Pain and Profit

Who is Responsible for the Opioid Crisis?

The following is a reprint of my article - “Pain and Profit: Who Is Responsible for the Opioid Crisis” - in the previous issue of Skeptic magazine. Thanks to

Michael Shermer

for giving me the green light to share this with my Just the Facts subscribers. (Please note, this is a long form article. If this newsletter is truncated in your email, just click “View the entire message” and you can read the full piece.)

In 2021 the CDC issued a grim statistic: more than one million Americans had died from overdoses since 1999 when it started tracking an opioid epidemic that began with prescription painkillers and is now dominated by fentanyl.^[i] Since that sobering milestone another 300,000 have died.^[ii] That is roughly the same number of Americans who died in all wars the United States has entered (1.3 million) combined, including the First and Second World Wars and the Civil War.^[iii] The opioid epidemic is, aside possibly from obesity, the biggest health crisis of our time.

Most know about the frenzy of finger pointing, lawsuits, bankruptcy filings among pharmaceutical companies, drug distributors, national pharmacy chains, medical associations, and the Federal Drug Administration. There is plenty of blame to go around. What is not often discussed in the extensive media coverage about the epidemic is how we got here.

The story of how the opioid crisis got underway and who is responsible is a tale of greed, poor government regulation, and many missed opportunities. It began with good intentions based on bad data and later became a movement in which profits took precedence over morals. It is a tragedy that was largely preventable and, as such, one of the most infuriating chapters in modern U.S. history.

History of Pain

Chronic pain affects 50 million Americans, more than those with high blood pressure, diabetes, or depression.^[iv]Developing a medication that alleviates pain without too many side effects has been one of the drug industry’s holy grails. The market is enormous, and most people are long-term patients. Opiates were isolated as effective pain killers in the 1800s. At the turn of the 20^th century—the drug industry’s Wild West days—they were dispensed over the counter. Over time, opiates earned a notorious and deserved reputation for addiction. German giant Bayer patented and marketed Heroin as, incredible as it now sounds, a cure for morphine addiction.

Congress did not pass a law requiring prescriptions for narcotic-based medications until 1938.^[v] It took another 33 years before the federal government created the Controlled Substances Act in 1971, listing oxycodone, fentanyl (along with cocaine and methamphetamine) as Schedule II drugs. That meant they had a risk of “severe psychological or physical dependence” but had medical and therapeutic uses. Doctors were supposed to balance the risks of opioids against the needs of patients who required them for short-term use after surgery or an accident, or longer treatment for disabling chronic pain. 

Throughout the 1970s and early 1980s, drug companies spent a lot of money searching for a nonaddictive painkiller. Every effort ended in failure. In a Science article, a pharmacologist and a chemist at the National Institutes of Health concluded that it was unlikely such a medication was possible.

This was the same time, however, when a few physicians were about to upend traditional medical views about pain and how to treat it. Until the early 1980s, medical schools taught that pain was only a symptom of some underlying physical condition. Physicians did not treat it as a stand-alone ailment but instead searched for what caused it. The specialty of “pain management” did not exist. An anesthesiologist, John Bonica, whom Time dubbed “pain relief’s founding father,” questioned the conventional wisdom. Bonica suffered chronic shoulder and hip pain from his pre-medical career, first as a professional wrestler, then a carnival strongman, and finally the light heavyweight world wrestling champion.^[vi]Bonica contended that underdiagnosing pain meant millions of patients suffered needlessly. He cofounded the International Association for the Study of Pain (its journal, Pain, is the field’s leading publication) in 1974, and three years later the American Pain Society (APS).^[vii]

The incipient movement to prioritize pain was not long underway when a five-sentence “letter to the editor” in the January 10, 1980, New England Journal of Medicine kicked off a parallel revolution in reconsidering established medical views about the risks of opioids. A doctor, Hershel Jick, and a grad student, Jane Porter, had examined 39,946 records of Boston University Hospital patients to determine adverse reactions and potential abuse for widely used medications. Almost a third (11,882) had “received at least one narcotic preparation” but they found only “four cases of reasonably well-documented addiction in patients who had no history of addiction.” Their conclusion was as unorthodox as it was decisive: “Despite widespread use of narcotic drugs in hospitals, the development of addiction is rare.”^[viii]

The letter cited two previous studies, both of which involved only hospitalized patients given small doses of opioids in a controlled setting. Very few had them been dispensed for more than five days. None were given painkillers after they were discharged from the hospital.

