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US government had role in Ebola drug given to aid workers

By Marilynn Marchione

Associated Press

Published: Monday, Aug. 4 2014 12:00 a.m. MDT

Updated: Tuesday, Aug. 5 2014 12:33 a.m. MDT

This Oct. 7, 2013 photo provided by Jeremy Writebol show his mother, Nancy Writebol, with children in Liberia. Writebol is one of two Americans working for a missionary group in Liberia that have been diagnosed with Ebola. Plans are underway to bring back the two Americans from Africa for treatment.

Courtesy Jeremy Writebol, Associated Press

Enlarge photo»

Two American aid workers infected with Ebola are getting an experimental drug so novel it has never been tested for safety in humans and was only identified as a potential treatment earlier this year, thanks to a longstanding research program by the U.S. government and the military.

The workers, Nancy Writebol and Dr. Kent Brantly, are improving, although it's impossible to know whether the treatment is the reason or they are recovering on their own, as others who have survived Ebola have done. Brantly is being treated at a special isolation unit at Atlanta's Emory University Hospital, and Writebol was expected to be flown there Tuesday in the same specially equipped plane that brought Brantly.

They were infected while working in Liberia, one of four West African nations dealing with the world's largest Ebola outbreak. On Monday, the World Health Organization said the death toll had increased from 729 to 887 deaths in Guinea, Sierra Leone, Liberia and Nigeria, and that more than 1,600 people have been infected.

In a worrisome development, the Nigerian Health Minister said a doctor who had helped treat Patrick Sawyer, the Liberian-American man who died July 25 days after arriving in Nigeria, has been confirmed to have the deadly disease. Tests are pending for three other people who also treated Sawyer and are showing symptoms.

There is no vaccine or specific treatment for Ebola, but several are under development.

The experimental treatment the U.S. aid workers are getting is called ZMapp and is made by Mapp Biopharmaceutical Inc. of San Diego. It is aimed at boosting the immune system's efforts to fight off Ebola and is made from antibodies produced by lab animals exposed to parts of the virus.

In a statement, the company said it was working with LeafBio of San Diego, Defyrus Inc. of Toronto, the U.S. government and the Public Health Agency of Canada on development of the drug, which was identified as a possible treatment in January.

The statement says very little of the drug is available and they are "cooperating with appropriate government agencies to increase production as quickly as possible," but gives no details on who else might receive it or when.

The U.S. Food and Drug Administration must grant permission to use experimental treatments in the United States, but the FDA does not have authority over the use of such a drug in other countries, and the aid workers were first treated in Liberia. An FDA spokeswoman said she could not confirm or deny FDA granting access to any experimental therapy for the aid workers while in the U.S.

Writebol, 59, has been in isolation at her home in Liberia since she was diagnosed last month. She's now walking with assistance and has regained her appetite, said Bruce Johnson, president of SIM USA, the Charlotte, North Carolina-based group that she works for in Africa.

Writebol has received two doses of the experimental drug so far, but Johnson was hesitant to credit the treatment for her improvement.

"Ebola is a tricky virus and one day you can be up and the next day down. One day is not indicative of the outcome," he said. But "we're grateful this medicine was available."

Brantly, 33, who works for the international relief group Samaritan's Purse, also was said to be improving. Besides the experimental dose he got in Liberia, he also received a unit of blood from a 14-year-old boy, an Ebola survivor, who had been under his care. That seems to be aimed at giving Brantly antibodies the boy may have made to the virus.

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