Controversy Rocks Ebola Treatment of US Doctors w/ ZMapp Cocktail
By Athena Yenko | August 6, 2014 10:19 AM EST
Pioneers of Ebola virus research had expressed their skepticsm about how the Ebola medical cocktail, ZMapp, was hurriedly administered to two American doctors infected with the virus.
Government health workers are seen during the administration of blood tests for the Ebola virus in Kenema, Sierra Leone, June 25, 2014. West African states lack the resources to battle the world's worst outbreak of Ebola and deep cultural suspicions about the disease remain a big obstacle to halting its spread, ministers said on Wednesday. The outbreak has killed 467 people in Guinea, Liberia and Sierra Leone since February, making it the largest and deadliest ever, according to the World Health Organization (WHO) Picture taken June 25, 2014.
The scenario fits a concept for a movie: There were two American doctors on their altruistic missionary work in Liberia that were infected by the deadly Ebola virus. At their perilous state, authorities made their last-ditch to save them by transporting an experimental serum to Liberia that had not been tested to humans. One of the doctors recovered from the virus an hour after the experimental medical cocktail was administered.
The medical cocktail, ZMapp, was administered to two Americans doctors, Dr. Kent Brantly and Nancy Writebol, as confirmed by a spokesperson from Christian aid organisation, the Samaritan's Purse.
ZMapp was made by a California-based company Mapp Biopharmaceutical, according to the director of the National Institutes of Health (NIH), Dr. Anthony Fauci.
Fauci describes ZMapp as a "cocktail of antibodies." It is made from combining two agents --- one made by Mapp with LeafBio in San Diego and another made by Defyrus Inc. in Toronto.
The first agent, the MB-003, was proven to be 100 per cent effective after being tested to monkeys. During the testing, the agent was administered at the very onset that the monkey was exposed to Ebola Virus.
The second agent, ZMAb, was proven to be 100 per cent effective in primates when administered a day after being exposed to the virus. The agent is still 50 per cent effective when administered after two days.
Mapp Biopharmaceutical was "in the midst of an intense effort to help address the Ebola outbreak in West Africa," Larry Zeitlin wrote in an e-mail to NBC.
ZMapp had never been tested to humans prior to Brantly and Writebol.
In a statement obtained by CNN, Fauci said that Samaritan's Purse had contacted officials of the U.S. Centers for Disease Control and Prevention and inquire on the status of any experimental Ebola treatments that they know of.
The officials contacted referred Samaritan's Purse to NIH scientists who were familiar to the Ebola outbreak in West Africa.
"The scientist was able to informally answer some questions and referred them to appropriate company contacts. She was not officially representing NIH and NIH did not have an official role in procuring, transporting, approving or administering the experimental products," the statement reads.
Fauci explained that the company had only three vials of ZMapp and that two of the vials were given to Brantly and Writebol.
"This was the first time it was put into humans, because all the previous work was done on animals and the results had been encouraging," Fauci said.
The success of ZMapp was still uncertain at this point.
"If you ask Sanjay Gupta, he says the effect was dramatic, but when you have one patient, you have nothing to compare it to. You can't make a definitive statement," Fauci said.
The speedy process by which the experimental drug was administered to Brantly and Writebol was met with skepticism, especially from pioneer researchers of Ebola virus.
"It is important to keep in mind that a large-scale provision of treatments and vaccines that are in very early stages of development has a series of scientific and ethical implications. As doctors, trying an untested drug on patients is a very difficult choice since our first priority is to do no harm, and we would not be sure that the experimental treatment would do more harm than good," Doctors Without Borders said in a statement.
Gregory Hartl, World Health Organization spokesman, also expressed his apprehension. He said that authorities "cannot start using untested drugs in the middle of an outbreak, for various reasons."
"I would be ecstatic if Larry's product helped save these people, but I also need to be extremely cautious. To say the whole thing cleared up in an hour, that doesn't happen in reality. That's like something that happens in a movie," said Thomas Geisbert, a professor of microbiology and immunology at the University of Texas Medical Branch at Galveston said.
Given that it was administered under the US Food and Drug Administration's "compassionate use"regulation, the protocol for approval was tedious and arduous. Brantly and Writebol was given ZMApp just within seven to ten days after they exposure to the virus.
Curiously, the Defense Threat Reduction Agency, handling chemical, biological, radiological, nuclear and high-yield explosive threats, gave MAPP Biopharmaceutical additional funding for its "promising results."
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