The Cost of Regulating Pain
New restrictions on opioid prescriptions have come at a price
For a doctor’s office, this one was surprisingly warm. Two men sat slumped on the waiting chairs — one with his eyes closed, propped up on one arm, white paint on his jeans, zipper undone, the other scrolling through his phone. A woman in a mustard sweater and brown suede sneakers sat near the front desk on the edge of her seat, waiting for something. It was almost the end of the work day.
On a bulletin board near the front desk were a series of warnings. “Your calls are very important to us. Please call ONCE and leave a voicemail,” said one. Another: “Prior authorizations will not be completed over the phone.” Below hung half a dozen thank-you cards. “Blessed are the givers,” read one. “And grateful are the receivers. Thank you so much.” The patient had signed their name with “Love” at the bottom. Another card read, “This grateful heart will always remember all that you’ve done for me!”
Dr. Suelane Do Ouro seems to have her fair share of satisfied patients. As a pain management specialist, she and her partner serve approximately 1,200 pain patients at a private practice tucked away on Second Ave. between 42 and 43 St. in Manhattan. Her most flattering ratings come from Google and ZocDoc, where she ranks nearly five stars out of five from approximately 40 reviews on each platform. “The doctor and her staff are very good they really care about you,” one review reads. “I called because I was in terrible pain. Dr. Do Ouro saw me within the hour,” says another.
Do Ouro has committed the larger part of her life to studying and practicing medicine. After graduating from a prominent medical school in Salvador, Brazil, in 1988, Do Ouro found her way to the States, where she completed a residency in anesthesiology, followed by a fellowship in pain management at the State University of New York Health Science Center. Before starting her own private pain management practice two years ago, Do Ouro served as a pain specialist at the Department of Pain Medicine and Palliative Care at Beth Israel Hospital and was for 15 years the associate director of the pain medicine fellowship program at Beth Israel Medical Center.
She entered the office for our interview a few minutes late, but warm and upbeat. She spoke with a thick accent, but an advanced English vocabulary. She was confident, with a “strong personality,” as she put it, something she finds necessary in her profession. Her face, which appeared to be bare of makeup, was dewy and bronzed, as if she had just returned from a sunny vacation. Her shiny gold bob of hair framed her face like a mushroom top, while neatly manicured nails with sheer lavender nail polish gave the impression Do Ouro was much younger than her mid-50s.
Sitting with her hands interlaced in front of her, Do Ouro, unprompted, spoke about what she sees as the critical component for doing her job.
“You’ve got to love what you do, and you want to do this because you want to help people,” she said. But her job as a pain specialist has gotten much more difficult in recent years.
Pain management was not always a popular concept in the medical field. Anesthesiologists kept patients from being in extreme pain during surgery, and over the counter medications like Aspirin or Tylenol mitigated moderate pain caused by fevers or sore muscles. But patients who suffered from chronic pain were left, for the most part, under treated.
This began to change in the 1990s, in no small part due to the aftereffects of the Vietnam and Gulf Wars. As veterans began to receive more medical attention, the concept of treating pain became more mainstream. Patients began to rate their health care experiences in formal surveys, and doctors and hospitals soon realized that patients, if dissatisfied with their treatment of pain, would rate them poorly. Vying for high scores, doctors were incentivized to “treat pain liberally,” according to Beth Macy, a journalist who chronicled the events that led to America’s opioid crisis in her Dopesick: Dealers, Doctors, and the Drug Company That Addicted America. Pain was suddenly seen as a “fifth vital sign,” on the same level as blood pressure, heart rate, breathing rate, and body temperature. The concept was strongly advocated first by the American Pain Society and eventually adopted in 2001 by the Joint Commission on Accreditation of Healthcare Organizations in its Pain Management Standards. The Numerical Pain Rating Scale, which goes from zero to 10 and had existed largely unused since the 1920s, became institutionalized so that patients could self-identify their level of pain.
At the same time, the prominent pharmaceutical company Purdue Pharma saw a business opportunity. With the treatment of pain going mainstream, there was now a growing market for painkillers. Having successfully sold an end-of-life painkiller in the 1980s, whose patent was about to expire, the company prepared to launch a drug to replace it, one meant for more everyday use, one that would disrupt the market on an unprecedented scale: OxyContin. This was a form of the opioid-based painkiller oxycodone, which had been around for decades; OxyContin was a delayed-release version of oxycodone, which Purdue believed, or pretended to believe, would make it less addictive. After securing Food and Drug Administration approval for the drug in 1995, Purdue launched an aggressive and deliberately deceptive marketing campaign that falsely boasted of the drug’s safety.
One company executive, David Haddox, himself a pain specialist, would describe the drug’s addiction risk as “one-half of one percent” when taken as prescribed. According to Macy, this was an extremely low estimate that the company fabricated. In actuality, as it turned out, the drug was highly addictive.
By 1999, nonprofit health care and hospital accreditation body Joint Commission on Accreditation of Healthcare Organizations had approved new mandatory standards for assessing and treating pain. The problem with quantifying pain was and remains that pain is subjective; patients may claim the same level of pain from drastically different injuries depending on their tolerance. Thus, starting in the early 2000s onward, pain scales, and the new patient mentality that zero pain was the ultimate goal, increased opioid prescriptions, Macy wrote, unwittingly making way for Purdue Pharma to exploit the market. “This presents Purdue with the opportunity to provide [hospitals] true value-added services as the ‘pain experts,’” the company wrote of the Commission’s new requirements in its budget plan at the time.
The company planned to hand out nearly $1 million worth of OxyContin-branded resources like pens, guides to the drug, and wall chart reminders that pain was the fifth vital sign, according to Macy. But Purdue also had other tactics. Purdue sales reps swarmed doctors’ offices, offering perks for prescribing the drug like free upscale dinners and speaker-training conference trips to resorts in Florida and Arizona, all while downplaying the risks of addiction. (One indicator that the sales force had become more aggressive and successful: sales-rep bonuses exploded from $1 million in 1996 to $40 million in 2001.) New patients were given “starter coupons” for free prescriptions of Oxy. The company spread a promotional video called “I Got My Life Back: Patients in Pain Tell Their Story” without seeking FDA approval. In all, Purdue pushed one message: prescribing OxyContin was the moral and responsible thing to do.
As someone who was not always familiar with chronic pain management, Do Ouro knows from first-hand experience the difficulties that faced doctors who began prescribing opioids at the turn of the century. They wanted to help patients who came to them in pain, but “really didn’t have the knowledge to make a good diagnosis, so the easy thing that would help would be a painkiller,” she said. “And the only painkiller they knew was oxycodone.”
Doctors interviewed by Macy admitted to overprescribing opioids like Oxy, fentanyl, or morphine without having a full understanding of their effects on the body. News of a growing number of people addicted to prescription opioids spread, originating in the rural parts of states like Virginia and Maine, Macy wrote. Crime also rose — reports began appearing of armed robberies of drug stores carrying Oxy or addicts selling stolen valuables on the black market to fund their next buy. People were being hospitalized; people were dying of overdoses. The FDA heightened its efforts to monitor pharmaceutical companies like Purdue Pharma, as well as physicians prescribing the drugs, but the crisis continued to grow.
By 2008, overall overdose deaths were nearly four times higher than they had been in 1999; opioids accounted for more than half of them. A 2011 report by the CDC found that overdose deaths involving opioids exceeded deaths involving cocaine and heroin combined. In the report, the agency cited parallel trends in deaths and opioid sales over the past decade and admitted that numerous warnings to educate prescribers had gone largely ignored.
