Report: The Opioid Epidemic, Big Pharma, and the Law
Grayson Kelly
ENG 391
Dr. Hannah
FA-20
Report: The Opioid Epidemic, Big Pharma, and the Law
POLICY PROPOSAL
for TAKING ACTION ON THE OPIOID CRISIS IN PINAL COUNTY, AZ
Introduction
The opioid epidemic is a serious national crisis that affects public health as well as the social and economic welfare of the American communities that it has ravaged since its inception around 1996. Current data shows that 128 Americans die every day after overdosing on opioids in the form of prescription pain pills like OxyContin, illegal street drugs like heroin, and synthetic opioids such as fentanyl. Arizonans have not been spared. The opioid epidemic has hit every community in Arizona hard, including Pinal County.
Background
Pinal County, AZ is home to a multitude of economically and medically vulnerable populations that are uniquely predisposed to opioid addiction (including the elderly). Pinal County dedicates substantial portions of its tax revenues to provide and pay for a broad array of services for its population, including healthcare, pharmaceutical care, law enforcement, foster care, public assistance, and other services and programs for families and children. However, as a result of the opioid epidemic, the County has been severely hampered in its ability to continue to provide the requisite level of service in each of these categories. Most who become addicted to opioids are no longer able to work and therefore no longer able to care for their families, earn a paycheck or spend money in the same way they did prior to falling victim to addiction. As a result, the County’s tax revenues have suffered.
This harm is the direct result of Purdue Pharma and the Sackler family’s scheme. These groups succeeded in dramatically increasing the number of opioid prescriptions being written in Pinal County and across the country by affirmatively concealing the truth about the risk of addiction and death associated with long term use of their product, and pressuring their respective sales forces to deceive and bribe local physicians, PA’s, NPs and other prescribers to flood AZ and Pinal County with enough opioid prescriptions for every single person in the County.
Steps for Action
Lawsuits
For the first step, Pinal County will file a lawsuit suing Purdue Pharmaceuticals and the Sackler family using the evidence laid out above. The county will seek reparations for the economic damage that the groups have imposed upon the county. Pinal County will also sue corporations who had pharmacies in Pinal County, incl. but not limited to: Walgreens, Walmart, Fry’s Food and Drug Stores, CVS Health, Costco, etc, as well as the certain stores that hand a hand in this. These “defendants” earned enormous profits by flooding the state of AZ incl. Pinal County with prescription opioids. They gained knowledge of the oversupply through extensive data and rather than act to stem the flow of opioids into communities like Pinal County, participated in and profited from the oversupply.
Pinal County will identify and sue healthcare providers who represented an important component of the manufacturers scheme, in return for various incentives--self enrichment, etc. The legal action should help, but another step should be reducing the flow of opioids into Pinal County and incentivizing accessible, affordable, high-quality non-opiate pain treatment. This can help prevent a new generation of individuals from being exposed to or dependent upon opioids.
IV. Solutions
After legal action is settled, Pinal County should use all funds and settlements owed to fund the creation of urgent, evidence-based public access programs: the first will be for prevention, education, and diversion, and the second will be for various harm reduction initiatives.
Education: In the past, we have seen programs like D.A.R.E. and how they do not work and in fact are counteractive in most cases. Instead of drug education/scaremongering, we need to fund a program that is school-and community-based drug prevention program for people. The program should seek to strengthen bonds between adults and youth, provide opportunities for positive community involvement, and offer mentoring, community service, social competence training, etc.
Treatment: Hospitals should be funded to research and develop new plans of treatment, and should partner with community-based programs. This step ncludes an emphasis on intensive outpatient detox programs and centers, as well as medication-assisted treatment.
V. Moving Forward
The justice system is supposed to keep Americans safe, hold criminals accountable, and deter would-be wrongdoers. If opioid companies (like Purdue) and executives like the Sacklers cause societal devastation and are allowed to get away with criminal activity, the system is failing at one of its core purposes. Another reason that this matters is because Pinal’s legal action could effectively deter such conduct from companies like Purdue in the future. If executives are not criminally charged, a message of impunity is sent to the public--that fines and lawsuits are just the cost of taking part in an otherwise profitable business--and the epidemic will continue. In fact, this opens the door to far more epidemics like the opioid crisis in future. If Pinal County is lucky in its pursuit to take action on the local opioid crisis, the County can be a shining beacon and model for other cities and locales who are dealing with the same issues. One thing is for sure: action must be taken soon, or countless more lives will be lost.
REPORT
Introduction
The Crisis
Since its inception in the mid-90’s, the opioid epidemic has become a serious national crisis, affecting public health as well as the social and economic welfare of the American communities it has left ravaged in its wake. Current data shows that 128 Americans die each day as a result of an opioid overdose. Opioids are painkillers, commonly found in a few different forms: prescription pills like OxyContin, illegal street drugs like heroin, and synthetic substances, like fentanyl. These drugs are highly, highly addictive. The impact of opioid abuse on individuals, families, and society is substantial; the burden of pain left by opioid addiction can feel insurmountable. The diminished quality of life as a result of opioid use disorder and addiction extends beyond the individual and affects the physical and mental health of the individual’s family, too.
