The Chief Executive Officer of the Food and Drugs Authority (FDA), Mr. Hudu Mogtari, has been in the news lately as the man on a mission to defend a proposed test of a certain Ebola Vaccine on some persons in the Volta Region. For my two cents, the man is on a rather slippery slope.
My opinion stems from the circumstances that got information on the proposed test into the public domain. It was reported that the implementers of the vaccine trials were distributing mobile phones and cash amounts in order to get persons to subscribe to the tests. The Ministry of Health (MoH) appeared to know very little about the trials while the FDA claimed the vaccine was safe. The basis of the FDA’s declaration of safety remains fictitious since they have not conducted similar tests on any known persons; at least not one that has been declared to the public.
It is rather unfortunate for a science based institution such as the FDA to proclaim that a vaccine, which is still being tested is safe. That can only be a complete misinformation of the public; to put it mildly. The proposed trials are a part of determining the safety of the vaccine and the possibility of any adverse events that may be associated with it.
One cannot be sure the stage of testing that is proposed to be carried out on Ghanaians, but all premarket tests are sure grounds for the pharmaceutical companies to gather information on all possible side effects that may come with the vaccine. As such, for the FDA to declare that the vaccine is safe is rather unfortunate. That the vaccine may not cause Ebola directly does not preclude the possibilities of other severe adverse events; which may range from mild effects to others as severe as brain damage.
More disturbing in this whole exercise is the attempt to coerce or lure unsuspecting persons with phones and monetary incentives to partake in these trials. This is a blatant violation of the Nuremberg Code which provides ethical guidelines for medical researchers to protect human test subjects in scientific experiments from injury, disability or death. The first principle of this code is that doctors must obtain voluntary informed consent from the person about to be experimented on. It appears this code is being ignored here since monetary incentives being provided in a deprived area will effectively eliminate the aspect of voluntary participation in these trials.
Another cause for concern is the lack of adequate information on this mystery vaccine. Before attempting to get persons in this country to volunteer, it is only crucial to know if the vaccine has been tested on humans elsewhere and the adverse events identified in those cases. A list of all other potential adverse events must be fully declared. The data sheet of the vaccine medium is information that is critical to help determine the sort of chemical substances that are to be administered into the system of subjects – since at this point it is most likely a full Vaccine Information Statement (VIS) is yet to be developed for the said vaccine.
Another red flag which the FDA seems to be sweeping aside is the background of the pharmaceutical companies reported to be championing these trials. The first, GlaxoSmithKline (GSK), in recent years has paid massive amounts to resolve wide-ranging charges brought against it. Some of the charges included a $750 million payment relating to the sale of adulterated products from a facility in Puerto Rico and a record $3 billion in connection with charges relating to illegal marketing, suppression of adverse safety research results and overcharging government customers. GSK is also known to set a record for the largest tax avoidance settlement with the U.S. Internal Revenue Service.
In the UK, GSK had to cough out $63 million due to their product, Pandemrix, the swine flu vaccine forced upon the public during the pandemic of 2009; which was later found to have caused brain damage in the victims. A few years ago, the Argentinean Federation of Health Professionals accused GSK of misleading participants and pressuring impoverished, disadvantaged families into enrolling their children in clinical trials of the experimental Synflorix pediatric pneumonia vaccine.
The second pharmaceutical giant reported in the matter is Johnson & Johnson. Through its subsidiaries, they were found at the wrong end of product malpractices including pleading guilty to a federal criminal charge of knowingly selling adulterated bottles of its painkillers for children and infants.
Background information with respect to vaccines of ‘Big Pharma’ leading to severe adverse events abounds. It therefore becomes a matter of serious concern that the FDA would want to give such an outright authorization for these same entities to conduct vaccine trials on Ghanaians with such dearth of information.
We cannot jump head long into vaccine trials on our citizenry when adverse events including autism, severe neurological impairment and other forms of disability are lately being directly linked to vaccines. Thus the cry of Ghanaians, leading to the intervention of the Ministry of Health to put these trials on hold is a timely one.
By Jason Tutu
Member – Biochemical Society of Ghana (BSoGh); Ghana Association of Biochemists (GAB)
 A possible side effect resulting from a vaccination is known as an adverse event