February 12, 2008. On January 16, 2008, MAPS Volcano vaporizer research protocol was resubmitted to HHS for the required scientific review by the National Institute of Drug Abuse--Public Health Service (NIDA-PHS). The submission included three supportive letters from peer-reviewers (see 1, 2, 3), confirming the scientific merit of the study and urging NIDA-PHS to approve it. The goal of this study is to gather further information about the chemical constituents that are contained in the cannabis vapor stream.
November 29, 2007. This press release discusses the North Dakota Supreme Court's rejection of the 8 year bid of North Dakota farmers to grow industrial hemp as well as the signing of a Memorandum of Understanding between North Dakota State University (NDSU) and the ND Supreme Court.
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).
November 9, 2007. The American Psychiatric Association has passed a unanimous resolution supporting medical marijuana.
November 4, 2007. According to a new study by Swiss researchers, teenagers who smoke marijuana but not tobacco appear to be more likely to get good
grades, play sports and live with both parents than those who also use tobacco. Moreover, the study found that teens who smoke pot were more likely to have a good relationship with their friends than teens who smoked neither tobacco nor pot, found the study published in the November issue of Archives of Pediatrics & Adolescent Medicine. Click here to read a report.
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.
July 3, 2007. MAPS President Rick Doblin, PhD, appeared as a special guest and gave a lengthy interview on the Deborah Ray Healthy Talk Show. (The interview comes on about halfway into the show.)
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.
June 16, 2007. An anonymous donor has pledged $10,000 to MAPS to enable MAPS to provide technical assistance to a small, legal medical marijuana production facility in Israel. The facility will be directed by an Israeli medical marijuana advocate, and has been authorized by the Israeli Ministry of Health to provide marijuana only to medical marijuana patients formally approved by the Ministry. MAPS is working to provide technical assistance to create an organic, hydroponic, standardized production facility, which will start small and give marijuana away for the next several months. Once a successful track record has been established, the Ministry will determine whether to permit the facility to produce medical marijuana on a commercial basis.
MAPS is bringing Canadian medical marijuana researcher and activist Philippe Lucas, founder of the Vancouver Island Compassion Society, to Israel in August to consult on the project. Mr. Lucas is currently a Center for Addictions Research of British Columbia graduate research fellow at the University of Victoria, and is currently involved in a number of research projects related to medical cannabis access and use. His experience as both a federally-licensed medical cannabis user and cultivator should prove useful to this new national program.
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 . . .
April 15, 2007. This op-ed published in the Sacramento Bee is an excellent summary of the political and legal implications of MAPS' recent legal victory over the DEA in MAPS' quest to put marijuana through FDA clinical trials.
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.
February 13, 2007. The Washington Post reported in "Research Supports Medicinal Marijuana" on Dr. Donald Abrams' double-blind study of smoked marijuana for HIV-related peripheral neuropathy that was published in the respected journal Neurology. The findings showed that marijuana can be a safe and effective medication for many people with this condition, and is evidence of marijuana's therapeutic potential. Yet, no researchers are continuing Dr. Abrams' promising research, because NIDA's monopoly and arbitrary review process deters any private sponsor from investing in a medical marijuana drug development effort. The article finished by mentioning MAPS' victory in our lawsuit against DEA/NIDA, although it unfortunately doesn't explicitly connect the two issues.
January 31, 2007. Reuters reported in "Smokable Pain Drugs Promise Faster Action" on Alexza's development of smokeable drugs for migraine, pain, panic and agitation. This development could have implications for research with medical marijuana, since one of the government's main arguments has been that no legitimate medicine is smoked.
December 4, 2006. "Safer Deals: the Pastor" was published in Crawford, Texas' Lone Star Iconoclast this week, describing some of the unusual alliances that have been formed between religious groups and secular activists in order to help medical marijuana research gain credibility. MAPS isn't mentioned explicitly but Professor Lyle Craker's DEA lawsuit for a MAPS-sponsored marijuana production facility is mentioned.
November 29, 2006. Of particular applicability to MAPS' medical marijuana drug development efforts is Brian Vastag's new article, "US marijuana laws clamping the lid on pot research," published in Nature Medicine, which speaks to the difficulties faced by marijuana researchers.
September 8, 2006. It has now been four months since lawyers representing MAPS and DEA filed final legal briefs in Prof. Lyle Craker's lawsuit against the DEA for refusing to license a proposed MAPS-sponsored marijuana production facility at the University of Massachusetts-Amherst. MAPS and medical marijuana reform advocates nationwide are eagerly awaiting a recommendation from DEA Administrative Law Judge (ALJ) Mary Ellen Bittner within the next two months.
In the meantime, we are focusing our attention on preparing to pressure the DEA to accept Judge Bittner's recommendation if she actually recommends that the DEA should issue a Schedule I license to Prof. Craker. Towards this end, MAPS is working with David Ostrow, M.D., who is funded by the Marijuana Policy Project (MPP), to lobby the American Medical Association (AMA) to pass a two-fold resolution at this November's annual meeting. The first part of the resolution says that privately-funded, FDA-approved research into marijuana's potential therapeutic uses should be encouraged, and that privately-funded production facilities that meet all regulatory requirements should be licensed by DEA to produce pharmaceutical-grade marijuana for use exclusively in FDA- and DEA-approved research. The second part of the resolution says that in states where patients are permitted to use medical marijuana for serious and/or chronic illnesses and the patient's physician has recommended its use in accordance with that state's medical practice standards, that patients should not be subject to federal criminal penalties for such appropriate medical use.
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.
May 5, 2006. The LA Times published "Puffing is the Best Medicine", an opinion piece by Lester Grinspoon supporting smoking as an effective means of taking medical marijuana in response to a recent statement on this topic from the FDA.
May 1, 2006. Two Texas researchers found that the ONDCP's anti-marijuana public service announcements may actually have made their attitudes toward pot less negative. The study, by M Czyzewska and HJ Ginsburg, was published electronically in the journal "Addictive Behaviors" (PDF).
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 26, 2006. The San Diego Union-Tribune published an Op Ed piece by Stephen Sidney and Bruce Mirken on the FDA statement on medical marijuana.
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.
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 27, 2005. The cannabis based medicine, Sativex, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology.
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 19, 2005. An article from Salon.com marks the The Return of Reefer Madness, as the US Drug Czar's marketing implies a connection between marijuana and insanity.
September 16, 2005. The
DEA requests to postpone hearings to December dates.
September 10, 2005. At the International Association for Cannabis as Medicine 3rd Conference, held in Leiden, Holland, Mr. Hector Vizoso, study coordinator for Dr. Donald Abrams' study of smoking v. vaporizing, discussed the results of their clinical trial in humans comparing cannabinoid blood levels, carbon monoxide levels, and subjective effects in subjects who smoke and at other times vaporize marijuana (with the Volcano vaporizer). When subjects used vaporizers, the study found reductions in blood carbon monoxide levels as compared to smoking. In addition, the study showed that the vaporizer produced reliable levels of cannabinoids. The study also found that more subjects preferred vaporizing over smoking. This study was funded by a grant of about $136,000 from the Center for Medicinal Cannabis Research (CMCR). MAPS and CaNORML contributed an additional $100,000 on preliminary laboratory data analyzing the content of the vapors produced by the Volcano vaporizer.
Results of a second paper on vaporization (with the Volcano vaporizer) were presented by Arno Hazekamp, Ph.D, of Leiden University. This study "confirms that the pulmonary administration of cannabinoids by evaporation certainly has a clinical potential. With the Volcano a safe and effective cannabinoid delivery system seems to be available to patients."
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 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. The ACLU issues a press release on the MAPS DEA Lawsuit proceedings.
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.
Dr. Lester Grinspoon wrote an excellent paper, "The History of Cannabis as Medicine" for the DEA Administrative Law Judge (ALJ) hearing starting August 22, 2005. The ALJ agreed with a DEA motion to exclude his testimony because the fundamental issue is whether Prof. Craker' facility or NIDA's monopoly is most in the public interest, since DEA doesn't dispute the need for marijuana research. That's progress!
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.
June 20, 2005. San Francisco Chronicle writer Joe Garofoli reports on the completion of the nation's first clinical human study on vaporization at UCSF. He gives an overview of vaporizer benefits and use, and informs readers how to obtain affordable vaporizers.
