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MAPS Bulletin Winter 2013: 2013 Annual Report
 
Research/MMJ > Medical Marijuana Timeline

contract Medical Marijuana Research Timeline
March 28, 2014
  MAPS "PRESS RELEASE: Historic Shift In Federal Policy As HHS Approves Medical Marijuana Study for PTSD" .

On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for researchers to purchase research-grade marijuana from the National Institute on Drug Abuse (NIDA) for a planned study of marijuana for symptoms of PTSD in 70 U.S. veterans.

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March 14, 2014

Public Health Service Approves Medical Marijuana Study, Marking Historic Shift in Federal Policy

On March 14, 2014, in an historic shift in federal policy, the U.S. Department of Health and Human Services granted permission for MAPS to purchase marijuana from the National Institute on Drug Abuse (NIDA) for our planned study of marijuana for symptoms of PTSD in U.S. veterans. We have been working for over 22 years to start marijuana drug development research, and this is the first time we’ve been granted permission to purchase marijuana from NIDA, the sole provider of marijuana for federally regulated research in the United States. We have been denied permission to purchase NIDA marijuana for two prior FDA- and IRB-approved studies and one laboratory vaporizer study, preventing them from taking place. It took over four and a half months for reviewers at the Public Health Service (PHS) to respond to our October 24, 2013, protocol resubmission, after initially rejecting the protocol on September 16, 2011. The study still requires final approval from the U.S. Drug Enforcement Administration, for which Principal Investigator Dr. Sue Sisley’s Schedule I application was submitted on March 25.  We are optimistic the DEA will approve the study in a timely manner. The study will also require funding support. "When it comes to researching the medical potential of Schedule I drugs," said MAPS Founder Rick Doblin, "Privately funded medical marijuana drug development research has been the last domino to fall." The tide has turned for medical marijuana research, and we look forward to starting the study. View the approval letter from HHS

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March 10, 2014

Arizona State Senator Blocks Funding for Medical Marijuana Research

On March 10, 2014, the Arizona House of Representatives passed HB 2333, a bill that could have provided up to $250,000 in funding for our planned study of marijuana for symptoms of PTSD in U.S. veterans. The funds would have come from over $7.5 million in fees collected from the Arizona medical marijuana program. The possibility for the study to receive this funding disappeared, however, when Arizona State Senator Kimberly Yee (R-Phoenix), who chairs the Senate Committee on Education, blocked the bill by refusing to put it on her committee’s agenda before the March 20 deadline. Senator Yee said that she prefers the funds to be used for anti-drug education. With these funds now unavailable, we will still need funding to make the study possible.

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February 21, 2014
  MAPS "PRESS RELEASE: Public Health Service Blocking FDA-Approved Medical Marijuana Research for PTSD" .

A Food and Drug Administration (FDA) and University of Arizona Institutional Review Board (IRB)-approved protocol for a study of marijuana for symptoms of PTSD in U.S. veterans, sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has been on hold for over 3½ months, as researchers wait for the PHS to respond to their request to purchase marijuana for the study.

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February 13, 2014

Rick Doblin to HHS: When Will You Stop Obstructing FDA-Approved Marijuana Research?

On February 13, 2013, MAPS Executive Director Rick Doblin, Ph.D., once again contacted the U.S. Department of Health and Human Services reminding the agency that more than three and a half months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization,” Doblin writes, “Can you help me understand why the Obama Administration still insists on obstructing medical marijuana research?”

Subject: More than 3 1/2 Months for PHS Marijuana/PTSD Protocol Review-2/13/14 NYTimes op-ed on federal obstruction of research

Date: February 13, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS

Sarah, +++

I imagine that you aren’t too happy to have the unenviable job of being the point person for obstructing privately-funded, FDA and IRB-approved medical marijuana research.

It’s now more than 3 1/2 months since Oct. 24, 2013, when MAPS submitted our FDA and IRB-approved protocol to you for the PHS review. As the saying goes, “Justice delayed is justice denied.”  MAPS is the conservative wing of the medical marijuana movement in that we are focused on conducting FDA-regulated research but our efforts are not welcomed.

Today’s NYTimes had an op-ed discussing the federal obstruction of medical marijuana research. Unfortunately from my perspective, the article focuses on rescheduling marijuana to facilitate research, which isn’t necessary or likely, and doesn’t mention the PHS protocol review process which is the key obstruction along with the NIDA monopoly.

We’re doing our best to focus public attention on the PHS review process but we have been less successful than I have hoped. I anticipate greater success in the future illuminating the problematic PHS review process.  We are considering bringing some vets to DC to protest the delays in the PHS review process but we’ll hopefully receive some favorable news from you before we organize the protest.

Do you have any idea when this interminable PHS review process will come to a conclusion, with either permission or rejection to purchase NIDA marijuana?  I’m aware, as I am sure you are also aware, that even if we pass the PHS review, we still need to obtain DEA approval for the protocol before we can start the study.  About 2200 vets have committed suicide since we submitted our protocol to you for review. Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization, can you help me understand why the Obama Administration still insists on obstructing medical marijuana research and hasn’t yet ended the PHS review process?

puzzled,

Rick

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January 27, 2014

FDA Sends Pre-Inactivation Letter after Three Years Waiting for Marijuana for Study

Over three years ago, on December 15, 2010, the U.S. Food and Drug Administration (FDA) approved the protocol for our planned study of marijuana for PTSD in U.S. veterans, pending information about the source of the marijuana to be used in the study. Due to the ongoing Drug Enforcement Administration-protected monopoly held by the National Institute on Drug Abuse on marijuana for research, over three years later we’ve still been unable to obtain marijuana for the study. In their January 27, 2014, letter, the FDA asked MAPS to respond within 30 days if we still wish to proceed with the study. In his February 17 response, MAPS Executive Director Rick Doblin, Ph.D., writes, “We still do plan on responding to the clinical hold deficiencies but we can’t say exactly when we will have located a supply of marijuana for the study.” We have now been waiting almost four months for a response from the Public Health Service to our October 24, 2013, protocol resubmission.

Update: On March 5, the FDA informed MAPS that our IND will remain active for another year.

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January 24, 2014

Three Months Later, Researchers Still Waiting for Response from Public Health Service

On January 24, 2013, MAPS Executive Director Rick Doblin, Ph.D., sent an email to the U.S. Department of Health and Human Services reminding the agency that three full months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues,” Doblin writes “This delay is itself an obstruction of medical marijuana drug development research.”

Subject: 3 Months for PHS Marijuana/PTSD Protocol Review, Chicago Tribune column

Date: January 24, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS

Sarah,

Today completes the third month since Oct. 24, 2013,  when we submitted to you our FDA and IRB-approved protocol for PHS review.  We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues. This delay is itself an obstruction of medical marijuana drug development research.

In our letter of Oct. 24, 2013, MAPS also requested that HHS end the PHS protocol review process for privately-funded medical marijuana drug development studies. PHS review is designed for evaluating grant applications for government funding of basic science. PHS review is not appropriate for privately-funded FDA drug development studies designed to meet FDA standards but not to gather basic science information.  The PHS review exists only because of NIDA’s DEA-protected monopoly.  Rather than the PHS review, NIDA should sell its marijuana at cost to all sponsors of research approved by FDA, DEA, IRB and state authorities. Those agencies already regulate privately-funded research with all other Schedule 1 drugs, without PHS involvement.

As you may have noticed, a column in yesterday’s Chicago Tribune by Steve Chapman, a member of the Tribune‘s editorial board, called on President Obama to end the PHS medical marijuana protocol review process.  Since it hasn’t ended yet, I look forward to working with you to find a way to start this much-needed study.

sincerely,

Rick

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October 24, 2013

Marijuana for PTSD Protocol Resubmitted to HHS; Researchers Await Response

On October 24, 2013, MAPS resubmitted to the U.S. Department of Health and Human Services the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. Currently, the National Institute on Drug Abuse holds a monopoly on the supply of marijuana for research in the U.S. Under current federal policies, reviewers from the Public Health Service (PHS, a division of the Department of Health and Human Services/HHS) must approve all privately funded research seeking to use NIDA marijuana. The FDA approved the protocol in April 2011, but HHS reviewers unanimously rejected the protocol in September 2011, preventing the study from going forward. At the time of the HHS rejection, the study had not yet been approved by an IRB.

In October 2012, the IRB at the University of Arizona approved the study protocol. The IRB accepted all the core elements of our design, added several safety measures and procedures, and rejected HHS’ critiques of the protocol design. We are requesting that HHS agree to sell MAPS the marijuana needed for the study, as well as to abandon the PHS review process entirely, which exists only for marijuana and not for research with any other drug. MAPS is also working with other groups on a Congressional Sign-On letter to HHS Secretary Kathleen Sebelius urging her to eliminate the PHS review and require NIDA to sell marijuana to sponsors of all protocols that obtain approval from FDA, IRB, DEA and relevant state authorities.

View the cover letter to HHS…

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April 15, 2013

U.S. First Circuit Court Upholds NIDA Monopoly on Marijuana for Research

On April 15, 2013, the United States Court of Appeals for the First Circuit rejected University of Massachusetts-Amherst Prof. Lyle Craker’s lawsuit against the Drug Enforcement Administration for denying him a license to grow marijuana for privately funded medical research. With its decision, the Court has ensured that the debate over the medical use of marijuana will continue to take place through political battles rather than through scientific research.

The decision brings to an end Craker’s 12-year effort to end the National Institute on Drug Abuse’s monopoly on the supply of marijuana for research. A laboratory at the University of Mississippi under contract to the National Institute on Drug Abuse is currently the only facility in the U.S. permitted to grow marijuana for research.

Prior to Craker’s application, NIDA had refused to sell marijuana to two FDA- and Institutional Review Board-approved protocols sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), preventing them from taking place. In September 2011, NIDA refused to sell marijuana to a third FDA-approved MAPS-sponsored protocol in 50 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).

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January 22, 2013

DEA Notifies Court of Marijuana Rescheduling Case; Craker’s Legal Team Responds

On January 22, 2013, the U.S. Drug Enforcement Administration filed a Notice of Supplemental Authority with the First Circuit Court of Appeals in Boston, Mass., in Prof. Lyle Craker’s ongoing federal lawsuit against the DEA for denying him a license to grow marijuana for medical research. The filing was intended to bring to the Court’s attention the outcome of a lawsuit against the DEA by Americans for Safe Access challenging the DEA’s denial of a petition to reschedule marijuana, acknowledging its medical uses. In the ASA case, the Court protected the DEA’s refusal to reschedule marijuana.

On January 30, 2013, Craker’s legal team filed a response to inform the Court that the ASA case is not legally relevant to Craker’s lawsuit.

The First Circuit Court’s decision in Lyle E. Craker v. Drug Enforcement Administration is still pending.

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October 25, 2012

Marijuana for PTSD: Institutional Review Board Approves Study Protocol

On October 25, 2012, the Institutional Review Board (IRB) at the University of Arizona notified Principal Investigator Sue Sisley, M.D., that they had approved the protocol for our planned study of marijuana for symptoms of PTSD in 50 U.S. veterans. The third and final IRB review took place on October 23. The Food and Drug Administration approved the protocol in April 2011, though the study has been blocked by the National Institute on Drug Abuse since September 2011. We are now preparing to resubmit the protocol and study documents, hoping that approval from both the IRB and the FDA will persuade NIDA to sell us the marijuana needed for the study.

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October 12, 2012

Marijuana for PTSD: Protocol Submitted for Third Time to IRB

On October 12, 2012, MAPS and Principal Investigator Sue Sisley, M.D., resubmitted to the Institutional Review Board (IRB) at the University of Arizona the revised protocol, informed consent, and other documents for our study of marijuana for veterans with PTSD. The study aims to explore the safety and effectiveness of smoked or vaporized marijuana for symptoms of PTSD in 50 veterans with chronic, treatment-resistant PTSD.

The FDA cleared the study on April 28, 2011, which has since been blocked by the National Institute on Drug Abuse/Public Health Service’s September 16, 2011, refusal to sell researchers the marijuana needed for the study. We are hopeful that approval from the IRB will increase pressure on the NIDA/PHS reviewers to evaluate the protocol on the basis of science rather than politics. NIDA/PHS approval would allow us to submit the protocol to the DEA for final approval, and allow us to continue working to develop more effective treatments for veterans with PTSD.

In their August 31 letter, the IRB indicated that they were satisfied with the overall study design, but required several minor changes regarding subject safety. The revised protocol addresses these requested changes, including a detailed safety plan for subjects participating in the study and revised informed consent forms.

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August 31, 2012

Marijuana for PTSD: IRB Requests Changes to Study Protocol, Researchers Respond

On August 31, 2012, the Institutional Review Board at the University of Arizona responded to our July 30 submission of the protocol for our planned study of smoked or vaporized marijuana for 50 U.S. veterans with chronic PTSD. After a meticulous review, the IRB committee sent Principal Investigator Sue Sisley, M.D., a list of nine issues to address, requiring relatively minor changes to the protocol and informed consent documents. The IRB’s letter indicated that they were satisfied with the key protocol design elements. MAPS and Dr. Sisley responded to the IRB’s comments on September 14, and we are hopeful that the protocol will be approved at the upcoming meeting of the IRB on September 25.

