April 1, 2004. Congressman Mark Souder, Chairman of the
U.S. House Government Reform Subcommittee on Criminal Justice, Drug
Policy, and Human Resources, held a hearing about "Marijuana and
Medicine: The Need for a Science-Based Approach." MPP Executive
Director Rob Kampia testified (video
and transcript)
and answered
questions (video
and transcript).
During his comments, he discussed the importance of MAPS' vaporizer
research efforts as well as the UMass Amherst project.
March 16, 2004. In response to DEA request (see entry for
Feb. 11, 2004), MAPS launches a campaign with MPP, Drug Policy Forum
of MA, CA NORML, and Americans for Safe Access, seeking letters
from physicians to DEA recommending that DEA give Prof. Craker his
license. These letters need to arrive before April 9. An
explanatory cover letter and a sample letter to DEA (Word format)
have been sent out.
Also available in
HTML format)
February 16, 2004. John Gilmore donates $100,000 to MAPS
for the creation of a start-up fund to assist new research projects
in getting off the ground, with the first project being the UMass
Amherst medical marijuana production facility. John's intention
is for the start-up fund to be used as a catalyst to start the UMass
Amherst project, with the money to be replenished if the UMass Amherst
project becomes fully funded so that the funds can then be used
again to help catalyze another research project.
February 11, 2004. Prof. Craker spoke at length with Ms.
Helen Kaupong of the Drug Enforcement Administration (DEA). Prof.
Craker learned that a meeting will take place in early April 2004
at which DEA officials will determine whether to recommend to senior
DEA Administrators to approve or reject the license for the UMass
Amherst marijuana production facility. Ms. Kaupong indicated that
it would help our case if we could obtain letters from physicians
indicating that the product available from NIDA was not adequate
and that an alternative source of supply was required. It's frustrating
that DEA's meeting is scheduled so far in the future, since about
4 1/2 months have already elapsed since the end of DEA's public
comment period. It's also not clear why these letters are needed,
since the law clearly requires competition in the supply of Schedule
I drugs, MAPS as a sponsor of research has already indicated that
NIDA's supply is inadequate, and Dr. Ethan Russo has already written
to DEA to say that an alternative to NIDA' supply is required. Still,
MAPS will work to gather letters and submit them to DEA.
February 10, 2004. Pipe Dream?
Rick Doblin has a prescription for fixing NIDA's ailing medical-marijuana
program: establish an alternative. By Bill Breen, Fast Company.
An excellent article about MAPS' UMass Amherst project.
January 18, 2004. The
Demonized Seed. Reporter Lee Green wrote an article for the
LA Times Sunday magazine about the DEA crackdown on hemp products
and on the growing of hemp. The article helps put in context MAPS'
struggle to sponsor a growing facility at UMass Amherst to produce
high-potency marijuana for federally-approved research.
December 29, 2003. MAPS receives a letter
regarding the UMass Amherst project from Ms. Laura Nagel, Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration. The letter acknowledges MAPS' letter of November
21, 2003, but says only that, "the DEA cannot officially comment
on the merit of any specific application." No timetable is given
regarding when DEA will officially reply to Prof. Craker's application,
for which DEA's public comment period ended September 22, 2003.
Once again, we see evidence that DEA's primary strategy is to delay
responding as long as possible. DEA fears that acceptance may eventually
lead to FDA approval of the prescription use of marijuana while
a refusal to approve the application will expose the hypocrisy of
the ONDCP/DEA line that more research into the medical use of marijuana
is required before patients can legally receive marijuana under
a doctor's recommendation or prescription.
November 26, 2003. MAPS
sent a letter today to NIDA Director Nora Volkow, Ph.D., responding
to a November 18, 2003 letter
from Dr. Volkow to Rick Doblin. This exchange of letters was
part of a package of material that MAPS sent today to members of
NIDA's National Advisory Council on Drug Abuse (NACDA) requesting
that NACDA recommend to NIDA that it write to DEA expressing support
for Prof. Craker's application for a license for a marijuana production
facility at UMass Amherst.
Dr. Volkow indicated in her thoughtful but careful letter that
since NIDA's mission doesn't include the medical use of marijuana,
that it wasn't appropriate for NIDA to recommend that DEA license
the UMass Amherst facility. In reply, Rick Doblin noted that, "it
is precisely because NIDA's mission doesn't include the study of
the medicinal uses of marijuana that NIDA's monopoly on the supply
of marijuana for FDA-approved medical research is so inappropriate.
