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Legitimization of Medical Marijuana in the United States

Info: 6298 words (25 pages) Dissertation
Published: 11th Dec 2019

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Tags: International StudiesMedical

Introduction

Legitimization of medical marijuana in the United States can be both good and bad., the impacts of which are quite uncertain. As definition, marijuana refers to  cannabis plant comprising of high levels of the main psychoactive chemical, tetrahydrocannabinol (Δ9 -THC) and minimal levels of the non-psychoactive chemical, cannabidiol. Regardless of the current surge of enthusiasm for the potential restorative utilization of various forms of cannabis, it merits recalling that  medical marijuana is not a new drug, and has been known to mankind since antiquity for its medical as well as non-medical uses. In examining conceivable clinical trials of cannabis or cannabinoids, there is something helpful to be gained from reviewing a tad bit of that history.1

History and Legal Status of Cannabis in the United States

Historically, marijuana has been utilised by different cultures and populaces worldwide as  autochthonous treatment for different medical conditions ranging from  prosaic issues such as fever, headache and constipation, to fairly uncommon conditions such as rheumatic pain, insomnia and wasting syndrome, and diseases  such as malaria and venereal diseases.  As a result of its expected wellbeing preferences, marijuana form of cannabis was seen as an official, licit drug and recorded in the U.S. Pharmacopeia in 1850.  The Prohibition Era emerged in the 1930s with the escalation  in the recreational use of cannabis. In 1937, the Marijuana Tax Act came into effect which contravened all cannabis use and interestingly, without imposing criminalization on its proprietorship or use. After a few years, in 1970, the Controlled Substances Act stratified marijuana and any formulation containing marijuana as “schedule I illicit drug”, the most restrictive class, mandating ownership of any form of cannabis as a nationwide crime. Up to date, the Food Drug Administration (FDA) concurs with the Drug Enforcement Agency (DEA), the agency regulating the Controlled Substances Act,  to continue classifying marijuana as Schedule I controlled substances as it still meets the three criteria for such placement under 21 U.S.C. 812(b) per definition in the Controlled Substances Act:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

A past assessment by the FDA, the National Institute for Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA), which are agencies within the  Department of Health and Human Services (DHHS), presumed that no stable logical reviews upheld therapeutic utilization of cannabis due to the absence of sound scientific studies justifying the medical appropriateness of marijuana and lacking animal or human data that would confirm for  the safe and effective use of marijuana as a medicine.2

Marijuana Pharmacology

Cannabis contains more than 400 known chemical compounds, out of which more than 60 are grouped collectively as cannabinoids.1 Δ9 THC, or tetrahydrocannabinol is the major psychoactive ingredient of cannabis which is so far the best known cannabinoid. Notably, Cannabis is not simply THC, and diverse assortments of cannabis create contrasting proportions of dynamic fixings. The intricate cooperations and proportions of these chemicals create differing restorative impacts. This variety in strength and body electorate, in addition, to the mind boggling compound corporations, additionally, consolidated with the path in which the body metabolizes these cannabis constituents, make steady therapeutic cannabis dose extremely difficult. Comprehending how and where the constituents of cannabis medicine are absorbed, metabolized, excreted, and stored within the body is important for demonstrating a fundamental understanding of how cannabis works as a medicine. In any case, such a comprehension is, from a logical stance, a dynamic target.  There is just so much that is at present thought about how the body follows up on cannabis medicine (called the pharmacokinetics of cannabis) and how the cannabis drugs follow up on the body (called pharmacodynamics).2

Absorption of Cannabis Medicines

Whenever smoked, the THC in cannabis formulation achieves its pinnacle blood plasma focuses within six to seven minutes of ingestion. THC from smoking is really recognizable a few moments after inward breath. The capacity of a patient to ingest THC through smoking or vaporization gives off an impression of being an educated conduct, with experienced clients more than twice as productive in their rate of retention as incidental clients. The productivity of breathed in cannabis is reliant on the size and span of the inward breath, in addition to what extent the breath is held. Holding one’s breath just marginally increments absorption.3

