We are faced with the exceedingly difficult question of how to measure exactly what MDMA can do to help cancer patients face their illness and impending death. Are we going to show change on standard measures of anxiety and depression, even though these tests have not been created to evaluate people facing death? How do we respond to the fact that the most appropriate measure of Quality of Life in terminal patients, the measure that explicitly evaluates a transcendent dimension related to changes in fear about and acceptance of death, is not yet scientifically validated for use in clinical research? Fortunately, the FDA is willing to let us start with a small pilot study with controls to determine what changes we are able to produce in a variety of measures.
FDA Memorandum of Telecon Meeting Minutes, dated July 23, 1999

In a surprise decision, Dr. McCormick announced a remarkable reversal of FDA policy as previously expressed in an earlier letter to Dr. Grob. Dr. McCormick announced that she had consulted with senior FDA officials and had reviewed the history of the efforts to study the therapeutic use of MDMA and had decided to give us a chance to demonstrate efficacy. No additional pre-clinical studies will be required at this time. No preliminary studies in MDMA-naive subjects who are not patients will be required. We will be permitted to initiate a pilot study in cancer patients focusing on a clearly defined clinical end-point, either depression, anxiety, pain, or perhaps quality of life if we can point out a sufficiently validated scale. If and when we get information about therapeutic effect size without producing serious adverse side effects, we will be permitted to initiate a large scale clinical trial designed to be one of the two "adequate and well controlled" trials necessary before FDA would approve a drug for marketing. If we do obtain promising data, we will need to go back and fill in the holes in the pre-clinical data (requiring substantial sums of money).

There are lots of details left to determine and negotiate. As we develop the protocol, we will seek out your advice. This FDA decision about MDMA research suggests that the FDA really will prioritize science over ideology, a position that NIDA only espouses rhetorically.

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.

Thursday, March 18, 1999: The FDA comments on the cancer patient study
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

January 29, 1999
Dr. Grob received a phone call from the FDA saying it would send a in several weeks which will include a critique from NIH oncology reviewers and FDA pharmacology and chemistry reviewers.