No one could have predicted the impact that letter had on the reassessment of using opioids to treat pain. During the next two decades it was cited over 600 times in textbooks, medical journals, and other publications. More than 80 percent of those who mentioned it left out that it only studied hospitalized patients who took opioids for a few days. Instead, that 99-word letter was widely cited to support far broader conclusions about the safety profile of opioids.^[ix](In 2017 the NEJM published a rare “Editor’s Note,” adding it to its webpage with the original Jick-Porter letter: “For reasons of public health, readers should be aware that this letter has been ‘heavily and uncritically’ cited as evidence that addiction is rare with opioid therapy.”)

The World Health Organization (WHO) cited the Jick-Porter letter in 1986 as a cornerstone for challenging decades of medical dogma that “the risks of widely prescribing opioids far outweighed any benefits.” Six weeks after the WHO publication, Pain published a startling report, the “Chronic Use of Opioid Analgesics in Non-Malignant Pain.” The lead author was Russell Portenoy, a 31-year-old Memorial Sloan Kettering physician specializing in anesthesiology, neurology, pain control, and pharmacology. His coauthor was Kathleen Foley, a top pain management specialist.

Portenoy and Foley had studied 38 patients who had been administered narcotic analgesics—a third took oxycodone—for up to seven years. Two thirds reported significant or total pain relief. There was “no toxicity,” the two doctors reported, and only two patients had a problem with addiction, both of whom had “a history of prior drug abuse.” They concluded that “opioid maintenance therapy can be a safe, salutary and more humane alternative to the options of surgery or no treatment in those patients with intractable non-malignant pain and no history of drug abuse.”^[x]

Pain as the Fifth Vital Sign

That paper kicked off a contentious and at times rancorous debate over whether opioids had been unfairly branded for decades and underutilized in pain management. The charismatic Portenoy emerged as the unofficial spokesman for the embryonic movement to reassess opioids. He saw himself as a pioneer in reexamining outdated views about opioids. If he could convince doctors not to fear dispensing opioids, it could help millions of patients suffering from chronic pain.

A diverse, informal network of physicians contributed to the emerging reevaluation. Doctors specializing in pain management formed The American Academy of Pain Medicine and the American Society of Addiction Medicine (its slogan is “Addiction is a chronic brain disease”). They in turn encouraged patients suffering from chronic pain to form advocacy groups and petition the FDA to loosen opioid dispensing restrictions.

In 1990, American Pain Society president, Dr. Mitchell Max, wrote a widely read editorial lamenting how little progress had been made in treating pain. “Unlike ‘vital signs,’ pain isn’t displayed in a prominent place on the chart or at the bedside or nursing station,” he wrote.”^[xi] Max’s fix was to have physicians ask patients on every visit about whether they were in pain. Doctors had for decades kept watch of four vital signs when examining patients: blood pressure, pulse, temperature, and breathing. The American Pain Society suggested “Pain as the 5th Vital Sign.”

There was no reliable diagnostic test, as there was for blood pressure or cholesterol. Pain was a subjective assessment based on the doctor’s observations and the patient’s descriptions of symptoms. What one patient described as moderate pain that restricted mobility might be excruciating and disabling for someone else. The first rudimentary measurements were developed around this time. One of them, the McGill Pain Index, had 78 words related to pain divided into 20 sections. Patients picked the words that best described their pain. Another, called the Memorial Pain Assessment Card, had eight simplified descriptions and patients selected the one that best matched their pain’s intensity. Yet another was developed by a pediatric nurse and child life specialist in Oklahoma—a chart for children with 10 hand-drawn faces ranging from happy and laughing to angry and crying. Variations of that scale soon became a 1 to 10 rating for adults, 1 being “very mild, barely noticeable,” and 10 signifying “unspeakable pain.”

Those tools meant that differing pain tolerances among patients were no longer important. What mattered was tracking whether a patient’s pain was getting better or worse. The Joint Commission, an independent, not-for-profit organization responsible for accrediting 96 percent of all U.S. hospitals and clinics, became the first major group to endorse pain as the fifth vital sign. After the Veterans Administration embraced it, it was adopted quickly in the private sector.^[xii]

Over the next few years, a series of other small trials published in medical journals reinforced Portnoy’s 1986 study. They uniformly concluded that opioids did not deserve their terrible reputation and that they were extremely “effective in treating long-term chronic pain.” Buried in scientific footnotes was that “long-term” usually meant 12 to 16 weeks and “effective in treating” meant “superior to placebo.”^[xiii]

