Federal Court Denies Lawsuit Claiming Marijuana's Medical Benefits
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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.