The tragedy of Ebola, in its now catastrophic development, besides wiping out so many human lives is already producing a cascade of effects at a global level whose extension and broad reach are impossible to foresee.
Also drug safety evaluation (or, as it is always better to say, the benefit-damage ratio) is undergoing a change that we could consider historic, hence it is probably the first time that – at international level - the canonical rules are “suspended”, rules resulted from an evolution process of several decades.
Last August, twelve world renowned experts summoned by Margaret Chan, the general director of WHO, discussed the emergency in videoconference and reached a unanimous conclusion: it is ethically and scientifically acceptable to use “unregistered interventions that have shown promising results in the laboratory and in animal models, but have not yet been evaluated for safety and efficacy in humans.” This quote represents the real “core” of the document, and therefore it is repeated identically in every sentence, so as to define with no ambiguity the limits within which this decision applies, a decision taken by the panel members with the explicit awareness that it is a “departure from the well-established, historically evolved system of regulation and governance of therapies and interventions”.
Obviously, this is not “all outs, all in free”: possible remedies against the Ebola virus that have not been experimented yet can be tried out in patients only if some elementary and precise conditions - listed in detail by the document “Ethical considerations for use of unregistered interventions for Ebola viral disease” - are respected: transparency, equity, solidarity, consensus, freedom of choice, confidentiality, respect, dignity and community involvement. Without forgetting the necessity of taking into account all the available scientific information, even if partial and preliminary, on effectiveness and safety of the interventions. And planning their use so as to collect and share the most accurate and reliable data on possible effects.
All these aspect neatly distinguish the exception for Ebola from what Stamina [Stamina is the name of an organization in Italy who pretended to cure a lot of diseases with infusions of mesenchymal staminal cells manipulated with a secret method and never experimented in humans or in animals] supporters wanted to obtain for an alleged remedy for fatal diseases, for which no data, not even about the preparation itself, are available.
For once, in fact, no dissenting voice was raised against the conclusion of the experts, who however acknowledge the necessity of a deeper understanding of some crucial aspects. For example: how could we transform the “compassionate use” in an opportunity for gaining scientifically based knowledge, on a tragedy field like this one? Or how do we decide which interventions have priority, or to whom should they go, in case of scarcity?
There is, anyway, one question not explicitly answered in the document, if not with a generic reference to the “exceptional circumstances” of the present Ebola outbreak; which criteria defines the exceptionality of a situation, in order to make sure that this dramatic event does not become the opportunity for an irreversible weakening of the rules, the classic hole in the dam that can only become bigger?
When an exception to the rule is clearly formulated, it offers an important opportunity to understand the nature of the rule itself more deeply. And rules are better followed when their reasons and history are well known.
In other words, we need to ask ourselves why we cannot apply usual rules to Ebola infected patients: is it because they are in life danger or because there are no treatments of established safety and effectiveness? These conditions are actually very common, for example for many types of cancer in advanced phase, or for rare, fatal diseases.
The real Ebola exceptionality is a sort of Catch-22 [From the novel Catch-22, which describes absurd bureaucratic constraints on soldiers in World War II] paradox: experimenting potential remedies is possible only if an outbreak is ongoing, but the difficulties that need to be faced during an ongoing Ebola outbreak practically prevent controlled and randomised experimenting (especially in the past, when epidemics, luckily, did not last for long).
The one currently ongoing, unfortunately, will not end soon, and the calamity is also an opportunity for the scientific community for releasing guilt about dismissing such a serious menace for global health (and not only), considering it of scarce interest for the “market” and for the Western world.