FDA Forced to Release Its Flawed Prohibition Endorsement

By Charlie Tetiyevsky

FDA Forced to Release Its Flawed Prohibition Endorsement

Anyone who follows the federal government’s cannabis policy is certain to know how frustrating the publicly available language can be, but it turns out that their internal reviews are just as maddening. VICE overcame several roadblocks to acquire the behemoth of a report the Food and Drug Administration (FDA) provided the Drug Enforcement Administration (FDA) recommending that cannabis remain a prohibited Schedule I substance, and it reveals the fragile backbone of the government’s aversion to admitting the medical potential of cannabis. It’s no wonder it took appealing the initial Freedom of Information request denial for these papers to be made available. 

Here are at four very big reasons why the FDA’s current argument that cannabis has “no currently accepted medical use in treatment in the United States” was built on a fractured foundation.

1: The FDA didn’t do their homework

It seems the government couldn’t shell out for journal subscriptions, single-article access or a JSTOR account because one of the report’s earliest red flags is the admission that it would only use articles published up through 2013 (much of the landmark studies were done in the last few years)—and in the public domain. No wonder the FDA dubiously claimed there is a lack of research on medical cannabis. This serious deficiency of clinical sources would be fine if this were an undergraduate lit paper but not for a scientific review of an emerging sector of study. The FDA’s noted methods of research seem cursory at best—rehashed reviews of PubMed abstracts offering data without much synthesized conclusion—and don’t seem to suggest any discussion with scientific experts on the matter. 

More strange is the fact that the government—through the National Institutes of Health (NIH) and National Institute on Drug Abuse (NIDA)—was the organization granting access to plant material and funding for studies, which one hopes would mean that they would have viewing rights to the results to leverage those for the public benefit (since that’s why they’re conducted, presumably).

There have been positive changes in methodology for certain recent medical cannabis studies, including some on bipolar disorder, and to some extent the government seems to agree, on a basic and simple level, that there are issues with the way their sponsored researchers conduct experiments. The report admits something is wrong with both the lengthy approval process and the research methodology itself (“some study design challenges […] need to be addressed to ensure that future studies generate scientific data that can be used to determine whether marijuana has an accepted medical use”). However, there is no mention that this is linked to the fact that studies, as researchers have made clear, are more likely to be funded if they look to test a negative aspect of cannabis use rather than a specific therapeutic use. For instance, the aforementioned studies on bipolar disorder had to address that cannabis use did not antagonize bipolar disorder, and the researchers’ findings that it actually aided certain bipolar patients was essentially an incidental medical discovery that the mental health community is lucky to have received and needs to address.

2: The FDA listened to Lincoln Chafee instead of existing cannabis knowledge

There’s the point made repeatedly in the document that different cannabis strains vary chemically in their effects and “toxicological profiles” and therefore “cannot be considered together.” And yet, despite the fact that this is clearly well-known scientific knowledge that could be leveraged rather than ignored in making a determination of therapeutic potential (say, of high-cannabidiol strains), the evaluation doggedly makes clear that it’s responding only to the naïve language of the petition. Submitted by governors Lincoln Chafee (Rhode Island) and Christine Gregoire (Washington), “the petition defines marijuana as including all Cannabis cultivated strains.” There seems to be a clear and willful choice to both acknowledge the complexity of the plant and ignore that awareness in the report’s conclusion.

The report also focuses on tetrahydrocannabinol (THC), which, while helpful to many people with physical ailments and disorders, might not be as important to those with mental health concerns like anxiety who would benefit greatly from the availability of cannabidiol (CBD)-rich products. The effects of CBD on the brain are not discussed in detail, while those of THC are, even though the review clearly states that “more research should be conducted into […] potential medical uses for marijuana and its derivatives.” If that’s the case, why not delve into what already exists?

A big part of the reason cannabis in general did not pass the DEA’s criteria for “currently accepted medical use” is that by the nature of how plant strains work it is not a monolithic drug the “chemistry [of which is] known and reproducible.” Had there been focus on specific strains or even cannabinoids rather than the idea that a vastly varying plant would be all-knowable in a restricted research environment, the review might have actually come to some sort of conclusion about the outlook of cannabis research and medical use.

