Making sure that consent is informed

My column in Mathrubhumi, published on September 13

 

 

Every day we wake up and hope that there will be some end in sight to this global pandemic that has killed thousands in India and around the world in a few months, and infected many more.  But that hope lies shattered as we continue to hear about more infections, and more deaths.  Even in states, and regions within states, where there was some success in dealing with the pandemic, Covid-19 has reappeared.

 

On top this, we have the recent news that the Phase 3 trials for one of the most promising vaccine candidates, the one being developed by AstraZeneca, has been put on hold temporarily.  Although politicians who want the vaccine to be delivered quickly, so that they can claim credit for it, are disappointed, people should in fact be glad that the problem has been detected. And trust that science will fix it.  As the Chief Scientist of the World Health Organisation, Soumya Swaminathan has said, "I think this is good. Perhaps a wake-up call or lesson for everyone to recognise that there are ups and down in research, and that we have to be prepared for those."

 

Coincidentally, the participant in the trial who developed adverse symptoms is a woman. This reminded me of the importance of "informed consent" before anyone participates in these trials.

 

The Covid-19 vaccine trials are high profile.  The whole world is watching, and waiting.  Here no one can afford to take shortcuts.

 

Unfortunately, this is not true of other such drug trials that have been conducted in the past.  And especially when it comes to the issue of "informed consent". 

 

There are examples that come to mind from not so long ago when women took part in clinical trials for vaccines without really knowing what this was all about.

For example, in 2009, a clinical trial to test the efficacy of the human papilloma virus (HPV) vaccine on young girls was conducted in Khammam district, Andhra Pradesh.

 

This vaccine held out the promise of preventing cervical cancer, something that afflicts and kills millions of women worldwide. So it was an important health intervention and its success would help women everywhere.

 

The problem was the choice of girls on whom this trial was conducted.  They were tribal girls, living in hostels away from their families. Neither they, nor their parents, understood what the trial was about. Yet, 14,000 girls between the ages of 10 and 14 were given three doses of the vaccine.

 

Things began to go wrong when four of the girls developed health problems after being given the vaccine and died.  It was not clear whether their death could be linked directly to the vaccine.  But what was clear was that these girls were not in the best of health and that they did not understand the possible complications of being injected with a live virus. The literature about the vaccine was in English, which neither they, nor their parents could read. In fact, even the health providers administering the vaccine could not read English.

 

Finally, due to the intervention of a women's group, the trials were suspended.  But they brought home forcefully the importance of respecting individuals, regardless of their social or economic status, if you put them through a human trial for a new vaccine.  One hopes that the fight to stop this trial is a lesson learned and that such a thing will not be repeated.

 

What we need to take home from such incidents is that the disempowered, including poor women and girls, often become the easiest choice for experimentation because they do not have the ability to object.