Focus: Legal Dimension
While there are large questions that need to be asked about the ethical dimension of the opioid epidemic--from opioids themselves, to the doctors who prescribe them, to the companies who produce them, and to governmental agencies like the F.D.A. who’ve allowed the crisis to flourish under their noses--this report will examine the legal dimension, more specifically how pharmaceutical companies have been held to account for the crisis. Society is negatively impacted by the opioid epidemic in tangible economic ways; in recent years, the public sector has been responsible for paying for over half of the direct medical costs incurred by opioid-related ED visits--some years reaching up to $100 million. This report will offer reasons why the funding for our outreach efforts should be secured from the owners of the pharmaceutical companies themselves.
Background
Purdue Pharmaceuticals
To understand the scope and scale of the opioid epidemic, it’s important to be familiar with its background. According to the CDC, the rise in opioid overdose deaths can be traced in three distinct waves: the first wave, in the 1990’s (prescription opioids); the second wave, beginning in 2010 (heroin); and the third wave, which began in 2013 (fentanyl). There are a number of factors that contributed to the marked growth of opioid abuse in the U.S., but early misinformation campaigns in the 90’s by Purdue Pharmaceuticals can be directly correlated with increased national opioid abuse, diversion, and addiction. Andrew Kolodny, the co-director of the Opioid Policy Research Collaborative at Brandeis University told a writer for the New Yorker that “though many fatal overdoses have resulted from opioids other than OxyContin, the crisis was initially precipitated by a shift in the culture of prescribing--a shift carefully engineered by Purdue. (Keefe) The following chart is from a 2015 report by the Annual Review of Public Health, highlighting the rates of opioid sales, opioid-related unintentional overdose deaths, and opioid addiction treatment admissions from 1999-2010. Kolodny, the author of the report, places the blame again on Purdue: “this acceleration is fueled in large part by the introduction in 1995 of OxyContin, an extended release formulation of oxycodone manufactured by Purdue Pharma” and “aggressive identification and treatment of pain, especially using opioids” funded by Purdue.
Annual Review of Public Health
Criminal and Civil Misconduct
Starting in 1996, “the year that prescribing really takes off,” Andrew Kolodny, the co-director of the Opioid Policy Research Collaborative at Brandeis University says, Purdue Pharma started to aggressively market OxyContin to healthcare providers. It was common for the company to spend more than $200 million on marketing and promotion in an array of approaches for OxyContin. The company even “paid doctors to make the case that concerns about opioid addiction were overblown, and that OxyContin could safely treat an ever-wider range of maladies,” raising ethical concerns regarding the company and the doctors themselves. Purdue sales were $48 million in 1996. OxyContin has since reportedly generated Purdue some $35 billion in profits.
Legal Ramifications
Recent current events have raised questions about the types of responsibilities drug companies like Purdue have in providing outreach for a solution to this issue. A few weeks ago, the Justice Department announced “a global settlement of civil and criminal investigations into Purdue Pharma's aggressive marketing of opioid medications, including OxyContin” that was valued at more than $8.3 billion.
The Problem Persists
While this sounds like great news, Purdue Pharmaceuticals filed for bankruptcy last year, meaning the settlement would “restructure the company to operate as a public trust under government control, continuing to manufacture opioid medications.” (Mann)
Furthermore, the opioid epidemic is still very real; opioids like OxyContin are still killing Americans every day. The legal response from the Justice Department holds the company accountable, in some aspects, but the problem is still here. The issue is still prevalent.
Legal Precedents
This isn’t the first time Purdue has been sued; in fact, the company (and it’s owners, the Sackler family) has been sued thousands of times over OxyContin, totaling upwards of trillions of dollars. Most of these lawsuits--and the recent Justice Department’s settlement--point to exactly how Purdue broke the law--marketing with the intent to defraud or mislead, and criminal misconduct. There are legal precedents for such cases. For example, in 2019, pharmaceutical companies Bayer and Johnson&Johnson paid a $775 million settlement to resolve “about 25,000 lawsuits, which claimed the companies failed to warn about deadly bleeding episodes caused by the drug.” (Thomas) The largest settlement ever was in a 2012 case involving pharmaceutical company GlaxoSmithKline, who plead guilty to criminal charges (“for promoting its best-selling antidepressants for unapproved uses and failing to report safety data”) and paid $3 billion in fines. Again, this all seems great; the companies are seemingly being held to account, at least financially. However, as New York attorney general Eliot Spitzer put it, “what we’re learning is that money doesn’t deter corporate malfeasance. The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.” (Thomas)
Accountability vs. Atonement
Purdue Pharmaceuticals, as a company, was found guilty both civilly and criminally; similarly, GlaxoSmithKline paid a criminal fine of $1 billion--the remaining $2 billion in their settlement was connected to civil charges. This amount of money seems astronomical, but according to the New York Times, “despite the large amount, $3 billion represents only a portion of what Glaxo made on the drugs”--upwards of $30 billion. (Thomas) Patrick Burns, a spokesman for a whistle-blower advocacy group, said that “a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business.” To institute real change, he says, “executives must be prosecuted criminally, or barred” from participating in medical programs in the future. (Thomas)
The Justice Department announced that while the deal with Purdue “won't result in company officials or members of the Sackler family, who own Purdue Pharma, serving prison time,” “this deal doesn't preclude future criminal prosecutions of individuals involved in Purdue Pharma's opioid marketing practices.” Unfortunately, the holding to account of key players in cases like this is rare. Thomas points out that “this has occurred in only a handful of cases, and rarely in a case involving a major pharmaceutical company. In 2011, four executives of the medical device company Synthes were sentenced to less than a year in prison for conducting clinical trials” not authorized by the F.D.A.
