OxyContin and me: drug company advertising and its influence on Maine physicians

The year was 1998. The continuing medical education (CME) lecture in Rockland, Maine was titled: Taking Chronic Pain Seriously, and was delivered by an anesthesiologist from my community hospital. As I settled into my seat in the crowded auditorium, I kicked off my shoes and opened the syllabus. This could be interesting. After all, nearly every patient I see with arthritis has some degree of chronic pain. Little did I realize that the lecture would radically change the prescribing habits of nearly every doctor in attendance, including me. Let the show begin.

First, The Set-up.  The house lights dimmed and our speaker stood at the lectern in the soft glow of a reading light. As a lecturer myself, I understood that the initial goal of any talk is to ‘hook’ the audience. Although it’s been more than a quarter century, I remember the set-up. It was pure Madison Avenue.

The carefully crafted message, sprinkled with medical references to maintain the trappings of a scientific lecture, outlined our shortcomings. In slide after slide, physicians in the audience were gently chastised for not taking the needs of our chronic pain patients seriously. They are your friends and neighbors we were reminded; your golf buddies; your colleagues. The chronic pain patient is the construction worker struggling to get up each morning for work; the fibromyalgia patient who tosses and turns all night; your elderly neighbor across the street struggling to maintain her independence.

We were told that chronic pain increases the risk of depression, leads to frequent absence from work, high rates of unemployment and alcohol abuse. It was a national disgrace that physicians weren’t doing a better job managing chronic pain. As physicians, the lecturer continued, we wouldn’t dream of undertreating pain in patients suffering with metastatic cancer. Why, then, don’t we offer the same options to our chronic pain patients? Around the country, in hundreds of lecture halls, well known physicians such as Russell Portenoy MD, a pain specialist at Memorial Sloan Kettering Cancer Center in New York, suggested that the medical establishment suffered from “opiophobia,” and that the risks of long terms narcotics were overblown.

Next, The Pledge. The solution for long-term management of chronic pain was with opioids, preferably with OxyContin, a twice daily sustained release drug with a favorable side-effect profile. I flipped to the back page of the conference materials and noted the sponsor for the talk was Purdue Fredericks Pharmaceutical, the makers of OxyContin. Never heard of them.

Despite my vague uneasiness that I was being manipulated, I found myself quietly agreeing with the basic premise: Yes, it’s time to take the unmet needs of our patients with chronic pain seriously. But what about addiction? What about diversion? What about tolerance? Where is the data? The lecturer, seemingly able to read my mind, clicked to a series of small print slides to address my concerns. I leaned forward to read the data. I couldn’t read the data. He summarized the data. Click, on to the next slide. Phrases such as, the risk of addiction is overblown, and a slide from the FDA approved package insert claiming that the patented delayed-absorption of OxyContin “is believed to reduce the abuse liability,” haunt me even today.

Finally, there was The Turn. The lecturer had made his case. Never mind that the FDA had not required Purdue to conduct long-term, real-world studies to test their dubious claims. Like a master magician, there had been misdirection–drawing attention away from the primary goal: Sell More OxyContin! Illusion, creating a false perception based on weak data. And finally, forcing, influencing behavior without doctors realizing they were being manipulated. The anesthesiologist ended his lecture with a warning. There had been the carrot, now, the stick. Not only was it important to recognize and treat our patient’s chronic pain, he looked soberly over the audience, but not doing so risked sanctions from our state medical societies and perhaps, lawsuits.

According to Patick Radden Keefe, the author of The Empire of Pain—a scathing history of the Sackler family and their promotion of Oxycontin through their family-owned business, Purdue Pharmaceutical—I was on the receiving end of a sophisticated infomercial aimed at changing my behavior. And it worked. Whether they admit it or not, nearly every physician who followed patients with chronic pain was influenced by this campaign.

In the following months and years, Purdue instructed sales representatives to follow-up with visits to physician’s offices, driving home a series of talking points. “Purdue instructed sales representatives to assure doctors—repeatedly and without evidence—that ‘fewer than one per cent’ of patients who took OxyContin became addicted.” *

*From The Family That Built an Empire of Pain, New Yorker, Oct 23,2017. In fact, according to Patrick Keefe, the company’s own records later revealed, the incidence of addiction to OxyContin was much higher. In one study (commissioned by Purdue Fredericks but never published), 29% of patients in West Virginia who were prescribed oxycontin for chronic headaches became addicted

At the end of the presentation, I was an agnostic, not a true believer. I noted that our lecturer presented only a single study demonstrating that narcotics can successfully treat chronic, non-malignant pain. His review of the study was superficial, and the duration of the study was relatively short. If we were to change our paradigm for treating long-term chronic pain, didn’t we need more data?

The stage had been meticulously set. A few years earlier, in 1995, the same year OxyContin was approved by the Food and Drug Administration (FDA), Dr. James Campbell addressed the American Pain Society urging that health care providers add pain to the traditional four vital signs: blood pressure, respiratory rate, temperature, and heart rate. A 10-point pain scale was soon adopted by hospitals and physician practices throughout the country instructing care providers to treat pain as the 5^th vital sign.

The inclusion of pain alongside the traditional vital signs was not without controversy. First and foremost, pain is a symptom, an individual experience. Signs are objective and can be measured. Changes in traditional vital signs may have serious implications: infection, respiratory failure, heart attack, stroke.

Symptoms cannot be independently verified or objectively measured on a 10-point scale. Pick a number and it is true, or as my nurse once commented, “One person’s 10 is another person’s 3.”  Was treating chronic pain really as simple as a patient reporting a number?

But even as an agnostic, even with the natural tendency for memory to gloss over past mistakes, I was subtly co-opted by that lecture. Despite my misgiving, my behavior changed; even an agnostic may attend church now and then.  Here are some examples.

The first involved a new patient to my practice. Smartly dressed in a button-down blue shirt with creased slacks and Top-Sider boat shoes, he claimed that he had recently moved to Maine from Pennsylvania for a new job. He brought no records but filled out his patient questionnaire in detail. On exam, when he stood and stretched his hands downward, his fingertips barely reached to his knees. An x-ray I obtained that morning demonstrated boney spurs throughout the lower spine (what is termed a ‘bamboo spine’) and a fused sacroiliac joint. The diagnosis: ankylosing spondylitis, one of my diseases. The patient was in the right office.

Our conversation turned to previous medications he had taken. Ibuprofen had triggered a bleeding ulcer. Prednisone had led to uncontrolled blood sugars. Mild pain medications such as Tylenol and Darvocet were ineffective for his pain. When his doctor prescribed OxyContin for his back pain it had worked. It was the first time in years that he slept through the night.

The patient was grateful that I was seeing him today; he was nearly out of his OxyContin prescription and hoped I could continue it. With it, he could go to work; without it, he was nearly bed-bound.

I filled his prescription, perhaps raising an eyebrow at the unusually high dose he claimed to be on. A week later I was called during office hours by the police from a neighboring town. My patient had been found dead, slumped in a bathroom stall with a syringe dangling from his arm and an empty bottle of OxyContin and a cigarette lighter on the tile floor. He’d melted down and injected the drug. My name was on the bottle. In his wallet were three photo IDs of him with three different names. Was there anything I could tell them about this man? It was embarrassing, but also true. I had met him once. Yes, I had written the prescription. No, I didn’t know he had recently been released from a half-way house in Pennsylvania. I had been duped.

In another case, a patient of mine was admitted to Mercy Hospital with a flare of lupus and abdominal pain. I consulted and was in charge of adjusting her immunosuppressive medications and also took responsibility for changing over her chronic oral narcotics I prescribed to intravenous narcotics after she underwent gallbladder surgery. Several hours later I received a phone call in my office. It was her floor nurse. “The patient is reporting her pain is an 8.” In response, I ordered a small bolus of narcotic and increased the infusion slightly. A few hours later, I was called again by a different nurse. “Your patient is reporting her pain is a 10! She’s writhing in the bed. Can’t you do something about her pain?” The sense of urgency was clear. The patient needed a higher dose of her IV narcotics.

I was in the middle of a busy afternoon seeing patients and instead of driving to the hospital and evaluating the patient, I relied on the number. I increased the dose. This was a serious mistake and it is mine alone. An hour later I was called by the charge nurse. “Your patient suffered a respiratory arrest. She stopped breathing almost immediately after the last dose of narcotics was infused. We were able to reverse it with Narcan.” There was a pause on the other end. “She’s fine now. That was an unusually high dose you wrote for.”

The meaning was clear. If the patient had died, I would have been directly responsible. I felt both guilty of poor judgement and puzzled how a patient could go from desperately crying out in pain to respiratory arrest with only a minor adjustment in their narcotic dose. On the basis of the number 10, I nearly lost a patient to a drug overdose. I never wrote another order for IV narcotics.

As the narcotic epidemic surged, the question of who should receive narcotics for chronic pain in my practice became, if anything, more complex. There were successes. For example, some of my patients had bone against bone arthritis in a knee or hip and suffered from chronic kidney failure, or heart failure, or uncontrolled diabetes. They were too high a risk to undergo joint replacement. In these cases, a small dose of a narcotic often reduced their burden of pain month after month, year after year.

In some of my rheumatoid arthritis patients with widespread damage to their joints, small doses of OxyContin improved their quality of life, allowing them to adopt healthy behaviors such as walking or swimming to further reduce chronic pain. Many of these patients never required higher doses of OxyContin to maintain their improvement.

Rheumatologists have always prescribed chronic opioids for this subset of patients in their practices. But it was a small subset. Despite our best efforts to prevent joint damage, some of our rheumatoid arthritis patients went on to crippling arthritis, and it was not uncommon for them to be prescribed low-dose codeine, propoxyphene, or even hydrocodone or oxycodone.

What was different now, was that the bar was suddenly lowered, the stigma eliminated, and we were awash with patient requests for better pain management. Some of these patients, as they say in the business, “Were not good candidates.” They had severe, chronic back pain with only minor x-ray evidence or damage. They had a history of alcoholism. They suffered from active depression or chronic anxiety and were not on medications or in therapy. There was a history of post traumatic stress disorder (PTSD).

One of the physicians in my practice was a medical Luddite. He rejected the notion that treating chronic pain with narcotics was an ethical imperative. He believed that there was no convincing evidence that opioids were effective in treating chronic pain. If an arthritis patient requested a narcotic, he simply told them to take up their request with their primary care provider. As the narcotic epidemic unfolded and narcotic prescriptions sky-rocketed, his practice was easier to manage. Because we covered for each other on weekends and vacations, it was soon apparent who was liberal with their narcotic prescriptions, who was an agnostic, and who was a Luddite.

As the narcotic epidemic raged, our private practice developed guidelines for narcotic prescribing, but it was reactive rather than proactive, too little and too late. We developed narcotic contracts. Patients provided urine samples to ensure they were taking their medication (and not diverting it for profit), but also to test for other addicting substances they might be taking.

We discharged some patients from the practice for violating the contracts. These were difficult visits. We changed out our prescription pads so that they could not be altered after a stack of prescription pads went missing. At our monthly meeting, we decided that no narcotic prescriptions were to be refilled by the on-call rheumatologist on weekends. It was the responsibility of the patient to call during the week when their prescribing physician was available. When our patients misplaced their pills, we refused to refill the prescription early. And no, we wouldn’t refill a prescription when the pills accidently fell in the toilet.

There were sophisticated ruses employed by addicts. I consulted on a middle-aged woman who lived in a rural community several hours north of Portland. At least 30 pounds underweight, she was a sad, small, wisp of a woman with extensive joint damage from rheumatoid arthritis. Her partner, a man who was twice her size, did much of the talking for her, finishing her sentences and telling me repeatedly, just how much pain she was suffering from. I found myself increasingly irritated by this.

When he finished yet another sentence for her, she looked down at the floor and quietly said, “Yes. I think that’s how I feel.”

After finishing my exam, I lightly touched her hand and said, “I believe with a change in your medications, we have a good chance of controlling the inflammation and reducing your pain.

“I’m all in favor of that,” her partner brightened. “The OxyContin her doctor prescribed worked like a charm. He’s moved on. He was only a temp. She was pain free when she was on the Oxy.”

“From the sound of it,” I said, acutely aware that her partner’s single-minded focus was on pain medications rather than the bigger picture of controlling her inflammation. “From the sound of it,” I repeated, feeling my way along in an increasingly uncomfortable interaction, “it’s been years since you’ve been prescribed what we call in rheumatology, a disease modifying medication. Going forward, my goal is to reduce pain by controlling inflammation, improve function by you working hand in hand with a physical therapist, and if the medications work well, we can prevent future damage.”

Her partner processed this. She continued to stare emotionlessly at the floor. “You mean to say,” he squinted at me, “You mean to say, that in addition to the Oxy, she needs other medications? That’s fine,” he decided. “She’s good at taking pills.”

“No.” I turned to meet his eyes. I was learning to trust my instincts in this new world of narcotic prescribing. “I mean that my focus will be on the treatment of her rheumatoid arthritis with medications that may place her in remission. Reducing inflammation will reduce pain. If we don’t meet that goal, I may add a narcotic, not before.”

“That don’t make no sense,” his voice had an edge to it. “She’s done just fine on the Oxy. I hear those other medications have side-effects.” He crossed his arms. It felt like a threat.

I ignored him and turned back to my patient. After reviewing potential side-effects of weekly methotrexate and the need for regular blood work to ensure its safety, I wrote out the prescription and asked her to stop in the lab for a blood draw. Then I handed her the billing sheet with a follow-up visit in six weeks. The visit was over. I didn’t look back. I suspected that I would never see the couple again. Once out of the room, I leaned against the wall and closed my eyes to clear my mind for the next patient. It was going to be a long day.

Over lunch, my nurse Joanne called the patient’s local pharmacy to verify her other medications. After a pause, the pharmacist noted that the patient’s Oxycontin prescription had been filled only a week previously and was relieved we were not prescribing the drug. “As a matter of fact,” he added, “I’ve had several calls about her in the past month. Apparently, she is on a number of prescriptions for Oxycontin from pharmacies outside our system.”

That was my first and last office visit with the patient. Her disease modifying medication was never picked up at pharmacy. I suspect, but don’t know with absolute certainty, that the unfortunate woman was being trafficked for drugs. The problem of patients going from doctor to doctor seeking narcotics would not be fixed until a state wide prescription monitoring program in Maine was established in 2003.

Purdue Pharmaceutical (owned by the Sackler family) has been sued for its role in promoting OxyContin. A number of these cases have been settled, not only against Purdue, but other conglomerates who played a role in the opioid epidemic. In Maine, despite controls on narcotic prescriptions, the number of fatal drug overdoses continues to climb. If the 1990’s were the decade of prescription opioids, the next decade was dominated by heroin, and recent years by fentanyl.

When I am asked my opinion as to whether Maine should legalize narcotics, I say we already tried that, and it was a disaster. Physicians were co-opted by an effective advertising campaign to write prescriptions for a population of patients who wouldn’t dream of taking an illegal narcotic but were prescribed oxycodone, hydrocodone, and OxyContin. A few benefitted. Many of our patients became addicted. Some of them died.

Today, I continue to struggle with how to manage chronic, severe pain. Mary-Ann Fitzcharles, MD, an associate professor of medicine at McGill University in Montreal, summarized the dilemma several years ago in an interview with Ronald Rapoport, MD for the on-line Rheumatology site, Helio Rheumatology. “Opioids are effective treatment for acute pain, but with limited evidence for effect in chronic rheumatic pain…They are not recommended for use for treatment of any rheumatic disease, largely based on the lack of studies and evidence for use.”

Based on this, some physicians never prescribe opioids for chronic pain, or if they assume the care of a patient whose doctor has moved or retired, the patient is required to taper down and discontinue their narcotic. This black and white attitude has left many patients bewildered and angry. One of my former patients with severe destructive RA who felt that low-dose narcotics had helped her cope with chronic pain, confided that she felt like a drug addict each time she refilled her narcotic prescription. The stigma is back.

In response, the New England Journal of Medicine, sought a middle ground. “As the pendulum swings from liberal opioid prescribing to a more rational, measured, and safer approach, we can strive to ensure that it doesn’t swing too far, leaving patients suffering as the result of injudicious policies.”

What is the future of chronic pain management? Science may yet solve the age-old dilemma of chronic pain as it has for so many of our ills. Where I lecture at the University of New England College of Osteopathic Medicine, and at other institutions around the country, research is ongoing for effective, non-addictive medications to reduce the burden of chronic pain. But there are other advances. Exercise, physical and occupational therapy as well as Yoga and Tai Chi have been shown to be effective adjuncts in managing chronic pain in carefully performed studies.

Cannabinoid derivatives may offer meaningful relief from pain. But again, perhaps not. According to Dr. Fitzcharles at the Louise and Alan Edwards Pain Management Centre at McGill University, “To date, there has been very limited study of pharmaceutical cannabinoid products in rheumatic diseases…and less convincing evidence for benefit. There are no published randomized clinical trials of herbal cannabis in rheumatic diseases.”

As clinicians we are trained to gather information, to assess the data, and to make evidence-based decisions. In the OxyContin magic show, the set up, the pledge, and then the turn, it was all an illusion. Physicians and their patients believed in the magic message. And we’re still paying the price.