As societies grow decadent, the language grows decadent, too. Words are used to disguise, not to illuminate, action: you liberate a city by destroying it. Words are to confuse, so that at election time people will solemnly vote against their own interests.” Gore Vidal.
In recent times there has been a raging debate on the benefit and risk analysis of an impending trial for a potential Ebola vaccine. I have worried about some of the information that has been banded in print, electronic and social media and the near confusion and acrimony that has surrounded this debate.
In today’s world, development costs for new biological agents are increasing, and the time span from laboratory research to introduction of a product on the world market is becoming longer. Sadly for certain diseases that affect very small populations, incentives have not warranted investment by multinational pharmaceutical companies.
This led to the introduction of what is known as the orphan drug policy; Orphan Drugs refer to pharmaceutical agents that are developed specifically to treat medically rare conditions. To develop these pharmaceutical agents, governments often have to provide incentives. The intervention by government on behalf of orphan drug development can take a variety of forms: tax incentives, enhanced patent protection and marketing rights, clinical research financial subsidization etc.
In October 2014, at the peak of the Ebola pandemic, the European Medicines Agency (EMA) in conjunction with the Food and Drugs Authority (FDA) of the USA and the Medicines and Health Products Regulatory Authority (MHRA) invited applicants for an Ebola vaccine search under the umbrella of Orphan Disease guidance. This officially blew the whistle for competition amongst multinational pharmaceutical companies and leading researchers in tropical diseases in an area that hither to had become dormant.
Such pharmaco-medical research races are extremely competitive and shrouded in secrecy, though all groups ultimately aim at obtaining a vaccine and or treatment. There are confidentiality clauses and non-disclosure arrangements at each point to prevent leakage of intellectual property. Most scientist see these as date with destiny. Contracts between researchers, lead investigators and pharmaceutical companies in respect of intellectual property arrangements are strictly confidential and often not disclosed.
This is what has brought us to the point where some of these potential vaccines have been and continue to be tried in humans and have been licensed in many other countries across the Globe.
Applications for a licence to undertake clinical trials are often made in the appropriate manner to the statutory drug regulator in the country, in the case of Ghana, the Food and Drugs Authority (FDA). The information is then shared with the Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC) of the health authority, in the case of Ghana, the Ministry of Health. The applicant is not allowed to publicise the contents of their application or educate prior to approval. The application process is covered by confidentiality clauses where the regulator cannot divulge information regarding any applications received. It is therefore disingenuous to blame the FDA for lack of education.
It is obvious from the above that the applicant and regulator had their hands tied as far as sharing information with the public was concerned. My belief is that aspects of the vaccine dossier and or communication between the parties were leaked, resulting in information getting into the public domain. Sadly the applicant and local researchers could not help but abide with international laid down conventions, much to their own disadvantage. The reality of this compliance is on the basis that the companies undertaking the trials are also bound by guidance of the ethics committees in their own countries.
I explained previously, the stages of clinical trials and would want to make one distinction that pertains to experimental vaccines. Vaccine trials differ from conventional drug trial in that, in a vaccine trial one does not work with diseased individuals. The notion that if one wants to undertake an Ebola vaccine trial, he requires diseased patients is incorrect for a Phase I and Phase II studies, where studies are conducted to test the safety of the product and whether the product being tested can induce an immune response in recipients. Sadly this has been the main contention of most commentators.
As a result of a request by the World Health Organisation for a fast-tracking of the vaccine production, Johnson and Johnson approached countries known to have good infrastructure for clinical trials. The criterion set included, the presence of an independent and strong ethical review board, an independent regulatory authority, qualified staff with a good knowledge of clinical trials, research ethics and Good Clinical Practice.
Countries selected included Kenya, Mali and Ghana in Africa, Australia, the United Kingdom and the United States. The researchers involved in this trial locally are also world renowned, so is Noguchi Memorial Institute, the local research partner.
In my view with such a high bar set that, Ghana made the list is even a feather in our cap. Unfortunately with the way things are going, we ran the risk of blowing it all up. Issues of human security and public health are taken seriously by the World Health Organisation and are often left to the experts. They are not matters for public debate as has been experienced in Ghana and continue unabated. Truth is pharmaco-medical research has consistently tried to stay independent of politics. In contrast anything Ghanaian is viewed through a political lens.
We are always calling for Independent state institutions devoid of political influence, yet when it suits us we are the very ones who cause politicians to intervene. From radio stations who invited politicians and not public health researchers or experts in medicines and health product regulation to speak on the subject matter, to constituency activist who eventually managed to get the speaker of parliament to usurp his powers and call for the trials to stop; all acted in flagrant contravention of all international protocols governing pharmaco-medical research.
Truth is anytime we take our children to hospitals for a vaccine, let us remember that once upon a time; there were volunteers in the midst of health populations from whose risks we reap benefits and accrue long life. The world has been here before and flinched in the early days of Ebola, when only 400 people were affected because public pressure botched a vaccine trial making it convenient for the world to walk away. Today affecting near to 40,000 people, as a country we are at the verge of flinching. Is this what the forbearers wished for us?
With or without Ghana these trials will continue in other selected countries and hopefully a vaccine will be found. However as a country we should be mindful of the potential collateral damage we are doing to our pharmaco-medical research potential and the reputations of some world renowned clinical researchers who happen to be Ghanaians.
Ebola virus in the Vaccine?
The rumours being spread that the vaccine contains the virus are unfortunate, sometimes ignorant and in some cases mischievous. Let it be known by all that the potential vaccines currently undergoing clinical trials in other countries and for which an application has been granted but suspended in Ghana, does not contain the virus, neither is it attenuated. It is a recombinant antigen extract that has the potential of inducing antibodies in humans thus conferring immunity from Ebola.
Like the proverbial vulture, we are waiting for the next Ebola pandemic only to turn to the WHO and the international community in our trademark begging fashion, to demand with our egoistic false sense of entitlement the very vaccine we fought so hard to destroy.
My views about the Food and Drugs Authority, (FDA), Ghana are well document and known but I am also man enough to stand and applaud when the right thing is being done. It is in this vein that I have backed the actions of FDA, Ghana, on this occasion and deplored the ugly noises.