MAPS is currently seeking regulatory approval to conduct a study of smoked and/or vaporized marijuana for symptoms of posttraumatic stress disorder (PTSD) in veterans of war.
MAPS is the only organization working to demonstrate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses to the satisfaction of the U.S. Food and Drug Administration.
Our efforts to initiate medical marijuana research have been hindered by the National Institute on Drug Abuse (NIDA) and the Drug Enforcement Administration (DEA) since our founding in 1986. NIDA's monopoly on the supply of marijuana for research and the DEA's refusal to allow researchers to grow their own has paralyzed medical marijuana research. For over 12 years, MAPS was involved in legal struggles against the DEA to end this situation.
Our study of smoked or vaporized marijuana for symptoms of PTSD in U.S. veterans has approval from the FDA and an Institutional Review Board. The study is currently on hold due to the Public Health Service's refusal to sell us the marijuana we need for the study.
See below for frequently updated information about completed, ongoing, or planned MAPS studies.
A Food and Drug Administration (FDA) and University of Arizona Institutional Review Board (IRB)-approved protocol for a study of marijuana for symptoms of PTSD in U.S. veterans, sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), has been on hold for over 3½ months, as researchers wait for the PHS to respond to their request to purchase marijuana for the study.
Rick Doblin to HHS: When Will You Stop Obstructing FDA-Approved Marijuana Research?
On February 13, 2013, MAPS Executive Director Rick Doblin, Ph.D., once again contacted the U.S. Department of Health and Human Services reminding the agency that more than three and a half months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization,” Doblin writes, “Can you help me understand why the Obama Administration still insists on obstructing medical marijuana research?”
Subject: More than 3 1/2 Months for PHS Marijuana/PTSD Protocol Review-2/13/14 NYTimes op-ed on federal obstruction of research
Date: February 13, 2014 From: Rick Doblin, MAPS To: Sarah Wattenberg, HHS
I imagine that you aren’t too happy to have the unenviable job of being the point person for obstructing privately-funded, FDA and IRB-approved medical marijuana research.
It’s now more than 3 1/2 months since Oct. 24, 2013, when MAPS submitted our FDA and IRB-approved protocol to you for the PHS review. As the saying goes, “Justice delayed is justice denied.” MAPS is the conservative wing of the medical marijuana movement in that we are focused on conducting FDA-regulated research but our efforts are not welcomed.
Today’s NYTimes had an op-ed discussing the federal obstruction of medical marijuana research. Unfortunately from my perspective, the article focuses on rescheduling marijuana to facilitate research, which isn’t necessary or likely, and doesn’t mention the PHS protocol review process which is the key obstruction along with the NIDA monopoly.
We’re doing our best to focus public attention on the PHS review process but we have been less successful than I have hoped. I anticipate greater success in the future illuminating the problematic PHS review process. We are considering bringing some vets to DC to protest the delays in the PHS review process but we’ll hopefully receive some favorable news from you before we organize the protest.
Do you have any idea when this interminable PHS review process will come to a conclusion, with either permission or rejection to purchase NIDA marijuana? I’m aware, as I am sure you are also aware, that even if we pass the PHS review, we still need to obtain DEA approval for the protocol before we can start the study. About 2200 vets have committed suicide since we submitted our protocol to you for review. Given the dramatic move in public opinion in support of medical marijuana programs, medical marijuana research, and marijuana legalization, can you help me understand why the Obama Administration still insists on obstructing medical marijuana research and hasn’t yet ended the PHS review process?
FDA Sends Pre-Inactivation Letter after Three Years Waiting for Marijuana for Study
Over three years ago, on December 15, 2010, the U.S. Food and Drug Administration (FDA) approved the protocol for our planned study of marijuana for PTSD in U.S. veterans, pending information about the source of the marijuana to be used in the study. Due to the ongoing Drug Enforcement Administration-protected monopoly held by the National Institute on Drug Abuse on marijuana for research, over three years later we’ve still been unable to obtain marijuana for the study. In their January 27, 2014, letter, the FDA asked MAPS to respond within 30 days if we still wish to proceed with the study. In his February 17 response, MAPS Executive Director Rick Doblin, Ph.D., writes, “We still do plan on responding to the clinical hold deficiencies but we can’t say exactly when we will have located a supply of marijuana for the study.” We have now been waiting almost four months for a response from the Public Health Service to our October 24, 2013, protocol resubmission.
Three Months Later, Researchers Still Waiting for Response from Public Health Service
On January 24, 2013, MAPS Executive Director Rick Doblin, Ph.D., sent an email to the U.S. Department of Health and Human Services reminding the agency that three full months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues,” Doblin writes “This delay is itself an obstruction of medical marijuana drug development research.”
Subject: 3 Months for PHS Marijuana/PTSD Protocol Review, Chicago Tribune column
Date: January 24, 2014 From: Rick Doblin, MAPS To: Sarah Wattenberg, HHS
Today completes the third month since Oct. 24, 2013, when we submitted to you our FDA and IRB-approved protocol for PHS review. We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues. This delay is itself an obstruction of medical marijuana drug development research.
