Why marijuana fans should not see approval for epilepsy drug as a win for weed

A Food and Drug Administration panel recommended approval of a drug made of cannabidiol on April 19 to treat two types of epilepsy. The FDA is expected to decide in June whether to accept the panel’s 13-0 recommendation to approve Epidiolex, which would would become the first drug made of cannabidiol, a compound in the cannabis plant, to gain approval from the FDA.

While the panel’s unanimous decision is not binding, the action will no doubt heighten public debate about the use of cannabidiol, medical marijuana, medical cannabis and hemp oil. Should cannabidiol, or CBD, or marijuana be legalized for medical purposes? What is the evidence that these products are beneficial? Are these products safe to use?

Those who support the use of marijuana for recreational or medicinal purposes might have found the timing of the panel’s ruling interesting. National Weed Day is April 20.

But weed is not cannabidiol, even though both come from cannabis.

No high, but healing?

A cannabis leaf. The plant produces several compounds, one of which is CBD

A cannabis leaf. The plant produces several compounds, one of which is CBD

As a professor of pharmacy with a special interest in epilepsy, I find it important that CBD may be a new option for the treatment of epilepsy. This new use has led me to carefully study published literature on CBD and discuss it as an option with patients who have epilepsy. Additionally, I have been involved with the American Epilepsy Society’s ongoing review of CBD as a possible treatment for epilepsy. From this perspective, I believe that CBD may offer benefits for patients with some types of epilepsy and possibly other disorders.

The cannabis plant produces hundreds of different compounds, many of which have differing effects in the body. Tetrahydrocannabinol, or THC, is the substance that is most known for its psychoactive effects, or the “high” associated with marijuana.

However, there are many other substances from the cannabis plant that also produce effects in the body. Many of these differ from THC in that they are not psychoactive – and they do not produce a “high.” Cannabidiol, or CBD, is one of those substances.

Cannabidiol is a complex molecule that is produced by the cannabis plant. Cannabis has been proposed for centuries as a medicinal plant. Only recently has CBD been studied scientifically for various disorders.

Compared to THC, CBD works at different receptors in the brain and other parts of the body. In this way, CBD is very different from THC and may offer new mechanisms of treatment. For this reason, CBD has received a great amount of attention as a possible treatment for many different disorders.

CBD has been proposed as a cure or treatment for many disorders and diseases, including epilepsy, chronic pain, anxiety, multiple sclerosis, amyotropic lateral sclerosis (ALS or Lou Gehrig’s disease) and insomnia. Some of these uses are based on science, but others are proposed by advocates of CBD and medical marijuana. Several anecdotal reports, case reports, case series and small studies have reported on CBD for many of these disorders. Information from these reports is conflicting. Case reports, case series and small studies are considered insufficient evidence to prove or disprove the safety and efficacy of a drug or treatment. This is because these studies are usually unable to distinguish between the effect of a drug and a placebo effect, or the patient thinking the drug is working when it really is not providing benefit.

However, there are two well-designed, large studies that indicate CBD is effective in two different epilepsy syndromes. In these studies, about 40 percent of patients taking CBD had a significant reduction in specific types of seizures.

Epilepsy is the only disorder where there is solid scientific evidence demonstrating that CBD is safe and effective. This does not mean that CBD will not work for other disorders, but epilepsy is the only one where we have clear, well-documented evidence that CBD helps.

Results from these studies show that CBD does have side effects. The most common ones are drowsiness, nausea, intestinal cramping, bloating and diarrhea. More serious side effects can occur. In one of the studies in epilepsy, about 10 percent of patients taking CBD had an increase in laboratory tests of liver function. These tests commonly indicate damage to the liver. About 2-3 percent of patients taking CBD had to discontinue it due to large increases in certain liver enzymes in laboratory tests, showing possible liver damage.

We are also learning about drug interactions that occur with CBD. In these studies, CBD slowed the metabolism of several drugs that are commonly given to individuals with epilepsy. The interactions between CBD and other drugs patients were taking caused side effects. It is unclear if these side effects were due to CBD, the other drugs, or a combination. Doses of the other drugs were reduced, due to the interactions.

