The Indian Supreme Court has sought answers from the government in a case in which some tribal children, who were allegedly inducted into a drug trial without their consent years ago, died because of reactions. The court criticised inaction of the government and gave it a month’s time to respond.
Some children out of a group of selected children died after being injected with Merck's Gardasil vaccine. The medicine is manufactured by GlaxoSmithKline. The medicine was administered on tribal girls in India.
According to some campaigners, a study, promoted by Bill and Melinda Gates Foundation, failed to obtain consent from children or their parents before they were administered with the drug. The allegations, if proved, would mean that the drug companies conducted an illegal drug trial on the kids.
The petitioners also asked judges to look into the way trials were conducted into Merck's new cervical cancer vaccine, Gardasil 9. Research by MailOnline, revealed that some children showed abnormal symptoms after they were administered the drug. Gardasil 9, is expected to be worth £1.2 billion a year in sales.
The Indian Council of Medical Research (ICMR) had in 2010, asked state governments to suspend the cervical cancer control vaccination programme for girls after four deaths and complications among 120 girls were reported. The girls complained of stomach disorders, epilepsy, headaches and early menarche.
An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics. Merck and GSK have both been ordered to respond to the allegations made by campaigners.
After hearing arguments of campaigners, the judges also ordered the government to produce an opinion on the issue of liability and compensation, which was welcomed by lawyers.
(The author is a professor at Thiruvananthapuram Medical College, Medicine Department)