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Churu Drug Trials: 4 Months On, Dalit Victims Report Severe Damage To Health And Caste-Based Harassment

By NEHA DIXIT | 

It was mid April, the onset of the heat wave in Rajasthan. Twenty-one-year-old Mamta had spent three consecutive days lying on her bed next to a mud wall in her round, thatched hut. That day she gave her husband, 24-year-old Oma Ram, an ultimatum: either he finds work outside their village or she would leave.

When Oma Ram was 13 years old, his father died. Since then, he had been fending for himself by alternating as a shepherd for the village cattle and as a farm labourer during the four-month farming season each year. Like most young men from his community—Meghwals, enlisted as a Scheduled Caste in Rajasthan—he owns a small patch of farm land, two beeghas that yield abysmal harvests from millets and barley. Depending on it for livelihood is not possible. In the last two years, since his marriage, the lack of money had marred his household more than ever. With increasingly dismal rainfall each year, chances of finding work on farms closer home had grown bleak. According to the local doctor, Mamta had contracted jaundice due to regular bouts of starvation and hunger.

Digaria, Oma Ram and Mamta’s village in Rajasthan’s Churu district, is occupied primarily by the Meghwals. The gram pradhan Umed Singh said that it has a voting population of 1,600, and is clubbed with four other villages under the Ghantiyal Badi panchayat. Untouchability is rampantly practised. Dalits are not allowed entry into the district’s famous Babosa Balaji Maharaj temple. They can only draw water from designated wells, and regularly face thrashing if found sitting on cots in the presence of the Rajput and Brahmin landowners whose farms they work in. Traditionally, the Meghwals worked as weavers and wood carvers, but over the years, working as farm labourers has become their primary occupation. Several people I met said that for a 12-hour shift, they are paid Rs 200.

On the day of Mamta’s ultimatum, Oma Ram went to the village square to look for leads for potential employment. Sher Singh, a Rajput truck driver from Palasa village, part of the same gram panchayat as Digaria, was recruiting daily-wagers to work at a week-long medical camp in Jaipur. The job, as Singh described to those interested, was to set up the tents, serve food and refreshments to incoming patients, keep the surroundings clean and help the medical personnel. The promised daily wage was Rs 500, alongside free food and lodging.

The next morning, on 18 April, Oma Ram and 20 other men from his village—all young Meghwals—left with Singh for Jaipur. After a five-hour drive, they reached the isolated Malpani Hospital and were lodged in its basement. The basement had seven other people from Bharatpur and Jaipur, who had come for the same work. The hospital workers told the men that the camp doctors will come two days later, and that until then they should not leave the basement at any cost. “The basement was filthy with mounds of medical trash in several corners. On one side, there were a couple of hospital beds and we were asked to rest there,” Sohan Lal, a 19-year-old student who had come to work so he could earn his college fee, told me.

On 19 April, around 10 am, they were provided with a meal. Several of the men recounted that Rahul Saini, a hospital doctor, gave all 28 of them small, white round tablets to swallow after they had eaten. “He said that we should take the tablets to get rid of any fatigue, indigestion or body pain,” Moora Ram, a 40-year-old farm labourer from Digaria, said. Saini said that the tablets “will help us relax and sleep better,” he added. “Once we take the tablets, we will also be eligible for free examination by the doctors.”

Within an hour of taking the tablets, 17 of the men fell unconscious. Seeing this effect, four others refused to take the tablet and escaped to Digaria. “They informed our family members of what was happening in the hospital,” Shammamal, a 25-year-old mason who had been administered the tablet, said.

“We could hardly get up from the bed the next day. Some had muscle cramps, skin allergies and fever. Others felt nauseous, got diarrhea.” Sohan Lal said. By then, their relatives from Digaria had arrived. “The hospital staff informed us that they conducted a medical prashikshan”—a clinical trial—“on us.”

When the Digaria residents who had gathered at Malpani Hospital learnt what had happened, they began protesting, and insisted that the hospital staff give them details of the trial. The staff gave in. It was then that Oma Ram and the others found out that they had been made to undergo a Phase 2 trial for GRC 27864, a drug manufactured by the pharmaceutical giant Glenmark. The drug is intended to treat hip- or knee-osteoarthritis pain on patients between the ages 40 and 60. Phase 2 trials are usually conducted on mid-sized groups, to assess how well the drug in question is performing.