An anesthesiologist and dentist, J. David Haddox, pushed the limits of the reevaluation movement. Haddox, who later became the American Academy of Pain Medicine president and went to work for Purdue Pharma, reported in Painabout the failure to treat the pain of a 17-year-old leukemia patient. That failure, wrote Haddox, had “led to changes similar to those seen with idiopathic opioid psychologic dependence (addiction).” “Pseudoaddiction” was a syndrome, he theorized, that doctors unintentionally caused when they failed to provide their patients with sufficient opioid painkillers. The “behavioral changes” that many doctors concluded constituted addiction, argued Haddox, was only evidence of how undertreated the patient was in terms of narcotic painkillers.^[xiv]

America’s three major pain associations embraced pseudoaddiction.^[xv] (It took a quarter century before a comprehensive study revealed that in the 224 scientific articles that cited pseudoaddiction, only 18 provided even the sketchiest anecdotal data to support the theory. The study concluded that pseudoaddiction was itself “fake addiction.”)

The same month that Haddox introduced pseudoaddiction, a dozen prominent doctors published “The Physician’s Responsibility Toward Hopelessly Ill Patients” in The New England Journal of Medicine. Although the study was limited to terminally ill patients, pain management advocates enthusiastically applied its conclusion to all patients: “The proper dose of pain medication is the dose that is sufficient to relieve pain and suffering.… To allow a patient to experience unbearable pain or suffering is unethical medical practice.”^[xvi]

New Jersey became the first state to adopt an “intractable pain treatment” law that recognized patients had a right to treat their pain. The statute shielded doctors from criminal or civil liability if the narcotics dispensed caused an addiction; 18 other states soon followed.

Enter Big Pharma

Portenoy and colleagues contended that opioids should be the first treatment option for chronic nonmalignant pain if the patient had no history of addiction. Instead of setting a maximum dose, the emerging standard of care was that opioids should be dispensed until the patient’s pain was relieved. The twin themes—that not treating pain was negligent and that opioids were safe for almost everyone—reinforced one another. The Sackler family, owners of a small drug company, Purdue Pharma, would have been hard pressed to plan a better lead-in to their release a decade later of OxyContin, their blockbuster opioid-based painkiller.

When the pain reevaluation movement had begun in the mid-1980s, OxyContin was not even on the drawing board. It was in early development when pain was on its way to becoming the fifth vital sign. In the following decade, Purdue did what every other drug company with an opioid-based product did: spent millions underwriting and subsidizing the doctors, advocacy organizations, and pain societies who were at the vanguard of the reevaluation movement. Many pioneering doctors reaped big fees as company lecturers. Purdue and other drug firms subsidized courses at medical schools, professional conferences and conventions, and continuing education classes. And, similar to what happened with the launch of other major drugs, some government officials (even a few key FDA officials) eventually went to work for Purdue and other firms selling opioids. Purdue and its competitors spent lots of money on the pain advocates precisely because they were promoting ideas about pain treatment that the drug manufacturers enthusiastically embraced.

The opioids revaluation movement might not have had such an impact if it was not for the development of a time-release opioid painkiller, OxyContin. Purdue, and its aggressive marketing of OxyContin, came at a time when doctors were more willing to believe that opioids could be safely prescribed.

Three psychiatrist brothers, Arthur, Mortimer, and Raymond Sackler had bought Purdue in 1952. It was then a tiny New York drug company whose product line consisted mostly of natural laxatives, earwax removers, and tonics that claimed to boost brain function and metabolism. A decade after purchasing Purdue, the Sacklers added a distressed British manufacturer, Napp Pharmaceuticals. The Sacklers had not thought about developing a painkiller until Napp took advantage of an opportunity in the United Kingdom.

Cicely Saunders, a British nurse-turned physician, had opened the world’s first hospice in London in 1967. Her biggest obstacle in alleviating patient’s terminal discomfort was the need to dose painkillers intravenously every few hours. The patients got little sleep and it was not possible to send them home to spend their last days surrounded by friends and family.

Morphine, Saunders found, was not as effective in alleviating pain as diamorphine (a brand name for heroin). Heroin’s biggest drawback, she concluded, was that “it may be rather short in action.”^[xvii] She experimented by adding sedatives and tranquilizers to extend the time pain was relieved, but she was stymied at every turn by intolerable side effects.

Still, Saunders had a permissive view of opioids and their addictive power. She did not think heroin had a “greater tendency to cause addiction than any other similar drug.… We have several patients in the wards at the moment who have come off completely without any withdrawal symptoms.”^[xviii]

What she wanted was a revolutionary narcotic painkiller. In a single dose, it had to provide long relief from intense pain without causing sleepiness, motor coordination problems, and memory lapses. Several independent British pharmaceutical companies accepted her challenge. Smith & Nephew developed Narphen, a synthetic opioid it claimed was 10 times more powerful than morphine, quicker acting, and had a milder side effects profile. Although Saunders acknowledged that Narphen was a better end-of-life drug, it was not her holy grail for terminal cancer pain.

