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What does medical research say?
38. Does the U.S. Food & Drug Administration (FDA) support the use of medical marijuana?
Though the FDA does not explicitly support the use of medical marijuana, the FDA has approved four medications made from marijuana or synthetic marijuana extract. Such approval is indicative of the FDA’s confirmation that marijuana has medicinal benefits as evidenced by rigorous clinical trials. Those drugs include:
Epidiolex: an oral solution approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gestaut syndrome and Dravet syndrome.
Marinol and Syndros: capsules and oral solution approved for the treatment of nausea and vomiting associated with cancer chemotherapy.
Cesamet: capsules approved for the treatment of nausea and vomiting associated with chemotherapy.
39. Why is a medical marijuana program necessary if we have four FDA-approved medications from real or synthetic marijuana extract?
The FDA-approved medications do not take the place of a medical marijuana program. Of the four FDA-approved medications, three are synthetic and the fourth, although made from real marijuana extract, only uses one of the more than 100 cannabinoids found in the plant. The three synthetic medications are only approved for nausea and vomiting associated with cancer chemotherapy and is available in oral solutions, which may be difficult for cancer patients who are struggling with nausea and vomiting. The fourth medication, Epidiolex, which is made from real plant marijuana extract is only approved for two rare and severe forms of epilepsy.
Mississippi’s medical marijuana program will serve 22 debilitating medical conditions, will allow qualified patients under the care of a physician to have safe and legal access to whole plant marijuana, and will provide varying delivery methods so that each patient can utilize their treatment in the way that works best for them.
40. Are there any research studies that demonstrate the effectiveness of medical marijuana?
Yes! There are many studies that show that medical marijuana is effective to treat a number of debilitating medical conditions. Some of those studies have been published in peer-reviewed medical journals including the following:
a. The National Academies of Sciences reported that “there is conclusive or substantial evidence that cannabis or cannabinoids are effective (1) for the treatment of chronic pain in adults, (2) as antiemetics in the treatment of chemotherapy-induced nausea and vomiting, and (3) for improving patient-reported multiple sclerosis spasticity symptoms.” (The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research, The National Academies of Sciences, p. 128)
b. The Journal of the American Medical Association published research that the “use of marijuana for chronic pain, neuropathic pain, and spasticity due to multiple sclerosis is supported by high-quality evidence.” (Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems, Journal of the American Medical Association, 2015)
c. The Canadian Medical Association published research that shows that “smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity.” (Smoked Cannabis for Spasticity in Multiple Sclerosis: A Randomized, Placebo-controlled Trial, Canadian Medical Association Journal, 2012)
d. The Lancet published medical research shows that adding cannabidiol to a medication regiment is “efficacious for the treatment of patients with drop seizures associated with Lennox-Gestaut syndrome and is generally well tolerated.” (Cannabidiol in Patients With Seizures Associated With Lennox-Gastaut Syndrome (GWPCARE4): a Randomized, Double-blind, Placebo-controlled Phase 3 Trial, The Lancet, Volume 391, Issue 10125, March 2018)
e. The European Journal of Medicine published research that “cannabis as a palliative treatment for cancer patients seems to be well tolerated, effective and safe option to help patients cope with the malignancy related symptoms.” (Prospective Analysis Of Safety And Efficacy Of Medical Cannabis In Large Unselected Population Of Patients With Cancer, European Journal of Internal Medicine, March 2018)
f. The International Journal of Neuroscience reported that “THC:CBD spray was effective and well tolerated as add-on therapy or as monotherapy in a relevant proportion of patients with resistant MS spasticity.” (Clinical Experience With THC:CBD Oromucosal Spray In Patients With Multiple Sclerosis-Related Spasticity, International Journal of Neuroscience, September 2013)
g. The medical journal Clinical Gastroenterology and Hepatology published research that shows that “a short course (8 weeks) of THC-rich cannabis produced significant clinical, steroid-free benefits to 10 of 11 patients with active Crohn's disease, compared with placebo, without side effects.” (Cannabis Induces A Clinical Response In Patients With Crohn's Disease: A Prospective Placebo-Controlled Study, Clinical Gastroenterology and Hepatology, October 2013)
h. The medical journal Clinical Rehabilitation published that “pain relief associated with both THC and CBD was significantly superior to placebo. Impaired bladder control, muscle spasms and spasticity were improved by cannabis medicinal extracts in some patients with these symptoms. Cannabis medicinal extracts can improve neurogenic symptoms unresponsive to standard treatments. Unwanted effects are predictable and generally well tolerated.” (A Preliminary Controlled Study To Determine Whether Whole-Plant Cannabis Extracts Can Improve Intractable Neurogenic Symptoms, Clinical Rehabilitation, February 2003)
i. The Journal of Neurology reported that “THC/CBD spray was beneficial for the majority of patients with peripheral neuropathic pain associated with diabetes or allodynia.” (A Multicentre, Open-Label, Follow-On Study To Assess The Long-Term Maintenance Of Effect, Tolerance And Safety Of THC/CBD Oromucosal Spray In The Management Of Neuropathic Pain., Journal of Neurology, 2015)
j. The Clinical Journal of Pain reported that “the treatment of chronic pain with medicinal cannabis in this open-label, prospective cohort resulted in improved pain and functional outcomes, and a significant reduction in opioid use. (The Effect of Medicinal Cannabis on Pain and Quality-of-Life Outcomes in Chronic Pain: A Prospective Open-label Study, Clinical Journal of Pain, 2016)
k. The Journal of Pain and Symptom Management reported that THC/CBD extract is a useful treatment for relief of pain in patients with advanced cancer who experience inadequate pain relief from chronic opioid therapy. (Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain, Journal of Pain and Symptom Management; Johnson, Jeremy, et al.)
