WHO eases new Ebola drug testing
Ebola drug testing – WHO sets the record straight
Parts of Africa have been gripped by fear and anxiety as rapidly increasing numbers of patients report being affected by the deadly Ebola virus. The four countries worst affected are Liberia, Guinea, Sierra Leone and Nigeria. Figures available as on August 22, 2014 so far show that the number of people infected with the virus stands at 2,615, out of which 1,528 are confirmed cases. The number of people who have so far succumbed to the disease is 11,427.
Two things make Ebola such a frightening epidemic. Nearly 55% of the affected people do not survive the attack. In other words, more than 50% of those who contact the disease die. The second is the absence of any proven antidote against Ebola.
A few American pharmaceutical firms have led the effort to invent a cure for Ebola. Without comprehensive clinical trials, no drug can be released for sale. This is where the American drug companies spearheading the research have been bogged down. In almost all the African countries, suspicion against the motive and methods of American drug firms have been quite entrenched. This makes the task of getting enough patient volunteers to be treated with new experimental drugs difficult. The other problem is the absence of sophisticated medical facilities where the effects of the new drug on other functions of the body can be accurately observed. So, it has not been clinical possible to conduct clinical trials in large scale so far. American firms have always been wary of court litigations and large compensation claims that they may have to face later.
The ferocity of the Ebola virus and its ability to proliferate at astounding speed very quickly as evidenced by the recent spurt in Ebola infections have underscored the need for certain concessions and relaxation of the conventional clinical trial norms.
The World Health Organization (WHO) deliberated on this issue and came out with a set of new guidelines that may pave the way for fast-tracking trial of new drugs. On August 11, 2014, a 12-member World Health Organization panel unanimously agreed that the use of “unproven interventions (meaning drugs)” in humans to treat or prevent the Ebola virus disease will not be considered un-ethical in the west African countries Liberia, Guinea, Sierra Leone and Nigeria. The interventions (or administration of new, unproven drugs is to be evaluated for safety and efficacy in the best possible clinical trial settings. The matter of ensuring “fair distribution” among the affected populations and countries has been left to be decided later.
The green signal has been given with regard to the extraordinary situation that has arisen due to Ebola epidemic has reached such alarming level in the four affected countries. It is subject to certain conditions like “transparency about all aspects of care, and informed consent” being met, and all clinical reports being maintained and kept in the public domain.