Smith & Nephew’s stumble handed the Sacklers an opportunity. Napp launched a significant research effort to find the new painkiller. When the breakthrough came in 1980, it promised not only to revolutionize pain care for the terminally ill, but it unwittingly provided the technology that would later fuel America’s opioid crisis. Napp introduced a morphine painkiller with a revolutionary, invisible-to-the-human-eye, sustained-release coating. That chemical layer consisted of a dual-action polymer mix that turned to a gel when exposed to stomach acid. Napp claimed the drug, MST Continus (continuous), released pure morphine at a steady rate over 12 hours. They could adjust the release rate by fine-tuning the density of the coating’s water-based polymer. It was the breakthrough painkiller for which Cicely Saunders had been searching since the late-1960s.

MST Continus carved out a market in the UK, but it was limited for end-of-life cancer and hospice patients. It took the Sacklers seven years (until 1987) to get FDA approval for that drug in the U.S. (which they renamed MS-Contin). The FDA had slowed the approval process since its active ingredient, morphine, was a Schedule II controlled substance. By the time it went on sale in America, Portnoy had published the first of his studies concluding that opioids were not as addictive as previously thought and that they should be prescribed liberally to treat pain.

Purdue, now run by two of the surviving Sackler brothers, Mortimer and Raymond, and some of their children, took note of the burgeoning pain management movement. Raymond’s son, Richard Sackler, also a doctor, led a company effort to find an improved painkiller, or at least one with much broader commercial appeal than MS-Contin. Richard Sackler thought that any new painkiller should not use morphine since it had a notorious reputation as an end-of-life medication. Purdue’s science team picked oxycodone, a chemical cousin of heroin. While there were some oxycodone-based painkillers on the market—Percodan (oxycodone and aspirin) and Percocet (oxycodone and acetaminophen)—they were immediate-release pills. If Purdue could master an extended-release oxycodone pill, it would be the first of its kind.

Their oxycodone-based drug was still an unnamed product. Its first clinical trial was only completed in 1989. It took until 1992 for Purdue to apply for a patent. In 1995, the company finally got FDA approval. And it also won an extraordinary concession from the government regulator. Although Purdue had not conducted clinical trials to determine whether OxyContin was less likely to be addictive or abused than other opioid painkillers, the FDA had approved wording requested by the company: “Delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”^[xix] (Curtis Wright, the FDA officer who oversaw the OxyContin label approval, soon left the agency to work at Purdue as its medical officer for risk assessment).

Marketing Pain

Purdue’s sales team highlighted that extraordinary sentence to convince physicians that it was a safer narcotic than its rivals. Purdue prepared an unprecedented marketing launch for OxyContin.  The late Arthur Sackler was a marketing genius, widely acknowledged as having introduced aggressive Madison Avenue advertising tactics to selling pharmaceuticals. Arthur had handled the promotion for Hoffman LaRoche’s 1960s blockbuster drugs, Librium and Valium, and had made them the biggest-selling drugs in the world for a record 17 years.

Purdue laid out a sales strategy for OxyContin straight from Arthur’s playbook. Its twin sales pitches were that OxyContin relieved pain longer than any other opioid painkiller, and because it was a time-release product, it was less likely to be addictive. 

Purdue sales reps raised “concerns about addiction” before physicians did. It was, they said, understandable that no matter how wonderful a drug, “a small minority” of patients “may not be reliable or trustworthy” for narcotic painkillers. If the doctors were still skeptical at that stage, the reps showed them the FDA-approved label that stated if OxyContin was used as prescribed for treating moderate to serious pain, addiction was “very rare.” What constitutes “very rare”? Less than 1%, according to the sales reps. To tilt the odds in favor of its “low risk of addiction” sales strategy, Purdue underwrote several studies that reported addiction rates from long-term opioid treatment between only 0.2 percent and 3.27 percent. However, those company-sponsored reports were never confirmed by independent studies.

Purdue also got help in promoting the “low risk of addiction” from the American Pain Society and the American Academy of Pain Medicine. Purdue and other opioid drug manufacturers were generous funders of both organizations. The groups issued a consensus statement emphasizing that opioids were effective for treating nonmalignant chronic pain and reiterating that it was “established” that there was a “less than 1 percent” probability of addiction.”