Sublingual (under the tongue) or oromucosal (on the tissues of the mouth) organization of cannabis solutions is not as productive as organization by inward breath, in spite of the fact that ingestion and onset of cannabis meds set underneath the tongue has been referred to happen as fast as five to 15 minutes after application. Top blood fixations for sublingual THC are come to inside four hours, with different cannabinoids, for example, CBD taking somewhat longer to peak.4

Oral ingestion of THC (sublingual or oromucosal) in cannabis pharmaceuticals is both moderate and conflicting. This irregularity has frequently been referred to as the motivation behind why numerous oral cannabis arrangements that were prominent in the nineteenth century along these lines dropped out of support with both specialists and patients. Most extreme blood plasma levels are frequently achieved within two hours, yet in a few reviews human subjects have required up to seven hours to attain these levels. Moreover, some THC is demolished by stomach acid. At that point, the liver snatches a great part of the THC before it can be bioaccessible through an effect  known as a first-pass impact.3

Topical assimilation of THC is troublesome and not especially effective but rather can be enhanced by mixing the THC into an unsaturated fat and propylene glycol. This approach has been utilized to treat skin conditions including psoriasis and provocative infirmities including osteoarthritis.4

Metabolism of Cannabis Medicines

After absorption in the blood plasma it binds 90% to the plasma protein. Here it goes along with the blood and reaches to the highly perfused tissues-organs such as liver, heart, fat cells, etc. Only 1% of protein bound THC absorbed into the brain. Certain organs in the body can separate THC into different atoms called metabolites. This digestion system happens fundamentally inside the liver, additionally inside the tissues of the heart and lungs. At the point when the liver separates THC, the essential metabolite is 11-hydroxy-THC, twice as psychoactive and enduring twice the length THC. In the long run, 11-hydroxy-THC experiences facilitate metabolic changes into an idle metabolite, before being discharged from the body. Cannabidiol is metabolized by the liver into 7-hydroxy-CBD. Next to no is thought about the pharmacology of this CBD metabolite.

Elimination of Cannabis from the Body

It is known that THC and its psychoactive metabolite gets eliminated from the systemic circulation within  roughly 36 hours after ingestion. Additionally, THC’s non-psychoactive metabolites can hang around for weeks in heavy users. Eventually, these metabolites will be excreted—around 30 percent excreted in urine and 70 percent in feces (about 5 percent of an oral dose will be excreted in the feces unchanged).3

 

Medical Marijuana: Origins of the Debate

A remarkable turning point of the contemporary era is the enactment of the first modern medical marijuana law in California in 1996.5 Since then, mammoth patients who have harnessed medical marijuana affirmatively claim about its remedial values in alleviating a number of illnesses. . Records of individuals ranging from instances of nausea, Asperger’s disorder and post-traumatic stress disorder (PTSD) to those with extreme agony from end stage cancer and HIV/AIDs, wild muscle fits, and numerous other restorative issues assert  encountering exceptional outcomes with marijuana.6

Undoubtedly, the stance towards medical marijuana is transforming remarkably. By the late 2012, eighteen states in the US had already legalized medical marijuana.7 It has been ascertained by a 2010 Pew Research poll that about 73 percent of the general population support that “their state should accommodate for the sale and utilization of marijuana as a medicinal option, probably under medical jurisdiction, that is via legit prescription by a practitioner.” In fact, their is a noteworthy aggrandize in the crowd upholding that marijuana is not a legal, but a medical issue and that it should be offered as a treatment alternative for the individuals who battle with debilitating nausea, agony and devastating diseases.8

