The use of unproven drugs to combat the deadly Ebola virus won support Tuesday from the World Health Organization, which cited deep concerns over “the largest, most severe and most complex outbreak of Ebola virus disease in history.”
The endorsement from the U.N.’s health care agency came after two American health care workers were treated with an experimental Ebola drug. Officials warned, however, that the improvement they showed may not have been directly related to the drugs.
WHO says 1,013 people have died since March in the outbreak, the vast majority of them in Liberia, Sierra Leone and Guinea. Officials estimate that Ebola kills about half of those afflicted with the disease.
“Over the past decade, research efforts have been invested into developing drugs and vaccines for Ebola virus disease. Some of these have shown promising results in the laboratory, but they have not yet been evaluated for safety,” WHO said in a statement.
In a meeting Monday, a dozen experts from around the world – including ethicists, infectious disease experts, drug regulators and patient advocates – gave the green light to treating patients even as research continues.
A number of drugs to treat and vaccines to prevent Ebola have been produced by scientists around the world. But in what Marie-Paule Kieny, WHO Assistant Director-General, declared a “market failure,” those approaches have not yet been tested in people.
“If it hadn’t been for the investment of a few governments, we’d be nowhere,” Kieny said in a press briefing Tuesday, praising the American and Canadian governments in particular for backing research. That research has stopped short of clinical trials in people, the most expensive part of the drug development process, which is generally handled by industry. With poor patients in poor countries, there is no obvious way for companies to make money on the drugs.
“This is why there are no stockpiles and we are not there yet. The only thing we can do now is accelerate the last stage of development and scale up production as quickly as possible,” she said.
While studies in monkeys can suggest effectiveness and safety, it is impossible to know how people will respond until they are given a treatment, Kieny said.
The people who have been given an experimental Ebola therapy so far help prove her point.
According to published reports about their responses, an American man seems to have improved dramatically after the first dose, an American woman also improved, but only after the second dose, and a Spanish priest who was to receive a course of treatment died Tuesday. It’s not clear whether the drug was responsible for his death, if the disease was too far along to be stopped, or even if he died before the first of three doses could be administered.
The experimental treatments are not necessarily a panacea, and WHO acknowledges they could be harmful. The Spanish missionary priest, Miguel Parajes, 75, died in a Madrid hospital, the hospital and his order said. The hospital would not confirm that he had been treated with the drug, but his order and Spain’s Health Ministry said earlier that he would be.
The WHO panel determined that, if stringent ethical criteria are met, the drugs should be used.
“These (criteria) include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community,” WHO said.
WHO stressed that Ebola outbreaks can be contained using available interventions such as early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control.
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SOURCE: USA Today
John Bacon & Karen Weintraub