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In the September Issue:
- ASA Analysis Reveals Flaws in DEA Rescheduling Denial
- PFC Educating Stakeholders and Developing Standards
- Appeals Court Rules Patients Can’t Buy Guns
- Ohio Medical Cannabis Law Takes Effect
- Maryland Selects Cultivation and Processing Businesses
- Montana Eliminates Access for 90% of Patients
- Activist Profile: Dixie Pace Family, South Carolina
- ACTION ALERT: Help Renew Federal Protections
ASA Analysis Reveals Flaws in DEA Rescheduling Denial
The Drug Enforcement Administration (DEA) relied on flawed or outdated scientific research when it rejected petitions to reclassify cannabis as having medical use, an analysis by Americans for Safe Access revealed this month. The new ASA report contrasts the research the DEA used with the full body of available data, including the research ASA used in its independent, peer-reviewed 8-Factor Analysis, which mirrors the analysis the Department of Health and Human Services (HHS) was required to provide. All members of Congress have been sent the report, titled “DEA’s Denial of Existing Medical Cannabis Research: A Peer-Reviewed Comparative Analysis of DEA’s ‘Denial of Petition to Initiate Proceedings to Reschedule Marijuana.’”
On August 10, the DEA denied two petitions to move marijuana from the Schedule I classification it was assigned in the Controlled Substances Act of 1970 (CSA). The DEA denial claims cannabis has no accepted medical use in the United States, has a high potential for abuse, and lacks an acceptable level of safety for use even under medical supervision. Those flawed findings are based on a scientific and medical evaluation and scheduling recommendation provided by HHS, including the required 8-Factor Analysis.
"Our analysis shows that the DEA failed to take into account over 9,000 patient-years of placebo-controlled clinical research with standardized cannabis-based medicines,” said ASA Chief Scientist Dr. Jahan Marcu. “Instead, nearly one third of the data cited in their report was derived from survey-based research, much of which does not have clinical significance, and almost 40% of the agency’s report relies on outdated research articles.”
While the DEA failed to conclude cannabis should be removed from Schedule I, their analysis marked a step forward from previous rescheduling decisions. The DEA now acknowledges cannabis satisfies several of the factors in the HHS’s 8-Factor Analysis. There is no significant diversion of the substance from legitimate channels (Factor 1b). Cannabis is related to other approved drugs with acceptable safety profiles (Factor 1d). There is no evidence for long term harms associated from the chronic use of cannabis (Factors 2 & 3). The gateway hypothesis is not supported by scientific evidence (Factor 6). And cannabis is not a precursor to another controlled substance (Factor 8).
“It is clear that the administrative process for rescheduling cannabis is broken and unworkable,” said ASA Executive Director Steph Sherer. “It is up to Congress to rectify this situation by passing the CARERS Act.”
The Compassionate Access, Research Expansion, and Respect for States (CARERS) Act (S. 683, H.R. 1538) would, if enacted, reschedule cannabis and remove cannabidiol (CBD) from the schedule entirely, allow states to establish medical cannabis access laws and product safety regulations without interference by the federal government, and remove current obstacles to research. The CARERS Act is currently stalled in the Senate Judiciary Committee because Chairman Chuck Grassley (IA) refuses to allow a vote on it.
Laws allowing some medical use of cannabis or its derivatives have been enacted by 41 states plus the District of Columbia, Puerto Rico and Guam.
ASA’s report on the DEA decision: DEA’s Denial of Existing Medical Cannabis Research
Key Findings from ASA report
ASA's 8-Factor Analysis
DEA’s 8-Factor: Rescheduling Denial
DEA’s Rescheduling Denial Press Release
Medical Cannabis Access for Pain Treatment: A Viable Strategy to Address the Opioid Crisis
CARERS Act Fact Sheet
American Academy of Pediatrics Statement on Rescheduling
American College of Physicians position paper
PFC Educating Stakeholders and Developing Standards
Staff from ASA’s Patient Focused Certification (PFC) program have been traveling the globe educating stakeholders about regulatory developments, while working to create new accreditation standards for laboratories that test cannabis products.
PFC staff have just completed a multi-city tour of California to educate participants on current trends in regulations. The tour is focused on demystifying the implementation of the state’s Medical Marijuana Regulation and Safety Act being carried out by California’s new Bureau of Medical Cannabis Regulation. The educational tour spanned 11 cities from one end of the state to the other.
PFC has begun work with A2LA, the largest accreditation body in the United States, on international standards for cannabis testing laboratories. PFC and A2LA are creating an ISO17025-type accreditation specific for cannabis that will incorporate regulatory compliance into the scope of accreditation.
So far this year, PFC has completed inspections and assessments of dispensing, manufacturing, cultivation, and laboratory operations in both the U.S. and internationally, including a laboratory in the Czech Republic that has begun testing CBD and other cannabis products available in Europe.
PFC’s international program is also conducting research on laboratory methods. As part of the program, the terpene and cannabinoid profiles resulting from different extraction methods such as ethanol, CO2 and water were investigated. Since then, PFC’s Kristin Nevedal and Jahan Marcu have presented around the world on the program and its international research efforts to various interested groups. In the U.S., that includes the Society of Toxicology, the National College of Natural Medicine, the Connecticut Pharmacists Association and two presentations to the American Chemical Society. Internationally, PFC has presented to the Czech Republic’s Academy of Sciences, the University of Leiden’s Cannabis Master Course, and the 2016 International Cannabinoid Research Society meeting in Poland.
ASA’s PFC program has more verified professional trainings scheduled in the next few months.
Appeals Court Rules Patients Can’t Buy Guns
A federal appeals court last month ruled that registered patients are barred from purchasing firearms because cannabis use is likely to produce "irrational or unpredictable behavior" that makes them dangerous. The case was brought by a Nevada woman who was not allowed to buy a gun because the store owner identified her as a medical cannabis cardholder.
The Bureau of Alcohol, Tobacco and Firearms in 2011 issued a letter to gun sellers that federal law that prohibits gun purchases by an "unlawful user and/or an addict of any controlled substance" applies to patients in state medical cannabis programs.
The ruling by the U.S. Circuit Court of Appeals for the 9th Circuit hinged on earlier cases that found those who committed violent crime were more likely to be a drug addict or have a history of using many types of illegal drugs.
Researchers have noted that cigarette smoking also correlates to criminal behavior, and alcohol use has a far stronger association with violent crime than cannabis use.
Ohio Medical Cannabis Law Takes Effect
Ohio’s medical cannabis law went into effect last month, though implementation of the new law may take another two years. Medical cannabis use is now legal for qualifying patients with certain conditions, such as pain, cancer, AIDS and PTSD, but there is no legal means to obtain it, and physicians do not yet have guidance from the state medical board on issuing recommendation.
Eventually, dispensaries will be licensed by the state Board of Pharmacy, which is currently developing licensing rules. State law prohibits smoking cannabis, but vaporizing, oils, tinctures, edibles and topicals will be allowed for patients qualifying under a broad list of medical conditions. The state Medical Marijuana Advisory Committee is slated to have members appointed by early October.
Maryland Selects Cultivation and Processing Businesses
Three years after Maryland enacted a medical cannabis law, the first businesses were selected to cultivate and process medical cannabis. Each must still pass background checks and undergo a facility inspection.
The political ties of many of the 30 successful applicants have raised questions, and the lack of minority businesses has drawn protest. Among those associated with the companies selected are major political donors and high-ranking law enforcement officials, including the head of the state police union and two former heads of the state’s marijuana eradication force.
Access for patients is not expected until next summer, as none of the up to 94 dispensary licenses have been decided yet.
Michigan Lawmakers Expand Safe Access
Eight years after Michigan voters approved a medical cannabis initiative, state lawmakers have enacted a trio of bills to implement it by legalizing and regulating edibles and dispensaries. Michigan Governor Rick Snyder signed the bills into law on September 20, praising the expansion of safe access.
"This new law will help Michiganders of all ages and with varying medical conditions access safe products to relieve their suffering," Snyder said. "We can finally implement a solid framework that gives patients a safe source from which to purchase and utilize medical marijuana."
The state Senate passed the bills a month earlier to address grey areas in the voter-initiated law, and the House then approved them each by margins of better than 3 to 1.
House Bill 4209, now known as Public Act 281 or the Medical Marihuana Facilities Licensing Act, creates a framework for licensing, taxing and regulating the cultivation, processing, transport and distribution of medical cannabis. Licenses must be renewed annually. Dispensaries must obtain local approval to operate and will be taxed 3% on “gross retail income.”
House Bill 4210, now Public Act 282, amends the original voter-approved Michigan Medical Marihuana Act to allow for the manufacture and use of cannabis-infused products by qualified patients. Edibles will be subject to limits on THC content.
