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In this Issue:
- White House Scraps Barrier to Cannabis Research
- Senate Pushes Medical Cannabis Policy Changes
- Study Finds Many Medical Edibles Mislabeled
- California Legislature Passes Transplant Bill
- California Moves toward State Regulation
- Colorado Court Rules against Employee Rights
- New Life for Pennsylvania Medical Cannabis Bill
- Activist Profile: The Collins Family, Virginia
- Action Alert: Support the CARERS Act
White House Scraps Barrier to Cannabis Research
A bureaucratic barrier to medical cannabis research has fallen. The Obama Administration has dropped a review requirement that researchers working with no other drug faced. Last month, the Office of National Drug Control Policy (ONDCP) announced that new cannabis research will no longer have to pass review by the Public Health Service (PHS) as well as the Food and Drug Administration.
In May, a bipartisan group of lawmakers led by Representative Earl Blumenauer (D-OR) had sent a letter to the Secretary of Health and Human Services calling for an end to the additional PHS review requirement. For the past 16 years, research studies on cannabis have been the only ones for which the government has required the extra step.
"The US government has systematically impeded marijuana efficacy research, and the PHS review has played a large role in that stonewalling," said Sue Sisley MD, whose research has been delayed. "To see the government finally eliminate this waste of taxpayer dollars is a triumph and hopefully represents another historic shift in drug policy reform."
Since 2009, Dr. Sisley has been attempting to start a research study on using cannabis to treat post traumatic stress disorder among veterans of the US military. The project, which is sponsored by the Multidisciplinary Association for Psychedelic Studies, received final approval March 12, 2014 from the Department of Health and Human Services. The State of Colorado has provided a $2 million grant for the study, but researchers are still waiting for federal cannabis to be released by the National Institute on Drug Abuse, which holds the only federal license to produce research cannabis in the US, despite a DEA ruling calling for more.
In a 2007 ruling related to this study, an administrative law judge for the Drug Enforcement Administration found that issuing additional licenses for the cultivation of research cannabis was in the public interest, but the DEA has refused to do so. No other drug is limited to a single production license, making heroin and cocaine easier drugs to research than cannabis.
“The next and even more crucial reform is ending the monopoly on DEA-licensed marijuana that can be used in FDA-regulated research,” said Rick Doblin, founder and executive director of MAPS.”Once there are privately-funded, DEA-licensed medical marijuana producers, then the question of the medical use of marijuana will be evaluated by the FDA based on scientific data, the same as with all other drugs."
Senate Pushes Medical Cannabis Policy Changes
Congressional support for new medical cannabis policy continues to grow. Last month, the powerful Senate Appropriations Committee adopted an amendment aimed at stopping federal interference with medical cannabis programs. The amendment offered by Sen. Barbara Mikulski (D-Mary.) to the Commerce, Science and Justice (CJS) Appropriations bill for fiscal year 2015 mirrors the Rohrabacher-Farr amendment that was added to the CJS bill in the House of Representatives in May by a vote of 242 to 186. The Mikulski amendment marks the first time the US Senate has voted on a measure that supports state-level medical cannabis programs. It passed out of the committee with the bipartisan support of 13 Democrats and 7 Republicans.
The amendment to the CJS budget bill would continue the one-year ban on federal interference with state medical cannabis programs that was enacted last year, to the surprise of many pundits. The Senate never voted on last year’s amendment, but the conference committee that resolved differences between the House and Senate versions of the budget preserved it, thanks to the support of Sen. Mikulski and others.
“Passage of the Mikulski medical cannabis amendment shows that Senate support exists for the central elements of the CARERS Act,” said Steph Sherer, ASA Executive Director. “The CARERS Act would make permanent the protections for medical cannabis programs and patients and create a much-needed framework for critical research.”
The increasing Congressional support for new medical cannabis policy is seen in not just the Rohrabacher-Farr amendment. Also progressing is a different budget measure that would enable Veterans Health Administration physicians to complete the paperwork their patients need to participate in state medical cannabis programs. The bipartisan Veterans Equal Access amendment was added by the Senate Appropriations Committee to their version of the Military Construction and Veterans Affairs Appropriations bill by Sens. Steve Daines (R-MT) and Jeff Merkley (D-OR). The amendment was originally offered by Reps. Earl Blumenaeur (D-OR), Sam Farr (D-CA) and Dana Rohrabacher (R-CA) but narrowly lost in the House in May.
