• Opioid use and policy in the US, a history

    The post below originally appeared on The Upshot (copyright 2014, The New York Times Company), where you can also see a related timeline assembled by Nadia Taha. I thank Jenny Gilbert for research assistance, Alan Flippin for editing, Keith Humphreys, Peter Friedmann, and an anonymous scholar for feedback on early drafts. Elsewhere, you can find a history of opium that begins in 3400 BC, a history of narcotic drugs and their uses since the 1800s, a history of US opioid-related laws, and a history of the war on drugs. Finally, a follow-up to this post that touches on racial issues is here.

    Even as the Food and Drug Administration approves new, powerful opioid-based painkillers, the United States is in the midst of an epidemic of opioid overuse. This is not the first time.

    As the accompanying timeline shows, since the late 19th century, there have been three eras in which opioid abuse has reached problematic levels and provoked policy responses.

    Opioids now cause more deaths than any other drug, more than 16,000 in 2010. That year, the combination of hydrocodone and acetaminophen became the most prescribed medication in the United States. Patients hereconsumed 99 percent of the world’s hydrocodone, the opioid in Vicodin. They also consumed 80 percent of the world’s oxycodone, present in Percocet and OxyContin, and 65 percent of the world’s hydromorphone, the key ingredient in Dilaudid, in 2010. (Some opioids are also used to treat coughs, but that use doesn’t seem to be a major factor in the current wave of problems.)

    Across the states and in the nation’s capital, policy makers are wrestling with ways to address the problems caused by high rates of opioid prescribing, while still permitting adequate access to these medications for patients who need them. Further complicating matters, while opioid-based medications are sometimes diverted to illegal markets and can be addictive, some formulations can also be helpful in treating those addictions.

    Devising policy to manage the competing uses and risks of narcotic painkillers has been a century-long challenge, complicated by shifts in the government’s approach to drug regulation, the nation’s culture of illicit drug use and the role played by the pharmaceutical industry.

    The most recent wave of opioid overuse can be traced back to at least the 1980s. Then, some doctors began reporting that addiction to them was rare, and drug companies vigorously promoted them as safe for a broad range of painful conditions. In a letter in The New England Journal of Medicine in 1980, Dr. Jane Porter reported that out of nearly 12,000 patients who had received a narcotic painkiller, only four became addicted. In a 1986 study published in the journal Pain, Dr. Russell Portenoy — at the time, a prominent proponent of narcotic painkillers whose work was backed by drug manufacturers — reported that only two of 24 patients treated with them for years had exhibited problems managing the medication. Other physicians expressed concern that by withholding opioid drugs, physicians could be under-treating pain.

    Encouraged by these findings, doctors who once thought long-term use of narcotic painkillers was unsafe began to prescribe them in greater numbers. In 1993, The Times reported that chronic pain sufferers were now able to find relief with powerful narcotic drugs. “There is a growing literature showing that these drugs can be used for a long time, with few side effects and that addiction and abuse are not a problem,” Dr. Portenoy said.

    In 1996, the American Pain Society — of which Dr. Portenoy would later be president — termed pain the “fifth vital sign,” to be routinely measured in patients along with the four traditional ones: body temperature, blood pressure, heart rate and breathing rate. Measurement of pain — for instance with a self-reported zero-to-10 rating — was recognized as a prerequisite to taking it seriously and treating it. Model guidelines developed in 1998 andupdated in 2004 were widely adopted by state medical boards and codified the use of opioids as standard pain treatment practice. For pain sufferers, these were welcome developments.

    The pharmaceutical industry also helped promote greater use of the narcotic medications it sold. It funded the American Academy of Pain Management and the American Pain Society. Pain clinics expanded, some funded by grants by companies that produced the narcotic painkillers they dispensed.

    The use of opioid-based medications for treatment of addiction and the use of antidotes for overdoses also advanced. In 2000, the Drug Addiction Treatment Act expanded opioid substitution therapy for treatment of addiction. Under the act, qualified physicians can prescribe opioid-based medications such as buprenorphine for use at home, an alternative to treatment with methadone at specialized clinics. In 2007, The Timesreported that naloxone, an antidote for an opioid overdose developed in the 1960s, had become an important, lifesaving tool in many cities and states.

    About a decade ago, problems with narcotic painkillers began to surface.The Times reported in 2003 that, according to a government survey, more than 20 percent of 18- to 25-year-olds abused prescription pain medication, up from only 7 percent in 1992. A federal task force was formed to crack down on illegal sales of narcotics over the Internet. There were increasing reports of physicians prescribing narcotic painkillers in unusually large quantities; some were arrested after their patients diverted the painkillers to illegal drug markets. Some doctors reported that as many as 20 percent of their patients were involved in such diversion or addicted to opioids or other drugs. At the same time, studies found that as many as half of pain sufferers received insufficient treatment.