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 13, 2005. The Boston Globe runs an article by Cathy Young entitled, "The Medical Pot Hysteria," that includes a mention of Sally Satel's terrific New York Times op-ed piece talking about federal obstruction of research.
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."
June 7, 2005. Eric Bailey of the LA Times writes: Marijuana Patients Remain Defiant
Ryan Grim, Salon Magazine, publishes his article A guide to Gonzales vs. Raich, What the medical marijuana ruling means for patients, the commerce clause, marital sex, Antonin Scalia's career and more. Ryan writes "But if the Supreme Court told us nothing else on Monday, it was that if this drug quagmire is ever going to end, it'll have to be stopped by the ones who started it: members of Congress. Until then, we'll gradually build our way to a society where half the population is locked in prison and the other half is guarding the prisoners."
Nature.com offers an article by Mark Peplow discussing the U.S. Supreme Court ruling against medical marijuana, mistakeningly stating that over the past two years MAPS has spent over $2 million on marijuana research when in fact, MAPS has spent that figure on all psychedelic research projects.
June 6, 2005. The Washington Post reports on today's Supreme Court decision supporting Federal power over State's rights in medical marijuana law: A Defeat For Users Of Medical Marijuana. The article quotes John Walters, President Bush's director of national drug control policy, who said: "Our nation has the highest standards and most sophisticated institutions in the world for determining the safety and effectiveness of medication. Our national medical system relies on proven scientific research, not popular opinion."
However, the WP article fails to adequately address Federal obstruction of all attempts to engage in research to demonstrate the medical efficacy of marijuana, exemplified by the difficulty MAPS has in obtaining Federal approval for The Amherst MMJ production facility project.
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.
April 18, 2005. Fox News Online recently published "Red Tape, Big Pharm Muscle Strangling Medical Marijuana," a piece discussing the difficulties of conducting medical marijuana research with current restrictions on the supply of cannabis for research, with quotes from Lyle Craker and John Halpern.
March 29, 2005. The New York Times published "Medicinal Marijuana On Trial", discussing medical marijuana research and Ashcroft v. Raich.
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.
February 5, 2005. The New Scientist publishes "Cannabis: Prescribing the Miracle Weed" by Clare Wilson. The initial MAPS-sponsored medical marijuana research efforts of Dr. Donald Abrams are discussed though MAPS is not mentioned.
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 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.
January 5, 2005. The San Diego City Beat published a discussion and analysis of a recent legal challenge to the HHS to change how marijuana is scheduled, with the legal challenge relying on a 2002 law, the Data Quality Act, originally crafted to benefit the tobacco industry and other corporate interests.
December 19, 2004. 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 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 7, 2004. Rep. Sam Farr (D-CA) has sent out a
Dear Colleague letter to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr's letter questions whether NIDA is unbiased and cites NIDA's refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA's monopoly on supply, which it uses to obstruct research.
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
October 8, 2004. The October 8-14 Boston Phoenix features an interview with MAPS' president Rick Doblin Ph.D. that discusses, among other things, ongoing research into the therapeutic effects of MDMA, psilocybin, and marijuana.
September 30, 2004. Reuters News Service published a story stating "British, French Drug Firms Lead in Marijuana Tests", noting that US drug development is hampered by marijuana's schedule 1 status and government control over the supply of marijuana researchers must use for their studies.
September 29, 2004. The second subject is enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The first subject was enrolled on September 21, 2004 (see that entry for more details about study design). This study is now well underway!
September 21, 2004. The first subject was enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The study requires subjects to live on an in-patient ward for 6 days, with each day involving either smoking marijuana or using the vaporizer. The research involves the use of 3 different marijuana cigarettes, one with 1.7 % THC, one with 3.5% THC and one with 7% THC. The cigarettes are cut in half and used in a randomized, double-blind manner, with half of each cigarette being smoked and the other half unrolled and the marijuana placed in the vaporizer.
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.
Statement of ROBERT J. MEYER, M.D., FDA, on Medical Marijuana.
Testimony of Nora Volkow, Director of NIDA, to Cong. Souder.
October 1, 2001. Penthouse Magazine publishes "The Gang That Couldn't Grow Straight"by Michael Simmons.
March 28, 2004. Ex-Surgeon General Joycelyn Elders publishes
a great op-ed, Myths
about Medical Marijuana.
February 27, 2004. The Ninth Circuit federal appeals court
has refused to reconsider its Raich-Monson decision that allows
Californians to grow and use marijuana to treat their illnesses.
Not a single judge on the circuit voted to accept the government's
request for reconsideration. The government's only recourse to reverse
the Raich-Monson decision is to appeal to the Supreme Court. The
government has 90 days to file a petition for certiorari. An
article about this decision by Dean Murphy appeared in the New
York Times.
February 17, 2004. Pot
Proponent Just Says No, by Bill Breen, Fast Company Online.
Medical marijuana's elder statesman is not convinced that the therapeutic
benefits of cannabis can be separated from the psychoactive effects
-- or that cannabis should be "pharmaceuticalized."
The
Cannabis Conundrum by Bill Breen, Fast Company Online.
As the founder of a British Pharmaceutical company put it, if it
weren't called Marijuana there would be an entire biotech business
built around this plant. And that's just what is starting to happen
(but not for the US drug industry or the patients these medicines
might help).
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 27, 2004. A
NY Times article about medical marijuana discusses the implications
for US drug policy of the impending approval of a medical marijuana
extract in England, with quotes from and illustrated by photos of
Lester Grinspoon and Rick Doblin.
Read Dr. Grinspoon's
comments
on this article.
December 16, 2003. Medical marijuana patient Angel McClary
Raich and her caregivers and Diane Monson won in an historic Ninth
Circuit decision in their injunction against Ashcroft, the DEA Chief,
and the Federal Government. The Court declared the Controlled Substances
Act unconstitutional for violating rights under the Commerce Clause
if the marijuana isn't sold, transported across state lines or used
for non-medicinal purposes.
MAPS, MPP and Dr. Ethan Russo filed an amicus
curiae brief in this case, which can be found here.
We testified about Executive branch obstructionism of medical marijuana
research and concluded, "The Court should not rule against patients'
constitutional rights to use cannabis based on the illusion of a
well-functioning FDA-approval process. Executive branch obstructionism
has made it necessary for patients to assert their constitutional
rights to use cannabis as a legal 'safety net' for a limited number
of patients."
In its decision, the Court noted, "The appellees also contend
that granting the appellants' requested injunction would create
a slippery slope as other plaintiffs seeking use of other schedule
I controlled substances would bypass the statutory process established
by Congress. The appellees claim that the appellants' proposed injunction
therefore has the potential to significantly undermine the FDA drug
approval process. Our holding is sufficiently narrow to avoid such
concerns." Though the Court didn't point this out, it's totally
hypocritical for the Bush Administration to accuse Angel Raich of
undermining the FDA drug approval process when DEA, with ONDCP support,
is obstructing privately-funded medical marijuana research by not
granting a license to grow marijuana for research to Prof. Craker
at UMass Amherst (Read
this for more details).
Fortunately, the Court's decision will increase pressure on the
Bush Administration to approve the UMass Amherst marijuana production
facility by making it more obvious that a denial just increases
the need for patients like Angel to grow their own medicine free
from federal persecution.
The Court's decision is
here. Click on "opinions"
at the upper left. Then select Raich vs.. Ashcroft
Download the major pleadings
from the litigation (Raich v. Ashcroft) here
and here.
Also read the Dec. 16, 2003,
Associated Press article, "
Federal Appeals Court OKs Medical Marijuana in Some Cases"
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 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 Rick Doblin, UMass Amherst
Prof. Lyle Craker, 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.
October 28, 2003. A New York Times article on doctors
and the law discusses the legal situation faced by physicians
who recommend marijuana to their patients.
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 19, 2003. Dr. Ethan Russo writes A
Requiem for the Journal of Cannabis Therapeutics. (also
available in Word
format)
October 17, 2003. Snake-oil
salesmen
Why does the Bush administration seem so intent on denying medical
marijuana to adults in extreme discomfort?, Kristen Lombardi, Boston
Phoenix
(MAPS comments on this article are here.)
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.
