As more companies step up efforts to develop vaccines targeting Ebola and the disease outbreak spreads in Africa, a doctor at Duke University warns that using untested drugs “could prove disastrous.”
“To use this drug without having any information on its human benefits or dangers runs the risk of mistakenly thinking it is either effective or not based upon anecdotal evidence, a difficulty that could prove disastrous for later in this outbreak or future ones,” said Dr. Philip Rosoff, who is a professor of pediatrics and medicine and director of the Clinical Ethics Program at Duke University Hospital.
Rosoff spoke out as efforts worldwide to develop a first-ever Ebola vaccine were stepped up.
The World Health Organization on Tuesday reported that two experimental Ebola vaccines could begin trials in the near future and that there could be enough early-stage data to determine possible emergency use before the end of the year. according to Reuters news service.
“There is a way to fast-track clinical trials,” WHO Assistant Director-General Marie-Paule Kieny said, according to Reuters.
GlaxoSmithKline, which operates its North American headquarters in Research Triangle Park, has a vaccine under development.
Meanwhile, Triangle-based BioCryst on Wednesday received another $4.1 million through an agency of the U.S. National Institutes of Health to continue its own vaccine program.
Experimental drug used
On Monday, in Spain, an experimental drug from the U.S. is being used to treat a missionary priest who was evacuated from Liberia last week after testing positive for the killer virus.
The Health Ministry announced that the ZMapp drug, made by Mapp Biopharmaceutical Inc. of San Diego, was obtained in Geneva over the weekend and brought to Madrid to treat Miguel Pajares. The 75-year-old priest was evacuated from Liberia and placed in isolation Thursday at Madrid’s Carlos III Hospital.
There is no known cure or licensed treatment for Ebola, which has killed more than 1,000 people in the current outbreak in West Africa.
WHO has declared the Ebola outbreak an international health emergency and urged nations worldwide to donate resources to battle the disease.
Two Americans diagnosed with Ebola in Liberia and evacuated back to the United States have been treated with the drug. One of them, Dr. Kent Brantly, said last week that his condition was improving and the husband of the aid worker being treated with Brantly said the same thing. Both are being treated in isolation at an Atlanta hospital.
“Extra caution” needed, doctor says
But Rosoff is urging caution.
“Desperately sick people and their families make decisions under very trying circumstances,” Rosoff said. “Often, they are willing to try anything that they believe — or can be led to believe — may offer some hope of improvement or a cure. As such, they can be ripe targets for those who would take advantage of their desperation and plight. Thus, extra caution and thought must be given to using experimental and possibly dangerous treatments in this population.”
In a statement provided by Duke University, Ross raised several points of concern, ranging from lack of informed consent and possible preferential treatment.
“The notion of informed consent in these situations is almost meaningless as the desire for something — anything — can lead patients and their families to ignore even the direst warnings. In the current epidemic of Ebola, there is the added ingredient of the long and sordid history of pharmaceutical companies from Western industrialized nations performing clinical trials in poor, undereducated populations for the benefit of the potential wealthy patients back in their home countries,” Rosoff said.
“Furthermore, the few patients who have been treated with this first-in-people drug for Ebola have all been white residents of Europe or the United States, a fact that could raise issues of preferential treatment.”
Another vaccine nears testing
On Thursday, an Iowa drug developer said it has enough doses of a possible vaccine to launch an initial round of human testing.
NewLink Genetics Chief Financial Officer Gordon Link said the timing of the trials is uncertain, but the company is receiving help from a number of sources to speed up the process.
NewLink Genetics Corporation says the vaccine has been 100 percent effective in preventing deadly Ebola infections in non-human primates, and it acts quickly enough to show effectiveness in animals that received a typically lethal dose of the virus.
(The Associated Press contributed to this report.)