Statistical Thinking through Media Examples

Oxycontin

10.6 Oxycontin and the Opioid Crisis

MEDIA 10.9: Sacklers Directed Efforts to Mislead Public About Oxycontin, New Documents Indicate

MEDIA 10.10: Understanding the Epidemic

STUDY 10.7: The Promotion and Marketing of Oxycontin: Commercial Triumph, Public Health Tragedy

MEDIA 10.11: Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse

MEDIA 10.12: The History of OxyContin, Told Through Unsealed Purdue Documents

MEDIA 10.13: McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses

MEDIA 10.14: Big pharma executives mocked ‘pillbillies’ in emails, West Virginia opioid trial hears

MEDIA 10.15: The Sacklers’ Last Poison Pill

MEDIA 10.16: Martin Luther King’s Last Speech: “I’ve Been to the Mountaintop”

Latest News 

August 2023New York Times: Supreme Court Pauses Settlement With Sacklers Pending Review. 

December 2023: What to Know About The Purdue Pharma Case Before the Supreme Court

CHAPTER 10: INTEGRITY IN RESEARCH
10.6 OXYCONTIN AND THE OPIOID CRISIS

Another pain medication that has led to far more deaths than Vioxx is called Oxycontin, approved for use by the FDA in 1996. As was the case with Vioxx, Purdue Pharma, the pharmaceutical company that manufactured the drug, went on a massive marketing campaign to physicians and the public without disclosing the fact that the drug was highly addictive. Oxycontin went on to become the most highly abused painkiller in the United States and a major contributor to the opioid epidemic. As the New York Times article titled “Sacklers Directed Efforts to Mislead Public About Oxycontin, New Documents Indicate” points out, the owners of Purdue Pharma were directly involved in the efforts to mislead physicians and the public about the dangers of the drug. Richard Sackler, son of the founder, advised doctors to prescribe the highest (and most profitable) doses and pushed the blame onto patients who became addicted, stating, “They are the culprits and the problem. They are reckless criminals.”

The Sacklers’ aggressive marketing campaign continued for more than two decades, long after it became clear the devastation Oxycontin was causing, mainly to poor rural white communities across the US. According to the Centers for Disease Control and Prevention (CDC) website, “From 1999–2018, almost 450,000 people died from an overdose involving any opioid, including prescription and illicit opioids.”

In the American Journal of Public Health article titled “The Promotion and Marketing of Oxycontin: Commercial Triumph, Public Health Tragedy,” the researcher, Art Van Zee, discusses the massive marketing campaign conducted by Purdue Pharma to promote the use of Oxycontin:

When Purdue Pharma introduced OxyContin in 1996, it was aggressively marketed and highly promoted. Sales grew from $48 million in 1996 to almost $1.1 billion in 2000. The high availability of OxyContin correlated with increased abuse, diversion, and addiction, and by 2004 OxyContin had become a leading drug of abuse in the United States.

When discussing the origins of the FDA approval of Oxycontin, the researcher states the following:

Randomized double-blind studies that compared OxyContin with controlled-release morphine for cancer-related pain also found comparable efficacy and safety. The FDA’s medical review officer, in evaluating the efficacy of OxyContin in Purdue’s 1995 new drug application, concluded that OxyContin had not been shown to have a significant advantage over conventional, immediate-release oxycodone taken 4 times daily other than a reduction in frequency of dosing.

Why did the FDA approve Oxycontin when it was found to no more effective than the pain medications already on the market and when it was found to be highly addictive? The FDA website provides an explanation of its reasoning at the time.

At the time of approval, FDA believed the controlled-release formulation of OxyContin would result in less abuse potential, since the drug would be absorbed slowly and there would not be an immediate “rush” or high that would promote abuse. In part, FDA based its judgment on the prior marketing history of a similar product, MS Contin, a controlled-release formulation of morphine approved by FDA and used in the medical community since 1987 without significant reports of abuse and misuse.

The FDA go on to state that there was no evidence at the time that crushing the drug to be snorted or ingested would become widespread. Unfortunately, they were wrong in their assessment of what would occur.

The STAT News article titled “The History of OxyContin, Told Through Unsealed Purdue Documents,” provides details on Purdue Pharma’s marketing strategy from 1993, before the drug was approved, to 2014. Although the drug was approved for cancer-related pain, the article discusses how the company (from very early on) planned to move into the more lucrative market of drugs for nonmalignant pain conditions.

In December 1994, Michael Friedman, the sale and marketing executive (who would become the chief executive officer), sent an email to Richard Sackler and two other members of the Sackler family, stating the following:

“Our current MS Contin business has created ‘a franchise’ with certain physicians who routinely write prescriptions for the drug,” Friedman wrote. These family physicians, general physicians, and internists “may be the bridge that we can use to expand the use of OxyContin beyond Cancer patients to chronic non-malignant pain”—a market that he noted accounted for 68.7 million prescriptions a year.

