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Medical marijuana fight: Health department lobbies against MMJ use in treatment of post-traumatic stress disorder

The use of the lifelike simulator shown here has been approved for PTSD treatment.
The use of the lifelike simulator shown here has been approved for PTSD treatment.
Photo by John J. Kruzel, courtesy of the U.S. Defense Department

Update, 4:00 p.m.: Representative Sal Pace's amendment relating to medical marijuana and post-traumatic stress disorder has been defeated, and the Marijuana Policy Project's Steve Fox isn't happy about it. Look for the new information after the original item below:

At today's judiciary committee hearing about HB 1284, a bill that aims to regulate the medical marijuana industry, Representative Sal Pace will offer an amendment to add post-traumatic stress disorder (PTSD) to the list of ailments that can be treated by MMJ.

Actively lobbying against his proposal? The Colorado Department of Public Health and Environment, which has been providing legislators with a fact sheet, on view below. Among the document's arguments: "There is no evidence of efficacy of marijuana for treatment of PTSD in the medical literature. In fact, the published literature suggests that such use leads to addiction and abuse of other substances."

This stand frustrates Steve Fox, director of state campaigns for the Washington, D.C.-based Marijuana Policy Project, who not only refutes this statement but points out that New Mexico has approved medical marijuana for PTSD treatment.

"In New Mexico, there's a medical advisory board that examined PTSD as a condition for medical marijuana patients and recommended that it be added as a qualifying condition," Fox says. "The secretary of the health department there looked at the evidence and agreed that it should be available for patients. But in Colorado, there doesn't seem to be any desire to examine the evidence.

"The standards the health department has set up is almost like an FDA-approval standard, where they're not going to approve any condition unless there are rigorous studies demonstrating its usefulness," he continues. "And while that would be nice, it's well known that the federal government has stood in the way of effective trials for decades. That's why we have medical marijuana approved on the state level -- because the federal government has blocked trials."

In Fox's opinion, this policy means the Colorado health department will continue to oppose the use of medical marijuana in PTSD treatment despite information available from the state directly to the south.

"If they would simply speak to people in New Mexico, where PTSD is the most common qualifying condition for medical marijuana treatment at this point, they would know it's helpful," he argues. "It's being recommended by psychiatrists" -- as Pace's amendment would require -- "and patients are truly benefiting from it. But they seem to have a callous disregard for this evidence."

This point of view is echoed by Mason Tvert, founder of SAFER (Safe Alternative For Enjoyable Recreation) and a prominent marijuana advocate.

"It's a legitimate treatment, and it's been found to be incredibly helpful," he says. "So it's ridiculous that our state health department is proactively fighting to keep our nation's veterans from getting access to a medicine that could very well benefit them."

Tvert's heard that health department personnel have suggested that giving medical marijuana to PTSD patients is the equivalent of giving alcohol to an alcoholic -- "which is incredibly ironic, because many people who suffer from PTSD also suffer from serious alcohol problems, which worsens their state of health. Whereas using marijuana can reduce their alcohol intake and dramatically improve their quality of life.

"We're talking about veterans who've served their country, and as a result have developed serious problems related to PTSD -- and they're being denied effective treatment," he adds. "And the worst part of this is, our bureaucrats at the department of health want that denial to continue. They clearly don't have the best interests of our veterans in mind."

Update, 4:00 p.m.: At the judiciary committee hearing today, Representative Pace presented a compromise measure that would have asked the state health department to hold a hearing to determine if post-traumatic stress disorder should be added to the list of treatable conditions. The committee defeated the amendment by a 6-5 vote, with chairwoman Claire Levy of Boulder casting the deciding vote.

To put it mildly, MPP's Fox was disheartened by this outcome. Here's his take, sent via e-mail:

"The House Judiciary Committee today showed no courage by punting on an issue that is literally a matter of life and death for many people who have truly served our country courageously. The Colorado Department of Public Health and Environment has proven over the past few days that it is absolutely hostile to expanding the list of qualifying conditions in a thoughtful manner like their counterparts in New Mexico. Directing CDPHE to hold a hearing to consider adding PTSD as a condition was likely going to be a useless gesture, but at least it would have demonstrated that the committee examined the information from New Mexico and wanted the Department to know that they cared about this issue. To reject even that amendment was both cowardly and heartless. We hope that veterans who have found relief in this medicine -- or who hoped to find relief in this medicine -- will let the members of the committee know how disappointed they are."

