A View of The Usage of Suboxone in The Battle Against Dependency on Opioid

Introduction

Opioid epidemics across the world create significant problems for infrastructure and regulation in governments. Suboxone is a drug that has recently been introduced to assist drug addicts with their addiction. Drug addiction has been rising exponentially as more users report chronic pain to depression. Cathy Reisenwitz, a member of the Foundation of Economic Education, proposes that the DEA is to blame for America’s opioid epidemic. For the purposes of this paper, the relationship between policing and recent efforts for lobbying in the US Congress will be examined.

After conclusion of the study, the paper finds that Reisenwitz’s claim that the DEA is at fault for the opioid crisis is inaccurate, due to many of her research conclusions yielding false tropes at legal enforcement rather than being rooted in fact. The best way to treat the opioid crisis is to introduce suboxone, as it is financially friendly for mass distribution and shown to be effective in other societies.

Study

There have been numerous studies and drugs designed to try and halt the problem of opioid addictions, yet nothing seems to stave off their rise in America. One of the drugs, suboxone, was recently introduced as another attempt at trying to help recovering drug addicts. Drug addiction has been rising exponentially as many users are getting hooked on painkillers to battle conditions varying from chronic pain to depression.

According to the CDC, 28 states saw their heroin overdose rates increase from 2010 to 2012. Furthermore, the overdose death rate has risen from 6.2% to 9% in the matter of a decade, according to the CDC. As a result, many governments are tasked with experimenting to see which drugs work best on helping patients recover, while posing the least risk. Cathy Reisenwitz, a member of the Foundation of Economic Education, believes that the DEA Is to blame for America’s opioid epidemic.

Mrs. Reisenwitz hypothesizes the claim that the growing opioid addiction crisis in America is not being handled effectively, due to the over-regulatory nature of the Drug Enforcement Administration of the United States. She utilizes studies to prove that suboxone and methadone are much more effective drugs to use to counter the addiction crisis, rather than maintain the status quo set forth by the DEA which stresses psychological treatments and regulations.

In order to truly understand how to counter the opioid epidemic, a government needs to identify the main demographics of its users. Reisenwitz cites that “a study in the Journal of the American Medical Association showed that half of all troops who return from Iraq and Afghanistan suffer from chronic pain” (Foundation for Economic Education).

By identifying a significant population of people who use the drug, Reisenwitz is able to then identify how problems arise in the treatment of this population. She suggests that the DEA is to blame for this population’s growing role in the opioid addiction epidemic. She cites how “in the 1970s, the DEA’s reporting requirements made many doctors decide to stop prescribing painkillers altogether” (Foundation for Economic Education).

By citing historical precedent, Reisenwitz is able to prove that the DEA has been continuing to promote dangerous habits for a significant period of time. She then follows up her claim by stating that the DEA is continuing to regulate, “deciding to require patients to see their doctor, in person, every month in order to get refills for hydrocodone-based medicine” (Foundation for Economic Research).

Reisenwitz suggests that this is an issue, but there are many problems with this approach. If this population decides to go around the legal framework for acquiring these painkillers, who is to say that their behavior does not pattern after other drug addicts who have never served in a war? It is difficult to distinguish whether the population chosen (army veterans returning from war with chronic pain conditions) is truly reflective of the entire drug addicted base of people in the world. In other words, is Reisenwitz truly effective by utilizing army veterans as a population, when they realistically are a small sample of the total drug addicted base?

A clinical trial conducted at Harvard Medical School in the mid-1990s demonstrated that a majority of persons with non psychotic unipolar depression who were unresponsive to conventional antidepressants and electroconvulsive therapy could be successfully treated with suboxone (Bell 2004). Clinical depression is currently not an approved indication for the use of any opioid (White 2017)

Alternative forms of suboxone are currently being examined, as they are currently undergoing phase III clinical trials in the United States for antidepressant therapy for treatment-resistant depression (White 2017). Reisenwitz effectively points out opioids have some issues as well in how they work inside the body. Opioids work by “mimicking chemicals our brains produce naturally. The problem for long-term users is that the brain stops producing them if it doesn’t have to. Stopping medication leaves sufferers “constantly sore, sensitive to pain, depressed, fatigued but unable to sleep,”” (Foundation for Economic Research).

As a result of this conclusion, we can understand that most returning veterans become attached to the opioids because of the potential for extreme pain if forced to withdraw from them. But how does the DEA factor in? Reisenwitz points out that “After the DEA rules change, [an army veteran’s] VA doctor couldn’t see him for nearly five months.” (Foundation for Economic Research). Consequently, we can conclude that if veterans are involuntarily forced off their opioids, they will likely find another outlet to fight chronic pain because of the symptoms of their withdrawal. These regulations force veterans into the black market to find other drugs, which when mixed with opioids can create a fatal mix.

The combination of methadone and suboxone are believed to be able to allow the user to get high, but activate receptors in the brain just enough to prevent withdrawal. Reisenwitz even points out how “France allowed doctors to prescribe methadone and buprenorphine when they deemed it necessary during the 1995 HIV outbreak. In the years since, France reduced their overdose deaths by 80 percent.” (Foundation For Economic Education).

This is the area where Reisenwitz’s usage of studies begins to verge from backed by research into opinion. The first issue Reisenwitz faces is that she does not cite any studies that were backed within the US which could prove that the regulations of the DEA were cause for the increase in opioid overdose. She later claims that the opioid epidemic can be accelerated into resolution by dismantling the DEA. Once again, there are extreme statistical concerns with her conclusion. Can we say, with enough of a confidence interval, that dismantling the DEA would resolve the opioid epidemic? While the subjects of the study are honorable people, the pain that they suffer from drives them into behaving like an average opioid street addict.

