A Canadian drug company said U.S. health officials have eased safety restrictions on an experimental Ebola drug that showed promise in primate testing but was placed on full clinical hold due to possible side effects in healthy human volunteers.
The new FDA easing could enable doctors to use the drug, called TKM-Ebola, on infected Ebola patients, Tekmira Pharmaceuticals said Thursday.
“We recognize the heightened urgency of this situation and are carefully evaluating options for use of our investigative drug within accepted clinical and regulatory protocols,” the president of the Vancouver company said.
The serum given to two American aid workers who were airlifted out of Western Africa appears promising, but production is a problem.
“It takes two to three months to make less than a hundred doses. We have to do better than that,” Dr. Anthony Fauci of the National Institutes of Health told the Daily News Thursday.
“And we don’t even know if it works yet. People are confused. There are claims it’s a miraculous cure. We don’t know. It might be dangerous. We need to balance the risk with compassion,” he said.
Fauci’s comments came as some questioned why the experimental treatment was never offered to any African victims.
“This shows simply that white patients and black patients do not have the same value in the eyes of world medicine,” said Nouridine Sow, a sociology professor at the Universal Institute of Guinea.
Source: NY Daily News