November 27, 2007.
SYNOPSIS OF DEA RESCHEDULING DRONABINOL
In late September, DEA proposed a new rule that
would effectively place dronabinol (the active
chemical in MARINOL) in Schedule III.
Wait a second, isn't MARINOL already in Schedule III?
It is. When MARINOL was first marketed, it was placed
in Schedule II. Once DEA was shown that it had
a low potential for abuse, they agreed to place it in Schedule
III. But the narrow language only places in Schedule III MARINOL's
specific formulation (synthetically derived dronabinol, suspended
in sesame oil). All other formulations remain in Schedule I.
Now that the MARINOL patent is almost up, Professor ElSohly
(yes, the same man who runs the only federally-approved marijuana
growing facility) has a contract to supply would-be generic manufacturers of
MARINOL. They petitioned DEA to re-schedule ALL formulations of dronabinol,
whether or not the chemical is suspended in sesame oil, and
whether or not the chemical is sourced from whole-plant marijuana.
That's right, folks! DEA may soon allow an FDA-approved medication
to be derived from the marijuana plant.
In order to applaud this change in thinking, and to insist that the
NIDA monopoly be lifted, MAPS submitted a public comment to
the Federal Register about the proposed new rule.
The focus of the comment is the issue of
fairness; namely, it is absolutely ridiculous that DEA would re-schedule
the active ingredient in MARINOL at the behest of a private producer
for private profit, all the while refusing to approve Professor Craker's
bid to grow marijuana for non-profit, research purposes.
See a PDF of MAPS Public Comment on Docket No. DEA-308P; 72 Fed.Reg. 54226 (Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols).
October 10, 2007. Senior US Senators Edward Kennedy and John Kerry have agreed to send a new letter to DEA Administrator Karen Tandy urging her agency to accept the recommendation of DEA Administrative Law Judge Mary Ellen Bittner to grant a Schedule I license to University of Massachusetts professor Lyle Craker, PhD, for his proposed MAPS-sponsored medical marijuana production facility. An independent supply of research-grade medical marijuana is the key prerequisite for MAPS' plan to conduct the clinical trials necessary to develop marijuana into a legal US FDA-approved prescription medicine. In 2004, before our successful lawsuit against DEA, the duo of Massachusetts Senators sent a similar letter to DEA urging the agency to license Prof. Craker. In the coming months, MAPS and our allies will be targeting several key Senators to add their names to Kerry and Kennedy's letter, building on the momentum of last month's letter from 45 US Representatives to DEA in support of Prof. Craker's proposed facility.
The DEA has no deadline to decide whether to accept or reject Judge Bittner's non-binding ruling. As a result, we expect that DEA will continue to use its best weapon against medical marijuana research -- inaction.
August 26, 2007. MAPS President Rick Doblin gave a comprensive interview about MAPS' medical marijuana efforts on Health Radio with Dr. Meg Jordan. Click here to listen to the full interview.
August 9, 2007. Orange County Register Senior Editor Alan Bock published an insightful editorial about the implementation of California's medical marijuana law. Bock connects the challenges of implementation to the federal government's obstruction of scientific research. He descibes MAPS' effort to establish the nation's first privately-funded research-grade marijuana production facility at UMass-Amherst, which would pave the way for an FDA drug development effort with marijuana.
June 29, 2007. Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS' campaign to break the federal government's illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA's standards for safety and efficacy.
May 31, 2007. The Los Angeles Times published a strongly supportive editorial in favor of MAPS and Prof. Craker in their struggle with the DEA to break the federal government's monopoly on medical marijuana research by establishing an independent research-grade marijuana production facility at University of Massachusetts.
May 21, 2007. The Economist published a great editorial in favor of MAPS and Professor Lyle Craker's application to establish the nation's first privately funded medical marijuana production facility.
May 15, 2007.
Today MAPS recieved a copy of the "Transmittal Letter" sent by ALJ Judge Mary Ellen Bittner to the DEA, transferring the record in the Craker matter to the DEA's Deputy Administrator, Michelle Leonhart on May 15, 2007. The letter was accompanied by this note:
1316.67 Final order
As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his final order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which date shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that the public interest in the matter necessitates an earlier effective date, in which event the Administrator shall specify in the order his findings as to the conditions which led him to conclude that an earlier effective date was required.
So let the "practicable" clock begin . . .
