Eric Campbell

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Eric Campbell

  1. 1. Industry Relationships in Medicine and Research Eric G. Campbell, Ph.D. Associate Professor
  2. 2. Disclaimer and Disclosure • Comments do not represent the views of the IHP, MGH, or HMS • No relationships of any kind with any firm whose products or services in any way relate whatsoever to the life science research enterprise • Research funding is from the NIH and the Greenwall Foundation, IMAP
  3. 3. Background: Definition of AIRs Academic-Industry Relationships (AIRs): Arrangements in which academic scientists, administrators and physicians receive industry resources in exchange for access to intellectual property, research services, or access to patients, medical students, residents or other physicians. Institutional Academic Industry Relationships (IAIRs): Arrangements when academic institutions, or any of their senior officials, have a financial relationship with or a financial interest in a public or private company
  4. 4. Types of Relationships • Individual Research Relationships – Grants and contracts, – Consulting – Gifts – Equity/ownership positions – Trips – Samples • Institutional – Discretionary funds – Equipment – Buildings – Programs
  5. 5. Thesis • Relationships with industry are ubiquitous in all aspects of academic medicine. These relationships are not universally bad or good. They have both risks and benefits. Banning industry relationships is neither possible or advisable in the current context. The challenge is to enact new policies and procedures related to the disclosure and management of these relationships such that the benefits are achieved and the risks are limited or eliminated. Failure to do so could have dire consequences for the future of medicine.
  6. 6. Third-Year Medical Students’ Exposure to Various Types of Drug Company Interactions AIRs are ubiquitous in the modern life science enterprise... 26 51 34 42 51 87 89 90 94 97 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Attend workshop Book donated Another social event Drug sample Dinner Grand rounds Snack Journal reprint Small, non-ed gift Lunch Sierles et al JAMA 2005 294:1034-1042
  7. 7. AIRs are ubiquitous...... Academic-based Researchers 6% 24% 32% 21% 18% 1%0% 20% 40% 60% Research funding Consultant Paid Speaker Scientific advisory board Support for students Officer/ executive Campbell, E.G., et al Survey of Academic Faculty 2007
  8. 8. AIRs are ubiquitous...... NIH Intramural Scientists and Investigators 17% 8% 16% 2%0% 20% 40% 60% Research funding Consultant Paid Speaker Scientific advisory board Support for students Officer/ executive n/an/a Campbell, E.G., et al Survey of NIH Intramural Faculty, 2008-9
  9. 9. AIRs are ubiquitous in the modern life science enterprise...... Percentage of IRB Members 2% 10% 14%17% 26% 14% 7% 0% 20% 40% 60% Research funding Pay-Attend Meetings Consultant Speakers bureau Scientific advisory board Support for students Officer/ executive Campbell, E.G., et al NEJM 2006 355(22):2321-2329
  10. 10. AIRs are ubiquitous in the modern life science enterprise...... Percentage of IRB Chairs 7% 12% 29% 17% 17% 17% 1%0% 20% 40% 60% Research funding Pay-Attend Meetings Consultant Speakers bureau Scientific advisory board Support for students Officer/ executive Campbell et al, unpublished data
  11. 11. AIRs are a fundamental part of the modern life science enterprise... Percentage of Department Chair Relationships 9% 14% 21% 28% 27% 27% 19% 16% 0% 20% 40% 60% Honoraria- Speaking Paid Consultant Advisory board Research funding CME speaker Speakers bureau Subsidized travel Founder of company Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
  12. 12. AIRs are ubiquitous in the modern life science enterprise...... Percentage of Clinical and Non-Clinical Departments 19% 36% 65% 51% 37% 30% 3%8%13%2%12%3% 0% 20% 40% 60% 80% 100% Support for CME Food & Beverage Support for residents Support for dept seminars Support for travel Unrestricted funds Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786 Clinical departments Non-clinical departments
  13. 13. AIRs are ubiquitous in the modern life science enterprise...... Percentage of Physicians 9% 18% 78% 83% 35% 15% 3% 0% 20% 40% 60% 80% 100% Drug samples Food & Beverage Reimburse- Meetings Consulting payments Speakers bureaus Advisory boards Payments for enroll patients Campbell et al NEJM 2007 356(17):742-750
  14. 14. AIRs are ubiquitous in the modern life science enterprise..... Percentage with any AIR 94% 60% 43% 36% 53% 0% 20% 40% 60% 80% 100% Faculty Researchers IRB Members IRB Chairs Dept. Chairs Physicians
  15. 15. AIRs are ubiquitous in the modern life science enterprise...... Departments with > 1 relationships 67% 80% 43% 0 10 20 30 40 50 60 70 80 90 All Clinical Depts Non-Clinical Depts Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
  16. 16. Other Relationships…. • Professional associations • Guideline committees • Purchasing agents • FDA review committees • Other government officials • Trustees • CME • Other relationships you would not believe… (see next 3 slides)
  17. 17. Background: Other Stuff • Medtronic and Ms. Kelly – UCLA dept. chair “like to be taken to Platinum Plus” – VP clinical affairs made $450,000 charging his OR time as consulting – $25,000 to docs to ride on Mardi Gras float – $15,000 for beads to throw from float – Trip to “think tank” in Alaska staffed by fishing guides – Adult companionship – Helicopter skiing trips – Fake patent royalties – Involves more than 100 surgeons nationally
