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THE COMPLEX ETHICS OF ACADEMIC-INDUSTRY COLLABORATIONS Ross McKinney, Jr, MD Duke University School of Medicine.

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Presentation on theme: "THE COMPLEX ETHICS OF ACADEMIC-INDUSTRY COLLABORATIONS Ross McKinney, Jr, MD Duke University School of Medicine."— Presentation transcript:

1 THE COMPLEX ETHICS OF ACADEMIC-INDUSTRY COLLABORATIONS Ross McKinney, Jr, MD Duke University School of Medicine

2 Outline  What is Conflict of Interest? (COI)  Areas of Concern  Federal rule changes  Duke processes

3 Don’t get the wrong message  In health care, almost no good idea will affect significant number of patients if it isn’t commercialized  Pharmaceutical & device companies don’t take care of patients – they need advice from people who do  Conflict of interest isn’t intrinsically bad – it’s a normal part of life  At Duke, we encourage working with industry (as distinct from for industry)

4 But…  Professionalism means putting the interests of your patients above your own self-interest  In research, professionalism means putting your science above your self-interests  Economic (promotion, salary, grants)  Social (status)  Identification with an idea  We need to educate, but we should do so without marketing (e.g. CME v. speakers bureaus)

5 Definition - COI  A conflict of interest exists when a primary interest or responsibility is (unduly) affected by a secondary interest or responsibility

6 Real World Examples  Dental work  Devils and Tar Heels

7 Example  An obvious charge - ignored... An obvious charge - ignored...

8 Key to the Example  Our perception is flavored by pre-set expectations and rationalizations of which we may not be aware  The whole crowd saw the same data, but drew very different conclusions

9 COI is part of every day life  Human beings are very aware of COIs  Every sales encounter  All fee-for-service medical encounters

10 The Human Response  We consider the paradigm, past history  We consider the secondary influences we can identify  Can we trust the provider?  If we break that trust as medical providers, what happens?  Decreased adherence / worse outcomes  Poor word-of-mouth  Malpractice cases

11 Be Aware  The public is paying increasing attention to examples of physicians appearing to act in self interest instead of the best interest of their patients  Should we collectively care?

12 A few industries  Airlines  Pharmaceuticals  Banking (71% trust in 2008 to 25% in 2011)  If people don’t respect and value physicians, will Congress use Medicare (i.e. physician payments) to balance the budget?

13 Areas of Concern  Clinical Research  Clinical Care  Education  Commercialization of ideas

14 Concerns: In Clinical Research  In science, reproducibility is the key test for validation  In clinical research, trials are often too expensive to reproduce  Don’t want to put people at risk unnecessarily  Primary means of validation is audit  Audit is not generally effective as a means to identify bias

15 Goals of COI Management in Research  Protect research subjects from biased decisions by conflicted investigators  Scientific integrity  Do not want clinical decisions based on data from biased studies  Don’t want conflicted investigators interpreting data  Role of the Academic as the fair-broker  Free of bias (at least financial)

16 JAMA – 2003 – Als-Nielsen, et al  370 randomized trials  Considered: 1) Outcome of trial; 2) Sponsor  Non-profit Sponsor - 16% recommended experimental drug as treatment of choice  Funding not reported: 30%  Mixed funding: 35%  For-profit organization: 51%  Difference significant (p<0.001)OR: 5.3; 95% CI 2.0-14.4)

17 NEJM Study - 2008  Studies of 12 anti-depressants, 12,564 patients  38 studies with positive FDA results, of which 37 were published, 1 not published  36 with negative FDA results  3 published, 22 not published  11 published with data selection to appear positive  In literature, 94% of publications were positive  Turner: NEJM 2008;258:252-260

18 Merck’s ADVANTAGE study - 2003  ADVANTAGE study: Assessment of Differences between Vioxx and Naproxyn to Ascertain Gastrointestinal Tolerance and Efficacy  After 3 months, 27% more people stopped taking Naproxyn than Vioxx

19 Brief Illustration  After 3 months, 27% more people stopped taking Naproxyn  Of course, that was 5.9% vs 8.1%

20 Brief Illustration  After 3 months, 27% more people stopped taking Naproxyn  Of course, that was 5.9% vs 8.1%

21 Brief Illustration  or better, 94% vs 92% tolerance

22 Seeding Study  ADVANTAGE was designed by the marketing department at Merck  Real subjects were the MDs  Did use of study increase prescription rate?  Complimented enrolling doctors  Used many primary care sites, rather than a few high enrolling centers

23 Brief Illustration  Personal experience – cost difference to me was 30x ($150 vs $5) [actually Celebrex vs ibuprofen]  Points like this have Congress’s eye as potential cost savings & unnecessary expenses  Migrate decision making from physicians to non-experts because of failure of physicians to perform the work of an expert adequately

24 The Complicated Question  Bayh-Dole Act of 1980  Inventions  Personal and institutional conflict  Safety concerns increase in import  The “rebuttable presumption”  Where’s the right balance?

