Controlled Substances 1 Business Case: Overlooking the Controlled Substance Act Colton White Buscom 201 Section 07 May 1st, 2020 Introduction The world of drugs is not only complex but can be seen simple to those that choose to keep an open mind. In today’s day in age, various companies produce drugs for individuals to be taken every day in various quantities. These substances can range from naturally grown remedies to pain such as kratom, to pills such as Adderall that grant laser focus and energetic effects. The difference between kratom and Adderall, however, is that one is illegal in multiple states and the other has almost an identical compound to that as meth. This can be identified as a flaw in the ranking of controlled substances and as new studies arise regarding the effects of certain substances, we need to adapt our views of these frowned upon drugs in relation to those prescribed. Drug, defined by the dictionary is, “a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body.” (2020). This tends to be a very broad term and houses the possibilities of minor things such as caffeine to be considered a drug. With this being said, the DEA or United States Drug Enforcement Administration, classifies the majority of the drugs with potential abuse as controlled substances. The FDA and the DEA work together to determine what should be considered a controlled substance and proceed to rank them in classifications referred to as schedules. There are exactly five schedules for which a drug can be ranked, due to their effectiveness in medicine as well as their potential abuse (DEA, n.d.). What brought us to this point is known as the Controlled Substance Act (CSA) of 1970, stating that drugs need to be put in groups and then regulated based on factors such as level of abuse. Those who manufacture or distribute controlled substances must do so by first registering with the DEA (CSA Schedules, 2018). “The Congress of the United States enacted into law the Controlled Substances Act (CSA) as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.1 The CSA serves as the legal foundation of the government's fight against drugs of abuse.”.(CSA Schedules, 2018) The CSA, signed by President Nixon can arguably be the first step towards what we know as the war on drugs. At this point in time, drugs were represented as our number one public enemy by Nixon, and funding for things such drug control and treatment increased drastically. Although, a man known as John Ehrlichman later admits this was all a politically scheme for Nixon’s elections. After the 1968 campaign Nixon had two relative enemies, antiwar and people of color. Nixon thought that if he could associate people of color and hippies with marijuana and heroin then he can ultimately alter the view of their cultures (A Brief History of the Drug War, n.d.). How do you do this? You do this by classifying drugs as schedule one temporarily, for which that drug was marijuana. In 1972 however, decriminalization for marijuana was recommended but ignored after that. After 50 years, this is still a great system. Although, I do believe that there are some changes to be made. I feel as if this CSA has trapped us in the 70’s, not allowing wiggle room for Controlled Substances 2 things such as research. With new studies coming out frequently regarding the effects of everyday drugs such as caffeine, I think it is important to understand the drugs we view as harmful as well. I had the intention of proposing Marijuana to be taken off the schedule one category. Though, through investigation and reasoning, I believe this system of scheduling, charging, and distributing controlled substances should be looked at twice. PART 1: The Problem When discussing the Controlled Substance Act, there isn’t a lot of controversy around itself, but more so the social constructs around the act. Following the act, we determined a home for each controlled substance based on abuse, medical use, and addictiveness. Because these drugs are now in classified groups, laws can be made using the umbrella term instead of the specific drug name. This provides inconsistency with laws and regulations and enables less harmfull substances to coexist with extremely harmful substances under the same category. This pushes away drugs like THC and Psilocybin, which are the psychoactive compounds in marijuana and mushrooms and are currently on the Schedule I classification. To understand the problem, we need to first understand the situation. There being five controlled substance schedules, these are the DEA’s definitions for each: - “Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse.” (DEA, n.d.) o Heroin, LSD, Ecstasy, Peyote, Marijuana, Mushrooms, etc. - “Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.” (DEA, n.d.) o Cocaine, Morphine, Methamphetamine, Fentanyl, Adderall, Ritalin, etc. - “Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV.” (DEA, n.d.) o Codeine, Ketamine, Anabolic Steroids, Testosterone, etc. - “Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence.” (DEA, n.d.) o Xanax, Soma, Darvon, Tramadol, etc. - “Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics.” (DEA, n.d.) o