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Beset By Lawsuits And Criticism In U.S., Opioid Makers Eye New Market In India

What began in India as a populist movement to bring inexpensive morphine to the diseased and dying poor has paved the way for a booming pain management industry. Now, new customers are being funneled to U.S. drugmakers bedeviled by a government crackdown back home.

 

Workers are packed into a pharmacy shop at the Bhagirath Palace pharmaceuticals market in Old Delhi, India.(Saumya Khandelwal/The Guardian)

This story is the first in a two-part series. Read part two here: “In India鈥檚 Slums, Painkillers Part Of Daily Routine.”

NEW DELHI 鈥 Pain, like death, is a universal phenomenon.

The sour grimace on the woman鈥檚 face, registering her bodily complaints to Dr. G.P. Dureja in his East Delhi office, would be recognized anywhere. Slouched shoulders, pinched forehead. She wore a willowy black kurta and cast a disapproving glance at the five pain physicians-in-training huddled behind Dureja, founder of Delhi Pain Management Centre and one of India鈥檚 pioneering pain physicians.

The five trainees, participants in the center鈥檚 acclaimed pain fellowship program, recorded the woman鈥檚 consultation on their smartphones, eager to see India鈥檚 famous pain doctor do his work. After their fellowships, they will return home, to Chennai, Kashmir, Rajasthan, ready to forge careers in India鈥檚 exploding pain industry.

The woman had been under Dureja鈥檚 care for some time now; he diagnosed her with fibromyalgia, a chronic neurological disorder of mysterious origin that causes pain throughout the body. But the regimen of Paracetamol and tramadol, an opioid analgesic, was not working and she was beyond fatigued. She wanted more relief.

Dr. G.P. Dureja, surrounded by medical trainees, consults with a patient in his office at Delhi Pain Management Centre, a chain of specialized medical centers dedicated to the minimally invasive treatment of chronic pain.(Saumya Khandelwal/The Guardian)

Indians once thought of pain relief as an indulgence of the West, Dureja said after the woman left his office gripping her new prescriptions. The old way of thinking was, 鈥淣obody has time to complain about pain in our country. But I鈥檓 getting five to seven new patients per day.鈥

Storefront for-profit pain clinics like Delhi Pain Management Centre are opening by the score across Mumbai, Kolkata, Bangalore and other cities in this teeming nation. After decades of stringent narcotics laws, borne of debilitating opium epidemics of centuries past, India is a country ready to salve its pain.

And American pharmaceutical companies 鈥 architects of the opioid crisis in the United States and avid hunters of new markets 鈥 stand at the ready to feed and fuel that demand.

For Indian cancer patients who once writhed in agony, there are fentanyl patches from a subsidiary of Johnson & Johnson.

For the country鈥檚 vast army of middle-class office workers wracked with back and neck pain, there is buprenorphine from Mundipharma, a network of companies controlled by the Sackler family, owners of Connecticut-based Purdue Pharma.

And for the hundreds of millions of aging Indians with aching joints and knees, there are shots of tramadol from Abbott Laboratories.

Behind the pharmacy counter at the Delhi Pain Management Centre.(Saumya Khandelwal/The Guardian)

A worker updates a register of medicines.(Saumya Khandelwal/The Guardian)

Palliative care advocates, who recount stories of patients enduring excruciating cancer pain or dying in agony, have persuaded reluctant government officials to allow high-powered opioid painkillers into doctors鈥 offices and onto chemists鈥 shelves in this nation of 1.37 billion people.

But what began as a populist movement to bring inexpensive, Indian-made morphine to the diseased and dying poor has given rise to a pain management industry that promises countless new customers to American pharmaceutical companies facing a government crackdown and mounting lawsuits back home.

The lure of a pain-free life is a revelation in a country where incomes are rising for many city dwellers and 300 million to 400 million people are approaching the middle class. Like other markers of the country鈥檚 post-colonial sprint into modernity, newly minted pain doctors promise aspiring Indians that life has more to offer in a body free from pain, and foreign brands are worth the extra rupees.

Dr. G.P. Dureja performs a short procedure on a patient at the Delhi Pain Management Centre.(Saumya Khandelwal/The Guardian)

鈥淒on鈥檛 listen to your forefathers,鈥 Dureja said, a mantra for the shifting mindset. 鈥淭hey said you should tolerate pain, you should not complain, you should not take painkillers. Now, everybody wants a better quality of life, and everybody wants to get rid of pain early.鈥

As major pharmaceutical companies look to capitalize on the opportunity, the playbook unfolding in India seems eerily familiar. Earnest advocates share heartbreaking stories of suffering patients; physicians and pharmaceutical companies champion pain relief for cancer patients and persuade regulators to grant greater access to ever more powerful opioids; well-meaning pain doctors open clinics; shady pain clinics follow; and a spigot of prescription opioids opens 鈥 first addressing legitimate medical uses but soon spilling into the streets and onto the black market.

