Medical marijuana for children with cancer? What providers think
Most providers willing to consider medical marijuana use in children with cancer
December 12, 2017
Science Daily/Ann & Robert H. Lurie Children's Hospital of Chicago
A study published in Pediatrics examined interdisciplinary provider perspectives on legal medical marijuana use in children with cancer. It found that 92 percent of providers were willing to help children with cancer access medical marijuana. However, providers who are legally eligible to certify for medical marijuana were less open to endorsing its use.
While nearly a third of providers received one or more requests for medical marijuana, the lack of standards on formulations, dosing and potency was identified as the greatest barrier to recommending it. These findings reflect survey responses from 288 providers in Illinois, Massachusetts and Washington.
"It is not surprising that providers who are eligible to certify for medical marijuana were more cautious about recommending it, given that their licensure could be jeopardized due to federal prohibition," said co-author Kelly Michelson, MD, Critical Care physician at Ann & Robert H. Lurie Children's Hospital of Chicago, Associate Professor of Pediatrics and Director of the Center for Bioethics and Medical Humanities at Northwestern University Feinberg School of Medicine. "Institutional policies also may have influenced their attitudes. Lurie Children's, for example, prohibits pediatric providers from facilitating medical marijuana access in accordance with the federal law, even though it is legal in Illinois."
Pediatric oncology providers received frequent requests for medical marijuana for relief of nausea and vomiting, lack of appetite, pain, depression and anxiety. Most providers considered medical marijuana more permissible for use in children with advanced cancer or near the end of life than in earlier stages of cancer treatment. This is consistent with the current American Academy of Pediatrics (AAP) position that sanctions medical marijuana use for "children with life-limiting or seriously debilitating conditions." Only 2 percent of providers reported that medical marijuana was never appropriate for a child with cancer.
The majority of providers (63 percent) were not concerned about substance abuse in children who receive medical marijuana. Their greatest concern was absence of standards around prescribing medical marijuana to children with cancer.
"In addition to unclear dosage guidelines, the lack of high quality scientific data that medical marijuana benefits outweigh possible harm is a huge concern for providers accustomed to evidence-based practice," said Michelson. "We need rigorously designed clinical trials on the use of medical marijuana in children with cancer."
https://www.sciencedaily.com/releases/2017/12/171212091039.htm
Marijuana derivative reduces seizures in people with treatment-resistant epilepsy
New open-label trial of prescription cannabidiol shows overall safety, efficacy
December 23, 2015
Science Daily/NYU Langone Medical Center / New York University School of Medicine
Cannabidiol (CBD), a medical marijuana derivative, was effective in reducing seizure frequency and well-tolerated and safe for most children and young adults enrolled in a year-long study led by epilepsy specialists at NYU Langone Medical Center.
These latest findings provide the first estimates of safety, tolerability and efficacy of prescription CBD in children and adults with severe, highly treatment-resistant epilepsy. Led by Orrin Devinsky, MD, professor of neurology, neurosurgery, and psychiatry and director of the Comprehensive Epilepsy Center at NYU Langone, the study is published in the December 23 issue of Lancet Neurology. While early findings have been released at medical meetings -- including the 2015 American Academy of Neurology conference -- these are the first findings from the trial to be published in a peer-reviewed journal.
The study took place at 11 epilepsy centers across the country. Patients were given the oral CBD treatment Epidiolex over a 12-week treatment period. Results showed a median 36.5 percent reduction in monthly motor seizures, with the median monthly frequency of motor seizures falling from 30 motor seizures a month at the study's start to 15.8 over the 12 weeks. Equally important, CBD was shown to have a sufficient safety profile and was well-tolerated by many patients, despite some isolated adverse events.
"We are very encouraged by our trial results showing that CBD was safe and well-tolerated for most patients, and that seizures dropped significantly," says Devinsky. "But before we raise hopes for families who regularly deal with the devastation of treatment-resistant epilepsy, more research, including further studies through our ongoing randomized controlled trial, are needed to definitively recommend CBD as a treatment to patients with uncontrolled seizures."
How the Research Was Conducted
The study was an open-labeled trial, meaning that both the researchers and participants' families knew they were receiving CBD, a compound in medical marijuana that does not contain psychoactive properties. Between January 15, 2014, and January 15, 2015, 214 patients between 1 and 30 years of age with intractable, or treatment-resistant, epilepsy were enrolled in the trial. Of that cohort, 162 (76 percent) had at least 12 weeks of follow-up after the first dose of CBD and were included in the safety and tolerability analysis. In addition, 137 of the original study cohort (64 percent) were included in the analysis to determine the drug's efficacy.
Patients were given an oral CBD regimen from 2-5 mg/kg per day, with a dose up-titrated until intolerance occurred or to a maximum dose of 25 mg/kg or 50 mg/kg per day, depending on the trial site. Seizures were recorded by parents or caregivers in diaries and reviewed by the study team at each visit.
Lab screenings also were conducted at baseline, and after 4, 8 and 12 weeks of CBD treatment. The study showed variability in responses of individual seizure types to cannabidiol treatment. For example, the median change in total seizures was 34.6 percent , with the greatest reduction occurring in patients with focal and atonic seizures followed by tonic or tonic-clonic seizures. Two patients were free of all seizure types over the entire 12 weeks.
