By Mary Beth Rhodes, MN, RN, CPHRM
Laura Hope Laws was prescribed an opioid-based medication after a broken jaw during a soccer game at age 14. She was a high school freshman. Addiction took over and she never made it to her senior year. She died of an accidental overdose on Nov. 17, 2013. She was seventeen.
A mother died after a 15-year battle with addiction to opioids that started with her third caesarean section. She was an extensive “doctor shopper.” She told her family she was “following doctor’s orders” by taking nearly 50 pills a day. She underwent 13 different treatment programs, but could not break the grasp of her addiction.
How did it start?
In 1986 a paper written by Dr. Russell Portenoy was published in the journal PAIN describing the treatment of 38 chronic pain patients and it concluded that opioid painkillers could be prescribed safely on a long-term basis. Dr. Portenoy was an early advocate for the use of opioids for chronic pain. He shared his opinion in journals, papers and conferences. He has now agreed to testify against drug manufacturers.
The manufacturer Purdue Pharma introduced OxyContin in 1996 and promoted it as a wonder drug suitable for all types of pain. Purdue started using a letter to the editor published in the New England Journal of Medicine in 1980 to say that less than 1 percent of patients became addicted. According to Herschel Dick, the author of the letter, the scope was extremely limited and not generalizable. This was a letter that was brief in content and that never went through a rigorous scientific process. According to the author he “was mortified this was used as an excuse by pharmaceutical companies to do what they did.” In 2017 the editor of the New England Journal of Medicine issued a corrective to the 1980 letter. In it he notes that the original letter was heavily cited as evidence that addiction is rare with opioid therapy; he includes reference to a new study on the topic. This is the only time in 17 years that the editor has taken such action. Questions have to be asked as to why it took 37 years.
In 1996, the rate of opioid prescribing began to rapidly increase following the 1995 FDA approval of OxyContin. Drug manufacturers funded more than 20,000 pain-related educational programs through sponsorships or financial grants and launched a campaign to promote long-term use of opioid painkillers for chronic, non-cancer pain.4 In 2001 a campaign entitled “Pain is the Fifth Vital Sign” encouraged clinicians to assess and treat pain with the same urgency as other vital signs and use opioids for non-cancer pain. Both the Veterans Affairs (VA) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) endorsed the campaign. In 2007 Purdue Pharma and three top executives pleaded guilty to misleading regulators, physicians and patients about OxyContin and agreed to pay $600 million in fines. In 2012 clinicians wrote prescriptions for 259 million bottles of narcotic pain killers, enough for every adult in the country according to the Centers for Disease Control. Opioids killed 28,000 people in 2014 and according to the CDC some 2.6 million people are addicted to opioids in the U.S.
The marketing push
Prior to this push, doctors were hesitant to prescribe opioids over fear that their patients would become addicted. Medical schools taught that opioids should be used for severe pain, cancer or surgery patients and not for back pain, headaches and osteoarthritis. In order to increase the use of opioids, pharmaceutical companies had to change the mindset of doctors regarding opioids and addiction. Details of the various marketing campaigns were revealed in the corporate documents and emails that were unsealed in the Cleveland case after a year-long fight by the Washington Post.
The drug manufacturers paid physicians and Hollywood stars to promote more aggressive treatment with opioids. Industry provided funding to groups such as the American Pain Foundation and the American Pain Society with the purpose to drive up sales of opioid pain medications. Bonuses and various contests were deployed to reward top salespersons. Janssen incentivized sales representative with prizes such as Caribbean cruises, Washington DC family trips, Trek bikes and patio packages. A judge in a lawsuit in Oklahoma ruled that Johnson & Johnson and Janssen had engaged in “false, misleading and dangerous marketing campaigns” and caused “exponentially increasing rates of addiction, overdose deaths” and babies born addicted.
