Opioid Guideline Panel Declarations of Interest Form Part A....

transcript

NAME: Chris Giorshev Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

ASH Guideline Panel Declarations of Interests Form | Page 1

Opioid Guideline Panel Declarations of Interest Form

Part A. Material Interests in Companies Equity 1. Do you currently or in the past 24 months have you had equity in any for-profit company that

develops, produces, markets, or distributes drugs, devices, services, or therapies used to diagnose,treat, monitor, manage, or alleviate health conditions? Equity includes stock, stock options, andother ownership interests but excludes diversified mutual fund shares.

☒ No

☐ Yes, as described below:

Add rows as needed for each equity interest.

Company Description Date Divested For NPC Internal Use

Patents and Royalties 2. Do you currently or in the past 24 months have you owned patents for or received royalties from

any intellectual property or product used to diagnose, treat, monitor, manage, or alleviate healthconditions?

☒ No

Add rows as needed for each patent or royalty interest.

Opioid Guideline Panel Declarations of Interests Form | Page 2

Personal Income or Other Remuneration 3. Do you currently or in the past 24 months have you received personal income or other

remuneration (e.g., reimbursement or financial support for the costs of travel) from any for-profit company that develops, produces, markets, or distributes drugs, devices, services, or therapies used to diagnose, treat, monitor, manage, or alleviate health conditions?

☐ No

☒ Yes, as described below:

Column 1 Name the company.

Column 2 Describe the activity for which you received income or other remuneration, e.g., employment, consultancy, speakers bureau involvement, service on an advisory committee or board, expert testimony.

Column 3 Indicate when the activity ended, if applicable. (If the activity has not yet ended, indicate “current” or “ongoing.”)

Add rows as needed for each activity.

To report activities that generate revenues for your institution, see Part B, Question 4.

Company Description End Date For NPC Internal Use

Purdue UDS Talk – 1hr Nov 23,2016

Purdue NOUGG Talk – 1 hr May 13, 2016

Industry-Funded Research 4. Do you currently or in the past 24 months have you been involved in research funded or supported

(e.g., in kind support) by any for-profit company that develops, produces, markets, or distributes drugs, devices, services, or therapies used to diagnose, treat, monitor, manage, or alleviate health conditions?

☒ No

Column 1 Name the company funding or supporting the research.

Column 2 Briefly describe the research project. Indicate if funding or support goes to you directly or to your institution.

Column 3 Describe your role: (a) national or overall principal investigator, (b) member of a steering committee of a study that does not have a principal investigator, (c) site or local investigator. If other than these options, please describe.

Column 4 Indicate when your involvement ended, if applicable. (If your involvement has not yet ended, indicate “current” or “ongoing.”)

Add rows as needed for each research project.

Company Description of Research My Role End Date For NPC Internal Use

My Partner’s or Spouse’s Interests 5. Currently or in the past 24 months has your partner or spouse had any of the interests described in

questions 1-4?

☒ No

Add rows as needed for each interest.

Part B. Interests That Are Not Mainly Financial You have been invited by the National Pain Centre (NPC) to participate in the development of clinical practice guidelines on the following topic(s):

Opioids for treatment of chronic non-cancer pain

The questions that follow are designed to elicit information about personal beliefs, intellectual positions or opinions, institutional relationships, and other interests that are not mainly financial and that may be relevant to guidelines on the above topic(s).

Personal Beliefs 1. Do you have strongly held beliefs related to the topic of these guidelines?

☐ No

☒ Yes

If yes, please explain: Guidelines are important to guide prescribing.

Previously Published Opinions 2. Have you ever authored, coauthored, or publicly provided an opinion related to the topic of these

guidelines, e.g., a clinical practice guideline, textbook, review article, meeting poster or presentation, grand rounds talk, letter to the editor?

☒ No

☐ Yes

If yes, what were those views and where were they made?

Research 3. Currently or in the past 24 months, have you been involved in a leadership role in any research

project not already reported under Part A, Question 4, relevant to the topic of these guidelines, e.g., a research project funded by a nonprofit or governmental organization?

☒ No

Column 1 Name the entity funding the research.

Column 2 Describe the research project.

