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)


Americans For Safe Access Activist Newsletter - May 2019


ASA Activist Newsletter
In the May 2019 Issue:

  • ASA Co-founder Named President of International Research Institute
  • Veterans Move Closer to Safe Access with New Congressional Strategy
  • California Lobby Day Brings Advocates to Sacramento
  • Upcoming ASA Events and Appearances
  • Activists of the Month: Rylie and Janie Maedler
  • Action Alert: Send Comments on CBD to the FDA
_________________________

ASA Co-founder Named President of International Research Institute


Americans for Safe Access announced this month that ASA co-founder Steph Sherer will serve as President of the International Cannabis and Cannabinoids Institute (ICCI) in Prague, Czech Republic. Sherer will provide vision and fundraising leadership as President of the ASA Board and will continue to work alongside Debbie Churgai, ASA’s Interim Director.

ICCI was co-founded by Sherer in 2015 as a joint project of patient organizations, scientific societies, and American investment company Dioscorides Global Holdings. Since then, ICCI has become a recognized Center of Excellence that works closely with international governments, universities, and research institutes as well as companies in cannabis, hemp, bio-tech, and agricultural sectors to strengthen the medical cannabis industry.

“We are excited that Steph has decided to focus more on ICCI in this next phase of her career,” said Dr. Pavel Kubu, the CEO of ICCI. “She has been a strong patient advocate and has a clear vision of the trajectory of the medical cannabis industry. I am dedicated to support ASA programs scaling to extend patient access globally.”

In her 17 years as executive director of ASA, Sherer helped to pass medical cannabis legislation and regulatory policy throughout the U.S. and built ASA into the largest nonprofit organization of patients, medical professionals, scientists, and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research.


“Now that societal and governmental barriers to patient access to medical cannabis are breaking down, it is important that the industry evolves to provide products that are safe, standardized and targeted and that there is the scientific infrastructure to support these efforts,” said Sherer. “I am excited to expand the community of scientists, investors, and industry leaders committed to serving the patient community and expanding access to medical cannabis.”

Sherer built collaborative relationships with the American Herbal Products Association (AHPA) and the American Herbal Pharmacopoeia (AHP) to create the first medical cannabis industry standards in the areas of distribution, cultivation, analytics, manufacturing, packaging, and labeling. Sherer’s international work has focused on medical cannabis policies at the United Nations and within countries as a founding member of the International Medical Cannabis Patients Coalition (IMCPC).

“Sherer has helped to change the perception of cannabis among governments, organizations, and the general public at the national and international levels,” said ASA co-founder and Board Member Don Duncan. “As a pioneer in national and global medical cannabis advocacy, Steph has helped push the conversation forward in such a fruitful way that cannabis and cannabinoids are now generally considered as a medicine in most U.S. states and several countries around the world. We have no doubt that under Sherer’s leadership as ICCI’s President, the organization will be able to thrive in their efforts to bring additional evidence-based science to the medical cannabis field.”

More Information:
ICCI Press Release
Forbes Article

_________________________

Veterans Move Closer to Safe Access with New Congressional Strategy
A trio of bipartisan bills that would help ensure safe access for veterans received hearings last month. The House Veterans’ Affairs Subcommittee on Health heard testimony on the VA Medicinal Cannabis Research Act of 2019 (H.R. 712), the Veterans Cannabis Use for Safe Healing Act (H.R. 2191), and the Veterans Equal Access Act (H.R. 1647). This hearing marks the first non-appropriations sub-committee hearing of the 116th Congress on the issue of veterans’ medical cannabis access.

These bills are opposed by VA officials but supported by many Veterans Service Organizations, including the Iraq Afghanistan Veterans of America (IAVA), the Veterans of Foreign Wars, and Disabled American Veterans. According to a poll conducted by the American Legion, 92% of all veterans support research into medical cannabis and 83% of veterans support legalizing medical cannabis. IAVA conducted a similar poll showing that 83% of its members also support the legalization of medical cannabis.

The Veterans Equal Access Act would allow Veterans Health Administration (VHA) doctors to help veteran patients fill out medical cannabis enrollment paperwork in states with a medical cannabis program.