Thousands of U.S. veterans are using marijuana to treat their PTSD symptoms despite the lack of any controlled research into its safety and effectiveness. Several medical marijuana states use this lack of research as justification for refusing to allow physicians to recommend marijuana for PTSD.

Our protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to the National Institute on Drug Abuse/Public Health Service’s refusal to sell researchers the marijuana needed for the study. One of the issues raised by the NIDA/PHS reviewers in their rejection was that the protocol had not yet received IRB approval, although IRB approval is not required for NIDA/PHS to accept a protocol. If NIDA/PHS still refuses to allow us to conduct the study once both the FDA and the IRB have cleared it, the political motivations behind the federal marijuana research blockade will be even more apparent, as will the need for state-level reform.

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July 30, 2012

Marijuana for PTSD: Protocol Submitted to Institutional Review Board

On July 30, 2012, MAPS and Sue Sisley, M.D., submitted the protocol for our FDA-approved study of marijuana for veterans with PTSD for review by the University of Arizona Institutional Review Board (IRB). The IRB review is scheduled for August 28. MAPS also submitted a detailed cover letter explaining our rationale for various elements of the protocol design.

The protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to NIDA’s refusal to sell researchers the marijuana needed for the study. We will respond to the NIDA/Public Health Service reviewers’ comments if the IRB also approves the study protocol.

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June 2, 2012

Arizona Medical Association Challenges NIDA Blockade of Medical Marijuana Research

On June 2, 2012, the Arizona Medical Association (ArMA) House of Delegates unanimously adopted a resolution (pdf) challenging the National Institute on Drug Abuse’s blockade of medical marijuana research. ArMA’s resolution is yet another pressure point on the federal government’s obstruction of medical marijuana research.

ArMA resolved that “once the protocol for privately-funded marijuana research has been reviewed and approved by the Food and Drug Administration and relevant Independent Review Board and the practitioner has obtained registration from the Drug Enforcement Administration, the National Institute of Drug Abuse shall, without further evaluation of the research protocol, supply marijuana for the research, at cost, upon the practitioner’s proper application.”

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May 11, 2012

U.S. First Circuit Court Hears Oral Arguments in Lyle Craker v. Drug Enforcement Administration

On May 11, 2012, the U.S. First Circuit Court of Appeals in Boston, Mass., heard oral arguments (audio, mp3) in the case of Lyle E. Craker v. Drug Enforcement Administration. The arguments are the culmination of 11 years of administrative and legal proceedings in response to the DEA’s denial of a license to Craker to start a production facility under contract to MAPS to grow marijuana exclusively for privately funded, federally regulated medical research.

Craker’s attorney from Washington, D.C., law firm Covington & Burling LLP, which is representing Craker pro bono, clarified the issues facing the court and urged the judges to require the DEA to issue Craker’s license. The DEA attempted to get the case thrown out before a ruling by claiming that the court has no jurisdiction over the issue, an argument that the court seems likely to reject. The court’s ruling should come in about three months. Meanwhile, the DEA is succeeding in preventing our medical marijuana research from moving forward.

Download the official press release (PDF).

Read the complete annotated transcript (PDF).

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May 4, 2012

DEA Lawsuit Reply Brief Submitted, Oral Arguments Scheduled for May 11, 2012

On May 4, 2012, the legal team representing Prof. Lyle Craker submitted their reply brief (PDF) in his federal lawsuit against the Drug Enforcement Administration for rejecting a DEA administrative law judge’s 2007 recommendation that it would be in the public interest to grant Prof. Craker a license to grow marijuana under contract to MAPS for federally-regulated research. Oral arguments in the case of Lyle E. Craker v. Drug Enforcement Administration will be presented on Friday, May 11, 2012 at around 9:30 A.M. at the U.S. First Circuit Court of Appeals in Boston, Mass.

For more information, download our official press release (PDF).

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April 28, 2012

Israeli Study Results Presented at Clinical Cannabis Conference

On April 28, 2012, the results of a recently completed exploratory study of medical marijuana in veterans with PTSD were presented (slides available here in PDF format) by Dr. Mordechai Mashiah, Deputy Director of the Abarbanel Mental Health Center in Israel, at the 7th National Clinical Conference on Cannabis Therapeutics, hosted by Patients Out of Time in Tucson, Ariz. The study was sponsored by the Israeli Ministry of Health.

MAPS Israeli Clinical Research Associate Mimi Peleg, Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Clinical Research Assistant Linnae Ponté, and Executive Director Rick Doblin, Ph.D., assisted Dr. Mashiah with data analysis and preparation of his presentation and abstract. MAPS also allocated about $6,000 to assist Dr. Mashiah in analyzing and presenting his results, and will further support him in preparing of a paper for publication in a peer-reviewed scientific journal.

To date, there are still no published, placebo-controlled studies of the use of marijuana by people with PTSD. MAPS’ protocol for a study of the safety and effectiveness of marijuana for 50 veterans with PTSD has been approved by the FDA, but the National Institute on Drug Abuse has blocked the study, preventing it from proceeding (see MAPS’ point-by-point annotated response (PDF) to the NIDA review).

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April 3, 2012

Medical Marijuana: New Arizona Law and Study for U.S. Veterans with PTSD

On April 3, 2012, Arizona governor Jan Brewer signed into law a bill prohibiting the use of medical marijuana on the campuses of schools, colleges, and universities in the state. The new law is an example of the current backlash against medical marijuana that is taking place at both the state and federal level across the United States. While the bill was intended to regulate state medical marijuana patients, some administrators at the University of Arizona have suggested that the bill could also apply to federally regulated medical marijuana research. This could prevent MAPS from being able to conduct our FDA-approved study of marijuana for PTSD on the campus of the University of Arizona in Phoenix, where Principal Investigator Sue Sisley, M.D., is planning to conduct the study.

In the study protocol, we propose to explore the safety and effectiveness of smoked and/or vaporized marijuana in 50 U.S. veterans with chronic, treatment-resistant PTSD. We are now seeking clarification on the extent of the new law, which is on shaky legal ground if used to ban federally regulated research. Meanwhile NIDA, which has a monopoly on the supply of marijuana for use in FDA-regulated research, continues to block the study by refusing to sell us the marijuana required for the study.

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March 22, 2012

DEA Files Opposition Brief in Federal Lawsuit for Blocking Medical Marijuana Research

On March 22, 2012, the Drug Enforcement Administration (DEA) filed its first response brief (81-page PDF) to Prof. Lyle Craker’s lawsuit in the First Circuit Court of Appeals, which he filed on December 15, 2011. Prof. Craker is objecting to the DEA’s rejection of DEA Administrative Law Judge Bittner’s recommendation that it would be in the public interest to license Prof. Craker to grow marijuana for federally-regulated research. Granting Prof. Craker this license would end the federal monopoly on marijuana for research and open the door for non-profit medical marijuana research.

In their response brief, DEA lawyers (1) argue that the First Circuit Court of Appeals lacks jurisdiction in the case, (2) move to strike parts of our argument based on NIDA’s September 2011 refusal to sell us marijuana for our FDA-approved protocol for veterans with PTSD, and (3) reiterate previous arguments claiming that international treaty obligations forbid granting Prof. Craker a license.

Prof. Craker’s lawyers are now developing what we believe will be an effective response to the jurisdictional issues as well as the substantive issues. The reply from Prof. Craker’s legal team will be submitted in early May.

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March 14, 2012

DEA Requests Third Extension for Filing Federal Lawsuit Opposition Brief

On March 14, 2012, Drug Enforcement Administration lawyers requested yet another extension—their third—on the deadline for filing their opposition brief in Prof. Lyle Craker’s lawsuit against the agency. The government’s brief is now due on March 21.

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February 22, 2012

DEA Requests Second Extension for Filing Opposition Brief in Federal Lawsuit

On February 22, 2012, the Drug Enforcement Administration requested a second extension on the deadline for filing its response brief in Prof. Lyle Craker’s federal lawsuit against the agency. The government’s brief is now due March 16.

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January 13, 2012

DEA Requests Extension for Filing Opposition Brief in Federal Lawsuit

On January 13, 2012, lawyers for the Drug Enforcement Administration called the lawyers representing Prof. Lyle Craker to request an extension until February 24 for filing their opposition brief in response to Craker’s opening brief, which was filed in the 1st Circuit Court of Appeals on December 15, 2011. Craker’s legal team granted the request for an extension.  Craker’s reply brief will now be due on March 9, two weeks after February 24, though the DEA lawyers indicated they would agree to an extension should it be requested. Once all opening briefs are filed, it’s likely that oral arguments will be scheduled.

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December 15, 2011

Craker’s Legal Team Submits Opening Brief in Federal Lawsuit against the DEA

On December 15, 2011, the legal team representing Prof. Lyle Craker filed their opening brief in their much-anticipated lawsuit against the Drug Enforcement Administration for denying Craker’s application to cultivate marijuana for medical research. The 232-page document (PDF) represents the combined efforts of Prof. Craker, the American Civil Liberties Union, Washington, D.C. law firm Covington & Burling LLP, and MAPS, and is a major challenge to DEA’s politically-motivated decision to uphold the federal blockade on marijuana for research. The DEA’s opposition brief is currently due January 20, though the agency may request an extension of a month or more. The brief was filed in the United States Court of Appeals for the First Circuit.

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September 21, 2011

MAPS Receives Pro-Bono Representation to Appeal Craker Case in First Circuit Court of Appeals

MAPS has received a generous offer for pro-bono legal representation from the Washington, DC law firm Covington & Burling LLP, one of the foremost law firms representing the pharmaceutical industry, to appeal the DEA’s August 15 final order in the First Circuit Court of Appeals. These legal actions would otherwise have cost MAPS an estimated $175,000 in legal fees, which we may or may not have been able to raise.

See MAPS’ official press release and Medical Marijuana Research page for more information about MAPS’ efforts to conduct privately-funded, FDA-reviewed medical marijuana research.

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September 16, 2011

NIDA/PHS Rejects Marijuana/PTSD Protocol, Blocking MAPS’ FDA-Reviewed Study

On September 16, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five NIDA/PHS reviewers had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. According to MAPS Executive Director Rick Doblin, Ph.D., the reviewers offered contradictory critiques, misunderstood key protocol design elements, requested expensive and tangential additions to the protocol, and made unfounded assumptions about the study design, revealing their focus on basic science research and lack of familiarity with drug development research. The reviewers also treated the submission as if MAPS were requesting a government grant for the study rather than using private funds. Even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.

For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS’ detailed, point-by-point response to the HHS review, see the annotated reviewer comments.

Download MAPS’ official press release announcing the HHS rejection.

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August 15, 2011

DEA Rejects Judge’s Recommendation, Upholding Federal Marijuana Monopoly

On August 15, 2011, the Drug Enforcement Administration (DEA) issued its final order rejecting DEA Administrative Law Judge Mary Ellen Bittner’s 2007 recommendation that it would be in the public interest to grant University of Massachusetts, Amherst Prof. Lyle Craker a license to grow marijuana for federally regulated research. The rejection preserves the monopoly held by the National Institute on Drug Abuse (NIDA) on the supply of marijuana for Food and Drug Administration (FDA)-regulated research.

ALJ Bittner issued her recommendation to license Prof. Craker on February 12, 2007, after extensive hearings. On January 14, 2009, almost two years later and six days before President Obama’s inauguration, DEA Acting Administrator Michelle Leonhart rejected the ALJ recommendation. In response, Prof. Craker’s lawyers filed a series of objections, which were denied in the final order. Prof. Craker’s only recourse is to appeal the DEA final ruling in the First Circuit U.S. Court of Appeals.

For more information, see our Medical Marijuana Research page.

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July 15, 2011

NIDA/PHS Completes Review of Marijuana for PTSD Protocol; MAPS Awaits Response

On April 28, 2011, the revised protocol for our planned study of marijuana for symptoms of PTSD in US veterans was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.

The HHS notice came only days before an article about the study in The New York Times (July 18, 2011) made MAPS’ marijuana research national news.

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April 28, 2011

FDA Accepts Marijuana for PTSD Protocol

On April 28, 2011, the U.S. Food and Drug Administration accepted MAPS’ protocol design for our study of marijuana for symptoms of PTSD in war veterans, stating that our revised protocol successfully addresses their previous concerns. Once again, the FDA has demonstrated its willingness to evaluate studies on the basis of scientific merit rather than political partisanship.

Although both MAPS and the FDA are satisfied with the protocol design, we cannot begin the study until passes yet another review process with the National Institute on Drug Abuse/Public Health Service (NIDA/PHS). This redundant review, which may take another year or more, is required solely because NIDA has a monopoly on the supply of marijuana for research, and NIDA/PHS must review the protocol before allowing us to purchase marijuana from the agency. NIDA’s mission does not include exploring the potential beneficial uses of marijuana.

MAPS has been pressuring the federal government through hearings, lawsuits, and appeals for over a decade to allow us to grow our own marijuana. The DEA has refused to accept the recommendation of its own Administrative Law Judge that it would be in the public interest for Professor Lyle Craker of the University of Massachusetts, Amherst, to receive a license to grow marijuana for research regulated by the FDA.

Many U.S. veterans already use medical marijuana to deal with their symptoms of PTSD. MAPS is seeking to conduct the first clinical trial testing the use of the smoked or vaporized marijuana plant in PTSD patients. Now the PHS/NIDA will decide if MAPS can obtain marijuana for 50 suffering veterans.

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April 1, 2011

DEA Asks Administrator to Reject Judge’s Recommendation in Response to Final Brief

On April 1, 2011, the DEA filed its response to the final brief in Professor Lyle Craker’s nearly decade-long lawsuit against the agency to end the federal government’s monopoly on the supply of marijuana for research. After (presumably) reviewing the final brief, agency officials asked DEA Administrator Michele Leonhart to reject DEA Administrative Law Judge Mary Ellen Bittner’s 2007 recommendation that Craker be allowed to start his own MAPS-sponsored medical marijuana production facility. We are now waiting for Leonhart to issue her final order, thus continuing to prevent the research from taking place. It may have been April Fool’s Day, but this is no joke, and the American public is not laughing.

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March 17, 2011

US Government Institution Acknowledges Medicinal Uses of Cannabis

The National Cancer Institute is the latest addition to a growing list of government agencies and professional medical associations—including the Institute of Medicine, the American Medical Association, and the National Institutes of Health—that have acknowledged the known and possible medical uses of marijuana. The announcement came when the NCI added several sections to its website about the use of marijuana in supportive care for cancer patients. In this article, the American Botanical Council summarizes the NCI’s perspective on medical marijuana, highlights its strengths and shortcomings, and explores its broader implications for research and public policy.

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March 15, 2011

MAPS Submits Revised Marijuana/PTSD Protocol to FDA

On March 15, 2011, MAPS submitted to the FDA the revised protocol for its planned study of smoked and/or vaporized marijuana for PTSD in war veterans. In a February 9 conference call, the FDA acknowledged that we had successfully addressed their concerns about subjects diverting unused marijuana, and requested that we submit this revised protocol. If after reviewing the revised protocol the FDA decides to allow the study to proceed, the next step will be to move the protocol through a complicated review process with the National Institute on Drug Abuse and the Public Health Service.

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March 7, 2011

Craker’s Lawyers File Final Brief in DEA Lawsuit to Grow Marijuana for Research

On March 7, 2011, Professor Lyle Craker, Director of the Medicinal Plant Program at the University of Massachusetts-Amherst and his lawyers at the American Civil Liberties Union and Washington, D.C., law firm Jenner & Block submitted their final brief in their marathon lawsuit against the Drug Enforcement Administration.

Right now, a lab at the University of Mississippi is the only facility in the U.S. with a license to grow marijuana for research. Any scientist who proposes a study of marijuana must purchase it from this lab, whether they’re interested in its risks or in its medical uses. Unfortunately, the National Institute on Drug Abuse—which funds the lab and therefore decides which studies get marijuana and which do not—only supports research into the potential harms of marijuana. That makes it practically impossible to do the research with the greatest potential for helping actual patients.

The only way to change the situation is to end NIDA’s monopoly, which is exactly what MAPS and Craker have been trying to do for nearly ten years. We’re expecting the FDA to allow us to proceed with our proposed study of the safety and effectiveness of smoked and/or vaporized marijuana for PTSD in war veterans, and NIDA (and its parent agency the Public Health Service) are the only ones standing in its way.

Read the MAPS press release announcing the latest developments in the case.

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February 9, 2011

MAPS Addresses FDA Concerns about Planned Marijuana/PTSD Study

On February 3, 2011, the U.S. FDA asked MAPS to provide additional information regarding the protocol for our planned study of the safety and effectiveness of smoked and/or vaporized marijuana for the treatment of PTSD symptoms in war veterans. The agency’s principal concerns involved the possibility of subjects giving or selling (“diverting”) unused marijuana during or after the study. This is an important point for the FDA given that this study would be the first outpatient marijuana study to be conducted in approximately 30 years.

On February 9, 2011, MAPS and the FDA had a teleconference to discuss these concerns. It was a major success. Prior to the meeting, MAPS prepared responses to each of the seven points raised in the February 3 letter and developed a chart listing of the advantages and disadvantages of several strategies for preventing diversion. We proposed a two-part solution: First, each subject will be given a handheld video camera (the Flip) with which they will record themselves removing the marijuana from its canister (containing one week’s supply), using it, and replacing unused material. Study staff will review these videos on a weekly basis prior to giving subjects their next week’s marijuana. Second, subjects will be asked to give us the name of a significant other who we can call weekly for independent verification that subjects used the marijuana themselves. If it cannot be verified that subjects used the marijuana themselves, they will be removed from the study.

During the teleconference, the FDA said our approach was reasonable. They indicated that we should submit the revised version incorporating the new safeguards for FDA review. The FDA saw that we were sincere in trying to address the issue of diversion control, and we saw that the FDA was willing to move forward with our study. However, if the FDA approves the protocol, we still need to run the gauntlet of the redundant Public Health Service/National Institute on Drug Abuse review process, which is likely to be much more difficult and much less reasonable than that of the FDA. At the very least, we are one crucial step closer.

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January 14, 2011

NIDA Claims to Have Marijuana Required for Marijuana/PTSD Study

On December 15, 2010, the FDA notified MAPS that our planned study of smoked or vaporized marijuana for veterans with chronic, treatment-resistant PTSD had been placed on full clinical hold until we are able to provide specific information about the source, composition, concentration, and manufacturing method of the active and placebo marijuana cigarettes we plan to use. We have requested that the National Institute on Drug Abuse (NIDA) provide the marijuana as a result of the agency’s monopoly on the legal supply of marijuana for use in FDA-approved studies. Despite having submitted the study protocol to NIDA and the Public Health Service (PHS) nearly two months ago, we still have not heard a word about the likely time frame for the NIDA/PHS protocol review.

Fortunately, the FDA has a set a precedent of reviewing and even approving protocol designs before having complete information on the source of the drug. We expect to receive FDA’s protocol critiques very soon. Even if we obtain FDA approval, the protocol must also be approved through the NIDA/PHS review process. In the 1990s, MAPS had two medical marijuana protocols approved by the FDA but rejected by NIDA, preventing the studies from taking place.

On January 14, 2011, an official from NIDA sent an email to MAPS Executive Director Rick Doblin, Ph.D., indicating that the agency does in fact have the various levels of marijuana with delta-9-tetrahydrocannabinol (THC) that we need for our study. The study protocol calls for marijuana with five different concentrations of THC and cannabidiol (CBD): 0% THC (placebo), 2% THC, 6% THC, 12% THC, and 6% THC/6% CBD. NIDA claims that it has marijuana cigarettes of 0.004% (placebo), 2.1%, 5.6%, or 6.7% THC. They also claim that their facility at the University of Mississippi has in stock bulk marijuana containing 12% THC that can be manufactured into cigarettes, and that they can blend different batches to produce cigarettes containing marijuana with 6% THC and between 4% and 6% CBD (despite their initial insistence that they did not have any marijuana with CBD).

NIDA appears to be doing its best to provide what we need for the study, perhaps due to the pressure we have been putting on them through Professor Lyle Craker’s ongoing lawsuit against the DEA seeking a license to grow marijuana for federally regulated research under contract to MAPS.

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December 15, 2010

On December 15, 2010, FDA placed MAPS’ study of marijuana for people with PTSD on full clinical hold. (Letter describing study placement on clinical hold.)

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December 6, 2010

DEA Administrator Explains Denial of Request to Reopen Craker Case

Professor Lyle Craker, Ph.D., of the University of Massachusetts at Amherst, with assistance from MAPS, continues to pursue his lawsuit against the Drug Enforcement Administration (DEA) for rejecting his application for a license to grow marijuana for federally regulated research under contract to MAPS and in doing so to break the monopoly held by the National Institute on Drug Abuse (NIDA). On January 30, 2009, lawyers for Prof. Craker filed a Motion to Reconsider the DEA’s January 14, 2009, final order rejecting the DEA Administrative Law Judge’s February 12, 2007, recommendation that it would be in the public interest for the agency to license Prof. Craker. On December 6, 2010 (nearly two years later), we received a memorandum from DEA Administrator Michele Leonhart (who was recently confirmed by the US Senate) detailing the reasons why our request to reopen the trial was rejected. Leonhart did, however, grant us the opportunity to submit another written brief objecting to her final order. Prof. Craker will be submitting his brief on or before the deadline of March 7, 2011. The DEA could take days, months, or years to reply.

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November 24, 2010

Marijuana for PTSD Protocol Submitted to FDA and NIDA

On Nov. 11, 2010, MAPS’ clinical research team submitted our newest marijuana protocol to the FDA. If approved, the study will gather preliminary information about whether medical marijuana is a safe and efficacious way to manage symptoms of PTSD. The FDA has already requested more information about where we would obtain the marijuana for the study. On Nov. 23, MAPS Executive Director Rick Doblin, Ph.D., wrote to the Chemistry and Physiological Systems Research Branch at the National Institute of Health (NIH)/National Institute on Drug Abuse (NIDA) to inquire about the cost and THC content of NIDA-supplied marijuana. On Dec. 2, we received an email from the agency informing us that NIDA could provide us with three out of the five potencies of marijuana we wish to test. According to the agency, NIDA has placebo marijuana cigarettes (containing just 0.004% THC) and marijuana cigarettes containing 2.1%, 5.6%, and 6.7% THC. It does not, however, have marijuana cigarettes containing 12% THC or the combination of 6% THC/6% CBD, which our protocol requires. NIDA also cautioned us that the THC content of its marijuana deteriorates over time, and that we should ask for updated potency information prior to ordering. On Dec. 3, Rick wrote back to NIDA asking how much it would cost and how long it would take for NIDA to develop marijuana that contained 6% THC/6% CBD and 12% THC. A NIDA representative replied to Rick’s inquiry on Dec. 8, informing him that Mahmoud Elsohy, Ph.D., the director of NIDA’s marijuana project at the University of Mississippi, was out of town and that NIDA would respond in several weeks.

Meanwhile, on Nov. 24, a representative from the FDA wrote to MAPS requesting information on behalf of the FDA’s Chemistry, Manufacturing, and Controls (CMC) team. They requested information regarding: (1) the source of the active and placebo marijuana cigarettes, including the name and address of the manufacturer, (2) the complete composition of each strength and technical grade of each excipient (the non-marijuana components of each cigarette), (3) how the specific concentration of THC and CBD in the marijuana plant is achieved, (4) the method of manufacture of the cigarettes, (5) the specifications for each strength and description of the analytical procedures, (6) the certificate of analysis for each strength to be used in the clinical study and the date of manufacture,  and (7) a letter of authorization to NIDA’s Drug Master File for marijuana cigarettes. Rick responded to the FDA letting them know that the organization has set a precedent of reviewing and approving protocols before having all the required information for the source of the drug to be used in the study. In such cases, the protocol can be approved, but the study is on clinical hold until the FDA CMC review team is satisfied with the information regarding the drug to be used in the study.

The Public Health Service (PHS)/NIDA protocol review process, which is required for all studies seeking NIDA marijuana (but which isn’t required for any of our psychedelic research since we have our own independent source), can take about six months, and it’s likely that the reviewers will have questions about the protocol. After we respond to those questions, it could take another six months for PHS/NIDA to comment on our replies—a process which will repeat until our protocol is either rejected or approved. Until those reviews are completed and NIDA approves the protocol, NIDA will not give MAPS permission to purchase its marijuana and cross-reference its Drug Master File. Therefore, while it is currently impossible for MAPS to provide the information requested by the FDA CMC review team, the FDA should be able to continue with its review.

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November 19, 2010

Marijuana/PTSD Study Gains Julie Holland, M.D., as Medical Monitor

Julie Holland, M.D., has reviewed the protocol and agreed to be the medical monitor for our newest study of marijuana as a treatment for PTSD. The protocol was submitted to the FDA on Nov. 12, 2010, and on Nov. 17, 2010, MAPS
received a new Investigational New Drug number for marijuana: #110513.

Dr. Holland recently edited and published The Pot Book, which is a magnificent resource about marijuana. The book is available in the MAPS store and proceeds directly fund MAPS’ medical marijuana research mission.

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November 17, 2010

MAPS Receives IND # for Marijuana

MAPS received an Investigational New Drug identification number for marijuana from the FDA. This is part of our study of marijuana for PTSD.

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November 6, 2010

MAPS Hosts Mile High Marijuana Summit

MAPS hosted the Denver Mile High Marijuana Summit which featured leading experts about marijuana policy:
*MAPS Executive Director Rick Doblin, Ph.D.,
*Ethan Nadelmann, Executive Director, Drug Policy Alliance, an national organization working to end the war on drugs by promoting policies based on science, compassion, health and human rights
*Mason Tvert, Executive Director of SAFER, a Denver based organization responsible for Denver’s 2005 and 2007 marijuana initiatives and Colorado State’s 2006 initiative
*Brian Vicente, Executive Director, Sensible Colorado, the organization is the primary resource for Colorado’s licensed medical marijuana patients, and has engaged in successful litigation involving the “Test Cases” of Denver’s I-100 Ordinance which removed penalties for adult possession of under an ounce of marijuana
*Aaron Houston, Executive Director, Students for Sensible Drug Policy, an international organization with hundreds of autonomous chapters on college and high school campuses
*Sue Sisley, M.D., private practice physician and medical marijuana activist from Phoenix will discuss the Arizona medical marijuana initiative
*Jeff Jones, Co-founder of Oaksterdam University and lead proponent of California’s Proposition 19, the tax and regulate Cannabis Initiative of 2010
*Steve Fox, Director of Government Relations, Marijuana Policy Project, a national organization responsible for passing several state’s medical marijuana laws

Video and audio of the conference is available here.

