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SAM Analysis of HHS Cannabis Rescheduling Rationale

Full Analysis: https://learnaboutsam.org/wp-content/uploads/2024/01/SAM-Analysis-of-HHS-Cannabis-Rescheduling-Rationale.pdf

Executive Summary   On August 30th, 2023, the Department of Health and Human Services (HHS) announced it recommended the reclassification of marijuana to Schedule III to the Drug Enforcement Administration (DEA). Four months later, HHS released an unredacted version of its recommendation to reclassify the drug. The 252-page review had been hidden from the public and was only released after legal action was threatened against HHS.     This HHS recommendation is based on cherry-picked data and represents a weak and intellectually dishonest argument to reschedule marijuana. This summary describes just a few of the many flaws in the HHS methodology and conclusions. SAM’s full report provides an in-depth analysis of what the HHS got wrong and how the process could have been strengthened.   In years past, the FDA, an agency of the HHS in charge of approving medicinal drugs, used an established five-factor analysis in determining whether Schedule I drugs have “currently accepted medical use.” In the current report supporting the recommendation to reschedule marijuana, the FDA changed these criteria to get its desired answer.     If marijuana had been held to the same standards as other drugs, it would not be deemed to have “currently accepted medical use,” due to the infeasibility of measuring all strains and the insufficient amount of existing research into its safety and efficacy. In fact, the FDA’s new two-factor test explicitly states that studies used to support marijuana’s accepted medical use do not need to be controlled, a standard that was required in the five-factor test (save an evaluation done by a consensus of experts).  It is not clear why the FDA moved away from the five-factor test, unless the agency approached the rescheduling review with a pre-determined conclusion.     The five-factor test has been used for decades by Republican and Democratic Administrations. Additionally, the United States Court of Appeals for the District of Columbia Circuit examined and validated the test in Alliance for Cannabis Therapeutics v. Drug Enforcement Administration. The marijuana industry petitioners in that case even conceded that the five-factor test had no flaws, as explained in the opinion for the court.  The FDA now considers the existence of state medical marijuana programs as evidence that marijuana has currently accepted medical use.     A drug’s popularity among the public has never been used as a standard to determine medicine. Supreme Court Justice Steven Breyer in Gonzalez v Raich (545 U.S. 1 (2005), a case involving a medical necessity for the use of marijuana, opined during oral arguments that “medicine by regulation is better than medicine by referendum.” The Court’s 6-3 decision, which Justice Breyer joined, upheld the prohibition of marijuana for medical use under the Controlled Substances Act (CSA). The FDA’s novel standard in recommending marijuana’s rescheduling is rooted in a logical fallacy: some people say that marijuana is medicine, so marijuana must be medicine. The FDA is delegating its authority to determine that medications are safe and effective to popular opinion, a practice that not only exceeds the statutory authority of the agency but makes a mockery of the congressional intent of the Food, Drug, and Cosmetic Act to protect the public health. Following the FDA’s logic, psychedelic drugs, which are seeing a popular push for medical legalization, could also be considered medicine and be rescheduled due to shifting public opinion.  The FDA compares marijuana to a limited, hand-picked list of other controlled and noncontrolled substances (e.g., heroin, alcohol, cocaine), not all Schedule I drugs.    In the recommendation, the FDA measured marijuana’s potential for abuse by comparing it to a hand-picked selection of Schedule I, II, and III drugs. For example, the FDA compared marijuana to heroin, another Schedule I drug. The recommendation claims that because marijuana has a lower abuse potential than heroin, it shouldn’t be in the same category. Yet the FDA failed to compare marijuana to other Schedule I drugs, such as LSD. Comparing marijuana’s abuse potential against all Schedule I drugs would have allowed for a more rigorous analysis, but it would not have allowed the FDA to conclude that marijuana belongs in Schedule III. To qualify for Schedule III, a drug or other substance must have “potential for abuse less than the drugs or other substances in Schedules I and II” (21 USC 812(b)). Fifty years of data published by HHS show that marijuana does not meet this standard.  None of the studies used by the FDA to justify its claim that marijuana is medicine support that conclusion.    The FDA determined that marijuana is acceptable for medical use for pain, nausea and vomiting, and anorexia. Only three studies were used to justify this claim. The first (University of Florida), concluded that results were “inconclusive or mixed.” The second (National Academies of Sciences & Medicine) relied primarily on a study for which the results were not statistically significant. For the third (Agency for Healthcare Research and Quality), the FDA concluded that the positive effects of marijuana in the study were small and that “the increased risk of dizziness, nausea, and sedation [from marijuana use] may limit the benefit” (page 27 of 252). Furthermore, some of these studies were with inhalable marijuana; prior FDA evaluations have excluded inhalable marijuana studies because of their unreliability and questionable practices. 