I request you reconsider your decision not to recommend a change
in the status quo."
November 25, 2003. 14 MA. State House Representatives
write to DEA/Gov. Romney. A
letter was sent today by Rep. Jehlen to DEA Administrator Karen
Tandy urging DEA to grant a license to UMass Amherst Prof. Lyle
Craker to grow marijuana for medical research. Rep. Jehlen circulated
the letter to colleagues in the House of Reps.
She collected signatures from Rep. Mark Carron, Rep. Anne Paulsen,
Rep. Mike Festa, Rep. Ellen Story, Rep. Ruth Balser, Rep. Frank
Smizik, Rep. Byron Rushing, Rep. Deborah Blumer, Rep. Elizabeth
Malia, Rep. Benjamin Swan, Rep. Kay Kahn, Rep. Shirley Gomes, and
Rep. Stephen Kulik. The Drug Policy Forum of Massachusetts worked
closely with Rep. Jehlen on the letter.
November 21, 2003. MAPS responds to Dr. ElSohly's letter
to DEA. Several days ago, as a result of its Freedom of Information
Act (FOIA) request, MAPS received a copy from DEA of the one
public comment about Prof. Craker's application for a license
to produce marijuana that was filed with DEA during the public comment
period that ended September 22, 2003. The comment was submitted
by Professor Mahmoud ElSohly, Director of NIDA's marijuana farm
at the University of Mississippi, who strongly opposed DEA licensing
of Prof. Craker's facility. MAPS'
reply to Prof. ElSohly's letter was sent today to DEA. Basically,
Prof. ElSohly wants to retain his monopoly.
Rather hilariously, he explains that he and NIDA didn't consider
it a significant issue that the marijuana cigarettes made available
to researchers for the last twenty years or so contained seeds and
stems. Nevertheless, they have installed "custom-manufactured deseeding
equipment that rids the plant material of any seeds and small stems
prior to the manufacturing of the cigarettes." One day, we can perhaps
look forward to NIDA's coming to understand the value of growing
female plants that aren't permitted to go to seed.
November 18, 2003. WBUR, the Boston NPR station, broadcast
a long, positive story about medical marijuana and the UMass
Amherst project, with interviews with a medical marijuana patient,
Dr. Lester Grinspoon, Rick Doblin, UMass Amherst Prof. Lyle Craker,
Joseph St. Laurent at Chemic Labs, and ONDCP's Dr. Andrea Barthwell.
The story, "Massachusetts Considers Medical Marijuana," is by Rachel
Gotbaum and begins by stating, "Governor Mitt Romney is expected
to decide later this month whether he will join Senators Kennedy
and Kerry and urge the federal drug enforcement administration to
allow a Massachusetts professor to grow marijuana for medical research."
Letter
from Dr. Volkow to Rick Doblin.
November 10, 2003. Gov. Romney's senior policy advisor
meets in the State House about the UMass Amherst project with Rick
Doblin and Scott Mortimer of the Drug Policy Forum of Massachusetts.
The meeting was arranged by Romney supporter Leo Kahn, who also
attended the meeting along with Joe Rosen.
Senators
support proposal to grow marijuana for research
Alcoholism & Drug Abuse Weekly, No. 43, Vol. 15; Pg. 8.
October 28, 2003. An article
"Senators back UM medical marijuana"
By Mary Carey, Staff Writer, is published in the Daily Hampshire
Gazette
October 27, 2003. MAPS sends a
short memo to David Murray, special assistant to ONDCP Director
John Walters, outlining the reasons why ONDCP and DEA should support
the licensing of Prof. Craker's UMass Amherst marijuana production
facility, sponsored by MAPS. This report was requested by David
Murray.
October 23, 2003. Both US Senators from Massachusetts support
UMass Amherst project!
Today, MAPS received a copy of an Oct. 20, 2003, letter
that Senators Kennedy and Kerry signed and sent to DEA Administrator
Karen Tandy, expressing their strong support for the UMass Amherst
marijuana production facility. The letter was fantastic and will
make it significantly more difficult for DEA to reject the application.
The Senators' wrote:
"We are writing to express our strong support for the
application by the University of Massachusetts Amherst for registration
as a bulk manufacturer of marijuana for distribution to researchers
in clinical investigations authorized by the Food and Drug Administration
and non-clinical investigations at DEA-licensed laboratories....
