Kizito O. Akali, Pharm.D.

, HCMBA November 18, 2012 Medical Marijuana Policy Proposal Executive Summary There is accumulating evidence that cannabinoids may be used to treat certain medical conditions. Research indicates that under a medical practitioners supervision, patients may benefit from the healing effects of cannabis. Medical cannabis has been shown to be effective in the treatment of several ailments, including peripheral neuropathy, nausea and vomiting, appetite stimulation, and muscle spasticity from multiple sclerosis. The federal government, however, under the auspices of Controlled Substance Act (CSA), places marijuana on the Schedule I substance list, which makes it illegal for anyone to manufacture, possess, or distribute it. In response to calls by majority of their citizens, to legalize marijuana for its medical benefits, several states began to enact laws that would authorize the medical use of marijuana under the supervision of a physician. Currently, 18 jurisdictions, including the District of Columbia have enacted such laws and seven more jurisdictions are with pending legislation. The states enactments, however, has created a conflict with the federal statute. This conundrum has caused patients, caregivers, state employees, and providers to become reluctant to enjoy the benefit or execution of the state medical marijuana laws, for fear of federal prosecution. To end this conflict, and with the authority of our client, the National Governors Association (NGA), a policy proposal is recommended. It is recommended that congress revise the CSA by reclassifying cannabis from a Schedule I to a Schedule II substance. This will allow medical cannabis to be prescribed by a physician and dispensed by a pharmacist as is currently done with other Schedule II drugs. It will create a standardized form of medical cannabis across the U.S., which is currently not the case. It will open a plethora of clinical studies to understand the full therapeutic effect of cannabis and identify other possible route of administration. The research and opinion reports cannabis presented by several institutions all point to the same conclusion; cannabis has a medical benefit and a manageable safety profile. The 1999 Institute of Medicine report concluded that cannabis has a medical benefit and recommended a short-term therapy for terminal patients and a need for further research. The Center for Medicinal Cannabis Research, after multiple studies, reported in 2010 that cannabis was effective in the reduction of neuropathic pain and muscle spasticity in muscle sclerosis, with minimal side effects. Grant Et al, through Open Neurology Journal and American Medical Association advocates that based on results from peer reviewed studies, the federal government should consider reclassifying cannabis from the Schedule I list of the CSA. There is currently a bill in the 112th congress, introduced by Representative Sam Farr on July 17, 2012. This is the Truth in Trials Act (H.R. 6134) bill. This bill will permit medical marijuana users, caregivers, and providers being prosecuted to tell juries in a federal court that their marijuana activity was medically related and approved by the state. This bill is currently waiting for consideration in the referred committees. This bill follows other bills that have been introduced leaning toward the relaxation of the federal marijuana prohibition for medical use,

