• Tidak ada hasil yang ditemukan

Is “Drug Reps Off-Campus” Wise Social-Distancing Policy?

Dalam dokumen Philosophy and Medicine (Halaman 87-94)

To determine the risks of policies restricting physicians’ access to drug reps, Chressanthis et al. (2012) studied the prescribing decisions of 58,647–72,114 physi- cians. Decisions were statistically analyzed using prescription data from IMS Health. A consulting firm database was used to determine access-to-reps levels for 300,000 physicians. (Reps have a strong financial incentive accurately to log this data because their pay is linked to it.) Physicians were sorted into four categories of access: very low, low, medium, and high. Only high-prescribing doctors of diabetes and lipid-lowering drugs were studied. Low prescribers were ruled out because drugs reps rarely target them.

The drugs were:

• An innovative drug for type 2 diabetes (Januvia-sitagliptin)

• An older diabetes drug with a new FDA-required black box warning for cardio- vascular safety (Avandia-rosiglitazone)

• A combination lipid therapy that had reported negative outcomes in a clinical trial (Vytorin-simvastatin+ezetimibe)

86

The authors found:

• Physicians with very low access to reps had the lowest overall adoption of new, first-in-class therapy and took 1.4 and 4.6 times longer to adopt than physicians with greater access.

• In responding to the FDA’s boxed warning for Rosiglitazone, physicians with very low access were 4.0 times slower to reduce their use of this treatment than those with greater access.

• Physicians with very low access to reps were significantly slower to change their prescribing based on negative industry news about combination lipid therapy.

• Overall, cardiologists were the most responsive to information changes relative to primary care physicians.

The authors conclude that limiting access to reps can have the unintended effect of reducing appropriate responses to negative information about drugs just as much as responses to positive information about innovative drugs. When new information became available, primary care physicians who had reduced access to drug reps were more likely to prescribe less effective and potentially more dangerous drugs.

A survey of 2996 physicians found that >50% are working in organized provider systems. Forty-two percent of those reported never seeing industry reps (compared with 25% of independent practitioners). Of those physicians working in organized provider systems who never see reps, 80% report that not seeing reps was due to organizational polices (Quantia and Capgemini Consulting 2014).

Supporters of restrictive drug rep access policies might object that reps have seeded physicians’ information environment with so much bad data that their mak- ing apparently beneficial compensatory updates appears attractive. Perhaps it is bet- ter to cut off the whole desultory exercise with a “nudging” social-distancing policy (Thaler et al. 2006) guided by principles of “libertarian paternalism” (Sunstein and Thaler 2003). The premises of these thinkers have received harsh criticism (Wright and Ginsburg 2012). A fuller discussion of freer versus more restricted information markets goes beyond my purposes.

Conclusion

Appreciation for physicians’ competing interests is not new. About 2500 years ago, Plato observed that the physician “professes medicine,” but he practices an addi- tional art not professed by him—the art of getting payments. Everyone practices the latter art—because no one takes on the troubles of strangers, to straighten them out, but everyone expects payment for that—for the opportunity cost thereby incurred, to use the language of economics.

Plato’s analysis recognized that money payments are not the only kind in which people take an interest. Indeed, money payments, while most common, are the low- est kind. Payments additionally include social recognition/status, affirmation from social sources that matter. Professionals commonly have accepted a payment

L.K. Stell

mix—money but also high status, patient approval, social appreciation for pro bono services, and self-approval for doing good, removing harm, and at least avoiding inflicting needless harm. Plato also mentioned the type of payment required to moti- vate the best of the best—those who had lost interest in money and in further social recognition. Such person could only be motivated to service by avoiding having less qualified, less excellent persons serve in their stead. These exalted souls could not live with themselves were they to allow that to happen. Thus the ultimate sanction and payoff was avoidance of self-disapproval for what one allowed to happen.

The COI cascade seriously misfires by fixating on monetary payoffs while ignor- ing all the other things that people care about, things that can bias their judgment and lead to wrongdoing. Wrongdoing should be the focus, not the temptations and motivations that sometimes result in it.

