“The greatest mistake in medical history” – The tragic story of OxyContin

In the history of human achievement, there are a number of medical developments that rank right up at the top. From the invention of antibiotics to the eradication of fatal diseases to the recent successes of the COVID-19 vaccine programmes, the medical industry has saved billions of lives. However, one recent medical decision has caused untold harm to people around the world: the release of OxyContin. Described by the former director of the FDA as “the greatest mistake in medical history”, OxyContin’s development, approval and aggressive marketing are considered by many to be the catalyst for the Opioid Crisis, which has resulted in 645,000 deaths between 1999 and 2021 in the United States alone.

This article will attempt to dissect the journey of OxyContin from a hailed miracle drug to the nucleus of a deadly epidemic. It will investigate what went wrong, the missed or deliberately ignored warning signs and who is to blame for the tragic loss of life.

To fully understand the story of OxyContin’s rise, it is crucial to understand the pain management landscape that existed prior to its introduction. Before OxyContin, various opioids had been used in healthcare for centuries, providing unparalleled pain relief benefits. However, with these benefits came the ever-present spectre of addiction. The use of morphine, originally developed as a non-addictive version of opium, saw hundreds of thousands of American Civil War soldiers addicted, while heroin, itself seen as a non-addictive alternative to morphine, has caused untold addiction devastation since it was first synthesised. With these previous attempts ending in unmitigated failure, there was still a huge, profitable gap in the market for an effective, non-addictive painkiller.

The development of OxyContin: Oversights and misunderstandings

Many experts agreed that the best way to avoid unwanted addictive properties was through a slow-release mechanism. The thinking was that by providing a steady release of the drug over several hours, drugs would be less appealing to those seeking a quick, intense high.

Oxycodone vs OxyContin: A new solution…

One question often asked is, “What is Oxycodone?” the active ingredient in OxyContin, used in medicine since the early 20th Century but came with the same addictive issues as other opioids. Purdue Pharma, however, used a patented technology called Contin to create a pill that released Oxycodone over 12 hours. As with any new drug, OxyContin went through pre-approval testing, but there has been serious scrutiny of the process in the years since.

First of all, critics point out that the trials for OxyContin were very short-lived, often lasting just a few weeks. This meant the potential for long-term addiction or misuse was not fully evaluated.

Second, while the trials may have indicated a lower risk of addiction when OxyContin is used correctly, real-world application saw a different story unfold, with misuse and addiction becoming significant problems.

After completing its test, OxyContin was approved by the FDA, a decision that would later be looked back on with enormous regret.

Oxycontin marketing: Mistruths and miracles

Having been given the green light, Purdue Pharma embarked on one of the most ambitious and aggressive marketing campaigns in medical history. Armed with a marketing budget exceeding $200 million a year by the late 1990s, OxyContin was sold to the world as a miracle drug providing 12-hour pain relief with a less than 1% risk of addiction. This statistic was based on a five-sentence letter about opioid treatment in hospitals that was published in the New England Journal of Medicine 15 years previously. The letter presented various reassuring data about addiction rates and concluded:

This letter, now commonly known as Porter and Jick after its authors, became so paramount to Purdue’s marketing claims that the company even trained its sales reps to cite it when faced with questions from doctors about the addictive potential of OxyContin.

The findings of the letter have been widely discredited in the years since, and Hershel himself deeply regretted its use to justify the widespread prescribing of OxyContin and other opioids, saying:

Armed with a sales force of thousands, Purdue began to target doctors through seminars, paid trips and bonuses. The company used cutting-edge analysis tools to target the doctors who were already frequent opioid prescribers in specific areas, states and across the country. Whether through Purdue’s persuasive marketing techniques or the ever-persuasive power of money, doctors across the United States began prescribing OxyContin to millions of patients, many of whom were told there was no risk of them ever becoming addicted.

Early red flags: Deaf ears and missed opportunities

By 2000, sales of Oxycontin had grown to $1.1 billion, and parts of the United States, particularly rural areas like Appalachia, which became known as OxyContin Express, were witnessing huge spikes in OxyContin addictions, hospital admissions and overdoses. The FDA was slow to grasp the scale of the problem fully, and Purdue continued to claim its drugs were safe despite, according to one lawsuit brought against the company by the state of Kentucky, “knowing that such assertions were false or misleading“.

Unperturbed by the emerging crisis, Purdue offered substantial bonuses to its sales teams, with annual bonuses averaging $71,500 on top of their $55,000 salary. In 2001 alone, Purdue paid $40 million in sales bonuses while its profits skyrocketed.

