MAPS News: May 2008 — Albert Hofmann Passes the Torch
Dear MAPS Members, Supporters, & Friends,
Theres some bittersweet news and lots of exciting new things to report this month. Heres whats going on:
- Albert Hofmann Dies on April 29th at the Age of 102
- New Developments Emerging from Discussions on Canadian MDMA PTSD Study
- Medical Marijuana Study Recruiting Patients with Chronic Pain
- MAPS Flagship MDMA/PTSD Study Nears Completion
- Possibility of a French MDMA/PTSD Study Moves Forward
- Swiss Medic Allows Non-Responders in MDMA PTSD Study to Have Additional Sessions
- Subjects Being Screened for Peter Gassers Swiss LSD Psychotherapy Study
- Positive Media Coverage of Israel’s MDMA/PTSD Study Brings New Subjects
- Strong, Positive Article in The Lancet about the Renewal of Psychedelic Research
- Positive Article About MDMA/PTSD Research in The London Sunday Times
- Psychedelic Elder Alexander Sasha Shulgin Recovering Well from Heart Surgery
- Signed Copies of LSD: My Problem Child & and Other Hofmann Memorabilia Going Fast
- MAPS to Co-sponsor Two MPP Fundraisers–NYC on May 14th and Playboy Mansion on June 12
- Expect the Spring MAPS Bulletin in Your Mailbox Soon (And Summer Membership Drive with Chance to WIN Shulgin Glassware!)
- MAPS Receives a $6000 Grant from the Marijuana Policy Project for Professor Lyle Craker
- MAPS Receives $119,000 for MDMA/PTSD Research
*** MAPS needs your generosity to empower staff, scientists, and volunteers to carry out pioneering research and educational projects. To donate, learn about the benefits of MAPS membership, or purchase books, clothes, art, and other merchandise, visit: store.maps.org/ ***
The legendary Swiss chemist and renowned mystic philosopher Dr. Albert Hofmann–who ushered in the Psychedelic Age with his historic discovery of LSD, and his isolation of psilocybin as the active compound in sacred mushrooms–died of a heart attack on the morning of April 29th at his glass-walled home in the mountains near Basel, Switzerland. He was 102 years old and was fully lucid until he died
MAPS President Rick Doblin, PhD had just spoken with Albert a few weeks before his passing and reports that Albert was deeply satisfied that LSD psychotherapy research had been permitted to resume and that he sounded in love with life but ready to die. On January 11, 2008 Rick and a small group visited with Albert at his home to celebrate his 102nd birthday and the renewal of LSD psychotherapy research–sponsored by MAPS and conducted by Swiss psychiatrist Dr. Peter Gasser in patients with anxiety associated with end-of-life issues. This study will become the first study of LSD-assisted psychotherapy in over thirty-six years–In a Swiss media interview conducted right before his birthday, Albert spoke about the renewal of research as the fulfillment of my heart’s desire.
Albert died less than five months after his wife Anita passed away on December 20, 2007. Their love affair lasted over seventy years, and it was the major factor contributing to their long healthy lives together. Obituaries for Albert have been printed in newspapers around the world, with links listed on the MAPS website. This wonderful tribute to Albert Hofmann and LSD is from NPR’s Rememberances featuring a comment by Harvard psychatrist and marijuana researcher Lester Grinspoon, MD.
Doblin attended Alberts funeral on May 9, which was celebratory and joyous. He paid respect to Albert on behalf all MAPS members and was the only person present from the US.
Doblin has been doing numerous interviews about Alberts life and work in the past two weeks. He was interviewed on NPRs Weekend Edition (MP3) and Warren Olneys Radio Show (MP3). He was also quoted about Albert in a New York Times obituary and a New York Times Sunday Week in Review article, as well as in many other widely read publications. Doblin wrote an especially beautiful obituary for Google News about Albert. In one of my favorite quotes he said, Inventions don’t get to pick their inventors, but if they did, LSD couldn’t have picked a better inventor than Albert Hofmann. Albert was already mystically inclined from childhood, and was able to appreciate the spiritual and therapeutic potential of LSD–even as he also experienced the fear of dying and the fear of going crazy in the worlds first LSD experience.
Just several weeks ago, Doblin told Albert that he looked forward to discussing the final results of Dr. Peter Gassers study with him in about a year and a half. Albert laughed and told Rick that hed help anyway he could, either from this side or the other side. So although we got Alberts commitment to continue helping us out from the Other Side, the primary responsibility of advancing medical research with psychedelics now falls onto our shoulders.
