The needs of others who can also benefit from opioids, however, are not being met. Millions of Indians currently battling incurable, debilitating conditions such as cancer, lung or heart failure, HIV are left in the lurch. While these cases are often terminal, a lot can be done to improve the quality of life even in their final days. This begins with managing their pain and reducing their suffering.
Known as palliative care, this approach focuses on improving the quality-of-life for patients and their families. Palliative care can be provided with or without the ongoing curative treatment. It begins as soon as the patient’s survival chances become clear and not necessarily just at the end of life. The World Health Organization (WHO) has declared opioid-based painkillers, especially morphine, as the “gold standard” for pain relief in such cases.
So, why do Indians not have better access? A key reason is the stigma attached to these substances. Take the opioid crisis currently unfolding in the US, for example. Between 1999-2017, overdose deaths due to prescription opioids in the US increased 5X. All told, some 218,000 deaths related to prescription opioids occured in the same period.
Purdue Pharma’s OxyContin, a brand of step II opioid oxycodone, has been held largely responsible for the widespread addiction and deaths due to overdose. After realising that the market for acute pain, pain after surgery or at end-of-life is small, Purdue changed its positioning and went after the chronic pain market, such as arthritis and backache. The company produced false evidence about OxyContin’s safety in daily use, influencing doctors to prescribe and patients to demand.
But India’s problems with opioid access predate the US situation. They go all the way back to 1985 when the government introduced the Narcotic Drugs and Psychotropic Substances (NDPS) Act in response to the global war on drugs. It stipulated rigorous punishment for medical professionals unable to produce proper documentation for storing and prescribing opioid medications.
The fear of falling foul of the NDPS Act saw doctors avoid opioids altogether. Sales of the cheapest strong opioid, morphine, dropped 97%, according to a 2002 study in the Journal of Pain Symptom Management. And while the stringent regulations have since been scaled back through a 2014 amendment, the problem of opioid access persists. A combination of a lack of awareness and training on the part of doctors, stigmas attached to opioids and half-baked distribution systems have kept it from reaching those in need.
“We are known for aping the west. Hence, the fear of what happened in the USA will get repeated here is so real, that we have cut all access. Forget reaching a crisis overuse situation, we are not even able to cover the basic population in writhing pain that needs it,” says Rajam Iyer. She is a pulmonologist and palliative care physician at Mumbai’s Hinduja Hospital and Bhatia Hospital. In India, she says, it is a problem of under-use, not overuse, and both are equally bad. So, are India’s patients doomed to suffer in pain?
The truth hurts
In India, there are about 1.6 million cancer patients and an unknown number of people with other incurable or disabling conditions such as heart failure, HIV, lung failure, etc. These patients are likely to be in pain and require immediate relief. And this number is only going up—a million new cancer cases are registered each year. But despite India being a leading manufacturer and exporter of opium, several barriers stand between Indian patients and potential relief from their ordeal.
Opioids are either derived from or based on the action of chemical compounds found in opium poppies. They stimulate brain receptors to trigger a pain-numbing effect, reducing anxiety and depression—common side effects of intense pain. However, the sensation they induce can be euphoric, leading to the scope for abuse and addiction.
The NDPS Act has provisions to combat this sort of misuse. The Act required maintenance of tedious documentation for import, export, storage, transport, and prescription. The regulations though drew a lot of criticism. M R Rajagopal, a palliative care physician often referred to as the father of palliative care in India, described it thus: “You put one lock to the door before stepping out to ensure there is no theft. But you won’t put five different locks with five different keys and throw them away making it impossible for you to get in, right?”
Rajagopal wasn’t being hyperbolic. That is what the Act looked like. Anyone procuring, storing and selling opioids needed to have six different licences. Unsurprisingly, doctors decided to avoid opioids altogether. A simple administrative or book-keeping error could land a physician in jail. Over the next decade or so, medical morphine consumption dropped by 97%.
The bigger problem, though, was the sense of fear it instilled. The NDPS Act instilled a sense of fear and stigma, in doctors. ‘Opiophobia’—the fear that patients might get addicted and doctors will be held accountable—persists within the doctor community.
The Act was amended in 2014, recognising the need for pain relief as the government’s obligation and reduced cumbersome documentation. It created a class of medicines—essential narcotic drugs (ENDs)—that were available for medicinal use. In order to make them easily accessible, the government also introduced Recognised Medical Institutions (RMIs) and professionals who would only require a one-time licence to stock and dispense these ENDs.