Finally, in 2016, the agency published a 52-page set of guidelines for prescribing opioids for chronic pain. Aimed at primary care physicians, the guidelines suggested a maximum prescribing dose for patients new to opioid treatment of 90 morphine milligram equivalents per day, a maximum prescribing period of under three months and patient monitoring and assessment methods. Non-opioid therapy, the guidelines made clear, was preferable whenever possible. However, for patients already on opioids, physicians should establish treatment goals for “continued opioid therapy.” For patients new to opioids who saw no improvement of pain or, worse, “escalating dosage requirements,” physicians were told to work with patients to come up with a slow and gradual taper plan. This would prove much easier said than done.
The guidelines were non-binding; if physicians prescribed outside of the recommendations, they were merely to ensure proper patient monitoring and be prepared to present written justifications. Nine times in the document, physicians were encouraged to consult with pain specialists on optimal pain management. The idea was to start addressing the opioid crisis at its source. The result has been a lot more complicated.
George and Cheryll Davis are 56 and 57, respectively. George, a former college and semi-pro football player who suffered injuries after falling out of a tree, has been on opioids since 2002. Cheryll, who has damage in every one of her spinal discs, largely from a motor vehicle accident, has been on opioids since 2001. They live in upstate New York, where until recently they had been seeing the same emergency medicine doctor, who was based in Binghamton.
Even before the CDC guidelines, the doctor was working with George to slowly taper his unusually high prescription doses of 30 milligram oxycodone eight times a day, alongside 40 milligram OxyContin three times a day. Whenever George needed to travel, the doctor in Binghamton was accommodating, offering to send his prescriptions to out-of-state pharmacies. Then, one day, the understanding stopped. It was 2018, around holiday time, and George had informed the doctor he would be traveling to Missouri to visit his son. As usual, he said, the doctor granted him permission. To get a head start on the drive, George set out on the road in his RV at around one o’clock in the morning. At nine a.m., he received a call from his doctor’s office. He was due at the office for a pill count within 24 hours.
Pill counts are common practice among doctors prescribing opioids. Patients are called in at random times to count how many pills they have left of their prescription for that month. The amount of pills remaining must match the amount of days left for that prescription, as proof they have been taking the medication as prescribed. The practice was recommended on a large scale in 2009 by the American Pain Society and the American Academy of Pain as a way to ensure adherence to treatment for patients on chronic opioid therapy. Though in its 2016 guidelines, the CDC found insufficient evidence to support the theory that pill counts help prevent misuse, they are still widely used by doctors in the field.
Knowing that he couldn’t possibly make it back to New York in time, George attempted to explain to the assistant that the doctor had authorized his travel. It didn’t matter, said the assistant. Increasingly worried, George offered alternatives: Could he visit a local pharmacy in Missouri for the pill count? No. Could he at least send gas receipts as proof of his travels? He could try. George collected his receipts and mailed them to Binghamton, anticipating approval. He still doesn’t know how long the package took to get there, or if it was even received. He never heard from the office again.
George managed to stretch his two-week supply for a month. Finally, he ran out. Within 24 hours, George was on the floor of his RV, throwing up. It was around Christmas. He was hospitalized for withdrawal, which, if untreated, is known to cause life-threatening complications like extreme dehydration or heart failure. Cheryll called the doctor to tell her what was happening to George, and to her surprise, the office informed her that George, and by extension she, was no longer their patient. They would only grant Cheryll one more 30-day refill while she found a new doctor; George was given no refills.
At the hospital, after undergoing medical detox, George was given a few opioids to hold him over until he found a new doctor. But unable to find one in time, a month later he again went into withdrawal and was hospitalized.
“It’s been a nightmare,” George told me.
When Cheryll learned that she no longer had a doctor, she reached out to her old pain clinic in Syracuse. On such short notice, she agreed to see whoever was first available, and ended up with a physician’s assistant who decided to put her on an entirely new regimen. Instead of her usual 15 milligram oxycodone three times a day, she was tapered immediately to zero. He also brought her fentanyl patch from 100 micrograms to 50, an extremely steep taper that the CDC has cautioned physicians against. After being on the 50 microgram patch for 30 days, Cheryll also went into withdrawal and was hospitalized. Then, that physician’s assistant dropped her, too.