A looming deluge of addictive painkillers terrifies some Indian medical professionals, who are keenly aware that despite government regulations most drugs are available for petty cash at the chemist shops that occupy nearly every city block and village center.

鈥淎re people going to figure out every trick in the game to make [opioid painkillers] widely available?鈥 asked Dr. Bobby John, a leading Indian public health expert based in New Delhi. 鈥淥f course it will happen.鈥

Shops advertise their drug supplies along a busy street in Old Delhi, India.(Saumya Khandelwal/The Guardian)

鈥楾he Market For Pain Is Good鈥

The headquarters of the Pain Clinic of India operates out of a closet-size office in Chembur, a tree-lined suburb in eastern Mumbai. The company鈥檚 presence on the internet is so prominent that Dr. Kailash Kothari, the clinic鈥檚 founder, has turned down requests from people in South Africa, Australia, Europe and the United States seeking prescription opioids.

Down an alleyway, the clinic鈥檚 small white-red-and-blue sign is difficult to spot. Around the side of a faded-pink building is a larger sign showing a shirtless, muscular white man gripping his back, another gripping his neck, another clutching his knee; a white woman with an excruciating headache presses her forehead and another grabs her shoulder. Back Pain. Neck Pain. Headache. Knee Pain. Shoulder Pain. Cancer Pain. The sign promises 鈥淭owards Pain Free Life.鈥

One of the principal architects of pain medicine in India, Kothari runs several clinics in Mumbai, consults at numerous hospitals and flies to his clinic in Goa once a week. He co-founded the Indian Academy of Pain, an educational branch of the Indian Society for the Study of Pain that aims to create standardized training for pain medicine, in part by offering qualifying exams to prospective physicians. 鈥淭his program is going to change the scenery of what we have in pain management,鈥 Kothari said.

Asserting control over who can call themselves a 鈥減ain medicine doctor鈥 in this fledgling industry is an urgent question. Spread across the subcontinent are nearly 10 million licensed physicians and a massive number of untrained medical providers. (In rural India, 70% of health care providers have no formal medical training.)

A man carries boxes of medicine through the Bhagirath Palace pharmaceuticals market in Old Delhi, India.(Saumya Khandelwal/The Guardian)

鈥淕eneral practitioners have started prescribing these drugs,鈥 Dureja said. 鈥淎nd we鈥檙e not educating the population on when to use and not to use.鈥

At Dureja鈥檚 clinics, as at most medical offices in India, patients pay cash for services and prescriptions. Delhi Pain Management charges $10 for a consultation; $10 for a Johnson & Johnson fentanyl patch; $10 for a Mundipharma buprenorphine patch. Dureja鈥檚 office takes a 15% cut of sales.

There are hints of American pharma鈥檚 fingerprints in a glass cabinet in the waiting room of his East Delhi clinic: awards from Johnson & Johnson honoring Dureja for symposia on pain management; a plaque for 鈥渉is valuable contribution as a speaker鈥 about tapentadol, an opioid marketed by Johnson & Johnson in 2009. The dispensing counter does a brisk business in Ultracet, branded tramadol tablets made by a Johnson & Johnson subsidiary.

Dureja鈥檚 training fellowships, like Kothari鈥檚, are broadly considered on the level; but many others are shady, and none are regulated.

Each year, some 20 fellows attend Kothari鈥檚 three- to six-month training programs, and by his calculation, he has trained 150 aspiring pain doctors. 鈥淭here are more than 50 people who already have their pain clinics in different parts of India,鈥 he said. Of those clinics, five or six 鈥渁re training people, and it鈥檚 a chain reaction, which is going to benefit pain management as a specialty.鈥

Kothari remembers when only a few hospitals in Mumbai treated cancer patients and had access to opioids. 鈥淏ut every year, we are accessing more of these kinds of drugs,鈥 he said. 鈥淢any chemists, hospitals and medical shops started acquiring the licenses for keeping these drugs, and availability is much, much better. Opioids are available in not just oral, but injectable, patches, syrups.鈥

Dr. G.P. Dureja in his office at the Delhi Pain Management Centre in New Delhi.(Saumya Khandelwal/The Guardian)

Storefront for-profit pain clinics like Delhi Pain Management Centre are opening by the score across Mumbai and other cities in India. After decades of restrictive narcotics laws, India is a country ready to salve its pain. (Sarah Varney/KHN)

Most large Indian hospitals have added pain management as a specialty in recent years. At the insistence of the professional societies that accredit hospitals in India, Kothari said, nurses and doctors now are required to assess pain as a fifth vital sign, along with pulse, temperature, breathing and blood pressure.