Today, the Sackler Family remains tight-lipped about the deadly legacy of Oxycontin, the product that made them their fortune and that continues to generate the family some $700 million a year from family companies. With their billions of dollars, the Sacklers have pursued a variety of philanthropic interests; one family member, also a member on the board of Purdue, was awarded the “Prince of Wales Medal for Art Philanthropy.” During his investigation for the New Yorker, Keefe wondered if the Sackler family’s philanthropy “might represent, for at least some of the Sacklers, a form of atonement.” Instead, he found that “when you consider the breadth of the family’s donations, one field is conspicuously lacking: addiction treatment, or any other measures that might serve to counter the opioid epidemic.” (Keefe)
Call to Action: Solutions
Accountability and atonement are two different things. Accountability, in the case of the Sacklers, Purdue, and the opioid epidemic, has been achieved--sort-of--financially. The reality, though, is that the opioid epidemic is still killing people every day while the Sacklers sit on their piles of blood money. The next logical step, and the suggestion of this report, is to demand atonement and reparations from the Sackler family themselves. Atonement, or reparation, is defined as the making of amends for a wrong one has done, by paying money to or otherwise helping those who have been wronged. In a New York Times op-ed, Gerald Posner and Ralph Brubaker posit that the settlement as it stands “would let the Sacklers walk away with an estimated several billion of OxyContin profits while leaving unresolved a crucial question asked by victims and their families: Did the Sacklers create and coordinate fraudulent marketing that helped make their bestselling drug a national scourge?” (Posner)
Ending a Culture of Impunity
The only way to hold Purdue, it’s leaders (the Sackler family) and other opioid company executives and owners is to bring criminal charges. German Lopez, a reporter for Vox, wrote that “this would go beyond recent lawsuits, which remain civil matters with no threat of jail or prison time. “The justice system is supposed to keep Americans safe, hold criminals accountable, and deter would-be wrongdoers,” Lopez argues. “If opioid company owners and executives like the Sacklers caused societal devastation and are allowed to get away with criminal activity, the system is failing at one of its core purposes.” The reason that this matters is because the criminal justice system is not appropriately or effectively deterring such conduct from companies like Purdue in the future.
In criminal justice policy, there is something called “certainty of punishment”, or the idea that people should know that if they commit crimes or harm, they will be held to account. Research suggests that certainty of punishment matters far more than severity, and the National Institute of Justice summarized the evidence by saying, “Research shows clearly that being caught is a vastly more effective deterrent than even draconian punishment.” If executives are not criminally charged, a message of impunity is sent to the public--that fines and lawsuits are just the cost of taking part in an otherwise profitable business--and the epidemic will continue. In fact, this opens the door to far more epidemics like the opioid crisis in future.
Works Cited
Keefe, Patrick Radden, and Margaret Talbot. “The Family That Built an Empire of Pain.” The New Yorker, www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain.
Kolodny, Andrew, et al. “The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction.” Johns Hopkins University, Annual Reviews Inc., 8 Apr. 2016, jhu.pure.elsevier.com/en/publications/the-prescription-opioid-and-heroin-crisis-a-public-health-approac-4.
Lopez, German. “The Case for Prosecuting the Sacklers and Other Opioid Executives.” Vox, Vox, 10 Oct. 2019, www.vox.com/policy-and-politics/2019/10/10/20881636/sacklers-purdue-opioid-epidemic-prison-prosecution-criminal-investigation?__c=1.
Mann, Brian. “Purdue Pharma Reaches $8B Opioid Deal With Justice Department Over OxyContin Sales.” NPR, NPR, 21 Oct. 2020, www.npr.org/2020/10/21/926126877/purdue-pharma-reaches-8b-opioid-deal-with-justice-department-over-oxycontin-sale.
Thomas, Katie, and Michael S. Schmidt. “Glaxo Agrees to Pay $3 Billion in Fraud Settlement.” The New York Times, The New York Times, 2 July 2012, www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html.
Thomas, Katie. “Bayer and Johnson & Johnson Settle Lawsuits Over Xarelto, a Blood Thinner, for $775 Million.” The New York Times, The New York Times, 25 Mar. 2019, www.nytimes.com/2019/03/25/health/xarelto-blood-thinner-lawsuit-settlement.html.