“This is their solution to the opioid crisis,” said Cheryll, who talks slowly with a raspy voice and pauses frequently to take long, laborious breaths. She now takes medical marijuana for her pain, though it is less effective and more expensive; George has managed to get a prescription for suboxone, a drug that treats dependence on opioids while alleviating pain.
“We just sit here and we suffer and we hope for better days,” he said.
The couple’s story is not unique. Since the CDC guidelines were published, pain patients across the country report being dropped by doctors; being suddenly “tapered”; and being treated like addicts, even if they are not. Many report becoming suicidal from the sudden onset of pain. Some take their own life, as one physician in North Carolina documents on his blog. Some patients have resorted to buying heroin or fentanyl on the street, extremely dangerous drugs that pose a high risk of overdose.
Michael Fingerhood, an associate professor of medicine and physician at Johns Hopkins University, was part of a team that was tasked with reviewing the language of the CDC guidelines before they were published in 2016. The CDC intended the guidelines to encourage responsible prescribing, Fingerhood told me. For high doses of opioids, he said, the guidelines were “clear” that doctors should “come up with a plan to taper” and “it has to be really slow.” To stop high doses abruptly would be irresponsible, resulting in potentially life-threatening patient withdrawals.
Fingerhood described the unintended, paradoxical consequence of the guidelines: they were meant to combat overdose deaths, but instead have led to deaths from patient withdrawals.
He isn’t the only one to notice the harm done to patients by doctors misapplying the recommendations. In an op-ed published earlier this year in the New England Journal of Medicine, three authors who helped write the CDC guidelines expressed their concern that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.” Whereas the limits on prescribing were meant for patients new to opioid therapy, they were being “used to justify abruptly stopping opioid prescriptions” for patients already on high dosages.
Another part of the problem is a “non-centralized response” to the crisis, said Travis Rieder, a research scholar and director of the Master of Bioethics program at John Hopkins’s Berman Institute of Bioethics. He pointed to various state policies that go beyond the CDC guidelines, spreading fear and reducing the number of prescribers of opioids. In 2016, North Carolina’s Medical Board implemented an initiative for safer opioid prescribing that has since spurred more than 100 investigations into physicians in the state who manage patients on high doses. In a survey of physicians conducted by the board, 43% of respondents said they stopped prescribing opioids to chronic pain patients altogether in response to the crisis. Rieder attributes that to pressure from the Medical Board.
In a letter to the CDC earlier this year, a group of more than 300 medical providers and health experts, including Fingerhood, demanded that the agency investigate reported suicides and issue clarifications, “particularly on the matters of opioid taper and discontinuation.” In response, the CDC published a statement saying it “does not support abrupt tapering or sudden discontinuation of opioids,” and cautioned that the side effects of tapering may include “severe opioid withdrawal symptoms including pain and psychological distress.” The agency stressed that “hard limits [on dosage] conflict with the Guideline’s emphasis on individualized assessment of the benefits and risks of opioids given the specific circumstances and unique needs of each patient.”
Despite clarifications on tapering opioids from not only the CDC, but also the Food and Drug Administration and Department of Health and Human Services, for most experts, the response was too little, too late. Doctors have already changed their practices; they have dropped thousands of patients.
While agencies were right to issue clarifications and warn against abrupt tapering, “it’s not going to undo the damage,” Rieder said. “Society is going to have to do something more if we actually expect this to change.”
Aside from some states taking extreme measures to threaten prescribing doctors, state departments of health also now send out cautionary letters to physicians and pain specialists. With the help of prescription monitoring programs, states can track how much and which drugs a doctor is prescribing. If a state health department determines they are prescribing too many opioids or at too high of doses, it sends them a letter notifying them that they may be engaging in “high-risk opioid prescribing.” If the doctor is not prescribing for end-of-life care — the main exemption from the CDC guidelines — the department urges them to “reconsider your prescribing practices.” Do Ouro, who says she sees many pain patients who have been abandoned by other doctors, believes the letters may have played a role in intimidating those doctors, leading them to quickly taper or cut off patients on high doses. Do Ouro has also received the letters, though she is not fazed by them. She worries, however, that others may be.