House Bill 4827, now Public Act 283 or the Marihuana Tracking Act, establishes a seed-to-sale tracking database for all medical cannabis.
Montana Eliminates Access for 90% of Patients
Thousands of patients in Montana lost access to medical cannabis last month as new restrictions took effect that eliminated dispensaries in the state. Five years ago, Montana state legislators gutted the medical cannabis measure voters passed in 2004, and last month the court challenges came to an end.
Now, the more than 13,000 qualified patients in Montana must either cultivate their own medicine or find a caregiver to do it for them. Registered caregivers in the state are now limited to providing medicine for no more than three patients, but there were only 305 registered providers as of the end of July who indicated they will accept 3 patients. That means 12,000 registered patients no longer have a legal means of obtaining it as they need it.
In addition to the restriction on providers, the Montana Supreme Court also upheld the 2011 state law’s ban on advertising and a requirement that doctors who write more than 25 recommendations a year must be automatically reviewed.
Patient advocates have qualified a new initiative of the upcoming election that would reinstate much of the medical cannabis program. Montana state law allows the legislature to modify initiatives passed by voters.
Activist Profile: Dixie Pace Family, South Carolina
Dixie Pace’s seizures started at age seven. At first, it was one every other week or so. After a year, they were weekly. With each passing year, the frequency increased until, a decade later, she was experiencing 50-100 seizures a day. By then, she was taking or had tried every anti-seizure medicine available.
The sedative effects of those pharmaceuticals left her with a lisp so severe her mother had to translate for other family members, and the serious side effects included a deadly rash and psychosis. Grand mal seizures necessitated a helmet to protect her from head injuries, and drop seizures caused so many shoulder dislocations that arm braces were required. When a qEEG digital brain scan revealed that the medications she was taking were causing more brain damage than the seizures, her parents had reached the end.
“We had heard about cannabis,” Dixie’s mother April says, “We got to studying, and met two ladies who were advocates.”
This was in the Fall, two years ago. Dixie was 18. The three families tried to get CBD under South Carolina’s new state law for pediatric seizure patients, but no one could find or obtain it. So they started looking for medicine on the underground market.
“We didn’t think our kids would make it to Christmas,” April says.
They started experimenting with CBD and THCa as much as they could, but like many patients in states without robust medical cannabis programs, they found it hard to obtain the types of medicine they sought, and often had to deal with shadowy, unreliable providers.
In July, the Pace family took Dixie to Maine for three weeks. There, she was able to try several different cannabis strains and products, and her seizures dropped immediately to only five to seven a day. Her cognitive functioning improved dramatically, as did her ability to speak and be understood. Instead of 13 medications -- eight anti-seizure, four to treat the side effects, and a sleep medicine -- she know takes just two.
“We’re living right now,” says April. “Before we had nothing. There were phases when all we could do was lay on the couch. Then she was a zombie from the medications.”
The Pace family has worked hard to educate elected officials in South Carolina and now enjoy support from their sheriff, state House representative and senator. They have been working closely with Senator Tom Davis, who has introduced legislation each of the past two years to expand South Carolina’s highly limited medical cannabis protections to a robust program that provides safe access.
“Our kids need protection and access to any strain, whether THCA, THC, or CBD,” says April. “We need the options.”
Neither bill passed, but last session Sen. Davis started reading a patient story each day in the Senate. April reports a palpable change swept over the statehouse. They will try again with a more limited bill in the next two-year session, which begins in January.
Dixie is 20 years old now, but after 13 years of attempting to manage her seizures, her mother is not done fighting for her and other kids who need medical cannabis. April will be working with Sen. Davis on new state legislation and has been lobbying her federal representatives, too. The day after the federal Drug Enforcement Administration again refused to reclassify cannabis for medical use, she met with her senior U.S. Senator, Lindsey Graham, who told her his whole office was behind her efforts, urged her to keep working at the state level, and assured her Congress would do something soon.
“We’re blessed that our daughter can speak,” says April. “So we let her be the voice for those who can’t.”
ACTION ALERT: Help Renew Federal Protections
The Rohrabacher-Farr amendment to the Department of Justice’s (DOJ) budget has been helping defendants win in federal court by blocking injunctions and prosecutions. But it is set to expire at the end of September. If that happens, federal prosecutions against those obeying their state medical cannabis laws could resume.
The amendment was passed in 2014 and 2015 thanks to the support of medical cannabis activists like you! Earlier this year, the Senate Appropriations Committee voted overwhelming to include it in next DOJ budget, but the House has yet to vote.
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