On April 15, 2015, U.S. District Court Judge Kimberly Mueller for the Eastern District of California ruled the federal statute prohibiting marijuana for all purposes was rationally justified and the defendants had not met their burden of being discriminated by enforcement of federal marijuana laws. The defense had petitioned the Court to reschedule marijuana from a Schedule I drug to a Schedule II drug under the Controlled Substances Act (CSA).
The decision dashed the expectations of marijuana advocates, investors, social engineers, users, and journalist-proponents who had hoped that the federal courts would do what they have not yet been able to get Congress to do.
Background
In 2011, 16 people were indicted by the U.S. Attorney’s office in Sacramento, California, for growing at least 1,000 marijuana plants on federal land. Seven of the 16 defendants pleaded guilty pre-trial and were sentenced to prison. San Francisco attorneys Zenia Gilg and Heather Burke filed a motion on behalf of the remaining defendants to dismiss the charges, claiming that the continued classification of marijuana as a Schedule I drug was unjustified. Gilg was the lead attorney, whose practice is limited to defending marijuana cases.
In late October 2014, the judge paused the criminal trial to preside over an evidentiary hearing for five days to thoroughly consider the matter. She considered the evidence for and against marijuana classification, before ruling on the motion to dismiss the charges.
The court received expert testimony from seven defense expert witnesses. I was the sole expert witness for the government.
The Case
The judge presided over an orderly, dignified court proceeding that lasted five days. The nine-person legal defense team was supported by a “marijuana expert,” tasked with whispering to Zenia Gilg, in order to refute my testimony.
The defense called on three medical experts to testify in court: Gregory T. Carter, MD, Philip A. Denny, MD, and Carl Hart, PhD. Additionally, they produced testimony of Marine Sergeant Ryan D. Begin, an Iraq war veteran; Jennie Stormes, mother of a child with pediatric epilepsy; James J. Nolan III, PhD, an associate professor of sociology and anthropology at West Virginia University; and Christopher Conrad, an expert on the cultivation of marijuana.
To prevail on the motion, the prosecutors had to show that marijuana failed to meet even one of five legal standards as a medicine that would permit shifting from Schedule I to Schedule II or lower.
Those five legal standards are:
- Does marijuana have a known and reproducible drug chemistry?
- Does marijuana have adequate safety studies?
- Are there adequate and controlled studies showing marijuana’s efficacy?
- Are marijuana’s therapeutic benefits accepted by qualified experts?
- Are scientific data available for scrutiny?
To sustain the view that marijuana should remain in Schedule I, the prosecution team also had to show that marijuana has:
- A high potential for abuse,
- No currently accepted medical use in treatment in the United States, and
- Unacceptable safety standards for its use under medical supervision.
Conversely, the legal defense team had to prove that marijuana was misclassified in Schedule 1 of the CSA and that it is a safe and effective medicine.
The defense witnesses claimed that the abuse and addiction potential of marijuana is low and much lower than other Schedule I drugs, that marijuana has widely accepted medicinal uses in the U.S, that its safety profile is superior to many drugs approved by the Food and Drug Administration (FDA), and that its chemical composition is known.
As “proof,” one witness claimed the existence of over 20,000 manuscripts proving marijuana’s medical benefits, and cited the research of the California Center for Medical Cannabis as further evidence. The defense also disputed each reported adverse consequence of marijuana on brain function, structure, psychosis, vehicular accidents, and others as “rare” or measures of association, not causality.
I focused my arguments on the need for marijuana to achieve the “high standards of proof” necessary to obtain FDA approval, how current marijuana science does not approach this standard, and that clear evidence for efficacy and safety is lacking as well as an accepted method of drug delivery. I rebutted each defense claim by citing peer-reviewed manuscripts in quality journals, federal databases, and other reliable sources of information. I pointed out that the defense’s citations of 20,000-plus peer-reviewed articles on marijuana benefits were grossly in error, as the majority of these cannabinoid articles described the adverse consequences of marijuana use, the neurobiology of the endocannabinoids and their receptors, synthetic cannabinoid drug discovery, analytical methods, epidemiological and psychological studies, and others irrelevant to investigating whether smoked marijuana has medicinal purposes.
Furthermore, I stated that the abuse potential of marijuana was high: 4.3 million Americans harbored abuse or addiction symptoms of a cannabis use disorder (CUD), more than any other illicit drug. I pointed out that youth had higher vulnerability to marijuana addiction, and more youth were in treatment for marijuana than for an alcohol use disorder.
The defense claimed that numerous, adequate efficacy and safety studies exist for using marijuana as a medicine.
I countered that by stating that although adequately powered and appropriately controlled clinical trials had been reported for isolated cannabinoids (approved by the FDA or by other nations), very few clinical trials investigating smoked marijuana have been reported.
Clinical trials of smoked marijuana (i.e., medical marijuana as it is purported to be used to confer therapeutic benefits) suffer credibility issues because of small numbers of test subjects, the use of subjects who are experienced marijuana users, issues with valid control groups, inconsistent dosing for the same indication, modest or not clinically robust effects, difficulty with blinding (i.e., people can surmise readily that they either are or are not smoking marijuana, which “unblinds” the study) and short-term protocol design with no long-term effectiveness, and safety monitoring.
