NEW TREATMENTS FOR Ebola need to be fast-tracked, say leading health experts.
In a letter to The Lancet journal, 17 senior health professionals and medical ethicists, from Africa, Europe, and USA, argue that randomised controlled trials are unethical and impractical.
They said the lack of effective treatment options for Ebola, high mortality with the current standard of care, and the paucity of effective health care systems in the affected regions means that alternative trial designs need to be considered.
Some US and British airports have begun screening passengers arriving from West African countries for Ebola, however, Ireland has ruled out any such measures, with the Minister for Health Leo Varadkar stating that it is far more effective to screen people as they leave countries where the virus is present, rather than screening people coming into a country.
The medical experts who wrote the letter stated:
No-one insisted that western medical workers offered zMapp and other investigational products were randomised to receive the drug or conventional care plus a placebo.None of us would consent to be randomised in such circumstances.
In cancers with a poor prognosis for which there are no good treatments, evidence from studies without a control group can be accepted as sufficient for deployment, and even for licensing by regulators, with fuller analysis following later.
There is no need for rules to be bent or corners to be cut: the necessary procedures already exist, and are used.
While they said they accepted that randomised controlled trials can generate strong evidence in ordinary circumstances, they do not agree that “in the midst of the worst Ebola epidemic in history” that they work in this case.
They said there is an urgent need is to establish whether new investigational drugs offer survival benefits, and which, if any, should be recommended by the World Health Organisation.
“We have innovative but proven trial designs for doing exactly that. We should be using them, rather than doggedly insisting on gold standards that were developed for different settings and purposes,” the concluded.