The rise in opioid-related overdose deaths is one of the greatest public health crises in modern American history. Between 1999 and 2019, opioid overdoses caused nearly 500,000 deaths in the United States. This crisis can be seen in three concurrent trends over the same time period: a more than 6-fold increase in the number of opioid overdose deaths, a more than 7-fold increase in the number of deaths per year from heroin overdose, and an almost 50-fold increase in the number of overdose deaths per year from synthetic opioids (including fentanyl but not including methadone).
How did we get here?
The Fraudulent Marketing Behind OxyContin
In 1995, Purdue Pharma received FDA approval for its drug OxyContin, a controlled-release pain reliever. Focus groups which Purdue used for market research showed that “physicians had great reservations about prescribing OxyContin” because of its potential for addiction and abuse. These same focus groups revealed to Purdue “that physicians wanted a long lasting pain reliever that was less addictive and less subject to abuse and diversion."
Purdue went on to fraudulently market the drug "by falsely claiming that OxyContin was less addictive, less subject to abuse, and less likely to cause withdrawal symptoms than other pain medications when there was no medical research to support these claims." The company also later admitted that certain supervisors and employees had “told certain health care providers that patients could stop therapy abruptly without experiencing withdrawal symptoms,” that the drug “had less abuse potential, was less likely to be diverted than immediate-release opioids, and could be used to ‘weed out’ addicts and drug seekers.”
In 2001 and 2002, Purdue also partnered with the Joint Commission on Accreditation of Healthcare Organizations. During that time, Purdue funded nine programs teaching “hospital physicians and staff on how to comply with [the Joint Commission]’s pain standards for hospitals and to discuss postoperative pain treatment." Additionally, under an agreement with the Joint Commission, “Purdue was the only drug company allowed to distribute certain educational videos and a book about pain management; these materials were also available for purchase from [the Joint Commission]’s Web site.”
The FDA reports having warned Purdue in 2003 on “misleading advertisements”, noting that “the ads left out and minimized the serious safety risks associated with OxyContin and promoted it for uses beyond those which had been proven safe and effective.”
A Surge in Prescriptions and Growing Abuse
“From the outset of the OxyContin marketing campaign, Purdue promoted the drug to physicians for noncancer pain conditions” and as “an initial opioid treatment for moderate-to-severe pain lasting more than a few days,” according to a 2003 GAO report to Congress. That same report noted an increase in the prescriptions of OxyContin for non-cancer pain “from about 670,000 in 1997 to about 6.2 million in 2002.” By 2003, almost half of all OxyContin prescriptions were being written by primary care physicians, as opposed to specialists like those in end-of-life care and cancer treatment.
The spreading abuse of the drug was already raising alarm in 2001. That year, the National Drug Intelligence Center reported that “diversion and abuse of the prescription pain reliever OxyContin is a major problem, particularly in the eastern United States.”
Rural areas were of particular concern. In 2002, Dr. H. Westley Clark testified before a congressional hearing that they were the location of "the most urgent new reports of abuse and addiction” with opioid drugs.
In 2002, 17 states had an age-adjusted opioid overdose death rate of 5 or more per 100,000 population, with the top 5 states at 9.7 or more. By 2019, 47 states had exceeded that age-adjusted opioid-involved death rate of 5 per 100,000 population, with the top 15 states having a rate of 20 or more per 100,000, and the top 5 states exceeding 30 per 100,000.
The Rise of Heroin and Fentanyl Deaths
As addiction through prescription opioids has spread, heroin and fentanyl overdose deaths have also increased. From 1999 to 2019, the number of heroin overdose deaths increased by more than 615% (reaching 14,019 in 2019) and the number of deaths involving synthetic opioids (including fentanyl but not including methadone) increased by more than 4880% (reaching 36,359 in 2019).
