MAPS News - December 2002

• December 20, 2002. Earlier Friday morning (Dec. 20), I (Rick Doblin) was interviewed by Wyatt Andrews of CBS national news for a story about drug information on the internet. The interviewers had actually wanted to interview Earth or Fire from Erowid, but they decided to communicate only via email with the reporters. The story will air in early January. Lots of delicate questions were asked. I think it went well but we won't know till the story airs. I didn't think it was fair to characterize our sites as pro-drug, in contrast to the government sites being anti-drug, since that implied that we were telling people to do drugs while the gov. sites told people not to do them. I agreed that we clearly spoke about potential beneficial uses of drugs but said that the sites also spoke about risks and did not urge people to do, or not to do, drugs, but instead emphasized that people needed to make up their own minds and be responsible for their own choices.

• December 17, 2002. A New Start. MAPS submitted the MDMA/PTSD protocol for review by a new IRB, with the protocol to be discussed by the review board on January 2, 2003. Officials at this IRB have read the entire correspondence between MAPS and the Western IRB and have indicated that they will carefully review the protocol on its merits without bias due to the controversial nature of MDMA-assisted psychotherapy research. This IRB has a reputation for being rigorous but fair, a set of characteristics that inspires confidence.

• December 16, 2002. Two DEA agents went to UMass Amherst to discuss Prof. Lyle Craker's June 2001 application to DEA for a license to grow marijuana for federally-approved research. This visit is the first direct DEA response to Prof. Craker's application in 18 months, a remarkable record of inaction (diagnosis: passive-aggressive). The DEA agents met with Prof. Lyle Craker and several senior UMass Amherst administrators including the Vice President for Research, the Dean, and the Director of the Office of Grants and Contracts.

  Prof. Craker reported that the main purpose of their visit, as far as he could tell, was to try to get the application withdrawn. Fortunately, the UMass Amherst administration didn't get dissuaded but instead just realized this is going to be a long fight. So DEA did not achieve its primary goal.

  For background information and documents, see http://www.maps.org/mmj/mmjfacility.html

• December 10, 2002. A Shameful Conclusion. On November 20, after the Western IRB decided not to review MAPS' MDMA/PTSD protocol, Rick Doblin spoke to James Baldwin, Ph.D., Executive Director of the Western IRB. Dr. Baldwin informed Rick that he was not authorized to speak about what motivated the Western IRB to decide not to engage in a dialogue about the rationale for WIRB's decision to revoke approval, to refuse to continue to review the protocol, and to refund MAPS' fee. Instead, Dr. Baldwin suggested that for more information, Rick should contact Mr. Ron Warren, Senior Vice President of the Western IRB. After Rick Doblin made repeated attempts over several weeks to speak with Mr. Warren, his secretary finally informed Rick Doblin on December 10 that he was unwilling to speak and had nothing to add to the letter. So it ends, with a shameful silence.

MAPS News - November 2002

• November 27, 2002. MDMA/PTSD Research in Israel. MAPS sent a draft of the MDMA/PTSD pilot study that MAPS is seeking to sponsor in Israel to Dr. Moshe Kotler and Dr. Jorge Gleser, Israeli Ministry of Health, for their review. MAPS' conference on MDMA/PTSD research, held at Beer Yakov Mental Health Center near Tel Aviv on November 14 for members of the Israeli Ministry of Health, the Israeli Society of Addiction Medicine, and the Israeli Anti-Drug Authority, was very well received. The conference and the proposed pilot study were discussed in a positive article mentioned on the front page of Maariv, Israel's second largest newspaper. The protocol design meeting, held at Beer Yakov on Nov. 17, was also productive, with the draft protocol submitted today reflecting design choices made at that meeting.

• November 20, 2002. Pathetic News. Ron Warren, Senior Vice President of the Western IRB, wrote a letter to Dr. Michael Mithoefer, reporting the outcome of the November 19 meeting of the WIRB's Executive Policy Committee. The WIRB letter was two short sentences, "The Western Institutional Review Board, Inc. (WIRB) has made the decision not to provide institutional review board services for the Multidisciplinary Association for Psychedelic Studies (MAPS). Please find enclosed a refund of your previously paid fees, along with the material you submitted for IRB review."
  The WIRB retreated from its supposed scientific rationale for revoking approval for MAPS' MDMA/PTSD study, as described in its September 6, 2002 letter and critiqued in MAPS' October 10 letter, and fell back on no rationale whatsoever. The WIRB has shown itself to be scientifically out of its depth and lacking of sufficient integrity to acknowledge its mistakes and refocus on a rational, data-based, risk/benefit analysis of MAPS' MDMA/PTSD protocol.
  Most importantly, MAPS will very soon start the process of submitting the protocol to another IRB for review.