In our letter of Oct. 24, 2013, MAPS also requested that HHS end the PHS protocol review process for privately-funded medical marijuana drug development studies. PHS review is designed for evaluating grant applications for government funding of basic science. PHS review is not appropriate for privately-funded FDA drug development studies designed to meet FDA standards but not to gather basic science information. The PHS review exists only because of NIDA’s DEA-protected monopoly. Rather than the PHS review, NIDA should sell its marijuana at cost to all sponsors of research approved by FDA, DEA, IRB and state authorities. Those agencies already regulate privately-funded research with all other Schedule 1 drugs, without PHS involvement.
As you may have noticed, a column in yesterday’s Chicago Tribune by Steve Chapman, a member of the Tribune‘s editorial board, called on President Obama to end the PHS medical marijuana protocol review process. Since it hasn’t ended yet, I look forward to working with you to find a way to start this much-needed study.
Marijuana for PTSD Protocol Resubmitted to HHS; Researchers Await Response
On October 24, 2013, MAPS resubmitted to the U.S. Department of Health and Human Services the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. Currently, the National Institute on Drug Abuse holds a monopoly on the supply of marijuana for research in the U.S. Under current federal policies, reviewers from the Public Health Service (PHS, a division of the Department of Health and Human Services/HHS) must approve all privately funded research seeking to use NIDA marijuana. The FDA approved the protocol in April 2011, but HHS reviewers unanimously rejected the protocol in September 2011, preventing the study from going forward. At the time of the HHS rejection, the study had not yet been approved by an IRB.
In October 2012, the IRB at the University of Arizona approved the study protocol. The IRB accepted all the core elements of our design, added several safety measures and procedures, and rejected HHS’ critiques of the protocol design. We are requesting that HHS agree to sell MAPS the marijuana needed for the study, as well as to abandon the PHS review process entirely, which exists only for marijuana and not for research with any other drug. MAPS is also working with other groups on a Congressional Sign-On letter to HHS Secretary Kathleen Sebelius urging her to eliminate the PHS review and require NIDA to sell marijuana to sponsors of all protocols that obtain approval from FDA, IRB, DEA and relevant state authorities.
U.S. First Circuit Court Upholds NIDA Monopoly on Marijuana for Research
On April 15, 2013, the United States Court of Appeals for the First Circuit rejected University of Massachusetts-Amherst Prof. Lyle Craker’s lawsuit against the Drug Enforcement Administration for denying him a license to grow marijuana for privately funded medical research. With its decision, the Court has ensured that the debate over the medical use of marijuana will continue to take place through political battles rather than through scientific research.
The decision brings to an end Craker’s 12-year effort to end the National Institute on Drug Abuse’s monopoly on the supply of marijuana for research. A laboratory at the University of Mississippi under contract to the National Institute on Drug Abuse is currently the only facility in the U.S. permitted to grow marijuana for research.
Prior to Craker’s application, NIDA had refused to sell marijuana to two FDA- and Institutional Review Board-approved protocols sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), preventing them from taking place. In September 2011, NIDA refused to sell marijuana to a third FDA-approved MAPS-sponsored protocol in 50 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).
Marijuana for PTSD: Institutional Review Board Approves Study Protocol
On October 25, 2012, the Institutional Review Board (IRB) at the University of Arizona notified Principal Investigator Sue Sisley, M.D., that they had approved the protocol for our planned study of marijuana for symptoms of PTSD in 50 U.S. veterans. The third and final IRB review took place on October 23. The Food and Drug Administration approved the protocol in April 2011, though the study has been blocked by the National Institute on Drug Abuse since September 2011. We are now preparing to resubmit the protocol and study documents, hoping that approval from both the IRB and the FDA will persuade NIDA to sell us the marijuana needed for the study.
Marijuana for PTSD: Protocol Submitted for Third Time to IRB
On October 12, 2012, MAPS and Principal Investigator Sue Sisley, M.D., resubmitted to the Institutional Review Board (IRB) at the University of Arizona the revised protocol, informed consent, and other documents for our study of marijuana for veterans with PTSD. The study aims to explore the safety and effectiveness of smoked or vaporized marijuana for symptoms of PTSD in 50 veterans with chronic, treatment-resistant PTSD.
The FDA cleared the study on April 28, 2011, which has since been blocked by the National Institute on Drug Abuse/Public Health Service’s September 16, 2011, refusal to sell researchers the marijuana needed for the study. We are hopeful that approval from the IRB will increase pressure on the NIDA/PHS reviewers to evaluate the protocol on the basis of science rather than politics. NIDA/PHS approval would allow us to submit the protocol to the DEA for final approval, and allow us to continue working to develop more effective treatments for veterans with PTSD.
In their August 31 letter, the IRB indicated that they were satisfied with the overall study design, but required several minor changes regarding subject safety. The revised protocol addresses these requested changes, including a detailed safety plan for subjects participating in the study and revised informed consent forms.
Marijuana for PTSD: IRB Requests Changes to Study Protocol, Researchers Respond
On August 31, 2012, the Institutional Review Board at the University of Arizona responded to our July 30 submission of the protocol for our planned study of smoked or vaporized marijuana for 50 U.S. veterans with chronic PTSD. After a meticulous review, the IRB committee sent Principal Investigator Sue Sisley, M.D., a list of nine issues to address, requiring relatively minor changes to the protocol and informed consent documents. The IRB’s letter indicated that they were satisfied with the key protocol design elements. MAPS and Dr. Sisley responded to the IRB’s comments on September 14, and we are hopeful that the protocol will be approved at the upcoming meeting of the IRB on September 25.
