The Trusted Source For Health
The latest coronavirus surge sweeping the United States, considerably of it driven by the extremely contagious Omicron variant, has manufactured a worrisome increase in hospitalizations amid young children, not to mention heightened stress and anxiety amid mother and father nationwide. Many states have noted increases …
Alemeno is an Artificial Intelligence (AI)-pushed platform that makes use of “gamification’ to inspire small children to eat healthy food stuff. Alemeno’s co-founders Deepak Gaikwad and Shubham Jain say they are on a mission to create a generation of wholesome youngsters and make mealtimes wholesome …
Epileptic seizure frequency fell by an average of 86{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} among 10 children treated with whole-plant medicinal cannabis, even though none of the children had responded to other conventional treatments, and some had failed to respond to a cannabidiol (CBD) product that is licensed for their condition. Findings from the case study have prompted the U.K.-based researchers to call for further exploration of the potential therapeutic benefits of whole-plant medicinal cannabis products.
Rayyan Zafar, PhD, at the Centre for Psychedelic Research and Neuropsychopharmacology, department of brain sciences, Imperial College London, and colleagues reported on their clinical study in BMJ Paediatrics Open, in a paper titled, “Medical cannabis for severe treatment-resistant epilepsy in children: a case-series of 10 patients,” in which they concluded, “This study establishes the feasibility of whole-plant medical cannabis as an effective and well-tolerated medicine for reducing seizure frequency in children suffering with intractable epilepsies.” Zafar, together with Imperial co-authors Anne Schlag, David J Nutt, and Lawrence Phillips, at the London School of Economics and Political Science, list their affiliation with DrugScience, which was founded by professor Nutt in 2010.
Whole-plant cannabis includes tetrahydrocannabinol (THC), which is the main psychoactive compound that is responsible for the characteristic “high” associated with recreational cannabis use. The plant also contains cannabidiol, other neuroactive cannabinoids, and molecules such as terpenes. Substantial anecdotal evidence as to the value of medicinal cannabis for treating childhood epilepsies has been accumulating since the 1800s, the authors wrote. However, they further explained, both recreational and medical cannabis were made illegal in the U.K. under the Misuse of Drugs Act 1971, so cannabis research largely ceased.
However, prompted by parents whose children had responded well to whole-plant medicinal cannabis extracts, but not to conventional antiepileptic drugs or purified cannabidiol (CBD oil), medicinal (whole plant) cannabis was designated a prescription medicine for the treatment of severe childhood epilepsy in 2018. “Led by parents whose children had responded well to whole-plant medical cannabis extracts but who had failed on conventional antiepileptic drugs (AEDs) and purified cannabidiol (Epidiolex), medical cannabis was re-initiated as a medicine in the British pharmacopeia in 2018,” the authors wrote.
Doctors in the U.K. have been extremely reluctant to prescribe whole-plant medicinal cannabis extracts to children with severe epilepsy, largely because of the lack of confirmatory clinical trial data, the team noted. “Despite the change in legal status of medical cannabis, most of these children have not benefited as to date there has been only three National Health Service (NHS) CBMPs [cannabis-based medicinal products] prescriptions made in total and only two in children,” the team noted. One of the reasons for resistance that is most argued by clinicians who might be prescribers, is the lack of evidence for efficacy of medical cannabis. “By this they usually mean that there are no randomized controlled trials (RCTs) that prove efficacy and without these they are not prepared to prescribe,” the authors wrote. However, they continued, it is generally accepted that RCTs are not the only way of generating evidence to the value of treatments.
The U.K.’s National Institute for Health and Clinical Excellence (NICE), which provides guidance on which treatments and therapies the health service in England should adopt, did recently put out a position statement accepting that real-world data, including case series, are valid sources of evidence, particularly where it’s difficult to carry out clinical trials—in children, for example. Zafar’s team suggested that patient case-series studies with before and after outcome measures, are, in fact “… particularly useful for conditions where RCTs are unlikely or impossible to perform in examples of rare and idiopathic conditions and especially in paediatric medicine.”
In light of NICE acceptance of case studies as valid evidence, the researchers carried out a study to evaluate the use of whole-plant medicinal cannabis in 10 children whose severe epilepsy hadn’t responded to conventional treatment, including two who hadn’t responded to the only pharmaceutical grade, purified CBD oil licensed for the condition in children (Epidyolex). The team wanted to assess the percentage change in monthly seizure frequency and the impact of medicinal cannabis on changes in conventional AED use. They also wanted to report the strengths and doses used and the costs incurred.
