Hoping against hope

In a clinical trial, participants such as Roy receive specific interventions according to the research plan or protocol created by the investigators. The trials look at new ways to prevent, detect or treat disease. These interventions may be medical products, such as drugs or devices, procedures, or changes to participants’ behaviour, such as diet.

Roy’s husband Atanu is filled with optimism. His words tumble over themselves in excitement as he describes how she can “feel”, prodding her ankle with a finger, jumping to demonstrate how she can “sit up”, propping her up gingerly against the bed post. These are all feats he attributes to the treatment received during the trial. When he looks at her fleetingly, his eyes questioning, Roy nods slightly, giving him the reassurance he needs to continue describing every step of her progress with delight.

Roy has lost track of when she and Atanu switched roles. It could have been after the first spinal surgery in 2004 — a titanium plate was inserted to hold her spine together. “The first few years, I was feverishly researching doctors and procedures, driving my family out of their shock into action. About a year ago, we started having the first arguments about the trial. After a point, you stop hoping for yourself, but you have to hope for the people who care for you,” she says.

Roy’s bed, next to the windowsill and opposite the very balcony she fell from, has a generous splash of sunlight. The catheter that has been with her since that fateful September afternoon sneaks out from underneath her bright blue quilt. Under her pillow is a four-line letter from Atanu: “Your smile makes me smile. Your fight makes me fight. Give me another chance. This is the last.” And fight she did. Not just through another surgery, but watching her husband watch her. “It hurts a little when I pass urine. Every time I feel pain, my doctors celebrate, my husband works himself into a fit,” says the former middle-school English teacher.

The ongoing trial used stem cells extracted from her own bone marrow, and injected them through a lumbar puncture near her D12 vertebra — the site of her injury. Dr Deepak Agarwal, professor of neurosurgery at AIIMS, says it is too early to celebrate. “Only the first round of this trial has been completed. Some patients have shown better urinary control, some have been able to sit up after decades. But it is too early to say anything, and communicating that to patients and family members, who are hanging on for some sign of hope, is extremely hard,” he says. Although patients entering these trials know it is not treatment, they still expect a cure. “I caution them multiple times so that they know what they are getting into. But there is an overdose of information on the internet, from private clinics and doctors, and it is hard to ensure a realistic expection,” he says.

Those who have entered trials for various neurological conditions in Delhi-NCR in the last three years in different hospitals say that it is hard to convince themselves and the people around them. The decision to enter a trial for a new treatment is not always taken by the family.

Dr Deepak Agarwal, professor of neurosurgery at AIIMS. (Photo: Tashi Tobgyal)

Madhavi Radhakrishnan, a college professor was diagnosed with multiple sclerosis (MS) in its early stages — genetically predisposed to rapid deterioration — entering the trial that is testing a new drug seemed the most obvious choice. As she was not yet visibly affected by MS, persuading her family was a different ordeal altogether. In her office, between classes, she draws out stacks of magazine articles collected over years on MS patients, and hospices. “When you are visibly sick and have the means, everyone is sympathetic if you want to participate in a trial. But when you are seen to be pre-empting an illness, everyone thinks you are crazy,” she says.

The pain of a degenerative disorder was raw — Radhakrishnan spent years of tending to her mother who suffers from MS as well. “She began showing symptoms at the same age as me…from her 40s. Now she is in her 60s, and she can barely move. I had her move in with me 10 years ago,” she says. Her mother wanted to stay independent for as long as she could, a feeling Radhakrishnan now understands only too well. The doctors advised her and her two siblings to get tested for MS soon after their mother’s diagnosis. She held it off till her 42nd birthday. “I had been getting flashes of double vision, and my arm felt weak when I carried the same books I had done for years. I knew the symptoms. Till then, I did not want to get spooked by tests, but I had to get them done,” she says.

MS does not have a single confirmatory test, which made it harder for Radhakrishnan. She underwent an MRI scan in a Gurgaon hospital and a lumbar puncture that tested her CSF sample at AIIMS. She did not tell her husband and daughter till the doctors confirmed her worst fears.

Two years after her own diagnosis, the family neurologist of 30 years first advised Radhakrishnan’s mother to participate in the trial. By now Radhakrishnan had adjusted to the twin roles she had to play — of caregiver and patient. “My mother filled the forms for the trial, she was keen, and we wanted to see how it would go. I helped her through the process, helping her understand the side effects, warning her not to have too much hope…I was so tired of seeing her disappointed. But after a month of the initial formalities, the doctor heard the company had decided to restrict the trial to early stage patients first,” she says. For the mother-daughter, the decision to switch roles was smooth. Radhakrishnan found her mother trying to check her own hopes, jokingly telling her MS was not all that bad. But her husband and their daughter were shocked. “No one believed I was sick or that I could ever be. My husband told me I was behaving like a pig preparing for slaughter,” she says.

It’s been six months and the trial has not shown any “real results”. Additionally, he pharmaceutical company has run into trouble with the Drug Controller General of India (DCGI). “I have been following the developments and I hear they have corrected where they erred. I hope they resume soon, because, if nothing else, it is hope. I want to be the guinea pig here,” she says and laughs. Radhakrishnan’s daughter is yet to get tested. “Even if they try drugs on me without success, maybe in 20 years, when my daughter grows up, they would have found something or ruled out something. If we do not try, how do we move ahead?” she asks.

Less than a few kilometres from the Delhi Universality campus, in Model Town, Suraj Malik, another participant of a multi-centric quadriplegia and paraplegia trial in his 30s, is carried by his elder brother Vimal; he places Malik on a chair in the balcony. Eight years after his injury, the trial, Malik says, came as a godsend. “I was researching trials. I realised very early on, treatment options after paralysis were little. Physiotherapy has helped me prevent sores, but I could not even sit like this till a month ago. Someone had to hold me up straight while feeding me,” he says. Malik’s research showed him that trials in private hospitals, and sponsored by pharmaceutical firms were expensive. “I learned that hospitals were not supposed to charge patients for stem cell treatment. I have gone to three clinics in Delhi offering neurological trials but they charge at least Rs 3-5 lakh per sitting — we could not afford that,” he says.

After his injury in a road accident that cracked open his skull, and left multiple spinal fractures, Malik had to quit his job as a sales executive in an IT company, and move in with his parents and brother. The news of a trial at AIIMS came as a boon. “They were particular about their selection criteria and I had to go through a long interview process. I am glad I got through, I am going to go with it all the way through,” he says.

As Malik goes through his files, Vimal asks him to take a break. “He keeps at this for hours, it has become an obsession. He used to paint, read, watch films on his laptop. Now the only thing on his mind is the trial,” he says, trying to help Malik into a kurta. “I don’t want to wear this. Did you think of asking me, before you shove things down my neck? My hands work just fine you know,” screams Malik.

A little later, he apologises. “Go to any paraplegic’s home and you’ll see that such fights are common. People forget we have some functional limbs and a brain that works. My folks think I am an ass because it’s been so long, it’s obvious there is no hope. But now, after years and years, I can tell when I want to have a leak. Do you know how liberating that is?” he says.

Malik does not know if this particular feat is related to the trial. “To be honest, I thought I felt the first signs before the trial, but my doctors say the stem cells have definitely aided the process. Honestly, I do not care how it happened as long as it happened,” he says.

All names have been changed to protect identities.