667597 INQXXX10.1177/0046958016667597INQUIRY: The Journal of Health Care Organization, Provision, and FinancingPatwardhan
`
`research-article2016
`
`Commentary
`
`Physicians-Pharmaceutical Sales
`Representatives Interactions and Conflict
`of Interest: Challenges and Solutions
`
`INQUIRY: The Journal of Health Care
`Organization, Provision, and Financing
` Volume 53: 1 –5
`© The Author(s) 2016
`Reprints and permissions:
`sagepub.com/journalsPermissions.nav
`DOI: 10.1177/0046958016667597
`inq.sagepub.com
`
`Avinash R. Patwardhan, MD1
`
`Abstract
`Physician-industry relationships have come a long way since serious debates began after a 1990 Senate Committee on Labor
`and Human Resources report on the topic. On one side, the Sun Shine Act of 2007, now a part of the Patient Protection
`and Affordable Care Act that mandates disclosure of payments and gifts to the physicians, has injected more transparency
`into the relationships, and on the other side, numerous voluntary self-regulation guidelines have been instituted to protect
`patients. However, despite these commendable efforts, problem persists. Taking the specific case of physician-pharmaceutical
`sales representative (PSR) interactions, also called as detailing, where the PSRs lobby physicians to prescribe their brand
`drugs while bringing them gifts on the side, an August 2016 article concluded that gifts as small as $20 are associated with
`higher prescribing rates. A close examination reveals the intricacies of the relationships. Though PSRs ultimately want to
`push their drugs, more than gifts, they also bring the ready-made synthesized knowledge about the drugs, something the busy
`physicians, starving for time to read the literature themselves, find hard to let go. Conscientious physicians are not unaware
`of the marketing tactics. And yet, physicians too are humans. It is also the nature of their job that requires an innate cognitive
`dissonance to be functional in medical practice, a trait that sometimes works against them in case of PSR interactions. Besides,
`PSRs too follow the dictates of the shareholders of their companies. Therefore, if they try to influence physicians using social
`psychology, it is a job they are asked to do. The complexity of relationships creates conundrums that are hard to tackle. This
`commentary examines various dimensions of these relationships. In the end, a few suggestions are offered as a way forward.
`
`Keywords
`pharmaceutical sales representative, conflict of interest, gifts to physicians, physician-industry relationships, medical ethics,
`brand prescriptions, detailing, sun shine act, learned intermediary doctrine, independent physician heuristic
`
`Introduction
`Trust is considered to be a key component or a cornerstone
`while discussing provider-patient relationship.1-4 Medical
`ethics is an imperative in the practice of health care for incul-
`cating professionalism and building trust.5 However, provid-
`ers being humans first, their vulnerability to conflict of
`interest is well documented in ancient6-8 as well as modern
`history.9
`Drugs make a big part of modern therapeutics. Furthermore,
`drugs have become expensive and pharmaceutical companies
`stand to gain a lot if more of their brand drugs are sold. For
`most part, physicians are the agents who write prescriptions.
`Therefore, it serves pharmaceutical industry to persuade phy-
`sicians to prescribe their brand drugs preferentially and in
`high volumes. One of the ways in which industry accom-
`plishes this objective is via one-on-one marketing in the form
`of physician-pharmaceutical sales representative (PSR) inter-
`actions, also called as detailing. In detailing, PSRs try to con-
`vince the physicians how their company products are the best
`
`and need to be prescribed, although marketing their brand is
`not the sole objective or purpose of detailing. It is also meant
`to provide busy physicians up-to-date information about the
`pros and cons of using the promoted drugs and to keep them
`abreast with the cutting-edge advances in the field in general.
`The borderline between genuine recommendation and profit-
`oriented persuasion is thin. Using smart marketing strategies
`and tactics such as offering gifts, friendship, and flattery,
`PSRs can influence physicians to prescribe their brand drugs
`in excess. While legitimate prescriptions are necessary and
`help patients, the profit incentives create an opportunity for
`
`1George Mason University, Fairfax, VA, USA
`
`Received 14 August 2016; revised manuscript accepted 14 August 2016
`
`Corresponding Author:
`Avinash R. Patwardhan, Department of Global and Community Health,
`George Mason University, 4400 University Drive, Fairfax, VA 22030, USA.