Thousands of U.S. veterans are using marijuana to treat their PTSD symptoms despite the lack of any controlled research into its safety and effectiveness. Several medical marijuana states use this lack of research as justification for refusing to allow physicians to recommend marijuana for PTSD.
Our protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to the National Institute on Drug Abuse/Public Health Service’s refusal to sell researchers the marijuana needed for the study. One of the issues raised by the NIDA/PHS reviewers in their rejection was that the protocol had not yet received IRB approval, although IRB approval is not required for NIDA/PHS to accept a protocol. If NIDA/PHS still refuses to allow us to conduct the study once both the FDA and the IRB have cleared it, the political motivations behind the federal marijuana research blockade will be even more apparent, as will the need for state-level reform.
Marijuana for PTSD: Protocol Submitted to Institutional Review Board
On July 30, 2012, MAPS and Sue Sisley, M.D., submitted the protocol for our FDA-approved study of marijuana for veterans with PTSD for review by the University of Arizona Institutional Review Board (IRB). The IRB review is scheduled for August 28. MAPS also submitted a detailed cover letter explaining our rationale for various elements of the protocol design.
The protocol received clearance from the FDA on April 28, 2011, but the study has been on hold since then due to NIDA’s refusal to sell researchers the marijuana needed for the study. We will respond to the NIDA/Public Health Service reviewers’ comments if the IRB also approves the study protocol.
Arizona Medical Association Challenges NIDA Blockade of Medical Marijuana Research
On June 2, 2012, the Arizona Medical Association (ArMA) House of Delegates unanimously adopted a resolution (pdf) challenging the National Institute on Drug Abuse’s blockade of medical marijuana research. ArMA’s resolution is yet another pressure point on the federal government’s obstruction of medical marijuana research.
ArMA resolved that “once the protocol for privately-funded marijuana research has been reviewed and approved by the Food and Drug Administration and relevant Independent Review Board and the practitioner has obtained registration from the Drug Enforcement Administration, the National Institute of Drug Abuse shall, without further evaluation of the research protocol, supply marijuana for the research, at cost, upon the practitioner’s proper application.”
U.S. First Circuit Court Hears Oral Arguments in Lyle Craker v. Drug Enforcement Administration
On May 11, 2012, the U.S. First Circuit Court of Appeals in Boston, Mass., heard oral arguments (audio, mp3) in the case of Lyle E. Craker v. Drug Enforcement Administration. The arguments are the culmination of 11 years of administrative and legal proceedings in response to the DEA’s denial of a license to Craker to start a production facility under contract to MAPS to grow marijuana exclusively for privately funded, federally regulated medical research.
Craker’s attorney from Washington, D.C., law firm Covington & Burling LLP, which is representing Craker pro bono, clarified the issues facing the court and urged the judges to require the DEA to issue Craker’s license. The DEA attempted to get the case thrown out before a ruling by claiming that the court has no jurisdiction over the issue, an argument that the court seems likely to reject. The court’s ruling should come in about three months. Meanwhile, the DEA is succeeding in preventing our medical marijuana research from moving forward.
DEA Lawsuit Reply Brief Submitted, Oral Arguments Scheduled for May 11, 2012
On May 4, 2012, the legal team representing Prof. Lyle Craker submitted their reply brief (PDF) in his federal lawsuit against the Drug Enforcement Administration for rejecting a DEA administrative law judge’s 2007 recommendation that it would be in the public interest to grant Prof. Craker a license to grow marijuana under contract to MAPS for federally-regulated research. Oral arguments in the case of Lyle E. Craker v. Drug Enforcement Administration will be presented on Friday, May 11, 2012 at around 9:30 A.M. at the U.S. First Circuit Court of Appeals in Boston, Mass.
Israeli Study Results Presented at Clinical Cannabis Conference
On April 28, 2012, the results of a recently completed exploratory study of medical marijuana in veterans with PTSD were presented (slides available here in PDF format) by Dr. Mordechai Mashiah, Deputy Director of the Abarbanel Mental Health Center in Israel, at the 7th National Clinical Conference on Cannabis Therapeutics, hosted by Patients Out of Time in Tucson, Ariz. The study was sponsored by the Israeli Ministry of Health.
MAPS Israeli Clinical Research Associate Mimi Peleg, Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., Clinical Research Assistant Linnae Ponté, and Executive Director Rick Doblin, Ph.D., assisted Dr. Mashiah with data analysis and preparation of his presentation and abstract. MAPS also allocated about $6,000 to assist Dr. Mashiah in analyzing and presenting his results, and will further support him in preparing of a paper for publication in a peer-reviewed scientific journal.
Medical Marijuana: New Arizona Law and Study for U.S. Veterans with PTSD
On April 3, 2012, Arizona governor Jan Brewer signed into law a bill prohibiting the use of medical marijuana on the campuses of schools, colleges, and universities in the state. The new law is an example of the current backlash against medical marijuana that is taking place at both the state and federal level across the United States. While the bill was intended to regulate state medical marijuana patients, some administrators at the University of Arizona have suggested that the bill could also apply to federally regulated medical marijuana research. This could prevent MAPS from being able to conduct our FDA-approved study of marijuana for PTSD on the campus of the University of Arizona in Phoenix, where Principal Investigator Sue Sisley, M.D., is planning to conduct the study.