Rather than address the issue of PTSD and medical marijuana in an interview, the health department provided the aforementioned release. Read it in its entirety below, followed by a report and minutes from the New Mexico medical advisory committee meeting in January 2009 at which medical marijuana was approved for treating PTSD. The latter were provided by MPP's Fox:

Colorado Department of Public Health and Environment release about medical marijuana and post-traumatic stress disorder:

Proposed amendment to HB 10-1284 to add Post-traumatic Stress Disorder (PTSD) to the list of conditions currently in the state Consitution.for which marijuana may be recommended

The Colorado Department of Public Health and Environment (CDPHE) opposes this amendment.

The Colorado Constitution already includes a mechanism for adding conditions to the existing list under Article XVIII, Section 14 (9): "...the state health agency shall accept physician or patient initiated petitions to add debilitating medical conditions to the list provided in this section and, after such hearing as the state health agency deems appropriate, shall approve or deny such petitions within one hundred eighty days of submission." CDPHE believes the General Assembly should not circumvent this constitutionally defined process, which includes an in-depth scientific review of the available evidence by medical experts.

CDPHE evaluates petitions for merit in deciding whether to bring forward to the State Board of Health for rulemaking to add conditions. In order to bring a petition forward, CDPHE requires there be clinical evidence in humans published in the peer-reviewed medical research literature in order to find merit.

Each of the conditions listed in the Constitution has at least some published evidence of efficacy in human clinical trials for the use of marijuana.

There is no evidence of efficacy of marijuana for treatment of PTSD in the medical literature. In fact, the published literature suggests that such use leads to addiction and abuse of other substances.

CDPHE contacted the psychiatry departments in the Veteran's Affairs Hospital and the University of Colorado School of Medicine. Both departments responded that marijuana should not be recommended for the treatment of PTSD. Such use is medically contraindicated.

New Mexico medical advisory committee report, January 15, 2009

Committee Report

Medical Advisory Committee to the New Mexico Medical Cannabis Program

Public Meeting, Thursday, January 15, 2009

Prepared by Steve Jenison, M.D., Medical Director, New Mexico Medical Cannabis Program

The Medical Advisory Committee to the New Mexico Medical Cannabis Program held a public meeting on Thursday, January 15, 2009 at the Los Griegos Community Center in Albuquerque to consider petitions for the addition of new conditions to those eligible for enrollment in the Program.

The following is a summary of the recommendations of the Committee:

I. Conditions that are recommended for addition to the list of eligible conditions:

A. Painful peripheral neuropathy

B. Intractable nausea / vomiting

C. Severe anorexia / cachexia

D. Hepatitis C infection currently receiving antiviral treatment

E. Crohn's Disease

F. Post-Traumatic Stress Disorder (PTSD)

G. Amyotrophic Lateral Sclerosis (ALS; Lou Gehrig's Disease)

H. Fibromyalgia

II. Conditions that are not recommended for addition to the list of eligible conditions:

A. Depression

B. Environmental Illness

C. Brain Dysfunction

D. Estrogen Replacement Therapy

E. Chronic Hepatitis C Infection (except for those currently receiving antiviral treatment)

III. Conditions that require further evaluation

A. Chronic pain

B. Arthritis

C. Asthma / Chronic Obstructive Pulmonary Disease (COPD)

D. Chronic Fatigue Syndrome

E. Chronic sinus congestions from blunt facial trauma

For each of the conditions that are being considered for addition to the list of medical conditions eligible for enrollment in the New Mexico Medical Cannabis Program, the following factors are discussed:

1. The biologic plausibility that medical cannabis would be helpful in the management of the condition based upon what is understood about the biology of cannabinoid receptors and their actions.