Purdue sales reps hammered home that OxyContin released oxycodone into the bloodstream at a steady rate over 12 hours. That, Purdue claimed, made it impossible for addicts to get the rush they chased. Without a high, patients would not want more of the drug as it wore off. The company knew that was not true—its own clinical trials demonstrated that for some patients up to 40 percent of oxycodone was released into the bloodstream in the first hour or two. That was fast enough to cause a high and a resulting crash that required another pill in order to feel better.

Purdue revised its compensation packages for its sales team, especially top performers, in time for the OxyContin launch. Large bonuses could double a sales rep’s salary. In an internal memo to the “Entire Field Force,” Purdue used a Wizard of Oz analogy to promise the reps who sold the most that “A pot of gold awaits you ‘Over the Rainbow.’” Two months later after Oxy went on sale, another memo titled, “$ It’s Bonus Time in the Neighborhood!”, urged the sales team to push doctors to prescribe the higher-dose pills.

There was far greater profit for Purdue, and more money for the sales team, by pushing higher doses. There were three strengths when it went on sale: 10, 20, and 40 milligrams. An 80 mg tablet was released a month later (15, 30, 60, and 160 mg pills would arrive in a few years). Purdue’s production costs were virtually the same for each since oxycodone, the active ingredient, was inexpensive to manufacture. However, Purdue charged more for each additional strength. On average, a bottle of 20 mg pills cost twice as much as the 10 mg variety, and 80 mg pills were about seven times more expensive. If a patient took 20 mg pills twice a week, Purdue made less than $40 in profit. The same patient prescribed 80 mg pills twice a week returned $200 to Purdue, a 450 percent increase (that profit exceeded $600 a bottle in another five years).

Dispensing physicians had no idea what Oxy cost, nor did most care. Since they did not pay for the drugs, they let patients and their insurance companies worry about that.

Purdue created “Individualize the Dose,” a campaign designed to push the strongest doses. Sales reps told doctors that the company’s studies showed it was best to start patients on a medium to higher dose. The stronger doses, Purdue assured physicians, could be dispensed even to people who had never used opioids, all without adverse effects. The field reps contended that the higher-dose pills were no more likely to cause addiction. That was not true. Internal documents later revealed that Purdue’s sales team knew that stronger doses carried a significantly higher likelihood of dependence, addiction, and even potentially lethal respiratory suppression. While the company’s press releases claimed “dose was not a risk factor for opioid overdose,” internal communications are replete with references to the dangers of “dose-related overdose.”

OxyContin was instantly the most successful drug Purdue ever released. By 2001, only five years after it had gone on the market, its cumulative sales had passed a billion dollars, a first for Purdue. Although a lucrative hit for the Sacklers, OxyContin was less than ten percent of the opioid market. Johnson & Johnson, Janssen, Cephalon, and Endo Pharmaceuticals had their own narcotic painkillers. Their sales teams pitched them as aggressively as Purdue pushed Oxy, and all the companies subsidized the same nonprofits and patient advocacy groups. Janssen managed to get FDA approval in 1990 for the first fentanyl patch to treat severe pain. Fentanyl was then the most potent synthetic opioid, one hundred times stronger than morphine and 1.5 times more powerful than oxycodone. Two years after the FDA had given a green light to OxyContin, it approved Cephalon’s Actiq, a fentanyl “lollipop,” for cancer patients whose intense pain did not respond to other narcotics. Fentanyl patches and Actiq pops were diverted illicitly for big profits and sometimes with lethal side effects. There were widespread industry rumors that Cephalon’s sales team pushed its lollipops off-label as “ER on a stick” for chronic pain.

Still, by 2001, it was OxyContin that was in the crosshairs of some angry patients, the media, and the DEA. Small towns throughout Appalachia seemed overrun by a deluge of OxyContin, locally called “Hillbilly Heroin.” The DEA, meanwhile, was investigating diversion of the drug from the manufacturing plant Purdue used in New Jersey. It was also compiling evidence that Oxy contributed to overdose deaths by examining autopsy reports from across the country. The DEA wanted the FDA to put strict restrictions on the number of refills allowed for the painkiller.

In February 2001, OxyContin appeared for the first time in the New York Times, a front-page story—“Cancer Painkillers Pose New Abuse Threat”—about how it had become an abused drug in at least seven states.^[xx] The Times raised the issue of whether Purdue’s hard-hitting marketing was partially responsible for the growing problems.

Purdue went all out to battle the bad press and its regulatory headaches. It hired big name legal talent. Rudy Giuliani, fresh off being America’s Mayor after his handling of the city in the aftermath of the 9/11 attacks, had just opened a private office and he began lobbying government officials on Purdue’s behalf. The company dispatched its medical officers and top executives to meet with the FDA and DEA. It assured both that it was working to control any abuse and diversion and it contested the findings about Oxy’s role in overdoses by pointing to the cocktail of illicit drugs in most of the autopsy reports. At that stage, the DEA could not find a death in which the victim had only Oxy, without alcohol, benzos, heroin, cocaine, cannabis, or some other drug. In the same month as the Times story, Richard Sackler sent an internal Purdue email that said, “We have to hammer on the abusers in every way possible. They are the culprits and the problem. They are reckless criminals.”

Purdue emerged mostly unscathed from all the extra scrutiny. Although the FDA did require changes to OxyContin’s label, it was far less than what activists wanted. The FDA ordered the addition of a so-called black box warning. The bold-font warning was a reminder to doctors that OxyContin was “a Schedule II controlled substance with an abuse liability similar to morphine.” No drug company liked having a black box warning on its label, but as I learned in my reporting, Purdue was not upset since it considered the language a good compromise. One marketing executive remarked later, “It is black box lite.” It merely reiterated what most physicians knew already about OxyContin.

In 2004, OxyContin officially earned the dubious distinction as the most abused drug in America.^[xxi] Parents who had lost children to OxyContin were trying to raise awareness about the drug’s dangers. The biggest concern for Purdue, however, was an ongoing investigation into Oxy’s marketing by the West Virginia U.S. Attorney, John Brownlee, who started his probe in 2002. West Virginia was one of states hardest hit by OxyContin. In 2006, Brownlee was ready to bring a case. He forwarded a six-page memo to the DOJ’s Criminal Division to get authorization to file felony charges against Purdue and its top executives for money laundering, wire and mail fraud, and conspiracy.^[xxii] 

Brownlee got bad news from headquarters. The Criminal Division vetoed all the serious felony counts and instead gave him permission only to bring less serious charges around misbranding the drug. That was a clean and straightforward prosecution.

In May 2007, Purdue and three non-Sackler executives accepted a plea agreement. The company and officers pled guilty to a scheme “to defraud or mislead, marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.”^[xxiii] Purdue’s fine was $634.5 million, and the three executives paid a combined $34.5 million.

Purdue signed both Consent and Corporate Integrity agreements. It agreed not to make “any written or oral claim that is false, misleading, or deceptive” in marketing OxyContin and to report immediately any signs of false or deceptive marketing. The strict terms of those agreements should have been the end of Oxy’s nationwide trail of devastation. Instead, the ink was barely dry before Purdue started flagrantly disregarding the rules. The deadliest years and record abuse with OxyContin came after the 2007 guilty pleas.

And Then It Got Even Worse

Purdue went on a hiring binge that eventually doubled its sales force. It unleashed them to push Oxy with a renewed vigor. The company also paid millions to the “key physician opinion leaders” so they would convince doctors that OxyContin should be their first choice whenever a patient presented with serious pain. The results were impressive. In the year that Purdue pled guilty, sales passed $1 billion annually and profits exceeded $600 million. OxyContin provided 90% of Purdue’s profits.

When Purdue faced the possibility of generic competition in 2010, the company devised a “new and improved” coating that it said was more difficult to crush, snort or inject. Although Purdue’s two small studies showed the new version had “no effect” in reducing the addiction and overdose potential, the FDA still approved tamper-resistant OxyContin. (It took ten years before an FDA advisory panel ruled that the tamper-resistant Oxy had failed to reduce opioid overdoses).

With the FDA approval, Purdue spent millions on a splashy ad campaign directed to physicians. Titled “Opioids with Abuse Deterrent Properties,” Purdue touted its crush-resistant formulation as the first ever narcotic pain reliever that reduced the chances for abuse and slashed the addiction rate. The campaign worked. Many doctors believed it and increased their prescribing pace.

In 2011, four years after Purdue’s criminal guilty plea, OxyContin surpassed heroin and cocaine to become the nation’s most deadly drug. Sales were also at a record, each year breaking the previous year’s record. When there was a slowdown in 2013, the Sacklers brought in McKinsey & Company consultants, who laid out a plan to “supercharge” sales. The results were almost immediate. In 2015, Forbes listed the Sackler family on its “Richest Families” list for the first time. The Sacklers, with an estimated net worth of $14 billion, had jumped ahead of the Rockefellers, Mellons, and Busches, among many others. Forbes titled the family “the OxyContin Clan”.^[xxiv]

The news about the Sacklers great fortune was lost under a deluge of news about the national toll from OxyContin. By 2015, for the first time opioids killed more people than guns and car crashes combined, and the lethal overdose even surpassed the peak year of HIV/AIDS deaths. Statisticians blamed OxyContin for the first decline in two decades in the life expectancy of Americans. And a CDC report confirmed what some doctors suspected: prescription opioid users were 40 times more likely to become heroin addicts, making Oxy the most effective gateway drug into heroin. The CDC urged doctors either to “carefully justify” or “avoid” prescribing more than 60 mg daily. Still, the guidelines were voluntary. Only seven states passed legislation to limit the number of prescriptions.

