All posts tagged: THC

USDA RELEASES DRAFT RULES FOR HEMP FARMING AND PRODUCTION, SETS 60- DAY WINDOW FOR PUBLIC COMMENT

By Shuki Greer, Esq.

Starting with the 2014 Farm Bill, and continuing with the 2018 Farm Bill, we have seen a dramatic shift in the landscape governing hemp. Prior to 5 years ago, hemp production was entirely illegal, as the Federal government handled industrial hemp the same as it handled high-THC marijuana. It was an established Schedule 1 controlled substance, entirely illegal to grow, harvest, or possess.

As awareness has grown, and the true benefits of the hemp plant have become more widely understood, the federal government has passed legislation to decriminalize hemp. However, although it is no longer considered a controlled substance, the questions about the process and regulatory requirements abound. This is because all plants grown in the United States are highly regulated by the United States Department of Agriculture, or the USDA, which has a complex framework of licensing, reporting, and general requirements for every specific product grown in the country.

Last week, the USDA published the draft of its regulations for the hemp industry. Since the 2018 farm bill, we have been living in the “wild west” for hemp. As promised, the USDA released its rules in time for farmers to get legal and licensed for the 2020 season. However, this long-awaited release has been met with mixed results.

Many lawmakers and industry leaders are happy that the federal government has finally put out regulations for hemp. First, they see this as a dramatic shift from the era of prohibition, alone a cause for celebration. Others see the certainty that we are going to have regulations put in place means that the industry will start to grow and develop at a much faster pace.  It is certainly true that the future is extremely bright for hemp. But other farmers and individuals have expressed concerns with some of the regulation’s details.

The “0.3% THC” limit, which delineates the difference between legal “hemp” and illegal “marijuana”, may be too stringent for some growers. They report that a mature hemp plant will have a THC content that will vary from day to day, including some spikes over the 0.3% limit. The new regulations require strict testing to be done prior to harvest, and if the resulting THC content is too high, the entire crop must be destroyed. This may cause farmers to harvest before true maturity, leading to a decrease in the potency or effectiveness of the CBD derived from such a harvest.

The regulations also allow the states to develop their own plans and submit them for approval. Some are concerned that some states may try to infringe on the interstate commerce occurring there, which could cause all kinds of problems and complications for the industry. Still others are worried that the method for disposing of “hot crops” requires just a little too much DEA involvement, which could also cause disruption or have a chilling effect on growth.

It is clear that these regulations are a good step in the right direction. It’s also clear that this is just the beginning, and there is still plenty of room for improvement. The USDA announced a 60-day window for submitting public comments, and then they will consider any suggestions, and then publish a final rule in the future. I encourage you to read the regulations or a summary of them. I encourage you to think about how you would be affected by these rules, and what suggestions you may have. Speak to an expert about how you can do your part to improve the landscape of the industry for the future.

Submit public comments here:

https://www.regulations.gov/document?D=AMS_FRDOC_0001-1919

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Benjamin Caplan, MDUSDA RELEASES DRAFT RULES FOR HEMP FARMING AND PRODUCTION, SETS 60- DAY WINDOW FOR PUBLIC COMMENT
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Could Inhaled Cannabis Be More Effective to Relieve Pain than Oral Cannabinoids?

Cannabis for Chronic Pain: Challenges and Considerations

In Summary:

Comparisons between the use of inhaled cannabis plant versus pharmaceutical-grade oral cannabinoids demonstrate an advantage of inhalation over oral delivery. Conditions for which inhalation has provided superior over oral consumption include:

HIV, diabetic neuropathy, post-herpetic neuralgia, complex regional pain syndrome, spinal cord injury, traumatic neuropathic pain, multiple sclerosis, and cervical disk disease.

An important note: patients consuming cannabinoids orally are more likely to withdraw from studies due to negative side effects and lack of efficacy. Also, edible cannabis may compete, amplify, or have effects delayed, when interacting with other ingested foods and drinks, A major advantage of inhalation is the opportunity for patients to titrate, or easily test varying dosages at home, with reasonably rapid feedback. On the other hand, dosage adjustments for oral food-borne cannabinoids are much more complex, and cannabis in the form of oral pharmaceutical-products may require a doctor visit and a new prescription.

Dr. Caplan and the #MDTake:

In the clinic, there seems to be a great divide in the population, a group of patients who simply adore the edibles (often in low-dose candies, low-dose chocolate, or titrated tinctures), and a group who use inhalation, almost exclusively. There are also some who are discovering topicals (salves, patches, lotions). There is a growing number of patients who use each of these methods with intention, related to their timing of onset and their duration of action, but this requires education, practice, and a degree of sophistication in use that is relatively new to the industry.

As with most consumption, medicinal or not, it seems common for individuals to find a method that they enjoy and stick to it. Interestingly, in recent years, the US cannabis industry has evolved in a wild growth phase. As it has embraced a dynamic landscape, with increasing competition from all sides, including new stores and product offerings popping up all the time, there seems to be a growing openness, in consumers, to trying new products and exploring new offerings. Coincidentally, this openness to change and the unfamiliar happens to mirror one of the core neurobiological functions of cannabis in the brain, as seen across the neuropsychiatric and neuroimaging cannabis literature.

How exciting to imagine a future medicine that may help consumers to be more open to change?

View this review (yellow link) or download:

This paper is also stored here:    http://bit.ly/2OmdM0S     inside the CED Foundation Archive

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Benjamin Caplan, MDCould Inhaled Cannabis Be More Effective to Relieve Pain than Oral Cannabinoids?
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Study Finds “Insufficient Evidence” to Support the Use of Medical Cannabis for Pain Management

In Summary:

In a recent review of systematic reviews and controlled studies, researchers were unable to find sufficient evidence to support the clinical use of medical cannabis or the pharmaceutical formulations for gastrointestinal, cancer, or rheumatic pain, or weight loss in cancer of AIDS. Many data from previous studies were either statistically insignificant or were of low quality. However, the authors did find that existing literature sufficiently supported the treatment of neuropathic pain with cannabis. Additional controlled studies may shed more light on the use of cannabis for general pain management. Interestingly, while the authors do raise two important limitations of the studies that they highlight in the article (inadequate size of some studies and generally limited supply of traditional scientific studies from which to draw conclusions) they do not address some of the more fundamental concerns with the reporting.

Dr. Caplan and the #MDTake:

The limitations of studies in cannabis are numerous and an important consideration for researchers as they study cannabis, and equally essentially to consider for those of us reading the study product. To my personal count, there are at least 40 different types of biases that can skew data in a way that delivers information other than a precise description of actual events. This study, as many like it, presumptuously assumes that, if data doesn’t show a trend that so-mocked “anecdotal” data shows, then surely the anecdote must be incorrect. What if the reviews are simply not yet accurately recording what human iteration has discovered repeatedly for millennia?

The conclusion the review draws follows:

Conclusion: The public perception of the efficacy, tolerability, and safety of cannabis-based medicines in pain management and palliative medicine con- flicts with the findings of systematic reviews and prospective observational studies conducted according to the standards of evidence-based medicine.

BUT…

Is the right question for science to question the validity of the stories that individuals are telling, against an imperfect science of information collection, as well as the limited scope of statistical validity for understanding data? Or is the right task for science to question its own methods of assumptions in discovery and understanding?

On the one hand, we have millions of people calling the color of the ocean “blue.” On the other hand, we have data that tells us that water, in fact, has no color. Similarly, the anecdotes from cannabis consumers are telling a story that is starkly different from the currently available data.

For those interested in combing through a close inspection of the many ways that data can be misrepresented and misunderstood, check out https://first10em.com/bias/

and/or watch the video below:

View this review (yellow link) or download:

This paper is also stored here:   http://bit.ly/34NXhQV      inside the CED Foundation Archive

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Benjamin Caplan, MDStudy Finds “Insufficient Evidence” to Support the Use of Medical Cannabis for Pain Management
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Is Sativex absorbed in the mouth or gut? To eat or not to eat beforehand?

Article Title: A meta-opinion: cannabinoids delivered to oral mucosa by a spray for systemic absorption are rather ingested into gastro-intestinal tract: the influences of fed/fasting states.

Sativex® spray is made of a 1:1 ratio of THC and CBD. It is marketed for use in the treatment of spasticity in patients with Multiple Sclerosis and is absorbed into the bloodstream through the oral mucosa. This absorption has the benefit of rapid absorption, as it avoids the slow process of digestion which is the typical path of absorption for edibles. This meta-opinion (expert opinion) review argues that Sativex is actually washed down by our saliva and digested through our gastrointestinal tract very much like edibles, and NOT merely absorbed in the mouth via oral mucosa, as the producers suggest. The authors reviewed several research studies which have found that the concentrations of THC and CBD in the body, following administration of Sativex differed if a patient had a meal or not beforehand. This would suggest that Sativex is indeed absorbed in the gastrointestinal tract, rather than merely through the oral mucosa.

How this matters to consumers:

Toward a goal of reproducible dosing and effects, consumers would do well to understand the effects of various methods of absorption. Specifically, it is helpful to know that the effect of Sativex may be delayed if it follows a meal.

View this review (yellow link) or download:

This paper is also stored here:    http://bit.ly/2MNjQ2u     inside the CED Foundation Archive

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Benjamin Caplan, MDIs Sativex absorbed in the mouth or gut? To eat or not to eat beforehand?
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Case Studies Reveal Difficulties in Differences between State Cannabis Laws

Crossing the Line: Care of a Pediatric Patient with Intractable Seizures and Severe Neuropathic Pain in Absence of Access to Medical Marijuana

A recent case report discussing a six-year-old patient suffering from a seizure disorder has exposed the difficulty is receiving treatment across state lines. The patient was prescribed medical marijuana that alleviated the severity and duration of her seizures but was weaned off of that medication when traveling to Nebraska for a therapeutic surgery, due to the legal status in the state. This case study exposes the difficulty of treating patients across the country due to the legal variability of cannabis across states.  

Author’s summary reflections:

“The current state-specific approach to medical marijuana notably burdens patients, families, and health care systems with a fragmented approach to symptom management based on local context. The stigmatization or legal implications of medical marijuana in certain settings may lead well-meaning providers to avoid asking about use or to struggle with appropriate response. Provider response to parents reporting medical marijuana use in Schedule I settings notably varies from direct inquiry, feigned ignorance, or informed ignoring. Ideally, providers would compassionately and competently inquire about pharmaceutical and nonpharmaceutical interventions (to include medical marijuana use) as part of comprehensive palliative care symptom assessments.”

View this review (yellow link) or download:

This paper is also stored here:     http://bit.ly/2IxPoWN    inside the CED Foundation Archive

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Benjamin Caplan, MDCase Studies Reveal Difficulties in Differences between State Cannabis Laws
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Video: 4 major risks of recreational cannabis use

Though cannabis has many medical benefits, using the drug without professional guidance can cause serious harm. Watch this video to learn about 4 major risks associated with recreational cannabis use

Benjamin Caplan, MDVideo: 4 major risks of recreational cannabis use
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Flavonoids as Pain Relief

Forget CBD; flavonoids found in cannabis have been found to be 30 times more effective painkillers than aspirin, targeting inflammation at the source and making them great alternatives for pain killers. If produced on a larger scale, they could help get away from the opioid crisis.

http://bit.ly/2TbAxoG

Here, a folder w/ hundreds more specific reviews of the medical benefits of flavonoids: http://bit.ly/2XugfvI

Benjamin Caplan, MDFlavonoids as Pain Relief
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