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Cannabis-Based Medicines

 

“Opium has medical value, and it is called morphine. Marijuana has medical value, too — but just as we don’t smoke opium to receive beneficial effects, we need not smoke marijuana to get its medical value.” — Project SAM

Projlogo16ect SAM calls for the following regarding cannabis-based medicines:

The rapid expansion of research into the components of the marijuana plant for delivery via non-smoked forms.

The establishment of an emergency or research FDA IND program that allows seriously ill patients to obtain non-smoked components of marijuana before final FDA approval.

The end of “cannabis clubs” and so-called “dispensaries” that are fronts for marijuana stores and do not follow appropriate standards of medical care.

We don’t have to smoke the stuff. Really.

Over the past two decades, the idea of marijuana as medicine has become increasingly popular. Citizens of several U.S. states, beginning in 1996, voted by referenda to allow the use of smoked marijuana as medicine. Countries such as Austria, Canada, Finland, Germany, Israel, Portugal and Spain also have some form marijuana as medicine regulation.

It is important to distinguish between the whole marijuana plant material and individual components within the marijuana plant. Some constituents of marijuana, including THC, are available today in pill form (dronabinol, or Marinol® is man-made THC); some synthetic mimics of those constituents are also available (nabilone, or Cesamet®).

The whole marijuana plant material, on the other hand, has thousands of unknown and carcinogenic components that have not been accepted by scientific and medical authorities as medicines. Medicines are rarely, if ever, smoked, and an exhaustive review in 1999 by the  U.S. Institute of Medicine concluded that smoked marijuana should “generally not be recommended for medical use.”[i] Additionally, smoked marijuana’s effective dose varies, due to individual differences in absorption and metabolism in the liver, as well as puff frequency, depth of inhalation and retention of inhaled smoke.[ii]

That smoked marijuana is not medicine doesn’t mean we should not pursue cannabis-based medicines in the form of pills, mouth-sprays, injections, patches and other acceptable routes of administration.

In some countries, marijuana-based medicines — meaning medications that aren’t smoked — have been approved to treat neuropathic pain related to cancer and spasticity related to Multiple Sclerosis (MS). These products include nabiximols (Sativex®),  which contains THC and another cannabinoid called cannabidiol (CBD). This mouth spray allows for proper titration of dosage and eliminates the major health consequences of inhaling smoke. The presence of CBD also tends to lessen the intoxicating effects of THC.


 

Current medical marijuana programs are a joke — but no laughing matter

  • A 2007 study analyzing more than 3,000 “medical” marijuana users in California found that an overwhelming majority (87.9 percent) of those queried about the details of their marijuana initiation had tried it before the age of 19. The average user was a 32-year-old white male. Approximately 74 percent of the Caucasians in the sample had used cocaine, and more than half had used methamphetamine in their lifetime.[i]
  • A 2011 study that examined 1,655 applicants in California who sought a physician’s recommendation for medical marijuana found that very few had cancer, HIV/AIDS, glaucoma or multiple sclerosis.[ii]
  • The Colorado Department of Health found that only 2 percent of “medical” marijuana users reported cancer, and less than 1 percent reported HIV/AIDS as their reason for seeking marijuana. The vast majority (94 percent) reported “severe pain.”[iii]
  • In Oregon, there are reports that only 10 physicians made half of all recommendations for medical marijuana[iv]. Agitation, seizures, cancer, HIV/AIDS, cachexia and glaucoma were the last six conditions cited for giving people “medical” marijuana.[v]
  • The use of marijuana under the guise of medicine has affected youth drug use patterns. A study by researchers at Columbia University looked at two separate data sets and found that residents of states with medical marijuana had marijuana abuse/dependence rates almost twice as high youth in states without such laws.[vi] Another study in the Annals of Epidemiology found that marijuana use rates were higher among youth ages 12 to 17 in states with medical marijuana laws (8.6 percent) compared with those without such laws (6.9 percent).[vii] More research on this connection is needed.


 

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Researching and developing
marijuana-based medicines the right way

It is clear that for some people, marijuana helps with chemotherapy-induced nausea, appetite enhancement and pain relief. But since smoking or ingesting the whole plant is undesirable, other methods should be developed for receiving the benefits of the drug. A possible solution would be to speed up research into marijuana’s components.