2. Published clinical evidence of the effectiveness of medical cannabis in the management of the condition.

3. The seriousness of the medical condition and whether alternative medications for its management are available.

4. Whether there are well defined and verifiable clinical criteria for making the diagnosis of that condition.

5. Specific considerations for including the condition as an eligible medical condition

I. Conditions that are recommended for addition to the list of eligible conditions:

A. Post-Traumatic Stress Disorder (PTSD)

1. Biological plausibility:

The two main cannabinoids present in smoked cannabis, delta9-tetrahydrocannabinol (delta9-THC) and cannabidiol (CBD) appear to differ in their effects upon induction of anxiety and relief of anxiety, and they appear to mediate this effect by acting on different areas of the central nervous system. The endocannabionoid system is also required for the extinction of conditioned fear responses which are characteristic of PTSD:

a. Fusar-Poli P et al., "Distinct effects of delta9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing", Archives of General Psychiatry 66: 95-105, 2009.

b. Chhatwal JP et al., "Functional interactions between endocannabinoid and CCK neurotransmitter systems may be critical for extinction learning", Neuropsychopharmacology 34:509-521, 2009.

c. Chhatwal JP et al., "Enhancing cannabinoid neurotransmission augments the extinction of conditioned fear", Neuropsychopharmacology 30:516-524, 2005.

d. Lin HC et al., "Effects of intra-amygdala infusion of CB1 receptor agonists on the reconsolidation of fear-potentiated startle", Learning & Memory 13:316-321, 2006.

e. Pamplona FA et al., "The cannabinoid receptor agonist WIN 55,212-2 facilitates the extinction of contextual fear memory and spatial memory in rats", Psychopharmacology (Berlin) 188:641-649, 2006.

f. Resstel LB et al., "5-HT receptors are involved in the cannabidiol-induced attenuation of behavioural and cardiovascular responses to acute restraint stress in rats" British Journal of Pharmacology 156:181-189, 2009.

2. Clinical data

There are no specific clinical trials data regarding the use of cannabinoids for the treatment of PTSD. However, there are some preclinical data related to the treatment of anxiety disorders with cannabidiol and cannabidiol cogeners. There is also a published survey study of Vietnam combat veterans in which participants reported that marijuana use made their PTSD symptoms better.

a. Roser P et al., "Potential antipsychotic properties of central cannabinoid (CB1) receptor antagonists", World Journal of Biological Psychiatry 7:1-12, 2008.

b. Bremner JD et al., "Chronic PTSD in Vietnam combat veterans: course of illness and substance abuse", American Journal of Psychiatry 153:369-375, 1996.\

3. Seriousness of the condition

PTSD is a very serious condition that significantly affects social functioning and quality of life. It can be difficult to treat with existing modalities. The lack of documented effective treatment modalities for PTSD is discussed at length in the Institute of Medicine Report titled "Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence" (IOM, October 17, 2007). In this study, the Institute of Medicine reviewed 90 randomized clinical trials, 37 pharmacotherapy studies and 53 psychotherapy studies. The panel concluded that, with the exception of exposure therapies, there was inadequate evidence to support the effectiveness of standard interventions for the management of PTSD. The panel recommended implementation of a rigorous PTSD treatment research program.

4. Verification of the condition

There are DSM-IV criteria for making the diagnosis of PTSD.

5. Special considerations for the inclusion of the condition

The Medical Cannabis Program should require medical records that document an assessment by a licensed psychiatrist and a DSM-IV diagnosis of PTSD. In addition, the psychiatrist should attest that other treatment modalities have failed to provide adequate relief of symptoms and that medical cannabis might be of benefit to the patient.

New Mexico medical advisory committee minutes, January 15, 2009 meeting

Committee Report

Medical Advisory Committee to the New Mexico Medical Cannabis Program

Public Meeting, Thursday, January 15, 2009

Prepared by Steve Jenison, M.D., Medical Director, New Mexico Medical Cannabis Program

The Medical Advisory Committee to the New Mexico Medical Cannabis Program held a public meeting on Thursday, January 15, 2009 at the Los Griegos Community Center in Albuquerque to consider petitions for the addition of new conditions to those eligible for enrollment in the Program.

