Wednesday, September 27, 2017

Petition: Polymyalgia Rheumatica

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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: Polymyalgia Rheumatica


Table of Contents
Pg.  1 Cover Page
Pg.  2 Petition Introduction
Pg.  3 Petition Purpose and Background
Pg.  11 Relief Requested In Petition
Pg.  11 References
Pg.  14 Appendix A

 




Petition Introduction: Requesting The Inclusion Of A New Medical Condition: Polymyalgia Rheumatica

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: Polymyalgia Rheumatica

This Petition: Requesting The Inclusion Of A New Medical Condition: Polymyalgia Rheumatica 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.

Polymyalgia rheumatica, also called: PMR, is an autoimmune disease that causes an inflammatory reaction affecting the lining of joints, especially the shoulders and hips, and sometimes the arteries and some major branches of the aorta.
•More than 200,000 US cases per year
•Treatable by a medical professional
•Requires a medical diagnosis
•Lab tests or imaging often required
•Chronic: can last for years or be lifelong
•Most people develop polymyalgia rheumatica after age 50. Sometimes this condition occurs with temporal arteritis, a more serious condition that causes inflammation of the lining of the arteries.
•Symptoms usually develop quickly and include aching of the shoulders, neck, or hips
•Treatment is usually a low dose of an oral corticosteroid, such as prednisone. Although treatment often lasts two to three years, most people start to feel better within a day or two.

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.

Definition: Polymyalgia rheumatica By Mayo Clinic Staff
Polymyalgia rheumatica is an inflammatory disorder that causes muscle pain and stiffness, especially in the shoulders. Symptoms of polymyalgia rheumatica (pol-e-my-AL-juh rue-MAT-ih-kuh) usually begin quickly and are worse in the morning. Most people who develop polymyalgia rheumatica are older than 65. It rarely affects people under 50.
You may receive symptom relief by taking anti-inflammatory drugs called corticosteroids. But relapses are common, and you'll need to visit your doctor regularly to watch for serious side effects of these drugs.
Polymyalgia rheumatica is related to another inflammatory disorder called giant cell arteritis, which can cause headaches, vision difficulties, jaw pain and scalp tenderness. It's possible to have both of these conditions together.
The signs and symptoms of polymyalgia rheumatica usually occur on both sides of the body and may include:
  • Aches or pain in your shoulders (often the first symptom)
  • Aches or pain in your neck, upper arms, buttocks, hips or thighs
  • Stiffness in affected areas, particularly in the morning or after being inactive for a long time
  • Limited range of motion in affected areas
  • Pain or stiffness in your wrists, elbows or knees (less common)
You may also have more general signs and symptoms, including:
  • Mild fever
  • Fatigue
  • A general feeling of not being well (malaise)
  • Loss of appetite
  • Unintended weight loss
  • Depression

When to see a doctor

See your doctor if you experience aches, pains or stiffness that:
  • Is new
  • Disrupts your sleep
  • Limits your ability to do your usual activities of daily living, such as getting dressed
The exact cause of polymyalgia rheumatica is unknown. Two factors appear to be involved in the development of this condition:
  • Genetics. Certain genes and gene variations may increase your susceptibility.
  • An environmental exposure. New cases of polymyalgia rheumatica tend to come in cycles and may develop seasonally. This suggests that an environmental trigger, such as a virus, might play a role. But no specific virus has been shown to cause polymyalgia rheumatica.

Giant cell arteritis

Polymyalgia rheumatica and another disease known as giant cell arteritis share many similarities. Giant cell arteritis results in inflammation in the lining of arteries, most often the arteries located in the temples. Giant cell arteritis can cause headaches, jaw pain, vision problems and scalp tenderness. If left untreated, it can lead to stroke or blindness.
Polymyalgia rheumatica and giant cell arteritis may actually be the same disease but with different manifestations. The overlap between the two diseases is significant:
  • About 20 percent of people with polymyalgia rheumatica also have signs and symptoms of giant cell arteritis.
  • About half of the people with giant cell arteritis may also have polymyalgia rheumatica.
Risk factors for polymyalgia rheumatica include:
  • Age. Polymyalgia rheumatica affects older adults almost exclusively. The average age at onset of the disease is 73.
  • Sex. Women are about two times more likely to develop the disorder.
  • Race and geographic region. Polymyalgia rheumatica is most common among whites in northern European populations.
Symptoms of polymyalgia rheumatica can greatly affect your ability to perform everyday activities. The pain and stiffness may contribute to difficulties with tasks such as the following:
  • Getting out of bed, standing up from a chair or getting out of a car
  • Bathing or combing your hair
  • Getting dressed or putting on a coat
These difficulties can affect your health, social interactions, physical activity, sleep and general well-being.
In addition, people with polymyalgia rheumatica seem to be more likely to develop peripheral arterial disease.
Treatment usually involves medications to help ease your symptoms. Relapses are common.

Corticosteroids

Polymyalgia rheumatica is usually treated with a low dose of an oral corticosteroid, such as prednisone. A daily dose at the beginning of treatment is usually 12 to 25 milligrams a day.
Thirty to 60 percent of people with polymyalgia rheumatica will have at least one relapse when tapering off the corticosteroids. Relapses (flares) are treated by increasing your drug dosage for a while then tapering again.

Monitoring side effects

Long-term use of corticosteroids can result in a number of serious side effects. Your doctor will monitor you closely for problems. He or she may adjust your dosage and prescribe treatments to manage these reactions to corticosteroid treatment. Possible side effects include:
  • Weight gain
  • Osteoporosis — the loss of bone density and weakening of bones
  • High blood pressure (hypertension)
  • Diabetes
  • Cataracts — a clouding of the lenses of your eyes
Pain (Neuropathic) From Polymyalgia rheumatica

Chronic Pain, classified as pain that persists for longer than three to six months is a common debilitating condition that affects hundreds of millions of people each and every day. The severity of chronic pain varies but extreme cases can be completely incapacitating. Due to how long Chronic Pain can persist, both an emotional and physical toll is taken on the sufferer. Common causes and examples of chronic pain include but are not limited to: headaches; joint pain (arthritis); pain from injuries or accidents; back pain resulting from complications of the spine; tendinitis; carpal tunnel syndrome; pain caused by other ailments or infections; and even some medical therapies and treatments may result in long lasting, substantial pain. Oftentimes anger, anxiety, and depression accompany Chronic Pain.
Neuropathic pain is characterized as a pain state caused in the sufferer’s nervous system. With this condition, an individual’s nerves may be damaged, dysfunctional, or separated completely. Causes and examples of Neuropathic Pain include but are not limited to: alcoholism, amputation and the resulting phantom limb syndrome, skeletal and muscular problems (pinched nerves), chemotherapy, diabetes, genetics, HIV/AIDS, Multiple Sclerosis, shingles, spinal injury, Polymyalgia rheumatica, and even surgery.
Using Cannabis to Treat Neuropathic Pain From Polymyalgia rheumatica
Cannabis is a complex medicinal plant that may actually be used to treat a variety of debilitating symptoms caused by a surprisingly large number of ailments. Its usefulness as a non-lethal medicine (you cannot die from an overdose of cannabis) cannot be overstated and its versatility in terms of how it can be consumed and as to how it can be useful for so many illnesses is something to be excited about. However, it is important to remember that consulting with your primary care physician should be your first priority when considering incorporating cannabis into one’s medical regiment and that cannabis is to be used as an adjunct therapy and not a replacement. It is also your responsibility to communicate with your doctor as to how your use of cannabis has affected your health and of your progress with utilizing medical cannabis.
With that said, studies have shown that cannabis may be quite useful for treating individuals suffering from Neuropathic Pain for the following reasons: significantly reducing the pain itself; assisting with sleep should the pain cause insomnia; and with dealing with possible depression and or anxiety should the individual suffer from it.
Beneficial Cannabinoids & Terpenoids for Neuropathic Pain From Polymyalgia rheumatica
The cannabis plant offers a plethora of therapeutic benefits and contains cannabinoids and terpenoid compounds that are useful for treating pain in general. In fact one study that analyzed both Tetrahydrocannabinol (THC) and Cannabidiol (CBD) published in a 2008 article in Therapeutics and Clinical Risk Management states that, “Cannabinoid analgesics have generally been well tolerated in clinical trials with acceptable adverse event profiles. Their adjunctive addition to the pharmacological armamentarium for treatment of pain shows great promise.”
The following chart denotes which cannabinoids and terpenoids work synergistically with each other for possible therapeutic benefit. It may be beneficial to seek out strains that contain these cannabinoids and terpenoids.

Cannabinoids in the management of difficult to treat pain.
By Russo EB1. (https://www.ncbi.nlm.nih.gov/pubmed/18728714)
Abstract
This article reviews recent research on cannabinoid analgesia via the endocannabinoid system and non-receptor mechanisms, as well as randomized clinical trials employing cannabinoids in pain treatment. Tetrahydrocannabinol (THC, Marinol((R))) and nabilone (Cesamet((R))) are currently approved in the United States and other countries, but not for pain indications. Other synthetic cannabinoids, such as ajulemic acid, are in development. Crude herbal cannabis remains illegal in most jurisdictions but is also under investigation. Sativex((R)), a cannabis derived oromucosal spray containing equal proportions of THC (partial CB(1) receptor agonist ) and cannabidiol (CBD, a non-euphoriant, anti-inflammatory analgesic with CB(1) receptor antagonist and endocannabinoid modulating effects) was approved in Canada in 2005 for treatment of central neuropathic pain in multiple sclerosis, and in 2007 for intractable cancer pain. Numerous randomized clinical trials have demonstrated safety and efficacy for Sativex in central and peripheral neuropathic pain, rheumatoid arthritis and cancer pain. An Investigational New Drug application to conduct advanced clinical trials for cancer pain was approved by the US FDA in January 2006. Cannabinoid analgesics have generally been well tolerated in clinical trials with acceptable adverse event profiles. Their adjunctive addition to the pharmacological armamentarium for treatment of pain shows great promise.
KEYWORDS:
analgesia; cannabidiol; cannabinoids; multiple sclerosis; pain management; tetrahydrocannabinol



References
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The Journal of Pain, 2008 Jun, 9(6): 506-521.
British Journal of Anaesthesia, 2008 May 29, 101(1): 59-68.
Therapeutics and Clinical Risk Management, 2008 Feb, 4(1): 245-259.
Cannabinoids and pain.King, Steven A.
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Rules, Regulations, & Policy Solution For Petition: Requesting The Inclusion Of A New Medical Condition: Polymyalgia Rheumatica
The approval of this Petition: Requesting The Inclusion Of A New Medical Condition: Polymyalgia Rheumatica, 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.

  1. Baron, E.P. (2015, June). Comprehensive Review of Medicinal Marijuana, Cannabinoids, and Therapeutic Implications in Medicine and Headache: What a Long Strange Trip It’s Been… Headache, 55(6), 885-916. Retrieved from http://onlinelibrary.wiley.com/wol1/doi/10.1111/head.12570/full.
  2. Boychuck, D.G., Goddard, G., Mauro, G., and Orellana, M.F. (2015 Winter). The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. Journal of Oral & Facial Pain and Headache, 29(1), 7-14. Retrieved from https://goo.gl/R28LWD.
  3. History of Cannabis. (n.d). BBC News. Retrieved from http://news.bbc.co.uk/2/hi/programmes/panorama/1632726.stm.
  4. Jensen, B., Chen, J., Furnish, T., and Wallace, M. (2015, October). Medical Marijuana and Chronic Pain: a Review of Basic Science and Clinical Evidence. Current Pain and Headache Reports, 19(10), 524. Retrieved from http://link.springer.com/article/10.1007%2Fs11916-015-0524-x.
  5. Menstrual cramps. (2014, May 8). Mayo Clinic. Retrieved from http://www.mayoclinic.org/diseases-conditions/menstrual-cramps/basics/definition/con-20025447.
  6. Sanchez, A.M., Vigano, P., Mugione, A., Panina-Bordignon, P., and Candiani, M. (2012, December). The molecular connections between the cannabinoid system and endometriosis. Molecular Human Reproduction, 18(12), 563-71. Retrieved from https://academic.oup.com/molehr/article-lookup/doi/10.1093/molehr/gas037.
  7. Sanchez, A.M., Cioffi, R., Vigano, P., Candiani, M., Verde, R., Piscitelli, F., Di Marzo, V., Garavaglia, E., and Panina-Bordignon, P. (2016, August). Elevated Systemic Levels of Endocannabinoids and Related Mediators Across the Menstrual Cycle in Women With Endometriosis. Reproductive Sciences, 23(8), 1071-9. Retrieved from http://journals.sagepub.com/doi/pdf/10.1177/1933719116630414.
  8. Taylor, A.H., Abbas, M.S., Habiba, M.A., and Konje, J.C. (2010, May). Histomorphometric evaluation of cannabinoid receptor and anandamide modulating enzyme expression in the human endometrium through the menstrual cycle. Histochemistry and Cell Biology, 133(5), 557-65. Retrieved from http://link.springer.com/article/10.1007/s00418-010-0695-9.
  9. Ware, M.A., Wang, T., Shapiro, S., and Collet, J.P. (2015, September 15). Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). The Journal of Pain. Retrieved from http://www.jpain.org/article/S1526-5900(15)00837-8/fulltext.
  10. 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.
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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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