OCCUPYGHANA ASKS: PROPOSED EBOLA VACCINE TRIALS – 12 QUESTIONS FOR THE FOOD AND DRUGS AUTHORITY AND THE MINISTRY OF HEALTH

OCCUPYGHANA ASKS: PROPOSED EBOLA VACCINE TRIALS – 12 QUESTIONS FOR THE FOOD AND DRUGS AUTHORITY AND THE MINISTRY OF HEALTH

OccupyGhana has observed with much concern, the ongoing brouhaha and sheer confusion over the proposed Ebola Vaccine Trials.Throughout the nation, in homes, on the media and even in Parliament, we have observed concern that has morphed into fear simply because the required information has not been made available.


Our chief concern is that what was meant to be a clinical trial of a possibly ground breaking vaccine to the dangerous Ebola virus, has been allowed to be blown away by the dual sidewinds of fear and lack of information. It is for these reasons that OccupyGhana welcomes the announcement, although probably fatally belated, by the Ministry of Health, and picked up from the Facebook Wall of the Dr. Victor Bampoe, the Honourable Deputy Minister of Health, that a Public Forum will be held on this matter on Thursday 18th June, 2015, at 2:00pm at the Conference Hall of the Head of the Public Service, Hohoe. For our education and edification and that of a good number of genuinely concerned Ghanaians, OccupyGhana would want to pose the following questions, which, hopefully, the Government of Ghana will provide answers to. The questions are as follows:
1. Has the Clinical Trials Technical Advisory Committee (CTTAC) required to be formed under the Public Health Act, 2012 (Act 851) been formed? If so, when? And who are the members?
2. Has the CTTAC met on the Ebola vaccine clinical trial, and if so, what was their advice to the Food and Drugs Authority (FDA)?
3. Has a formal application for clinical trials been filed with the FDA, and has the FDA issued a certificate to approve the trials?
4. What were the details of the application, particularly with respect to obtaining an ethical clearance issued by an approved institute for medical research?
5. What information has been provided as guidelines for conducting this trial?
6. If FDA has approved this, can the Authority share the results of the investigations it was required to conduct, and indicate whether it is satisfied that the vaccine is reasonably safe, efficacious and of acceptable quality?
7. Which documents, dossiers and laboratory investigations were submitted with the application?
8. Has the “informed consent” of volunteers been obtained? If so, were the aims and objectives of the trial, the possible risk, discomforts and other adverse effects fully explained to them?
9. What have been put in place to ensure that the volunteers are not injured by this trial?
10. Has the FDA been indemnified with respect to this trial, as required by law?
11. What are the trial’s reporting requirements, and how ready is the FDA to step in to stop, suspend or vary the trial if adverse events occur?
12. What are the monitoring protocols for this trial?
These questions arise from our simple reading of the existing law. However, we appreciate that over and above the law, there could be genuine, even if scientifically misplaced, concerns about the proposed trial. We therefore require the Government of Ghana to respond to the following:
1. How true is the assertion by the Ghana Academy of Arts and Sciences that the Phase II of this trial will “necessitate importing [into Ghana] patients who have had the disease”?
2. How plausible is the claim that the vaccine could itself introduce the virus into Ghana?
3. How credible is the allegation that volunteers are going to be paid only a fraction of what has been, or will be, paid elsewhere?
OccupyGhana considers it imperative that these questions are answered. If there are no answers or if there are unsatisfactory answers to any of the above questions, then OccupyGhana would urge the Ministry of Health and FDA to suspend the trials forthwith until the required answers are sought and obtained. Even if there are answers, OccupyGhana would urge the Ministry of Health and FDA to proceed with extreme caution, particularly with respect to the dissemination of information. There should be no room for elevated ignorance, baseless panic and unwarranted emotionalism. This is supposed to be science, and so records, empirical records, and compliance with laid down regulations and protocols are supposed to be paramount.
Yours in the service of occupying minds and hearts for God and country.
OccupyGhana®
For further information please contact Ing. Nana Sarpong Agyeman-Badu, OccupyGhana® Media Relations by replying to this email, or on +233 264771508 or info@occupygh.com.