[Blog] The ‘licit’ opioid-based painkiller that became a weapon of mass addiction

During the New Year holidays, I came across a non-fiction contemporaneous book entitled The Empire of Pain by Patrick Radden Keefe. It deals with the malevolent connection between Big Pharma and narcotics. As opioids are a subject of high interest in Mauritius, I blindfoldedly plunged into the thick-volumed book.

It starts with the tale of the Sackler philanthropic dynasty, listed a few years ago in Forbes magazine as one of the 20 wealthiest families in the USA. Their circle comprised an international spectrum of friends that included names like former Princess Diana, Nobel Prize winners and many others belonging to the upper crust of society. Their names used to adorn museums, universities, medical facilities, libraries, research centres and so on.

The present protagonists are grandchildren of Jewish immigrants from Ukraine and Poland who settled in Brooklyn after the World War. Their three sons chose the medical path, became psychiatrists and later branched into pharmaceuticals, which became their pivotal business concern.

At first, the brothers bought a struggling pharmaceutical concern named Purdue Frederick, changed its name into Purdue Pharma and, initially, as a conservative company, were involved mainly in over-the-counter products. Their initial success came with the marketing of Betadine, Valium and Senekot, the latter becoming the mainstay of the company for its powerful laxative properties.

The quantitative leap, however, came with the development of a product called MS Contin. It was a revolutionary product in view of its delivery system. In the past, morphine had to be taken every 4 hours to control chronic pain. “MS Contin used a systematised film coating that allowed the morphine to dissolve slowly, providing a relief of 12 hours.” It was aimed at end-of-life care, mainly terminally ill cancer patients. Having obtained its FDA approval in 1987, it sold very well.

The problem arose with what is known as the “patent cliff”. Any new product in the USA normally receives a patent of exclusivity for a period of 20 years. After this time frame, the product could be copied and exclusivity is lost. As the patent expiration for MS Contin was approaching in the mid-90s, the Sacklers faced a terrifying prospect: their golden goose would become a generic. That would cause massive loss of profits for the company.

Hence, the Sacklers, especially under the impulse of young Richard Sackler, undertook a race against time to come up with a new product. In other words, they needed a “bridge” to maintain their dominance in the highly profitable pain management market. As a result, their scientists looked for another opioid that could be “delivered via their proprietary contin system”.

It is thus that they came across the powerful oxycodone, a semi-synthetic opioid developed by German scientists in 1916. Considered as more potent than morphine, it was believed to be highly effective at managing pain. The “genius” of the Sacklers was to take the old chemical and wrap it in their patented “contin” to create a successor to MS Contin, which they called OxyContin.

To put all the chances of success on their side, they enlisted the support of medical thought leaders and luminaries such as Dr Kathleen Foley and Dr Russell Portenoy. The latter was a renowned neurologist, nicknamed “The King of Pain”. He championed the idea that opioids could be used safely for long-term chronic pain and that the risk of addiction was “less than 1%”. For the Sacklers, OxyContin was the grail. Now the market would not be only cancer patients but millions of people suffering from chronic pain.

So they rushed to seek the approval of the FDA. They did what is known as “regulatory capture”. They cultivated an inside man called Curtis Wright who, as a medical officer, was responsible for overseeing the approval process of OxyContin. He proved to be collaborative with Purdue Pharma far beyond what was considered standard professional distance.

This is due to the “revolving door” phenomenon. This describes a practice of regulators who tend to be lenient and cooperative when they know they might end up with a lucrative job in a company they are currently policing. It is not a surprise, therefore, that in December 1995 Purdue obtained FDA approval in a record time of 11 months and 14 days. It is equally not a surprise that sometime afterwards Curtis Wright obtained a highly paid job at Purdue Pharma.

OxyContin was launched with much fanfare in 1996. It was a great success. This was due to the aggressive and unorthodox marketing carried out by Purdue Pharma. An army of sales representatives was recruited to scour the country and convince doctors that OxyContin was the magic wand for the treatment of chronic pain and that it was virtually non-addictive.

They based their argument on the FDA-approved insert which stated that “delayed absorption as provided by OxyContin tablets is believed to reduce the abuse ability of a drug”, despite a lack of clinical evidence to support this claim. All sorts of marketing techniques were used. Doctors were flooded with gifts and other incentives to prescribe the drug.

To create artificial demand, potential patients were given starter coupons with a free 7- to 30-day supply of OxyContin tablets. Opinion leaders in the medical field were paid to give speeches in seminars to advocate that OxyContin was the “gold standard” for the treatment of all sorts of chronic pain. Paid advertisements splashed magazines and journals.

The sales representatives, “oxy crusaders”, incentivised with eye-popping bonuses, were trained to promote the concept of “pseudo-addiction”, that is, if a patient showed signs of drug-seeking behaviour, it meant that they were not getting the right dose, which needed to be increased. It is not a surprise, therefore, that sales of OxyContin soared exponentially from $48 million in 1996 to $1.1 billion in 2000. In 2001–2002, it became a multi-billion blockbuster.

But soon cracks began to appear. Sales representatives began reporting withdrawal symptoms among patients after a period of 8 to 10 hours. There was a craving for further doses. Some whistle-blowers denounced cases of overdose, resulting quite often in death. But they were all silenced through bribery and threats. The press was unwilling to take up cudgels with the Sacklers in view of their leverage in different spheres of life.

When cases reached the ears of some senators, a Senate hearing was instituted, but it came to nothing as the Sacklers had strong political connections. Cases which were brought to court were won by them as they enlisted the services of top lawyers who put up as defence the plea that the problem was not in the drug per se but the patients themselves who had a predisposition to addiction.

At the same time, the Sacklers involved themselves in intense “reputation laundering” by intensifying their philanthropic activities: huge donations to museums, arts centres, universities, medical institutions, funding of scholarships and professorships, and so on.

But the situation on the ground was getting out of control. Word got around that the powerful opioid oxycodone could be accessed directly by removing the coating of the pill, and the effect of inhaling and sniffing was euphoric. This led to a massive wave of diversion - a process by which a drug intended for medical use is funnelled into the illegal market.

A twin phenomenon was being witnessed: doctor shopping and pill mills. On one hand, people began visiting multiple doctors to obtain multiple prescriptions. On the other, dealers formed long queues in front of some doctors’ practices who, on payment of a cash fee, concentrated on prescribing high doses of OxyContin pills which ended up in back alleys, downtowns, slums and other areas through a lucrative black market.

A sort of an opioid epidemic broke out in the USA. The result was devastating. Many of those who started with OxyContin transitioned to street drugs like heroin and fentanyl. According to the Centers for Disease Control and Prevention, some 400,000 Americans lost their lives through opioid-related overdose. OxyContin was “the taproot of the opioid epidemic”.

The authorities could no longer turn a blind eye to this social catastrophe. In 2007, the Department of Justice slapped a fine of $600 million on Purdue Pharma for “misbranding” and lying about the drug’s addictive potential. However, as the members of the Sackler family themselves were not personally charged, they were able to continue their business for another decade.

But in 2017–2019, thousands of lawsuits were filed by cities, states and groups which targeted individual Sackler family members, accusing them of “siphoning billions of dollars out of Purdue Pharma into offshore accounts to protect their wealth from future legal judgments”.

However, a deal was reached in 2019. Purdue filed for bankruptcy. The company was dissolved and the Sackler family agreed to pay $6 billion over the years to fund addiction treatment and rehabilitation programmes. In return, they demanded “third-party release granting them permanent legal immunity from all future lawsuits related to OxyContin”.

Hence, their company might have gone, but their billions amassed through an opioid-related drug are still in their pockets.

As Mauritius is grappling with a scathing drug problem and several solutions are being envisaged, including opioid-related ones, a word of caution is never too superfluous.

Azize Bankur