So, did the amendment improve access? “Not really,” says Sushma Bhatnagar, professor and head of onco-anaesthesia, pain and palliative care at the All India Institute of Medical Sciences (AIIMS), Delhi. “It might have slightly helped with the availability issue, but not to the effect of solving the problem on the whole. It still does not reach the vast majority.”
With little to no access to RMIs, rural areas are almost entirely without access. But the situation in metros is also abysmal. In Mumbai, for example, only six medical centres/pharmacies—National Chemist and hospitals such as Breachcandy, Hinduja, Saifee, Jaslok, and Tata Memorial—carry morphine. Even among these Tata Memorial only gives it out to its own patients. As such, patients frequently travel long distances to get a dose of painkillers, especially problematic since it is a one-time-use prescription. As of 2019, two out of six ENDs are not available even at RMIs; significantly worsening the burden of pain.
Production pains
Regulation hasn’t just affected distribution. Production, too, is an issue. Grown in only three states—Madhya Pradesh, Rajasthan and Uttar Pradesh—under strict governmental licensing, the government-owned Opium and Alkaloid Works has two factories that process poppy plants into morphine for the entire country. The Department of Revenue handles these licences because historically opium was a large source of revenue for the British East India Company. “The existing department is being proactive, but this is a bit of a joke. Health Ministry and Drug Controller should be in charge,” says Rajagopal.
Similarly, pharmaceutical companies in India face regulatory challenges when it comes to manufacturing and sale of other opioids as licences issued by the government are limited. For instance, only one pharmaceutical company has a licence to sell methadone in India, an important step III opioid which is cheap and works well for patients.
While the pharma industry is lobbying for getting more licences, it has been accused of driving inexpensive opioid drug alternatives out of the market. Dextropropoxyphene, the cheapest step II opioid alternative in India, once easily available in rural areas and used in chronic pain management, is one such drug. Used commonly in cases of cancer, it was banned in 2013 when research claimed its efficacy was low. Since 90% of research on drugs is funded by the pharmaceutical industry, the withdrawal has drawn criticism and worsened access issues for pain relief.
Doctors The Ken spoke to also raised concerns about the pharma industry misleading doctors into prescribing the less efficacious tramadol, a mild step II opioid, and fentanyl, the most expensive of the step III opioids (Rs 600 ($8.5) for a single dose). These instead of the far cheaper morphine (which costs less than Rs 5 ($0.07) for an oral tablet). This is especially concerning given the current fentanyl crisis playing out in the US.
Fatal overdosing on fentanyl has increased by 113% between 2013 and 2016, due to trafficking from the Mexican border and over-prescription by physicians. A US court found John Kapoor, founder of pharmaceutical company Insys Therapeutics, and four other top executives guilty earlier this month. The four were accused of paying bribes and kickbacks to physicians who prescribed large amounts of a fentanyl spray to patients who didn’t need the painkiller.
“There are several problems with that (fentanyl),” says Iyer. Fentanyl is available as a skin patch, absorption of which in a tropical country such as India is inconsistent due to sweating. Besides, it takes 12 hours for the medicine to kick in, as opposed to immediate-release in morphine; and even when it does release, doctors are not sure whether to increase or decrease the dose as they are unsure how much of the drug is still floating in the body.
Morphine, on the other hand, is first given as an injection in increasing doses until the patient stops complaining of pain or starts feeling drowsy. That dose is then given orally as a tablet every four hours. “That way, someone who enters the hospital in pain, can walk out the same day after being treated with morphine. Can’t say the same about fentanyl,” says Iyer. This approach seems obvious. And indeed it would be, except it isn’t taught in Indian medical schools.
Doctor who?
Indeed, even if morphine production is ramped up, the major barrier, many argue, is the attitude of the medical professional. Pain management in 2019 is not practised, except through expensive interventions. Rajagopal believes that the majority of specialists are not embracing pain management and practising it rigorously either because of their training or because they take pain matter-of-factly. “If someone goes and complains of pain, the doctor says, ‘Of course, you have cancer, what else do you expect?’”
This approach is problematic when you consider that pain management is mainly dependent on patients’ description and doctors’ interpretation. For instance, in the case of a cancer patient, the oncologist hands over a chart to the patient. This chart has a scale of 1 to 10, where 10 represents maximum pain. Depending on the selected pain intensity, the dosage of opioid painkiller is determined. Tom’s 6 could be Harry’s 10, thus making every case and dosage unique and challenging. Pain, however, is considered an important vital statistic when it comes to palliative care.