Between 2006 and 2012 Walgreens was the dominant player in the nation’s retail opioid market. They bought 13 billion pills—3 billion more than CVS, which was the closest competitor. Walgreens saw tremendous growth due in part to lack of oversight as pills were sent out without limit or review. In 2013 Walgreens agreed to pay $80 million dollars to resolve allegations that it failed to report suspicious orders, thus allowing oxycodone and other prescription pain medications to be diverted for abuse and illegal black market sales. In 2014 a pharmacy tech stole about 25,000 pain pills from a Walgreens in Missouri. He told investigators that another employee told him how to steal the pills and then sell them in the store bathroom and parking lot. In summer of 2016 a Walgreens pharmacy tech stole 7500 pain pills. She told investigators it was easy to take the pills and not be detected.
Because Walgreens was acting as its own distributor, it had the responsibility of reporting to the DEA suspicious activity of its own pharmacies. 2400 cities and counties throughout the nation allege Walgreens failed to report signs of diversion and incentivized pharmacists with bonuses to fill more opioid prescriptions. Walgreens denies they incentivized pharmacists. They have however removed sales of opioids from its bonus calculations for pharmacists according to court filings.
Since Walgreens acted as a distributor it had access to data regarding distribution within its pharmacies. Because they had this data they may be held to an even higher standard. Walgreens stopped internal distribution in 2014. In 2009 the Drug Enforcement Administration (DEA) threatened to revoke the registration of a store in San Diego. The investigation found that the store was filling prescriptions for providers not licensed in California. The DEA also found the store was dispensing controlled substances to people it knew or should have known were diverting these drugs. In 2011 Walgreens entered into an agreement with the DEA to settle the case. The DEA also found evidence that Walgreen stores in the Florida market were being ranked on the amount of oxycodone being dispensed and had instructed the pharmacists “to make sure they were not turning away legitimate prescriptions.” A California Walgreens location also came under scrutiny. This one was in Modesto and it was purchasing 17,500 pills per week. This put the store over the limit imposed by Walgreens corporate office. The allegation is that in order to obtain more pills the pharmacy ordered directly from Cardinal Health bypassing Walgreens’ distribution channel. At some point Cardinal Health had concerns regarding the distribution and cut off the store. The pharmacy then resorted to borrowing from other Walgreens locations. Cardinal Health in 2008 paid $34 million in fines for failure to report suspicious orders. Cardinal Health has recently reached an agreement in national opioid litigation.
Recent legal proceedings
In 2019 Purdue Pharma agreed to pay the state of Oklahoma $270 million dollars rather than go to trial on allegations of misleading marketing practices and misrepresentation of OxyContin. Endo Pharmaceuticals also agreed to pay Oklahoma $8.8 million to settle allegations that its marketing contributed to the opioid crisis. This money will go to the opioid lawsuit fund. Johnson & Johnson, the first case to go to trial in the U.S., resulted in a win for Oklahoma, but the original $572 million was reduced to $465 million in November 2019, the allegation being they, along with others, fueled the opioid crisis with deceptive marketing. Teva Pharmaceuticals, the world’s largest generic drug maker, agreed to pay $85 million in May 2019 to the Oklahoma opioid fund. Endo has also agreed to pay $10 million dollar to two counties in Ohio to settle suits related to opioids. Still pending is the Multidistrict Litigation (MDL) in the U.S. District Court for the Northern District of Ohio under Judge Dan Polster. The plaintiffs include cities, counties, states, individuals, consumers, hospitals, third-party payers and Native American tribes. The defendants include opioid manufacturers, distributors and physicians. On January 23, 2020 the founder of Insys Therapeutics, John Kapoor, was sentenced to 5.5 years of jail time for his role in the company’s plan to illegally boost sales of its prescription Fentanyl drug (Subsys). He and four other former Insys officials were convicted in federal court in Boston of conspiring to bribe physicians and defraud health insurers. Insys has settled with the U.S. Department of Justice for $225 million to end its criminal and civil probes. The company has filed for bankruptcy protection.
