Ethical Perspective Address correspondence to Dr Daniel G. Larriviere, Ochsner Neuroscience Institute, Department of Neurology, 1514 Jefferson Hwy, New Orleans, LA 70121, [email protected]. Relationship Disclosure: Dr Larriviere is a compensated faculty member of the American Academy for the Advancement of Science and serves as an associate editor for Continuum Audio. Unlabeled Use of Products/Investigational Use Disclosure: Dr Larriviere discusses the unlabeled use of cannabis for the treatment of HIV-associated sensory neuropathy. * 2014, American Academy of Neurology.
Medical Marijuana for HIV-Associated Sensory Neuropathy: Legal and Ethical Issues Daniel G. Larriviere, MD, JD, FAAN
ABSTRACT The number of states legalizing medical marijuana is increasing. Medical marijuana is possibly effective therapy for HIV-associated sensory neuropathy. Despite legalization at the state level, however, the current and contradictory federal drug enforcement policy creates the risk that physicians who recommend medical marijuana to their patients will lose their ability to prescribe medications. The federal-state tension has legal and ethical implications for neurologists who receive a request for medical marijuana from their patients since neurologists must strive to both relieve suffering and obey relevant laws. Recommendation of medical marijuana by neurologists to their patients is ethically permissible but is not ethically mandatory. Continuum (Minneap Minn) 2014;20(5):1426–1429.
Case A 40-year-old HIV-positive patient with HIV-associated sensory neuropathy returned to his neurologist’s office for uncontrolled symptoms of aching, burning, and increased sensitivity to innocuous stimuli in his feet. His symptoms were quite bothersome and limited his ability to sleep, which was having an impact on his performance as a certified public accountant. He was no longer going to the gym to swim because of fatigue. He had gained 6.8 kg (15 lbs) since he stopped exercising. He had tried lamotrigine, gabapentin, amitriptyline, and capsaicin cream at adequate doses but stopped them because of either lack of efficacy or side effects. His friend mentioned to him that smoking cannabis may relieve neuropathy symptoms. He had smoked cannabis in the past, but not since the onset of his neuropathic symptoms. After purchasing cannabis from a dealer, he smoked some and found that it did, in fact, reduce his symptoms. He was uncomfortable purchasing the drug on the street, however, and would prefer to buy it legally from a licensed distributor through the state’s medical marijuana program. He scheduled the office visit to obtain a medical recommendation for the drug. After conducting a literature search, the neurologist found some evidence to support the use of smoked cannabis in this condition.1Y3
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Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
October 2014
DISCUSSION Questions to consider in weighing the neurologist’s legal and ethical obligations in this case: 1. What are the relevant state and federal legal issues surrounding the recommendation of medical marijuana by physicians to their patients? 2. Assuming the literature supports its use in a given condition, is the neurologist ethically obligated to recommend the drug for his or her patients? Legal Framework Although states generally regulate the practice of medicine, federal law specifically determines the range of drugs available for prescription by physicians in the United States.4 For centuries, physicians have observed that cannabis is efficacious for the treatment of pain, yet it was removed from the United States Pharmacopoeia in 1942 and then listed as a Schedule I drug by Congress in 1970.5 Schedule I drugs are defined as drugs with no currently accepted medical use and a high potential for abuse. Beginning in the 1990s, states began enacting laws decriminalizing the use of marijuana for medical purposes. Federal policy was changed in 1996 as a response to this trend. The federal policy states that a physician’s action of recommending or prescribing Schedule I substances is not consistent with the public interest (as reflected in the Controlled Substances Act) and such actions may lead to revocation of the physician’s Drug Enforcement Administration (DEA) registration to prescribe controlled substances.4 This change was followed by a letter from the Department of Justice and the Department of Health and Human Services to national, state, and local practitioner organizations stating that physicians who ‘‘intentionally provide their patients with oral or written statements in order to enable