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October 3, 2010

MAPS’ New Marijuana/PTSD Study Design Finalized

On Oct. 3, Research and Information Specialist Ilsa Jerome, Ph.D., Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and Executive Director Rick Doblin, Ph.D., finalized the study design for our investigation of marijuana as a treatment for Posttraumatic Stress Disorder (PTSD). We are preparing to submit the protocol and informed consent forms to the FDA by the end of this month. We currently consider marijuana usage to be more useful in treating symptoms of PTSD and requiring regular administration, while MDMA-assisted psychotherapy is aimed at achieving a cure by getting to the core of the problem.

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September 22, 2010

MAPS Hires Lobbyist for Marijuana Production Facility/Professor Craker Campaign

MAPS signed a contract with The Raben Group, a Washington, D.C., lobbying group. The Raben Group will initially review and analyze the political situation relating to the Craker case, then provide MAPS with recommendations on next steps for MAPS to consider. If MAPS and The Raben Group agree that securing the license is possible, The Raben Group will develop supporting materials; assist with outreach to other organizations or people willing to support MAPS’ efforts; schedule and staff meetings with the Department of Justice; and provide any necessary follow-up to Department of Justice staff as well as strategic counsel to MAPS.

According to IRS rules, technically none of this work counts as lobbying since we are not trying to change any laws. Instead, we are working with a regulatory and enforcement agency, the DEA, to encourage it to follow the recommendations of DEA Administrative Law Judge Bittner. The judge determined that it would be in the public interest for DEA to issue a license to Prof. Craker to grow marijuana for MAPS for federally-regulated research.

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August 9, 2010

New Marijuana-for-PTSD Protocol Close to Complete

MAPS is preparing a marijuana/PTSD pilot study in veterans of war to be conducted by Principal Investigator Sue Sisley, M.D. in Arizona.  The protocol is close to being submitted to the FDA after having been reviewed, critiqued, and revised by several outside experts. The study is being developed in response to anecdotal reports of marijuana being used to alleviate PTSD symptoms. At present, there is no published data from a randomized,
placebo-controlled, double-blind study of the risks and benefits of marijuana for chronic PTSD sufferers.

Forty subjects will be randomly allocated to one of four treatment groups. Each subject will be provided with two rolled cigarettes daily, each weighing 0.9 grams, the standard-size marijuana cigarette provided by the National Institute on Drug Abuse (NIDA). The cigarettes will contain either (1) 2% D9-tetrahydrocannabinol (THC), (2) 6% THC, (3) 6% THC and 6% cannabidiol (CBD), or (4) 12% THC. The subjects who receive 2% THC will serve as the low-dose/active placebo group; while an ideal placebo would not contain any potentially therapeutic action, previous research has shown completely inactive marijuana is rarely effective at producing an effective double-blind. Marijuana will be self-administered daily on an outpatient basis for four weeks, followed by two weeks of none. Within each treatment group, five of 10 subjects will smoke marijuana cigarettes; the other five are assigned to use a vaporizer.

In this groundbreaking study, marijuana will be used as a pharmacological medicine without associated psychotherapy. The primary outcome variable measuring the severity of PTSD will be the Clinician Administered PTSD Scale (CAPS), required by FDA and the European Medicines Agency (EMEA).

At present, the NIDA does not produce any marijuana with significant levels of CBD. We are specifically requesting NIDA produce such a strain for this study. NIDA has previously indicated that it could provide any marijuana strains requested by researchers. Should NIDA be unable to provide marijuana with CBD—due to NIDA’s monopoly on the supply of marijuana for FDA-regulated research—we would have no other sources of supply and we would be forced to eliminate the 6% THC/6% CBD group from the protocol.

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August 2, 2010

MAPS Intensifies Campaign For Craker’s Marijuana Production License

MAPS has hired Chris Chiles and Stephen Morseman to coordinate a campaign to obtain a DEA license for Professor Lyle Craker of UMass Amherst to grow marijuana under contract to MAPS, and end the National Institute on Drug Abuse (NIDA) monopoly over the supply of marijuana available to the research community. Chiles and Morseman are attempting to have the issue brought up at the Senate Judiciary Committee’s confirmation hearing for the new DEA Administrator. President Barack Obama has nominated DEA Deputy Administrator Michele Leonhart, but she is a holdover from President Bush and her track record does not bode well for medical marijuana and marijuana research.

On February 12, 2007, DEA Administrative Law Judge (ALJ) Mary Ellen Bittner ruled it is in the public interest for the DEA to license Craker. However, on January 12, 2009, Leonhart rejected this recommendation. On January 30, 2009, Craker’s lawyers at the American Civil Liberties Union (ACLU) filed a Motion to Reconsider. The DEA has not responded. The ACLU has filed nine status updates (every 60 days) with the U.S. Court of Appeals, First Circuit, in case the DEA conclusively rejects the ALJ recommendation and a legal appeal is needed.

The goal of MAPS’ campaign is to push three key senators—Senators Patrick Leahy (D-Vermont), Sheldon Whitehouse (D-Rhode Island) and Al Franken (D-Minnesota)—to ask Leonhart during the confirmation hearing to grant Craker’s motion and accept the administrative law judge’s recommendation to end the federal monopoly on the supply of marijuana for federally regulated research.

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August 1, 2010
  High Times "Crop Blockers" by David Jay Brown.

This is an excellent expose about Dr. Mahmoud Elsohly’s NIDA sponsored marijuana production facility at the University of Mississippi. The article discusses the federal government’s blocking of research into the benefits of marijuana.

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June 16, 2010

Oregon Board of Pharmacy
800 NE Oregon St., Suite 150
Portland, OR 97232-2162

News Release
For Immediate Release

Contact:            

Paige Clark, R. Ph.           
.(JavaScript must be enabled to view this email address) 

State Board of Pharmacy reclassifies marijuana

To implement S.B. 728, Board makes marijuana a Schedule II drug

Portland The Oregon State Board of Pharmacy acted today to remove marijuana from the list of Schedule I Controlled Substances, in accordance with a bill the legislature passed last year.

The new law, ORS 475.059 established by Senate Bill 728, requires marijuanas removal from a list of controlled substances that have a high abuse potential and no acceptable medical use in the United States.

The Board placed marijuana into Schedule II Controlled Substances, which contains substances that have a high abuse potential with severe psychological or physical dependence liability, but are accepted for medical use in the US and are available by prescription.  The Oregon Controlled Substances Act provides three additional schedules for substances that are progressively less serious or dangerous, Schedules III, IV and V.

The Board reviewed scientific and medical literature and heard testimony from experts and members of the public before voting to move marijuana into Schedule II. This action is consistent with Oregons assertion that marijuana does have an acceptable medical use.

Contact:
Gary A. Schnabel, Executive Director, Oregon Board of Pharmacy
971-673-0001

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May 19, 2010

NPR. “Can Marijuana Ease PTSD? A Debate Brews” (Audio File) (Webpage)  by Jeff Brady.

This article reports on persons with PTSD, including veterans of war, who are using medical marijuana to ease anxiety and other symptoms, the debate within the Veterans Affairs, and the conflict between state laws and federal laws.

“The Department of Veterans Affairs finds itself in a difficult position because some vets want to use marijuana to treat symptoms of post-traumatic stress disorder. Pot possession remains illegal under federal law. The VA says that as a federal agency its doctors can’t recommend using it.

The problem is especially acute in New Mexico, where one-fourth of the state’s more than 1,600 medical marijuana patients are PTSD sufferers.”

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April 22, 2010

Craker’s lawyers file seventh update with U.S. Court of Appeals, First Circuit

Prof. Craker’s lawyers filed a seventh update with the U.S. Court of Appeals, First Circuit.  It has now been 15 months since our lawyers filed our Motion to Reconsider. The DEA’s tactic of delay is once again in full effect.

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April 1, 2010

Marijuana PTSD Study in the Works in Arizona

MAPS is currently working with Principal Investigator Sue Sisley M.D., of Phoenix, Arizona to develop a new marijuana/PTSD protocol in order to get a marijuana study underway in the U.S. Weve already developed a protocol summary. Were anticipating that the protocol will be ready for submission to the Institutional Review Board (IRB) and the FDA this summer. Were sadly anticipating that this study is likely to be delayed for at least a year by NIDAs review process—should they even approve it, which is doubtful. In addition, were asking for marijuana with THC and CBD in it, which NIDA does not have available.

There is not at yet a possibility of importing any marijuana into the United States that contains significant amounts of both THC and CBD.  This shows clearly how the DEA support of NIDAs monopoly on the supply of marijuana for research is fundamentally obstructing drug development research aimed at transforming marijuana into an FDA-approved prescription medicine. The DEA/NIDA obstruction of FDA research is one of the primary reasons why state medical marijuana reform efforts are essential.

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April 1, 2010

Professor Craker, UMass, and MAPS Efforts to Create a Privately-Funded Medical Marijuana Production Facility

Since 2001, MAPS has worked with Professor Craker at UMass Amherst to try to obtain a license for our own production facility of marijuana for FDA-approved research. NIDA currently has a monopoly on cannabis production for research purposes, and the DEA has been protecting that monopoly, which fundamentally obstructs drug development research for a number of reasons.

President Obama has recently nominated Michelle Leonhart as the new DEA Administrator, which will complicate the fate of our marijuana drug development efforts. Since 2004, Leonhart has been the Acting Deputy Administrator of the DEA, after being appointed by President Bush. Although she had several jobs, shes been in a leadership role at DEA, and has been behind the crackdown on the state medical marijuana patients, growers, and providers. Most significantly, she rejected the February 12, 2007, recommendation of DEA Administrative Law Judge Mary Ellen Bittner, who found that it would be in the public interest for Professor Craker to receive a DEA license for the production of marijuana for research.

Professor Crakers lawyers have filed a motion to reconsider to Michele Leonhart, with her response still pending. President Obamas nomination of her to be the Administrator of the DEA is not encouraging, even though President Obama has also ordered his Attorney General Eric Holder to stop the DEA raids on cannabis dispensaries in states that allow medical marijuana, so long as they are operating in compliance with state law. Were hoping that opening the door to scientific research is something that President Obama, his senior staff, members of Congress, and members of the Senate confirmation hearing will understand is a priority principle that Michele Leonhart needs to share to be confirmed as the next Administrator of DEA.

We expect the senate confirmation hearings to take place in the next month or two. We strongly encourage people to contact their Senators about the Michelle Leonhart confirmation, saying that she should not be confirmed unless theres a pledge to accept the recommendation of the Administrative Law Judge, or a pledge to facilitate medical marijuana research and not protect the NIDA monopoly.

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February 25, 2010

Crakers lawyers file fifth update with U.S. Court of Appeals, First Circuit

Prof. Crakers lawyers filed a sixth update with the U.S. Court of Appeals, First Circuit.  It has now been over one year since our lawyers filed our Motion to Reconsider and we still have not heard from the DEA in this matter.

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January 8, 2010

New Marijuana/PTSD Study Initiated

 

Executive Director Rick Doblin, Ph.D., Research and Information Specialist Ilsa Jerome, Ph.D., and Clinical Research Associate Berra Yazar-Klosinski, Ph.D. Candidate are exploring funding and collaborating on a new study of medical marijuana for the treatment of posttraumatic stress disorder (PTSD) with principal investigator Sue Sisley, M.D. The study is tentatively titled "Placebo-controlled, double-blind study of the safety and efficacy of smoked cannabis in 30 veterans with PTSD."
 

This study is currently designed to enroll 32 veterans diagnosed with PTSD by the clinician administered PTSD scale (CAPS). Scores of 50 or higher can be included in a placebo-controlled, double-blind study of self-administered smoked cannabis for the treatment of PTSD symptoms. Study duration will be six weeks. Participants will be randomly assigned to one of four conditions, receive 2 grams per day of 1) placebo, 2) 6% THC, 3) 12% THC cannabis, or 4) 6%thc/6%CBD cannabis. The study will begin with an hour-long baseline assessment of PTSD symptoms and one 30-minute introductory session to prepare subjects for the use of marijuana. This will be followed by self-administration of cannabis for four weeks. PTSD symptoms will be assessed at four weeks, followed by a two week medication cessation period after the cannabis use has stopped, and a third 60-minute assessment of PTSD symptoms at six weeks. Participants who originally received the placebo can enroll in a second open-label segment following identical study procedures where they can choose to receive full doses of either 6% THC, 12 % cannabis, or 6%THC/6%CBD cannabis.
 

The proposed study has already received informal comments about the design from health personnel inside the Department of Veterans Affairs. MAPS has applied for grant from the Marijuana Policy Project to partially fund this study. 

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December 28, 2009

Fifth Status Update Filed with Appeals Court in Craker Marijuana Lawsuit

The fifth status update in the ongoing attempt to license Professor Lyle Craker to grow marijuana for research at UMass Amherst has been filed with the United States Court of Appeals First Circuit. It has now been almost one year since the DEA rejected the recommended ruling of their own Administrative Law Judge Mary Ellen Bittner. Judge Bittner ruled in favor of licensing Craker and ending the U.S. governments supply of marijuana for research. We have been hopefully waiting for President Obama to appoint a new leader at the DEA who would adhere to the original ruling, rather than the ruling written by DEA acting administrator Michelle Leonhart.

