Cannabis-Based Drug is Priced at $32,500

GW Pharmaceuticals PLC said  it plans to charge about $32,500 per patient annually in the U. S.

for its new treatment for rare forms of epilepsy, the first prescription drug derived from the marijuana plant.

The U. S. Food and Drug Administration approved Epidiolex, also known as cannabidiol, in June to

reduce seizures associated with forms of epilepsy known as Lennox-Gastaut syndrome and Davet syndrome, in patients 2 years of age and older.

GW Pharmaceuticals, based in the UK, makes cannabidiol from a proprietary strain of cannabis designed to maximize a therapeutic component while minimizing components that produce euphoria or a high.

Chief Executive Justin Gover said in an interview Wednesday that the company set the price to be in line with other brand-name epilepsy drugs, such as Lundbeck AS\’s Onfi.  He noted that the FDA designated the product as \”orphan drug\”, meaning it treats rare conditions, and that some other orphan drugs carry higher prices. . . .

Out of pocket costs for patients taking Epidiolex could range from $5 to $10 a month for those in state Medicaid programs to as high as $200 a month for some private insurance plans. . . . Uninsured patients may qualify for receiving the drug free.

Jacqueline French, chief scientific officer of the Epilepsy Foundation, said there are low-cost generic epilepsy drugs on the market, but many patients with rare forms of the disease have tried them and the drugs didn\’t help much.

Dr. French said Epidiolex improved symptoms for many children in clinical trials, and she is happy the price isn\’t significantly higher.

The company expects to make the drug available after the U. S. Drug Enforcement Agency assigns it a controlled substance classification, a decision expected by late September.  GW Pharmaceuticals will distribute the drug through specialty pharmacies that ship directly to patients and caregivers.

Wall Street Journal, Aug. 9, 2018 – Business & Finance

https://www.wsj.com/news/business

Myanmar\’s meth crisis reaches as far as Australia

July 2018

In Myanmar, the more conflict there is, the more drug production you\’ll find.

And the trade has brought together unlikely friendships.

Last year, Myanmar soldiers drove 700,000 Rohingya from their homes in Rakhine state, often burning their villages to the ground. Now, some of the same soldiers are reportedly working with poverty-stricken refugees trafficking drugs.

The unlikely partnership speaks to the breadth of Myanmar\’s drug crisis, with even a monk arrested last year in Rakhine State carrying 400,000 meth pills.

\”No walk of life is untouched by the drug problem\” says Troels Vester, UNODC Myanmar country director.

From jungle meth labs to Australia\’s streets

Myanmar is the second largest producer of opium in the world, after Afghanistan. It\’s also one of the largest producers of methamphetamine and much of it is making its way to Australian streets.

It doesn\’t take much to produce \”yaba\” – small red pills made from meth and caffeine – just a small kitchen and a few chemicals.

Mobile labs can easily pack up and run, which Myanmar authorities say makes it difficult to track down labs.

\”Myanmar can\’t produce chemicals, but we are situated between China and India which are the biggest producers,\” explains Police Colonel Zaw Lin Tun.

For complete story http://www.abc.net.au/news/2018-07-29/myanmars-meth-crisis-reaches-australia/10044502

Perinatal Marijuana Use and the Developing Child

Lauren M. Jansson, MD¹; Chloe J. Jordan, PhD²; Martha L. Velez, MD¹

JAMA. Published online July 16, 2018. doi:10.1001/jama.2018.8401

Increasing public attention has recently been paid to the opioid epidemic and attendant effects on prenatally exposed infants and children.¹ Current literature has emerged proposing marijuana as a safe alternative to opioids in addressing pain² and cannabis legalization as a way to decrease opioid fatalities.³ As a result, perceptions of cannabis safety have increased, and the prevalence of marijuana use among pregnant women has expanded; past-month cannabis use among pregnant US women increased from 2.4% to 3.9% between 2002 and 2014.⁴ Further, cannabis potency has been substantially increasing over the past 4 decades in the United States, and will likely continue to do so as extraction procedures of active components improve.

Although cannabis does have known medical utility for some conditions, its associated acute and long-term psychoactive effects on brain function are also known. Expanding use of cannabis among pregnant and lactating women (as likely will occur with legalization) may lead to increased risk from fetal and child exposures if the teratogenic potential of cannabis remains underappreciated …The exogenous supply of cannabinoids resulting from THC exposure can adversely affect fetal growth as well as structural and functional neurodevelopment.⁶

Prenatal THC exposure has been documented to adversely affect infant neurobehavior and child development up through the teen years,⁵ and postnatal exposures may compound prenatally acquired deficits. Neurobehavioral effects associated with prenatal THC exposure range from dysregulated arousal and motor difficulties at birth to disturbed sleep, memory impairment, aggression, and other developmental and behavioral concerns in childhood.⁵

Despite these risks, it appears that clinicians are not addressing cannabis use during pregnancy or lactation; in one study of 74 lactation professionals, 85% encouraged breastfeeding among marijuana-using mothers.⁷ Most national breastfeeding guidelines (eg, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists) have remained steadfast in recommending against cannabis use during lactation….

The medical community should advise pregnant women to avoid perinatal THC exposure and intervene for women needing treatment, for children at risk for neurobiological and developmental problems, or for dyads at risk for negative outcomes associated with an untreated substance use disorder. Advice from medical professionals should be consistent: pregnant and lactating women should be advised to avoid cannabis use, and women (and men) caring for developing children also should be advised to maintain abstinence. Treatment programs for women with CUD should be available and accessible, and gender and culturally specific, particularly during pregnancy and postpartum periods. Converging, systematic research is necessary at both the preclinical and clinical levels to address insufficient evidence regarding maternal cannabis use⁹ and to fully understand the short- and long-term effects of perinatal THC exposure, the effects of maternal cannabis use on fetal outcomes, and the consequences of polysubstance use in treatment and intervention efforts.

For complete article and download PDF, go to https://jamanetwork.com/journals/jama/fullarticle/2688303?utm_source=twitter&utm_campaign=content-shareicons&utm_content=article_engagement&utm_medium=social&utm_term=071818#.W087qx1cBWE.twitter

The following graphs make plane the 12-fold variation in the published rate of gastroschisis across Canada, taken directly from the attached major review by the Canadian Government (see Table B7.2A/B on page 115)!!!!

Congenital anomalies – Canada

Naturally these crude rates do not adjust for maternal age which is also known to be important.

However it is noteworthy that all 9 provinces for which data exists do not intersect the confidence intervals for Nunavut!!!!

I think these trends are very striking and very noteworthy, and also very consistent with what is seen in other places internationally.

Cannabis harmful to fish embryos, University of Alberta study finds

StarMetro Edmonton, Canada   July 2018

EDMONTON–An Edmonton researcher says people who are pregnant should take precautions with cannabis, after a study showed the plant’s compounds have harmful effects on developing zebrafish embryos.

The study led by Declan Ali, a professor in the University of Alberta’s biological sciences department, exposed fish embryos to tetrahydrocannabinol (THC) and cannabidiol (CBD), which are the main chemicals in cannabis that affect cell receptors in the brain and body. For more https://www.thestar.com/edmonton/2018/07/12/cannabis-harmful-to-fish-embryos-university-of-alberta-study-finds.html

THC exposure of human iPSC neurons impacts genes associated with neuropsychiatric disorders

Translational Psychiatry volume 8, Article number: 89 (2018)

Abstract

There is a strong association between cannabis use and schizophrenia but the underlying cellular links are poorly understood. Neurons derived from human-induced pluripotent stem cells (hiPSCs) offer a platform for investigating both baseline and dynamic changes in human neural cells. Here, we exposed neurons derived from hiPSCs to Δ9-tetrahydrocannabinol (THC), and identified diagnosis-specific differences not detectable in vehicle-controls. RNA transcriptomic analyses revealed that THC administration, either by acute or chronic exposure, dampened the neuronal transcriptional response following potassium chloride (KCl)-induced neuronal depolarization. THC-treated neurons displayed significant synaptic, mitochondrial, and glutamate signaling alterations that may underlie their failure to activate appropriately; this blunted response resembles effects previously observed in schizophrenia hiPSC- derived neurons. Furthermore, we show a significant alteration in THC-related genes associated with autism and intellectual disability, suggesting shared molecular pathways perturbed in neuropsychiatric disorders that are exacerbated by THC.

In summary, we found significant associations of THC- related pathways to autism and intellectual disability. Furthermore, we have used a dynamic, human-relevant system to demonstrate a phenotypic link between THC treatment and schizophrenia. We hypothesize that THC exposure, by impacting many of the same synaptic and epigenetic pathways already associated with psychiatric disorders, may serve as an additive risk to existing genetic/ epigenetic risk factors.

For complete paper go to https://www.nature.com/articles/s41398-018-0137-3