By not interrogating the long-term effects of daily marijuana on daily function and addiction in patients with chronic diseases, I testified that it is not possible to learn of putative adverse side effects. Prescribed medicines are approved by a rigorous FDA process of testing in human subjects for safety, efficacy, long-term effects, and side effects for a single medical condition, in addition to meeting many other standards, including measuring shelf life, gauging manufacturing and labeling practices, and inspecting the cleanliness of the facilities in which the drug is manufactured.
There are no standards for how much smoked or vaporized marijuana enters the bloodstream or the brain. The amount of Tetrahydrocannabinol (THC), the active ingredient in marijuana, and the amounts of other cannabinoids vary. The time course of peak effects varies, and delivery efficiency varies. All medicines approved by the FDA have a known range of safe and effective doses. In other words, there is no standardization of the chemical nature of medicinal marijuana sold in dispensaries, and this void would not be acceptable with any other medicine.
While there is growing evidence that isolated THC, THC-cannabidiol (CBD) mixtures, CBD alone, other phytocannabinoids, and synthetic cannabinoids have promise as medicine, that does not indicate that the marijuana plant (of unknown quality, composition, and side effects) is a medicine. If anything, it means that the traditional process of isolating and standardizing these compounds, now routine for other plant-based medications, will obviate the disputes about the use of marijuana (and especially smoked marijuana) as medicine.
The Institute of Medicine (IOM) marijuana report stressed the importance of focusing research efforts on the therapeutic potential of synthetic or pharmaceutically pure cannabinoids and stated that there is no future in smoked marijuana, a crude drug delivery system that exposes patients to a significant number of harmful substances. I cited meta-analyses of existing reports showing that the majority of medicinal claims for smoked marijuana were designated inadequate by reviewers.
Regarding safety, long-term use of marijuana can affect memory, attention, decision-making, IQ, psychiatric status, and even brain structure and connectivity. Most if not all of these effects have been shown to be worse in adolescents. Clinical trials have not been reported to show whether marijuana is safe for long-term use in chronic conditions, whether it interferes with daily functioning, whether it compromises brain function, whether its use extends to family members or children, or how many daily “medical marijuana” users become addicted to the drug.
Qualified experts do not accept marijuana as a medicine. The American Medical Association, the largest national organization representing physicians in the United States, is opposed to legalization of marijuana for medical purposes, calling for further study. So are the American Society of Addiction Medicine and the American Cancer Society. Other key medical associations agree.
The American Psychiatric Association position is equally clear:
There is no current scientific evidence that marijuana is in any way beneficial for the treatment of any psychiatric disorder. Further research on the use of cannabis-derived substances as medicine should be encouraged and facilitated by the federal government. Policy and practice surrounding cannabis-derived substances should not be altered until sufficient clinical evidence supports such changes.
Medical treatment should be evidence-based and determined by professional standards of care; it should not be authorized by ballot initiatives. No medication approved by the FDA is smoked. Marijuana that is dispensed under a state-authorized program is not a specific product with controlled dosages. The buyer has no way of knowing the strength or purity of the product, as cannabis lacks the quality control of FDA-approved medicines.
I concluded by outlining how marijuana fails to fulfill each of the five criteria required to designate it as a medicinally useful drug and explaining why, due to its abuse liability and lack of a safety profile, it should remain a Schedule I drug.
Before the Ruling
In the weeks leading up to the final ruling, the press salivated at the prospect of a victory. Judge Mueller—an Obama appointee to the court—would most certainly rule in favor of medicalizing marijuana. Some even claimed the ruling would advance the marijuana machinery toward national legal status.
A sampling of some headlines in the blogosphere:
“Federal Judge May Declare Pot’s Schedule I Classification Unconstitutional”
“A Single Judge May Turn the War on Marijuana Upside Down”
“Could a Judge in Sacramento Undo Fed’s War on Marijuana?”
“Will Judge Mueller Be the Chosen One for Marijuana Stocks?”
“Medical Cannabis May Get Out of CSA Classification Prison”
“Judge Could Smash Marijuana Law”
“US District Judge Mueller Could Be About to Start a Legal Revolution”
“Getting Closer to Declassification of Cannabis by Judge Mueller”
“Marijuana Will be Legal Across America on March 25?”
“Legal Marijuana Is Coming to the United States”
“Marijuana Prohibition Will Be Ruled Unconstitutional in California This Month”
The Ruling
In the end, however, the judge remained faithful to the law and established science and refused to grant the defendant’s motion.
U.S. Attorney Benjamin Wagner, whose office prosecuted the case, stated in The Los Angeles Times that the issue
was not whether marijuana should be legalized for medical or recreational use, but whether decisions concerning the status of marijuana under federal law should properly be made in accordance with the science-based scheduling process set forth in the Controlled Substances Act passed by Congress.