Marijuana-scheduled drug

Irrespective of the diversified categorization of marijuana amongst different states in the US, marijuana continually sojourns as a Schedule I drug by the Federal Law; extrapolating its possession, cultivation, prescription, dispensing, and selling as illegal.5 Nonetheless, 20 U.S. states and the District of Columbia to date, have passed enactment permitting the utilization of marijuana for therapeutic reasons.9 Consequentially, there prevails significant inconstancy in the medical conditions that fit the bill for treatment; a few states permit conditions to be considered by the general wellbeing division on a case-by-case premise. Defenders argue that medical marijuana is inevitably tectonic for restorative reasons by citing that it helps in various conditions, including intractable pain disease, body wasting as a result of conditions such as AIDS and cancer related treatments, enfeebling nausea and vomiting,  muscle spasm in multiple sclerosis, and other innumerable neurologic illnesses, after failure of all other accessible therapies.9,10 On the other hand, adversaries of therapeutic marijuana utilization raise worries about its antipathetic impacts, for instance, extended recreational marijuana utilization and intensifying crime, particularly in neighborhoods where restorative marijuana dispensaries are sited.11 Among the central concerns are the feelings of trepidation that it would “empower youth marijuana abuse across the board,” and that any progression of current medication utilize laws would negate antidrug messages targeting our youngsters and counter existing impression of marijuana as a harmful substance, and that adolescents would look for solutions for utilizing when it is not plainly indicated.12

A Clash Between State and Federal Laws

At present, medical marijuana is subject to various  human, legal, and political issues. The prevailing laws in the many states which allow for the legitimization of medical marijuana are in direct discord with the federal laws which enjoin to restrict marijuana use for any purpose.13  This creates a situation of legal bemusement amongst patients and within the states. For instance, in California, a marijuana dispensary is obligated by the state law to be able to ratify that it procured its marijuana from within the state itself and just from state-endorsed cultivators. Many California dispensaries have been shut down with a claim of not abiding to such  state laws even after successful arguments in the courts by the growers and dispensaries of operating as per the state guidelines.14

Epidemiology of Cannabis Use and Addiction

Cannabis (as alluding to smoking of cannabis plants) is one of the most extensively abused unlawful substance in the US. As per data from The National Survey on Drug Use and Health,4,5 44% of males and 35% of females have encountered the use of marijuana at any rate and at least once in lifetime. More recent studies suggest that regular use of marijuana is increasing. Data from National Survey on Drug Use and Health6 indicate that in persons over the age of 12, the rate of past month cannabis use and the number of users in 2009 (6.6 percent or 16.7 million) were higher compared to 2008 (6.1% or 15.2 million) and 2007 (5.8% or 14.4 million).15

Medicinal Use of Cannabinoids in Pill Form

THC was first extraced and purified7 from the cannabis plant in 1965. Since then,  more than 400 chemicals have been segregated and around 60 of which are cannabinoids. As noted earlier, cannabinoids are the active agents of cannabis. Approximately 21 cannabinoids are under systematic review by the US FDA. This undoubtedly mirrors a rapidly emerging enthusiasm for the therapeutic potential of cannabis.16

Two types of cannabinoid receptors have been identified lately. CB1, which is instituted mainly within the central nervous system is believed to be responsible for the psychoactive properties of cannabis, and CB2 has been mostly found in the systemic circulation, immune tissues, and the spleen. Anti-inflammatory and immunological effects of cannabis are believed to be due to CB2 receptors. A gathering of endo-cannabinoids has been additionally distinguished, e.g., arachidonoylethanolamine or anandamide, as endogenous concoction modulators which impersonate the activities of phytocannabinoids and initiate cannabinoid receptors.17 These revelations have prompted to the improvement of various CB receptor agonists and antagonists and various studies have attempted to validate the therapeutic implications for these chemical compounds. Medications containing natural or synthetic cannabinoids currently approved or being considered for sanction for medicinal utility are listed below:

Compound CSA class Proprietary name Content/s Dosage form FDA approved indication CNS effects
Dronabinol Schedule III Marinol Synthetic THC Oral capsules §  Antiemetic in cancer patients undergoing chemotherapy

§  Appetite stimulant in patients with body wasting due to HIV/AIDS

§  To augment analgesic treatment (less frequently)

