The UMass Amherst MMJ Production Facility Project
MAPS, in association with Prof. Lyle Craker, Director, Medicinal Plant Program, UMass Amherst Department of Plant and Soil Sciences, is in the midst of the process of seeking DEA permission to establish a medical marijuana production facility to grow high-potency marijuana for FDA-approved research. MAPS recently completed a congressional sign-on letter campaign, gathering signatures from 38 members of Congress (36 Democrats and 2 Republicans) for a letter to DEA Administrator Karen Tandy expressing support for the proposed UMASS-Amherst medical marijuana production facility.

At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, seriously hindering medical marijuana research. NIDA provides inferior, low-potency marijuana to researchers whose protocols it approves and denies marijuana even to FDA-approved protocols it doesn't approve, preventing those studies from taking place.

No privately-funded sponsor (such as MAPS or alternatively a for-profit pharmaceutical company) will invest significant sums in a realistic drug development research program aimed at obtaining FDA-approval for the prescription use of marijuana without first obtaining its own independent source of supply of a drug whose quality, price and availability it determines. As far as we can tell, there has been no US-based privately-funded marijuana production facility since 1942, when marijuana was removed from the US Pharmacopoeia and its medical use was prohibited.

Dr. Lyle Craker originally submitted the application for a license to DEA in June 2001. In December 2001, DEA claimed it was lost. We subsequently resubmitted a photocopy but were told in February 2002 that the photocopied application was invalid since it didn't have an original signature. In July 2002, the original application was returned, unprocessed, with a DEA date stamp showing it had been received in June 2001. Dr. Craker resubmitted the original application to DEA on August 20, 2002, which DEA finally acknowledged receiving.

MAPS has worked with the Marijuana Policy Project on a Congressional sign-on letter to the DEA expressing support for the UMass Amherst license. This letter was submitted to DEA Administrator Asa Hutchinson on June 6, 2002.

DEA Administrator Asa Hutchinson responded in a letter to Rep. Barney Frank on July 1, 2002. DEA has questioned whether this new facility would be in the public interest, since NIDA currently grows marijuana for research.

In response, MAPS has written a document explaining why it would be in the public interest for DEA to grant a license for the UMass Amherst facility, and submitted the document to DEA, the Office of National Drug Control Policy (ONDCP) and NIDA.

The DEA has also indicated that granting such a license might conflict with US international treaty obligations, specifically the Single Convention on Narcotic Drugs.

MAPS has worked with Graham Boyd of the ACLU Drug Policy Litigation Project and Peter Barton Hutt and Alexei Silverman, of the DC law firm Covington & Burling, on the development of a legal document detailing why US international treaty obligations do not prevent the licensing of the UMass Amherst facility.

This legal analysis was submitted to the DEA along with Prof. Craker's August 20, 2002 resubmission of his license application, along with a response to a series of questions from DEA about the bulk manufacturing purposes and processes.

On July 24, 2003, DEA finally filed a notice in the Federal Register about Prof. Craker's application, with a public comment period ending on September 23, 2003. MAPS obtained a copy through Freedom of Information Act (FOIA) request of the only comment filed. The comment by Prof. Mahmoud ElSohly, the director of NIDA's marijuana farm at the University of Mississippi objected to the licensing on grounds that MAPS has challenged in MAPS' response letter to the Administrator of the DEA. In 2004, Senators Kennedy and Kerry wrote a letter (PDF) to the Administrator of the DEA expressing their strong support for DEA licensing of the facility. On November 18, 2003, the Boston NPR station aired an almost nine minute story by reporter Rachel Gotbaum about MAPS' UMass Amherst and vaporizer research projects. We had expected DEA to either approve or reject Prof. Craker's application sometime before the end of 2003 but that hasn't occurred yet as DEA is once again choosing to delay any decision as long as possible.

On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits against DEA and also against HHS/NIH/NIDA for obstructing medical marijuana research. On July 29, 2004, MAPS filed a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.

On October 13, 2004, MAPS and MPP filed our amicus curiae brief in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research and DEA's lack of response to Prof. Craker's application for a license to establish a medical marijuana production facility. Oral arguments in the case are scheduled for November 29, 2004.

