By Percy Menzies originally featured on TheFix.com at 01/28/15

“Once an Opioid Addict, Always an Opioid Addict” should not be a guiding principle of the treatment system.

The epidemic of overprescribing opioid pain medications and the new restrictions placed on prescribing opioids has led to a new problem – an alarming increase in the use of heroin and overdose deaths. I am convinced that the problem is only going to grow, as we see several factors coming together to cause a veritable tsunami of heroin.

In the shadow of all the attention that the prescription opioid epidemic has been receiving, heroin has been steadily and stealthily creeping into the U.S., as small time dealers have begun selling heroin under the radar to a white, suburban crowd that was previously not their target market. By the time the DEA got wind of the problem, it was almost too late. We saw the problem in the St. Louis region around 2006. The Mexican Mafia and cartels started selling Mexican “black tar” heroin to white suburban users, mostly young white males, then shrewdly recruited them as small time dealers and distributors. They used heroin while staying at home, raising no suspicion from their parents. The signs and symptoms of heroin use are difficult to detect and it was inconceivable for most parents to even remotely suspect their kids were using heroin—a highly stigmatized drug, historically confined to poor black inner-city communities. The change in behavior and other signs were there—missing spoons, money and valuables stolen from the home, falling grades, abrupt changes of friends—but none of these behavioral changes raised the suspicion of heroin use.

Because there are so many opioid addicted people in the U.S., the country is extremely vulnerable to a veritable tsunami of heroin addiction due to the voluminous influx of cheaper heroin. Afghanistan, Burma and Mexico produce 90% of the world’s heroin. Afghanistan and Burma are becoming increasingly unstable. In anticipation of the withdrawal of the U.S. and NATO troops from Afghanistan this year, the acreage of opium cultivation has exploded. The weak Burmese government has little to no control on the opium growing regions of Burma. Additionally, the unintended consequence of legalizing marijuana in states like Colorado and Washington has virtually dried up the demand for Mexican marijuana. These farmers controlled by the Mexican drug cartels have switched to growing the opium poppies that are used to produce heroin.

Cheap and ubiquitous heroin coming from Mexico is going to be purer and more potent. Our citizens will no longer have to be introduced to opioids from prescription painkillers. A truly frightening scenario exists—how did we get here?

A Brief History of Opioid Addiction and Treatment

Methadone, a potent synthetic opioid, was developed by the Germans during the Second World War as a “synthetic” morphine. Years later, in response to the surge in heroin use in the 1960s, methadone was studied as a maintenance drug to treat heroin addiction. Although this was controversial, the use of methadone as a potential treatment got a boost when the Nixon Administration, alarmed by the potential “spread” of heroin addiction on the U.S. mainland by the returning GIs from Vietnam, was willing to try anything. Methadone was controversial from the start. The addictive properties of methadone were known all along, but were overlooked in the rush to protect society by offering heroin addicts a legal drug as treatment. So methadone was approved for the treatment of heroin addiction without a formal approval by the FDA! Aware of the potential for abuse and diversion, the newly created Drug Enforcement Agency required the administration of methadone in highly regulated clinics, which continues to this day.

Substituting one drug for another appeared both counterintuitive and archaic, as substitution treatments had been tried and discarded in the past: morphine addiction treated with heroin; heroin addiction with cocaine; alcohol with morphine, beer and benzodiazepines and the list goes on. In each case the remedy was worse than the addiction. Dr. Vincent Dole justified the use of methadone on the basis of an unproven theory—that opioids cause permanent mutation of the opiate receptors—therefore people addicted to opioids needed replacement treatment just as diabetic patients needed insulin! Asked to prove his theory, he responded by stating that if heroin addicts are taken off the methadone, they will go back to using heroin.

Vietnam Veterans Disproved the Theory

The near hysteria that returning soldiers addicted to heroin in Vietnam would spread the “contagion” in the U.S. proved to be completely unfounded. Less than 10% of the soldiers returned to heroin addiction after being detoxed—most went on with their lives, opioid-free. Dr. Lee Robins, from Washington University School of Medicine in St. Louis published a fascinating paper: Vietnam Veterans’ Rapid Recovery from Heroin Addiction: A Fluke or Normal Expectation? (Addiction (1993) 88, 1041-1054). We now know that the environment played a major role in these veterans not relapsing. Imagine what would have happened if these veterans were sent back to Vietnam?

