Greetings, MAPS members! This is the third edition of the MAPS news email update. We’re happy to report several items of progress in both research projects and in our efforts at outreach and education. This edition includes the following updates:
- DEA finally announces UMass Amherst medical marijuana facility application
- New study: Short-term medical cannabis does not harm HIV+ patients
- Institutional Review Board reviews Dr. Michael Mithoefer’s MDMA/PTSD study
- MAPS in the media: New Scientist, Salon.com, and Teen People
- MAPS offers psychedelic emergency services at Burning Man
1. UMass Amherst medical marijuana farm: Struggle for DEA license passes critical hurdle.
On July 24, 2003, the DEA finally posted an announcement in the Federal Register reporting on the MAPS-sponsored application for a license for a medical marijuana production facility submitted to DEA by Prof. Lyle Crake, UMass Amherst. By filing in the Federal Register, DEA initiated a 60-day public comment period ending Sept. 22, 2003, with comments solicited only from other people or organizations who either hold a similar license or are applying for a similar license. As far as we know, this applies only to the National Institute on Drug Abuse (NIDA), which has marijuana grown under contract at the University of Mississippi and retains a monopoly on the supply of marijuana that can be used in FDA-approved research.
You can view the Federal Register announcement at: http://www.deadiversion.usdoj.gov/fed_regs/manufact/app/2003/fr07245.htm
The DEA should have posted an announcement about the application shortly after the application was originally filed on June 25, 2001, over two years ago. Instead, for the first year, DEA claimed it “lost” the application until it mysteriously returned the original application to Prof. Craker without comment in an envelope with no cover letter and no identification as to who at DEA “found” and returned it. During the second year, DEA tried and failed to get Prof. Craker and the UMass Amherst administration to withdraw the application.
The DEA has finally realized that it can’t sweep the application under the rug. According to a letter from DEA Acting Administrator William Simpkins to Rick Doblin, received on August 7, 2003, the DEA will either grant or reject the UMass Amherst license shortly after the public comment period is over.
MAPS is going to work with the Drug Policy Alliance and NORML to direct public comments to the Office of National Drug Control Policy (ONDCP, the Drug Czar’s office), which determines US drug policy and will instruct DEA how to rule on the application. We’ll send more details about this campaig= n to MAPS members once we have developed all our materials. MAPS is also working with the Marijuana Policy Project and the Drug Policy Alliance to gather support for the project from members of the US Congress (House and Senate).
If DEA rejects the application, MAPS will initiate a lawsuit which will result in a very public DEA Administrative Law Judge hearing that is bound to be embarrassing to DEA. The UMass Amherst effort, along with Chemic Lab’s MAPS-sponsored effort to import marijuana from the Dutch Office of Medicinal Cannabis for its vaporizer research, raise hopes that NIDA’s monopoly will be ended, sooner or later. Once an independent source of high-potency marijuana is available, and vaporizers can be used in human clinical research, it finally would be reasonable to spend the sums necessary to conduct a serious drug development effort aimed at FDA approval of marijuana as a prescription medicine.
2. Short-Term Medical Cannabis Does Not Harm HIV+ Patients
On Monday, August 18, at 5:00 PM EDT, UC San Francisco issued a press release about the publication by Dr. Donald Abrams and co-authors of an article in the Annals of Internal Medicine discussing the results of their study of the effects of marijuana in HIV+ subjects. Here’s the headline, “Short-Term Medical Cannabis Does Not Harm HIV+ Patients,” with the rest of the press release at the end of this message.
This is the first publication of the results of a double-blind, controlled study of the effects of smoked marijuana in a patient population in twenty years. It took MAPS and Donald=B9s group five and a half years to get this study started, with help from MPP lobbying NIDA. We leveraged a $10,000 donation to MAPS from Peter Lewis, used to support work by Donald=B9s group preparing protocols, into a $1 million NIDA grant for a compromised but still worthy study. In order to obtain NIDA marijuana, we had to agree to conduct a safety study in HIV+ subjects who didn’t suffer from AIDS-wasting, instead of going forward with our FDA-approved safety and efficacy study in treatment-resistent AIDS-wasting subjects. When it came time to report the results, the paper was rejected by several journals that weren=B9t comfortable with its conclusions. Finally, the Annals of Internal Medicine had the courage to publish it.
