The candle in the shrine in the corner of the room the Dhawan family call home flickers and gutters out. There is silence, all eyes on Aman, shy and awkward, sitting on the end of the bed that dominates the small space.
“Go on,” his mother Seema says, gently. “You can say it. What did you want to be before you became ill?”
He looks around desperately and there are tears in his eyes.
“A dancer,” he whispers. “I wanted to be a famous dancer.” Pause. “But I can’t be a dancer now. My body is too weak. I don’t have the strength. So now, I don’t know. Maybe I will open a shop …”
The house lies off an alley in the Pancham Ki Phel slum in the city of Indore in Madhya Pradesh state, the heart of India. It is a typical slum home: tiny inside, the family crammed together, one bed for all of them. Outside, there are open drains, animals wandering around, the smell of raw sewage. The people who live here are generally poor and ill-educated. But to some, it is a goldmine.
Until 2010, when he had his first vaccination, Aman was a healthy young boy.
Then he started to lose weight and strength. His parents did not connect it to a series of injections: after all, the doctors had assured them that the medicine was the way to a life free of illness.
The invitation to receive the vaccinations had come from a neighbour. Other parents were doing it, she said, and not only were their children getting a fantastic new western cure-all, they were getting money for going too. What was there to lose? Plenty, it turned out. Some, like the Dhawans, were already noticing changes in their children – late menstrual periods, dizziness and weakness.
But most of those who had taken the bait were poor and illiterate, unable to resist the tempation of free medicine in a country where they would normally be unable to afford such drugs and where doctors are regarded by many as only one step down from gods. If a doctor told them it was for their own good, they were happy to believe that to be true. And they were not alone.
It wasn’t a miraculous, free cure-all they were receiving but vaccines on trial for western pharmaceutical companies. Over the past decade, drug trials have become a £300 million (Dh1.63 billion) a year business in India. In 2003, there were fewer than 50 clinical trials running in India, but the number increased rapidly as pharmaceutical firms realised that costs were up to 60 per cent lower in India than in the US. By 2011, there were 1,852 trials registered with the government, involving an estimated 150,000 patients.
Cost was one reason for the the surge in the number of trials, but there were other factors at play too.
India was unusual in that there was a large pool of poorly educated people willing to take part in trials in return for a handful of rupees. Many of the trials were also subject to very light regulation, so that shortcomings were not flagged up in the way that might have happened in the US and Europe. Ethics committees, which were supposed to be monitoring trials, were often unaware of what was going on, or even of what should be happening. The trials were also susceptible to the corruption that pervades all levels of the Indian system. The result was that unscrupulous doctors were able to sign subjects up for trials without bothering to get their informed consent, a legal requirement elsewhere in the world.
The money poured in. But the human cost was also rising. Reports began to circulate of deaths among people participating in trials. Civil rights groups started asking questions and bringing legal actions. Pressure mounted on the government to respond.
In 2013 India’s health minister Ghulam Nabi revealed that 2,868 people had died since 2005 in government-approved drug trials.
But the lack of oversight meant that there had been few autopsies and only 80 cases could be directly linked to trials. There was no system in place to flag up that a patient who died was taking part in a drugs trial, so most bodies were quickly cremated.
Seven months later, the wheels came off the gravy train. Opposition to the trials had been mounting: now, the Supreme Court intervened decisively to put all 162 ongoing trials on hold until new rules were in place to safeguard patients.
“Foreign companies are treating India as a heaven for clinical trials, but it is proving hell for India,” the judges stated.
What tipped the balance was a scathing report by the Parliamentary Standing Committee on Health and Family Welfare into one hotly contested vaccination trial involving tribal girls, some of whom had subsequently died. (The cause of deaths in all cases could not be established with certainty, the report noted.)
India’s tribal people are among the poorest section of the country’s society and have limited access to education and health services.
The committee thought this was important: it noted that a large number of participants were illiterate and had apparently consented by placing a thumbprint on forms they could not read. The court agreed.
That report would never have been filed had it not been for the work of Kalpana Mehta, an activist based in Indore. Mehta, a veteran of the Indian women’s movement, is an engineer with an MBA and has been involved in health issues for the best part of 20 years. She was a formidable opponent to those behind India’s drugs trials and was at the forefront of calls for more accountability.
Bustling round a cluttered office in the back room of her house, she says many patients do not realise that they have rights.
“Even when they know it is wrong, they don’t want to fight. We still live in a country were they think doctors are gods. There are no risks [for the drug companies] here.”
Mehta’s focus has been on a cervical cancer vaccine, but she believes that the issues that her campaign has uncovered apply across the country on a much broader scale.
Central to her concerns is this issue of informed consent. Most of those who have taken part in trials signed consent forms – or applied their thumbprints to them. But as her researchers discovered, many of those who took part maintain they were unaware of what they were signing up for.
Mazhar Ansari, 17, and his sisters Sana, 18 and Aasiya, 16, were signed up after a cousin heard about the injections from a local doctor.
“It should not have been done. It is completely wrong,” says their father Mohammed Umar Ansari.
Both girls say they have experienced problems with their menstrual periods, which have become late and irregular.
It is the same story with Muskan and Akash Hansari. Both had the injections, but their father told the researchers he was led to believe that it would prevent all sicknesses and illness in general.
