Some Ebola Patients Should Get Placebo in Drug Tests: FDA

Some Ebola patients need to forgo potentially life-saving treatments so researchers can see how they fare compared to people who get the experimental drugs, a Food and Drug Administration official said today.

While randomized trials would be “challenging,” they’re needed to understand whether or how well the medicines work, said Edward Cox, director of the FDA’s Office of Antimicrobial Products, at an American Society of Tropical Medicine and Hygiene conference in New Orleans. Trials would compare “the best supportive care versus the best supportive care with a drug,” he said.

The agency has a meeting next week to hear from companies making experimental treatments, Cox said. He declined to name the companies, saying “those products are out there in the news.” Chimerix Inc., Mapp Biopharmaceutical Inc., Tekmira Pharmaceuticals Corp. and FujiFilm Holdings Corp. are among the firms developing medicines.

The idea of using placebos in West Africa, where many of the trials may be done, has created an ethical debate pitting one of the world’s deadliest pathogens against the need to better understand exactly which drugs are most effective.

Trials where everyone gets an experimental drug may be misleading, making doctors think a treatment is more or less effective than it actually is. It could also mask harm in critically ill patients.

Ethical Debate

Yet 17 medical ethicists and health providers from across the world last month denounced efforts to require randomized controlled trials that don’t give the therapies to everyone. The lack of effective treatments for Ebola, its high mortality rate, and poor infrastructure where it is prevalent means novel approaches are needed, they wrote in the journal Lancet.

The FDA oversees trials that generate data for approval of medical products. The current outbreak has killed about 5,000 people, largely in Liberia, Sierra Leone and Guinea, according to the World Health Organization.

In order to speed up the hunt for the best drug, the FDA is planning to check on effectiveness at “multiple intervals” during the trials -- with more interim analysis than is done in regular clinical trials -- until a drug shows signs of working, said Cox.

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