Home Health Ebola: Ethical questions around experimental drug

Ebola: Ethical questions around experimental drug


Ebola experimental drug, ZMapp sparks ethical controversyBy Julia Belluz

The Ebola outbreak in Africa has confronted ethicists and health officials with a terrible dilemma: when a limited amount of an experimental treatment exists, who should get access first?

There are currently no Ebola treatments on the market. But in this deadliest Ebola outbreak in history, two Americans missionaries received an experimental Ebola drug called ZMapp after getting the disease in Liberia.

Now, infectious disease experts around the world are proclaiming that African Ebola victims should have the same right. In response, both the Obama administration and the World Health Organization set-up expert groups to weigh the moral debates around the more widespread use of untested drugs in what has now been deemed an international health crisis.

To make sense of the thorny problems at the heart of this outbreak’s morality crisis, we called medical ethicists and doctors. Here are the four questions they say they are grappling with.

1) Is it okay to skip the drug testing pathway in a crisis? In order to get a drug on the market, a rigorous (though admittedly flawed) process has been established. Generally it works like this: first drugs are tested in animals, then in a small group of humans for safety, and if all goes well, testing moves to a larger group of people for efficacy.

“That’s the path ZMapp drug was on,” said Dr. Ezekiel Emanuel, chair of the department of medical ethics and health policy at University of Pennsylvania’s medical school. “Now because we have a crisis, we have short-circuited that path on the grounds of compassionate use.”

Clinical Trials Phases from ClinicalTrials.Gov

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use. There’s an open debate about whether this is appropriate: While experimental treatments may offer potential help, they can also be risky because of the lack of testing.

The ethical argument for skipping the clinical trials process is that patients with a high chance of dying have few alternatives. So sometimes regulators grant them access to treatments outside of the well-worn clinical trials, before they are approved, because their only other alternative is probably death.

This is reportedly how Dr. Kent Brantly and Nancy Writebol, the American missionaries working in West Africa, got access to this very early-stage drug.

But there is another ethical justification for potentially doing harm to a patient in a moment of crisis, said Jonathan Moreno, a professor of medical ethics at the University of Pennsylvania. In addition to the “do no harm” adage, in emergencies, the physician and philosopher Hippocrates advised that medics should “be bold.” So, he added: “There’s huge lethality and we don’t have much in the way of alternatives, so Hippocrates would have said, ‘Let’s get in there’ (with experimental drugs).”

2) Why did Americans get an experimental drug while hundreds of Africans die of Ebola? But it’s not that easy. Giving the drug to the missionaries raised another ethical dilemma: Why did the Americans get to try ZMapp, while Africans did not?

Emanuel said this is a common problem that comes up when you skip the clinical trials and drug approvals processes. “Once you do compassionate use, you invariably create inequalities,” he explained. “Some people get it, and other people don’t get it, and largely though not exclusively the people who end up getting it are well connected and somehow much better off.”

That was the case here: ZMapp is in limited supply in America, created using mostly Department of Defense funding, so Emanuel said he was not surprised that Americans with connections to government were granted access.

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