The Legalization of Marijuana; thoughts and opinions

Drew Horowitz, MA, LADC, LPCC, CIP
Owner & CEO, Horowitz Health

Minnesota Legalizing Marijuana Is a Big, Potentially Bad Deal
For those who are easily influenced, mentally shaky or predisposed to addiction, legalization is as good as an endorsement, one that’s more likely to harm than not.  

It’s not going to be OK.  

As someone who, substance-wise, has been there, done that; who founded and operates multiple Twin Cities substance abuse recovery programs; who as a clinical therapist and interventionist has helped more than 1,000 families steer their loved ones into treatment, I sound this ominous note from too much hard experience. Plenty of research (linked throughout) backs up that this isn’t just me being a naysayer—research that stands to become reality in Minnesota after recreational marijuana becomes legal August 1, 2023.    Legalization sends the message, particularly to those most at risk—youth—that marijuana is safe enough to be legal just like alcohol and nicotine, never mind that those substances are ineffectively subject to the same age 21 limitation and are addiction mainstays. For many—especially, again, our youth—the state’s medical marijuana preestablished a luster around marijuana that, if it’s helpful and good for some, it’s helpful and good for anyone experiencing any pain or discomfort. Look where medical endorsement of opioids as painkillers led us. Apples to oranges? The point is people don’t ask questions when they’re seeking relief.   

Promoting marijuana as a means of self-medication or, worse, a casual, “recreational” plaything will be extremely harmful to our community, and by “community” I don’t just mean the recovery community.  

Here’s what I anticipate is coming and what we can do about it:  

Increased marijuana use
“Why not? It’s legal!”Research in the Journal of the American Medical Association’s (JAMA’s) psychiatry publication showed that legalizing recreational marijuana in the U.S. has led to increases in cannabis use disorder in both adults and respondents ages 12 to 17 years, despite the legal age for use being 21. This early reliance sets the stage for marijuana-related mental health and substance use disorders.  

Addiction and dependence
Although marijuana isn’t considered as physically addictive as, say, opioids, many individuals develop a psychological dependence on it. Some of the most horrifying cases I’ve faced professionally were those who classified as “chronic marijuana users.” If it alters your mood, it’s addictive, period. Research in Drug and Alcohol Dependence, an international journal on biomedical and psychosocial approaches, examined medical marijuana laws across the country and found that legalization increased dependence and addiction by almost 4 percent: a relatively significant jump, given the total population. Marijuana users are also more likely to consume alcohol compared to non-users, according to research published in the National Institute of Health’s National Library of Medicine.  

Mental health impact
Marijuana use has been associated with an increased risk of mental health issues, particularly in vulnerable individuals. These conditions include 1) anxiety disorders, 2) depression, 3) psychosis and 4) an increased risk in predisposed individuals of developing schizophrenia. I’ve seen countless teens and young adults become psychotic from marijuana use. Worse is when they become isolated, paranoid and unable to function at a standard level. Preteens, teens and young adults don’t cognitively process risk and reward the way adults do, plus they’re more prone to experiment if substances are easy to come by and don’t have legal consequences. Trauma (known or repressed) survivors of all ages as well as individuals with existing anxiety disorders tend to become more symptomatic with marijuana use, opening the floodgates to ever-worsening conditions.  

Impaired cognitive functioning
Heavy, prolonged marijuana use, especially during adolescence (defined as ages 10 through 24) when the brain is still developing, has been linked to cognitive impairments the likes of reduced intelligence, memory deficits (Lisdahl et al., 2012)and decreased attention span. Such diminishment can affect educational and occupational outcomes and may require interventions to support affected individuals. In my practice, I notice that many of the students and young adults who already struggle with academics/work demands, anxiety or low self-esteem appear to begin using marijuana to cope with these issues, only to discover that marijuana make them worse, which then causes more challenges: dependence, mental health problems and hopelessness.   