Now we have yet another response to Dr. Andrea Barthwell, deputy director of ONDCP, who concluded her July 22, 2003 Op-Ed against the medical use of marijuana by saying, “The overarching charge to any physician is: ‘First, do no harm.’ That is the test smoked marijuana cannot pass.” On the contrary, this new study demonstrates that it has passed that test, at least sufficiently so that Dr. Barthwell’s only ethical option is to encourage research into marijuana’s potential beneficial uses in patient populations and to recommend that DEA license the UMass Amherst facility to produce high-potency marijuana for medical research.
Here’s the rest of the press release:
EMBARGOED FOR RELEASE
5:00 PM, EDT, August 18, 2003
TO COINCIDE WITH PUBLICATION IN THE ANNALS OF INTERNAL MEDICINE
UCSF Study Finds No Harm to HIV+ Patients with Short-Term Medical Cannabis.
UCSF researchers found no harmful changes in HIV virus levels in patients on combination antretroiviral therapy in a safety study looking at both smoked marijuana and dronabinol, an oral medical cannabinoid.
“People with HIV are a vulnerable population, so successfully addressing the safety concerns allows us to move on to effectiveness studies, three of which are currently underway here,” said study author Donald Abrams, MD, professor of clinical medicine in the UCSF Positive Health Program at San Francisco General Hospital Medical Center (SFGHMC).
The findings, which appear in the August 19, 2003 issue of the Annals of Internal Medicine, mark the first publication of a randomized, controlled study involving medical marijuana in a major peer-reviewed journal in several years.
Sixty-two HIV-infected patients on antiretroviral regimens containing a protease inhibitor completed the 25 day inpatient study. Patients were randomized to three groups–20 received smoked marijuana, 22 received dronabinol, and 20 received an oral placebo.
The study measured changes in HIV virus levels in blood (rising levels tend to indicate disease progression) and CD 4 and CD 8 T lymphocyte cell counts. These disease- fighting white blood cells are essential for defending against infections and are targeted and destroyed by the HIV virus.
The study investigated whether cannabinoids would alter the levels of the virus either by changing the levels of the protease inhibitor medication or by a direct effect on the immune system. Fifty-eight percent of the participants entered the study with levels of HIV virus circulating in their blood below the limit currently detectable by the usual tests. They ended the study with no change in their undetectable status. In all three arms, patients with detectable levels of virus saw no change in the levels of HIV in their blood over the three-week study period.
There was no significant change in CD 4 or CD 8 T-cell counts for the placebo group over the course of the study. CD 4 T-cell counts rose by about 20 percent for both the smoked marijuana and the dronabinol group. CD 8 T-cell counts rose by 20 percent in the smoked marijuana group and by 10 percent in the dronabinol group. “The change in lymphocyte counts for the smoked marijuana group is intriguing. At a minimum, it contradicts findings from previous studies suggesting that smoked marijuana suppresses the immune system,” said Abrams.
While not the primary objective of the study, weight gain was observed in all three groups, possibly due to regularly scheduled meals and snacks. Statistically significant weight gain occurred in both the smoked marijuana and the dronabinol arms compared with the placebo arm, though the gain was fat, not in the desired lean body mass compartment.
Co-authors of the study are Joan F. Hilton, DSc, MPH, UCSF associate professor of epidemiology and biostatistics; Roslyn J. Leiser, RN, clinical nurse, Starley B. Shade, MPH, senior statistician, Steven G. Deeks, MD, UCSF associate professor of medicine, and Thomas F. Mitchell, MPH, program director, all in the UCSF Positive Health Program at SFGHMC; Tarek A. Elbeik, PhD, UCSF associate researcher in laboratory medicine at SFGHMC; Francesca T. Aweeka, PharmD, UCSF professor of clinical pharmacology; and Neal L. Benowitz, MD, UCSF chief of the division of clinical pharmacology and vice chair of the department of biopharmaceutical sciences. Also, Barry M. Bredt, MA, specialist, and Morris Schambelan, MD, UCSF professor of medicine and director, General Clinical Research Center at SFGHMC; Bradley Kosel, PharmD, visiting postdoctoral scholar in clinical pharmacology at UCSF; Judith A. Aberg, MD, associate professor of medicine at Washington University, St. Louis, Mo.; Kathleen Mulligan, PhD, UCSF associate professor of medicine at SFGHMC; and Joseph M. McCune, MD, PhD, UCSF professor of medicine at the Gladstone Institute of Virology and Immunology.