Both appropriations bills have to go through the House-Senate conference committee and get re-voted on as a whole before they go to President Obama for a signature.
Study Finds Many Medical Edibles Mislabeled
American consumers expect to be able to check the labels of food products to determine what is in them. For products infused with medical cannabis, that is all the more important, but a new study finds that cannabis products may be more often mislabeled than not.
Last fall, researchers from Johns Hopkins University School of Medicine collected edible medical cannabis products from dispensaries in San Francisco, Los Angeles and Seattle. Their analysis, published this month in the Journal of the American Medical Association, found that THC and CBD content matched the labels in only 13 of the 75 different products tested. Accurate labeling considered to be anything measuring within 10 percent of the listed amount.
THC content was less than the product label listed in 45 of the 75 samples, sometimes strikingly so. According to lead author Ryan Vandrey, two products that were supposed to contain 100 milligrams of THC had only two to three milligrams.
Perhaps even more problematic than patients not getting the medicine they pay for was the study’s finding that 23 percent of the products contained more THC than the label indicated. The lag time between ingesting a product and feeling its effects make proper dosing tricky. Ingesting a more potent product than intended can be counterproductive to the therapeutic benefits sought and produce uncomfortable side effects
Cannabidiol (CBD) was also consistently mislabeled or not labeled at all. Of the 75 products tested, 54 showed detectable levels of CBD, but only 13 had CBD content labeled, and none were accurate. Four had less CBD than labeled, while nine had more.
“The manufacture and labeling of medicines must meet the most stringent standards,” said Kristin Nevedal, director of the Patient Focused Certification program at Americans for Safe Access. “That’s why third-party audits and verification are so important at every step, from cultivation to distribution to testing.”
ASA’s Patient Focused Certification program is working with industry stakeholders and regulators to provide objective verification that products and organizations meet the national standards established by the American Herbal Products Association for botanical medicines. To date, the PFC program has certified the compliance of companies in Arizona, California, Colorado, Maine, New Mexico, Washington State and the District of Columbia.
The study abstract: http://jama.jamanetwork.com/article.aspx?articleid=2338239
ASA’s Patient Focused Certification: http://patientfocusedcertification.org/
California Moves toward State Regulation
On June 5, the California Assembly passed a compromise bill by a vote of 60-8 that would create a comprehensive regulatory structure for the state’s medical cannabis program. The measure is now before the state Senate, where it is scheduled for hearings before the Health Committee on July 8. Americans for Safe Access supports AB 266, the Medical Cannabis Regulation and Control Act, and is working to further improve it.
“AB 266 helps put aside issues that distract from ensuring access to medicine for patients in California,” said ASA Executive Director Steph Sherer. “Americans for Safe Access supports amending the proposed licensing structure to protect the historic diversity of the California's medical cannabis program and allow new entrants to the industry.”
Rival bills, AB 266 and AB 34, were merged to create the measure which passed. Assembly member Rob Bonta (D-Oakland) was made lead author of the new bill, with original proponent Ken Cooley (D-Rancho Cordova) and Reginald Byron Jones-Sawyer (D-Los Angeles) listed as coauthors. AB 266 is supported by the Emerald Growers Association, which lobbies for small cannabis farms, as well as the Police Chiefs Association and the League of California Cities.
AB 266 would create an Office of Marijuana Regulation to oversee the implementation of the licensing and regulation of commercial cannabis operations. Responsibility for various aspects of operations would be split between state agencies already tasked with similar oversight. The state Department of Agriculture would be in charge of cannabis cultivation. The Department of Public Health would monitor cannabis testing, laboratory certification and product safety. The Board of Equalization would be in charge of dispensaries and transportation. Tiers of licenses would be available, based on the size of the operation, with separate licenses for cultivation, distribution and transportation of cannabis. No licenses or permits would be required for patient collectives of five or fewer persons, so long as they were not selling medical cannabis products
“California was the first state in the nation to approve medical cannabis with the passage of Prop 215 in 1996, but since then we as a state have stagnated, and it is time that the Legislature takes definitive action on this important issue,” said Assembly member Bonta. “As Chair of the Assembly Health Committee, I feel it is imperative that we create a viable framework for medical cannabis that preserves our core priorities and provides strong patient protections and access to their medicine.”
