Challenge Trials

Challenge trials. It is the process of deliberately infecting healthy individuals with a disease. The intent can be to confirm how a disease is transmitted. Or it can be to check if a possible cure works.

 

This sounds terrible to most of us. Didn’t many of those medical experiments conducted by the Nazis and Japanese during World War II involved deliberately infecting POW’s? Didn’t the Americans do such experiments on blacks and mentally retarded patients in the past?

 

But it turns out there are many valid reasons for this practice. Let’s look at an actual example from the past – challenge trials are how they found that mosquitoes are responsible for transmitting malaria! One is inclined to argue with the other need – testing a cure. Why not test the cure on someone who is already infected? And yes, that is the preferred method indeed. But sometimes, the patient having one disease inevitably has other conditions, which makes it hard to test and confirm if a cure actually works (since the patient has other conditions as well). In fact, many vaccines throughout history have been tested by deliberate infection.

 

India has decided to move ahead with framing the laws to allow challenge trials. Why? Rahul Matthan looks into the reasons. First, 30% of diseases in India are communicable, so it would be very useful to learn more about them. Second, the West will not dig too much into India-specific diseases, so we need to dig in ourselves. Plus, we’d understand other India-specific variables in the equation.

“Controlled human infection studies carried out in endemic settings are far more likely to uncover immunity patterns, associated co-infections, existing pharmacogenomic data and other relevant factors such as nutrition, etc, that could help deliver more effective treatments.”

 

The concerns were many – the risk of abuse. The morality of doing deliberate harm. The risk that poor people would become the guinea pigs. That a largely uneducated populace would not understand the risks in such trials. That many people would sign up because of their abject poverty, that their desperate need for money would drive them to agree to such trials.

 

All valid concerns indeed. I was impressed by one of the criteria on who can be enrolled for such trials – it addresses many of the above concerns at one stroke. The enrolee must be a graduate. While it is nobody’s argument that a graduate is smarter, it is reasonable to say his/her understanding of the risks would be better and that they are less likely to be in dire straits financially. Is this a foolproof criteria? Obviously not. Is it worth a shot given what is stake (30% transmittable diseases, nobody else will research it if we don’t)? I would say Yes.