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Winter/Spring 2005 O'Shaughnessy's Journal of the California Cannabis Research Medical Group

ASA Goes to Washington

Americans for Safe Access has filed a petition charging the federal Department of Health and Human Services with violating the “Data Quality Act” by ignoring studies confirming the medical safety and efficacy of cannabis. To publicize the petition —and to protest the pseudo-science that has denied Americans safe access to cannabis all these years— ASA director Steph Sherer and 13 other patients and advocates got arrested Oct. 5 as they tried to enter the HHS office building in Washington. They were draped in a huge print-out containing the names of 7,000 pro-cannabis doctors (obtained by the Marijuana Policy Project). They chanted “Truth and evidence, cannabis is medicine” and “Schedule One to Schedule Three, cannabis is helping me.”

“First time in Washington, first time in a paddy wagon, first time in a DC jail.” —Bill Britt

Bill Britt of Long Beach was among those willing to get arrested. “First time in Washington, first time in a paddy wagon, first time in a DC jail,” he reported. “Very clean facility, but six hours in a cell with only a metal bench to sit on was very painful.” (Bill is thin and walks with crutches. He has epilepsy and post-polio syndrome.) He appreciated the effort ASA had put into organizing the action. “Our bail was all paid for before we were even arrested, we had lawyers on hand...It was a wonderful experience for me. It was worth the pain —which took a few days to recover from.
“We were there to tell [HHS Director] Tommy Thompson that patients need to be involved in the policy-making process. We’re not going to sit at home. We’re not going to let fear and pain stop us from speaking out. We’re people who normally wouldn’t do this. It’s sad that sick people have to go all the way to Washington to demand their rights. But if it takes getting arrested to draw attention [to the lies that uphold prohibition], we’re ready.
“There were people from all over the country. My arrest buddy was from Texas. We had somebody from Tennessee, Florida, Louisiana, Washington, D.C., New York, Oregon. People from states who had no hope of ever passing anything. We were their hope. They looked at us from California in awe. It was really sad. They had a lot more to lose than we did by exposing themselves.”
Britt is optimistic about the chances of ASA’s petition in court.
Washington Post science writer Rick Weiss thought the use of the Data Quality Act was clever. “The act’s use by marijuana advocates represents a peculiar political twist,” he reported Oct. 4. “The act was written by a tobacco industry lobbyist and slipped into a huge piece of legislation after the 2000 election without any congressional discussion or debate. It has been used almost exclusively by corporations challenging the validity of scientific information that they fear might lead to costly regulations...
“The petition calls for the government to correct ‘scientifically flawed statements’ about marijuana published in the Federal Register, a move that would allow —though not compel— the Drug Enforcement Administration to declare it a ‘Schedule II’ drug. That would allow it to be prescribed for specified conditions and more easily obtained for research.
“The petition challenges the government contention that ‘there have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition.’ In fact, the group notes, a 1999 Institute of Medicine report concluded that studies have found marijuana helpful ‘for pain relief, control of nausea and vomiting, and appetite stimulation...’”
ASA’s petition was drafted and filed by staff attorney Joe Elford. It challenges statements made by HHS in rejecting a petition to reschedule marijuana filed with the DEA by John Gettman in 1995. After sitting on Gettman’s petition for two years, DEA sent it to HHS for evaluation. If HHS found that marijuana was safe and had a currently accepted medical use, according to Elford, the DEA would have had to reschedule it. HHS asked the FDA Controlled Substances branch to do the evaluating. FDA ignored the safety question and rejected Gettman’s claim that marijuana had a currently accepted medical use.
“One quote we are challenging,” says Elford, “is that there have been ‘no studies that have scientifically assessed the efficacy of marijuana for any medical condition.’ Which is, of course, complete BS. The easiest one to cite is the Institute of Medicine Report of 1999, which was requested by the White House Office of Drug Control Policy, expecting to get a negative finding.”
Another quote being challenged is that the chemistry of marijuana is not “known and reproducible... because a complete scientific analysis of all the chemical components found in marijuana has not been conducted.” This is true of lettuce and everything else we eat, Elford observes; “it’s an impossible standard to meet, a standard which is not applied to any other substance.”
ASA is also objecting to HHS’s statement that, “a material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts. It is clear that there is not a consensus of medical opinion concerning medical applications of marijuana.” FDA’s usual standard for approval is simply “accepted by qualified experts,” i.e. some qualified experts. By demanding a consensus on marijuana, HHS raised the bar and showed bias.
Note the gratuitious and meaningless term “material conflict of opinion.” What is “material” about a conflict of opinion? The only purpose of the fancy adjective is to make the noun seem more important (as in “‘clinical’ depression”).
The Data Quality Act requires that the challenged agency respond within 60 days. Elford expects HHS to delay “by saying ‘it’s complicated, we need more time.’ Or they may say it’s moot because there’s a new petition pending [to reschedule marijuana, Gettman’s third attempt]....They may say they don’t need to respond because this information was disseminated prior to the Data Quality Act.”
If rejected on any grounds, ASA would request a hearing before an administrative law judge (employed by HHS). Elford hopes the process won’t take more than six months. The more drawn out the hearing, the more opportunity it will provide for patients to expose the corrupt, deceitful, intellectually embarrassing process by which the truth about marijuana has been suppressed.
An adverse decision from HHS’s Administrative Law Judge would be appealed to the Northern District of California, and then, if necessary, to the Ninth Circuit. If the highest judges ultimately find that HHS was wrong on all three points, it is not clear whether DEA -a branch of the Justice Department- would be compelled to reschedule marijuana.
“Technically, all we’re asking them to do,” Elford explains, “is correct misstatements they have made and continue to disseminate. We’re not asking them to reschedule anything. But if they make these corrections, it gets into a very tricky procedural area. Given that this deals with a petition that’s already been rejected, if they make these corrections in connection with that petition, does that bind DEA to have to reschedule marijuana on its own? That’s the argument we hope to make —DEA can do it on its own, or at the request of an interested party.”
P.S. in the interests of data quality.
The White House knew what to expect from the Institute of Medicine report, and although it was commissioned by the Drug Czar’s office, it wasn’t Barry McCaffrey’s idea. Soon after McCaffrey told the world that marijuana is “a hoax... Cheech and Chong medicine” (on Dec. 30, 1996), the Clinton Administration reined him in and adopted a more defensible, durable line: “more research is needed.” The new line was promulgated by Harold Varmus, MD, PhD, director of the National Institutes of Health, who ranked way above McCaffrey in the real Clintonite hierarchy, and even above Donna Shalala, his nominal boss. Varmus, a Nobel Prize winning cancer researcher who now heads Sloane-Kettering, was undoubtedly embarrassed by McCaffrey’s nutcake pronouncements. “More research is needed” is a brilliant lie because it’s always true, in a sense.
In January ’97, on the same day the New England Journal of Medicine called the marijuana prohibition “federal foolishness,” Varmus announced he was convening a panel of “experts” on the subject because “I don’t think anyone wants to settle issues like this by plebiscite.” Soon thereafter McCaffrey commissioned the IOM Report and began telling the media, “Let’s wait until we have sound science on this.”