Prior to 2015, prescription opioid pain relievers were driving the opioid crisis, however, they now share equally with heroin, synthetic opioids other than methadone (mostly illicit fentanyl) and, increasingly, cocaine and methamphetamine. Due to leveling off and declines in opioid prescribing rates since 2012 and high dose prescribing rates since 2009 the data suggests providers have responded and are more cautious in their opioid prescribing practice. However additional measures are needed to address a diverse and changing utilization of different drug types. Today the drug manufacturers seem to be taking the brunt of the public outcry for this crisis; however, there may come a point in the future where all healthcare providers, accrediting bodies, associations, advocacy groups as well as patients and families may be called upon to examine their role in the national opioid crisis.
1. Prescription Drug Monitoring Programs: Critical Elements of Effective State Legislation March 2016. Shatter Proof: Stronger Than Addiction
2. Portenoy RK, Foley KM. (1986). Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain 25:171-86
3. The report of the International Narcotics Control Board for 2007. International Narcotics Control Board. Https://www.incb.org/incb/en/publications/annual-reports/annual-report-2007.html Accessed 12/16/2019.
4. Prescription drugs: OxyContin abuse and diversion and efforts to address the problem. (December 2003). Report to congressional requesters. United States General Accounting Office. Http://www.gao.gov/new.items/d04110.pdf Accessed 12/16/2019.
5. Haddox JD, Joranson D, Angarola RT, Brady A, Carr DB, et al. (1997) The use of opioids for the treatment of chronic pain: a consensus statement from the American Academy of Pain Medicine and the American Pain Society. Clin. J. Pain 13:6-8
6. Abelson, J., Williams, A; Ba Tran, A; Kornfield, M. (2019) ‘At Walgreens 13 billion pills and problems with oversight.’ The Washington Post. Nov. 11. Page 1.
7. Centers for Disease Control and Prevention. Annual Surveillance Report of Drug- Related Risks and Outcomes-United States 2017. Surveillance Special Report 1. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. Published August 31, 2017. https://www.cdc.gov/drugoverdose/pdf/pubs/2017-cdc-drug-surveillance-report.pdf Accessed 11/13/2019
8. Horwitz, S; Higham S; Bennett D; Kornfeld M. (2019) ‘Inside the industry’s marketing machine.’ The Washington Post. Dec. 9. Page 1.
9. Zhang, S. The One Paragraph Letter from 1980 That Fueled the Opioid Crisis. The Atlantic. June 2, 2017. https://www.theatlantic.com/health/archive/2017/06/nejm-letter-opioids/528840/ Accessed 12/16/2019
10. Scharper, J. Administered for Pain Drugs like OxyContin have taken a massive toll. Johns Hopkins Magazine. Fall 2016. https://hub.jhu.edu/magazine/2016/fall/opioid-addiction-pain-management/ Accessed 12/16/2019
11. https://www.cnbc.com/2019/04/08/physician-agrees-to-testify-against-purdue-and-other-opioid-drugmakers.html Accessed 1/20/2020
12. https://www.healio.com/rheumatology/practice-management/news/print/healio-rheumatology/%7B9563752c-75d5-47ea-ae5d-49d41645ff4e%7D/landmark-270-million-opioid-lawsuit-settlement-opens-door-for-dozens-of-pending-cases/ Accessed 1/20/2020
13. https://www.bizjournals.com/philadelphia/news/2019/09/05/endo-opioid-litigation-settlement.html Accessed 12/19/2019
14. https://www.reuters.com/article/us-usa-opioids-litigation-oklahoma/teva-pharm-to-pay-oklahoma-85-million-to-settle-opioid-claims-idUSKCN1SW0MS Accessed 12/19/2019
15. https://www.reuters.com/article/us-usa-opioids-litigation-oklahoma/oklahoma-judge-reduces-johnson-johnson-opioid-payout-to-465-million-idUSKBN1XP27F Accessed 12/20/2019
16. Berry, Melissa D. Thomson Reuters September 28, 2018. http://www.legalexecutiveinstitute.com/opioid-litigation-consolidated/ Accessed 1/20/2020
17. Walker, Joseph & Kamp Jon. The Wall Street Journal. Founder of opioid maker sentenced to 5.5 years in prison. January 23, 2021.
18. The Washington Post. Filed by the Associated Press. January 24, 2020. Page 2.