In Search of a Safe Painkiller for Kids

The FDA recently approved OxyContin for pediatric patients. Many believe the decision will harm more children than it helps.

Eric Thayer / Reuters

Imagine your alarm ringing in the early morning. You reach over and hit the snooze button, but the buzzing won’t stop. In desperation, you unplug the clock, take out the batteries, even throw the darn thing against the wall—but defying all reason, the noise repeats endlessly. This is how Rachael Coakley, a psychologist at Boston Children’s Hospital, describes life with chronic pain: a broken alarm clock in the body, the pain constantly ringing out, with no purpose and no relief.

Thirty years ago, clinicians questioned whether or not infants could even feel pain, labeling an infant’s pain response as a “reflex.” Today, some studies using MRI scans suggest that babies may experience pain more intensely than adults. But while adults can choose from a plethora of pain pills to stop the metaphorical clock—Vicodin, Percocet, Dilaudid—the options for children are much more limited. Pediatric patients are far less likely to be prescribed narcotics; instead, they’re often given inadequate doses of analgesia, leaving their pain unresolved, often for months at a time.

Recognizing pain in children is one problem; managing it is another. With only 12 percent of clinical drug trials in the United States incorporating pediatric testing, doctors simply don’t know how to safely prescribe most medications to children, much less risky narcotics—which is why, when the FDA approved the use of OxyContin for children this past August, the news rocked the pediatric-pain world. For the first time, the agency was sanctioning an extended-release opioid pill for children as young as 11 years old.* On the one hand, a proven effective painkiller would finally be available for suffering children—but on the other hand, recent history suggests that the decision may harm some of the kids it’s meant to help.

When OxyContin hit the market in the United States in 1996, it filled a distinct need. An extended-release version of oxycodone, the shiny pink pills from Purdue Pharmaceuticals allow patients to take pain pills less often—every 12 hours, down from every four to six.** But the same trait that makes OxyContin a more manageable treatment for patients also renders it highly addictive: Because each tablets contains a concentrated dose, the pill mimics the powerful euphoria of heroin when it’s crushed and snorted, or mixed with water and injected, or simply swallowed by the handful. As an opioid, OxyContin shares a similar structure with heroin—both drugs are derived from the opium poppy, a brightly colored flower that has been used for millennia to relieve pain.

In fact, heroin itself was once used as a medication for both adults and children. In 1898, the German pharmaceutical-company Bayer introduced the drug as a cough medicine to ease the pain of the growing number of patients with tuberculosis. At the time, heroin was touted as an effective, non-addictive painkiller and cough suppressant for all ages; one advertisement of the time featured the words “The cough disappears” beneath an image of a mother feeding the “heroin medicine” to her little girl. But less than three decades later, addiction, abuse, and heroin-related crime had become so rampant that the U.S. outlawed the manufacturing of the drug with the Heroin Act of 1924.

A century later, its descendant, OxyContin, similarly benefited from an initial aggressive marketing campaign. From 1997 to 2005, the marketing budget for prescription drugs rose from $11 to $30 billion. As part of OxyContin’s aggressive publicity, Purdue boasted that its extended-release formula made the drug less addictive than other painkillers—a claim that eased the mind of general practitioners, many of whom practiced in rural areas and had little prior experience in prescribing pain medication. (In 2007, that blatant lie would lead to criminal charges against the company and three of its executives, along with $600 million in fines.)

Thanks to relentless promotion, the name OxyContin became more than simply a drug: It was now a brand, meaning physicians were more likely to prescribe it and patients were more inclined to ask for it. The strategy paid off; Purdue Pharmaceuticals has seen sales of more than $35 billion from OxyContin.

After its wide distribution, oxycodone, like heroin, soon found a place on the black market, especially in the Appalachian communities of Kentucky, Ohio, and West Virginia, before spreading across the country; today, it’s one of the most widely abused types of prescription medication in the U.S. In 2010, to combat the surge of abuse, Purdue Pharma came out with a reformulated drug, OxyContin OP, which turns to mush when it’s crushed. But this formula, widely described as “tamper-proof,” didn’t completely live up to that reputation. The rise of oxycodone has led to what the Centers for Disease Control calls an opioid-addiction epidemic: Of the nearly 23,000 Americans who die from prescription-drug overdoses each year, more than 16,000 died from opioid painkillers, either on their own or in conjunction with other drugs.***

If the drug has been destructive to its adult users, many people argue, its youngest patients may be even more vulnerable. In a New York Times op-ed earlier this year, Peter Shumlin, the governor of Vermont, argued that the drug is “poison for kids” and described the FDA approval as a “reckless act”; Hillary Clinton has called it “absolutely incomprehensible.” Meanwhile, Massachusetts is considering legislation prohibiting prescriptions of the drug for patients younger than 17, and a bipartisan group of U.S. Senators is calling for an investigation into the FDA’s decision, concerned about both the potential for abuse and the effects the drug may have on developing minds and bodies.

In a response to Shumlin’s editorial, Stephen Ostroff, the acting commissioner of the FDA, wrote that the approval “is not intended to expand the use of OxyContin among children, but to give doctors evidence-based information to safely prescribe the drug to opioid-tolerant pediatric patients,” particularly children in severe pain from debilitating illnesses or extensive surgeries. In fact, even before official FDA approval, OxyContin was already being prescribed to children—since 1994, opiate prescriptions for teens and young adults have nearly doubled.

But both proponents and opponents of the FDA’s recent move generally agree that use of the drug should be limited. In her clinic at Boston Children’s Hospital, Coakley routinely sees children and adolescents who have been suffering with unrelenting pain for months or even years—and many also suffer from anxiety and depression as a result. In these situations, Coakley says of her patients’ experience with opioids, “I hear them say, ‘It not only helps with my pain, it takes away my stress.’” But this comfort is often fleeting. While opioids broadly treat pain by dulling the activity of the central nervous system, they can also worsen a patient’s mood and increase anxiety; other side effects include persistent fatigue, impaired memory, and problems with concentration. The therapy also usually isn’t sustainable—unlike with adults, who may be prescribed narcotics for months or years, physicians are reluctant to treat pediatric patients with prescription painkillers over an extended period.

As Coakley describes in her forthcoming book When Your Child Hurts, she’s found a multidisciplinary approach to be effective with her patients. In addition to using non-opioid medications, she teaches parents and kids strategies like relaxation, mindfulness, and breathing techniques, and helps them construct return-to-function plans for returning to their lives after illness. Although she acknowledges the usefulness of OxyContin for short-term pain relief or recurring disease-related pain, such as cancer, Coakley worries that the FDA’s decision may lead to dangerous overuse in kids: “Many parents don’t realize that in young patients, even one extra dose can be lethal.”

That one extra dose could also open the door to abuse. The new FDA approval will undoubtedly help many pediatric patients, but it also means that OxyContin, like heroin before it, may be aggressively promoted as a medication for children. For a drug that has proven intensely profitable in the adult population, such a marketing strategy would likely be a lucrative one—and possibly a dangerous one as well. It remains to be seen, in other words, whether the relief that OxyContin brings to suffering children is enough to mitigate the risk that it presents.

“Pain relief,” writes Neil Schechter, the director of the chronic-pain clinic at Boston Children’s Hospital “is a basic human right.” But for many children, the alarm clock keeps ringing, with no safe, effective way to make it stop.

* This article has been updated to clarify the distinction between OxyContin and oxycodone. Additionally, it originally stated that OxyContin was the first opioid drug approved for pediatric use. We regret the errors.

** This article previously misspelled the name of Purdue Pharmaceuticals.

***  This article previously misstated the number of deaths attributable to opioid abuse.