them to obtain controlled substances in violation of federal lawIrisk revocation of their DEA prescription authority.’’6 A suit for permanent injunction preventing enforcement of the law was filed in California, and the Ninth Circuit Court of Appeals eventually heard the case. At issue on appeal was whether the federal government has the power to prevent physicians from recommending medical marijuana for their patients. The Court held that the law does not have the requisite narrow specificity to justify its restriction of First Amendment rights and is therefore unconstitutional.6 However, in separate litigation, the US Supreme Court held that dispensing marijuana for medical purposes is not exempt from federal prosecution under federal law.7 In order to clarify the apparent conflict between federal law supporting prosecution for utilization of medical marijuana and the growing number of state laws that had decriminalized the use of medical marijuana, the Department of Justice issued a memorandum in August 2013. In the memorandum, the deputy attorney general of the Department of Justice reiterated the broad goals of marijuana policy as follows: & Preventing the distribution of marijuana to minors; & Preventing revenue from the sale of marijuana from going to criminal enterprises, gangs, and cartels; & Preventing the diversion of marijuana from states where it is legal under state law in some form to other states;
Continuum (Minneap Minn) 2014;20(5):1426–1429
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&
Preventing state-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity; & Preventing violence and the use of firearms in the cultivation and distribution of marijuana; & Preventing drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use; & Preventing the growth of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands; and & Preventing marijuana possession or use on federal property.8 The deputy attorney general outlined the historical relationship between federal and state enforcement of drug laws, noting that dealing with ‘‘lower level’’ or ‘‘localized [drug] activity’’ is an issue for state enforcement and does not warrant federal intervention unless and until such activity implicates the goals enumerated in the memorandum. The deputy attorney general further stated that the rise of state laws governing medical marijuana remains consistent with the historical relationship between federal and state enforcement responsibilities as long as the state regulatory scheme is adequately funded and the limitations within the laws are vigorously enforced. The deputy attorney general reserved the right of federal intervention in those cases in which the state laws are not being enforced or when particular enterprises grow to a size that implicates federal priorities. Finally, the deputy attorney general noted that participation in or with the distribution or sale of medical marijuana is not a defense to a federal prosecution and that the federal government would not in any way limit its prosecutorial power under the Controlled Substances Act.8 Currently, 21 states authorize some form of medical marijuana use. The regulatory schemes vary widely by state, but common issues addressed by these laws include: & A requirement that physicians comply with the usual standards of care for the condition in question (eg, conduct an appropriate history, physical examination, and workup; explain the range of available therapies, along with their risks and benefits; and provide for follow-up care) as well as any additional requirements for medical marijuana recommendation (eg, many states require an in-person visit with the physician prior to recommendation) & An enumeration of conditions that may be treated with medical marijuana & Possession limits & Steps that a physician must take to become ‘‘certified’’ to recommend medical marijuana if the state requires such certification & Notation that medical marijuana is still a Schedule I drug and prescribing it is illegal so physicians may only recommend it to their patients In the present case, many of the standard-of-care issues appear to have been satisfied since this is a patient known to and treated by the neurologist. However, before issuing a recommendation to the patient, the neurologist should check state law to determine answers to the other issues outlined above. Many states have on-line resources for physicians, and other sites have also aggregated that information for all states.9 Once the neurologist has complied with the necessary legal steps to recommend the drug, he or she needs to consider the ethical issues embedded in this issue.