The VA Medicinal Cannabis Research Act would direct the Secretary of the VA to carry out clinical trials on the effects of cannabis on health conditions prevalent in the veteran community, including chronic pain and post-traumatic stress disorder.

The Veterans Cannabis Use for Safe Healing Act would prohibit the VA from denying benefits to a veteran who is participating in a state approved medical cannabis program. The VHA system serves over nine million veterans, but VHA doctors are prohibited from recommending cannabis. Veterans disproportionately suffer from conditions such as PTSD and chronic pain that are often treatable with medical cannabis.

"As the largest healthcare provider in the country, the VA must adopt policies to appropriately serve the needs of the veteran community, especially when it comes to providing access to medical cannabis," said David Mangone, ASA Director of Government Affairs. “After returning from war, America's heroes are faced with another battle at home against pills and suicide, and these bills would give them the tools they need to help win this battle by providing less dangerous, non-addictive methods for symptom management."

The VA bills are part of a new Congressional strategy on medical cannabis. Instead of tacking on amendments to appropriations bills for the Department of Justice (DOJ), medical cannabis champions in Congress are pursuing legislation that would not have to be renewed each year. As a result, spending bills are emerging from the House without medical cannabis language requested by bipartisan groups.

Federal raids and criminal prosecutions of patients and providers effectively ended after 2014, when Congress began adding budget riders that block the DOJ from interfering in state medical cannabis programs. A version of the amendment has been included in the appropriations bill each year since.

Rep. Earl Blumenauer (D-OR), one of the cosponsors of the amendment currently in effect, said before the midterm elections that he had developed a “blueprint” to pass comprehensive cannabis legislation. The Democrat’s latest policy retreat even included a panel on cannabis law reform. The result is full-fledged bills are advancing in the House.

In addition to the VA bills, a bipartisan bill to allow medical cannabis businesses to use financial services has been approved by the House Financial Services Committee. The Secure and Fair Enforcement (SAFE) Banking Act is cosponsored by 168 representatives, more than one-third of the House. The bipartisan Senate version, filed by Sens. Cory Gardner (R-CO) and Jeff Merkley (D-OR), has 20 cosponsors. The change is supported by banking groups, but the Republican chairman of the Senate Banking Committee, Mike Crapo (R-ID), has yet to commit to holding hearings.

Attorney General William Barr said in his confirmation hearing that he supported legislation that would allow state medical cannabis programs to operate in harmony with federal law.

More Information:
Video of the House hearing.
VA cannabis policies.

_________________________

California Lobby Day Brings Advocates to Sacramento
The month of May kicked off with about 100 advocates gathering in Sacramento for the third annual California state lobby day, sponsored by NORML and Americans for Safe Access. After a continental breakfast, California state Senator Scott Wiener and Nicole Elliott, Senior Advisor on Cannabis to Governor Gavin Newsom, each addressed the group.


Following that, attendees went to the capitol for pre-arranged meetings with lawmakers and their staffers about several pending bills. ASA and NORML are urging support for:

SB 34 - To Protect Cannabis Compassion Programs in California
AB 286 - To Temporarily Lower Cannabis Taxes
SB 233 - To Allow Medical Cannabis Access in Schools
AB 1465 - To License Cannabis Consumption Caf├ęs and Lounges
SB 305 - To Allow Qualified Patients Medical Cannabis Access in Healthcare Facilities

Other bills to provide tax relief to veterans purchasing medical marijuana, provide fee waivers to equity business applicants, and abolish the state narcotics offenders’ registry will also be presented.

After lobbying, participants completed feedback forms about their visits and their representatives’ positions on bills, which they turned in before attending a VIP reception for lawmakers that evening.


