Ebola and Sidestepping the Clinical Trial System

August 7, 2014 | The situation in West Africa is presenting many challenges for health care delivery, global health, and medical aid ethics. But the experimental drugs given to two US aid workers are also presenting huge challenges for the clinical trial and drug approval infrastructure. The "right to try" movement is not limited to diseases as exotic and frightening as Ebola. The same reasoning argues for cancer treatments to be made available to terminally ill patients who apply for a compassionate use waiver. In this case, as in others, some researchers and the FDA argue that stepping outside of the traditional clinical trial system does more harm than good--muddying the evidence waters and potentially harming patients. 

The two aid workers receiving experimental drug doses so far, Dr. Kent Brantly and Nancy Writebol, seem to be improving. But it's impossible to say whether that is due to the drug, to other treatment offered in Liberia (Dr. Brantly received a blood transfusion from a recovered patient), or from the care they have received once they were transported to the US. Or possibly they are just getting better. The mortality rate for Ebola is high, but it's not 100%. Some patients have always survived.

The situation is challenging for drugmakers too. Mapp Biopharmaceutical, maker of the ZMapp drug that Dr. Brantly and Ms. Writebol received, only has a few doses on hand. Widespread use would require making a lot more of a drug that the company is not actually testing. Other companies working on Ebola treatments are anxious to offer their drugs. Sarepta Therapeutics in Boston says they have enough of their compound to treat about 24 patients within a week. But again, these are samples of drugs that have not been proven safe or effective in humans. 

But that doesn't keep patients--and in this case, governments--for lobbying for the experimental drugs. The World Health Organization said yesterday that it would convene a panel of experts to look at the question. 

LA Times 

Washington Post


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