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Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
October 2014
Ethical Framework Is physician recommendation of medical marijuana to patients ethically obligatory, permissible, or prohibited? Physicians have ethical obligations to treat disease and relieve suffering as part of their obligation to act beneficently and to minimize the risk of harm to the patient (nonmaleficence). The effects of neuropathic pain on quality of life are evident generally and in the present case.10 There is, therefore, a presumption that the neurologist is ethically obligated to consider recommending medical marijuana in this case since some evidence supports its useVboth in the literature and in the patient’s experienceVand because the patient has failed a multitude of other neuropathic pain therapies. However, the American Academy of Neurology’s Code of Professional Conduct requires neurologists to comply with applicable laws.11 Given the real (if unlikely) risk of federal prosecution for recommending medical marijuana outlined above, the neurologist is not ethically obligated to recommend the drug. However, such a recommendation is ethically permissible given the state-based statutory framework that legalizes such action. If neurologists choose to recommend medical marijuana for a patient, they must comply with all relevant laws and regulations pertaining to the practice. They must also discuss the evidence supporting its use as well as risks and side effects of the medication with the patient. Screening for a history of prior substance abuse and mood disorders that may be exacerbated by cannabis use is also ethically required in order to minimize risk of harm and to maximize the benefit of the proposed intervention. Prudence would also require neurologists to caution patients about the use of equipment or driving while taking the drug and to establish ground rules regarding use, misuse, and diversion. REFERENCES 1. Abrams DJ, Jay CA, Shade SB, et al. Cannabis in painful HIV-associated sensory neuropathy: a randomized-placebo controlled trial. Neurology 2007;68(7):515Y521. 2. Ware MA, Wang T, Shapiro S, et al. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ 2010;182(14):E694Y701. 3. Ellis RJ, Toperoff W, Vaida F, et al. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology 2009;34(3):672Y680. 4. Controlled Substances Act, 21 USC x802 et seq-823f (2008). 5. Aggarwal SK. Cannabinergic pain medicine: a concise clinical primer and survey of randomized-controlled trial results. Clin J Pain 2013;29(2):162Y171. 6. Conant v Walters, 309 F 3d 629 (9th Cir 2002). 7. United States v Oakland Cannabis Buyers’ Cooperative, 532 US, 483 (2001). 8. Cole JM; US Department of Justice. Memorandum for all United States attorneys: guidance regarding marijuana enforcement. www.justice.gov/iso/opa/resources/ 3052013829132756857467.pdf. Published August 29, 2013. Accessed June 1, 2014. 9. Marijuana Policy Project. Key aspects of state and D.C. medical marijuana laws. www.mpp.org/ assets/pdfs/library/Medical-Marijuana-Grid.pdf. Updated June 2, 2014. Accessed June 2, 2014. 10. Jensen MP, Choddroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology 2007;68(15):1178Y1182. 11. American Academy of Neurology. AAN Code of Professional Conduct. www.aan.com/uploadedFiles/ Website_Library_Assets/Documents/8.Membership/5.Ethics/1.Code_of_Conduct/Membership-EthicsAmerican%20Academy%20of%20Neurology%20Code%20of%20Professional%20Conduct% 20(2).pdf. Published December 2009. Accessed June 1, 2014.
Continuum (Minneap Minn) 2014;20(5):1426–1429
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Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
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Medical Marijuana for HIV-Associated Sensory Neuropathy: Legal and Ethical Issues Daniel G. Larriviere, MD, JD, FAAN
ABSTRACT The number of states legalizing medical marijuana is increasing. Medical marijuana is possibly effective therapy for HIV-associated sensory neuropathy. Despite legalization at the state level, however, the current and contradictory federal drug enforcement policy creates the risk that physicians who recommend medical marijuana to their patients will lose their ability to prescribe medications. The federal-state tension has legal and ethical implications for neurologists who receive a request for medical marijuana from their patients since neurologists must strive to both relieve suffering and obey relevant laws. Recommendation of medical marijuana by neurologists to their patients is ethically permissible but is not ethically mandatory. Continuum (Minneap Minn) 2014;20(5):1426–1429.
