Journal of the California Cannabis Research Medical
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
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.”
is the journal of the CCRMG/SCC. Our primary goals are the same
as the stated goals of any
reputable scientific publication: to bring out findings that are
accurate, duplicable, and useful to the community at large. But in
order to do this, we have to pursue parallel goals such as removing
the impediments to clinical research created by Prohibition, and
educating our colleagues, co-workers and patients as we educate ourselves
about the medical uses of cannabis.
| The Society
of Cannabis Clinicians (SCC) was formed in the Autumn of 2004 by
the member physicians of CCRMG
to aid in the promulgation of voluntary standards for clinicians
engaged in the recommendation and approval of cannabis under California
law (HSC §11362.5).
As the collaborative effort continues to move closer to issueing
guidelines, this site serves as a public venue for airing and
discussing these guidelines.
Visit the SCC Site for more information.