From very early on, the Sackler family planned to push a drug that they knew was highly addictive on as many people as they possibly could. This type of behavior is no different from your street corner drug pusher, except that the Sacklers had a much more sophisticated operation for massive distribution and sales.

The November 2020 New York Times article titled “McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses” discusses how in 2017, McKinsey, the world’s largest consulting firm, laid out different options to Purdue Pharma for increasing sales of Oxycontin. One of the options was “to give Purdue’s distributors a rebate for every OxyContin overdose attributable to pills they sold.” As late as 2017, when hundreds of thousands of Americans had already died from overdosing on Oxycontin, the Sackler family were working with their distributors to squeeze every last dollar they could out of pushing the drug. How much more callous and calculating could the individuals involved in these sorts of decisions be?

In a May 2021 news article in The Guardian titled “Big pharma executives mocked ‘pillbillies’ in emails, West Virginia opioid trial hears”, the author discusses how executives at AmerisourceBergen, a major distributor of Oxycontin, mocked the people who got addicted to the drug. They call them “Pillbillies” and “described Kentucky as “Oxycontinville” because of the high use of the drug in the poor rural east of the state.” The disdain these corporate executives show for poor rural people who got addicted to the product they were pushing shows clearly the type of individuals that often make it to the top of the ladder in corporate America.

The Sackler family are one of the richest families in the US, estimated to have made $10.7 billion in profits from the sales of Oxycontin over 20 years. However, according to the New York Times article (from December 2020) titled “The Sackler’s Last Poison Pill,” they may never spend any time in jail. The Sackler legal team managed to push back a meeting with the House Committee on Oversight and Reform (the main investigative committee of the United States House of Representatives) to January 2020. In essence, through legal maneuvering and members of the House of Representatives buoying to pressure, the Sackler family may never face real accountability for what they did:

By then, a bankruptcy plan to reorganize Purdue will probably have been proposed. If, as expected, the plan seeks to release the Sacklers from liability, it will become practically impossible to uncover the full truth about the Sacklers’ role in the opioid crisis.

Why were the Sackler legal team allowed to do this? Do the politicians in the US represent the people or large corporations? Are particular politicians lining their pockets by giving large corporations what they want at the expense of the people? Are we all just pawns in their game?

The truth is that the Sackler family have made so much money from pushing their drug that they may never serve a day in prison. However, they are and should always be guilty in the court of public opinion. What they did was premeditated and planned. The level of death and devastation they brought on so many American families is second only to the COVID-19 pandemic. They spread their virus (in the form of a pill) across the landscape of American life.

Moral outrage was mounting up against the Sackler family before the COVID-19 pandemic hit. Hopefully, moral outrage will rise again, and the public demands that the punishment fit the horrendous crimes these individuals committed. The COVID-19 pandemic awakened many of us to the fact that life is short and precious. No one deserves to lose everything they are and everything they could be in this way. Their families and loved ones should not have to suffer such a premature and painful loss. Punishment for these sorts of crimes should amount to more than a hit to the almighty bottom line. The punishment should fit the crime. If that is not the truth, then I don’t know what is.

In both the case of Vioxx and Oxycontin, the individuals involved were willing to sacrifice their integrity to ensure that as many Americans as possible consumed a flawed and potentially deadly product. When the truth regarding these dangerous products eventually came to light, they knew they could hide behind their company names, agreeable politicians, and lawyers, who were also willing to sacrifice their integrity for a sizable paycheck. The truth and the lives lost and destroyed did not matter to any of these individuals.

As we have learned throughout this book, the path to truth is a challenging one. There will always be opportunities to take the easier path to “success,” often defined in terms of monetary gain. However, at the end of the day, you will have to contend with where those paths have led you, no matter how much money you make.

One of the greatest of American leaders, Dr. Martin Luther King, who followed his path to truth with passion and integrity, had the following words of advice to share with future leaders:

May I stress the need for courageous, intelligent, and dedicated leadership…. Leaders of sound integrity. Leaders not in love with publicity, but in love with justice. Leaders not in love with money, but in love with humanity. Leaders who can subject their particular egos to the greatness of the cause.

Dr. Martin Luther King used his natural intelligence and leadership skills to move forward with a cause he truly believed in. He had the courage and commitment to follow his path to truth until he reached the mountaintop (and was rewarded for his efforts). Watch the last three minutes of his final speech where he tries to express the inner reward and insight he received from living a life dedicated to the “greatness of the cause”. I hope you will have the courage to follow in his footsteps. America, now more than ever, needs great young leaders willing to take on challenging causes, maintain their sense of integrity, and follow their path to truth. It is hard and courageous work, but it is worth it and a very American thing to do. So, work hard, be brave and show the world what it truly means to be an American!

Latest News 

August 2023: New York Times: Supreme Court Pauses Settlement With Sacklers Pending Review. 

December 2023: What to Know About The Purdue Pharma Case Before the Supreme Court

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