This is the second part of a two part series. Read Part 1 HERE.
The refusal of the DEA to reschedule marijuana is based on a narrow interpretation of the Controlled Substances Act (CSA), which is based on the premise that only standardized pharmaceutical products can have an accepted medical use in the United States.
The DEA’s action, formally announced in extensive filings in the Federal Register on August 12, came in response to separate rescheduling petitions—one filed by the states of Rhode Island and Washington and another filed by nurse practitioner Bryan Krumm (from New Mexico). The DEA decision is largely based on a literature review conducted by the Food and Drug Administration (FDA) and that agency’s subsequent recommendation to reject the petitions’ request that marijuana be rescheduled.
The scientific and medical review conducted by the FDA includes a number of interesting conclusions about what research on marijuana has established about the effects of acute (initial) and chronic (regular) use of the drug. Many of these conclusions are favorable to the argument that marijuana is not sufficiently dangerous to justify criminal sanctions for its cultivation, distribution or use. There is a lot here that supports arguments for legalization.
Here are some of the conclusions reached in the FDA review.
First, just what are the effects of marijuana use?
According to the FDA, the effects of marijuana use include “disinhibition, relaxation, increased sociability, and talkativeness, Increased merriment and appetite . . .exhilaration at high doses, enhanced sensory perception, which can generate an increased appreciation of music, art, and touch, [and] heightened imagination, which can lead to a subjective sense of increased creativity.” However, additional effects include “initial dizziness . . .disorganized thinking . . .impaired judgement . . .illusions, delusions . . . [and] confusion, drowsiness and panic attacks, which are more common in inexperienced or high-dosed users.” These are the psychoactive effects, but they leave out any recognition of the therapeutic effects recognized by patients and medical practitioners.
Second, many people are curious why marijuana is not officially recognized as having accepted medical use, while Marinol, a synthetic THC (the primary active ingredient in marijuana) pill, does. Basically, the CSA was written by Congress and interpreted by the FDA and DEA to favor standardized pharmaceutical products.
As such, Marinol was able to satisfy the criteria used to determine accepted medical use in the United States. Futhermore, Marinol (claims the DEA) has a lower potential for abuse than marijuana because it consists of a “highly complex . . . encapsulated sesame oil mixture” in which the oral route of administration mitigates against abuse. Also, despite the drug’s widespread availability, there “have been no significant reports of abuse . . . due to Marinol.” The high potential for abuse of marijuana gets tamed by placing the active ingredient into a sesame oil capsule.
One of the latest concerns being used to argue against marijuana’s legalization is that recent research has established that heavy marijuana use causes cognitive impairment, that is, has lasting effects on users’ mental abilities, such as decision making and comprehension.
However, according to the FDA, cognitive deficits associated to cannabis use are reversible, especially among moderate users. Furthermore, the age of first use appears to “be a critical factor in the intensity and persistence of impairment resulting from chronic marijuana use.” This is important because it highlights the importance and value of using legal regulatory provisions to reduce teenage access to marijuana. Heavy, chronic users of marijuana who started use before age 16, for example, were more likely to display cognitive deficits involving executive functioning than users who started later in life.
Another scare tactic used by opponents of legalization is that marijuana use can lead to psychosis. This too is debunked by the FDA. “The available data do not suggest a causative link between marijuana use and the development of psychosis. Numerous large, longitudinal studies show that subjects who used marijuana do not have a greater incidence of psychotic diagnoses compared to those who do not use marijuana.”
Okay, what about the effect of marijuana smoke on the lungs? Of course, this is really an impact of smoking the vegetative material containing the chemicals in marijuana, and this potential harm is prevented through the use of vaporizer. Nonetheless, how does marijuana smoke affect the lungs?
According to the FDA, the primary effect of marijuana on the lungs is “transient bronchodilation,” an expansion of the bronchial air passages. Long-time use can produce chronic coughs. Evidence linking marijuana smoking to cancer “is inconsistent,” and “in a large study with 1,650 subjects, a positive association was not found between marijuana and lung cancer.”