The mechanism for these interactions indicate that there are likely several other interactions between CBD and other common medications. Cannabidiol needs to be used cautiously in combination with other medications.

Issues beyond effectiveness

There are several other factors to consider in regards to CBD. Cannabidiol does not dissolve well in water. For this reason, oral products of CBD are made with an oil, often some type of vegetable oil. It is important that the right oil is used.

Also, less than 20 percent of an oral dose of CBD is absorbed. This makes it difficult to produce a CBD product where CBD is reliably and consistently absorbed.

An FDA study of unregulated CBD products available on the market shows these products are frequently contaminated with things like pesticides, herbicides, fungus or bacteria. Additionally, the FDA found that over 50 percent of CBD products may not contain the amount of CBD on the label. This is especially true in states where CBD products are not regulated by the state. In 17 states where there is regulation, there is much better control on product quality and purity.

Finally, there are two pharmaceutical-grade CBD products that have been studied for production by a pharmaceutical company. One is Epidiolex, approved by the FDAD panel on April 19, and the other is still being studied. Epidiolex would be approved only for use in two types of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.

So far, the evidence is that CBD is safe and effective for specific epilepsy syndromes. There is insufficient scientific evidence to indicate that it is effective or ineffective for other disorders. Information from well-designed studies do indicate that CBD causes important side effects and drug interactions that must be considered. Individuals who wish to use CBD should be managed and monitored by health care professionals familiar with its use.

Study reveals negative long-term effects of heavy cannabis use on brain function and behavior

Study reveals negative long-term effects of heavy cannabis use on brain function and behavior

Young people with cannabis dependence have altered brain function that may be the source of emotional disturbances and increased psychosis risk that are associated with cannabis abuse, according to a new study published in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging. The alterations were most pronounced in people who started using cannabis at a young age. The findings reveal potential negative long-term effects of heavy cannabis use on brain function and behavior, which remain largely unknown despite the drug's wide use and efforts to legalize the substance.

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How marijuana promoters bypass the law — and the public good

How marijuana promoters bypass the law — and the public good

When I graduated from pharmacy school, I voluntarily pledged to use my knowledge, experience, and skills to the best of my ability to ensure optimal drug therapy outcomes for the patients I serve, and to consider the welfare of humanity with the full realization of the responsibility entrusted by the public.

To me this means that we, as pharmacists, must step up and speak the truth when it comes to claims about “medical” marijuana.

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Kicking Pot To The Curb

Kicking Pot To The Curb

Renowned Alzheimer’s researcher Dr. Vincent Fortanasce says marijuana use may lead to the disease

An estimated 200,000 people in the United States under age 65 are living with younger-onset Alzheimer’s disease. And hundreds of thousands more are coping with mild cognitive impairment, a precursor to Alzheimer’s and other dementias.

“It’s beyond epidemic proportions. There truly is a tidal wave of Alzheimer’s disease,” said Dr. Vincent Fortanasce, a clinical professor of neurology in Southern California who is also a renowned Catholic bioethicist, author and radio host.

Fortanasce, a member of Legatus’ San Juan Capistrano Chapter, for several years has studied Alzheimer’s disease, its underlying causes and treatments. Through his research, he believes there may be a link between chronic use of marijuana — especially when started at a young age — and Alzheimer’s.

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Don't Let Anyone Tell You Youth Marijuana Use Hasn't Gone Up in States Like Colorado

Don't Let Anyone Tell You Youth Marijuana Use Hasn't Gone Up in States Like Colorado

Despite claims to the contrary by Colorado Governor John Hickenlooper, and other officials, the nation's only representative sample of people in U.S households released special Colorado state data finding increases in marijuana use.

Colorado past-month marijuana use among 12-to-17 year-olds saw a significant increase, from 9.82% to 12.56%, according to the most recent year-by-year comparison looking at pre-legalization data. 

The National Survey on Drug Use and Health data also found that Colorado teens and adults use marijuana at a higher rate than the rest of the country. Colorado legalized marijuana in 2012 and implemented legal marijuana stores in 2014. At the same time, the sales of alcohol shows a slight increase.