The following is a summary of the recommendations of the Committee:

I. Conditions that are recommended for addition to the list of eligible conditions:

A. Painful peripheral neuropathy

B. Intractable nausea / vomiting

C. Severe anorexia / cachexia

D. Hepatitis C infection currently receiving antiviral treatment

E. Crohn's Disease

F. Post-Traumatic Stress Disorder (PTSD)

G. Amyotrophic Lateral Sclerosis (ALS; Lou Gehrig's Disease)

H. Fibromyalgia

II. Conditions that are not recommended for addition to the list of eligible conditions:

A. Depression

B. Environmental Illness

C. Brain Dysfunction

D. Estrogen Replacement Therapy

E. Chronic Hepatitis C Infection (except for those currently receiving antiviral treatment)

III. Conditions that require further evaluation

A. Chronic pain

B. Arthritis

C. Asthma / Chronic Obstructive Pulmonary Disease (COPD)

D. Chronic Fatigue Syndrome

E. Chronic sinus congestions from blunt facial trauma

For each of the conditions that are being considered for addition to the list of medical conditions eligible for enrollment in the New Mexico Medical Cannabis Program, the following factors are discussed:

1. The biologic plausibility that medical cannabis would be helpful in the management of the condition based upon what is understood about the biology of cannabinoid receptors and their actions.

2. Published clinical evidence of the effectiveness of medical cannabis in the management of the condition.

3. The seriousness of the medical condition and whether alternative medications for its management are available.

4. Whether there are well defined and verifiable clinical criteria for making the diagnosis of that condition.

5. Specific considerations for including the condition as an eligible medical condition

The conditions reviewed by the Medical Advisory Board to the Medical Cannabis Program will be discussed in the following order:

1. Conditions that are recommended for inclusion in the list of conditions eligible for enrollment in the New Mexico Medical Cannabis Program.

2. Conditions that are not recommended for inclusion in the list of conditions eligible for enrollment in the New Mexico Medical Cannabis Program.

3. Conditions that the Medical Advisory Board believes need further examination before making a recommendation.

I. Conditions that are recommended for addition to the list of eligible conditions:

A. Painful peripheral neuropathy

1. Biological plausibility:

CB1 receptors present in peripheral nerves mediate the major activity of endogenous and exogenous cannabinoids. There may be a minor role of CB2 receptors in decreasing inflammatory processes in some forms of peripheral neuropathy. (Martín Fontelles et al., "Role of Cannabinoids in the Management of Neuropathic Pain", CNS Drugs 22:645-653, 2008).

2. Clinical data:

Two recently published clinical trials of neuropathic pain associated with HIV disease and its treatment support the effectiveness of smoked cannabis in the relief of neuropathic pain. A study of pain related to brachial plexus avulsion showed a benefit in terms of pain relief and sleep for two cannabis based medicinal extracts not currently available in the U.S.

a. Abrams DI et al., "Cannabis in painful HIV-associated sensory neuropathy; a randomized placebo-controlled trial", Neurology 68:515-521, 2007.

b. Ellis RJ et al. ,"Smoked medical cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial", Neuropsychopharmacology 34:672-680, 2009.

c. Berman JS et al., "Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomized controlled trial", Pain 112: 299-306.

3. Seriousness of the medical condition:

Painful peripheral neuropathy is a serious medical condition that can have a significant impact upon the mobility, daily functioning and quality of life of an individual. It is pain condition that is very difficult to manage in many cases with existing medications.

4. Verification of the medical condition

The diagnosis of peripheral neuropathy can be confirmed by diagnostic tests and by the evaluation of a qualified medical practitioner.

5. Specific conditions for inclusion of the condition:

All cases of peripheral neuropathy should be verified by objective diagnostic testing and should be confirmed by a qualified medical practitioner. Application to the Medical Cannabis Program should be accompanied by medical records that confirm the presence of intractable nausea and vomiting that has been refractory to other treatments.