May 4, 2007. Prof. Craker filed the final legal brief today in the Craker v. DEA case, assisted by a great legal team led by Julie Carpenter, Jenner & Block, Allen Hopper, ACLU, and Emanuel Jacobowitz, Steptoe & Johnson, and including Christina Alvarez, ACLU and Lauren Anderson Payne, MAPS. This brief is a strong response to the DEA's "exceptions" to ALJ Bittner's recommendation that it would be in the public interest for DEA to register Prof. Craker as a bulk manufacturer of marijuana, for use in FDA and DEA-approved clinical studies sponsored by MAPS.
March 26, 2007. DEA Attorney Submits DEA Attorney Charles Trant submitted DEA's "exception" to the February 12, 2007 opinion of ALJ Bittner. Trant objected to ALJ Bittner's recommendation that it would be in the public interest for DEA to give Prof. Lyle Craker a license for a MAPS-sponsored medical marijuana production facility. Lacking much in the way of a good argument, Trant spent lots of time talking about international treaty obligations, and criticizing MAPS President Rick Doblin, at one point comparing him to Pablo Escobar.
A detailed rebuttal is being prepared by Prof. Craker's legal team, to be submitted to the ALJ's office by May 4, 2007. A few weeks or so after that, ALJ Bittner will forward her recommendation, along with the dueling legal documents, to DEA for a formal ruling. A coalition of medical marijuana and drug policy reform groups will try to generate pressure on DEA from Congress, seeking Representatives and Senators willing to sign a letter to DEA Administrator Tandy, urging her to accept ALJ Bittner's recommendation. Unfortunately, DEA has no time limit for when it must issue its final ruling.
March 14, 2007. In light of our recent hard-won victory in Prof. Craker's lawsuit against the DEA, we're ramping up for a lobbying campaign of unprecedented significance and scale. MAPS must show DEA that there is substantial public support for scientific freedom in marijuana research. Thats why MAPS is coordinating a lobbying campaign aimed at pressuring DEA to actually accept Judge Bittner's recommended ruling.
On March 26, DEA's lawyers will submit their critique to DEA Administrative Law Judge (ALJ) Mary Ellen Bittner's recommended ruling that DEA grant a Schedule I license to Prof. Lyle Craker for his proposed MAPS-sponsored marijuana production facility. On May 4, our lawyers will submit a reply to the DEA lawyers' critique, and then within a few weeks the ALJ will formally submit her recommendation and the dueling comments from the two legal teams to DEA. The DEA has an unlimited amount of time to make a final ruling.
MAPS has already utilized over $250,000 in resources to help Prof. Craker win his lawsuit against DEA, mostly in the form of pro bono legal services. Now, we must harness the momentum from this victory to demonstrate to DEA that the public wants to see the safety and efficacy of marijuana determined by rigorous scientific research, not by the vested political interests of NIDA and DEA. The opportunity to resolve the controversy over medical marijuana through FDA-approved clinical trials hangs in the balance.
We estimate that the odds of prevailing over DEA are 2-1 against us -- in other words, more favorable than many of MAPS' long-shot efforts. Even if we lose, we win in some important ways. If the DEA rejects the ALJ's recommendation, it will highlight DEA obstruction of FDA-approved research and will help build support for state-level medical marijuana reform efforts.
Last week, our lobbying campaign received a big boost with news that MAPS has been awarded a grant of $45,000 from the Marijuana Policy Project (MPP). Over the next few weeks, we'll be formulating a strategy. Then, well ask MAPS members and many others to contact their Congressional legislators to request that they write to DEA urging the agency to accept the ALJ's recommendation.
May 28, 2006. The Boston Sunday Globe published "Weed Control," an article describing the proposed medical marijuana growing facility at the University of Massachusetts-Amherst, the current government monopoly on marijuana grown for research and the MAPS-supported lawsuit filed against the DEA to end this monopoly. The piece describes MAPS' involvement in developing the proposed facility and features quotes from MAPS' president Rick Doblin. The article, with multiple graphics, was the lead article in the Ideas section which most everyone reads since it contains the editorials, the op-eds and other feature articles.
May 21, 2006. The New York Times published a letter to the editor from Jerry Epstein of the Drug Policy Forum of Texas, in which he cites the federal governement's obstruction of Dr. Lyle Craker's proposed MAPS-sponsored medical marijuana production facility as an example of its "insane policy against the medical use of marijuana". Click here to read the full text of Epstein's letter.