MAPS Researcher Michael Mithoefer, M.D., President Rick Doblin, Ph.D., Research Specialist Ilsa Jerome, Ph.D., and Clinical Research Associate Valerie Mojeiko have had several productive teleconferences with new Canadian therapist team Andrew Feldmar, PhD and Ingrid Pacey, MD to discuss protocol design details for MAPS upcoming MDMA/PTSD study in Vancouver. The main protocol design details have been agreed upon and a series of teleconferences and protocol writing sessions are underway.
The study will be a comparison of twelve subjects–eight subjects who will be given MDMA, and four subjects will be given an active placebo. Every subject will receive two blind sessions (neither subject or therapist will know who is receiving the drug and who is receiving the placebo). A placebo in this study will actually be low-dose MDMA– 25 milligrams followed two to two and a half hours later with 12.5 mg. Were using this design with the active placebo being low-dose MDMA since its likely that the solution to the problems associated with doing double-blind studies with psychedelics will be by conducting a dose-response study. Although the placebos will create some measurable effect, this seems the only reasonable option for doing double-blind research with psychedelics.
What is most likely to fool people are the different dose-responses to the drug, and the FDA is likely to decide that our Phase 3 trials are probably going to be designed in that way.Dose-response in this context means that everybody knows theyre getting MDMA, but they dont know what dose theyre getting. People are more likely to be confused about the dose when they will be receiving doses like 25 mg, 75 mg, and 125 mg. Our research will have to demonstrate that subjects receiving the higher doses did better.
After the psychotherapeutic sessions the blind will then be uncovered, and a comparison will be done between two MDMA sessions versus two placebo sessions. All the MDMA subjects will have two additional sessions following that, with the option–based on both therapist and patient decisions–to go up to 150 milligrams from 125. The placebo subjects will also have the option for doing four sessions of open-label MDMA after completing placebo sessions.
MAPS is now assisting with subject recruitment in Dr. Donald Abrams medical marijuana and opiate interaction study at the University of California, San Francisco. Dr. Abrams study, which is being sponsored by the National Institute on Drug Abuse (NIDA), is designed to evaluate whether or not patients who are using the opiate drugs Oxycontin or MS Contin (or Kadian) for pain will receive less benefit if the drugs are used in conjunction with marijuana administered by a vaporizer. This research–which will be studied in twenty-four subjects who are currently taking pain medications–will provide clinical evidence to help decide whether cannabis, when added to conventional narcotic pain drugs, will reduce the effectiveness of the opiates, or can provide added relief and thereby allow much-reduced doses of these dangerous narcotics. The study is taking place at the San Francisco General Hospital, in the clinical research center, and it requires a five-day inpatient stay.
The second to last experimental session took place on Monday in MAPS-sponsored MDMA/PTSD study led by Dr. Michael Mithoefer M.D. in Charleston, SC. There are just two more open label MDMA sessions to go. One will be next week and the last one will be in July. The subject who will be the last to finish will have the final outcome evaluation in September, and then the study will be finished. Four additional subjects have had all their experimental sessions and will have their final outcome measures in the next two months.
A volunteer data management expert with eight years of clinical trials experience (who wishes to remain anonymous) came to MAPS Love Creek headquarters over this last weekend, created a database for the study, and entered most of the data points that we have on file so far. We are on schedule to have all data entered and ready for analysis by the time the last subject has the last visit.
MAPS received an anonymous donation of $90,000 for this study recently. There has also been a money-saving development with the institutional review board (IRB), which in the past has required that MAPS indemnify them for a million dollars. (To indemnify means that, in case theyre sued, we cover their costs.) MAPS has had to purchase insurance to indemnify the IRB, and in Dr. Mithoefers study so far that insurance has cost us $49,000– to protect the IRB from the extremely unlikely event that a subject would sue the IRB for being in the study and win the case. The good news is that the IRB has now permitted us to self-insure. We are still are indemnifying them, but because were now permitted to self-insure, this just saved us $9,600 in insurance premiums.
MAPS has submitted a draft MDMA/PTSD protocol to a team of French psychiatrists who are still in discussion with their local institution about whether we might be permitted to sponsor a pilot study.
MAPS Clinical Research Associates Valerie Mojeiko and Josh Sonstroem will be going to France on June 27th for a pre-study visit to meet with the research team that is currently working to obtain permission for MDMA/PTSD research.
SwissMedic, and our Swiss Ethics Committee, have agreed to allow non-responders in Dr. Peter Oehens MAPS-sponsored Swiss MDMA/PTSD study have the option to receive two additional sessions–and the possibility of going up to a 150 mg dose from 125 mg. All of the subjects will receive three sessions, and non-responders will be able to have a fourth and–if doctors and patient agree–a fifth session
An anonymous donor has sent MAPS $29,000 to complete the Swiss MDMA/PTSD study. However, this was for completing it as it had been originally designed–without the additional sessions for nonresponders–so we still need to raise more funding for this study, roughly estimated at $20,000.