Some potential for psychological and physical dependence.
Nabilone Schedule II Cesamet Synthetic cannabinoid §  Oral capsule §  Antiemetic in cancer patients undergoing chemotherapy who fail to respond to conventional antiemetics

§  Appetite stimulant in AIDS patients for anorexia and weight loss

High potential for mental health side effects and addiction.
Sativex Phase III studies of Sativex are currently underway in the US, thus it does not have a schedule assigned to it. THC, cannabidiol (CBD), and other cannabinoids. §  Oral spray (“liquid marijuana”) -liquid extract from cannabis plant §  For neuropathic pain

§   Antiemetic

§  For overactive bladder

§  For spasticity

(in several countries including England, Canada, and Spain.)

In addition to the the approved indications (nausea, vomiting, cachexia) as stated above, these medications  are currently being studied for several new indications, including neuropathic pain and other pain syndromes as well as spastic syndromes and neurological disorders, among others. It is noteworthy that use of such medications which have been clinically tested for safety and efficacy by sound clinical trials is approved by the FDA and  therefore, not subject to controversial. However, any attempt  with an endeavour to legitimize  unprocessed (crude) cannabis plant is objectionable as that would sidestep government administrative procedures that were set up in first place to ensure the general well-being of the public.

Approaching Cannabis Policy with Marketing Strategies

Whether marijuana legalization is net positive or negative for public health and public safety largely depends on regulatory decisions and how they are implemented. According to the discussion aforementioned, there is need to come up with a rational policy that could be adopted with a net benefit of controlling harm due to cannabis misuse and subsequent legal policies adopted to regulate its use. Several studies have researched on the various challenges facing the development of a rational policy in legalization of marijuana. Hall and Lynskey summarized that “Development of a more rational cannabis policy requires better evaluations of both the health consequences of regular cannabis use and of the costs and benefits of enforcing the existing prohibition on its use. It also requires the liberalization of the international control system to allow member states to experiment with different methods of regulating and controlling cannabis use”.18

The process is quite perplexing. But we have to find a way to at least alleviate the mammoth harm cannabis is directly and indirectly causing to the nation and worldwide. Also many studies have proposed that teenagers and adolescents are a big culprit to cannabis mal possession in a way or another. To protect the future we need to protect the young generation from drowning the horrendous ocean of marijuana. Apart from creating awareness and legal regulation of cannabis, there are other strategies which can be implemented to improve the current status of cannabis. Taking this in to consideration, this study was focused in designing considerations addressing jurisdictions that are pondering a change in cannabis policy from a marketing point of view.

The insights the insights that are going to discuss are based on a number of collaborations and many were previously mentioned in a published op-ed.18–21 The article was also an area of focus, which discussed the 8 Ps’. As such it is also important to know that any given design will serve some goals better than others; this review’s suggestions may not sound exhaustive. The study article22 inspired us into instigating the marketing principles that may benefit marijuana regulation. All in all this review focused on cannabis from the roots, covering the history behind it, its benefits and harms, debate on its legalization and the checks and balances of legal policies controlling its flow.

 

Proposed Strategies That Could Be Implemented In The Cannabis Policy Change

Production and Place

As Kotler puts it, “Selling starts only when you have a product. Marketing starts before there is a product. Marketing is the homework the company does to figure out what people need and what the company should make.”23 This reflects that for the flow of market, product is the starting point- but an idea that concocts the product is at prime position in any market. The market need is the ultimate driving force in the genesis of the product. Due to marijuana prohibition which denies its access to the market makes it a major force in exaggerating its market demand;  and thus when we consider cannabis, it is a much more expensive commodity pertaining to its legal confinement as compared to an instance where it were to be traded in a legal market. This inflation in price attributes to the production and distribution of cannabis as well as to the economic compensation for the black market dealers and others along the supply chain for their risk of arrest, incarceration, and assault. Critiques argue that this generates robust profits that could be used to corrupt law enforcement officials. It should also be notable that a lot of cannabis is easily grown indoors which makes difficult for police to prevent its cultivation thereby releasing cannabis growers from corrupting law enforcement officials.24,25

