Intractable Pain Advisory Panel Meeting October 6, 2015 Present: Orlando Charry, Amy Anderly-Dotson. Nancy Jaworski, Erin Krebs, Mary Pat Noonan, Daniel Truax, Neal Walker, Arthur Wineman, MDH Staff Present: Tom Arneson, Alison Bjork, Michelle Larson, Alix Noonan, Susan Anderson, Deepa McGriff, Deputy Commissioner Dan Pollock Facilitated by: Charlie Petersen, Management Analysis and Development

Introductions Charlie Peterson welcomed the panel to its third meeting, led introductions, and reviewed the agenda. Charlie noted that there will be no public comment at this and the next advisory panel meeting.

Medical Cannabis for Non-cancer Chronic Pain: Systematic Review Mary Butler, PhD, University of Minnesota Evidence-based Practice Center

Discussion Study authors did not specifically attend to addiction or habituation. This may be due to the short duration of the studies. Dr. Butler’s review excluded cancer-related pain. Had cancer-related pain been included, results in the JAMA article remain fairly applicable. When asked whether there was anything from Dr. Butler’s presentation they did not expect, panel members identified: • • •

The paucity of studies in rest of world The large number of studies that are funded by industry1 How little studies addressed pain-related function and longer term pain

Key points to keep in mind include: •

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Lack of available data, particularly on largest cohort, musculoskeletal pain, and on most concerning harm: addiction and dependence. .

Industry funders were the pharmaceutical companies selling either Sativex or Nabilone.

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In some cases, there was enough harm that patients stopped treatment, which not evident in the anecdotal reports from public comment.

This study report will be available to panel members by end of day Friday.

Addiction Medicine and Pain Management Dr. Charlie Reznikoff, Hennepin County Medical Center

Discussion Dr. Reznikoff pointed out that if prescribed enough, medical cannabis—much like Vicodin— will create some addictions. The advisory panel replied that that is something they would like to avoid, if possible.

Medical Professionals Physician systems are not ready for medical cannabis. Panel members mentioned doctors often fear chronic pain patients are looking for a magic bullet to cure their pain, rather than following a regimen or attending physical therapy. The medical industry is reeling with pain and its associated psychological distress, social issues, sedentary lifestyle, etc. In response to Dr. Reznikoff’s survey results that indicated doctors do not feel prepared or knowledgeable enough to certify patients, panel members agreed that even if they could request training for doctors, there is a paucity of trial data to give them.

Definitions Some doctors have requested a narrow definition of intractable pain that qualifies for medical cannabis. A panel member asked Dr. Reznikoff if a more restricted definition would do more harm than good. Dr. Reznikoff replied that sending patients to pain clinics to get certified for medical cannabis might not be a good solution because it could fill the waiting rooms in pain clinics and create opportunities for unscrupulous certification practices. Dr. Reznikoff recommended that the advisory panel construct definition language in a manner helps doctors avoid uncomfortable conversations with patients for whom medical cannabis is not an appropriate treatment. The panel discussed that this would reduce or eliminate the need for multiple referrals that complicate access for rural and residents and those who cannot afford multiple clinic visits.

Patient experience A panel member asked whether cannabis causes psychosis or merely unmasks a predisposition to schizophrenia. Some people have had building anxiety for years and have used drugs or alcohol to mollify the anxiety. Others have a specific COMT gene variant that cannot take the dopamine surge caused by cannabis. Panel members discussed public testimony that said opioids were doing more harm than good, and patients were turning to cannabis. Discussion included the following points:

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Some patients will use cannabis in addition to opioids. The degree to which use of cannabis can result in decreased opioid use is not clear. Panel members and certifiers cannot discount the importance of normalization. Cannabis use for adolescents is more complicated due to increased risks, but for adolescents whose development or quality of life is already low, it may be useful to consider a risk-to-benefit ratio.

Panel members discussed the need to avoid or reduce addiction to cannabis if they were to approve intractable pain as a qualifying condition. Several members commented that the medical cannabis available in Minnesota is likely safer than street forms of cannabis, which may contain unknown additives. If doctors know their patient is using street forms, the doctor must then consider whether it would be safer to certify the patient. There is currently no medical treatment for cannabis addiction. Addiction to cannabis is not as common or “soul-crushing” as some other drugs. Cognitive behavioral intervention and emotional interviewing sometimes work. Some are still unable to stop using cannabis. Panel members expressed desire for the ability to monitor patients’ cannabis use, rather than certifying a patient and not being able to follow up with them. Email Dr. Reznikoff for similar data on opioids or visit monitoringthefuture.com

Intractable Pain Public Comments Update Lisa Anderson provided update on public comments. A public comment synthesis report will be available at the next Advisory Panel meeting.

