In the June 2019 Issue:
- ASA Testifies at FDA Hearing on CBD
- ASA Releases Patient’s Guide to CBD
- Colorado Now Allows Doctors to Substitute Cannabis for Opioids
- ASA Interim Director Speaks at Women Grow Leadership Summit
- ASA at MJBizconNEXT in New Orleans, June 13
- ASA’s Steph Sherer Named Top-100 Most Creative People by Fast Company
- Activist Profile: Todd Larkin, Ardmore, Oklahoma
- ACTION ALERT: Last Chance for CBD Comments!
ASA Testifies at FDA Hearing on CBD
The U.S. Food and Drug Administration (FDA) on May 31 held a nearly 10-hour public hearing to collect scientific information and data on cannabis and cannabis-derived products, including cannabidiol (CBD). Americans for Safe Access's Director of Patient Focused Certification (PFC), Heather Despres, was among those selected to present. Her testimony can be seen on ASA’s YouTube channel.
As part of the ASA and PFC mission to ensure access to safe products, Despres told FDA officials about safe production and how standardization of the industry across all states will improve patient access and provide consistent products to patients across the country.
The questions posed by the FDA include questions around manufacturing and product safety, industry standards, and labeling. The PFC program was created around these very issues, so Despres was able to advise the FDA on current industry standards that can be adapted on a national level to encourage consistency in products between states.
The FDA received almost 400 requests to present and/or provide oral remarks at the hearing. Americans for Safe Access was one of 113 organizations selected to give a formal presentation, and one of only 72 organizations selected to give a full five-minute presentation with slides.
Several organizations argued that the FDA should allow the sale of hemp-derived CBD-infused under the 2018 Farm Bill. Some also suggested that these products be regulated under the existing dietary supplement framework.
Patient advocates urged additional scientific research on the therapeutic value of CBD in treating conditions such as epilepsy, Alzheimer’s and dementia. Many Americans have already turned to CBD products to assist with general wellness.
A critical review by the World Health Organization determined last year that CBD’s safety profile and lack of abuse potential means it does not need to be a controlled substance. The FDA classifies CBD as a controlled substance but does not currently allow the sale and marketing of CBD-infused products because a CBD medicine, Epidiolex, has been approved by the agency as a Schedule V drug.
The FDA commissioner said in April that regulations may be released as early as this summer. The FDA is taking written public comments until July 2. See this month’s Action Alert for how to submit comments.
ASA Releases Patient’s Guide to CBD
Americans for Safe Access (ASA) has released an educational booklet, the Patient’s Guide to CBD. The publication comes in conjunction with ASA’s presentation to the Federal Drug Administration (FDA) regarding products containing cannabis and cannabis-derived compounds.
At the May 31 hearing, ASA was one of organizations chosen to formally present scientific information with slides and data about cannabis, cannabidiol (CBD), and other cannabis compounds.
The Patient’s Guide to CBD is a comprehensive resource that covers a wide range of topics, including available forms for use, what to look for on package labels, how to read a certificate of analysis, how CBD interacts with the endocannabinoid system, the current state of research, the compound’s legal status, and how to talk to one’s doctor about CBD.
Interest in CBD has been increasing with accumulating medical research on its benefits and the FDA approval of a CBD medicine for the treatment of seizures in children. Congress made hemp, a potential source of CBD, legal nationally with the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), which has further heightened interest, as well as confusion, regarding CBD products.
“ASA created the guide to be an educational reference so that patients, healthcare providers, consumers, policy makers, and regulators could have an accurate and scientific source to turn to in order to make informed decisions regarding CBD,” said Debbie Churgai, ASA Interim Director.
ASA submitted written comments to the FDA to supplement the information provided in the oral presentation by Heather Despres, the Director of ASA’s Patient Focused Certification (PFC) program.
"We look forward to providing the FDA with additional data to inform their decision-making,” said Steph Sherer, ASA’s President and Founder. “We are eager to clear up any misunderstandings or misinformation and contribute to the body of knowledge regarding cannabidiol through the release of our Patient's Guide to CBD."
