The Ugly Face of Clinical Trials in India!.Pharmaleaders accesses 3 expert reports of Health Ministry on the clinical trials conducted by Path in which Indian were used as Guinea Pigs, a trial that was facilitated by certain Indian agencies. The reports reveal explosive details about how the Government knew about the Human Trials and Ethical violations way back in February 2011 itself, yet no action was taken against the perpetrators of this crime against our Country’s children.
Pharmaleaders accesses 3 expert reports of Health Ministry on the clinical trials conducted by Path in which Indian were used as Guinea Pigs, a trial that was facilitated by certain Indian agencies. The reports reveal explosive details about how the Government knew about the Human Trials and Ethical violations way back in February 2011 itself, yet no action was taken against the perpetrators of this crime against our Country’s children.
Here are the details of what these reports reveal –
Health Ministry CLINICAL TRIAL REPORT 1 – Date – Feb 2011
The report admits that the primary end point of the study was to find out adverse health effects of the drug trial on health of children (proving that this was a classic case of Vulnerable Children being used as Guinea Pigs for human trials)
The report –
1. There was DCGI guidelines violations which says Third phase trial cannot be conducted on children unless it was conducted in adults
2. The Children were not monitored after administering drugs
3. Path has insurance cover for itself but did not have insurance cover for children on whom the trials were done
CLINICAL TRIAL Report 2 – Report of Dr YK Gupta
(Was there a cover up in the death cases?)
The report –
1. In one case in Gujarat, death they say occurred due to anaemia. But medical opinion says death occurred due to congestive cardiac failure. No post mortem also done
2. In second case in Gujarat, they say death occurred due to snake bite on 2/11/2009, but on paper it shows tat it occurred on 1/11/2009. The spot report doesn’t mention site of bite, presence of fang marks or any snake bite symptoms.
3. In AP, the first death they say occurred due to Subarachnoid Hemorrhage. Post mortem not done. No details provided on actual problem.
4. In another case in AP, the child suffered fever and died within 2 weeks of vaccination. The child dies because she could not be admitted in the hospital because of lack of beds. Wasn’t it Path’s responsibility to have provided medical aid to the child
5. In another case in AP, they say death happened due to poisoning, but 3 different versions of poisoning is given in case sheet, SHO report and post mortem report.
6. In a case in AP, they say death happened out of drowning. But case record is incomplete. Preceding sequence of events not mentioned.
7. In another case of death out of poisoning, the FIR doesn’t mention any such signs of poisoning during admission to hospital, though post mortem says it’s a case of poisoning
8. Report also says that health centres were not able to handle serious adverse effects arising out of consumption of the drug
CLINICAL TRIAL Report 3 – Report of Dr. Rani Kumar
(SHOCKING DETAILS ON HOW EVEN PAPER WORK WAS MANIPULATED)
1. Paper work on consent forms completely manipulated
2. Same serial numbers repeated on different forms
3. Name of parents and signatures do not match
4. Casual approach by team
5. Children didn’t know about drug administration, parents dint know, principals signed on forms
6. Date of vaccination is much earlier than date of signature of parents
7. The project was a human drug trial done under the shadow of national immunization programme
After being severly indicted by a Parliamentary panel, the Indian Council of Medical Research (ICMR) has admitted that there were irregularites in the drug trials of untested vaccines. The panel report alleges that ‘clinical trials’ were conducted on tribal Girls in Andhra Pradesh and Gujarat, and indicts Indian medical bodies for allowing untested HPV vaccine trial. But the ICMR has deflected the blame for the deaths caused in India by trials of a cervical vaccine produced by foreign pharma firms.