Adverse events were reported among participants, including drowsiness, decreased appetite, diarrhea, fatigue and convulsion. Most were mild to moderate and transient, but 20 patients had serious adverse events related to CBD use -most commonly status epilepticus, or seizures that last too long or too close together. Five patients had to discontinue treatment due to these adverse events.
Devinsky is currently leading a randomized, controlled trial -- considered the gold standard of scientific research -in which CBD or a placebo is randomly assigned to patients to better tease out the drug's effects and better eliminate research bias.
"I empathize with parents who are looking for answers and will try anything to help their children suffering the devastating effects of intractable epilepsy. But we must let the science, and not anecdotal success stories and high media interest, lead this national discussion," cautions Devinsky. "Taking CBD in a controlled medical setting is vastly different from going to a state where medical marijuana is legal and experimenting with dosing and CBD strains."
https://www.sciencedaily.com/releases/2015/12/151223221532.htm
Medical marijuana for children with developmental and behavioral disorders?
February 5, 2015
Science Daily/Wolters Kluwer Health: Lippincott Williams and Wilkins
As medical marijuana becomes increasingly accepted, there is growing interest in its use for children and adolescents with developmental and behavioral problems such as autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD), according to a review in the February Journal of Developmental & Behavioral Pediatrics, the official journal of the Society for Developmental and Behavioral Pediatrics.
That's despite a lack of studies showing any clinical benefit of cannabis for young patients with these disorders -- whereas evidence strongly suggests harmful effects of regular marijuana use in the developing brain. Scott Hadland, MD, MPH, John R. Knight, MD, and Sion Kim Harris, PhD of Boston Children's Hospital write, "Given the current scarcity of data, cannabis cannot be safely recommended for the treatment of developmental or behavioral disorders at this time."
"Children with severe ASD cannot communicate verbally and may relate to the world through loud, repetitive shrieking and hand-flapping that is very disruptive to their families and all those around them," comments Dr Knight, the study's senior author. "So my heart goes out to families who are searching for something, anything to help their child," he continues. "But in using medicinal marijuana they may be trading away their child's future for short-term symptom control."
Known Harmful Effects of Marijuana in Children and Teens...
The review was prompted by rapid changes in US marijuana policy, with marijuana being permitted for medical use in many jurisdictions and legalized in others. "Amidst this political change, patients and families are increasingly asking whether cannabis and its derivatives may have therapeutic utility for a number of conditions, including developmental and behavioral disorders in children and adolescents," according to Dr Knight and colleagues.
They review the important pharmacological properties of cannabis and related compounds, along with data on marijuana use in the population. Adolescents with developmental and behavioral disorders -- especially ADHD -- may be predisposed to early and heavier substance use. Meanwhile, a growing body of evidence links cannabis to "long-term and potentially irreversible physical, neurocognitive, psychiatric, and psychosocial adverse outcomes."
Over time, regular cannabis use by adolescents has been linked to persistent declines in intelligence quotient and increased risk of addiction, major depression, anxiety disorders, and psychotic thinking. The adolescent brain may be uniquely susceptible to the harmful effects of marijuana, reflecting the role of the cannabinoid receptors in normal neurodevelopment. Brain abnormalities in adults who are heavy marijuana users may have their origin in neurodevelopmental changes starting in adolescence.
...With Little Data on Benefits in Developmental or Behavioral Disorders
While cannabis has been proposed to have a broad range of clinical benefits in adults, "At this time, good evidence is almost entirely lacking for its application in pediatric developmental and behavioral conditions," Dr Knight and coauthors write.
"The scant research that we have on adolescent use is alarming enough," says Leonard Rappaport MD, MS, Chief of the Division of Developmental Medicine at Boston Children's Hospital and past president of the Society for Developmental and Behavioral Pediatrics. "But we are really moving into entirely new territory when we consider giving cannabis to children as that has not even been done in neurotypical children, let alone those with developmental or behavioral problems."
And yet, a number of online groups are advocating the use of "medical marijuana" for children with autism, ADHD, and other developmental and behavioral conditions. These groups often cite evidence from animal research, or from a small number of clinical reports, to claim beneficial effects of cannabis in children. Those beneficial effects are likely from cannabidiols, which also benefit children with uncommon forms of epilepsy and have limited euphoric effects; rather than tetrahydrocannabinol (THC), with its strong euphoric and neurotoxic effects.
This movement, coupled with the increased willingness of physicians to prescribe cannabis, "may result in issuing of medical marijuana permits for developmental or behavioral diagnoses for which no data on efficacy, safety, or tolerability exist," the researchers write. They note that if and when studies of cannabis for developmental and behavioral conditions are performed, they will likely use extracts formulations of known dosage -- rather than plant forms of medical marijuana, which vary widely in strength and effects. Dr Knight adds, "We need more research on cannabidiols, and development of products that are high in cannabidiols and low in THC."
Dr Knight and coauthors hope their article will draw attention to the potential harmful effects of marijuana in young people -- as well as lack of evidence on its effects in those with developmental or behavioral disorders. They conclude, "As marijuana policy evolves and as the drug becomes more readily available, it is important that practicing clinicians recognize the long-term health and neuropsychiatric consequences of regular use."
https://www.sciencedaily.com/releases/2015/02/150205122733.htm