B. Intractable nausea / vomiting

1. Biological plausibility:

CB1 receptors are present both in the dorsal vagus complex of the brainstem and in the myenteric plexus of the stomach and duodenum. The role of central CB1 receptors probably mediates the effect of cannabinoids on "anticipatory" nausea and vomiting. (Croxford JL et al., "Therapeutic potential of cannabinoids in CNS disease", CNS Drugs 17: 179-202, 2003.

2. Clinical data:

There is an extensive medical literature on the effectiveness of cannabinoids in the treatment of intractable nausea and vomiting, much related to cancer chemotherapy-induced nausea and vomiting. This experience is reviewed in:

Machado Rocha FC et al., "Therapeutic use of Cannabis sativa on chemotherapy-induced nausea and vomiting among cancer patients: systematic review and meta-analysis", European Journal of Cancer Care 17: 413-443, 2008.

3. Seriousness of the condition:

Intractable nausea and vomiting has a significant impact upon functionality and quality of life. It can have an impact as well upon nutrition and can lead to damage of the upper gastrointestinal tract.

4. Verification of the medical condition

The condition can be verified by medical history and the evaluation of a qualified clinician.

5. Specific conditions for inclusion of the condition:

Application to the Medical Cannabis Program should be accompanied by medical records that confirm the presence of intractable nausea and vomiting that has been refractory to other treatments.

C. Severe Anorexia / Cachexia

1. Biological plausibility:

The appetite stimulatory effects of the cannabinoids are well described and are mediated by CB1 receptors in the central nervous system. (Croxford, ibid.)

2. Clinical data:

A randomized placebo-controlled trial of smoked cannabis in patients with HIV demonstrated benefits in terms of calorie intake and weight gain:

Abrams DI et al., "Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized, placebo-controlled clinical trial", Annals of Internal Medicine 139:258-266, 2003.

3. Seriousness of the condition:

Severe anorexia related to medical conditions can have a significant effect upon nutritional status and quality of life.

4. Verification of the medical condition

The condition can be verified by medical history, by a nutritional evaluation and physical examination by a qualified clinician.

5. Specific conditions for inclusion of the condition:

Application to the Medical Cannabis Program should be accompanied by medical records and the evaluation of a qualified clinician that confirm the presence of severe anorexia that has been refractory to other treatments.

D. Hepatitis C infection under current antiviral treatment

1. Biological plausibility:

Treatment of hepatitis C with exogenous interferons in particular is associated with frequent and significant adverse events including severe nausea, vomiting and anorexia. The biological role of cannabinoids in treating nausea, vomiting and anorexia are described above.

2. Clinical data:

There is one clinical trial of the use of oral cannabinoids in the management of HCV therapy related symptoms. That study showed significant relief of symptoms, with a higher proportion of oral cannabinoid users being able to complete a full course of HCV treatment:

Costiniuk CT et al., "Evaluation of oral cannabinoid-containing medications for the management of interferon and ribavirin-induced anorexia, nausea and weight loss in patients treated for chronic hepatitis C virus", Canadian Journal of Gastroenterology 22:376-380, 2008.

One cautionary study is worth noting. Recent studies have found an association between daily cannabis smoking, hepatic steatosis and progression of fibrosis in chronic hepatitis C.

Therefore, cannabis could not be recommended at this time for people with chronic hepatitis C except for those individuals currently undergoing treatment with interferon:

a. Hézode C et al., "Daily cannabis smoking as a risk factor for progression of fibrosis in chronic hepatitis C", Hepatology 42: 63-71, 2005.

b. Hézode C et al., "Daily cannabis use: a novel risk factor of steatosis severity in patients with chronic hepatitis C. Gastroenterology 134: 432-439, 2008.

3. Seriousness of the condition:

Severe side effects related to exogenous interferon therapy can significantly affect the ability of the patient to complete a course of treatment.

4. Verification of the medical condition

The presence of hepatitis C infection and its current treatment are readily verified with medical records.

5. Special considerations for inclusion of the condition:

Application to the Medical Cannabis Program should be accompanied by medical records and the evaluation of a qualified clinician that confirm that the patient has hepatitis C infection and is currently undergoing antiviral treatment for the hepatitis C infection.

