Letter from Paul J. Larkin on North Carolina S.B. 3
February 7, 2023
Paul J. Larkin
The John, Barbara, and Victoria Rumpel Senior Legal Research Fellow
Edwin Meese III Center for Legal and Judicial Studies
The Heritage Foundation
My name is Paul J. Larkin. I am the John, Barbara, and Victoria Rumpel Senior Legal Research Fellow at the Heritage Foundation. I note my title and affiliation for identification purposes only. I offer my statement in my individual capacity. Members of the Heritage staff submit written statements as individuals discussing their own independent research. The views expressed here are my own and do not reflect an institutional position for Heritage or its board of trustees. Nothing I write or say should be construed as representing the views of Heritage.
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Pending before the North Carolina General Assembly is a bill—S.B.3—that would legalize cannabis use for medical purposes. The bill is unwise as a matter of policy, for a host of reasons. I will summarize a few of them below. A lengthier discussion can be found in the articles that, for your convenience, are cited in footnotes below and that accompany this letter.
1. S.B. 3 gets off on the wrong foot with its very first proposed finding: “Modern medical research has found that cannabis and cannabinoid compounds are effective at alleviating pain, nausea, and other symptoms associated with severe debilitating medical conditions.” That proposed finding is quite misleading.
For more than 80 years, the nation has endorsed the judgment that no one should be free to distribute any “new drug” in interstate commerce unless and until the Commissioner of Food and Drugs has found (inter alia) that the drug is “safe” and “effective” for its intended use. Under the Federal Food, Drug, and Cosmetic Act of 1938, the responsibility to approve the distribution of a “drug” in interstate commerce rests with the Commissioner. Aided by his or her lieutenants and staff at the U.S. Food and Drug Administration (FDA), the Commissioner must review all “new drugs” to determine whether they are “safe,” “effective,” and uniformly made for their intended treatment purposes. The FDA has never found that the agricultural or botanical form of cannabis is safe and effective. On the contrary, the FDA—along with other allied federal health care agencies such as the Office of the U.S. Surgeon General, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, and the Department of Health and Human Services—has consistently found that botanical cannabis is not a legitimate medication and that that smoking marijuana is not a legitimate medical treatment. As Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA), once wrote, “[m]arijuana is not a benign drug. It is illegal and has significant adverse health effects and consequences associated with its use.”
To be sure, the cannabis plant contains certain cannabinoids—viz., biologically active elements—that have therapeutic value if they are manufactured and processed by legitimate pharmaceutical companies. The FDA has approved the synthetic delta-9-THC analogues dronabinol (Marinol) and nabilone (Cesamet) for treatment of chemotherapy-induced nausea and emesis, as well as appetite stimulation in cachexic patients suffering from cancer or HIV/AIDS wasting syndrome. The FDA has also approved Epidiolex, a purified form of cannabidiol, for use in the treatment of Dravet's Syndrome and Lennox-Gastaut Syndrome, two severely debilitating forms of childhood-onset epilepsy. But the FDA has never approved the agricultural form of cannabis as a legitimate treatment. Indeed, the Biden Administration reiterated that conclusion as recently as April 2022, noting “HHS’s determination that cannabis has not been proven in scientific studies to be a safe and effective treatment for any disease or condition.”
Further research is necessary. Given the passage in the last Congress of the Medical Marijuana and Cannabidiol Research Expansion Act, which expands the opportunity for research to investigate the potential value of additional cannabinoids, there might be additional proof and potentially new FDA-approved treatments in the near future. It would be precipitous to approve a medical cannabis program until that research has been completed.