Click here to see an interview with the 2008 Purdue “Salesmen of the Year”.

One question that remained to Purdue was: “What is OxyContin used for?” Previously, opioids were prescribed only for serious chronic pain, such as cancer-related pain, but Purdue pushed for OxyContin to be used for “non-malignant” pain management. Essentially, this meant prescribing the drug for less serious forms of pain than most opioids were intended to target. This push saw non-cancer OxyContin prescriptions rise from 670,000 in 1997 to 6.2 million in 2002, with doctors jumping on board Purdue’s “Partners Against Pain” campaign, resulting in joint 2001 and 2002 sales hitting $3 billion.

The reckoning: Carnage too great to ignore

Image credit: CDC

By the mid-2000s, there was no denying the truth. Opioid-related deaths, the vast majority linked to OxyContin, reached levels that had never been seen before and would not be outdone until the synthetic Opioid Crisis of the following decades. OxyContin addiction was rampant across the United States, with people of every age, gender and socio-economic position affected.

Purdue soon found itself facing legal challenges from every direction, and in 2007, the company pleaded guilty to misleading the public about OxyContin’s addiction risk and paid a $600 million fine as part of a plea agreement with the U.S. Department of Justice. U.S. Attorney John Brownlee said at the time:

But that wasn’t the end of Purdue’s legal troubles. Here is a detailed timeline of the lawsuits faced by the company:

2001…

• The state of West Virginia was among the first to file a lawsuit against Purdue, alleging that it persuaded doctors to unnecessarily prescribe OxyContin by underplaying its addictive potential.

2004…

• The West Virginia case settled, with Purdue agreeing to pay $10 million over four years to support programs combating drug abuse in the state.

2007…

• Purdue and three of its top executives pleaded guilty to criminal charges of misleading the public about OxyContin’s addictive properties and agreed to pay the $600 million in fines and payments.

2015…

• Kentucky settled a lawsuit against Purdue for $24 million, with the state claiming that Purdue’s aggressive marketing tactics had fueled its opioid crisis.

2017…

• Ohio filed a lawsuit accusing Purdue and other drugmakers of conducting deceptive marketing campaigns that downplayed the risks of addiction.
• Other states followed suit with similar claims, including Missouri, New Hampshire, and South Carolina.

2018…

• Purdue Pharma and the state of New York reached a $270 million settlement.
• Purdue faced over 1,000 lawsuits from cities, counties and states claiming the company’s misleading marketing tactics led to enormous social and economic costs.

2019…

• Purdue Pharma reached a $270 million settlement with the state of Oklahoma, which would be used for addiction research and treatment in the state.
• Purdue filed for Chapter 11 bankruptcy as a part of a framework for settling the multitude of lawsuits it was facing.
• The company proposed a settlement estimated to be worth $10 billion to $12 billion over time, which would include donating drugs for addiction treatment and overdose reversal.

2020…

• A report revealed that members of the Sackler family, who owned Purdue Pharma, withdrew more than $10 billion from the company as scrutiny over OxyContin intensified.
• Purdue reached an $8.3 billion settlement with the federal government over its role in the opioid crisis.
• The Sackler family agreed to pay $225 million to resolve civil fines.

2021…

• Purdue Pharma dissolved, and its assets were used to create a new company dedicated to combating the opioid crisis.
• The Sackler family was shielded from future opioid lawsuits but had to pay $4.5 billion from their personal fortune over a nine-year period.

The story of OxyContin and the Sackler family has been dramatised in the Netflix Painkiller series.

Lessons to be learned from the case of OxyContin

The OxyContin saga serves as a compelling and tragic cautionary tale with profound lessons for every stakeholder in the healthcare, drug development, regulation and marketing industries. Huge mistakes were made during the testing and regulatory phases, exacerbated by Purdue’s unchecked and clearly deceptive marketing strategies. The entire “for-profit” basis of the United States healthcare system meant that Purdue was able to incentivise doctors to prescribe OxyContin at reckless levels while soaring profits for the company meant that, for a long time, they were able to price in lawsuits and damages.

Most importantly, the OxyContin story is one of untold damage to individuals, their families and entire communities. Miracle drugs provide hope to people who are desperately seeking it, and millions of people were lied to in the name of profits. If another crisis is to be avoided, governments and regulatory bodies must remember that medical advancements should first be about helping those in need, not making money.