E. Crohn's Disease

1. Biological plausibility:

CB2 receptors within the gastrointestinal tract appear to modulate intestinal inflammation and limit visceral sensitivity and pain. Gastrointestinal CB2 receptors are being actively investigated as targets for treating inflammatory bowel diseases:

Wright KL et al., "Cannabinoid CB2 receptors in the gastrointestinal tract: a regulatory system in states of inflammation", British Journal of Pharmacology 153: 263-270, 2008.

2. Clinical data:

A Medline search reveals no published clinical data on the use of medical cannabis for the treatment of inflammatory bowel disease.

3. Seriousness of the condition:

Crohn's disease can be manifested by severe inflammatory disease and associated abdominal pain and GI dysmotility.

4. Verification of the medical condition

The presence of Crohn's disease is readily verified by medical records and by the evaluation of a qualified medical practitioner.

5. Special considerations for the inclusion of the condition:

Application to the Medical Cannabis Program should be accompanied by medical records and the evaluation of a qualified clinician that confirm that the patient has Chrohn's disease and that it is refractory to treatment with other modalities.

F. Post-Traumatic Stress Disorder (PTSD)

1. Biological plausibility:

The two main cannabinoids present in smoked cannabis, delta9-tetrahydrocannabinol (delta9-THC) and cannabidiol (CBD) appear to differ in their effects upon induction of anxiety and relief of anxiety, and they appear to mediate this effect by acting on different areas of the central nervous system. The endocannabionoid system is also required for the extinction of conditioned fear responses which are characteristic of PTSD:

a. Fusar-Poli P et al., "Distinct effects of delta9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing", Archives of General Psychiatry 66: 95-105, 2009.

b. Chhatwal JP et al., "Functional interactions between endocannabinoid and CCK neurotransmitter systems may be critical for extinction learning", Neuropsychopharmacology 34:509-521, 2009.

c. Chhatwal JP et al., "Enhancing cannabinoid neurotransmission augments the extinction of conditioned fear", Neuropsychopharmacology 30:516-524, 2005.

d. Lin HC et al., "Effects of intra-amygdala infusion of CB1 receptor agonists on the reconsolidation of fear-potentiated startle", Learning & Memory 13:316-321, 2006.

e. Pamplona FA et al., "The cannabinoid receptor agonist WIN 55,212-2 facilitates the extinction of contextual fear memory and spatial memory in rats", Psychopharmacology (Berlin) 188:641-649, 2006.

f. Resstel LB et al., "5-HT receptors are involved in the cannabidiol-induced attenuation of behavioural and cardiovascular responses to acute restraint stress in rats" British Journal of Pharmacology 156:181-189, 2009.

2. Clinical data

There are no specific clinical trials data regarding the use of cannabinoids for the treatment of PTSD. However, there are some preclinical data related to the treatment of anxiety disorders with cannabidiol and cannabidiol cogeners. There is also a published survey study of Vietnam combat veterans in which participants reported that marijuana use made their PTSD symptoms better.

a. Roser P et al., "Potential antipsychotic properties of central cannabinoid (CB1) receptor antagonists", World Journal of Biological Psychiatry 7:1-12, 2008.

b. Bremner JD et al., "Chronic PTSD in Vietnam combat veterans: course of illness and substance abuse", American Journal of Psychiatry 153:369-375, 1996.

3. Seriousness of the condition

PTSD is a very serious condition that significantly affects social functioning and quality of life. It can be difficult to treat with existing modalities. The lack of documented effective treatment modalities for PTSD is discussed at length in the Institute of Medicine Report titled "Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence" (IOM, October 17, 2007). In this study, the Institute of Medicine reviewed 90 randomized clinical trials, 37 pharmacotherapy studies and 53 psychotherapy studies. The panel concluded that, with the exception of exposure therapies, there was inadequate evidence to support the effectiveness of standard interventions for the management of PTSD. The panel recommended implementation of a rigorous PTSD treatment research program.

4. Verification of the condition

There are DSM-IV criteria for making the diagnosis of PTSD.

