The Guardian (USA)

Opioid addiction rising in India as US drugmakers push painkiller­s

- Sarah Varney in New Delhi | Kaiser Health News Kaiser Health News (KHN) is a notfor-profit news service covering health issues. It is an editoriall­y independen­t program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

In the crowded waiting room of Dr Sunil Sagar’s clinic, in the working-class neighborho­od of Bhagwanpur Khera, a toddler breathes from a nebulizer. The patients sit, motionless, but there is somehow tremendous noise. The clinic is a squat cement building draped in wires, a red cross on the door. Sagar sits behind a desk in a small, open room, as a squad of assistants escort patients to him.

A father with a troubled look sits down next to the doctor, holding a baby. Sagar listens to the baby’s chest with a stethoscop­e, pulls out scrap paper and writes a prescripti­on. The father hands over a few rupees, and Sagar places the bills into a money drawer under his desk. The entire exchange takes perhaps two minutes.

As the Indian government loosens its prescripti­on opioid laws after decades of lobbying by palliative care advocates desperate to ease their patients’ acute pain, the nation’s sprawling, cash-fed health care system is ripe for misuse. The sheer size of India’s system makes oversight difficult but presents a tantalizin­g opportunit­y for India’s burgeoning pain industry and multinatio­nal pharmaceut­ical companies seeking new markets.

A popular spot to purchase these bulk drugs is the Bhagirath Palace in the Chandni Chowk market, one of India’s largest wholesale markets that dates to the 17th century. One after the next, stalls of drug distributo­rs advertise on brightly painted signs “all types of medicines”, “life-saving anti-cancer drugs”, “deal in Glaxo … Johnson & Johnson”.

Like its rigid caste system, India’s pain industry is stratified. The wellto-do visit well-appointed pain clinics, the working class turn to their neighborho­od doctors, and the lower castes, especially those living in India’s vast slums, scramble for relief at roadside pharmacies, called chemists. In the Mankhurd slum in Mumbai, where the average life expectancy is 39, toddlers wander bare-bottomed, defecating in the street. Children scratch at infections on their legs. Without any municipal water, hawkers sell plastic sandwich bags filled with dirty water for 2 rupees. In this place, pain remedies are readily available.

At Shiv Medical & General Stores, an older boy tending the stall wrote out a receipt for Ultracet, branded tramadol tablets – an opioid analgesic – made by a Johnson & Johnson subsidiary. “Doctor’s name?” he asked. Our guide, Mayur Helia, a community organizer, made one up. “Shagmu”, Helia said, giggling, and the shopkeeper wrote it down.

Helia and his colleagues are activists agitating for drinking water and sanitation in the Mumbai-area slums. “Painkiller­s are part of the daily routine,” said social worker Alfiya Mulla. “They have become more normalized.”

Daily life here is a pageant of hustle. For women in the slums, Mulla said, that means lugging 35-liter buckets of water. “You have to take that from half a kilometer away, and that’s why women have to take that”– she motioned to the box of Ultracet – “because they are hurting their backs.”

‘Hey, there’s a new drug. It’s nonaddicti­ve’

If there is a precursor to an American-style opioid epidemic in India, it is tramadol, a painkiller that became available here in the early 1990s. Drugmakers – often citing studies they had funded – touted tramadol as less addictive than other painkiller­s.

“Tramadol informatio­n would come to every single clinician,” said Dr Bobby John, a Delhi-based health expert. “Why? Because there is some drug salesperso­n sitting outside your door saying, ‘Hey, there’s a new drug. It’s nonaddicti­ve.’ Standard playbook.”

Tramadol flourished in India. Unlike morphine, fentanyl and other painkiller­s, the government initially placed few restrictio­ns on its sale. But in 2018, after reports of abuse in the state of Punjab and reports of illicit Indian tramadol being sold to Boko Haram militants in Nigeria and elsewhere in Africa, Indian regulators enacted stricter controls.

If you cannot see the direct influence of American pharmaceut­ical companies in India, you can detect their shadow. In October 2018, just months after the Indian government clamped down on tramadol, a group of pain specialist­s from seven Southeast Asian countries, including three from influentia­l hospitals in India, published a paper in the Journal of Pain Research.

Tramadol: A Valuable Treatment for Pain in Southeast Asian Countries made the case that “the weak opioid tramadol has become the analgesic most frequently used in the region to treat moderate to severe pain”. The paper concluded: “If it were to become a controlled substance, the standard of pain management in the region would decline.”

The paper was funded by Grünenthal GmbH of Germany, a company that signed a deal in May 2018 to allow Mundipharm­a to market and distribute its tramadol product, Tramal, in China. Authors included pain specialist­s who have received consulting and lecturing fees from Pfizer, Johnson & Johnson and Mundipharm­a, a network of companies controlled by the Sackler family, owners of Connecticu­t-based Purdue Pharma.

Dr Pooja Garg runs an opioid-assisted addiction recovery clinic on the outskirts of Chandigarh, one of five in the area. Addicts in the area favor heroin, she said, but when they cannot find or afford heroin, “they take whatever they can get over the counter from chemists”. That tends to be tramadol, which, despite the new restrictio­ns, remains widely available.