The Patient's Guide to CBD is available for download here.
Colorado Now Allows Doctors to Substitute Cannabis for Opioids
Last month, Colorado Governor Jared Polis 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 physician requirements for patients who are minors and allows them to consume non-smokable forms of cannabis on school grounds. The law goes into effect 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 and state lawmakers for doing their part to reduce opioid overdose deaths by allowing the substitution of cannabis for opioids in pain management,” said David Mangone, Esq., ASA’s Director of Government Affairs. “ASA launched a national campaign, End Pain, Not Lives in 2017 to promote cannabis as a tool to combat the opioid crisis, and we’re gratified to see another state adopt this approach."
Americans for Safe Access provided testimony in support of this bill in January.
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. In 2017, Colorado had 373 deaths involving prescription opioids and 224 involving heroin. According to the National Institutes of Health, over 130 Americans die each day due to opioid-related causes nationwide.
“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.”
ASA Events and Appearances
ASA Interim Director Speaks at Women Grow Leadership Summit
ASA Interim Director Debbie Churgai presented last month at the Women Grow Leadership Summit in Washington, D.C. Churgai brought the patient perspective to a panel about crafting medical cannabis legislation called “From Policy to Prescription: Changing Laws to Dispense Medicine.” ASA also had a table at the event, where staff and volunteers distributed educational materials.
ASA at MJBizconNEXT in New Orleans, Thursday, June 13
This month, ASA Interim Director Debbie Churgai will be attending MJBizconNEXT in New Orleans, Louisiana. On Thursday, June 13, ASA will be part of MJBizDaily’s Night in New Orleans give-back event benefiting local non-profits. The Night in New Orleans event brings together the cannabis industry to recognize those groups and associations helping to drive the cannabis industry forward. The event is from 7:00pm to 9:30pm at Café Istanbul, 2372 St. Claude Avenue. This event is free to add to conference registration for conference attendees. ASA newsletter subscribers can save $50.00 off conference registration with code: GIVEBACKASAF50.
ASA’s Steph Sherer Named Top-100 Most Creative People by Fast Company
ASA Founder and President Steph Sherer was named one of the Most Creative People of 2019 by Fast Company magazine for her contributions to medical cannabis standards. Citing her nearly two decades of innovative advocacy and organizational work, the magazine called out her role in also cofounding the International Cannabis and Cannabinoids Institute, where she is currently serving as president and director of innovations. She also got a nod for spearheading ASA’s collaboration with the American Herbal Products Association and the American Herbal Pharmacopoeia, which produced “the first medical cannabis industry standards in the areas of distribution, cultivation, analytics, manufacturing, packaging, and labeling.” fastcompany.com/person/steph-sherer
Activist Profile: Todd Larkin, Ardmore, Oklahoma
In 2011, ten years after enlisting in the U.S. Army and serving tours of duty in Egypt and Afghanistan, Todd Larkin was discharged an E5 Sergeant and returned to his wife and kids in his hometown of Ardmore, Oklahoma, between Oklahoma City and Dallas. He had joined the military straight out of high school, and returned to work and coach at that school, but within a year, the Veterans Health Administration diagnosed him with post-traumatic stress disorder (PTSD) and depression. His mental health deteriorated over the next few years until his mood problems got him suspended from coaching football for a couple of games and he became suicidal.
“I was going down a road that wasn’t me,” he says. That’s when a friend from high school intervened, telling him repeatedly that he needed to try cannabis. “I didn’t think it would do anything,” Todd says. “My wife was pretty adamant about me not trying it.”
But Todd began to do research and reached out to people in the cannabis industry with questions. He became convinced it was worth a try, and broached the idea with his wife again. They decided to do a short trial of using cannabis obtained on the underground market, as there was not legal access in Oklahoma at the time.
“After about a month, we were completely sold,” Todd says. “We both saw a complete change in my mentality and mood. It was night and day from the VA meds.”
