Several Major Universities To Offer Cannabis Courses and Even Grow Some on the Side!

In a previous blog post I wrote that several community colleges and lesser know universities were offering summer and/or continuing education classes about cannabis.  While these course offerings were impressive, most were community-based and specifically designed to support local cannabis growers and the emerging cannabis business in these locales.

More recently, however, several major universities including Ohio State University, the University of Washington, the University of Vermont and the University of California-Davis announced that they will offer courses designed to provide students and healthcare professionals with an understanding of the physiology, medical and legal implications of cannabis use.

And, quite surprisingly, Louisiana State University has entered into a private agreement with a Las Vegas-based biopharmaceutical pharmaceutical company GB Sciences to cultivate and supply cannabis for disease indications that the company plans to treat including chronic pain, arthritis, cardiovascular problems, asthma and inflammatory bowel disease. While LSU entered into this agreement, it is not clear whether or not it relationship with GB Sciences may affect its sources of federal funding because cannabis is still illegal at the federal level.

Nevertheless, it is becoming abundantly clear that academia sees an opportunity to get into the cannabis business one way or the other. Below is a sampling of the cannabis courses and seminars that are currently being offered.

The University of Vermont offers a medical marijuana and cannabis certification course for clinicians who want the latest information regarding medical cannabis and possible healthcare applications of the plant.

The Moritz College of Law at Ohio State University offers a seminar style course on the legalization of cannabis that will examine the social and historical backdrop of intoxicant prohibition, and assess the legal reforms and political debates now having an impact on the control and regulation of marijuana distribution and use.

The University of Washington offers a course for healthcare professionals on the use of medical cannabis to treat chronic pain.

The University of California-Davis will offer a course to biology majors that will cover the biology of cannabis and cannabinoids as well as their physiological effects in multiple systems, underlying mechanisms and therapeutic values. It also will survey the history of cannabis use, cover the endocannabinoid system and discuss potential medical targets for cannabis and their relative effectiveness.

Finally, there is a big push at University of California at Los Angeles to create a research center to study the medicinal effects of cannabis on a variety of disease indications.

References

  1. http://cannabisscienceblog.com/2017/06/15/69/ accessed September 25, 017
  2. https://www.businessreport.com/article/lsu-finalizes-medical-marijuana-agreement-gb-sciences/ accessed September 25, 2017
  3. http://learn.uvm.edu/com/program/cannabis-science-and-medicine/ accessed September 25, 2017
  4. http://moritzlaw.osu.edu/academics/course-explorer/category/criminal-law/ accessed September 25, 207
  5. http://adai.uw.edu/mcacp/ accessed September 25, 2017
  6. http://www.ucdmc.ucdavis.edu/physiology/ accessed September 25, 2017
  7. http://dailybruin.com/2017/05/23/editorial-ucla-must-build-marijuana-research-center-study-effects-of-legalization/ accessed September 25, 2017

Cannabis and PTSD: A Clinical Trial Update

The Marijuana for Symptoms of PTSD in US Veterans clinical trial being conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS, a Santa Cruz-based 501 (c)(3) a private non-profit research organization)  is believed to be the first randomly controlled clinical trial to evaluate medical marijuana as a treatment for post-traumatic stress disorder (PTSD) in US military (1).  Officially, the study title is “Placebo Controlled, Triple Blind, Randomized Crossover Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)”.  The study protocol with inclusion and exclusion criteria can be found here .

The principal investigator of this federally-approved study is Sue Sisley, MD with help from Marcel Bonn-Miller, MD (coordinating PI formerly of the University of Pennsylvania) and co-investigator Paula Riggs, MD (University of Colorado) and the project is funded by a $2, 156, 000 grant from the State of Colorado. Although the project was approved in 2014, it has been plagued by a variety of political and legal issues.

First, the National Institute on Drug Abuse (NIDA) which is the only legal source of marijuana for federally sanctioned research in the US has been unable to provide the Cannabis required for the study. Incidentally, the only legal grower of Cannabis in the US is the University of Mississippi. The university was awarded that license in 1968. However, recent reports suggest that the Cannabis provided by the university is contaminated with lead, yeast and mold which could raise concerns about efficacy and safety if used in the trial (2). Also, the university has not established testing guidelines for the Cannabis that is produces.

Second, the study was initiated in Phoenix, Arizona because the city’s VA hospital has a very high density of treatment resistant PTSD patients (those who continue to experience symptoms despite undergoing VA-sanctioned treatment and/or therapy) and Dr. Sisley was on the faculty at the University of Arizona. Unfortunately, Dr. Sisley was fired from the university for political reasons. This delayed the start of the study and has subsequently slowed its progress.

Finally, Phoenix VA hospital administrators have been slow and unwilling to provide Dr. Sisley with the data that she and her team need to identify patients to complete enrollment for the study. At present, 22 patients have been enrolled and treated. Investigators must screen 6,000-8,000 veterans to identify the remaining 54 patients to complete the study (3).

The MAPS trial has the support of most veteran groups including the American Legion, Iraq and Afghanistan Veterans of America, Veterans of Foreign Wars and Disabled American Veterans.  However, the Trump administration has clearly its distaste for all things Cannabis and, despite anecdotal evidence that Cannabis can help treat PTSD and traumatic brain injury (4), the current political climate has made it difficult to conduct this very important clinical trial.  According to Dr. Sisley, “All we get from them [VA hospital administrators] is polite responses about marijuana being federally illegal.” (3)

To put PTSD in perspective, America loses an estimated 15,000 veterans each year to drug overdoses and suicide. It is a shame that the federal government will not allow a scientifically-designed clinical trial to be conducted to help determine whether or not Cannabis is a safe and effective treatment for PTSD.  Thankfully, PTSD can be treated with Cannabis in many states that have already legalized medical marijuana.

References

  1. http://www.maps.org/research/mmj/marijuana-us
  2. http://www.pbs.org/newshour/updates/scientists-say-governments-pot-farm-moldy-samples-no-guidelines/
  3. http://www.thecannabist.co/2017/08/29/veterans-administration-ptsd-marijuana-study-enrollment
  4. https://www.nytimes.com/2017/09/01/opinion/marijuana-legalization-veterans.html?ref=todayspaper

 

Commercializing Cannabis-Derived Pharmaceuticals: Manufacturing, Quality and Healthcare Challenges

While overcoming the legal and regulatory challenges for commercializing cannabis- derived pharmaceuticals is essential, there are a variety of technical, manufacturing and healthcare obstacles that must be addressed before this class of molecules can be successful.

First, substantial financial investment must be made in infrastructure and production facilities to breed and grow different cannabis strains to obtain appropriate chemical compositions and extracts to treat specific therapeutic indications (1). Industry experts contend that this investment must include research on strain construction, cannabinoid concentrations at different stages of plant growth/harvest times and yield improvements. Interestingly, crop failure (not having a redundancy of supply) is a serious issue that all commercial entities in the medical cannabis industry must address and contend with to meet commercial demand.

Second, plant growth (use of insecticides, herbicides etc), extraction processes, and product formulation of cannabis-derived pharmaceuticals must be conducted according to Current Good Manufacturing Practices (CGMP) and rigorous quality standards (1). After all, the primary reason for seeking regulatory approval for these drugs is to demonstrate to patients and healthcare providers that cannabis-derived pharmaceuticals have been thoroughly reviewed, are well characterized and determined to be safe and effective. Implementation of pharmaceutical CGMPs (2) will ensure cannabis-derived pharmaceutical product safety, efficacy and quality over time.

Third, the route of delivery and dosing regimens for cannabis-based pharmaceuticals for specific indications will be vitally important. While smoking/vaporizing cannabis is currently the most obvious method to deliver desired therapeutic effects, it may not be the most effective to maximize its therapeutic benefits for different indications and individual patients (3). Over the past few years, there has been a growing interest in exploring oral, oromucosal, topical and sustained release delivery of cannabis-derived pharmaceutical depending upon the therapeutic indication of interest.

Fourth, efforts must be initiated to get Cannabis-derived pharmaceuticals on the drug formularies of state government insurers and third party insurance companies. At present, medical marijuana costs are usually not reimbursable by conventional health insurance companies (4) and out-of-pocket expenditures can be costly especially for those individuals who suffer from long term, chronic clinical indications like cancer, multiple sclerosis and epilepsy. However, if Cannabis-derived pharmaceuticals are approved by the US Food and Drug Administration (and are rescheduled) it is likely that these drugs will be covered by government and third party healthcare payers (5).

Finally, safeguards must be put into place to ensure protection against misuse, fraud and abuse of Cannabis-derived pharmaceuticals by healthcare providers and patients. The development of novel metered dose devices to deliver these products will help to limit misuse and abuse.

References

  1.  https://daggacouple.co.za/wp-content/uploads/2014/07/Economies_Scale_Production_Cannabis_Oct-22-20131.pdf Accessed July 18, 2017
  2. https://www.fda.gov/food/guidanceregulation/cgmp/  Accessed July 18, 2017
  3. https://www.medicaljane.com/category/cannabis-classroom/consuming-cannabis/   Accessed July 18, 2017
  4. http://www.cheatsheet.com/money-career/why-your-health-insurance-wont-cover-medical-marijuana.html/?a=viewall  Accessed July 18, 2017
  5. http://www.medicalmarijuanainc.com/medical-marijuana-covered-health-insurance/ Accessed July 18, 2017

 

Medical Marijuana Courses Are Now Available for College Credit!

Back in the day when I was going to graduate school in Madison, WI,  there was no such thing as medical Cannabis (although there was plenty of weed to go around).  But, as the line in that old Dylan song goes “the times they are a changin”

Late last month, the University of California-Davis announced that it would be joining Humboldt State University in offering undergraduate students a course entitled Physiology of Cannabis.  FYI, Humboldt State has been offering courses in medical Cannabis since 2012 (not surprising since the school is located in prime Cannabis cultivation territory).

According to UC-Davis officials the semester-long, three credit course will be aimed at biology students and will cover the endocannabinoid system, the effects of cannabinoids on the human body and the therapeutic value of Cannabis.

Likewise, Sonoma State University announced that it will be offering a one day symposium on March 11, 2017  to members of the healthcare industry in the Bay area. The symposium is entitled Medical Cannabis: A Clinical and it is intended as a workforce development course.  Nurses, physicians and pharmacists can get continuing education credit for the course. Topics that will be covered include the history of cannabis, an introduction to cannabinoids and terpenes, dosing and administration of cannabinoids, legal implication and other medical-related issues. The university is also planning a three day course on Cannabis regulatory issues later in the month.

While these courses are available, there is currently no undergraduate degree program in Cannabis science/medicine offered by any US university or college. That said, don’t be surprised if this major becomes a reality in States where medical and recreational Cannabis are legal.