All the participants were recruited from two charities representing children using medicinal cannabis to treat their severe epilepsy. The children’s average age was 6 years, but ranged from 1–13 years. They had a range of epilepsies and three had other concurrent issues, including infantile spasms, learning disabilities, and global developmental delay. Data were collected from their parents or carers via phone or video conference calls between January and May 2021. All the participants received whole-plant extract cannabis-based medicinal products either through private prescription, or through the NHS. “The CBMPs used included Bedrolite (<1{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} THC and 9{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} CBD), Bedica (14{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} THC and <1{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} CBD), Celixir 20 (<1{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} THC and 20{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} CBD), Sweet Pink CBD (<1{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} THC and 10.6{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} CBD), and Althea 100 (<1{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} THC and 10{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d} CBD),” the team wrote.
The children had tried an average of seven conventional epilepsy drugs. After starting to take medicinal cannabis, this fell to an average of one each, with seven of the children stopping them completely. Monthly seizure frequency reduced for all 10 children by an overall average of 86{b574a629d83ad7698d9c0ca2d3a10ad895e8e51aa97c347fc42e9508f0e4325d}. The researchers say that full chemical analysis of the whole-plant medicinal cannabis products used is ongoing, but they were able to assess the THC and CBD content. This showed that the children took an average of 5.15 mg THC and 171.8 mg CBD every day.
Parents and carers reported significant improvements in the health and wellbeing of their children, including in sleep, eating, behavior, and cognition after they started to take whole-plant medicinal cannabis products. “Our patient group almost universally reported highly improved cognitive and behavioral outcomes, likely due both to reduced seizure frequency and reduced use of other AEDs,” the researchers noted. They further stressed that the results “ … suggest that whole-plant medical cannabis products are superior to isolated CBD products in the patients examined.” Moreover, only a few minor side effects, such as tiredness, were reported. The average monthly cost of the medicinal cannabis products was £874. One child had obtained their prescription for free on the NHS.
The authors acknowledged limitations to their study, in that it was observational and involved a small number of participants. They also noted that the trial was retrospective and relied on parental recall, with no comparator group. So it’s possible that only those parents in whom medicinal cannabis worked well decided to take part.
The investigators further commented that additional research will be required to define the mechanisms by which the respective additive constituents of whole-plant products lead to improved clinical results. And this must include comparing the unwanted effects of whole-plant medicinal cannabis with the known harmful effects of conventional epilepsy medicines, they said. Despite the trial limitations, the researchers concluded, “Our findings are in line with several observational and controlled interventional studies that have seen significant reductions in seizure frequency following treatment with medical cannabis …”
The authors pointed out that two of the children in their sample had failed on Epidyolex. And for this reason, they said, “NICE guidance has recently been updated to clarify that this should not deter clinicians from prescribing off-license medical cannabis products such as the whole-plant cannabis medicines of which our data support for such prescribing.”
They further stated, “We believe that our data on whole-plant medical cannabis in childhood-onset severe treatment-resistant epilepsy provides evidence to support its introduction into the NHS within current NICE prescribing guidelines … Such a move would be hugely beneficial to the families, who in addition to having the psychological distress of looking after their chronically ill children, have also to cover the crippling financial burden of their medication.”
Texas is leading the nation with more than one million children living without health insurance, according to the Texas Medical Association. One East Texas nonprofit is working to challenge those rates as they try to reach as many parents as possible. The Children’s Defense Fund …
1. Park, J. Y. & Wu, L. T. Prevalence, reasons, perceived effects, and correlates of medical marijuana use: A review. Drug. Alcohol. Depend. 177, 1–13. https://doi.org/10.1016/j.drugalcdep.2017.03.009 (2017). Article PubMed PubMed Central Google Scholar 2. Epidyolex|European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/epidyolex (2021). 3. Anwar, A., Saleem, S., Patel, …
North Carolina contracts with several psychiatric residential treatment facilities to take in kids, many in foster care, who have severe mental health and behavioral problems. These facilities are supposed to provide treatment. Often, kids leave with more trauma because of the physical and sexual abuse they receive, according to an investigation by the USA Today Network.
Fred Clasen-Kelly, the lead reporter for the series, spoke to WFAE’s Lisa Worf about the facilities and the investigation’s findings.
