Happy Autumn, MAPS members!
It’s been a while since the last email update, and we’ve been quite busy — as you’ll read here.
In this issue:
1. DEA agents inspect Dr. Mithoefer’s office for MDMA diversion control issues
2. Nov 16-17 meeting scheduled for MDMA/PTSD team to prepare to start
3. MAPS files FOIA request about retracted MDMA/Parkinson’s study
4. Both MA Senators write DEA to support UMass Amherst facility application
5. Daily Hampshire Gazette reports on UMass Amherst project
6. MAPS awarded $30,000 grant from Marijuana Policy Project
7. Rick Doblin to receive Norman E. Zinberg Award at Drug Policy Alliance conference
8. New MAPS bulletin in the works
1. DEA agents inspect Dr. Mithoefer’s office for MDMA diversion control issues
On October 28, 2003, several DEA agents finally inspected Dr. Mithoefer’s facilities in Charleston, South Carolina. This was part of DEA’s review of Dr. Mithoefer’s July 2002 application for a Schedule I license to handle the 3.5 grams of MDMA needed for the entire study. The inspectors focused on issues of diversion control and checked out the safe, the alarm system and the forms and procedures that will be used to track the MDMA and placebo capsules. The DEA agents were interested in helping Dr. Mithoefer understand and follow their rules and were quite reasonable. Dr. Mithoefer was told he will probably receive his license in several weeks to several months. This is the last step before we can begin recruiting patients for the study. While we won’t believe it until Dr. Mithoefer has his Schedule I license in hand, it may be the case that MAPS’ 17+year effort to start MDMA-assisted psychotherapy research is approaching a successful conclusion.
2. Nov 16-17 meeting scheduled for MDMA/PTSD team to prepare to start
On November 16, 2003, the entire team involved in the MDMA/PTSD study will meet in South Carolina to review all the forms and procedures involved in the study. Professional researchers who monitor clinical trials for a large pharmaceutical company are volunteering their time to MAPS, monitoring all data-gathering processing for the project. After this meeting, the study should be ready to begin after Dr. Mithoefer receives his Schedule I license.
3. MAPS files FOIA request about retracted MDMA/Parkinson’s study
In the continuing story of Dr. Ricaurte et al.’s retracted MDMA neurotoxicity study, MAPS has filed a Freedom of Information Act (FOIA) request to NIDA, asking for more information about the taxpayer-funded research. Specifically, we asked for a list of all other studies which used the methamphetamine mislabelled as MDMA, as well as a list of the studies which used the mislabelled MDMA (the two bottles supposedly were switched at the pharmaceutical house). We asked for information such as doses, route of administration, ambient temperatures, number and kind of animals used, animal death rate, etc. We also asked for information about the studies in which genuine MDMA was orally administered and injected into primates without causing any dopaminergic neurotoxicity. We received a confirmation letter from NIDA (https://maps.org/mdma/retraction/foia.jpg) and now await further communication.
4. Senators write DEA to support UMass Amherst facility application
Senators Kennedy and Kerry (a presidential candidate) wrote a strong letter of support to DEA Administrator Karen Tandy, urging DEA to approve Dr. Lyle Craker’s Schedule I license application for the proposed UMass Amherst medical marijuana production facility. The letter (view at https://maps.org/mmj/kkletter102003.html), which offers the support of both U.S. Senators from Massachusetts, adds much stronger political backing to the UMass Amherst project. We are actively seeking to obtain support from MA Gov. Mitt Romney and await the DEA’s decision on Dr. Craker’s license.
5. Daily Hampshire Gazette reports on UMass Amherst project
A great article was published about the UMass Amherst project in the Daily Hampshire Gazette newspaper on October 28. That article is included at the bottom of this email.
6. MAPS awarded $30,000 grant from Marijuana Policy Project
We have been awarded our full $30,000 grant request from the Marijuana Policy Project (MPP). The grant will be used to support MAPS’ work on the vaporizer and the UMass Amherst projects. For more on these projects, go to https://maps.org/mmj.
