Federal panel to ponder using Ebola drugs; FDA eases hold on one
The Obama administration is setting up an Ebola working group to consider making policy for the possible use of experimental drugs in West Africa's Ebola epidemic, Reuters reported yesterday, while the Food and Drug Administration (FDA) lifted a barrier to the potential use of an unlicensed drug made by a Canadian company.
There are no licensed drugs for Ebola, but several companies have experimental drugs. Two infected American medical workers were recently treated with one of them, ZMapp, and some are advocating broader emergency use of candidate drugs.
An unnamed Obama administration official told Reuters the working group is being formed under Nicole Lurie, assistant secretary for preparedness and response at the Department of Health and Human Services.
The group will include officials from such agencies as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID).
Fauci told Reuters he was unsure when the group would meet or who would be there, but said, "I'm sure they'll tap people from NIAID with competence in clinical trials. . . . You need to balance compassion with the need to figure out if something actually works."
Aug 7 Reuters story
Meanwhile, the FDA has loosened its "full clinical hold" on TKM-Ebola, an experimental drug made by Tekmira Pharmaceuticals of Vancouver, B.C, permitting its potential use in Ebola patients, the company announced yesterday.
In a press release, Tekmira President and CEO Mark Murray, PhD, commented, "We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola."
Tekmira said the FDA's hold on clinical use of the drug still applies to the "multi-ascending dose portion" of a phase 1 clinical trial.
TKM-Ebola is being developed under a $140 million contract with the US Department of Defense. In an earlier study, the drug protected monkeys from an otherwise lethal dose of Ebola Zaire virus.
Aug 7 Tekmira press release
CDC issues guidance on case definitions, contact monitoring
The CDC yesterday posted two more Ebola virus disease (EVD) resources for clinicians: an updated case definition and interim guidance for monitoring and movement of people who have been exposed to the virus.
The medical evacuation of two American missionaries infected with the virus from Liberia to Atlanta and the evolving situation in West Africa prompted the CDC to increase its response to the highest level, which has included a steady flow of resources for clinicians.
The case definition update briefly spells out definition for persons under investigation, probable cases, and confirmed cases. It also defines contacts of EVD cases, stratifying those by level of exposure risk.
For example, a high-risk exposure contact would be someone with a needlestick injury or mucous membrane exposure to body fluids of an EVD patient, a lab worker exposed to body fluids without wearing appropriate personal protective equipment (PPE), or a person who participated in funeral rites in an outbreak country without wearing appropriate PPE.
The monitoring and movement guidance walks health professionals through the exposure risk tiers, with recommendations for medical evaluation, infection control considerations, and travel decision guidance at each level. For example, for an afebrile medical worker in an outbreak country who didn't provide high-risk care, the CDC recommends conditional release and controlled movement until 21 days after the last known exposure.
Aug 7 CDC updated EVD case definition
Aug 7 CDC interim guidance for monitoring and movement of people exposed to Ebola
Nigeria declares emergency, screens travelers
Nigerian President Goodluck Jonathan declared a state of emergency today in view of Ebola cases in the country, says a Reuters report, and Minister of Health Onyebuchi Chukwu announced yesterday that the country would be screening all outbound travelers for the disease.
Emergency funds amounting to the equivalent of $11.6 million were approved by Jonathan to help contain the Ebola virus.
Outbound travelers showing symptoms will not be allowed to leave Nigeria, according to a posting yesterday on the online version of Nigeria's This Day newspaper. Non-Nigerians found to be symptomatic at screening will be allowed to leave the country only if their home country is able to provide proper evacuation and treatment, the story says.
Nigeria reported its first case of Ebola Jul 25, in a man who flew in from Liberia and died of the disease, and has since had at least 13 more confirmed or suspected cases, all or most of them in health workers who had contact with the man, including a nurse who has died. A story in The Guardian says some 70 people who had contact with him are under observation, and Vanguard, a Nigerian news outlet, reports that 139 people are being monitored.
Ebola cases suspected in Greece, Benin
One patient in Greece and two in Benin are being tested for possible Ebola virus disease, according to separate Agence France-Presse (AFP) stories.
The Greek patient, a man who recently traveled to Nigeria, is in an Athens hospital, AFP reported today. Few details were available, but a health ministry spokesperson said the man likely checked himself in at the hospital.
The man was mistakenly identified as Nigerian earlier by the health ministry. Another Greek who had traveled to Nigeria was suspected earlier this week of having Ebola but now has been diagnosed with malaria.
Airport and port staff in Greece have been warned to remain vigilant for the disease.
Aug 8 AFP story
The other story said Benin, a tiny country that borders Nigeria, has placed two people in isolation with possible Ebola infections, pending test results.
One patient is hospitalized in Porto-Novo, the capital, and the other in Cotonou. The latter city is only a few hours' drive from Lagos, Nigeria, and traffic between the two cities is heavy, according to AFP. Nigeria has reported one fatal imported case of Ebola and several cases in contacts of the index case.
Moufalilou Aboubaker, of the country's health ministry, advised journalists that blood samples from the two patients have been sent to foreign labs, says the story.
Aug 7 AFP story