Fred Clasen-Kelly: These places often hire folks with very few qualifications to look after kids. They are not highly paid. The places are often understaffed and too often when a child acts out. We are seeing places use both physical restraints and chemical restraints. In other words, they’re giving kids shots to sedate them.
And what we see over and over in state records and in interviews with kids is that kids will get choked, kids will have bones broken, kids will be bruised. They will have elbows and shoulders sprained as workers try to bring them under control and there are definitely some cases that are just gross, including, the report that a 15-year-old boy was repeatedly punched in the face by a worker and ended up with a broken eye socket and was not taken to the hospital for four days.
“What we see over and over in state records and in interviews with kids is that kids will get choked, kids will have bones broken, kids will be bruised.”
— Fred Clasen-Kelly
Worf: Why does the state continue to send children to these places when they’ve racked up violations like this?
Clasen-Kelly: That is a great question. I’m not sure, even after writing these six stories, that we’ve been given a good answer to that question. I do think one of the ways to avoid sending kids to these places is to commit to spending money early on, to doing early interventions in families where there might be abuse and neglect.
But North Carolina historically has been unwilling to spend the money to provide those services early, and so the state ends up paying a much heavier price later on because these facilities are not cheap. I mean, the state spends $100 million a year on them but doesn’t actually know if they work because the state doesn’t do full tracking. And if advocates were on here, they would point out that building up community services where kids can receive services while they’re at home is actually cheaper and research shows is more effective.
Literally, that is a point the state does not disagree with. They agree that that’s the best way to do things and their own reports going back more than a decade say that’s the best way to do things. There just hasn’t been any action taken to turn things around.
Worf: So, what does it look like in Mecklenburg County as far as some of these referrals?
Clasen-Kelly: It’s a rough picture. When a child comes into foster care in Mecklenburg County, there’s a scramble to find a place for these kids to go. And so a scenario we heard from multiple advocates and others is: Child comes into the DSS office on a Friday night, and the caseworker has to figure out where to put them. There is literally no place to put them. And so, kids end up sleeping in government offices, hospitals, motel rooms until something opens up.
Worf: As far as foster children being referred to some of these centers who don’t need any treatment, who just need a bed: How many of those children are we talking about?
Clasen-Kelly: Don’t know. What I do know is that a multitude of advocates say that in Mecklenburg and counties across North Carolina, it’s an open secret that kids are being placed in facilities without a medical justification.
“It’s a rough picture. When a child comes into foster care in Mecklenburg County, there’s a scramble to find a place for these kids to go.”
— Fred Clasen-Kelly
Worf: And now, the state disputes that they are placing mentally healthy kids in these homes.
Clasen-Kelly: Well, the state can say they look for appropriate placements but that clinicians can disagree on cases. That’s what they told us.
Worf: Now, your reporting also looked at some solutions to what could happen in this case. What did you find?
Clasen-Kelly: There are places like New Jersey and like Milwaukee that have greatly reduced the use of these psychiatric centers and where there’s a belief that they’re not effective and in some cases really harming children. And so, they put money into early intervention. They put money into mentoring and tutoring and more supports for adoptive parents and foster families.
I guess one thing I want to just go back to your question about why hasn’t it happened. I just think a lot of these kids come from very, very poor families, and a lot of these kids are Black and brown. And so, I do not think their fates have mattered a whole lot, so I do not think there’s this powerful political constituency standing up for them in Raleigh, and I don’t think that there is an awareness on the part of the public that they’re suffering. And in many ways, even when we bring our series forward, there will be people who still avert their eyes and just sort of move on with their lives because it’s easier to not think about them.
” I don’t think that there is an awareness on the part of the public that they’re suffering.”
— Fred Clasen-Kelly
WFAE reached out to the North Carolina Department of Health and Human Services and the Mecklenburg County Department of Social Services about the series. The county DSS office says it’s “not responsible for licensing or monitoring facilities that house children with behavioral health concerns.” It says the state needs to address any concerns about the facilities.
The state DHHS says it will not tolerate “gross abuses” such as those reported in the series, and that it’s taken a range of actions against the facilities mentioned in the reports, including suspending licenses.
“The state and the nation must do better by children experiencing a behavioral health crisis,” the state department said in its response. “North Carolina, like the country, is facing a behavioral health crisis that has been decades in the making and has only worsened during the pandemic.”
The statement says there are multiple compounding factors such as limited access to preventive services and underinvestment in community services.