Almost 20 years since voters approved medical cannabis use, production and distribution, California still lacks a statewide regulatory system. Research conducted by ASA has shown that sound regulation can both ensure safe access and reduce crime and community complaints. The federal Department of Justice has said it will defer to state law enforcement on medical cannabis only when and where there is a robust regulatory system in place.
ASA Report: Medical Cannabis Dispensing and Local Regulation
California Legislature Passes Transplant Bill
An ASA-sponsored bill to prevent medical cannabis patients from being denied life-saving organ transplants is on the desk of California Governor Jerry Brown, awaiting his signature.
On June 22, the California Senate approved AB 258, the Medical Cannabis Organ Transplant Act, to prohibit discrimination against medical cannabis patients. AB 258 passed the Senate by a vote of 33 to 1 after 200 patients and advocates visited Senate offices in support of it as part of ASA’s California Citizen Lobby Day. The bill, sponsored by Assembly Member Marc Levine (D-San Rafael), passed the state Assembly on April 30 by a vote of 64 to 12.
Medical cannabis patients in California are routinely removed from the organ transplant waiting list if they test positive for cannabis use, even when that use was recommended by their doctor. Many transplant centers define all cannabis use as drug abuse, making qualified patients ineligible for transplants. Those policies have cost several Californians their lives.
ASA member Norman Smith, who had liver cancer, died in 2012 after Cedars-Sinai Medical Center in Los Angeles denied him a transplant because of the cannabis use his oncologist had recommended. Toni Trujillo was denied a life-saving kidney transplant at Cedars-Sinai in 2012 because her medical cannabis use was also classified as “substance abuse.” Richard Hawthorne was denied a liver transplant by Stanford Medical School last year, despite a friend offering to be a donor.
Unlike many other medical cannabis states, California does not protect patients from civil liabilities or discrimination based on their legal medical cannabis use. California patients face pervasive discrimination in employment, housing, parental rights, and access to health care.
Colorado Court Rules against Employee Rights
Qualified patients in Colorado can be fired for cannabis use away from the workplace, even though its use is legal for all adults in the state. That was the decision of the Supreme Court of Colorado, which ruled unanimously that a quadriplegic employee who used cannabis legally to control leg spasms was lawfully terminated because all marijuana use is illegal under federal law. Brandon Coats was fired in 2010 by the Dish Network when he failed a random drug test.
A landmark case in California, Ross v. Raging Wire, whose appeal was litigated by ASA, came to a similar end with the state Supreme Court ruling that employers can use federal law as a reason for terminating employees who comply with state law.
Many states with more recently enacted medical cannabis laws have included explicit civil protections for patients, shielding them from discrimination in hiring, housing and other matters.
New Life for Pennsylvania Medical Cannabis Bill
Patients and advocates in Pennsylvania have new hope. A medical cannabis bill that seemed dead in the House after it was assigned to a committee chaired by a vocal opponent has been revived.
Senate Bill 3, which had 27 cosponsors and passed the Senate by an overwhelming margin in May, was moved to a new committee last week to thwart a parliamentary maneuver that would have brought it to the floor of the House for an immediate vote.
Gov. Tom Wolf has said he will sign a medical cannabis bill if it reaches him. A similar measure passed the Senate last year but was never voted on by the House.
SB 3 would license dispensaries from which qualified patients could obtain a limited variety of medical cannabis products. Patients with certain serious medical conditions whose physicians recommend cannabis use would be allowed to register with the state to participate but would be limited in how they could use the medicine.
According to polls, nearly nine out of 10 Pennsylvania voters support safe access, and nine out of 10 Pennsylvania doctors would recommend it to their patients who might benefit from it.