l. The Journal of Oncology Practice reported that patients enrolled in Minnesota’s medical marijuana program showed significant improvements in symptoms related to cancer and cancer treatment including reductions of anxiety, lack of appetite, depression, disturbed sleep, fatigue, nausea, pain and vomiting. (Impact of Medical Cannabis on Patient-reported Symptoms for Patients with Cancer Enrolled in Minnesota’s Medical Cannabis Program, Journal of Oncology Practice, March 2019)
41. Is there anything that is preventing more research of medical marijuana?
Unfortunately, yes. Marijuana is one of the tightest-controlled substances under federal law. The U.S. government considers it a Schedule I drug, meaning the Drug Enforcement Administration considers it to have no medical value. To do research on marijuana, scientists need approval from several federal departments, which is rare because the government classifies it as Schedule I.
Conducting clinical research in the United States on medical marijuana involves receiving approval from several federal agencies. This includes a registration from the Drug Enforcement Administration (DEA); obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA), within the National Institutes of Health; and review by the FDA of an investigational new drug (IND) application and research protocol. Additionally, because marijuana is currently listed as a Schedule I controlled substance under the Controlled Substances Act, the DEA has additional Schedule I-level security requirements at the site marijuana will be studied.
These bureaucratic hurdles have hindered many research facilities from researching the effects of marijuana on various medical conditions. However, there is considerable medical research being conducted in other parts of the world.
42. What has been the experience in the 33 states that currently allow for the use of medical marijuana?
Some states regularly provide statistics on their medical marijuana programs and others have conducted patient surveys since legalizing medical marijuana. For example, the Minnesota Department of Health (MDH) studied more than 1,000 patients enrolled in Minnesota’s medical marijuana program who were undergoing cancer treatment. The published evidence showed that these patients experienced “significant improvement in symptoms, including reduced anxiety, lack of appetite, depression, disturbed sleep, fatigue, nausea, pain and vomiting, within four months of starting the medication.” (News Release: Medical cannabis reduces severity of symptoms for some patients with cancer, according to new study, MN Department of Health, 4/8/2019.)
The Minnesota Department of Health further reported that its medical marijuana program “is providing many people with substantial benefits, minimal side effects and no serious adverse events.” MDH conducted a patient survey after its program had been operating for one year. The results of that survey found the following:
“Patients responded to a survey question asking how much benefit they believe they received from using medical cannabis on a scale from 1 (no benefit) to 7 (great deal of benefit). Across all patients, 64 percent indicated a benefit rating of 6 or 7. In the area of symptom reduction, patients achieved at least a 30 percent reduction in symptoms (an amount considered clinically meaningful) for conditions including seizures, Tourette syndrome, Crohn’s disease and muscle spasms.
For most symptoms, between half and two-thirds of patients who achieved clinically meaningful improvement also retained that degree of improvement over four months. A small but important proportion of patients, 9 percent, indicated little or no benefit with a rating of 1, 2 or 3. Patients also reported that affordability continues to be a problem as medical cannabis is not covered by health insurance.” (News Release: Majority of medical cannabis patients saw benefit during the program’s first year, MN Department of Health, 05/16/2019)
New Jersey released program priorities to improve its medical marijuana program by expanding the initial list of debilitating medical conditions that qualify a patient to access medical marijuana, increasing product supply and reducing patient costs. “The Medicinal Marijuana Program has always prioritized patient needs above all else. Whether they are individuals with debilitating chronic pain, folks with end-stage cancer, or veterans with post-traumatic stress disorder, patients simply cannot wait any longer for therapy that is both more affordable and easier to access,” New Jersey Health Commissioner Dr. Shereef Elnahal said. “The need for this program is greater than ever.”
Importantly, no state that has legalized medical marijuana has reversed that decision since making it legal. More than 2.8 million Americans have safe and legal access to medical marijuana in states with medical marijuana programs.