7. Rick Doblin to receive Norman E. Zinberg Award at Drug Policy Alliance conference
MAPS president Rick Doblin has been awarded the Norman E. Zinberg Award for Achievement in the Field of Medicine by the Drug Policy Alliance. He will accept the honor at the 2003 Biennial Drug Policy Alliance Conference later this week. The Zinberg Award “recognizes medical and treatment experts who perform rigorous scientific research and who have the courage to report their findings even though they may be at odds with current dogma.” Congratulations, Rick!
8. New MAPS bulletin in the works
A number of you have written to ask whether you’ve missed the latest MAPS bulletin. Due to all the exciting developments at MAPS over the past few months, we’ve (unfortunately) had to postpone the latest issue. However, that issue is now in the works, and we expect to send it to the printers soon. It’s a good one — full of the research updates, conference reports, personal accounts and book reviews that you expect from MAPS. Look for it soon!
Thanks as always for your continued support! Please reply to this email if you have an address change or if you’d like to stop receiving the email updates. And read on for the Daily Hampshire Gazette article on the UMass Amherst project.
Best wishes from MAPS,
Brandy
—
Brandy Doyle
Director of Special Projects
MAPS
(941) 924-6277
Senators back UM medical marijuana
By Marey Carey, Staff Writer
Daily Hampshire Gazette
http://www.gazettenet.com)
Tuesday, October 28, 2003 — Both U.S. senators from Massachusetts, Edward
M. Kennedy and John Kerry, have written a letter to the federal Drug Enforcement Administration urging approval of an application by the University of Massachusetts to grow high-quality marijuana for medicinal research.
Backers of the proposal by plant and soil sciences professor Lyle Craker say support from Kennedy and Kerry, along with the recent refusal by the Supreme Court to consider penalizing doctors for recommending medicinal marijuana, put UMass in a much better position to win DEA approval than previously. UMass would be only the second legal grower of marijuana for research purposes. The University of Mississippi has supplied the National Institute on Drug Abuse with marijuana for 30 years.
In their Oct. 20 letter addressed to DEA administrator Karen Tandy, Kennedy and Kerry wrote, ”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.”
According to Kennedy and Kerry, the current lack of 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.”
Kerry and Kennedy also said in their letter that UMass is ”one of the nation’s most distinguished research universities, and it is highly qualified to manufacture marijuana for legitimate medical and research purposes with effective controls against diversion.”
Craker first applied to the DEA in June 2001, for permission to grow, in a secure building on the Amherst campus, an initial 25 pounds of high-potency marijuana, which would be supplied to government-approved researchers. The project would receive funding from the Multidisciplinary Association for Psychedelic Studies (MAPS), a Florida-based nonprofit research and educational organization that seeks to develop marijuana as a prescription medication approved by the U.S. Food and Drug Administration.
Massachusetts Congressmen John Olver, Barney Frank, James McGovern, William Delahunt and Michael Capuano, who support Craker’s proposal, wrote to the DEA urging its approval in June, 2002. But then DEA administrator Asa Hutchinson responded in a July 1, 2002 letter addressed to Frank that increasing the numbers of marijuana growers could put the United States in violation of international treaties and that the University of Mississippi supply has proven adequate for 30 years.
Rick Doblin, president of the Multidisciplinary Association, said Monday that supporters of the University of Massachusetts proposal believe Kennedy’s and Kerry’s support is a crucial turning point.
”I think the letter from Kennedy and Kerry shows that there is law on the other side – the law saying we need a competitive environment – to try to get the data to see whether we can justify to the FDA that marijuana is safe and efficacious so that it should be a medication. I think the DEA loses more credibility by trying to protect the government monopoly and obstruct research,” Doblin said.
Doblin said he has approached Gov. Mitt Romney’s administration to ask for the governor’s support. ”As a venture capitalist in the past, he is dubious of government monopoly and sympathetic to private industry,” Doblin said. ”If Romney comes out and says that it’s time for a plan, let science have its day, I think that will be have the final step. Then we would have bipartisan support in Massachusetts.”
Romney spokeswoman Nicole St. Peter said Monday of the Romney administration’s position on the UMass proposal, ”We do not have enough information about this project to form a decision at this time.” Mary Carey can be reached at .(JavaScript must be enabled to view this email address).