The longest day of winter has passed, and maybe so has the decades-long era of resistance to psychedelic research. On December 17, the FDA approved Dr. John Halpern's MAPS-sponsored MDMA/cancer anxiety study. This ensures that we will now be able to begin psychedelic research at Harvard for the first time since studies ended in 1965, doing it carefully with the advantage of hindsight and the lessons learned from the past.

Read about this and other MAPS news below:

1. FDA approves Harvard Medical School MDMA/cancer anxiety study
2. FDA approves changes on MDMA/PTSD study, benefiting placebo group and opening to more patients
3. DEA finally responds to, and rejects, UMass Amherst medical marijuana farm application
4. DEA finally responds to request to obtain marijuana for vaporizer research
5. MAPS law brief mentioned on the floor of the Supreme Court in medical marijuana case
6. Ibogaine outcome study investigators participate in training
7. Job opportunity at MAPS: Replace me!
8. MAPS auction now scheduled for February
9. Psytopia event in Jamaica to benefit MAPS

1. FDA approves Harvard Medical School MDMA/cancer anxiety study Dr. John Halpern's MAPS-sponsored study investigating MDMA-assisted psychotherapy as a treatment for anxiety associated with advanced-stage cancer was approved by the FDA on December 17. This follows approvals from both necessary Institutional Review Boards (IRBs), both the IRB for McLean Hospital, where the study will take place, and the IRB for the Lahey clinic, where the subjects are treated for cancer.

To start the study, Dr. Halpern will need a DEA Schedule I license, which we expect will take 1-2 months. After that, we will be ready to start recruiting subjects!

The protocol and informed consent forms are posted on the MAPS website MDMA page in the Clinical Research section at the top.

MAPS is now actively seeking to raise $250,000 to fund this historic study. If anyone has potential donors to whom they would like the MAPS office to send information, please contact .

2. FDA approves changes on MDMA/PTSD study, benefiting placebo group and opening to more patients

On the same day that the FDA approved Dr. Halpern's study, they also approved a set of requested changes in Dr. Mithoefer's study. Most significantly, the study will now be open not only to those with PTSD as a result of crime victimization (mostly sexual and/or physical assault), but also to those with war-related PTSD of five years or less duration, such as Iraq vets.

Another change we are very pleased to report relates to those subjects in the study's placebo group. The FDA has agreed to allow study investigators to offer the option of two open-label (no double-blind) sessions of MDMA-assisted psychotherapy and associated non-drug psychotherapy sessions to subjects in the placebo group. This would take place after they have completed their final follow-up outcome measures two months after their second experimental session.

MAPS needs to raise an additional $100,000 for these treatments. Offering the placebo subjects the possibility of MDMA after they have completed the study will facilitate enrollment and will give us fascinating data with placebo subjects acting as their own control.

3. DEA finally responds to, and rejects, UMass Amherst medical marijuana farm application

After three and a half years, the DEA has finally responded to Professor Lyle Craker's application to start a MAPS-funded medical marijuana production facility at UMass Amherst, rejecting the application. This follows a lawsuit (download at ) against DEA from MAPS which charged the DEA with "unreasonable delay." The DC Circuit Court of Appeals sided with MAPS on this section of the lawsuit, and ordered the DEA to respond to our claims of "unreasonable delay" within 30 days, by December 22. Instead of trying to justify the unjustifiable, DEA issued an Order to Show Cause on December 10, 2004, which outlined the reasons why DEA planned to reject the application. MAPS was given 30 days, until January 10, 2005, to file for a DEA Administrative Law Judge hearing objecting to DEA's "Order to Show Cause," or if not, the rejection would become final. MAPS will definitely request a DEA Administrative Law Judge hearing and is now in the process of assembling our legal team.

The DEA's rejection claims that such a production facility is "not in the public interest," presenting a convoluted argument reasoning that because marijuana will never be a prescription medicine, research is unnecessary. DEA also claims that US international treaty obligations prevent it from issuing the license, ignoring the existence of GW Pharmaceuticals in England which has had a license since 1998 from the Home Office to grow marijuana for privately-funded research. England is part of the same international drug control treaties as the US and has never been criticized by the International Narcotic Control Board (INCB) for its licensing of GW Pharmaceuticals.

This wont be the first DEA Administrative Law Judge hearing in MAPS history. The seed of MAPS was planted in 1984 when MAPS founder Rick Doblin filed a request for a DEA Administrative Law Judge hearing objecting to DEA's plans to criminalize MDMA. Though the DEA Administrative Law Judge ruled that MDMA should be in Schedule 3 and thus available for prescription use, the Administrator of DEA overruled the Administrative Law Judge's recommendation. After DEA suffered several losses in the DC Circuit Court of Appeals, it succeeded in keeping MDMA in Schedule I. MAPS was started to continue the struggle through FDA-approved MDMA-psychotherapy research, research which has taken 20 years to start. Now we're suing DEA again in an Administrative Law Judge hearing to win the right to sponsor medical marijuana research, in a struggle that is likely to take much less than 20 years to win.

DEA's document, MAPS' comments, and background lawsuits are all posted on the UMass Amherst page of the MAPS website.

Read the New York Times, Boston Globe, and numerous other articles about this.

4. DEA finally responds to request to obtain marijuana for vaporizer research

On December 10, 2004, "after careful review of the protocol" (a review process which apparently took over 17 months), DEA informed Chemic Labs that its analytical laboratory license is not sufficient to conduct further vaporizer research, but that it also needed a "research license. This research license, which Chemic has already applied for, will take about 2-3 months to obtain. Once this license is granted, which is just a matter of time, DEA and NIDA will have to focus on reviewing the underlying protocol and requests to import 10 grams from the Dutch Office of Medicinal Cannabis and to purchase 10 grams from NIDA.

DEA noted in its "Order to Show Cause" rejecting the UMass Amherst application, "Marijuana is the most heavily abused of all Schedule I controlled substances, and limiting the supply of marijuana under these circumstances is reasonable."

Indeed, the mind reels at the thought of the havoc those 20 grams (less than one ounce) could wreak if somehow that entire amount was diverted to non-medical uses.

5. MAPS law brief mentioned on the floor of the Supreme Court in medical marijuana case

On November 29, the Supreme Court considered the legality of state-approved medical marijuana in Raich vs. Ashcroft. During the hearing, the attorney for Angel Raich mentioned MAPS' amicus curiae (friend of the court) brief (see Oct. 13, 2004 entry at ) regarding the government monopoly on research marijuana. A transcript of this portion of the argument is below:

JUSTICE BREYER: And while the FDA can make mistakes, I guess medicine by regulation is better than medicine by referendum.
MR. BARNETT: Well -
JUSTICE BREYER: So that's -- I just want to know why.
MR. BARNETT: Well, Your Honor, first of all, that whole process wouldn't dictate what the power of Congress is to reach this activity -?
JUSTICE BREYER: That's all true, but as long as that hasn't been done, don't I have to take this case on the assumption that there is no such thing as medical marijuana that's special and necessary?
MR. BARNETT: I would -
JUSTICE BREYER: If has been done, maybe I shouldn't make it.
MR. BARNETT: -- I would simply ask Your Honor to read the amicus brief by Rick Doblin, in which it describes the government's obstruction of scientific research that would establish the safety and efficacy of cannabis by denying supplies of cannabis -- of medical -- of cannabis for medical experimentation.

The Supreme Court is expected to rule on the case around June 2005.

6. Ibogaine outcome study investigators participate in training

MAPS staffer and outcome study Principal Investigator Valerie Mojeiko organized a weekend training for the Ibogaine Association clinic staff who will be administering the MAPS-funded ibogaine outcome study, and for the staff of the now-closed Iboga Therapy House. The training is one step in becoming certified to administer the ASI, or Addiction Severity Index, the primary outcome measure used in the study. Ibogaine treatment advocates Howard and Norma Lotsof also attended the weekend in New York.

The ibogaine outcome study will start in early January, following up monthly for one year on 20 consecutive patients treated for addiction-related disorders at the Ibogaine Association.

7. Job opportunity at MAPS: Replace me!

After four years, I will be leaving MAPS at the beginning of June for other adventures. We are looking for a new MAPS staff member to work with Valerie in the Sarasota office. Read about the job and application process.

8. MAPS auction now scheduled for February

Because we've had such a busy fall, and because so many wonderful items have come in recently, MAPS has postponed the online benefit auction to mid-February. Listed below are a few of the items already donated for the auction:

A gorgeous 4 by 2.5 Huichol yarn painting
Signed book by author Tom Robbins
Handpainted glass chandelier by Ulla Darney
Hardcover signed edition of The Secret Chief
Blotter art signed by Tim Leary, Albert Hofmann, and others
Beautiful handcrafted wooden boxes
Handpainted pottery from the Peyote Way Church
Test tubes and beakers donated by Alexander Shulgin from his home laboratory
A week in a house in southwest France
Books, posters, and other psychedelic memorabilia
A signed copy of Kylea Taylor's Exploring Holotropic Breathwork

And more art, books, and other great items! If you still wish to donate something, please contact me at .(JavaScript must be enabled to view this email address). I will try to have photos of all the items up a few weeks before the auction, so you can plan your bidding.

9. Psytopia event in Jamaica to benefit MAPS

A portion of the proceeds from Psytopia, a seven-day event with bands and speakers to be held at a Jamaica resort, will be donated to MAPS. The event, August 17-23, 2005, will bring Alex Grey, Erowid, Zoe Seven, and other psychedelic speakers. Go to for more information.

That's all! As always, please contact us with any address changes!

Happy Solstice,
Brandy
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Brandy Doyle
MAPS Projects and Communications Director

p 941.924.6277
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