43. There are a number of national groups, like the Epilepsy Foundation and National Multiple Sclerosis Society, that raise money to help fight diseases. Do any of them support the use of medical marijuana?
Yes. The Epilepsy Foundation’s position is: The Foundation is committed to supporting provider-directed care and to exploring and advocating for all potential treatment options, including medical cannabis and CBD. We support lifting federal barriers to research on cannabis and CBD and support access to these potential therapies, through state-regulated programs, for individuals when other treatment options have failed them. If an individual and their health care team feel that the potential benefits of medical cannabis for uncontrolled epilepsy outweigh the risks, then the individual should have safe, legal access to medical cannabis.
The National Multiple Sclerosis Society’s position is: The Society supports the rights of people with MS to work with their health care provider to access cannabis for medical purposes in accordance with legal regulations in those states where such use has been approved. In addition, the Society supports the need for more research to better understand the benefits and potential risks of cannabis and its derivatives as a treatment for MS and its symptoms.
44. Has there been any research into the impact medical marijuana has had on America's opioid crisis?
Yes. A study by JAMA (Journal of the American Medical Association) documented that opioid overdoses are as much as 25% lower in states where medical marijuana has been made available as an alternative to opioids compared with states without medical marijuana laws. (Medical Cannabis Laws And Opioid Analgesic Overdose Mortality In The United States, 1999-2010, Journal of the American Medical Association, October 2014). JAMA also reported that opioid prescribing has been significantly reduced in the Medicare Part D population in states with medical marijuana programs. (Association Between US State Medical Cannabis Laws And Opioid Prescribing In The Medicare Part D Population, Journal of the American Medical Association, May 2018)
To combat the opioid epidemic, the New York State Department of Health recently began urging doctors to consider medical marijuana as an alternative to prescribing opioids for patients with severe pain. New York joins New Jersey and Pennsylvania as states that are using medical marijuana to treat opioid withdrawal. The JAMA researchers concluded that if medical marijuana legalization can continue to be linked to reductions in opioid overdose deaths, then the legalization of medical marijuana can be advocated as part of a comprehensive attack to reduce the risk of opioids.
45. Has there been any research into the allegation that marijuana is a gateway to other illegal drugs?
Yes. The National Academies of Sciences, Engineering, and Medicine published evidence by unequivocally stating that “There is no conclusive evidence that the drug effects of marijuana are causally linked to the subsequent abuse of other illicit drugs.” Additionally, the research concluded that “There is no evidence that marijuana serves as a stepping stone on the basis of its particular physiological effect.”
There is also a broad social concern that sanctioning the medical use of marijuana might increase its use among the general population. However, The National Academies of Sciences concluded that “at this point there are no convincing data to support this concern. The existing data are consistent with the idea that this would not be a problem if the medical use of marijuana were as closely regulated as other medications with abuse potential.” (Marijuana and Medicine: Assessing the Science Base, The National Academies of Sciences, Engineering, and Medicine, p.129)
46. Have any research studies found that medical marijuana causes any harmful side effects?
Scientific research and patient testimonials show that medical marijuana provides relief for the symptoms associated with certain debilitating medical conditions (see #2 above). Despite these proven benefits, some patients have reported temporary side effects after consuming medical marijuana, such as feelings of dizziness, dry mouth, loss of balance and disorientation. However, the side effects of medical marijuana are within the acceptable risks associated with pharmaceutical drugs. This means that using medical marijuana is no riskier than using prescription medications. (Marijuana and Medicine: Assessing the Science Base, The National Academies of Sciences, Engineering, and Medicine, p.127, 1999).
Additionally, research published in the journal Neurotherapeutics showed that regularly smoking marijuana can increase the risk of chronic bronchitis, emphysema, chronic respiratory inflammation and impaired respiratory function. (Safety and Toxicology of Cannabinoids, Neurotherapeutics, Aug. 2015). Fortunately, patients can consume medical marijuana in many ways that don’t require smoking, such as edibles, patches, creams, oils, vaporizers, aerosols and tinctures.
Lastly, unlike prescription opioids which caused more than 17,000 overdose deaths in the United States in 2017, “no deaths from overdose of marijuana have been reported” according to the DEA. (A DEA Resource Guide: 2017 Edition, United States Drug Enforcement Administration, p.75; CDC Morbidity and Mortality Weekly Report, Centers for Disease Control and Prevention, Jan. 4, 2019). Some states are urging doctors to consider medical marijuana as an alternative treatment option for certain patients as opposed to opioids.
As with any prescription medication, physicians and patients should discuss the risks and benefits associated with using medical marijuana. Medical marijuana is not a wonder drug, just as no prescription medication is a cure-all. However, medical marijuana has been proven by research and the experiences in 33 other states to be a valid option for patients with certain debilitating medical conditions.