5. Special considerations for the inclusion of the condition

The Medical Cannabis Program should require medical records that document an assessment by a licensed psychiatrist and a DSM-IV diagnosis of PTSD. In addition, the psychiatrist should attest that other treatment modalities have failed to provide adequate relief of symptoms and that medical cannabis might be of benefit to the patient.

G. Amyotrophic Lateral Sclerosis (Lou Gehrig's Disease)

1. Biological plausibility

Cannabinoids appear to have a neuroprotective effect in certain neurodegenerative diseases through activity upon CB2 receptors:

a. Weydt P et al., "Cannabinol delays symptom onset in SOD1 (G93A) transgenic mice without affecting survival" Amyotrophic Lateral Sclerosis & Other Motor Neuron Disorders 6: 182-184.

b. Shoemaker JL et al., "The CB2 cannabinoid agonist AM-1241 prolongs survival in a transgenic mouse model of amyotrophic lateral sclerosis when initiated at symptom onset", Journal of Neurochemistry 101:87-98, 2007.

c. Kim K et al., "AM1241, a cannabinoid CB2 receptor selective compound, delays disease progression in a mouse model of amyotrophic lateral sclerosis", European Journal of Pharmacology 542:100-105, 2006.

2. Clinical data

There are no clinical data that are directly relevant to the evaluation of medical cannabis in ALS. There is one published survey of the use of medical cannabis by ALS patients that indicates that patients received benefit in terms of reducing symptoms of appetite loss, depression, pain, spasticity and drooling, but no relief in terms of speech and swallowing or sexual dysfunction:

Amtmann D et al., "Survey of cannabis use in patients with amyotrophic lateral sclerosis", American Journal of Hospice and Palliative Care 21:95-104, 2004.

3. Seriousness of the condition

ALS is a very serious condition with significant morbidity and a poor prognosis. Therapeutic options, both in terms of slowing disease progression and managing clinical manifestions, are available.

4. Verification of the condition

The diagnosis of ALS is verifiable by clinical criteria and diagnostic tests.

5. Special considerations for inclusion of the condition

The Medical Cannabis Program should require medical records that document the diagnosis of ALS, and a written statement from the patient's attending physician that medical cannabis is likely to be of benefit.

H. Fibromyalgia

1. Biological plausibility

Fibromyalgia is a pain syndrome with a poorly defined pathophysiology:

Bradley LA. "Pathophysiologic mechanisms of fibromyalgia and its related disorders" Journal of Clinical Psychiatry 69 Suppl 2: 6-13, 2008.

It is conceivable that the action of cannabinoids of CB1 receptors might have a beneficial effect upon the pain that is characteristic of fibromyalgia:

a. McPartland JM. "Expression of the endocannabinoid system in fibroblasts and myofascial tissues", Journal of Bodywork & Movement Therapies 12:169-182, 2008.

b. Russo EB. "Clinical endocannabinoid deficiency (CECD): can this concept explain therapeutic benefits of cannabis in migraine, fibromyalgia, irritable bowel syndrome and other treatment-resistant conditions?" Neuroendocrinology Letters 29:192-200, 2008.

2. Clinical data

There are no published clinical data regarding the effectiveness of medical cannabis in the management of fibromyalgia.

3. Seriousness of the condition

Fibromyalgia can have a significant impact upon social functioning and quality of life.

4. Verification of the condition

The American College of Rheumatology "1990 Criteria for the Classification of Fibromyalgia" (Wolfe F et al., "The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia: Report of the Multicenter Criteria Committee", Arthritis & Rheumatism 33:160-172, 1990) include:

a. History of widespread pain present for at least 3 months, on both sides of the body and above and below the waist.

b. Pain in 11 of 18 tender point sites on digital palpation ("trigger points")

c. In addition to muscular pain, frequent association of the following signs and symptoms: fatigue, insomnia, joint pains, headaches, restless legs, numbness and tingling, impaired memory, leg cramps, impaired concentration, nervousness, major depression

5. Special considerations for inclusion of the condition

For the purposes of the Medical Cannabis Program, the clinical diagnosis of fibromyalgia would be problematic to verify.


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