Smokin Moose
Fallen Cannabis Warrior & Ex Moderator
MAPS, in conjunction with California NORML, has been working for quite a few years to sponsor scientific research into the effects of vaporizers and waterpipes. We have conducted laboratory research testing the content of combusted and vaporized marijuana for cannabinoid and toxin levels but have been stalled since June 2003 waiting for NIDA to review a request to purchase 10 grams of its marijuana to continue our research.
We learned early on that waterpipes don't help filter out undesirable particulate matter, although waterpipes may help reduce certain water-soluble gases. In contrast, vaporizers do eliminate combustion products and address the Institute of Medicine's preference for non-smoking delivery systems for the medicinal use of marijuana. Furthermore, vaporizers are the only non-smoking delivery system that uses the marijuana plant, unlike marijuana extracts in spray, lozenge, drops, or pill form, and could conceivably be used in conjunction with material that patients grow themselves.
While the use of vaporizers in medical marijuana research is the most politically desirable route, since they don't involve smoking, we plan to include groups that smoke as well as vaporize marijuana in future studies. We would be surprised if there are significant differences in safety and efficacy for most patients and feel that this is an issue that needs to be resolved scientifically.
California's Center for Medicinal Cannabis Research (CMCR) approved Dr. Donald Abrams' Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000. 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. This study will start enrolling subjects in Summer 2004.
The protocol has also been reviewed and approved by the FDA. The vaporizer that Dr. Abrams will use is the Volcano.
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. _In June 2003,_ Chemic Laboratories, where the project will be conducted, 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. Unfortunately, DEA has refused to review the import permit request until NIDA decides the protocol is "scientifically meritorious" and NIDA has let the request languish unevaluated since June 2003. NIDA is clearly doing its best to provide evidence supporting our argument that we need an independent source of supply.
On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits against DEA and also against HHS/NIH/NIDA for obstructing medical marijuana research, and on July 29, 2004, MAPS filed a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.
On September 21 and 29, the first and second subjects were enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana from a vaporizer.
On October 13, 2004, MAPS and MPP filed our amicus curiae brief in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research, as evidenced by DEA's lack of response to Chemic's application for a permit to import 10 grams for further vaporizer research from the Dutch Office of Medicinal Cannabis, and HHS/NIH/NIDA's lack of response to Chemic's application to purchase 10 grams for further vaporizer research. Oral arguments in the case are scheduled for November 29, 2004.
On November 22, 2004, the Court required DEA to respond by December 22, 2004 to the portion of our lawsuit against DEA about the UMass Amherst marijuana production facility. This is a positive development in that DEA can no longer just delay and not have to explain why.
On December 3, 2004, MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 1/2 months to our applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.
For further background, also see:
Cannabis Vaporizer Combines Efficient Delivery of THC with Effective Suppression of Pyrolytic Compounds, by Dale Gieringer, Joseph St. Laurent, Scott Goodrich. Journal of Cannabis Therapeutics, (2004) 4(1): 7-27.
"Study Shows Vaporizer Can Drastically Reduce Toxins in Marijuana Smoke"
California NORML/ MAPS Press Release – May 2, 2003
"Vaporizer Research: An Update"
Dale Gieringer, Ph.D. canorml@igc.apc.org, MAPS Bulletin, Spring 2003; Volume XIII, Number 1
Chemic Laboratory research report April 15, 2003.
Project status:
November 27, 2007.
SYNOPSIS OF DEA RESCHEDULING DRONABINOL
In late September, DEA proposed a new rule that would effectively place dronabinol (the active chemical in MARINOL) in Schedule III.
Wait a second, isn't MARINOL already in Schedule III?
It is. When MARINOL was first marketed, it was placed in Schedule II. Once DEA was shown that it had a low potential for abuse, they agreed to place it in Schedule III. But the narrow language only places in Schedule III MARINOL's specific formulation (synthetically derived dronabinol, suspended in sesame oil). All other formulations remain in Schedule I.
Now that the MARINOL patent is almost up, Professor ElSohly (yes, the same man who runs the only federally-approved marijuana growing facility) has a contract to supply would-be generic manufacturers of MARINOL. They petitioned DEA to re-schedule ALL formulations of dronabinol, whether or not the chemical is suspended in sesame oil, and whether or not the chemical is sourced from whole-plant marijuana. That's right, folks! DEA may soon allow an FDA-approved medication to be derived from the marijuana plant.
In order to applaud this change in thinking, and to insist that the NIDA monopoly be lifted, MAPS submitted a public comment to the Federal Register about the proposed new rule. The focus of the comment is the issue of fairness; namely, it is absolutely ridiculous that DEA would re-schedule the active ingredient in MARINOL at the behest of a private producer for private profit, all the while refusing to approve Professor Craker's bid to grow marijuana for non-profit, research purposes.
See a PDF of MAPS Public Comment on Docket No. DEA-308P; 72 Fed.Reg. 54226 (Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols).
June 29, 2007. Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS' campaign to break the federal government's illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA's standards for safety and efficacy.
May 16, 2007. Two new studies, one from University of California-San Francisco, and the other from SUNY-Albany, provide strong evidence that vaporization has promising potential as a method of medical marijuana delivery. The first study, published online by the journal Clinical Pharmacology and Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and compared a commercially available vaporizer to smoking in 18 volunteers. The researchers found that, "vaporization of marijuana does not result in exposure to combustion gases, and therefore is expected to be much safer than smoking marijuana cigarettes." Dr. Abrams was able to obtain permission from FDA to conduct his study based in part on data on the composition of the ingredients in marijuana vapor gathered in research sponsored by MAPS and CaNORML. That line of MAPS-sponsored research is currently blocked since NIDA has refused to sell marijuana for additional studies. Click here to read Dr. Abrams' full report.
The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and published in Harm Reduction Journal, was based on an extensive survey of over 7,000 marijuana users. After adjusting for variables such as age and cigarette use, Earleywine found that vaporizer users were 60 percent less likely than smokers to report respiratory symptoms such as cough, chest tightness or phlegm, and that the effect of vaporizer use was more pronounced the larger the amount of marijuana used. Click here to read Dr. Earleywine's full report.
MAPS hopes to eventually put vaporized marijuana through FDA clinical trials, but has been stalled since June 2003 because of NIDA's monopoly on the supply of research-grade marijuana. Research into alternative delivery methods such as vaporization was one of the primary recommendations of the Institute of Medicine's landmark 1999 report on medical marijuana.
Marijuana vaporization is an effective delivery method because it has the rapid action and easy dose adjustment of inhalation, but without the respiratory hazards associated with smoking. Unlike smoking, a vaporizer does not burn the plant material, but heats it just to the point at which THC and cannabinoids vaporize into steam.
May 15, 2007.
Today MAPS recieved a copy of the "Transmittal Letter" sent by ALJ Judge Mary Ellen Bittner to the DEA, transferring the record in the Craker matter to the DEA's Deputy Administrator, Michelle Leonhart on May 15, 2007. The letter was accompanied by this note:
1316.67 Final order
As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his final order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which date shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that the public interest in the matter necessitates an earlier effective date, in which event the Administrator shall specify in the order his findings as to the conditions which led him to conclude that an earlier effective date was required.
So let the "practicable" clock begin . . .
The Walrus published a fascinating article entitled "Peaking on the Prairies" that describes Dr. Humphrey Osmond's extensive psychedelic therapy research program in the 1950's.
March 17, 2007. On February 16, MAPS President Rick Doblin met with Joe St. Laurent and Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed the development of a new vaporizer research protocol to submit to NIDA for review, once again seeking to purchase 10 grams from NIDA and seeking DEA permission to import 10 grams of high THC/high CBD marijuana from the Netherlands, with a cannabinoid content that NIDA doesn't have available. The design work and the study itself, should we eventually obtain approval from NIDA, will be co-funded by MAPS and CaNORML, as have all our previous vaporizer research projects.
This new protocol seeks to analyze the constituents of the vapor produced in the Volcano vaporizer, from samples of NIDA marijuana that contain THC and samples of imported marijuana that contain both THC and CBD. During the meeting at Chemic, we reviewed in detail the critiques of the original vaporizer research protocol that the PHS/NIDA reviewers offered back in August 2005. We will make a few changes in the protocol so that this will be a new submission and we will respond in detail to each critique. The proposed methodology will call for testing at various temperatures, and will measure for carbon monoxide levels, cannabinoids and certain particulates.
PHS/NIDA's handling of the original version of this protocol was another classic case of the dysfunctional nature of NIDA's monopoly on research-grade marijuana. After waiting for more than two years for PHS/NIDA to review the protocol, during which time we unsuccessfully sued NIDA for unreasonable delay in the DC Circuit Court of Appeals, the critique that was finally issued contained several important misunderstandings and seemed to come from people who had barely even read the protocol. Chemic filed a response to the critiques in September 2005, which PHS/NIDA has totally ignored for more than 17 months. There seems to be no appeal process at all in the PHS/NIDA review of medical marijuana research proposals and there are certainly no deadlines that compel PHS/NIDA to respond within any reasonable period of time. This is in contrast to FDA, which must reply to protocol submissions within 30 days and has a clearly defined and prompt appeal process.