October 1, 2003. Nature publishes an
excellent article on medical marijuana research (also available
in pdf format).
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 18, 2003. Dr. Abrams and team publish an article
in the Annals of Internal Medicine, claiming "Short-Term Medical
Cannabis Does Not Harm HIV+ Patients"! For more details, see MAPS'
Comments and UCSF Press Release.
April 30, 2003. MAPS, MPP and Dr. Ethan Russo filed an updated
version of this amicus
curiae brief in the US Court of Appeals for the Ninth Circuit
case of Angel Raich et al. v. John Ashcroft as Attorney General
and Asa Hutchinson, Administrator of the DEA. (PDF Format)
November 9, 2002. Dr. Donald Abrams and Dr. Ethan Russo
report on their medical marijuana research at the Marijuana Policy
Project (MPP)/Students for a Sensible
Drug Policy (SSDP) conference in Anaheim, California.
View Dr. Abrams' powerpoint presentation,
"Clinical Trials of Cannabis in California." (IE4+ required to view
this presentation)
View Dr. Russo's powerpoint presentation,
"Chronic Cannabis Use in the Compassionate Investigational New Drug
Program: An Examination of the Benefits and Adverse Effects of Legal
Clinical Cannabis" (IE4+ required to view this presentation)
In addition to supporting Dr. Abrams' protocol investigating the
effects of marijuana in HIV+ subjects, the
first study in 15 years to investigate the therapeutic application
of cannabis, MAPS has supported the efforts of Dr. Ethan Russo, University of Montana, for
expenses involved in preparing NIH grant applications for the study
of the use of marijuana in the treatment of people whose migraines
fail to respond to conventional medications. This study continues
to face difficulties in getting started. In 1997, MAPS submitted
an application to the Food and Drug Administration's Office of Orphan
Drug Products requesting that cannabis be designated an Orphan Drug
for the treatment of AIDS wasting syndrome. This effort recently
came to fruition. MAPS has also co-funded
studies of medical marijuana
potency and water pipes and vaporizers.
On February 20, 2001, MAPS, MPP and Dr. Ethan Russo filed an
Amicus Curiae brief in the
medical marijuana case, US v. Oakland Cannabis Buyers' Cooperative.
Even though FDA approved Dr. Russo's MAPS-supported protocol to
study the use of smoked marijuana in treating patients suffering
from migraines, NIDA refused to supply the marijuana. As a result,
Dr. Russo's study never took place. We have tried to turn our
frustrating experience with NIDA to the advantage of medical marijuana
patients by letting the U.S. Supreme Court know that the FDA drug
development process is politically obstructed. Our brief's basic
point is that these obstructions create more of a need for the
medical necessity defense for patients who run into conflict with
the police over their use of marijuana as medicine.
On April 30, 2003, MAPS, MPP and Dr. Ethan Russo filed an updated
version of this amicus
curiae brief in the US Court of Appeals for the Ninth Circuit
case of Angel Raich et al. v. John Ashcroft as Attorney General
and Asa Hutchinson, Administrator of the DEA. (PDF Format)
Dr. Russo has abandoned his struggle
to conduct FDA-approved research. Instead, he has designed a
basic safety study of the few patients remaining alive who
legally receive marijuana from NIDA as part of the Compassionate
IND program that was closed by HHS in 1992. MAPS donated $10,000
to this study, which started in May 2001. Preliminary
results of the study show therapeutic benefits, with no significant
adverse effects. The final paper about
the study, reference below, reports on the study
in detail.
[ Russo E, Mathre ML, Bryne A, Velin R, Bach P, Sanchez-Ramos
J, Kirlin K. Chronic Cannabis Use in the Compassionate Investigational
New Drug Program: An Examination of Benefits and Adverse Effects
of Legal Clinical Cannabis. Journal of Cannabis Therapeutics Vol.
2 (1) (2002): 3-57. ]
View Dr. Russo's powerpoint presentation,
"Chronic Cannabis Use in the Compassionate Investigational New
Drug Program: An Examination of the Benefits and Adverse Effects
of Legal Clinical Cannabis" (IE4+ required to view this presentation)
Read about the struggle to begin
medical marijuana research in the 90's.