    In the late 2000s, investigations revealed that the rapid increase in the prescribing of narcotics was encouraged by drug companies’ false claims about their safety made over the prior decade. In one of the largest settlements by a pharmaceutical company, the maker of OxyContin agreed to pay about $600 million when it pleaded guilty to such charges in 2007. Other narcotic painkiller manufacturers also paid large fines for false claimsand illegal marketing. In 2012, a bipartisan Senate investigation was opened to examine ties between pharmaceutical companies and medical groups that advocate for opioids.

    New studies showed that opioids may help only half of patients prescribed them, and many of those, only temporarily. The greatest proponents of narcotic pain killers have recognized their dangers. “Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,” Dr. Portenoy said that year in an interview with The Wall Street Journal. “We didn’t know then what we know now.”

    Some physicians specializing in the treatment of pain are beginning to reduce therapeutic use of narcotics in favor of other treatments such as nonopioid drugs, physical therapy andacupuncture.

    Despite the growing recognition of the limitations of opioids for pain, we are still in the midst of an epidemic. Policy makers continue to struggle to balance access to appropriate medications with their risks, while the pharmaceutical industry provides and promotes new formulations of narcotic painkillers. The tension was exemplified in 2011. That year, an Institute of Medicinereport characterized chronic pain as a disease in its own right, deserving of greater attention and treatment, including, as appropriate, properly monitored use of opioids. Also that year, the Obama administration released a plan to handle the “drug abuse crisis” fueled by prescription opioids, and the F.D.A. required a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.

    As this third United States opioid epidemic continues, we can look back on its predecessors. The first peaked around the end of the 19th century, when opioid products were unregulated. Bayer Pharmaceuticals introduced heroin as a cough suppressant in 1898 and heroin was widely prescribed into the 1920s. One common medical use was the treatment of menstrual pain. In 1906 the Pure Food and Drug Act required the contents of drugs to be listed on their labels, including opioids. A 1911 New York Times article asserted that “at least one druggist out of every ten exists by means of profits from the sale of habit-forming drugs, of which, of course, opium and its derivatives are most important.”

    Though use of opioids was already on the decline, the 1914 Harrison Narcotics Tax Act codified national policy makers’ ambition to curb their useby taxing them. The act also regulated medical applications, permitting opioids to be used for pain treatment, but not as maintenance treatment for addiction, which was not legalized by the Supreme Court until 1925.

    The Federal Medical Center in Lexington, Ky., opened in 1935 as the first center dedicated to the treatment of substance use disorders. It was the site of early addiction research experiments with methadone maintenance and other therapies.

    Narcotics use spiked again in the middle of the 20th century. The Times documented growing use and overdose deaths in New York, including in a1951 article that noted a “tremendous increase” in teenage users admitted to local hospitals. Another article in 1969 reported that arrests for narcotics in the city were up 46 percent compared with the previous year. Also in 1969,Dr. Robert DuPont found that over 40 percent of people entering jails in the District of Columbia tested positive for heroin. In 1971, The Times reportedon widespread narcotic use and drug addiction by returning Vietnam veterans.

    In response to this second opioid epidemic, first states, and then the federal government in 1966, passed laws permitting involuntary hospitalization of addicts. Methadone clinics were established with the Controlled Substances Act, supported by various intervention studies that found such treatment effective. The Drug Enforcement Agency was established under President Nixon to consolidate and coordinate federal antidrug activities.

    During this second wave of increased narcotic use and response, in 1961, the United Nations declared access to pain medication a human right, adding that countries should provide appropriate access to pain management, including opioids. This foreshadowed the third, current wave of opioid overuse, growing out of an effort to more fully recognize and treat pain.

    Today, states and federal policy makers are offering new approaches to promote responsible, safe opioid use for pain and addiction treatment, which is highly cost-effective. All states but Missouri have or will soon have drug databases to track prescribers of opioid painkillers and those that use them. States that have required doctors to check the databases before prescribing the drugs have seen large decreases in prescribing. Physicians and F.D.A. officials have called for more tamper-resistant formulations that cannot be easily crushed for snorting or adapted for injecting. And states’ expansion of access to the overdose antidote naloxone could save many lives.

    In light of the crisis, these are sensible responses. But it is instructive to remember how we got here. History shows both that it’s possible to overprescribe and misuse powerful narcotics, and that it’s possible to undertreat pain and addiction to them. Balancing the competing needs and risks is a continuing struggle.

    @afrakt

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