The study was supported by a research grant from the National Institute on Drug Abuse, a part of the National Institutes of Health, which also supplied the marijuana cigarettes for the trial. The dronabinol and placebo were supplied by Roxane, Inc., Columbus, Ohio.
2. New IRB has reviewed Dr. Mithoefer’s MDMA/PTSD protocol. In response to the problems we’ve faced finding an Institutional Review Board (IRB) willing to review Dr. Mithoefer’s MAPS-sponsored MDMA/PTSD protocol, MAPS explored the possibility of creating our own IRB. MAPS identified a group of experts willing to serve on the IRB and even created a formal set of standard operating procedures. Though we discovered that it was entirely possible and acceptable to FDA for MAPS to establish its own IRB, we decided to seek one last review from an existing IRB before going forward with a MAPS IRB. Approval from an outside IRB would make skeptics of this research more comfortable than if we had to rely on a MAPS IRB.
On July 22, 2003, on outside IRB formally reviewed the protocol after MAPS organized a tremendous display of support for the project from over 15 scientists worldwide who submitted letters of information and/or support to the IRB. To its substantial credit, this IRB based its review on science, not politics. The IRB indicated that it would approve the protocol after we resolved eight items, all of which we are willing to address. Only one of the protocol modifications is major, that being the requirement that we keep subjects overnight in the treatment facility rather than send them home with a support person of their own choosing who would also bring them back the next morning for the non-drug follow-up psychotherapy session. This change is something that we had contemplated but weren’t sure we could do in the present location.
After the IRB requested this modification, we checked with legal advisors and learned that we can indeed provide overnight stay. Although it will increase the cost of the study by $10,000-15,000 for the overnight staff person, this marks the first time that an IRB’s comments have substantially improved our study.
We have submitted our reply to all eight items, and expect to hear from the IRB within a few weeks. While we can’t say for sure that all our responses will meet with IRB approval, we are cautiously optimistic. Even the DEA has indicated that once it receives the final approval letter from the IRB, it will probably issue Dr. Mithoefer his schedule I license, saying “though we still have concerns, they probably don’t rise to the level of trying to stop the study.” We shall see!
3. MAPS in the Media: New Scientist Magazine, Salon.com, and Teen People
Go to http://maps.org/media/ to check out three recent articles that mention MAPS and MDMA. The August 8, 2003, New Scientist magazine features an excellent commentary by Kurt Kleiner about MAPS’s ongoing efforts to navigate the Institutional Review Board process for the MDMA/PTSD study.
On July 31 and August 1, 2003, Salon.com ran a two-part article on ecstasy by Larry Smith. The first half discusses both risks and benefits of recreational use, and the latter half focuses on research, including quotes from Rick Doblin and Ecstasy: The Complete Guide author Dr. Julie Holland.
Also written by Larry Smith, the August 2003 Teen People features an article entitled “The X Files: Experts answer your top questions about ecstasy.”
4. MAPS volunteers offering psychedelic emergency services at Burning Man Project
MAPS volunteers will be providing psychedelic emergency services at this year’s Burning Man festival, August 25-31. This project builds on MAPS’ experiences coordinating psychedelic emergency services at the Hookahville music fest in Ohio and the Boom Fest in Portugal. Our goal in providing these services is not just to calm people down, but to help them transform frightening experiences into difficult but healing ones.
As always, please respond to this message if you would like to update us with your new contact information, or if you’d like to be removed from the email update list.
Thanks for your continued support – it’s more necessary than ever as we move forward on some exciting paths!
Warm thoughts from sunny Sarasota,
MAPS Director of Special Projects