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including H.R. 5842, H.R. 2835, and H.R. 3939, but have not gone past the referred committee stage. Problem Statement: There are growing evidence that patients with terminal or debilitating medical conditions may, under the supervision of a healthcare provider, benefit from the use of botanical cannabis products. This has prompted 17 states plus the District of Columbia, amid overwhelming approvals by their citizens, to enact laws that would legalize the medical use of cannabis (ProCon.Org). Even with the overwhelming evidence showing quality of life improvement, cannabis, also known as marijuana, is still considered illegal under the federal law. It is classified as a Schedule I substance under the Controlled Substance Act (CSA) (Drug Enforcement Agency, 2011). This means that under federal guidelines, marijuana is a substance with a high potential for abuse, no currently accepted medical use, and lack of accepted safety. The discord between the states and federal law prompts a situation lacking a safe and regulated system that would allow legitimate patients access to the product. This is because of the struggles in managing the safe access of medical cannabis to the patients by the jurisdictions and the federal policies that do not provide means of safe access to the patient in need (Gov. Gregoire & Gov. Chafee, 2011). The federal government would solve this conflict with the states that allow legalization of cannabis through the use of medical cannabis, by the reclassification of cannabis under the CSA from a Schedule I substance to a Schedule II substance. Target Audience: The Client is the National Governors Association. This is a bipartisan organization of the nations governors. It promotes visionary leadership and allows the governors to speak with a collective voice in matter of national policy (National Governors Association). Background The cannabis sativa plant has been used throughout history as part of the medical healing armamentarium. Growing and using marijuana has been legal under both the federal and state laws for most of American history. The therapeutic potential of cannabis was recognized by U.S. physicians in the late 18th century, and it became part of the United States Pharmacopeia (USP) in 1850 (Eddy, 2010). In 1936, however, all 48 states promulgated laws to regulate marijuana, fuelled by reports of marijuanas harmful effects on its users and the discoveries of other pain modulating drugs, like aspirin and morphine. The congress, in 1937, enacted the Marijuana Tax Act, in spite of the opposition from American Medical Association (AMA). This Act imposed cumbersome registration and reporting requirements, and imposed tax on the growers, sellers, and buyers of marijuana (Bearman). This Act did not make marijuana illegal, but it caused pharmaceutical companies to withdraw from the market all medicinal products containing marijuana. This led to the removal of marijuana from the National Formulary and USP in 1941. Controlled Substance Act (CSA)

