1. VCU Pauley Heart Center:

2. Conflict of Interest Issues: Balancing Industry Involvement
George W. Vetrovec, MD.
Kimmerling Professor of Medicine
VCU Pauley Heart Center
Virginia Commonwealth University
Richmond, Virginia

3. Disclosures:
Consultant: Merck, Lilly (Non Paid), FDA, Abiomed, Corindus
Speaking: Abiomed, Corindus

4. Conflict of Interest Issues: Balancing Industry Involvement
A few Editorial Comments
Current Climate
Cautious Balance between Investigators, Institutions and Industry
Practical recommendations

5. Conflict of Interest Issues: Balancing Industry Involvement
A few Editorial Comments
Current Climate
Cautious Balance between Investigators, Institutions and Industry
Practical recommendations

6. Conflicts Are there Others? Focus on Money Honoraria Ownership
Research Grants
Are there Others?

7. The Most Appropriate Disclosure for Today’s Presentation

8. Disclosures:
Consultant: Merck, Lilly (Non Paid), FDA, Abiomed, Corindus
Speaking: Abiomed, Corindus

9. The Most Appropriate Disclosure for Today’s Presentation
Or is it?

10. Disclosures for Interventional Presentations

11. I am an Interventional Cardiologist
Disclosures:
Consultant: Merck, Lilly (Non Paid), FDA, Abiomed, Corindus
Speaking: Abiomed, Corindus
I am a Capitalist
I am an Interventional Cardiologist

12. Should the Disclosure of a Vehement Advocate of Medical Therapy Include?
Studies Supported by Industry for which the speaker was the Principal Investigator.
Such Studies Contributed to his/her overall Success and notoriety.
Despite no direct payment to the individual.

13. Should Op-Ed Pieces Include Major Political Affiliations/Political Contributions of the Authors?

15. Should each Political Candidates be Required to Show a Slide with their Major Contributors Prior to each Debate?

16. My Plea: Reported Conflicts should be Comprehensive and Not Just Direct Money

17. Conflict of Interest Issues: Balancing Industry Involvement
A few Editorial Comments
Current Climate
Cautious Balance between Investigators, Institutions and Industry
Practical recommendations

18. Reality: There has been Misbehavior on the Part of Doctors and Industry
Over-prescribing
Over-advertising
Creating Studies which “Can’t Lose” and are targeted at marketing and not science

19. Reasons for the Current Environment
Cost of Health Care
Role of Industry
Effect of Industry on Doctor behavior
Prescriptions or Recommended Therapy
The Public is aware and concerned

20. of doctors for consulting, speaking, research, travel and meals.
Since 2009, 15 major drug companies have paid $2.1 billion to thousands
of doctors for consulting, speaking, research, travel and meals.
USA Today

21. Public Reporting Pro Publica
Mandatory Government Website as a Mandate in the Affordable Care Act

24. How important are the Conflicts in Study Results?

26. Conflict of Interest Issues: Balancing Industry Involvement
A few Editorial Comments
Current Climate
Cautious Balance between Investigators, Institutions and Industry
Practical recommendations

27. The Advantages of an Inventor/Developer Involved in Their Own Scientific Development
Committed.
Motivated.
Potentially have the best perspective and understanding of new entity.

28. Would We Still Be in a Horse and Buggy if Henry Ford had to Divest Himself of Experimental Involvement?

29. The Disadvantages of an Inventor/Developer Involved in Their Own Scientific Development
Potentially over-zealous.
May not be sufficiently conscious of value or even risk of future development.
Demand for success interferes with honest scientific assessment of risk/benefit of future product

30. Advantages of Interactions Between Industry and Investigators
Better communication to achieve a better Product.
Common goals to have a successful and useful product can be enhanced as each has a separate but important role.
For Investigator better product knowledge.
For Industry important clinical and functional feedback

33. N Engl J Med 363;7: 12, 2010

34. Current NIH Guidelines

35. Comments on Federal Guidelines

36. Governmental Control Unintended consequences of Legislating Change
Kesselheim AS: N Engl J Med 2010; 363:

37. Safeguards Public Reporting of conflicts with industry.
Protects against under reporting a adverse study findings in publications
ClinicalTrials.gov
FDA Panels Require extensive vetting of potential panelists for conflicts
New Issues
Large Data
Data Sharing

38. Challenge: Provide Protection without Destroying Favorable & Beneficial Investigator-Industry Relations

39. Conflict of Interest Issues: Balancing Industry Involvement
A few Editorial Comments
Current Climate
Cautious Balance between Investigators, Institutions and Industry
Practical recommendations

40. How to Keep the Industry-Investigator Relationship Appropriate
Investigator has full access to the data.
Investigator has right of independent publication; industry has right of review and comment.
Independent IRB review of study/trial to be certain study fulfills appropriateness for the study participants.
Industry cannot interfere with good scientific practices, or independent medical care decisions.
Investigators must disclose conflicts

41. VCU Pauley Heart Center:

42. Topol and Krumholtz Letter to NY Times

43. Topol and Krumholtz Letter to NY Times

44. Topol and Krumholtz Letter to NY Times
Important Statement, But do on line publications
tend to benefit from early release?

45. Topol and Krumholtz Letter to NY Times
Note the “Disclosure of the Authors

46. Dr. Topol’s “Other” Work

47. Is There a Potential Conflict?
Could an On-Line release provide an opportunity for on line digital news reporting via Medscape?
Should he have disclosed this conflict in his Affiliation?

48. Krumholtz
Dr. Krumholtz’s “Affiliations”
BMJ.com/US

49. Is There a Potential Conflict?
Could an On-Line release provide an opportunity for on line digital news reporting for the BMJ on-line USA?
Should he have disclosed this conflict in his Affiliation?

50. NEJM: SPRINT Trial

51. NEJM Response

52. NEJM Response