Case A 40-year-old HIV-positive patient with HIV-associated sensory neuropathy returned to his neurologist’s office for uncontrolled symptoms of aching, burning, and increased sensitivity to innocuous stimuli in his feet. His symptoms were quite bothersome and limited his ability to sleep, which was having an impact on his performance as a certified public accountant. He was no longer going to the gym to swim because of fatigue. He had gained 6.8 kg (15 lbs) since he stopped exercising. He had tried lamotrigine, gabapentin, amitriptyline, and capsaicin cream at adequate doses but stopped them because of either lack of efficacy or side effects. His friend mentioned to him that smoking cannabis may relieve neuropathy symptoms. He had smoked cannabis in the past, but not since the onset of his neuropathic symptoms. After purchasing cannabis from a dealer, he smoked some and found that it did, in fact, reduce his symptoms. He was uncomfortable purchasing the drug on the street, however, and would prefer to buy it legally from a licensed distributor through the state’s medical marijuana program. He scheduled the office visit to obtain a medical recommendation for the drug. After conducting a literature search, the neurologist found some evidence to support the use of smoked cannabis in this condition.1Y3
1426
www.ContinuumJournal.com
Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
October 2014
DISCUSSION Questions to consider in weighing the neurologist’s legal and ethical obligations in this case: 1. What are the relevant state and federal legal issues surrounding the recommendation of medical marijuana by physicians to their patients? 2. Assuming the literature supports its use in a given condition, is the neurologist ethically obligated to recommend the drug for his or her patients? Legal Framework Although states generally regulate the practice of medicine, federal law specifically determines the range of drugs available for prescription by physicians in the United States.4 For centuries, physicians have observed that cannabis is efficacious for the treatment of pain, yet it was removed from the United States Pharmacopoeia in 1942 and then listed as a Schedule I drug by Congress in 1970.5 Schedule I drugs are defined as drugs with no currently accepted medical use and a high potential for abuse. Beginning in the 1990s, states began enacting laws decriminalizing the use of marijuana for medical purposes. Federal policy was changed in 1996 as a response to this trend. The federal policy states that a physician’s action of recommending or prescribing Schedule I substances is not consistent with the public interest (as reflected in the Controlled Substances Act) and such actions may lead to revocation of the physician’s Drug Enforcement Administration (DEA) registration to prescribe controlled substances.4 This change was followed by a letter from the Department of Justice and the Department of Health and Human Services to national, state, and local practitioner organizations stating that physicians who ‘‘intentionally provide their patients with oral or written statements in order to enable them to obtain controlled substances in violation of federal lawIrisk revocation of their DEA prescription authority.’’6 A suit for permanent injunction preventing enforcement of the law was filed in California, and the Ninth Circuit Court of Appeals eventually heard the case. At issue on appeal was whether the federal government has the power to prevent physicians from recommending medical marijuana for their patients. The Court held that the law does not have the requisite narrow specificity to justify its restriction of First Amendment rights and is therefore unconstitutional.6 However, in separate litigation, the US Supreme Court held that dispensing marijuana for medical purposes is not exempt from federal prosecution under federal law.7 In order to clarify the apparent conflict between federal law supporting prosecution for utilization of medical marijuana and the growing number of state laws that had decriminalized the use of medical marijuana, the Department of Justice issued a memorandum in August 2013. In the memorandum, the deputy attorney general of the Department of Justice reiterated the broad goals of marijuana policy as follows: & Preventing the distribution of marijuana to minors; & Preventing revenue from the sale of marijuana from going to criminal enterprises, gangs, and cartels; & Preventing the diversion of marijuana from states where it is legal under state law in some form to other states;
Continuum (Minneap Minn) 2014;20(5):1426–1429
www.ContinuumJournal.com
Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
1427
Medical Marijuana for Neuropathy
&
Preventing state-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity; & Preventing violence and the use of firearms in the cultivation and distribution of marijuana; & Preventing drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use; & Preventing the growth of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands; and & Preventing marijuana possession or use on federal property.8 The deputy attorney general outlined the historical relationship between federal and state enforcement of drug laws, noting that dealing with ‘‘lower level’’ or ‘‘localized [drug] activity’’ is an issue for state enforcement and does not warrant federal intervention unless and until such activity implicates the goals enumerated in the memorandum. The deputy attorney general further stated that the rise of state laws governing medical marijuana remains consistent with the historical relationship between federal and state enforcement responsibilities as long as the state regulatory scheme is adequately funded and the limitations within the laws are vigorously enforced. The deputy attorney general reserved the right of federal intervention in those cases in which the state laws are not being enforced or when particular enterprises grow to a size that implicates federal priorities. Finally, the deputy attorney general noted that participation in or with the distribution or sale of medical marijuana is not a defense to a federal prosecution and that the federal government would not in any way limit its prosecutorial power under the Controlled Substances Act.8 Currently, 21 states authorize some form of medical marijuana use. The regulatory schemes vary widely by state, but common issues addressed by these laws include: & A requirement that physicians comply with the usual standards of care for the condition in question (eg, conduct an appropriate history, physical examination, and workup; explain the range of available therapies, along with their risks and benefits; and provide for follow-up care) as well as any additional requirements for medical marijuana recommendation (eg, many states require an in-person visit with the physician prior to recommendation) & An enumeration of conditions that may be treated with medical marijuana & Possession limits & Steps that a physician must take to become ‘‘certified’’ to recommend medical marijuana if the state requires such certification & Notation that medical marijuana is still a Schedule I drug and prescribing it is illegal so physicians may only recommend it to their patients In the present case, many of the standard-of-care issues appear to have been satisfied since this is a patient known to and treated by the neurologist. However, before issuing a recommendation to the patient, the neurologist should check state law to determine answers to the other issues outlined above. Many states have on-line resources for physicians, and other sites have also aggregated that information for all states.9 Once the neurologist has complied with the necessary legal steps to recommend the drug, he or she needs to consider the ethical issues embedded in this issue.