Several subjects are now being screened for Peter Gassers Swiss LSD psychotherapy study with subjects suffering from anxiety secondary to an advanced-stage illness. The first subject has been enrolled with the first experimental session to start in May. There was a positive article about Dr. Gassers LSD psychotherapy study in the London Bloomberg News entitled LSD May Shed Hippie Image With Swiss Study of Medical Benefits.
Two major news sources in Israel have recently covered the MAPS-sponsored Israeli MDMA/PTSD study in a positive light, and, as a result, subject recruitment has started to pick up. The first subject has already been treated and the second subject has been enrolled. Study Investigator Rakefet Rodrigez, MD appeared in a newspaper called Maariv (PDF), and on a prestigious daily television news show called Ereb Chadash (meaning “New Evening), which discusses current happenings.
There was an excellent article by Kelly Morris about the renewal of psychedelic drug research around the world in the May, 2008 issue of Britains prestigious medical journal The Lancet. The article was titled Psychedelic research moves into the mainstream, and it contained a very positive summary of the psychotherapeutic studies that are currently underway with MDMA, LSD, and psilocybin.
The London Sunday Times ran a positive article about MAPS MDMA/PTSD research. The article by Amy Turner, entitled Ecstasy is the key to treating PTSD ran in the May 4th issue.
We reported in the last email news update that Alexander Sasha Shulgin–legendary psychedelic chemist, consciousness explorer, and author–had heart surgery on Tuesday, April 8th. The surgery was done in order to replace a defective aortic heart valve. According to his wife Anne, Sasha is recovering well and his strength is steadily improving. We anticipate complete recovery within a few months. The CaringBridge website is being used to keep us up-to-date on Sasha’s progress.
Only a limited number of signed copies of Albert Hofmanns classic book LSD: My Problem Child remain for sale. Because there is such a limited number of these signed books, and because Albert really wanted to help raise money for LSD research, weve increased the price for the remaining eight copies to $1000. if you want to own one of these last remaining historic books, order a copy today!
There are several beautiful portraits of Hofmann for sale in the webstore (some signed by Albert). Purchasing this art would be another way to honor his life and his work, as the funds go to support LSD psychotherapy research.
MAPS will be a cosponsoring two Marijuana Policy Project (MPP) fundraisers in New York City on May 14th and at the Playboy Mansion on June 12th.
To acknowledge Alberts death, a few last minute changes were made in the Spring MAPS Bulletin, and this delayed sending it out by about a week. However, it is currently at the printers and will be in arriving in mailboxes by the end of May (longer for international delivery). This is a special, extra-thick theme edition of the Bulletin that I edited about technology and psychedelics–which is simply bursting at the seams with fascinating essays, rare information, compelling interviews, and extraordinary artwork.
MAPS has received a $6000 grant from the Marijuana Policy Project (MPP) for Professor Lyle Craker, Ph.D.s work on the DEA application process, seeking a license to build a medical marijuana production facility under contract to MAPS.
So far, for over a year, the DEA has delayed issuing a Final Ruling in response to the recommendation by the DEA Administrative Law Judge (ALJ) Mary Ellen Bittner that it would be in the public interest for DEA to issue Prof. Craker a license.
A new donor to MAPS, who first purchased art from the MAPS webstoreimmediately after the World Psychedelic Forum, has since donated $90,000 to our US MDMA/PTSD study and $29,000 to our Swiss MDMA/PTSD study. This significant support from a completely new donor is especially heartening since he was involved in the pharmaceutical industry and understands the drug development process. This pivotal support from a new donor suggests that MAPS’ non-profit drug development strategy is not completely unrealistic, that as long as we continue to conduct methodologically rigorous and therapeutically beneficial research, funders will see the value of supporting MAPS even as we expand into our large-scale, multi-site Phase 3 studies costing millions of dollars.
Alberts passing on to the Other Side marks an important transition in our work to help make psychedelic substances into legal prescription medicines. Now that the grandfather of psychedelic research has departed from the Earthly realm, the great responsibility of integrating psychedelic therapies into mainstream medicine now falls more directly onto our shoulders. Alberts dream became a reality that he lived to see, as the Swiss LSD psychotherapy study is now underway. Since weve only raised half of the money for the study, this would be an excellent time to make a donation in honor of Albert. Hes passed the torch to us and its now our responsibility to carry this valuable research forward. Please consider making a generous donation to MAPS today.
Onward and Upward,
David Jay Brown, M.A.,
MAPS Guest Editor