Digaria, Churu: On the morning of 18 April, 19 residents of Digaria village got on a bus to Jaipur, 250 kms away. These men were told they would be taken to a “medical camp,” where there would be some work, some remuneration, some alcohol and an opportunity to watch the IPL cricket match.
When they reached Jaipur, some wandered off to watch the match, others headed to Malpani Multispeciality Hospital, where the medical camp and the money were supposed to be. They were served dinner at the hospital and then went to sleep.
The next morning, they told The Wire, a doctor by the name of Rahul Saini came and spoke to them. “We are going to give you some medicines. If you feel uncomfortable, do not worry as we are all doctors here…” He told them they would be given nine different tablets over the next nine days, and gave them one tablet to be taken that same morning (19 April).
From here on, things got a little fuzzy for these men as they fell asleep and then woke up again after about a day. And that’s when they realised something had gone wrong– they were feeling drowsy and some said they are still in pain, days after they were given these tablets.
Rahul Saini at the Malpani hospital told The Wire that the patients had come for a drug trial by Glenmark Pharmaceuticals, but were found ineligible and hence were turned away. Glenmark Pharmaceuticals has suspended this trial at Malpani hospital, pending an enquiry.
A team from the Central Drugs Standard Control (CDSCO), along with state government officials and the local police, has commenced an investigation into the matter.
Clinical trial or medical camp?
The Hindi newspaper Patrika, first reported the news of 21 Digaria villagers being tricked into participating in Glenmark’s clinical trial at the Malpani hospital. Other news reports added that the victims were promised a job in Jaipur for which they would be paid Rs 500 per day.
When The Wire visited Digaria, the victims said they had gone to Jaipur with the understanding that they would be given some work at a “medical camp”, not participate in a clinical trial.
Both medical camps and clinical trials are commonly misused in India by private hospitals who dupe poor, uneducated and unsuspecting victims. Medical camps are often organised as a stand-in, to fill up empty hospitals during the time of government inspections. In this case, however, the medical camp and the clinical trial could in fact be the same thing.
However, Malpani hospital maintained that no medicine was given to the men from Digaria. “The patients who came were ineligible for the clinical trial. On the basis of their age, we rejected them all. No medicine was given to them,” said NK Malpani, the proprietor of the hospital.
“Out of humanity, we asked them to stay at night because they reached the hospital in the evening and we couldn’t proceed then. In the morning, Dr. Rajiv Gupta, the principal investigator (PI), rejected them and they were asked to leave, after which they created a scene. We didn’t give them any medicine so there is no question of informed consent,” said Rahul Saini, who has been coordinating clinical trials at Malpani hospital.
Did a local driver dupe the villagers?
On the ground at Digaria, villagers told The Wire that it was in fact Rahul Saini’s driver, a man named Vishnu, who had cajoled them into agreeing to come for this “medical camp.”
One of the victims, 23-year-old Sohan Lal Meghwal said, “Sher Singh [] informed us that his brother-in-law, Bhor Singh has arranged for work for at least 20 people in a hospital in Jaipur. He told us that it will be a medical camp where we would volunteer for making arrangements there at Rs 500 per day.”
When reached on the phone, Vishnu told The Wire, “When I was in my village Palasana some time back, I had mentioned that I work for a doctor and if they have any joint pain, he [Saini] can help them. I never mentioned about any camp or money they will be given here.”
When reached again for his comments on these allegations, Saini refused to speak to The Wire.
Blaming Vishnu for the matter, Sher Singh, one of the people who underwent the clinical trial, who convinced the village people to go to the hospital told The Wire, “Bhor Singh knows Vishnu and Vishnu said that his boss Saini, needed some people for a camp at their hospital for which they will pay Rs 500 per day to each person. He [Vishnu] also mentioned that he has been doing this [bringing in subjects for study] for 13 years now and it’s completely safe.”
“I was not at all aware that the hospital wanted to try medicines on us that could have dangerous side effects,” said Sher Singh.
