Analysis of HHS Cannabis Rescheduling Rationale

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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.  

1. 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). 

2. 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. 

3. 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. 

4. 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. 

5. 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. 

Why Legal Pot Makes This Physician Sick→

Last year, my husband and I took a 16-day road trip from Kentucky through Massachusetts to Maine. On our first morning in Boston, we exited the Park Street Station en route to Boston Common but instead of being greeted by the aroma of molasses, we were hit full-on with a pungent repulsive odor. "That's skunk weed," my husband chuckled as we stepped right into the middle of The Boston Freedom Rally, a celebration of all things cannabis.

As we boarded a hop-on-hop-off bus, we learned that this was the one week of the year that the city skips testing tour bus drivers for tetrahydrocannabinol (THC), "because we all test positive," the driver quipped. As our open-air bus circled the Common, a crowd of pot enthusiasts displayed signs in support of relaxed regulation for public consumption.

The 34-year-old Boston Freedom Rally is a sign that US culture has transformed forever. Mary Jane is no friend of emergency physicians nor of staff on hospital wards and offices. Healthcare workers should brace for the true impact of THC as its adoption by all ages rises.

Toking Boomers and Millennials

Researchers at University of California, San Diego looked at cannabis-related emergency department visits from all acute-care hospitals in the state from 2005 to 2019 and found an 1808% increase in patients aged 65 or older (that is not a typo) who were there for complications from cannabis use.

The lead author said in an interview that, "Older patients taking marijuana or related products may have dizziness and falls, heart palpitations, panic attacks, confusion, anxiety or worsening of underlying lung diseases, such as asthma or [chronic obstructive pulmonary disease]."

A recent study from Canada suggests that commercialization has been associated with an increase in related hospitalizations, including cannabis-induced psychosis.

According to a National Study of Drug Use and Health, marijuana use in young adults reached an all-time high (pun intended) in 2021. Nearly 10% of eighth graders and 20% of 10th graders reported using marijuana this past year.

The full downside of any drug legal or illegal is largely unknown until it infiltrates the mainstream market, but these are the typical cases* we see:

Let's start with the demotivated high school honors student who dropped out of college to work at the local cinema. He stumbled and broke his clavicle outside a bar at 2 AM, but wasn't sure if he passed out so a cardiology consult was requested to "rule out" arrhythmia associated with syncope. He related that his plan to become a railway conductor had been upended because he knew he would be drug tested and just couldn't give up pot. After a normal cardiac exam, ECG, labs, a Holter, and an echocardiogram were also requested and normal at a significant cost.

Cannabinoid Hyperemesis Syndrome

One of my Midwest colleagues related her encounter with two middle-aged pot users with ventricular tachycardia (VT). These episodes coincided with potassium levels < 3.0 mEq/L in the setting of repetitive vomiting. The QTc interval didn't normalize despite a corrected potassium level in one patient. They were both informed that they should never smoke pot because vomiting would predictably drop their K+ levels again and prolong their QTc intervals. Then began "the circular argument" as my friend described it. The patient claims, "I smoke pot to relieve my nausea," to which she explains that "In many folks, pot use induces nausea." Of course, the classic reply is, "Not me." Predictably one of these stoners soon returned with more VT, more puking, and more hypokalemia. "Consider yourself 'allergic' to pot smoke," my friend advised, but, "Was met with no meaningful hint of understanding or hope for transformative change," she told me.

I've seen cannabinoid hyperemesis syndrome several times in the past few years. It occurs in daily to weekly pot users. Very rarely, it can cause cerebral edema, but it is also associated with seizures and dehydration that can lead to hypovolemic shock and kidney failure.

Heart and Brain Harm

Then there are the young patients who for various reasons have developed congestive heart failure. Unfortunately, some are repetitively tox screen positive with varying trifectas of methamphetamine (meth), cocaine, and THC; opiates, meth, and THC; alcohol, meth, and THC; or heroin, meth, and THC. THC, the ever present and essential third leg of the stool of stupor. These unfortunate patients often need heart failure medications that they can't afford or won't take because illicit drug use is expensive and dulls their ability to prioritize their health. Some desperately need a heart transplant but the necessary negative drug screen is a pipe dream.

And it's not just the heart that is affected. There are data linking cannabis use to a higher risk for both ischemic and hemorrhagic stroke. A retrospective study published in Stroke of more than 1000 people diagnosed with an aneurysmal subarachnoid hemorrhage found that more than half of the 46 who tested positive for THC at admission developed delayed cerebral ischemia (DCI), which increases the risk for disability or early death. This was after adjusting for several patient characteristics as well as recent exposure to other illicit substances: cocaine, meth, and tobacco use were not associated with DCI.

