Why Aren't Medical Authorities Giving Africa a Potential Cure for Ebola?

Christian Sager

Photo: anyaivanova/iStock

Since two Americans with Ebola were flown into Atlanta last week, I've been receiving messages from my family. They want to know if my wife and I are safe since the Emory hospital the victims are being treated at is five miles away from our home. There's clearly misinformation about Ebola spreading across the U.S. Some people are so confused as to how the virus is transferred that they're actually sending death threats to Emory. Which makes me wonder... if we're that misinformed about the virus, how little do we know about its potential cure?

The two victims at Emory were given an experimental serum before leaving Africa that seems to have saved their lives. It's called ZMapp. But how does it work? And why was it only given to these two Americans when around 1,600 others in West Africa are infected and dying from the same virus?

ZMapp (also called MB-003) was created in San Diego, California by drug company Mapp Biopharmaceutical Inc. It had never been tried on human beings before. Only monkeys have taken the serum in experiments. Specifically, four monkeys were infected with Ebola and then survived after they were given the serum 24 hours later. Another batch of monkeys received the serum 48 hours after their infection. Only two of them survived. One monkey in this trial wasn't given any treatment and died with five days. As cruel as that sounds, I suspect it was used as "control" in Mapp's experiments.

Three vials of the serum were stored at freezing temperature and flown to Liberia. There they thawed naturally before being administered to the American victims. It hasn't been confirmed yet, but many think that ZMapp was given to the pair by the U.S. Food and Drug Administration (FDA) through their "compassionate use" regulation. The World Health Organization have made it clear that they weren't involved. While the monkeys received ZMapp within 48 hours of their infection, the first of the Americans didn't receive it until after he'd already been sick for nine days.

Mapp developed the medicine by exposing mice to fragments of Ebola and then harvesting antibodies from their blood. While it seems to have helped the two American victims, there is still very little known about how this drug works in human bodies. But scientists think it prevents the Ebola virus from entering and infecting new cells. Mapp also says the drug can be further produced from proteins in tobacco plants.

On July 30, 2014, the military's Defense Threat Reduction Agency paid Mapp Biopharmaceutical additional funding thanks to ZMapp's "promising results." Founded in 2003, the company says that ZMapp was the result of collaborating with LeafBio, Defyrus Inc, the US government and Canada's Public Health Agency. The project's lead investigator is Gene Olinger, Ph.D., a virologist at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). ZMapp wasn't identified as a drug candidate until January 2014, so very little of it is currently available. More of the serum is being manufactured by Kentucky BioProcessing and shipped to Emory University Hospital for further treatment. But the process reportedly takes at least two weeks to generate a new lot before it could address the outbreak of Ebola. It's still unknown who paid the company for the recent doses administered, but it's possible Mapp donated the product under compassionate use. Since ZMapp hasn't been approved by the FDA, a health insurance company probably didn't pay for its use in treatment. In fact, because companies like Mapp don't see much profit in vaccinations for ebola, they rarely bother developing them. As such, no treatments have been approved for use in humans.

Why? Well, health authorities like the FDA and WHO primarily won't use untested drugs because of their obligation to "do no harm." Doctors have no idea what kind of repercussions a drug like ZMapp may have, even if it does help fight the ebola virus. In theory, the subjects could suffer from physical or psychological suffering greater than Ebola's symptoms. Since 10% of Ebola victims survive without a vaccine, the philosophical argument is that an untested drug could harm potential survivors as well, making the situation worse.

Both of the Americans who were given ZMapp understood these risks and gave their informed consent before receiving the drug. The medical community understands "informed consent" as not just an agreement, but a full understanding of participation. Therefore, they have ethical concerns about treating so-called "vulnerable populations," such as children or the institutionalized. What's difficult to swallow is that most research ethics boards also consider the Liberians currently suffering from Ebola to be "vulnerable" people. They assume that the victims won't understand the implications of taking an untested drug, especially due to cross-cultural miscommunication. And if something did go wrong, who takes the blame?

And so the medical authorities continue to withhold a possible cure to a virus that is killing more people every day. WHO have formed a panel of ethicists to consider ZMapp's distribution to Ebola patients. If they can make a decision while Mapp and Kentucky Bioprocessing manufacture more of the serum, there may be hope for containing the outbreak and helping those infected.

SOURCES