_________________________

UPCOMING ASA EVENTS & APPEARANCES
Webinar: Creating a Cascade of Care Model for Medical Cannabis


ASA’s free webinar on creating a Cascade of Care Model for medical cannabis patients has been rescheduled to Thursday, May 9 at 2pm. Technical difficulties prompted the change. The webinar with Grace E. Macalino, PhD, MPH, of Marimac Insight and ASA Interim Director Debbie Churgai, MA will discuss how the model can identify gaps in services, develop strategies to improve engagement in care, and increase health outcomes. Everyone from patients and caregivers to providers and policy makers will benefit from a clear and simple framework to guide future medical cannabis research, interventions, education, and resources. There will be an interactive follow-up webinar two weeks later for participants to share their stories. https://www.safeaccessnow.org/cascade_of_care_webinar


Improving the Standards of Cannabis as a Medicine

On May 22 in Philadelphia, ASA Interim Director Debbie Churgai will be moderating a panel on Improving the Standards of Cannabis as a Medicine at the Innovation in the Cannabis Industry event. The event considers what the US can learn from Israel about best practices, technology, and research from Israel. Sponsored by Greenhouse Ventures LLC and Philadelphia-Israel Chamber of Commerce, serving Pennsylvania, New Jersey and Delaware, the event will bring together international professionals, researchers, and investors. ASA newsletter subscribers can save 25% off the ticket price until May 12 when using code GHVASA at https://greenhouseventures.regfox.com/innovation-in-cannabis.


Cannabis Compliance West Summit

On Thursday May 30, ASA's William Dolphin, co-author of The Medicalization of Marijuana: Legitimacy, Stigma and the Patient Experience, will be part of a panel at the Cannabis Compliance West Summit on “Access and Delivery: Balancing Consumer Rights and Local Control,” along with the deputy city attorney of Los Angeles, the lead cannabis staffer for former Governor Jerry Brown, and the community impact director from TELOS. The 6th Annual Canna WEST Compliance, Testing & Safety Summit takes place May 29-31 at the Sofitel Beverly Hills in Los Angeles.

National Cannabis Policy Summit and Festival on 4/20


Last month, ASA Interim Director Debbie Churgai, spoke during the National Cannabis Policy Summit in Washington, D.C. about the importance of medical cannabis advocacy, ending the stigma, and protecting free expression of cannabis communities while introducing the panel Cannabis in the Crosshairs: How do Big Media Companies Enforce “Community Standards” While Protecting Free Expression? The summit was aired live and can be watched at C-SPAN.org.

ASA staff also contributed to two panels on 4/20 at the National Cannabis Festival and staff manned a table distributing information about safe access. Government Affairs Director David Mangone was on the “Key Barriers to Safe and Legal Access” panel and Regulatory Affairs Coordinator Sean Khalepari was on the East Coast Round Up panel.

_________________________

Activists of the Month: Rylie and Janie Maedler, Delaware


Janie Maedler wasn’t planning on raising a medical cannabis activist. She just wanted the best possible treatment for her young daughter’s rare medical condition. But half a dozen years later, her daughter Rylie, now 13, has been instrumental in the passage of three medical cannabis laws in Delaware, one of which is named for her.

Rylie’s parents first grew concerned when, as a seven-year-old, she began exhibiting unusual symptoms: first, what looked like a persistent cold, then a blocked nostril, then losing her teeth. After months of uncertainty, a CAT scan found an aggressive tumor attacking one side of Rylie’s face. Then, as she was being prepped for surgery and chemotherapy, a final bone biopsy came back negative. It wasn’t a malignant cancer, after all. Forty-seven tests later, doctors concluded it was a very rare form of tumor, aggressive giant cell granuloma. Surgery and chemotherapy were still the treatment, so the Maedler family began a complementary treatment with cannabis. Janie had done some research on what her young daughter was facing and had decided cannabis could be effective in fighting Rylie’s recurrent tumors.

A year later, in 2014, Rylie was speaking at Rotary Clubs and other groups, raising funds and support to start a nonprofit, Rylie’s Smile Foundation, for children suffering from rare diseases. Then she and her mother turned their attention to the Delaware legislature, campaigning for a medical cannabis law that would allow access for other children such as Rylie, who had now also developed a seizure disorder that cannabis extracts helped control, along with her tumors. After months of testifying at hearings and speaking to the media, Delaware passed “Rylie’s Law” in 2015, establishing legal access to medical cannabis on the 
recommendation of a pediatrician.


Rylie and her family soon discovered that there is more to safe access than passing a law. In Delaware, cannabis could not be brought on school grounds, so Rylie had to leave school each day to administer her medicine, crossing a bridge to meet her mother.

Then, there was the bomb threat.