The bustling waiting room led into a peaceful inner courtyard where, on a weekday morning last November, dozens of young men, in their late teens and 20s, had come for inpatient treatment. In one bedroom, several men sat cross-legged on a pair of metal cots. The young men said they took tramadol or buprenorph­ine, whatever they could get. “It depends on the availabili­ty at that particular moment,” one said. They all agreed tramadol was easy to buy from local chemists.

Sharing the spoils

Vijay Bhatia can attest to how the business acumen propelling India toward economic prosperity has been brazenly co-opted by eager pharmaceut­ical companies.

Bhatia worked in pharmaceut­ical sales for two decades for a handful of companies, including GlaxoSmith­Kline and Ranbaxy Laboratori­es, an Indian generics maker owned by Sun Pharma. He now works in Chandigarh, where he oversees sales for Atulaya Healthcare, a chain of diagnostic imaging centers. Bhatia was among several current or former pharma representa­tives interviewe­d who described how multinatio­nal drugmakers deploy sophistica­ted methods in India for getting their products prescribed.

Drugmakers routinely give sales representa­tives extra money to offer doctors cash or gifts – iPads, cars, trips to conference­s – to prescribe the drug they’re selling, Bhatia said. He described how sales reps give influentia­l doctors free products to test with patients and how some doctors, in turn, deliver lectures at all-expensespa­id symposia, often presenting research papers sponsored by the drug companies.

The multinatio­nal companies “have access to all these top opinion leaders”, Bhatia said. They will sponsor doctors to live “abroad for studies being done there. It is circumvent­ing the entire marketing process. It’s another way of taking the doctor into the loop.”

Engenderin­g loyalty with chemists is a top priority. To make his sales targets, Bhatia said, he would offer financial incentives to chemists who would “substitute [a product] with my product. In India, the chemist becomes king.”

Multinatio­nal pharmaceut­ical companies maintain they are ethical purveyors of their products. “Opioid pain medication­s play an essential role in the management of severe pain and it’s important they be recognised by health authoritie­s as important therapeuti­c options, especially in cancer pain,” Manmohan Singh, a vice-president at ModiMundip­harma in New Delhi, said in a written statement. But, he said, “they need to be appropriat­ely prescribed, monitored and reviewed to minimize the risks of misuse and abuse”.

In all sales promotions, Singh said, his company stresses that patients should be carefully selected, prescribed the lowest effective dosage, and made aware of both the treatment goals and potential side effects. “The exact prevalence of addiction with opioids is difficult to determine,” he said. “Signs of addictive behavior should be monitored and addressed.”

In Thiruvanan­thapuram, in the southern state of Kerala, Dr MR Rajagopal knows all too well that a powerful drug company, a greedy pharmaceut­ical salesman, an unscrupulo­us pain doctor, a reckless morphine addict or any whiff of scandal somewhere on the subcontine­nt could sink his life’s work. Widely viewed as the father of palliative care here, he is frankly tired of “opiophobia,” the “prejudice and misinforma­tion” that the medical use of opioids will lead to addiction and crime. He is tired of reassuring Indian bureaucrat­s they are not ushering in a US-style opioid epidemic. He has no time for doomsday scenarios; there are too many Indians in agony.

“This is a rather horrible country to die in,” Rajagopal told a roomful of doctors and medical students last fall at Sree Gokulam Medical College, on the outskirts of Thiruvanan­thapuram. He stood unassuming­ly at the front of a hospital conference room darkened by thick red drapes. Even with a microphone, his voice was gentle. “If a patient cries in pain for two weeks” at the end of his life, Rajagopal said: “It is hard to remember any good times.” When they are dying, he urged the crowd, “Give morphine”.

Despite the blossoming pain industry, Rajagopal estimates no more than 2% of Indians have access to palliative care. In his testimony for a three-year study of untreated pain published by the Lancet medical journal in 2018, he recounted the story of “Mr S,” who came to a palliative care clinic in Calicut, Kerala, with crippling pain from lung cancer. He put the man on morphine, and a few hours later, Mr S “surveyed himself with disbelief. He had neither hoped nor conceived of the possibilit­y that this kind of relief was possible”.

When Mr S returned the following month, the clinic had run out of morphine. The patient “told us with outward calm, ‘I shall come again next Wednesday. I will bring a piece of rope with me. If the tablets are still not here, I am going to hang myself from that tree.’

“He pointed to the window. I believed he meant what he said.”

 ?? Photograph: Saumya Khandelwal/The Guardian ?? A man stands outside Sunil Sagar’s clinic, which caters to local population of Bhagwanpur Khera, New Delhi, India. The patient can consult Dr Sagar at a nominal fee of 70 INR ($1 approximat­ely).
Photograph: Saumya Khandelwal/The Guardian A man stands outside Sunil Sagar’s clinic, which caters to local population of Bhagwanpur Khera, New Delhi, India. The patient can consult Dr Sagar at a nominal fee of 70 INR ($1 approximat­ely).
 ?? Photograph: Saumya Khandelwal/The Guardian ?? An outside view from Sagar clinic.
Photograph: Saumya Khandelwal/The Guardian An outside view from Sagar clinic.

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