The Failure of Prohibition

The U.S. government’s current strategy of trying to restrict the supply of opioids for nonmedical uses is not working. The U.S. Centers for Disease Control and Prevention (CDC) reported a record-high number of opioid overdose deaths in 2015—33,091—more than half of which were from heroin.1 In 2016, the drug-overdose death rate then increased 28 percent to 42,249, with heroin and fentanyl causing the majority of those deaths, and the rate of fentanyl (plus fentanyl analog) overdoses doubling from 2015 to 2016.2 In August 2018, the preliminary estimates for 2017 were released, showing the opioid overdose rate increasing again to over 49,000, primarily due to a 37 percent increase in deaths involving fentanyl. Overdoses in 2017 from prescription drugs dropped 2 percent and overdoses from heroin dropped 4 percent.3

A study published in November 2017 finds that, while government efforts to reduce the supply of legal opioids have reduced the availability of common prescription drugs like hydrocodone and oxycodone, the use of heroin as an initiating opioid for nonmedical users has grown at an alarming rate. In 2015, more than 33 percent of heroin addicts entering treatment initiated their nonmedical opioid use with heroin, up from 8.7 percent in 2005.

Part of this effect may be economic: in 2015, the CDC director estimated the black-market price for heroin was one-fifth the price of prescription opioids.4 The gradual substitution of heroin for prescription opioids may be behind the soaring overdoses. The researchers concluded, “Given that opioid novices have limited tolerance to opioids, a slight imprecision in dosing inherent in heroin use is likely to be an important factor contributing to the growth in heroin-related overdose fatalities in recent years.”5

Figure 1: National overdose deaths from select prescription and illicit drugs

Harm Reduction

*Includes deaths with underlying causes of unintentional drug poisoning (x40–x44), suicide drug poisoning (x60–x64), homicide drug poisoning (x85), or drug poisoning of undetermined intent (y10–y14), as coded in the International Classification of Diseases, 10th Revision.National Institute on Drug Abuse, Overdose Death Rates, https://www.drugabuse.gov/related-topics/trends-statistics/overdose-dea… ; CDC, National Center for Health Statistics, https://www.cdc.gov/nchs/ ; CDC WONDER, https://wonder.cdc.gov/

Unlike prohibition, harm-reduction strategies begin with the realistic and nonjudgmental premise that “there has never been, and will never be, a drug-free society.”6 Akin to the credo of the medical profession—“First, do no harm”—harm reduction seeks to avoid measures that exacerbate the harms the black market already inflicts on nonmedical users and to focus strictly on the goal of reducing the spread of disease and death from drug use.

Many who prefer stigmatizing rather than tolerating drug use7 criticize harm reduction as “a signal of defeat.”8 But harm reduction has a success record that prohibition cannot match. Decades of experience in several developed nations show harm-reduction strategies reduce overdose deaths, the spread of infectious diseases, and, in many cases, the nonmedical use of dangerous drugs.9

Harm reduction involves a range of public health options. These include medication-assisted treatment, needle exchange programs, safe injection sites, heroin-assisted treatment, deregulation of overdose treatments like naloxone, and decriminalization of cannabis (marijuana).

Medication-Assisted Treatment

Medication-assisted treatment provides drugs that help to wean users off opioids. Opioid-replacement therapy involves the replacement or substitution of an illegal opioid, such as heroin (diacetylmorphine or diamorphine), with a legal one that is less sedative and euphoric.10 The idea behind opioid-replacement therapy is to help the addict avoid experiencing withdrawal from heroin, reduce cravings for the drug, and eliminate the euphoria associated with heroin use. The goal is to facilitate a resumption of stability in the user’s life, end the spread of disease through needle sharing, reduce the risk of overdose and, over time, wean the user off the replacement drug. Some users stay on the replacement drug indefinitely.

Echoing other critics, in 2017 Health and Human Services secretary Tom Price characterized medication-assisted therapy as “just substituting one opioid for another, not moving the dial much.”11 The evidence tells a different story. Medication-assisted therapy decreases both exposure to infectious diseases and the risk of overdose from black-market opioids that may be laced with dangerous additives.12

The choice of opioid used in replacement therapy is a function of its absorption rate, the degree to which it binds with opioid receptors, and the duration of its effects. In some countries, such as Switzerland and Austria, orally administered slow-release morphine is occasionally used for opioid-replacement therapy. Extended-released dihydrocodeine has been used in Germany and Austria.

Methadone (brand name Dolophine) is a form of medication-assisted treatment used in the United States and many other developed countries. It has roughly the same potency as heroin, 2.5 times the strength of morphine. If injected intravenously, it will have roughly the same effect on the patient but is longer-acting than either morphine or heroin.

Also in common use is buprenorphine (brand name Subutex). Buprenorphine and methadone are administered orally. When absorbed from the intestinal tract, they bind with opioid receptors to prevent withdrawal symptoms from heroin abstinence but at absorption levels that do not lead to the sedation and euphoria that addicts experience.