An estimation was found of cost comparison by Caulkins et al. postulated in the study “Policy designs for cannabis legalization: starting with the eight Ps” by Kilmer. Caulkins et al. examined the production costs associated with other transplant crops and calculated that full industrial farming could bring the production costs for a pound of high-potency cannabis to approximately $20 whereas growers in California currently make up to about $2000 for the same amount.26 No modern nation has ever legalized commercial marijuana production, so there are literally no relevant data to guide estimates of marijuana-production costs after legalization. Caulkins et al. came up with the closest estimates of production costs in different places, viz. in-door, out-door and green-house. From that study, it could be assumed that decision makers could attempt to limit cost deflation by only allowing indoor production; however, the drop in cost would still be substantial. In other words after legalization, the production costs will depend more on just where production takes place eliminating the extravagant costs posed due to the illegal or black market production consequences. The number of producers and types of products allowed will influence these costs as will decisions about whether producers can vertically integrate with processors and retailers or operate multiple facilities.27

If a proposal was made that legalization will remove the penalties for selling and possessing marijuana; this will lower production and distribution costs ultimately decreasing the selling price and thus will relieve the burden of consumers buying price. This can also follow the utilization of large scale production and efficient cultivation technology that can otherwise be implemented were the cannabis production legal. Also considering the availability of labor; full time growers can then be employed which can ultimately reduce the production costs.27

The place where cannabis will be sold also is a prime thing to consider. With all the legal restrictions imposed on it, there are obviously not many places where it would be sold. The cannabis companies ought to target certain states where the users are maximum. Since about 80% of the cannabis market is driven by the roughly 20% of past year users who use on a daily or near daily basis companies ought to start their selling places in states and locations that are accessed by such users in order to maximize their profit. Also, in this way the non-users shall not be exposed unnecessarily. “For example, jurisdictions could permit home production, cannabis buyers’ clubs, non-profit cooperatives, or even a state monopoly. While some US states have monopolies on certain aspects of their alcohol control systems, this option has not gained traction in US cannabis debates since states cannot order their employees to violate the federal laws”.28

Price and Promotion

Cannabis is not an ordinary product; its demand and elasticity is disparate as compared to other commodities pertaining to its consistent popularity in the market constrained by governmental prohibition.

An estimate of the current price of cannabis is required to assess price-induced changes in the consumption. Price change can be computed as the difference between the projected post-legalization price and the current price. The current price of cannabis greatly depends on its availability because of the users’ inability to abstain from it. Shoppers and potential users are sensitive to the price of cannabis: a 10% decline in price is likely to lead to approximately a 3% increase in cannabis participation.29,30 Considering legalization, the price will be influenced by the type of the product and the location where it is sold. For instance, consider the price of beer in a grocery store and that in a bar. The price of beer in a bar is far higher due to the extra costs incurred viz. cost of rent, wait staffs’ wages, and such. Similarly, suppliers can come up with different forms of marijuana at different prices. Unbundled marijuana that is one that is marijuana sold as marijuana (as opposed to marijuana-impregnated brownies, beer, or other products) to be consumed off-premises.27

The retail price of cannabis will determine what happens to consumption, tax revenues, and diversion to other jurisdictions.26 For instance, by estimating the current consumption rate, the revenue collected post-legalization can be evaluated. The average retail price paid will depend on what taxes are imposed and collected.27 The governing authority can influence retail price through tax rates, production types, frequency of producers allowed, standards pertaining to purity and potency, manipulating the direction of market flow and others.