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Federal control laws came under scrutiny with the increasing use of marijuana and other street drugs in the 1960s. To combat the rising drug use, the congress enacted the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Eddy, 2010). Included in the new law was the Controlled Substance Act (CSA), which placed cannabis in Schedule I. Schedule I is reserved for drugs that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety standards for use of the drug under medical supervision (United States Code, 2005) This puts marijuana in the same category as heroin, LSD, and PCP. Drugs with potential for abuse but with recognized uses were assigned to Schedule II through V, including opium, cocaine, and amphetamine. Despite its placement in Schedule I, the number of health care professionals and their patients who believed in the plants therapeutic use continue to grow. In a 2011 CBS news poll conducted on marijuana and medical marijuana, result shows that while only 40% of Americans think that marijuana should be legalized, 77% support allowing physicians to prescribe marijuana for serious medical conditions (Backus, 2011). It is surveys like this and preliminary research data that prompted 18 jurisdictions, including the District of Columbia, to enact laws legalizing medical cannabis use and seven more jurisdictions with pending legislation (ProCon.Org). See Appendix A for the full list. The CSA, unfortunately, does not place a distinction between recreational and medical use of marijuana. Under the federal statute, possession of marijuana can lead to one year in prison and a fine of up to $100,000. To grow a single plant can get an individual up to five years and up to $250,000 fine (Eddy, 2010). This creates a conflict with the states that has enacted medical use exception for cannabis and its derivatives. As a result of the supremacy law, the CSA preempts the states medical marijuana law. This means that federal agents can investigate, arrest, and prosecute medical marijuana patients, caregivers, providers, and state employees in accordance with the CSA, irrespective of the medical marijuana status. This conundrum, which puts patients and providers at risk, can be solved if congress can relax the federal marijuana prohibition, by reclassifying it to Schedule II under the CSA. Such reclassification will accomplish the following: It will standardize medical marijuana across the federation. Medical marijuana will be prescribed by a physician and dispensed by a pharmacist. It will eliminate the need for patients to grow their own plant, thus plugging the hole that could increase recreational use of marijuana. Federal agents, in concert with the states drug monitoring department, can easily monitor the manufacture and distribution of medical cannabis. Obama Administration It is worthwhile to note that while the administration of President George W. Bush has frowned upon states medical marijuana laws, the present administration has been somewhat accommodating. In fact, in his 2008 interview with The Mail Tribune (Obama, 2008), then Senator Barrack Obama stated that my attitude is that if its an issue of doctors prescribing medical marijuana as a treatment for glaucoma or as a cancer treatment, I think that should be appropriate because there really is no difference between that and a doctor prescribing morphine. In November 24, 2007, during a town-hall meeting (Obama, Should Marijuana be a Medical Option?, 2007), Senator Obama said my attitude is, if the science and the doctors suggest that the best palliative care and the best way to relieve pain and suffering is through medical marijuana, then thats something Im open to, because theres no difference between
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that and morphine when it comes to just giving people relief from pain. In a statement in March, 2009 and formalized in October 19, 2009, Attorney General Eric Holder authorized the cease of raids on medical marijuana dispensaries. He directed the U.S. Attorneys in states with medical marijuana program not to focus their investigative and prosecutorial resources on patients with serious illnesses or their caregivers who are complying with state laws on medical marijuana (DOJ, 2009). This directive, in addition to the Presidents position, indicates the administrations willingness to be receptive to any request that would ask for a compromise on this conflict between the states and federal marijuana laws. Furthermore, it will indicate that the administration is listening to the 77% of the population that would like medical marijuana to be prescribed by a physician and also the 51% of the population that does not think marijuana should be legalized (Backus, 2011). It will also make it easier for the U.S. Attorneys to investigate and prosecute anyone that illegally manufactures and distributes marijuana. Landscape There has been mounting evidence that refutes classifying marijuana as a Schedule I substance. Clinical studies show that (Gov. Gregoire & Gov. Chafee, 2011): Medical cannabis, in comparison to Schedule II drugs, has a relatively low potential for abuse. There is concluding evidence among the medical community that cannabis has an accepted medical use. Cannabis has accepted safety profile when used under the supervision of a healthcare provider. Institute of Medicine (IOM) 1999 Report In their literature review of the scientific evidence on the potential benefits and risks of cannabis, IOM, under commission from the Director of the Office of National Drug Control Policy, made the following observations and recommendations (Institute Of Medicine, 1999): Scientific data shows the therapeutic potential of cannabinoid drugs for pain relief, control of nausea and vomiting, and appetite stimulation. Though long=term effects of smoking marijuana still has to be ascertained, it is not of a concern for certain patients, such as the terminally ill or those with debilitating disease. The suggestions that medical availability would increase drug abuse should not be a factor in considering the medical use drugs. While marijuana withdrawal has been identified, it is, however, mild and short-lived. The report concluded by recommending a short-term use of smoked marijuana (less than six months) for patients with debilitating symptoms and further clinical trials to be conducted to study the full physiological effects. Center for Medical Cannabis Research (CMCR) 2010 Report This center was commissioned by California Governor, Grey Davis, in 1999 to conduct research studying the therapeutic usages of marijuana (CMCR, 2010). Several studies were conducted. While some studies are still ongoing, the concluded studies show that: Smoking marijuana is efficacious when used as analgesic to control neuropathic pain in HIV related peripheral and painful neuropathy.

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Smoked cannabis ameliorates marked muscle spasticity and pain intensity associated with multiple sclerosis. The benefit provided seems to be above that achieved by currently prescribed treatments. Overall, smoked cannabis was well tolerated, with no safety concerns raised. The side effects experienced, such as sedation, anxiety, and dizziness, were mild.