The new vaporizer protocol will be submitted to NIDA in April. Then, we anticipate a long wait. NIDA has successfully ignored Chemic's response to its critiques but it will be more difficult for NIDA to ignore a new protocol submission.
October 19, 2005. October 19, 2005. Mother Jones Magazine publishes, "Respectable Reefer," an excellent article about medical marijuana by Gary Greenberg that discusses GW Pharmaceuticals, MAPS and drug war politics.
September 10, 2005. At the International Association for Cannabis as Medicine 3rd Conference, held in Leiden, Holland, Mr. Hector Vizoso, study coordinator for Dr. Donald Abrams' study of smoking v. vaporizing, discussed the results of their clinical trial in humans comparing cannabinoid blood levels, carbon monoxide levels, and subjective effects in subjects who smoke and at other times vaporize marijuana (with the Volcano vaporizer). When subjects used vaporizers, the study found reductions in blood carbon monoxide levels as compared to smoking. In addition, the study showed that the vaporizer produced reliable levels of cannabinoids. The study also found that more subjects preferred vaporizing over smoking. This study was funded by a grant of about $136,000 from the Center for Medicinal Cannabis Research (CMCR). MAPS and CaNORML contributed an additional $100,000 on preliminary laboratory data analyzing the content of the vapors produced by the Volcano vaporizer.
Results of a second paper on vaporization (with the Volcano vaporizer) were presented by Arno Hazekamp, Ph.D, of Leiden University. This study "confirms that the pulmonary administration of cannabinoids by evaporation certainly has a clinical potential. With the Volcano a safe and effective cannabinoid delivery system seems to be available to patients."
September 9, 2005. Chemic Laboratories sends a letter to Assistant Secretary for Health Joel Egertson, responding to his July 27, 2005 letter (received August 15, 2005) rejecting Chemic's June 2003 application to NIDA to purchase 10 grams of marijuana for further vaporizer research. Chemic's letter rebuts every critique of the protocol used by Mr. Egertson and urges him to reconsider. After taking over two years to reply, HHS/NIDA's protocol reviewers didn't take the time to read the protocol carefully and made some rather basis mistakes in the review. HHS/NIDA's refusal to sell Chemic 10 grams of marijuana for MAPS-sponsored vaporizer research is yet another example of the need to break NIDA's monopoly on the supply of marijuana that can be used in legal research.
August 18, 2005. The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.
August 15, 2005. Chemic Laboratories receives a response letter from the Department of Health and Human Services (view as html), rejecting the vaporizer protocol and recommending that NIDA not sell Chemic 10 grams of laboratory-grade marijuana for the vaporizer studies. This response took more than two years and arrived, coincidentally and conveniently, just one week before the start of the DEA Administrative Law Judge hearings over DEA refusal to grant a license to Prof. Craker, UMass Amherst, for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Chemic's reply to the critiques was sent to HHS/NIDA on September 9, 2005.
July 26, 2005. U.S. Congressional Representatives John Olver (D-MA) and Michael Capuano (D-MA) have sent a letter to DEA Administrator Karen Tandy urging DEA to issue a license to Prof. Craker for his MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. This letter will be sent to other members of Congress seeking additional signatures.
Prof. Lyle Craker filed his updated and final prehearing statement in his DEA Administrative Law Judge hearing regarding DEA refusal to issue him a license to establish a MAPS-sponsored facility to grow marijuana for federally-approved research. DEA also filed an updated prehearing statement with additional witnesses, demonstrating that DEA will spare no expense in trying to show that blocking medical marijuana research is somehow in the public interest. Testimony begins on August 22, 2005.
July 22, 2005. DEA files a motion seeking to disqualify four of our proposed witnesses. We'll prepare a reply within the next several weeks.
June 20, 2005. San Francisco Chronicle writer Joe Garofoli reports on the completion of the nation's first clinical human study on vaporization at UCSF. He gives an overview of vaporizer benefits and use, and informs readers how to obtain affordable vaporizers.
A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation, Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.
December 10, 2004. After almost 18 months, DEA finally responds to the applications from Chemic Laboratories to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis, and to purchase 10 grams of marijuana from NIDA, for further vaporizer research. DEA claims that Chemic actually needs a "Research" license instead of an "Analytical Laboratory" license, which may take another 4-6 months to obtain. DEA's rationale is not stated but it seems that they now consider the research to be publicly funded, which requires a "Research" license. However, this research is not publicly funded. DEA's theory seems to be that since the analytical data has been used by Dr. Donald Abrams to obtain FDA permission for a clinical study comparing smoked v. vaporized marijuana, in a study funded by the State of California, that Chemic's privately-funded research is actually publicly funded. Chemic will immediately file for a "Research" license and we will seek more information about DEA's rationale.
December 7, 2004. Rep. Sam Farr (D-CA) has sent out a Dear Colleague letter to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr's letter questions whether NIDA is unbiased and cites NIDA's refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA's monopoly on supply, which it uses to obstruct research.
December 3, 2004. MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 ½ months to our applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.
November 29, 2004. We have a decision regarding MAPS' lawsuits against DEA and against HHS/NIH/NIDA regarding our claim of "unreasonable delay" in responding to MAPS-sponsored applications to NIDA to purchase 10 grams of marijuana for vaporizer research (submitted June 24, 2003), to DEA to import 10 grams of marijuana for vaporizer research from the Dutch Office of Medicinal Cannabis (submitted June 24, 2003), and to DEA for a license to grow marijuana for research at UMass Amherst (submitted June 2001).
MAPS's lawyer's assessment: The decision is very particular about the applications delayed, so they obviously read & at least partially understood what was what. Unfortunately, 17 months delay to the court (unlike patients needing pain relief) is no biggie, so we lose on compelling action on the application to HHS/NIDA to purchase 10 grams for research and on the application to DEA to import 10 grams. The 3 1/2 year delay in DEA non-response to the UMass Amherst application for a license to grow marijuana for research trips the further inquiry wire at DEA, however, so there apparantly is a chance for some oversite. Reconsideration (of the outright denials) must be filed within 14 days [5pm Dec. 6], which we will file.
Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.
November 22, 2004. The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."
November 11, 2004. MAPS initiates work on a legal motion for expedited scheduling of our lawsuits against DEA and against HHS/NIH/NIDA. It's now been more than 3 1/2 months since July 21, 2004, when MAPS, Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, and Prof. Lyle Craker, UMass Amherst, filed a lawsuit against DEA, and MAPS and Valerie Corral filed a lawsuit against HHS/NIH/NIDA.
The lawsuits claimed that the agencies were engaging in unreasonable delay in not responding to MAPS-sponsored requests to grow, import and purchase marijuana for a program of scientific research designed to develop marijuana into an FDA-approved prescription medicine. We hope the motion for expedited scheduling will get this case before the judge sooner than if we were to do nothing. The lawsuits have been filed in the United States Court of Appeals for the District of Columbia Circuit.
October 13, 2004. MAPS and MPP filed our amicus curiae brief today in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research. The goal of the brief is to educate the Supreme Court judges so that they don't rule against medical marijuana patients under the false assumption that the FDA drug development approach is a viable alternative to state medical marijuana initiatives and legislative actions. As long as the obstruction of MAPS' medical marijuana research efforts continues, the only way that patients can obtain legal access to the medical use of marijuana is through the decision of the 9th Circuit Court of Appeals, which decided that there was no interstate commerce involved when patients or caregivers grow marijuana for patients' personal medical use. That decision prohibited the federal authorities (DEA) from enforcing the Controlled Substances Act prohibitions against the use of marijuana, which the 9th Circuit judges declared unconstitutional when applied against patients or caregivers growing marijuana in states that had approved such use. MAPS and MPP's brief transforms our failure to obtain the necessary permissions and supply of marijuana for MAPS' research efforts into a weapon against the forces of repression (DEA and the Drug Czar ).
September 29, 2004. The second subject is enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The first subject was enrolled on September 21, 2004 (see that entry for more details about study design). This study is now well underway!
September 21, 2004. The first subject was enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The study requires subjects to live on an in-patient ward for 6 days, with each day involving either smoking marijuana or using the vaporizer. The research involves the use of 3 different marijuana cigarettes, one with 1.7 % THC, one with 3.5% THC and one with 7% THC. The cigarettes are cut in half and used in a randomized, double-blind manner, with half of each cigarette being smoked and the other half unrolled and the marijuana placed in the vaporizer.
July 29, 2004. MAPS files a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.
July 22, 2004. Newspapers around the country have carried an AP wire story on MAPS' lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.
July 21, 2004. MAPS, Prof. Lyle Craker and Valerie Corral, file lawsuits against DEA and against HHS/NIH/NIDA for obstructing medical marijuana research. MPP sends out a press release..
June 9, 2004. NIDA Director Dr. Nora Volkow responds to MAPS' letter of May 19, as well as MAPS' May 24, 2004 letters to HHS Secretary Tommy Thompson and Director of the National Institutes of Health Dr. Elias Zerhouni. Dr. Volkow writes, "As you know, NIDA is just one of the participants on the HHS review panel...It is not NIDA's role to set policy in this area...Moreover, it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for the establishment of facilities to support this research. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns."
