'In Bhopal, every rule in the vaccine trial book has been broken'

'We are rolling out a vaccine when we don't even have the phase 2 trial results; forget about phase 3 trial results.'
'Why are we playing with people's lives?'

Serious violations that have taken place in the phase 3 trial of Covaxin developed by the Hyderabad-based Bharat Biotech in Bhopal have shocked scientists, activists and citizens.

First. The volunteers of the trial conducted by the People's College of Medical Sciences and Research Centre were residents from the areas close to the Union Carbide factory, or rather the 1984 Bhopal gas victims.

Then, it came to light that the 'poor and illiterate' volunteers didn't know they were participating in a trial.

A majority of these volunteers signed the consent forms thinking they were getting vaccinated against coronavirus and not taking part in a trial. And the Rs 750 offered by the hospital was a large amount for these poor people.

Finally, the death of a 42-year-old daily labourer who had participated in the vaccine trial.

The hospital and Bharat Biotech strongly refuted the allegations by the family and activists that his death was related to the vaccine. According to the hospital, it was due to poisoning.

This incident has cast a shadow over the way medical trials are conducted in India.

Rachna Dhingra, an activist who has been working with the gas victims of Bhopal, tells Shobha Warrier/Rediff.com, what happened in the Covaxin trial.

"We are not questioning the vaccine. We are only questioning the massive violation of the law in carrying out this trial," she says.

You tweeted that every law in the rule book in conducting a clinical trial was violated in the phase 3 trial of Covaxin in Bhopal.
When did you discover that the gas victims were signed as volunteers in the Covaxin trial without informing them that it was a trial?

It was in early December that we heard about vans of People's Hospital coming in the neighbourhood behind the Union Carbide factory, and announcing that they would give Rs 750 and an injection for coronavirus to all the people who come forward.

At that time itself, it looked suspicious because they were alluring people by promising money. And no one was told that they were going to participate in a trial, and not getting vaccinated against the coronavirus.

Since we work among these gas victims, we came to know about this quite early. Some of the community members informed us that many people had joined the vaccination drive.

That was when we spoke to the volunteers to find out what exactly was happening.

We found out that no one was given an informed consent form.

It is the informed consent form that is the bedrock of any drug trial as it explains the purpose of the study, the risks involved, inclusion and exclusion and also the rights of the participants.

When we asked them about the consent form, they said they were asked to sign many forms, but they were not given a copy of the signed consent form.

It is another matter that most of these people are illiterate and not able to read what is in the form; they can only sign their names.

When we asked them whether anyone read it out to them or explain to them what was written in the form, the answer was in the negative.

In fact, they told us that they were told nothing bad would happen to them, and if at all they faced any problem they could call the hospital, and they would be taken care of.

The volunteers were given a one-page participant information sheet which had the name of the principal investigator, his initials, the participant's initials, the date of the two shots.

They were also given a bunch of empty sheets where they were supposed to record what they were feeling.

Why would these people do that when they had no idea they were part of a trial? For them, they got vaccinated and also got Rs 750. So, it is over.

Above all, most of these volunteers are illiterates, and can't read or write!

They were also told the hospital would call to enquire about their condition.

You should understand that phones do not work among these communities. They may have balance charge in the phone today, but not tomorrow. Also, there may be just one phone for the entire family. Anyway, in most cases, there was no follow-up that happened.

We were waiting to see whether the hospital would give the informed consent form after the second dose. When they didn't give even after the second dose, we realised that it was a case of violation, and nothing was going by the book.

When they are dealing with poor and vulnerable people who cannot read or write, is there not a law in the rule book that says their consent should be recorded in a way they understand?

Yes, there is a law that says their consent should be recorded in an audio-visual format. And, do you know how this law came into being?

From 2004-0208, many illegal gas trials were conducted on the gas victims in Bhopal Memorial Hospital, and 13 of them died. This news came out in 2010 and there was a huge uproar.

That was when the law was changed; that if those conducting a trial were going to bring in vulnerable people, they were to have an audio-visual consent form.

In the Covaxin trial also, there was no audio-visual consent form.

So, we wrote a letter to the prime minister on how these vulnerable people were misguided and no audio-visual consent was done.

It was reported that those who experienced adverse reactions were not treated and some of them were even asked to pay...

Yes, there was denial of proper medical treatment to participants who experienced adverse reactions.

Only when we tweeted about these incidents, they were asked to go to the hospital. Then they were not charged.

