Carly’s Law study at UAB finds medical marijuana oil helps epilepsy patients
It’s official: cannabidiol, or CBD oil, oil derived from marijuana plants, helps reduce the number of seizures in patients with treatment-resistant epilepsy. That’s according to findings by the University of Alabama at Birmingham (UAB) released earlier this month. CBD oil, which contains little of the “high-inducing” chemical THC, came into the Alabama lexicon with the passage of “Carly’s Law,” in 2014 after piece of legislation provided the UAB Epilepsy Center and Children’s of Alabama the ability to conduct clinical trials of cannabidiol, a component of cannabis. Starting in 2015, UAB launched the landmark study, which focused on 132 patients, 72 children and 60 adults, with intractable epilepsy who did not respond to traditional therapies. “The study analyzed data from the 132 patients at baseline and at visits at 12, 24 and 48 weeks. Seizure frequency decreased from a mean of 144 seizures every two weeks at baseline to 52 seizures over two weeks at 12 weeks into the study. The reduction remained stable through the 48-week study period,” wrote Bob Shepard at UAB. “This is a highly significant reduction in the number of seizures that the majority of patients experienced, nearly a two-thirds reduction across the entire study population,” said Martina Bebin, M.D., professor in the Department of Neurology in the School of Medicine and principal investigator of the pediatric arm of the study. “Some patients experienced an even greater reduction of seizure frequency.” The investigators also noted parallel decreases in both seizure severity and seizure frequency, indicating that, for many patients, use of CBD oil led to both fewer and less intense seizures. UAB research makes national impact Thanks in part to the research coming out of UAB, on June 25, the U.S. Food and Drug Administration (FDA) approved Epidiolex® for seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, marking the first FDA approval of a purified drug derived from cannabis. “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”
Robert Bentley signs Leni’s Law, decriminalizes medical marijuana oil in Alabama
Alabama Governor Robert Bentley on Wednesday signed HB61, also known as Leni’s Law, which makes medical cannabidiol (CBD) available to Alabamians. CBD oil came into the Alabama lexicon with the passage of “Carly’s Law” last year, a piece of legislation which provided the University of Alabama at Birmingham the ability to conduct clinical trials of the cannabis-based medicine. But “Carly’s Law” left out many desperate children in Alabama deemed too sick to participate in the trials. Leni’s Law, introduced by Madison-Republican Rep. Mike Ball, was the solution. Named for Leni Young, a 4-year-old Alabama girl whose family was forced to move to Oregon to gain access to the medicine after she was excluded from the CBD study, Leni’s Law decriminalizes the possession of CBD oil and gives caretakers the ability to discuss the use thereof with physicians. “As a physician, I believe it is extremely important to give patients with a chronic or debilitating disease the option to consider every possible option for treatment,” Governor Robert Bentley said. “With Leni’s Law, citizens in Alabama will have access to cannabidiol that may help with treatment. Through a study at UAB, we have seen the benefit of cannabidiol to help with chronic seizures. I hope we will be able to collect information that will determine the efficacy of this substance in other chronic debilitating diseases.” The law will go into effect on June 1.
Alabama legislative week in review: March 21 – March 25, 2016
Legislators briefly passed through Montgomery this week with an eye toward their spring break, which began Thursday and won’t have them back in the statehouse until April 5. Despite only two legislative action days this week, both bodies took up high-profile legislation. Tuesday, the 17th day of the legislative session, got under way with the Alabama House of Representatives clearing the long-contested bill to provide a path to visitation rights for grandparents. HB334 from Rep. Mike Jones (R-Andalusia) passed with an affirmative vote from 97 lawmakers, though debate came over the fact that the bill may circumvent the will of fit parents to make decisions regarding the welfare of their children. Over in the Senate, lawmakers passed SB260 from Sen. Clay Scofield (R-Guntersville). The bill would bar the state from taking money from the state’s park system to prop up the General Fund. The practice is a legitimate concern, as lawmakers have taken $15 million from state park coffers over the past five years to deposit into the General Fund. The Senate also cleared HB34 from Rep. Mac McCutcheon (R-Capshaw). The bill, which was carried by Sen. Greg Reed (R-Jasper), provides tax breaks for state ports in an effort to remain competitive among states with similar incentives. Supporters say the move will attract large businesses and bring jobs to the state. The Senate continued on its roll Wednesday with the passage of SB205 from Sen. Paul Sanford (R-Huntsville), which would prohibit the location of abortion clinics within 2,000 feet of a school and bar the Alabama Department of Public Health from reissuing licenses to any clinic in violation of the new law. The Senate also approved a General Fund budget, which lacks sufficient funding for Medicaid, despite a veto threat from Gov. Robert Bentley. The Senate’s session came to a halt when it stalled a vote on Bentley’s landmark prison transformation bill. In committee hearings this week, the Mobile delegation declined a bill along party lines that would allow county residents to vote on whether or not to raise the local minimum wage to $10.10 an hour. A house committee approved a bill that will put to a vote the notion that a person is a person from the time of fertilization, effectively outlawing abortion in the state. A Senate committee took up a bill that would decriminalize possession of the epilepsy-relieving drug cannabidiol (CBD), but did not vote on the measure. It will likely come up for discussion again when legislators return from spring break April 5.