The sample of people used to qualify the study is relatively random, and we cannot capture the general behaviors of the drug-abusing population through this group. How can this be improved? I think that a group of army veterans can be utilized as a control group, as their behavior can relatively safely be deemed as prudent. The study should be extended to opioid addicts outside of the military, to see if the use of methadone and suboxone truly decrease their desire to continue to abuse opioids.

Can we say, with enough of a confidence interval, that dismantling the regulations built into healthcare law would not actually allow for more abuse and more opioid addicts across the country? Most of the data Reisenwitz uses is rather qualitative when she addresses how the opioid epidemic is being treated in the United States. She shifts to quantitative numbers when she discusses how methadone and suboxone are financed in other countries, but fails to recognize that the world economy is much different from our own.

In terms of the budgetary impact of the implementation of methadone and suboxone, Spain recently captured this issue by commissioning a study to see the economic impact of implementing suboxone and methadone on the market. Over the first three years of the study, “86,017 patients would be inserted into a study for an agonist opioid treatment program” (Suboxone in Spain 14).

It is safe to say that the study’s estimate of how many people would be utilized in their study is more than enough to capture the true effects of the drug on a group of people. One of the controls that they insert into the experiment is the effect of the introduction of suboxone and methadone into the sample. They believe that there would be “no increase in the number of patients expected with the introduction of B/N combination” (Suboxone in Spain, 16).

Reisenwitz’s conclusions in her study confirm this thought, as it is proven across the world that suboxone and methadone work to decrease the total number of opioid addict use. The research group estimates that “the budgetary impact (drugs and associated costs) for agonist opiate treatment in the first year of the study would be 89.53 million euros” (Suboxone in Spain, 22). This figure is an important statistic for the study, because subtracting the new figure from the old figures for investment in treatments will show how much it costs, and efficient the drug is through how much it costs to implement the drug per person. Later in the study, the researchers state that “ In the first year of B/N use, the budgetary impact would rise by 4.39 million EUR (4.6% of the total impact), with an incremental cost of 0.79 million EUR (0.9% of the total impact).

The budgetary increase would be 0.6% (0.48 million EUR increase) and 0.6% (0.49 million EUR increase) in the second and third years of use, respectively.” (Suboxone in Spain, 25). We can see that the budget is impacted by 5% more in costs, with incremental increases after the first year of implementation. As a result, we can conclude that the costs of implementation are diminishing over a longer period of time. While this is a useful piece of information to have, it would also be important to answer the question that Reisenwitz does not; how much does it cost the government per person to implement suboxone in the market?

The researchers conclude that “The mean cost per patient in the first year with and without B/N would be EUR 1,050 and 1,041, respectively. With an additional cost of only EUR 9 per patient, B/N is an efficient addition to the therapeutic arsenal in the drug treatment of opiate dependence, particularly when considering clinical aspects of novel pharmacotherapy.” (Suboxone in Spain, 40-41). We can thus conclude that Reisenwitz is correct, to a certain degree – investment in suboxone, rather than traditional psychological methods, is the most efficient way to work towards resolving the opioid crisis. Perhaps instead of Reisenwitz’s suggestion to dismantle the DEA, the DEA can begin to implement the use of suboxone across the country.

In the United States, buprenorphine and buprenorphine with naloxone (suboxone) were approved for opioid addiction by the United States Food and Drug Administration in October 2002 (Bell 2004). The FDA rescheduled buprenorphine from a Schedule V drug to a Schedule III drug just before approval of Subutex and Suboxone (White 2017). The ACSCN for buprenorphine is 9064, and being a Schedule III substance it does not have an annual manufacturing quota imposed by the DEA (As, 2017).

In the years prior to Suboxone's approval, Reckitt Benckiser had lobbied Congress to help craft the Drug Addiction Treatment Act of 2000 (DATA 2000), which gave authority to the Secretary of Health and Human Services to grant a waiver to physicians with certain training to prescribe and administer Schedule III, IV, or V narcotic drugs for the treatment of addiction or detoxification (As, 2017). Prior to the passage of this law, such treatment was not permitted in outpatient settings except for clinics designed specifically for drug addiction.

The waiver, which can be granted after the completion of an eight-hour course, is required for outpatient treatment of opioid addiction with Subutex and Suboxone. Initially, the number of patients each approved physician could treat was limited to ten. This was eventually modified to allow approved physicians to treat up to a hundred patients with buprenorphine for opioid addiction in an outpatient setting. This limit was recently increased by the Obama administration, raising the number of patients to which doctors can prescribe to 275. Still, due to this patient limit and the requisite eight-hour training course, many continuing patients can find it very difficult to get a prescription, despite the drug's effectiveness.

In the European Union, Subutex and Suboxone, buprenorphine's high-dose sublingual tablet preparations, were approved for opioid addiction treatment in September 2006. In the Netherlands, buprenorphine is a List II drug of the Opium Law, though special rules and guidelines apply to its prescription and dispensation.

Conclusion

We can conclude that while Reisenwitz’s claim that the DEA is at fault for the opioid crisis is inaccurate, many of her research conclusions are true. Opioid epidemics across the world have been solved by the implementation of suboxone and methadone. The budgetary analysis conducted by Spanish researchers prove that the implementation would actually be very cost efficient to the United States. Perhaps, in the future, the drug addiction crisis may eventually be resolved by suboxone.