When the fight for survival gets too hard and circumstances force you to jeopardize your life for some quick money, that’s when you realize how desperate this ruthless life has made you. This is what is happening in case of hundreds of poor people who are over volunteering for clinical trials across India.
Clinical trials are usually conducted by Clinical Research Organizations for carrying out bioequivalence studies.
In layman terms, when a patented drug gets expired there is a requirement for bioequivalence studies to prove that the generic versions of the drug are just as same and safe to be released in the market. Drug makers from high-income countries like the US are constantly in need of generic versions of the drugs which makes it a pretty booming business in India.
And the brunt of releasing safe drugs in the market, as expectedly, falls on the underdogs i.e. people from the lowest strata of the society.
How Bad Is The Situation In India?
Recently, a case had come up on The Hindu where a poor 53-year old father of three from Telangana had suddenly taken ill and died after one such clinical trial. Further investigation revealed that there are many like him who have volunteered for clinical trials quite often and continue to do so.
This trend of over volunteering for clinical trials by extremely poor people is rising at a tremendous rate. There is a high demand for volunteers in India and the poverty-stricken see this as an opportunity to earn extra money to sustain.
Each volunteer is paid money ranging from Rs. 10,000 to 30,000 for one trial. This amount of money is like heaven for a daily wage worker who earns only one-tenth of this.
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And this is exactly the reason why hundreds of volunteers deceive the investigators of the trials by lying about their age, health-related issues, and other medications.
Not only that, they also break numerous rules to keep the CROs in the dark by not giving the required gap between two consecutive trials (according to WHO, there should be a minimum of 90-days gap between two clinical trials) and by consuming alcohol which is prohibited by the investigators.
This lying and deceiving not only puts their health at a great risk but also affects the credibility of the studies. Not adhering to the trial rules and regulations deteriorates the quality of the data collected and increases the chances of unsafe drugs being released in the market.
Also, this willful deception can actually be more harmful than it appears. Many clinical trials for generic drugs have minimum risk. However, the poor people are not literate enough to realize that there are different degrees of health risks for every trial. Some are potentially riskier than others and those risks need to be understood by the volunteers before consenting to a trial.
Sadly though, desperation to earn more and fast money forces these destitute people to throw their consent forms, containing all the vital information, away so that their families are also kept in the dark.
Imagine what it feels like to be that weak in lieu of circumstances!
And every such situation has some people who are hungry to take advantage of poor peoples’ helplessness.
A sting operation conducted by The Hans India has revealed that there are agents in this market who create WhatsApp groups named BloodMoney, Bombay Boys, Mumbai Friends etc which inform willing volunteers all over the country about these clinical trials conducted in various CROs.
The details given for such trials are limited to only the name of the CRO, the amount of money that would be given and the amount of blood which would be taken. These agents are then heavily compensated by the CROs for bringing those volunteers and nobody asks any more relevant questions.
That is how cheap their lives have become.
What Should Be Done To Rectify This?
There is no doubt in the fact that over volunteering in clinical trials has serious consequences ranging from minor health issues like swelling, severe back pain to major issues like temporary psychosis to death.
I can’t see what these helpless people did wrong to deserve this in the first place.
That is why it is the need of the hour to understand the gravity of this problem and act on it.
There are a couple of things that could be done:
#1 Better Monitoring: Developed countries like Europe have a National Registry of volunteers which helps them monitor the volunteers available for trials and also if a volunteer registers for more than one trial. India could use such a registry to monitor its volunteer base efficiently. This will not only save the poor from an untimely death but also ensure the entry of safe drugs in the market.
#2 Spreading Awareness: The most crucial step that needs to be taken is encouraging people from all classes of the society to willingly volunteer for such clinical trials. There is a social taboo surrounding volunteering for medical science because of the popular belief that they are unsafe and not the right way to make money. But please remember that this is the only way by which you could ensure that safe drugs enter the market that you only use. Those drugs are hardly affordable for the poor. So it is deeply unfair that only the poor bear the burden of this.
In the end, I would add that no matter how poor and helpless one is, all lives matter and we must do everything we can to respect that.
Information sources: The Hindu, The Hans India, The Reuters
Images Source: The Hindu, Google Images
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