Neutral Testimony of Paul J. Larkin on Kansas S.B. 555
March 28, 2024
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 Larkin, and I am the John, Barbara & Victoria Rumpel Senior Legal Research Fellow in the Edwin J. Meese III Center for Legal and Judicial Studies at the Heritage Foundation.REF Among other subjects, I research issues that fit under the umbrella of drug policy. I have written on the subject of cannabis in articles published by the Heritage FoundationREF and by private law or public policy journals.REF I also have testified before Congress and the state legislatures in Virginia and South Carolina on that subject.REF In my opinion, Kansas Senate Bill 555, which seeks to create a medical cannabis program, is unwise for several reasons summarized below.
In short, the bill fails to recognize that the term “medical cannabis” (or “medical marijuana”) is an oxymoron. The cannabis plant contains numerous biologically active compounds, known as cannabinoids. Some of them are useful. Others might be, depending on their concentration, but we do not yet know whether they are useful or harmful. Still others likely are not beneficial and might well be harmful to humans. We do not yet know the answer to those questions for every cannabinoid because neither the federal government nor Kansas has adequately studied the potential benefits of cannabinoids. What we do know is that Senate Bill 555 does not require participants in the proposed medical cannabis program to await the determination of the Food and Drug Administration (FDA) before distributing cannabis flowers, pills, tablets, patches, or ointments to patients. For 86 years, the nation has entrusted the FDA with the responsibility of protecting the public against the distribution of potentially unsafe, ineffective, and disuniform pharmaceuticals. This bill mistakenly rejects that judgment. It commits other errors too.
I. The Kansas Medical Cannabis Pilot Program
Kansas Senate Bill 555 seeks to create a “Medical Cannabis Pilot Program” to be administered by the state Secretary of Health and the Environment.REF The program would empower that official to enter into contracts with no more than fourREF “medical cannabis operators”">REF to allow “distribution hubs”—viz., wholesale or retail stores that sell cannabisREF—to sell “medical cannabis product[s]”—viz, a product containing one or more biologically active compounds known as cannabinoidsREF—in the form of pills, tablets, patches, and ointments, as well as the cannabis flower itself, to users.REF Some of those products will be infused with delta-9-tetrahydrocannabinol (THC), the principal psychoactive ingredient in cannabis.">REF The apparent goal is to alleviate the symptoms of onlyREF the “qualifying medical conditions” diseases identified in the bill, such as AIDS, Lou Gehrig’s Disease, Parkinson’s Disease, and multiple sclerosis.REF
II. The Mistakes that California Made in the Original State-Authorized Medical Cannabis Program
Senate Bill 555 would not make the same mistakes that California made in 1996 by passing Proposition 215—a citizens’ initiative entitled the Compassionate Use Act—that created the nation’s first state-authorized medical cannabis program.REF Reformers argued that medical cannabis was necessary to alleviate the suffering of the dying and crippled in a manner that no other drug could effect. In truth, however, as the initiative’s supporters ultimately admitted,REF the bill was just a disguised effort to legalize recreational cannabis use.REF “Medical marijuana advocates also took advantage of the belief that little harm and possibly some good could result from allowing medically-condemned patients to achieve some respite from their tragic predicaments by whatever means they found useful, means that harmed no one else.”REF That initiative allowed the use of old-fashioned smokable botanical-form cannabis to be deemed a legitimate medical treatment—even though the Federal Food and Drug Administration has never approved agricultural cannabis as a legitimate medical therapy for any affliction,REF and no responsible physician would recommend inhaling burnt carbon products into one’s lungs.REF Moreover, while the California initiative legalized the sale of agricultural cannabis for a host of truly serious maladies, such as end-stage cancer and multiple sclerosis, that was just a marketing ploy. Proposition 215 also authorized a physician to recommend its use for “any other illness for which marijuana provide relief,” which includes a mild feeling of sadness caused by a cloudy day, or any other condition that a physician thought could be comforted by getting “buzzed.”REF Because “[t]he claim that the plant form of marijuana can and should be smoked for medical purposes is a hobgoblin,”REF the hypocrisy of California’s “medical” cannabis Proposition 215 should be a “given.”REF
Sadly, other states have succumbed to the same tempting hypocrisy. They have passed similar laws, perhaps for the purpose of appeasing the interest groups in favor of liberalized cannabis use, perhaps to give in to every legislator’s ever-present, never-satisfied desire to find an additional activity to tax to fund favored programs, or perhaps to satisfy patients (and their families) clamoring for whatever relief cannabis’s euphoria might provide the dying. The first two explanations are hardly noble ones, but the last reason is just self-delusion. “Caring without science is well intentioned kindness,” but it is “not medicine.”REF Hopefully the Kansas legislature will not yield to one of those rationales. That other states have made such mistakes should not serve as a precedent for Kansas following suit.