From 2007 to 2011, the National Institutes of Health provided more than $14 million for cannabinoid research (both clinical and preclinical) into the following diseases and conditions:

pain, addiction (marijuana, alcohol, tobacco, opiate), cancer (lung, breast, prostate), diabetic neuropathy, Tourette’s syndrome, irritable bowel syndrome, multiple sclerosis,

brain damage, organophosphate toxicity, depression, glaucoma, Alzheimer’s disease, stroke, Autoimmune Hepatitis, ALS, viral infection, liver disease, cardiotoxicity,

HIV/AIDS, emesis, itch, schizophrenia, sleep, Crohn’s Disease, bipolar disorder, Post Traumatic Stress Disorder, anorexia nervosa, fibromyalgia, graft vs. host disease, cervical dystonia, and trichotillomania/OCD.[i]

The National Institute on Drug Abuse (NIDA) has funded another 18 studies involving smoked, oral, IV or vaporized marijuana for addiction (marijuana, opiates), schizophrenia, wasting due to HIV/AIDS, neuropathic pain, irritable bowel syndrome, diabetic neuropathy and cancer-related pain.[ii]

This demonstrates that if a proposed study has a high-quality trial design and an experienced investigator, the research is very likely to be approved, and perhaps even funded. It is important to understand that the people who decide whether a study is approved for funding are skilled researchers, not government officials.


 

Could current research and development processes be improved? Certainly.

Perhaps the federal government could develop a variety of marijuana extracts and other cannabinoid preparations and make those available to researchers.

Perhaps marijuana-derived products could be afforded fast-track status in the FDA process, even though they may only be alleviating symptoms, rather than slowing disease progression.

Perhaps such products could even be allowed to be marketed in a limited manner, based on promising efficacy data and a good safety profile (followed by one or more confirmatory studies), as is the case in Canada under its Notice of Compliance with Conditions (NOCc) program.[iii]

These and other refinements to the current system could facilitate the availability of marijuana-derived medications without sacrificing good science and proper standards of medical care. Indeed, the government could freely provide non-intoxicating extracts of marijuana, such as CBD, to those with a real need and a legitimate doctor’s oversight. This can be done legally today through the U.S. Food and Drug Administration’s Investigative New Drug program.

Sources:

[i] We conducted a search of NIH-funded studies on the use of cannabinoids for the treatment of various diseases/conditions using the NIH Reporter. The initial search was done using the terms “cannabinoid” and “marijuana” for fiscal years 2007-2011. The lists then were pared manually to include only studies examining the use of cannabinoids for treatment. Web Search using NIH RePORT Research Portfolio Online Reporting Tools (RePORT) website: http://projectreporter.nih.gov/reporter.cfm. Search strings “marijuana”.

[ii] Web Search using NIH RePORT Research Portfolio Online Reporting Tools (RePORT) website: http://projectreporter.nih.gov/reporter.cfm. Search strings “marijuana”

[iii] Health Canada, Notice of Compliance with Conditions Fact Sheet, http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/noccfs_accfd-eng.php.

[i] O’Connell, T and Bou-Matar , C.B. (2007). Long term marijuana users seeking medical marijuana in California (2001–2007): demographics, social characteristics, patterns of marijuana and other drug use of 4117 applicants. Harm Reduction Journal, http://www.harmreductionjournal.com/content/4/1/16

[ii] Nunberg, Helen; Kilmer, Beau; Pacula, Rosalie Liccardo; and Burgdorf, James R. (2011) “An Analysis of Applicants Presenting to a Medical Marijuana Specialty Practice in California,” Journal of Drug Policy Analysis: Vol. 4: Iss. 1, Article 1. Available at: http://www.bepress.com/jdpa/vol4/iss1/art1

[iii] See Colorado Department of Public Health, http://www.cdphe.state.co.us/hs/medicalmarijuana/statistics.html

[iv] See for example, Danko, D. (2005). Oregon Medical Marijuana Cards Abound, The Oregonian, January 23, 2005. Also see Oregon Medical Marijuana, Protect the Patients & Treat it Like Medicine, http://www.oregon.gov/Pharmacy/Imports/Marijuana/Public/ORStatePolice_OMMALegPP.pdf?ga=t

[v] Oregon Medical Marijuana Program Statistics, http://public.health.oregon.gov/diseasesconditions/chronicdisease/medicalmarijuanaprogram/pages/data.aspx

[vi] Cerda, M. et al. (2012). Medical marijuana laws in 50 states: investigating the relationship between state legalization of medical marijuana and marijuana use, abuse and dependence. Drug and Alcohol Dependence. ;120(1-3):22-7.

[vii] Wall, M. et al (2011). Adolescent Marijuana Use from 2002 to 2008: Higher in States with Medical Marijuana Laws, Cause Still Unclear, Annals of Epidemiology, Vol 21 issue 9 Pages 714-716.

[i] Williamson, EM & Evans, FJ (2000). Cannabinoids in clinical practice. Drugs, 60(6):1303-1314.

[ii] American Society of Addiction Medicine, ASAM Medical Marijuana Task Force White Paper, 2011.

[i] Joy, J. E., Waston, S. J., & Benson, J. A. (Eds.). (1999). Marijuana and medicine: Assessing the science base. Washington, DC: National Academy Press.

[ii] Gorelick, DA & Heishman, SJ (2006). Methods for clinical research involving marijuana administration. In Methods in Molecular Medicine: Marijuana and Cannabinoid Research: Methods and Protocols (Ed. E. S. Onaivi). New Jersey: Humana.