Funder Description of Research My Role End Date

Institutional Relationships 4. Do you generate revenues or nonfinancial benefits for your institution by teaching, speaking,

consulting, testifying, writing, or otherwise sharing your knowledge or opinions about this guideline topic?

☐ Don’t know

☒ No

☐ Yes

If yes, please explain:

5. Could your institution benefit or be harmed by recommendations of guidelines on this topic?

☐ Don’t know

☒ No

☐ Yes

Career Advancement 6. How would you characterize the support you would receive from your primary mentor, institution,

or other entities if your work on this panel or authorship of these guidelines generated a strong reaction from peers outside your institution?

Advocacy and Policy Positions 7. Do you work for or are you a member of an organization with a stated position related to the topic

of these guidelines, e.g., position statement, editorial, blog, amicus brief, or legislature or legal testimony?

☒ No

☐ Yes

If yes, are you involved in formulating or voting for positions?

☒ No

☐ Yes

If yes, could recommendations of these guidelines conflict with policies you have promoted or are obligated to follow?

☐ Don’t know or not applicable

☐ No

☐ Yes

Professional Specialty 8. What is your primary clinical specialty or subspecialty? Pain Medicine, Addiction Medicine,

Emergency Medicine

9. Do you prescribe or otherwise recommend diagnostic tests or treatments that may be addressed by these guidelines?

☐ No

☒ Yes

If yes, please explain: I prescribe opioids for chronic pain

Expected Interests 10. Do you expect new financial or nonfinancial interests relevant to the topic of these guidelines not

already declared in Part A or Part B of this form?

☒ No

☐ Yes

If yes, please describe:

Part C. Summary (NPC Internal Use) The NPC will review your disclosures and summarize here interests that are judged to be current, material, and with an affected company. You will then be invited to review our determinations and to agree to make all parts of this form (A, B and C) publically available.

Name of guideline panel(s) Canadian Opioid Guideline

Approved to participate? Status

Date reviewed by staff

Date confirmed by oversight officer or committee Notes

No Clinical expert Jan 4, 2017 Jan 4, 2017

Notes:

Approved to participate as non-voting content expert.

NAME: David Juurlink Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

develops, produces, markets, or distributes drugs, devices, services, or therapies used to diagnose, treat, monitor, manage, or alleviate health conditions? Equity includes stock, stock options, and other ownership interests but excludes diversified mutual fund shares.

☒ No

any intellectual property or product used to diagnose, treat, monitor, manage, or alleviate health conditions?

☒ No

questions 1-4?

☒ No

☐ No

☒ Yes

If yes, please explain: I believe that opioids have a role to play in the treatment of chronic pain, but that the most appropriate role is very different from current patterns of practice. Most importantly, I believe they should be used less often and at lower doses.

☐ No

☒ Yes

Over the past 7-8 years I have given hundreds of media interviews and scores of talks on this topic, published dozens of related manuscripts, and penned several commentaries in the lay press. I have also made my views public on social media.

☐ No

CIHR Multiple studies Various – nominated PI of CDSERN

March 31, 3017

Ontario MOHLTC Multiple studies Various – co-PI of ODPRN

Ongoing

Most of these studies address prescribing trends of safety concerns associated with opioid use. A list of publications is available upon request

☒ Don’t know

☐ No

☒ Yes

If yes, please explain: While most of my talks are given for free, I am occasionally paid a stipend – eg. for a lecture given at a continuing medical education event. I have also provided expert opinion on medicolegal matters, some of which have involved opioids (although in no instances have I engaged in paid work for or against opioid manufacturers.) Income received from speaking or expert testimony is tithed by The Sunnybrook Department of Medicine as part of our academic practice plan.

☒ Don’t know

☐ No

☐ Yes

If yes, please explain: This seems unlikely.

My institutions are very supportive of my work in the field of drug safety and on the opioid crisis in particular.

☐ No

☒ Yes I am an unpaid member of Physicians for Responsible Opioid Prescribing (PROP), which is sometimes cast as an “anti-opioid” group but in actuality is invested in prescribing that is safer and more evidence-based. I am also a member of the American College of Medical Toxicology. Both groups have publicly available positions on this issue

☐ No

☒ Yes I have previously coauthored a letter (PROP 2012) petitioning the FDA to revise its labeling around opioids to better align with the available evidence.

