Randomized Trials for Ebola Drugs: Are We Focusing on the Wrong Thing?

Tags

, , , , , , , , , ,

With the recent worldwide fears associated with the ebola outbreak, which is quickly outpacing the attempts to control it, new controversy has arisen regarding randomized control trials (RCTs) and new medications. The drug zMAPP was first used on the first Americans brought back to the USA having caught the disease working in West Africa and the decision to use the untested drugs on these particular people led to its own host of outcries. What has become the hot issue within the bioethical world is the use of RCTs in these particular circumstances.

To give background to those not aware, a new drug is required to go through RCT prior to its use. This means that it has to be tested in a way in which some people with the particular illness receive the trial drug and others receive a placebo. In the wake of the Ebola crisis, many are calling the use of a RCT unethical as it requires some to receive a placebo in a situation where there is no better cure. This is a difficult issue and there is not straightforward answer.

What I find particularly interesting is that this was an issue long before this particular crisis. I remember having this conversation with my dad (who works in the pharmaceutical industry) many years ago. There has always been an ethical issue with RCTs as they require some to receive a placebo when they could be receiving life-saving treatment. In some instances the benefits of RCTs outweigh the harms. Generally in testing pain medications, for example, it is more important to test if the medication works as it is supposed to even if it means some people receive a placebo and may be in more pain. In many other instances, cancer and other terminal illnesses for example, the use of RCTs has long been called inhumane and unethical. If a person is going to die anyway, why put them through the anguish of potentially only taking a placebo instead of a life saving drug?

It is incredibly important that we have data on drugs that are being created and used prior to using them on patient populations. The well known scandals regarding drugs that have had serious, unknown side effects illustrate this far better than one could write about it. However, sometimes the potential benefits may outweigh these risks.

Many far more intelligent and well-spoken people have discussed the issue of RCTs and ebola in far greater detail, and I would recommend you read their thoughts on the issue. The general consensus among the bioethical community appears that it is unethical to use RCTs in the case of ebola medications.

If this is the case then I think that we should be taking a step back and thinking of other situations that one may liken to Ebola. Ebola is an incredibly deadly virus with no treatment and no cure and a high fatality rate; many are calling for the skipping of the important RCT stage of drug research. Maybe we should also be considering other conditions that have no cure and a high fatality rate, and maybe we should be allowing patients access to untested drugs in these circumstances as well. Is it possible that there are instances where long-held experimental protocols, which I am not doubting is vital in the majority of circumstances, should be ignored?

Follow

Get every new post delivered to your Inbox.

Join 232 other followers