Senate committee hears arguments over decriminalization of cannabis oil
The Senate Judiciary Committee met Wednesday in a room filled to the brim with desperate families and ailing children. The contingent was on hand to hear the committee discuss SB115 from Sen. Paul Sanford (R-Huntsville), which would decriminalize possession of the seizure-reducing drug cannabidiol (CBD). The bill is the Senate version of HB61 from Rep. Mike Ball. Ball brought forth the legislation, also known as “Leni’s Law,” after the previously passed “Carly’s Law” left many needy children out of the CBD studies. Ball’s legislation is named for Leni Young, a 4-year-old Alabama girl whose family was forced to move to Oregon to gain access to the medicine after she was excluded from the CBD study. According to Amy Young, Leni’s mother, access to the marijuana-derived medication has allowed Leni to improve by leaps and bounds. The little girl is now verbal and able to sit on her own, two things she was not able to do before moving across the country. Ten minutes after the meeting was set to begin, the contingent was told to move to the seventh floor. Sanford introduced the legislation, referencing Leni and the failures of “Carly’s Law” to include more families. “Basically, an Alabama family has turned into refugees,” Sanford said. “I believe government is basically standing in the way right now.” Sanford said the new law would provided families with an “affirmative defense” against prosecution for possession of the medicinal oil. “These parents are not criminals,” Sanford said. “They’re trying to help their children.” Despite a public hearing being scheduled and there being no plans for a vote on the bill, Sen. Bobby Singleton (D-Greensboro) immediately called for a vote on the legislation. “We’re talking about the lives of children,” Singleton said, noting his disdain for opponents of the measure. “I think we need to go and vote on this bill and get it out of committee and give these children what they need.” Committee chairman Sen. Cam Ward (R-Alabaster) noted Singleton’s suggestion, but added that each side has a right to plead its case. One of the opponents was Dr. Roxanne Travelute, president of the Jefferson County Medical Society. Travelute contended that the bill’s allowance of CBD oil containing as much as 3-percent THC, the psychoactive chemical in marijuana, would cause addiction and neurological disorders, as well as widespread use for illnesses the drug was not designed to treat. Another opponent was Dr. Shannon Murphy, speaking on behalf of the American Academy of Pediatrics (AAP), who opposed the bill on the basis that CBD oil attained by parents may not be safe for patients. “We all sympathize greatly with these families,” Murphy said. “But as physicians, our Hippocratic Oath requires that we first do no harm.” Dr. Gina Dawson spoke in favor of the bill, saying that many of the claims made by opponents are patently false. Dawson noted that the AAP opposes legalization but has said exceptions should be made for “compassionate use.” She cited drugabuse.gov, which says that abuse of CBD oil is almost nonexistent, and remarked that the Epilepsy Foundation has called for legislation providing access to CBD oil to be passed. Dawson also noted that CBD oil is expensive and has no street value. Parents would willingly be on the hook for the cost of the medicine, but drug dealers would not be interested in a high-cost, low-potency drug for sale on the black market. Another proponent, Joe Church, noted that the ingredients in Tylenol or Ibuprofen are more dangerous than CBD oil, as are the mind-numbing drugs these children must take every day. He also alleged that much of the opposition to Leni’s Law comes from GW Pharmaceuticals, which has $1.1 billion invested in its stranglehold over the manufacturing of the oil. The committee is scheduled to take the legislation up again after spring break.
