By Steven Wishnia / Alternet
Preserving the main legal barrier to medical marijuana, a federal appeals court on Jan. 22 rejected a lawsuit intended to force the Drug Enforcement Administration to move marijuana out of Schedule I, the federal law that classifies marijuana as a dangerous drug with no valid medical use.
The U.S. Court of Appeals for the District of Columbia Circuit ruled 2-1 that the medical-marijuana advocates who filed the suit—Americans for Safe Access, a California-based patient-advocacy group; the Coalition to Reschedule Cannabis, Patients Out of Time, and four individual medical users, including Air Force veteran Michael Krawitz—had not proved that the DEA’s decision to keep marijuana in Schedule I was “arbitrary and capricious.” The court held that marijuana had failed to meet the five standards the DEA sets for drugs to qualify as having a valid medical use.
The court “seemed to defer to the DEA,” by focusing on whether adequate scientific studies had been done to show marijuana’s medical efficacy, says ASA spokesperson Kris Hermes. The plaintiffs’ lawyer, Joe Elford of San Francisco, says the court didn’t close off the possibility that future studies will show its efficacy more conclusively. They plan to appeal the decision, first to the full 13 judges of the D.C. Circuit, and then to the Supreme Court if they lose.
The dissenting judge said the court should not consider the case because none of the plaintiffs had legal standing to file a suit. The majority held that Krawitz did, because he had been forced to pay for an outside doctor after the Veterans Health Administration refused to prescribe him painkillers unless he signed a contract agreeing not to use marijuana. Krawitz, who has had surgery 13 times since he was seriously injured in a car accident in 1984, says the best relief for his chronic pain is a combination of cannabis and opioid painkillers.
“What would be ‘arbitrary and capricious,’ if this isn’t?” he asks rhetorically. “You talk to the DEA about medical marijuana, and they go ‘la-la-la’ with their fingers in their ears.”
The DEA referred discussion of the ruling to the Department of Justice, which did not respond to an e-mailed list of questions by press time.
Under the Controlled Substances Act of 1970, which placed marijuana in Schedule I, the DEA has the power to decide which drugs belong in which schedules. For more than 40 years—since 1972, when the federal Shafer Commission recommended decriminalization—it has resisted moving marijuana out of Schedule I, the category for drugs with “a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and no “accepted level of safety for use under medical supervision.”
Heroin, LSD and PCP are also in Schedule I, and thus completely illegal for medical use. Cocaine, methamphetamine, morphine, and OxyContin are in Schedule II, drugs that are legal for medical use but have enough abuse potential to warrant maximum restrictions. Marinol, synthetic THC, is in Schedule III—moved from Schedule II in 1999, after several states voted to legalize medical marijuana.
To be recognized as having a valid medical use, drugs have to meet the DEA’s “five-prong test,” which was developed in a 1991 court ruling on the first challenger to marijuana’s Schedule I status. They have to have “a known and reproducible drug chemistry, adequate safety studies, adequate and well-controlled studies demonstrating efficacy, acceptance of the drug by qualified experts, and widely available scientific evidence.”
In denying this for marijuana, the D.C. Circuit cited findings submitted to the DEA by the federal Department of Health and Human Services. The department said that marijuana did not have a “known and reproducible” chemistry, because it contains more than 480 known compounds, including 66 cannabinoids, which are not known to exist in any other plant, and there has never been “a complete scientific analysis” of its components. It said there were no studies of sufficient quality to assess “the efficacy and full safety profile of marijuana for any medical condition”; a “material conflict of opinion among experts” about its safety and efficacy, and that the raw research data typically were not available in a format that would allow “adequate scientific scrutiny of whether the data demonstrate safety or efficacy.”
Specifically, the court held, peer-reviewed studies were too small-scale to prove that marijuana was a safe and effective medicine, and there have been no Phase II or Phase III clinical trials conducted on it—the large-scale studies needed for a drug to be approved by the FDA.
The federal government, contends Hermes, is saying that marijuana would have to go through the FDA’s new-drug process before they’ll even consider whether it has a valid medical use. As no herbal drug is a single, identifiable, patentable molecule, he says, that’s “applying a standard that’s impossible to meet.”
The new-drug procedures cost around $180 million for three-phase trials, and it’s extremely unlikely that any pharmaceutical company would spend that kind of money on a drug it can’t patent. “No one’s going to do that for a plant,” New York State Assemblymember Richard Gottfried, the main sponsor of medical-marijuana legislation there, told BQ Brew magazine earlier this month.
In contrast, herbal supplements are largely unregulated — although federal law would still have to change for medical marijuana to be legal. “Marijuana should be considered a botanical medicine,” Hermes says. ASA is working with the American Herbal Products Association, he adds, which has a committee developing standards for medical-cannabis production and testing.
Meanwhile, he says, “there are millions of patients in the U.S. that benefit from this substance. Shame on the Obama administration for not being willing to address this in a sensible and rational way.” With Marinol already approved, and Sativex, a spray made from cannabis extract, in clinical trials, he adds, “it’s going to become increasingly difficult to say marijuana has no medical value if you’re approving other drugs made from the plant.”
That is one ground on which ASA is appealing. “The federal government has sought and obtained a patent for the medical use of cannabinoids; yet, it claims in these proceedings that marijuana has no medical use,” ASA’s appeal brief says. “There are numerous peer-reviewed studies establishing that marijuana is effective in treating AIDS wasting syndrome, muscle spasticity, emesis, appetite loss, negative side effects of chemotherapy, and chronic pain, as several of the government’s own commissions and administrative law judges have recognized. The government, however, simply ignores these well-controlled studies, and instead, demands proof of medical efficacy for marijuana far beyond that which it requires for other scheduled substances—proof that is not required by the federal Controlled Substances Act or the federal agencies’ own regulations.”
Another ground for appeal, says Joe Elford, is that the decision “says nothing about relative abuse potential.” He calls that a major omission. “It is only by failing to apply the appropriate standards and make the required comparisons that the federal government could conclude that marijuana is as harmful as heroin and PCP and even more harmful than methamphetamine, cocaine and opium, and should remain in the CSA’s most restrictive Schedule I,” the appeal brief states. “It does not require an expert in marijuana to recognize, although there are many of them, such obvious untruths.”
One small but important victory, Elford says, is that the court did recognize that Michael Krawitz had legal standing to challenge the Schedule I classification. Courts have dismissed previous suits, such as one filed by marijuana-policy expert Jon Gettman, on the grounds that the plaintiffs lacked standing.
If the full D.C. Circuit hears the case, the 13 judges who would rule on it include Laurence H. Silberman and David B. Sentelle, both key figures in Kenneth Starr’s inquisition into President Bill Clinton’s sex life; Janice Rogers Brown, a George W. Bush appointee who has said that rent-control laws are worse than slavery; and Douglas H. Ginsburg—who was nominated to the Supreme Court by Ronald Reagan in 1987, but famously withdrew after it was revealed that he’d inhaled on several occasions before he became a judge.