BIOETHICS IN EBOLA CLINICAL TRIALS

Mobile Ebola Lab in Guinea

By Alexandra Reich
Staff Writer

There are certain drugs that may successfully treat the Ebola virus that is currently epidemic in West Africa and has captured the world’s attention. Several experimental Ebola drugs are currently in production, with optimistic experimental success rates. One of them is ZMapp, created by Mapp Biopharmaceutical. It takes months to make a small dose, so this is not viable as a long-term Ebola treatment. A few other Ebola treatments are currently being researched by other pharmaceutical companies.

Now that several Ebola drugs may soon become approved for use in treating people in West Africa, world health powers are expressing conflicting views on how these are to be implemented. The World Health Organization (WHO) has approved the use of experimental drugs in the treatment of Ebola, with the patient’s informed consent. The long-term side effects of the under-tested drugs are not closely scrutinized when the short-term result may be a cure for Ebola. However, epidemiologists estimate that the supply of these experimental drugs is insufficient for the number of people estimated to be infected. Widespread distribution of trial drugs isn’t a viable option due to the barriers of cost and availability.

There is another issue; the U.S. Food and Drug Administration (FDA) is supporting the standardized clinical trial process for the experimental Ebola drugs, where one group receives the potentially life-saving experimental drug, and the other group receives a placebo. The placebo groups acts as a control, so that the scientists can observe an experimental drug’s effect while monitoring the results under the exact same experimental conditions without the drug. This system of study is widely accepted in the scientific community under less urgent conditions. However, with the death rate of Ebola documented as high as 70 percent, one has to consider the social constructs and morality issues surrounding Ebola clinical trials in the field. A clinical trial participant who is placed in the placebo group has basically been handed a death sentence by the scientific community, for the purpose of advancing scientific knowledge. In epidemic conditions, the ethics of medicine must be considered, in addition to scientific advancement.

How can researchers, in good moral conscience, give only half of research participants a life-saving drug? The WHO expressed concerns about both the morality and safety of having randomized-placebo clinical trials. Global health scholar Trudie Lang argues that this form of clinical trial implementation is unethical, and potentially dangerous for healthcare workers who would deliver life-saving drugs to only some patients. A clinical trial participant, knowing the placebo group likely means death, could act out in order to access the lifesaving drug.

This brushes against the larger issue concerning trust of foreign healthcare products and workers in African nations. Violence against foreign healthcare workers is not unheard of. In February 2013, nine people working in Nigerian polio immunization clinics were shot and killed by armed men. The implementation of standardized clinical trials in Ebola-impacted nations could result in similar mistrust that could lead to violent actions. If pharmaceutical companies conduct randomized clinical trials that intentionally leave a placebo group to face Ebola without treatment of drugs in the name of scientific advancement, Ebola-infected nations have every right to be skeptical. Any scientific research on the Ebola epidemic needs to be done with the consideration of moral standards first, and scientific advancement second.

Bioethics is frequently debated during epidemic outbreaks, especially concerning the responsibilities of developed nations. Wealthier nations are depended upon to provide research into new, and potentially life-saving, drugs. However, this does not rationalize a paternalistic position towards the impacted countries. Scholars argue that to alleviate concerns of exploitation of Ebola-impacted communities for scientific advancement, research teams should make contributions to improving their host communities, such as working to improve the local healthcare facilities. Efforts made by clinical trial researchers toward truly improving the Ebola-impacted communities may help to lessen any distrust of the researchers.

If given access to the resources needed to save lives, pharmaceutical companies have a moral obligation to give people access to these drugs. As noted before, widespread distribution of experimental Ebola drugs is not feasible because there is not a large enough supply. Considering the smaller numbers of people in clinical trials, there is no morally sound reason to keep the placebo group. While the furthering of scientific knowledge of Ebola is important, it should not be collected by means of human experimentation.

Image by European Commission DG ECHO

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