Conflict of Interest & Commitment

W. Robert Taylor, MD, PhDApril 3, 2020

Is a Conflict of Interest a “Bad Thing” ??

Disclosures

• Microbial Medical, LLC – Equity Interest, Board Member

• NIH – NIH RO1, PPG (Emory) and SBIR (Microbial Medical, LLC) funding

• Georgia Research Alliance – GRA Phase I & II funding

• Intellectual Property – Patents related to Maltodextrins

• Intellectual Property – Patents and License Revenue for Hydrocyanine Dyes

How about this definition ??

• "A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance compromise the integrity of the research." NAS, Integrity in Scientific Research

Is a Conflict of Interest a Bad Thing???

Is this better??

•A conflict of interest exists when two or more contradictory interests relate to an activity by an individual or an institution. The conflict lies in the situation, not in any behavior or lack of behavior of the individual. That means that a conflict of interest is not intrinsically a bad thing.

How About this one?

•Conflicts of interest are "situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's judgement in conducting or reporting

research." AAMC, 1990

What are the key points?

• COI is not a sin…

• A conflict of interest can be a Confluence of Interest

• COI can involve an institution or an individual

• The appearance of a COI can be as important as the situation in which inappropriate actions occurred

• A COI most often occurs as the result of a situation, not as the result of poor behavior.

Let’s take a broader look….

• Conflict of Commitment• What is your day job?• Is Emory paying you to develop IP and subsequent revenue?• NIH, VA, CDC and Federal Government all have rules about this.

• Conflict of Interest related to patient care• Prescribing patterns• Purchasing equipment• Doing procedures that generate revenue for a vendor

• Conflict of Interest Related to Research• NIH and Emory have rules• Guidelines form various professional organizations (AAMC, AMA, etc.)

A Emory - Two types of COI review

• For issues related to grants (especially NIH)• Conflict of Interest Committee

• Faculty peers

• Ex officio members (OTT, IRB, IACUC, OSP)

• For issues related to speaking, honorariums, start-up companies, consulting, etc.• SOM COI office

• Administrative review to verify compliance with SOM and University policies.

WHO REVIEWS WHAT?WHO DO YOU CONTACT?

DEAN’S OFFICE

• Review of all external activity agreements (e.g., consulting, advisory board membership, start-ups)

• Time commitment issues

• Gifts to Emory

• Nepotism

• Services competitive to Emory

• Vendor/Procurement issues

• Trainees (graduate student, medical student, post doctoral fellow) involvement in a conflicted investigator’s research project

Policies:

o SOM Industry & Other External Professional Relationships Compendium

o Emory University COI Policy 4.87

COI REVIEW OFFICE/COMMITTEE

• Evaluation of investigator’s relationship with a company and how that is related to their research activities

• Institutional Conflict of Interests: Emory’s interests in a company & relationship of research activities

Policies:

o Emory Investigator Financial Interest Policy 7.7

o Emory Institutional COI Policy 7.24

WHAT TRIGGERS A

POTENTIAL COI REVIEW?

SIGNIFICANT FINANCIAL INTERESTS RELATED TO RESEARCH INCLUDE:

Consulting fees, licensing fees/royalties, honoraria, publicly traded stock that are greater than $5000 from:o For profit entitieso Non-profit entitieso Non-US institutions of higher learning, research institutes, hospitals, and

medical centers

Any ownership/equity interests in non-publicly traded entity

Management/fiduciary positions in a non-Emory entity

For federally funded investigators, potentially any travel (over $5k) sponsored by:o For profit entitieso Non-profit entitieso Non-US institutions of higher learning, research institutes, hospitals, and

medical centers

*Investigators must report Significant Financial Interests of their spouses and dependent children as well as their own.

How do you disclose?

Grants - How do we classify a Conflict of Interest for a NIH Study?

•No Conflict – just what it sounds like

•Significant Financial Interest (SFI)(a) that would reasonably appear to be affected by the Research on which the Investigator is working; or

(b) that is held in an entity whose financial interests would reasonably appear to be affected by the Investigator’s Research. ($5K threshold or fiduciary role)

•Financial Conflict of Interest (FCOI)•Significant Financial Interest (i.e., consulting, equity, royalties) that is determined by Emory University to significantly and directly affect the design, conduct or reporting of Research

Can we manage a COI?

Common Management Tools

• Disclosure• To team• In publications• To sponsor• To subjects• To regulatory agencies

• Reporting and oversight

• Blinding of data, third party review of data/publications

• Delegation of conflicted duties

• Can just say No

Some Obvious Cases

• Dr. Melissa DelBello, of the University of Cincinnati, told university officials that she earned approximately $100,000 from 2005 to 2007 from eight drug makers, but AstraZeneca alone paid her $238,000 during the period.

