In the October 2017 Issue:
- ASA Weighs in as World Health Org Considers CBD
- PFC Educating Doctors, Conducting Trainings in 3 States
- American Legion Urges VA Secretary to Back Medical Cannabis Study
- New Bipartisan Bill to Aid Cannabis Research
- DC May Expand Access to Medical Cannabis to Stem Opioid Crisis
- Acting DEA Chief Resigns, Longtime Deputy Appointed
- ASA Activist Profile: Amy Mellen, Maryland
- ACTION ALERT: End Pain, Not Lives – Sign the Petition Today
ASA Weighs in as World Health Org Considers CBD
As federal and international health officials consider new drug rules, Americans for Safe Access is urging them to remove all restrictions on cannabidiol (CBD). ASA submitted the formal comments on the medical efficacy of CBD in response to a public request from the Food and Drug Administration (FDA). The FDA asked for input on CBD and 16 other substances prior to a November meeting of the World Health Organization’s (WHO) Expert Committee on Drug Dependence (ECDD). The committee meets in Geneva, Switzerland from Nov. 6 to 10 to prepare recommendations for the United Nations Secretary-General.
ASA urged the FDA to use its traditional rulemaking process to remove CBD from the drug schedules that currently prohibit access to the safe, non-psychoactive drug. Descheduling CBD would allow consumers to obtain those cannabis-based products without a prescription anywhere in the U.S.
ASA’s comments also highlighted benefits of CBD compared to the social and economic costs associated with long-term use of opioids and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). CBD and other cannabis therapies have been shown to be effective in treating many of the conditions that are normally treated with opioids and NSAIDs.
Cannabidiol was the only substance mentioned in the federal notice that is derived from a natural product. The other substances listed are synthetically produced. Over 6,500 comments were submitted, most stating CBD is medically useful.
“CBD is only one of many beneficial compounds of the cannabis plant,” said ASA Executive Director Steph Sherer, “But engaging policy makers about it on an international scale is a significant step in removing barriers to accessing this important medicine.”
The DEA classifies CBD as a Schedule I substance, so any research on CBD faces the same onerous bureaucratic hurdles as studying whole-plant cannabis. CBD is not listed in the 1961 UN Single Convention on Narcotic Drugs or its 1972 amendment, but language about resin and extracts has been interpreted as encompassing CBD and other components of cannabis.
Each of the last two years, WHO committee members asked for a new evaluation of cannabis. In 2016, they set an 18-month window for gathering more information about not just cannabis but extracts and tinctures and its constituent chemicals CBD, delta-9 THC, and THC stereoisomers. A statement from the WHO Director-General recommending the review noted the “increase in the use of cannabis and its components for medical purposes,” as well as the development of standardized pharmaceutical preparations.
If the WHO committee’s “pre-review” of the evidence warrants further investigation, a formal critical review process will begin that would be the basis for recommending a reclassification of cannabis. The WHO has never conducted a review of cannabis. Any recommendations for change would go to the United Nations for consideration.
As ASA’s comments proceed through the consideration process, you can follow them at www.regulations.gov with the tracking number 1k1-8yrw-wp4v.
PFC Educating Doctors, Conducting Trainings in 3 States
ASA’s Patient Focused Certification program has upcoming trainings in Maryland, Tennessee and Pennsylvania, as well as new webinars and facebook live events. The Maryland trainings are scheduled for next Tuesday and Wednesday, October 17 and 18 in Fulton. The trainings in Philadelphia will be November 6 and 7. PFC started the month with an invited presentation to the Pennsylvania Medical Cannabis Society, where Dr. Marcu was joined by the author of the state’s medical cannabis law, state Senator Mike Folmer, and the director of the Pennsylvania program, John Collins. Locations and other details for PFC events are at www.safeaccessnow.org/events.
This month, Dr. Marcu will also be conducting grand rounds at Temple University Hospital, discussing with the attending physicians, residents and medical students what professionals need to know about cannabis, including the extensive educational resources available for doctors and patients through the Cannabis Care Certification. The university has also asked Dr. Marcu to do an onstage interview of a local cannabis business entrepreneur, Lindy Snider, the founder and CEO of LindiSkin, a skincare company specializing in the needs of people living with cancer.
PFC staff will be in Nashville, Tennessee October 25-27 educating advocates and regulators. Dr Marcu will be working with Safe Access Tennessee’s local advocate David Hairston to show advocates how to better use PFC resources as tools for enacting legislation.
