Autumn 2005
O'Shaughnessy's
Journal of the California Cannabis Research Medical
Group
|
NIDA Blocks Vaporization Study;
Researchers Appeal to DEA
O'Shaughnessy's News Service
After 18 months of regulatory delay, a laboratory study of marijuana
vaporization sponsored by MAPS (the Multidisciplinary Assocation for
Psychedelic Studies) and California NORML has been blocked by the National
Institute on Drug Abuse (a branch of the U.S. Public Health Service).
The lab sought to buy 10 grams of marijuana for research purposes.
NIDA rejected the application in a letter dated July 27. Because NIDA
controls the only legal supply of marijuana in the U.S., its refusal
effectively prevents the vaporizer study from proceeding.
The vaporization study is aimed at developing a smokeless delivery
system for medical marijuana patients. Previous studies have indicated
that vaporization can deliver medically active cannabinoids while eliminating
the toxic byproducts of smoke by heating marijuana to a temperature
just short of combustion.
Because of concern over the dangers of smoked medicine,
the development of vaporization is viewed as an essential step to obtaining
FDA
approval of marijuana as medicine. In its 1999 report, “Marijuana and
Medicine,” the Institute of Medicine concluded that there was
little future in smoked marijuana and so recommended that research
be conducted into “developing rapid-onset, reliable, and
safe delivery systems.”
Dale Gieringer of California NORML says the federal government
has created “a Catch 22 for medical marijuana. First, it claimed
that marijuana couldn’t be used as a medicine because there weren’t
sufficient FDA studies of safety and efficacy. Then it refused
to provide marijuana to conduct the studies. Then it contended
that
marijuana
was inappropriate for FDA approval in the first place due to the
dangers of smoking. Now it is blocking the very studies called
for by the Institute
of Medicine to develop non-smoked alternatives to smoking.”
In its rejection letter, NIDA indicated that the proposed
vaporization study lacked scientific merit. Researchers reply that
NIDA’s
reasons are bogus and display a basic misunderstanding of the study. “NIDA
could have easily cleared up any questions they had with a simple phone
call, rather than sitting on the application a year and a half and
issuing a politically motivated rejection letter,” says Gieringer.
Hearings at DEA Headquarters
NIDA made it known that it was rejecting the application just days
before the opening of DEA hearings on an application by Prof.
Lyle Craker of the University of Massachusetts to license an independent
marijuana production facility for use in FDA-approved medical
marijuana
R&D sponsored by MAPS (Multidisciplinary Association for
Psychedelic Studies).
The hearings were held August 22-26 at the DEA’s headquarters
in Pentagon City, Virginia, before administrative law judge Mary Ellen
Bittner. Bittner is the successor and former protégée
of the late Francis Young, who presided over the marijuana rescheduling
hearings in 1988. Young ruled that marijuana clearly had “accepted
medical use” and should accordingly be reclassified as a Schedule
II prescription drug. Administrative Law Judges don’t make rulings,
they make recommendations to the agencies that employ them; Young’s
recommendation was overruled by DEA Administrator Jack Lawn, who made
prior FDA approval a defining element of “accepted medical use.” Bittner’s
task is to decide whether granting Craker’s application for a
DEA license to manufacture marijuana would be in the public interest
as specified in 21 USC 823(a). It remains to be seen whether DEA can
concoct a way to redefine “public interest” in the
event Judge Bittner rules against it.
Craker, a professor of Plant and Soil Sciences at U Mass Amherst, is
an expert on the cultivation of medicinal plants. He testified that
he had no experience with marijuana before being contacted by Rick
Doblin to apply for a DEA license to manufacture it legally for use
in approved FDA research sponsored by MAPS.
MAPS has obtained an FDA “orphan- drug” designation
to develop marijuana as a prescription drug for AIDS wasting
syndrome. However, NIDA has repeatedly refused to allow its marijuana
to
be
used by MAPS and other researchers. For this reason, advocates
contend that
an independent, non-NIDA source of supply is needed to break
the government stranglehold on research.
At the hearings, advocates countered the government’s claim that
it has already made adequate provision for medical marijuana research
by allowing marijuana to be provided to a series of studies at the
California Center for Medicinal Cannabis Research. Speaking as a member
of the CMCR’s advisory council, Dale Gieringer testified that
the CMCR’s studies were neither designed nor intended to
advance FDA approval of marijuana, but simply to answer basic
questions about
safety and efficacy outlined in its implementing legislation.
He explained that it would be necessary for the state to establish
its own source
of marijuana independent of NIDA in order to pursue new drug
approval,
and that there were no plans or resources to do so. The CMCR
has some 15 clinical studies currently in progress, two of which
are
finally
nearing publication. However, even if all were complete, they
would not constitute the kind of evidence necessary to win FDA
approval.
Former state Sen. John Vasconcellos, the author of the
legislation establishing CMCR, noted that $9 million had been appropriated
to the CMCR’s research budget, and that money had already been fully
committed to ongoing studies. He opined that further appropriations
were highly unlikely in light of the state’s massive $40 billion
budget deficit. DEA attorney Imelda Paredes tried to smear Vasconcellos
with an ad hominem attack. She noted that he is listed in a recent
(right-wing) best seller, “One Hundred People Who Are Screwing
Up America,” and ridiculed his famous California panel for self-esteem,
which she claimed had been scientifically discredited. Vasconcellos
forcefully responded that he was proud to be listed in the book along
with President Jimmy Carter, and berating Paredes’ evident
ignorance of the scientific literature on self-esteem.
Petitioners presented evidence that NIDA’s marijuana was of inferior
quality for medical purposes. They cited reports that NIDA’s
pot was contaminated by stems and seeds, harsh to smoke, and
of much lower potency than the medical sinsemilla commonly sold
at
cannabis
clubs, so that subjects had to inhale more smoke to obtain the
same effective dose.
Doblin cited the experience of an AIDS patient from Redwood
City, Philip Alden, who had enlisted in a CMCR study using NIDA pot
after several
years’ experience smoking marijuana from California’s cannabis
clubs. Alden found that smoking NIDA’s pot caused him to develop
bronchitis for the first time in his life. The bronchitis disappeared
after he dropped out of the study and returned to smoking the clubs’ marijuana.
Alden was one of several witnesses who had originally been scheduled
to testify but withdrew out of fear of possible legal repercussions.
Another medical marijuana patient, Irvin Rosenfeld, also dropped out
on advice of his attorney. Patients were apparently concerned about
being forced to testify about use of non-NIDA medical marijuana, which,
though legal in many states, remains illegal under federal law. Numerous
other, scientific witnesses declined to testify publicly out of concern
that their research activities might be imperiled by DEA or NIDA.
Their fears were highlighted by a nasty turn in the DEA’s
tactics during the third day of the hearings, which had hitherto
been marked
by a degree of relaxed cordiality under the good-humored guidance
of Judge Bittner. DEA attorneys bore down on Doblin in the cross-examination,
trying unsuccessfully to get him to disclose the names of patients
who had been involved in research projects that had skirted DEA
regulatory restrictions. Finally, DEA attorney Brian Bayly zeroed
in on Doblin
himself, asking whether he had ever smoked marijuana for recreational
use.
Over the strenuous objection of Doblin’s attorney, Judge Bittner
ruled that she would admit the question and decide later whether it
was relevant. Doblin answered with a forthright “Yes.” Bayly
bore down further, asking Doblin to tell when, how often, and
how recently he had smoked marijuana. Doblin replied that he
used it
weekly.
The judge finally halted the inquisition when Bayly asked
Doblin to tell the source of his marijuana. Doblin says he is glad
to
have answered
honestly and hopes that it will not prejudice the judge’s
decision.
Doblin was ably represented by attorney Julie Carpenter
of Jenner and Block with assistance by Allen Hopper of the ACLU. A
second round of
hearings is scheduled for December. A full transcript of the
DEA hearings may be found at: http://www.maps.org/mmj/legal/crakerdea/transcript0824.html