ZMapp: Not Yet for Africa

The health of Ebola-sickened American Aid workers Kent Brantly and Nancy Writebol has “miraculously improved” after receiving experimental drug ZMapp last week. Since news of their improving health, many health experts in the affected countries have been requesting access to the drug, including Nigerian President, Goodluck Jonathan. In response, ZMapp manufacturers, Mapp Industries Inc., has recently sent shipments of the drug to Africa and will continue to do so as more doses of the drug are developed. But the question still remains whether the experimental drug is effective against the deadly Ebola virus. The drug is not yet proven to be safe nor its efficacy validated for human use – in fact, the drug has not been approved for human use yet. But Ebola experts in Africa are urging the World Health Organization, FDA, and drug manufacturers for more access to ZMapp so that they can provide them to the hundreds of Ebola-sickened Africans. ZMapp seems to sound like the hope to stop Ebola from spreading, but they are still not the answer to stop the deadly disease. Access to the drug should still be limited and the focus should remain to improve and provide more needed people, facilities, and supplies to the affected countries.

Developed by San Diego’s Mapp Biopharmaceutical Inc., ZMapp is one of several medicines around the world being made to thwart the increasing spread of Ebola. Other companies developing Ebola medicines include Tekmira Pharmaceuticals Corp. and BioCryst Pharmaceuticals Inc. But like ZMapp, their drugs have only since been tested on animals. According to Mapp and Tekmira, however, results from animal testing “have been promising.” But the drug has not yet passed the most important phases of the Federal Drug Administration-mandated clinical trials: testing on humans. So for good reason, the FDA cannot approve the drug for wide use until it has gone through this normal testing process.

There isn’t even enough ZMapp to go around. As of today, the current Ebola outbreak has resulted in over 1,750 cases of the disease including more than 1000 deaths according to the World Health Organization. Even if the drug were approved for human use, there are “virtually no doses available” says Mapp Industries after sending shipments of the drug to Africa. Many will die waiting for the treatment drug as various sources report that there may be no more than a few hundred doses in a few months.

Doctors cannot even be certain that the improving health of Brantly and Writebol is a direct result of receiving the drug ZMapp. Dr. Anthony Fauci, immunologist and director of the US National Institutes of Health said, “It is not known if the improvements are a direct result of the drug” and added, “we don’t even know if it works” and cited the possibility that the both of them could have been among the 40 percent of people who are surviving the outbreak anyway. In recent reports, Spanish priest Rev. Miguel Pajares, who also contracted Ebola in Liberia and was the third person to be administered the drug ZMapp, has died. However, there is no conclusive evidence to suggest that he died as a result of receiving the drug or that he died as a result of his age and complications of his condition. Regardless, we would not be able to know specifically why and how he died because there is no scientific history or evidence of human reaction to ZMapp.

Moreover, there is no correlation between the results from Mapp’s animal testing and the results from Brantly and Writebol’s reaction to the drug. In Mapp’s testing of the drug in monkeys, all infected monkeys survived when given the drug one hour after infection. When six monkeys were given ZMapp 48 hours after infection, only four survived. In current tests, scientists wait until monkeys show symptoms before administering the drug, by which only 43% of the monkeys survive. Brantly and Writebol were sick for nine days and four days, respectively, before being administered the drug. Additionally, Brantly was given blood from an Ebola survivor, which doctors speculate may have had an effect to his recovery. This may suggest that the drug ZMapp is not entirely a lifesaver. This also may suggest that Emory Hospital’s facilities and resources may have  impacted both Brantly and Writebol’s improving health, which many doctors and experts strongly believe. But certainly, the results (or lack of) show that Brantly and Writebol are still merely a science experiment.

According to journalist and CDC director Dr. Tom Frieden, “drugs won’t stop the current outbreak” and alluded that “patients who receive good supportive care can get better … if they get good hydration, or oxygen and treatment for other infections.” Affected countries Liberia, Guinea, Sierra Leone, and Nigeria are among the many third-world areas of Africa that cannot provide good supportive care due to an underdeveloped public healthcare infrastructure. Frieden also noted that when patients infected with diseases as deadly as Ebola are given the required supportive treatment and care they need, in reference to a similar outbreak scenario a few years ago, the patients have a tremendous chance at surviving. Those who are sick in Africa need to be identified and isolated so that they can be provided good supportive care and fight the deadly infection with a greater chance for recovery. Moreover, good supportive care can be provided to all of the infected because care is not limited to expensive and often rare resources that are needed to develop drugs like ZMapp.

Even President Barack Obama agrees “it is too soon to send an experimental drug to Africa” and also alluded that the Ebola virus “both currently and in the past – is controllable if you have a strong public health infrastructure in place.” Our focus should be on providing the needed resources to help the infected in Africa. We should be setting up better and improved facilities so that we can provide the sick with the supportive care they need to recover. Although these facilities does not necessarily need equal facilities and resources like Emory Hospital here in the U.S., facilities should certainly be equipped and able enough to provide protection for healthcare workers and have enough resources to treat the sick, including more experienced healthcare workers, oxygen, antibiotics, and clean water.

God forbid the result of the drug does more harm than good, but like every experimental drug, there is the possibility that ZMapp can result in unforeseen and adverse consequences. If perhaps ZMapp does do more harm than good, then Americans would be crucified for not having done proper testing and evaluations of the experimental drug – we would be to blame. Doctors Without Borders, the organization who is currently aiding the infected in Africa, cautions 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.” There is a reason why the FDA and WHO require pharmaceuticals to go through many rigorous tests and clinical trials. In 1996, Pfizer’s experimental drug killed 11 children because there was uncertainty and miscalculation over the number of doses that should be administered. Writebol was given two doses of the drug ZMapp before getting better. But Writebol and Brantly’s reactions are the only two results of the experimental drug known today – they are still sick, however. Pfizer’s experimental drug included 200 children. Increasing the access to the drug may and can result in a similar consequence as the 1996 Malaria outbreak in Nigeria – no one knows yet.

Some might argue the drug should be given more access so that healthcare workers are safe from contracting Ebola. In recent reports, nurses and doctors are afraid to go to work because so many healthcare workers have been infected and have died from the deadly infection. Accordingly, they feel that the drug should be given to them so that they can go to work and help those in need without having to worry about contracting the disease. This idea is certainly something to consider if we did have successful Ebola treatments today. But the obvious result of healthcare workers not showing up to work is the increased amount of infection and death by the deadly disease. Many patients who may have had the chance to recover by being provided good supportive care are dying at homes and on the streets; they are arriving at hospitals where help is no longer there, or they are denied help because facilities lack the resources.

This growing concern should be the primary focus of the WHO and other international health agencies: there is a more dire need to provide the resources necessary to help contain the spread of Ebola and to help provide the proper care for the sick. Instead, WHO, FDA, and other health agencies around the world are busy deciding whether to go forward with the wide-scale use of the experimental drug ZMapp. The WHO and other international health agencies plan to meet and deliberate soon to discuss whether to go forward with experimental drugs.

Every human being on this planet faces the current issue of Ebola. Should there be a continued absence in the resources for caring for the infected, the highly contagious and deadly Ebola virus will continue to spread and kill at an alarming rate. I believe that we must first get the needed people, facilities, and supplies to the sick quickly and establish a strong public health foundation to enforce and strengthen the systems that are already in place. Once we have these supports in place, then we can consider the use of experimental Ebola drugs on those who need it most. Ebola is not a new disease that we are battling; the only things different this time are the places of infection and the large numbers of people living in those places.

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