To make sure the public has as much confidence as possible in new products, all drugs have to undergo exhaustive, time-consuming and expensive testing. When high-profile media events like ebola, which killed 1/13,000th as many Americans this week as heart disease did, happen, there are calls to throw ethics and testing protocols out the window.
In a letter to The Lancet, 17 senior health professionals and medical ethicists from Africa, Europe, and USA, argue that randomized controlled trials are not needed for ebola, because the lack of effective treatment options and high mortality with the current standard of care means that alternative trial designs need to be considered.
In other words, right from the lab to human use, no stage I, II or III clinical trials.
Clement Adebamowo, Oumou Bah-Sow, Fred Binka, Roberto Bruzzone, Arthur Caplan, Jean-François Delfraissy, David Heymann, Peter Horby, Pontiano Kaleebu, Jean-Jacques Muyembe Tamfum, Piero Olliaro, Peter Piot, Abdul Tejan-Cole, Oyewale Tomori, Aissatou Toure, Els Torreele, and John Whitehead write that “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.”
“We accept that RCTs can generate strong evidence in ordinary circumstances; not, however, in the midst of the worst Ebola epidemic in history”, they conclude. “The urgent need is to establish whether new investigational drugs offer survival benefits, and thus which, if any, should be recommended by WHO to save lives. 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.”
Citation: Randomised controlled trials for Ebola: practical and ethical issues, Clement Adebamowo, Oumou Bah-Sow, Fred Binka, Roberto Bruzzone, Arthur Caplan, Jean-François Delfraissy, David Heymann, Peter Horby, Pontiano Kaleebu, Jean-Jacques Muyembe Tamfum, *Piero Olliaro, Peter Piot, Abdul Tejan-Cole, Oyewale Tomori, Aissatou Toure, Els Torreele, John Whitehead, The Lancet, 10 October, 2014