The Open Neurology Journal 2012 Report In a 2012 published report in The Open Neurology Journal, Grant et al concluded that classification of marijuana as Schedule I drug creates an obstacle to medical progress in this area (Grant, Atkinson, Gouaux, & Wilsey, 2012). According to the report, it is inaccurate that cannabis has no medical value or that information on safety is lacking. The report concluded with recommendation that, with its abuse potential, the profile of cannabis resembles drugs in Schedule III. American Medical Association (AMA) 2009 Report The AMA adopted a new policy on November 10, 2009, urging the federal government to review marijuanas status as a Schedule I controlled substance, to facilitate conducting of clinical research. The report affirmed the therapeutic benefits of marijuana and called for further research (American Medical Association, 2009). The report concluded that short-term controlled trials indicated that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake, especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with muscle sclerosis. As plethora of research evidence begins to mount, several medical organizations are beginning to support the need for medical cannabis. See Appendix B for complete list. Legislations in Pipeline On April 17, 2008, Representative Barney Frank introduced H.R. 5842, the Medical Marijuana Patient Protection Act, in the second session of the 110th congress (110th Congress, 2008). The bill would have moved marijuana from Schedule I to Schedule II of CSA. However, the bill died when referred to the House Committee on energy and Commerce. The bill was re-introduced in the 111th congress as H.R. 2835 on June 11, 2009 by Representative Frank and 31 cosponsors. It was referred again to the House Committee on Energy and Commerce, where no further action was seen (111th Congress, 2009) A second bill in the same congress, the Truth in Trials Act (H.R. 3939), was introduced by Representative Sam Farr on October 27, 2009. This bill will permit medical marijuana users and providers being prosecuted to tell juries in a federal court that their marijuana activity was medically related (111th Congress, 2009). As can be recalled, it is no longer permissible for defendants in a federal court to use the evidence that their marijuana related activity is for a valid medical purpose authorized by state law. This bill was referred to the Committee on Judiciary and the Committee on energy and Commerce. No further action was seen. The Farr bill was re-introduced on July 17, 2012 in the 112th congress as H.R. 6134 by Representative Sam Farr. It was sent to a congressional committee on July 17, 2012, where it is currently waiting for consideration (112th Congress, 2012).

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Options The evidence clearly shows that cannabis does indeed have medical benefits when used under medical supervision. The current administration has indicated sympathetic undertones toward the patients that would most benefit from the use of medical cannabis. Majority of the public has indicated they would be okay if marijuana is used by patients under a recommendation or prescription form a healthcare provider (Backus, 2011). Yet, the divergence in state and federal laws has created a situation where legitimate patients cannot get access to medical marijuana in a regulated and safe fashion. The federal government can end this conflict by considering either of two options. First Option By the act of congress, the federal government can relax the federal marijuana prohibition enough to permit medicinal use of cannabis products when recommended by a physician, especially in those states that have enacted medical marijuana programs. While this will be a welcome approach since patients, caregivers, state employees, and healthcare providers will be free from federal prosecution, it does come with some concerns. Since manufacture and dispensing of the plant is placed in their hands, it will be difficult to monitor the potency of medical cannabis patients are using. Reports have surfaced that the mean potency of marijuana seized by federal and state authorities has more than doubled over the last 15 years (Grant, Atkinson, Gouaux, & Wilsey, 2012). As a result, cannabis obtained from dispensaries or self manufactured may have potency far exceeding that used in clinical trials. Having individuals cultivate their own marijuana plants, as currently prescribed in several states, may also potentially lead to recreational use of the drug, thus deflating the positive effects and purpose of the enacted state laws. Second Option By the act of congress, the CSA is revised to reclassify cannabis from a Schedule I substance to a Schedule II substance. Categorizing medical cannabis as a Schedule II drug will create a standardization across the U.S., where physicians will be allowed to prescribe it and pharmacists will be allowed to dispense it. This means that only patients in need will have access to the drug, just like it is done with other controlled substances. There will be minimal room for recreational use, as individuals will no longer be allowed to plant their own, nor the current dispensary shops be allowed to dispense it. Third Option This option will leave things as they are currently. The problem with this option is that the patients that need the product may not adequately get the medical benefit of cannabis due to fear of federal prosecution. As a result of uncontrolled pain, nausea and vomiting, affected patients might end up in hospital, thereby accruing medical costs that otherwise would have been subverted. Another problem is that the cost of constant raids on medical marijuana dispensary shops and individuals homes in medical marijuana states by the Drug Enforcement Agents and federal prosecutors may come at a high cost to the taxpayers. This high cost of operation may be reduced if the states and federal government come to a compromise.

