Smart Approaches to Marijuana opened its case in the federal rescheduling hearing Monday with a simple argument: nothing about the science has changed since the government repeatedly kept marijuana in Schedule I, only the test the government chose to apply.
SAM counsel John McNichols told the court the country has “seen this movie before,” noting this is the fourth time since 2000 that federal agencies have weighed moving marijuana out of Schedule I. Every prior time, he said, HHS, FDA and DEA concluded it had no accepted medical use and a high potential for abuse. The only thing that could justify a different result now, he argued, would be genuinely new clinical data. That data does not exist. He pointed the judge to the government’s own memorandum, which still describes the evidence on pain, nausea and anorexia as inconclusive or mixed.
McNichols returned to a concession the government’s FDA witness made earlier in the hearing, when the witness acknowledged that when faced with two studies, one positive and one negative, the review would still credit the positive one. “That is not science,” McNichols told the court. He also argued the government dropped the extensive psychosis analysis from its 2015 review and leaned on a handful of the deadliest drugs, including heroin, fentanyl and cocaine, as comparators to make marijuana look benign, the same approach HHS itself rejected as inappropriate a decade ago.
The centerpiece of the day was SAM’s first witness, Dr. Bertha Madras, a Harvard Medical School professor of psychobiology and two-time presidential appointee. Notably, Madras served as the government’s own expert defending marijuana’s Schedule I status in a prior federal case, which the government won. The government objected to the scope of her expertise, arguing she is not a physician and was not formally offered as a marijuana-scheduling expert. The judge overruled the objection and provisionally accepted her, allowing her full testimony.
Madras drew a sharp line between the isolated, FDA-approved cannabinoids and the unregulated products sold in dispensaries, testifying that whole-plant marijuana meets none of the agency’s standards for purity, dosing or route of administration. She walked the court through rising rates of cannabis use disorder, climbing potency, and the cross-national research linking marijuana to psychosis and schizophrenia, which she said most psychiatrists now regard as a contributing cause. She also explained that marijuana lacks the brainstem receptor activity that makes opioid overdoses fatal, while cautioning that a lower overdose risk does not make the drug safe, given its links to addiction, psychosis, traffic deaths and harm to the developing brain.
The government’s cross-examination was brief and produced little. It drew concessions on scope, that Madras has never worked at the FDA or HHS and is not a medical doctor, before the judge tied her opinions to the statutory definition of marijuana, which she confirmed targets the unregulated botanical products rather than the approved isolates. SAM waived redirect.
SAM’s second witness, Dr. Luli Akinfiresoye, a current DEA scientist subpoenaed to testify, is expected to appear next. The hearing continues this week ahead of its scheduled conclusion.