It is also important to recognize that cannabis cannot serve as an analgesic substitute for opioids. While it is true that numerous individuals have long argued (and some government reports and private studies have even concludedREF) that the psychoactive ingredient in cannabis has an analgesic effect for some types of pain,REF THC cannot alleviate the type of pain characteristic of end-stage cancer; only opioids can provide the necessary relief.REF Studies also reveal that the hoped-for pain-relieving effect of cannabis has not panned out.REF Besides, if every substance that offered some pain-killing benefit were deemed a “medicine,” the ethanol in Wild Turkey would be on that list. Dr. Peter Bach, a physician and Director of the Center for Health Policy and Outcomes at the Memorial Sloan Kettering Cancer Center, certainly would not classify either one of those “painkillers” as a medicine. In his words, “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.”REF
III. The Mistakes that Kansas Would Make in Its Proposed Medical Cannabis Pilot Program
While Senate Bill 555 avoids the mistakes that California made—and its drafters and sponsors deserve credit for avoiding those flaws—the bill makes other mistakes in the process. They are discussed below.
A. Senate Bill 555 Would Approve the Distribution of Drugs that the FDA Has Not Found to be “Safe,” Effective,” and “Uniform”
In 1938, Congress and the President teamed up to enact the Federal Food, Drug, and Cosmetic Act (FDCA), to protect the nation against the interstate distribution of harmful drugs.REF Since then, the nation has trusted the Commissioner of Food and Drugs with the responsibility to decide whether a particular compound is a “new drug,” and, if so, whether it is “safe,” “effective,” and “uniform.”REF The U.S. Department of Health and Human Services, the FDA’s parent agency, has concluded that the plant form of cannabis is a “new drug,” rendering it subject to the FDCA, and the FDA has never found that the cannabis plant itself is “safe,” “effective,” and “uniform” conditions that must be satisfied before any new drug may be distributed in interstate commerce.REF Extracting THC from cannabis plants and manufacturing pills, capsules, patches, and ointments containing that ingredient is not materially different from the process of using any other agricultural product as the raw material for a hoped-for medical therapy. Opioids, for example, can be synthesized from the poppy plant. That is how pharmaceutical companies manufacture morphine.
The FDA is certainly capable familiar with this matter. That agency has approved the synthetic THC analogues dronabinol (Marinol) and nabilone (Cesamet) for treatment of chemotherapy-induced nausea and emesis, and appetite stimulation in cachexic patients suffering from cancer or HIV/AIDS wasting syndrome. The FDA has also approved Epidiolex, a purified form of cannabidiol (CBD), for use in the treatment of Dravet's Syndrome and Lennox-Gastaut Syndrome, two severely debilitating forms of childhood-onset epilepsy. So, the FDA knows how to decide whether a particular pill or tablet is helpful or harmful. Senate Bill 555 rejects that approach without offering a justification for doing so.
B. Senate Bill 555 Would Approve the Distribution of Drugs that Contain Dangerous Contaminants
Senate Bill 555 does not prohibit the appearance of dangerous toxins in pills, capsules, and the like. There is, of course, no guarantee that cannabis will not be dangerous. Dr. Nora Volkow, the Director of the National Institute on Drug Abuse, told Congress in 2020 that “in general,” we lack “adequate and well-controlled studies” to test the safety and efficacy of the cannabis sold in states with legalized medical-use or recreational-use régimes.REF As a result, “individuals across the country are using cannabis strains and extracts that have not undergone the rigorous clinical trials required to show that they are safe and effective for medical use, and are not regulated for consistency or quality.”REF The ancient age of the cannabis plant does not prove that it is safe, REF nor is that age proof that the FDA would find that today’s cannabis products are safe.REF In fact, commercial cannabis can contain a “hodgepodge” of more than 400 compounds, some of which are dangerous contaminants.REF
Senate Bill 555 attempts to avoid those problems in several ways. It empowers the Secretary of Health and Environment to enter into a contract with a laboratory for batch testing purposes.REF The bill also directs that laboratory to establish “compliance thresholds” for harmful substances such as microbials (e.g., E. coli, fungi, mold), toxins (e.g., aflatoxins), pesticides (e.g., organophosphates), and heavy metals (e.g., arsenic, cadmium, lead, mercury).REF And the bill directs the remediation or destruction of batches that do not meet these safety standards.REF
The problem, however, is that Senate Bill 555 does not explain why the compliance standard for such obvious contaminants should not be zero. Why should any amount of E. coli, aflatoxin, organophosphate pesticides, and heavy metals like arsenic, cadmium, lead, or mercury be allowed in any product sold in Kansas. Why is that a reasonable approach to protecting public health? Does the state health code permit those contaminants in any other drugs sold in Kansas? The people for whom this bill is supposed to alleviate their suffering are already very or deathly ill, so why should they be exposed to poisons like those? Senate Bill 555 does not address those questions. Nor does the bill explain why the FDA would permit a drug to be distributed in interstate commerce that contains such contaminants. Finally, the bill does not explain why Kansas should expose its citizens to dangerous contaminants that the FDA would not allow to be contained in drugs that are sold to residents in other states.
It should. There is no good reason why Kansas legislators should avoid taking a position on those questions and accepting responsibility for the distribution and use of harmful contaminants by directing a state-contracted laboratory to decide just how much danger a cannabis product should pose. That is not the appropriate action of a responsible legislator. Insofar as the issue would be based on a scientific estimate of the amount of E. coli or mercury that should be allowed in pharmaceuticals sold in that state, the legislature is in a position to convene a hearing so that it can obtain the opinions of physicians, toxicologists, scientists, and others who are experts on the subject. Insofar as that judgment might need to be updated on an annual basis, the state legislature can reconvene whatever hearings are necessary, or seek the opinion of the Kansas Secretary of Health and Environment.
C. Senate Bill 555 Does Not Address the Problem of Drug-Impaired Driving
Cannabis, like alcohol, impairs a driver’s ability to handle a motor vehicle safely.REF “Today there is a wealth of evidence that marijuana is an impairing substance that affects skills necessary for safe driving.”REF Cannabis use enhances the risk of roadway, crashes, maimings, and fatalities, and thereby poses a serious national problem.REF In 2010, Gil Kerlikowski, Director of the Office of National Drug Policy in the Obama Administration, found that drug-impaired driving is as serious a problem as the better-known problem of alcohol-impaired driving and deserves the same aggressive response.REF Cannabis’ impairing effect is aggravated when a user also consumes alcohol, a not-infrequent occurrence. “The psychoactive ingredient in each drug—THC- and ethanol, respectively—amplifies the effect of the other, making a cocktail of the two a particularly dangerous combination.”REF As a result, a person who has consumed THC and ethanol can be incapable of safe driving even if he or she does not have a sufficient quantity of alcohol in his or her blood to fail the standard 0.08 grams per deciliter (g/dL) blood-alcohol test.REF
In its current form Senate Bill 555 will exacerbate the problem of drug-impaired driving in Kansas. Kansas Bill 555 recognizes that problem because Section 22(d) makes clear that authorization to use cannabis for medical purposes is not permission to “drive while stoned.”REF Numerous proposals would address this problem. Among them are the following:
- Proposal: Apply to every driver under age 21 who tests positive for any illicit or impairing drug, including cannabis and impairing prescription drugs, the same zero-tolerance standard specified for alcohol, the use of which in this age group is illegal.
- Proposal: Apply to every driver found to have been impaired by drugs, including cannabis, the same remedies and penalties that are specified for alcohol-impaired drivers, including administrative or judicial license revocation.
- Proposal: Test every driver involved in a crash that results in a fatality or a serious injury (including injury to pedestrians) for alcohol and impairing drugs, including cannabis.
- Proposal: Test every driver arrested for driving while impaired for both alcohol and impairing drugs, including cannabis.
- Proposal: Require state and local law enforcement officers to use reliable oral fluid testing technology at the roadside for every driver arrested for impaired driving.
- Proposal: Collect data on all crashes in which cannabis is suspected to have contributed to the crash and report that data to the National Highway Traffic Safety Administration.
- Proposal: Require hospitals, emergency care, and related facilities to collect/collate/publish alcohol/drug/polydrug data.
- Proposal: Create a database collecting the information for alcohol- and drug-impaired driving arrests and convictions that is accessible by state and local law enforcement officers and transmit that information to the FBI for its National Crime Information System database.
- Proposal: Require that every person applying for a driver’s license and renewing a past license to be informed of all prescription drugs that can impair driving, as well as all illicit drugs.
- Proposal: Implement a “24/7 Sobriety” program like the one in South Dakota.REF
- Proposal: Require that the Commonwealth’s DWI recordkeeping separately classify alcohol, drugs, and polydrug use.
- Proposal: Lower the Blood-Alcohol Content Threshold from 0.08 g/dL to 0.05—or 0.0—for every driver who has consumed cannabis.
- Proposal: Fund pilot projects in various districts to determine how many people are driving while impaired by drugs or alcohol.
- Proposal: Improve the training for state and local law enforcement officers necessary to recognize drug-impaired drivers.
- Proposal: Prohibit anyone who has consumed cannabis from driving for 24 hours after use.REF
Unfortunately, Senate Bill 555 contains none of these proposals. It should add all or at least some. That would not eliminate all of the problems in the bill, but it might actually save lives by reducing the likelihood that someone who is “one toke over the line”REF will get behind the wheel of a car.
Thank you for the opportunity to submit this statement.
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