PFC’s webinar series continues this month with special guest John MacKay, who brings his 30-years of experience with laboratory analytics to bear on cannabis extracts and quality in his talk, “Good is Not a Number.” PFC webinars appear online every other Thursday and are archived on ASA’s YouTube channel. The recent webinar on standardizing products is going up soon. Subscribe to ASA’s YouTube channel today to see them all.
On Tuesday, October 17 at 3:00pm eastern Dr Marcu will host his 25-minute program, Cannabis Science Corner on facebook live. Follow ASA’s facebook page to get all the notifications.
American Legion Urges VA Secretary to Back Medical Cannabis Study
A stalled clinical research study on treating post-traumatic stress disorder (PTSD) in U.S. military veterans got support from the American Legion last month. The organization’s national commander, Denise Rohan, urged the head of the Veterans Administration (VA), Dr. David Shulkin, to support the federally approved study.
Dr. Sue Sisley, who has worked for nearly a decade to get the study going, has funding from the Colorado Department of Health and a research site at the Scottsdale Institute near Phoenix, Arizona but has had difficulty finding study participants. The researchers report that the Phoenix VA Health Care System has been blocking their access to the veterans who might be candidates for the study.
Rohan’s letter asks for direct involvement by VA Secretary Shulkin so that “this critical research is fully enabled.” The Legion’s spokesman noted the VA in Phoenix has prevented Dr. Sisley from communicating with either VA staff or veterans receiving care there.
The researchers are seeking an additional 54 participants for the PTSD study, which they estimate will require screening between 6,000 and 8,000 veterans.
The Legion’s letter reminds Shulkin that the VA has a research mandate, and notes that many of its members have shared “very compelling” stories of how cannabis has “materially improved their health and well-being.”
The letter follows an unsuccessful attempt by the American Legion earlier in the year to convince President Trump to reschedule cannabis to allow research.
PTSD is increasingly recognized as a qualifying condition for state medical cannabis programs. Colorado recently added it, and Delaware last month enacted the Bravery Bill, making it easier for patients with PTSD to qualify there because of the prevalence of the condition among veterans.
New Bipartisan Bill to Aid Cannabis Research
A new bipartisan bill in the Senate would remove barriers to research on medical cannabis. Sponsored by Senators Orrin Hatch (R-UT) and Brian Schatz (D-HI) the Marijuana Effective Drug Study Act of 2017, or MEDS Act, is cosponsored by Cory Gardner (R-CO), Chris Coons (D-DE) and Thom Tillis (R-NC). Schatz introduced a similar bill last year.
“Regulatory acrobatics can take researchers over a year if not more to complete, and the longer researchers have to wait, the longer patients have to suffer,” Hatch told his fellow senators in a speech introducing the bill. “We need to remove the administrative barriers preventing legitimate research into medical marijuana.”
If enacted, the MEDS Act would accelerate the research registration process for new cannabis studies, increase the availability of cannabis research materials and require the government to issue best-practice recommendations for cannabis cultivation and manufacturing, among other provisions.
DC May Expand Access to Medical Cannabis to Stem Opioid Crisis
The District of Columbia may expand its medical cannabis program to better fight the opioid epidemic. Last month, Councilmember David Grosso introduced the Medical Marijuana Improvement Amendment Act of 2017, which adopts components of ASA’s model legislation.
If adopted, it would allow a patient to receive cannabis on the same day a doctor’s recommendation is issued, like any other medicine, and allows for delivery of medical cannabis. It also allows a patient without a primary care physician, such as many low-income residents, to self-certify a medical condition through a signed affidavit.
“We are thrilled with Councilmember Grosso’s leadership in fighting the opioid crisis,” said ASA Executive Director Steph Sherer. “Medical cannabis is a critical tool in combating the opioid epidemic, so lowering barriers to access will further reduce the toll opioids are taking on this community.”
A 25% reduction in opioid deaths was found in states with medical cannabis programs, according to research published in the Journal of the American Medical Association.
“Medical marijuana has been shown to be a viable alternative to the prescription of opioid painkillers, which can set people down the path to addiction,” said Grosso. “While we have made significant improvements to our medical marijuana program here in D.C., there is more we can do to improve access for patients and reduce opioid reliance and overdose.”
ASA has launched a petition urging President Trump to formally declare the opioid epidemic a national health emergency. Grosso was joined by District Councilmembers Vincent Grey, Robert White, Jr., and Brianne Nadeau in introducing the bill.
Acting DEA Chief Resigns, Longtime Deputy Appointed
With just five days’ notice, the acting head of the Drug Enforcement Administration, Chuck Rosenberg, resigned his position as of October 1. After two days without leadership, Robert Patterson, a longtime DEA employee and former number two in the agency, was appointed to temporarily fill the position.
