Record of Discussion - Expert Advisory Committee on Information for Physicians on Marihuana for Medical Purposes (EAC-IPMM) - January 26-27, 2012

Delta Hotel, Ottawa

Present

Members, EAC- IPMM

• Dr. Harold Kalant (Chair)
• Dr. Mary Lynch
• Dr. Mark Ware
• Dr. Paul Daeninck
• Dr. Pierre Beaulieu
• Dr. Jason McDougall
• Dr. Keith Sharkey
• Dr. Boris Gorzalka
• Dr. Tony George

Observers

• Dr. Maura Ricketts (Canadian Medical Association)
• Mr. Pascal Charron (Canadian Medical Association)

Health Canada

• Executive Secretary:
  • Mr. Stéphane Lessard (for Ms. Cathy Sabiston)
  
  
  
• EAC Secretariat:
  • Dr. Suzanne Desjardins
  • Dr. Hanan Abramovici
  • Ms. Allison Vadneau
  • Ms. Erin Rutherford

Regrets

Dr. Cory Toth

1. Welcome and Opening Remarks

Mr. Stéphane Lessard, Executive Secretariat, welcomed everyone and thanked the EAC members for attending and providing their expertise. Mr. Lessard provided a brief overview of the rationale for this committee.

2. Opening Remarks from the Chair and EAC Secretariat

Dr. Suzanne Desjardins, Director of the Office of Research and Surveillance (ORS), thanked the EAC members as well as the observers from the Canadian Medical Association (Dr. Maura Ricketts and Mr. Pascal Charron) for attending the meeting.

Dr. Desjardins explained that ORS staff would serve as the Secretariat for the Committee, and outlined what services it would perform in that role.

Dr. Desjardins instructed Committee members to review their respective biography and declaration of affiliations and interests as this information will be posted on the Health Canada website.

The Chair thanked the Committee members for their attendance and invited them to introduce themselves and declare their affiliations.   The Chair reminded the Committee of the nature and limits of its mandate, and of the fact that discussion would relate exclusively to information for physicians concerning authorized medical use of cannabis and cannabinoids.

3. Approval of Terms of Reference (TOR)

The TOR were approved by the Committee.

4. Clarification of Meeting Agenda

The Chair indicated that the list of discussion points that were identified during the peer-review of the Information Document and following additional consultations needed to be prioritized in the agenda.

The Committee prioritized the discussion points listed on pages 3 and 4 of the agenda and added the following items:

• palliative care
• endocannabinoids and the endocannabinoid system
• tolerance
• timeframe for future updates to the document

5. Discussion Points

The Committee reviewed and discussed each of the items listed on pages 4 and 5 of the agenda.

The primary recommendations that were put forth by the Committee during these discussions were as follows:

1. The title of the document should be broadened to: "Information for Health Care Professionals on Therapeutic Uses of Marihuana and Cannabinoids".
2. No statements for or against the use of cannabis in the treatment of any illness should be made in this document, because any such decision in a given case is the responsibility of the treating physician. The document should only state the available scientific information and evidence. Any reference in the current text to a recommendation for or against the use of cannabis or cannabinoids in the treatment of illness should be removed.
3. No statement should be made in regard to whether the benefits of using cannabis or cannabinoids outweigh the risks in the treatment of any particular illness or for any particular patient population (such as those whose immune systems may be compromised).
4. No statement regarding the claimed benefits of using different strains of marihuana containing varying levels of cannabinoids should be made at this time because there is  insufficient scientific evidence.
5. No statement regarding dosing or a dosing guideline should be proposed at this time, as the scientific evidence is insufficient.
6. The approach and wording of the document regarding the purported indications and clinical use (Section 4.0) and the health risks of using cannabis or cannabinoids (Section 8.0, Adverse Effects) are well balanced and should not be altered.
7. No statement regarding patient monitoring should be formulated, as it is beyond the scope of this document.
8. A table summarizing the available information regarding cannabis/cannabinoids for various medical conditions (using "stars" or "points" to denote for every medical condition the quality of the evidence or the success achieved with each type of therapeutic modality for each medical condition), should not be included as the rating of the available evidence goes beyond the scope of the Committee's mandate.

6. Section by Section Review of the Document "Information for Health Care Professionals"

The Committee reviewed the contents of the document section by section. Members highlighted typographical errors and stylistic revisions to improve the clarity of the document. They also made suggestions regarding content organization (separate sections for gastrointestinal system and liver, arthritides, the endocannabinoid system, tolerance and palliative care).  Other suggestions included addition of a brief section 4.6.10 on Emerging Uses suggested by current research, enlargement of Section 8.6 to include gastrointestinal tract as well as liver, and enlargement of Section 8.7.2 to include a discussion of driving impairment and accident risk.

The Committee agreed that it would be useful to include a table which summarizes the pharmacokinetic and pharmacodynamic commonalities/differences between the different cannabinoid preparations (cannabis, Sativex®, nabilone, dronabinol, etc.).

It was also agreed that comments and suggestions concerning the use of cannabis or cannabinoids in the treatment of fibromyalgia would be provided to the Secretariat.

7. Additional Questions

At the close of the meeting on Friday January 27th, Committee members were asked if they had any additional questions in regards to the role of the Committee going forward or in regards to the document itself.

The question was posed as to how frequently the content of this document will be updated. Dr. Desjardins clarified that the intention is to update this document periodically and not on an ongoing basis. There is also the possibility of producing a supplement to this document should a breakthrough study become available.

The question of a second meeting to address the remaining portion of the EAC mandate was also addressed. The executive secretary, Mr. Stéphane Lessard, agreed that a second meeting should be considered but only after a physician needs assessment is completed and the results are analyzed.

Next Steps and Closing Remarks

Dr. Desjardins and the Chair thanked everyone for attending and for providing their input and expertise.

The next step for the EAC Secretariat will be to prepare the draft record of discussion (ROD), incorporating any additional comments received and to circulate to Committee members and the Chair.

Committee members are asked to send their comments and changes to the ROD out to all Committee members when responding by e-mail.

The suggestions and recommendations made by the Committee will be considered and the information document ("Information for Health Care Professionals") will be finalized.

Once the document has been finalized, Committee members will have a chance to review the document and to indicate if the changes made by Health Canada are consistent with the Committee's recommendations.

This report is submitted on behalf of, and with the approval of, all the members of the Committee who participated in the meeting.

Harold Kalant, M.D., Ph.D., Chair

Dated:  June 1, 2012