Unemployed youth are enticed by the idea of making a quick buck – and healthy volunteers are then used as subjects to test new drugs by laboratories.

Blood for money How young men in this Telangana district are lured into clinical trialsAll images: Nitin B
Delve Delve Wednesday, June 20, 2018 - 18:01

In June last year, 53-year-old Vangara Nagaraju came back to his small brick house in the remote village of Nagampeta in Telangana's Karimnagar district from Bengaluru. A father of three, Nagaraju had been feeling uneasy and complained to his family that he was having difficulty in walking. His hand also showed signs of swelling.

After being taken to a local doctor, Nagaraju collapsed at his residence on the evening of June 2, and died.

His shocked family did not know what to do, and went through his belongings, which revealed something far more gruesome than they had expected.

An Informed Consent Form (ICF) and an ID card of Lotus Laboratories, a clinical research organisation (CRO) based in Bengaluru, made them realise that Nagaraju had been participating in several clinical trials for years.

Vangara Nagaraju

"He never told us anything at home. We believed that he was going to Hyderabad on catering assignments, which is why he would be gone for a few days, and then keep travelling back and forth," says Nagaraju's son.

According to the ICF, days before his death, Nagaraju had completed phase 1 of a clinical trial at Lotus Labs, that was designed to compare an unapproved formulation of melatonin, with a formulation that was already in the market.

How do clinical trials work?  

Clinical trials are the government-approved method of testing new drugs that manufacturers want to introduce in the market. Depending on the drug and the company testing it, human volunteers are usually paid to be part of the experiments.

While phase 1 involves testing on animals, phase 2 and 3 trials test for the first time if a drug is safe and effective in humans. Usually, such trials are carried out on patients who can offer their consent, and not on healthy people.

However, in India, healthy volunteers usually participate in bioequivalence studies, which either test new versions of already existing drugs in the market, or generic versions of drugs whose patents have expired.

For this, CROs conduct tests on several volunteers at once, and constantly monitor the effects of the drug once it is consumed. In Nagaraju's case, he was one among 60 volunteers participating in the melatonin bioequivalence study.

Vulnerable volunteers

Chiluveri Ashok Kumar was around five years old, when he lost his father. Sitting in a one-bedroom rented house in Jammikunta town where he stays with his mother and younger sister, the 26-year-old says that he was never really interested in education.

"After my father died, my mother raised all of us with her income as a sanitation worker in the school. So after my schooling and Intermediate, I discontinued my Degree course, and began working," the soft-spoken youngster says.

Just a few months ago, Ashok tried to kill himself after claiming that 'voices in his ear' were telling him to jump off a nearby hill.

Chiliveri Ashok Kumar

"He came home in October last year after he told me that he went to Hyderabad looking for a job. He began having violent outbursts and tried to burn portraits of gods in our house. He even tried to hit me and almost killed me, saying that the voices were not stopping," narrates Kamala, Ashok's mother.

"I took him to several dargahs, where they told me that evil spirits had possessed him. We tried everything from prayers to rituals, and even shaved his head. We had to tie him up to keep him from harming himself," she adds.

In his frenzy, Ashok even burnt some documents including his ICF from the clinical trial he participated in, in Bengaluru.

After his case came to light, the local administration admitted him to Hyderabad's Institute of Mental Health in Erragadda, and he was discharged after proper medication.

"My head still feels heavy sometimes and I can't stand in the sun for long. I'm too weak to go back to work, and I have received no proper compensation from the government or the company," Ashok says.

Though Ashok had worked in marketing for a Telugu newspaper for close to six years in Warangal and Karimnagar, he says that he went for the trial after he was lured with the promise of making a quick buck.

"I went a few times in 2015, and I only had minor side effects. Tempted to go again, I went in 2017, and it became one of the worst decisions of my life. I don't know how things will be normal again," he says.   

Activists in the area say that there are hundreds of youngsters in the area who participate in these trials, as unemployment is rife and job opportunities are far too few.

In Ashok's case, he claims that he was introduced to the trials via a friend, Boga Suresh, from his native village of Kothapalli.

33-year-old Suresh's shop is hardly a kilometre from Ashok's house.

Sitting between portable gas cylinder stoves that he repairs for a living, Ashok looks around with fear when approached, before leading us to his house.

"I have participated in at least 35 to 40 trials since 2003. I was introduced to it when I was working at a catering firm in Hyderabad. Many people participate in bioequivalence studies over there, as employment opportunities are far too few over here in Karimnagar district," Suresh says.

Boga Suresh

In November last year, Suresh was hospitalised after he vomited blood. He later said that his health condition had deteriorated due to the trials, as he began to experience a breathing problem, and his hands started shaking.

Suresh says that the catering business is seasonal and only offers regular employment during the wedding season in summer. For the rest of the year, many don't have a source of income. It is these vulnerable youth who are hired by 'agents' to participate in these studies.

Recruiting agents

There are two types of agents according to volunteers. The first kind are agents that are attached to one company alone, while the other are 'freelance' agents, who pocket a commission for providing volunteers. The commission for these agents also depends on the city where they operate.

"It is a massive business with different rates. While a study in Hyderabad can pay you somewhere between Rs 8,000 and Rs 12,000, a study in Bengaluru pays much better, between Rs 24,000 and Rs 32,000 – similar to Mumbai. In places like Gujarat, a single trial in Ahmedabad can even pay more than Rs 50,000," Suresh says.