Under the law, it is mandatory to get written consent from the clinical-trial participant. Each victim I spoke to said that they were not informed of the trial, nor were any others present in the basement. Further, the trial was conducted on healthy men who were far younger than the target age for the drug. Shammalal said, “We had gone to earn a living, we ended up losing all our strength to do that in the days to come.”

 

*

According to an RTI response from the Director General of Health Services in India to a query filed by the Swasthya Adhikar Manch, a public-health advocacy group, nearly 5,000 people lost their lives between 2005 and 2017 as a result of clinical trials in India, and 20,758 were reported to have faced severe adverse health consequences. Till date, compensation has been given in only 187 cases of death.

Data presented before the Supreme Court by the Rajasthan government states that between 2005 and 2013, 95 people in the state lost their lives due to clinical trials, and 361 patients continue to face adverse effects. In 2012, the Swasthya Adhikar Manch, the Drug Trial Peedit Sangh, Rajasthan Nagrik Manch, Bhopal Gas Peedit Mahila Udyog Sangathan and Jan Swasthya Abhiya—all civil-society organisations—filed a PIL in the Supreme Court to demand strict regulations for ethical clinical trials in India, adequate compensation for victims and action against guilty medical practitioners. Since then, the court has passed several orders in the case—including directions that the central government must discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India. “Uncontrolled clinical trials are causing havoc to human life,” the court reportedly said. “There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.” The PIL is next slated for hearing on 12 September.

Despite the ongoing hearing, since 2015, the government has amended crucial rules concerning drug trials in India, walking back many of the progressive changes from previous years. On the eve of the PIL’s hearing, the ordeal undergone by the men from Churu and what has followed since the case was first reported in April are sobering reminders of the reality of clinical drug trials in India.

In the days following the illegal trial in April, several local and mainstream media outlets reported the story. Three days later, on 23 April, the Swasthya Adhikar Manch, the chief petitioner in the PIL before the court, filed a complaint with the National Human Rights Commission. Referring to the media reports regarding the illegal trial, the complaint requested that “the matter be investigated and that action be taken against the hospital and medical practitioners involved in the incident.”

Meanwhile, Sohan Lal and several other victims decided to file a police complaint against Sher Singh and the hospital staff. A group of them visited the Vishwakarma police station in Jaipur, under which Malpani Hospital falls. “We had to do a sit-in protest outside the police station for two weeks to get the complaint filed,” he said. In the FIR filed on 29 May, Sohan Lal’s statement said, “Since the trial, we have developed skin allergies, chest pain, weakness, nausea and diarrhea … many of those who were with me and I are still under treatment for the effects of the trial at the government hospital in Sandwa, Sujangarh and Bidasar.” He added, “The effects of the drug are impacting our minds and bodies even today.”

On 2 May 2018, the Office of the Drugs Controller General of India, which falls under the Central Drugs Standard Control Organization, issued a notice to Glenmark Pharmaceutical Limited. The DGI’s notice stated that, taking cognisance of the media reports regarding the trial, an investigation team constituted by the CDSCO had looked into the trial and discovered multiple violations. The team found that, as per Malpani Hospital’s records, only three people were officially enrolled for the Phase 2 clinical trial of GRC 27864 tablets. While looking into the records of the three persons, the CDSCO team found that the identities of all the three people were falsified in all accounts—their address, phone numbers and their signatures on the consent forms. The report also mentioned that around 25 people were recruited as volunteers without following the procedure for ethical trials, or without seeking their prior approval.

The CDSCO investigators also found that the clinical-trial room was “not adequate,” as it did not have any ventilation, washrooms or proper spacing between beds. They also found that neither the procedures for recruiting the 25 or so subjects nor the procedure for the trial was reviewed by the Ethics Committee—under Schedule Y of the Drugs and Cosmetics Rules, 1945, approval from an ethics committee within the institute or an independent committee is mandatory.

According to the CDSCO, Malpani Hospital in Jaipur is conducting 18 drug trials at present. The hospital is one of 23 sites where Glenmark had initiated Phase 2 clinical trials for GRC 27864. Soon after the CDSCO notice, Glenmark issued a media statement: “As soon as we became aware of the alleged irregularities at Malpani Hospital, we suspended the trial at the site in the interest of patient safety. Further, we have all the requisite approvals in place for the trial at the site and have submitted all supporting documents of our approvals to the regulator.”

In the last four months, despite the fact that several investigations by the media as well as government-constituted teams have found that the drug trial was non-consensual and that the complainants continue to face adverse health effects, no officials have met the complainants. The ethics committee members and the principal investigators of the trial, who are responsible for the medical management of the victims, have not visited or met them either.