It is true that people have reported, and some studies have therefore concluded, that smokable cannabis can alleviate some pain—not severe or chronic pain, by the way; cannabis is not remotely potent enough to have that effect—through its euphoric effect. But so does bourbon, and that does not make a distilled spirit into a medication. Dr. Peter Bach, a physician and Director of the Center for Health Policy and Outcomes at the Memorial Sloan Kettering Cancer Center, made that very point. In his words, “[c]laims that marijuana relieves pain may be true. But the clinical studies that have been done compare it with a placebo, not even a pain reliever like ibuprofen. That's not the type of rigorous evaluation we pursue for medications.” Moreover, “every intoxicant would pass that sort of test because you don't experience pain as acutely when you are high. If weed is a pain reliever, so is Budweiser.” And no one claims that Budweiser is a safe and effective drug.
2. Atop that, the FDA could not find that raw cannabis is a safe, effective, and uniformly made. That is true for several reasons.
a. Start with the fact that commercially manufactured prescription and over-the-counter medicines contain pure and stable chemicals, which enables the FDA and physicians to know precisely what their patients are taking. Botanicals like marijuana do not. Unlike ordinary pharmaceuticals, marijuana is not a “standardized good”—that is, the plant is not a single chemical compound or a product with precise and uniform ingredients, formulations, and potency. On the contrary, the cannabis plant is “a chemically complex and highly variable” product—or, put more colorfully, “a complex chemical slush”—containing hundreds of different chemicals. Its chemical composition can vary along a host of parameters, such as strain, breeding, region, conditions and process of cultivation, harvesting stage, processing method, storage time, and the like. Moreover, due to selective breeding, marijuana comes in “hundreds of strains” with different chemical compositions. The lack of certainty and uniformity in the chemical makeup of different varieties of cannabis is a critical shortcoming under the standards demanded by contemporary medicine and law because neither the FDA nor a treating physician could know precisely what substances a patient would use.
b. Atop all that is another problem. Commercially sold marijuana can contain a “hodgepodge” of dangerous contaminants. Among them are microbials (e.g., E. coli, fungi, mold), toxins (e.g., aflatoxins), hazardous chemical solvents remaining from the extraction process (e.g., butane, hexane, propane), pesticides (e.g., organophosphates), heavy metals (e.g., arsenic, cadmium, lead, mercury), and other substances that are either harmful (e.g., formaldehyde) or distasteful (e.g., insects). The presence of any such dangerous contaminants would render a drug “adulterated,” and the FDA could not approve it.
c. The uncertain chemical content of the cannabis plant is not the only problem. The psychoactive component of marijuana—delta9-tetrahydrocannabinol or THC—has increased remarkably over time as growers have sought to enhance their profits by creating a more attractive psychotropic product. From the 1960s through the 1980s, marijuana had a THC content of approximately 3-4 percent. Today, the THC content can be 12-20 percent in the plant form or in hashish (dried cannabis resin and crushed plants). Hash oil, an oil-based extract of hashish, has a greater THC content in the range of 15-65 percent, while other formulations, such as oil extracts, can be in the 90-plus percent range for THC. Moreover, the psychoactive effect of THC varies according to an individual’s “set” (viz., user expectation) and the “setting” (viz., environment) in which use occurs. Given their variance from person to person and occasion to occasion, a physician could not be confident when predicting the effect of THC use on an individual patient. The result is that neither the FDA nor a recommending physician would know the potency of the cannabis that a patient would use, so neither one could accurately approve or recommend its use, respectively.
That development is an important one when considering whether to legalize cannabis for medical use. As NIDA Director Dr. Volkow has noted, that increase in THC content “raises concerns that the consequences of marijuana use may be worse now than in the past.” That is why Doctor Volkow has questioned “the current relevance of the findings in older studies on the effects of marijuana use, especially studies that assessed long-term outcomes.”
3. Some women who would be eligible for medical-use cannabis under S.B. 3—particularly, any woman seeking to obtain cannabis as a means of dealing with Post Traumatic Stress Disorder (PTSD)—could be pregnant. The result is that “two different individuals may experience the potential adverse effects of cannabis,” only one of which has any say in the matter. Numerous women use cannabis while pregnant or nursing, and THC rapidly crosses the placenta, becoming present in a child in utero (albeit in a lower quantity). There is a considerable body of research discussing the adverse effects of maternal alcohol use and cigarette smoking on fetal development. By contrast, there are fewer studies of the effect of maternal cannabis use on a developing child, and they point both ways. Nonetheless, the evidence that does exist gives reason for concern and makes it unwise to allow physicians and others to encourage cannabis use by women while pregnant or nursing. In fact, given what we now know, the appropriate response would be to make it a crime to dispense cannabis to such women.
4. Cannabis use by minors is a potentially serious problem. S.B. 3 does not protect against the risk of children obtaining cannabis edibles made to look like candies. Juveniles have a labile (i.e., still developing and easily altered) brain, and cannabis can adversely affect its development. That is why, along with the federal government agencies noted above, the American Medical Association, the American Psychiatric Association, the American Academy of Pediatrics, the American Cancer Society, the American Academy of Ophthalmology, the National Institute for Drug Abuse, and others agree that minors should not use cannabis. Yet, “[b]usinesses have developed edibles that resemble the traditional candies attractive to children. Some edibles resemble ‘Gummy Bears,’ while others have been labeled as ‘Pot Tarts,’ ‘Buddahfinger,’ ‘Munchy Way,’ or ‘Keef Kat.’” S.B. 3 does not forbid the manufacture or creation of cannabis edibles in forms that would be attractive to minors, especially children.
5. Finally, S.B. 3 takes no steps, let alone any serious ones, to forestall the increase in cannabis-impaired driving that would inevitably occur if North Carolina were to allow medical-use cannabis. Like alcohol, the principal psychoactive ingredient in cannabis—THC—compromises a person’s ability to safely handle a motor vehicle. THC impairs the mental functioning necessary to drive safely by (among other things) slowing reaction time, weakening attention, distorting time and space, creating short-term memory deficits, and hampering eye-hand-foot coordination. That impairment does not automatically or rapidly dissipate. It can last for hours; in long-term heavy users, it can last for as much as several weeks. Unfortunately, a fair number of cannabis users reported driving under the influence of cannabis. (What is truly frightening is that a considerable number of individuals believe that cannabis use not only does not impair their ability to drive safely, but also that it actually improves their driving skills, a conclusion that is demonstrably false.) Atop that, a large number of cannabis users combine it with alcohol, which multiplies the problem, because each substance augments the disabling effect of the other. Sadly, the evidence from Colorado reveals that in 2019 one person died every 3.5 days from a marijuana-related traffic crash. It therefore should surprise no one that the National Highway Traffic Safety Administration, the National Transportation Safety Board, White House Office of National Drug Control Policy, the Governors Traffic Safety Council, the AAA Foundation for Highway Safety, the Insurance Institute for Highway Safety, the International Association of Chiefs of Police, the National Sheriffs Association, the National District Attorneys Association, and private researchers are troubled by the risks posed by cannabis-impaired driving. It would be perilous to approve cannabis use even for medical treatment without first acting to prevent the maiming and death of innocent victims of drug-impaired driving.
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The bottom line is this: smokable cannabis is not a legitimate therapeutic treatment modality. The late Charles Krauthammer—a graduate of the Harvard Medical School, a psychiatrist, and a political commentator—made that point well, precisely, and simply. As he explained, to “pretend” that cannabis “is merely help for the terminally ill” is simply an attempt to legitimize a “morally dubious proposition.” Smokable cannabis as medicine? “Be serious. The medical effects of marijuana for these conditions are nil. They are, as everyone involved in the enterprise knows—and as many behind [California’s 1996] Prop 215 intended—a fig leaf for legalization.”
I do not mean to suggest that everyone who supports legalizing cannabis for medical use is acting out of an illegitimate motive. Some people certainly are, but not everyone is. Some individuals are motivated by compassion for the dying, and compassion is a virtue. But we should not confuse compassion with medicine. “Caring without science is well-intentioned kindness, but not medicine.” Bills like S.B. 3 conflate the two.