We are now starting the sixth year of MAPS’
efforts to sponsor a privately-funded facility to
produce marijuana for FDA and DEA-approved research.
When we wrote about University of Massachusetts-Amherst
Prof. Lyle Craker’s lawsuit against the DEA in the Spring
2006 MAPS Bulletin*, lawyers for both sides were working
on the final legal briefings for this case. Both MAPS and the
DEA filed final briefs to DEA Administrative Law Judge (ALJ)
Mary Ellen Bittner on May 8, 2006.
Prof. Craker, Director the Medicinal
Plant Program in the Dept. of Plant, Soil
and Insect Sciences at UMass-Amherst,
MAPS staff, and medical marijuana
advocates and patients throughout the
country are now eagerly awaiting a
decision that will tell us a lot about the
course of medical marijuana reforms over
the next few years. Waiting and preparing,
that is, because even if Prof. Craker
receives a favorable recommendation,
there’s much more work to be done to
ensure that Prof. Craker’s facility becomes
a reality, since DEA Administrator Karen
Tandy can either accept or reject ALJ
Bittner’s recommendation.
For researchers seeking to perform
FDA-approved clinical studies with most
Schedule I substances, it is a relatively
simple matter to obtain a license from the
DEA to possess the actual research material,
once the security of their laboratories
has been demonstrated. Not so with
marijuana. Marijuana alone is subject to
a monopoly controlled by the National
Institute on Drug Abuse (NIDA), a
government agency whose mission is
certainly not to examine the beneficial
uses of controlled substances. Further,
Prof. Mahmoud El Sohly of the University
of Mississippi, NIDA’s producer of marijuana,
has a personal financial interest
that conflicts with smoked marijuana
becoming a prescription medicine. Prof. El
Sohly personally has patents on a marijuana
suppository delivery system, and he
has a DEA license to grow marijuana for
his own private gain in order to supply
THC extract under contract to a pharmaceutical
company that produces generic
Marinol. Both of these products would face
direct competition from prescription
marijuana, either smoked or vaporized.
The results of these several levels of
conflict of interest are as one might
imagine: NIDA’s marijuana supply is of
the low quality that befits NIDA’s agenda
to research the harms of mariiuana, and,
more importantly, NIDA’s lack of competition
produces arbitrary and total control
over the supply. As a result, NIDA has
been able to halt MAPS’ medical marijuana
research program for the last decade
by refusing to sell marijuana to several of
MAPS’ FDA-approved studies. NIDA has
even refused to sell 10 grams of marijuana
for a MAPS-sponsored laboratory study of
the chemical composition of marijuana
vapors produced by the Volcano vaporizer,
a non-smoking delivery system that
successfully addresses FDA concerns about
the inhalation of marijuana smoke.
MAPS and Prof. Craker are seeking to
break this monopoly by opening a MAPS-funded
production facility run by Prof.
Craker. This facility would provide
marijuana for all of MAPS’ FDA-approved
protocols and would spur additional new
research, as the threat of a years-long
bureaucratic nightmare is removed from
MAPS’ research-planning picture. More
importantly, a private facility would create
the possibility for MAPS to initiate its
medical marijuana drug development
clinical trials to evaluate whether marijuana
can become an FDA-approved
medicine. Clinical trials of a plant-based
medicine must take place using the same
strain of plant material that a drug developer
plans to market, since the effects and side
effects of another strain with different
chemical concentrations could vary. No
rational drug developer would invest
millions of dollars in researching a lowpotency,
low-quality strain that is controlled
by NIDA, a government body that could
withdraw or refuse permission to use the
strain at will, and that in any event is not
permitted to be the supplier of marijuana for
prescription medicine distribution, leaving
the sponsor with the need to negotiate with
Prof. El Sohly despite his major conflicts of
interest. As one of our fellow medical
cannabis advocates recently noted, this is
like Pfizer spending millions of dollars
researching a new pill that Merck owns the
rights to, which would clearly be a foolish
investment.
MAPS’ final brief to the court, prepared
by lawyers Julie Carpenter (Jenner
& Block, LLP), Allen Hopper (ACLU Drug
Law Reform Project), and Emanuel
Jacobowitz (Steptoe & Johnson, LLP)
highlighted these and other arguments,
and can be found with other information
related the case at http://www.maps.org/
mmj/DEAlawsuit.html. The DEA’s reply
brief, also filed on May 8, was rather
empty of analysis and legal arguments and
was padded, like a weak high school term
paper, with a long reiteration of the
contents of the testimony of each witness.
Unfortunately but unsurprisingly, DEA
lawyers resorted to ad hominem attacks on
Rick Doblin for his personal marijuana
use, despite the fact that he would never
have access to any of the marijuana in
Prof. Craker’s facility. Since Rick had
never sampled NIDA’s supply of marijuana
he had therefore not “diverted”
legal marijuana to non-medical purposes.
The DEA’s brief can also be viewed on
the MAPS website.
The final recommendation from ALJ
Bittner is expected approximately four to
six months after the brief filing date,
which would be sometime between
September and November. We’ve been
spending these months preparing actively
for the recommendation, because–unlike a
decision in state or federal court–the DEA
is not obligated to follow a recommendation
from its own administrative law
court. For comparison, some of you may
be surprised to learn that DEA ALJs have
already recommended rescheduling both
marijuana and MDMA, and it is obvious
how far that did not go!
With this historical trend in mind, the
MAPS staff has been working hard to
gather support from a broad range of
individuals and organizations to put
political pressure on the DEA to issue the
license should Judge Bittner recommend
that course of action. Our supporters
include 38 members of Congress, Senators
Kennedy and Kerry of Massachusetts, the
state medical associations of California
and Texas, the state nurses associations of
New Mexico, North Carolina, and Wisconsin,
the Lymphoma Foundation of
America, the National Association for
Public Health Policy, the United Methodist
Church, the Drugs and the Law Committee
of the Association of the Bar of the
City of New York, Grover Norquist,
president of the conservative organization
Americans for Tax Reform, and several
other notable organizations. Efforts are
continuing to get support letters from
other organizations such as the American
Nurses Association and the American
Cancer Society.
MAPS has also just joined forces with
the Medical Marijuana Policy Advocacy
Project (MMPAP), a coalition of medical
marijuana advocates who are working
toward getting support from the American
Medical Association (AMA) for more
reasonable medical marijuana policy. The
AMA House of Delegates already has a
very positive resolution calling for further
research into the use of marijuana as
medicine**. MMPAP is working to find
state delegations of the AMA who will
help us propose a new resolution at the
November House of Delegates meeting,
calling for support for private production
facilities like Prof. Craker’s. The proposed
resolution also supports protecting
patients in medical marijuana states from
criminal prosecution, in hopes that AMA
support will assist the passage in Congress
of the Hinchey-Rohrabacher amendment,
which aims to codify such patient protection
into federal law. The passage of our
AMA resolution depends on support from
state medical associations, so if you have
or know of good connections with any
state medical associations, particularly in
states that have medical marijuana laws,
please contact me at kelly426@gmail.com.
We are hopeful that Judge Bittner will
issue a favorable recommendation, and
that the broad base of support that we
have collected will convince the DEA to
follow that recommendation. If the DEA
does not follow a favorable recommendation,
we can still pursue the case in federal
court, arguing that the DEA’s reasons for
not following the recommendation are
flawed. More litigation would delay Prof.
Craker’s facility from opening for many
more years, so this is certainly not our
desired outcome. However, if the DEA
does fail to follow a favorable recommendation,
or for that matter if the recommendation
is unfavorable, it will only boost
the efforts to pass state medical marijuana
initiatives by providing even stronger
evidence that the federal process for
making marijuana into a medicine is
blocked. What happens over the next few
months in Prof. Craker’s case will be a
decisive factor in what sorts of medical
marijuana reform efforts we see in the
future, nationwide. We hope we’ll have
some good news for you on this front in
an upcoming monthly email update and
in the next MAPS Bulletin!
* See Spring 2006 article at
http://www.maps.org/news-letters/v15n4-html/dea_case.html
** See http://www.amaassn.org/apps/pf_new pf_online?f_n=browse&doc=policyfiles/HnE/H-95.952.HTM |