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Giving Americans Drug for Ebola Virus Prompts Flak
ATLANTA—As the second U.S. Ebola patient arrived in Atlanta on Tuesday, health authorities in Liberia raised questions about how the woman and an American doctor were given an experimental U.S. treatment unavailable to the hundreds of Africans sickened by the deadly virus.
For the drug to be used in Liberia, it would have to be approved by the country's Ministry of Health Ethical Committee, said Bernice Dahn, Liberia's chief medical officer. Dr. Dahn said she wasn't aware of the committee approving any experimental Ebola treatment, though she also wasn't aware of any being disapproved. Liberia's assistant health minister, Tolbert Nyenswah, didn't know of any approval. Liberia's presidency also wasn't aware, said Information Minister Lewis Brown. Now, Dr. Nyenswah said, officials have been beset with requests from dying patients and their relatives for the same treatment. "This is something that has made our job most difficult," Dr. Nyenswah said. "The population here is asking: 'You said there was no cure for Ebola, but the Americans are curing it?'"
Details of how ZMapp was administered to the patients in Liberia—and who authorized its use—remained sketchy Tuesday. Bruce Johnson, president of SIM USA, the Charlotte, N.C.-based charity with which Ms. Writebol, 59, and her husband, David, went to Africa, said at a news conference Tuesday that the decision to use the drug was left to the patients, their families and their doctors. An Obama administration official said Tuesday that the treatment was arranged by Samaritan's Purse, a humanitarian organization that sponsored Dr. Brantly in Liberia. The National Institutes of Health provided Samaritan's Purse with contacts at the company developing this treatment, the official said. "The NIH did not procure, transport, approve or administer the experimental treatments in Liberia," the official said. A spokeswoman for the U.S. Food and Drug Administration said the FDA can provide access to experimental treatments by a mechanism known as an emergency investigational new drug application, and that the agency's approval is required before an experimental drug can be given in the U.S. Mapp Biopharmaceutical Inc. of San Diego, which developed ZMapp, describes the drug as a cocktail of three "humanized" monoclonal antibodies that are manufactured using tobacco plants. A monoclonal antibody is a laboratory-engineered version of natural antibodies found in humans and animals that help combat disease. Monoclonal antibodies are typically injected or infused; some already on the market treat diseases ranging from cancer to rheumatoid arthritis. ZMapp was derived from mouse cells that were "humanized," or infused with human components, to work in people, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. The cocktail comprises components of two older experimental drugs: MB-003, which was developed by Mapp; and ZMab, developed by Defyrus Inc. of Toronto and the Public Health Agency of Canada. MB-003 showed promise in treating monkeys infected with Ebola, according to a study published last year in the journal Science Translational Medicine. ZMapp is made by infecting tobacco plants with certain proteins, growing them in the plants, then extracting and purifying the proteins, according to David Howard, spokesman for tobacco-products maker Reynolds American Inc. A Reynolds unit, Kentucky BioProcessing LLC, has a contract to make the drug in Owensboro, Ky., Mr. Howard said. Kentucky BioProcessing is working with Mapp and government agencies to increase production of ZMapp, he said. In addition, the company complied with a request from Emory University, at whose hospital the two patients are being treated, and Samaritan's Purse to provide a limited amount of ZMapp to Emory, said Mr. Howard. He declined to say how much was provided. An Emory spokeswoman wouldn't confirm the request. Posted by: Steve White 2014-08-07 |
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