In the study protocol, we propose to explore the safety and effectiveness of smoked and/or vaporized marijuana in 50 U.S. veterans with chronic, treatment-resistant PTSD. We are now seeking clarification on the extent of the new law, which is on shaky legal ground if used to ban federally regulated research. Meanwhile NIDA, which has a monopoly on the supply of marijuana for use in FDA-regulated research, continues to block the study by refusing to sell us the marijuana required for the study.
DEA Files Opposition Brief in Federal Lawsuit for Blocking Medical Marijuana Research
On March 22, 2012, the Drug Enforcement Administration (DEA) filed its first response brief (81-page PDF) to Prof. Lyle Craker’s lawsuit in the First Circuit Court of Appeals, which he filed on December 15, 2011. Prof. Craker is objecting to the DEA’s rejection of DEA Administrative Law Judge Bittner’s recommendation that it would be in the public interest to license Prof. Craker to grow marijuana for federally-regulated research. Granting Prof. Craker this license would end the federal monopoly on marijuana for research and open the door for non-profit medical marijuana research.
In their response brief, DEA lawyers (1) argue that the First Circuit Court of Appeals lacks jurisdiction in the case, (2) move to strike parts of our argument based on NIDA’s September 2011 refusal to sell us marijuana for our FDA-approved protocol for veterans with PTSD, and (3) reiterate previous arguments claiming that international treaty obligations forbid granting Prof. Craker a license.
Prof. Craker’s lawyers are now developing what we believe will be an effective response to the jurisdictional issues as well as the substantive issues. The reply from Prof. Craker’s legal team will be submitted in early May.
DEA Requests Third Extension for Filing Federal Lawsuit Opposition Brief
On March 14, 2012, Drug Enforcement Administration lawyers requested yet another extension—their third—on the deadline for filing their opposition brief in Prof. Lyle Craker’s lawsuit against the agency. The government’s brief is now due on March 21.
DEA Requests Second Extension for Filing Opposition Brief in Federal Lawsuit
On February 22, 2012, the Drug Enforcement Administration requested a second extension on the deadline for filing its response brief in Prof. Lyle Craker’s federal lawsuit against the agency. The government’s brief is now due March 16.
DEA Requests Extension for Filing Opposition Brief in Federal Lawsuit
On January 13, 2012, lawyers for the Drug Enforcement Administration called the lawyers representing Prof. Lyle Craker to request an extension until February 24 for filing their opposition brief in response to Craker’s opening brief, which was filed in the 1st Circuit Court of Appeals on December 15, 2011. Craker’s legal team granted the request for an extension. Craker’s reply brief will now be due on March 9, two weeks after February 24, though the DEA lawyers indicated they would agree to an extension should it be requested. Once all opening briefs are filed, it’s likely that oral arguments will be scheduled.
Craker’s Legal Team Submits Opening Brief in Federal Lawsuit against the DEA
On December 15, 2011, the legal team representing Prof. Lyle Craker filed their opening brief in their much-anticipated lawsuit against the Drug Enforcement Administration for denying Craker’s application to cultivate marijuana for medical research. The 232-page document (PDF) represents the combined efforts of Prof. Craker, the American Civil Liberties Union, Washington, D.C. law firm Covington & Burling LLP, and MAPS, and is a major challenge to DEA’s politically-motivated decision to uphold the federal blockade on marijuana for research. The DEA’s opposition brief is currently due January 20, though the agency may request an extension of a month or more. The brief was filed in the United States Court of Appeals for the First Circuit.
MAPS Receives Pro-Bono Representation to Appeal Craker Case in First Circuit Court of Appeals
MAPS has received a generous offer for pro-bono legal representation from the Washington, DC law firm Covington & Burling LLP, one of the foremost law firms representing the pharmaceutical industry, to appeal the DEA’s August 15 final order in the First Circuit Court of Appeals. These legal actions would otherwise have cost MAPS an estimated $175,000 in legal fees, which we may or may not have been able to raise.
NIDA/PHS Rejects Marijuana/PTSD Protocol, Blocking MAPS’ FDA-Reviewed Study
On September 16, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five NIDA/PHS reviewers had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. According to MAPS Executive Director Rick Doblin, Ph.D., the reviewers offered contradictory critiques, misunderstood key protocol design elements, requested expensive and tangential additions to the protocol, and made unfounded assumptions about the study design, revealing their focus on basic science research and lack of familiarity with drug development research. The reviewers also treated the submission as if MAPS were requesting a government grant for the study rather than using private funds. Even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.
DEA Rejects Judge’s Recommendation, Upholding Federal Marijuana Monopoly
On August 15, 2011, the Drug Enforcement Administration (DEA) issued its final order rejecting DEA Administrative Law Judge Mary Ellen Bittner’s 2007 recommendation that it would be in the public interest to grant University of Massachusetts, Amherst Prof. Lyle Craker a license to grow marijuana for federally regulated research. The rejection preserves the monopoly held by the National Institute on Drug Abuse (NIDA) on the supply of marijuana for Food and Drug Administration (FDA)-regulated research.
ALJ Bittner issued her recommendation to license Prof. Craker on February 12, 2007, after extensive hearings. On January 14, 2009, almost two years later and six days before President Obama’s inauguration, DEA Acting Administrator Michelle Leonhart rejected the ALJ recommendation. In response, Prof. Craker’s lawyers filed a series of objections, which were denied in the final order. Prof. Craker’s only recourse is to appeal the DEA final ruling in the First Circuit U.S. Court of Appeals.
NIDA/PHS Completes Review of Marijuana for PTSD Protocol; MAPS Awaits Response
On April 28, 2011, the revised protocol for our planned study of marijuana for symptoms of PTSD in US veterans was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS). On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.
Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 50 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Clinical Investigator: Sue Sisley, M.D.
This study will look at whether smoking or vaporizing marijuana can help reduce PTSD symptoms in fifty veterans with posttraumatic stress disorder (PTSD). Participants can be men or women aged 18 or older with a diagnosis of PTSD that has not improved after they have tried either medication or psychotherapy.
$10,000 needed for protocol development and approval / $10,000 raised
On February 9, 2011, the FDA and MAPS held a teleconference during which MAPS successfully addressed the FDA’s concerns, including the potential for diversion of marijuana used in the study.
On March 15, 2011, MAPS submitted the revised protocol incorporating the changes discussed on February 9 to the FDA.
On April 28, 2011, the revised protocol was accepted by the FDA, and submitted to the Department of Health and Human Services (HHS) to be reviewed by the National Institute on Drug Abuse (NIDA) and the Public Health Service (PHS).
On July 15, 2011, HHS informed MAPS that the NIDA/PHS review had been completed and that we should receive the report soon.
On September 16, 2011, HHS informed MAPS that the NIDA/PHS reviewers had unanimously rejected the protocol as currently designed. For a concise summary of the HHS review, see the September 16 HHS cover letter. For MAPS’ detailed, point-by-point response to the HHS review, see the annotated reviewer comments.
On October 25, 2012, the University of Arizona Institutional Review Board (IRB) approved the study protocol.
On October 24, 2013, MAPS resubmitted the study protocol (cover letter) to HHS.
MAPS Efforts to Obtain a DEA License for a Medical Marijuana Production Facility
DEA Lawsuit Overview
MAPS is seeking to developing the plant form of marijuana into a prescription medicine for the purpose of making medical marijuana legally available on a federal level. If marijuana were a U.S. FDA-approved prescription medicine, it would no longer be up to individual states to decide on the legal status of medical marijuana. Nationwide, any person with a doctor’s prescription would be legally allowed to use the medicine.
To date, the FDA has not evaluated marijuana as part of a prescription drug-development process. The National Institute on Drug Abuse’s monopoly on the supply of marijuana for federally approved research is in the way.
Prior to initiating a full drug development research program for medical marijuana, MAPS must obtain an independent source of marijuana that is legal for clinical research.
NIDA does not have a monopoly on any other Schedule I drug, such as MDMA, LSD, or psilocybin. NIDA only makes its marijuana available to projects it approves.
MAPS, in association with Professor Lyle Craker of the University of Massachusetts-Amherst Department of Plant and Soil Sciences has been locked in a decade-long struggle to obtain DEA permission to establish a marijuana-growing facility for FDA-approved research, and to end NIDA’s monopoly. On April 15, 2013, the U.S. First Circuit Court of Appeals upheld the DEA’s rejection of the 2009 DEA Administrative Law Judge recommendation that it would be in the public interest for the DEA to license Prof. Craker to grow marijuana under license to MAPS for federally regulated research, thereby ending the NIDA monopoly on marijuana for research. Following the First Circuit decision, Prof. Craker’s legal team decided that the Court acted within its jurisdiction and that there was no point in appealing the case to the U.S. Supreme Court.
MAPS’ current strategy to obtain FDA approval for medical marijuana depends on importing medical grade marijuana into the U.S. for FDA-approved studies. However, as of May 2013, there is no source of medical grade marijuana available for import. Perhaps in several years, medical grade marijuana will be available for import from Israel or Canada or elsewhere enabling MAPS to finance clinical research to develop marijuana into an FDA-approved prescription medicine.
If successful, MAPS would bring smoked and/or vaporized marijuana to market under a nonprofit pharmaceutical model similar to the Population Council’s development and distribution of RU-486.
Note: Despite NIDA’s obstructionism, MAPS has been able to provide some analytical data about marijuana vapor produced by vaporizers to Donald Abrams, M.D., of the University of California, San Francisco. He has used this data as part of his successful application to the FDA to conduct a study evaluating the effects of marijuana on human subjects, cannabinoid blood levels, and carbon monoxide levels in subjects who smoke marijuana and those who use a vaporizer.
History of MAPS Orphan Drug Designation for Smoked Marijuana for AIDS Patients
On May 25, 1999, MAPS successfully secured Orphan Drug Designation for Marijuana in the treatment of AIDS wasting syndrome. Since it is not possible to obtain a patent on marijuana for use as a prescription medicine, an Orphan Drug Designation makes marijuana available for research and development into a prescription medicine. The Orphan Drug Designation program was developed by congress to facilitate the development of rare drugs. In the years since MAPS obtained permission to study this treatment, the advent of protease inhibitors has largely eliminated AIDS wasting syndrome in the US. As a result, we have not pursued this research.
MAPS, in conjunction with the California branch of the National Organization to Reform Marijuana Laws, worked between 1993 and 2009 to sponsor research into the effects of vaporizers and water-pipes in filtering the fumes of inhaled marijuana. Our goal was to determine if water-pipes or vaporizers could reduce the health risks of smoking marijuana.
From 1993 to 2002, we sponsored research at DEA-licensed laboratories testing the content of combusted and vaporized marijuana for cannabinoid particulate and carbon monoxide levels.
Between June 2003 and August 2009, MAPS attempted to purchase marijuana from the National Institute on Drug Abuse for more research with vaporized marijuana. Due to excessive delays and frustration, in August 2009, the laboratory we were working with on the project withdrew its efforts.
MAPS is no longer working on specific vaporizer research, although our protocol for our marijuana/PTSD research requires some subjects to use a vaporizer and others to smoke marijuana.
Timeline of MAPS Blocked Vaporizer Research
February 6, 2009 Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research:
In the January 23, 2009 message, HHS provided a list of questions for Chemic Labs to use as guidance for the validation study, but in their own words the questions are not inclusive of all aspects of method validation. Therefore, we could spend $50,000 or more on this validation study and HHS could claim that we did not meet all of the requirements and could request additional expensive validation data, all before reviewing the vaporizer protocol itself, which would only cost an estimated $25,000.
What makes this especially frustrating is that a validation study isn't truly necessary for the sort of academic study we're seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as an FDA-approved medical device, which MAPS isnt seeking to do. We're exploring collaborating with Dutch scientists from the University of Leiden, who are already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less than half the cost of the validation study.
We are wary of conducting a validation study, or even a cross-validation study, without HHS/NIDA having reviewed and approved the vaporizer protocol itself. Well get back to HHS after we determine if we can make a case for a cross-validation study, then well ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.
MAPS President Rick Doblin and Dutch PhD student Justin Fischedick of Leiden University, met with Joseph St. Laurent and Scott Goodrich at Chemic Labs, outside of Boston LINK to CHEMIC. Justin and his associates have been conducting marijuana vaporizer research at Leiden University using the Volcano vaporizer. They have decided to share data and procedures with Joseph St. Laurent and Scott Goodrich, who have been trying without success for over 5 1/2 years to purchase 10 grams of marijuana from NIDA for MAPS and CaNORML-sponsored vaporizer research.
Justin and his associates have been looking mostly at what is in the marijuana vapors, such as cannabinoids and terpinoids. In order to determine whether vaporization is an effective harm reduction device, the Chemic researchers intend to mostly investigate what isn’t likely to be in the marijuana vapors, but is in marijuana that is burned. This research will focus on various tars and products of combustion such as carbon monoxide.
Chemic is waiting on reviewers from NIDA and the Public Health Service to review their latest reply to questions about their proposed protocol, submitted on November 6, 2008. Once permission is eventually obtained for their research, they will check with Justin to see what his team has learned and then move forward.
We have now been trying without success for more than five years to purchase 10 grams of marijuana from NIDA for the expansion of our vaporizer research.
The questions about our protocol raised by NIDA/PHS were unusually exhaustive, sometimes questioning design elements that had been added in response to suggestions from prior reviewers, and seemed to have been intentionally designed to delay our ability to move forward with this study—which they were successful in doing. The NIDA/PHS critique discouraged and demoralized Chemic Labs, who in turn were slow to respond to NIDA.
Now that our response has been submitted, we are hopeful that NIDA will grant us permission to purchase government-grown marijuana for use in our vaporizer protocol. Unfortunately, we may need to wait another 6 months or so for NIDA/PHS to reply to our response to their critiques. There is no regulatory time limit governing the NIDA/PHS response. Weve already been waiting about three years for a NIDA/PHS response to our reply to their previous critique of an earlier protocol, which is why we went ahead and submitted our new protocol on January 16, 2008.
On June 18th, after a five month review process, the National Institute of Drug Abuse-Public Health Service (NIDA-PHS) finally responded to our revised vaporizer research protocol, submitted for review January 16, 2008. The submission included three supportive letters from peer-reviewers, confirming the scientific merit of the study and urging NIDA-PHS to approve it. By responding, NIDA/PHS avoided MAPS filing another lawsuit for unreasonable delay, which wed intended to file in the middle of August.
MAPS has still been waiting two years and nine months for NIDA/PHS to respond to our September 2005 reply (PDF) to their rejection of our previous vaporizer protocol (PDF), which we initially submitted in June 2003, after which it took them more than two years to evaluate! We submitted the revised protocol in January 2008 to see if that might motivate NIDA to respond, which it has.
According to Rick, The review is filled with issues designed to delay and exhaust us, that have little importance to the safety or relevance of the intended research, but I don’t think it will deter us for too long. We’ll respond thoroughly and quickly before the end of July, and then wait yet again for a reply. Now that NIDA/PHS are familiar with the issues and have articulated their concerns, their response to our comments should be faster. We’re already making progress in that the strategy of delay has been overcome and a review was issued.
If this situation werent so genuinely tragic for all the sick people who might benefit from this research, then it would simply appear ridiculous. All MAPS is requesting to do is purchase ten grams of marijuana—something virtually any high school student in the US could obtain—so that we can move forward with a study of a non-smoking delivery system for marijuana that might benefit people suffering from a wide range of debilitating, difficult-to-treat illnesses.
The FDA has thirty days to review complicated human protocols. With NIDA/PHSs dysfunctional review process, they have provided us with powerful evidence for why we need to break the NIDA monopoly on the supply of marijuana that can be used in research, said Doblin.
MAPS has been waiting since February 12, 2007 for the DEA to issue a final ruling in response to DEA Administrative Law Judge Bittners recommendation (PDF) that the NIDA monopoly on the production of marijuana legal for research be ended, and that Professor Lyle Craker be issued a DEA license for a MAPS-sponsored medical marijuana production facility.
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.
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.
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.
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.
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.
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."
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.
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.
View As Single Entry > 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
During his comments, he discussed the importance of
MAPS’ vaporizer research efforts as well as the UMass Amherst project.
March 19, 2004. Dr. Donald Abrams receives word that his FDA-approved Phase I vaporizer study
is now ready to enroll subjects. He will be comparing cannabinoid and carbon monoxide levels and
subjective effects in subjects who at different times inhale either marijuana smoke from a burning
cigarette or marijuana vapors from the Volcano vaporizer. Being able to use a vaporizer in FDA-approved
clinical trials is one of MAPS’ two prerequisites to justifying the expense of a $5 million effort to
develop marijuana into an FDA-approved prescription medicine, the other prerequisite being an independent
source of supply of marijuana for research other than using material from the National Institute on Drug Abuse (NIDA).
March 17, 2004. In an effort to find out what is going on with the Health and Human Services (HHS) review of the scientific merit of the vaporizer protocol, an exchange of email took place today between Willem Scholten, Head of the Dutch Office of Medicinal Cannabis and Rear Admiral, Assistant Surgeon General and Deputy Assistant Secretary for Health (Operations) Arthur J. Lawrence.
Willem Scholten inquired about the status of the review.
Dr. Lawrence replied
that the responsibility for the review was being shifted from his office and at the moment he
didn’t know exactly to where or what was going on.
He was, however, sure that, " this protocol will, as all proposed protocols for this sort of research are, be
given fullest consideration and deliberation in the scientific review."
Somewhat dissatisfied with the review seemingly being on the slow track to nowhere,
MAPS President Rick Doblin replied to Dr. Lawrence.
He requested whatever help Dr. Lawrence
could offer in expediting the review, noting that the protocol was first submitted for review
on June 24, 2003 and that all we were asking for was to purchase 10 grams of NIDA marijuana and import 10 grams from the Dutch.
He concluded by stating, "The vaporizer research project is part of MAPS’ efforts to work through the
rigorous FDA drug review process to conduct exactly the sort of studies that DEA, ONDCP, NIDA, IOM, all
claim to want to see conducted. Given the difficulties in purchasing a tiny amount of marijuana for this
simple vaporizer research protocol, it should not be surprising why so many States have gone ahead and
legalized the medical use of marijuana in one form or another without waiting for the FDA to approve
its medical use on the basis of double-blind, randomized, placebo-controlled research."
Also, Dr. Scholten informed MAPS that some vaporizer research with the same Volcano device was being conducted
in the Netherlands. We’ve sent a message to the researcher and look forward to collaborating and sharing information.
January 29, 2004. The scientific review of the vaporizer protocol being
conduced by the federal Dept. of Health and Human Services is now being
supervised by Assistant Surgeon General Arthur J. Lawrence Ph.D. Mr. Joel Egertson,
senior drug policy advisor to the Secretary of HHS, has retired and the
responsibility for the review has been reassigned. A revised and updated package of
information has been submitted today by Chemic Labs to Assistant Surgeon
General Lawrence. If HHS determines that the vaporizer protocol is
scientifically meritorious, NIDA will agree to sell us 10 grams of marijuana and DEA will
be required to address our request to import 10 grams of marijuana from the
Dutch Office of Medicinal Cannabis. The protocol is a rigorous investigation
and, if reviewed in an unbiased manner, will be determined to be scientifically
meritorious. MAPS initially requested permission in June 2003 to purchase
marijuana from NIDA and import marijuana from the Dutch. This delay is clear
evidence why NIDA’s monopoly on supply of research marijuana serves more to
obstruct than to facilitate marijuana research.
December 16, 2003. MAPS received a grant of $13,000 for further vaporizer
research from the Marijuana Policy Project. The grant includes $5,000 for the
writing of a scientific paper about the results of the research for submission
to a journal indexed in Medline. Also included is $8,000 for a study of the
cannabinoid content of each of the 1st, 2nd, and 3rd balloons created by the
Volcano vaporizer from the same sample of marijuana. We want to see if we can
eliminate the use of the 3rd balloon in clinical research if only minimal amounts
of cannabinoids are released the third time the same sample is heated and
vaporized. This study can be conducted only after we have been able to obtain
approval from HHS to purchase 10 grams of marijuana from NIDA, a time-consuming
hurdle that wouldn’t be necessary if MAPS had its own independent source of
supply of marijuana that could be used in federally-approved research (as we have
with MDMA and psilocybin, for example).
December 4, 2003. The manufacturers of the
that MAPS and CaNORML are using in our vaporizer research, STORZ & BICKEL GMBH & CO. KG,
announce that they have received the Dr. Rudolf Eberle Prize,
the prize for innovation of the State of Baden-Wurttemberg. This prize has been
on an annual basis since 1985 to small and medium-sized industrial and craft firms who
have successfully implemented outstanding technical innovations. The prize
committee uses the criteria of technical progress, special entrepreneurial
achievement and the economic success of the innovation to make its decision.
November 14, 2003. Vaporizer protocol likely to start early in 2004.
According to Dr. Donald Abrams, "As far as I know we are awaiting our award from
CMCR. All approvals are granted and we plan to commence the vaporizer protocol
in January 2004."
October 10, 2003.
The analytical lab conducting the vaporizer research has
received replies from NIDA and the DEA regarding its requests to import 10
grams of marijuana from the Dutch Office of Medicinal Cannabis and to purchase 10
grams from the National Institute on Drug Abuse (see entry below for June 24,
2003). The reply from NIDA came from Joel Egertson, Senior Drug Policy
Advisor to the Secretary of Health and Human Services (HHS). Mr. Egertson wrote,
"It has been determined that there is insufficient information in the
application to judge the merits of the proposal. " Mr. Egerston had been submitted the
protocol for which the 10 grams was requested but asked for additional
information that has already been generated from previous research protocols and has
already been submitted to the FDA. This additional information will be
submitted to Mr. Egerston very soon for HHS review.
The reply from DEA indicated that it would not proceed with the import permit
until the scientific merits of the protocol had been accepted by HHS.
While a decision on these requests has been delayed, we believe we can
adequately address all the issues raised by HHS and DEA. Yet again, this prolonged
process to purchase tiny quantities of marijuana for important privately-funded
research demonstrates the need for MAPS to sponsor a privately-funded
facility to produce marijuana for federally-approved research, as we are attempted to
do in partnership with Prof. Craker at UMass Amherst.
June 24, 2003. Grant for Vaporizer Study with Humans Approved Contingent upon Regulatory Approval. California’s Center for Medicinal Cannabis Research (CMCR) preliminarily approved Dr. Donald Abrams’ Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000, contingent upon the protocol obtaining all the necessary regulatory approvals. The study will compare subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath in subjects on six different days, three days smoking 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC, and three days vaporizing 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC.
The protocol now goes to FDA for its review, finally. The big question is whether the FDA will want more data than MAPS and California NORML have already gathered on the Volcano (www.vapormed.de) or will accept the data we have already submitted, which is more than FDA has about what is in marijuana smoke post-combustion. We should hear from FDA within 4-6 weeks or so.
Also reviewing the protocol will be NIDA (since NIDA pot is being requested), DEA (supposedly to see what it can do to prevent the diversion of research supplies), and the Research Advisory Panel of California (which reviews all Schedule I research in California). The key review will be by FDA, since it will decide whether or not MAPS and California NORML need to raise more funds for additional vaporizer research.
June 24, 2003. Maps Working to Import Dutch Cannabis for Research. MAPS has completed negotiations with the head of the Dutch Office of Medicinal Cannabis for the importation of ten grams of high THC, high CBD marijuana for use in the next phase of the vaporizer research project. Chemic Laboratories, where the project will be conducted, has submitted an application to the DEA for an import license. This request to the DEA is, to our knowledge, the first attempt to import the marijuana plant from the Netherlands, through the newly established Office of Medicinal Cannabis. Chemic Laboratories has also submitted a request to NIDA for ten grams of its best quality product for the vaporizer project.
"Vaporizer Research: An Update" (PDF Format)
MAPS Bulletin, Spring 2003; Volume XIII, Number 1
April 15, 2003. Vaporizer Study Report.The Vaporizer report is now
available. The findings show substantial reduction (about 99%) in certain
toxins in the vapor as compared to marijuana smoke, and substantial amounts
of cannabinoids produced by the vaporizer. The results could hardly have been
better. This report has been submitted to FDA as part of Dr. Donald Abrams’
IND application to study subjective effects and cannabinoid blood levels in
subjects who both smoke marijuana and then at a later time inhale marijuana
vapors. We should hear from FDA in early May about what additional
information, if any, it needs to have before deciding if the vaporizer can be
used in a clinical trial.
January 21, 2003. MAPS and CANorml sign a contract for a $25,000
protocol study to evaluate the contents of the vapor stream from the Volcano
Vaporizer (http://www.vapormed.de). The
purpose of the study is stated in the contract as follows: This protocol is
intended to provide guidance on the completion of an extraction evaluation of
emissions produced when marijuana is vaporized using the Volcano; to provide
evidence of product efficiency to MAPS, which would subsequently design and
seek agency (FDA) approval for the protocol development and initiation of a
Phase I clinical investigation comparing cannabinoid blood levels in subjects
smoking (i.e. pyrolysis) marijuana versus marijuana vaporized with the Volcano,
and to meet the requirements of cGMP: 21 CFR Part 160.
We expect the study to be completed by the end of March 2003.