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December 14, 2009
  The Huffington Post "President Obama: Free the Medical Marijuana Researchers!" by Doug Bandow.

The Huffington Post. "President Obama: Free the Medical Marijuana Researchers!" By Doug Bandow

This editorial urges President Obama to instruct the DEA to license Professor Craker to be able to grow marijuana for research, among other suggestions for increases scientific investigations of medical marijuana.

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November 20, 2009
   "Join Together. “AMA Calls for More Research into Medical Use of Marijuana”" by Bob Curley.

The federal government should consider moving marijuana out of Schedule I of the Controlled Substances Act in order to facilitate clinical research and development of cannabinoid-based medications, the American Medical Association (AMA) said in a new policy statement. Rick Doblin, Ph.D., executive director of MAPS, said the AMA policy shift demonstrates that there is "clearly more interest in medical marijuana in the medical community than ever before." However, Doblin -- who has long contended that NIDA has worked to block medical-marijuana research through its gatekeeping role over supplies of marijuana for research -- said the policy will have "zero effect in getting NIDA out of the loop." Doblin said that a unique and open-ended Public Health Service (PHS) review process for medical-marijuana research, coupled with NIDA's monopoly on the drug supply, has prevented most basic research studies on smoked marijuana from getting off the ground.

Originally appeared at:

http://www.jointogether.org/news/features/2009/ama-says-marijuana-has.html

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November 15, 2009

Israel Explores Possibilities of Permitting Medical Marijuana Sales

Under the direction of the Knesset (Israels legislative body), the Israeli Ministry of Health is considering allowing medical marijuana producers to sell marijuana to Ministry of Health approved patients. If this plan is implemented, the marijuana producers will be able to increase the amount they produce and the Ministry of Health will approve more patients. Furthermore, if the plan is implemented, Israel will become a model state for the safe distribution of medical marijuana to medical marijuana patients.

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November 2, 2009
Prof. Craker’s lawyers filed a fourth update with the U.S. Court of Appeals, First Circuit. The filing with the Court of Appeals is a part of our continuing defensive action in case DEA rejects our Motion to Reconsider and DEA’s Final Ruling goes into effect.

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September 4, 2009

First Circuit Court of Appeals Third Status Update Submitted in Prof. Crakers Marijuana Production Facility Case

 

On September 4, 2009, Professor Lyle Craker, Ph.D.s ACLU Drug Law Reform Project lawyers filed the third Status Update with the U.S. Court of Appeals, First Circuit. The update reports on the DEAs lack of response to the witness and document list filed with the DEA on June 5, 2009, in support of Prof. Crakers Motion to Reconsider the DEAs Final Ruling. The lawyers are asking the Court to hold the appellate proceedings in abeyance until we learn the DEAs final decision. The DEAs final order was scheduled to go into effect July 1, 2009, but the DEA lawyers have previously indicated that it is not unusual to have a Motion to Reconsider still pending after the effective date of a final agency order. 

For the first time since we began this court case in 2001, we are in alignment with the DEAs tactic of delay. We have read rumors that Obama is considering appointing new leadership at the DEA from outside of the current DEA. Hopefully, any new leadership replacing the Bush-holdovers who are still running the DEA will reverse the rejection of the Administrative Law Judge (ALJ)s recommendation to license Prof. Craker.

Crakers lawyers are required to file a status report with the Court of Appeals every 60 days until a decision is finalized by the DEA. These status report filings preserve Crakers right to appeal should the DEA deny him a license to grow marijuana for research purposes at UMASS Amherst, under contract to MAPS. 

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August 24, 2009

Rick Doblin, Mike Corral Visit Israel to Help Medical Marijuana Program.

On August 24, 2009, MAPS Executive Director Rick Doblin, Ph.D. met with Israeli Ministry of Health official Yehuda Baruch, M.D. who is in charge of the Ministry’s medical marijuana program. Boaz Wachtel, an Israeli medical marijuana activist, was also at the meeting. They discussed various issues regarding the expansion of the Israeli medical marijuana program. Currently, there are a handful of marijuana producers licensed to grow marijuana and give the product away to about 500 licensed medical marijuana patients. In order to create a sustainable business model, there will need to be a transition to allowing the producers to sell their product. However, it seems that the transition to sales will not be imminent. There will need to be more work done to persuade the Ministry of Health that selling the medicine to patients is an appropriate course of action. Despite no guarantee of future sales, the various producers are taking on investors in hopes of building for-profit businesses. Consequently, MAPS has stopped donating money to Israeli production facilities. MAPS is still trying to help support medical marijuana research in Israel by urging the Ministry to approve sales as soon as possible.

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July 2, 2009

Professor Crakers Attorneys File Second Status Update in Court of Appeals

On July 2, 2009, Professor Lyle Craker’s ACLU Drug Law Reform Project lawyers filed the Second Status Update with the US Court of Appeals, First Circuit. The update reports on DEA’s lack of response to the witness and document list filed with DEA on June 5, 2009, in support of Prof. Craker’s Motion to Reconsider DEAs Final Ruling. The lawyers are asking the Court to hold the appellate proceedings inabeyance until we learn the DEAs final decision. DEA’s final order was scheduled to go into effect July 1, 2009, but DEA lawyers have previously indicated that it is not unusual to have a Motion to Reconsider still pending after the effective date of a final agency order.

Crakers lawyers are required to file a status report with the Court of Appeals every 60 days until a decision is finalized by DEA. These status report filings preserve Crakers right to appeal should DEA deny him a license to grow marijuana for research purposes at UMASS Amherst, under contract to MAPS. We are currently comfortable with DEAs delay as we are hoping that new leadership at DEA will soon be appointed by the Obama administration. New leadership at DEA will hopefully be more likely to reverse the rejection of the Administrative Law Judge (ALJ)s recommendation to license Prof. Craker than the Bush-holdovers still running DEA who initially rejected the ALJs recommendation.

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June 5, 2009

Craker’s lawyers filed an impressive list of potential witnesses and documents regarding our pending Motion to Reconsider. DEA has until July 1 to decide whether or not to grant our Motion.

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May 14, 2009

On June 5, Crakers Lawyers Filed Witness and Document Lists, DEA has until July 1 to respond.

On June 5, Crakers lawyers filed potential witness and document lists regarding our pending Motion to Reconsider. On May 18, DEA filed an Interim Order requesting that Craker submit witness and document lists by June 5, 2009.  DEA also extended the effective date of its final ruling to July 1, 2009, leaving it three weeks to consider whether or not to grant our Motion to Reconsider.  On May 11, 2009, we asked the First Circuit, US Court of Appeals (where in a defensive maneuver we have filed a new lawsuit against DEA) to delay consideration of our case until after we learn how DEA responds to our pending Motion.

On April 29, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEAs final decision regarding Prof. Crakers application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker by asking the DEA to cease going forward on its May 1 deadline.

On April 13, the DEA filed its final response to Crakers March 11 Supplemental Motion To Reconsider and Exhibits submitted to DEA Deputy Administrator Michelle Leonhart, adding to a Motion to Reconsider filed January 30. These motions request a hearing to present opposing arguments to new evidence that DEA cited in its January 14, 2009, Final Order rejecting DEA Administrative Law Judge Bittners February 12, 2007 recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Crakers facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS.

 

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May 13, 2009

Rick Doblin, Mike Corral Visit Israel to Help Medical Marijuana Program.

From April 19 to April 22, 2009, MAPS President Rick Doblin went to Israel to work with Ministry of Health-approved medical marijuana producer Yohai Golan and Golans investors. Ricks efforts in Israel involved consulting with the Ministry of Health about the possibility of allowing production facilities to sell marijuana to Ministry of Health-approved patients in order to create a sustainable system. Currently, the Israeli government has only given Golan, and several other producers, permission to give away the medicine they grow, but not to sell it. Rick is hopeful that the Ministry of Health will eventually permit sales of marijuana, but he recognizes that the wheels of bureaucracy turn slowly.

On Tuesday, May 12, 2009, Mike Corral--an experienced medical marijuana grower from the Wo/mens Alliance for Medical Marijuana--arrived in Israel to consult with three different growing facilities on techniques to maximize yield while reducing costs. An anonymous donor funds Mikes work in Israel through MAPS.

While in Israel Rick heard good news about several current studies investigating clinical applications for medical marijuana. Among the studies taking place are a study with patients with Crohn’s disease and patients with posttraumatic stress disorder (PTSD). The PTSD study will use THC drops as opposed to smoked marijuana. Raphael Mechoulam, Ph.D, who was a part of a team of scientist to first isolate and identify THC as the active ingredient in marijuana, developed the THC drops. Nearly three decades later he led a team that identified the endocannabinoid anandamide, part of an endogenous cannabinoid system in the human nervous system.

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May 11, 2009

May 1 Comes and Goes Without DEA Action - Craker’s Marijuana Production Application Still Pending

 

On January 14, 2009, DEA issued a Final Order rejecting DEA Administrative Law Judge Bittner’s February 12, 2007, recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Craker’s facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS. Ending the federal monopoly on the supply of marijuana for research would be the beginning of a serious drug development effort aimed at transforming marijuana into an FDA-approved prescription medicine.

May 1, 2009, was the effective date of DEA’s final ruling rejecting Prof. Craker’s license. However, we have still heard nothing from DEA in response to Prof. Crakers Motion to Reconsider.  Based on conversations between Allen Hopper, Prof. Crakers ACLU attorney, and Teresa Wallbaum, Acting Deputy Chief for Policy and Appeals, US Department of Justice, Criminal Division, Narcotic and Dangerous Drug Section, and also additional conversations between Senator Durbin’s staff and DEA officials, we have learned that DEA review of the Motion to Reconsider is still pending and that DEA intends to issue a written order adjudicating the Motion. We also learned that it is not rare for Motions to Reconsider, like the one filed here, to be resolved even after so-called final orders have become effective.  In other words, there is still some possibility that DEA may grant in part or in whole the still-pending Motion to Reconsider, which could significantly change the final order. As the saying goes, Its good to be the King, since you can ignore your own deadlines. 

On May 11, 2009, Prof. Crakers lawyers filed an update in the First Circuit Court of Appeals. We have asked for a delay in consideration of our case until after we learn how DEA responds to our pending Motion, which they may accept or reject. On February 13, 2009, in a prescient defensive maneuver, Prof. Crakers attorneys filed a placeholder notice of appeal in the U.S. Court of Appeals for the First Circuit in Boston, preserving Prof. Crakers right to appeal just in case DEA eventually denies the Motion to Reconsider; such a denial would effectively end the administrative proceedings and retroactively finalize the already-published final order denying his application. On March 12, the Court granted Prof. Crakers attorneys request that the appeal be docketed but no further action be taken until such time as DEA rules on the Motion to Reconsider.  The Court also ordered Prof. Crakers attorneys to file an update every 60 days about the status of the case, with May 11 being the due date for the first update. If DEA denies the Motion to Reconsider, the appeal process is already started and a briefing schedule will be set. If DEA grants in part or in whole the Motion to Reconsider, the attorneys will focus on presenting new information to DEA and can further postpone (or completely eliminate the need for) the appeal. We are hoping that new leadership at DEA appointed by President Obama will thoroughly review the administrative proceedings, perhaps allow the submission of additional information, and eventually grant Prof. Crakers application for a license to grow medical marijuana for FDA-approved research.

On April 29, 2009, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEA’s final decision regarding Prof. Craker’s application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker by asking DEA to cease going forward on its May 1 deadline.  Since there has still been no final negative action by DEA, it appears these letters may have had an impact.

Now were back in waiting mode, with no deadline for DEA to file its decision regarding our Motion to Reconsider. Delay has always been DEAs preferred strategy.  Until there is new leadership at DEA appointed by President Obama, delay is now our preferred strategy as well.

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May 1, 2009

May 1 Comes & Goes Without DEA Action - Craker’s Marijuana Production Application in Limbo.

The effective date of DEA’s final ruling rejecting Prof. Craker’s license was supposed to be May 1. However, we have heard nothing so far directly from DEA regarding a response to our pending Motion to Reconsider. Based on conversations between our attorneys and the Department of Justice, and Senator Durbin’s staff and DEA,  we have learned that DEA review of our Motion to Reconsider is still pending, and that it is not rare for such matters to take place after final orders have become effective. As a result on May 11, 2009, we asked the First Circuit, US Court of Appeals (where in a defensive maneuver we have filed a new lawsuit against DEA) to delay consideration of our case until after we learn how DEA responds to our pending Motion.

On April 29, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEA’s final decision regarding Prof. Craker’s application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker by asking the DEA to cease going forward on its May 1 deadline.

On April 13, the DEA filed its final response to Craker’s attorney’s March 11 Supplemental Motion To Reconsider and Exhibits submitted to DEA Deputy Administrator Michelle Leonhart, adding to a Motion to Reconsider filed January 30. These motions request a hearing to present opposing arguments to new evidence that DEA cited in its January 14, 2009, Final Order rejecting DEA Administrative Law Judge Bittner’s February 12, 2007 recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Craker’s facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS. We will inform our supporters as soon as we hear anything from DEA.

 

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March 31, 2009
  Jerusalem Post "A growth sector" by David Brinn.

