Thursday, May 30, 2019

Colorado Joins Americans for Safe Access End Pain, Not Lives Campaign


Law Passed Allowing Doctors to Recommend Cannabis Instead of Opioids

Washington, DC — Governor Jared Polis has signed into law SB-013, a bill that allows Colorado physicians to authorize individuals to use medical cannabis instead of opioids, including for acute pain. The bill also removes specific specialist requirements for physicians for minor patients and allows minor patients to consume non-smokable forms of cannabis on school grounds. The law will go into effect on August 2, 2019.

A majority of states around the country allow medical cannabis to be used for chronic pain, but only a handful allow its use for acute pain or other conditions for which an opioid may be prescribed.

“Americans for Safe Access applauds Governor Polis for signing SB-013. Even in states with flourishing non-medical cannabis markets, it is important to remember that thousands of people count on cannabis as a medicine,” said David Mangone, Esq., ASA’s Director of Government Affairs. “Recognizing this, in 2017, ASA launched a national campaign called End Pain, Not Lives to promote cannabis as a tool to combat the opioid crisis, and it is great to see Colorado doing its part to reduce preventable opioid overdose deaths by allowing the substitution of cannabis for opioids in pain management."

According to the National Institutes of Health, over 130 individuals die each day due to opioid-related causes nationwide. In Colorado in 2017 (the most recent year for which data are available), there were 373 deaths involving prescription opioids and 224 involving heroin. Colorado joins Illinois and New York in allowing cannabis to be recommended by authorized healthcare providers for any condition for which an opioid would be appropriate.

Related Article: 2019 New Mexico Petition: Requesting The Inclusion Of A New Medical Condition: Substance Abuse Disorder (Approved by MCAB Doctors in March 2019 and awaiting Secretary Kunkel's final decision.)  http://www.cannabisnewsjournal.co/2019/02/2019-petition-requesting-inclusion-of.html

“According to CDC, Colorado loses a community member to drug overdose roughly every 9 hours, with opioids contributing to over half those deaths,” said Cindy Sovine, Colorado ASA member and President of Sovine Consulting.  “This bill is the result of a multi-year, multi-stakeholder effort brought forward to give Coloradans a safer option, keeping them alive and out of the cycle of addiction while meeting their pain management needs.”

Americans for Safe Access provided critical testimony in support of this bill in January.

Contact: David Mangone | david@safeaccessnow.org

Friday, May 24, 2019

California Senate Passes Bill Allowing Vets to Recommend Medical Cannabis For Pets



Veterinarians in California could soon recommend medical cannabis for pets.

The California Senate voted 33-0 Thursday to let pet owners 18 and older purchase medical cannabis for their animals if they have a recommendation from a veterinarian who has completed a specific course.

The bill would give veterinarians the same protections as doctors who recommend cannabis for human patients. And it would prevent the Veterinary Medical Board from disciplining veterinarians who recommend medical cannabis.

Last year, former Gov. Jerry Brown signed a law a bill making California the first state in the U.S. to recognize cannabis in veterinary medicine, providing legal protection to veterinarians who talk with pet owners about its use.




The bill now goes to the state Assembly.




Wednesday, May 22, 2019

Submitting Comments To The FDA That Will Make A Difference


Americans for Safe Access Wants to Help You Navigate the Federal Regulatory Process

Earlier this spring, the Food and Drug Administration (FDA) issued a notice in the Federal Register that invited the public to submit scientific information and comments on cannabis and cannabis products. This is not the first time that the FDA has called for comments. In 2018, the FDA solicited public comments to help determine the United States’ position on the rescheduling of CBD and other cannabis compounds under international law. Fortunately, in recent years, there has been a shift in the FDA’s attitude about cannabis. Currently, their website acknowledges that states are developing their own programs and that there is medical value to, at a minimum, isolated components of the cannabis plant, marking a shift from previous years when the agency outright ignored the progress being made at the state level.
Regulatory comments are a good way for activists to make their voices heard. However, unlike typical grassroots campaign activities that rely on building coalitions and generating large scale support, regulatory comments do not benefit from a large number of people saying the same thing. In fact, the FDA itself specifies that the FDA comment process is not a popularity contest in which the agency will adopt the policy position promoted by the greatest number of commenters. What the FDA and other regulatory agencies look for during the commenting process are concise, well-thought-out responses that cite scientific research and make recommendations for sound public policy.
The FDA identifies very specific questions that it wants answered in Section III of the notice. These questions are listed in the subcategories of 1) Health and Safety Risks, 2) Manufacturing and Product Quality, and 3) Marketing/Labeling/Sales. The FDA is asking for input on 15 distinct questions, many of which have multiple subparts. A sampling of questions from each category have been summarized below:
Health and Safety Risks
a) Based on what is known about the safety of products containing cannabis and cannabis-derived products, are there particular safety concerns that FDA should consider regarding its regulatory oversight off these products?
i) How does the mode of delivery (e.g., ingestion, absorption, inhalation) affect the safety and exposure to cannabis and cannabis-derived compounds?
Manufacturing and Product Quality
a) What validated analytical testing is needed to support the manufacturing of safe and consistent products?
b) What are the functional purposes of adding cannabis-derived compounds, such as CBD, to foods (e.g., nutritive value, technical effect), both in terms of manufacturer intent and consumer perceptions and/or expectations? To the extent a compound is added to food to achieve a particular functional purpose, what evidentiary support is available to demonstrate that the addition of such compound has the intended or perceived effect?
Marketing/Labeling/Sales
a) How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about? Are there any subpopulations for which additional warnings or restrictions are appropriate? Please explain your reasoning.
b) What conditions, restrictions, or other limitations on the manufacturing and distribution of these products have been put in place under State or local law, particularly with respect to food products containing cannabis-derived compounds such as CBD (which may, in some cases, be lawful at the State level but not the Federal level)? What other conditions, restrictions, or other limitations might be appropriate to ensure adequate consumer information and to protect the public health?

What to Do

  • DO read the submission guidelines carefully before submitting.
  • DO include the docket number [FDA-2019-N-1482-0001] in the beginning of your comments either on a title page or in your introduction, especially if you mail them or submit them as an attached PDF.
  • DO support your comments with scientific research. For example, instead of just describing how cannabis or cannabis-derived products helped your condition, look to see if there is research for other people with your condition to strengthen your anecdote.
    • Not effective: I used CBD to relieve my arthritis pain.
    • More Effective: Like many other individuals, I have had success using CBD for my arthritis pain. A 2016 study published in the European Journal of Pain found that the topical application of CBD had the potential to relieve pain and inflammation associated with arthritis. Additionally, according to the World Health Organization, “CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health related problems associated with the use of pure CBD.”
  • DO include your contact information if you want the FDA to be able to follow up with you on your comments. Providing your contact information is not required.
  • DO read the comments Americans for Safe Access is submitting before writing your own to get inspiration and ideas.

What not to do

  • DO NOT try to answer all of the FDA’s questions. Pick one (or a few) and make sure your answers stay on topic.
  • DO NOT make up data. If there is limited research on an area you are addressing in your comments, indicate that more research is needed and that the FDA should allow this research to proceed unimpeded.
  • DO NOT limit your comment to a personal story. The two comments below have already been submitted to the FDA; while both are well-intentioned, they do not provide the FDA with enough specifics to create regulations or policy.
I want legal, regulated cbd products. Keeping it in this gray legal area is extremely harmful to people.
Do the right thing. CBD saves lives and works with our natural receptors in our body. Don't let big Pharma and greed control a natural substance that is derived from plants. Our Endocannabinoid system has receptors that benefit from CBD. It can help many illnesses and cut down our enormous health care costs in this country by healing the root causes for disease and not just putting bandaids on the symptoms.
  • DO NOT use threatening, profane, or rude language. The comment below has already been submitted to the FDA; it will not receive serious consideration because it fails to answer any of the FDA’s questions and is threatening, profane, and rude.
Yo, ya demons wearin human suits, all yall mofos work for We The People. How dare yall think that yall kkkan tell grown folk what we can & cannot do? I HAVE PAID THE COST TO BE MY OWN BOSS! My Mama & Daddy are dead/no longer physically among us. Marijuana & all its constituents (CBD, THC, et al) have been my medicine for more than 50 years. I AM living proof of weed's medicinal properties. My long-term weed use has protected my brain & mostly kept me me, despite TWO strokes. 'legal' or not, weed WILL continue to medicate me. F**k yall. The tide is turning & prayerfully, the evil oppression that we've allowed to be 'in charge' is soon outie. DIE!
Your comments do not need to be completed in advance of the FDA hearing on May 31, 2019. In fact, you may hear information at the public hearing that you would like to incorporate into your comments. The FDA is accepting comments through July 2, 2019, and ASA will send periodic reminders about comment submission.

Wednesday, May 15, 2019

Haleigh's Hope® Receives Very First USDA Organic Certification for a Vertically Integrated Hemp CBD Product.

Image result for haleigh's hope
Credit: Haleigh's Hope

DENVER, March 31, 2019  -- Haleigh's Hope®, a high quality, whole-plant hemp extract containing naturally occurring cannabinoids, receives USDA organic certification for handling in addition to the previously awarded organic certification for crop. This makes Haleigh's Hope® the first USDA Organic Certification for a vertically integrated hemp CBD product.

All stages of production— from growing, extracting, manufacturing—take place in Haleigh's Hope® owned and operated facilities in Colorado. Haleigh's Hope® is made from 100% organic, non-GMO ingredients.

With the passing of the 2018 Farm Bill, hemp cultivation is now regulated by the U.S. Department of Agriculture (USDA). Prior to this bill, the USDA certified several hemp growers and hemp labs, but until now, no hemp CBD product has been named a 100% vertically integrated USDA Certified Organic product.

"This USDA designation really positions Haleigh's Hope above and beyond other similar products. By controlling all aspects of production ourselves, we can assure the highest quality possible for our product," said Jason Cranford, founder of Haleigh's Hope®. "It is extremely rewarding to see all the hard work from our entire team pay off with this certification."

Cranford is a Health Care Associate for the Society for Cannabis Clinicians, and an expert botanist who specializes in the organic cultivation of medical grade cannabis and the development of highly medicinal cannabis infused products. He is also the Founder and Chairman of the Flowering HOPE Foundation, a non-profit established to facilitate safe access to life changing medication and expand research of Cannabis Sativa L.

To qualify for USDA Organic Certification a company must provide extensive record keeping, as well as have all ingredients, handling operating procedures and packaging operating procedures approved prior to use to meet all USDA organic standards during random inspections.

Image result for haleigh's hope organic botanical oil blend
Credit: Haleigh's Hope


About Haleigh's Hope®
Haleigh's Hope® is a high quality, whole-plant hemp extract containing naturally occurring cannabinoids. It is made from 100% organic, non-GMO ingredients.

Haleigh's Hope® is named after Haleigh Cox who in conjunction with Haleigh's Hope has a state law named "The Haleigh's Hope Act" in their honor. Her Epilepsy and Cerebral Palsy were greatly affected by an oil derived from this strain of hemp. This low-THC, high-CBD cannabinoid profile was finally achieved after five years of crossing and selecting from hundreds of different phenotypes. Haleigh's Hope® is considered a hemp product because it was derived from a Cannabis sativa L. plant containing less than 0.3% THC.

SOURCE Haleigh’s Hope

Tuesday, May 14, 2019

Randomized blinded controlled clinical trial to assess the effect of oral cannabidiol administration in addition to conventional antiepileptic treatment on seizure frequency in dogs with intractable idiopathic epilepsy

Image result for Randomized blinded controlled clinical trial to assess the effect of oral cannabidiol administration in addition to conventional antiepileptic treatment on seizure frequency in dogs with intractable idiopathic epilepsy

Note from Cannabis News Journal: 
When looking for a medical cannabis product to give to your pet, the most important things to look for are medicines that will be safe AND effective. The following 10 points will help you keep your pet safe and feeling great. 
by Dr. Gary Richter

1.There are many medically active components in cannabis (THC, CBD, terpenes, etc.). If possible, consult with your veterinarian about which medicine is best for your pet.

2.Some cannabis products are hemp-based CBD and others are made from medical marijuana and contain THC. Either can be effective medicine, but it is important to know what you are giving and what the product contains.

3.CBD products made from hemp are generally safe for most pets. If you can buy it online or from a store that is not a cannabis dispensary, the product is hemp-based CBD.

4.Check with the company to find out how the medication was grown. Is it organic? Is it
Pesticide-free? 

5.Ask for a certificate of analysis (C of A) from a state lab based in your home to show the product contains what it claims on the label.

6.Check the C of A to confirm there are no pesticides, fungicides, fungal toxins, etc.

7.Never, ever give a cannabis product made for humans to an animal unless you have been specifically directed to do so by your veterinarian.

8.The most effective way to administer cannabis to pets is orally either with an oil or given as treats.

9.Never blow cannabis smoke or vapor into your dog’s face as a means of medicating them. This is an ineffective way to dose medicine and it can damage their sensitive lungs.

10.If you are unable to get direct veterinary advice, there are references available to help guide you. The Ultimate Pet Health Guide has an entire chapter dedicated to the use of medical cannabis in pets. You can find the book at www.DrGaryRichter.com


Randomized blinded controlled clinical trial to assess the effect of oral cannabidiol administration in addition to conventional antiepileptic treatment on seizure frequency in dogs with intractable idiopathic epilepsy
Abstract

OBJECTIVE
To assess the effect of oral cannabidiol (CBD) administration in addition to conventional antiepileptic treatment on seizure frequency in dogs with idiopathic epilepsy.


DESIGN
Randomized blinded controlled clinical trial.


ANIMALS
26 client-owned dogs with intractable idiopathic epilepsy.


PROCEDURES
Dogs were randomly assigned to a CBD (n = 12) or placebo (14) group. The CBD group received CBD-infused oil (2.5 mg/kg [1.1 mg/lb], PO) twice daily for 12 weeks in addition to existing antiepileptic treatments, and the placebo group received noninfused oil under the same conditions. Seizure activity, adverse effects, and plasma CBD concentrations were compared between groups.


RESULTS
2 dogs in the CBD group developed ataxia and were withdrawn from the study. After other exclusions, 9 dogs in the CBD group and 7 in the placebo group were included in the analysis. Dogs in the CBD group had a significant (median change, 33%) reduction in seizure frequency, compared with the placebo group. However, the proportion of dogs considered responders to treatment (≥ 50% decrease in seizure activity) was similar between groups. Plasma CBD concentrations were correlated with reduction in seizure frequency. Dogs in the CBD group had a significant increase in serum alkaline phosphatase activity. No adverse behavioral effects were reported by owners.


CONCLUSIONS AND CLINICAL RELEVANCE
Although a significant reduction in seizure frequency was achieved for dogs in the CBD group, the proportion of responders was similar between groups. Given the correlation between plasma CBD concentration and seizure frequency, additional research is warranted to determine whether a higher dosage of CBD would be effective in reducing seizure activity by ≥ 50%.



June 1, 2019, Vol. 254, No. 11, Pages 1301-1308

Stephanie McGrath DVM, MS1Lisa R. Bartner DVM, MS1Sangeeta Rao BVSc, PhD1Rebecca A. Packer DVM, MS1 and Daniel L.Gustafson PhD1
1Department of Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, CO 80523. (, , , , )
Address correspondence to Dr. McGrath ().

Friday, May 10, 2019

Just Released: Multistate, Multicenter Clinical Study For The Efficacy and Safety of Medical Cannabis Needs 10,000 Participants

ClinicalTrials.gov

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Medical cannabis has been legal in parts of the USA since 1996, with the stated intention of reducing pain (both acute and chronic) as well as for treatment of multiple other conditions. The original implementation of medical cannabis in the USA was implemented in California as a compassionate measure to treat the HIV/AIDS epidemic. Additional studies have shown promising outcome for patients with multiple sclerosis, seizures, cancer, and other chronic conditions. However, there have been few comprehensive studies that have actually measured whether cannabis is an effective treatment for pain reduction. There is an absence of multistate, multicenter clinical studies with cannabis as medicine, not only in the USA but globally. With the expansion of medical cannabis into more than 38 states in the US, this type of clinical study is now feasible.

This study will utilize an anonymous novel online questionnaire to determine study participants' qualifying condition(s) for medical cannabis use, cannabis ingestion method, frequency of use, prescription drug use, and demographic information. Secondary factors will include evaluation of pain control, quality of life metrics, any adverse side effects from cannabis use, as well as changes in adjunctive treatments. Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.

Conditions or diseases to be studied with medical cannabis use:
Chronic Pain
Chronic Pain Syndrome
Chronic Pain Due to Injury
Chronic Pain Due to Trauma
Fibromyalgia
Seizures
Hepatitis C
Cancer
Crohn Disease
HIV/AIDS
Multiple Sclerosis
Traumatic Brain Injury
Sickle Cell Disease
Post Traumatic Stress Disorder
Tourette Syndrome
Ulcerative Colitis
Glaucoma
Epilepsy
Inflammatory Bowel Diseases
Parkinson Disease
Amyotrophic Lateral Sclerosis
Chronic Traumatic Encephalopathy

Eligibility Criteria:
Ages Eligible for Study: 7 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample

Study Population
Surveys will be administered to legal medical cannabis patients of OMNI Medical facilities conducting clinical research in multiple states in clinical research centers, with expansion to other states as medical cannabis laws permit.
Criteria

Inclusion Criteria:
Clinical diagnosis of a Qualifying Condition for Medical Marijuana
Must be 18 years or older unless they have consent from their parent or legal guardian as defined under state law parameters
Must be willing to complete online surveys at baseline and the follow up points in this study

Exclusion Criteria:

None

ClinicalTrials.gov

To Learn More About This Study or To Enroll In ClinicalTrials.gov Identifier: NCT03944447 Click Link Here: 
Outcomes Mandate National Integration With Cannabis as Medicine (OMNI-Can)