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Freedom to Innovate: The Perils of Centralized Medical Research

Freedom to Innovate: The Perils of Centralized Medical Research Prasad and colleagues1 present a viewpoint on the evolution of medical practices, with a striking claim and a problematic recommendation. They claim that there is “no incentive for companies to test scientific questions, which may only diminish market demand.”1(p957) Their proffered solution is that “trial funding should move away from industry-sponsored studies and toward a model where funds are pooled into a central and impartial agency that decides what trials to administer.”1(p957) The claim has empirical and theoretical problems. One counterexample is the study of the selective benefit of cetuximab in patients with colorectal cancers, funded in part by ImClone Systems and Bristol-Myers Squibb. This expensive drug, the study found, should be withheld from the more than 40% of the market with mutated K-ras genes.2 Another is the Bayer Healthcare–funded study of the safety of their aprotinin drug in cardiac surgery. Conducted at the specific request of Bayer, the study found significantly higher mortality among patients receiving aprotinin.3 Bayer passed the preliminary findings on to the Food and Drug Administration within 2 weeks and ultimately withdrew it from the market. A view of manufacturer incentives that focuses myopically on short-term revenues and market share struggles to explain these examples. More correctly, reputation matters greatly in highly regulated industries in which companies interact repeatedly with customers, health care providers, and regulators. Instead of reinforcing such reputational incentives through, for example, greater transparency, better enforcement, and lower costs to enter into the “market for trials,” Prasad and colleagues1,4 recommend centralization and nationalization of trials. We are wary of placing this much hope and burden on a single institution and an omniscient central decision maker. Consider the backstory to Mario Capecchi's Nobel Prize: The National Institutes of Health (NIH) had unanimously recommended that he abandon attempts to target genes in mammalian cells. Instead, at great professional risk, he concentrated all his efforts on developing the knockout mice of today. The NIH critique for his subsequent grant renewal started: “We are glad that you didn't follow our advice.”5 Existing institutional arrangements need strengthening so that academic institutions, firms, and government agencies have the means and the incentive to develop more innovative, safer, and more appropriate medical technology. Limiting the number of players conducting scientific research only heightens the inherent risks posed by our reliance on imperfect human institutions. This strategy is akin to placing all our technological eggs into one small and fragile basket. Back to top Article Information Correspondence: Dr Lakdawalla, Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, University Park Campus, UGW-Unit A, Los Angeles, CA 90089-7273 (dlakdawa@healthpolicy.usc.edu). Conflict of Interest Disclosures: Dr Huesch has consulted for Precision Health Economics. Dr Lakdawalla is a founding partner and managing director of Precision Health Economics, which consults to firms in the life sciences industry, including Bristol-Myers Squibb. References 1. Prasad V, Rho J, Cifu A. The diagnosis and treatment of pulmonary embolism: a metaphor for medicine in the evidence-based medicine era. Arch Intern Med. 2012;172(12):955-95822473672PubMedGoogle Scholar 2. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008;359(17):1757-176518946061PubMedGoogle ScholarCrossref 3. Schneeweiss S, Seeger JD, Landon J, Walker AM. Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med. 2008;358(8):771-78318287600PubMedGoogle ScholarCrossref 4. Prasad V, Cifu A, Ioannidis JP. Reversals of established medical practices: evidence to abandon ship. JAMA. 2012;307(1):37-3822215160PubMedGoogle ScholarCrossref 5. Azoulay P, Graff Zivin JS, Manso G. Incentives and creativity: evidence from the academic life sciences. RAND J Econom. 2011;42:527-554Google ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Freedom to Innovate: The Perils of Centralized Medical Research

Archives of Internal Medicine , Volume 172 (21) – Nov 26, 2012

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References (6)

Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/2013.jamainternmed.53
Publisher site
See Article on Publisher Site

Abstract

Prasad and colleagues1 present a viewpoint on the evolution of medical practices, with a striking claim and a problematic recommendation. They claim that there is “no incentive for companies to test scientific questions, which may only diminish market demand.”1(p957) Their proffered solution is that “trial funding should move away from industry-sponsored studies and toward a model where funds are pooled into a central and impartial agency that decides what trials to administer.”1(p957) The claim has empirical and theoretical problems. One counterexample is the study of the selective benefit of cetuximab in patients with colorectal cancers, funded in part by ImClone Systems and Bristol-Myers Squibb. This expensive drug, the study found, should be withheld from the more than 40% of the market with mutated K-ras genes.2 Another is the Bayer Healthcare–funded study of the safety of their aprotinin drug in cardiac surgery. Conducted at the specific request of Bayer, the study found significantly higher mortality among patients receiving aprotinin.3 Bayer passed the preliminary findings on to the Food and Drug Administration within 2 weeks and ultimately withdrew it from the market. A view of manufacturer incentives that focuses myopically on short-term revenues and market share struggles to explain these examples. More correctly, reputation matters greatly in highly regulated industries in which companies interact repeatedly with customers, health care providers, and regulators. Instead of reinforcing such reputational incentives through, for example, greater transparency, better enforcement, and lower costs to enter into the “market for trials,” Prasad and colleagues1,4 recommend centralization and nationalization of trials. We are wary of placing this much hope and burden on a single institution and an omniscient central decision maker. Consider the backstory to Mario Capecchi's Nobel Prize: The National Institutes of Health (NIH) had unanimously recommended that he abandon attempts to target genes in mammalian cells. Instead, at great professional risk, he concentrated all his efforts on developing the knockout mice of today. The NIH critique for his subsequent grant renewal started: “We are glad that you didn't follow our advice.”5 Existing institutional arrangements need strengthening so that academic institutions, firms, and government agencies have the means and the incentive to develop more innovative, safer, and more appropriate medical technology. Limiting the number of players conducting scientific research only heightens the inherent risks posed by our reliance on imperfect human institutions. This strategy is akin to placing all our technological eggs into one small and fragile basket. Back to top Article Information Correspondence: Dr Lakdawalla, Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, University Park Campus, UGW-Unit A, Los Angeles, CA 90089-7273 (dlakdawa@healthpolicy.usc.edu). Conflict of Interest Disclosures: Dr Huesch has consulted for Precision Health Economics. Dr Lakdawalla is a founding partner and managing director of Precision Health Economics, which consults to firms in the life sciences industry, including Bristol-Myers Squibb. References 1. Prasad V, Rho J, Cifu A. The diagnosis and treatment of pulmonary embolism: a metaphor for medicine in the evidence-based medicine era. Arch Intern Med. 2012;172(12):955-95822473672PubMedGoogle Scholar 2. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008;359(17):1757-176518946061PubMedGoogle ScholarCrossref 3. Schneeweiss S, Seeger JD, Landon J, Walker AM. Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med. 2008;358(8):771-78318287600PubMedGoogle ScholarCrossref 4. Prasad V, Cifu A, Ioannidis JP. Reversals of established medical practices: evidence to abandon ship. JAMA. 2012;307(1):37-3822215160PubMedGoogle ScholarCrossref 5. Azoulay P, Graff Zivin JS, Manso G. Incentives and creativity: evidence from the academic life sciences. RAND J Econom. 2011;42:527-554Google ScholarCrossref

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Nov 26, 2012

Keywords: medical research

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