Baghu Ram, a 23-year old, has lost ten kgs since April. He told me that he was admitted in the Sandwa Community Health Centre for a lung infection and chest pain that he had had for over a month. He can no longer take up a labour-intensive job. “My parents lost all their savings in getting me treated. I used to work as a part-time mason. But I can hardly pick up more than two bricks at a time.”

Sohan Lal, the 19-year-old, said he had missed most classes this college semester. He complained of incessant breathlessness, headaches and poor eyesight. “In a government hospital, if you tell the doctor that you have a headache, they give you a tablet. If you say that you are restless, they again give you a tablet. That is the only medical treatment they know of,” he said. “No one is checking on us for the long-term impact of this trial on us. And we can’t afford to pay a private doctor to know on our own.”

Baghu Ram's prescription for treatment. Credit: Neha Dixit for The Caravan.
Baghu Ram’s prescription for treatment. Credit: Neha Dixit for The Caravan.

Post the trial, Oma Ram has suffered from restlessness and anxiety. “I feel like sleeping in the dark the whole day. I take up work but feel jittery. It happened four or five times, when I started working at a local construction site and could not concentrate,” he told me, “as if someone has kept a rock on my body.”

Meanwhile, the FIR filed by Sohan Lal and others against Sher Singh and Malpani hospital has resulted in the Dalits facing threats and harassment in the village. Sohan Lal told me that on 15 May, Sher Singh came to Digaria with goons in tow, attempting to scare them into withdrawing their police complaint against Malpani hospital. The Rajputs also threatened the Dalit labourers, saying that they will make sure that the complainants do not get work in the farmlands in the next cropping season.

“We have informed the police several times over but there has been no action. When Rajputs file a case against us even for asking our wages on time, the police do not even take a minute to take us into custody,” says Moora Ram.

Sohan Lal says that their fight is now for systemic change. “We don’t want compensation. We want dignity and justice.” Last month, a newly constructed Ambedkar shrine was vandalised for the third time since its construction. “We know the Rajputs. We have removed the Ambedkar statue for now. We will place it back once we get justice,” he said.

I contacted Rajiv Gupta, the principal investigator for the clinical trial at Malpani hospital. He refused to comment, saying that “the investigation is on.” NK Malpani, founder of Malpani hospital, declined to comment on the incident

*

Before 2005, clinical trials in India were only allowed on drug molecules discovered in the country. In 2005, Schedule Y of the Drugs and Cosmetics Act was modified to allow early-phase clinical trials to be conducted in the country. Soon after, global pharmaceutical companies began to project India as the preferred destination for global clinical trials.

Internationally, recruiting patients for clinical trials is a difficult and expensive task—the cost of standard of clinical care, mandatory health insurance, high documentation, counselling and training for a clinical-trial volunteer as mandated by law is high even in developed countries. Many trials that are conducted in India could not be conducted in these countries, as they rely on people’s lack of access to affordable, good-quality care.

With the arrival of global clinical trials in India, the Indian Council for Medical Research revised its first guidelines on “Ethical considerations involved in research on Human Subjects” in 2000, and again in 2006. There was a multifold increase in new trials from 2008 to 2012.

According to the Drugs and Cosmetics Act, each clinical trial needs the approval of an Institutional Ethics Committee that comprises 8 to 10 members. According to the Clinical Development Services Agency (CDSA) under the Ministry of Science and Technology in India, the responsibility of the Ethics Committee is to review studies that are to be conducted on humans. “The committee will make unbiased recommendations on all types of research proposals with a view to safeguard the dignity, rights, safety and well-being of all actual and potential research subjects. The goals of research, however important, should not be permitted to override the health and well-being of the research subjects,” the CDSA states. It adds that the committee shall also look into “the informed consent process, study/ protocol risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensation process, wherever required” and will “review the proposals before start of the study and monitor the research throughout the study until and after completion of the study through appropriate well documented procedures, for example … assessment of all Severe Adverse Events and advise for compensation to regulatory authority.”

But until 2012, any ten people sitting in any part of the country could approve a clinical trial. Instances of abuse, neglect and exploitation were disturbingly common—including trials on mentally ill patientsand on Bhopal gas victims in Madhya Pradesh. After the Swasthya Adhikar Manch’s PIL was filed, the court directed that no new drug trials be allowed to begin unless they were conducted strictly under Schedule Y of the Drugs and Cosmetics Act. Further, the court noted that the only trials that could proceed were to do with unmet medical needs in the country, where risk-and-benefit analysis had been conducted, and which related to an innovation pertaining to an existing therapy.

Around the same time, the 59th Parliamentary Standing Committee report on Health and Family Welfare commented on the functioning CDSCO, claiming that there was an “apparent nexus that exists between drug manufacturers and many experts” at the organisation and that there had been many reported instances of poor and illiterate citizens of India being used as “guinea pigs” by multinational drug manufacturers.

In 2013, a committee constituted by the Ministry of Health and Family Welfare and headed by the professor Ranjit Roy Chaudhury reviewed issues pertinent to clinical trials in India, and suggested corrective measures—broadly, that clinical trials must only take place at government-accredited centres; that informed consent must be taken and that the process of obtaining it must be recorded; and there must be a provision for the care of those suffering from adverse health effects due to the trial. Schedule Y was soon amended in accordance with these. These amendments included compensation of trial injuries, limiting the number of trials an investigator can undertake, mandatory audio–video recording of the informed-consent process and reporting deadlines for serious adverse events, among others.

But after these regulations were brought in, global sponsors began pulling out and the number of new trials plummeted. The United States government halted federally funded trials in India.

Since 2015, many of these changes have been diluted or reversed. The latest rules favour the pharmaceutical companies and deliberately overlook the rights of the clinical-trial participants. For instance, a government circular issued on 2 August 2016 removed the 50-bed restriction for conducting clinical trials. The DGCI also modified the requirement regarding audio-video recordings of consent procedure, limiting it to new chemical studies or studies for anti-HIV and anti-leprosy drugs.

The CDSA’s guidelines allow the ethics committees to oversee clinical trials and decide on the level of compensation given to patients who suffer adverse events. In 2016, the government also removed the restriction on the number of trials a principal investigator can work on at any given time, which was previously set at three, stating that and this too could be decided by the ethics committee. The CDSCO also noted that the EC can approve the addition of a new site or investigator to a trial in the normal course of the trial without obtaining a No Objection Certificate from Drug Controller General of India. These new rules and circulars clearly go against the spirit of the Supreme Court orders. “Fearful of losing clinical trial business to ‘rival’ countries, the Indian government is diluting its laws related to drug trials,” Amulya Nidhi, the convenor of the Swasthya Adhikar Manch, said.

In India, the concerns regarding drug trials do not end at the procedure followed during the investigation. Several independent reports confirm that most trials in India have been conducted on the poor. While this alone is grave cause for concern, the benefits of the research that is carried out do not reach the communities that the subjects are part of—most often poor and oppressed castes—as drugs found to be effective following these trials are not affordable for these groups. Such practices are in violation of the Declaration of Helsinki, a set of ethical principles followed by the global medical community, which states that “medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.”

“The Indian example suggests that research-ethics frameworks and national policies for economic development are increasingly intertwined,” Nidhi said. “Most, if not all, clinical trials happen because of financial interests of the pharmaceutical or implant company involved in the trial. The government should ask for further transparency in such trials.”

According to Sanjay Parikh, a Supreme Court lawyer who is representing the Swasthya Adhikar Manch in their PIL, most clinical trials in India are conducted in violation of laws and human rights. “The drug companies have been exploiting the poor people, taking advantage of the fact that there is no proper implementation of laws and strict monitoring by the concerned authorities. There is still no provision for criminal liability of the pharma companies who act in gross negligence resulting in deaths and serious adverse events. If clinical trials have to be conducted in our country, there has to be strict regulation and implementation in consonance with our constitutional protections, in particular for the lives of the poor people.”

On 24 May 2018, the National Human Rights Commission issued a notice to the principal secretary in Rajasthan government’s health department and the commissioner of police in Jaipur, asking them to respond with their investigation of the Churu trials within four weeks. There has been no response till date.

For the Dalit residents of Digaria, the hopelessness that set in with the lack of jobs has only been aggravated by fear. “Till date, only the educated, the rich were migrating from the village for jobs. When the poor migrate, they turn us into guinea pigs,” said Baghu Ram. He told me that most residents have become fearful of leaving the village. The area is also rife with rumours of organ-trafficking and human trafficking. “As it is we could never finish school, we don’t have land. Now, what are they getting by incapacitating us, depriving us of the physical energy to eat two square meals?”

Oma Ram said that his wife Mamta left 20 days after his return from Jaipur. “She said I was a coward who was making excuses not to work,” he said, before adding, “At least she will get two square meals at her parents’ house.”

Churu Drug Trials: Four months on, Dalit victims report severe damage to health and caste-based harassment

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