Conspicuosly missing from Dr. Volkow's letter was any information whatsoever about where in the process is the review of the vaporizer protocol. As a result, MAPS is now considering a lawsuit against HHS/NIDA claiming "unreasonable delay" under the Administrative Procedures Act.
May 19, 2004. MAPS has sent a letter to NIDA Director Dr. Nora Volkow, and all members of NIDA's National Advisory Council on Drug Abuse (NACDA), asking them to expedite the NIDA/HHS review of Chemic's vaporizer research protocol. Chemic initially submitted the protocol to NIDA on June 24, 2003, as part of a request to purchase 10 grams of NIDA's marijuana needed for the study. MAPS' letter explains that there has so far been an eleven month delay in MAPS' research agenda, while MAPS waits to see if NIDA/HHS considers the protocol to be "scientifically meritorious" and therefore worthy of the privilege of purchasing NIDA's low-potency marijuana. The letter protests that this is an unreasonable delay of MAPS' efforts to conduct research to evaluate marijuana's potential use as an FDA-approved prescription medicine. The letter informs Dr. Volkow and the members of the NACDA that NIDA/HHS is doing its best to provide clear and persuasive evidence that NIDA's monopoly on the supply of marijuana for research is a fundamental obstruction that must end, preferably with DEA licensing of the UMass Amherst production facility.
April 1, 2004. 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 testified (video and transcript) and answered questions (video and transcript). 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 Volcano vaporizer 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 awarded 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)
Dale Gieringer, Ph.D. (canorml@igc.apc.org)
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 (https://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.
Here are urls for various vaporizers:
* www.vapormed.de
* Home
* Air-2.com: Makers of the Vapir Digital Herbal Vaporizer
* vaporeizer engels
* research&experience
# "MAPS/NORML Study Shows Vaporizers Reduce Toxins in Marijuana Smoke"
Dale Gieringer, Ph.D.
NORML California State Coordinator (canorml@igc.apc.org)
MAPS Bulletin, Spring 2001. Volume XI, Number 2.
Medical marijuana patients may be able to protect themselves from harmful toxins in marijuana smoke by inhaling their medicine using an electric vaporizer, according to initial results of a study by the Multidisciplinary Association for Psychedelic Studies (MAPS) and California NORML. Research expenditures to date are roughly $50,000.
The study showed that it is possible to vaporize medically active tetrahydrocannabinol (THC) by heating marijuana to a temperature short of the point of combustion, thereby eliminating or substantially reducing potentially harmful smoke toxins that are normally present in marijuana smoke. Vaporizers may therefore substantially reduce what is widely regarded as the leading health concern associated with marijuana, namely respiratory harm due to smoking. In addition, many medical marijuana patients say they prefer vaporizers because they deliver smoother, less irritating medication.
MAPS and NORML sponsored the study in the hopes of helping medical marijuana patients and others reduce the health risks of smoking marijuana. A major obstacle to approval of natural cannabis by the Institute of Medicine (IOM) in its 1999 report, "Marijuana and Medicine," was that smoking is an "unhealthy" delivery method. The IOM report failed to note the possibility of vaporization. The MAPS-NORML study tested a device called the M1 Volatizer(R), an aromatherapy vaporizer developed by Alternative Delivery Systems, Inc. It consisted of an electric heating element in a chamber that radiates heat downwards over a sample of marijuana contained in a standard bowl. Output from the vaporizer was analyzed and compared to smoke produced by burning the sample.
The vaporizer produced THC at a temperature of 200° C. (392° F.) while completely eliminating three measured toxins - benzene, a known carcinogen, plus toluene and naphthalene. Temperatures of around 200° C. appear to be most efficient for vaporization. The potency of the cannabis in the study was on the order of 10% - 12%. Significant amounts of THC (around 5%-6%) begin to be released at 180° C., with slightly more (7% or 8%) at 200° C. Carbon monoxide and smoke tars were both qualitatively reduced by the vaporizer, but additional testing is needed to quantify the extent of the decrease.
The vaporizer study was undertaken as a follow-up to a previous MAPS-NORML marijuana smoking device study, which concluded that vaporizers offered the best prospects for smoke harm reduction: MAPS - Volume 6 Number 3 Summer 1996 -
MAPS and NORML are currently seeking support for further research and development of vaporizers. Research is presently underway to explore the optimal temperature and conditions for vaporization. An additional $85,000 is needed to provide accurate measurement of carbon monoxide and other toxins, such as polycyclic aromatic hydrocarbons. Further studies may be needed to explore alternative device designs and the effects of different consistencies, potencies and preparation methods of the samples of marijuana.
PDF version of this document
# "Marijuana Water Pipe and Vaporizer Study"
Dale Gieringer, Ph.D. (canorml@igc.apc.org
MAPS Bulletin, Summer 1996. Volume VI, Number 3.
September 21, 2000 update: MAPS and CA-NORML are sponsoring a new vaporizer study. Testing and data analysis have been completed. A detailed report will be issued soon. The design and cost of additional studies are currently being discussed with the analytical lab.
The new study is a $25,000 proof of principle study designed to determine if marijuana vaporizers can indeed reduce particulate matter and carbon monoxide as compared to the combustion of marijuana. We have a very high-tech lab doing the research, but unfortunately the lab wants to remain anonymous. They are concerned about becoming known as a place with marijuana (all they have is 5 grams!), but the major reason for their reluctance to get publicity is due to industrial espionage. They do lots of work for major pharmaceutical companies who want discretion, so they don't advertise. I was personally recommended to them by an organic chemistry company that is making psilocybin for MAPS for a U. of Arizona study of psilocybin in the treatment of OCD.
Anyway, the results of the vaporizer study do show substantial reductions in particulate matter and in carbon monoxide. I conceive of this study as contributing to the argument in favor of permitting patients to grow and use their own marijuana, instead of having to purchase patented, FDA-approved cannabinoid or marijuana-extract products from Unimed or GW Pharmaceuticals. Vaporizers are the only non-smoking marijuana delivery systems that can be used with home-grown marijuana. We are trying to create evidence to show that there is a favorable risk/benefit ratio from using high-potency marijuana in vaporizers.
The main tradeoffs that patients will face are slightly highly but probably not clinically significant health risks but lower price from high-potency marijuana delivered in vaporizers as compared to Unimed or GW products. Efficacy will probably be similar. The health effect of wealth (the impact on the health of patients from the extra money they save from using home-grown in vaporizers as compared to other products) will, perhaps, outweigh the additional health risks. This is all speculative and there is certainly a major need for FDA-approved products that can be paid for by insurance, since home-grown used with vaporizers will probably not become approved by FDA anytime soon, at least not in the current political climate.
See also:
Why Marijuana Smoke Harm Reduction?
The Struggle to Do Medical Marijuana Research
Medical Cannabis Potency Testing Project
Contrary to popular impression, waterpipes don't necessarily protect smokers from harmful tars in marijuana smoke, according to a new study sponsored by MAPS and California NORML (National Organization for the Reform of Marijuana Laws). The reason is that waterpipes filter out more psychoactive THC than they do other tars, thereby requiring users to smoke more to reach their desired effect. The study does not rule out the possibility that waterpipes could have other benefits, such as filtering out gases, but it suggests that other methods, such as the use of high potency marijuana, vaporizers, or oral ingestion are needed to avoid harmful toxins in marijuana smoke.
Seven Devices Tested
The study, which was supported by the Drug Policy Foundation and private donors, was conducted at a research lab with expertise in the analysis of various chemical properties of tobacco and marijuana. Researchers tested the smoke from seven different sources: a regular rolled joint, a joint with a cigarette filter, three different waterpipes, and two vaporizers, designed to heat marijuana to a temperature where psychoactive vapors form without producing smoke. The waterpipes included a standard bong (Picture #1), a small portable device with a folding pipestem (Picture #6), and a battery-operated model with a motorized paddle to thoroughly mix the smoke in the water (Picture #3). The first vaporizer (Picture #5), commercially produced in Canada, consisted of a battery-powered metal hot plate inside a jar to trap the marijuana vapor. The second (Picture #4) was a homemade, hybrid apparatus, in which vapors were produced by a hot air gun and then drawn through a beaker of water, thereby combining vaporization with water filtration. The smoke was produced from standard NIDA-supplied marijuana drawn through a smoking machine adjusted to mimic the puff length of marijuana smokers.
Focus: Cannabinoid/Tar Ratio
The study focused on two key components of the smoke: (1) total solid particulates, or tars, which are noxious waste by-products of burning leaf like those from tobacco; and (2) cannabinoids, the chemicals distinctive to marijuana, including its major psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), and its two commonest chemical relatives, cannabinol (CBN) and cannabidiol (CBD), which are only weakly psychoactive but may have medical benefits.
