Tuesday, August 12, 2014

Untested Ebola drugs ethical, says WHO




The first two doses of an experimental serum created to treat Ebola went to American missionaries.
Then the drug was sent to treat a Spanish priest.
The two Americans, Dr. Kent Brantly and Nancy Writebol, appear to be recovering. The priest, Miguel Pajares, died Tuesday morning.
That’s the problem with experimental drugs that have never been clinically tested in humans: No one knows whether they’ll work — and if they do, in whom.


This week, the World Health Organization gathered a group of ethicists to decide whether proven medications and vaccines should be used in the current Ebola outbreak. As the death toll from the epidemic soared over 1,000, the WHO panel unanimously concluded that it is ethical to offer medications to fight the Ebola virus, even if their effectiveness or adverse effects are unknown.
“The large number of people affected by the 2014 west Africa outbreak, and the high case-fatality rate, have prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic,” the World Health Organization said Tuesday.
WHO says it believes the virus has infected 1,848 people and killed 1,013, making this the deadliest Ebola outbreak in history.

The difference between this outbreak and other Ebola outbreaks is that traditional methods of stopping the virus from spreading — protective gear, contact tracing, etc. — don’t seem to be working fast enough, said Dr. Marie-Paule Kieny, WHO’s assistant director-general. The health care systems in the affected countries are also weak, so resources are scarce.
“If these treatments can save lives, should we not use them to save lives?” Kieny said the panel asked.
Desperation has pushed Liberia’s government to ask for the experimental serum used to treat the Americans and Spanish priest, in order to treat two local doctors.
The U.S. Food and Drug Administration approved Liberia’s request for access to ZMapp, which was created by the San Diego-based biotech firm Mapp Biopharmaceutical Inc. Sample doses of the medicine will be sent to Liberia this week to treat doctors who have contracted the virus, the Liberian government said.

Mapp Biopharmaceutical said Monday that its supply has been exhausted after fulfilling the request of a West African country. (It did not name the country.) Kentucky BioProcessing, which manufactures a version of the drug, is working to increase production of ZMapp, but the process will take several months, company spokesman David Howard said last week.
“There are not adequate supplies of any of the investigational agents anywhere near ready for human use,” said Dr. Jesse Goodman, director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University Medical Center, referring to all drugs being developed to treat Ebola.
“Not (adequate) to treat all the patients in this outbreak, even if we knew they worked.”

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