Dear Dr. Volkow:

Thank you for your thoughtful letter of November 18, 2003, written also on behalf of the Secretary of Health and Human Services (HHS) and the Director of the National Institutes of Health (NIH). I appreciate the time you took to respond to my requests that NIDA support DEA licensing of Prof. Craker's marijuana production facility at UMass Amherst, and that NIDA release additional information about Drs. Ricaurte and McCann's retracted MDMA research.

In regard to Prof. Craker's DEA application, you wrote, "it is not NIDA's mission to study the medicinal uses of marijuana and, therefore, it also is not NIDA's role to advocate for the establishment of facilities to support this research." Yet it is precisely because NIDA's mission doesn't include the study of the medicinal uses of marijuana that NIDA's monopoly on the supply of marijuana for FDA-approved medical research is so inappropriate. I request you reconsider your decision not to recommend a change in the status quo. Current policy keeps NIDA integrally involved in an area of research outside its mission. NIDA's monopoly is especially problematic since it compromises the efforts of private funders to sponsor necessary medical marijuana research.

While NIDA itself is taking no official position on Prof. Craker's application to DEA, I'm not sure if you are aware that Dr. Mahmoud ElSohly, Director of NIDA's production facility at the University of Mississippi, actively opposes Prof. Craker's application. Dr. ElSohly submitted the only public comment to DEA regarding Prof. Craker's application, a copy of which (enclosed) we obtained recently through a Freedom of Information Act (FOIA) request. Dr. ElSohly stated in his letter to DEA that the marijuana he supplies NIDA is "enough both qualitatively and quantitatively to satisfy any possible needs of the research community." He went on to state, "we object to the issuance of a manufacturer's registration to the University of Massachusetts-Amherst."

Despite his assertion, Dr. ElSohly's production does not satisfy the needs of the research community. In just one example, MAPS is sponsoring analytical research at Chemic Labs into the constituents of the vapors of marijuana that is heated but not burned in a device known as a vaporizer. Chemic requires samples of marijuana that contain high levels of THC and CBD since both cannabinoids possess medicinal properties that we seek to study. In order to conduct its research, Chemic Labs has submitted an application to DEA to import 10 grams from the Dutch Office of Medicinal Cannabis of a specific variety of marijuana that contains cannabinoid levels that NIDA does not have available (SIMM 18 variety, with 13.2% THC and 7.6% CBD). Joel Egertson, senior drug policy advisor to the Secretary of HHS, is coordinating the exhaustive HHS review of the scientific merit of the vaporizer protocol to determine whether to permit Chemic Labs to purchase 10 grams of standard material from NIDA (roughly $70 worth) and whether to recommend to DEA that it permit the importation of 10 grams of high-potency material.

Dr. ElSohly's letter to DEA doesn't address the other ways in which NIDA's monopoly obstructs privately-funded research. NIDA's monopoly prevents sponsors of privately-funded research from choosing the strain of marijuana they would prefer to research, makes privately-funded sponsors dependent on NIDA for price and availability, and forces sponsors to conduct research with a plant strain provided by NIDA that cannot be guaranteed to be available for prescription use. No rational private sponsor will invest the millions of dollars needed to conduct the research required by FDA with the limitations imposed by NIDAÕs monopoly on supply. Dr. ElSohly also didnÕt comment on how NIDAÕs monopoly is inconsistent with US law requiring competition in the production of scheduled materials for use in research.

As a result of historical circumstances, NIDA plays a critical role in medical marijuana research. Since the UMass Amherst facility is intended to relieve NIDA of a task that is outside its mission, I urge you to reconsider whether it would be in NIDA's best interests, as well as the country's, for NIDA to actively support DEA licensing of Prof. Craker's privately-funded production facility.

In regard to my request that NIDA release additional information about Drs. Ricaurte and McCann's retracted MDMA research, you stated, "we believe that information has been made available to a variety of sources, including NIDA and the affected journals." While some information has been released, there are still more questions than answers. I appreciate and will take your helpful suggestion to request information directly from Drs. Ricaurte and McCann. Nevertheless, I think NIDA should be forthcoming with the information requested. To do otherwise leaves the impression that NIDA is not actively and aggressively trying to clear up this disturbing episode that has damaged the credibility of NIDA's educational efforts regarding the risks of MDMA and other illegal drugs.

You pointed out that "the dopaminergic neurotoxicity findings published by Dr. Ricaurte were not incorporated by NIDA into its publications or educational efforts." The caution you demonstrated in not immediately raising that particular alarm is admirable. I only wish such caution had been taken by NIDA before you arrived concerning the PET data published by Drs. McCann and Ricaurte, which was used as the basis of NIDA's anti- ecstasy educational campaign (the Plain Brain/Brain After Ecstasy image). I've enclosed an editorial by Stephen Kish, Ph.D., from Movement Disorders, which discusses the rush to implicate MDMA in Parkinson's, which NIDA itself wisely avoided. Dr. Kish's editorial also discusses newer, larger and more controlled PET research which contradicts reports by Drs. McCann and Ricaurte of massive serotonin reductions in Ecstasy users.

I fully agree with your statement that MDMA can be harmful. Tragically, it can even be deadly in certain rare circumstances. Precisely because of these genuine risks, it's essential to have credible educational messages.

You wrote, "Dr. Ricaurte is to be commended for his efforts in bringing this incident to the attention of the public and the scientific community." I wonder if you are making a virtue out of necessity? In a November 2003 article (enclosed) by Harry Shapiro in the magazine DrugLink, the claim is made that "It is also alleged that the error came to light when a student attempted to replicate the study and then made an official complaint when permission to publish the new findings [of no dopaminergic neurotoxicity] was denied. It is thought that Nora Volkow, newly installed Executive Director of NIDA, the research funder, intervened to ensure retraction." According to this version, which may or may not be accurate, you are the one who deserves to be commended.

You wrote, "NIDA can never be certain where the error occurred" A November 10, 2003 article in the Triangle Business Journal (enclosed) reports that Research Triangle Institute denies that it made the mistake of switching the bottles of MDMA and methamphetamine (and puts the cost of the retracted research at $1.3 million). If NIDA were to proactively release the information sought in MAPS' FOIA request, a careful review of the side effect profile of the research animals exposed by mistake to either MDMA or methamphetamine might help determine where and when the materials were switched, either at RTI or at Johns Hopkins. While I share your view that the mislabeling of the drugs was not intentionally done by Drs. Ricaurte or McCann, NIDA has a responsibility to continue to try to find out and make public what happened.

I'm expecting that DEA will soon give Dr. Mithoefer his Schedule I license so that MAPS will finally be able to start our research into the potential risks and benefits of the use of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder (PTSD). Perhaps in the future as our MDMA drug development effort moves forward, we can find ways to work together to educate the scientific and public community about the risks and benefits of MDMA.

Thank you again for responding to my messages. Most importantly, I deeply appreciate the many policies and procedures you have put in place to strengthen NIDA's position as a credible source of science-based information.

Sincerely yours,

Rick Doblin, Ph.D.
MAPS President