Rosenberg’s DEA has been attempting to clear away barriers to accessing research cannabis by issuing more licenses to cultivate it, but the Justice Department has stymied those efforts.
Rosenberg, who was appointed to the acting position by President Obama, was reported to have been approached about accepting the permanent job by the Trump Administration but declined. He had previously worked as a U.S. attorney and as an assistant to then-FBI Director James Comey.
The Trump Administration has not indicated who the candidates to lead the DEA may be, though the head of the New Jersey State Police is rumored to be under consideration for the position.
ASA Activist Profile: Amy Mellen, Maryland
Amy Mellen knew something about pain from the hormonal migraines she began experiencing in 1998. But a major car accident in 2006 ushered her into the world of severe chronic pain. After her vehicle flipped several times, she awoke in the hospital with an IV drip delivering the first of the opiate painkillers that would come to define her life for the next eight years. Those IV narcotics were her introduction to real intoxication, since she’d never used drugs or been drunk. She left the hospital with a supply of pills that would be refilled through nine surgical procedures on the hand and arm she nearly lost in the accident. Then came the complications. The next 17 years would bring the total to 20 surgeries, but the turning point was another traffic incident.
Prescribed gabapentin for her pain, Amy blacked out while driving. Prior to that, she’d never had a speeding ticket, but she lost her drivers’ license as a result of that incident and realized she had to find an alternative and get off the pain meds.
In October of 2014, Amy tried smoking cannabis. After four months, she tried topical cannabis medicines. Two months of that and she began ingesting cannabis oil extracts. The oil made the difference. Soon, she was cutting back on the Baclofen, OxyContin, Effexor and Klonopin she had relied on since 2006, though she would go through detox 27 times before pulling free.
“It literally changed my life,” Amy says. It not only helped control her pain, but within two months of starting it, she was shocked to discover the cannabis oil treatment had reversed her Type 2 diabetes, further evidence of the role cannabinoids have in regulating insulin.
Within a year, Amy had also lost over 100 pounds. Now, three years after starting cannabis therapy, she’s dropped over 200 from the 400 pounds she’d reached at her heaviest. That transformation has come with a sense of obligation to share her experience with others.
“I knew people need to hear my story,” she says. That meant building a social media network beginning with a simple meme with bullet points of what cannabis had done for her. Amy’s facebook group Squash the Stigma now has over 2,000 members who use it to sort through information about cannabis and ask questions where they won’t be judged.
“If you don’t have experience with cannabis, you can be so overwhelmed, there’s so much information,” Amy says. “It’s hard for us new people – you don’t know who to ask, and it can be hard to know who to believe.”
Through social media and other networking, she tries to help other patients through the learning process about dispensaries and how to save time and money. In December 2015, Al Jazerra released a documentary on her healing with cannabis, showing how cannabis can be an “exit drug” for people dependent on opiates and other medications or substances.
Amy is also lobbying for better medical cannabis policies. Originally a registered patient in Oregon, before her husband’s work took them to Maryland, she testified at the Oregon Health Association and before the state legislature. Once in Maryland, Amy became the second qualifying patient registered in the state and has been working to push forward implementation in the state, which has been painfully slow. Maryland approved medical cannabis four years ago but still does not have a functioning system to provide patients with medicine.
Last year, Amy received an ASA scholarship to attend the National Unity Conference in Washington, D.C., where she networked with experts and other activists and, as she says, got her first dose of real advocacy, taking those new skills to Capitol Hill. From there she went to a conference in Baltimore, and then returned to Oregon as an invited participant in the Cannabis Science Conference in Portland.
“In 2011, I had a dream I’ve now had three times,” Amy says. “I was standing at a podium holding up a book about my life. I didn’t know then what it meant, but what I’m doing now is writing that story.”
Al Jazerra documentary Part 1: https://youtu.be/VpEQaa6jzUU, Part 2: https://youtu.be/dp1WYSFVWb4
Onebeautifulhotmess page link https://www.facebook.com/onebeautifulhotmess/
Squash the Stigma group link: https://m.facebook.com/groups/196188170839734
ACTION ALERT: End Pain, Not Lives – Sign the Petition Today
Opioid drugs claim the lives of 91 individuals every day. With nearly 60,000 overdose deaths in 2016, 60% of which were related to prescription opioids, it is clear that there is a major public health crisis in our country. That is why we are launching our End Pain Not Lives campaign to educate patients and doctors that cannabis can be an alternative or adjunct to opioid therapies.