In 2016, OxyContin and the opioid epidemic became a presidential campaign issue. The Joint Commission, responsible for accrediting hospitals and clinics, reversed its 2001 position that pain should be the fifth vital sign. Even the FDA was slowly recognizing the extent of the problem. Parents who lost children to opioids had submitted a citizen’s petition to the FDA, pleading with the regulators to classify Oxy for severe pain only. After eight years on the back burner, the agency was seriously considering it.

It's Only Money

Suddenly, the Sacklers and Purdue, and their competitors, were on the defensive. The Trump administration declared the opioid epidemic a public health emergency in 2017. That action freed up extra federal resources for treatment. A few months later, forty-one state attorneys general subpoenaed internal Purdue marketing and promotion documents. Purdue announced plans to slash its sales force by half and that it would no longer market Oxy directly to individual physicians, instead concentrating on hospitals and clinics.

In 2019, a judicial panel decided to streamline the more than 2,500 pending lawsuits under the jurisdiction of a single federal judge in Ohio. The consolidated lawsuit was called the National Prescription Opiate Litigation. The following month, the Massachusetts Attorney General filed an amended complaint that was different from all others. It relied on Purdue’s internal records to conclude that eight of the Sackler-family directors had “created the epidemic and profited from it through a web of illegal deceit.” The New York Attorney General filed a similar action a few weeks later and added that the Sacklers had personally transferred hundreds of millions in assets to offshore tax havens.

To drive home how much the Sacklers had profited from OxyContin, court documents filed by the attorneys general revealed that the family directors had voted payments of $12 to $13 billion in profits since OxyContin went on sale. By the end of 2019, OxyContin had $35 billion in sales from its launch, while America recorded its 200,000 death since the government had begun tracking them.^[xxv]

In the end, it was lawyers, state prosecutors, and the nation’s top class action litigators, who pried some financial justice from the many parties that shared responsibility for the national tragedy. Purdue filed for bankruptcy protection in late 2019 and the Sacklers sought protection from all the civil litigation so long as they contributed a lot of money to an overall settlement. In 2022, the family agreed to pay $6 billion toward a settlement and a bankruptcy judge signed off on a plan that freed them from civil litigation.^[xxvi] (I co-wrote two New York Times opinion pieces that argued the judge had exceeded his bankruptcy court authority by discharging all actions pending against the Sacklers, who had not themselves, filed bankruptcy. That issue and the complex bankruptcy plan are now pending before the Supreme Court.) Under the bankruptcy plan, Purdue became a public entity that continued to sell OxyContin, with any proceeds going to treatment and public health.

In 2022, Johnson and Johnson paid $5 billion to settle the litigation pending against it. J&J also announced it was quitting the opioid painkiller business. The country’s three largest wholesale drug distributors—AmerisourceBergen, Cardinal Health, and McKesson—reached a settlement in the tsunami of litigation pending against them by paying a combined $21 billion.^[xxvii] Another $13.8 billion came from the big three pharmacy chains, Walmart, Walgreens, and CVS. Rite Aid filed for bankruptcy protection. The litigation has produced about $55 billion in total settlements.^[xxviii]

Still none of that matters to many families who lost loved ones to the overzealous marketing of prescription painkillers. And, with the many families I have interviewed, they note that no one has gone to prison for having made such enormous profits off the deaths of several hundred thousand Americans. Many who helped fuel the epidemic, such as overprescribing doctors, owners of pill mills, and lax regulators at the FDA and in state health agencies, got away without so much as a slap on the wrist.

An unnamed plaintiff’s lawyer told The Guardian in 2018 that the Sacklers were “essentially a crime family…drug dealers in nice suits and dresses.” No prosecutors, however, had the courage to bring a criminal action against the Sacklers and other opioid kingpins.

What a shame.

