Experts question ethics of placebo drug trials in case of Ebola

Mon Oct 13, 2014 7:20am EDT
 
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By Kate Kelland

LONDON Oct 13 (Reuters) - A group of influential health experts has argued the standard practice of using placebos in drug trials would be unethical in the case of experimental medicines for Ebola, given that the world is in the middle of a deadly epidemic.

Faced with a disease with a death rate of between 40 and 90 percent, randomised controlled trials (RCTs) -- where patients are assigned to get either the drug or a dummy pill -- would be unfair and ethically unacceptable, according to the disease specialists from Europe, Africa and the United States.

"We accept that RCTs can generate strong evidence in ordinary circumstances; not, however, in the midst of the worst Ebola epidemic in history," experts including David Heymann, head of the Chatham House Centre on Global Health Security, wrote in a letter to the Lancet medical journal.

Some trials of potential Ebola treatments or vaccines in West Africa have just begun, or are due to start in the coming months, and the World Health Organization (WHO) has said it hopes some medicines may start to be deployed in the West Africa outbreak early next year.

A different group of disease experts last month argued in a letter to the Journal of the American Medical Association that experimental Ebola drugs were best tested in normal RCTs.

A similar debate is going on in the field of cancer drugs, where researchers increasingly question whether randomisation -- where some patients are given a treatment and others get a "control" substance for comparison -- makes sense in patients with an incurable disease.

In cancer, new trial designs are being pioneered that allow faster testing on experimental medicines in smaller, more targeted groups, potentially shaving major costs and significant time off the usual drug development process.

The Ebola expert group writing in the Lancet -- which also included Peter Piot, a professor and director at the London School of Tropical Medicine who was one of the discoverers of Ebola -- stressed that "the urgent need is to establish whether new investigational drugs offer survival benefits" and therefore which, if any, should be recommended by the WHO to save lives.   Continued...