A serious, but a typical health crisis that has shaken America, is now, apparently, in search of its prey in India – a soft target to ignite a raging fire of misuse or abuse of prescription drugs of addictive in nature. That India could probably be the next victim of this menace, is now being widely discussed and reported in the international media, though not so much in India, itself.

The January 2019 communique of the National Institute of Drug Abuse spotlights: ‘Every day more than 130 people in the United States die after overdosing on opioids.’ Whereas, in 2017, more than 47,000 Americans, among 1.7 million suffering people, died as a result of an Opioid overdose. Snowballing effect of Opioids addiction commenced over a couple of decades ago and includes – both prescription pain relievers and synthetic Opioids, such as fentanyl, among others.

The health menace of this humongous dimension is not only jeopardizing public health, but also impacting the social and economic welfare, work productivity, besides drug addiction related criminal behavior of an increasing number of addicts.

In this article, exploring the factors – that not just ignited, but fueled this fire, I shall try to explain why India could be a fertile ground for another opioid epidemic. The key intent is to thwart this menace without further delay, learning from the ‘Opioid crisis’ in the United States. Moving towards that direction, I begin with a brief description of the genesis of this crisis, primarily to ensure that all my readers are on the same page to feel the gravity of the situation.

The genesis of Opioid crisis:

The terms – ‘Opioid epidemic’ or ‘Opioid crisis’are generally referred to rapid increase in consumption of prescription and nonprescription Opioid drugs in America that began in the late 1990s. It is noteworthy, until the mid-1980s and early 1990s, physicians seldom prescribed opiates because of the fear of addicting patients. This was established in several studies, such as, the July-August 2016 Article, titled ‘Drug Company Compensated Physicians Role in Causing America’s Deadly Opioid Epidemic: When Will We Learn?’

In the ninety’s, as the above paper indicates, some “medical experts and thought leaders led by the neurologist and pain specialist Russell Portenoy, MD, proclaimed that the risks of addiction to Opioids were minimal and that not treating pain was cruel and even amounted to medical negligence.” Incidentally, Russell Portenoy was at that time known as the “King of Pain” and was the Chairman of Pain Medicine and Palliative Care at Beth Israel Hospital in New York.

The paper also articulated, “Portenoy and his acolytes wrote articles and gave lectures to physicians about the safety of narcotics. They repeatedly cited a study by Porter and Jick in ‘The New England Journal of Medicine’ that stated that only one percent of patients treated with narcotics became addicted.” It is a different matter, as the authors indicated, the above trial was ‘not a controlled study at all. It consisted of a short 101-word one paragraph letter to the editor.’

Understandably, the rapid spread of Opioid use in America commenced on the following years. As The author highlighted: “To this day in most American hospitals, nurses on their daily rounds, ask patients to rate their pain on a scale of one to ten and then may administer a narcotic accordingly.”

HHS corroborates the fact:

In line with the finding of the above paper, the U.S. Department of Health and Human Services (HHS) traces the origin of the U.S. Opioid Epidemic in the late 1990s. When, asHHS also reiterated, ‘pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers.’ Presumably, the general image of the pharma industry not being as questionable as today, ‘health care providers began to prescribe them at greater rates,’ – HHS further noted.

Thereafter, all hell broke loose, as it were.With increased prescriptions of Opioid medications, the widespread misuse of both prescription and non-prescription Opioids started taking its toll. Obviously, it happened as the prescribers were not as cautious and restrictive and concerned about prescribing Opioids because of their addictive nature, as they were before 1990s. It seems unlikely that astute medical practitioners won’t be able to fathom the devastating health impact of such highly addictive medications on the users.

America had to declare the Opioid crisis as public health emergency: 

In 2017 HHS declared Opioid crisis as a public health emergency, announcing a strategy to combat this epidemic. Separately, in October 2017, President Trump also declared the same as the ‘worst drug crisis in U.S. history’.One can sense this Presidential level urgency from the recent report of The Washington Post. It emphasized - ‘America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012, as the nation’s deadliest drug epidemic spun out of control.’

The above information comes from a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States – from manufacturers and distributors to pharmacies in every town and city. The data would provide an unprecedented look at the surge of legal pain pills that fueled the Opioid epidemic, resulting in nearly 100,000 deaths from 2006 through 2012, as the article highlighted.

In view of this, and also looking at the chronology of the genesis of this crisis, it is worth exploring the role of pharma companies in triggering this health hazard in America.

The role of pharma companies in the crisis: 

That there is, apparently, a role of some big pharma players in the Opioid crisis was widely reported by the international media. One such article titled, ‘Big Pharma Is Starting to Pay for the Opioid Crisis. Make Those Payments Count,’ was publishesby The New York Times, on August 28, 2019.

It said: ‘As innumerable court documents and investigations have shown, Opioid makers, including Purdue and Johnson & Johnson, routinely and knowingly misled the public about their products. They played down the risks of addiction, insisting that their drugs were safe and, if anything, underutilized. And they combated growing concerns with aggressive lobbying and public relations campaigns.’

The September 01, 2019 article titled – ‘America’s Opioid catastrophe has lessons for us all, about greed and racial division’, published in The Guardian went a step forward. Explaining the reason for the situation to attain a ‘crisis’ stage, it said, ‘big pharma saw huge profits in medicalizing the social stress of the white working class.’ Thus, the question that comes up, is there any strong and credible evidence to associate Opioid crisis with pharma marketing?

