Congressman Mark Souder, Chairman of the U.S. House
Government Reform Subcommittee on Criminal Justice, Drug Policy, and
Human Resources, held a hearing about "Marijuana and Medicine: The Need
for a Science-Based Approach." MPP Executive Director Rob Kampia
During his comments, he discussed the importance of
MAPS’ vaporizer research efforts as well as the UMass Amherst project.
March 19, 2004. Dr. Donald Abrams receives word that his FDA-approved Phase I vaporizer study
is now ready to enroll subjects. He will be comparing cannabinoid and carbon monoxide levels and
subjective effects in subjects who at different times inhale either marijuana smoke from a burning
cigarette or marijuana vapors from the Volcano vaporizer. Being able to use a vaporizer in FDA-approved
clinical trials is one of MAPS’ two prerequisites to justifying the expense of a $5 million effort to
develop marijuana into an FDA-approved prescription medicine, the other prerequisite being an independent
source of supply of marijuana for research other than using material from the National Institute on Drug Abuse (NIDA).
March 17, 2004. In an effort to find out what is going on with the Health and Human Services (HHS) review of the scientific merit of the vaporizer protocol, an exchange of email took place today between Willem Scholten, Head of the Dutch Office of Medicinal Cannabis and Rear Admiral, Assistant Surgeon General and Deputy Assistant Secretary for Health (Operations) Arthur J. Lawrence.
Willem Scholten inquired about the status of the review.
Dr. Lawrence replied
that the responsibility for the review was being shifted from his office and at the moment he
didn’t know exactly to where or what was going on.
He was, however, sure that, " this protocol will, as all proposed protocols for this sort of research are, be
given fullest consideration and deliberation in the scientific review."
Somewhat dissatisfied with the review seemingly being on the slow track to nowhere,
MAPS President Rick Doblin replied to Dr. Lawrence.
He requested whatever help Dr. Lawrence
could offer in expediting the review, noting that the protocol was first submitted for review
on June 24, 2003 and that all we were asking for was to purchase 10 grams of NIDA marijuana and import 10 grams from the Dutch.
He concluded by stating, "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."
Also, Dr. Scholten informed MAPS that some vaporizer research with the same Volcano device was being conducted
in the Netherlands. We’ve sent a message to the researcher and look forward to collaborating and sharing information.
January 29, 2004. The scientific review of the vaporizer protocol being
conduced by the federal Dept. of Health and Human Services is now being
supervised by Assistant Surgeon General Arthur J. Lawrence Ph.D. Mr. Joel Egertson,
senior drug policy advisor to the Secretary of HHS, has retired and the
responsibility for the review has been reassigned. A revised and updated package of
information has been submitted today by Chemic Labs to Assistant Surgeon
General Lawrence. If HHS determines that the vaporizer protocol is
scientifically meritorious, NIDA will agree to sell us 10 grams of marijuana and DEA will
be required to address our request to import 10 grams of marijuana from the
Dutch Office of Medicinal Cannabis. The protocol is a rigorous investigation
and, if reviewed in an unbiased manner, will be determined to be scientifically
meritorious. MAPS initially requested permission in June 2003 to purchase
marijuana from NIDA and import marijuana from the Dutch. This delay is clear
evidence why NIDA’s monopoly on supply of research marijuana serves more to
obstruct than to facilitate marijuana research.
December 16, 2003. MAPS received a grant of $13,000 for further vaporizer
research from the Marijuana Policy Project. The grant includes $5,000 for the
writing of a scientific paper about the results of the research for submission
to a journal indexed in Medline. Also included is $8,000 for a study of the
cannabinoid content of each of the 1st, 2nd, and 3rd balloons created by the
Volcano vaporizer from the same sample of marijuana. We want to see if we can
eliminate the use of the 3rd balloon in clinical research if only minimal amounts
of cannabinoids are released the third time the same sample is heated and
vaporized. This study can be conducted only after we have been able to obtain
approval from HHS to purchase 10 grams of marijuana from NIDA, a time-consuming
hurdle that wouldn’t be necessary if MAPS had its own independent source of
supply of marijuana that could be used in federally-approved research (as we have
with MDMA and psilocybin, for example).
December 4, 2003. The manufacturers of the
that MAPS and CaNORML are using in our vaporizer research, STORZ & BICKEL GMBH & CO. KG,
announce that they have received the Dr. Rudolf Eberle Prize,
the prize for innovation of the State of Baden-Wurttemberg. This prize has been
on an annual basis since 1985 to small and medium-sized industrial and craft firms who
have successfully implemented outstanding technical innovations. The prize
committee uses the criteria of technical progress, special entrepreneurial
achievement and the economic success of the innovation to make its decision.
November 14, 2003. Vaporizer protocol likely to start early in 2004.
According to Dr. Donald Abrams, "As far as I know we are awaiting our award from
CMCR. All approvals are granted and we plan to commence the vaporizer protocol
in January 2004."
October 10, 2003.
The analytical lab conducting the vaporizer research has
received replies from NIDA and the DEA regarding its requests to import 10
grams of marijuana from the Dutch Office of Medicinal Cannabis and to purchase 10
grams from the National Institute on Drug Abuse (see entry below for June 24,
2003). The reply from NIDA came from Joel Egertson, Senior Drug Policy
Advisor to the Secretary of Health and Human Services (HHS). Mr. Egertson wrote,
"It has been determined that there is insufficient information in the
application to judge the merits of the proposal. " Mr. Egerston had been submitted the
protocol for which the 10 grams was requested but asked for additional
information that has already been generated from previous research protocols and has
already been submitted to the FDA. This additional information will be
submitted to Mr. Egerston very soon for HHS review.
The reply from DEA indicated that it would not proceed with the import permit
until the scientific merits of the protocol had been accepted by HHS.
While a decision on these requests has been delayed, we believe we can
adequately address all the issues raised by HHS and DEA. Yet again, this prolonged
process to purchase tiny quantities of marijuana for important privately-funded
research demonstrates the need for MAPS to sponsor a privately-funded
facility to produce marijuana for federally-approved research, as we are attempted to
do in partnership with Prof. Craker at UMass Amherst.
June 24, 2003. Grant for Vaporizer Study with Humans Approved Contingent upon Regulatory Approval. California’s Center for Medicinal Cannabis Research (CMCR) preliminarily approved Dr. Donald Abrams’ Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000, contingent upon the protocol obtaining all the necessary regulatory approvals. The study will compare subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath in subjects on six different days, three days smoking 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC, and three days vaporizing 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC.
The protocol now goes to FDA for its review, finally. The big question is whether the FDA will want more data than MAPS and California NORML have already gathered on the Volcano (www.vapormed.de) or will accept the data we have already submitted, which is more than FDA has about what is in marijuana smoke post-combustion. We should hear from FDA within 4-6 weeks or so.
Also reviewing the protocol will be NIDA (since NIDA pot is being requested), DEA (supposedly to see what it can do to prevent the diversion of research supplies), and the Research Advisory Panel of California (which reviews all Schedule I research in California). The key review will be by FDA, since it will decide whether or not MAPS and California NORML need to raise more funds for additional vaporizer research.
June 24, 2003. Maps Working to Import Dutch Cannabis for Research. MAPS has completed negotiations with the head of the Dutch Office of Medicinal Cannabis for the importation of ten grams of high THC, high CBD marijuana for use in the next phase of the vaporizer research project. Chemic Laboratories, where the project will be conducted, has submitted an application to the DEA for an import license. This request to the DEA is, to our knowledge, the first attempt to import the marijuana plant from the Netherlands, through the newly established Office of Medicinal Cannabis. Chemic Laboratories has also submitted a request to NIDA for ten grams of its best quality product for the vaporizer project.
"Study Shows Vaporizer Can Drastically Reduce Toxins in Marijuana Smoke"
California NORML/ MAPS Press Release — May 2, 2003
"Vaporizer Research: An Update" (PDF Format)
MAPS Bulletin, Spring 2003; Volume XIII, Number 1
April 15, 2003. Vaporizer Study Report. The Vaporizer report is now
available. The findings show substantial reduction (about 99%) in certain
toxins in the vapor as compared to marijuana smoke, and substantial amounts
of cannabinoids produced by the vaporizer. The results could hardly have been
better. This report has been submitted to FDA as part of Dr. Donald Abrams’
IND application to study subjective effects and cannabinoid blood levels in
subjects who both smoke marijuana and then at a later time inhale marijuana
vapors. We should hear from FDA in early May about what additional
information, if any, it needs to have before deciding if the vaporizer can be
used in a clinical trial.
January 21, 2003. MAPS and CANorml sign a contract for a $25,000
protocol study to evaluate the contents of the vapor stream from the Volcano
Vaporizer (http://www.vapormed.de). The
purpose of the study is stated in the contract as follows: This protocol is
intended to provide guidance on the completion of an extraction evaluation of
emissions produced when marijuana is vaporized using the Volcano; to provide
evidence of product efficiency to MAPS, which would subsequently design and
seek agency (FDA) approval for the protocol development and initiation of a
Phase I clinical investigation comparing cannabinoid blood levels in subjects
smoking (i.e. pyrolysis) marijuana versus marijuana vaporized with the Volcano,
and to meet the requirements of cGMP: 21 CFR Part 160.
We expect the study to be completed by the end of March 2003.