The Critical Need for FDA Approved Cannabis Clinical Research


The following is in response to a reply of my LinkedIn post of January 24, 2018 in which I shared the Washington Post article, “Study: Legal marijuana could generate more than $132 billion in federal tax revenue and 1 million jobs.”

A healthcare industry colleague working in pharma (for a top opioid manufacturer) responded with a comment to my post that there is a lack of information on medical cannabis to guide physicians. There are a number of U.S. – based and international studies of the benefits of botanical cannabis but yes, there is a tremendous void of the gold standard FDA approved clinical studies. This is the catch-22 of medical cannabis. The DEA Schedule 1 classification of cannabis makes it extremely difficult to obtain and support clinical studies. It’s time to change the classification of cannabis.

Medical cannabis has been found to have tremendous benefits as a pain analgesic; increases appetite and decreases weight loss in people with HIV/AIDS and undergoing cancer treatment; relieves symptoms of PTSD; relieves anxiety; has efficacy as sleep aid and substantially decreases – even eliminates seizures (the CNN piece of Charlotte’s Web strain put the efficacy of medical cannabis on the map for many). When I share my professional focus, most people now respond with some sort of personal story instead of the old side eye snicker. A 2016 Gallup Poll reported 64% of Americans think that “marijuana use should be legalized”.

Per a 2017 Science Magazine article, continued Schedule 1 classification by DEA is one of the biggest issues creating hurdles to clinical study – it creates extra paperwork, expenses, and delays for researchers. Another obstacle acknowledged in the article is the limited supply of cannabis for U.S. researchers, who have only one option for getting the drug: a government-run farm at the University of Mississippi in Oxford, MS. The variety and lack of standardization of potency of products available lag behind what patients can obtain at state-legalized dispensaries, the report notes. Federally grown cannabis is sometimes harvested and then stored in a freezer for years, potentially diminishing its quality.

There are cannabis physicians, providers and cannabis industry experts who are very well versed in “appropriate/safe formulations”. In my home state of Maryland, it’s illegal for cannabis providers to share specific ratios of CBD and THC with their patients. If they do, they’re illegally prescribing. It’s up to the dispensary agent (minimum of 21 years of age and without regulated education requirements other than a high school degree) to follow up on a provider’s recommendation with the cannabis patient on what they need. As one might think, there are some inconsistencies in the quality of the relayed information.

There are indeed some side effects which are relatively mild and there is the possibility of some patient’s developing cannabis dependence syndrome and associated psychosis but this pales, just pales in comparison the Centers for Disease Control report that fifty-three thousand Americans died from opioid overdoses in 2016.

We’re certainly on our way to recognizing the uses of this “new” medicine which has a 10,000 year old history. Just about every day, there’s news of cannabis regulation reform across the country but until cannabis is moved from Schedule 1, it’s unfortunate that the federal government is prohibiting much needed information and education for our healthcare providers.

Clinical Trial Resources:

Patients Out of Time – A 501c3 tax exempt nonprofit organization dedicated to educating doctors, nurses, other healthcare professionals, attorneys, patients, and others about medical cannabis, the endocannabinoid system, and cannabis science.

Palliatech – A biotech company focused in product development, science advancement and accessibility in the cannabis industry.

Society of Cannabis Clinicians – An organization of physicians and clinicians; healthcare associates and graduate students, all focused on cannabis for medicinal use. Its website is deep in clinical information and studies.

Medical Cannabis: What Clinicians Need to Know and Why – – Basic Science and Clinical Applications – This book came highly recommended to me by a California based cannabis physician, trained in Washington, DC. This is a textbook written for clinicians and medical students about the use, efficacy, and monitoring of medical cannabis. 

Photo credit: Jacquie Cohen Roth, MS

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