Activist Profile: The Collins Family, Virginia
Over the past 18 years, 23 states and the District of Columbia have created full-fledged medical cannabis programs. Over the past 18 months, 15 other states have enacted laws allowing limited cannabis extract use. Behind that recent string of legislative victories are parents. Few politicians can say no to someone with a seriously sick child, and ever since Dr. Sanjay Gupta’s first CNN special on medical cannabis highlighted how extracts can help children with seizure disorders, parents have been lining up at statehouse doors around the country, demanding access.
In most of those 15 new states, the law requires those extracts to be predominately or exclusively cannabidiol (CBD), a non-psychoactive constituent of cannabis that has therapeutic properties. Most also restrict legal use to managing seizure disorders, in some cases only minor children may use it legally.
Of the five medical cannabis laws that have passed so far this year, Virginia is notable for allowing extracts that contain not just CBD but THCA, the plant’s precursor of delta-9 tetrahydrocannabinol (THC). THCA is non-psychoactive but converts to psychoactive THC when heated. THCA is also what has proven effective for managing one young Virginian’s intractable seizures, though she and her mother had to move to Colorado to discover that.
Jennifer Collins, now 15, has been back in Fairfax, Virginia since last December, after spending a year in Colorado, separated from her father and sister. She and her mother returned because the stress of having the family split between two states was taking a toll on all of them, but a letter Jennifer had written to the Virginia legislature prompted Senator David Marsden to introduce a bill that would make her medicine legal.
Jennifer and her parents, Beth and Patrick Collins, successfully lobbied for the bill during a session that saw three medical cannabis measures introduced but none expected to pass. Along with other parents, Beth worked with Virginia Parents for Medical Marijuana, the national Parents Coalition for Rescheduling Medical Cannabis, and Americans for Safe Access in convincing lawmakers that her daughter needed legal access to the medicine they had discovered worked far better than conventional pharmaceutical drugs.
“Citizen lobbying made a difference in Virginia,” said Mike Liszewski, ASA Government Affairs Director. “The Collins family shows how powerful the voices of both parents and patients can be in these debates.”
Jennifer suffers from a seizure disorder known as Jeavons Syndrome, a type of childhood-onset epilepsy that is lifelong and highly resistant to treatment. Jennifer was diagnosed in 2008 after her parents noticed her eyelids would flutter involuntarily at the dinner table. The small seizures she was having increased to as many as 300 a day as she grew older. When she reached puberty, they began to occur in clusters that produced serious grand mal seizures that would leave her blue and convulsing. Her doctors tried a dozen different pharmaceutical medications with little success. The drugs controlled the grand mal seizures but not the smaller ones, and the side effects were serious, including cognitive decline, suicidal thoughts and unpredictable rages. Since she began using THCA oil, Jennifer has reduced the number of both seizures and medications, as well as what she calls “outrageous side effects.”
Beth and Patrick Collins have not stopped their advocacy efforts. They are working to see the law expanded and a robust medical cannabis program established in the Commonwealth. Virginia’s new law does not allow for the legal production or distribution of the cannabis oil their daughter needs; the law just provides a mechanism for keeping them out of jail if they are charged with a marijuana offense because of it.
“We want the law to protect everyone who may be using medical marijuana,” said Beth.
“We support the CARERS Act,” added Patrick.
Fifteen states now allow use of CBD extracts: Alabama, Florida, Georgia, Iowa, Kentucky, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin. Idaho passed a similar bill in 2015, but it was vetoed by their governor.
ACTION ALERT: Tell Congress to Pass the CARERS Act TODAY!
Congress has the chance to take comprehensive action on medical cannabis with the Compassionate Access, Research Expansion, and Respect States (CARERS) Act. First introduced in the Senate, a bipartisan companion bill is now also in the House.
Take action today! Tell your Senators and Representative they need to resolve the conflicts between new state laws and outdated federal policies. CARERS would do that, as well as reschedule cannabis, allow VA doctors to discuss medical cannabis with veterans, and allow cannabis businesses to have bank accounts. Sign the Petition to tell Congress to support the CARERS Act at SafeAccessNow.org/carers.
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