Purdue Pharma, the manufacturer of OxyContin, an extended-release preparation of oxycodone, filed for Chapter 11 bankruptcy protection in the US Bankruptcy Court for the Southern District of New York, in White Plains, New York, on September 15, 2019. Their proposed settlement of $12 billion is being backed by 24 US states, five US territories and lawyers acting for over 2,000 cities, counties and Native American tribes. Twenty-six other states are separately suing or considering suing the company and eight members of the Sackler family, the billionaire owners of Purdue Pharma, having rejected the proposed settlement as inadequate compensation for the actual damage caused.
This legal action is the latest twist in a saga of opioid addiction, abuse and deaths that has ravaged large sections of mainly white working-class communities in the de-industrialised regions of the “Rust Belt” and many economically deprived rural areas of America, especially in Appalachia and the Midwest. Only shortly before, in August 2019, a court in Oklahoma has ordered Johnson & Johnson to pay $572 million as compensation for the company’s responsibility for an epidemic of opioid addiction in that state. Several other pharmaceutical manufacturers and supply-chain players, such as major distributors and pharmacies, are also facing litigation for their part in this crisis, frequently in the form of class actions.
Oxycodone is a narcotic drug, which was launched by Purdue Pharma in 1996. Opium, opiates and opioids are all classed as narcotics, a term which originally referred to a wider group of drugs that relieve pain, induce sleep and often modify mood and behaviour. Opium is the resin formed upon air-drying the milky liquid or latex that emerges when the capsules of green, or unripe, seed pods of the opium poppy (Papaver somniferum) are incised. Other narcotics include opiates or naturally occurring opium alkaloids (codeine, morphine, thebaine) and opioids, which are either semi-synthetic derivatives of opium alkaloids (diacetylmorphine, heroin, oxycodone, hydrocodone and hydromorphone), or synthetic drugs (fentanyl, methadone, pethidine, tramadol). Some authorities class naturally occurring opiates and synthetic opioids together under the umbrella term of “opioid” as they all act upon the opioid receptors in the brain and spinal cord.
Oxycodone and hydrocodone are the drugs most frequently implicated in the current prescribed opioid crisis. Oxycodone is frequently crushed and snorted or dissolved in water and injected when abused, rather than ingested in tablet form. Manufacturers have themselves provided further options for use in the form of transdermal patches, nasal sprays and oral dissolving strips. While fentanyl deaths have been rising sharply in recent years, most abused fentanyl is manufactured illegally and hence considered to be an illicit rather than a prescribed opioid
Over-prescription of high-strength opioids for chronic pain management has been facilitated by aggressive marketing tactics, direct-to-consumer advertising, and financial incentives to doctors to prescribe these drugs freely, regardless of the actual indication. Some opioid abusers have manipulated the system for personal gain by shopping around for prescriptions from different doctors and even in different states, often paying with cash rather than through their insurance plans. All of this has been happening in an environment in which the risks of addiction have been underplayed and the benefits from consumption over-emphasised. In response to the resulting crisis, the FDA in the US has recently introduced REMS (Opioid Analgesic Risk Evaluation and Mitigation Strategy) as a requirement prior to the prescription of any opioid. This is meant to deter profligate prescribing practices.
Opioid addiction has become a major public health problem in America. The Centers for Disease Prevention and Control have thus classified prescription painkiller abuse as a health epidemic. Deaths from the misuse of prescribed opioids in the US have continued to rise, from just over 3, 400 in 1999 to 17,029 in 2017. These figures do not include deaths from illicit opioids, such as heroin and fentanyl. Looking at the bigger picture, more Americans died from drug overdoses of all kinds in 2017 alone than during the entire Vietnam War.
Poverty, loss of employment, a lack of economic opportunities, and limited access to a social safety net have combined to create a fertile ground in which opioid addiction can flourish with impunity. It seems that social deprivation often requires chemical remedies in the absence of any other readily available options. The societal costs of undoing and reversing the effects of widespread opioid abuse are likely to be much greater than the amounts of money that can be recouped merely through legal action.
In the short term, opioid treatment programmes have emerged, which provide opiate agonists such as methadone or buprenorphine under medical supervision in outpatient clinics. The aim is to reduce harm by treating withdrawal symptoms and to facilitate weaning from opioid drugs of misuse. Detoxification is ideally followed by such treatments as cognitive behavioural therapy to prevent a relapse of addictive behaviour.
In the longer term, a strong political will is needed to drive change. The positive effects of President Donald Trump’s Initiative to Stop Opioid Abuse are eagerly awaited.
Ashis Banerjee