‘It is difficult to get a man to understand something when his salary depends upon him not understanding it.’

Upton Sinclair (1878–1968)

Facilitator: Dr. Peter Loewen | Associate Professor | David H MacDonald Professor of Clinical Pharmacy | UBC Faculty of Pharmaceutical Sciences

Background

Because of their specialized knowledge and skills, pharmacists are in a privileged position to make decisions that affect the health of other people. Patients, therefore, expect that pharmacists’ decisions are based primarily on what is in their best interests. In our complex healthcare environment, pharmacists have the opportunity to form many different kinds of professional and personal relationships with a wide variety of people. Each of these relationships has the potential to positively or negatively affect the professional integrity each pharmacist. Therefore, pharmacists who are interested in maintaining a high degree of professional integrity must appreciate the implications of each relationship from this viewpoint.

Objectives

After the session and upon personal reflection, participants should be able to

• articulate a personal vision for what professional integrity means to them.
• weigh the benefits and risks of entering relationships which may have implications for their professional integrity.

Preparation

Read and think about the following:

1. I’m OK, You’re Biased

2. Is this a conflict of interest?: Eat Less Red Meat, Scientists Said | Unprocessed Red Meat and Processed Meat Consumption | Scientist Who Discredited Meat Guidelines Didn’t Report Past Food Industry Ties

3. Is this a conflict of interest? Is this?

4. Funding deals gave Coca-Cola power to quash health research, study says

5. The Impact of Disclosing Financial Ties in Research and Clinical Care Arch Intern Med. 2010;170(8):675–682

Then…

Read and reflect on the first 6 scenarios below from the viewpoints of:

• What are the ethical, professional integrity and/or potential conflict of interest issues here?
• If it's possible, how do you think the situation could be managed?

During the session, you will discuss these questions in groups with your colleagues and share your thoughts with the rest of the class. These are all real scenarios Dr. Loewen has encountered in his career so far.

Scenarios

Scenario 1 - How mighty is the pen?

You attend a small-group industry-sponsored dinner/talk at Chambar, and receive a token gift of a Cross pen emblazoned with Brilinta®. You were invited because you are considered to be a local opinion leader. You carry this pen on rounds the next day.

Scenario 2 - A mysterious benefactor

You are at a conference. The registration was paid for by your institution’s education fund, and you are planning on paying for your hotel. When you go to check out on the last day, the hotel informs you that your bill has already been paid for. When you ask for details, the hotel gives you the name of a pharmaceutical rep you met with several times as the owner of the credit card who paid.

Scenario 3 - Guilt about associations

In March, you accepted an invitation to speak at your professional society’s AGM (think CSHP). Over the summer, this happened: - The Sackler family is trying to shield billions in opioid profits through Purdue Pharma bankruptcy - The thousands of lawsuits against opioid companies, explained - Purdue Pharma offers $10–12 billion to settle opioid claims - Purdue Pharma, drugmaker accused of fueling the opioid epidemic, files for bankruptcy In September, out of curiosity, you check who sponsors the society you’re giving the talk for, and on their website Purdue is listed as a “Major Benefactor”. Now what?

Scenario 4 - How clean is this laundry?

You’re looking forward to speaking about lipid management at a pharmacists CE conference next month. The conference is sponsored in the usual way by industry money laundered through a university’s CE division. The conference organizer asks whether you’d mind if your talk about statins was shown on the program as “supported by an unrestricted educational grant from Pfizer” (maker of one of several statins available).

Scenario 5 - A curious omission

In trying to make a treatment decision for a patient with CAP, you decide that several antibiotics are viable (and have equivalent efficacy/safety). You seek, therefore, to use the least costly one. You notice that the costs of all but two are displayed in your pocket formulary. Upon inquiring with your director about the costs of the other two, you’re told that, “that information is confidential, per the contract we signed with the manufacturers.”

Scenario 6 - Whispered secrets

You’re chair of a provincial drug benefits committee, composed of a lay-member plus a bunch of clinicians, researchers, lawyer, etc. At this week’s meeting while reviewing an expensive MS drug for coverage status, the person beside you whispers that they know the lay member’s wife has severe MS.

Useful Concepts

• Fundamental attribution error
• Actor-Observer Bias
• Cognitive dissonance
• Availability heuristics

More Scenarios

If you're interested, consider reviewing the additional scenarios below (also all real) and if you want to discuss anything related to any of this, email Dr. Loewen to ask questions or make a time to talk.

Scenario 7 - Optical illusion

You’re a clinical pharmacist just assigned to work in the new “CV Risk Reduction Clinic” at your institution. You’re aware that the clinic is funded through an “unrestricted grant” from the makers of perindopril. In return, perindopril was added to the institution’s formulary.