A well-written, detailed article about an Israeli medical marijuana facility that MAPS helped fund.

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March 16, 2009

Productive Planning Produces Productive Pot Production in Israel:

On Friday, March 6, MAPS brought Val Corral and Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) to Israel to work with Yohai Golan at his medical marijuana production facility. Joined by Rick Doblin, they had very productive meetings with the team that is producing marijuana for Israeli Ministry of Health-approved patients. Lester Grinspoon, MD, Donald Abrams, MD, and Rick Doblin agreed to be on the board of advisors for the production facility. The team is still negotiating with the Ministry of Health to obtain permission to sell their product to their patients; currently they are only legally allowed to supply the medicine free of charge. MAPS has arranged with the support of an anonymous donor for Mike Corral, a greenthumb gardener from WAMM, to go to Israel soon to further consult with the production facility in order to help maximize their yield.

Rick, Val, and Mimi were able to tour the facility, which includes a multi-acre greenhouse that is gradually filling up with medical marijuana plants in various stages of growth. Rick says, It is a tremendously exciting situation and we are looking forward to continuing to be involved in the project.

Furthermore, the Ministry of Health is granting licenses for people who have PTSD to use medical marijuana. Rick had a conversation with one of the doctors who prescribes marijuana to patients with PTSD. It is possible that we will become involved in a marijuana/PTSD study in Israel, which will complement and clarify our other MDMA/PTSD Studies.

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March 10, 2009
  Los Angeles Times "The science of pot" by Editorial Desk.

The Los Angeles Times editorialized in favor of DEA licensing of Prof. Craker's medical marijuana production facility, citing as support President Obama's March 9, 2009 statement about scientific integrity. The LA Times editorial said, "DEA is one of the many federal agencies ready for enlightenment."

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March 4, 2009

Wammovie

Wammovie is feature length documentary film that will show the human drama of facing disease, the end of life and a person's right to choose how they deal with both. This film is based on footage and interviews collected over the past four years of volunteer work with a collective of patients and caregivers called the Wo/men's Alliance for Medical Marijuana (WAMM).

Wammovie is the story of patients and caregivers fighting for their right to choose what medicine is most suitable for their particular circumstance. It is the story of faith in the power of collective compassion and one of ultimate loss. Wammovie is the account of Jackie, a caregiver who came to WAMM as a skeptic and emerged as an advocate. Jackie bakes medicinal muffins for her friends because she thinks that they deserve a break from nausea or constant pain. Even if the relief she provides is a brief moment it is worth every ounce of effort. It is the story of Jeremy, an HIV/AIDS patient who delights in helping others in need access their medicine. He was diagnosed over 20 years ago and has watched many friends succumb to a disease that he was sure would have taken him long ago. It is the story of Dianne who has battled breast cancer and won. She signifies her victory by transforming her mastectomy scar into a powerful image of beauty and strength. Her emergence as a survivor has inspired her to educate others about breast cancer.

Wammovie is about surviving and making positive experiences out of every moment but it is also about letting go and being present for the exquisite journey to the end of life. Lucy is dying of ovarian cancer; she has been for some time. She is afraid but struggling to hold things together for her 15-year-old daughter that she has been raising by herself. As Lucy's conditions worsen a team of her loved ones swing into action to provide round the clock care. Lucy's care team did not set out to nurse her back to health or even to extend her life. They were there to ensure that her quality of life was as best as possible and that the end was as she wanted it.

Wammovie is about the life that happens after the worst has been faced and there is nowhere left to go but forward. That is the time when being alive really is about the very moment of existence that you experience. In this story, a young woman, Lucy's daughter was forced to grow up too early; she lost her mother to ovarian cancer yet found another place to call home with her mother's friend and deathbed companion Valerie Corral.  In this story, Jackie finds love with another WAMM member and is married at a joyous occasion that takes the place of a previously planned triple memorial. According to Val, The connection between the marriage and the memorial is a transcendence into love. Wammovie is about our transcendence into love.

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February 6, 2009

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February 6, 2009

Congress and Professor Craker Respond to Bush Administration and DEA’s Obstruction of Scientific Freedom:

On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the Drug Enforcement Administration’s (DEA) final ruling, which was the Bush Administration’s parting blow to medical marijuana research. Professor Craker rebutted DEA’s final order with the support of MAPS and the American Civil Liberties Union (ACLU) on grounds that new evidence was introduced in the final ruling that was not included during testimony in the case. 

On February 6, 2009, 16 members of the United States Congress sent a letter to new Attorney General Eric Holder urging him to have DEA “amend or withdrawal the Final Order in this matter to permit President Obama’s new Deputy Attorney General and DEA appointees to review Prof. Craker’s merits, once they are in office.” This letter was orchestrated by our sister organization Americans for Safe Access (ASA), who also distributed a press release. The 16 signatories are Representatives John Olver, Maurice Hinchey, Ron Paul, Tammy Baldwin, Raul Grijalva, Sam Farr, Robert Wexler, Ed Pastor, Neil Abercrombie, Gary Ackerman, Lynn Woolsey, William Delahunt, Barney Frank, Zoe Lofgren, Michael Capuano, and Dennis Kucinich.

The motion of reconsideration and Congressional letter are responses to the Bush Administration’s last-minute obstruction of legitimate science on January 14th, when DEA filed in the Federal Register its final ruling refusing to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA’s final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. Her February 12, 2007, recommendation stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEA’s contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA’s monopoly fundamentally obstructs MAPS’ research aimed at developing smoked or vaporized marijuana into a prescription medicine.

MAPS is hopeful that the Obama Administration will honor its commitment to science over ideology. The Obama administration should support MAPS’ efforts to sponsor research aimed at gathering evidence about marijuana to present to FDA, and should stop DEA’s and NIDA’s obstruction of our attempts to transform marijuana into an FDA-approved prescription medicine.

There are several media articles about DEA’s ruling on the MAPS in the media page.

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January 30, 2009

On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the DEAs final ruling, which was the Bush Adminstration’s final blow to medical marijuana research.

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January 26, 2009

 Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel:

On Monday, January 26, MAPS funded Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) in Santa Cruz, CA, to travel to Victoria, British Columbia, Canada to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS). Mimi and Philippe are advising a MAPS-supported medical marijuana production facility in Israel, licensed by the Israeli Ministry of Health. MAPS donated $15,000 as a matching grant to Yohai Golan’s medical marijuana production facility that is giving marijuana away for free to Ministry of Health-approved patients under the Israeli Health Minister’s guidelines. MAPS is also sponsoring Mimi Peleg and WAMM’s founder and president Val Corral to visit Israel next month for in-person consultation. An anonymous donor is covering expenses and Val and Mimi’s trip to Israel.

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January 23, 2009

Gregory Goldstein, HHS Senior Public Health Advisor,  Office of the Assistant Secretary of Health, sent a letter to Chemic on January 23, 2009,  saying that HHS would require a validation study showing that Chemic could reliably measure various cannabinoids before it would even review Chemic’s November 6, 2008 reply to the June 18, 2008 PHS/NIDA critique of Chemic’s January 16, 2008 protocol.

  However, there is no guarantee that PHS/NIDA would approve the protocol after funds for the validation study had been spent.  Furthermore, a validation study could cost $40,000 and isn’t really necessary for the sort of academic study we’re seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as a medical device, a task best left to the manufacturer of that vaporizer. We’re exploring a collaboration with Dutch scientists already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less then half the cost of the validation study.

Chemic initially submitted a protocol in June, 2003, seeking to purchase 10 grams from NIDA. That protocol was rejected on July 27, 2005, more than two years later. Chemic’s reply to that rejection was submitted on September 9, 2005, and was ignored by NIDA for over two years and four months, prompting us to submit a new protocol on January 16, 2008, to see if it might somehow catalyze a review process.

Progress is slow in Chemic’s efforts to purchase 10 grams of marijuana from the government’s monopoly provider, NIDA.  It’s encouraging that the first hint in over 5 1/2 years that NIDA might actually sell Chemic 10 grams for its research took place on January 23, 2009, three days after Obama became President.

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January 14, 2009

The Bush administration struck a parting shot to legitimate science on January 14th, as the Drug Enforcement Administration (DEA) refused to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research.  DEA’s final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. The prior recommendation on February 12, 2007, stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEAs contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA’s monopoly fundamentally obstructs MAPS research aimed at developing smoked or vaporized marijuana into a prescription medicine.

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January 9, 2009

 Medical Marijuana Donation Leveraged in Israel 

For the last several years, MAPS has provided financial support for the development of the compassionate use of marijuana in Israel, in conjunction with a program of medical access developed by the Israeli Ministry of Health. The Ministry reviews applications from physicians on behalf of their patients and has licensed four different medical marijuana production facilities. These facilities have permits from the Israeli Ministry of Health to provide marijuana for free to Ministry-approved patients. Since the production facilities can only give marijuana away, they rely on donations to cover costs. An excellent article on the Israeli medical marijuana program was published recently in an Israeli newspaper, and has been translated by Dana Peleg, MA.

In November, MAPS offered $15,000 as a matching grant to Yohai Golan, who has one of the Ministry production licenses. In December, Yohai managed to obtain $15,000 as his match from Israeli donors and MAPS sent him our $15,000, provided by an anonymous donor. Over the last several weeks, Yohai has concluded negotiations with Israeli investors (not donors) who are providing sufficient funding (roughly $200,000 per year) to cover the provision of enough marijuana for 500 patients for the next two years. These investors are gambling that they can make money providing marijuana extracts to the pharmaceutical industry, since they can grow marijuana for this purpose as well as for free distribution to patients. In addition, they expect they will eventually be given permission to sell marijuana to patients, though how much research will have to be conducted first remains to be determined.

As a side project to the production facility, Yohai’s team will be producing organic cannabis oil tinctures that can be used as a substitute for smoking for patients who prefer not to – or cannot – inhale smoke or vapors from a vaporizer. The tinctures will use donated fair-trade organic olive oil produced by Palestinians in the West Bank and Israelis in Israel.

Yohai Golan has estimated that the value of the marijuana that they will give away is roughly $6 million per year, based on prices for legal Dutch medical marijuana and prices for medical marijuana in the US.

MAPS colleagues Val Corral and Mimi Peleg from the Wo/Mens Alliance for Medical Marijuana (WAMM) will travel to Israel, probably in February, to help Yohai create a functional administrative system to distribute the medicine that will be harvested at the end of March. MAPS will pay for their travel through funds that have been donated and restricted to this project. Prior to going to Israel, Mimi Peleg will travel to Victoria, Canada, to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS), to learn about his approach to distribution and research. Previously MAPS has sponsored Philippe to consult with another medical marijuana production facility in Israel. 

Yohai expressed his gratitude to MAPS President Rick Doblin PhD, “I would like to thank Rick for his constant support and late night chats helping me keep focused and looking ahead. Without his guidance and constant advice, I would not have come this far in Israel and would have given up.”

MAPS is extremely gratified that our original funding of a mere $15,000 was the catalyst for this significantly larger investment!

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January 9, 2009

Medical Marijuana Donation Leveraged in Israel 

 

For the last several years, MAPS has provided financial support for the development of the compassionate use of marijuana in Israel, in conjunction with a program of medical access developed by the Israeli Ministry of Health. The Ministry reviews applications from physicians on behalf of their patients and has licensed four different medical marijuana production facilities. These facilities have permits from the Israeli Ministry of Health to provide marijuana for free to Ministry-approved patients. Since the production facilities can only give marijuana away, they rely on donations to cover costs. An excellent article on the Israeli medical marijuana program was published recently in an Israeli newspaper, and has been translated by Dana Peleg, MA.

In November, MAPS offered $15,000 as a matching grant to Yohai Golan, who has one of the Ministry production licenses. In December, Yohai managed to obtain $15,000 as his match from Israeli donors and MAPS sent him our $15,000, provided by an anonymous donor. Over the last several weeks, Yohai has concluded negotiations with Israeli investors (not donors) who are providing sufficient funding (roughly $200,000 per year) to cover the provision of enough marijuana for 500 patients for the next two years. These investors are gambling that they can make money providing marijuana extracts to the pharmaceutical industry, since they can grow marijuana for this purpose as well as for free distribution to patients. In addition, they expect they will eventually be given permission to sell marijuana to patients, though how much research will have to be conducted first remains to be determined.

As a side project to the production facility, Yohai’s team will be producing organic cannabis oil tinctures that can be used as a substitute for smoking for patients who prefer not to – or cannot – inhale smoke or vapors from a vaporizer. The tinctures will use donated fair-trade organic olive oil produced by Palestinians in the West Bank and Israelis in Israel.

Yohai Golan has estimated that the value of the marijuana that they will give away is roughly $6 million per year, based on prices for legal Dutch medical marijuana and prices for medical marijuana in the US.

MAPS colleagues Val Corral and Mimi Peleg from the Wo/Mens Alliance for Medical Marijuana (WAMM)  will travel to Israel, probably in February, to help Yohai create a functional administrative system to distribute the medicine that will be harvested at the end of March. MAPS will pay for their travel through funds that have been donated and restricted to this project. Prior to going to Israel, Mimi Peleg will travel to Victoria, Canada, to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS), to learn about his approach to distribution and research. Previously MAPS has sponsored Philippe to consult with another medical marijuana production facility in Israel. 