While it is unclear as to how much money these agents make per volunteer, it is known that they get an 'order' for 40 to 50 volunteers at a time, and pocket a big commission for coordinating between volunteers and the companies.

"We get paid in thousands, but agents get paid several lakhs for their jobs," says Suresh, as he narrates the tale of an agent who goes by the name 'Kishan'.

According to Suresh, Kishan is a freelance agent who speaks several languages and has taken around nine rooms in Hebbagodi, in the outskirts of Bengaluru, permanently on rent.

"He lodges the volunteers in these rooms and provides them with more comforts than they can imagine, coming from small towns. From here, he sends them to his clients," Suresh says.

In some cases, experienced volunteers turn into agents themselves, thereby increasing their income more than tenfold. In all cases, volunteers say that the agents not only meet their targets, but largely overshoot it.

Suresh holds up a cheque, with the amount he was paid for a trial

"In Ameerpet’s Swarnajayanthi Complex in Hyderabad, there is a lab where I have done at least 12 studies. There are three agents who started their career as volunteers in the lab, and then spoke to a doctor there and became agents," Suresh says.

When TNM visited the complex in Ameerpet, it learnt that the company had packed up and shifted to more guarded premises in the city's Nacharam area in 2015.

Locals said that the company left amid allegations of a raid due to poor quality of drugs being approved.

"The entire floor has been abandoned since then. There used to be hotels in the ground floor where the volunteers would be housed by the agents. Even they shut down after the lab shifted, as they went into loss," a security guard at the spot said.

"At the end of it all, the companies are benefited and so are the agents. However, the volunteers who sell their blood for money due to helplessness continue to suffer," Suresh adds.

There is also another important tool that agents use, to recruit volunteers; WhatsApp. You can read TNM's earlier story here.

The legal loopholes and violations

Clinical trials in India are still governed by the archaic Drugs and Cosmetics Act, 1940, a law that is almost 80 years old. Under this law, only the central government can look into violations in clinical trials, and the police cannot arrest anyone for violating the law.

The Drug Controller General of India (DCGI) is responsible for approving and overseeing all clinical trials in the country. The companies approach DCGI and register for all phases of drug trials, after which an Ethics Committee from the Central Drugs Standard Control Organization (CDSCO) visits the lab and approves the trial.

While the companies say that they ensure that all rules are followed, to avoid getting rebuked by the government, many volunteers say that violations continue to happen.

Another important body is the Clinical Trials Registry of India (CTRI), which is hosted at the National Institute of Medical Statistics (NIMS) in the national capital.

The CTRI, launched in 2007, is meant to be an online public record system, where every clinical trial being conducted in the country should be registered. In 2009, the DCGI made it mandatory to register any trial with the CTRI.

However, legal experts say that the Drugs and Cosmetics Act, as well as later guidelines laid down by the Supreme Court, only defines compensation provided to the volunteer, and it is up to a committee constituted by the Centre to decide whether any action should be taken.

As almost all clinical trial subjects visit the CRO out of their own will and even sign a consent form, it is up to them to file an application with the company in case of death or injury of the volunteer.

Only if the company fails to compensate them within a stipulated time according to existing guidelines, can the volunteer or his family move court.

"As clinical trials are absolutely essential before any medicine can come into the market, are legally granted permission by the central government and have consensual volunteers, the entire situation is complex," says Karunakar, an advocate based in Hanamkonda.

While the local police often file a case under Section 304A (Causing death by negligence) of the Indian Penal Code (IPC), this often doesn't stand legal scrutiny and the FIR is quashed in court.

"Each judgement under this issue is also different from case to case, as every volunteer's case is unique. There is very little scope to interpret the words from earlier judgements," Karunakar explains.

"As there is no question of negligence as such, because the risks of the trial are clearly explained in the ICF, the only way to legally fight this is to invoke Article 21 of the Constitution, which states that Right to Life is a fundamental right of every Indian citizen," he adds.  

The labs’ react

When TNM reached out to GVK Biosciences for a statement on the allegations that it had moved its premises from Ameerpet amid allegations of unreliable study results, the Director – Corporate Communications said, “Our focus is more on Contract Research and Development (CRDO) with limited business interests in the BA/BE studies vertical. The overall business sentiment in the BA/BE studies vertical is also weak and we are limiting our business interests in this space – though we continue to have few staff handling regulatory compliance.”

“The sponsors would be in a better position to answer the question on clinical trials and we are not aware of the same. We are keen to grow in the Contract Research and Development business with focus on Research & Development of new molecules going forward and limiting our work and business in BA/BE studies,” the statement added.

Repeated calls over a span of many days to Lotus Labs went unanswered.

However, TNM managed to access the copy of a letter that was written by company officials to Chiluveri Ashok Kumar and his mother.

The letter acknowledges that Ashok was a participant of a trial in the lab and states that his health was fine when he left to go back home.

“We deeply regret for the ill health of your son,” the letter states, adding that the lab had tried to reach out to them multiple times on the phone numbers provided by Ashok.

Asking for cooperation, the company said that it was willing to treat Ashok and bear the expenses if the duo approached the lab immediately upon receiving the letter. The company also said that it would move forward as per the stipulated guidelines.

However, Ashok’s family stated that the letter dated December 1, did not reach them in time and the damage had already been done.

 

Show us some love and support our journalism by becoming a TNM Member - Click here.