Scenario 8 - A rock and a hard place

You are a PharmD working for a drug company. You are responsible for the development of educational/promotional material for a new drug. In your review of the literature you notice flaws in the studies and you are not convinced that your drug showed advantages over the comparator. Meanwhile, your performance evaluation is coming up. You are the sole source of income for your family.

Scenario 9 - Regifted

While in a community pharmacy, a visit from an OTC drug rep brings in samples for Aerius – which I give to my allergy prone, impoverished university student brother. I have notified him that all non-sedating antihistamines are the same and that these are only free because the drug rep was feeling generous toward me.

Scenario 10 - Side-hustle

Your hospital pharmacist colleague tells you that he has a “side consulting business” where he takes fees from drug manufacturers to counsel them on the processes involved and gives tips for getting their drugs favourably reviewed and approved by regional, provincial, and national formulary committees.

Scenario 11 - Valuable opinions

As the CCU pharmacist, you are invited by Ipsos Reid (contracted by the manufacturers of a new CHF drug) to their offices to participate in an informal focus group. These questions would relate to your opinions about ‘approaches to managing CHF’. It may also involve discussion of the barriers that may impede formulary approval of the drug at a hypothetical hospital. In return for your time, you would be provided with a $1000 honorarium for your valuable time and a complementary meal during the question period.

Scenario 12 - Swept under the rug

You have acted as a principal investigator for an industry-sponsored bioequivalence trial. Preliminary results do not favour the sponsor’s drug. The sponsor isn’t happy. They inform you that they now believe the study methodology was flawed and do not wish the data to be published. They also inform you that you will receive the full grant funds promised.

Scenario 13 - Chemistry setup

You are an attractive young PharmD on the Drugs and Therapeutics committee at your hospital. A new antibiotic is being considered for formulary status and you have been asked to provide the committee with an evidence-based review of the drug. The sales rep for this particular antibiotic happens to also be an attractive person and when you meet to ask for information, the two of you hit it off. Soon you're having dinner at Fable and then watching The Vampire Diaries at their place.

Scenario 14 - Pump junket

A manufacturer that you have been doing business with on infusion pumps invites you to a users group meeting in which all expenses are paid but no honorarium. Smart infusion pumps are used in about 50% of your hospital at the current time.

Scenario 15 - Branding people

A pharmacy faculty is considering creating a white coat ceremony for their incoming students. A pharmaceutical manufacturer has been asked to and has agreed to cover the costs of the purchase of the white coats on the condition that the company’s logo and/or one of their products be embroidered on the coats. The faculty is discussing whether this should occur. As a student representative on the Faculty Advisory Committee, what is your position?

Bottom Lines

• What value do you place on maintaining your professional integrity and the trust of your patients and colleagues.
• LEARN about the sometimes-unforseen consequences of certain courses of action you take, so they’re no longer unforseen.
• WEIGH the pros and cons of each relationship/situation. Don’t just react to things reflexively.
• Think of COI as merely a part of the broader issue of bias, and bias as part of the broader issue of integrity.
• Only presume there’s a conflict when the sway in judgment that’s involved is such that it’s a compromise in judgment.

Electrifying Resources for Deeper Learning

1. What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry
2. Managing conflicts of interest in the development of health guidelines
3. MLA should leave ride-hailing committee because his dad is a taxi driver: B.C. Liberals
4. Top Sloan Kettering Cancer Doctor Resigns After Failing to Disclose Industry Ties
5. Confluence, Not Conflict of Interest
6. Think You’re Immune From Bias? Think Again
7. Association Between Industry Payments to Physicians and Device Selection
8. Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer
9. It’s All How You “Spin” It: Interpretive Bias in Research Findings in the Obstetrics and Gynecology Literature
10. A decade of reversal: an analysis of 146 contradicted medical practices
11. Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes 12. BMJ editor Fiona Godlee takes on corruption in science
13. Retraction Watch
14. Beauty Council wants cities to regulate hair salons and more
15. On the Psychology of Pharmaceutical Industry Gifts to Physicians
16. Too Few, Too Weak: Conflict of Interest Policies at Canadian Medical Schools
17. Effect of Reminders of Personal Sacrifice and Suggested Rationalizations on Residents’ Self-Reported Willingness to Accept Gifts
18. Organizational Approach to Conflicts of Interest: Lessons From Non-Health Care Businesses
19. CBS Bans SodaStream Ad
20. CBC Tamiflu probe sparks drug policy review.
21. B.C. health ministry fires four, calls RCMP to investigate conflict allegations | Research Stopped by Ministry Might Have Cut Big Pharma Profits | UBC drug researchers appeal for access to crucial data
22. UBC Policy 97: Conflict Of Interest and Conflict Of Commitment
23. Managing Financial Conflict of Interest in Biomedical Research
24. GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY