The well-funded movement to medicalize marijuana spreading across our nation calls out for caution and restraint. Activists claim that marijuana is a safe medicine but de facto, it is evolving into a gateway for marijuana legalization. The claim conflicts with current science, with intelligent public health policy, with rigorous standards of the drug approval process, and with best practices of medicine.
In 2014, Floridians wisely rejected legalization of marijuana as a medicine by their votes on a ballot initiative. This sensible outcome was shaped by enough funds to educate the public on the realities of this critical issue and to counter misinformation circulating in Florida. But once again, the persistent marijuana industry is knocking on the gates of Florida, this time through legislative action in the Florida state House.
Florida Senator Rob Bradley, R-Orange Park, recently introduced an amendment to Florida Bill SB 460. In its original form, the bill limits the potency THC, of the main psychoactive, intoxicating, and addictive substance in marijuana, to 0.8%. The spirit of the bill was to provide access to cannabidiol, a candidate anti-seizure medication that has been essentially bred out of most of the marijuana sold in dispensaries nation-wide. Cannabidiol is not intoxicating, is not addictive, does not interfere with learning and memory, and may even oppose the psychosis induced by THC in susceptible people. In its original language, the bill allows for “low-THC cannabis”, the dried flowers of which contain 0.8 percent or less of tetrahydrocannabinol (THC), the main psychoactive and addictive component of marijuana and more than 10 percent of cannabidiol (CBD).
The Bradley amendment is a “Hail Mary pass” or a “cloaking device” or a “stealth bomber” –choose your metaphor. It is a furtive attempt to circumvent the decision of sage Florida voters who turned down the medical marijuana ballot initiative in 2014. The original bill wisely set THC levels at 0.8%, which are not generally intoxicating. Instead of referring to low-THC-cannabis, the amendment (line 35 onwards) now refers to low-THC cannabis and/or medical cannabis. By not defining medical cannabis, nor stating limits on THC doses, it opens the floodgates to “anything goes” – unspecified THC levels in marijuana that may range from 0.8 percent to 80 percent. In its current amended form, SB 460 creates a marijuana industry, allowing high potency marijuana and marijuana edibles (cookies, sodas, candy), which are inherently hazardous and without any scientific evidence of medical safety or effectiveness.
To circumvent FDA experts and the process, the marijuana industry and their advocates devised ballot or legislative initiatives, flooded public media, engaged in extensive lobbying of legislative bodies, with scientifically barren emotional claims. Whole plant marijuana as a medicine is not approved by the Food and Drug Administration (FDA), as the evidence is insufficient to fulfill rigorous criteria for approval. To weigh the scientific evidence within the legitimate drug approval process, the FDA convenes an expert team of chemists, pharmacologists, physicians, other scientists, statisticians who study thousands of pages of scientific data, before a decision is made to approve a drug and provide surveillance after approval. This effective and rigorous scientific process is reflected in physician and patient packet inserts of prescription drugs – they include the precise chemical composition of a drug that a patient will introduce into their body, how often to use it, evidence-based safe doses, how frequently it should be taken, what types of studies were used to show the drug’s effectiveness for a specific condition, how long it takes to have an effect and stay in the body, how the body metabolizes the drug, drug interactions, who should/should not use the drug, a list of unwanted side effects and what proportion of people manifest them, adverse events, and precautions, and other information. This type of document does not exist in marijuana dispensaries. If a false claim is made or an adverse effect sets in, who will protect the public? If a pharmaceutical company makes a false claim for an approved drug, the FDA sweeps in and fines them. It has extracted over $10 billion from drug companies in the past few years for unapproved claims. If adverse events rise to unacceptable levels, the FDA can restrict use of the drug, or label the drug with a severe “Black Box” warning, or withdraw the drug. These protections don’t exist for marijuana; there is no recourse for patients.
Why is whole plant marijuana not approved? Concerns focus on abuse liability, safety and effectiveness.
Abuse liability. Marijuana has high abuse potential, no currently approved medical use and is considered unsafe. At least 4.2 million Americans have a cannabis (marijuana) use disorder, with about 30.5 percent of current marijuana users harboring this problem. Long-time heavy users can experience a robust withdrawal, reflecting adaptive changes in the brain and body caused by the drug. Shortly after use, marijuana intoxicates and impairs higher brain functions, learning, memory, planning, and decision-making. Driving skills are reduced and the risk for injuries increases. Functioning at school or at work is compromised, especially because marijuana takes so long to clear from the body, days to weeks, and much longer compared with an alcohol binge. Complex human performance can be impaired as long as 24 hours after smoking a moderate dose of marijuana and the user may be unaware of the drug's influence. For 7 to 20 days, abstinent marijuana users may have impaired attention, concentration and impulse control. The most robust, durable deficits are documented in heavy, steady marijuana users. Even after one month of withdrawal, daily, heavy marijuana smokers can manifest impaired higher brain functions. Yet the indications for marijuana are for chronic medical conditions, requiring daily or more frequent use.
Safety. There is a strong association between marijuana use and psychosis or schizophrenia, in at least four ways: (1) marijuana can produce transient schizophrenia-like symptoms in some healthy individuals; (2) in those harboring a psychotic disorder, marijuana may worsen the symptoms, trigger relapse, and negatively affect the course of the illness; (3) susceptible individuals in the general population develop a psychotic illness with heavy marijuana use, which is associated with age of onset of use, strength of THC in marijuana, frequency and duration of use; (4) marijuana use is associated with lowering the age of onset of schizophrenia. Among youth, marijuana use is associated with poor grades and with high school drop-out rates, with those dropping out of school engaging in high rates of frequent marijuana use. Early use of heavy marijuana is associated with lower income, lower college degree completion, greater need for economic assistance, and higher unemployment. In sum, marijuana use is associated with an increased risk of degraded brain function, increased motor vehicle crashes, emergency department visits, psychiatric symptoms, reduced educational and employment achievement, reduced motivation, increased use of, and addiction to other drugs, and adverse health effects on the developing fetus.
Effectiveness. The FDA is not the only body that has questioned the effectiveness of marijuana. Non-government academic physicians and scientists have extensively scrutinized biomedical research (meta-analyses) on the use of whole plant marijuana for medical indications. Independently, they have concluded that there is scant, inadequate or no evidence that whole plant medicine is valuable as a first line treatment for a myriad of medical conditions claimed by the marijuana lobby. For edibles, rigorous evidence is at zero or near-zero levels. Indeed, many specialty medical associations (Neurology, Psychiatry, Ophthalmology, Pediatrics) do not endorse marijuana as a medicine.
Clearly, this collective information impacts the amended Florida bill! First, the amendment places no limits on THC concentration, and does not address marijuana potency to be used for a single medical condition. No potency limits for chronic conditions are incompatible with growing evidence that the stronger the marijuana and the more frequently it is used, the more likely (1) for symptoms of psychosis to appear, (2) for reduced age of onset of schizophrenia, (3) for increased impairment of driving and brain function. Second, in chronic medical conditions, daily and more frequent use of marijuana is likely and this will increase the many risks outlined above. Third, the amendment is vague on who can use, at what dose and for which specific diseases or symptoms. Yet, the more frequently marijuana is used and the longer the period of use, the more likely (1) for susceptible persons to become addicted to marijuana; (2) to become addicted to other drugs; (3) to sustain a reduction in I.Q.; (4) to be on welfare and unemployed; (5) to have psychotic episodes; and (6) to be less likely to complete high school or college.
The Bradley amendment, whether intended or not, is likely to set Florida on a well-trodden path to legalization of marijuana. Its current objective is to normalize and legalize distribution of potent, intoxicating marijuana as a medicine, in the absence of solid medical evidence. If it passes, the safeguards in the amended bill will not protect the public from an inevitable march towards unfettered access to, and de facto legalization of marijuana. The bill has little to do with compassionate use of marijuana for health, as open-ended THC doses have no scientific basis in medicine. But it will ensure that high potency marijuana becomes available to the public at large, inevitably spreading to youth, the real target of the marijuana industry. Early onset of marijuana use greatly increases the risk of becoming addicted to marijuana and to other drugs. Efforts to shield youth from marijuana have failed in states with “medical marijuana” laws as in these states, youth use marijuana more than in nonmedical marijuana states.
This amendment ignores the FDA, ignores meta-analyses completed by independent biomedical researchers, ignores the policy statements of reputable medical associations, and ignores current marijuana science. In 2014, Floridians wisely voted not to accept THC-laden marijuana as a “medical option”. Senator Bradley’s current amendment maneuvers the bill around the will of the people. Above all, this bill ignores the voters of Florida and the democratic process. Floridians should protest this amendment, a blunt force to suppress their opposition to marijuana.
Bertha K. Madras is a professor at Harvard Medical School.