Like tobacco, marijuana tars are rich in carcinogenic compounds known as polycyclic aromatic hydrocarbons, which are a prime culprit in smoking-related cancers. However, cannabinoids themselves are not carcinogenic. An obvious way to protect smokers' health is therefore to minimize the content of smoke tars relative to cannabinoids.
One way to do this is to increase the THC potency of the marijuana. Assuming smokers adjust their smoke intake to the cannabinoid dosage, the higher the concentration of cannabinoids, the lower the amount of tars they are likely to consume.
Another strategy is to try to reduce the tars in the smoke with some kind of filtering device. Obviously, this is beneficial only to the extent that THC isn't also reduced, thereby inducing users to smoke more to compensate. A major aim of the study was to determine the efficacy of various smoking devices at reducing the concentration of tars relative to cannabinoids. The performance of each device was accordingly rated in terms of the cannabinoid-to-tar ratio in its smokestream.
Joints and Waterpipes
Surprisingly, the unfiltered joint outperformed all devices except the vaporizers, with a ratio of about 1 part cannabinoids to 13 parts tar. This disturbingly poor ratio may be explained by the low potency of the NIDA-supplied marijuana used in the study, which was around 2.3%.
Disappointingly, waterpipes performed uniformly worse than the unfiltered joint. The least bad waterpipe, the bong, produced 30% more tar per cannabinoids than the unfiltered joint. Ironically, the pipe with the electric mixer scored by far the worst of any device. This suggests that water filtration is actually counterproductive, apparently because water tends to absorb THC more readily than noxious tars. Like the waterpipes, the cigarette filter also performed worse than the unfiltered joint, by about 30%. Researchers speculate this is because cannabinoids are exceptionally sticky and adhere to other solids. Hence, any filtration system that picks up particulates is likely also to screen out cannabinoids.
Vaporizers
The vaporizer results appeared more promising, but confusing. The two vaporizers were the only devices to outscore unfiltered joints in terms of raw cannabinoid/tar ratio. The electric hotplate vaporizer did best, with a performance ratio about 25% higher than the unfiltered joint. The hot air gun was just marginally superior, but might have done better had it not been for its water filtration component.
However, the situation was complicated by the fact that the cannabinoids produced by the electric hotplate vaporizer were unusually high in CBN, leaving 30% less THC as a percentage of the total cannabinoids than with the other smoking devices. Since CBN is not psychoactive like THC, recreational users might be expected to consume more smoke to make up for the deficit. (The situation may be different for medical users, who could experience other, medicinal benefits from CBN). For this reason, it seemed advisable to recompute the performance efficiencies of the vaporizers in terms of THC, rather than all cannabinoids. When this was done, the electric hotplate vaporizer turned out to have a lower THC/tar ratio than the unfiltered joint, while the hot air gun was still marginally higher.
The reason for the excess CBN from the hotplate vaporizer remains unexplained. Because CBN is produced from THC by chemical oxidation, it has been suggested that the device somehow exposed the sample to too much oxygen. However, there is no evidence that this was the case. As for the second, hybrid vaporizer, it seems likely that its performance could have been improved by deleting its water component.
The results clearly indicate that more developmental work needs to be done on vaporizers. Theoretically, an ideal vaporizer could minimize production of tars by holding the temperature above the point at which THC vaporizes, but below that where carcinogenic hydrocarbons are produced by combustion [Note] In practice, both vaporizers produced over ten times more tars than cannabinoids, indicating that there is plenty of room for improvement.
In the late 1970s, a vaporizer known as the Tilt appeared on the market. According to the manufacturer, laboratory tests showed that it released 80% more THC and 79% less tar than a regular pipe, a performance ratio almost ten times better than any observed in this study. It is to be hoped that these impressive results can be replicated in the future. Unfortunately, the Tilt was withdrawn from the market in the early 1980s due to the passage of anti-paraphernalia laws.
As for waterpipes, the prospects for improvement appear more dubious. It has been suggested that the performance of waterpipes could be improved by using liquids other than water or by changing the temperature of the liquid. However, it seems doubtful whether such tactics would circumvent the basic problem of separating the tars from the sticky cannabinoids.
Are Waterpipes Counterproductive?
The study results are obviously discomforting to waterpipe enthusiasts, many of whom prefer the cooler, milder smoke they produce, and have naturally assumed it is also more healthful. Unfortunately, however, the study indicates that waterpipes may actually be counterproductive in increasing consumption of carcinogenic tars.
Nonetheless, it is still premature to judge that waterpipes are actually unhealthful, since they may filter out other, non-solid smoke toxins occurring in the gas phase of the smoke, which was not analyzed in the study. Noxious gases known to occur in marijuana smoke include hydrogen cyanide, which incapacitates the lung's defensive cilia; volatile phenols, which contribute to the harshness of the taste; aldehydes, which promote cancer; and carbon monoxide, a known risk factor in heart disease. Previous studies indicate that water filtration may be quite effective in absorbing some of these [Nicholas Cozzi, Effects of Water Filtration on Marijuana Smoke: A Literature Review, MAPS Newsletter, Vol. IV #2, 1993]. If so, waterpipes might still turn out to have net health benefits.
MAPS and California NORML are planning to undertake a second phase of the waterpipe study for the purpose of analyzing the gaseous phase of marijuana smoke.
In the meantime, the easiest way for most smokers to avoid harmful smoke toxins may be simply to smoke stronger marijuana. This strategy is apt to be more effective than any smoke filtration device. By simply replacing the low, 2.3% potency NIDA marijuana used in this study with high-quality 12%-sinsemilla, smokers could presumably reduce their tar intake by a factor of five while still achieving the same effect. Further improvements could be had by using pure THC or hash oil, which has been tested at potencies of 60%.
The notion that high-potency marijuana is less harmful directly contradicts official government propaganda, which maintains that marijuana has become more dangerous since the '60s due to increased potency. This claim appears to rest less on scientific evidence than on the desire to frighten the public. A careful analysis of government data by Dr. John Morgan has shown that the supposed increase in potency has been greatly exaggerated [American Marijuana Potency: Data Versus Conventional Wisdom, NORML Reports (1994)]. In any case, however, there is no good reason to presume that higher potency marijuana is more harmful, given the potential respiratory benefits of reduced smoke consumption. The hazards of excessive potency are purported to be an increased risk of acute overdose and greater susceptibility to dependency. However, both problems can be avoided if users adjust their dosage to potency. For most users, such hazards may well be outweighed by the benefits of reduced smoke consumption.
Research in Australia
The Australian government is currently conducting another study that may cast further light on the effects of potency variations. The study is designed to determine baseline THC, tar, and carbon monoxide levels from marijuana and marijuana-tobacco mixtures smoked through joints and waterpipes. The samples being tested come from police seizures in six different Australian states. Researchers say that they have observed "incredible" variations in tar and THC potency among different samples. Their report is expected shortly.
THC Transfer Rate
The MAPS-NORML study provides new information on the efficiency of different devices in delivering THC from marijuana to the user. Previous studies have shown that 60% - 80% of the THC burned in joints or waterpipes is lost in slipstream smoke, adhesion to the pipestem and bowl, pyrolysis, etc. [Mario Perez-Reyes, Marijuana Smoking: Factors that Influence the Bioavailability of Tetrahydrocannabinol, in C. Nora Chiang and Richard Hawks, ed., Research Findings on Smoking of Abused Substances, NIDA Research Monograph 99, 1990]. The percentage of total THC delivered to the user is called the THC transfer rate. The unfiltered joint scored surprisingly well in smoking efficiency, coming in second place with a transfer rate close to 20%. The portable waterpipe did slightly better, and the bong slightly worse. The other devices did notably worse. The vaporizers and electric waterpipe did especially poorly, with transfer rates less than one-third that of the top three devices. Thus, heavy smokers could literally be blowing most of their stash away with bad pipes.
Note:
Contrary to the initial version of this article, which erroneously stated that THC vaporizes at 155º C, the Merck Manual lists the vaporization point of THC as 200º in vacuum. The vaporization point at normal atmospheric pressure appears to be unknown, but is thought to be in the range 250-400º.
California NORML
2215-R Market St. #278
San Francisco, CA 94114
CANORML@igc.apc.org
We learned early on that waterpipes don't help filter out undesirable particulate matter, although waterpipes may help reduce certain water-soluble gases. In contrast, vaporizers do eliminate combustion products and address the Institute of Medicine's preference for non-smoking delivery systems for the medicinal use of marijuana. Furthermore, vaporizers are the only non-smoking delivery system that uses the marijuana plant, unlike marijuana extracts in spray, lozenge, drops, or pill form, and could conceivably be used in conjunction with material that patients grow themselves.
While the use of vaporizers in medical marijuana research is the most politically desirable route, since they don't involve smoking, we plan to include groups that smoke as well as vaporize marijuana in future studies. We would be surprised if there are significant differences in safety and efficacy for most patients and feel that this is an issue that needs to be resolved scientifically.
California's Center for Medicinal Cannabis Research (CMCR) approved Dr. Donald Abrams' Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000. 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. This study will start enrolling subjects in Summer 2004.
The protocol has also been reviewed and approved by the FDA. The vaporizer that Dr. Abrams will use is the Volcano.
