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Labs exploiting ignorant clinical trial volunteers
The bogey of clinical trial casualties is once again raising its ugly head in both Telugu speaking states. The spate of deaths especially from Wardhannapet in Warangal a few years ago is still fresh in everyone’s mind. Irregularities abound in the nine clinical laboratories allege subjects (volunteers).
Hyderabad: The bogey of clinical trial casualties is once again raising its ugly head in both Telugu speaking states. The spate of deaths especially from Wardhannapet in Warangal a few years ago is still fresh in everyone’s mind. Irregularities abound in the nine clinical laboratories allege subjects (volunteers).
According to statistics there are close to two lakh volunteers in Telangana and Andhra Pradesh who offer themselves for clinical trials to nine labs that include Vimta Labs, QPS Bioserve India, Spra Lab, Clinsion Lab, Axis Lab, Yanclor Lab, Agent Lab, CR Bhayo Lab and Actimas Lab.
Highlights:
- Labs are conducting clinical trials every month while they are supposed to conduct them only once in three months.
- Finger prints from the thumb and index finger are to be taken but labs record prints of all 10 fingers so that they could tamper investigations
- The Informed Consent Form (ICF) is not provided to donors or subjects and are kept in the dark
- Mobile phones are seized before starting clinical trials and are not allowed to contact even family members
Out of the nine labs, only one - Actimas is in AP and the rest are situated in and around Hyderabad. There are 10-15 thousand volunteers from each of the districts in both states who are volunteers.
In a fresh appeal to the National Human Rights Commission (NHRC) last week, a group of volunteers headed by M S Swamy Choudary of Hyderabad and Shaik Sabir Ali of Jammikunta in Karimnagar have appealed to investigate into the irregularities.
It is alleged that about 3,000 people die in India every year due to the side-effects of clinical trials and out of the 25 lakh volunteers across India two lakh are from AP & Telangana.
According to rules, a volunteer should give a gap of three months but labs conduct trials every month. Swamy says, “Volunteers from remote areas do not know to read and write and fall prey to agents and labs.
Every day 700-1000 people are undergoing clinical trials.” He further questions why the ethics committee members are never present during the selection.
Shaik Sabir Ali says, “Mobiles are seized and volunteers cannot even contact family members. Sometimes one has to stay at the lab for 72 hours to 15 days, depending on the drug. Also a copy of the Informed Consent Form (ICF) is never given to volunteers and most of them do not know its contents.”
Repeated attempts to contact officials of the Central Drug Standard Control Organisation (CDSCO), zonal office, Hyderabad proved futile. While companies argue that they follow global standards, the lack of sound regulation is putting the lives of lakhs of innocent people in danger.
Raghavan, a social scientist who has been working closely with volunteers says, “With the new rules it is going to be worse. In the past compensation would have to be paid regardless whether the drug was the cause of a reaction, now compensation is to the point that the drug did the damage.”
Added to that, there is a possibility that audio visual recording of informed consent too would be removed for certain trials and the labs take the finger prints of all ten fingers just to evade investigations Swamy says. When asked they just blackmail volunteers by saying that they would blacklist them so that they would no longer be able to be donors, he adds.
