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US officials unveil novel plan to test Ebola drugs

November 5, 2014

NEW ORLEANS (AP) — The quest for an Ebola treatment is picking up speed. U.S. officials have unveiled a plan to test multiple drugs at once, in an umbrella study with a single comparison group to give fast answers on what works.

“This is novel for us” and is an approach pioneered by cancer researchers, said Dr. Luciana Borio, head of the Food and Drug Administration’s Ebola response. “We need to learn what helps and what hurts” and speed treatments to patients, she said.

She outlined the plan Wednesday at an American Society of Tropical Medicine and Hygiene conference. Thousands of scientists have crowded into day and late-night sessions on Ebola, which has killed nearly 5,000 West Africans this year.

There is no treatment for Ebola, but several experimental ones such as ZMapp have been tried on a few patients, and scientists are looking at some others that were developed for different conditions but may also fight the virus.

“There’s this tremendous urge to want to give people these experimental therapies,” but it’s crucial to make sure they don’t do harm, said the FDA’s Dr. Edward Cox.

Everyone in the umbrella study would get supportive care, such as intravenous fluids, then be assigned to receive one of several drugs or be in a comparison group. That’s needed because without one, there’s no way to know if any problems or deaths are from the drug or the disease, Cox said.

Instead of waiting until a certain number of patients are treated to look at results, as is usually done, researchers will monitor results as they come in, pairing each person on a drug with someone from the comparison group to see if a pattern can be detected.

Cox said the FDA could not name the drugs being considered, but said a meeting next week with various companies should finalize the plans.

Other developments:

VACCINES

Ten potential vaccines have been developed, and two should enter mid- to late-stage testing in December or January, Dr. Cathy Roth of the World Health Organization told the conference via Skype from Geneva. GlaxoSmithKline’s is one of them, and it’s too soon to say when it could be ready for wide use or what it would cost, said the company’s Dr. W. Ripley Ballou.

Poor countries “can’t be expected to pay for it,” so groups that have given aid in the past likely will be asked to do that, he said.

FEAR, TRAVEL BANS

At least 30 scientists were barred from the conference because Louisiana state officials told attendees to stay away if they had traveled to certain West African countries or had contact with an Ebola patient in the last 21 days, Ebola’s maximum incubation period. One was Dr. Amanda Tiffany of Doctors Without Borders, who was to give a talk on how to limit the spread of Ebola, based on her work on some of the very first cases in Guinea.

“The stigma American and other colleagues are now facing is great,” she said in a statement read by a colleague. “We need information disseminated through the media based on science and medicine and not on fear.”

SURVIVING EBOLA

A study published online by the New England Journal of Medicine confirmed a previous one that suggested age plays a key role in surviving Ebola. Patients over 40 were nearly four times more likely to die than younger ones were, a study in Guinea led by Dr. Robert Fowler at the University of Toronto found. Thomas Eric Duncan, the Liberian man who died at a Dallas hospital where he sought treatment, was 42.

COLLATERAL DAMAGE

Ebola is setting back even the crude health care available in West Africa. In Sierra Leone, there now are no doctors willing to do Caesarean sections on pregnant women, whether they are known to have Ebola or not, because of the fear of exposure to so much blood, said Dr. Lina Moses, another Tulane researcher who works in that country.

“Maternal health is a serious issue right now,” she said. “We’re expecting maternal mortality to skyrocket.”

ARE CASES PEAKING?

New cases in some parts of Liberia are falling, but doctors fear it might be that fewer people are seeking treatment or staying away out of anger over seeing loved ones’ corpses burned instead of the traditional funeral practices that can spread the virus, said Dr. Armand Sprecher, another Doctors Without Borders physician.

“I would really like to believe that things are slowing down there, but I’m not going to get too optimistic yet,” he said.

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