UAB provides first results of ‘Carly’s Law’ study
The University of Alabama at Birmingham released results from its Cannabidiol Program study, which was created to test the efficacy and tolerability of CBD oil, a marijuana-derived medicine with only trace amounts of the high-inducing chemical THC meant to assist in the quelling of seizures. According to the results, half of the 51 patients saw sustained improvement of seizure control – specifically a 32 to 45 percent decline in seizures depending on the dose. Two patients were seizure-free at the end of the study and nine others were forced to drop out due to side effects or ineffectiveness. Currently, 49 children and 30 adults are enrolled in the studies. “The studies are ongoing, and we have a lot more to learn; but these preliminary findings are encouraging,” Jerzy Szaflarski, M.D., Ph.D., professor in the Department of Neurology and principal investigator of the adult study said in a press release. “Among our goals was to determine the safety of CBD oil therapy, and it appears that, in many cases, patients tolerate the oil quite well. The evidence of seizure reduction gives us hope that, the more we learn about CBD oil, the better we will be able to tailor this therapy to provide relief for those with severe epilepsy.” The study began in April of 2015 after the legislature unanimously passed “Carly’s Law” the year before. While the legislation approved the study of the CBD oil on patients with intractable seizures, it has drawn the ire of many CBD supporters who complain that the studies aren’t inclusive enough. “Leni’s Law,” sponsored by Rep. Mike Ball (R-Madison), seeks to decriminalize the oil at the center of the UAB studies in order to make it more readily available to desperate citizens throughout the state. The law’s namesake, Leni Young, and her family fled Alabama to seek relief in Oregon. Despite having been on the front lines of the push to pass “Carly’s Law,” Leni was left out of the initial study. While the medication that Leni receives is slightly different from CBD oil, or more specifically the epidiolex being given to patients in the “Carly’s Law” studies, she has improved by leaps and bounds since moving to Oregon. UAB’s results will be described at the annual American Academy of Neurology meeting in Vancouver, Canada, which takes place April 15 through 21.
Mike Ball to introduce new bill aimed at decriminalizing marijuana medicinal oil
A new bill aimed at decriminalizing the possession of CBD oil will likely come up for discussion during the upcoming legislative session, according to the bill’s sponsor, GOP state Rep. Mike Ball of Huntsville). A previous bill, “Carly’s Law,” gave the University of Alabama – Birmingham the opportunity to research the use of CBD oil, a medicinal oil derived from marijuana but containing little of the “high-inducing” chemical THC, and eventually led to chemical trials for children and adults suffering from myriad ailments. However, after the U.S. Food and Drug Administration narrowed the margins for who could have access to the medicine, many of the state’s most needy were denied access to the program. Specifically Leni Young and her family, who fled to Oregon last year where access to the oil is more readily available. “They’re refugees,” Ball said. Leni’s parents fought tirelessly for “Carly’s Law,” only to see their daughter, who suffers from intractable complex epilepsy and a rare form of cerebral palsy, left out of the trials and following dispersion of medication. Since moving to Oregon and using “high CBD cannabis oil” regularly, Leni has gone from hundreds of seizures a day to one every four to six weeks and has had her cocktail of medication reduced by 20 percent with no adverse side effects. Further, Leni is using her hands for the first time, engaging with her family more thoroughly and able to sit on her own with minimal assistance. Thus, Ball will introduce “Leni’s Law” during the upcoming session. “This is a spiritual issue, not a political issue” Ball said. “It’s time to take this step.” To ensure that his bill is on legal footing, Ball had the bill drafted by the Alabama Law Institute and is planning to have it examined by district attorneys. Ball noted that the issue is complex – federal law has created a climate where doctors are afraid to prescribe the drug and desperate families are afraid to be in possession of it. For that reason, Ball believes a resolution should be drafted to petition the federal government to change its stance on marijuana policy, specifically as it pertains to the use and dispersion of CBD oil, and the Alabama legislature should eradicate fears of prosecution for potential patients. “These people are not criminals,” Ball said. “It’s just common sense. Leni is the catalyst for me, but there are lots of other families who need this medication and we have got to do something to help them.”
