Here’s an argument for the need for accountability in #cannabisindustry. What is sold ought to be closer to what is advertised. Is government regulation the solution? 3rd party transparency? Individual accountability? Court of public opinion?
Kudos @abbierosner for this moving piece in CBD Today, “SENIORS, CBD, AND THE LAWS OF ATTRACTION” The article reviews an evolving #CBD playing field, the fears, the market, and a few sprinkled quotes by Dr Laurie Vollen, @JamiePaz, and me!
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
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.
Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents
As of 2016, upwards of 60 clinical trials relating to the use of medical cannabis were in progress. The scope of clinical trials included conditions such as anxiety, cocaine dependence, infantile spasms, schizophrenia, solid tumor, and many more. The status of cannabis as a Schedule I drug, under the Controlled Substance Act, limits researchers’ ability to freely collect data if they require support from NIH funding. While there are opportunities for researchers to study cannabis and its derivatives with the support of private funds, this typically risks an appearance of sacrificed scientific integrity and independence. Very few private entities would condone research which might shed an unfavorable light on their products. On the other hand, current NIH-funded research requires the use of the national supply of cannabis, a crop well-known to be very limited in quality. Increasingly, more states have been legalizing the medical and recreational use of cannabis in recent years, allowing scientists with more opportunities for private funding in which to shed more light on the vast medicinal benefits of cannabis. Animal models and human trials have pointed toward clinical applications of medical cannabis including anxiety, nausea, seizures, and inflammation, although the array of competing and synergistic compounds within the plant seem to continually open new doors to relief from a large array of illnesses.
Although results from many bench-scientific and preclinical animal trials support the use of medical cannabis for pain management, there is not yet an equal body of evidence in human clinical trials. However, this is, in part, due to the fact that, despite millennia of accounts supporting the use of cannabis to treat a large number of medical concerns, in the shorter history of cannabis research, the number of controlled, double-blind, placebo studies are limited, and to some points of view, may not even be possible. Additionally, in an era where increasingly more patients request cannabis therapy from their clinicians, health professionals are catastrophically undereducated on the topic. Furthermore, given the status of the modern opioid crisis, there is a growing need for alternative pain management strategies: states with medical marijuana laws experience significantly fewer opioid-related deaths than states lacking them. Additional research could reduce these deaths further and provide viable alternatives for patients seeking pain management when other therapies have failed.
Below are interesting clippings from this article, points that are either described eloquently or bring a welcome addition to the ongoing discussion:
Benjamin Caplan, MDInforming Doctors and Patients on Cannabis Use for Pain
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.“
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/
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.
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.”