Intractable Pain Advisory Panel Discussion Charlie asked the advisory panel to reflect on the information and discussions they have had to date and share one thing that surprised them or caught their attention, one thing they found helpful, one thing that concerned them, and what they would like themselves and their colleagues to keep in mind.

Things that were surprising or caught attention: • • • • • • •

The impacts allowing intractable pain as a qualifying condition would have on primary care and how it may distract from other, proven treatment methods. High level of concern about adult addiction to cannabis, given what we know about opioid addiction. Doctors are not prepared to certify for medical cannabis for intractable pain and think it will take too much time to learn How little information clinical trial is available (x2) Correlation of reduced opioid overdose deaths in states that have medical cannabis programs. Agent could reduce hypersensitization to pain. Medical cannabis may be beneficial for neuropathic pain

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Overwhelming anecdotal evidence of benefits of cannabis

Things that the advisory panel found helpful include: • • • • •

Information on contraindications, such as psychosis help to quantify and scope intractable pain Dr. Reznikoff’s reasoned approach, given the paucity of little scientific evidence of effectiveness Looking at the primary care crisis Learning about the need for training by practitioners Did not hear about fatal marijuana overdoses

Things that concern advisory panel members include: • •

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Inability to monitor the use of medical cannabis like doctors can monitor other legal drugs 2 The cost is so high, even if we recommend intractable pain as a qualifying condition, it might be for naught o May prevent the resale and abuse of medical cannabis o Centers may be forced to close down if they don’t build an adequate patient base If the panel allows expanded use of medical cannabis without pushing for research, the research may never happen o There are not adequate studies on vaping or the health effects of inhaling cannabis, particularly on lungs There has not been much observed pain benefit from Sativex, a 50/50 mix of THC and CBD concentration

Key points to keep in mind For selves • Benefit to the patient is first and foremost • Need for additional research • Need to define patient or disease state(s) that are most likely to benefit and those that are most at risk • Patients haven’t exhausted all pain remedies but think they have • Focus on the big picture, for the system and for the individual • Look at all factors For colleagues • Lack of evidence and research • Many questions that remain unanswered • Physician resistance to becoming certifiers due to hassle factors The Minnesota Medical Cannabis program registry allows health care practitioners to view information about patients they certify: medical cannabis purchases, side effects, and symptom status.

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Contraindications of medical cannabis Opportunities and options for educating primary care clinicians Advisory panel points of agreement Focus on the big picture, for the system and for the individual What is needed to build a holistic system

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The data is there, but it’s not empirical. There is some signal. This is more of a philosophic argument than a scientific argument. With scientific evidence lacking on benefits, there is also little evidence on harms and some anecdotal evidence that some people have found relief using cannabis. In 2014, there were 140 deaths attributed to opiates. How many of the same were there for cannabis? I don’t think we’ll see the devastating numbers as we would with opiates and continue that path. There are strong arguments for allowing defined conditions, such as neuropathy or specific causes of pain, rather than more abstract symptoms. One solution may be to limit the use of medical cannabis to specific conditions, with inclusion or exclusion criteria, such as psychosis. More work would need to be done to determine that criteria, especially for adolescents. Medical cannabis is not necessarily an alternative to opioids. Patients believe they have tried everything to relieve pain, when there are often several options they have not tried. Many people are lacking appropriate care. There is no evidence that this will cure opioid mess. This is not a miracle cure. One panel member stated they would rather forward certification duties to pain clinics because there should be a multidisciplinary pain group that reviews cases for certification. The panel member acknowledged that this may be more difficult for people in rural areas and suggested they may have to do more networking. Another panel member asked if a doctor could un-certify a patient for reasons other than noncompliance with the program. Once a patient is certified, they remain certified for twelve months. However a doctor can choose to not recertify after the twelve months.

Next Steps Charlie gave instructions for completing the worksheet. The deadline for completing the worksheet is Wednesday, October 14th at 12:00 pm. The final advisory panel meeting will be Thursday, October 29th 1:00pm - 3:00pm at the Wilder Center. The Commissioner of Health is planning an additional public meeting to discuss the advisory panel recommendations. If Advisory Panel members have feedback about the process the Office of Medical Cannabis has followed for determining whether to add intractable pain as a qualifying condition, please share them with Tom Arneson.