Examining The Roots of a Crisis

Examining the Roots of a Crisis: The Creation of an Opiate Market that Continues to Evolve

This report examines the timeline from the distribution of pain pills that created a market for opiates, to the responses by medical and government authorities, and to the subsequent legal and regulatory changes that created the current conditions of the U.S. heroin crisis.

The pharmaceutical and illegal drug industries should be completely separate, maybe even polar opposites—the only similarity being the two share the word “drug.” After all, the pharmaceutical industry is a regulated industry led by professionals whose mission is to create, manufacture, and sell medications that improve peoples’ lives. This stands in stark contrast to the illegal drug market that is patrolled, rather than regulated, and where career success hinges on one’s ability to avoid jail. Nevertheless, the span of events when opiate pain relievers first began to be used to treat a wide range of conditions, to the unprecedented distribution of the drug by so-called pill mills, to eventually the rise in heroin use shows that the policies and practices of the pharmaceutical industry created conditions for the heroin epidemic.

Purdue Pharma

Opioids are substances that attach to brain receptors to block pain signals. The body produces opioids naturally but not enough to stop severe or chronic pain. When prescribed and used properly, opiates can mitigate pain, allowing patients to feel and function normally. The purpose of these drugs is not to give people a buzz or high, but to relieve them of pain. Opiates are commonly used to treat patients in severe pain from cancer treatment or major surgery. Opioids are also an effective medication for patients with chronic pain. One opiate narcotic painkiller often prescribed by doctors is Oxycodone, which when taken, has an immediate painkiller effect. Another painkiller, Oxycontin, was developed in 1995 for those suffering from mild to moderate pain and needing pain relief for a longer period. Oxycontin has a much stronger effect on pain because it has a high concentration of Oxycodone. Medications that have Oxycodone added can relieve pain for between four to six hours, while Oxycontin can relieve pain for about 12 hours.

The addictiveness and potential for abuse of opiates dictated a long-standing prescription practice administered by specialists. This practice changed in 1996 when Purdue Pharma introduced a controlled-release version of Oxycontin designed to be less addictive than the instant-release version but equally as effective in relieving pain. This claim became a huge selling point of Purdue Pharma’s advertising campaign of Oxycontin—an advertising campaign that led to a sharp increase in the rate of opioid prescriptions.

From 1996 to 2002, Purdue Pharma annual sales of Oxycontin increased from $44.7 million to $1.5 billion (U.S. General Accounting Office Report – Oxycontin). One factor contributing to the unprecedented success of the drug’s sale was Purdue Pharma’s effective marketing campaign. At the time of Oxycontin’s release in 1996, there were no regulatory guidelines that dictated how a prescription drug could be marketed. To increase its marketing reach to physicians, Purdue doubled the size of its prescription sales division, creating a division specifically focused on doctors that operated out of hospitals. In 1996, its 300-person sales team had a call list ranging from 33,400 to 44,500 doctors. By 2001, the sales team had grown to 700 representatives with a call list ranging from 70,500 to 94,000 doctors (U.S. GAO – Oxycontin).

As Purdue Pharma began its advertising campaign, the firm began to make greater use of prescriber profiles. As a practice, pharmacies sell information on prescription drug sales to various entities. This information excludes the doctors’ name, but it does include the identification number associated with it that the Drug Enforcement Administration (DEA) uses to track the sale of controlled substances. This benefits pharmaceutical companies because they can purchase a master file from the American Medical Association that has all registered doctors and their corresponding identification numbers. In terms of marketing drugs to doctors, pharmaceutical companies are able to use this data to see which doctors are prescribing which drugs virtually anywhere in the United States. For Purdue Pharma, the use of prescriber profiles and its increased sales force helped dramatically expand the marketing of Oxycontin.

As part of their marketing strategy, Purdue also hosted several physician symposiums focused on pain management and the effectiveness of Oxycontin. At these symposiums, primary care physicians were informed that there was a lower risk of abuse and addiction with the controlled-release version of Oxycontin because the drug was designed to treat pain over an extended period through the gradual release of Oxycodone. The small, intermittent releases of Oxycodone, in turn, were supposed to be less attractive to abusers because the person would not experience the same effect as an instant-release pill should they try to abuse it. The controlled-released Oxycontin pills, however, generally contained more Oxycodone than the instant-release. The label on Oxycontin, approved by the Food and Drug Administration warned users that the pills should not be crushed or chewed because that would result in the patient accessing a rapid and potentially dangerous dose of the active ingredient.

As noted, Purdue’s marketing strategy of Oxycontin was a success. Prescriptions for Oxycontin from primary care physicians was Purdue’s leading source of sales from 1996 to 2002. Unfortunately, Oxycontin’s popularity was not limited to just pain management. Problems with Oxycontin abuse and diversion began surfacing in 2000 when there was an increase in the number of reports of patients visiting several doctors in hopes of receiving one or multiple prescriptions. In 2002, Oxycontin was cited as one of the leading causes of admittance to rehabilitation clinics in several Appalachian states. The rise in OxyContin abuse, in turn, led to a congressional hearing in 2001 in which officials from Kentucky, Virginia, and West Virginia testified to lawmakers about Oxycontin abuse in their states. In 2003, the United States General Accounting Office released a report in which it recommended a new FDA label for Oxycontin and the development of a risk-management plan to lower the abuse of Oxycontin along with a national response to deal with Oxycontin abuse going forward.

Pain Clinics and the Oxy Alley

For drug companies, prescriber profiles identify doctors with a large number of patients in need of a particular drug. The prescriber profiles, however, did not screen out lenient doctors and primary care physicians lacking adequate training and experience in abuse and addiction from being prospected.

Dr. Eleanor Santiago was the medical director at Lake Medical, a California pain clinic started by a convicted felon. During her time at Lake Medical, Dr. Santiago was writing a staggering number of monthly prescriptions for 80-milligram Oxycontin. This is the highest dosage that Purdue manufactured, and unsurprisingly, the 80-milligram pills had the highest street value, which is exactly where they were headed. Dr. Santiago raised a red flag at Purdue in December of 2008 when she wrote prescriptions for over 30,000 80-milligram pills in that month alone. A Purdue review board met to discuss the case, leading to the addition of Eleanor Santiago’s name to an internal list of physicians Purdue suspected of wrongdoing. Uninformed by Purdue that she was under review or on their list, Dr. Santiago continued to prescribe pills at an alarming rate. In September of 2009, she prescribed 68,000 pills.

For Lake Medical, meeting the growing demand for Oxycontin was not a problem. Lake Medical often paid groups of homeless people to fill out medical forms at their clinic and sit through a fake examination. They then drove them to pharmacies to pick up the drugs. The homeless people were then paid and the drugs sold to dealers or directly to addicts. The Los Angeles Times reported that from its opening in September of 2008 to its shut down in March of 2010, Lake Medical accounted for 1.1 million Oxycontin pills flooding the streets of Los Angeles before being dispersed throughout the country.

Acting as a supplier of many high dosage opiates to addicts, Lake Medical was not unique. In fact, a large concentration of pain clinics was located in Florida—the largest being American Pain. American Pain started in 2008 as a single pain clinic in Florida, growing to four clinics by 2010 when it shut down. Unlike Lake Medical, American Pain dealt only with generic opioids. This allowed them to accept only cash in exchange for the pills. Because patients paid with cash and the doctors’ compensation consisted of a flat fee per prescription, almost every person who visited American Pain walked away with opioids. What started as a clinic to serve the Floridian pain market quickly expanded its reach to anyone who was willing to travel down “Oxy Alley”—the term used to describe the stretch of highways people from northern states would take to visit the clinics. American Pain was shut down in 2010 in “Operation Oxy Alley.” Despite being open for only two years, law enforcement officials estimate American Pain was responsible for distributing approximately 20 million opioid pills.

Stemming the Increasing Trend in Prescription-Drug Overdose

The shutdown of American Pain was part of a statewide effort in Florida that resulted in closing down over 400 of the estimated 1,000 pain clinics in the state. By 2010, national awareness of the problems associated with overprescribing opioids was growing and led other states to crack down on the clinics operating in their jurisdictions. Along with the closing of pain clinics, state and local law enforcement agencies implemented stricter monitoring methods to track the prescriptions of painkillers and began suspending the medical licenses of doctors found guilty of inappropriate prescriptions. In Ohio, for example, the Governor’s Cabinet Opiate Action Team (GCOAT) was launched in 2011 to combat the state’s prescription opioid abuse. In May of 2011, the governor also signed Ohio House Bill 93, which placed tighter controls and limitations on physicians prescribing opioids. (In 2011, 27 of 136 physicians were targeted in Ohio for inappropriate prescriptions or lenient pain clinic operations.)

By all accounts, the concerted efforts in Ohio, Florida, and other states were effective in reversing the increasing trend in prescription-drug overdose. In Ohio, for example, prescription opiates decreased from 45% of all unintentional drug overdoses in 2011 to 22% in 2015.The number of prescriptions for opiates and patients receiving opiates also dropped significantly from 2012 to 2015.

Unfortunately, while the closing of pill mills and the suspension of medical licenses for inappropriate prescriptions reversed the prescription opiate epidemic, it did not stop increases in the number of opiate overdoses. In 2004, the West Virginia Attorney General sued Purdue for reimbursement for excessive prescription costs. West Virginia was followed by Kentucky in 2007 when their Attorney General sued Purdue over widespread oxycontin abuse in Appalachia. By January 2019, 36 states had filed suits against Purdue Pharma. Finally, in October 2020, Purdue agreed to an $8 billion settlement, pleaded guilty to three criminal charges, and agreed to reorganize as a public benefit company under a trust that is required to consider American public health.

The Heroin Substitute

The decline of opioid availability left the large number of people who had developed a prescription-opiate addiction with few options. Addicts could try to find a new doctor to prescribe an opioid, but the numbers of such doctors were few given the increased monitoring and limitations on prescriptions. They could enter rehabilitation and treatment centers, which some did. Addicts could also buy the drugs illegally, but here the limited availability of the pills had driven up their prices in the black market. A final option, though, was for addicts to buy an illegal substitute drug that comes from the same plant as opioids, is chemically similar, is relatively cheap, and is more addicting—heroin. Narcotics traffickers and drug cartels realized that an illicit market for opioids had already been created and, with demand in place, saw the opportunity to profit from distributing the horrendous substitute. Many people addicted to prescription opiates discovered that they experience a very similar high from using heroin.

Unfortunately, as attested by the heroin epidemic, many people chose this last option. A 2016 DEA Intelligence study reports that nationwide heroin-related deaths more than tripled from 2010 to 2014. In Ohio, the proportion of drug overdoses due to heroin surpassed prescription opiates in 2012, and from 2013 to 2015, heroin accounted for over 45% of all unintentional drug overdose deaths.

Fentanyl

The opiate epidemic confronting state officials took on a new dimension in 2013 when toxicology reports discovered fentanyl in the systems of overdose patients. Fentanyl is a synthetic opioid pain reliever that is usually injected for certain surgeries. Fentanyl is 50 to 100 times stronger than heroin. The Ohio Addiction & Recovery Center reported that fentanyl was involved in about 80% of all heroin-related overdose deaths in 2018, 74% of all cocaine-related overdose deaths, and 67% of all psychostimulant/methamphetamine-related overdose deaths.

Carfentanil

Late in August of 2016, a batch of heroin in Greater Cincinnati led to 174 overdoses in one week. Doctors were dumbfounded when they found traces of Carfentanil in the body. Carfentanil is an elephant tranquilizer that can be up to 100 times stronger than fentanyl, which is 50 to 100 times stronger than heroin. There are absolutely no human uses for Carfentanil, but cartels and dealers were willing to do whatever it takes to keep making the drugs stronger and stronger. The Ohio Addiction & Recovery Center reported that Carfentanil was involved in 1,010 overdose death in 2017 but only 75 in 2018.

Opioid Crisis in 2020

After declining 4.1% from 2017 to 2018, the Centers for Disease Control and Prevention (CDC) reported an 18% increase in the number of overdose deaths for the preceding 12 months ending in May 2020, with 25 states reporting increases over 20%. West Virginia saw a 32% increase in overdose deaths for that time period compared to the previous year. In Kentucky, deaths climbed by 27% and in Ohio by 16%. Overall, the CDC reported 81,230 drug overdose deaths occurred in the United States in the 12 months ending in May 2020, the largest number of drug overdoses for a 12-month period ever recorded. The CDC report, in turn, identified synthetic opioids linked to illicitly manufactured fentanyl as the primary cause for the increases in overdose deaths.

Percentage change in Overdose deaths from 12-months ending in June 2019 to 12-months ending in May 2020.

Centers for Disease Control and Prevention’s (CDC)

Concluding Thought

The underlying causes of the US heroin epidemic are social, economic, and psychological in nature. Prescription pain pills alone are certainly not the sole cause of the current heroin crisis. However, in retrospect, the wide availability of prescription opiates did act as the catalyst to the heroin problem. The epilogue to this prescription-pain story is that wrong incentives and controls coupled with regulatory and governmental actions coming too late allowed what some would say was an easily dismissed pill problem to morph into a nationwide opiate crisis.