchi Memorial Institute for Medical Research which conducts all suspected Ebola tests has stated that procedures were followed and that the trials were clean. Is it the case where Parliament trusts no other institution to function for the welfare of Ghana than themselves? I think this was a knee jerk reaction by parliament in a move that appears more populist than policy driven. The questions parliament should be asking are “what are the risks”? “Have they been managed well”? “How will this benefit the country?” etc.
5. Why Ghana? What do we stand to gain?
As part of clinical trials, there is a phase which involves testing the vaccine on health unaffected volunteers to observe bodily interactions. Trying the vaccine in Ghana is actually an important opportunity for us to help in the development of a vaccine that is specific to our biology. It means that in the case Ghana experiences Ebola, we would have a much more useful vaccine that is specific to our biological peculiarities.
In a country at potential risk of Ebola, we should be happy that this exercise is being done. It is unfortunate that we have to play politics with this one too, with both ends of the political divide seeking to strategically position themselves at a location that is presumably appealing. It is also selfish on our part to stall a process that could save thousands of Africans from potential horrifying death. It sounds even more inward looking and plainly insensitive when we remark that the tests are unnecessary because we have not yet gotten a case of Ebola here in Ghana.
6. What are the important issues in clinical trials?
The most important issues that arise in clinical trials are issues regarding ethics, safety, and wellbeing of participants. If politicians had demonstrated even minutely that any of these standards were compromised by the FDA, then we would have a genuine case for calling for a suspension of the trials.
I cannot however absolve the FDA of all blame. It is my view that information about the clinical trials and the necessary public education was taken for granted. This gave way for all sorts of conspiracy theories that have left a great scientific enterprise in our country in a limbo.
7. Are we safe from Ebola in Ghana?
Let us remember that the Ebola problem is far from over; There were 31 new cases of Ebola Virus Disease (EVD) in the week ending on June 7, 2015 alone (WHO). The countries contributing this figure were Guinea and Seirra Leone. Guinea alone has recorded a total of 2,437 deaths out of 3,670 cases of EVD as of June 7 and counting (WHO). Do we wait for this to be visited on us in Ghana before we contribute to the science of managing it? We seem to be drumming home the message that Ebola is over, that’s a far cry from the truth. Politicians also seem to be creating the impression we are not threatened by Ebola. With a public health system and border control as weak as ours I wonder how we are able to make that assertion with so much conviction. The absence of Ebola in Ghana does not make us invincible. We must take steps to manage Ebola, it may as well start by engaging in research for a vaccine. All the much touted medicines and vaccines that we use today, including the measles vaccine we give our children were all tested on normal people just like us.
The writer is a graduate nurse and a clinical psychologist trainee.
Email: efogawu@yahoo.com
Phone: 0204112487
