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Short Term Effects of Cannabinoids in HIV Infection

On December 6, 1999, Dr. Ethan Russo, U. Montana, heard that NIDA's special review committee convened in November 1999 rejected his MAPS-supported, IRB-and FDA-approved protocol. He was informed that he will not be permitted to purchase marijuana from NIDA for his study. In February 2000 Russo received a letter from NIDA with a Summary Statement explaining the reasons for the review committee's rejection. The protocol was approved by the FDA in September 1999.

A press release was prepared by the Marijuana Policy Project, which has been lobbying against the new HHS guidelines for medical marijuana research which permit NIDA to create its own special review committee to review protocols that have already been approved by FDA and Institutional Review Boards. All that Dr. Russo and MAPS have been seeking is the ability to purchase low quality marijuana from NIDA at a price that has not yet been made public. The sad truth is that NIDA is still successfully blocking medical marijuana research.

We are currently reassessing how to proceed with efforts to conduct privately funded medical marijuana research. NIDA's monopoly control over the supply of marijuana that can be used in FDA-approved research projects highlights the important of MAPS' long-term effort to obtain permission from DEA to establish an independent facility to produce marijuana for FDA-approved research.

While Dr. Russo is seeking to study cannabis in the treatment of migraines, he has discussed patient reports and biological studies that suggest a variety of psychedelics could also be helpful to patients with migraines and cluster headaches. Read commentary

About this protocol

In the Spring of 1997, with the aid of a $3,500 grant from MAPS, Dr. Ethan Russo submitted a research proposal to the National Institutes of Health (NIH). The design of this study was for 30 patients meeting criteria of acute migraine with or without aura, and in whom treatment with subcutaneous sumatriptan has been ineffective or poorly tolerated.

NIH Rejects First Application for Cannabis in Migraine Treatment Study
In the Spring of 1998, Dr. Russo learned that NIH had rejected his application. In Dr. Russo's words: "I recently received the "formal" critique of our team's proposal by the NIH Review Committee. Although I would admit to discouragement, and my doubts as to how to rectify deficiencies that may not in fact exist, my research partners and I intend to re-submit this proposal to NIH for the Spring cycle. The critique contained many instances calling for elements that the protocol in fact already contained. ...of 29 members of the review team... only eight were neurologists, and none appear to be headache specialists." [read Dr. Russo's full response to NIH] With additional assistance from MAPS, Dr. Russo submitted a revised application for the July 1, 1998 NIH grant cycle deadline.

Second Application Denied
In November 1998, despite the elation of the medical marijuana victories at the 1998 ballot box, it became evident that research was no easier to initiate. Dr. Ethan Russo learned on November 12, 1998 that the NIH rejected his second MAPS-supported application to study the use of marijuana in the treatment of migraine sufferers.

The formal NIH critique of this second application was prepared in January 1999. The reviewers focused in large part on an issue that cannot be resolved and that has nothing to do with the scientific merit of the protocol design, the supposed need for preliminary data to supplement extensive historical and anecdotal reports. Dr. Russo's response to the critique describes why he initially decided to not attempt a third application to the NIH to study cannabis for migraine.

Migraine Protocol Finally Critiqued by FDA
Despite the setbacks, the protocol was revised and on Friday, May 14, 1999, after refusing to do so for two years, the FDA formally critiqued Russo's protocol. The FDA's comments were reasonable, though extraordinarily cautious. Both Dr. Russo and MAPS believed that the revised versions of the protocol and informed consent form would subsequently receive FDA approval. Minutes of May 14 meeting

Cannabis in Migraine Treatment Project Close to FDA Approval
In July 1999, Dr. Russo received word from the FDA that his revised protocol for the Cannabis in Acute Migraine Treatment Project has been accepted by that agency, but remained on "clinical hold" pending receipt of a letter from NIDA authorizing access to the Drug Master File on cannabis.

FDA Approves Investigational IND for Cannabis in Migraine Treatment
On October 1, 1999, after almost three years of effort by Dr. Ethan Russo and MAPS, the FDA approved the study of the effects of smoked cannabis (marijuana) as compared to oral dronabinol (Marinol®) and injected sumatriptan. The study will enroll 40 patients with severe migraine...

More about this study

• Psychedelics for Migraines. Information about the use of psychedelic drugs such as LSD to treat vascular headaches, and cluster headaches in particular has been assembled by Craig Adams of OUCH (Organisation for Understanding Cluster Headaches)
• HHS Review Criteria for and Rating of Unsolicited Research Applications for the Study of Medical Uses of Marijuana
• The February 2000 letter from HHS Public Health Service describing reasons why the protocol was rejected for the third time
• The November 1999 Review Committee's formal critique, amending the February 2000 letter
• September 1999 Letter from Alan Leshner (NIDA) to Cynthia McCormick (FDA) permitting Russo to cross-reference the NIDA Drug Master File for cannabis
• September 1999 Letter from the FDA approving the protocol
• The May 1999 formal critique of the protocol by the FDA
• Second application submitted to the NIH in 1998
• January 1999 NIH critique of the 1998 application
• Dr. Russo's response to the January 1999 NIH critique of the 1998 application
• December 1997 NIH critique of the 1997 application
• Dr. Russo's response to NIH's rejection of the protocol, Spring 1998
• A brief description of Dr. Russo's research protocol as it was first submitted to NIH in June 1997
• Dr. Russo's article, Cannabis for Migraine Treatment: The Once and Future Prescription?: An Historical and Scientific Review. From the Journal Pain, June 1998 (as PDF File)
• Commentary on Cluster Headaches

Read more about MAPS' support of medical marijuana research