May 8, 2006. Prof. Lyle Craker, assisted by lead lawyer Julie Carpenter, Jenner & Block, Allen Hopper, ACLU and Emanuel Jacobowitz, Steptoe & Johnson, filed the final brief (PDF) in his lawsuit against DEA. DEA also filed a final brief (PDF) for this lawsuit. We anticipate that DEA ALJ Judge Bittner will issue her recommendation to DEA Karen Tandy within the next two to four months.
April 28, 2006. On this date, a letter to FDA was sent by 24 Members of Congress asking for the scientific basis of the recent statement by FDA on the medicinal potential of marijuana first published on April 20, 2006.
April 27, 2006. The critical backlash against the FDA's transparent politicization of science continued with a thorough and well-documented article in The Economist entitled "Reefer Madness: Marijuana is medically useful, whether politicians like it or not." The article discusses Prof. Lyle Craker's proposed MAPS-sponsored medical marijuana production facility and his ongoing MAPS-supported DEA lawsuit.
April 23, 2006. The Chicago Tribune responded to the FDA's recent statement concerning the medicinal potential of cannabis with an editorial, "Dissembling on Medical Pot" that quotes Prof. Lyle Craker of the University of Massachusetts at Amherst, saying "The reason there's no good evidence is that they don't want an honest trial."
April 22, 2006. The New York Times published an editorial, "The Politics of Pot" that refers to the FDA statement on the medicinal value of marijuana as "disingenuous," and ending with this statement, "It's obviously easier and safer to issue a brief, dismissive statement than to back research that might undermine the administration's inflexible opposition to the medical use of marijuana."
April 21, 2006. The FDA issued a statement indicating that marijuana had no currently accepted medical uses. Stories in the New York Times, the Washington Post and the Associated Press reported on this statement and responses to it within and outside the medical community. Prof. Lyle Craker is quoted discussing his lawsuit against the DEA for refusing to issue him a license for a marijuana production facility. NIDA's marijuana was criticized for poor quality, but not for the more comprehensive lack of an "adequate and uninterrupted" supply that is the basis of Prof. Craker's lawsuit. FDA's statement wasn't that marijuana had no medical uses. Rather, what the statement actually means is that due to a lack of research data from large Phase III studies, which won't take place until NIDA's marijuana monopoly is broken, FDA will consider marijuana to have no currently accepted medical uses. This statment points yet again to the need for large-scale, privately-funded Phase III studies with smoked and vaporized marijuana, which DEA is blocking by refusing to issue Prof. Craker his license.
April 11, 2006. DEA lawyers have formally petitioned DEA Administrative Law Judge Mary Ellen Bittner to extend the deadline for filing our final legal briefs to May 8, 2006. Lawyers for Prof. Craker have agreed to DEA's request, as a matter of professional courtesy. We expect that once the final briefs are filed, DEA ALJ Bittner will take 2-4 months to issue her recommendation to DEA Administrator Karen Tandy
April 7, 2006. The Daily Nexus published Activists Assemble for Cannabis Conference, announcing The Fourth National Clinical Conference on Cannabis Therapeutics at Santa Barbara City College, which features lectures from doctors, health care researchers and patients, as well as talk show-host and medical marijuana advocate Montel Williams.
April 6, 2006. The Drugs and the Law Committee of the Association of the Bar of the City of New York has sent a tremendous letter to DEA Administrator Karen Tandy urging her to issue a license to Prof. Lyle Craker for a MAPS-sponsored marijuana production facility. The letter, signed by Chair John H. Doyle III, Esquire, cites specific testimony from the hearings to support a series of legal arguments that make a compelling case for DEA's legal obligation to issue the license.
March 7, 2006. Lawyers from both sides of the case have filed motions to extend the deadline to April 27 for the submission of final legal briefs in Prof. Lyle Craker's MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility. DEA Administrative Law Judge Mary Ellen Bittner is now expected to make a decision three to six months after the briefs have been submitted.
February 3, 2006. Steve Carell and Stephen Colbert of The Daily Show hilariously debate pro and cons of medical marijuana.
January 31, 2006. Click here to listen to a podcast news update produced by MAPS about Prof. Lyle Craker's MAPS-supported lawsuit against the DEA for obstructing a MAPS-sponsored medical marijuana production facility.
January 6, 2006. Our lawyers learned today that DEA has decided not to hold the final hearing that had been scheduled for January 17, solely in order to cross-examine under oath our rebuttal witness, Al Byrne. Perhaps DEA lawyers read my commentary posted on the MAPS website on December 20, 2005, in which I suggested that it would be wise for them not to call Al as a witness since he would have persuasively testified to the low quality of NIDA marijuana and to the veracity of the picture of the seeds and stems in three NIDA marijuana cigarettes that Prof. ElSohly had foolishly challenged as being somehow not accurate. Probably, DEA lawyers were just trying to intimidate Al into withdrawing his affidavit in order to avoid having to testify under oath inside DEA headquarters. When that failed, they decided to cancel the hearings regardless of my suggestions, which they haven't taken in other instances anyway. In any case, there will now be no more courtroom drama, only dueling legal briefs. At this point, I guess that the final briefs will be due in several months and that DEA Administrative Law Judge Mary Ellen Bittner will issue her recommendation to DEA Administrator Karen Tandy in late Spring or early Summer 2006.
December 27, 2005. The New York Daily News Washington Bureau published
a succint and informative article about the DEA Lawsuit.
December 19, 2005.
The Daily Journal published Ole Miss marijuana monopoly under fire, reporting on the University of Mississippi's insistence that their marijuana is of an acceptable grade.
December 15, 2005. Join Together published Researchers Seek New Source of Marijuana.
December 13, 2005. The Associated Press published Prof. questions gov't monopoly on marijuana, a positive article about the DEA Lawsuit.
The West Palm Beach Florida News published Government's Medical Pot 'Just Isn't Strong Enough'.
December 12, 2005. The Washington Post published Federal Marijuana Monopoly Challenged, an article that comprehensively summarizes the MAPS/Craker DEA Lawsuit, quoting Lyle Craker, Rick Doblin, and Grover Norquist.
December 6, 2005. 38 Members of Congress (36 Democrats and 2 Republicans) sent a letter to DEA urging the approval of Prof. Lyle Craker's application to DEA for a license for a marijuana production facility. Republican political activist Grover Norquist also sent a letter to DEA. These should get DEA's attention!
December 5, 2005. A press release was issued today, "DEA to Argue Against U. Mass Growing of Medicinal Cannabis at Administrative Hearing December 12-16: Grover Norquist, Medical Groups and 35 Members of Congress Tell DEA They Support Expanded Research." We've also posted background information including transcripts of the hearing.
November 30, 2005. MAPS and MPP file an amicus curiae brief in the on-going Raich v. Gonzales case. On June 6, 2005, the US Supreme Court rejected the decision of the 9th Circuit Court of Appeals that there was no interstate commerce, and thus affirmed federal jurisdiction over state medical marijuana laws. However, a new lawsuit making other legal arguments has been filed. The amicus curiae brief describes the federal obstruction of MAPS' efforts to conduct federally-approved medical marijuana research.
November 29, 2005. NORML.org published NIDA's Pot Monopoly To Resume Next Month.
November 16, 2005. The
ALJ denies Craker's attempt to admit Scherer's testimony
November 14, 2005. The
DEA files an opposition to the motion to have Dr. Scherer testify
November 8, 2005. The
ALJ rules on the DEA witnesses
November 2, 2005. Prof.
Lyle Craker files a motion to have Dr. Scherer testify. [Also
see: Scherer motion
in word format]
October 20, 2005. The
DEA responds to our motion to exclude
October 19, 2005. October 19, 2005. Mother Jones Magazine publishes, "Respectable Reefer," an excellent article about medical marijuana by Gary Greenberg that discusses GW Pharmaceuticals, MAPS and drug war politics.
September 22, 2005. Click to contact your local congressional representative, urging them to sign-on to the letter to DEA Administrator Karen Tandy expressing support for the proposed UMASS-Amherst medical marijuana production facility. You can view the congressional members that have signed on so far.
September 16, 2005. The
DEA requests to postpone hearings to December dates.
