Ebola, experimental treatments get the green light, the WHO shows the way forward…
The Ebola epidemic has already caused thousands of deaths this summer, mainly in West Africa. It is one of the most serious viral diseases known to man. It is transmitted by wild animals and then spreads through populations from one person to another. The virus causes severe haemorrhagic fever and has a fatality rate of up to 90%. Numerous countries, including France, are mobilised to prevent the virus spreading to other parts of the world.
In response to this emergency, the WHO has given the green light for experimental treatments, despite uncertainties relating to their efficacy and safety in humans. Three health professionals infected by Ebola have already been treated with a serum containing three types of antibodies, which had previously yielded positive results only in monkeys.
It must have been a real dilemma for the WHO ethics committee to approve a treatment never before tried in humans, with the potential risk of doing more harm than good. What’s more, we’re talking about a necessarily very expensive product, stocks of which remain extremely limited, aimed at populations benefiting from few health services.
The WHO’s decision thus sets a remarkable precedent, when we consider that three clinical trial phases are usually required – a rigid and expensive process that takes several years – before any new drug can be authorised.
An exceptional procedure for exceptional circumstances, you might say. Hence this “compassionate” response on the part of the WHO, which gave the go-ahead not to wait… for the patient’s condition to worsen.
The WHO has therefore proved that, in certain specific circumstances, we can cast off the shackles of procedures, skip steps and try to save precious time to beat a disease. However, this does not mean we can eliminate all the safeguards concerning treatment conditions (transparency of treatment, informed consent, freedom of choice, confidentiality, respect for individuals, etc).
At a time when the urgency is very real for numerous forms of leukodystrophy, the contrast between the rules imposed by the legislator in France and Europe and the approach adopted by the WHO in response to Ebola is stark. Any trial, even one presenting a very low risk, any compassionate use at all, even with a known and tested drug, is fraught with difficulties and endless delays for those in the front line: the patients themselves.
To gain a measure of this increasingly cumbersome bureaucracy, simply look at the fact that the number of clinical trials carried out in Europe fell by 25% between 2007 and 2011. The resolution adopted by the European Parliament in April 2014 to simplify procedures and encourage clinical trials in rare diseases reflects its concern at the situation. But these measures, late in the day, fall short of addressing the urgency of a number of very serious, fast-progressing diseases, such as leukodystrophies.
Somewhere between the necessary caution with respect to experimental treatments and the state of emergency represented by certain diseases, between the weighing up of the benefit/risk balance for patients, there is room for braver and bolder legislation designed to benefit our patients. In response to exceptional circumstances, the WHO has given experimental treatments the green light and shown the way forward…
Guy Alba, Chairman