They were not given any information on the insurance policy; they were just asked, who they would like to nominate. In fact, some of the participants got worried when they were asked about the nomination.

When they asked, 'Will something happen to me?', the answer was, 'Nothing will happen to you. We are just asking a routine question.'

Even then, they were not told it was a clinical trial.

I read that there were two sites where the clinical trials were going on.
How is it that the government hospital got hardly 100 people for the trial while the private hospital got 1700 participants?
Was it because the participants were promised Rs 750?

In fact, the government hospital was giving Rs 800.

Then, why didn't they get more volunteers?

That is because they didn't advertise like the private hospital did. Nobody from the government hospital went to the communities and said, 'Come, get the corona vaccine and also Rs 750!'

You can give money, but you don't advertise, and give it as an allurement.'

What the private hospital did was, they identified the areas where daily wage workers gathered in the mornings. That was how Deepak Marawi, who died on the 21st of December, was enrolled. 

They also systematically identified communities close to the hospital and picked them up. 

About the death of Deepak Marawi, both the hospital and Bharat Biotech issued statements saying his death had nothing to do with the vaccine, and that it was due to positioning. What exactly happened?

He died on the 21st of December. Though the People's Hospital got the post-mortem report, the family did not get it till the 8th of January, that also after there was pressure from all quarters.

The post mortem said, 'Suspected poisoning'.

The person who conducted the post-mortem was not even told that he was a participant of the Covaxin clinical trial.

So, a regular autopsy was not going to give you any result on the vaccine. Only a trained pathologist who was given a specific protocol could find it out.

When the subject expert committee, which gave the approval to Bharat Biotech to conduct the trial, had a meeting on the 31st of December, they were not told about the death of a participant.

Do you suspect it was because of the vaccine that he died?

He didn't leave the house after he was given the shot. So, there is nothing that he ate or drank had poisoned him.

But it has to be investigated.

What is the ethics committee doing? Is it not the duty of the ethics committee to reach out to the family of a trial participant and inform them about what exactly happened?

Do you think this incident will cast a shadow on the other trials that are going on, and on the way trials are conducted in India?

Absolutely. It should.

All we are saying is, be transparent.

If you have made mistakes, admit it, stop what is going on and follow up with everyone who is given the shots.

Also, how many of the participants are poor people? I can tell you out of the 1,700, 1,000 will be people like these.

I don't know about the other places where vaccine trials are going on. But I can tell you, in Bhopal, every rule in the vaccine trial book has been broken.

And the co-sponsor of the trial is ICMR...

Yes, you see the conflict of interest!

Where is the medical ethics here?

Exactly! The ICMR is the apex body that has laid down standards for biomedical research, ethical guidelines, etc.

Now, Bharat Biotech is reacting, but ICMR is completely silent on the incident. Do we not lose faith in our institutes when they stay quiet in such times?

We don't want a public health disaster to be unleashed on the 16th (when the coronavirus vaccinations will begin in India).

ICMR needs to understand that they have a crucial role to play in this, and them being silent only says they are complicit in this.

The biggest joke right now is, we are rolling out a vaccine when we don't even have the phase 2 trial results; forget about phase 3 trial results. This is way beyond anyone's comprehension.

Why are we doing this? Why are we playing with people's lives?

My experience with drug trials is that, not a single company, not a single official was punished.

When you don't punish people for the illegal trials that violate the law, the message you are giving out is, you can kill a few and get away with it; you can violate a few rules and get away with it.

That is exactly why they went into this community. That is exactly why they did it too these people.

Is this not exploitation of the poor and the vulnerable?

Can you imagine a hospital van coming into your neighbourhood and announcing, come get corona vaccine and also Rs 750? They will never do that.

They will never do that in any affluent neighbourhood. They will never do that where people are aware of the trials.

They will only go to these communities because the idea is to feed on the vulnerability.

After you raised public attention about this incident, many people are criticising you for making people more scared about the vaccine when there is already vaccine-hesitancy in the country.

That is absolutely not the intention. We are not questioning the vaccine. We are only questioning the massive violation of the law in carrying out this trial.

How can the data of this trial be trusted when serious violations are documented?

This is all we are saying.

We are not saying stop the Bharat Biotech vaccine altogether; we are only saying 'Stop this trial because we have documentary evidence about serious violations. We are giving you evidence, so please do an investigation and punish those who are responsible.'