☒ Don’t know or not applicable

☐ No

☐ Yes

Professional Specialty 8. What is your primary clinical specialty or subspecialty?

Internal Medicine, Clinical Pharmacology, Medical Toxicology

☐ No

☒ Yes

If yes, please explain: As part of my practice I treat patients with chronic pain, sometimes with opioids.

☒ No

☐ Yes

No Clinical expert December 14, 2015

January 4, 2017

Notes:

No financial COI declared. Active researcher in the area of opioids for CNCP, contributed extensive empirical evidence relevant to area. Acknowledged potential non-financial COI. Approved to participate as content expert.

NAME: Dwight Moulin Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

☒ No

☐ No

Cambridge University Press

Book Editor – ‘Neuropathic Pain’

Ongoing

☐ No

Johnson & Johnson Ad Board- acetaminophen

Amgen Canada Teaching Nurse Practitioners – pain management

Mar 2016

☐ No

Pfizer Canada Managing Neuropathic Pain in Primary Care

Member of Steering Committee – funds held by Lawson Health Research Institute and distributed to Dept of Family Medicine, McMaster University

Dec 2016

questions 1-4?

☒ No

☐ No

☒ Yes

If yes, please explain: Striking reasonable balance between appropriate opioid use and opioid misuse

☐ No

☒ Yes

Consensus Statement sponsored by Can Pain Society on management of neuropathic pain which includes evidence-based recommendations on opioids for treatment of neuropathic pain(first author – Pain Research and Management, 2014)

☐ No

CFI and Pfizer Canada Long-term outcome of management of neuropathic pain including role of opioids using national database

PI – major paper published in J Pain 2015

Study completed Dec 2011 but still using funds for ongoing stats analysis in further studies

☐ Don’t know

☐ No

☒ Yes

If yes, please explain: Teaching in Undergrad Education at Schulich School of Medicine at Western University

☐ Don’t know

☐ No

☒ Yes

If yes, please explain: Potential benefit to Western University and its medical students by teaching updated guidelines

or other entities if your work on this panel or authorship of these guidelines generated a strong reaction from peers outside your institution? Very strong support from Western University and Schulich School of Medicine

☒ No

☐ Yes

☐ No

☐ Yes

☐ No

☐ Yes

Professional Specialty 8. What is your primary clinical specialty or subspecialty? Neurology

☐ No

☒ Yes

If yes, please explain: I treat patients in both non-cancer pain and cancer pain clinics.

☒ No

☐ Yes

No Clinical expert January 4, 2017

January 4, 2017

Notes:

Acknowledged potential financial and non-financial COI. Approved to participate as non-voting content expert.

NAME: Gary Franklin Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

☒ No

questions 1-4?

☒ No

☐ No

☒ Yes

If yes, please explain:I rported the first deaths from prescription opioids in the peer reviewed literature and have had more than 10 publications on the topic

☐ No

☒ Yes

If yes, what were those views and where were they made?Talks at least monthly. Position paper published for the American Academy of Neurology.

☒ No

☐ Don’t know

☒ No

☐ Yes

☐ Don’t know

☒ No

☐ Yes

No response at all

☐ No

☒ Yes

☐ No

☒ Yes

☒ No

☐ Yes

Professional Specialty 8. What is your primary clinical specialty or subspecialty? Neurology

☒ No

☐ Yes

☒ No

☐ Yes

January 4, 2017

Notes:

Acknowledged potential intellectual COI. Approved to participate as non-voting content expert.

NAME: Jeff Harris Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

☒ No

questions 1-4?

☒ No

☐ No

☒ Yes

If yes, please explain: I believe we should balance risks and benefits, based on high quality evidence

☐ No

☒ Yes

If yes, what were those views and where were they made? ACOEM and RxSafe Marin guidelines. Presentations summarizing same at GIN and Cochrane Collaboration 2011, 2015

☒ No

☐ Don’t know

☒ No

☐ Yes

☐ Don’t know

☒ No

☐ Yes

Positive – we are working along the same lines

☐ No

☒ Yes

☐ No

☒ Yes

☒ No

☐ Yes

Emergency Medicine, General Preventive Medicine, Occupational Medicine

☐ No

☒ Yes

I sometimes have patients in acute pain and refer CNCP patients to our pain management program

☒ No

☐ Yes

Name of guideline panel(s) Canadian Opioid guideline

January 4, 2017

Notes:

Acknowledged potential non-financial COI. Approved to participate as non-voting content expert.