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. _In June 2003,_ Chemic Laboratories, where the project will be conducted, 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. Unfortunately, DEA has refused to review the import permit request until NIDA decides the protocol is "scientifically meritorious" and NIDA has let the request languish unevaluated since June 2003. NIDA is clearly doing its best to provide evidence supporting our argument that we need an independent source of supply.
On July 21, 2004, MAPS, Prof. Craker and Valerie Corral filed lawsuits against DEA and also against HHS/NIH/NIDA for obstructing medical marijuana research, and on July 29, 2004, MAPS filed a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.
On September 21 and 29, the first and second subjects were enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana from a vaporizer.
On October 13, 2004, MAPS and MPP filed our amicus curiae brief in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research, as evidenced by DEA's lack of response to Chemic's application for a permit to import 10 grams for further vaporizer research from the Dutch Office of Medicinal Cannabis, and HHS/NIH/NIDA's lack of response to Chemic's application to purchase 10 grams for further vaporizer research. Oral arguments in the case are scheduled for November 29, 2004.
On November 22, 2004, the Court required DEA to respond by December 22, 2004 to the portion of our lawsuit against DEA about the UMass Amherst marijuana production facility. This is a positive development in that DEA can no longer just delay and not have to explain why.
On December 3, 2004, MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 1/2 months to our applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.
For further background, also see:
Cannabis Vaporizer Combines Efficient Delivery of THC with Effective Suppression of Pyrolytic Compounds, by Dale Gieringer, Joseph St. Laurent, Scott Goodrich. Journal of Cannabis Therapeutics, (2004) 4(1): 7-27.
"Study Shows Vaporizer Can Drastically Reduce Toxins in Marijuana Smoke"
California NORML/ MAPS Press Release – May 2, 2003
"Vaporizer Research: An Update"
Dale Gieringer, Ph.D. canorml@igc.apc.org, MAPS Bulletin, Spring 2003; Volume XIII, Number 1
Chemic Laboratory research report April 15, 2003.
Project status:
November 27, 2007.
SYNOPSIS OF DEA RESCHEDULING DRONABINOL
In late September, DEA proposed a new rule that would effectively place dronabinol (the active chemical in MARINOL) in Schedule III.
Wait a second, isn't MARINOL already in Schedule III?
It is. When MARINOL was first marketed, it was placed in Schedule II. Once DEA was shown that it had a low potential for abuse, they agreed to place it in Schedule III. But the narrow language only places in Schedule III MARINOL's specific formulation (synthetically derived dronabinol, suspended in sesame oil). All other formulations remain in Schedule I.
Now that the MARINOL patent is almost up, Professor ElSohly (yes, the same man who runs the only federally-approved marijuana growing facility) has a contract to supply would-be generic manufacturers of MARINOL. They petitioned DEA to re-schedule ALL formulations of dronabinol, whether or not the chemical is suspended in sesame oil, and whether or not the chemical is sourced from whole-plant marijuana. That's right, folks! DEA may soon allow an FDA-approved medication to be derived from the marijuana plant.
In order to applaud this change in thinking, and to insist that the NIDA monopoly be lifted, MAPS submitted a public comment to the Federal Register about the proposed new rule. The focus of the comment is the issue of fairness; namely, it is absolutely ridiculous that DEA would re-schedule the active ingredient in MARINOL at the behest of a private producer for private profit, all the while refusing to approve Professor Craker's bid to grow marijuana for non-profit, research purposes.
See a PDF of MAPS Public Comment on Docket No. DEA-308P; 72 Fed.Reg. 54226 (Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols).
June 29, 2007. Nature published an excellent article ("Scientists stir the pot for right to grow marijuana") about MAPS' campaign to break the federal government's illegal monopoly on the supply of research-grade marijuana for use in privately funded clinical studies that would determine whether marijuana meets the FDA's standards for safety and efficacy.
May 16, 2007. Two new studies, one from University of California-San Francisco, and the other from SUNY-Albany, provide strong evidence that vaporization has promising potential as a method of medical marijuana delivery. The first study, published online by the journal Clinical Pharmacology and Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and compared a commercially available vaporizer to smoking in 18 volunteers. The researchers found that, "vaporization of marijuana does not result in exposure to combustion gases, and therefore is expected to be much safer than smoking marijuana cigarettes." Dr. Abrams was able to obtain permission from FDA to conduct his study based in part on data on the composition of the ingredients in marijuana vapor gathered in research sponsored by MAPS and CaNORML. That line of MAPS-sponsored research is currently blocked since NIDA has refused to sell marijuana for additional studies. Click here to read Dr. Abrams' full report.
The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and published in Harm Reduction Journal, was based on an extensive survey of over 7,000 marijuana users. After adjusting for variables such as age and cigarette use, Earleywine found that vaporizer users were 60 percent less likely than smokers to report respiratory symptoms such as cough, chest tightness or phlegm, and that the effect of vaporizer use was more pronounced the larger the amount of marijuana used. Click here to read Dr. Earleywine's full report.
MAPS hopes to eventually put vaporized marijuana through FDA clinical trials, but has been stalled since June 2003 because of NIDA's monopoly on the supply of research-grade marijuana. Research into alternative delivery methods such as vaporization was one of the primary recommendations of the Institute of Medicine's landmark 1999 report on medical marijuana.
Marijuana vaporization is an effective delivery method because it has the rapid action and easy dose adjustment of inhalation, but without the respiratory hazards associated with smoking. Unlike smoking, a vaporizer does not burn the plant material, but heats it just to the point at which THC and cannabinoids vaporize into steam.
May 15, 2007.
Today MAPS recieved a copy of the "Transmittal Letter" sent by ALJ Judge Mary Ellen Bittner to the DEA, transferring the record in the Craker matter to the DEA's Deputy Administrator, Michelle Leonhart on May 15, 2007. The letter was accompanied by this note:
1316.67 Final order
As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his final order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which date shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that the public interest in the matter necessitates an earlier effective date, in which event the Administrator shall specify in the order his findings as to the conditions which led him to conclude that an earlier effective date was required.
So let the "practicable" clock begin . . .
The Walrus published a fascinating article entitled "Peaking on the Prairies" that describes Dr. Humphrey Osmond's extensive psychedelic therapy research program in the 1950's.
March 17, 2007. On February 16, MAPS President Rick Doblin met with Joe St. Laurent and Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed the development of a new vaporizer research protocol to submit to NIDA for review, once again seeking to purchase 10 grams from NIDA and seeking DEA permission to import 10 grams of high THC/high CBD marijuana from the Netherlands, with a cannabinoid content that NIDA doesn't have available. The design work and the study itself, should we eventually obtain approval from NIDA, will be co-funded by MAPS and CaNORML, as have all our previous vaporizer research projects.
This new protocol seeks to analyze the constituents of the vapor produced in the Volcano vaporizer, from samples of NIDA marijuana that contain THC and samples of imported marijuana that contain both THC and CBD. During the meeting at Chemic, we reviewed in detail the critiques of the original vaporizer research protocol that the PHS/NIDA reviewers offered back in August 2005. We will make a few changes in the protocol so that this will be a new submission and we will respond in detail to each critique. The proposed methodology will call for testing at various temperatures, and will measure for carbon monoxide levels, cannabinoids and certain particulates.
PHS/NIDA's handling of the original version of this protocol was another classic case of the dysfunctional nature of NIDA's monopoly on research-grade marijuana. After waiting for more than two years for PHS/NIDA to review the protocol, during which time we unsuccessfully sued NIDA for unreasonable delay in the DC Circuit Court of Appeals, the critique that was finally issued contained several important misunderstandings and seemed to come from people who had barely even read the protocol. Chemic filed a response to the critiques in September 2005, which PHS/NIDA has totally ignored for more than 17 months. There seems to be no appeal process at all in the PHS/NIDA review of medical marijuana research proposals and there are certainly no deadlines that compel PHS/NIDA to respond within any reasonable period of time. This is in contrast to FDA, which must reply to protocol submissions within 30 days and has a clearly defined and prompt appeal process.
The new vaporizer protocol will be submitted to NIDA in April. Then, we anticipate a long wait. NIDA has successfully ignored Chemic's response to its critiques but it will be more difficult for NIDA to ignore a new protocol submission.
October 19, 2005. October 19, 2005. Mother Jones Magazine publishes, "Respectable Reefer," an excellent article about medical marijuana by Gary Greenberg that discusses GW Pharmaceuticals, MAPS and drug war politics.
September 10, 2005. At the International Association for Cannabis as Medicine 3rd Conference, held in Leiden, Holland, Mr. Hector Vizoso, study coordinator for Dr. Donald Abrams' study of smoking v. vaporizing, discussed the results of their clinical trial in humans comparing cannabinoid blood levels, carbon monoxide levels, and subjective effects in subjects who smoke and at other times vaporize marijuana (with the Volcano vaporizer). When subjects used vaporizers, the study found reductions in blood carbon monoxide levels as compared to smoking. In addition, the study showed that the vaporizer produced reliable levels of cannabinoids. The study also found that more subjects preferred vaporizing over smoking. This study was funded by a grant of about $136,000 from the Center for Medicinal Cannabis Research (CMCR). MAPS and CaNORML contributed an additional $100,000 on preliminary laboratory data analyzing the content of the vapors produced by the Volcano vaporizer.
