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Human Drug Testing Clinical Trials, Unethical Practices by Soma Hegdekatte

The Author: Soma Hegdekatte is a Law Student Studying at Gujarat National Law University, Gandhinagar

Venkatamma’s eyes fill with tears when she remembers the fateful day of 21th Jan 2010. The vivid memory of finding her daughter’s motionless body still haunts her. The doctors stated ‘suicide’ as the reason of death on the death certificate. But Venkatamma knew otherwise.

Her daughter had been in excruciating pain for the past few days and had suffered constant epileptic seizures. Venkatamma’s daughter wasn’t the only one in the district of Khammam, Andhra Pradesh, who had suddenly committed ‘suicide’. 4 other girls from nearby villages died in similar circumstances and 120 other girls faced severe complications like allergies and dizziness. What linked all these girls was the fact that they all studied in the nearby Lakshminagaram Residential Hostel, a hostel made for young poor tribal girls, and that they had been administered a vaccine for the Human Papilloma Virus (HPV), as part of an observational study of the effects of this drug on prevention for cervical cancer[i].

What was Venkatamma’s daughter’s fault? Was her life of lesser worth because she came from a poor and vulnerable background?

Introduction

Human drug testing trails are very important for research in medicine. A clinical trial is defined as ‘’any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome’[ii]. Mere animal testing cannot always be accurate and precise. Without these trials, a pharmaceutical company would never know the effects a medicine could have on people after its release in the market. Nevertheless due to the perilous nature of such tests, due care and precaution is a sine qua non to clinical trials. Only after laborious research and experimentation, are human trials allowed.

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