Taxes deserve special attention because if not can lead to tax evasion. If taxes are set too high, users would repulse to the black market for an untaxed and unregulated productthat would otherwise cost them lower.27,29 This follows that just because an excise tax is levied does not mean that it will be collected. To highlight this we need not to go farther than the findings from the tobacco experience that are particularly relevant. Tax rates that bring about the desired balance are difficult to foretell and are thus subject to change as need be.31,32

Also, the way the taxes are levied will result in different consequences. Instituting the taxes as a function of the total weight will not be a good idea. Consider that a $50 per ounce tax is set on weight basis. This will further incentivize the production of more cannabis and channelize to covert smuggling.27 Colorado imposes taxes based on the value of the cannabis and Washington will do the same. However, taxes could also be based on THC potency or the THC: CBD ratio.  “Marijuana is consumed in many different forms that vary in THC content, ranging from commercial grade (low potency) to domestic midgrade to high-grade sinsemilla (higher potency), as well other variants. The price per gram is roughly proportional to the THC content. For example, DEA data show that sinsemilla has about 2.4 times the potency and is a little more than twice as expensive per unit weight as commercial grade (NIDA, 2008).33 A tax assessed on the weight of marijuana (e.g., $50 per ounce) is higher in terms of dollars per unit of THC or per hour of intoxication for lower-potency forms than for higher-potency forms”16. The tax projections allow for the possibility that the mix of marijuana types may shift toward higher-potency forms.27,34

The price of cannabis would probably be lower in a legal market in order to undercut the black market. Consumers who were deterred previously by prohibition may incline in consumption if they showed an increased demand; also consumption would increase if the current users continued or increased their usage.35,36 Without knowing how sensitive cannabis use would be to a lower price, it is difficult to estimate what the total tax revenue would be in a legal cannabis market. Revenue could nonetheless be substantial even if not as large as that generated by the black market.37

To streamline and maintain the cannabis income into the governmental revenue the retail price and taxes imposed should be strategically manipulated. They should be such as to maintain its value in market at the same time satisfying consumers’ perceived and expected cost. The governmental should tactically manipulate the price such that the users adhere to the legal market and not repose back to the black market.23

With the development of legal cannabis market, it becomes evident to hold on the users so as to maintain the business. Promotion has two main aspects: to create awareness then to remind the consumer about the product. The public has seen marijuana is not an ordinary product, so the policy makers should come up with unique promoting ideas that would effectively make the product consumer recognizable at the same time preventing the misuse and come back of the black market. “Policymakers in Colorado and Washington are attempting to limit cannabis advertising, but prohibition is difficult in the US with its doctrine of commercial free speech. Targeting cannabis firms that market in ways that appeal to minors is a DOJ enforcement priority”.28

“Cannabis companies may attempt to create and keep heavy users through marketing and advertising. Jurisdictions seeking to reform cannabis laws should consider how promotion is handled inside and outside of the stores (e.g. billboards, social media, packaging, in-store display). It will be interesting to see how federal prosecutors determine when companies have crossed the line and how these violations will be addressed”. Promoting cannabis is a perplexing activity with the legal restrictions imposed; but the suppliers need to employ customized promotional means. For instance, personal selling can be adopted as an advertising approach.28

Market Segmentation

Business stability rating, which tells about how safe a particular state is to run a cannabis business in for the next year, can evaluate likelihood of local regulations changing, local official’s attitude towards medical marijuana, lawsuits that could affect the industry and any major expected development. According to which Maine and Washington are considered as most stable since they haven’t experience huge fluctuations, whereas Montana and Colorado showing most fluctuation in marketing. Business opportunity rating, which tells about how good the opportunity in each particular state to start or expand a cannabis related business, can evaluate legal considerations, current amount of competition, estimated market demands, potential for growth, maturity of market, local limitations-such as restrictions in number of dispensaries. According to which Colorado and Washington have high potential for generating hundreds of millions in revenue whereas, Maine and Montana states have least opportunity for marketing medical marijuana because of local limitations.38

Likewise one can segment state as per their stability and opportunity get the best segment to market and to create huge amount of revenue possible. In the micro-segmentation one can consider HIV and chemotherapy patients with high potential for GI motility and pain respectively, excludes minor under age of 18 year.

References:

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