Results of a second paper on vaporization (with the Volcano vaporizer) were presented by Arno Hazekamp, Ph.D, of Leiden University. This study "confirms that the pulmonary administration of cannabinoids by evaporation certainly has a clinical potential. With the Volcano a safe and effective cannabinoid delivery system seems to be available to patients."
September 9, 2005. Chemic Laboratories sends a letter to Assistant Secretary for Health Joel Egertson, responding to his July 27, 2005 letter (received August 15, 2005) rejecting Chemic's June 2003 application to NIDA to purchase 10 grams of marijuana for further vaporizer research. Chemic's letter rebuts every critique of the protocol used by Mr. Egertson and urges him to reconsider. After taking over two years to reply, HHS/NIDA's protocol reviewers didn't take the time to read the protocol carefully and made some rather basis mistakes in the review. HHS/NIDA's refusal to sell Chemic 10 grams of marijuana for MAPS-sponsored vaporizer research is yet another example of the need to break NIDA's monopoly on the supply of marijuana that can be used in legal research.
August 18, 2005. The Perspective Section of the New England Journal of Medicine published an article, "Medical Marijuana and the Supreme Court," by Susan Oakie, MD, a contributing editor of the Journal. Click here for full text version.
August 15, 2005. Chemic Laboratories receives a response letter from the Department of Health and Human Services (view as html), rejecting the vaporizer protocol and recommending that NIDA not sell Chemic 10 grams of laboratory-grade marijuana for the vaporizer studies. This response took more than two years and arrived, coincidentally and conveniently, just one week before the start of the DEA Administrative Law Judge hearings over DEA refusal to grant a license to Prof. Craker, UMass Amherst, for a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Chemic's reply to the critiques was sent to HHS/NIDA on September 9, 2005.
July 26, 2005. U.S. Congressional Representatives John Olver (D-MA) and Michael Capuano (D-MA) have sent a letter to DEA Administrator Karen Tandy urging DEA to issue a license to Prof. Craker for his MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. This letter will be sent to other members of Congress seeking additional signatures.
Prof. Lyle Craker filed his updated and final prehearing statement in his DEA Administrative Law Judge hearing regarding DEA refusal to issue him a license to establish a MAPS-sponsored facility to grow marijuana for federally-approved research. DEA also filed an updated prehearing statement with additional witnesses, demonstrating that DEA will spare no expense in trying to show that blocking medical marijuana research is somehow in the public interest. Testimony begins on August 22, 2005.
July 22, 2005. DEA files a motion seeking to disqualify four of our proposed witnesses. We'll prepare a reply within the next several weeks.
June 20, 2005. San Francisco Chronicle writer Joe Garofoli reports on the completion of the nation's first clinical human study on vaporization at UCSF. He gives an overview of vaporizer benefits and use, and informs readers how to obtain affordable vaporizers.
A new political advertisement about medical marijuana, mentioning federal obstruction of research and providing a link to the MAPS website for more information, appeared in the National Review, the New Republic, the American Prospect, The Nation, Reason Magazine, and The Progressive. The ad was placed by Common Sense for Drug Policy.
December 10, 2004. After almost 18 months, DEA finally responds to the applications from Chemic Laboratories to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis, and to purchase 10 grams of marijuana from NIDA, for further vaporizer research. DEA claims that Chemic actually needs a "Research" license instead of an "Analytical Laboratory" license, which may take another 4-6 months to obtain. DEA's rationale is not stated but it seems that they now consider the research to be publicly funded, which requires a "Research" license. However, this research is not publicly funded. DEA's theory seems to be that since the analytical data has been used by Dr. Donald Abrams to obtain FDA permission for a clinical study comparing smoked v. vaporized marijuana, in a study funded by the State of California, that Chemic's privately-funded research is actually publicly funded. Chemic will immediately file for a "Research" license and we will seek more information about DEA's rationale.
December 7, 2004. Rep. Sam Farr (D-CA) has sent out a Dear Colleague letter to all member of the US House of Representatives, in response to a bill filed by U.S. Rep. Mark Souder that seeks to have the National Institute on Drug Abuse (NIDA) write a report about the "medical" uses of marijuana for FDA to distribute. Rep. Souder is the Chairman of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources and the author of the much criticized bill that denies federal student loans to anyone convicted of a drug-related crime. Rep. Farr's letter questions whether NIDA is unbiased and cites NIDA's refusal in over 17 and 1/2 months to provide 10 grams of marijuana for vaporizer research (sponsored by MAPS and CaNORML). Federal obstruction of medical marijuana research is starting to get more attention. This may help generate pressure to break NIDA's monopoly on supply, which it uses to obstruct research.
December 3, 2004. MAPS mailed petitions for reconsideration to the DC Circuit Court of Appeals, asking again for the Court to pressure HHS and DEA for not responding in 17 ½ months to our applications to purchase 10 grams and import 10 grams, respectively, in both cases for marijuana vaporizer research.
November 29, 2004. We have a decision regarding MAPS' lawsuits against DEA and against HHS/NIH/NIDA regarding our claim of "unreasonable delay" in responding to MAPS-sponsored applications to NIDA to purchase 10 grams of marijuana for vaporizer research (submitted June 24, 2003), to DEA to import 10 grams of marijuana for vaporizer research from the Dutch Office of Medicinal Cannabis (submitted June 24, 2003), and to DEA for a license to grow marijuana for research at UMass Amherst (submitted June 2001).
MAPS's lawyer's assessment: The decision is very particular about the applications delayed, so they obviously read & at least partially understood what was what. Unfortunately, 17 months delay to the court (unlike patients needing pain relief) is no biggie, so we lose on compelling action on the application to HHS/NIDA to purchase 10 grams for research and on the application to DEA to import 10 grams. The 3 1/2 year delay in DEA non-response to the UMass Amherst application for a license to grow marijuana for research trips the further inquiry wire at DEA, however, so there apparantly is a chance for some oversite. Reconsideration (of the outright denials) must be filed within 14 days [5pm Dec. 6], which we will file.
Slate has recently published an extensive commentary on how the Supreme Court is and will approach Ashcroft v. Raich. MAPS had filed an amicus curiae concerning the obstruction of efforts to conduct FDA-approved medical marijuana research.
November 22, 2004. The popular science magazine Scientific American published an editorial in support of making it easier to perform medical marijuana research in the US, describing current restrictions on medical marijuana research as "absurd."
November 11, 2004. MAPS initiates work on a legal motion for expedited scheduling of our lawsuits against DEA and against HHS/NIH/NIDA. It's now been more than 3 1/2 months since July 21, 2004, when MAPS, Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, and Prof. Lyle Craker, UMass Amherst, filed a lawsuit against DEA, and MAPS and Valerie Corral filed a lawsuit against HHS/NIH/NIDA.
The lawsuits claimed that the agencies were engaging in unreasonable delay in not responding to MAPS-sponsored requests to grow, import and purchase marijuana for a program of scientific research designed to develop marijuana into an FDA-approved prescription medicine. We hope the motion for expedited scheduling will get this case before the judge sooner than if we were to do nothing. The lawsuits have been filed in the United States Court of Appeals for the District of Columbia Circuit.
October 13, 2004. MAPS and MPP filed our amicus curiae brief today in the US Supreme Court in the Ashcroft v. Raich medical marijuana case. The brief describes the political obstruction of MAPS' efforts to conduct FDA-approved medical marijuana research. The goal of the brief is to educate the Supreme Court judges so that they don't rule against medical marijuana patients under the false assumption that the FDA drug development approach is a viable alternative to state medical marijuana initiatives and legislative actions. As long as the obstruction of MAPS' medical marijuana research efforts continues, the only way that patients can obtain legal access to the medical use of marijuana is through the decision of the 9th Circuit Court of Appeals, which decided that there was no interstate commerce involved when patients or caregivers grow marijuana for patients' personal medical use. That decision prohibited the federal authorities (DEA) from enforcing the Controlled Substances Act prohibitions against the use of marijuana, which the 9th Circuit judges declared unconstitutional when applied against patients or caregivers growing marijuana in states that had approved such use. MAPS and MPP's brief transforms our failure to obtain the necessary permissions and supply of marijuana for MAPS' research efforts into a weapon against the forces of repression (DEA and the Drug Czar ).
September 29, 2004. The second subject is enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The first subject was enrolled on September 21, 2004 (see that entry for more details about study design). This study is now well underway!
September 21, 2004. The first subject was enrolled in Dr. Donald Abrams' FDA-approved study comparing subjective effects, cannabinoid blood levels and carbon monoxide levels in subjects who smoke marijuana or inhale the vapors of the same amount of marijuana generated by a vaporizer. The study requires subjects to live on an in-patient ward for 6 days, with each day involving either smoking marijuana or using the vaporizer. The research involves the use of 3 different marijuana cigarettes, one with 1.7 % THC, one with 3.5% THC and one with 7% THC. The cigarettes are cut in half and used in a randomized, double-blind manner, with half of each cigarette being smoked and the other half unrolled and the marijuana placed in the vaporizer.
July 29, 2004. MAPS files a motion to consolidate the lawsuit against the DEA and the lawsuit against HHS, NIH and NIDA.
July 22, 2004. Newspapers around the country have carried an AP wire story on MAPS' lawsuits against DEA/HHS/NIH/NIDA for obstructing medical marijuana research. An original article from the Springfield Republican (in MA) is representative of the favorable treatment our suit has obtained in the media.
July 21, 2004. MAPS, Prof. Lyle Craker and Valerie Corral, file lawsuits against DEA and against HHS/NIH/NIDA for obstructing medical marijuana research. MPP sends out a press release..
June 9, 2004. NIDA Director Dr. Nora Volkow responds to MAPS' letter of May 19, as well as MAPS' May 24, 2004 letters to HHS Secretary Tommy Thompson and Director of the National Institutes of Health Dr. Elias Zerhouni. Dr. Volkow writes, "As you know, NIDA is just one of the participants on the HHS review panel...It is not NIDA's role to set policy in this area...Moreover, it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for the establishment of facilities to support this research. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns."
Conspicuosly missing from Dr. Volkow's letter was any information whatsoever about where in the process is the review of the vaporizer protocol. As a result, MAPS is now considering a lawsuit against HHS/NIDA claiming "unreasonable delay" under the Administrative Procedures Act.
May 19, 2004. MAPS has sent a letter to NIDA Director Dr. Nora Volkow, and all members of NIDA's National Advisory Council on Drug Abuse (NACDA), asking them to expedite the NIDA/HHS review of Chemic's vaporizer research protocol. Chemic initially submitted the protocol to NIDA on June 24, 2003, as part of a request to purchase 10 grams of NIDA's marijuana needed for the study. MAPS' letter explains that there has so far been an eleven month delay in MAPS' research agenda, while MAPS waits to see if NIDA/HHS considers the protocol to be "scientifically meritorious" and therefore worthy of the privilege of purchasing NIDA's low-potency marijuana. The letter protests that this is an unreasonable delay of MAPS' efforts to conduct research to evaluate marijuana's potential use as an FDA-approved prescription medicine. The letter informs Dr. Volkow and the members of the NACDA that NIDA/HHS is doing its best to provide clear and persuasive evidence that NIDA's monopoly on the supply of marijuana for research is a fundamental obstruction that must end, preferably with DEA licensing of the UMass Amherst production facility.
April 1, 2004. 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 testified (video and transcript) and answered questions (video and transcript). 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 Volcano vaporizer 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 awarded 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)
Dale Gieringer, Ph.D. (canorml@igc.apc.org)
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 (https://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.
Here are urls for various vaporizers:
* www.vapormed.de
* Home
* Air-2.com: Makers of the Vapir Digital Herbal Vaporizer
* vaporeizer engels
* research&experience
# "MAPS/NORML Study Shows Vaporizers Reduce Toxins in Marijuana Smoke"
Dale Gieringer, Ph.D.
NORML California State Coordinator (canorml@igc.apc.org)
MAPS Bulletin, Spring 2001. Volume XI, Number 2.
Medical marijuana patients may be able to protect themselves from harmful toxins in marijuana smoke by inhaling their medicine using an electric vaporizer, according to initial results of a study by the Multidisciplinary Association for Psychedelic Studies (MAPS) and California NORML. Research expenditures to date are roughly $50,000.
The study showed that it is possible to vaporize medically active tetrahydrocannabinol (THC) by heating marijuana to a temperature short of the point of combustion, thereby eliminating or substantially reducing potentially harmful smoke toxins that are normally present in marijuana smoke. Vaporizers may therefore substantially reduce what is widely regarded as the leading health concern associated with marijuana, namely respiratory harm due to smoking. In addition, many medical marijuana patients say they prefer vaporizers because they deliver smoother, less irritating medication.
MAPS and NORML sponsored the study in the hopes of helping medical marijuana patients and others reduce the health risks of smoking marijuana. A major obstacle to approval of natural cannabis by the Institute of Medicine (IOM) in its 1999 report, "Marijuana and Medicine," was that smoking is an "unhealthy" delivery method. The IOM report failed to note the possibility of vaporization. The MAPS-NORML study tested a device called the M1 Volatizer(R), an aromatherapy vaporizer developed by Alternative Delivery Systems, Inc. It consisted of an electric heating element in a chamber that radiates heat downwards over a sample of marijuana contained in a standard bowl. Output from the vaporizer was analyzed and compared to smoke produced by burning the sample.
The vaporizer produced THC at a temperature of 200° C. (392° F.) while completely eliminating three measured toxins - benzene, a known carcinogen, plus toluene and naphthalene. Temperatures of around 200° C. appear to be most efficient for vaporization. The potency of the cannabis in the study was on the order of 10% - 12%. Significant amounts of THC (around 5%-6%) begin to be released at 180° C., with slightly more (7% or 8%) at 200° C. Carbon monoxide and smoke tars were both qualitatively reduced by the vaporizer, but additional testing is needed to quantify the extent of the decrease.
The vaporizer study was undertaken as a follow-up to a previous MAPS-NORML marijuana smoking device study, which concluded that vaporizers offered the best prospects for smoke harm reduction: MAPS - Volume 6 Number 3 Summer 1996 -
MAPS and NORML are currently seeking support for further research and development of vaporizers. Research is presently underway to explore the optimal temperature and conditions for vaporization. An additional $85,000 is needed to provide accurate measurement of carbon monoxide and other toxins, such as polycyclic aromatic hydrocarbons. Further studies may be needed to explore alternative device designs and the effects of different consistencies, potencies and preparation methods of the samples of marijuana.
PDF version of this document
# "Marijuana Water Pipe and Vaporizer Study"
Dale Gieringer, Ph.D. (canorml@igc.apc.org
MAPS Bulletin, Summer 1996. Volume VI, Number 3.
September 21, 2000 update: MAPS and CA-NORML are sponsoring a new vaporizer study. Testing and data analysis have been completed. A detailed report will be issued soon. The design and cost of additional studies are currently being discussed with the analytical lab.
The new study is a $25,000 proof of principle study designed to determine if marijuana vaporizers can indeed reduce particulate matter and carbon monoxide as compared to the combustion of marijuana. We have a very high-tech lab doing the research, but unfortunately the lab wants to remain anonymous. They are concerned about becoming known as a place with marijuana (all they have is 5 grams!), but the major reason for their reluctance to get publicity is due to industrial espionage. They do lots of work for major pharmaceutical companies who want discretion, so they don't advertise. I was personally recommended to them by an organic chemistry company that is making psilocybin for MAPS for a U. of Arizona study of psilocybin in the treatment of OCD.
Anyway, the results of the vaporizer study do show substantial reductions in particulate matter and in carbon monoxide. I conceive of this study as contributing to the argument in favor of permitting patients to grow and use their own marijuana, instead of having to purchase patented, FDA-approved cannabinoid or marijuana-extract products from Unimed or GW Pharmaceuticals. Vaporizers are the only non-smoking marijuana delivery systems that can be used with home-grown marijuana. We are trying to create evidence to show that there is a favorable risk/benefit ratio from using high-potency marijuana in vaporizers.
The main tradeoffs that patients will face are slightly highly but probably not clinically significant health risks but lower price from high-potency marijuana delivered in vaporizers as compared to Unimed or GW products. Efficacy will probably be similar. The health effect of wealth (the impact on the health of patients from the extra money they save from using home-grown in vaporizers as compared to other products) will, perhaps, outweigh the additional health risks. This is all speculative and there is certainly a major need for FDA-approved products that can be paid for by insurance, since home-grown used with vaporizers will probably not become approved by FDA anytime soon, at least not in the current political climate.
See also:
Why Marijuana Smoke Harm Reduction?
The Struggle to Do Medical Marijuana Research
Medical Cannabis Potency Testing Project
Contrary to popular impression, waterpipes don't necessarily protect smokers from harmful tars in marijuana smoke, according to a new study sponsored by MAPS and California NORML (National Organization for the Reform of Marijuana Laws). The reason is that waterpipes filter out more psychoactive THC than they do other tars, thereby requiring users to smoke more to reach their desired effect. The study does not rule out the possibility that waterpipes could have other benefits, such as filtering out gases, but it suggests that other methods, such as the use of high potency marijuana, vaporizers, or oral ingestion are needed to avoid harmful toxins in marijuana smoke.
Seven Devices Tested
The study, which was supported by the Drug Policy Foundation and private donors, was conducted at a research lab with expertise in the analysis of various chemical properties of tobacco and marijuana. Researchers tested the smoke from seven different sources: a regular rolled joint, a joint with a cigarette filter, three different waterpipes, and two vaporizers, designed to heat marijuana to a temperature where psychoactive vapors form without producing smoke. The waterpipes included a standard bong (Picture #1), a small portable device with a folding pipestem (Picture #6), and a battery-operated model with a motorized paddle to thoroughly mix the smoke in the water (Picture #3). The first vaporizer (Picture #5), commercially produced in Canada, consisted of a battery-powered metal hot plate inside a jar to trap the marijuana vapor. The second (Picture #4) was a homemade, hybrid apparatus, in which vapors were produced by a hot air gun and then drawn through a beaker of water, thereby combining vaporization with water filtration. The smoke was produced from standard NIDA-supplied marijuana drawn through a smoking machine adjusted to mimic the puff length of marijuana smokers.
Focus: Cannabinoid/Tar Ratio
The study focused on two key components of the smoke: (1) total solid particulates, or tars, which are noxious waste by-products of burning leaf like those from tobacco; and (2) cannabinoids, the chemicals distinctive to marijuana, including its major psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), and its two commonest chemical relatives, cannabinol (CBN) and cannabidiol (CBD), which are only weakly psychoactive but may have medical benefits.
Like tobacco, marijuana tars are rich in carcinogenic compounds known as polycyclic aromatic hydrocarbons, which are a prime culprit in smoking-related cancers. However, cannabinoids themselves are not carcinogenic. An obvious way to protect smokers' health is therefore to minimize the content of smoke tars relative to cannabinoids.
One way to do this is to increase the THC potency of the marijuana. Assuming smokers adjust their smoke intake to the cannabinoid dosage, the higher the concentration of cannabinoids, the lower the amount of tars they are likely to consume.
Another strategy is to try to reduce the tars in the smoke with some kind of filtering device. Obviously, this is beneficial only to the extent that THC isn't also reduced, thereby inducing users to smoke more to compensate. A major aim of the study was to determine the efficacy of various smoking devices at reducing the concentration of tars relative to cannabinoids. The performance of each device was accordingly rated in terms of the cannabinoid-to-tar ratio in its smokestream.
Joints and Waterpipes
Surprisingly, the unfiltered joint outperformed all devices except the vaporizers, with a ratio of about 1 part cannabinoids to 13 parts tar. This disturbingly poor ratio may be explained by the low potency of the NIDA-supplied marijuana used in the study, which was around 2.3%.
Disappointingly, waterpipes performed uniformly worse than the unfiltered joint. The least bad waterpipe, the bong, produced 30% more tar per cannabinoids than the unfiltered joint. Ironically, the pipe with the electric mixer scored by far the worst of any device. This suggests that water filtration is actually counterproductive, apparently because water tends to absorb THC more readily than noxious tars. Like the waterpipes, the cigarette filter also performed worse than the unfiltered joint, by about 30%. Researchers speculate this is because cannabinoids are exceptionally sticky and adhere to other solids. Hence, any filtration system that picks up particulates is likely also to screen out cannabinoids.
Vaporizers
The vaporizer results appeared more promising, but confusing. The two vaporizers were the only devices to outscore unfiltered joints in terms of raw cannabinoid/tar ratio. The electric hotplate vaporizer did best, with a performance ratio about 25% higher than the unfiltered joint. The hot air gun was just marginally superior, but might have done better had it not been for its water filtration component.
However, the situation was complicated by the fact that the cannabinoids produced by the electric hotplate vaporizer were unusually high in CBN, leaving 30% less THC as a percentage of the total cannabinoids than with the other smoking devices. Since CBN is not psychoactive like THC, recreational users might be expected to consume more smoke to make up for the deficit. (The situation may be different for medical users, who could experience other, medicinal benefits from CBN). For this reason, it seemed advisable to recompute the performance efficiencies of the vaporizers in terms of THC, rather than all cannabinoids. When this was done, the electric hotplate vaporizer turned out to have a lower THC/tar ratio than the unfiltered joint, while the hot air gun was still marginally higher.
The reason for the excess CBN from the hotplate vaporizer remains unexplained. Because CBN is produced from THC by chemical oxidation, it has been suggested that the device somehow exposed the sample to too much oxygen. However, there is no evidence that this was the case. As for the second, hybrid vaporizer, it seems likely that its performance could have been improved by deleting its water component.
The results clearly indicate that more developmental work needs to be done on vaporizers. Theoretically, an ideal vaporizer could minimize production of tars by holding the temperature above the point at which THC vaporizes, but below that where carcinogenic hydrocarbons are produced by combustion [Note] In practice, both vaporizers produced over ten times more tars than cannabinoids, indicating that there is plenty of room for improvement.
In the late 1970s, a vaporizer known as the Tilt appeared on the market. According to the manufacturer, laboratory tests showed that it released 80% more THC and 79% less tar than a regular pipe, a performance ratio almost ten times better than any observed in this study. It is to be hoped that these impressive results can be replicated in the future. Unfortunately, the Tilt was withdrawn from the market in the early 1980s due to the passage of anti-paraphernalia laws.
As for waterpipes, the prospects for improvement appear more dubious. It has been suggested that the performance of waterpipes could be improved by using liquids other than water or by changing the temperature of the liquid. However, it seems doubtful whether such tactics would circumvent the basic problem of separating the tars from the sticky cannabinoids.
Are Waterpipes Counterproductive?
The study results are obviously discomforting to waterpipe enthusiasts, many of whom prefer the cooler, milder smoke they produce, and have naturally assumed it is also more healthful. Unfortunately, however, the study indicates that waterpipes may actually be counterproductive in increasing consumption of carcinogenic tars.
Nonetheless, it is still premature to judge that waterpipes are actually unhealthful, since they may filter out other, non-solid smoke toxins occurring in the gas phase of the smoke, which was not analyzed in the study. Noxious gases known to occur in marijuana smoke include hydrogen cyanide, which incapacitates the lung's defensive cilia; volatile phenols, which contribute to the harshness of the taste; aldehydes, which promote cancer; and carbon monoxide, a known risk factor in heart disease. Previous studies indicate that water filtration may be quite effective in absorbing some of these [Nicholas Cozzi, Effects of Water Filtration on Marijuana Smoke: A Literature Review, MAPS Newsletter, Vol. IV #2, 1993]. If so, waterpipes might still turn out to have net health benefits.
MAPS and California NORML are planning to undertake a second phase of the waterpipe study for the purpose of analyzing the gaseous phase of marijuana smoke.
In the meantime, the easiest way for most smokers to avoid harmful smoke toxins may be simply to smoke stronger marijuana. This strategy is apt to be more effective than any smoke filtration device. By simply replacing the low, 2.3% potency NIDA marijuana used in this study with high-quality 12%-sinsemilla, smokers could presumably reduce their tar intake by a factor of five while still achieving the same effect. Further improvements could be had by using pure THC or hash oil, which has been tested at potencies of 60%.
The notion that high-potency marijuana is less harmful directly contradicts official government propaganda, which maintains that marijuana has become more dangerous since the '60s due to increased potency. This claim appears to rest less on scientific evidence than on the desire to frighten the public. A careful analysis of government data by Dr. John Morgan has shown that the supposed increase in potency has been greatly exaggerated [American Marijuana Potency: Data Versus Conventional Wisdom, NORML Reports (1994)]. In any case, however, there is no good reason to presume that higher potency marijuana is more harmful, given the potential respiratory benefits of reduced smoke consumption. The hazards of excessive potency are purported to be an increased risk of acute overdose and greater susceptibility to dependency. However, both problems can be avoided if users adjust their dosage to potency. For most users, such hazards may well be outweighed by the benefits of reduced smoke consumption.
Research in Australia
The Australian government is currently conducting another study that may cast further light on the effects of potency variations. The study is designed to determine baseline THC, tar, and carbon monoxide levels from marijuana and marijuana-tobacco mixtures smoked through joints and waterpipes. The samples being tested come from police seizures in six different Australian states. Researchers say that they have observed "incredible" variations in tar and THC potency among different samples. Their report is expected shortly.
THC Transfer Rate
The MAPS-NORML study provides new information on the efficiency of different devices in delivering THC from marijuana to the user. Previous studies have shown that 60% - 80% of the THC burned in joints or waterpipes is lost in slipstream smoke, adhesion to the pipestem and bowl, pyrolysis, etc. [Mario Perez-Reyes, Marijuana Smoking: Factors that Influence the Bioavailability of Tetrahydrocannabinol, in C. Nora Chiang and Richard Hawks, ed., Research Findings on Smoking of Abused Substances, NIDA Research Monograph 99, 1990]. The percentage of total THC delivered to the user is called the THC transfer rate. The unfiltered joint scored surprisingly well in smoking efficiency, coming in second place with a transfer rate close to 20%. The portable waterpipe did slightly better, and the bong slightly worse. The other devices did notably worse. The vaporizers and electric waterpipe did especially poorly, with transfer rates less than one-third that of the top three devices. Thus, heavy smokers could literally be blowing most of their stash away with bad pipes.
Note:
Contrary to the initial version of this article, which erroneously stated that THC vaporizes at 155º C, the Merck Manual lists the vaporization point of THC as 200º in vacuum. The vaporization point at normal atmospheric pressure appears to be unknown, but is thought to be in the range 250-400º.
California NORML
2215-R Market St. #278
San Francisco, CA 94114
CANORML@igc.apc.org
