Rear Admiral Arthur J. Lawrence
Assistant Surgeon General
Deputy Assistant Secretary for Health (Operations)
Dear Dr. Lawrence,
As the director of MAPS, the non-profit research and educational organization that is the co-sponsor (with California NORML) of the proposed vaporizer research by Chemic Labs, I'd also like to express my appreciation for your prompt reply to Mr. Scholten's message. Unfortunately, your reply is the only part of this entire process that has been prompt.
This set of protocol documents was submitted to your office over a month and a half ago (January 29, 2004). The initial set of documents was first submitted more than eight months ago (June 24, 2003) to NIDA and DEA. More than three and a half months after the initial submission, on October 10, 2003, Mr. Joel Egertson, Senior Drug Policy Advisor, Office of the Secretary of HHS, replied to Chemic Labs and stated, "It has been determined that there is insufficient information in the application to judge the merits of the proposal." As a result, an expanded and somewhat revised version was resubmitted on January 29, 2004.
The protocol itself is not unusually complicated, is being conducted by a highly professional analytical laboratory with extensive prior experience in this exact area of research, and has already been favorably reviewed in writing by a qualified peer scientist. As you may be aware, we are requesting to purchase 10 grams of marijuana from NIDA at a total price likely to be less than $100 and are requesting to import 10 grams of high-THC, high-CBD marijuana (a variety for which NIDA has nothing even close) from the Dutch Office of Medicinal Cannabis. HHS staff costs for the protocol review will far exceed the cost of the marijuana we are seeking to purchase and import.
The vaporizer research project is part of MAPS' efforts to work through the rigorous FDA drug review process to conduct exactly the sort of studies that DEA, ONDCP, NIDA, IOM, all claim to want to see conducted. Given the difficulties in purchasing a tiny amount of marijuana for this simple vaporizer research protocol, it should not be surprising why so many States have gone ahead and legalized the medical use of marijuana in one form or another without waiting for the FDA to approve its medical use on the basis of double-blind, randomized, placebo-controlled research. If there is anything that you can do to expedite the review process of the vaporizer protocol, I and many others, especially including quite a few doctors and patients, would greatly appreciate it.
Rick Doblin, Ph.D.