The ability of the veterans to stay opioid-free after returning from war was in stark contrast to individuals addicted to heroin who were sent from U.S. cities to the treatment farm in Lexington, Kentucky. This cohort had relapse rates in excess of 90% when they returned home to their environments of past drug use. This clearly shows that the environment, coupled with price and access, are major factors contributing to the spread of the “contagion.”

What We’ve Learned from Buprenorphine and Naltrexone

After a lengthy and hard-fought debate in Congress, Suboxone and Subutex were approved by the FDA in 2002 with the passing of the Drug Addiction Treatment Act 2000 (DATA 2000). This was a peculiar approval that occurred at the height of the epidemic of opioid prescription overuse. Never before has an office-based drug been introduced with so many restrictions. Buprenorphine, a drug originally developed as a potent opioid pain medication in the late 1970s, was reformulated and introduced as an office-based treatment for opioid addiction. Physicians had to take an eight-hour course and obtain a waiver from the DEA to prescribe Suboxone/Subutex. There were additional restrictions placed on the number of patients a physician could treat at any given time. No other medication approved by the FDA had these kinds of restrictions in place. The intention was to prevent physicians’ offices from becoming pill mills and to protect the methadone clinics.

There were problems from the outset. Physicians did not rush to take the required eight-hour course and obtain the DEA waiver, so not as many physicians as had been hoped, especially primary care physicians, obtained the waiver. Some, who did obtain the waiver, wound up irregularly prescribing the medication. And many who did remained less-than-expert with respect to the pharmacology of buprenorphine and the potential for abuse of this effective medication.

Despite these factors, for the first time in the history of the treatment of addictive disorders, an addiction medicine drug, Suboxone, became a blockbuster drug, attaining sales in excess of $1.5 billion. The sales of all buprenorphine formulations are likely to exceed $2 billion. Like all opioid drugs, buprenorphine is being abused and diverted. Critically, despite the robust sales of buprenorphine, we have not seen any substantial drop in the use of opioids and heroin.

The introduction of buprenorphine should have made a significant dent in the rates of opioid abuse, overdoses and deaths, but we have not seen that happen.

Naltrexone, the first non-addicting medication developed by the federal government to prevent heroin addicts from relapsing when they returned home, was based on what had happened in Lexington. Naltrexone acts as a de facto “vaccine” against heroin, ranging from one to 28 days (if the sustained release preparation sold under the brand name Vivitrol is used). Naltrexone was actually approved by the FDA over thirty years ago, but virtually unused, thanks to the enduring notion of “once an opioid addict, always an opioid addict” and the different clinical skill sets required to use an opioid antagonist. Vivitrol is now being increasingly seen as an important medication to prevent relapses and overdoses of patients returning home from residential treatment and incarceration.

Unfortunately, given the prevailing idea that people addicted to opioids should remain on an opioid indefinitely, when buprenorphine is prescribed patients are generally encouraged to stay on it indefinitely. More long-term opioid prescribing. And now we are going to see a lot more heroin coming to this country.

The Conundrum of Opioids to Treat Opioid Addiction

There is no doubt that opioids like methadone and buprenorphine are highly effective in not only keeping patients off heroin, but also in preventing blood-borne infections like HIV and hepatitis C. On the flip side, these drugs can have the unintended consequence of aiding the spread of heroin addiction, just like prescription opioids. What would happen if the regulations on methadone were removed and any physician could prescribe it to treat opioid addiction? What would happen if the present restrictions on buprenorphine were removed? Physicians no longer would need to take the eight-hour course, apply for a DEA waiver or have a limit on the number of patients they could prescribe it to?

The answer, without a doubt, in my opinion, would be a disaster. Methadone has worked well because of the clinics. The diversion and overdose deaths that are attributed to methadone have largely occurred from physicians using the drug to treat chronic pain. Buprenorphine is a widely abused drug worldwide, and the diversion and abuse will greatly increase if the present restrictions are removed. We will have a similar problem if the regulations on methadone clinics are removed and physicians are allowed to prescribe the drug to treat opioid addiction as office-based treatment.

As long as we persist in using addictive drugs that can be abused and diverted to treat addiction, we are going to face the same problems encountered with the opioid drugs used to treat chronic pain. Moreover, the treatment will remain controversial and stigmatized. After almost 50 years of methadone use, the treatment remains controversial and outside the ambit of mainstream medicine. This is not unique to our field. It is an axiom of medicine that drugs with an addiction potential are inappropriate for the treatment of chronic conditions and have to be used with caution, and yet look at what has happened with prescribed opioids, benzodiazepines, sleeping pills and other medications that were never intended to be prescribed forever, but often are.

Poor Treatment Outcomes Lead to a Call for Drug Legalization

The present treatment of opioid addiction remains controversial and stigmatized. Any time an addicting and abusable drug is used to treat an addiction, the controversy is inevitable. We saw this when benzodiazepines were promoted and used for the treatment of alcoholism. In the end, benzodiazepines did little to reduce or eliminate drinking and only exacerbated the problem with alcoholism.

Unfortunately, we are seeing a steep increase in the use of benzodiazepines for non-alcohol related conditions that are worsening the treatment of addictive disorders. Indeed, benzodiazepines have an additive effect with buprenorphine.

The poor treatment outcomes for opioid addiction have emboldened groups advocating for the legalization of heroin, cocaine and other powerful drugs. The logic seems compelling. Legal opioids like methadone and buprenorphine are the mainstay to treat heroin, also an opioid, then why not make heroin legal? Countries like Switzerland have done it and others are seriously looking at legalization.

We all know what a disaster this would be! Addiction impacts poor people disproportionately. Look at the devastation caused by heroin in countries bordering the heroin-producing countries, Afghanistan and Burma! Iran, Pakistan, India and Russia, and the parts of China bordering Burma are all heavily impacted.

There are no easy answers, but some steps can be taken to prepare for the coming problem. Methadone clinics have a great opportunity to become opioid treatment clinics offering methadone, buprenorphine and naltrexone to the appropriate patients. These clinics can expand the hours of services and treat significantly more patients. Much will have to be done to change the regulations and the training of the staff on the pharmacology of the various medications used.

Incentives should be provided to open virtual opioid treatment clinics within medical practices. We have virtual clinics within medical practices to treat diabetes, asthma, cardiovascular diseases and smoking cessation programs. The treatment of opioid addiction and alcoholism should be brought into the realm of medical treatment. We in the treatment community continue to blame stigma as the main impediment to treatment, while the problem is our refusal to utilize evidence-based treatments that have been proven effective, but rarely used.

Here is the key issue: The longer a patient is on an opioid (methadone or buprenorphine), the harder it is to wean him off it. I believe that patients should be kept on opioids for the shortest possible time—that they should be weaned off of the opioids gradually and medically, using opioids like buprenorphine, along with other medications such as clonidine, cyclobenzaprine and even oral benzodiazepines. Unfortunately, the vast majority of people addicted to opioids are “socially” detoxed, receiving no medications whatsoever. As a result, the majority of them leave AMA (or ASA—against staff advice—since most treatment centers have no medical staff on board), and likely relapse on their opioid-of-choice back out on the street.

I believe that “social detox” is both ineffective and inhumane, and fortunately the State of Missouri agrees! We have demonstrated that medical detox from opioids followed by naltrexone and Vivitrol is extremely effective, and Missouri is willing to pay for up to two years of Vivitrol injections to protect patients from relapse and reduce recidivism rates. After 12-24 months on naltrexone, coupled with relapse prevention counseling, case management and supportive services, patients can come off naltrexone and go on with their lives. There is a misunderstanding that abstinence should be off all drugs, but I believe that patients should be offered non-addicting drugs like naltrexone, which should be viewed as enhancing abstinence.

We missed the opportunity to bring effective treatments to help the tens of thousands of patients iatrogenically addicted to opioids resulting in thousands of lost lives. With the coming tsunami of heroin addiction, we can’t afford to drop the ball this time and repeat the tragedy.

Percy Menzies hold a Master’s degree in Pharmacy and is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis.

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