A risk of buprenorphine is that users can dissolve and inject it, achieving an opioid high. However, a related medication-assisted treatment that goes by the brand name Suboxone combines buprenorphine and naloxone to create an abuse-deterrent formulation of buprenorphine. Naloxone is an opioid antagonist that attaches to opioid receptors and blocks opioid agonists (e.g., buprenorphine) from activating those receptors. Since the intestinal tract does not absorb naloxone to any significant degree, adding naloxone has little effect on patients who take the drug orally as intended. If a Suboxone recipient attempts to inject it, however, the naloxone will bind to the recipient’s opioid receptors and block the effects of the buprenorphine.

The buprenorphine in Suboxone is a partial opioid agonist, meaning it occupies some but not all of a patient’s opioid receptors. Methadone is a full agonist. It can be taken in amounts that occupy all the opioid receptors and therefore is more effective in treating patients who have grown dependent on high doses of opioids. Because buprenorphine is only a partial agonist, it causes less respiratory depression than methadone and thus has less overdose potential.

In the United States, methadone maintenance therapy started in the early 1960s. Methadone can only be dispensed at centers certified by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) as an Opioid Treatment Program clinic, and registered with the U.S. Drug Enforcement Administration (DEA). The patient must go to the clinic daily to receive the methadone until the treating physician deems the patient is stable enough to take the methadone at home.

The U.S. Food and Drug Administration (FDA) approved Suboxone for use as opioid replacement therapy in 2002. Subutex is no longer available in the United States. Its manufacturer took it off the market in 2011, essentially replacing it with the “abuse-deterrent formulation” Suboxone.13 Generic competitors to Suboxone, such as one selling under the brand name Zubsolv, are now available.14

Doctors may prescribe Suboxone in private clinics, as well as in community hospitals, health departments, and prisons. Doctors wishing to prescribe Suboxone as an opioid replacement must take an eight-hour class on addiction treatment (or already possess such credentials) and obtain a special license and number from the DEA. They are permitted to treat only 100 patients at a time, expandable to 275 patients after the first year, while nurse practitioners and physician assistants may only prescribe Suboxone if they obtain a waiver from SAMHSA and the DEA.15

The longer a patient stays in a treatment program, the less likely the patient will resume heroin use.16 Factors favoring retention include a higher dose of opioid replacement, free treatment, greater contacts with the clinic, and counseling.17

Retention of patients within opioid replacement therapy programs is a significant problem. Many leave the program and resume their heroin use, while some divert their methadone for intravenous nonmedical use. (Suboxone, as mentioned earlier, contains the opioid antagonist naloxone and is unsuitable for diversion.) A 2008 study in the Journal of Addictive Diseases found one-year retention rates in either methadone or buprenorphine maintenance programs averaged in the range of 50–60 percent and correlated with the doses given to patients.18 An earlier study of patients in Washington and Oregon placed retention rates even lower.19

For patients who remain in buprenorphine or methadone programs, opioid replacement therapy has been found to significantly reduce mortality from all causes of overdose. A systematic review and meta-analysis of cohort studies in the BMJ in March 2017 found methadone treatment was associated with a 69 percent reduction in all-cause mortality and buprenorphine treatment was associated with a 55 percent reduction in all-cause mortality.20

While methadone has been in use for a long time, buprenorphine (Suboxone) has been less widely used and for a shorter period, so there are few good studies comparing the two to determine which is the better treatment. Cochrane literature reviews are highly regarded for their quality and rigor, and Cochrane officially collaborates with the World Health Organization. A 2003 Cochrane review found buprenorphine considerably less successful than methadone in retaining patients in treatment.21 A 2012 review found methadone to be slightly more successful and less expensive than buprenorphine as an opioid replacement.22 However, a 2015 study by Peddicord et al. concluded that “the research does not indicate that one medication is a better option than the other. This decision must be made on an individual basis after reviewing important patient factors such as health status and access to the medication.”23

A different approach to medication-assisted therapy is naltrexone (Vivitrol). Nal­trexone is a long-acting opioid antagonist that blocks the opioid receptors, similar to naloxone. Thus, it may precipitate withdrawal symptoms in patients who are physically dependent on opioids. It can be taken orally, with the effects lasting 24 to 48 hours, or injected intramuscularly in an extended-release form on a monthly basis. For it to be effective, treatment should start only after the patient has detoxified. The rationale behind naltrexone treatment is to provide negative feedback to the use of opioids, following detoxification, when the patient is exposed to the usual social cues and stressors that would lead an addict to resume use of the drug. The hope is that by blocking the opioid, naltrexone will eventually eliminate the patient’s conditioned response of turning to opioids in such situations. Subdermal naltrexone implants that slowly release naltrexone have received government approval for use as an adjunct to the oral therapy.