“On Thursday, Bhor Singh asked us to take a bath and have breakfast. Soon after that, he asked us to take a medicine that will help in proper digestion. The minute we took the medicine, we started feeling very drowsy. It was only after a day that I gained consciousness,” Lichu Ram, one of the victims, said.
The men say that the hospital took their Aadhaar cards and later returned them. They also added that they were supposed to get a course of nine tablets.
“The doctor, before giving us the medicine, said he would give us nine tablets in the next nine days, starting from 200 mg up to 600 mg. We all took the first medicine, except four of us who were out of the hospital then,” said Ranjit Singh (42), one of the oldest villagers who went to the hospital.
The villagers do not know what drug they took. Bhor Singh later came and woke people up.
“We asked him to arrange a bus to go back to the village. Meanwhile, some people from our village had reached Jaipur to take us back home. We asked Rahul Saini what had happened to us, and then Saini tried to hand over Rs 8,000 for all of us but we refused,” said Oma Ram, another victim.
Even though the villagers got back home, some of them are still unwell due to side effects of the medicine.
“It’s been three days since I came back to village from Jaipur but I can’t even stand because of pain, forget go out for work. There is no money at home to even eat,” Sawarlal (25) told The Wire.
Hospital says they did not give any medicine
Malpani hospital is a three-storey building whose first floor is under construction– the doctors mostly work from the basement. The hospital had perhaps less than 50 beds and most of the people who seek treatment there are out-patients.
There are 45 registered trials that are currently going on in the small campus of the Malpani hospital, according to the Indian Clinical Trial Registry. A large number of the trials here appear to be for arthritis drugs.
Of the 45 trials, the hospital said that the villagers from Digaria had come to participate in the Glenmark trial, even though they themselves were not aware of which drug trial they had been brought for.
NK Malpani, the proprietor describes how they go about trials: “We have been performing clinical trials for many years now. This time we had a trial in pipeline for osteoarthritis patients. Usual procedure for selecting patients for such studies is that we ask our friends and relatives to send persons who can volunteer themselves for trials. Out of miscommunication, this time, they sent all young persons. Our principal investigator, in fact, rejected the patients over telephone. It’s a fabricated news.”
He also added that if 21 patients had fallen ill suddenly, they would have surely been admitted in some nearby hospital for treatment and not returned to their village.
“They are just reacting negatively because they were rejected from taking part in this trial,” said Malpani.
Dr Rajiv Gupta, the PI of this trial, told The Wire that he had no idea how these patients landed up at his hospital. “Woh kyun aaye, kab aaye, kahan se aaye, mujhe kuch pata nahi. (I don’t know why, when and from where the patients came to the hospital for the trial). Nothing happened to those patients as they are claiming in the media. Surprisingly, they didn’t seek treatment at any hospital, actually, and are enjoying in their villages at present. Nowadays, companies select sites [for conducting trials] that have ethical committees which can approve the trial,” he said.
All the same, Glenmark has suspended its trial at this hospital. In a statement to The Wire they said, “in the wake of the event of media reports alleging irregularities at the hospital, the company has decided to immediately investigate the matter and suspend the clinical trial at the site. Glenmark will also fully support and cooperate with the regulatory authorities in any investigation on this trial. As a responsible organisation, we will not compromise safety of patients.”
Was a Glenmark drug given to these victims?
Patrika reported that the adverse reactions of these villagers were from a Glenmark drug. According to ANI, a “foreign based company” had tried drugs meant for animal testing, but on humans.
A foreign-based pharma company allegedly tested their medicines on humans instead of animals. Victims now admitted to Jaipur hospital, allege ’21 people from our village Bidasar (Churu district) came here, the company offered us Rs 500/day for taking the medicines’. #Rajasthan pic.twitter.com/ui3MD9FB2e
— ANI (@ANI) April 21, 2018
Some of this reporting has been inaccurate.
Glenmark’s drug trial at Malpani is for GRC 27864, which is a drug for patients with moderate hip or knee osteoarthritis pain. The trial has received regulatory clearance from CDSCO. Malpani hospital’s institutional ethics committee has also approved this trial.
The trial aims to be conducted on 624 subjects. The trial is currently underway in 38 sites around the country, including two sites in Rajasthan, both in Jaipur, one of which is Malpani hospital. It is a randomised, double blind, placebo controlled phase 2 trial.
ANI reported that these drugs were meant for animal testing. But this is not likely as phase 2 trials are conducted on humans, not animals.
In this trial, subjects are put on a course for 12 weeks, to receive oral tablets, once everyday. According to the trial’s filing on the Indian government’s registry, “Any adverse event, either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality.”
But a 12-week regimen is at odds with what villagers in Digaria told The Wire. They were not able to name the drug given to them, but insisted that Saini told them the drug was for for nine days and not 12 weeks.
The trial’s inclusion criteria is people in the age group of 40 to 70 years, who have been diagnosed with primary osteoarthritis of the hip or knee for at least three months in accordance with American College of Rheumatology clinical and radiological criteria. This is the reason cited by Malpani hospital to have rejected all the men who came from Digaria village, most of whom were younger than 40.
Except for one, all the villagers who went to Jaipur that The Wire met with were younger men, under 35 years, and who were unemployed due to lack of opportunities in the remote village.
Investigations underway in Churu district
While poor patients have routinely been exploited during clinical trials in India, here investigators will have to ascertain whether the villagers had been put through trials at all, or if some other medical procedure had been conducted.
They also have to figure out which drugs were given to these villagers, if at all any, and what side effects they may be facing because of that. The nature of conduct in Malpani hospital’s other clinical trials will also have to be examined. Glenmark and other companies which deal with Malpani hospital will have to answer questions about how well they monitor their trials.
On Tuesday, social activists carried out a protest in Jaipur and said the hospital “infringed all protocols and standard procedures that were laid down by the Drug Controller General of India by conducting this drug trial.” They urged government officials to ascertain whether the adverse effects that the victims were facing are only symptomatic or have caused more serious damage to body organs. They also want Malpani hospital’s registration to be cancelled and Glenmark to be investigated.
CDSCO officials told The Wire that they are investigating the issue. They have finished a primary investigation in Jaipur at the Malpani hospital and plan on meeting the villagers next.
Rajasthan health department’s director, VK Mathur said, “Inspection by CDSCO is still going on. We can comment only after the final report is submitted. However, the hospital has provided all the regulatory documents needed to conduct a trial.”
The Jaipur police team that went to Digaria to record the victims’ statement say that no FIR has been registered so far.
The Hindi press in the country widely quoted a person named Vimal who was identified as a social activist who told them that Malpani hospital was duping patients in clinical trials, without their consent.
As the issue began to flare up, Vimal was unreachable but later gave The Wire a somewhat altered statement:“The matter was blown out of proportion by the media. The hospital was conducting the trial legally. However, the procedure was not followed properly.”
This same trial is also going on in Gujarat, at the Sanjivani Super Speciality Hospital. Dr. Sharad Purohit, who is the PI there, spoke to The Wire: “We usually go for OPD patients when selecting patients for trial and all three at our hospital, had taken treatment from me for arthritis in the past. It may be possible that out of miscommunication or lack of knowledge, they called the young people and later found that they don’t fit the criteria. As per rules, it is the duty of the PI to ensure that the patients are informed about the side-effects in advance.”
The trap of poverty and desperation that keeps people at risk of being exploited remains at the backdrop of this controversy in Jaipur. “Digaria is a remote area and due to acute shortage of water, even farming can’t be done here. People are mostly jobless or go to work in a quarry nearby. So, it’s not impossible that they got trapped by someone to grab any work in lure of money,” said Prahlad Rai, station house officer at Bidasar police station.
With inputs from Anoo Bhuyan