US government and public health officials have used the term opioid crisis or opioid epidemic to describe the sharp recent rise in the number of Americans who abuse or are addicted to opioids. Opioids are a class of drugs that relieve pain by working on opiate receptors in the user’s brain. They can be made from naturally produced derivatives of a flowering plant known as the opium poppy, or they can be created synthetically in a laboratory. Examples of opioids with approved medical uses include codeine, morphine, hydrocodone, oxycodone, and hydromorphone, among others. Fentanyl is approved for use as an anesthetic and, in rare cases, to manage severe pain. Others, such as heroin and carfentanil, circulate primarily or exclusively on the black market.
The opioid crisis began after numerous pharmaceutical companies developed and marketed novel painkiller formulations in the 1990s. These drug manufacturers assured health care officials and the general public that their new formulations were safe and abuse-resistant, and physicians and other health care providers with prescriptive authority such as physician assistants and nurse practitioners began to prescribe them to patients at increased rates. Previously, opioids had largely been reserved for people suffering from chronic or severe pain, such as cancer patients and patients recovering from major surgery. Despite manufacturer claims, the drugs proved to be highly addictive. This increased proliferation of opioids led to fast-rising rates of abuse, with large amounts of prescription painkillers being diverted onto the black market through a range of channels, including theft, unscrupulous pharmacy practices, and patients who illegally sell legitimately obtained drugs to unauthorized users.
Opioid drugs are very effective at relieving pain, and, at higher doses, they produce euphoric side effects that make them prone to abuse for off-label purposes. These pleasurable side effects create a serious risk of addiction, and individuals who abuse opioids often become tolerant to low dosages and start taking the drugs in higher and higher doses. Because opioids depress the user’s respiratory system and heart rate, these high doses are extremely dangerous and can have fatal consequences. Opiate addiction is caused by a combination of neurological and physiological factors, which can combine to create overpowering cravings in people who have been using the drugs for an extended period of time. Users who suddenly cease their intake of opioids are vulnerable to strong withdrawal symptoms, which can lead them to seek available alternatives on the black market.
Statistics compiled by the US Department of Health and Human Services (HHS) indicate that about 11.4 million Americans misused or abused opioid drugs in 2016, with 2.1 million of those users having or developing a diagnosed or diagnosable opioid use disorder. In 2017 over 42,000 Americans died as the result of an opioid overdose, in large part because addicts often turn to street opioids, such as illicitly produced fentanyl or heroin, when pharmaceutically manufactured substitutes become unavailable. An estimated 81,000 Americans used heroin for the first time in 2016. A study published in the Journal of the American Medical Association in 2018 detailed the skyrocketing abuse rates of heroin and synthetic opioids like fentanyl. Between 2010 and 2016, the number of fatal heroin overdoses in the United States more than tripled, while the number of fatalities caused by synthetic opioid overdoses soared from about 3,000 in 2010 to more than 19,000 in 2016.
Opioids are a highly addictive class of drugs that relieve pain by working on opioid receptors in the brain. They can be produced from natural derivatives of the opium poppy, a flowering plant, or they can be created synthetically in a laboratory. Opioids include prescription painkillers like oxycodone and illicit drugs like heroin.
In the twenty-first century, the United States has faced unprecedented rates of opioid misuse and addiction, a nationwide problem commonly referred to as an opioid crisis or opioid epidemic. The Centers for Disease Control and Prevention (CDC) has estimated that 115 people died each day from opioid-related overdoses in 2017. In October 2017 the presidential administration of Donald Trump declared the opioid crisis a public health emergency.
The origins of the modern opioid crisis can be traced to marketing tactics employed by Purdue Pharma, the manufacturer of OxyContin, which targeted physicians and influenced opioid prescribing practices. The company has faced several lawsuits for its role in the opioid crisis. In 2007, for example, the company and three of its executives pleaded guilty to defrauding doctors and consumers and paid $634.5 million in civil and criminal fines.
Efforts to curb rates of opioid addiction, abuse, and overdose have focused largely on regulations intended to restrict access to prescription opioid medications. While prescribing rates have decreased as scrutiny of prescribing practices has increased, law enforcement and public health officials have noted a corresponding sharp rise in abuse rates of street opioids like heroin and illicitly manufactured fentanyl.
Federal and state agencies have mobilized to develop additional programs and strategies targeting opioid abuse beyond prescription pain relievers. The US Department of Health and Human Services, the CDC, and the National Institutes of Health have partnered to track and monitor data, raise awareness, conduct research, and develop effective intervention and addiction treatment strategies. Additionally, the Federal Bureau of Investigation and the Drug Enforcement Administration are working together to target illegal smuggling, distribution, and prescribing of opioids.
Promotion and Sales
One particular brand name drug, OxyContin, has been singled out as a major contributor to the opioid crisis. The drug, patented and manufactured by Purdue Pharma, provides a sustained, time-released formulation of oxycodone, a potent opioid pain reliever. Though Purdue Pharma initially maintained that the drug was tamperproof, users discovered that crushing and snorting or chewing the tablets allowed its entire oxycodone content to be released at once, delivering a powerful, euphoric, and addictive effect. Subsequent investigation revealed that Purdue Pharma misrepresented the drug’s abuse potential, and that the company was aware its product was addictive well before the opioid crisis reached epidemic levels.
Purdue Pharma used aggressive tactics to market OxyContin to physicians, and as a result, sales of the drug ballooned from $48 million in 1996 to over $1 billion in 2000. During in-person visits to physicians, sales representatives misrepresented and downplayed the drug’s abuse potential to generate higher sales volumes, which were attached to incentives like financial bonuses. Manufacturers also routinely offered gifts to providers, which subsequent studies found had influenced health care providers’ prescription-writing tendencies. As of 2018, 26 US states and Puerto Rico had sued Purdue Pharma over their marketing of OxyContin, which the plaintiffs allege was both fraudulent and a central contributing factor to a dangerous and costly public health epidemic. OxyContin sales remain up from 2000 levels, with health care industry sources claiming the company sold $1.94 billion worth of the drug in 2017.
Multiple media outlets have reported that the US pharmaceutical industry’s powerful lobbying capabilities have impeded lawmakers’ efforts to reform industry sales practices and further regulate the distribution of opioid painkillers. Related allegations contend that major pharmaceutical companies, or Big Pharma, engage in anticompetitive activities aimed to prop up sales of patented opioid painkillers and limit the availability of less expensive generic alternatives. Big Pharma has also been accused of lobbying to make opioid-based medications that are used to treat addiction, such as Suboxone (buprenorphine with naloxone), more difficult and expensive to access.
Prescribing Patterns and Access
While the actions of Big Pharma manufacturers like Purdue have drawn a great deal of scrutiny and criticism, so too have the prescribing habits of health care providers. Physicians and other providers have been accused of acting irresponsibly with regard to opioids, which they began prescribing for relatively minor injuries and medical complaints with the rise of OxyContin in the late 1990s. Thousands of people have reported developing a drug addiction after being given an opioid prescription for an injury or condition that could have been managed with a less potent drug.
In 2006 American health care providers wrote 72.4 opioid painkiller prescriptions per 100 people, a rate that increased annually by 4.1 percent from 2006 to 2008 and by 1.1 percent until 2012 (when it reached 81.3 per 100), then began a downward trend, decreasing annually by 4.9 percent between 2012 and 2016. The increase coincided with the opioid crisis reaching epidemic levels while the decrease coincided with dangerous synthetic opioids like fentanyl becoming more widely available on the black market.
Physicians and other health care providers have become more aware of the need to balance effective pain management with addiction risks. The Centers for Disease Control and Prevention (CDC) introduced updated guidelines for physicians in 2016 that set more stringent standards for the prescription of opioid pain relievers and assessing the risk of misuse, which providers have been actively encouraged to incorporate into their patient care protocols. Concerns over inadvertently supplying opioids to the black market led providers to further scale back opioid prescriptions between 2014 and 2017. However, law enforcement and public health officials have noted that increased scrutiny over prescription practices has coincided with a sharp rise in overdose deaths from street opioids like heroin and illicitly manufactured fentanyl.
Pill mills present another problem for public health and law enforcement authorities. These clinics operate in a legal grey area, employing physicians who write legal opioid prescriptions for patients who have little or no medical need for the drugs. In a typical pill mill scenario, a physician, who is often facing some type of disciplinary action but maintains a valid license, will see patients who present questionable pain-related medical complaints. The physician then prescribes the patient a large quantity of high-dosage opioid painkillers in exchange for a clinical fee of several hundred dollars. A landmark 2015 case found a California physician who was running a pill mill criminally responsible for second-degree murder after several of her patients suffered fatal overdoses of opioid drugs, leading some advocates to muse as to whether criminally prosecuting providers might offer an effective way to address the overprescribing of addictive painkillers. However, these reduction strategies have negatively affected chronic pain patients with legitimate needs for opioid medications, as some states have passed laws introducing prescription limits and caps on daily dosage allowances.
Governmental and Community Interventions
On July 1, 2018, Tennessee introduced some of the strictest prescription opioid laws in the United States, limiting opioid prescriptions to a maximum of three days’ worth of medication unless a precise set of inflexible conditions are met. Exemptions require documentation and can only be applied in a rare set of circumstances. While analysts expect the new law to succeed in reducing the number of prescription opioids circulating through underground channels, physicians and patient advocates have expressed concerns that the new rules will inhibit their ability to treat patients with legitimate medical needs effectively and efficiently. Instead of continuing to restrict access to legitimate prescription medications, such critics have argued, strategies for combating the opioid crisis should focus on access to overdose and addiction treatment resources and services, including ensuring that medical first responders have access to the overdose-reversing drug naloxone and operating safe-injection sites in high-risk areas.
The Trump administration officially declared the opioid crisis a public health emergency in October 2017, marking intensified federal containment and coordination efforts by agencies including the CDC, HHS, and the Drug Enforcement Administration (DEA). The CDC has partnered with forty-five US states and the District of Columbia to launch the Overdose Prevention in States (OPIS) initiative. The program uses numerous monitoring and reporting techniques to identify areas at elevated risk for a high concentration of opioid overdoses, promotes prescription drug monitoring programs, and monitors prescribing activities. The OPIS program has led to several noteworthy successes, with numerous states identifying and shutting down pill mills. HHS has adopted a five-point plan to address the opioid crisis, with provisions including improved treatment and recovery services, more accurate and timely data collection, better support for pain management alternatives, increased availability of overdose-reversing drugs, and more intensive research on addiction and pain.
Meanwhile, the DEA and other law enforcement entities have prioritized efforts to intercept and seize dangerous illicit opioids like fentanyl, and to prosecute individuals involved with their production, importation, and circulation. Most illicit opioids in the United States are produced overseas in underground laboratories, then surreptitiously shipped to the United States for distribution on the black market. One major initiative is Operation Disarray, a partnership between the DEA and the Federal Bureau of Investigation (FBI), which seeks to disrupt underground sales of these synthetic opioid drugs by targeting online channels, particularly those on the dark web.