“I didn’t know why she wasn’t at our regular spot and the regular time,” Janie says. “I had no way to know, and she had no way to tell me, that the school had moved all the students to a secure location.”

Rylie didn’t get her medicine that day, and had a seizure.

Delaware lawmakers were soon opening handwritten letters from Rylie explaining that she needed one more thing from them. She could make it across that bridge in a Nor’easter, even if the rain and lightning made it scary. But what about other kids? Kids with oxygen tanks or mobility problems? How were they going to get their medicine?

By the time Rylie was done lobbying, the state board of education and the state nurses association both supported the change unanimously, and in 2016 the legislature passed the bill. Rylie asked the then-governor, Jack Markell, to sign the bill at her school so the other kids could see why she’d missed so much school going to the capital. He obliged.

“Sometimes people will call me a “poster child,” Rylie says. “This bothers me so much because I work my butt off. My mom is an outspoken advocate, and I begged her to let me do this. When I was 11years old, we made some agreements that I had to take care of my health and grades first, but she and my dad would let me.”

In 2017, Janie and Rylie began trying to figure out how to add other conditions after hearing the story of a boy named Jonathan. Jonathan’s autism was not a qualifying condition in Delaware, but because it was severe enough to cause wasting, his parents were able to qualify him under that. The bill to go from a legislative process to a petition process for adding conditions stalled after passing out of committee in the summer of 2017. At the end of June, with two weeks left in the session, Janie started spending late nights at the capitol rallying legislators they’d built relationships with. At midnight on the last night of the session, “Jonathan’s Law” passed.


Rylie’s nonprofit, Rylie’s Smile Foundation, filed a petition to add autism under the new law. At first officials balked at a blanket autism diagnosis, insisting on limiting it to “severe autism” or “autism with aggression.” Janie helped organize mothers of children with autism to come to the hearing and read off their children’s symptoms to lawmakers.

“I told them, ‘If you pass it this way, I will file 20 more petitions for each type of autism,” Janie says.

In December 2017, Delaware added “severe debilitating autism.”

Last year, Rylie went back to Legislative Hall with a list of five things to work on, including opening qualifying conditions to what a doctor determines, allowing all licensed physicians to recommend for children, and requiring continuing medical education in cannabis to recommend. A competing bill made the politics challenging, but Rylie and Janie persist, even as Rylie’s advocacy goes global.

She appeared in Australia and Israel last year, will be in Hong Kong for a technology conference on market disruptors in October, and gave the keynote address at the Cannabis Science Conference East this spring.

“I have so much that I want to do and say. I felt like I could not be heard if I did not do this,” Rylie says. “There is a stigma in our own community that the pediatric patients are not heard, yet we are the ones who change so many laws.”

Meanwhile, the Maedlers have launched a pilot hemp project at their family farm in Virginia. If it goes well, they plan to have as much as 40 acres under hemp cultivation soon, with the hope of being able to provide other patients in need with free medicine.

_________________________

Action Alert: The FDA Needs to Hear from You on CBD

The U.S. Food and Drug Administration (FDA) will hold a public hearing on May 31 on how to regulate CBD in products for human consumption such as foods, beverages, and dietary supplements. The FDA is also taking public comment on the issue into June. This is your chance to make an impact on important federal policy.

ASA will be releasing specific comment guidelines in mid May, but you can read here ASA's general suggestions. Take action this month at www.safeaccessnow.org/fdacomment.
_________________________

William Dolphin, Americans for Safe Access

Image result for The Medicalization of Marijuana: Legitimacy, Stigma, and the Patient Experience

William Dolphin is responsible for ASA's newsletters and other print publications, such as the booklets on treating specific conditions, state legal manuals, and activist training materials. He has been part of ASA's communications team since 2002, following a media relations campaign for Ed Rosenthal's landmark federal trial that generated coverage by the New York Times and major networks. William is a widely published author and editor and has taught at San Francisco State University, Rhodes College, and UC Berkeley. He is currently on the faculty at University of Redlands and is the co-author of The Medicalization of Marijuana: Legitimacy, Stigma, and the Patient Experience (Routledge), the first comprehensive study of what it means to participate in a state medical cannabis program.