We believe that the National Institute on Drug Abuse facility at
the University of Mississippi has an unjustifiable monopoly on the
production of marijuana for legitimate medical and research purposes
in the United States...The current lack of such competition may
well result in the production of lower-quality research-grade marijuana,
which in turn jeopardizes important research into the therapeutic
effects of marijuana for patients undergoing chemotherapy or suffering
from AIDS, glaucoma, or other diseases."
This is a major step forward in MAPS' efforts to create the conditions
necessary for a serious medical marijuana drug development effort
aimed with FDA-approval of the prescription use of marijuana, with
the two essential elements being an independent source of supply
of high-potency marijuana and FDA-approval of the use of vaporizer
in clinical research.
To show what an incredible accomplishment it was to obtain support
from Senator Kerry for medical marijuana research, see the text
of a letter
he sent on October 21, 2003 to a constituent in which he expresses
his reasons for supporting the current criminalization of the non-medical
use of marijuana.
October 20, 2003. MAPS sends a
letter to all members of the National Institute on Drug Abuse's
National Advisory Council on Drug Abuse, requesting that it recommend
that NIDA support Prof. Craker's application to DEA for a privately-funded
medical marijuana production facility as an alternative source of
supply to NIDA. (also available in Word
format)
October 7, 2003. MAPS files FOIA request with DEA. MAPS
learned through a phone call to DEA that only one public comment
about Prof. Craker's application for a license to produce marijuana
was filed with DEA during the public comment period that ended September
22, 2003. However, we also learned that we could see that comment
only by filing a formal Freedom of Information Act (FOIA) request,
which we did today.
September 29, 2003. MAPS sponsors two talks by Dr. Russo
at UMass Amherst.
The first talk was titled "Cultivation of Marijuana for Pharmaceutical
Application" and "Medical Marijuana: A Doctor's Perspective." The
later talk is the subject of a September 30 article
in the campus paper, The Massachusetts Daily Collegian. Following
the article is a short letter to the editor by Dr. Russo clarifying
a few comments.
According to Prof. Craker,
"At least four or five faculty and the Department Head
have indicated they thought the afternoon seminar was excellent
and that they really began to see another side to the story of marijuana.
The evening presentation was also well received. Although I have
seen only a few students in the short time since the presentation,
they have indicated the talk was very informative. I think the number
of questions from students at the end testified to the positive
reception."
September 16, 2003. MAPS sends a letter
to NIDA director Nora Volkow requesting that NIDA submit a comment
to DEA supporting Dr. Craker's application.
August 29, 2003. Drugsense helps out with the UMass Amherst
Action Alert campaign! For more details, look here.
August 29, 2003. An article
entitled "UMass professor seeks OK to grow marijuana legally" written
by Marcella Bombardieri was published in the Boston Globe
Note: several news stations have reported this story, including
NBC San Diego, FOX-Texas, ABC and NBC-Boston, and a TV station in
Jacksonville, FL.
August 28, 2003. An article
was published in GazetteNet in which Rep. Olver (D-MA) (from the
Amherst area) issues a statement supporting the MAPS/UMass Amherst
application.
August 25, 2003. NORML issues an action alert focused on
urging Dr. Andrea Barthwell, Deputy Director of Demand Reduction
at the White House office of National Drug Control Policy (ONDCP)
to support Prof. Craker's application to DEA for a license to establish
a medical marijuana production facility. NORML's alert can be found
here
August 22, 2003. The Drug Policy Alliance issues an action
alert focused on urging Dr. Andrea Barthwell, Deputy Director of
Demand Reduction at the White House office of National Drug Control
Policy (ONDCP) to support Prof. Craker's application to DEA for
a license to establish a medical marijuana production facility.
The DPA alert can be found at
The Drug Policy Alliance Action Center
August 22, 2003. UMass Amherst Chancellor Lombardi agrees to
support our efforts! MAPS learned today that UMass Amherst Chancellor
John V. Lombardi supports our efforts to secure a license to grow
marijuana for federally-approved research. Thus, we have a green
light throughout the research track at the University. This means
that we now have a much stronger chance of obtaining letters to
the DEA from Senators Kennedy and Kerry.