On November 22, 2004, the Court required DEA to respond by December 22, 2004 to the portion of our lawsuit against DEA about the UMass Amherst marijuana production facility. This is a positive development in that DEA can no longer just delay and not have to explain why.

On December 3, 2004, MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 ½ months to our applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.

On December 10, 2004, DEA finally rejected (see MAPS comments) the application from Prof. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed. DEA acted under pressure from MAPS' July 21 lawsuit arguing "unreasonable delay" and the DC Circuit Court of Appeals Nov. 22 decision which gave DEA until Dec. 22 to reply. Just as we'd hoped, the lawsuit forced DEA to issue its ruling, which we can now challenge in the context of Administrative Law Judge hearings.

On February 28, 2005, DEA filed its prehearing statement in the DEA Administrative Law Judge (ALJ) hearing. In DEA's initial "Order to Show Cause" explaining its rationale for rejecting Prof. Craker's application (see entry for Dec. 10, 2004), DEA claimed that it would be against the public interest for it to approve the license, and that, in any case, US international treaty obligations prevented DEA from issuing the license. Surprisingly, the prehearing statement speaks only to the issue of public interest and says nothing about DEA's international treaty claims. Could it be that DEA realizes it has a weak case on that point? Prof. Craker has until April 22 to file his prehearing statement. Then the ALJ will schedule a conference to meet with lawyers for both parties to discuss the case and set the date for the formal hearing itself.

On April 22, 2005. Prof. Lyle Craker filed his prehearing statement in his DEA Administrative Law Judge hearing, with assistance from lead lawyer Julie Carpenter of Jenner & Block, Allen Hopper of the ACLU Drug Law Reform Project, and Emanuel Jacobowitz, Steptoe & Johnson, all working on a pro-bono basis. Prof. Craker is seeking a DEA license to establish a MAPS-sponsored facility to grow marijuana for federally-approved research. The hearings are scheduled to take place August 22-26, 2005, with additional weeks in September and December if necessary. [Also see: prehearing statement in word format]

On July 22, 2005, DEA filed a motion to exclude four of our witness.

On July 26, 2005, Prof. Lyle Craker filed his updated and final prehearing statement in his DEA Administrative Law Judge hearing regarding DEA refusal to issue him a license to establish a MAPS-sponsored facility to grow marijuana for federally-approved research. DEA also filed an updated prehearing statement with additional witnesses, demonstrating that DEA will spare no expense in trying to show that blocking medical marijuana research is somehow in the public interest. Testimony begins on August 22, 2005. [Also see: Craker prehearing statement in word format, DEA prehearing statement in word format]

On August 8, 2005, we filed our objections to the governments motion to exclude four of our witnesses. [Also see: exclusion objection in word format]

On August 11, 2005 , the DEA filed a supplemental prehearing statement, indicating that under DEA law and policy, a researcher (though not Prof. Craker) might be allowed to grow various strains of marijuana for medical marijuana research. DEA seems to have abandoned the argument that international treaty obligations prevent it from issuing a license to anyone other than a NIDA-sponsored grower.

On August 12, 2005, DEA Administrative Law Judge Mary Ellen Bittner issued a ruling granting the government's motion to exclude several of our witnesses, Angel Raich and Valerie Corral, and limited the testimony of Dr. Lester Grinspoon, on the grounds that they would have testified about the medical uses of marijuana which was irrelevant to the issue of whether Prof. Craker's facility would be in the public interest since both sides have stipulated that research is ongoing and can be conducted under current regulations. This seems reasonable to us and in some senses favorable since we don't need to argue about the scientific research. Judge Bittner rejected the government's request to exclude our witness, Dr. Irwin Martin, who will testify about how the pharmaceutical drug development process normally takes place, with the sponsor of research selecting and producing the drug to be tested. This also is a reasonable ruling.

On May 8, Prof. Lyle Craker filed a final brief (PDF) for the lawsuit against the DEA for refusing to permit him to establish a MAPS-sponosored medical marijuana growing facility at UMass-Amherst. DEA also filed its brief (PDF) for the suit on this date. The briefs will reviewed by DEA Administrative Law Judge (ALJ) Mary Ellen Bittner, who will likely issue her recommendation to DEA Administrator Karen Tandy in the next two to four months.


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:

  1. 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.]
  2. 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.]
  3. 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: