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Curbing Misconduct in the Pharmaceutical Industry: Insights from Behavioral Ethics and the Behavioral Approach to Law

Published online by Cambridge University Press:  01 January 2021

Yuval Feldman ,
Rebecca Gauthier  and
Troy Schuler
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Extract

To sell a new drug, pharmaceutical companies must discover a compound, run clinical trials to test its efficacy and safety, get it approved by regulatory bodies, produce the drug, and market it. As this process brings the drug through so many hands, there are risks of many kinds of corruption. The pharmaceutical industry has recently gone from being one of the most admired industries to being described by the majority of Americans as “dishonest, unethical, and more concerned with profits than with individual and public health.” Legal scholar Marc Rodwin suggested that the pharmaceutical industry can be viewed through the lens of institutional corruption as defined by legal scholar Lawrence Lessig, whereby widespread or systemic practices undermine the main purposes of drug therapy — healing illness, preventing medical problems, and alleviating suffering. Many drugs do serve these goals, yet a significant number of drugs churned out by pharmaceutical companies are ineffective or have dangerous side effects that could have been predicted had the companies conducted the appropriate research.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 41 , Issue 3 , Fall 2013 , pp. 620 - 628
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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References

Miller, J., “On Restoring Trust and Ethics in Pharma,” available at <http://www.ethics.harvard.edu/lab/blog/274-on-restoring-trust-and-ethics-in-pharma#_edn1> (last visited June 10, 2013).+(last+visited+June+10,+2013).>Google Scholar
Rodwin, M. A., “Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform,” Journal of Law, Medicine & Ethics 40, no. 3 (2012): 511–522. See, also, Rodwin, M., “Five Un-Easy Pieces to Pharmaceutical Policy Reform,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 581–589.CrossRefGoogle Scholar
Id.Google Scholar
See, for example, Gagnon, M.-A., “Corruption of Pharmaceutical Markets: Addressing the Misalignment between Financial Incentives and Public Health,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 571–580.CrossRefGoogle Scholar
For a classical discussion of the effect of being part of the group on accounting for negative consequences of a behavior, see Mynatt, C. Sherman, S. J., “Responsibility Attribution in Groups and Individuals,” Journal of Personality and Social Psychology 32, no. 6 (1975): 1111–1118.CrossRefGoogle Scholar
Bazerman, M. Tenbrunsel, A., Blind Spots: Why We Fail to Do What's Right and What to Do about It (Princeton University Press, 2011): at 153–173; Bazerman, M. Mahzarin, B. “The Social Psychology of Ordinary Ethical Failures,” Social Justice Research 17, no. 2 (2004): 111–115.CrossRefGoogle Scholar
Feldman, Y. Lobel, O., “The Incentives Matrix: The Comparative Effectiveness of Rewards, Liabilities, Duties, and Protections for Reporting Illegality,” Texas Law Review 88, no. 6 (2010): 1151–1211.Google Scholar
These measures included the Hamilton rating scale for depression, the K-SADL depression scale, the Mean Clinical Global Improvement Score, the Autonomous function check list, a self-perception profile, a sickness impact scale, and a measure of relapse during maintenance. See Jureidini, J. N. McHenry, L. B. Mansfield, P. R., “Clinical Trials and Drug Promotion: Selective Reporting of Study 329,” International Journal of Risk and Safety in Medicine 20, no. 1 (2008): 73–81; Goldacre, B., Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Toronto: Signal, 2012): at 204.Google Scholar
Often times, meta-analyses of drugs are conducted as a mechanism to account for flaws within any one study. Unfortunately, these analyses are typically limited to published data, which often suffers its own selection bias. Though the effect of including unpublished trials varies from drug to drug, there's evidence that many drugs would be shown to have significantly less efficacy if unpublished data were included. Hart, B. Lundh, A. Bero, L., “Effect of Reporting Bias on Meta-Analyses of Drug Trials: Reanalysis of Meta-Analyses,” BMJ 344, no. 7838 (2012): 1–11.CrossRefGoogle Scholar
Id., at 184. See also, Abramson, J., Overdo$ed America: The Broken Promise of American Medicine (New York: Harper Perennial, 2004): at 31–33.Google Scholar
Id.Google Scholar