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Don’t let Big Marijuana prioritize profits over public safety

Don’t let Big Marijuana prioritize profits over public safety

Simply put, the current fragmented patchwork of laws governing marijuana in states is unsustainable. Despite the oft-repeated refrain that marijuana enforcement is an issue of “states’ rights,” the consequences of legalization are not confined by geographic borders. Since Colorado legalized, marijuana has streamed into neighboring states and emboldened drug trafficking organizations there. In fact, in Nebraska and Oklahoma, the inflow of marijuana trafficking has been so dramatic that the states sued Colorado. Interstate drug tourism is thriving, with companies in states with legal pot advertising across state lines and online.

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National Academy of Sciences report finds marijuana use compromises mental, physical health and public safety

National Academy of Sciences report finds marijuana use compromises mental, physical health and public safety

The National Academy of Sciences (NAS), in a landmark report written by top scientists, The Health Effects of Cannabis and Cannabinoids: Current State of Evidence and Recommendations for Research, concluded after a review of over 10,000 peer-reviewed academic articles, that marijuana use is connected to, among other problems:

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Nearing the Falls in America’s Drug Crisis

Nearing the Falls in America’s Drug Crisis

Never before in American history has our country faced a drug abuse, drug crime, and drug overdose crisis of the magnitude now confronting our society. Last week, the Centers for Disease Control (CDC), within the Department of Health and Human Services (HHS), announced that more than 50,000 Americans last year died from drug overdoses. That is a surge of death around us.

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5 Former DEA Administrators urge Governor Brown to Oppose Prop 64

5 Former DEA Administrators urge Governor Brown to Oppose Prop 64

As former heads of the Drug Enforcement Administration, we write to ask you, the State’s highest level and most visible political leader, to take a position on Proposition 64 before the election next Tuesday. For the reasons set out below, we urge you to oppose Prop 64. Your voice, Governor, is critical.

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Californians Call on Governor Brown To take An Oppose Position on Prop 64

Californians Call on Governor Brown To take An Oppose Position on Prop 64

It is curious that Governor Brown said while being interviewed by “Meet the Press,” March 2, 2014, “The problem with anything, a certain amount is OK.  But there is a tendency to go to extremes, and all of a sudden, if there is advertising and legitimacy, how many people can get stoned and still have a great State.”  Carla Lowe, Founder, Co-chair, Citizens Against Legalizing Marijuana (CALM)said, “He then turned his back on Californians 4 days later and accepted over $108,000 from Sean Parker and his wife, both financial backers of Prop 64.  We believe he further put California in jeopardy, maybe forever, by allowing it to become the world’s largest producer of marijuana by not demanding enforcement of federal law.

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Why Legalizing Marijuana Would Be a Big Mistake

Why Legalizing Marijuana Would Be a Big Mistake

The marijuana of today comes in numerous forms; smoked, vaporized, butters, waxes, oils, and edibles.  What they all have in common is their THC potency (THC is the psychoactive, intoxicating and addictive cannabinoid in marijuana)  which is 10-40x greater than the marijuana of the 1960’s.  Today’s marijuana has been genetically engineered to maximize THC and minimize CBD (the non-psychoactive, non-intoxicating, non-addictive; cannabinoid with potentially therapeutic value).   

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Marijuana Mass Poisonings on the Rise

Marijuana Mass Poisonings on the Rise

"While many would have you believe marijuana is a harmless drug, those of us in the public safety arena have seen increases in medical emergencies from marijuana ingestion," he said in the report. "It is noteworthy that our system of emergency medical transport was completely tapped in order to handle this event. Thankfully, no other medical emergencies occurred simultaneously (sic), otherwise someone might not have received timely emergency help."

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What Scientific and Medical Journals and Experts Say About Marijuana

Below are a sample of 30 studies and statements, of over 20,000, on the harms of marijuana. More found here.

1. Marijuana use creates neurocognitive impairments and cannabis intoxication in both frequent and infrequent users. 
-- Journal of Scientific Reports, May 2016 (Cannabis and Tolerance: Acute Drug Impairment as a Function of Cannabis Use History).

2. Prevalence of cannabis use is expected to increase if cannabis is legal to use and legally available.
-- International Journal of Drug Policy, May 2016 (Correlates of Intentions to Use Cannabis among US High School Seniors in the Case of Cannabis Legalization)

3. Regular exposure to cannabis is associated with neuroanatomic alterations in several brain regions.
-- Journal of Biological Psychiatry, April 2016 (The Role of Cannabinoids in Neuroanatomic Alterations in Cannabis Users)

4. Marijuana is addicting, has adverse effects upon the adolescent brain, is a risk for both cardio-respiratory disease and testicular cancer, and is associated with both psychiatric illness and negative social outcomes.
-- Statement of the American College of Pediatricians, April 2016 (Marijuana Use: Detrimental to Youth).

5. Marijuana use has significant neuropharmacologic, cognitive, behavioral, and somatic consequences.
-- Statement of the American Academy of Pediatrics, March 2015 (The Impact of Marijuana Policies on Youth: Clinical, Research, and Legal Update)

6. Marijuana use is associated increased incidence and worsened course of psychotic, mood, anxiety, and substance use disorders across the lifespan…and marijuana’s deleterious effects on adolescent brain development, cognition, and social functioning may have immediate and long-term implications.
-- Statement of the American Academy of Child & Adolescent Psychiatry, 2014 (AACAP Marijuana Legalization Policy Statement)

7. Marijuana use may cause impairment in memory, concentration, and executive functioning…and may lead to permanent nervous system toxicity.
-- Statement of the American Academy of Neurology (Position Statement: Use of Medical Marijuana for Neurologic Disorders)

8. There is a strong association of cannabis use with the onset of psychiatric disorders. Adolescents are particularly vulnerable to harm, given the effects of cannabis on neurological development.
-- Statement of the American Psychiatric Association, December 2013 (Position Statement on Marijuana as Medicine)
 

9. Both marijuana-related hospitalizations and ED visits have increased substantially in recent years.                                                 -- Newsletter of the American College of Physicians, January 2016 (Public Health Researchers Look at Rise in Marijuana-related Hospitalizations)

10. Cannabis dependence is not associated with fewer harmful economic and social problems than alcohol dependence.
-- Journal of Clinical Psychological Science, June 2016 (Persistent Cannabis Dependence and Alcohol Dependence Represent Risks for Midlife Economic and Social Problems: A Longitudinal Cohort Study)

11. Repeated exposure to cannabis during adolescence may have detrimental effects on brain resting functional connectivity, intelligence, and cognitive function.
-- Journal of the Cerebral Cortex, February 2016 (Adverse Effects of Cannabis on Adolescent Brain Development: A Longitudinal Study)

12. Negative health effects of marijuana use can include addiction, abnormal brain development, psychosis, and other negative outcomes.
-- New England Journal of Medicine, June 2014 (Adverse Health Effects of Marijuana Use)

13. One in six infants and toddlers admitted to a Colorado hospital with coughing, wheezing and other symptoms of bronchiolitis tested positive for marijuana exposure.
-- American Academy of Pediatrics, April 2016 (One in Six Children Hospitalized for Lung Inflammation Positive for Marijuana Exposure)

14. Study respondents who were high had higher odds driving while intoxicated (on either marijuana or alcohol).
-- Journal of Health Education Research, April 2016 (Association Between Self-reports of Being High and Perceptions About the Safety of Drugged and Drunk Driving)

15. Cannabis use during adolescence increases the risk of developing a psychiatric disorder in adulthood, including anxiety, depression, and schizophrenia.
-- Frontiers in Neuroscience, November 2014 (Long-term Consequences of Adolescent Cannabinoid Exposure in Adult Psychopathology)

16. Childhood exposure to marijuana increases in marijuana friendly states and can lead to coma, decreased breathing, or seizures.
-- Journal of Clinical Pediatrics, June 2015 (Marijuana Exposure Among Children
Younger Than Six Years in the United States)

17. Use of marijuana in adolescence found to increase developing psychosis,
schizophrenia, anxiety, and depression in adulthood.
-- Boston Children’s Hospital/Harvard Medical School, 2014 (Marijuana 101, Dr. Sharon Levy)