1428
www.ContinuumJournal.com
Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
October 2014
Ethical Framework Is physician recommendation of medical marijuana to patients ethically obligatory, permissible, or prohibited? Physicians have ethical obligations to treat disease and relieve suffering as part of their obligation to act beneficently and to minimize the risk of harm to the patient (nonmaleficence). The effects of neuropathic pain on quality of life are evident generally and in the present case.10 There is, therefore, a presumption that the neurologist is ethically obligated to consider recommending medical marijuana in this case since some evidence supports its useVboth in the literature and in the patient’s experienceVand because the patient has failed a multitude of other neuropathic pain therapies. However, the American Academy of Neurology’s Code of Professional Conduct requires neurologists to comply with applicable laws.11 Given the real (if unlikely) risk of federal prosecution for recommending medical marijuana outlined above, the neurologist is not ethically obligated to recommend the drug. However, such a recommendation is ethically permissible given the state-based statutory framework that legalizes such action. If neurologists choose to recommend medical marijuana for a patient, they must comply with all relevant laws and regulations pertaining to the practice. They must also discuss the evidence supporting its use as well as risks and side effects of the medication with the patient. Screening for a history of prior substance abuse and mood disorders that may be exacerbated by cannabis use is also ethically required in order to minimize risk of harm and to maximize the benefit of the proposed intervention. Prudence would also require neurologists to caution patients about the use of equipment or driving while taking the drug and to establish ground rules regarding use, misuse, and diversion. REFERENCES 1. Abrams DJ, Jay CA, Shade SB, et al. Cannabis in painful HIV-associated sensory neuropathy: a randomized-placebo controlled trial. Neurology 2007;68(7):515Y521. 2. Ware MA, Wang T, Shapiro S, et al. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ 2010;182(14):E694Y701. 3. Ellis RJ, Toperoff W, Vaida F, et al. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology 2009;34(3):672Y680. 4. Controlled Substances Act, 21 USC x802 et seq-823f (2008). 5. Aggarwal SK. Cannabinergic pain medicine: a concise clinical primer and survey of randomized-controlled trial results. Clin J Pain 2013;29(2):162Y171. 6. Conant v Walters, 309 F 3d 629 (9th Cir 2002). 7. United States v Oakland Cannabis Buyers’ Cooperative, 532 US, 483 (2001). 8. Cole JM; US Department of Justice. Memorandum for all United States attorneys: guidance regarding marijuana enforcement. www.justice.gov/iso/opa/resources/ 3052013829132756857467.pdf. Published August 29, 2013. Accessed June 1, 2014. 9. Marijuana Policy Project. Key aspects of state and D.C. medical marijuana laws. www.mpp.org/ assets/pdfs/library/Medical-Marijuana-Grid.pdf. Updated June 2, 2014. Accessed June 2, 2014. 10. Jensen MP, Choddroff MJ, Dworkin RH. The impact of neuropathic pain on health-related quality of life: review and implications. Neurology 2007;68(15):1178Y1182. 11. American Academy of Neurology. AAN Code of Professional Conduct. www.aan.com/uploadedFiles/ Website_Library_Assets/Documents/8.Membership/5.Ethics/1.Code_of_Conduct/Membership-EthicsAmerican%20Academy%20of%20Neurology%20Code%20of%20Professional%20Conduct% 20(2).pdf. Published December 2009. Accessed June 1, 2014.
Continuum (Minneap Minn) 2014;20(5):1426–1429
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Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited.
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