August 21, 2003. MAPS' FIRST ACTION ALERT, IN PARTNERSHIP WITH
THE DRUG POLICY ALLIANCE. Earlier today, MAPS and the Drug Policy
Alliance started an action alert
against ONDCP about medical marijuana, focused on the MAPS-supported
UMass Amherst application to DEA for a license to establish a medical
marijuana growing facility. Could you help out by sending a letter
to Dr. Andrea Barthwell at ONDCP? Anything that you can do would
be great since the Drug Czar's office is quite vulnerable on this
issue. Background meterials are available.
August 7, 2003. DEA Responds to MAPS. DEA Acting Administrator
William Simpkins' letter to MAPS
acknowledges MAPS' June 10, 2003, letter to DEA (see June 10 entry
for this letter) and says that the DEA will either grant or reject
the UMass Amherst license shortly after the public comment period
is over.
If DEA rejects the application, MAPS will initiate a lawsuit which
will result in a very public DEA Administrative Law Judge hearing
that is bound to be embarrassing to DEA. The UMass Amherst effort,
along with Chemic Lab's MAPS-sponsored effort to import marijuana
from the Dutch Office of Medicinal Cannabis for its vaporizer research,
raise hopes that NIDA's monopoly will be ended, sooner or later.
Once an independent source of high-potency marijuana is available,
and vaporizers can be used in human clinical research, it finally
would be reasonable to spend the sums necessary to conduct a serious
drug development effort aimed at FDA approval of marijuana as a
prescription medicine.
July 24, 2003. Out of the shadows. Today, the DEA filed
a notice
in the Federal Register about the UMass Amherst application for
a Schedule I license to grow marijuana for medical research. They
even report the initial application date as June 25, 2001, but don't
bother to explain how the application submitted two years ago just
now gets mentioned in the Federal Register.
The notice limits public comment only to a very small set of people,
similar applicants or people who already have such licenses. I'm
not sure if DEA really can limit public comments this way and am
checking to see if we could open it up ourselves to thousands of
letters from all directions.
This feels like a significant step forward. It does look like
this will lead to an Administrative Law Judge hearing, but perhaps
there is a chance to influence DEA so that the application is granted
without the need for the DEA Administrative Law Judge hearings.
July 19, 2003. Several excellent questions about strategy.
MAPS received a series of questions via email from a reader of Jacob
Sullum's Jully 11 Reason article
about MAPS' effort to break NIDA's monopoly on the supply of marijuana
available for research. The questions
and answers concern the possible importation of marijuana from
the Netherlands as another way to break the NIDA monopoly (which
we are trying in the context of the vaporizer research), the basis
for a potential MAPS lawsuit against DEA, and the potential safety
advantages of using hash rather than bud.
July 11, 2003.An article
entitled "Privatizing Pot - Can the marijuana monopoly be broken?"
written by Jacob Sullum was published in Reason.
June 10, 2003. MAPS Responds to DEA. MAPS sent a
letter to DEA responding to a March
4, 2003 letter to Prof Lyle Craker from Mr. Frank Sapienza,
Chief, DEA Drug and Chemical Evaluation Section. MAPS' letter pointed
out that while the poor quality of NIDA material was an important
problem, DEA had ignored other important reasons why NIDA's monopoly
impedes medical marijuana research. As long as NIDA retains its
monopoly on the supply of marijuana that can be used in research,
private sponsors of medical marijuana research 1) cannot select
the exact strain of marijuana with the exact mix of cannabinoid
content that the sponsors consider most likely to be safe and efficacious,
2) cannot manufacture the drug they wish to research and thus are
not in control of either availability and cost, and 3) cannot supply
the exact drug that was used in research for possible prescription
use since NIDA is legally authorized to grow marijuana for research
but cannot supply it on a prescription basis.
Furthermore, NIDA will not sell marijuana to a researcher with
a privately-funded and FDA-approved protocol unless the protocol
is also approved by a NIDA/ PHS review process. Since NIDA has a
monopoly on the supply of marijuana, but not any other Schedule
I drug such as MDMA, LSD or psilocybin, this additional review process
exists only for marijuana research and has twice been used to prevent
privately-funded, FDA-approved protocols from taking place.
As a result of NIDA's monopoly, no rational sponsor will invest
millions of dollars in medical marijuana research while it remains
dependent for its supply of research material on NIDA, whose institutional
mission is diametrically opposed to exploring the beneficial uses
of marijuana and which cannot legally provide marijuana for prescription
use.
