Tag: ethics

BIOETHICS IN EBOLA CLINICAL TRIALS

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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

EBOLA VACCINE DEVELOPMENT PROVOKES STEM CELL CONTROVERSY

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Stem Cell Research, Attempting to Cure Blindness

By Jubilee Cheung
Staff Writer

The Ebola scare currently sweeping across the United States is far from unfounded; the outbreak of the disease in West Africa is acknowledged as the most widespread to date, having now killed over 5,000 people. It recently threatened to spread across Mali, where it has already claimed the life of a nurse who had been treating an infected individual. Sierra Leone has also been hit particularly hard by the disease, as caregivers continue to test positive for Ebola. The remaining staff are understandably unnerved, and some have gone on strike in response to a lack of monetary compensation for the risky nature of their work.

American nurses and other volunteers appear to echo this sentiment, criticizing the inadequate protection provided to caregivers combating the illness overseas. Though the United States was recently declared free of Ebola, it had been viewed as a very real concern only a short time ago. The first case in the states occurred in September, where a man in Texas was diagnosed with Ebola and died eight days later; two of the nurses tasked with treating him were also infected, but survived. The most recent case manifested in the Oct. 23 diagnosis of a doctor who had been combating Ebola in Guinea, and has since been discharged.

Though the eradication of the disease in the United States does mark a celebratory milestone, the Ebola scare has certainly left its mark as steps have been taken to develop a functioning vaccine. A vaccine developed by GlaxoSmithKline (GSK), as well as by the US National Institutes of Health, is expected to commence with human trials in West Africa as early as next month. These apparent medical strides in the fight against Ebola, however, have garnered a less than enthusiastic response among ardent pro-life groups. On group in particular, Children of God for Life, is opposing the vaccine on the grounds that it was developed through stem cell research. Working with stem cells often provides doctors with important insights regarding organismal development, and the practice has proven invaluable in its potential to fight disease. But there is a somewhat questionable means to that end – stem cells are primarily obtained through the destruction of human embryos. A member of Children of God for Life, Debi Vinnedge, has gone so far as to criticize the Obama administration as being “completely irresponsible” for approving the development of these vaccines, claiming that they cannot be “[used] in good conscience”. The group is currently pushing for “morally acceptable alternatives”.

Controversy surrounding stem cell research is not a new phenomenon – the two have coexisted since the inception of the latter. It is primarily the methods through which doctors and researchers obtain stem cells that occasionally incite public backlash, more so than the practice of working with these cells itself. One common way of acquiring stem cells is though the deliberate creation, and invariably subsequent destruction, of human embryos. Stem cells can also be harvested from “aborted fetal cell lines,” which is the practice that the Children of God for Life alleges is being employed in the development of Ebola vaccines. The potential benefits surrounding the use of embryonic stem cells in medical research are staggering. Observing stem cells allows an enriched understanding of how a disease first occurs, as well as the effects it has on the body. Stem cells are undifferentiated, unspecialized cells with the extraordinary capacity to later develop into different types of cells. They are highly regenerative, and have the potential to be manually developed into a particular variety of cell – the qualities most responsible for their appeal in drug and medicinal testing.

As complicated as it is to denounce the benefits derived from stem cell research, it is equally complicated to ignore the ethical issues that also concern it. Many of these problems find some overlap with those revolving around the concept of abortion; chief among said issues is the matter of human life, what defines it, and where it begins. There are some religions – namely Catholicism – that maintain that human life begins at fertilization; there also exist other parties that, speaking from what they refer to as a more scientific point of view, question this idea and propose that human life may begin farther along chronologically. Whatever one chooses to accept as true, it is probably with some measure of difficulty that they reconcile themselves to the use of human embryonic stem cells in such a manner, versus that of another animal species.

The central issue at hand concerning stem cell research involves the matter of their acquisition: the Children of God for Life group, is demonstratively opposing the development of the Ebola vaccine on the grounds that it is being tested on stem cells derived from aborted fetuses. The concept of using induced pluripotent stem cells (iPSCs), versus stem cells obtained from human fetuses, has the potential to eliminate such controversy. iPSCs are defined as adult cells, often taken from the blood or skin, that are then programmed to return to an embryonic state closely mirroring that of stem cells. In this regard, the iPSCs can act as a benignly obtained substitute for stem cells that ultimately serves the same purpose. While iPSCs have tremendous potential, as a newer scientific breakthrough further research is required before they can reach quite the same level of practical usefulness as traditional embryonic stem cells.

If the progress in the production of preventative vaccines as substantial as it promises to be, it would arguably be unethical not to pursue their development to the fullest extent. The current Ebola outbreak has afflicted 14,000 and killed over 5,000. The method in which the potential vaccines are tested might be morally troubling, but stem cell research is not a new concept. Stem cell research is being used in other studies at this very moment, in the search for cures to ailments such as Alzheimer’s among many others. It is the prevalent fear that the rigorous spread of Ebola has incited that has given a new face to an old controversy. If there are indeed economically feasible ethical alternatives to such testing, it is worth noting that they might merit trial in the future. The use of iPSCs, for example, shows great promise in the future of drug and medicinal testing. But as matters stand right now, pursuing a vaccine that combats an obviously very pervasive illness should be the world’s first priority. Tragic as it is, there are nearly always casualties where global advancement is concerned.

Image by Bryan Jones