25 Concerns: In Clinical Care  The fee for service model  Note articles about inappropriate use of open breast biopsies (vs. needle), stenting of chronic stable angina, of spine surgery, of in-house diagnostic and treatment devices, of infusion therapies where the primary beneficiary seems to be the infuser rather than the infused  Insertion of flawed devices by physician developers and advocates  Routine procedures with reimbursement (EKGs, etc)

26 Concerns: In Education  FDA Rules about talking off label  Speaker’s bureaus  If you know someone is being paid to give a talk, does it change your perception of the message?

27 Concerns: In Education  FDA Rules about talking off label  Speaker’s bureaus  If you know someone is being paid to give a talk, does it change your perception of the message?  What if it’s true, but you don’t know?

28 Physician Sunshine Act  Section 6002 of the Affordable Care Act  As of January 2012, pharmaceutical and device manufacturers must report all gifts and payments to physicians and teaching hospitals to a federal database  Threshold is $10 per item, or $100 per year  Results will be published in 2013 in a web based, searchable format

29 Public awareness  What will the ramifications be of public disclosure?  An example, using the fact Minnesota has had a public database for several years

30 New York Times article  Front Page – May 10, 2007  “Psychiatrists, Children and Drug Industry’s Role”  “When Anya Bailey developed an eating disorder after her 12th birthday, her mother took her to a psychiatrist at the University of Minnesota who prescribed a powerful antipsychotic drug called Risperdal.”

31 The problem  Anya gained weight but within two years developed a crippling knot in her back. She now receives regular injections of Botox to unclench her back muscles. She often awakens crying in pain.

32 The COI  In 2003, the year Anya came to his clinic, Dr. Realmuto earned $5,000 from Johnson & Johnson for giving three talks about Concerta.

33 The COI  In 2003, the year Anya came to his clinic, Dr. Realmuto earned $5,000 from Johnson & Johnson for giving three talks about Concerta.  However, not clever to say –  “Academics don’t get paid very much. If I was an entertainer, I think I would certainly do a lot better.”

34 The COI  In 2003, the year Anya came to his clinic, Dr. Realmuto earned $5,000 from Johnson & Johnson for giving three talks about Concerta.  However, not clever to say –  “Academics don’t get paid very much. If I was an entertainer, I think I would certainly do a lot better.”  (Dr. Realmuto’s university salary is $196,310.)

35 Minnesota case  Was it really the result of COI?  Amount of money was small  Adverse events happen  Perception of outsiders may differ from our own  Malpractice attorneys eagerly awaiting the federal database

36 The role of gifts  Duke rules prohibit gifts, including meals, from pharmaceutical and device reps  Unrestricted educational grants to the institution are allowed  True CME can be supported – no quid pro quo allowed  Gifts are a part of relationship building  Reps goal is to convert the relationship from a business one to a personal one  Airline example

37 NIH Rules Recently Changed  $5,000 threshold for management and reporting to the NIH All cases of FCOI of $5K or more.  Must report all sponsored travel (other than government, universities, and medical centers)  Require review of all personal FCOIs prior to any NIH grant expenditures (even on renewal)  Web site to post all FCOIs linked to grants (perhaps)

38 Process  Annual report in March  Review (in order)  Review each grant application  Review IRB submissions  Review each grant award  Now consider purchasing, research, and (to a degree) clinical issues

39 Limits  Require annual reporting of all relationships >$600/year (likely to except universities, academic medical centers, government, and research institutes)  As of January 1, management at $5K/year if there is an overlap with research  At $25K/year, can no longer be PI on related research

40 Other limits  Treat equity as if it’s payments ($20,000 in stock is the same as $20,000 in payments)  Non-publically traded equity is treated as >$25K  Stock options are treated as >$25K  We look at royalty arrangements case-by-case

41 Summary  Conflict of Interest is present in everyday life  Providing transparency is critical  Public perception may different from the insider’s view  If we want to remain professionals, we need to maintain the interests of our patients first


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