Wednesday, September 27, 2017

Petition: Muscular Dystrophy

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Saturday, September 16th 2017


New Mexico State Department of Health
Medical Cannabis Advisory Board
Medical Cannabis Program
PO Box 26110
Santa Fe, NM, 87502-6110


Petition: Requesting The Inclusion Of A New Medical Condition: Muscular Dystrophy


Table of Contents
Pg.  1 Cover Page
Pg. 2 Petition Introduction
Pg. 3 Petition Purpose and Background
Pg. 10 Relief Requested In Petition
Pg. 10 References
Pg. 11-12   Appendix A

 




Petition Introduction: Requesting The Inclusion Of A New Medical Condition: Muscular Dystrophy

New Mexico’s medical cannabis history started in 1978, after public hearings the legislature enacted H.B. 329, the nation’s first law recognizing the medical value of cannabis. The New Mexico’s medical cannabis program (MCP)  is the only program in the U.S. that places sole responsibility for regulation on the state’s Department of Health. Doctors must comply with state requirements for patients to be considered for applying to the medical cannabis program.

In the Lynn and Erin Compassionate Use Act, (2007) the law states; The Secretary of Health shall establish an advisory board consisting of eight practitioners representing the fields of neurology, pain management, medical oncology, psychiatry, infectious disease, family medicine and gynecology. The practitioners shall be nationally board-certified in their area of specialty and knowledgeable about the medical use of cannabis. The members shall be chosen for appointment by the Secretary from a list proposed by the New Mexico Medical Society. A quorum of the advisory board shall consist of three members. The advisory board shall:
A. review and recommend to the department for approval additional debilitating medical conditions that would benefit from the medical use of cannabis;
B. accept and review petitions to add medical conditions, medical treatments or diseases to the list of debilitating medical conditions that qualify for the medical use of cannabis;
C. convene at least twice per year to conduct public hearings and to evaluate petitions, which shall be maintained as confidential personal health information, to add medical conditions, medical treatments or diseases to the list of debilitating medical conditions that qualify for the medical use of cannabis;
D. issue recommendations concerning rules to be promulgated for the issuance of the registry identification cards; and
E. recommend quantities of cannabis that are necessary to constitute an adequate supply for qualified patients and primary caregivers.

First, do no harm.  As an important step in becoming a doctor, medical students must take the Hippocratic Oath. And one of the promises within that oath is “first, do no harm”.  

We have a sound law in the Lynn and Erin Compassionate Use Act, as Section 2 reads; PURPOSE OF ACT.--The purpose of the Lynn and Erin Compassionate Use Act is to allow the beneficial use of medical cannabis in a regulated system for alleviating symptoms caused by debilitating medical conditions and their medical treatments.
“ARTICLE 2B. LYNN AND ERIN COMPASSIONATE USE ACT
N.M. Stat. Ann. § 26-2B-2 (2009)
    § 26-2B-2. Purpose of act
The purpose of the Lynn and Erin Compassionate Use Act [26-2B-1 NMSA 1978] is to allow the beneficial use of medical cannabis in a regulated system for alleviating symptoms caused by debilitating medical conditions and their medical treatments.
HISTORY: Laws 2007, ch. 210, § 2.
EFFECTIVE DATES. --Laws 2007, ch. 210, § 12 makes the act effective July 1, 2007.”

Mosby’s Medical Dictionary states that “medical treatment” means; the management and care of a patient to combat disease or disorder. Medical treatment includes: Using prescription medications, or use of a non-prescription drug at prescription strength; and or treatment of disease by hygienic and pharmacologic remedies, as distinguished from invasive surgical procedures. Treatment may be pharmacologic, using drugs; surgical, involving operative procedures; or supportive, building the patient's strength. It may be specific for the disorder, or symptomatic to relieve symptoms without effecting a cure.(Mosby's Medical Dictionary, 9th edition.)