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Recommendation The policy proposal that is believed should be considered is the second option. The congress should end the conflict between the federal government and the states that authorize medical cannabis by revising the Controlled Substance Act through the reclassification of cannabis from a Schedule I substance to a Schedule II substance. The rationale behind this choice is as follows: Medical cannabis potency will become standardized across the United State. Rather than just recommending it, physicians will be prescribing medical cannabis just like they do with other Schedule II drugs. The prescription will be filled at a licensed pharmacy just like other Schedule II drugs. Individuals are no longer allowed to grow marijuana, removing the slippery slope and fear of potential abuse and recreational usage. The usage of medical cannabis will be easily monitored by the federal agents. Researchers are able to conduct further clinical studies on the full physiological impact of the drug, including alternative routes of administration.

Conclusion Evidence is mounting that cannabinoids may be used to treat certain medical conditions. Research indicates its effectiveness in the treatment of several ailments, including peripheral neuropathy, nausea and vomiting, appetite stimulation, and muscle spasticity resulting from multiple sclerosis. Notwithstanding the overwhelming evidence, the federal government still does not consider cannabis as having any medical value by classifying it as a Schedule I substance under the Controlled Substance Act (CSA). Amid overwhelming calls by their citizens to legalize medical marijuana and given the medical evidence, several states have enacted laws to authorize the use of medical cannabis under the supervision of a healthcare provider. With the state enactments in direct conflict with the federal statute, patients, caregivers, and providers are reluctant to benefit from the state medical marijuana program for fear of federal prosecution. This paper recommends two policy proposals to alleviate this conundrum. The first option is for congress to enact an act that would relax federal marijuana prohibition among the states that permit medical cannabis. This proposal, however, comes with severe consequences that would make it unattractive. The second option, which is highly recommended, is for congress to revise the CSA through the reclassification of cannabis from a Schedule I substance to a Schedule II substance. This act will allow medical cannabis to be prescribed and dispensed like other Schedule II drugs. It will also open a chapter of clinical studies to elucidate the full therapeutic potential of cannabis and other routes of administration.

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Appendix A (ProCon.Org)

Summary Chart: 17 states and DC that have enacted laws to legalize medical marijuana State Year Passed How Passed (Yes Vote) Fee Possession Limit Accepts other states' registry ID cards? unknown

1. Alaska

1998

Ballot Measure 8 (58%) Proposition 203 (50.13%) Proposition 215 (56%)

$25/$20

1 oz usable; 6 plants (3 mature, 3 immature)

2. Arizona 3. California 4. Colorado

2010 1996 2000

$150/$75 $66/$33

2.5 oz usable; 0-12 plants

Yes
4

8 oz usable; 6 mature or 12 immature plants

No No

Ballot $35 Amendment 20 (54%) House Bill 5389 (96-51 * House, 2113 Senate) Amendment Act B18** 622 (13-0 vote) Senate Bill 17 (27-14 House, 174 Senate) Senate Bill 862 (32-18 House; 1312 Senate) Ballot Question 2 (61%) Proposal 1 (63%) Initiative 148 (62%) Ballot Question 9 (65%) Senate Bill 119 (48-14 House; 2513 Senate) Senate Bill

2 oz usable; 6 plants (3 mature, 3 immature)

5. Connecticut

2012

One-month supply (exact amount to be determined)

No

6. DC

2010

2 oz dried; limits on other forms to be determined

unknown

7. Delaware

2011

***

6 oz usable

Yes

8. Hawaii

2000

$25

3 oz usable; 7 plants (3 mature, 4 immature)

No

9. Maine

1999

$100/$75

2.5 oz usable; 6 plants

Yes6

10. Michigan 11. Montana 12. Nevada

2008 2004 2000

$100/$25 $25/$10 $200 +fees

2.5 oz usable; 12 plants 1 oz usable; 4 plants (mature); 12 seedlings 1 oz usable; 7 plants (3 mature, 4 immature)

