Judges demand answers after children die in controversial cancer vaccine trial in India

By Gethin Chamberlain

• Tribal girls were given shots of cervical cancer vaccines during trial
• Children given Merck’s Gardasil and Cervarix vaccines
• Petitioners also asked judges to investigate trials of new drug Gardasil 9
• Drug has allegedly caused side-effects in children as young as nine
• Investigation claims children were used as unwitting human guinea pigs
• Supreme Court has given the government one month to provide answers

Judges in India’s Supreme Court have demanded answers after children died during a controversial cervical cancer vaccine trial.

Young tribal girls received shots of pharmaceutical company Merck’s Gardasil vaccine and Cervarix, manufactured by GlaxoSmithKline.

The vaccines are given to girls as young as nine in many countries – including the UK and the US – to protect against the human papilloma virus, one of the major causes of cervical cancer.

But the Indian court yesterday heard a challenge by campaigners who claim the study – funded by the Bill & Melinda Gates Foundation – failed to obtain the informed consent of the children or their parents.

They say that a ‘study’ carried out for the foundation by a US organisation was in fact an illegal drugs trial.

Unaware: Aman Dhawan (pictured), 16, is one of many youngsters who took part in the trial without being aware they had been signed up to test Merck’s new Gardasil 9 drug, aimed at preventing cervical cancer

‘Guinea pig’: Sana Ansari, 19, her brother Mazhar and sister Asiya were all enrolled in the trial of Gardasil 9 drug – but she and her family say she had no idea she was testing the drug

The petitioners have also asked judges to look into the way trials were conducted into Merck’s new cervical cancer vaccine Gardasil 9.

A MailOnline investigation published earlier this month uncovered claims that children as young as nine suffered side-effects after being used as unwitting human guinea pigs for the new drug.

Gardasil 9, which is expected to be worth £1.2 billion a year in sales, has already been approved for use in the US and could be available in the UK later in the year.

At a hearing of India’s Supreme Court in Delhi yesterday judges expressed frustration that the country’s government had failed to provide answers to what had happened during the earlier trials of the original Gardasil and Cervarix.

They gave the government a month to explain what action had been taken to investigate and what efforts had been made to obtain the consent of those taking part in the trials.

They wanted to know whether there had been any follow-up or monitoring of the girls to see whether they had suffered adverse health consequences.

And the judges also ordered the government to produce an opinion on the issue of liability and compensation. 

Side effects: Aman Dhawan, 16, from Indore, lost weight and strength after being enrolled in the Gardasil 9 trial, which he didn’t know he had signed up for either

Lawyers for the campaigners who brought the case said they were pleased with the fact that, for the first time, liability and compensation for the victims had come up in court.

‘It is a very encouraging development that the judges are now discussing accountability and not just accountability but also compensation, so the tone of the hearing today was very positive for us because it’s clear from all the parties, including from government reports, that there were, at best, serious irregularities and, at worst, gross violations of fundamental human rights,’ said Kerry McBroom, one of the lawyers.

An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics amounting to child abuse and ‘a clear cut violation of the human rights of these girl children and adolescents’.

The committee’s report said it had been established that clinical trials of the vaccines had been carried out ‘under the pretext of an observation/demonstration project’ in violation of all laws and regulations laid down by the government for such trials.

The group accused of carrying out the trial under the ‘pretext’ of carrying out an academic study – PATH – said it ‘strongly disagreed with the findings, conclusions, and tone of the released report and its disregard of the evidence and facts.’ 

Injected: Mazhar Ansari (pictured), 18, who was enrolled in a trial of Merck’s new Gardasil 9 drug

Revealed: Whistleblower Dr Anand Rai (pictured), 37, lifted the lid on the scandal of illegal drugs trials in the city and now has been given an armed guard to protect him

In court yesterday a bench of judges headed by Justice Dipak Misra criticised the Indian government for failing to act on the committee’s report. 

‘It should be the concern of [the government] that health of people is preserved,’ they said.

‘Don’t leave the matter to court. It is for the government to find out a way. 

‘If parliamentary committee has done something then it is obligatory for the executive government to take action on this report.

‘File affidavit stating protocol to be followed by getting consent of people to undergo trial and the process to find out what is the effect of vaccination and whose liability is it to pay compensation.’

Merck and GSK have both been ordered to respond to the allegations made by campaigners. 

Yesterday’s hearing was told that Merck had provided a six volume document amounting to around 2,000 pages of evidence – but that GSK had so far failed to respond.

Gardasil is now given to girls aged 12 and 13 as a vaccination against HPV, a sexually transmitted virus which causes most cases of cervical cancer

Both companies have denied any wrongdoing. In court yesterday the judges also heard from lawyers for PATH – the US-based group that organised the ‘study’ – which emphasised the vaccines were safe and the vaccinations had been carried out in the interests of public health.

McBroom said she and her team would be referring to the latest trials of Gardasil 9 in their closing submissions.

MailOnline’s investigation into Gardasil 9 revealed how several children used in those trials claimed to have suffered problems including weight loss, fatigue, dizziness and menstrual problems.

They and their parents maintained that they did not give their informed consent and that that they were not aware that they were taking part in the trial of an untested drug.

Among those who took part was 16-year-old Aman Dhawan, who lives in the Pancham Ki Phel slum in the city of Indore. 

His family say they were told the drug was a new medicine that would prevent a range of diseases, including malaria.

But Aman said that after he was given the vaccine he began to see changes in his body and he lost weight and strength.