Lomotil, Motofen, etc. With background understanding of each drug schedule, it comes off as fair in regard to how a drug is scheduled. Schedule I has high abuse and it has absolutely no medical value. Meaning marijuana and psilocybin have no medical benefits whatsoever. Unlike schedule I, schedule II is accepted in the medical field for potential use. Meaning there is more of a use for morphine, methamphetamine, and fentanyl than there is for THC. This can be a very clear problem when discussing new studies that counteracts these ideas. Studies proving naturally occurring compounds have positive effects when micro dosed. Controlled Substances 3 Another problem with the drug scheduling has to do with manufacturing and distributing both illegally and legally. More recently, Trump had a DEA temporary ban on Fentanyl analogues and allowed the ban to proceed for the next 15 months. This sparked a lot of controversy amongst the scheduling of these drugs. Fentanyl does have a medical use, but it also has a place for abuse, “Even though everyone agrees that fentanyl analogues are dangerous—up to 100 times more potent than fentanyl, which is itself 50 times more potent than heroin—“ (Strohman, 2020). Through this spark of controversy, Andrew Strohman, a healthcare data analysis, suggests that characterizing fentanyl as a schedule II is a “Mixed bag”. Allowing fentanyl to be a schedule II drug allows manufactures to not only make the drug but distribute them as well. Although these controlled substances have harsh restrictions and are only given to credentialed providers, it will never have the illicit restrictions and supreme limited access as that of a schedule I. This is because government entities crack down on illegal manufacturing and distribution which can ultimately lead to saving more lives. The negative to classifying a controlled substance as a schedule I is just as important as well. This is because drugs that are under a schedule I category significantly limits the amount of research you can do, if any. As David Nutt says from the Imperial College of London, putting a substance into schedule I makes it difficult to find drugs similar in effect that may be a success in the medical field (Nutt, 2015). This is a big reason that marijuana research is being delayed year after year, holding us back from a medical discovery whether it be good or bad. The same can be said for other controlled substances included in the schedule I. PART 2: The Solution This may seem as if it a tough situation to beat, and that is because it is. Not only because drugs and substances play a large role in modern day, but because this is a controversial issue where two parties must agree before action is taken. Being a part of the war on drugs movement, both right and left will have vast opinions regarding the scheduling of drugs. So, a solution that will work is a solution that won’t step on toes. While this is already a controversial issue, some believe that the system is okay how it is and shouldn’t be touched. Rather, policy makers and those creating substances should be aware of these class schedules beforehand as well as the flaws of research when placed as schedule I. Although this isn’t a solution, it is something that could be agreed upon by everyone. This would be the simplest and most cost-efficient change. Basically stating, don’t change, adapt. Why not change and adapt an alternative way? We see more and more studies arising from the shadows regarding natural remedies such as marijuana proving to be helpful. This is a system that allows you to access morphine for pain treatment, which is essentially heroin, but not marijuana. Most importantly these are the statements that are leading us to revolutionary discoveries. You ask questions, get answers, and adapt. This is a superior form of adaptation, but it is easier said than done. Although Adderall has a high medical use, it also has a high addictiveness and abuse use as well. Fentanyl has a high medical use, and also a high addictiveness and abuse. Though, the difference between these addictions are dramatically different. The withdrawals, the addictiveness, the Controlled Substances 4 abuse, it is all different, but these two substances are housed in the same schedule. This is why these factors such as abuse, and medical use need to be examined individually. Another example is that nicotine is more addictive than heroin, on paper that looks bad, but we all know the addiction to heroin is different than the addiction to nicotine. This allows the comparison to be unequal. So, the question boils down to; What do you do? The answer would be to separate the qualifications for each controlled substance schedule. You cannot rank one drug by medical use, addictiveness, and abuse, especially if the research for said substance is limited. This results in less harmful drugs such as THC to be extracted from society when it could pose a miracle-like benefit. Medical use, abuse, and addictiveness are all things that should be reviewed together but feel as if medical benefits out way the abuse and addictive factor. If we want something to work, controlled substances need to have two individual rankings