KURT HEGMANN

NAME: Kurt Hegmann Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Part C. Summary (NPC Internal Use) The NPC will review your disclosures and summarize here interests that are judged to be current,

material, and with an affected company. You will then be invited to review our determinations and to

agree to make all parts of this form (A, B and C) publically available.

January 4, 2017

Notes:

Acknowledged potential non-financial COI. Approved to participate as non-voting content expert.

NAME: Lydia Hatcher Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

☒ No

☐ No

Purdue Pharma Advisory board, speaker bureau

ongoing

Astra Zeneca Advisory board October 2015

Tilray Advisory board ongoing

Eli Lilly Advisory board, speaker bureau

ongoing

☒ No

questions 1-4?

☒ No

☒ Yes

I believe it’s vital to have robust, evidenced based guidelines on which to base the practice of safe prescribing of opioids.

☐ No

☒ Yes

I was one of the two content experts who developed the CME for the guidelines. I have given talks both nationally and internationally on the guidelines. See CV for specifics.

I have co-authored letters to the Federal government regarding safe opioid prescribing through the Canadian Pain Society (CPS) and the College of Family Physicians of Canada (CFPC)

☒ No

☐ Don’t know

☐ No

☒ Yes

I teach as part of my role at McMaster University as associate clinical professor family medicine and other residents and fellows about pain management and the guidelines. I have also done faculty development workshops. I have done talks for Memorial University of Newfoundland also. I also do peer reviews for the College of Physicians and Surgeons of Ontario around safe prescribing of controlled substances. I reference the guidelines in all of this work.

☐ Don’t know

☐ No

☒ Yes

I think the institutions benefit from learning about guidelines that promote safe prescribing

I think it enhances the relationship with peers and produces credibility as an educator, researcher and as a clinician.

☐ No

☒ Yes

☒ No

☐ Yes

☒ No

☐ Yes

Family Medicine- focused practice in chronic pain

☐ No

☒ Yes

I follow the guidelines where appropriate. I prescribe opioids.

☒ No

☐ Yes

January 4, 2017

Notes:

NAME: Mark Sullivan Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

☒ No

☐ No

Janssen Consultant on QI measures in chronic pain care

12-15-14

Relievant Consulting on analysis of clinical trial data

6-10-15

☐ No

Pfizer Development and testing of PainTracker Self-Manager web platform

PI ongoing

questions 1-4?

☒ No

☐ No

☒ Yes

If yes, please explain: I think the harms of long-term opioid therapy have been demonstrated more clearly than the benefits. There may be modest benefits for select groups of people.

☐ No

☒ Yes

I have published many research articles and opinion pieces on these issues. The best single summary is the plenary lecture I gave in Milan in 2014, which is summarized here: Sullivan MD, Howe CI, Opioid Therapy for Chronic Pain in the US: promises and perils, Pain, 2013; 154 Suppl 1:S94-100. doi: 10.1016/j.pain.2013.09.009.

☐ No

US Centers for Disease Control and Prevention

Evaluation of effects of Washington State Opioid Guideline

Co-investigator 1-1-15

☐ Don’t know

☒ No

☐ Yes

☐ Don’t know

☒ No

☐ Yes

They would be supportive.

☐ No

☒ Yes

☒ No

☐ Yes

☒ Don’t know or not applicable

☐ No

☐ Yes

I am a board member of Physicians for Responsible Opioid Prescribing which advocates a cautious approach to opioid therapy. They are in support of evidence-based guidelines. I am not obligated to follow any PROP recommendations.

Professional Specialty 8. What is your primary clinical specialty or subspecialty? Psychiatry, Pain Medicine

☐ No

☒ Yes

I imagine the guideline may address the use of urine toxicology screens and opioid and non-opioid analgesics, all of which I order at times.

☒ No

☐ Yes

January 4, 2017

Notes:

NPC note: Mrs Diane Buckley's interests are described on preceding page

NAME: Norm Buckley Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

January 4, 2017

Notes:

Acknowledged potential financial COI. Practiced clinically prescribing opioids for CNCP for >25 years. Active involvement in development of 2010 Canadian Opioid Guidelines.

Approved to participate as content expert.

N�ME:Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

Opioid Guideline Panel

Deel a rations of Interest Form

Part A. Material Interests in Companies

Equity 1. Do you currently or in the past 24 months have you had equity in any for-profit company that

develops, produces, markets, or distributes drugs, devices, services, or therapies used to diagnose,treat, monitor, manage, or alleviate health conditions? Equity includes stock, stock options, andother ownership interests but excludes diversified mutual fund shares.

!!1'.No

D Yes, as described below:

Company Description Date Divested

any intellectual property or product used to diagnose, treat, monitor, manage, or alleviate healthconditions?

D Yes, as described below:

Company Description Date Divested

ASH Guideline Panel Declarations of Interests Form I Page 1

PAT MORLEY-FORSTER

NAME: Pat Morley-Forster Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

No Clinical expert January 4, 2017

January 4, 2017

Notes:

PRIYA MANJOO

NAME: Priya Manjoo Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

January 4, 2017

Notes:

Acknowledged potential financial COI. Approved to participate as non-voting content expert.

NAME: Roman Jovey Guideline Panel for the Canadian Guideline for Safe and Effective Use of Opioids for CNCP

☐ No

Purdue Pharma Consultancy, speakers’ bureau, advisory boards

ongoing

AstraZeneca Consultancy, advisory boards

ongoing

Eli Lilly Consultancy, speakers’ bureau, advisory boards

Knight Therapeutics consultancy ongoing

Tribute Pharma consultancy 2015

Medical Futures Inc Consultancy, speakers’ bureau

CPM Centres for Pain Managment

Consultancy, management ongoing

☐ No

questions 1-4?

☐ No

☐ Yes

If yes, please explain: I have 25 years of hands-on experience in the outpatient management of patients with chronic non-cancer pain. During this time I have seen people’s lives changed for the better by the careful prescribing of long-term opioids, I have seen people obtain little or no benefit and I have seen people harmed. I have started and followed many people on opioids – some for almost 20 years - and I have taken many people off of opioids when appropriate.

I have worked in Addictions Medicine for 30 years up until 2015, where I have seen the harms of misused opioids by people without pain. In my opinion, these are mostly two separate issues.

We have little long-term evidence for most treatments for chronic pain. Therefore I believe that patients with chronic pain deserve informed access to ALL available treatment options for pain – including opioids, if appropriately managed. I also believe that all physicians should be exposed to mandatory training on pain assessment and management – including the appropriate use of opioids.

☐ No

☐ Yes

Chair of a committee of the Canadian Pain Society regarding a consensus statement and guidelines for the Use of Opioid Analgesics for the Treatment of Chronic Non-Cancer Pain – 2002

Editor of an industry-sponsored book called Managing Chronic Pain –The Canadian Healthcare Professional’s Reference, published in 2002 and updated in 2008

I attach a CV with other educational activities and publications.

☐ No

☐ Don’t know

☐ No

☐ Yes

☐ Don’t know

☐ No

☐ Yes

My pain organization provides strong support for the work that I do as we are interested in providing best practice pain management for our patients.

☐ No

☐ Yes, not sure if the info below is what you are asking about

Mentor for the Medical Mentoring for Addictions and Pain program of the Ontario College of Family Physicians where

Member of the Pain Committee of the College of Family Physicians of Canada

Member of the Canadian Pain Society

☐ No

☐ Yes – as a member of the CFPC Chronic Pain committee I have contributed to the development of positions (ie training of new and existing physicians in pain management)

☐ Yes

General Practice in Ontario - with a focused practice in chronic pain management and addiction

☐ No

☐ Yes

If yes, please explain: prescribe opioids for chronic pain and order urine drug screening as a regular part of opioid prescribing

☐ No

☐ Yes

To The Committee:

To stay true to the principles of EBM I hope that the final expert panel has a balance of those whose knowledge of using opioids to treat people with pain comes from reading papers (desk experts), those who have clinical hands-on experience with opioids (field experts) and patients with chronic pain. Which group each individual participant fits into should be clearly known by all at the beginning of the process.

Roman Jovey

No Clinical expert Jan 4, 2017 Jan 4, 2017

Notes:

Opioid Guideline Panel Declarations of Interest Form Part A....

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