Todd was being prescribed nine separate medications, including Xanax, Prozac, a sleeping medicine and two more drugs to control the stomach problems from the other medications. To identify and obtain the types of cannabis medicine that work for him, Todd and his wife made trips to neighboring Colorado.
In 2017, sitting at dinner one night, Todd told his wife she should prepare herself, because he was ready to share more of his story. She was ready for it because she’d seen how much it helped not just his life but hers and the family’s.
Todd resigned from the high school to work full time on providing safe access to veterans and other patients in need in Oklahoma. He and his wife went to Las Vegas to meet with friends in the industry, tour facilities and meet manufacturers. When they came home, Todd was putting gas in his car when he discovered CBD being sold in his local gas station.
“I was really disheartened by how it was being sold and what people were being told,” he says.
He decided he needed to get involved to help ensure quality products and educate consumers and other veterans.
“The biggest thing was showing people I’m a normal everyday guy with a wife and three kids, good job, served my country,” Todd says. “Patients like me are not the traditional stoners people want to see us as. I’m someone who never thought cannabis could work.”
In January 2018, Todd opened Pure Wellness Medical providing CBD products. He was also involved in the campaign that got State Question 788 on the June primary ballot. June was also the month he formed Texoma Veterans Alliance, a cannabis-specific group that now has over 100 members, with 70 or so participating at meetings that include education on topics such as safety, terpenes and cultivation.
After the state’s voters approved one of the most robust medical cannabis programs in the nation, they became a full-fledged medical cannabis dispensary in October 2018, now seeing as many as 200 or more patients a day. In support of his patients who are veterans, Todd reaches out to local businesses such as a plumbing company for donations to cover the cost of medicine. As a result, he was able to outfit 58 veterans with WarFighter CBD last month. Like him, many were being treated by the VA but not seeing good results.
Todd’s outreach includes lobbying at the state capitol and in Washington, D.C. The took a group of veterans to the state house in February to testify before lawmakers about program changes, pushing for, among other things, a reduced-price registration for veterans. Originally set at $500 per patient, the governor just signed a bill to reduce it to $22 for veterans, starting November 1. Currently, 22 veterans a day commit suicide. Oklahomans on fixed incomes will be eligible for the same reduced-cost registration.
This Memorial Day, Todd went to D.C. for a rally with the veterans’ group Plants Over Pills in Lafayette Square across from the White House.
“It was the second time I’d ever told my story. It was very refreshing,” Todd says of speaking at the rally of about 80 veterans. “Listening to other vets reminded me I’m not alone, that a lot of them had the same experience, though lots did not come home to the stability I had.”
Borrowing from what he learned attending ASA’s Lobby Day in March, he organized lobbying visits for the veterans, getting 40 veterans into 12 different meetings with national lawmakers or their staff.
Todd’s end goal is federal medicinal legalization, but he’s also focused on ensuring that Oklahoma has a good program. The state will not allow medicinal cannabis to be given away, but Todd’s working on establishing a program similar to one in Oregon that allows for “waste” or “expired” medical cannabis to be donated to veterans.
“If you’d told me 10-15 years ago this would be the medicine that helped, I wouldn’t believe it,” he says. “What has helped the most in Oklahoma has been education. It’s not what we were told all our lives--far from it.”
Yet old attitudes die hard. When Todd tried to donate $1500 to his old high school’s athletic program, the school rejected it, even though he’d worked there five years.
“I want to make it more normal for my kids, so we need to not whisper about it,” Todd says. “We talk about Xanax in the open, so why not this?”
ACTION ALERT: Last Chance for CBD Comments!
This month is your final opportunity to help the Food and Drug Administration (FDA) regulate cannabis and derivatives such as CBD. The FDA is accepting public comments on their website until July 2. The FDA is asking for feedback on specific areas, including: 1) Health and Safety Risks, 2) Manufacturing and Product Quality, and 3) Marketing/Labeling/Sales. ASA has prepared guidelines to make it easy to submit comments that make a difference. Read the blog here: https://www.safeaccessnow.org/fda_comments_blog. Then submit your comments today!