September 9, 2005. Chemic Laboratories sends a letter to Assistant Secretary for Health Joel Egertson, responding to his July 27, 2005 letter (received August 15, 2005) rejecting Chemic's June 2003 application to NIDA to purchase 10 grams of marijuana for further vaporizer research. Chemic's letter rebuts every critique of the protocol used by Mr. Egertson and urges him to reconsider. After taking over two years to reply, HHS/NIDA's protocol reviewers didn't take the time to read the protocol carefully and made some rather basis mistakes in the review. HHS/NIDA's refusal to sell Chemic 10 grams of marijuana for MAPS-sponsored vaporizer research is yet another example of the need to break NIDA's monopoly on the supply of marijuana that can be used in legal research.
September 1, 2005. A summary of recent press coverage of the MAPS/Craker/DEA hearing is available here.
August 27, 2005. The New York Times published op-ed column "Marijuana Pipe Dreams" by John Tierney, reporting on the current Craker-DEA lawsuit. In a subsequent letter to the editor responding to the mention of a Marinol patient choking to death on his own vomit, Michael Simmons informed the New York Times of the vomit-choking myth.
August 26, 2005. Rick Doblin and Allen Hopper after the first week of testimony in the DEA Administrative Law Judge hearings. It's been a long way for both of them since sharing a dorm room at New College.
August 25, 2005. The Sacramento Bee Washington Bureau published Clash over pot research gets personal, an article about the DEA-Craker lawsuit proceedings including a quote from Rick Doblin.
August 22, 2005. August 22-26, 2005: The DEA Administrative Law Judge hearings took place, starting with witnesses for Prof. Lyle Craker and including one DEA witness. Transcripts are available of each day's hearing. For various legal motions since the hearing, see Timeline section below. The second round of DEA hearings will take place December 12-16, with additional DEA witnesses. For further details, see our page related to our Congressional sign-on letter campaign, in which over 34 members of the U.S. House of Representatives have signed on to a letter to DEA Administrator Karen Tandy urging her to issue a license to Prof. Craker.
August 18, 2005. The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.
August 17, 2005. Commentary in the Journal of the American Medical Association (JAMA), by Dean Lawrence Gostin, Georgetown Law School, criticizes NIDA for blocking medical marijuana research. The article is entitled, "Medical Marijuana, American Federalism, and the Supreme Court."
August 16, 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.
August 15, 2005. Chemic Laboratories receives a response letter from the Department of Health and Human Services (view as html), rejecting the vaporizer protocol and recommending that NIDA not sell Chemic 10 grams of laboratory-grade marijuana for the vaporizer studies. This response took more than two years and arrived, coincidentally and conveniently, just one week before the start of the DEA Administrative Law Judge hearings over DEA refusal to grant a license to Prof. Craker, UMass Amherst, for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Chemic's reply to the critiques was sent to HHS/NIDA on September 9, 2005.
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.
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.
August 8, 2005. MAPS filed objections to the governments motion to exclude four of our witnesses.
Prof.
Lyle Craker filed a motion to exclude some DEA witnesses.
[Also see: exclusion
objection in word format]
July 26, 2005. U.S. Congressional Representatives John Olver (D-MA) and Michael Capuano (D-MA) have sent a letter to DEA Administrator Karen Tandy urging DEA to issue a license to Prof. Craker for his MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. This letter will be sent to other members of Congress seeking additional signatures.
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.
July 22, 2005. DEA files a motion seeking to disqualify four of our proposed witnesses. We'll prepare a reply within the next several weeks.
July 6, 2005. The American Medical Student Association submits a letter to the DEA stating their support for scientific research into marijuana's medical cababilities.
June 20, 2005. A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation,
Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.
June 8, 2005. Sally Satel pens an Op-Ed in the New York Times today about medical marijuana, focusing on Lyle Craker, UMass Amherst and Federal obstruction of medical marijuana research.
Wired Magazine writes Legal Pot's No Pipe Dream, discussing the recent Supreme Court decision on medical marijuana and MAPS efforts to estabish a medical marijuana pilot production facility at the University of Massachussets at Amherst with Professer Lyle Craker.
DesMoines Register Columnist Rekha Basu delivers a compassionate and practical article on the benefits of marijuana and the "Catch-22" of the present medical marijuana struggle. She dicusses the treatment limitations that patients with serious illnesses face and urges Americans to "push their representatives for legalization of medicinal marijuana and for more unbiased research."