18. Cannabis use may cause enduring neuropsychological impairment that persists beyond the period of acute intoxication.
-- Proceedings of the National Academy of Sciences, July 2012 (Persistent Cannabis Users Show Neuropsychological Decline from Childhood to Midlife)

19. Cannabis use disorder is prevalent, associated with comorbidity and disability, and largely untreated.
-- The American Journal of Psychiatry, March 2016 (Prevalence and Correlates of DSM-5 Cannabis Use Disorder, 2012-2013: Findings from the National Epidemiologic Survey on Alcohol and Related Conditions–III)

20. We recorded clear and consistent associations and dose-response relations between the frequency of adolescent cannabis use and all adverse young adult outcomes.
-- The Lancet-Psychiatry, September 2014 (Young Adult Sequelae of Adolescent Cannabis Use: An Integrative Analysis)

21. While marijuana may be safer than alcohol in some respects, there are important dimensions along which marijuana appears to be the riskier substance.
-- Carnegie Mellon Research/Jonathan P. Caulkins, October 2014 (Is Marijuana
Safer than Alcohol? Insights from Users’ Self-Reports)

22. Potential impacts of recreational marijuana include not only increased availability, resulting in ED visits for acute intoxicating effects of marijuana use, but also effects on mental health disorders and psychiatric-related illnesses.
-- American College of Emergency Physicians/ACEP NOW, October 2014 (How Legalizing Marijuana Has Impacted Colorado)

23. Marijuana changes the structure and function of the adolescent brain.
-- Bertha Madras, Professor of Psychobiology, Harvard University, May 2014 (Marijuana and Opioids Risks for the Unborn, the Born)

24. Dramatic increase in newborns testing positive for marijuana in Colorado hospitals.
-- Parkview Medical Center, St. Mary-Corwin Medical Center, Pueblo Community Health Center, April 2016 (Recreational Retail Marijuana Endangers Health of Community & Drains Precious Health Resources)

25. Casual use of marijuana is related to major brain changes.
-- Journal of Neuroscience, April 2014 (Cannabis Use Is Quantitatively Associated with Nucleus Accumbens and Amygdala Abnormalities in Young Adult Recreational Users)

26. It needs to be emphasized that regular cannabis use, defined here as once a week, is
not safe and may result in addiction and neurocognitive damage, especially in youth.
-- Journal of Current Addiction Reports, April 2014 (Considering Cannabis: The Effects of Regular Cannabis Useon Neurocognition in Adolescents and Young Adults)

27. Exposure to cannabis in adolescence is associated with a risk for later psychotic disorder in adulthood.
-- Journal of Current Addiction Reports, June 2014 (Impact of Cannabis Use on the Development of Psychotic Disorders)

28. Marijuana is not benign and there's a mountain of scientific evidence, compiled over nearly 30 years, to prove it poses serious risks, particularly for developing brains.
-- Diane McIntosh, Professor of Psychiatry-University of British Columbia, April 2016 (You Can't Deny Marijuana Is Dangerous For Developing Minds)

28. Marijuana may actually worsen PTSD symptoms or nullify the benefits of specialized, intensive treatment. Cessation or prevention of use may be an important goal of treatment.
-- Journal of Clinical Psychiatry, September 2015 (Marijuana Use is Associated With Worse Outcomes in Symptom Severity and Violent Behavior in Patients With Posttraumatic Stress Disorder)

29. Converging epidemiological data indicate that adolescent cannabis abusers are more likely to develop psychosis and PFC-related cognitive impairments later in life.
-- Journal of Molecular Psychiatry, March 2014 (CB1 Cannabinoid Receptor Stimulation During Adolescence Impairs the Maturation of GABA Function in the Adult Rat Prefrontal Cortex)

30. Regular cannabis use in adolescence approximately doubles the risk of being diagnosed with schizophrenia or reporting psychotic symptoms in adulthood.
-- Journal of Addiction, January 2015 (What Has Research Over the Past Two Decades Revealed About the Adverse Health Effects of Recreational Cannabis Use)
 

Credit to Arizonans for Responsible Drug Policy for this list. You can find out more about their organization by going to www.ardp.org