There is a "repeatedly confirmed" cycle of teens and young adults beginning their drug abuse with prescription opioids and then graduating to heroin, according to the Deputy Assistant Administrator of the DEA’s Office of Diversion Control. He added that "the 'street' cost of prescription opioids steadily increases with the relative strength of the drug... These increasing costs make it difficult, especially for teens and young adults, to purchase [prescription opioids] in order to support their addiction, particularly when many first obtain these drugs for free from the family medicine cabinet or friends. Not surprisingly, some users of prescription opioids turn to heroin, a much cheaper opioid."
Nearly 80% of “recent heroin initiates” (between 12 and 49 years old) had a history of using nonmedical pain relievers (NMPR), according to a 2013 study by the Center for Behavioral Health Statistics and Quality. However, the study added that “the vast majority of NMPR users have not progressed to heroin use. Only 3.6 percent of NMPR initiates had initiated heroin use within the 5-year period following first NMPR use.”
Fentanyl, which is 50-100 times more potent than morphine, is commonly mixed with heroin “with or without the user's knowledge — to increase its euphoric effects.” According to the DEA, the drug is “the primary driver behind the ongoing opioid crisis, with fentanyl involved in more deaths than any other illicit drug.”
The National Forensic Laboratory Information System (NFLIS) saw a vast increase in fentanyl reports, rising from 934 cases in 2013 to 100,378 in 2019. Approximately 42% of fentanyl reports to the NFLIS in 2019 were found in combination with another drug, with 22% “of all fentanyl exhibits examined” containing heroin.
Rogue Practitioners and Suspicious Orders
Purdue was not the only organization to profit from this crisis.
In 2014, the DEA launched its largest-ever prescription drug operation, targeting “the largest sources of illegally diverted pharmaceuticals in Arkansas, Louisiana, Mississippi, and Alabama.” By then, these four states had some of the highest opioid dispensing rates in the country.
In addition to more traditional criminal organizations, the operation went after rogue medical practitioners, pharmacists, and other DEA registrants, revealing how pervasive the problem truly is. Those arrested and charged are quite illustrative: a doctor, a pharmacist, and a physician’s assistant associated with “a 'pill mill,' where individuals obtained prescriptions for narcotic drugs without having legitimate medical need," and a pharmacist who sold pills after hours while forging prescriptions to account for the missing inventory.
One of the other major companies implicated in this crisis was the McKesson Corporation. In 2017, the U.S. DOJ announced that the McKesson Corporation, "one of the nation’s largest distributors of pharmaceutical drugs, agreed to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act (CSA)," including having failed "to design and implement an effective system to detect and report 'suspicious orders' for controlled substances distributed to its independent and small chain pharmacy customers." The settlement also required that the company "suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for multiple years."
The Purdue Settlements
In 2007, Purdue Pharma pleaded guilty to misrepresenting the addictive properties and abuse potential of OxyContin. The company was handed $600 million in monetary sanctions. In addition, former President and CEO Michael Friedman, Purdue’s Chief Legal Officer Howard R. Udell, and former Chief Scientific Officer Paul Goldenheim agreed to collectively pay $34.5 million in fines.
In 2020, Purdue pleaded guilty to “one count of dual-object conspiracy to defraud the United States” and “two counts of conspiracy to violate the Federal Anti-Kickback Statute.”
In that plea, Purdue acknowledged that it had failed to maintain an effective anti-diversion program when the company continued to market opioids to healthcare providers it determined were potentially diverting opioids and had misrepresented its sales numbers to the DEA. According to the DOJ, Purdue “reported misleading information to the DEA to boost Purdue’s manufacturing quotas.” Purdue also acknowledged it had “knowingly and intentionally conspired and agreed with others to aid and abet” healthcare providers’ dispensation of prescription drugs “without a legitimate medical purpose and outside the usual course of professional practice (and thus without a valid prescription).”
We will be taking a deeper look at these court cases — in particular the conditions of Purdue’s 2020 guilty plea — in our next installment of this story.