Yohai expressed his gratitude to MAPS President Rick Doblin PhD, “I would like to thank Rick for his constant support and late night chats helping me keep focused and looking ahead. Without his guidance and constant advice, I would not have come this far in Israel and would have given up.”

MAPS is extremely gratified that our original funding of a mere $15,000 was the catalyst for this significantly larger investment!

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January 9, 2009

Bush Administration Last Minute Blow to Scientific Freedom

 

Only 10 days before the Bush Administration leaves office, the DEA has issued a final ruling denying a license to Prof. Lyle Craker, UMass Amherst, to grow marijuana for MAPS-sponsored medical research. The DEA is responding to a February 12, 2007 recommendation by DEA Administrative Law Judge Mary Ellen Bittner who found after extensive legal hearings that it would be in the public interest for DEA to issue Prof. Craker a license.  The DEA is determined to protect the federal monopoly on the supply of marijuana that is legal for research that is held by the National Institute on Drug Abuse (NIDA). NIDA uses its monopoly to fundamentally obstruct research aimed at developing marijuana into an FDA-approved prescription medicine. For example, Chemic Labs has been seeking without success for over  5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored research into the effectiveness of the Volcano vaporizer as a non-smoking drug delivery device.

We have yet to see the DEA brief, which we have been told is 180 pages. We’ll be formulating a new strategy as quickly as we can to deal with this last minute blow to scientific freedom from the Bush Administration.

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December 1, 2008

Israel Medical Marijuana Production Facility Receives $15,000 in Matching Funds: MAPS sent $15,000 to an Israeli medical marijuana production facility directed by Yohai Golan, who produces medical marijuana with a license from the Israeli Ministry of Health.  This was a matching grant, which required Yohai to first raise $15,000, which he was able to do. The production facility has legal permission to grow and distribute marijuana to Ministry of Health-approved patients. However, the facility must give away the medicine for free and cannot sell it until marijuana has been approved as a prescription medicine by the Ministry of Health -which will require substantial clinical research. In the long run, this policy requiring the free distribution of medicine is an unsustainable model because the facility can only operate on donations while the patient base is steadily increasing. Meanwhile, some useful data is being gathered from the patients provided medicine by the facility and more doctors and patients are becoming comfortable with medical marijuana use.

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November 6, 2008
  Slate Magazine "High Expectations" by Amanda Schaffer.

Slate Magazine contributor Amanda Schaffer wrote an excellent article on the promise of, and obstacles to, medical marijuana research. The article discusses a variety of successful research applications of marijuana and marijuana derivatives.

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November 6, 2008

Chemic Labs submitted a response to a June 16, 2008, critique of our vaporizer protocol (PDF) by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). We submitted the protocol to NIDA/PHS on January 16, 2008, along with three letters of support from peer reviewers. 
 
  We have now been trying without success for more than five years to purchase 10 grams of marijuana from NIDA for the expansion of our vaporizer research. 
 
  The questions about our protocol raised by NIDA/PHS were unusually exhaustive, sometimes questioning design elements that had been added in response to suggestions from prior reviewers, and seemed to have been intentionally designed to delay our ability to move forward with this study—which they were successful in doing. The NIDA/PHS critique discouraged and demoralized Chemic Labs, who in turn were slow to respond to NIDA. 
 
  Now that our response has been submitted, we are hopeful that NIDA will grant us permission to purchase government-grown marijuana for use in our vaporizer protocol. Unfortunately, we may need to wait another 6 months or so for NIDA/PHS to reply to our response to their critiques. There is no regulatory time limit governing the NIDA/PHS response. Weve already been waiting about three years for a NIDA/PHS response to our reply to their previous critique of an earlier protocol, which is why we went ahead and submitted our new protocol on January 16, 2008.

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October 15, 2008

 We are requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University. It is urgent that the study, finds the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers (PDF) and posting them at facilities such as medical marijuana dispensaries, and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study. If you would like more information about how you can help us recruit patients for this study, please contact: .(JavaScript must be enabled to view this email address)

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October 15, 2008

Were requesting that MAPS supporters actively help us recruit subjects for Dr. Abrams National Institute on Drug Abuse-funded study of vaporized marijuana in patients who are already using opioid medications for pain. This is one of only two medical marijuana studies in patients currently taking place in the US. Dr. Abrams investigation was scheduled to conclude in Fall 2008, but the study completion date has been extended to January 9th, 2009, in order to provide more time to recruit subjects. The study (PDF) was designed for 24 subjects, 16 of which have completed the study and an additional 8 more are needed. MAPS is supporting this study by paying for travel and lodging for participants who live outside of the San Francisco Bay area, with funding donated to MAPS by California medical marijuana dispensaries Capital Wellness Collective, Harborside Health Center, and Green Door, as well as from Oaksterdam University.
 
  It is urgent that the study, finds the remaining subjects. Preliminary results are positive and the study will be more persuasive if the initially intended number of 24 subjects is actually enrolled. Supporters can help us by downloading flyers  (PDF) and posting them at facilities such as medical marijuana dispensaries, and pain management centers. We would also appreciate it if people would post the text found in this link on appropriate web pages, blogs, and online forums. Subjects cannot have used marijuana within the previous 30 days, so pain patients on opiates from states without medical marijuana laws may be especially interested in volunteering for the study. If you would like more information about how you can help us recruit patients for this study, please contact: .(JavaScript must be enabled to view this email address)

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October 10, 2008

An anonymous donor has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to David’s $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us. David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs.

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October 10, 2008

David Bronner, of Bronner’s Magic Soaps, has agreed to donate $5500 to support research on patients who receive medical marijuana from an Israeli production facility under the direction of Tsachi Cohen. David had previously donated about $50,000 to Tsachi’s facility. These new funds are a grant to Dr. Ephraim Lansky for a study of the demographics, the amounts of marijuana used, and the effects of the marijuana on patients who have been receiving marijuana from the facility over the last several years

David has also donated $15,000 as a matching grant to a second Israeli medical marijuana production facility, led by Yohai Golan. Current Israeli medical marijuana regulations require that marijuana providers not charge for medicine. Providers must give the medicine away for free to Ministry of Health-approved patients, which is why the project needs subsidies. Yohai has raised $25,000 in matching funds from Israelis in response to David’s $15,000 matching grant, so we are now seeking an additional $10,000 to match the additional Israeli matching funds. If any MAPS supporters are able to or know someone who would be interested in helping match the other $10,000, please contact us.

David has also donated $5000 to Philippe Lucas of Vancouver Island Compassion Society (VICS) for research with patients who have been provided marijuana from VICS over the last several years. David had previously donated $8000 to this project. The goal of this research is to see if we can match demographics of patients with particular strains of marijuana, in order to see if particular strains are best for particular illnesses and medical needs. 

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August 8, 2008

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April 24, 2008

 

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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.

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December 28, 2007
   "Licensed by the State of Israel" .

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November 29, 2007
   "FOR IMMEDIATE RELEASE" .

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.

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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).

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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).

 

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November 9, 2007
  Salem-News "American Psychiatric Association Assembly Unanimously Backs Medical Marijuana" by Tim King.

The American Psychiatric Association has passed a unanimous resolution supporting medical marijuana.

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November 4, 2007
  Drugsense.org Blog "Teens Who Smoke Pot But Not Tobacco Function Well" by .

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.

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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.

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August 26, 2007
   "External Source" by .

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.

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August 9, 2007
  Orange County Register "Treatment Interrupted" by Alan Bock.

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.

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July 3, 2007
   "MP3 File" by .
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.)

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June 29, 2007
  Nature Medicine "Scientists Stir the Pot for Right to Grow Marijuana" by Arran Frood.

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.

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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.

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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.

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May 31, 2007
  LA Times "Not Enough Marijuana" by .

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.

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May 21, 2007
  The Economist "Joint Action" by .

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.

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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 . . . 

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April 15, 2007
  Sacramento Bee "OPED: Rejected in Court, Medical Pot Advocates Turn to DEA" by Claire Cooper.

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.

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March 26, 2007

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.

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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.

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February 13, 2007
  Washington Post "Research Supports Medicinal Marijuana" by Rick Weiss.

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.

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February 7, 2007
  New York Times "Court Allows Medicinal Use of Marijuana" by DEAN E. MURPHY.
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.

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January 31, 2007
  Reuters "“Smokable” Pain Drugs Promise Faster Action" by Toni Clarke.

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.

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December 4, 2006
  Lone Star Iconoclas "Safer Deals: The Pastors" by Nathan Diebenow.

"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.

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November 29, 2006
  Nature Medicine "US Marijuana Laws Clamping the Lid on Pot Research" by Brian Vastag.

Of particular applicability to MAPS' medical marijuana drug development efforts is Brian Vastag's new "US marijuana laws clamping the lid on pot research," published in Nature Medicine, which speaks to the difficulties faced by marijuana researchers.

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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.
 

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May 28, 2006
  Boston Globe "Weed Control" by .

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.

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May 25, 2006
  Cancer Monthly "Medical Marijuana: The FDA Loses More Credibility" .

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May 21, 2006
  New York Times "The New York Times published a letter to the editor from Jerry Epstein of the Drug Policy Forum" by .

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.

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May 17, 2006
  Medscape General Medicine "Medical Marijuana; Politics Trumps Science at the FDA" by Gregory T. Carter MD; Bruce Mirken.

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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. 

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May 5, 2006
  LA Times "Puffing is the Best Medicine" by Lester Grinspoon.

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.

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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).

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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).

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April 27, 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.

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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.

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April 27, 2006
   "24 Members Say Agency Needs To Start Responding To Science & Not To Political Pressure" .

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April 27, 2006
  The Economist "Medical Marijuana" by .

Following the FDA’s abrupt and poorly documented statement on April 20th, a critical backlash has ensued. The Economist published “Reefer Madness: Marijuana is medically useful, whether politicians like it or not” on the heels of editorials in the New York Times and the Chicago Tribune admonishing the FDA for its transparent politicization of science.

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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.” (Permalink) The article discusses Prof. Lyle Craker’s proposed MAPS-sponsored medical marijuana production facility and his ongoing MAPS-supported DEA lawsuit.

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April 26, 2006
   "Politics Trumps Science at the FDA" .

The San Diego Union-Tribune published an Op Ed piece by Stephen Sidney and Bruce Mirken on the FDA statement on medical marijuana.

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April 23, 2006
  Chicago Tribune "Dissembling on Medical Pot" .

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.”

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April 21, 2006
  Associated Press "FDA Rejects Marijuana for Medical Uses" by Lou Kesten.

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April 21, 2006
  Washington Post "FDA Criticizes Attempts To Legalize Marijuana" .

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April 21, 2006
  New York Times "FDA Dismisses Medical Benefit From Marijuana" by Gardiner Harris.

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.

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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

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April 7, 2006
  Daily Nexus "Activists Assemble for Cannabis Conference" by Ryan Grandov.

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.

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March 29, 2006
  Cal NORML "Ninth Circuit Asks Probing Questions at Raich Hearing" by Dale Gieringer.

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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.

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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. 

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December 27, 2005
  The New York Daily News Washington Bureau "City Pols vs. Feds Over Medical Pot" by Kenneth R. Bazinet.

The New York Daily News Washington Bureau published a succint and informative article about the DEA Lawsuit.

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December 19, 2005
  Daily Journal "Ole Miss Marijuana Monopoly Under Fire" by Andy Kanengiser.

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.

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December 15, 2005
  Join Together "Researchers Seek New Source of Marijuana" .

Join Together published Researchers Seek New Source of Marijuana.

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December 13, 2005
  Associated Press "Prof. Questions Gov’t Monopoly on Marijuana" by Andrew Miga.

The Associated Press published Prof. questions gov't monopoly on marijuana, a positive article about the DEA Lawsuit.

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December 13, 2005
  WPBFNews.com "Government’s Medical Pot ‘Just Isn’t Strong Enough’ Professor Sues For Permit To Grow Marijuana" by .

The West Palm Beach Florida News published Government's Medical Pot 'Just Isn't Strong Enough'.

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December 12, 2005
  The Washington Post "Federal Marijuana Monopoly Challenged" by Marc Kaufman.

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.

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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!

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December 5, 2005
   "DEA to Argue Against U. Mass Growing of Medicinal Cannabis at Administrative Hearing December 12-16" by .

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.

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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.

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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.

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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.

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November 29, 2005
  NORML News "Legal Challenge To NIDA’s Pot Monopoly To Resume Next Month" by .

NORML.org published NIDA's Pot Monopoly To Resume Next Month.

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November 16, 2005

The ALJ denies Craker’s attempt to admit Scherer’s testimony

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November 14, 2005

The DEA files an opposition to the motion to have Dr. Scherer testify

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November 8, 2005

The ALJ rules on the DEA witnesses

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November 2, 2005

Prof. Lyle Craker files a motion to have Dr. Scherer testify. [Also see: Scherer motion in word format]

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October 20, 2005

The             DEA responds to our motion to exclude

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October 19, 2005
  Mother Jones Magazine "Respectable Reefer" by Gary Greenberg.

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.

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September 27, 2005
  Neurology "Sativex, a Cannabis-Based Medicine, Significantly Reduces Central Neuropathic Pain" .

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.

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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 by clicking on ‘read more’ below.

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September 19, 2005
  Salon.com "The Return of Reefer Madness" by Maia Szalavitz.

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.