May 18, 2005. A prehearing conference took place today between the DEA Administrative Law Judge, our lead lawyer Julie Carpenter of Jenner and Block, and DEA's lawyer. The Judge set the dates for the hearing as August 22-26, 2005, with two additional weeks if needed, those being September 26-30 and December 12-16. We have the burden of proof and have to go first. Supplemental pre-hearing statements are due July 26, with any new exhibits.
May 11, 2005. Cannabis Culture offers an article on medical marijuana patient Angel Raich's struggle in the Supreme Court
April 25, 2005. "Science, not politics, should govern medical research," says ACLU in challenge to the DEA's marijuana policy. The American Civil Liberties Union (ACLU) issued a press release about the filing of the prehearing statement in the lawsuit against the U.S. Drug Enforcement Agency (DEA) filed by University of Massachutes-Amherst Professor Lyle Craker, objecting to DEA's refusal to issue him a license for a MAPS-sponsored facility to produce marijuana for federally-approved research. For more information, see the ACLU statement by Allen Hopper and the MPP statement by Steve Fox.
April 22, 2005. ACLU enters marijuana research dispute.
Washington, DC, Apr. 22 (UPI) -- The American Civil Liberties Union Friday challenged the Drug Enforcement Administration's refusal to allow an alternative source of research marijuana.The ACLU said it filed a statement with a federal administrative law judge opposing the DEA's refusal to allow University of Massachusetts Professor Lyle Craker to grow the alternative source of research-grade marijuana.A hearing before the judge is slated to begin this summer.
February 28, 2005. DEA files its prehearing statement in the DEA Administrative Law Judge (ALJ) hearing. The ALJ hearing is taking place because of a lawsuit that Prof. Lyle Craker, Director, Medicinal Plant Program, Dept. of Plant and Soil Sciences, has filed against DEA for refusing to grant him a license for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. 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.
February 8, 2005. A new medical marijuana DEA Administrative Law Judge hearing was formally launched on Monday, February 7. Prof. Lyle Craker, UMass Amherst, filed a request for a hearing about DEA's proposed rejection of his application for a license to establish a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Our goal is to break the government's monopoly on the supply of marijuana that can be used in FDA-approved research, thereby creating the proper conditions for a $5 million, 5 year drug development effort designed to transform smoked and/or vaporized marijuana into an FDA-approved prescription medicine.
MAPS has arranged for a consortium of lawyers to represent Prof. Craker on a pro-bono basis. These lawyers include lead counsel Julie Carpenter of Jenner and Block (DC law firm), Allen Hopper, ACLU Drug Law Reform Project, and Emanuel Jacobowitz of Steptoe & Johnson (DC law firm). The estimated value of this pro-bono support is more than $100,000.
Within about a week, the DEA ALJ office will issue a timetable for the submission of prehearing statements, with DEA being given 3 weeks and Prof. Craker being given 6 weeks, ending about March 28 or so. The ALJ will then review the prehearing statements and schedule a meeting with the lawyers to discuss the scope of the case, probably taking place sometime in April. At that meeting, the date for the hearing itself will be set. Most likely, the hearing will take two days and take place in DC in late spring/early summer.
The two main issues to be argued are 1) whether it is in the public interest for there to be a facility at UMass Amherst producing marijuana for federally-approved research and 2) whether US international treaty obligations permit DEA to issue a license to a privately-funded production facility.
It took suing the DEA for "unreasonable delay" in the DC Circuit Court of Appeals to get DEA to finally reject Prof. Craker's application, after 3 1/2 years of delay. We're delighted to have finally gotten the opportunity to argue this issue on the merits.
January 25, 2005. Common Sense for Drug Policy just placed an ad in 6 or 7 major political magazines (Nation, New Republic, Weekly Standard, etc) about MAPS'
lawsuits v. DEA/HHS.NIDA.
January 20, 2005. The Drug-Free America Foundation, Inc. reports on its website on the DEA rejection of the UMass Amherst application for a license to establish a facility to produce marijuana for federally-approved research.
January 18, 2005. A Newsweek article about DEA's rejection of Prof. Craker's UMass Amherst application does a good job of explaining the issues but takes some pot shots at MAPS.
January 16, 2005. The Boston Globe published an article contrasting FDA approval of MAPS' study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer with DEA rejection of Prof. Lyle Craker's MAPS-sponsored application for a license to establish a facility to produce marijuana for federally-approved research.
January 7, 2005. An editorial published by The Oregonian, "Stop Blocking Marijuana Research", supports the UMass Amherst project.
