Pain brings more people into contact with medical professionals than any other problem. The most common medical treatment for pain—both acute and chronic—is opioid medications (so-called “painkillers”), such as hydrocodone (Vicodin, Lortab) and oxycodone (Percoset, OxyContin).
OxyContin, a high-dose, sustained-release form of oxycodone, was approved by the US Food and Drug Administration (FDA) to treat pain in adults in 1999. This past August, the FDA approved the use of OxyContin for a new population—children and adolescents, ages 11 to 16 who are suffering from long-term pain. Prior to this, physicians could use their discretion to prescribe OxyContin and other opioids to this population.
Very few opioid pain medications are approved for use with children. This notwithstanding, the FDA issued this approval without convening an advisory committee of professionals to consider potential risks and benefits—a process the agency typically uses when facing a controversial decision.
The Genesis of an Epidemic
Since the late 1990s the sales, use, and abuse of prescription opioids have escalated dramatically, begging the question: What changed?
What changed was that pharmaceutical companies began to make a concerted effort to shape medical opinion and practice.[i] A 2009 article in the American Journal of PublicHealth described how, for the first time in history, a drug company effectively created an epidemic. “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy,” provides an in-depth analysis of how this opioid medication was aggressively promoted and marketed by its manufacturer, Purdue Pharma.
Retail sales of OxyContin in the US grew from $48 million in 1996 (when it was first introduced) to almost $1.1 billion in 2000. The proliferation of OxyContin correlated with increased abuse, diversion, and addiction, and by 2004 OxyContin had become one of the most abused drugs (and the most abused prescription drug) in the United States.[ii]
During that same five-year period, Purdue Pharma sponsored dozens of all-expenses paid national pain-management and speaker-training conferences that were attended by thousands of physicians, pharmacists, and nurses—who were then recruited and trained for the company’s national speaker bureau. Purdue Pharma sent sales reps out to physicians across the country, distributing marketing materials and promotional items branded with the OxyContin name to such a degree that, according to the DEA, it was unprecedented for a Schedule II opioid. This multifaceted campaign was designed to promote the use of opioids for use in treating non-cancer-related chronic pain.
Historically, doctors had generally been conservative about prescribing opioids to anyone except patients with cancer or in acute pain due to surgery, broken bones, etc. However, pharmaceutical companies, along with some pain specialists, helped create a body of scientific research that allayed the traditional concerns about opioids with studies demonstrating that the risks posed by opioids, including addiction, were minimal. This research was uncritically accepted by the FDA, as well as by certain US medical journals. In response, state medical boards loosened their standards for prescribing opioids,[iv] and, the use of opioids was expanded to the treatment of people with a wide variety of chronic pain conditions
In 2007, an affiliate of Purdue Pharma, along with several company executives, pleaded guilty to criminal charges of falsely claiming that OxyContin was less addictive and less likely to be abused and diverted than other opioids, and were required pay more than $600 million in fines.
Many well-intentioned physicians continue to overestimate the efficacy of opioids to treat chronic pain and underestimate their addictive potential. In 2010: 254 million prescriptions for opioids were filled in the US, according to Wall Street analysts Cowen & Co. As reported by the federal Centers for Disease Control and Prevention (CDC), enough painkillers were prescribed to “medicate every American adult around the clock for a month,” and the “nonmedical use of prescription painkillers costs health insurers up to $72.5 billion annually in direct health care costs.” The market research firm Frost & Sullivan estimated that opioids generated $11 billion in revenues for pharmaceutical companies (http://fortune.com/2011/11/09/oxycontin-purdue-pharmas-painful-medicine/(link is external))
Although there has always wide spread agreement in the medical community regarding the use of opioids in the treatment of acute pain or cancer-related pain, there continues to be considerable disagreement about the longer-term use of opioids for chronic pain not associated with cancer. Arguably, the most important issue related to the use of opioids in the treatment of chronic non-cancer-related pain is the potential for addiction.
The addictive potential of opioids is so high because their chemical composition closely resembles that of heroin, and these medications pull all of the same neurochemical levers and create the same effects in the brain and body. As a result, taking opioids (even strictly as prescribed) inevitably causes physical dependence, leading to tolerance requiring higher doses over time to achieve the same pain-reliving effects, along with and an often unbearably uncomfortable withdrawal syndrome when these medications are reduced or unavailable. For people in recovery, taking opioids, even when medically necessary, can trip a switch in the brain that not infrequently precipitates relapse. This can be true whether or not opioids were part of a recovering person’s active addiction previously.
In 2013, the F.D.A. approved a brand new opioid painkiller called Zohydro (a high-dose extended-release formulation of hydrocodone) over the objection of its own advisory committee, which voted 11 to 2 against approval, citing the epidemic levels of opioid addiction in America and the potential for Zohydro to make that problem worse. That same year, the CDC reported that more than 16,000 prescription drug overdose deaths involved opioids (http://www.cdc.gov/nchs/deaths.htm(link is external)).
From Opioids to Heroin
Over the last decade, the increasing use of opioid pain medications has led to a resurgence in heroin use. Heroin addiction is increasing among men and women, among most age groups and all income levels. As people become dependent upon and addicted to opioids, they frequently transition to heroin which is cheaper and often more easily available.
A July 2015 CDC report stated that the strongest risk factor for a heroin abuse/addiction is prescription opioid abuse/addiction. In fact, people who become addicted to prescription opioid painkillers are forty times more likely to become addicted to heroin. As heroin use increases, not surprisingly more people are dying from heroin overdoses. Heroin-involved overdose deaths nearly doubled between 2011 and 2013; more than 8,200 people died in 2013 alone. (http://www.cdc.gov/media/releases/2015/p0707-heroin-epidemic.html(link is external))
None of these points are intended to minimize the importance of finding effective ways to assist those who struggle with chronic pain. There are alternative methods to treat pain. Many people find significant relief through acupuncture, acupressure, massage, physical therapy, electrical nerve stimulation, hydrotherapy, ice, heat, chiropractic, hypnosis, guided imagery/visualization, meditation, bio- and neurofeedback, reiki, Chi Kung, topical treatments such as lidocaine, voltaren or capsaicin patches or creams, and non-opioid analgesic and anti-inflammatory medications.
The wisdom, as well as the efficacy of making opioids ever more widely available is highly questionable. We know that teenagers are at a higher risk for addiction than adults because of their immature brain development. And we know from significant demonstrated history that even if prescribed with the best of intentions, expanding the availability of opioid pain medications can have unforeseen and tragic consequences.