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September 16, 2005

The             DEA requests to postpone hearings to December dates.

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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 [included in the full text article] (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."

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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.

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September 1, 2005
   "A Summary of Recent Press Coverage of the MAPS/Craker/DEA Hearing" by .

A summary of recent press coverage of the MAPS/Craker/DEA hearing is available here.

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August 27, 2005
  Penthouse "The Gang That Couldn’t Grow Straight" by Michael Simmons.

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August 27, 2005
  The New York Times "Letters to the Editor/The New York Times" by Michael Simmons.

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August 27, 2005
  New York Times "Marijuana Pipe Dreams" by John Tierney.

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.

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August 25, 2005
  Sacramento Bee Washington Bureau "Clash Over Pot Research Gets Personal" by Michael Doyle.

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.

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August 22, 2005
  ACLU "External Source" by .
The ACLU issues a press release on the MAPS DEA Lawsuit proceedings.

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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.

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August 22, 2005

The ACLU issues a press release on the MAPS DEA Lawsuit proceedings.

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August 18, 2005
  New England Journal of Medicine "Medical Marijuana and the Supreme Court" by Susan Oakie.

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.

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August 17, 2005
   "PDF Article" by .

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."

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August 16, 2005

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!

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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.

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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.

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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.

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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.

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August 8, 2005

Prof.            Lyle Craker filed a motion to exclude some DEA witnesses.            [Also see: exclusion             objection in word format]

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August 8, 2005

MAPS filed objections to the governments motion to exclude four of our witnesses.

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July 26, 2005
  San Francisco Chronicle "Controlling Medical Pot is Not Such an Out-of-control Idea" by Ethan Nadelmann.

San Francisco Chronicle publishes this op-ed about medical pot regulation and the measures San Fransciso is taking to protect its medical marijuana patients.

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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.

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July 26, 2005

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

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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.

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June 20, 2005
  San Francisco Chronicle "Vaporized fumes said to be cleaner, almost toxin-free" by Joe Garofoli.

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.

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June 20, 2005
   "PDF Article" by .
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.

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June 13, 2005
  Boston Globe "The Medical Pot Hysteria" by Cathy Young.

The Boston Globe ran 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.

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June 8, 2005
  Wired Magazine "Legal Pot’s No Pipe Dream" by .

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.

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June 8, 2005
  Op-Ed New York Times "Good to Grow" by Sally Satel.

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.

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June 8, 2005
  DesMoines Register "Let Terminally Ill Ease Their Pain by Smoking Pot" by Rekha Basu.

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."

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June 7, 2005
  LA Times-THE NATION "Marijuana Patients Remain Defiant" by Eric Bailey.

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June 7, 2005
  Nature.com "Marijuana: the dope" by Mark Peplow.

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.

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June 7, 2005
  Salon Magazine "A Guide to Gonzales vs. Raich" by Ryan Grim.

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."

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June 6, 2005
  Washington Post "A Defeat For Users Of Medical Marijuana" .

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.

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May 25, 2005
  MPP "Statement by Steve Fox, Director of Government Relations, MPP" by Steve Fox.

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May 25, 2005
  ACLU "STATEMENT OF ALLEN HOPPER, ATTORNEY WITH THE ACLU DRUG LAW REFORM PROJECT" by Allen Hopper.

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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.

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May 11, 2005
  Cannabis Culture "Waiting to inhale" by Christine Trudeau.

Cannabis Culture offers an article on medical marijuana patient Angel Raich’s struggle in the Supreme Court

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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.

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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.

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April 19, 2005
  FOX News "Painkiller Warnings Rekindle Debate Over Medical Marijuana" by C. Spencer Beggs.

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April 18, 2005
  Fox News Online "Red Tape, Big Pharm Muscle Strangling Medical Marijuana" by C. Spencer Beggs.

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.

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March 29, 2005
  The New York Times "Medicinal Marijuana On Trial" by Dan Hurley.

The New York Times published "Medicinal Marijuana On Trial", discussing medical marijuana research and Ashcroft v. Raich.

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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.

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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.

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February 5, 2005
  New Scientist (UK) "Cannabis: Prescribing the Miracle Weed" by Clare Wilson.

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.

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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.

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January 20, 2005
   "The Drug Enforcement Administration (DEA) Recently Turned Down a Research Bid" by .

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.

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January 7, 2005
  The Oregonian "Stop Blocking Marijuana Research" by .

An editorial published by The Oregonian, "Stop Blocking Marijuana Research", supports the UMass Amherst project.

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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.

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January 5, 2005
  San Diego City Beat "Feds v. Meds" by Dean Kuipers.

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.

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December 19, 2004
  The Providence Journal "Drug Warriors Make Millions off Marijuana" by Froma Harrop.

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.

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December 18, 2004
  counterpunch.org "DEA Upholds Grower’s Marijuana Monopoly" by Fred Gardner.

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 MAPS' UMass-Amherst application.

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December 10, 2004

DEA finally rejected (see MAPS comments by clicking ‘read more’ below) 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.

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December 7, 2004
   "Souder is Right:  Let’s Prove that Marijuana is Safe" by Sam Farr.

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.

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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.

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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.

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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.

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November 29, 2004
  Slate "Dude, Where’s My Integrity?" .

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.

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November 29, 2004
  Slate "Dude, Where’s My Integrity? Medical marijuana tests the Supreme Court’s true love of federalism" by .

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.

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November 22, 2004
  Scientific American "Current Restrictions on Marijuana Research are Absurd" by The Editors.

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."

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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.

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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 ).

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October 10, 2004
  San Francisco Chronicle "Medical Marijuana Advocates Likely to Get a Break Under Kerry" by Bob Egelko.

The San Francisco Chronicle reports that "Medical Marijuana Advocates Likely to Get Break Under Kerry". MAPS' UMass Amherst project is mentioned in the article.

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October 8, 2004
  Boston Phoenix "This is your Brain on Drugs" by Mike Miliard.
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.

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September 30, 2004
  Reuters News Service "British, French Drug Firms Lead in Marijuana Tests" by Leonard Anderson.

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.

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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! 

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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.

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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.

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July 29, 2004

MAPS files a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.

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July 28, 2004
  Nature "Joint Suits Aim to Weed Out Agencies’ Red Tape" by Helen Pearson.

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.

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July 22, 2004
   "Newspapers around the country have carried an AP wire story on MAPS’ lawsuits" by .

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.

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July 22, 2004
  The Republican (Springfield, MA) "Marijuana Research Lawsuits to be Filed" by Holly Angelo.

The Springfield Republican publishes an article about MAPS recent medical marijuana research lawsuits.

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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..

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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.

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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.

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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.

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April 1, 2004

Testimony of Nora Volkow, Director of NIDA, to Cong. Souder.

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April 1, 2004

Statement of  ROBERT J. MEYER, M.D., FDA, on Medical Marijuana.

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March 28, 2004

Ex-Surgeon General Joycelyn Elders publishes a great op-ed, Myths about Medical Marijuana.

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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.

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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).

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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.

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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.

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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.

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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"

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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"

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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."

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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.

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November 18, 2003

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

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November 18, 2003

Letter from Dr. Volkow to Rick Doblin.

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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.

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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.

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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.

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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.

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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)

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October 19, 2003

Dr. Ethan Russo writes A Requiem for the Journal of Cannabis Therapeutics. (also available in Word format)

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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

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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.

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October 1, 2003

Nature publishes an excellent article on medical marijuana research (also available in pdf format).

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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.

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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.

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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.

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August 20, 2003

August 20, 2003. JAMA article about CMCR. The JAMA article on CMCR showed how important it is to obtain alternative sources of funding for medical marijuana research, since Center Co-director Andrew Mattison makes it clear that the ultimate goal is not FDA approval of marijuana but the development of "new molecules that interact with the body’s built-in cannabinoid receptors." Even Stage #2, which is the development by CMCR of non-smoking delivery systems, was described in the article as focusing primarily on products like the GW Pharmaceutical mucosal spray, which requires a marijuana extract, rather than the vaporizer, which can be used with the marijuana plant itself.

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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.

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July 25, 2003

An excellent and detailed interview with Dr. Geoffrey Guy founder of GW Pharmaceuticals from the Anderson Valley Advertiser

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July 11, 2003

An article entitled "Privatizing Pot - Can the marijuana monopoly be broken?" written by Jacob Sullum was published in Reason.

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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.

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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)

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April 25, 2003
   "PDF File" by Rick Doblin.

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

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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.

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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.

 

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October 27, 2002
  Time.com "Is Pot Good For You?" by John Cloud.

This article by from Time magazine discusses the potential risks and benefits of marijuana.

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March 2, 2002

"Netherlands to run trials of marijuana in patients with multiple sclerosis" Tony Sheldon British Medical Journal () 324:504.

The Dutch government has announced a small scale cross over trial into the effect of three sorts of medical marijuana, plus a placebo, on 16 patients with multiple sclerosis.

Two foundations in Rotterdam, the Institute for Medical Marijuana and Maripharm, have been contracted by the government to produce the drug to a standard quality and provide metal pipes for inhalation.

A Bureau for Medical Cannabis, set up by the ministry and the Amsterdam’s Free University medical centre, will run the year’s trial.

The bureau also intends to make medicinal cannabis available through pharmacists on prescription by spring 2003. The Dutch cabinet recently agreed to change the law to permit this.

Four trials of cannabis are taking place in the United Kingdom. The cannabis in multiple sclerosis (CAMS) study, which is sponsored by the Medical Research Council, started at Derriford Hospital, Plymouth, last year and aims to take in 660 participants in 40 centres.

Three smaller phase II trials - in Guernsey, Oxford, and Norfolk - have been under way since autumn 2000, examining a sublingual spray developed from plants grown by G W Pharmaceuticals in Kent. The researchers expect to extend these trials to 2000 patients over two years and to enroll not only people with multiple sclerosis but also patients with various chronic pain syndromes, such as neuralgia and lower back pain.

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December 14, 2001

"After Two-Decade Halt, Marijuana Research Is Set" - Philip J. Hilts, The New York Times

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November 28, 2001

"University of California at San Diego Gets Approval for Medical Marijuana Study"

A California university has received final approval from the federal government for a study on medical marijuana.

Two professors of neurology at the University of California at San Diego Medical Center plan to study the effects of marijuana on patients with multiple sclerosis and those who suffer neuropathy, or nerve pain, associated with AIDS.

The studies will be the first to emerge out of the university’s Center for Medicinal Cannabis Research (CMCR), a program created by the state Legislature in 1999.

Since California became the first state to approve medical marijuana in 1996, six other states have followed suit. Federal law, however, prohibits the sale of marijuana for medical uses.

The Drug Enforcement Administration granted the final approval Wednesday, saying it hoped to introduce some science into what has been an emotionally charged debate. The agency maintains that past studies have shown no medical benefit to smoking marijuana.

"The question of whether marijuana has any legitimate medical purpose should be determined by sound science and medicine," DEA Administrator Asa Hutchinson said in a statement.

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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.

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May 21, 1999

HHS Policy Statement about Access to NIDA’s Marijuana. Announcement of the Department of Health and Human Services’ Guidance on Procedures for the Provision of Marijuana for Medical Research.

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February 25, 1997

NIH Workshop on the Medical Utility of Marijuana. MAPS report (Turning Protests into Protocols: Dr. Harter´s Legacy) to NIDA’s Expert Panel on Medical Marijuana Research - submitted February 25, 1997 following the February 19-20, 1997 NIH Workshop on the Medical Utility of Marijuana held at the NIH Campus in Bethesda, MD. Five recommendations to proactively expedite medical marijuana research.

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December 2, 1996

After Proposition 200 and 215
December 2, 1996 Senate Judiciary Committee Hearing on Medical Marijuana - A message to new visitors of the MAPS website.
MAPS Policy in Response to Prop. 200 and Prop. 215

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August 22, 1996

NIH Grant Application Process
NIH August 1996 Rejection and Critique of "Smoked Marijuana for HIV-Associated Anorexia and Wasting Protocol"

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July 1, 1996

Water Pipe Study by Dale H. Gieringer, Ph.D. (Summer 1996)
Why Marijuana Harm Reduction? by Dale H. Gieringer, Ph.D. (Summer 1996)

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April 1, 1996

Smoked Marijuana for HIV-Associated Anorexia and Wasting Protocol, (IND#43,542) submitted to the NIH May 1, 1996 by Dr. Donald Abrams.

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January 1, 1995

FDA-approved research and the effort to begin it Dr. Donald Abrams’ FDA-approved research protocol, (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.

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January 1, 1994

A comprehensive clinical plan developed by MAPS in consultation with the FDA for the investigation of marijuana’s medical use in the treatment of the HIV-related wasting syndrome. This Clinical Plan was submitted with Dr. Donald Abrams’ research protocol (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.It is designed to also be adapted for indications other than the wasting syndrome. Originally printed in the Summer 1994 MAPS Newsletter.

Minimum Informational Requirements for Establishing an FDA Drug Master File for Cannabis - Questions To Be Answered by Potential Manufacturers.

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January 1, 1990

Doblin/Kleiman Survey of Oncologists

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Give Our Veterans Hope
1 in 7 Iraq and Afghanistan veterans suffer from PTSD, in many cases leading to suicide. We owe it to our veterans to stop this epidemic.

Tell the Pentagon to fund MAPS' groundbreaking work to treat PTSD.