January 6, 2005. Dr. Lyle Craker has received a 30-day extension on the deadline for submitting a request for a DEA Administrative Law Judge hearing concerning DEA's decision to deny his application for a license to establish a MAPS-sponsored marijuana production facility at UMass Amherst. The new deadline is February 8, 2005. While we were extremely reluctant to be responsible in any way for further delays in this process, which DEA has successfully managed to delay already for 3 1/2 years, we do not as of yet have our complete legal team assembled. We are seeking pro-bono representation which takes time to obtain. We have been assured that Dr. Craker's request for a hearing will definitely be granted once we submit it, so it's all the more important that we have our legal team ready to work on the case before we submit the request for the hearing.
December 19, 2004. An op-ed by Steve Chapman of the Chicago Tribune criticizes the DEA for blocking the UMass Amherst marijuana production facility
The Providence (RI) Journal published an excellent op-ed about the financial reasons why drug warriors don't want to see the licensing of the UMass Amherst production facility.
December 18, 2004. An expanded article by Fred Gardner appears on counterpunch.org, "DEA Upholds Grower's Marijuana Monopoly." This is the most detailed critique yet published of DEA's rationale for rejecting the UMass Amherst application.
December 16, 2004. An excellent article in the Boston Phoenix dissects the DEA's rejection of the UMass Amherst application.
December 15, 2004. An article in the Boston Globe gives background to the DEA rejection of the UMass Amherst project and explains the legal pressure that forced DEA to act, the DEA's obstruction of research, and political support for the license.
An article in the Anderson Valley Advertiser, "DEA Upholds Grower's Monopoly," by Fred Gardner, discusses in detail the DEA's rejection of the UMass Amherst application. The Anderson Valley Advertiser has followed the details of the medical marijuana issue more closely than any other paper.
Howie Carr of the Boston Herald writes IN AT LEAST ONE WAY, ZOOMASS ISN'T GOING TO POT.
December 14, 2004. The New York Times reports that the DEA has rejected the application from UMass Amherst for a license to grow marijuana. The article notes that there is a 30 days period within which an appeal can be filed, which we will do.
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.
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.
November 29, 2004. We have a decision regarding MAPS' lawsuits against DEA
and against HHS/NIH/NIDA regarding our claim of "unreasonable delay" in
responding to MAPS-sponsored applications to NIDA to purchase 10 grams of
marijuana for vaporizer research (submitted June 24, 2003), to DEA to
import 10 grams of marijuana for vaporizer research from the Dutch Office
of Medicinal Cannabis (submitted June 24, 2003), and to DEA for a license
to grow marijuana for research at UMass Amherst (submitted June 2001).
MAPS's lawyer's assessment: The decision is very particular about the
applications delayed, so they obviously read & at least partially
understood what was what. Unfortunately, 17 months delay to the court
(unlike patients needing pain relief) is no biggie, so we lose on
compelling action on the application to HHS/NIDA to purchase 10 grams for
research and on the application to DEA to import 10 grams. The 3 1/2 year
delay in DEA non-response to the UMass Amherst application for a license
to grow marijuana for research trips the further inquiry wire at DEA,
however, so there apparantly is a chance for some oversite.
Reconsideration (of the outright denials) must be filed within 14 days
[5pm Dec. 6], which we will file.
Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.
November 22, 2004. The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."
November 11, 2004. MAPS initiates work on a legal motion for expedited scheduling of our lawsuits against DEA and against HHS/NIH/NIDA. It's now been more than 3 1/2 months since July 21, 2004, when MAPS, Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, and Prof. Lyle Craker, UMass Amherst, filed a lawsuit against DEA, and MAPS and Valerie Corral filed a lawsuit against HHS/NIH/NIDA.
The lawsuits claimed that the agencies were engaging in unreasonable delay in not responding to MAPS-sponsored requests to grow, import and purchase marijuana for a program of scientific research designed to develop marijuana into an FDA-approved prescription medicine. We hope the motion for expedited scheduling will get this case before the judge sooner than if we were to do nothing. The lawsuits have been filed in the United States Court of Appeals for the District of Columbia Circuit.
October 13, 2004. MAPS and MPP filed our amicus curiae brief today 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. The goal of the brief is to educate the Supreme Court judges so that they don't rule against medical marijuana patients under the false assumption that the FDA drug development approach is a viable alternative to state medical marijuana initiatives and legislative actions. As long as the obstruction of MAPS' medical marijuana research efforts continues, the only way that patients can obtain legal access to the medical use of marijuana is through the decision of the 9th Circuit Court of Appeals, which decided that there was no interstate commerce involved when patients or caregivers grow marijuana for patients' personal medical use. That decision prohibited the federal authorities (DEA) from enforcing the Controlled Substances Act prohibitions against the use of marijuana, which the 9th Circuit judges declared unconstitutional when applied against patients or caregivers growing marijuana in states that had approved such use. MAPS and MPP's brief transforms our failure to obtain the necessary permissions and supply of marijuana for MAPS' research efforts into a weapon against the forces of repression (DEA and the Drug Czar ).
October 10, 2004. The San Francisco Chronicle reports that "Medical Marijuana Advocates Likely to Get Break Under Kerry". MAPS' UMass Amherst project is mentioned in the article
August 10, 2004. In response to an inquiry to DEA from Prof. Lyle Craker, Mr. Wayne Raabe, DOJ Criminal and Dangerous Drug Division, called Prof. Craker and said that DOJ is making a decision this week on which division will be handling the case. He promised to call and let Prof. Craker know as soon as the decision on handling the case was made. Taxpayer money would be much better spent if, instead of working on responding to the lawsuit from MAPS and Prof. Craker, DEA and DOJ would just make a decision on the application for a license to establish a facility to grow marijuana exclusively for federally-approved research, which Prof. Craker submitted over three years ago! Yet more evidence that the Bush Administration is actively working to obstruct medical marijuana research.
July 29, 2004. MAPS files a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.
July 28, 2004. Scientific Journal Nature publishes an article about MAPS's lawsuit against DEA, HHS, NIH, and NIDA for obstructing Marijuana research. Dr. Stanley Watson of the University of Michigan, Ann Arbor, who co-authored a 1999 Institute of Medicine report agrees that political factors are obstructing medical marijuana research.
July 22, 2004. Newspapers around the country have carried an AP wire story on MAPS' lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research.
An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.
The Springfield Republican publishes an article about MAPS recent medical marijuana research lawsuits.
July 21, 2004. MAPS, Prof. Lyle Craker and Valerie Corral, file lawsuits against DEA and against HHS/NIH/NIDA for obstructing medical marijuana research. MPP sends out a press release..
June 9, 2004. NIDA Director Dr. Nora Volkow responds to MAPS' letter of May 19, as
well as MAPS' May 24, 2004 letters to HHS Secretary Tommy Thompson and
Director of the National Institutes of Health Dr. Elias Zerhouni. Dr.
Volkow writes, "As you know, NIDA is just one of the participants on the
HHS review panel...It is not NIDA's role to set policy in this
area...Moreover, it is not NIDA's mission to study the medicinal uses of
marijuana or to advocate for the establishment of facilities to support
this research. Therefore, I am sorry but I do not believe that we can be
of help to you in resolving these concerns."
Conspicuosly missing from Dr. Volkow's letter was any information
whatsoever about where in the process is the review of the vaporizer
protocol. As a result, MAPS is now considering a lawsuit against HHS/NIDA
claiming "unreasonable delay" under the Administrative Procedures Act.
May 19, 2004. MAPS has sent a letter to NIDA Director Dr. Nora Volkow, and all members of NIDA's National Advisory Council on Drug Abuse (NACDA), asking them to expedite the NIDA/HHS review of Chemic's vaporizer research protocol. Chemic initially submitted the protocol to NIDA on June 24, 2003, as part of a request to purchase 10 grams of NIDA's marijuana needed for the study. MAPS' letter explains that there has so far been an eleven month delay in MAPS' research agenda, while MAPS waits to see if NIDA/HHS considers the protocol to be "scientifically meritorious" and therefore worthy of the privilege of purchasing NIDA's low-potency marijuana. The letter protests that this is an unreasonable delay of MAPS' efforts to conduct research to evaluate marijuana's potential use as an FDA-approved prescription medicine. The letter informs Dr. Volkow and the members of the NACDA that NIDA/HHS is doing its best to provide clear and persuasive evidence that NIDA's monopoly on the supply of marijuana for research is a fundamental obstruction that must end, preferably with DEA licensing of the UMass Amherst production facility.
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:
