MAPS News - December 1999

• December 6, 1999. Frustration. Dr. Ethan Russo, U. Montana, heard that NIDA's special review committee rejected his MAPS-supported, IRB-and FDA-approved protocol, and that he will not be permitted to purchase marijuana from NIDA for his study. Dr. Russo was told nothing about why the protocol was rejected and was also told he should expect to wait a month or longer before receiving any formal notification from NIDA. FDA gave its final approval to the study months ago. On December 8, MAPS gave a grant to Dr. Russo for his continued efforts on behalf of the study. Read more

• December 2, 1999. The National Institute on Drug Abuse and community-based partners announced a national research and education initiative about club drugs. See the RealVideo clip of the press conference and the new NIDA website about club drugs.

• A radio show called Demon Drugs, formerly titled The Psychedelic Revival is airing this month. It will also be archived soon. People interviewed for this show include: Rick Doblin, Charles Grob, Sasha and Ann Shulgin, Jerry Beck, Ethan Nadelmann, Marsha Rosenbaum, Emanuel Sferios, George Greer, David Nichols and Maria Mangini.

MAPS News - November 1999

• Getting High: A History of LSD. The History Channel is running a program on the history of LSD beginning Monday, November 8 at 8 pm (other times: 11/9 at Midnight and 4 am, 11/13 at 2 pm). Description: "How did the synthetic form of Lysergic Acid Diethylamide, which occurs naturally in ergot (a rye and wheat fungus), have such an impact on America in the 1960s? Take a trip back as we explore LSD's role in the cultural upheavals of the '60s, and trace its roots back to "kykeon", the drug used in ancient Greek Eleusinian rituals."

• Ecstasy and Pregnancy
  The press has recently covered a study reporting infants born to mothers who used MDMA (ecstasy) during pregnancy are at increased risk of congenital birth defects. A new page on this site examines this.

• Read an article covering Dr. Ethan Russo's cannabis/migraine study.

MAPS News - October 1999

• October 23, 1999. New psilocybin study approved by the FDA. The first FDA-approved study in more than 20 years to examine the use of psilocybin in a patient population is close to being initiated.

• October 12, 1999. Study Shows Body's Own "Marijuana" May Affect Glaucoma. A recently completed study was begun by David Pate in 1993 at the Department of Pharmaceutical Chemistry, University of Kuopio, Finland to investigate an eyedrop form of anandamide, also called arachidonyl ethanolamide (AEA)...

• New page on this site. The MDMA Research Page is a narrative account of the effort to conduct MDMA therapy research. It includes history, challenges, risk overviews and personal accounts.

• FDA Approves Investigational IND for Cannabis in Migraine Treatment
  After almost three years of effort by Dr. Ethan Russo and MAPS, the FDA has approved a study of the effects of smoked cannabis (marijuana) as compared to oral dronabinol (Marinol®) and injected sumatriptan. The study will enroll 40 patients with severe migraine.

• Success. MAPS announces Orphan Drug Designation for Cannabis. Two and a half years ago, MAPS submitted an application to the Food and Drug Administration's Office of Orphan Drug Products requesting that cannabis be designated an Orphan Drug for the treatment of AIDS wasting syndrome.

• New papers on this site. From the MAPS-sponsored conference on the clinical use of MDMA: Structuring Psychotherapy Sessions with MDMA in a Research Context by George Greer.

  A review of the literature on MDMA and kidney function by John Podraza, Department of Biological Sciences, Hartwick College, Oneonta, New York.

  A Masters thesis in Mental Health Studies: A Critical Review of Theories and Research Concerning LSD and Mental Health by David Abraham.

• The Autumn 1999 Bulletin is available
  Articles include: MDMA Neurotoxicity Discussed
  MDMA and Memory Impairment: Proven or Not Proven?
  MDMA in a couple struggling with cancer: Two Years Later
  Medical Cannabis Potency Testing Project
  and Do entheogen-induced mystical experiences boost the immune system?
  Start at the beginning

MAPS News - September 1999

• New in MDMA research. MAPS sponsored an international conference on the clinical use of MDMA, August 31 and September 1, 1999. Scientists presented data on therapy and neurotoxicity research, among other topics. Read more about it.

• The historic study of the Short Term Effects of Cannabinoids in HIV Infection is looking for the final 18 participants to complete the trial.

MAPS News - July 1999

• July 27, 1999. Cannabis in Migraine Treatment Project Close to FDA Approval. The principal investigator of this study, Dr. Ethan Russo, received word from the FDA that his revised protocol for the Cannabis in Acute Migraine Treatment Project has been accepted by that agency, but remains on "clinical hold" pending receipt of a letter from NIDA authorizing access to the Drug Master File on cannabis. Read more

• Rick Doblin interviewed for Salon. An article called The Big E appeared recently on the Salon site. Doblin was also interviewed by The Village Voice for the article Drug Cocktails: Pleasures, Risks and Reasons (July 21-27 issue).

• July 1, 1999. New grant for Swiss MDMA Research. MAPS has pledged a grant of $10,000 to Alex Gamma of the Vollenweider group at the Psychiatric University Hospital - Zurich, Switzerland for work on four to five papers to be published in peer-reviewed journals. Completion date for these papers is end of January, 2000.

  These findings will make a significant contribution to our knowledge about the potential risks and mechanism of action of MDMA. They will also help make the case for the safety of MDMA when used in clinical research.