Do Ouro opened her pain practice in 2017, several months after the CDC issued its guidelines. But she had been a practicing pain specialist for years before then. The guidelines seem to have never really worried her.
“I have never changed my practice, even now, because I’ve always tried to do what’s right before,” she said.
To Do Ouro, best practice means using “multi-disciplinary” approach, or considering alternative treatments like physical therapy before prescribing patients opioids. Do Ouro says she is “very rigorous” when choosing to whom to prescribe. Patients must meet her criteria and be willing to try non-opioid therapy first.
“I tell them, ‘Listen, if you’re here to get your oxycodone and go home, this is not the place,’” Do Ouro said.
Before taking on a new patient, she vets them on New York’s prescription monitoring program, where she can access their history with controlled substances. New patients must also take a drug test to prove they’re compliant with their prescriptions. Then, they discuss options for treatment.
Do Ouro considers patients who require high doses of opioids “candidates” for an intrathecal pump, which is implanted in a patient’s stomach and delivers lower doses of medicine to the patient’s spinal cord with a catheter. The pump, which requires 100 times less medicine than its oral equivalent, may sometimes initially be off-putting for patients, Do Ouro admitted. It is metal, the size of a baseball, leaves a patient’s stomach bulging, and must be refilled every three months by the insertion of a long needle into the stomach, an uncomfortable process. Nevertheless, Do Ouro said nearly half of her patients — about 500 — have pain pumps, including cancer patients, and so far, they work “pretty good.”
For the “very few” who are too fragile to receive the implantable pump, Do Ouro says she agrees to maintain them on a high dose orally, as needed.
Of course this is also easier said than done. Since the guidelines, Do Ouro and other doctors have been slammed with enormous amounts of paperwork and phone calls. When pharmacies, insurers, or hospitals require Do Ouro’s prior authorization on a patient’s medicine, patients reach out to Do Ouro with their requests, calling her office and texting her cell phone with pleas countless times a day. On the first Tuesday of November, Do Ouro received messages from at least 10 patients in the span of less than two hours. Do Ouro’s office receives, on average, 150 calls a day, she said. But Do Ouro does not seem to mind. She responds to every one she can.
“Nucynta isn’t available in 100 mg. with Walgreens, can you please send a prescription to another pharmacy that carries the medication?” one patient’s text read.
Do Ouro explained that one of her patients had to visit six pharmacies to find one that carried their prescription. Other times, she said, insurance companies refuse to cover certain pain medications; if a patient cannot afford the drug without insurance, Do Ouro looks for a suitable alternative the insurer agrees to cover.
One of Do Ouro’s patients had been in the hospital over the weekend where a doctor didn’t show up, so she was unable to receive pain medicine. She was texting with Do Ouro. She had to wait until she was discharged before Do Ouro was able to prescribe her medicine.
“I’m in a lot of pain in my back and right leg, which my orthopedist…keeps saying to call you for pain meds. But I have been trying to stick it out, and can’t do it anymore. I have an appointment in November with you to go over everything. Is there anything you can do for me until the appointment?” one patient pleaded over text.
Do Ouro said she came in and they were able to put her on a pain medicine.
One text Do Ouro received was from a pharmacist, demanding a document explaining why Do Ouro’s patient was being prescribed their pain medication. “We need to have those documents in our system for the Drug Enforcement Administration,” the pharmacist’s text read.
“So I need to prove to them why I’m doing those prescriptions,” Do Ouro said.
Do Ouro says she checks her cell phone throughout the day in between patients, whenever she gets a break. Patients can call the office, but they may not always be able to get in touch with Do Ouro that way. “I use this,” Do Ouro said, holding her iPhone, “because if they try to get to the office, and they don’t reach the office, they have my cell phone.” Do Ouro needs to be there for her patients, because they are in pain.