“Overall, new evidence suggests that the effects of marijuana smoking on respiratory function and carcinogenicity differ from those of tobacco smoking.”
Does marijuana have a negative effect on the endocrine system? No, not really.
With respect to hormones, the FDA concludes that “experimental marijuana administration to humans does not consistently alter many endocrine parameters, [and] in women, smoked marijuana did not alter hormone levels or the menstrual cycle.”
Legalization opponent are also fond of citing drug treatment admission statistics to prove marijuana cause addiction problems. However, the FDA acknowledges that “the criminal justice system referred more than half (51.6 percent) of primary marijuana admissions” to drug treatment programs. Also, to the extent that some users develop dependence on the drug, the FDA explains that “the withdrawal syndrome indicates that marijuana produces physical dependence that is mild, short-lived, and comparable to tobacco withdrawal.”
The most popular argument used by politicians and opponents of legalization is that marijuana use leads to the use of other, more dangerous drug. The FDA, finally, sets this claim to rest.
The FDA has acknowledged that “research does not support a direct causal relationship between regular marijuana use and other illicit drug use.” In other words, the gateway theory is incorrect because “little evidence supports the hypothesis that initiation of marijuana use leads to an abuse disorder with other illicit substances.” As critics have been arguing for years, the FDA now correctly explains that “although many individuals with a drug abuse disorder may have used marijuana as one of their first illicit drugs, this fact does not correctly lead to the reverse inference that most individuals who used marijuana will inherently go on to try or become regular users of other illicit drugs.”
As explained above and in part 1 of this column, the major problem that exists in recognizing that marijuana has accepted medical use in the United States is that marijuana is a complex substance which the drug approval process and the CSA is not designed to evaluate.
One of the problems in evaluating marijuana according to the same criteria used for proprietary pharmaceutical products is that cannabis is a very complex substance which varies from specimen to specimen. Consider this explanation provided by the FDA:
“Marijuana products from different strains may have different safety, biological, pharmacological, and toxicological profiles. In addition to differences between cultivated strains, the concentration of delta9-THC and other cannabinoids in marijuana may vary with growing conditions and processing after harvest. In addition to genetic differences among Cannabis species, the plant parts collected—for example, flowers, leaves, and stems—can influence marijuana’s potency, quality, and purity. Overall, these variations in the concentrations of cannabinoids and other chemical constituents in marijuana complicate the interpretation of clinical data using marijuana. The lack of consistent concentrations of delta9 -THC and other substances in marijuana from diverse sources makes interpreting the effect of different marijuana constituents difficult.”
Furthermore, they recognize that they really don’t yet understand the impact of non-cannabinoid aspects of cannabis, such as terpenoids and flavonoids, to the overall pharmacological profile of the drug. Simply put, “marijuana is not a single chemical with a consistent and reproducible chemical profile or predictable and consistent clinical effects.”
The process used by the FDA and the DEA for recognizing accepted medical use depends on tests and studies of a standardized product. These are hard to apply to marijuana use, in part because of the federal governments prior policies of obstructing such research, but also because of the complexity of this marvelous botanical compound.
It is appropriate to criticize the obvious flaws in the DEA decision to deny these (and prior) rescheduling decisions, and to note the clear contradiction between the official findings of no accepted medical use and widespread public and state recognition of marijuana’s medical use.
But the most important aspect of the DEA’s actions in this matter is that it should establish, conclusively, that the CSA does not provide an adequate or useful remedy to the clash between state and federal law regarding marijuana’s use in the United States. A great deal of the FDA’s scientific review supports the argument that marijuana is not sufficiently dangerous or harmful to justify criminal sanctions, and both they and the DEA acknowledge that current laws have failed to prevent marijuana use in the nation.
Clearly, some other form of national regulatory law is required to provide a meaningful and effective means for restricting teenage access to marijuana and regulating marijuana commerce in ways that improve, rather than compromise, public health throughout the nation.
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