Dear Dr. Volkow,
I'm not sure if you realize this, but NIDA/HHS is seriously obstructing a privately-funded drug development program aimed at evaluating marijuana's potential use as an FDA-approved medication. As a result, NIDA is providing evidence supporting the view that its monopoly on the supply of marijuana for research is a fundamental problem. Furthermore, by blocking drug development research, NIDA/HHS is significantly bolstering the case for state-based medical marijuana laws and programs and judicial lawsuits seeking to make marijuana legally available to patients outside of FDA prescription use.
On June 24, 2003, Chemic Laboratories, a DEA-licensed analytical lab, applied to NIDA to purchase ten grams of marijuana for use in a MAPS-funded laboratory analysis study of the constituents of the vapors of marijuana released when marijuana is heated, but not combusted, in a vaporizer. Eleven months later, the NIDA/HHS review of Chemic's protocol to determine if it is "scientifically meritorious" has not yet been completed, effectively halting our research for almost a year. As I am sure you realize, this excessively lengthy review process completely undermines any program of research.
On October 12, 2003, three and a half months after Chemic's submission, Mr. Joel Egertson, senior drug policy advisor, Office of the Secretary of HHS, wrote to Chemic requesting additional information. It wasn't obvious why additional information was needed or why three and half months had gone by before any response.
On January 29, 2004, Mr. Egertson told Chemic that he was retiring as of January 30, 2004 and that further communications should be directed to RADM Arthur J. Lawrence, Ph.D., Assistant Surgeon General, Deputy Assistant Secretary for Health (Operations). Chemic submitted a somewhat revised protocol to Dr. Lawrence on January 30, 2004.
On March 17, 2004, Dr. Lawrence informed us that "the responsibility for conducting the reviews is in the process of being transferred to a different unit of the Department. At the moment, I don't have the ability to specify where this particular protocol is in the process." Dr. Lawrence has not responded to repeated inquiries over the last several months as to the status of the review.
On June 24, 2003, Chemic also applied to DEA to import ten grams of high- THC, high-CBD marijuana, which NIDA does not have available, from the Dutch Office of Medicinal Cannabis. DEA has indicated that it will not even review Chemic's application for an import permit until NIDA/HHS completes its review of the scientific merit of Chemic's protocol.
DEA has also not responded to an application submitted three years ago by Prof. Lyle Craker, Director of the Laboratories for Natural Products, Medicinal and Aromatic Plants, Department of Plant and Soil Sciences, for a license to establish a privately-funded growing facility to produce marijuana exclusively for federally-approved research.
On October 20, 2003, Senators Kennedy and Kerry wrote a letter to DEA Administrator Karen Tandy expressing their strong support for the licensing of the UMass Amherst facility. They wrote, "We believe that the National Institute on Drug Abuse facility at the University of Mississippi has an unjustifiable monopoly on the production of marijuana for legitimate medical and research purposes in the United States."
I appeal to you for assistance in resolving the serious problems with the NIDA/HHS process for reviewing applications for the purchase of marijuana for privately-funded research. Please expedite the review of Chemic's protocol.
Sincerely yours,
Rick Doblin, Ph.D.
MAPS President