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Tuesday, August 12, 2014

Unproven Ebola Drugs Are Ethical to Use in Outbreak: says WHO

Developers of unproven Ebola drugs received backing from medical ethicists to deploy the therapies against the worst outbreak of the deadly disease on record.
The decision, by a panel of outside advisers to the World Health Organization, gives stricken West African nations more confidence to request drugs and may yield valuable information on whether, and how, the medicines work. Finding doses poses an immediate challenge after one drugmaker, Mapp Biopharmaceutical Inc., said yesterday it’s already exhausted its supply.
There are no approved drugs or vaccines against Ebola, which has killed 1,013 of the 1,848 people infected in four nations. Nigeria and Liberia requested access to ZMapp, Mapp’s experimental antibody therapy, which has been used to treat two Americans who are improving and a Spanish priest who died. Sierra Leone had been awaiting the panel’s conclusion before pursuing ZMapp, said its chief medical officer, Brima Kargbo.
“In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects as potential treatment or prevention,” the WHO said in a statement today.
The use of unproven treatments should be guided by criteria such as informed consent, freedom of choice, confidentiality, preservation of dignity and involvement of the community, the Geneva-based health agency said.

Boosting Production

San Diego-based Mapp and its partners, Defyrus Inc. and a subsidiary of Reynolds American Inc., are working with the U.S. government to quickly increase production, the company said.
Liberia’s government said today the U.S. has approved its request for sample doses of experimental serum to treat two Liberian doctors. A U.S. government representative will bring the doses to the West African nation later this week.
Providing a small amount of an experimental drug won’t help control the outbreak, said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases. The focus needs to remain on basic public health and infection-control measures, he said.
“How can a couple of doses control an outbreak with hundreds and hundreds of people?” Fauci said by phone.
U.S. regulators last week said a treatment by Tekmira Pharmaceuticals Corp. could be tested in infected patients, while Mapp’s drug has already been used to treat two American aid workers Kent Brantly and Nancy Writebol, who were infected in Liberia. The pair were flown to Emory University Hospital in Atlanta, where relatives and supporters have said they are improving, though it remains unclear if or how much the drug helped.
 
Workers unload medical supplies for countries hit by the Ebola outbreak .

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