Professional preparedness
Not only will legalization likely increase demand for mental health services and treatment, substance use disorder recovery programs will have to adapt their approaches and develop specialized programming. Marijuana users argue that its effects and impacts aren’t as harmful as stronger substances such as cocaine and heroin. Less lethal or not, it’s all relative when it comes to treating addiction, which is less about the drug’s strength than who can function or not function while using. Many of those in treatment for more harmful substances will agree to discontinue the bad stuff but continue to use the more widely accepted and now- legal marijuana. This will trigger an increase in relapse, which typically leads a person back to their substance of choice (the more lethal one). As it stands currently, marijuana is illegal and counselors are able to point to the fact that using illegal substances is highly discouraged and risky for continued sobriety. Counselors can certainly still point out that marijuana is a dangerous substance for those in recovery.  Addiction, however, is an illness of justification, one that uses any angle possible to justify a return to use.  

Concern about readiness to deal with more marijuana-related health issues isn’t limited to those of us who treat substance use disorder. It applies to physical health, too: Take organ transplants as Exhibit A. And it very much applies, as touched upon above, to mental health. The American Counseling Association has issued guidelines around the mixed messaging, i.e., marijuana may be legal in Minnesota but is still classified as a controlled substance federally. The Minnesota Psychiatry Society issued a statement not supporting legalization. And now?  

As a professional at the nexus of the above considerations, I’m grateful that the consequences of marijuana legalization are still being studied; however, we’ve already crossed into a dangerous area: The Minnesota law is passed. Only with candid, widespread public education can its impacts defy the existing research.  

To be totally transparent, I’m scared. 
I’m scared for our children, teens and high schoolers who’ll gravitate toward trying a drug they never thought they would.  

I’m scared for the kid—the adult! —who’s depressed and withdrawn and who, instead of considering a true antidepressant medication or natural coping strategies, will use marijuana to address their issue.  

I’m scared for addiction and mental health professionals. We’ll be on the receiving end of a massive influx in hospitalizations, people seeking treatment, high rates of relapse and substantially worsening mental health symptoms—this on the heels of COVID, during which we’ve seen a surge in mental health needs and massive spike in addiction. We simply are not prepared for this never-seen-before phase into which we’re being pushed.  

The call now—and it’s a loud, urgent one—is for education, be it parents to their kids, teachers to their students, friends to their friends, counselors to their clients, doctors to their patients, recovery professionals to everyone who’ll listen: Marijuana may be legal, but it’s not without substantial risk.