• Dr. DelBello had received grants from NIH and was working on a key study involving AstraZeneca’s Seroquel anti-psychotic.

• Dr. Joseph Biederman, a renowned child psychiatrist at Harvard Medical School failed to report almost a million dollars in outside income from various pharmaceutical companies, including Eli Lilly. Dr. Biederman received an NIH grant to study the effects of an Eli Lilly drug in children.

• Dr. Biederman’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

• Thomas Zdeblick, a prominent spine surgeon and researcher at the University of Wisconsin, who told the university in each of the five years he received payments from Medtronic that he’d received $20,000 or more from the company.

• However, over five years Dr. Zdeblick received $19 million in consulting and royalty payments from Medtronic to help develop and promote products for the spine; specifically the Infuse Bone Graft.

• Infuse Bone Graft part of ongoing Department of Justice investigation for off-label use.

A lot of this is common sense….

Some Cases….#1•Dr. X has developed a drug for treating ALS and Emory has licensed that drug to a major drug company. Dr. X has received license payments in excess of $5,000. She now has written an NIH RO1 to study this drug in a mouse model of epilepsy….does she have a COI?•Would your answer change if this was a human clinical trial?•Would your answer change if the owner of the license was a company owned in part by Dr. X?

Emory’s Role

Emory in the Spotlight

• Professor, psychiatrist, and former Chair of the Department of Psychiatry, Dr. Charles Nemeroff, earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, and failed to report at least $1.2 million of that income to Emory.

• Many of these fees were received from GlaxoSmithKline while also researching that same company’s drugs with a large NIH grant.

• As investigations were prompted by both Senator Chuck Grassley and NIH, Dr. Nemeroffstepped down as Chair; he later resigned from Emory.

• Emory NIH grant was temporarily “frozen” and no work could be done on the project.

• Emory was placed on special reporting obligations by NIH for one year.

• Emory continues to serve as an “example COI case study” at national conferences.

Excuse or Reality

• Dr. Nemeroff claimed that since he received consulting fees from all of the major drug companies he was by definition, not conflicted as regards endorsing one drug over another.

Challenging Issues: Insider Trading

• Sidney Gilman, MD and SAC Capital Advisors• Players: Matthew Martoma, SAC Capital Advisors, Gerson Lehrman

Group (GLG), Dr. Gilman, and Stan Cohen• Drug: Bapineuzumab produced and developed by Elan/Wyeth• Relationships: Dr. Gilman had a consulting agreement with Elan and

served on the DSMB for clinical trials of bapineuzumab. He also had a consulting agreement with GLG. SAC and Martoma were GLG clients. Dr. Gilman shared efficacy information with Martoma; Martoma traded on and shared information with SAC; SAC netted $276 million

• Outcome: SAC closed business, paid $616 million and criminal fine of $1.8 billion; Martoma sentenced to 9 years prison and ordered divestment of $9.38 million; Dr. Gilman resigned from Michigan, paid divestment of $234k, plea agreement without criminal charges in exchange for testimony against SAC and Martoma

Should a faculty member be allowed to advise an investment company?

Another Case….

• Dr. X has developed a computer program to be used in testing for memory deficits. It has been licensed to a company for distribution. Dr. X and the University receive royalties in excess of $5,000 annually.

• Dr. X is really one of the world experts in this field.

• A colleague is using this test in a human study using a pharmacological intervention that is funded by the NIH. Dr. X will interpret the results of the test.

• Does Dr. X have a COI?

• Would it matter if Dr. X was blinded?

• Does it matter if the test results are a primary or secondary endpoint?

What about pens, note pads, coffee cups?

• If a physician takes a pen with a add on it for a medication, does that influence his/her prescribing practices?

• What do patients think?

• Would it matter if it was a book?

• How about an educational dinner?

• or a trip to an educational meeting?

• being asked to serve on a DSMB for an honorarium?

• or receiving speakers’ fees for giving talks to other physicians?

Conflict of Commitment?

• What does this mean

• Up to 20% of your time with permission

from your chair and the Dean

• Includes things like consulting, DSMB, etc.

Running a company as a faculty member

• Dr. Z is a Professor of Chemistry who has developed a novel compound for treating colon cancer.

• She has been supported by the GRA and started a new company (with permission from Emory). • Can she be CEO of the company?

• Can she serve on the board of the company?

• Can she hold an equity interest?

Any situations you would like to discuss?

• Please use chat function…