Yes No No

13. New Jersey

2010

$200/$20

2 oz usable

No

14. New Mexico

2007

$0

6 oz usable; 16 plants (4 mature, 12 immature)

No

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523 (36-31 House; 323 Senate) 15. Oregon 1998 Ballot $200/$100 Measure 67 (55%) Senate Bill $75/$10 0710 (52-10 House; 331 Senate) Senate Bill $50 76 (22-7) HB 645 (8259) Initiative 692 (59%) **** 24 oz usable; 24 plants (6 mature, 18 immature) No

16. Rhode Island

2006

2.5 oz usable; 12 plants

Yes

17. Vermont

2004

2 oz usable; 9 plants (2 mature, 7 immature)

No

18. Washington

1998

24 oz usable; 15 plants

No

7 States with Pending Legislation to Legalize Medical Marijuana (as of Aug. 22, 2012) State Arkansas Illinois Massachusetts Missouri New York Ohio Pennsylvania Initiative Arkansas Medical Marijuana Act House Bill (H.B. 0030) Senate Bill (S.B. 1548) House Bill (H.B. 625) Senate Bill (S.B. 1161) Senate Bill (S.B. 818) House Bill (H.B. 1421) Senate Bill (S7283) Assembly Bill (A7347) House Bill (H.B. 214) Senate Bill (S.B. 1003) House Bill (H.B. 1653)

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Appendix B (Gov. Gregoire & Gov. Chafee, 2011) With respect to a consensus of medical opinion, currently all of the following health organizations have issued statements in favor of medical cannabis International and National Organizations AIDS Action Council, AIDS Treatment News, American Academy of Family Physicians, American College of Physicians, American Medical Association, American Medical Student Association, American Nurses Association, American Preventive Medical Association, American Public Health Association, American Society of Addiction Medicine, Arthritis Research Campaign (United Kingdom), Australian Medical Association (New South Wales) Limited, Australian National Task Force on Cannabis, Belgian Ministry of Health British, House of Lords Select Committee on Science and Technology, British House of Lords Select Committee on Science and Technology (Second Report), British Medical Association, Canadian AIDS Society, Canadian Special Senate Committee on Illegal Drugs, Dr. Dean Edell (surgeon and nationally syndicated radio host), French Ministry of Health, Health Canada, Kaiser Permanente, Lymphoma Foundation of America, The Montel Williams MS Foundation, Multiple Sclerosis Society (Canada), The Multiple Sclerosis Society (United Kingdom). State and Local Organizations Alaska Nurses Association, Being Alive: People With HIV/AIDS Action Committee (San Diego, CA), California Academy of Family Physicians, California Medical Association, California Nurses Association, California Pharmacists Association, Colorado Nurses Association, Connecticut Nurses Association, Florida Governor's Red Ribbon Panel on AIDS, Florida Medical Association, Hawaii Nurses Association, Illinois Nurses Association, Life Extension Foundation Medical Society of the State of New York, Mississippi Nurses Association, New Jersey State Nurses Association, New Mexico Medical Society, New Mexico Nurses Association, New York County Medical Society, New York State Nurses Association, North Carolina Nurses Association, Rhode Island Medical Society, Rhode Island State Nurses Association, San Francisco Mayor's Summit on AIDS and HIV, San Francisco Medical Society, Vermont Medical Marijuana Study Committee, Virginia Nurses Association, Washington State Medical Association, Washington State Pharmacy Association, Whitman-Walker Clinic (Washington, DC),Wisconsin Nurses Association. Statement of Grounds National Academy of Sciences Institute Of Medicine (IOM), National Association for Public Health Policy, National Nurses Society on Addictions, Netherlands Ministry of Health, New England Journal of Medicine, New South Wales (Australia) Parliamentary Working Party on the use of Cannabis for Medical Purposes, Dr. Andrew Weil (nationally recognized professor of internal medicine and founder of the National Integrative Medicine Council).

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