Experimental Ebola treatment given to Americans, but when will regulatory pathway extend to sick Africans?

The two Ebola-infected Americans recently evacuated from Liberia were given an experimental drug that probably saved their […]

The two Ebola-infected Americans recently evacuated from Liberia were given an experimental drug that probably saved their lives, but Popular Science raises an interesting point – no Africans are likely to get the same treatment. Not anytime soon, that is.

Kent Brantly and Nancy Writebol, the two volunteers in an Ebola clinic that contracted the deadly virus, were given a serum developed by San Diego’s Mapp Biopharmaceutical right before they were jetted to Atlanta for treatment at the CDC, CNN reports.

The serum hasn’t yet been tested in humans – only in mice and a few lucky monkeys. It’s rare for such therapies to be used in such emergency scenarios but not unheard of, Popular Science said – but the regulatory pathway to get the treatment into wider use among Africans infected with Ebola has far too many stopgaps – or stumbling blocks – in the way.

The two Americans were able to sidestep the regulatory pathway through what the FDA calls “expanded access” or “compassionate use,” Popular Science writes.

Expanded Access allows patients with life-threatening conditions to legally take experimental drugs (although there’s no guarantee a company will agree to sell an untested drug in this way).

A July 25 report from Science says that with 1,048 reported Ebola cases and 632 deaths (at that time), the West African Ebola outbreak “shows no sign of tapering off.” However, though several drugs and vaccines are being developed against the virus, the lack of human safety testing has prompted a debate over whether such experimental therapies should be fast-tracked into human use.

As the outbreak worsened, debates intensified among scientists, government officials, and company executives about bringing some of these unapproved products to Africa on a so-called compassionate use basis.

But the organizations fighting Ebola on the ground say they can’t bring an untested, unlicensed drug or vaccine to a population that’s already distrustful of the teams fighting the outbreak.

That last point is quite critical. Popular Science expounds on this:

However, doctors on the ground say they’re already dealing with a lot of distrust and even violence from locals, who sometimes believe healthcare workers actually bring the disease to them. Throw rumors of an “untested injection” into the mix and, well, organizations such as Doctors Without Borders think it would be counterproductive.

Add that to regulatory pathways that require three phases of human trials, and you’ve got perhaps thousands more lives on the line. However, according to the BBC, the U.S. plans to send at least 50 public health workers to West Africa to help rein in the disease. Additionally, the NIH has announced that an Ebola vaccine will begin clinical testing in September.

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