after research has been concluded. PART 3: The Benefit Although the solutions are miniscule, the changes are profound. Redesigning controlled substance scheduling will separate the medical benefit to the scheduled rankings. Meaning methamphetamine, although has a surprising medical benefit should be placed on the schedule I classification for abuse, addictiveness, and for charges and trafficking. On the medical side however, remain noticed and available, happily sitting in the schedule II classification. This not only allows for these controlled substances to remain in the medical field, but it also recognizes that although this may have a medical use, it is schedule I for addictiveness and abuse. This will allow for testing and research to be done with all drugs, for every drug and substance is viewed as if it has a medical use. With this being said, benefits will range all across the board with improved testing and more efficient data. Viewing every single substance as a possible medical benefit will allow for better restrictions on widely used drugs and open doors for substances we’ve been pushing away. Along with this, successful testing of schedule I substance will allow a better understanding of their effects whether negative or positive. It will allow us to rule out medical use once and for all and help us understand the effects of recreational use whether it be prolonged use or not. All-in-all, the more research we can do on these certain drugs, the more breakthroughs we can find. Even though research on drugs such as THC and psilocybin are restricted in society, that doesn’t necessarily imply that research is nonexistent. Restriction on research is ultimately a restriction on breakthrough as I stated previously. However, with the little research that has been done, we have been able to introduce a few drugs into the market with active ingredients found in schedule I controlled substances. One of these drugs is known as Epidiolex and has been approved by the FDA. Epidiolex is an oral prescription that is used to treat two types of rare epilepsy with the main ingredient being cannabinol, or CBD (Slowiczek, P. D., 2019). Drugs such as Epidiolex are paving the way for our future prescriptions and as more uses for Epidiolex are discovered, it will take time due to scheduling restrictions. Epidiolex represents the value of rethinking the scheduling altogether and opens up reasonings to remove drugs such as marijuana off the schedule I class. Controlled Substances 5 Taking a look at a bigger picture, this business case needs to help economically and provide an incentive for growth. Research on these drugs may not pose a benefit every time but allowing substances to be looked at as a medical benefit may introduce a medical miracle some time or another. This can be seen as “innocent until proven guilty”, but for controlled substances. Looking at substances that have been pushed to the side such as marijuana has the ability to introduce a prescription such as Epidiolex. After this discovery however, Epidiolex brought almost 300 million dollars in sales in the launch year alone (Clifford, 2020). Allowing for us to take a second look at the CSA and question the scheduling process of controlled substances will essential lead to marijuana legalization. There are too many benefits to marijuana for it to be hidden in the schedule I class and with more research, marijuana being medically available everywhere is in the near future. Looking at marijuana alone we can discuss economic twist and turns, along with employment and business growth. Since weed has been legalized state-wide in many regions of the United States, we have been granted the outside look as the guinea pigs do their thing. In 2019 alone, Colorado brought in over $300 million in taxes over this single plant. Cannabis company analytics, New Frontier, suggest that we could possibly see over $100 billion in federal taxes in the next five years (Krishna, 2019). This same report suggested 1 million jobs may be available if this were to succeed in the next five years. Along with this, reports from ICF suggest in increase in labor income to be somewhere near $3.5 billion. Suggesting the federal legalization of marijuana, or simply just a change in scheduled classification can do all of this by itself. This allows us to see the major drawbacks we endure when being closed minded about a simple plant. Controlled Substances 6 References _TylerTheTyler_. (2020, January 17). FDA-backed CBD drug brings in $296 million in 'incredible launch year,' GW Pharma CEO says. Retrieved April 28, 2020, from https://www.cnbc.com/2020/01/16/cbd-epilepsy-drug-does-incredible-296-million-in-sales-gwpharma-ceo.html A Brief History of the Drug War. (n.d.). Retrieved April 28, 2020, from https://www.drugpolicy.org/issues/brief-history-drug-war An Overview and Update of the Controlled Substances Act of 1970. (n.d.). Retrieved from https://www.pharmacytimes.com/publications/issue/2007/2007-02/2007-02-6309 CSA Schedules. (n.d.). Retrieved April 28, 2020, from https://www.drugs.com/csa-schedule.html Drug Classifications. (2019, June 25). 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