Ebola Drug Panel Set by WHO to Weigh Unproven Drugs UseMakiko Kitamura
The World Health Organization will convene a panel of medical ethicists next week to explore the use of experimental treatments for Ebola amid the worst outbreak of the disease on record.
An experimental antibody cocktail developed by Mapp Biopharmaceutical Inc. was used to treat two infected American health workers whose conditions have improved. Before the announcement from the WHO, Nigeria’s health ministry said it had written to the director of the U.S. Centers for Disease Control and Prevention requesting access to the drug.
Use of the drug, called ZMapp, is raising questions about whether a medicine that hasn’t been shown as safe in humans should be distributed more widely during the outbreak and, given the limited amount of medicine available, who should get it, the WHO said in a statement.
“We have a disease with a high fatality rate without any proven treatment or vaccine,” said Marie-Paule Kieny, assistant director-general at the World Health Organization, in the statement. “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”
Nancy Writebol and Kent Brantly, American aid workers who contracted Ebola in Liberia, have been given doses of ZMapp. Writebol, 59, was showing “continued improvement” yesterday as she arrived in the U.S. for treatment, said Bruce Johnson, the president of SIM USA, the charity that sponsored her work in Liberia.
U.S. President Barack Obama, speaking today about the Ebola outbreak after a three-day summit in Washington with African leaders, said he is monitoring the progress of tests for the Mapp drug and other experimental treatments for the virus.
“I don’t think all the information is in on whether this drug is helpful,” Obama said when asked about the ethics of making ZMapp available to the two Americans. “I will continue to seek information about what we’re learning with respect to these drugs going forward.”
While Tekmira Pharmaceuticals Corp. was conducting early-stage tests of its Ebola therapy in humans, the U.S. Food and Drug Administration in July placed the trial on hold due to safety concerns. Other companies developing drugs for the deadly disease include Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc. and Sarepta Therapeutics Inc.
The WHO also said today it put together a committee to assess whether the Ebola outbreak should be declared an international public-health emergency, spurring further action. The agency said it would release the panel’s findings on Aug. 8.
Separately, the FDA said today it has authorized use of a “real-time” diagnostic test developed by the U.S. Department of Defense to help detect the Ebola virus in Africa. A positive result from the test should be be considered “presumptive” rather than conclusive, according to a fact sheet provided by the defense department. The FDA approval allows the test to be used for U.S. citizens, Cmdr. Amy Derrick-Frost, a spokeswoman for the department, said in an e-mail.
The defense department has distributed the test to overseas laboratories, including those in West Africa, and has been training people in its use, Derrick-Frost said.
The CDC may distribute the kit to some U.S. state and local labs, Barbara Reynolds, a CDC spokeswoman, said in an e-mail. Previously, all Ebola diagnostic testing has been done by the CDC, she said.
The outbreak of the Ebola virus had killed 932 people as of Aug. 4, the WHO said today. Most of the cases are in Guinea, Liberia and Sierra Leone in West Africa. Two deaths have been reported in Nigeria.