  18. 18. • Dr. Charles B. Nemeroff, chair of Emory University's department of psychiatry: – Failed to disclose ~ $500,000 he received from GlaxoSmithKline for giving talks that promoted the company's drugs (The New York Times, 10/04/08) – As the editor-in-chief of the journal, Depression and Anxiety, wrote a “Dear Me” letter in 2000, indicating that he was paying himself $3,000 to write an article to celebrated the 5th anniversary of the introduction of Effexor, an antidepressant created by Wyeth (Wall Street Journal, 12/18/08) • Nemeroff also billed Emory for $3,000 for this work, which was paid for by a grant from Wyeth • Bristol-Myers Squibb – Paid over $515 million in 2007 to resolve allegations involving their drug marketing and pricing practices (Department of Justice, 09/28/07) • Physician kickbacks included: travel to luxurious resorts, illegal remuneration (consulting fees, expense payment) • Retail and wholesaler kickbacks: stocking allowances, price protection payments, prebates, market share payments and free goods
  19. 19. • Pfizer – Paid over $430 million in 2004 to illegal marketing charges for drug Neurontin due to activities by Warner-Lambert (acquired by Pfizer in 2000) between 1996-2000 (Department of Justice, 06/2004) • Paid physicians to attend “consulting meetings” at destinations such as Hawaii, Florida and the 1996 Olympic Games in Atlanta • Physicians paid to allow sales reps see patient with them to allow the drug reps to offer off-label pro-Neurontin treatment advice • Blackstone Medical – Paid Arkansas neurosurgeon, Dr. Patrick Chan, (and other physicians) for bogus consulting contracts, fake research studies and gifts (Boston Globe, 01/08) • Schering-Plough (New York Times, 06/27/04) – Sent physicians checks for $10,000 “in exchange for an attached 'consulting' agreement that required nothing other than his commitment to prescribe the company's medicines”
  20. 20. AIRs have benefits... • Funding to support research ($1.5 billion in 1995) • Increased academic productivity • Increased commercial productivity – Patent applications, patents granted, licenses, start-ups, etc • Increased access to resources • Opportunity to participate in application of research • Offset wage differential between industrial and non- industrial sectors that will assist in recruitment an retention of scientists and administrators • Samples for poor people
  21. 21. AIRs have benefits... • New drugs and medical devices • Access to newest information • Address under use of medications and technology • Free meals for physicians and staff • Trips to nice places • Tickets to sporting events
  22. 22. Relationships have risks….. • Industry funding is limited in amount and short in focus compared to other funding sources • Secrecy in science • Shifting focus of science away from basic research • Bias in research • Increased management and negotiation costs • Perception of being “bought out” • Conflicts of interest (surgical dept example)
  23. 23. Please estimate the effect, if any, of your personal financial relationships with industry on: 11% 11% 14% 27% 20% 24% 88% 88% 83% 68% 74% 69% 1% 1% 2% 5% 5% 6% 0% 20% 40% 60% 80% 100% Recruiting new faculty Retaining current faculty Securing internal resources from your institution Your personal financial status Your department financial status Bringing in industry sponosred research grants & contracts % Positive % No effect % Negative N=270 Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
  24. 24. Please assess the relative effects on each of the following types of industry relationships with respect to a department’s ability to pursue independent, unbiased research: 10% 18% 17% 7% 8% 21% 28% 12% 72% 45% 48% 72% 0% 20% 40% 60% 80% 100% More than one of the below Serves on board(s) Consults for ≥ 1 company Substantial ownership/role in start-up(s) TypeofRelationship % Positive % No effect % Negative N=450 Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
  25. 25. Other things to know ….. • I am entitled to these things… • Patients don’t care… • Drug samples are for my poor patients… • Information provided by drug reps tends to be biased towards company products… • We can’t educate medical students and residents without these…… • Some companies differentially recruit cheerleaders for drug sales jobs….
  26. 26. Manage relationships • Disclosure • Review disclosures in context of established institutional policies and procedures • Ban some relationships (but not all) – Research relationships • PI with equity in clinical trials • Gifts to individual scientists – Non research relationships • No lunches, dinners, sporting tickets…. • Very little contact (if any) between medical students and residents and industry • Monitor relationships that need monitoring • Ignore and pray
  27. 27. Failure to do so could have dire consequences for the future of the life science enterprise. • Scandals • Compromise of key values – Biased education and research • Human subjects concerns • Increased governmental regulation • Loss of public support for academic science
  28. 28. Policy Projections • Scaling back/bans at medical schools and teaching hospitals • More public reporting • Establishment of institutional level review boards with external membership • Companies images with public will continue to fall • Companies will become increasingly sly.. – Hotel lunches off campus – Blurring of accredited and non-accredited CME

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