02.03.17

The Cannabis Update: Germany legalizes for medical use while scientists in the USA analyze existing scientific evidence

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Germany joins the growing cannabis experiment  

On January 19th, Germany joined the growing list of countries who have legalized marijuana for medical purposes. The bill, which was passed unanimously by the German Parliament after being first approved by the country’s cabinet in May 2016, will come into effect March 2017. The law allows doctors to prescribe cannabis to patients with multiple sclerosis and other severe illnesses as well as to those patients for whom the substance could alleviate certain symptoms, such as nausea or chronic pain, or who may see a positive effect on their disease progression.

Up until now, only certain people with serious medical conditions could be granted permission to use the drug for self therapy, and the bar was set fairly high. Only around 1,000 people in the whole country currently have been given permission to use the drug. Personal possession of the drug remains illegal in Germany, though small quantities in possession are not usually prosecuted.

Germany will provide patients with cannabis through a state-regulated program, allowing cannabis products to be grown under state supervision. Private producers could eventually also apply, but the requirements for approval would be very strict. The idea for a state-regulated program is that it will help in ensuring the plants quality. Until they are able to launch this program and grow enough plants, the products needed for patients will be imported.

Additionally, the Federal Health Minister, Hermann Gröhe, announced that “costs of using cannabis for medicinal purposes will be met by the health insurance companies of the critically ill, if no other form of treatment is effective.” Another win for public health is that along with the legalization, Germany is also planning to launch research to study the positive effects of such therapy, the appropriate dosage of the drug, and also its side effects. For this purpose, anonymous data on patients will be transferred to the Federal Institute for Drugs and Medical Devices (BfArM).

Growing information on existing evidence 

A week before Germany legalized cannabis for medical cannabis, a new report from the National Academies of Sciences, Engineering, and Medicine was presented on the risks and benefits of cannabis use. “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research” is one of the most comprehensive studies of recent research on the health effects of recreational and therapeutic cannabis use, offering a rigorous review of relevant scientific research published since 1999. This report summarizes the current state of evidence regarding what is known about the health impacts of cannabis and cannabis-derived products, including effects related to therapeutic uses of cannabis and potential health risks related to certain cancers, diseases, mental health disorders, and injuries. More than 100 conclusions about the health effects of marijuana, including claims of both helpful and harmful effects, were evaluated by the National Academies of Sciences, Engineering and Medicine. The report is the product of 16 experts in their fields, including neurologists, oncologists, epidemiologists and child psychiatrists.

The report concludes that there is not enough research to reach conclusive judgments on whether marijuana can effectively treat most of the symptoms and diseases it is advertised as helping. However, the same is also true of many of the risks said to be associated with using cannabis.

There was only enough evidence to conclusively support treatment for three therapeutic uses, the study found: to reduce nausea and vomiting from chemotherapy, to treat chronic pain and to reduce spasms from multiple sclerosis.

The following is a list of some of the therapeutic uses analyzed with the existing scientific and medical evidence (the definitions used in the report can be accessed here):

There is conclusive or substantial evidence that cannabis or cannabinoids are effective:

  • For the treatment for chronic pain in adults (cannabis)
  • Antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids)
  • For improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids)

There is moderate evidence that cannabis or cannabinoids are effective for:

  • Improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea syndrome, bromyalgia, chronic pain, and multiple sclerosis (cannabinoids, primarily nabiximols)

There is limited evidence that cannabis or cannabinoids are effective for:

  • Increasing appetite and decreasing weight loss associated with HIV/AIDS (cannabis and oral cannabinoids)
  • Improving clinician-measured multiple sclerosis spasticity symptoms (oral cannabinoids)
  • Improving symptoms of Tourette syndrome (THC capsules)
  • Improving anxiety symptoms, as assessed by a public speaking test, in individuals with social anxiety disorders (cannabidiol)
  • Improving symptoms of post-traumatic stress disorder

There is limited evidence of a statistical association between cannabinoids and:

  • Better outcomes (i.e., mortality, disability) after a traumatic brain injury or intracranial hemorrhage

There is limited evidence that cannabis or cannabinoids are ineffective for:

  • Improving symptoms associated with dementia (cannabinoids)
  • Improving intraocular pressure associated with glaucoma (cannabinoids)
  • Reducing depressive symptoms in individuals with chronic pain or multiple sclerosis (nabiximols, dronabinol, and nabilone)

 

All signs point to the need for more research

While the paper is broad and wide-ranging, it is unlikely to end debate on any number of treatments. One researcher studying the therapeutic impacts of the cannabis compound cannabidiol on children with epilepsy said researchers’ conclusions were broadly “conservative”, and on epilepsy “wrong”.

“For science to do what it does, I think when they do a scientific review they should incorporate all the evidence that is out there for that disorder, and I don’t think they did that for epilepsy,” said Orrin Devinsky, director of New York University Langone Medical Center’s comprehensive epilepsy center. Still, he called the report “very valuable”.

However, even though there may be some controversy surrounding the report, one thing is clear: there is a need for more and better research. Among the review’s most fervent calls were for more investigation with many researchers stating that conclusive evidence about the positive and negative medical effects is hard to come by.

The report also took the unusual step of calling for private funding sources to advance marijuana research. Researchers found it “difficult to gain access to the quantity, quality, and type of cannabis product necessary”, the report said. “A diverse network of funders is needed to support cannabis and cannabinoid research.” Currently, because cannabis in the US is a Schedule I drug, research is prohibited. Only the University of Mississippi is allowed to grow research-grade marijuana, making the supply extremely limited. If we want to obtain the research to obtain conclusive evidence, it will be necessary to have bigger and more studies.

 

 

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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