June 2, 2003. Prof. Lyle Craker sends a letter to DEA responding
to Mr. Frank Sapienza's letter of March 4, 2003.
May 2, 2003. The Drug Policy Alliance's Executive Director,
Ethan Nadelmann, also sent a letter
to the DEA.
April 25, 2003. MAPS publishes "DEA and the UMass Amherst
Medical Marijuana Production Facility: An Update" by Rick Doblin,
Ph.D. (pdf
format) in the MAPS Bulletin, Spring 2003; Volume XIII,
Number 1
On March 25, 2003, The Marijuana Policy Project also sent
a letter to the DEA.
On March 4, 2003, two and a half months (not three weeks)
after DEA said it would send Prof. Lyle Craker a written response
to his application, a letter
was sent to Prof. Craker by Frank Sapienza, Chief, DEA Drug and
Chemical Evaluation Section. This is the first written response
to Prof. Craker after DEA kept him waiting for more than 20 months
after his initial application was submitted in June 2001.
DEA's primary argument was that "the
quality of marijuana available from NIDA [National Institute on
Drug Abuse] is acceptable. DEA discounted complaints about NIDA's
poor quality material contained in a letter
submitted to DEA on 12/31/02 by Dr. Ethan Russo, on the grounds
that Dr. Russo "has not been registered by the DEA to conduct research
with marijuana." Ironically ( at least to us), Dr. Russo was not
registered with DEA to conduct human clinical research with marijuana
(though he is registered with the DEA to conduct laboratory research
with marijuana) because NIDA and the Public Health Service (PHS)
didn't like his privately-funded, FDA-approved protocol and refused
to sell him marijuana, effectively preventing his study from taking
place. Dr. Ethan Russo responded
to the DEA with a letter sent on March 11, 2003.
On Monday, December 16, 2002, two DEA agents went to UMass
Amherst to discuss Prof. Lyle Craker's June 2001 application to
DEA for a license to grow marijuana for federally-approved research.
This visit is the first direct DEA response to Prof. Craker's application
in 18 months, a remarkable record of inaction (diagnosis: passive-aggressive).
The DEA agents met with Prof. Lyle Craker and several senior UMass
Amherst administrators including the Vice President for Research,
the Dean, and the Director of the Office of Grants and Contracts.
Prof. Craker reported that the main
purpose of their visit, as far as he could tell, was to try to get
the application withdrawn. Fortunately, the UMass Amherst administration
didn't get dissuaded but instead just realized this is going to
be a long fight. So DEA did not achieve its primary goal.
DEA arguments:
- Nobody has ever complained about the quality of NIDA pot and
no new sources of supply are needed. [There have been lots of
complaints, but perhaps not submitted in a formal manner that
would appear in the files. The argument that no privately-funded
drug development program will be initiated unless there is an
independent source of high-potency marijuana wasn't addressed
by the DEA officials.]
- There are no approved researchers waiting to use UMass Amherst
pot. [Obviously not, since scientists cannot count on this supply
ever becoming available and thus would not go to the trouble of
obtaining FDA permission for a study with a non-existent source
of supply.]
- MAPS is a questionable organization that the DEA officials said
doesn't have a license to handle marijuana. [MAPS won't ever need
a license since the marijuana would go from UMass Amherst direct
to FDA and DEA-approved researchers, with MAPS never being in
possession of any material.]
Note that US international treaty obligations were not mentioned
despite this being DEA Administrator Asa Hutchinson's main argument
against privately-funded production facilities in his response to
the June 6, 2002 letter to DEA from Rep. Barney Frank and four other
Massachusetts congressional representatives. The omission of this
argument by the DEA agents may have something to do with the legal
analysis by Washington, DC law firm Covington & Burling and the
ACLU, submitted to DEA after Administrator Hutchinson's letter.
Several times, the DEA agents made it clear to Prof. Craker and
the UMass Amherst Administrators that they would welcome a withdrawal
of the application. Instead, the UMass Amherst administrators asked
for a written response from DEA to the application. One of the DEA
agents promised a written response within the next three weeks (we
shall see).
We are now back to waiting to hear from DEA in response to our
letters. MAPS and MPP have been in touch with Senator Edward Kennedy
and his staff about the UMass Amherst project and have requested
that the Senator take an active role in communicating to DEA the
importance of this project.
Also see:
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