Global Ganja Report

British firm GW Pharmaceuticals has won "orphan drug status"—a special category for agents developed to treat rare diseases—from the US Food and Drug Administration (FDA) for Epidiolex, a derivative of cannabidiol (CBD), to treat Dravet syndrome, a severe form epilepsy. In Utah, parents who are lobbying to import CBD-rich cannabis strains from Colorado, say they will keep up their campaign. "This changes nothing" in regard to children being able to access CBD, said Jennifer May, mother of 11-year-old Stockton, who suffers from Dravet syndrome. "On the other hand, it does lend credibility to the potential of CBD as a treatment." Like many Dravet patients, Stockton has tried dozens of pharmaceutical fixes, and run out of options. He can no longer use the toilet and has to be fed from a tube. "Orphan drug" designation qualifies GW for tax credits and exclusive rights to the drug if approved. But FDA approval for Epidiolex could take a year or more. (Salt Lake Tribune, Nov. 18)

The US Supreme Court on Oct. 7 rejected a challenge to the federal government's classification of cannabis as a Schedule I drug with no legitimate medical use. Challenger Americans for Safe Access contended that more than 200 studies have established that cannabis is safe and effective in relieving pain and nausea, and in relieving the effects of chemotherapy, among other medical uses. But federal courts have let stand the Drug Enforcement Administration's stance that the studies are insufficient.

Over the past generation, an informal alliance of activists, cultivators, entrepreneurs and medical professionals has struggled to redefine how the United States views the cannabis plant. Victories at state and municipal levels have created a new field of medicinal treatment for a wide variety of ailments in California and other mostly western states. Medical marijuana marks the starkest point in the divide between an industrial model of healthcare and a millennia-long tradition of herbal self-treatment—because nowhere else has the federal government been so intransigent.

Raw Story reported May 12 that researchers at Weill Cornell Medical College have successfully used a vaccine to produce a long-lasting anti-cocaine immunity in non-human primates. "The vaccine eats up the cocaine in the blood like a little Pac-man before it can reach the brain," the study’s lead investigator, Dr. Ronald G. Crystal, said in a press release. "We believe this strategy is a win-win for those individuals, among the estimated 1.4 million cocaine users in the United States, who are committed to breaking their addiction to the drug. Even if a person who receives the anti-cocaine vaccine falls off the wagon, cocaine will have no effect." Human clinical trials for the vaccine are expected soon.

Medical marijuana patient advocacy group Americans for Safe Access (ASA) filed a petition with the federal court of appeals March 22 in a widely watched case that seeks to reclassify cannabis for medical use. Plaintiffs in the case, ASA v. Drug Enforcement Administration, are requesting a rehearing before the original panel, as well as seeking full (en banc) review by the US Court of Appeals for the DC Circuit. On Jan. 22, the DC Circuit granted plaintiffs standing—the right to sue the federal government to reclassify cannabis—but, in a 2-1 ruling, denied the appeal on the merits by setting what ASA calls a "virtually-impossible-to-meet standard" for assessing medical efficacy. (ASA, March 22)

More than a dozen members of Congress co-introduced legislation Feb. 14 that would reclassify cannabis for medical use and provide federal defendants the right to use state law compliance as evidence in medical marijuana trials, a right they're currently denied. Rep. Earl Blumenauer (D-OR) authored H.R. 689, the "States’ Medical Marijuana Patient Protection Act," which in addition to rescheduling cannabis will allow states to establish production and distribution laws without interference by the federal government, and will remove current obstacles to research. Rep. Sam Farr (D-CA) authored H.R. 710, the "Truth in Trials Act," to overturn the prohibition on medical marijuana evidence in federal court. 

The United States Court of Appeals for the DC Circuit issued a ruling Jan. 22 in the medical marijuana reclassification case, Americans for Safe Access v. Drug Enforcement Administration. In a 2-1 decision, the Court granted standing in the case—the right to bring a claim against the federal government—but denied the legal challenge on the merits, agreeing with the government's assertion that "adequate and well-controlled studies" on the medical efficacy of marijuana do not exist.

The Cannabis Committee of the American Herbal Products Association (AHPA) issued recommendations this week to regulators of dispensaries in California, Colorado, and Massachusetts, and will make similar recommendations in other medical marijuana states over the next days. The committee, in cooperation with Americans for Safe Access (ASA), has over the past year coordinated the development of best practice protocols in several areas, including cultivation; manufacturing, packaging and labeling; laboratory practice; and distribution.