Association of Opioid crisis with pharma marketing:

Several reports point towards a possible pharma-doctor nexus for the Opioid crisis. One such evidence is provided by the same  July-August 2016 Article, as quoted above. The paper said:‘Recently and belatedly, Portenoy has backtracked and admitted he was wrong about the addictive properties of Opioids.’ He was quoted in the article saying: “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”

Another original investigation report in this regard, titled ‘‘Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses’, was published in JAMAon January 18, 2019. The paper concluded:‘In this study, across US counties, marketing of Opioid products to physicians was associated with increased Opioid prescribing and, subsequently, with elevated mortality from overdoses. Amid a national Opioid overdose crisis, reexamining the influence of the pharmaceutical industry may be warranted.’

The article also indicated: ‘Recent data suggest that when physicians receive Opioid marketing, they subsequently prescribe more Opioids.’ The researchers pointed out:‘Amid a worsening Opioid crisis, our results suggest that industry marketing to physicians may run counter to current efforts to curb excessive Opioid prescribing.’

Again, the same September 01, 2019 article, published in The Guardian, also stresses– ‘The relationship between big pharma and US doctors can only be described as corrupt.’ Quoting the official figures, it highlighted: ‘The total paid to doctors and hospitals by drug companies was more than $9bn. Unsurprisingly, the greater the payments, the more willing doctors were to prescribe Opioids.’

The India’s tryst with Opioid drugs:

As many would know, India has remained for a long time one of the largest Opioid medicine producers in the world. However, most of the country’s population had a restricted access to Opioid pain relief drugs.

This was because, 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.’

The amendment came in 2014:

According to reports, the need for pain relief being “an important obligation of the government,” the Narcotic Drugs and Psychotropic Substances Act, was amended in 2014, creating a class of medicines called the “essential narcotic drugs.” The list of which includes, morphine, fentanyl, methadone, oxycodone, codeine and hydrocodone. Alongside, the conditions for bail in drug offenses will be relaxed and the mandatory death penalty for those previously convicted of certain offenses will be revoked.This is expected to create a better balance between narcotic drug control and the availability of Opioid drugs, for beneficial use of patients.

The flip side – a looming threat?

So far so good. Nevertheless, another article – ‘How big pharma is targeting India’s booming Opioid market,’ appeared in The Guardian on August 27, 2019, shows the flip side of this development. It says, as India loosens its stringent narcotics laws, ‘American pharmaceutical companies – architects of the Opioid crisis in the United States and avid hunters of new markets – stand at the ready to fuel that demand.’

Many are truly concerned about it, especially in a country like India, where any medicine can be procured over the counter, hoodwinking robust drug laws. Thus, as the above article adds, ‘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 local chemist shops.’

Providers of pain management are increasing, so also self-medication:

Today, ‘pain management’ as a specialty treatment, can be seen in many hospitals of the country. In tandem – apparently, ‘at the insistence of the professional societies that accredit hospitals in India, nurses and doctors are now encouraged to assess pain as a “fifth vital sign“, along with pulse, temperature, breathing and blood pressure.’ Besides, as The Guardian article of August 27, 2019 also noted, ‘General practitioners have started prescribing these drugs.’

Yet another important point to note, according to studies, one of the most common reasons for self-medication is for pain – 18.34 percent, where self-medication is done with nonsteroidal anti-inflammatory drugs in 49.4 percent of cases. Keeping pace with this trend, most generic pharma companies are having pain management product in their brand portfolio, unlike a couple of decades ago.

Early signs of drug companies’ special marketing activities:

There are many examples. But I shall quote The Guardian article again to drive home this point. The paper talks about hints of ‘American pharma’s fingerprints’ in a glass cabinet in the waiting room of a famous clinic in Delhi. Some of these include ‘awards from Johnson & Johnson honoring the doctor for symposia on pain management; a plaque for “his valuable contribution as a speaker” 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.’

Alongside, another interesting point is peeps in – the drugs, which are now commonly prescribed for chronic pain were first 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.’

Every year, more of such drugs are coming to market. Many chemists, hospitals and medical shops are also acquiring requisite licenses for keeping these drugs. Curiously, Opioids are available in not just oral, but injectable, patches and syrups – the article noted.

Conclusion:

There are many striking similarities between the developments that preceded the American Opioid crisis and the emerging scenario of the same in India. One such is, its onset in America was in the late 1990s, with the regulatory relaxation in introducing Opioid drugs. However, the first announcement of the full-blown crisis on the same, took a couple of decades to come.

In India, the regulatory relaxation for some Opioid drugs came in 2014, and now its 2019. Thus, it’s possibly too early to even track, in which direction it is moving. However, given the prevailing overall healthcare scenario in India, the concern remains palpable. The decision makers, hopefully, would consider putting in place effective checks and balances, taking a leaf from the American Opioid epidemic. The measures should include, among others, effective implementation of legal and regulatory provisions; making health care delivery systems robust and transparent; protecting vulnerable patients from rampant and irresponsible self-medication, besides promptly addressing general concerns with pharma marketing practices.

The whole process should be aimed at benefitting the deserving patients, suffering from excruciating pain, while minimizing Opioid drug misuse or abuse. There should not be any repetition of human sufferings on this score, like what people are now witnessing in America. Effective action from all concerned – right from now, will decide whether or not Opioid crisis is a looming threat that India can successfully neutralize.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.