What is a chronic medical condition?
A chronic disease is one lasting 3 months or more, by the definition of the U.S. National Center for Health Statistics. Chronic diseases generally cannot be prevented by vaccines or cured by medication, nor do they just disappear. Harvard Medical Dictionary defines chronic as: Any condition that lasts a long time or recurs over time; chronic pain as: Pain that persists after an injury has healed or a disease is over; and chronic pain syndrome as : Long-term, severe pain that doesn't spring from an injury or illness, that interferes with daily life, and is often accompanied by other problems, such as depression, irritability, and anxiety.
What is the meaning of debilitating?
Something that's debilitating seriously affects someone or something's strength or ability to carry on with regular activities, like a debilitating illness. Debilitating comes from the Latin word debilis, meaning "weak." That's why you'll often see the adjective used to describe illness, despite the negative reference.
Petition Purpose and Background

The purpose of this Petition: Requesting The Inclusion Of A New Medical Condition: Muscular Dystrophy

This Petition: Requesting The Inclusion Of A New Medical Condition: Muscular Dystrophy, is being provided to the state Department of Health Medical Cannabis Program so the advisory board can review and recommend to the department for approval additional debilitating medical conditions that would benefit from the medical use of cannabis with the Lynn and Erin Compassionate Use Act.

Who Should Qualify for Medical Cannabis Use?
According to Americans For Safe Access Policy Studies & Research:
Background: The most fundamental aspect of medical cannabis laws is the relationship between a patient and their physician. It is often only the physician and the patient that possess information about a patient’s health condition. However, many public officials and others who oppose medical cannabis laws often make assumptions about people’s health. The media have even fomented such inappropriate assumptions by naming a category of patients “Young Able Bodied Males,” condemning certain patients by visual assessment alone.

Findings: The health care information discussed between a patient and physician is considered private and protected under federal HIPAA laws. It is typically the purview of state medical boards to assess whether a physician has inappropriately recommended cannabis to someone who should not be qualified. Studies have shown in some medical cannabis states that the majority of patients suffer from chronic pain, an ailment that is not obviously detectable by another person. Nevertheless, police will often harass and arrest patients based on the assumption that someone is faking their illness.

Position: Medical professionals should have an unrestricted ability to recommend cannabis therapeutics and that should not be impacted by law enforcement’s perceptions.

Americans For Safe Access policy further states:
“Qualifying medical condition” shall mean any condition for which treatment with medical cannabis would be beneficial, as determined by a patient's qualified medical professional, including but not limited to cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, post-traumatic stress disorder, arthritis, chronic pain, neuropathic and other intractable chronic pain, and multiple sclerosis.
“Qualifying patient” shall mean a person who has a written recommendation from a qualified medical professional for the medical use of cannabis.

Petition Research For Muscular Dystrophy
Muscular dystrophies are a group of genetic diseases characterized by progressive muscle weakness and degeneration that primarily affect young boys. Studies have shown that marijuana helps reduce the pain and involuntary muscle contractions associated with the disease.

OVERVIEW OF MUSCULAR DYSTROPHY

Muscular dystrophy is a collection of genetic diseases that progressive degeneration of the skeletal muscles. The cause of muscular dystrophy is a defective gene, which is sometimes inherited, that causes damaged muscle fibers and muscle weakness.
There are many types of muscular dystrophy. The most common one is Duchenne muscular dystrophy, which accounts for about half of muscular dystrophy cases and typically affects boys, with symptoms of frequent falling, muscle pain and stiffness and waddling gait commonly appearing between the ages of 2 and 3. Myotonic is the most common type of muscular dystrophy that affects adults, and it is characterized by an inability to relax muscles after they contract. Other types of muscular dystrophy include Becker, Fascioscapulohumeral, Congenital, Emery-Dreifuss and Limb-girdle.
With muscular degeneration come additional complications like the inability to walk, contractions, breathing problems, scoliosis, and heart problems and swallowing problems.
While there is no cure for muscular dystrophy, treatment can help to manage the disease’s associated symptoms and slow its progression. Corticosteroid medications and exercising helps to improve muscle strength and slow the disease’s progression.

Variations of Muscular Dystrophy

There are nine different types of MD that vary in their onset and severity. They are all caused by a genetic defect and are all degenerative:
1. Myotonic
Most common form of MD for adults that is caused by a repeat in their genetic code.
  • Common Symptoms: Weight loss, frontal baldness, drowsiness, infertility, difficulty swallowing, vision problems, long thin face and neck, coronary issues that could become fatal before age 50
  • Progression: Develops in men and women from 20 to 30 years of age.
2. Duchenne
Accounting for more than 50% of cases, Duchenne is the most severe form of MD affecting children.
  • Common Symptoms: Weakness in the pelvis and upper legs, difficulty running and jumping, waddle gait, fat accumulation in calf muscles, fall down a lot
  • Progression: A fast progression in boys from age three and is usually non-ambulatory by age 12. The life expectancy is approximately 20 years.
3. Becker
Similar in nature to Duchenne, Becker MD can move quickly or slowly.
  • Common Symptoms: Difficulty getting up from the floor, frequent muscle cramps, walking on tiptoes, falling down a lot
  • Progression: Boys between 11 and 25 can begin to show symptoms, and it is often non-ambulatory by the mid-thirties or later.
4. Limb-Girdle
Both boys and girls can inherit the defective gene from either parent or, in more severe cases, the same genetic defect from both parents.
  • Common Symptoms: Fall down a lot, develop hip weakness that spreads to shoulders, legs and neck, waddle gait, rigid spine, difficulty climbing stairs
  • Progression: Usually presents in young adults and progresses to severe symptoms within the next 20 years.
5. Facioscapulohumeral
This form of MD affects the face, shoulders and upper arms, although the exact gene that causes it is not known.
  • Common Symptoms: Difficulty closing and opening eyes, trouble smiling or puckering, bicep and tricep reflex impairment, hearing problems, lordosis curve of the spine, muscle wasting around shoulders
  • Progression: Both boys and girls are affected in their teens. The life span is normal, but symptoms can be debilitating.
6. Congenital
Most often caused by a genetic defect in muscle fiber proteins but can sometimes affect the central nervous system.
  • Common Symptoms: Scoliosis (curvature of the spine), muscle shortening that stiffens joints, difficulty with muscle control from birth, feet deformities, intellectual disabilities, trouble breathing and swallowing
  • Progression: Evident by age two in boys and girls. Ambulation may never occur, but death is possible in infancy.
7. Oculopharyngeal
This form of MD is common in specific ethnic groups including French-Canadian, Jewish Ashkenazi and Hispanics from the southwestern United States.
  • Common Symptoms: Heart problems, drooping eyelids, muscle wasting in shoulders and neck, trouble swallowing
  • Progression: Symptoms usually reveal before age 60 and progress slowly. Some become non-ambulatory.
8. Distal
Distal MD can present in men and women, and it affects the forearms, lower legs, hands and feet.
  • Common Symptoms: Trouble extending fingers, difficulty hopping or standing on heels, inability to climb stairs without difficulty, trouble forming hand gestures
  • Progression: Usually presents between ages 40 to 60. Progression is slow but could eventually result in the need for a ventilator.
9. Emery-Dreifuss
This MD variation is caused by a defect in the proteins surrounding cell nucleus, and it affects boys primarily.
  • Common Symptoms: Elbows may lock in a flexed position, shoulder deteriorates, walk on tiptoes, rigid spine, facial muscle weakness, chronic muscle shortening in back of neck, ankles, knees, elbows or spine
  • Progression: Symptoms often present by age ten. Heart problems occur in late 20s, and death from pulmonary or cardiac failure is likely in middle age.
MD is considered a rare disease by the National Institutes of Health because it affects fewer than 200,000 people in the US population. Each year, between 500 and 600 male infants are diagnosed with MD, putting the incidence rate at approximately one in every 544,000. For the thousands who suffer, MD is a debilitating and potentially fatal condition

FINDINGS: EFFECTS OF CANNABIS ON MUSCULAR DYSTROPHY

Cannabis can help those with muscular dystrophy to manage the pain and involuntary muscle tightness commonly associated with the disease.
Two major cannabinoids found in cannabis, tetrahydrocannabinol (THC) and cannabidiol (CBD), effectively lower pain because they activate the two main cannabinoid receptors (CB1 and CB2) of the endocannabinoid system within the body. These receptors regulate the release of neurotransmitter and central nervous system immune cells to manage pain levels (Woodhams, Sagar, Burston & Chapman, 2015). Cannabis has even been found to significantly improve neuropathic pain in patients who had previously attempted to treat their discomfort with more conventional methods (Wilsey, et al., 2013). One study found that smoking cannabis three times daily for five days reduced the intensity of chronic pain and improved sleep (Ware, et al., 2010).
Along with pain, muscle spasm (involuntary muscle tightness) is the most common reason that medical cannabis is recommended and prescribed by medical professionals (Borgelt, Franson, Nussbaum & Wang, 2013). Evidence suggests that, like pain, cannabinoid-induced reductions in muscle tremors and spasticity are due to the activation of the CB1 and CB2 receptors (Pertwee, 2002). Studies have demonstrated that medical cannabis offers significant improvements in muscle spasticity, both in mice trials and in human subjects (Borgelt, Franson, Nussbaum & Wang, 2013) (Baker, et al., 2000).

STATES THAT HAVE APPROVED MEDICAL CANNABIS FOR MUSCULAR DYSTROPHY

Currently, just Illinois, Louisiana, New Hampshire and New Jersey have approved medical cannabis specifically for the treatment of muscular dystrophy.
A number of other states, however, will consider allowing medical cannabis to be used for the treatment of muscular dystrophy with the recommendation of a physician. These states include: California (any debilitating illness where the medical use of marijuana has been recommended by a physician), Connecticut (other medical conditions may be approved by the Department of Consumer Protection), Massachusetts (other conditions as determined in writing by a qualifying patient’s physician), Nevada (other conditions subject to approval), Oregon (other conditions subject to approval), Rhode Island (other conditions subject to approval), and Washington (any “terminal or debilitating condition”).
In Washington D.C., any condition can be approved for medical cannabis as long as a DC-licensed physician recommends the treatment.
In addition, 16 states have approved medical cannabis for the treatment of spasms (contractions/tightness), which can be a symptom associated with Myotonic and Emery-Dreifuss muscular dystrophies. These states include: Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Maryland, Michigan, Minnesota, Montana, Nevada, New Hampshire, Oregon, Rhode Island and Washington. Several states have approved medical marijuana specifically to treat “chronic pain.” These states include: Alaska, Arizona, California, Colorado, Delaware, Hawaii, Maine, Maryland, Michigan, Montana, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, and West Virginia. The states of Nevada, New Hampshire, North Dakota, Montana, Ohio, and Vermont allow medical marijuana to treat “severe pain.” The states of Arkansas, Minnesota, Ohio, Pennsylvania, Washington, and West Virginia have approved cannabis for the treatment of “intractable pain.”

RECENT STUDIES ON CANNABIS’ EFFECT ON MUSCULAR DYSTROPHY

How Cannabis Benefits Muscular Dystrophy

Scientific studies on cannabis and MD are sorely lacking despite the fact cannabis has been shown effective against common symptoms of MD such as pain and stiffness. There is evidence suggesting it may help related conditions, e.g., amyotrophic lateral sclerosis, which has some similar characteristics, such as impaired movement and muscle loss. A 2010 study in The American Journal of Hospice & Palliative Care described how cannabis could potentially benefit ALS through the following mechanisms. At least some of these effects could theoretically benefit MD as well.
  • Reducing glutamate transmission
  • Antioxidant activity
  • Anti-inflammatory activity
  • Modulation of microglial cell activity
  • Prevents apoptosis (cell death) in healthy cells
  • Neuroprotective and neurotrophic (helps neurons grow) effects
  • Enhances function of mitochondria
Formal studies have determined cannabinoids are effective against pain, one of the most destructive symptoms of MD. A double-blind, placebo-controlled trial in 2013 found even low doses of vaporized THC was effective for reducing neuropathic pain. An earlier randomized trial concluded that smoking cannabis three times daily reduced pain measures and improved sleep.
“Doctors and nurses have seen that for many patients, cannabis is more useful, less toxic, and less expensive than the conventional medicines prescribed for diverse syndromes and symptoms, including multiple sclerosis, Crohn’s disease, migraine headaches, severe nausea and vomiting, convulsive disorders, the AIDS wasting syndrome, chronic pain, and many others.” – Lester Grinspoon, MD, Emeritus Professor of Psychiatry at Harvard Medical School
The only study directly examining cannabinoids and MD is an article in Forensic Science. The abstract seemed to suggest that THC and CBD may benefit symptoms of the disease. Unfortunately, due to the article’s age, the full text is not available, leaving the researchers’ complete observations a mystery.
Despite these amazing properties, it is unlikely that cannabis extracts alone could eliminate every symptom of MD. All forms are genetically inherited or derive from spontaneous mutations in genes. For example, in DMD, a mutation prevents the body from producing dystrophin, a protein that helps maintain the stability of muscles. Inherited genetic defects are especially difficult to treat, but since cannabinoids have shown promise in normalizing the expression of genes, they very well may be able to treat the root causes of MD.

Reports of Success from Muscular Dystrophy Patients

The scientific evidence certainly suggests that cannabinoids could help MD, but what really matters is how patients are responding. Numerous reports across the Internet suggest that patients are benefiting immensely from various cannabinoid therapies.
An article from a New Jersey newspaper described the experience of young Michael Oliveri. He suffered from tremendous MD-associated pain that numerous medications failed to relieve, so he used medicinal cannabis as a last resort. Oliveri said the medicine “miraculously improved” his quality of life, so much so that he knew he must say goodbye to family and friends in New Jersey to relocate to California to gain safe access to cannabis.
Dan Pope is a Colorado resident with MD. In a US News article, he stated that cannabis helps control his muscle spasms. It also makes his pain more tolerable. Another man named Patrick McClellan also reported that eating or vaporizing cannabis significantly reduces his muscle spasms and pain.
Medical Jane spoke with a patient in Florida named John who has myotonic dystrophy, a form of MD. He described the ability of cannabis to “turn down the volume” on his pain, while also helping him relax and go to sleep. John prefers indica-dominant strains, as sativa varieties can be too stimulating. Since indica strains generally have stronger effects on the body than the mind, it makes sense they would work better for MD.


Rules, Regulations, & Policy Solution For The Petition: Requesting The Inclusion Of A New Medical Condition: Muscular Dystrophy
The approval of this Petition: Requesting The Inclusion Of A New Medical Condition: Muscular Dystrophy, that is being provided to the state Department of Health Medical Cannabis Program so the advisory board can review and recommend to the department for approval additional debilitating medical conditions that would benefit from the medical use of cannabis with the Lynn and Erin Compassionate Use Act.

The approval of this petition would bring the Department of Health in compliance with the intent of the law and uphold the spirit of the Lynn and Erin Compassionate Use Act, 2007. Fulfilling both;“ Section 2. PURPOSE OF ACT.--The purpose of the Lynn and Erin Compassionate Use Act is to allow the beneficial use of medical cannabis in a regulated system for alleviating symptoms caused by debilitating medical conditions and their medical treatments” And  Section 6. ADVISORY BOARD CREATED--DUTIES: The advisory board shall: A. review and recommend to the department for approval additional debilitating medical conditions that would benefit from the medical use of cannabis.” New Mexico’s medical cannabis history started in 1978.  After public hearings the legislature enacted H.B. 329, the nation’s first law recognizing the medical value of cannabis...the first law.


References
Understanding medical cannabis.Elemental Wellness Center, 2014 Jul.

