THE BLOG
08/12/2014 02:11 EDT | Updated 10/12/2014 05:59 EDT

The Ethics of Using Untested Ebola Drugs in Africa

Out of sight, out of mind. That about sums up Canadians' attitudes towards the Ebola virus. Until now, this was one of those rare diseases that a few people succumbed to in countries on the other side of the world. But with the virus now having killed over 1,000 people in Africa, the World Health Organization (WHO) declaring Ebola an international public health emergency, and infected people now being treated in the U.S. and elsewhere, it's now impossible not to worry about it.

And Toronto's Dr. Jim Lavery has brought up another important issue that goes well beyond containment and tracking: Ethics. The researcher with the Ethical, Social and Cultural Program for Global Health of St. Michael's Hospital reminds us that Ebola (named after the Ebola River in the Democratic Republic of Congo) is a "frightening disease" that produces up to 90 percent mortality with no preventive vaccines in sight. The highly infectious virus causes hemorrhagic fever, internal bleeding, and affects multiple organs.

Responding to the question of ethics, experts from around the world gathered yesterday to draft guidelines for using non-authorized medicines in emergencies. Dr. Lavery explained that the fact that we now have a potential therapy, a compound called ZMapp (a combination of three different monoclonal antibodies, two of which were developed in Canada, that bind to the protein of the Ebola virus) has opened a new ethical debate centred around various questions. Among them, should we consider this so-called drug which has been tested on monkeys but never on humans an actual therapy? And is it ethical to give it to one group but not another?

So far ZMapp has been used to treat two infected Americans and a Spaniard who unfortunately has since died; it is now being sent to treat infected people in Liberia. Some people have accused the Americans of withholding the drug, but Dr. Lavery says little is actually known about ZMapp. "We have animal data, but it has never been given to humans. The only reasonable way to think of it is to give it as a humanitarian gesture and not offer it as beneficial therapy. The fact that it has helped American workers is not really evidence that it worked. We don't know what would have happened to them in the absence of the drug."

In a YouTube video found at https://www.youtube.com/watch?v=Id8DSK3ANUc he went on to say that because Ebola has such a high death rate there is a tendency to believe that if there is anything at all that would help we should make it available. But because we don't know much about this serum it may end up having variable effects, he adds. "We may end up saving a few people but it may compound other people's problems and end up increasing the mortality rate."

Dr. Lavery adds that in his view ZMapp is not an easy compound to deliver and monitor and, chances are, the expertise needed to provide it properly still won't be available at all the sites required. Even if it were made more widely available, it is not clear that the companies would be able to scale up production to the amounts required for the outbreak that exists or is anticipated. He also has concerns ethically-speaking that hopes would be raised, then shattered if the drug did not work or caused more harm.

These are issues that concern doctors -- all of whom are trained to "first, do no harm." But seeing the positive response to the drug from the two American patients has helped to change Dr. Lavery's mind about whether such an untested drug should be made available. "For me, there is now evidence that the drug had some benefit. It seems hard to make a case for not trying to save individuals. If it can be produced it should be given under the most rigorous protocol so we can learn from it and increase the value of these exercises in the world."

Even if production can be ramped up to do what WHO has called "the responsible thing" its unclear how fast the drug can be made (recent reports says its current supply is exhausted) and how it would be distributed. Dr. Lavery says there are multiple players in the process, including the private company that owns the compound, their various partners who have been helping to develop it, the FDA which has obligations to ensure its safety, and WHO which would seem to have the strongest global authority. To make the decision will require a lot of goodwill and flexibility on the part of those interested parties to come together.