Op Ed in Denver Post

By BOB TROYER | Guest Commentary
September 28, 2018 at 4:51 pm
In 2012 we were told Colorado would lead the nation on a grand experiment in commercialized marijuana. Six years later – with two major industry reports just released and the state legislature and Denver City Council about to consider more expansion measures – it’s a perfect time to pause and assess some results of that experiment.
Where has our breathless sprint into full-scale marijuana commercialization led Colorado?
Well, recent reports from the Rocky Mountain High Intensity Drug Trafficking Area, from Denver Health, from Energy Associates, from the Colorado Department of Revenue and from the City of Denver should be enough to give everyone in this race pause.
Now Colorado’s youth use marijuana at a rate 85 percent higher than the national average. Now marijuana-related traffic fatalities are up by 151 percent. Now 70 percent of 400 licensed pot shops surveyed recommend that pregnant women use marijuana to treat morning sickness. Now an indoor marijuana grow consumes 17 times more power per square foot than an average residence. Now each of the approximately one million adult marijuana plants grown by licensed growers in Colorado consumes over 2.2 liters of water – per day. Now Colorado has issued over 40 little-publicized recalls of retail marijuana laced with pesticides and mold.
And now Colorado has a booming black market exploiting our permissive regulatory system – including Mexican cartel growers for that black market who use nerve-agent pesticides that are contaminating Colorado’s soil, waters, and wildlife. Marijuana commercialization has led Colorado to these places. It also has led to Colorado’s prominence in other states considering commercialization.
As the U.S. attorney leading other U.S. attorneys on marijuana issues, I have traveled the country and heard what people are saying about Colorado. Do they tout Colorado’s tax revenue from commercialized marijuana? No, because there’s been no net gain:  marijuana tax revenue adds less than one percent to Colorado’s coffers, which is more than washed out by the public health, public safety, and regulatory costs of commercialization.
Do they highlight commercialization’s elimination of a marijuana black market? No, because Colorado’s black market has actually exploded after commercialization: we have become a source-state, a theater of operation for sophisticated international drug trafficking and money laundering organizations from Cuba, China, Mexico, and elsewhere.
Do they promote our success in controlling production or containing marijuana within our borders?  No, because last year alone the regulated industry produced 6.4 metric tons of unaccounted-for marijuana, and over 80,000 black market plants were found on Colorado’s federal lands.
Does the industry trumpet its promised decrease in alcohol use? No, because Colorado’s alcohol consumption has steadily climbed since marijuana commercialization. How about the industry’s claim that marijuana will cure opioid addiction? No, a Lancet study found that heavy marijuana users end up with more pain and are more likely to abuse opioids.
Yet on that last point, the marijuana industry is trying to exploit our nation’s opioid tragedy to push its own controlled substance as a panacea. Why? It’s a profit opportunity.
Which is also how they see our youth. Which is why in Colorado they now sell marijuana-consumption devices that avoid detection at schools, like vape pens made to look like high-lighters and eye-liner.
These are the same marketers who advertise higher and higher potency marijuana gummi candy, marijuana suppositories, and marijuana “intimate creams.” This aggressive marketing makes perfect sense in addiction industries like tobacco, alcohol, opioids, and marijuana. These industries make the vast majority of their profits from heavy users, and so they strive to create and maintain this user market. Especially when users are young and their brains are most vulnerable to addiction.
I’m not sure the 55 percent of Coloradans who voted for commercialization in 2012 thought they were voting for all this.
These impacts are why you may start seeing U.S. attorneys shift toward criminally charging licensed marijuana businesses and their investors. After all, a U.S. attorney is responsible for public safety.
My office has always looked at marijuana solely through that lens, and that approach has not changed. But the public safety impacts of marijuana in Colorado have.
Now that federal enforcement has shot down marijuana grows on federal lands, the crosshairs may appropriately shift to the public harms caused by licensed businesses and their investors, particularly those who are not complying with state law or trying to use purported state compliance as a shield.
We should pause and catch our breath before racing off again at the industry’s urging. Let’s call it “just say know.” Let’s educate ourselves about the impacts of commercialization. Let’s reclaim our right as citizens to have a say in Colorado’s health, safety, and environment. Unfettered commercialization is not inevitable. You have a say.
Bob Troyer became the U.S. attorney for the District of Colorado in 2016 after working as first assistant U.S. attorney for six years.
https://learnaboutsam.org/

The Fentanyl: The Real Deal

The Fentanyl: The Real Deal video release event is scheduled for 30 August 2018 from 2:00 – 3:30 p.m. EST (1:00 p.m. to 2:30 p.m. CST).

America’s first responders—including law enforcement officers, firefighters, and emergency medical services (EMS) providers—are increasingly likely to encounter fentanyl and other synthetic opioids during the course of their daily activities, such as overdose calls and traffic stops, arrests, and searches.

The video is designed for roll call training and reinforces key messages from the Fentanyl Safety Recommendations for First Responders.

Please feel free to join the launch of the video on livestream at https://www.youtube.com/watch?v=UkxT0bgekQ8.

Chronic State

Chronic State is a new and powerful documentary on the consequences of drug legalization. It was produced by the DrugFree Idaho coalition in Boise, Idaho in partnership with the amazing documentary film team of Ronn Seidenglanz and Tanya Pavlis (Sidewayz.com).

Short Trailer: https://vimeo.com/280127474

Free access to full documentary, “Chronic State” can be found on the DrugFree Idaho website.

The documentary can also be accessed directly from DrugFree Idaho’s Vimeo page.

Chronic State