3: Their model of abuse is muddied and—let’s say it—puritanically outdated

It turns out that there isn’t even a standard definition of what “abuse” means. “The CSA [Controlled Substances Act] does not define the term ‘abuse.’ However, the CSA’s legislative history suggests the following in determining whether a particular drug substance has a potential for abuse.”

The four categories of consideration are: that the drug is taken “in amounts sufficient to create a hazard to [the users’] health or to the safety of other individuals or to the community,” that “there is a significant diversion of the drug […] from legitimate drug channels,”1 that people are using the drug of their own accord instead of being given it by a doctor2, and, surprisingly the doozy of the bunch, that the drug is “a new [drug] so related in [its] action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.”

Yes, weed is apparently a new version of weed, which has already been proven to be a high candidate for abuse because it’s like weed. So not only are these considerations based not on some sort of actual scientific definition of abuse but a series of bureaucratic semantic sustainments of the drug enforcement status quo. 

Even though animal trials mentioned in the review suggested that THC has a unique effect in a particular type of study where animals have to figure out if they’re being given a placebo or drug—and that the “discriminative stimulus effect” found in this study is unlike those of other licit and illicit drugs—the language surrounding cannabis’ “relatedness” to other, abuse-likely drugs does not reflect those findings.

1 Those “legitimate channels”? The report defines them as the currently single farm at Ol’ Miss growing federal cannabis (not including state programs)—bud sent to the few researchers whose studies were approved by the NIDA and DEA and the whopping 30 federal patients who were ever included in the Compassionate Use Investigational New Drug program. (Plus, consider this: Those 30 people were the few citizens who were able to pass muster through a large maze of bureaucratic shenanigans to get cannabis to treat their conditions instead of just doing what everyone else does and grow their own or buy off the black market.) To base abuse potential off such a small supply simply doesn’t make sense in this particular instance.

2 If you consider the state cannabis programs, plenty of doctors prescribe cannabis. Plenty of doctors of all sorts, American and from elsewhere, including internists, general practitioners and psychiatrists, who endorse cannabis use for certain conditions and understand how helpful it can be even in circumstances when it hasn’t been government sanctioned. That’s just what good doctors do: listen to anecdotal evidence from their patients and do their best to keep up with research—and I’m not just talking papers in the public domain here. And yet the way this summary puts it, those doctors and others who actually give cannabis recommendations are essentially less legitimate than the doctors who run pill mills, all because a patient has taken the initiative to care for themselves when they’re being denied access to care by others. It’s not abuse; for many patients, it’s self-preservation. But the study doesn’t seem to agree with letting doctors choose a patient’s course of treatment in this instance, saying that “medical practitioners who are not experts in evaluating drugs are not qualified to determine whether a drug is generally recognized as safe and effective or meets NDA (New Drug Application) requirements.”

4: The FDA is concerned they can’t control the supply—and market it effectively

Speaking of “legitimate channels,” a definite anxiety permeates the report about the proliferation and current widespread nature of cannabis, which somehow apparently affects its potential as a medicine. But it’s not just control of the supply: I don’t need to tell you guys that pharmaceuticals are all about money, and this report has no scruples mentioning it. The commentary on the potential of cannabis abuse largely centers on how much of it is already available via an illicit market and how easy it is to self-produce—in other words, qualities that would make the product harder to control for sale or prescription. As the report notes, “The FDA has not approved any drug product containing marijuana for marketing.”

The report makes note of Marinol, a synthetic version of THC in capsule form, which was initially released in Schedule II and then moved down to III—something anyone would assume would be a perfect example of what is called an “FDA-approved marijuana drug.” And yet because Marinol contains THC only and does not include actual plant material, it’s not considered to count as a “marijuana drug” or be indicative of any healing potential of marijuana as a whole.

In the end, these flaws were the foundation the FDA and DEA used to deny the rescheduling of cannabis, which the agencies had to consider based on petitions filed by state governors in 2011. Considering all the new clinical studies and the government’s own patent on the medical benefits of cannabis, the rescheduling denial surprised most people, but it is historically consistent with the government’s stubborn refusal to even consider an end to cannabis prohibition.

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