The pharmaceutical industry has kept pace. Twenty years ago, only a few pharmaceutical companies marketed pain medicines in India, Kothari said. 鈥淭oday, almost every company is having pain management as a separate division. In the last five years alone, I must have met more than 15 or 20 companies that have started separate pain management divisions.鈥

A salesman for Sun Pharma, India鈥檚 largest drugmaker by sales, echoed the point during an interview in Chandigarh, the capital of Punjab and Haryana. The market for pain medications 鈥渉as totally changed鈥 in the past five years, he said. He shifted nervously and agreed to speak frankly only if his name wasn鈥檛 published, for fear of losing his job.

鈥淣ow everyone has a car, and [they get] back pain, and now they take medication.鈥 Growing obesity rates in India were also fueling demand, he said, as patients look for relief from weight-related knee and back pain. 鈥淪o the market for pain is good.鈥

Abbott Laboratories and Johnson & Johnson did not respond to requests for comment for this report.

Manmohan Singh, a vice president at Modi-Mundipharma in New Delhi, said opioid pain medications are an important therapeutic option, especially for cancer pain. He also said company promotions stress that physicians should familiarize themselves with product safety information. 鈥淧atients should be made aware of the clear treatment goals related to pain and function, as well as the potential opioid side effects and the potential for misuse, abuse and addiction,鈥 he said in a written statement.

A man buys medicine from a pharmacy shop at the Bhagirath Palace pharmaceuticals market in Old Delhi.(Saumya Khandelwal/The Guardian)

One False Step

The ascendance of pain management in India comes at a fortuitous political moment. Ahead of his reelection earlier this year, Prime Minister Narendra Modi invested heavily in health care. Last fall, the Indian government launched the world鈥檚 biggest public health insurance program, called Ayushman Bharat. Dubbed 鈥淢odicare,鈥 it guarantees half a billion poor Indians nearly $7,000 in hospital expenses, paid to private insurers, and, by 2020, the government is to open 150,000 primary care centers. The government has set aside $484 million to fund Modi鈥檚 signature program.

None of this would have been possible without the loosening of India鈥檚 strict narcotics laws.

The International Narcotics Control Board, established in 1968, and the Narcotic Drugs and Psychotropic Substances Act of 1985 codified the bureaucratic thicket for any doctor who wanted to prescribe opioid painkillers. Physicians feared fines, jail sentences and losing their medical license if they skirted regulations. While the government granted licenses to Indian farmers to grow poppies, most of the morphine produced from the crops was exported.

Dr. M.R. Rajagopal was a young medical student in Thiruvananthapuram at the time and remembers a neighbor with advanced cancer. 鈥淚 [had] seen him screaming his way over weeks to death,鈥 Rajagopal said. 鈥淚t was horrendous, and there was nothing being done about it.鈥 He chose to become an anesthesiologist because it was the only specialty then focused on pain.

Rajagopal is widely viewed as the father of palliative care in India; whispers of a Nobel Prize follow him. For decades, he has worked assiduously to convince national and state lawmakers that opioid medicines are not an indulgence but a humane refuge, and it is largely a function of his advocacy that morphine and other painkillers can be prescribed in India. 鈥淭wo generations of doctors had not seen a tablet of morphine,鈥 he said.

A pharmacy in New Delhi stocks painkillers.(Saumya Khandelwal/The Guardian)

The , as amended in 2014, recognized that the need for pain relief was 鈥渁n important obligation of the government.鈥 The revised law created a class of medicines called the 鈥溾 list, which includes morphine, fentanyl, methadone, oxycodone, codeine and hydrocodone.

Rajagopal鈥檚 days are filled with the tedious work of building a movement: speaking at colleges and public forums, penning editorials and medical papers about palliative care and overseeing Pallium India, a nonprofit medical center and training institute that is singularly focused on palliative care.

Pallium鈥檚 pharmacy is a testament to Rajagopal鈥檚 persistence. Drugs once banned now fill the shelves: fentanyl injections and patches, oral morphine and, most recently, methadone, approved for pain relief in 2018.

Rajagopal seems aware that one false step would invite the government to clamp down on the availability of opioids, reversing decades of his work. He does not advise using oxycodone or hydrocodone, though they are included on the 鈥渆ssential narcotic drugs鈥 list, and he does not accept funding from pharmaceutical companies, instead putting his hand out to temple trustees and for donations from families cared for by Pallium鈥檚 home visiting teams.

But the pharmaceutical industry is a wily adversary. American activists made many of the same arguments decades ago as they sought relief for dying patients. Drugs now commonly prescribed for chronic pain first were approved for use by cancer patients. One of the first formulations of fentanyl, for example, was a lollipop because chemotherapy left cancer patients too nauseated to eat. In India, pain physicians now prescribe fentanyl patches to patients with chronic muscular pain.

Purdue Pharma鈥檚 international affiliate, Mundipharma, 鈥渋s very good at co-opting regulators,鈥 said Keith Humphreys, a professor of psychiatry at Stanford University. 鈥淎s happened in the U.S., they are easily converted into useful idiots.鈥

Read part two of this two-part series: “In India鈥檚 Slums, Painkillers Part Of Daily Routine.”

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