Natural My…

I'm certain my anti-cannabis stance will strike a nerve with those who love their recreational THC and push for its legal sale, after all, "It's perfectly natural." But I counter with the fact that tornadoes, earthquakes, cyanide, and appendicitis are all natural but certainly not optimal. And what we are seeing in the vascular specialties is completely unnatural. We are treating a different mix of complications than before pot was readily accessible across several states.

Our most effective action is to educate our patients. We should encourage those who don't currently smoke cannabis to never start and those who do to quit. People who require marijuana for improved quality of life for terminal care or true (not supposed) disorders that mainstream medicine fails should be approached with empathy and caution.

A good rule of thumb is to never breathe anything you can see. Never put anything in your body that comes off the street: Drug dealers who sell cannabis cut with fentanyl will be ecstatic to take someone's money then merely keep scrolling when their obituary comes up.

Let's try to reverse the rise of vascular complications, orthopedic injuries, and vomiting across America. We can start by encouraging our patients to avoid "skunk weed" and get back to the sweet smells of nature in our cities and parks.

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*Some details have been changed to protect the patients' identities, but the essence of their diagnoses has been preserved.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology. She enjoys locums work in Montana and is a champion of physician rights and patient safety. In addition to opinion writing, she enjoys spending time with her husband and daughters, and sidelines as a backing vocalist for local rock bands. Her Heartfelt column was the 2022 northeast regional gold and national silver Azbee award winner. 

Brutal Marijuana Studies Now Emerging - It Should Never Have Been Fully Legalized

For years, marijuana advocates claimed that if only America would loosen restrictions, we'd all see how beneficial the drug is. But now, more than 10 years after the first efforts to do just that, we are seeing that the critics were right. Liberal pot laws and increased usage are far from the panacea pot-lovers claimed. Starting back in 2012, Colorado passed a law to allow private use of marijuana. Soon the state of Washington joined the Centennial State in loosening its pot laws. And many more came in the following years, especially when the states began to realize it could tax "legal" marijuana and bring millions into their state treasuries. Now even the federal government is looking to loosen the reins and is preparing to take pot off its Schedule One prohibitions, a move said to be the first step in decriminalizing marijuana. But now these states are finding that it is time to pay the piper, as a raft of ill-effects are spreading like wildfire all across the country. From mental illness to addiction and impaired driving, the effects on many are not as beneficial as advocates claimed. There do seem to be a very few beneficial uses for pot for a small number of people. It does help in pain relief for the chronically afflicted, it can help with nausea from chemotherapies and it is sometimes effective for those with anxiety. But all those benefits are limited and are far outweighed by the deleterious effects seen when widespread use is factored in, according to a raft of new studies reported by the Daily Mail. With a pool of more than 40 million pot users to look at, researchers are finding that recreational use of the drug is becoming an increasing problem everywhere it is being tried. As the Mail noted, researchers from the Aarhus University Hospital in Denmark have found that despite claims by pot advocates, the drug is just as addictive as any other drug. And 41 percent of users have developed major problems with depression. The research found that chronic marijuana use quadrupled risk of developing a bipolar disorder and added to a rise in psychotic breaks, including thoughts of, and deaths by, suicide, with pot linked to 30 percent of cases of schizophrenia. The researchers added that people who already have a propensity for these mental disorders often find that pot makes them worse, not better. That is nothing like the benign effects pot advocates claimed we'd be seeing. Pot advocates also claimed that one can't really become addicted to the drug. This has also been revealed as false. "New research from University of Washington and Kaiser Permanente Washington Health Research Institute estimates 21 percent of marijuana users had become addicted," the Mail reported, adding that at least four million Americans have developed "marijuana use disorder" since pot became so much easier to get. Another claim that many advocates have made is that pot will calm you and make sleep come easier. This is also not true, studies have found. "A 2021 study in the journal BMJ reported adults who used cannabis 20 or more times in the previous month were more likely than non-users to get six or fewer hours of sleep per night," the Mail reported. In addition, 39 percent of daily pot users developed clinical insomnia. An even more alarming study says that pregnant women will put themselves at a 70 percent higher risk of birth defects if they regularly use pot during pregnancy, and they will be 2.3 times more susceptible to a stillbirth. Also, "A 2022 study published in JAMA Pediatrics found prenatal cannabis exposure after five to six weeks of pregnancy is associated with attention, social and behavioral problems that persist into early adolescence," the Mail reported. Finally, the evidence seems irrefutable that heavy pot smoking is just as bad on your body as heavy tobacco smoking. Smoking anything -- pot or tobacco -- increases the risk of coronary artery disease and also puts users at an increased risk of lung disease. A study from Canada found that "three-quarters of marijuana users had emphysema - a lung disease which leaves sufferers struggling to breathe -- compared to two-thirds of tobacco users," the Mail wrote. While it might be a better idea to go to a prescription model, where only seriously ill people are able to gain access to pot, it seems clear that recreational and non-medicinal use has had detrimental effects on Americans.