In India, however, doctors are not taught the WHO ladder of pain management. Every drug on the ladder needs to be used differently. For instance, only two-thirds will show improvements with morphine; others might need other options such as methadone or fentanyl. “Eventually, when the education is complete, one would know how to use these medications correctly and effectively. Learning is a must as it might be almost impossible to kill someone using oral morphine but can’t say the same about methadone,” says Rajagopal.
But the Indian approach to treating the terminally ill isn’t pain management but to treat till death. The concept of dying pain-free and with dignity is a rarity. Painful deaths and poor quality of life towards the end are common across socio-economic divides. “In the end, everyone suffers. The poor die of neglect, middle-class dies of ignorance, and the rich die on ventilators,” rues Iyer, adding, “The onus of when to stop curative treatment and when to start palliative care is on the healthcare professionals. Families are always going to want you to do everything.”
“Doctors don’t want to have an uncomfortable conversation and are afraid to be viewed as a quitter,” says Bhatnagar. However, this is in no small part due to palliative care and opioid use not being a part of the curriculum. “For having tough conversations like these, doctors need to go through attitudes, ethics and communications training,” says Iyer.
The situation on that front offers little hope. In 2010, 90% of medical students believed that the use of morphine would lead to addiction. Given that pain management is yet to be added to the syllabus, these numbers have probably not changed much. “The Medical Council of India is in talks of adding palliative care in the curriculum from August 2019 onwards,” says Bhatnagar.
There are a handful of national conferences organised by the likes of AIIMS and Tata Memorial to train doctors in palliative care. However, these are few and far between and don’t strike at the root of the problem—the study of medicine itself. Rajagopal, Bhatnagar and Iyer are hopeful that training will make a huge difference in managing the overall social and economic burden of pain. However, even then, it will take decades to have an entire generation practising this.
Just the right amount of “What if”
Figuring out a policy to ensure that pain medications are accessible, dispensed optimally, and not abused will require a meticulous structure. Policymakers will have to work hard to ensure control over procurement channels, while also training doctors to use these drugs judiciously. However, much like with reforming medical studies to include palliative care, this will take time. Time most patients in need of these drugs do not have.
But what if there was an alternative? One that’s been staring us in the face all along? “We are flooded with end-of-life or patients seeking palliative support with existing chemotherapy or radiation, who have gone through allopathic treatments and have come to Ayurveda as the last ray of hope,” says Yogesh Bendale. He is a doctor at the Rasayu Cancer Clinic in Pune, Maharashtra.
Though it does not have instant relief medicines such as morphine, Ayurveda develops individual goals for patients and works backwards to alleviate pain. Bendale explains: “Ayurveda does not target the pain but the cause of pain. In the case of opioids, patients have complained of constipation, which is the root cause of pain. We treat the overall well-being and pain gets managed.”
But is there evidence?
“We have managed thousands of patients over the years,” Bendale offers. While on its own this doesn’t seem particularly convincing, it cannot be dismissed out of hand either. As Marcia Angell wrote in an editorial published in the New England Journal of Medicine in 1998, “There cannot be two kinds of medicine—conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset.” Angell is an American physician and the first woman to serve as editor-in-chief of the New England Journal of Medicine.
Indeed, alternative approaches such as Ayurveda are gaining acceptance in areas such as cancer care. Apex US-based research institutes Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center jointly published evidence-based clinical practice highlighting alternative medicine in cancer care.
“There is a strong consensus already that pain and palliative care, as well as supportive care during chemotherapy and radiation, are some areas where Ayurveda systems can make substantial contributions,” said Sankara Chaitanya, medical director of Kerala’s Amrita School of Ayurveda, in an interview with the Indian Express. There are even proposals to integrate various forms of alternative medicine like Ayurveda in the government’s national palliative care system, which includes adding it to insurance reimbursements policies.
For patients struggling with intense pain and without access to pain medication, this sort of solution could be a useful stop-gap. Words lose meaning when you see a loved one suffer. As Iyer says, “The last moments of an individual are etched in the memories of their family members. If you ask a room full of terminal patients ‘How do you want to die?’ no one really opts to be on ventilator, intubated, or on dialysis machine. They all want to go out pain-free.”