Baker, D., Pryce, G., Croxford, J.L., Brown, P., Pertwee, R.G., Huffman, J.W., and Layward, L. (2000, March 2). Cannabinoids control spasticity and tremor in a multiple sclerosis model. Nature, 404(6773), 84-7. Retrieved from http://www.nature.com/nature/journal/v404/n6773/full/404084a0.html.
Borgelt, L.M., Franson, K.L., Nussbaum, A.M., and Wang, G.S. (2013, February). The pharmacologic and clinical effects of medical cannabis. Pharmacotherapy, 33(2), 195-209. Retrieved from http://onlinelibrary.wiley.com/wol1/doi/10.1002/phar.1187/full.
Muscular dystrophy. (2014, November 27). Mayo Clinic. Retrieved from http://www.mayoclinic.org/diseases-conditions/muscular-dystrophy/basics/definition/con-20021240.
NINDS Muscular Dystrophy Information Page (2015, September 24). National Institute of Neurological Disorders and Stroke. Retrieved from http://www.ninds.nih.gov/disorders/md/md.htm.
Pertwee, R.G. (2002, August). Cannabinoids and multiple sclerosis. Pharmacology & Therapeutics, 95(2), 165-74. Retrieved from http://www.sciencedirect.com/science/article/pii/S0163725802002553.
Ware, M.A., Wang, T., Shapiro, S., Robinson, A., Ducruet, T., Huynh, T., Gamsa, A., Bennett, G.J., and Collet, J.P. (2010, October 5). Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. Canadian Medical Association Journal, 182(14), E694-701. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2950205/.
Wilsey, B., Marcotte, T., Deutsch, R., Gouaux, B., Sakai, S., and Donaghe, H. (2013, February). Low-dose vaporized cannabis significantly improves neuropathic pain. Journal of Pain, 14(2), 136-48. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3566631/.
Woodhams, S.G., Sagar, D.R., Burston, J.J., and Chapman, V. (2015). The role of the endocannabinoid system in pain. Handbook of Experimental Pharmacology, 227, 119-43. Retrieved from http://link.springer.com/chapter/10.1007%2F978-3-662-46450-2_7.


Appendix A:
WHEREAS cannabis (marijuana) has been used as a medicine for at least 5,000 years and can be effective for serious medical conditions for which conventional medications fail to provide relief;

WHEREAS modern medical research has shown that cannabis can slow the progression of such serious diseases as Alzheimer’s and Parkinson’s and stop HIV and cancer cells from spreading; has both anti-inflammatory and pain-relieving properties; can alleviate the symptoms of epilepsy, PTSD and multiple sclerosis; is useful in the treatment of depression, anxiety and other mental disorders; and can help reverse neurological damage from brain injuries and stroke;

WHEREAS the World Health Organization has acknowledged the therapeutic effects of cannabinoids, the primary active compounds found in cannabis, including as an anti-depressant, appetite stimulant, anticonvulsant and anti-spasmodic, and identified cannabinoids as beneficial in the treatment of asthma, glaucoma, and nausea and vomiting related to illnesses such as cancer and AIDS;

WHEREAS the American Medical Association has called for the review of the classification of cannabis as a Schedule I controlled substance to allow for clinical research and the development of cannabinoid-based medicines;

WHEREAS the National Cancer Institute has concluded that cannabis has antiemetic effects and is beneficial for appetite stimulation, pain relief, and improved sleep among cancer patients;

WHEREAS the American Herbal Pharmacopoeia and the American Herbal Products Association have developed qualitative standards for the use of cannabis as a botanical medicine;

WHEREAS the U.S. Supreme Court has long noted that states may operate as “laboratories of democracy” in the development of innovative public policies;

WHEREAS twenty-eight states and the District of Columbia have enacted laws that allow for the medical use of cannabis;

WHEREAS seventeen additional states have enacted laws authorizing the medical use of therapeutic compounds extracted from the cannabis plant;

WHEREAS more than 17 years of state-level experimentation provides a guide for state and federal law and policy related to the medical use of cannabis;

WHEREAS accredited educational curricula concerning the medical use of cannabis have been established that meets Continuing Medical Education requirements for practicing physicians;

WHEREAS Congress has prohibited the federal Department of Justice from using funds to interfere with and prosecute those acting in compliance with their state medical cannabis laws, and the Department of Justice has issued guidance to U.S. Attorneys indicating that enforcement of the Controlled Substances Act is not a priority when individual patients and their care providers are in compliance with state law, and that federal prosecutors should defer to state and local enforcement so long as a viable state regulatory scheme is in place.

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