Last week the WHO approved the use of experimental
treatments in the Ebola outbreak in West Africa. There had been mounting pressure about this
issue, particularly after three leading Ebola experts called for the WHO to
take the lead in agreeing the use of such treatments the week before (http://blog.wellcome.ac.uk/2014/08/06/experimental-medicine-in-a-time-of-ebola/). The report of the 12-member panel that the
WHO convened is now publically available, so let’s break down the dilemma …
What do you mean, experimental?
Before treatments obtain a licence, they go through a lengthy process of
experimentation and testing. Usually
they are first tested on tissues in a lab setting – no live creatures involved. They may then be tested on animals, and
usually drugs must be successfully tested on two types of animals before they
go forward to clinical trials in humans.
The WHO has expressed a preference for experimental drugs that have
shown promising results on primates in the case of Ebola treatments that may be
used in this outbreak.
In order to prove their worth, the bottom line for new drugs
is that they must be safe and efficacious. Safe means that they don’t hurt people – a few
minor side effects are one thing, but we need to know if a drug might cause an
unacceptable level of harm compared to the potential for good. Efficacious means that they work. The dilemma in the use of experimental Ebola
drugs is that we don’t know, in humans, whether they are safe and efficacious.
Why should they be used?
Taking a drug when we don’t know either whether it will work or what
negative effects it might have is a risk.
The question is, is it a risk worth taking? The WHO has decided that in this instance,
such treatments may be used on compassionate grounds (i.e. outside of a
clinical trial), because the scale of the outbreak is unprecedented, and health
systems in the affected countries are already way beyond their capacity. At the end of the day, the only way of
finding out whether an Ebola treatment is safe and efficacious is during an
outbreak – and some of the drugs under development are ready for human testing.
What are the conditions?
Informed consent and understanding of the risks is vital for patients,
their families and carers, and medical personnel administering the drugs, along
with management of communities’ expectations more widely. The capacity to care for the patient who is
receiving the experimental treatment fully must be there, including monitoring
and treating any side effects. The panel
asserted that there is a moral duty to collect scientifically useful
information during the use of untested treatments that can be used to
understand how safe and effective they are in the interim until clinical trials
can be conducted. Finally, the use of
experimental treatments should not distract attention from the public health
interventions which are the main means of controlling the outbreak.
Who gets them? Perhaps
the thorniest issue of all – technically, the WHO has agreed to the use of
experimental treatments for possible
treatment of those that are infected, for people who have been exposed to
the disease but have not yet shown any symptoms (post-exposure prophylaxis), or for people who may be exposed (pre-exposure prophylaxis). In reality, the supply of these drugs is very
limited, so decisions need to be made about who gets it and who does not. The main debate is about whether health care
workers should be given priority – the main ethical principles for are reciprocity
(after all, they are putting their lives at risk by treating Ebola patients)
and social usefulness (we need them to fight the outbreak). But where does this leave victims of Ebola in
communities that have been affected?
It makes you wonder, under
what circumstances would you agree to someone putting a drug in your body when
no one knows whether it will work or the damage that it might do? I don’t have the answer for myself, but I do
know I would want to be given the choice.
No comments:
Post a Comment