A 2011 Cochrane analysis showed that oral naltrexone therapy, because of its short duration of action, had high drop-out rates and was no better than placebo, with or without adjuvant psychotherapy.24 The extended-release form of naltrexone presumably would yield better results, but there are very few studies on that approach thus far. A few studies have shown improved retention rates (53–70 percent) when using the intramuscular or subdermal/oral approach.25

Medication-assisted treatment is already an accepted approach in the United States and deserves further support and development. Congress should reduce or eliminate the complex application processes and tight restrictions it imposes on health care practitioners who provide medication-assisted treatment. It should allow practitioners to take on more patients and reduce administrative hurdles that inhibit participation in such programs. It should eliminate requirements that nurse practitioners and physician assistants must obtain special waivers from SAMHSA and the DEA to provide these services. It should liberalize restrictions on methadone maintenance programs to allow the creation of more centers, particularly in hard-hit communities. It should allow primary care practitioners with an interest in treating substance abuse disorders to prescribe methadone to their patients in an ambulatory setting, as they may now do with Suboxone. This policy has been successful for decades in several developed countries, such as Australia, the United Kingdom, and Canada.26 Until Congress acts, SAMHSA and the DEA should themselves take as many of these steps as is consistent with the law.

Needle Exchange Programs

Needle exchange programs seek to reduce the spread of HIV, hepatitis, and other infectious diseases by providing clean needles and syringes for users of heroin and other injectable drugs.

The Netherlands developed needle exchange centers in the 1970s in response to an outbreak of hepatitis B. The idea gained acceptance in other countries with the advent of the AIDS pandemic. The oldest continuing needle exchange program in the United States, located in Tacoma, Washington, has been operational since 1988.27 As of 2012, needle exchange programs operated in at least 35 states.28 Congress banned federal funding of needle exchange programs in 1988 and then lifted the ban in 2009.

Needle exchange centers are often in clinics that offer referral for addiction therapy and counseling. To increase outreach, some programs operate mobile vans or delivery services, or else have centers along pedestrian routes.29 Many offer HIV and hepatitis testing, male and female condoms, and bleach and alcohol to clean drug paraphernalia.

Needle exchange programs appear to reduce the spread of infectious disease. Seven federally funded studies conducted between 1991 and 1997 found needle exchange programs reduce the risk of HIV infections among intravenous drug users and their partners.30 A 2013 systematic review conducted by the CDC confirmed that needle exchange programs are associated with a decreased prevalence of HIV and hepatitis C infections.31 A 2014 systematic review and meta-analysis of 12 studies comprising 12,000 person-years found that needle exchange programs coincide with a 34 percent reduction in the rate of HIV transmission, with a 58 percent reduction among the six studies that were of a “higher quality.”32 SAMHSA maintains a bibliography of studies on needle exchange programs on its website, and endorses needle exchange programs for their “efficacy and facilitating entry into treatment for intravenous drug users (IDUs) and thereby reducing illicit drug use.”33 The CDC endorses and promotes the implementation of needle exchange programs with guidance and, in some cases, financial assistance to local jurisdictions.34

Many state and local laws inhibit needle exchange programs.35 Some states outlaw the sale or even the possession of syringes or needles without a prescription.36 In a 2009 national survey, a significant number of needle exchange programs reported that police confiscate syringes and even arrest clients on their way to and from needle exchange centers. Reports of confiscation and arrest were more than four times more prevalent around needle exchange programs serving areas where clients were predominantly people of color.37

Safe Injection Sites

While needle exchange programs seek to decrease the spread of infectious diseases, safe injection site programs have more ambitious goals.38 Safe injection sites allow intravenous drug users to inject in a clean and safe environment, with almost no chance of overdose death, free from harassment as well as the risks of theft and physical or sexual assault. Safe injection sites furnish sterile syringes and needles as well as a clean, clinical setting where intravenous drug users can inject illicitly obtained substances. Onsite health care professionals have naloxone available to treat overdoses and can refer patients for medical treatment and rehabilitation. Like needle exchange programs, safe injection sites also prevent the patient from passing used needles and syringes to others.

As of 2016, about 100 safe injection sites operated in 66 cities around the world.39 The first professionally staffed injection room opened in Rotterdam, the Netherlands, in the early 1970s. The Dutch government officially sanctioned such centers in 1996.40 In 1986, a safe injection site that started informally in a café in Bern, Switzerland, eventually received government sanction for users over the age of 18. During the 1990s and early 2000s, legal facilities opened in Switzerland, Germany, the Netherlands, Spain, Luxembourg, Norway, Canada, and Australia.41 Germany’s first “drug consumption room” (DCR) opened in Berlin in 1994. Australia opened its first facility in the Kings Cross district of Sydney in 2001. Canada’s first facility, called “Insite,” opened in the Downtown Eastside district of Vancouver in 2003.

The evidence is strong that safe injection sites reduce the transmission of HIV and hepatitis, prevent overdose deaths, reduce public injections, reduce the volume of shared or discarded syringes, and increase the number of drug users entering treatment programs.42 A 1996 report on “injecting rooms” in Switzerland concluded: