For the first time since 1941, the federal government's
illegal monopoly on research-grade marijuana is in real danger
of being vanquished. If so, the window of opportunity would
finally be open for putting marijuana through Food and Drug
Administration (FDA)-approved clinical trials seeking to develop
the marijuana plant, smoked and/or vaporized, into a legal
Professor Lyle Craker, Ph.D., Director, Medicinal Plant Program,
Department of Plant, Soil and Insect Sciences, at the University
of Massachusetts-Amherst (UMASS-Amherst), has been attempting
for six years to obtain a Drug Enforcement Administration
(DEA) Schedule I license to manufacture marijuana exclusively
for privately-funded, federally-approved research, under contract
to the Multidisciplinary Association for Psychedelic Studies
(MAPS). Prof. Craker's
case is the focal point of the struggle to bring medical marijuana
before FDA, to actually determine once and for all whether
it meets FDA's standards for safety and efficacy.
On February 12, 2007, following a comprehensive review of
the available evidence gathered during the 2005 DEA Administrative
Law Judge (ALJ) hearings, DEA ALJ Mary Ellen Bittner issued
a decisive—but non-binding-Opinion and Recommended Ruling
that Prof. Craker's application be approved. ALJ Bittner's
thorough 87-page ruling rebukes each of DEA's arguments and
concluded that it was in the public interest for DEA to issue
Prof. Craker his license. It is now up to DEA to decide whether
to accept or reject ALJ Bittner's recommendation.
Prof. Craker's applications for regulatory approval, legal
struggles, and proposed facility are sponsored by MAPS, a
non-profit research and educational organization that plans
to design, fund, obtain government approval for and conduct
the clinical research necessary to develop marijuana into
an FDA-approved prescription medicine. If successful, MAPS
would bring smoked and/or vaporized marijuana to market under
a non-profit pharmaceutical model similar to Planned Parenthood
and the Population Council's development and distribution
of RU-486. DEA licensing is the final regulatory hurdle in
MAPS' quest to create a privately-funded federally-approved
medical marijuana production facility, which would pave the
way for a drug development effort aimed at developing marijuana
into an FDA-approved prescription medicine.
NIDA's Monopoly: Game Over?
Since 1968, the federal government's National Institute on
Drug Abuse (NIDA) has maintained a monopoly over the supply
of marijuana-but no other Schedule I drug-and uses that monopoly
to obstruct privately funded research. NIDA's monopoly makes
very little sense given that DEA has licensed privately-funded
manufacturers of methamphetamine, LSD, MDMA (Ecstasy), heroin,
and cocaine, and virtually all other controlled substances.
According to federal law, which clearly requires "adequate
competition in the production of Schedule I drugs," NIDA's
monopoly is illegal [21 U.S.C. § 823(a)(1); 21 C.F.R.
But that's just the beginning. Human studies on any Schedule
I drug must gain approval from the Food and Drug Administration
(FDA), yet for studies with marijuana, researchers must submit
their protocols for an additional review process by NIDA and
the Department of Health and Human Services (HHS) that exists
for no other drug. This extra review process has been imposed
on medical marijuana research as a result of NIDA's monopoly
power, The HHS/NIDA review board is composed entirely of government
employees, with no outside experts. It has no deadlines-in
contrast to FDA's 30-day deadline—and no formal appeals
process. Thus, NIDA's monopoly results in lengthy delays or
refusals in providing research material.
For instance, NIDA has refused to supply marijuana to two
FDA-approved protocols sponsored by MAPS, preventing these
studies from taking place (Dr. Abrams, University of California
-San Francisco, marijuana for AIDS wasting syndrome-IND #43-542;
Dr. Russo, U. Montana, marijuana for migraines—IND #58,
177). In addition, for the last three and a half years, NIDA
has refused to sell 10 grams of marijuana to a MAPS/California
NORML-sponsored laboratory study evaluating the effectiveness
of a marijuana vaporizer, a non-smoking drug delivery device
that eliminates the products of combustion that patients inhale
after burning marijuana. NIDA has also prevented this study
from taking place, despite the fact that the development of
non-smoking drug delivery devices was recommended by the Institute
of Medicine in its 1999
report on medical marijuana.
For those researchers whose protocols it approves, NIDA provides
inferior, low-potency marijuana. NIDA's marijuana has limited
cannabinoid profiles (containing low levels of Tetrahydrocannabinol
(THC)—and virtually no Cannabidiol), so researchers
are unable to optimize the strain of marijuana they prefer
to use for costly drug development efforts. The highest potency
marijuana available from NIDA for research is 7%; the marijuana
used by patients in states where it is legal has been documented
to be between 12–20%.
NIDA's lone marijuana production facility is directed by
Prof. Mahmoud El Sohly, at the University of Mississippi.
Another egregious conflict of interest for NIDA is that Prof.
El Sohly has personal commercial interests in marijuana-based
products. This includes both his THC suppository and his new
DEA license permitting him to grow marijuana to extract THC
for sale to the pharmaceutical company, Mallinckrodt, to manufacture
generic Marinol. Prof. El Sohly would have a major conflict
of interest if he were the sole supplier of marijuana to MAPS
for prescription use, since marijuana would compete with products
in which he has a personal financial interest.
To put the nail in the coffin, NIDA cannot even guarantee
that the same research material will be available for prescription
use if FDA clinical trials determine that marijuana meets
its guidelines for safety and efficacy. This makes any drug
development effort using NIDA marijuana a futile exercise.
As NIDA well knows, sponsors will not invest millions of dollars
into research studies until there is reliable access to a
supply of high quality research material that can be used
both in research and-if the research should prove successful-as
an FDA-approved prescription medicine.
The Quest for Independent Supply, the "Holy
Grail" of Marijuana Research
Considering the problems with NIDA's monopoly, for the past
six years MAPS has prioritized creating an independent supply
of legal research-grade marijuana for use in FDA-approved
studies. One of DEA's primary tactics for stifling research
is delay, and Prof. Craker's application has been an especially
Orwellian case in point.
In June 2001, with support from MAPS and UMASS-Amherst's blessing,
Prof. Craker applied to DEA for a license to manufacture marijuana
exclusively for use in federally-approved research. About
six months after the application was submitted, DEA claimed
it was lost. Prof. Craker then resubmitted a photocopy of
the original application, but when he inquired to DEA several
months later about the status of his application, DEA informed
him that his application had been rejected since it did not
contain an original signature. Shortly after that, Prof. Craker
received an envelope with a DEA return address, but no cover
letter or any indication of whom at DEA had sent it. Inside
was the original application, with a DEA date stamp showing
that it had been received when Prof. Craker first submitted
it, meaning that it had not been lost after all. Prof. Craker
then resubmitted the application, with original signature.
After DEA failed to respond for more than two years, Prof.
Craker sued DEA in federal court claiming unreasonable delay
under the Administrative Procedures Act. This prompted DEA
to finally reject Prof. Craker's application in December 2004,
three and a half years after the original application was
submitted. In turn, MAPS and Prof. Craker immediately requested
an Administrative Law Judge hearing, which was held over the
course of eleven months in 2005.
Prior to the February 2007 ruling, organizations that had
already written to DEA in favor of Prof. Craker's application
included the Multiple Sclerosis Foundation, the Lymphoma Foundation
of America, the National Association for Public Health Policy,
the United Methodist Church, Americans for Tax Reform, the
American Medical Students Association, several state nurses'
associations, the Massachusetts Dept. of Public Health, and
the California and Texas State Medical Associations, the two
largest US state medical associations. Also, as a result of
MAPS' Congressional lobbying efforts Massachusetts Senators
Kerry and Kennedy and 38 members of the US House of Representatives
have already previously written to DEA in support of Prof.
Those of you who have followed the drug policy reform movement
since the 1980's will remember two decisive instances in which
DEA rejected the advice of its administrative law judge. First,
in 1986, DEA rejected a DEA ALJ ruling that MDMA be placed
in Schedule III, rather than Schedule I. Then, in 1989, DEA
famously rejected a
ruling from the same ALJ, recommending that marijuana be rescheduled,
also from Schedule I to Schedule III.
Now that the drug policy reform movement has gained unprecedented
political muscle and momentum over the past two decades, however,
we actually have a fighting chance to pressure DEA to accept
this new ruling.
MAPS will be coordinating another Congressional and organizational
lobbying campaign after DEA's lawyers submit their objections
on March 26. DEA will begin to process the Judge's recommendation
in May, and has an unlimited amount of time to issue a formal
response. In previous DEA ALJ hearings, DEA has taken anywhere
between 5–15 months to respond. We will use this intervening
period to broadly expand on our Congressional and organizational
lobbying efforts, to demonstrate to DEA that there will be
a political backlash if they continue to obstruct legitimate
and highly demanded scientific research.
Conclusion: The Strategic Benefits of the
Federal Research Route
If DEA still decides to reject Judge Bittner's recommendation,
this action will contribute to the passage of state and local
marijuana reform efforts. If DEA rejects the ruling, it will
be clear that the appropriate administrative channels have
been exhausted and that FDA drug development route is fundamentally
blocked by NIDA's monopoly. MAPS and Prof. Craker will appeal
in the DC Circuit Court of Appeals, but that would tie the
case up in the courts for several more years. A lot of patients
and their families can't wait that long.
Eleven states and numerous municipalities have enacted laws
protecting patients who use marijuana when prescribed by a
doctor. Several more states, such as New York, Illinois, Minnesota,
New Mexico, and Wisconsin are considering similar legislation
this year. While recognizing the inspiring success of state
and local initiatives over the past decade, it is also important
to understand their historical context as it relates to NIDA
and DEA's obstruction of the FDA drug development route, which,
for better or worse, is the regulatory channel that all other
prescription medicines must successfully pass through in the
While enforcement is generally left up to local authorities,
there are no guarantees that the Feds will not intervene.
In 2005, the US Supreme Court did rule in Gonzales v.
Raich that the federal government can arrest medical
marijuana patients and enforce federal marijuana laws even
in states where it is legal. Justice Breyer stated in oral
arguments during the Raich case that medical marijuana patients
should go through FDA's regulatory process to get marijuana
approved as a prescription medicine, rather than focusing
on courts and referendums. Patients, doctors and scientists
are in a catch-22 because the Supreme Court has insisted that
they to go to FDA, but DEA, NIDA and the federal government
have systematically obstructed their ability to perform FDA-approved
As discussed earlier, clinical research with human subjects
that meets FDA's strict guidelines is costly. MAPS estimates
that it would cost $5–$7 million to get marijuana approved
as a prescription medicine, spent over the course of 5–7
years. Expenditures of this magnitude make sense only after
there is an independent source of supply.
When compared to the costs of other forms of medical marijuana
policy reform, however, such as statewide ballot initiatives,
the costs of research are a bargain. One statewide ballot
initiative can cost several million dollars; it would be many,
many times more costly for all 50 states to individually pass
medical marijuana laws than it would be to go for the whole
ball of wax by gaining FDA approval.
Why is the federal government going to such lengths to stop
MAPS and Prof. Craker? The federal government knows that if
FDA had the opportunity to evaluate medical marijuana based
on science, not politics, it would likely approve it for medical
For the first time in six and a half decades, since marijuana
was removed from the US Pharmacopeia in 1941, there is a window
of opportunity for the establishment of a privately-funded
source of research-grade marijuana. To take advantage of this
unique opportunity, we need all supporters to contact their
federal legislators. Ask your Representatives and Senators
to add their signature to the Congressional Sign-On letter
urging DEA to issue a Schedule I license to Prof. Craker.
Tell them that you would like to see the controversy over
the medical use of marijuana resolved through FDA-approved
Please visit www.MAPS.org
for more information.
Editor's Note: Jag Davies is
the Director of Communications for The
Multidisciplinary Association for Psychedelic Studies (MAPS).
Rick Doblin, Ph.D. is the President of