MAPS News - June 1999

• June 24, 1999. The FDA grants permission for MDMA therapy research. Early this morning, a teleconference took place between FDA officials and proponents of MDMA psychotherapy research. A remarkable reversal of policy took place. The history of the efforts to study the therapeutic use of MDMA have been reviewed and the decision has been made to permit a pilot study in cancer patients. This study will focus on a clearly defined clinical end-point, either depression, anxiety, pain, or perhaps quality of life.

  There are lots of details left to determine and negotiate, with a protocol submission intended for sometime in September or October 1999, after the Israel MDMA conference. This is some of the best news that MAPS has had in many years!

• Migraine Study reviewed. Ethan Russo has received a review of his protocol from the FDA, and we are hopeful the next revision will be approved. (Read more about it).

• June 15, 1999. MDMA research meeting scheduled. MAPS has a telephone conference scheduled for June 24 with the FDA to discuss the issue of whether any additional pre-clinical animal studies will be required before MAPS can sponsor any MDMA psychotherapy studies in humans. A meeting with the FDA to discuss how we will be able to proceed with human studies is being planned for sometime in October, after the Israel MDMA conference. MAPS has hired Matthew Baggott (UCSF), to summarize the scientific literature for presentation to the FDA. On June 4, 1999 MAPS signed a consulting contract with PPD Development, a contract research organization that specializes in assisting pharmaceutical companies to negotiate with the FDA.

• June 9, 1999. Rick Doblin met with Dr. Janet Woodcock, Director of FDA's Center for Drug Development and Research. They discussed the history and current policies of the FDA's regulation of Schedule 1 drugs, particularly psychedelics and marijuana. Doblin left the meeting hopeful that this field of research will be able to move forward, as long as we submit scientifically rigorous protocols.

MAPS News - April 1999

• April 19, 1999.MAPS just spent $3,500 to bring one MDMA researcher from Israel, three from the US, and myself to a scientific conference on the neurotoxicity of amphetamine, methamphetamine, and MDMA. We went to the meeting to gather information for the design of research applications to the authorities in the US and Israel. Suffice it to say that the evidence for harmful effects of MDMA-neurotoxicity is underwhelming. A future issue of the MAPS Bulletin will focus in detail on MDMA neurotoxicity issues.

• Two days ago, MAPS donated $6,000 to the MDMA/PET scan research of Franz Vollenweider, U. of Zurich. Vollenweider's team can administer MDMA to MDMA-naive subjects and will gather data that is directly relevant to estimating the risks of the administration of one or two doses of MDMA to patients in a carefully controlled research setting.
  

MAPS News - March 1999

• March 18, 1999. Dr. Charles Grob's eight-month wait for a response from the FDA concerning his MAPS-supported MDMA/breast cancer patient protocol finally ended. Not unexpectedly, the FDA rejected the dose-response safety study. The rationale for the rejection is based on a lack of animal data and a concern over neurotoxicity. We feel that the FDA is overlooking existing data (In 1986, MAPS submitted to FDA a 28-day toxicity study in dogs and rats though we were told we still needed to produce such data) or misinterpreting existing data (there is no evidence whatsoever suggesting that a single dose of MDMA is likely to have any clinically significant neuropsychological consequences stemming from supposed neurotoxicity). Dr. Grob and I are preparing a written response to FDA requesting a meeting to discuss these matters. - Rick Doblin, MAPS President

• Thursday, March 18, 1999. I was at FDA headquarters today complaining to the FDA ombudsman and to a senior FDA official that the FDA was blocking medical marijuana research by refusing to review protocols until NIDA agreed to provide the marijuana. This policy forced all potential marijuana researchers to submit protocols to NIH for federal funding, a review guaranteed to delay research and almost certain to result in rejection. The MAPS-supported efforts of Dr. Donald Abrams, UC San Francisco, are the only exception I know of.

  The timing of the meeting with FDA officials couldn't have been more fortuitous since that very morning news of the IOM report and its recommendation that studies with smoked marijuana be approved were all over the front pages of the Washington Post, NY Times, USA Today, etc. I argued that the FDA should review protocols so we could get the benefit of FDA expertise in protocol design, and that sponsors of non-federally funded projects deserved the opportunity to try to convince NIDA that their studies were "scientifically meritorius," the current phraseology used by Dr. Leshner to describe his criteria for letting lose of his hold on NIDA's monopoly supply of marijuana for FDA-approved research. I think some headway was made and that the policy will change. Dr. Ethan Russo will test the waters in the next week or so with his MAPS-supported protocol to study the use of smoked marijuana in the treatment of migraines, in order to see if a new policy is really put in place. Dr. Russo's protocol has been rejected by the NIH twice, the last time primarily because it was a controlled trial instead of simply a preliminary study. Whether the policy does indeed shift will be an important sign of whether the Clinton Administration is still obstructing medical marijuana research while pretending to be in favor of research. - Rick Doblin, MAPS President

• March 1, 1999. The NIH critique of the second "Cannabis in Acute Migraine Treatment" study application which was turned down is now online, as is Dr. Russo's response to the critique. Dr. Russo has decided to not attempt a third application to the NIH to study cannabis for migraine.

MAPS News - February 1999

• February 2, 1999. The Winter 1998 MAPS Bulletin has been posted.

  On January 13, The FDA held a meeting to review the current MDMA/cancer safety study protocol. The FDA remarks on the protocol are expected by the beginning of March 1999.