---

Gerald Posner is an award-winning journalist and author of thirteen books, including New York Times nonfiction bestsellers Why America Slept (about 9/11) and God’s Bankers (about Vatican finances), and the Pulitzer Prize finalist Case Closed (about the JFK assassination). His latest, Pharma, is a “withering and encyclopedic indictment of a drug industry that often seems to prioritize profits over patients.” (NY Times) A graduate of the University of California at Berkeley, he was a litigation associate at a Wall Street law firm. Before turning to journalism, he spent several years providing pro bono legal representation on behalf of survivors of Nazi experiments at Auschwitz. That led to his first book, Mengele, a biography of the Nazi doctor.

---

^[i] https://rb.gy/6a7hv

^[ii] https://rb.gy/8pyh2

^[iii] https://rb.gy/h7pop

^[iv] https://rb.gy/lviuy; https://rb.gy/wrekp

^[v] Cavers, D. F. (1939). The Food, Drug, and Cosmetic Act of 1938: its legislative history and its substantive provisions. Law & Contemp. Probs., 6, 2.

^[vi]  “John Bonica, Pain’s Champion and the Multidisciplinary Pain Clinic,” Relief of Pain and Suffering, John C. Liebeskind History of Pain Collection, Box 951798, History & Special Collections, UCLA Louise M. Darling Biomedical Library, Los Angeles, CA.

^[vii] Brennan, F. (2015). The US congressional “Decade on pain control and research” 2001–2011: a review. Journal of pain & palliative care pharmacotherapy, 29(3), 212-227.; https://rb.gy/zmifj

^[viii] Porter, J., & Jick, H. (1980). Addiction rare in patients treated with narcotics. The New England journal of medicine, 302(2), 123.

^[ix] https://rb.gy/zmg4c; https://rb.gy/leawh. In 2017, six researchers published in the NEJM the results of their review of all subsequent citations to the 1980 letter. “In conclusion, we found that a five-sentence letter published in the Journal in 1980 was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy. We believe that this citation pattern contributed to the North American opioid crisis by helping to shape a narrative that allayed prescribers’ concerns about the risk of addiction associated with long-term opioid therapy.” Dr. Jick told the Associated Press in 2017: “I’m essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did.”

^[x] Portenoy, R. K., & Foley, K. M. (1986). Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain, 25(2), 171-186.

^[xi] Max quoted in Schottenfeld, J. R., Waldman, S. A., Gluck, A. R., & Tobin, D. G. (2018). Pain and addiction in specialty and primary care: the bookends of a crisis. Journal of Law, Medicine & Ethics, 46(2), 220-237.

^[xii] Morone, N. E., & Weiner, D. K. (2013). Pain as the fifth vital sign: exposing the vital need for pain education. Clinical therapeutics, 35(11), 1728-1732.

^[xiii] Sullivan, M. D., & Howe, C. Q. (2013). Opioid therapy for chronic pain in the United States: promises and perils. PAIN®, 154, S94-S100.

^[xiv] Weissman, D. E., & Haddox, J. D. (1989). Opioid pseudoaddiction—an iatrogenic syndrome. Pain, 36(3), 363-366.

^[xv] “Definitions Related to the Use of Opioids for the Treatment of Pain,” Consensus Statement of the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine, approved by the American Academy of Pain Medicine Board of Directors on February 13, 2001, the American Pain Society Board of Directors on February 14, 2001, and the American Society of Addiction Medicine Board of Directors on February 21, 2001 (replacing the original ASAM Statement of April 1997), published 2001.

^[xvi] Wanzer, S. H., Federman, D. D., Adelstein, S. J., Cassel, C. K., Cassem, E. H., Cranford, R. E., ... & Van Eys, J. (1989). The physician's responsibility toward hopelessly ill patients. A second look.

^[xvii] Saunders, C. (1965). The last stages of life. The American journal of nursing, 70-75.

^[xviii] Saunders, C. (1963). The treatment of intractable pain in terminal cancer. Proceedings of the Royal Society of Medicine, 56, 195-197.

^[xix] https://rb.gy/l7kvh

^[xx] https://rb.gy/tzwla

^[xxi] Cicero, T. J., Inciardi, J. A., & Muñoz, A. (2005). Trends in abuse of OxyContin® and other opioid analgesics in the United States: 2002-2004. The Journal of Pain, 6(10), 662-672.

^[xxii] https://rb.gy/xdv0m

^[xxiii] 2007-05-09 Agreed Statement of Facts, Para 20.

^[xxiv] https://rb.gy/qi6ph

^[xxv] https://rb.gy/67baw

^[xxvi] https://rb.gy/580po

^[xxvii] https://rb.gy/hz79m

^[xxviii] https://rb.gy/ma2m8

---