Today, more than 50% of physicians are practicing within some type of health- care system. Their compensation is tied to various performance metrics—process measures, outcome measures, patient volume, and satisfaction measures. They have much lower access to drug reps than in the past. More than 1/3 of physicians are part of an integrated health network, the most restrictive environment for rep access.

Seventy percent of physicians who have been out of medical school for 10 years or less are employed by an organized health system. More than 50% of physicians have their prescribing decisions constrained by a formulary and a care pathway or require prior authorization. Prescribing restrictions are greater for in-patients than out-patients.

Conversations with drug reps, where allowed, are rule-constrained. It is not enough for a physician to be convinced about a drug’s appropriateness to have it dispensed successfully to a patient. The drug must be on formulary and listed as available on the patient’s electronic health record. It is not easy for a physician to discover which drugs are on formulary. He will receive notification in the event he prescribes off-formulary. Nor may a rep detail a product to a physician if it is not already on formulary. Suggestions for formulary additions must be submitted to a Pharmacy and Therapeutics Committee, not to an individual physician. Lobbying an individual physician to submit a formulary addition request is a violation which carries a campus-exclusion penalty for the rep—as long as 90 days.

Corruption fears have resulted in social-distancing policies of drug reps from physicians, and they have given us sharply constrained information markets. There is some evidence that this may be disadvantageous to patients. Information market restrictions do promote powerful political and corporate interests. Interests that can- not reach these levers of power are disadvantaged. Whether there are compensating benefits in reduced expenditures on drugs and devices, which account for roughly 10% of healthcare expenditures, remains to be seen. The prices of some generics have increased sharply. We can only hope that our institutional policies eventually will be revised in a manner that better respects physicians as sophisticated consum- ers of product marketing and holds them accountable for their choices not their motivational states.

88

Acknowledgment I am indebted to Thomas P.  Stossel, MD, for the PowerPoint slides and to David Barton for the Excel spreadsheet chronographing the COI cascade.

References

AdvaMed Code of Ethics. 2009. http://advamed.org/res.download/112. Accessed 11 Aug 2016.

Barton, D., T. Stossel, and L. Stell 2014. After 20 Years, industry critics bury skeptics, despite empirical vacuum. . International Journal of Clinical Practice, June 2014, 68(6): 666–673.

Ben-Shahar, O., and C.E.  Schneider. 2010. The Failure of Mandated Disclosure. University of Chicago Law & Economics, Olin Working Paper No. 516; University of Michigan Law &

Economics, Empirical Legal Studies Center Paper No. 10-008.

Brennan, T.A., D.J. Rothman, L. Blank, D. Blumenthal, S.C. Chimonas, J.J. Cohen, J. Goldman, J.P. Kassirer, H. Kimball, J. Naughton, and N. Smelser. 2006. Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers. Journal of the American Medical Association 295(4): 429–433.

Brody, H. 2007. Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry.

Lanham: Rowman-Littlefield.

———. 2010. Major New Study Published in PLoS Medicine. Wednesday, October 20, 2010.

http://brodyhooked.blogspot.com/2010/10/major-new-study-published-in-plos.html. Accessed 15 Mar 2015.

Cain, D., G. Loewenstein, and D.A. Moore. 2005. The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest. The Journal of Legal Studies 34: 1–25.

Chressanthis, G.A., et al. 2012. Can Access Limits on Sales Representatives to Physicians Affect Clinical Prescription Decisions? A Study of Recent Events With Diabetes and Lipid Drugs.

Journal of Clinical Hypertension 14(7): 435–446.

DeAngelis, C.D., and P.B. Fontanarosa. 2008. Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence. Journal of the American Medical Association 299(15):

1833–1835.

Dukeminier, J., S.M. Johanson, J. Lindgren, and R.H. Sitkoff. 2005. Wills, Trusts, and Estates 158.

7th ed. Rockville: Aspen Publishers, Inc.

Epstein, R.M. 1999. Mindful Practice. Journal of the American Medical Association 282(9):

833–839.

Epstein, B.J., K. Vogel, and B.F. Palmer. 2007. Dihydropyridine Calcium Channel Antagonists in the Management of Hypertension. Drugs 67(9): 1309–1327.

Erde, E. 1996. Conflicts of Interests in Medicine: A Philosophical and Ethical Morphology. In Conflicts of Interest in Clinical Practice and Research, ed. R.G.  Spece, D.S.  Shimm, and A.E. Buchanan, 12–41. New York: Oxford University Press.

Estate of Auen. 1994. 35 Cal.Rptr.2d 557.

Ford, E.S., et al. 2007. Explaining the Decrease in U.S. Deaths from Coronary Disease, 1980–

2000. The New England Journal of Medicine 356: 2388–2398.

Gieser, N. 2009. Financial Conflict-Of-Interest Disclosure and Voting Patterns at FDA Advisory Committee Meetings. http://www.fda.gov/downloads/AdvisoryCommittees/

AboutAdvisoryCommittees/UCM165328.pdf. Accessed 11 Aug 2016.

Haayer, F. 1982. Rational Prescribing and Sources of Information. Social Science & Medicine 16(23): 2017–2023.

Hayward, R.A., S.M.  Asch, M.M.  Hogan, T.P.  Hofer, and E.A.  Kerr. 2005. Sins of Omission:

Getting Too Little Care May be the Greatest Threat to Patient Safety. Journal of General Internal Medicine 20: 686–691.

Hirsch, L.J. 2009. Conflict of Interest, Authorship and Disclosures in Industry-Related Scientific Publication: The Tort Bar and Editorial Oversight of Medical Journals. Mayo Clinic Proceedings 84(9): 811–821.

L.K. Stell

Huddle, T.S. 2008. Drug Reps and the Academic Medical Center: A Case for Management Rather Than Prohibition. Perspectives in Biology and Medicine 51(2): 2521–2560.

IMS Institute for Health Informatics. 2014. Medicine Use and Shifting Costs of Health Care: A Review of the Use of Medicines in the United States in 2013. http://www.imshealth.com/

deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/

Secure/IIHI_US_Use_of_Meds_for_2013.pdf. Accessed 15 Mar 2015.

Institute of Medicine of the National Academies Website. 2009. Conflict of Interest in Medical Research, Education and Practice. Released April 28, 2009. http://www.iom.edu/

CMS/3740/47464/65721.aspx. Accessed 15 Mar 2015.

Jones, D.J., A.N. Barkum, Y. Lu, et al. 2012. Conflicts of Interest Ethics: Silencing Expertise in the Development of International Clinical Practice Guidelines. Annals of Internal Medicine 156:

809–816.

Kahnemann, D. 2011. Thinking Fast and Slow. New York: Farrar, Strauss and Giroux.

Kao, A.C., et  al. 2001. Physicians Incentives and Disclosure of Payment Methods to Patients.

Journal of General Internal Medicine 16: 181–188.

Keitz, S.A., K.M. Stechuchak, S.C. Grambow, C.M. Koropchak, and J.A. Tulsky. 2007. Behind Closed Doors: Management of Patient Expectations in Primary Care Practices. Archives of Internal Medicine 167: 445–452.

Koch, C., and C. Schmidt. 2010. Disclosing conflicts of interest – Do Experience and Reputation Matter? Accounting, Organizations and Society 35: 95–107.

Kuran, T., and C. Sunstein. 1999. Availability Cascades. Stanford Law Review 51: 683–768.

Langbein, J. 2005. Questioning the Trust Law Duty of Loyalty: Sole Interest or Best Interest. Yale Law Journal 114: 929–990.

Lebel, C., and C. Beaulieu. 2011. Longitudinal Development of Human Brain Wiring Continues from Childhood into Adulthood. Journal of Neuroscience 31(30):10937–10947. doi: 10.1523/

JNEUROSCI.5302-10.2011.

Lesko, R., S.  Scott, and T.P.  Stossel. 2012. Bias in High-Tier Medical Journals Concerning Physician-Academic Relationships with Industry. Nature Biotechnology 30: 320–322.

Lichtenberg, F. 2006. The Effect of Using New Drugs on Admissions of Elderly Americans to Hospitals and Nursing Homes: State-level Evidence 1997-2003. PharmacoEconomics 24(Suppl 3): 5–25.

Lurie, P., M.  Cristina, C.M.  Almeida, N.  Stine, A.R.  Stine, and S.M.  Wolfe. 2006. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings. Journal of the American Medical Association 295(16):

1921–1928.

Mackey, T.K., and B.A. Liang. 2013. Physician Payment Disclosure under Health Care Reform:

Will the Sun Shine? Journal of the American Board of Family Medicine 26(3): 327–331.

Madoff, R.D. 1997. Unmasking Undue Influence. Minnesota Law Review 81: 571.

McDaniel, S.H. et al. 2007. Physician Self-Disclosure in Primary Care Visits: Enough About You, What About Me? Archives of Internal Medicine 167(12):1321–1326.

Mukherjee, S. 2010. The Emperor of All Maladies: A Biography of Cancer. New York: Scribner.

Opie, L.H., and R. Schall. 2002. Evidence-Based Evaluation of Calcium Channel Blockers for Hypertension. Journal of the American College of Cardiology 39: 315–322.

Pearson, S.D., and T. Hymans. 2002. Talking about Money: How Primary Care Physicians Respond to a Patient’s Question about Financial Incentives. Journal of General Internal Medicine 17:

75–78.

Phillips, L.S., W.T. Branch, C.B. Cook, J.P. Doyle, et al. 2002. Clinical Inertia. Annals of Internal Medicine 135: 825–834.

PhRMA Code. 2008. http://www.phrma.org/principles-guidelines/code-on-interactions-with- health- care-professionals. Accessed 11 Aug 2016.

Policy and Medicine. http://www.policymed.com/physician-payment-sunshine-act/page/11/.

Accessed 15 Mar 2015.

90

Prasad, V., A.  Vandross, C.  Toomey, et  al. 2013. A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices. Mayo Clinic Proceedings 88(8): 790–798.

Psaty, B.M., and S.P. Burke. 2006. Institute of Medicine on Drug Safety. The New England Journal of Medicine 355: 1753–1755.

Quantia & Capgemini Consulting. 2014. Working the System: 4 Trends Driving New Opportunities for Engaging Organized Physicians. http://ebooks.capgemini-consulting.com/Whitepaper%20 -%20Quantia%20-%20Capgemini%20Consulting%20-%20Working%20the%20System.pdf.

Accessed 11 Aug 2016.

Rohloff, A., and S. Wright. 2010. Moral Panic and Social Theory: Beyond the Heuristic. Current Sociology 58(3): 403–419.

Rothman, K. 1993. Conflict of Interest: The New McCarthyism in Science. Journal of the American Medical Association 269(21): 2782–2784.

Scalise, R.J. 2008. Undue Influence and the Law of Wills: A Comparative Analysis. Duke Journal of Comparative & International Law 19: 41–106.

Scannell, J., A.  Blanckley, H.  Boldon, and B.  Warrington. 2012. Diagnosing the Decline in Pharmaceutical R&D Efficiency. Nature Reviews Drug Discovery 11: 191–200.

Shekelle, P.G., E. Ortiz, S. Rhodes, et al. 2001. Validity of the Agency for Healthcare Research and Quality Clinical Practice Guidelines: How Quickly Do Guidelines Become Outdated? Journal of the American Medical Association 286(12): 1461–1467.

Sherif, M. 1937. An Experimental Approach to the Study of Attitudes. Sociometry 1: 90–98.

Shimm, D.S., and R.G. Spece Jr. 1996. Introduction. In Conflicts of Interest in Clinical Practice and Research, ed. R.G. Spece Jr. et al., 1–11. New york: Oxford University Press.

Shojania, K.G., M. Sampson, M.T. Ansari, et al. 2007. How Quickly Do Systematic Reviews Go Out of Date? A Survival Analysis. Annals of Internal Medicine 147: 224–233.

Sorrell v. IMS Health Inc.. 2011. No. 10–779 131 S.Ct. 2653.

Spurling, G.K., P.R. Mansfield, B.D. Montgomery, J. Lexchin, J. Doust, et al. 2010. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing:

A Systematic Review. PLoS Medicine 7(10): 1–22.

Stelfox, H.T., G. Chua, K. O’Rourke, and A.S. Detsky. 1998. Conflict of Interest in the Debate over Calcium-channel Antagonists. The New England Journal of Medicine 338: 101–106.

Stell, L.K. 2002. Two Cheers for Physicians’ Conflicts of Interest. The Mount Sinai Journal of Medicine 71(4): 236–242.

———. 2005. Against the Flow: Why Physicians Should Listen to Drug Reps. ASBH Exchange 8:

1–5.

———. 2009. Drug Rep Off Campus! Promoting Professional Purity by Suppressing Commercial Speech. The Journal of Law, Medicine & Ethics 37(3): 431–443.

Stossel, T.P. 2005. Regulating Academic-Industry Relationships—Solving Problems or Stifling Progress? The New England Journal of Medicine 353: 1060–1065.

Stossel, T.P. 2008. Has the Hunt for Conflict of Interest Gone Too Far? Yes. British Medical Journal, 336(742):476 PMID:18309999;PMCID:PM2258346.

Stossel, T.P., and L.K. Stell. 2011 Time to ‘Walk the Walk’ About Industry Ties to Enhance Health.

Nature Medicine 17(4): 437–438.

———. 2002. Conformity and Dissent. University of Chicago Public Law & Legal Theory Working Paper No. 34.

Sunstein, C.R. 2005. Laws of Fear: Beyond the Precautionary Principle. Cambridge: Cambridge University Press.

Sunstein, C.R., and R.H. Thaler. 2003. Libertarian Paternalism is Not an Oxymoron. University of Chicago Law Review 70(4): 1159–1202.

Thompson, D.F. 1993. Understanding Financial Conflicts of Interest. The New England Journal of Medicine 329(8): 573–576.

Timbie, J.W., D.S.  Fox, K.  Van Busum, and E.C.  Schneider. 2010. Five Reasons That Many Comparative Effectiveness Studies Fail to Change Patient Care and Clinical Practice. Health Affairs 31(10): 2168–2175.

L.K. Stell

Todd, J.S. 1991. Professionalism at its Worst. Journal of the American Medical Association 266(23): 3338.

United States v Caronia. 2012. 2d Cir.

Vera-Badillo, F.E., R. Shapior, A. Ocana, E. Amir, and I.F. Tannock. 2013. Bias in Reporting of End Points of Efficacy and Toxicity in Randomized, Clinical Trials for Women with Breast Cancer. Annals of Oncology 24: 1238–1244.

Wazana, A. 2000. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? Journal of the American Medical Association 282: 373–380.

Wingrove v Wingrove. 1885. 11 P.D.81: 82–83.

Woolley, K.L., R.A.  Lew, S.  Stretton, J.A.  Ely, N.J.  Bramich, J.R.  Keys, J.A.  Monk, and M.J. Woolley. 2011. Lack of Involvement of Medical Writers and the Pharmaceutical Industry in Publications Retracted for Misconduct: A Systematic, Controlled, Retrospective Study.

Current Medical Research and Opinion 27(6): 1175–1182.

Wootton, J.  2006. Bad Medicine: Doctor Doing Harm Since Hippocrates. Oxford/New York:

Oxford University Press.

Wright, J.D., and D.H. Ginsburg. 2012. Behavioral Law and Economics: Its Origins, Fatal Flaws and Implications for Liberty. Northwestern University Law Review 106(3): 1033–1088.

93

© Springer Science+Business Media B.V. 2017

D. Ho (ed.), Philosophical Issues in Pharmaceutics, Philosophy and Medicine 122, DOI 10.1007/978-94-024-0979-6_6

Dalam dokumen Philosophy and Medicine (Halaman 87-94)