O'Leary, P., “Credible Deterrence: The Park Doctrine and the FDA in the 21st Century,” (forthcoming, Food and Drug Law Journal 68, no. 2). See, also, Gagnon, , supra note 4.Google Scholar
In reality, the company can often neutralize a penalty by paying managers a bonus to neutralize the fine.Google Scholar
Lam, A., “What Motivates Academic Scientists to Engage in Research Commercialization: ‘Gold’, ‘Ribbon’ or ‘Puzzle’?” Research Policy 40, no. 10 (2011): 1354–1368.CrossRefGoogle Scholar
Id; Göktepe-Hulten, D. Mahagaonkar, P., “Inventing and Patenting Activities of Scientists: In the Expectation of Money or Reputation?” Journal of Technology Transfer 35, no. 4 (2010): 401–423; Fini, R. Grimaldi, R. Sobrero, M., “Factors Fostering Academics to Start Up New Ventures: An Assessment of Italian Founders' Incentives,” Journal of Technology Transfer 34, no. 4 (2009): 380–402; Baldini, N. Grimaldi, R. Sobrero, M., “To Patent or Not to Patent? A Survey of Italian Inventors on Motivations, Incentives, and Obstacles to University Patenting,” Scientometrics 70, no. 2 (2007): 333–354.CrossRefGoogle Scholar
Indeed, this intuition seems to exist in other areas of the law. Within securities litigation, the Supreme Court recently decided in Janus Capital Group Inc. v. First Derivative Traders, that a 10b-5 suit for fraud relating to securities could not be brought against an individual for “making a statement” unless they had final authority over that statement. Janus Capital Group Inc. v. First Derivative Traders, 131 S. Ct. 2296 (2011).Google Scholar
Kahneman, D., Thinking, Fast and Slow (New York: Farrar, Straus and Giroux, 2011): at 20–21; Stanovich, K. West, R., “Individual Differences in Reasoning: Implications for the Rationality Debate?” Behavioral and Brain Sciences 23, no. 5 (2000): 645–665; JSBT Evans, “In Two Minds: Dual-Process Accounts of Reasoning,” Trends in Cognitive Sciences 7, no. 10 (2003): 454–459.Google Scholar
Haidt, J., “The Emotional Dog and Its Rational Tail: A Social Intuitionist Approach to Moral Judgment,” Psychological Review 108, no. 4 (2001): 814–834; Haidt, J. Joseph, C., “Intuitive Ethics: How Innately Prepared Intuitions Generate Culturally Variable Virtues,” Daedalus 133, no. 4 (2004): 55–66.Google Scholar
Langevoort, D., “Resetting the Corporate Thermostat: Lessons from the Recent Financial Scandals about Self-Deception, Deceiving Others and the Design of Internal Controls,” Georgetown Law Journal 93, no. 1 (2004): 285–317; Greenfield, K., “Using Behavioral Economics to Show the Power and Efficiency of Corporate Law as Regulatory Tool,” UC Davis Law Review 35, no. 3 (2001): 581–644; Sah, S. Fugh-Berman, A., “Physicians Under the Influence: Social Psychology and Industry Marketing Strategies,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 665–672.Google Scholar
Kunda, Z., “Motivated Inference: Self-Serving Generation and Evaluation of Causal Theories,” Journal of Personality and Social Psychology 53, no. 4 (1987): 636–647; Kunda, Z., “The Case for Motivated Reasoning,” Psychological Bulletin 108, no. 3 (1990): 480–498.Google Scholar
Shu, L. L. Gino, F., “Sweeping Dishonesty under the Rug: How Unethical Actions Lead to Forgetting of Moral Rules,” Journal of Personal Social Psychology 102, no. 6 (2012): 1164–1177; Balcetis, E. Dunning, D., “See What You Want to See: Motivational Influences on Visual Perception,” Journal of Personality and Social Psychology 91, no. 4 (2006): 612–625.CrossRefGoogle Scholar
Bandura, A., “Moral Disengagement in the Perpetration of Inhumanities,” Personality and Social Psychology Review 3, no. 3 (1999): 193–209; Moore, C. et al., “Why Employees Do Bad Things: Moral Disengagement and Unethical Organizational Behavior,” Personnel Psychology 65, no. 1 (2012): 1–48.Google Scholar
Mazar, N. Amir, O. Ariely, D., “The Dishonesty of Honest People: A Theory of Self-Concept Maintenance,” Journal of Marketing Research 45, no. 6 (2008): 633–644; Ariely, D., The Honest Truth about Dishonesty: How We Lie to Everyone – Especially Ourselves (New York: Harper, 2012).Google Scholar
For a recent account of the various sanction-based mechanisms that could be used against misconducts in the pharmaceutical industry, please see O'Leary, , supra note 12.Google Scholar
Gneezy, U. Rustichini, A., “Fine Is a Price,” Journal of Legal Studies 29, no. 1 (2000): 1–28.CrossRefGoogle Scholar
Tenbrunsel, A. Messick, D., “Sanctioning Systems, Decision Frames, and Cooperation,” Administrative Science Quarterly 44, no. 4 (1999): 684–707. Follow up works by Feldman, et al. have shown that this effect is more nuanced for legal fines depending on the timing of the payment (before or after violation), the recipient of the payment (direct compensation to the person being harmed versus a payment to a third party (e.g., state). Additionally, payments proffered for performing good actions can elicit a moral frame while payments for immoral actions trigger a business frame. See Feldman, Lobel, , supra note 7; Feldman, Y. Teichman, D., “Are All Legal Dollars Created Equal,” Northwestern University Law Review 102, no. 1 (2008): 223–262; Feldman, Y. Perez, O., “How Law Changes the Environmental Mind: An Experimental Study of the Effect of Legal Norms on Moral Perceptions and Civic Enforcement,” Journal of Law and Society 36, no. 4 (2009): 501–535; Feldman, Y. Perez, O., “Motivating Environmental Action in a Pluralistic Regulatory Environment: An Experimental Study of Framing, Crowding Out, and Institutional Effects in the Context of Recycling Policies,” Law & Society Review 46, no. 2 (2012): 405–442.Google Scholar
Kouchaki, M. et al., “Seeing Green: Mere Exposure to Money Triggers a Business Decision Frame and Unethical Outcomes,” Organizational Behavior and Human Decision Processes 121, no. 1 (2013): 53–61.CrossRefGoogle Scholar
Fehr, E. Gächter, S., “Do Incentive Contracts Crowd Out Voluntary Cooperation?” Institute for Empirical Research in Economics University of Zurich, working paper no. 34 (2001): 1–46.CrossRefGoogle Scholar
Lessig, L., Republic, Lost: How Money Corrupts Congress – and a Plan to Stop It (New York: Twelve, 2011); Vohs, K. Mead, N. Goode, M., “The Psychological Consequences of Money,” Science 314, no. 5802 (2006): 1154–1156; Vohs, K. Mead, N. Goode, M., “Merely Activating the Concept of Money Changes Personal and Interpersonal Behavior,” Current Directions in Psychological Science 17, no. 3 (2008): 208–212.Google Scholar
See Feldman, Y., “The Complexity of Disentangling Intrinsic and Extrinsic Compliance Motivations: Theoretical and Empirical Insights from the Behavioral Analysis of Law,” Washington University Journal of Law and Policy 35, no. 1 (2011): 11–51.Google Scholar
Bazerman, M. Loewenstein, G. Moore, D. A., “Why Good Accountants Do Bad Audits,” Harvard Business Review 80, no. 11 (2002): 96–103; Rodwin, M. A., “Independent Clinical Trials to Test Drugs: The Neglected Reform,” Saint Louis University Journal of Health Law & Policy 6, no. 1 (2012): 113–166; also see Brown, A., “Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 611–619.Google Scholar
Rodwin, M. A., “Independent Clinical Trials to Test Drugs: The Neglected Reform,” Saint Louis University Journal of Health Law & Policy 6 (2012): 113–166.Google Scholar
See Bazerman, Tenbrunsel, , supra note 6.Google Scholar
It should be noted, however, that other research finds that requiring some disclosures ahead of time may actually serve to encourage unethical behavior later on. Cain, D. M. Loewenstein, G. Moore, D. A., “The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest,” Journal of Legal Studies 34, no. 1 (2005): 1–25.CrossRefGoogle Scholar
Pharmaceutical Research and Manufacturers of America, Principles on Conduct of Clinical Trials Communication of Clinical Trial Results (2011).Google Scholar
See Brown, A., “Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 611–619.CrossRefGoogle Scholar
See Kunda, , supra note 20.Google Scholar
One problem that will need to be addressed is how to guarantee that these review boards are, in fact, independent, as opposed to falling prey to the same implicit biases and motivations as researchers.Google Scholar
Bard, J., “What to Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for Medical Researchers,” Indiana Health Law Review 9, no. 1 (2011): 1–96.Google Scholar
Even in the case of outside auditors, behavioral biases from familiarity over time with the client as well as wanting the client to continue to hire you lead good accountants to perform bad audits. See Brown, , supra note 36.Google Scholar
See Feldman, Lobel, , supra note 7; Ashforth, B. Anand, V., “The Normalization of Corruption in Organizations,” Research in Organizational Behavior 25, no. 1 (2003): 1–52.Google Scholar
See Feldman, Lobel, , supra note 7.Google Scholar
See Bard, , supra note 39.Google Scholar
Compare this with Cain, et al., supra note 34. For additional discussions of the limitations of transparency and disclosures, see in this issue of the Journal of Law, Medicine & Ethics 41, no. 3 (2013): Cosgrove, L. Wheeler, E. E., “Drug Firms, the Codification of Diagnostic Categories, and Bias in Clinical Guidelines,” at 644–653, and Sismondo, S., “Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light On,” at 635–643.Google Scholar