`Email: apatward@gmu.edu
`
`Creative Commons Non Commercial CC-BY-NC: This article is distributed under the terms of the Creative Commons
`Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial
`use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and
`Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
`
`Page 1 of 5
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1619
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`

`

`667597 INQXXX10.1177/0046958016667597INQUIRY: The Journal of Health Care Organization, Provision, and FinancingPatwardhan
`
`research-article2016
`
`Commentary
`
`Physicians-Pharmaceutical Sales
`Representatives Interactions and Conflict
`of Interest: Challenges and Solutions
`
`INQUIRY: The Journal of Health Care
`Organization, Provision, and Financing
` Volume 53: 1 –5
`© The Author(s) 2016
`Reprints and permissions:
`sagepub.com/journalsPermissions.nav
`DOI: 10.1177/0046958016667597
`inq.sagepub.com
`
`Avinash R. Patwardhan, MD1
`
`Abstract
`Physician-industry relationships have come a long way since serious debates began after a 1990 Senate Committee on Labor
`and Human Resources report on the topic. On one side, the Sun Shine Act of 2007, now a part of the Patient Protection
`and Affordable Care Act that mandates disclosure of payments and gifts to the physicians, has injected more transparency
`into the relationships, and on the other side, numerous voluntary self-regulation guidelines have been instituted to protect
`patients. However, despite these commendable efforts, problem persists. Taking the specific case of physician-pharmaceutical
`sales representative (PSR) interactions, also called as detailing, where the PSRs lobby physicians to prescribe their brand
`drugs while bringing them gifts on the side, an August 2016 article concluded that gifts as small as $20 are associated with
`higher prescribing rates. A close examination reveals the intricacies of the relationships. Though PSRs ultimately want to
`push their drugs, more than gifts, they also bring the ready-made synthesized knowledge about the drugs, something the busy
`physicians, starving for time to read the literature themselves, find hard to let go. Conscientious physicians are not unaware
`of the marketing tactics. And yet, physicians too are humans. It is also the nature of their job that requires an innate cognitive
`dissonance to be functional in medical practice, a trait that sometimes works against them in case of PSR interactions. Besides,
`PSRs too follow the dictates of the shareholders of their companies. Therefore, if they try to influence physicians using social
`psychology, it is a job they are asked to do. The complexity of relationships creates conundrums that are hard to tackle. This
`commentary examines various dimensions of these relationships. In the end, a few suggestions are offered as a way forward.
`
`Keywords
`pharmaceutical sales representative, conflict of interest, gifts to physicians, physician-industry relationships, medical ethics,
`brand prescriptions, detailing, sun shine act, learned intermediary doctrine, independent physician heuristic
`
`Introduction
`Trust is considered to be a key component or a cornerstone
`while discussing provider-patient relationship.1-4 Medical
`ethics is an imperative in the practice of health care for incul-
`cating professionalism and building trust.5 However, provid-
`ers being humans first, their vulnerability to conflict of
`interest is well documented in ancient6-8 as well as modern
`history.9
`Drugs make a big part of modern therapeutics. Furthermore,
`drugs have become expensive and pharmaceutical companies
`stand to gain a lot if more of their brand drugs are sold. For
`most part, physicians are the agents who write prescriptions.
`Therefore, it serves pharmaceutical industry to persuade phy-
`sicians to prescribe their brand drugs preferentially and in
`high volumes. One of the ways in which industry accom-
`plishes this objective is via one-on-one marketing in the form
`of physician-pharmaceutical sales representative (PSR) inter-
`actions, also called as detailing. In detailing, PSRs try to con-
`vince the physicians how their company products are the best
`
`and need to be prescribed, although marketing their brand is
`not the sole objective or purpose of detailing. It is also meant
`to provide busy physicians up-to-date information about the
`pros and cons of using the promoted drugs and to keep them
`abreast with the cutting-edge advances in the field in general.