“[He has] no idea as to what cervical cancer is. Doesn’t know what a uterus is let alone where it is located,” the researchers noted.
Shaurya Mishra’s father told the researchers the family felt “short-changed and cheated” by the doctors after the 13-year-old was signed up for the trials. He was told the vaccine would prevent cervical cancer but confessed he did not know what this was.
The man who has done most to expose the use of India’s human guinea pigs sits in the canteen of the MY Hospital in Indore, watching his new bodyguard clean a double-barrelled shotgun. “I’ve only just got him,” says Anand Rai, cheerfully. “It’s all a bit new. But some people are unhappy with me.”
He is 38 and married with one son. The whistle-blower is taking the death threats seriously.
Rai was just starting out in his medical career when he first noticed something odd about his colleagues’ behaviour in 2005. Some patients were coming in to the hospital regularly and receiving special attention instead of waiting in line. One day a very senior doctor walked out of an operation just to meet what appeared to be an ordinary patient. Rai was intrigued. What was so special about this patient? He started asking questions, and that’s when he found out that some patients were enrolled in drug trials.
“The first [trial] was an inhaler tested on asthmatics. But the side effect was that they began to lose sight. They developed cataract of the eye, then my head of department used to remove the cataract,” he says.
Rai was president of the junior doctors’ association. He felt that those taking part in the trial were unaware that their inhaler was responsible for the cataracts and when he found a consent form in English with a thumb impression taken from the patient by a doctor, he objected. It did not help his career, but he persevered.
“I was threatened by senior doctors and warned that I would not be given support. They would not give me clinical work,” he says.
“Documents used to come from the medical school, sealed documents. I managed to get hold of some and went through them and found how the drug trials were taking place.
“In none of the cases did I come across anyone who knew that they were the subject of a clinical trial.”
Local politicians and then the ministry of health started to pay attention. The story came out.
“There were 81 people who had serious adverse effects; 35 people died,” he says.
“They chose poor groups, weaker groups, illiterate groups, those who needed medicine at any cost. They are poor. They have to rely on these doctors, they have to rely on government hospitals because they don’t have any option.
“International companies use Indians as guinea pigs.”
Among the 81 was Chandrakala Sodhey, 45, a sweeper for the health department.
She had been enrolled in a trial to assess the effects of a drug on acute decompensated heart failure. The trial was discontinued in 2009 on the recommendation of the Data Safety Monitoring Board. But by then, Chandrakala was dead.
She had developed pains in her chest and went for treatment at the MY Hospital, says her son Vijay, 30. He has no idea what medication she was given but her condition started to deteriorate and she eventually succumbed. “We had no idea that it was a drug trial,” he says. “These types of foreign medicines should not be tried on the people here. If they have to test them it should not be done on us. They should not use us like that.”
Amina Bi was luckier. She recovered, but it was a close call.
The 52-year-old is number 25 on Rai’s list. This time the trial was intended to test a new drug in the prevention of stroke in patients with atrial fibrillation. The investigator received 216,500 Indian rupees [Dh12,705].
A mother to 10 children, she lives with her husband Khalik, a goat and cow dealer, in a ramshackle house on the edge of Indore Rama Sector 3. She had developed chest pains and ended up at the MY Hospital.
“We went to the doctor and he said we are giving you this medicine all the way from Singapore,” says Khalik. “He said it was very good and fantastic and when you have finished it you bring us the empty box and we will pay you 200 rupees because you are coming a long way.
“They always took a blood sample and gave us new medicine. She took it three or four times.”
Amina produces the package. She cannot read the words on it: Acetylsalicylic acid/Placebo. Below it are the words Caution New Drug – Limited by United States Law to Investigational Use. But Amina cannot read English. She says she had no idea she was taking part in a drug trial, nor even what a placebo might be.
Her health began to decline and she was admitted to the hospital.
“In the last phase she reached such a state that she needed shock treatment,” says Khalik. “They gave her seven shocks and the family was told that she was not going to survive. But at the last moment the attendant noticed blinking on the monitor and they tried an eighth shot and she recovered.
“Then a lot of doctors turned up and they were very happy to know what had happened. But I have lost faith in the doctors. We used to do what they said before. Now we will ask: what kind of medicine is this? It is only the doctors and the god who knows why they have done this to my family.”
Spurred into action by the Supreme Court’s stay on trials – which has now been lifted – and conscious of the value to the economy of the trials, the Indian government has started to take action. In an attempt to tackle the issue of informed consent, all trials must now be registered and there must be an audiovisual recording of the consent process. New local ethics committees have been registered and there are stricter rules on the payment of compensation. But the damage has been done. The number of trials has fallen. Trust has been lost.
Back in the Pancham Ki Phel slum, Aman’s exasperation spills over. He has had enough of their justifications, he says. “Once I plucked up the courage and asked the doctor when he gave me the medicine, ‘Why are you giving me this medicine every time? Has something happened to me?’ But the doctor said it was just a medicine to keep me fit and safe from disease and it wouldn’t harm me.
“I am angry. Now that I know everything that’s been done to my body I fear for what is going to happen to me. I am full with anger.”
Gethin Chamberlain is a photojournalist specialising in human rights investigations.
thereview@thenational.ae