• November 18, 2002. MAPS submitted a short letter to the Western IRB's Executive Policy Committee, in advance of its November 19 meeting at which it will discuss its review of MAPS' MDMA/PTSD protocol. The letter discussed MAPS' Israeli MDMA/PTSD project, briefly reviewed US government and international treaty policies regarding research with Schedule I drugs, and reported that MAPS had submitted unpublished data to FDA about MDMA and heart valve tissue, data which the WIRB cited as partial justification for revoking approval which neither MAPS nor FDA had seen.

MAPS News - October 2002

• October 17, 2002. A Surprising New Issue. After reviewing MAPS' letter, Dr. James Baldwin of the WIRB informed RIck Doblin that the October 30 meeting was canceled, but not for the reasons MAPS had hoped. Dr. James Baldwin said that the meeting was "premature" because the WIRB now needed to convene its Executive Policy Committee (EPC) to discuss whether the WIRB should be involved with research with Schedule I drugs. The next EPC meeting is scheduled for November 19. The WIRB is no longer reviewing the protocol based on the science but on non-scientific, internal policy issues, not a very encouraging development.

• October 11, 2002. A Comprehensive, Strong Response. MAPS submitted a lengthy written response to the WIRB letter, along with 14 letters of information and support from MDMA scientists around the world. MAPS' letter addressed every point raised in the WIRB letter and was so solid that we thought perhaps the WIRB would conclude that the October 30 meeting was not necessary.

• October 3, 2002. A Glimmer of Hope. Rick Doblin speaks with James Baldwin, Ph.D., Executive Director of the WIRB. Dr. Baldwin apologized for the tone of the WIRB letter and seemed to view favorably MAPS' arguments. He was informed that the one scientist whom the WIRB letter claimed was against the study was actually in favor of the study (subject to two conditions that MAPS could easily agree with), that the second scientist cited in the WIRB letter was strongly in favor of the study, and that the third scientist was probably not fully informed about the details of the protocol and was neither opposed to or in favor of the study. Dr. Baldwin tentatively scheduled a meeting between Rick Doblin and Michael Mithoefer and the WIRB for October 30, in Olympia, Washington.

MAPS News - September 2002

• September 27, 2002. Outrageous News. Dr. George Ricaurte publishes an article in Science reporting on primate data that he claims suggests that even one night's recreational use of Ecstasy can lead to Parkinson's. This government-funded research, which ignored the high mortality rate of the test animals and directly contradictory human data, is a classic example of risk amplification and the demonization of illegal drugs. MAPS obtained a copy of this article before publication and responded by sending out our first press release ever. MAPS' critique was favorably reported in articles in the New York Times and Washington Post and elsewhere. MAPS has also written a letter to the editor of Science.

• September 6, 2002. Terrible News. The Western IRB, which approved the MDMA/PTSD protocol on July 10, informed us by letter that approval was withdrawn. The revocation was based on secondhand reports of conversations (not on data!) that a WIRB staff person had with three MDMA researchers. The WIRB letter was written in a surprisingly insulting manner and contained numerous mistakes. MAPS was not informed that the protocol was being reevaluated and did not have an opportunity to respond to the reports by the WIRB staff person, who didn't like the fact that the WIRB had approved the protocol.

MAPS News - July 2002

• July 17, 2002. On July 10, we received word that the Institutional Review Board (IRB) had approved MAPS' MDMA/PTSD study! We can now definitely say that the US study will take place. Dr. Michael Mithoefer still needs to obtain his DEA Schedule 1 license, which should take about 4-6 weeks, but this is just a matter of time.

  There is now an excellent chance that the Israeli Ministry of Health will approve an Israeli MDMA/PTSD study. Michael and I are tentatively planning to go there in late September or early October for a one-day seminar organized by the Ministry to discuss the latest findings in MDMA research, and protocol design options for the Israeli study.

  Here are the financial implications:

  We still need to raise an additional $60,000 for the US MDMA/PTSD study and another $60,000 for the Israeli study. MAPS is also seeking $10,000 for our National Institute of Mental Health (NIMH) grant application for support for the development of a treatment manual that describes in detail hw MDMA-assisted psychotherapy for PTSD should be conducted and provides specific ways to evaluate whether the therapy technique itself is being delivered appropriately. We are also seeking $20,000 for our ongoing MDMA literature review. Any help or suggestions would be greatly appreciated.

  Read more about the struggle to conduct research into the therapeutic use of MDMA.