`The borderline between genuine recommendation and profit-
`oriented persuasion is thin. Using smart marketing strategies
`and tactics such as offering gifts, friendship, and flattery,
`PSRs can influence physicians to prescribe their brand drugs
`in excess. While legitimate prescriptions are necessary and
`help patients, the profit incentives create an opportunity for
`
`1George Mason University, Fairfax, VA, USA
`
`Received 14 August 2016; revised manuscript accepted 14 August 2016
`
`Corresponding Author:
`Avinash R. Patwardhan, Department of Global and Community Health,
`George Mason University, 4400 University Drive, Fairfax, VA 22030, USA.
`Email: apatward@gmu.edu
`
`Creative Commons Non Commercial CC-BY-NC: This article is distributed under the terms of the Creative Commons
`Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial
`use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and
`Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
`
`Page 1 of 5
`
`

`

`2
`
`INQUIRY
`
`misuse and conflict of interest leading to violation of medical
`ethics on the part of the physicians.
`Lately, physician-pharmaceutical industry relationships
`have come under great scrutiny. While the old reasons for
`concern such as increased vulnerability to side effects and
`potential for being subjected to unnecessary ineffective treat-
`ment are still valid, what appears to be strongly driving the
`recent enhanced interest in the topic are the economic fac-
`tors. In 2012 alone, pharmaceutical industry spent $89.5 bil-
`lion on detailing, accounting for 60% of the global sales and
`marketing spending.10 It is known that the brand prescrip-
`tions add to the cost of care, mostly at no added value.11
`When the increasing health care cost is becoming a global
`concern,12 it is natural that the stakeholders would scrutinize
`physician-industry relationships related to excessive pre-
`scribing. Another cost-related factor could be an increase in
`the litigations due to adverse drug events following an
`increase in the brand or off label prescriptions. For example,
`between 2009 and 2010, 8 cases involving issues of drug
`safety were settled for $8.6 billion.13
`Following excesses in prescribing in 1980s, a report of the
`1990 Senate Committee on Labor and Human Resources set
`forth the discussions, debates, and actions on this issue.14
`However, as Mulinari says, there also appears to be cyclical-
`ity in the phenomenon.15 For example, in 2003, Katz et al
`mentioned that gifts of negligible value can influence the
`behavior of the recipient.14 Almost 13 years later, the same
`sentiment is echoed in an August 2016 article.16 In 2016
`alone, there is a volley of articles on the topic of industry-
`sponsored gifts/payments and their impact on the prescribing
`patterns of the physicians, bringing perspectives from diverse
`fields such as public health, epidemiology, health policy,
`regulation, law, and from diverse geographies like Ethiopia
`and Pakistan.15-24
`As a caveat, it is noted here that other health professionals
`such as doctors of pharmacy, physician assistants, and nurse
`practitioners also carry prescribing authority. Although 2
`publications from 2016, included in the citations, address the
`issues related to nonphysicians, data about them are cur-
`rently inadequate. Therefore, for the sake of convenience,
`the article has used the word physician(s) throughout the nar-
`rative as the representative of the health professionals with
`prescribing authority. Similarly, though the physician-indus-
`try relationships are spread over diverse domains of activi-
`ties ranging from big research projects involving a lot of
`money to small face-to-face interactions between an indi-
`vidual physician and a PSR, involving small token gifts such
`as sponsoring of meals, again for the sake of convenience
`and focus, the latter is treated as the topic of discussion.
`Attempts have been made to mitigate this challenge using
`different approaches. Numerous self-regulatory initiatives
`such as American Medical Association (1990) guidelines for
`gifts to physicians from industry, or “Pharmaceutical
`Research & Manufacturers of America” (2002) guidelines
`for ethical conduct of sales representatives have been
`
`instituted.25 Academic Medical Centers are increasingly
`restricting PSR access to their physicians.10,26 On the legal
`front, between 1993 and 2005, several US states adapted
`laws for transparency and disclosure of industry payments
`to physicians.27 In addition, the 2007 Sunshine Act that
`required pharmaceutical and medical device makers to col-
`lect, track, and report financial relationships with physicians
`and teaching hospitals is now a part of the 2010 Patient
`Protection and Affordable Care Act in the United States.15
`Furthermore, US Food and Drug Administration keeps a
`watch on the conduct of the industry using whistle-blower
`incentives.28 Europe, Canada, and Australia have been
`equally engaged in addressing this issue, and in those coun-
`tries equivalent self-regulatory and legislative regulatory
`checks and balances are in place.15 In emerging economies
`like India and China, however, the landscape appears to be
`murky.29
`What stands out in this, about quarter of a century-long
`story regarding the conflict of interest generated by physi-
`cian-industry financial relationships and the attempts to
`mitigate it, is that the problem still persists. Despite efforts
`to dissuade or restrict physician-PSR encounters that are
`accompanied by gifts to physicians, data show that these
`interactions are known. A study based on 2013 Medicare
`data found that 2% to 12% physicians received payments in
`the form of sponsored meals related to promotion of the
`target drugs.16 Two studies in Germany that sampled differ-
`ent groups of physicians in 2010 showed that 77% to 84%
`of the physicians saw PSRs at least once a week and they
`accepted gifts.30,31
`The physician-industry relationships, even if laden with
`the conflict of interest, cannot be simply wished away. There
`are arguments that these interactions add value and are good
`for the patients.32,33 Moreover, the law itself cannot eliminate
`physician-industry relationships due to the first amendment
`issue of freedom of commercial speech.22 In the current sce-
`nario, small gifts to physicians are allowed. One may think
`that reducing the limit on the gift amount still further might
`work, and there have been proposals for a total ban on the
`gifts.25,26,34 However, the issue appears to be nuanced.
`Though very small amounts of gift can sway the prescriber
`patterns of practice,14,16 it is not clear where the de minimis
`is or whether a total ban will work at all.14
`The question is what more can be done? Is there a defini-
`tive doable solution? The best way forward might be to
`understand the perceptions, attitudes, and environments of
`the prescribers and the marketing strategies of the PSRs. In
`addition, the circumstances that create catch-22 situations
`will need a close examination. It is also important to become
`aware of the rapidly changing landscape of medical science
`and technology and that of the drug discovery. Without
`knowing these, optimum viable solutions might prove elu-
`sive. The article will take a high-level overview of these top-
`ics and then conclude by offering a few comments on the
`future directions.
`
`Page 2 of 5
`
`

`

`Patwardhan
`
`3
`
`Prescribing Physicians: Perceptions and
`Attitudes
`Studies related to the perception and attitudes of the physi-
`cians show that mostly physicians deny that they get influ-
`enced by the promotional pitches of the PSRs,32,35,36 although
`there is evidence that physicians admit that they get influ-
`enced.21,31 Paradoxically, many physicians believe that their
`peers get influenced by the marketing though they them-
`selves are immune to it.30,37 Notwithstanding, studies have
`shown that many physicians are unable to discern between
`promotional evidence and scientific evidence.38,39 Social
`psychology theories have tried to explain this phenome-
`non.33 Sah and Fugh-Berman have nicely elucidated how
`physicians easily believe biased information and suffer from
`cognitive dissonance, self-serving biases, and a sense of
`entitlement.40
`
`PSRs Use Social Psychology Techniques
`in Their Marketing Strategies
`Behind a PSR trying to influence a physician’s prescribing
`pattern stands a huge industry that he or she serves and rep-
`resents. Complex analyses and planning in the backend pre-
`cede the PSR-physician meetings. These include details such
`as the expected role practice, physician’s broad background,
`or time management.10 During the meetings, PSRs usually
`resorts to adaptive selling behavior and alter and adjust the
`sales behaviors based on the perceived nature of the situa-
`tion.41 Principles of reciprocation, commitment, social proof,
`liking, authority, and scarcity, as delineated in social and psy-
`chological sciences, are routinely used by the PSRs to influ-
`ence the minds of physicians at subconscious level.40,42,43
`Fugh-Berman and Ahari in their article conclude that “physi-
`cians are susceptible to influence because they are over-
`worked, overwhelmed . . . and feel underappreciated . . .
`bearing food and gifts, drug reps provide respite and sympa-
`thy . . .”37 Katz et al remark that food flattery and friendship
`are powerful tools of persuasion, more so when they are
`combined.14 However, providing respite and sympathy is
`only half of the job. Studies show that PSRs downplay the
`information about safety and side effects and exaggerate
`benefits regarding their products.43,44 The 2-pronged strategy
`brings about the desired effects.
`
`Paradoxes and Dilemmas
`Physicians and Cognitive Dissonance
`On a closer look, it appears that cognitive dissonance is a
`necessary, inevitable, and unavoidable part of a physician’s
`persona. Absence of cognitive dissonance can overwhelm a
`physician and make the practice of clinical medicine impos-
`sible. Probably in recognition of this paradoxical anomaly,
`courts have consistently applied the “learned intermediary
`
`doctrine” and used the “independent physician heuristic” in
`the trials involving pharmaceutical litigations.45 Therefore,
`education and awareness can assuage the problem, but a resi-
`due of dissonance will always remain.
`
`Pharmaceutical Sales Representatives
`It is impossible to totally delegitimize the profit-driven
`business strategies, tactics, and maneuvering of the phar-
`maceutical industries unless the government owns the
`industries. Such a socialistic solution is a far cry, but the
`argument elucidates the daunting nature of the challenge of
`regulating the pharmaceutical marketing. If the industry
`uses social psychology to manipulate physicians, then that
`is what its shareholders’ dictated job is. Managers are paid
`to think creatively to increase business.10 It is conceivable
`that if a zero-dollar limit on the gifts is imposed,26 the
`industry might start offering goodwill gesture free services
`instead to the physicians in their daily personal lives. As
`Katz et al wistfully suggest, industry will find out a way to
`go around the law.14
`
`Changing Landscape of Pharmaceutical and
`Health care Field
`Discussions about the conflict of interest concerning pre-
`scribers do not highlight adequately the dramatic changes in
`the field of health sciences and technologies. The days of
`blockbuster drugs are over.46 Specialty drugs and personal-
`ized medicine domains are already highly monitored and
`regulated. One wonders if the current topic might lose rele-
`vance in 25 years in the futuristic world of telemedicine and
`medical robotics.
`
`Future Directions
`It seems that it is practically impossible to eliminate alto-
`gether the conflict of interest in health care. It is also uncer-
`tain if public disclosure of physician-industry relationships
`data in itself will make a major difference in the outcomes,
`though morally it is the right thing to do. It is suggested that
`more attention should be given to understanding those prob-
`lems of the physicians where PSRs are adding value, albeit in
`exchange of favors. Probably the mid-career physicians suf-
`fer the most. They are in scarcity of ready-made up-to-date
`current usable information. They are neither fresh from the
`academy to know it all, nor well settled in practice yet to
`afford the luxury of time to acquire knowledge on their own.
`A popular article calls doctors as cheap dates for the industry
`because they get influenced with even small gifts.47 Reality
`might be subtler. The castigated gift might be the face of the
`currently undetected issues that bother physicians. While
`the other measures might be pursued enthusiastically, the
`best approach today seems to be, as Grande suggests, having
`
`Page 3 of 5
`
`

`

`4
`
`INQUIRY
`
`public-funded academic detailing programs to replace indus-
`try-driven detailing.25
`
`Acknowledgments
`I wish to thank Swati Patwardhan, my wife, for serving as a sound-
`ing board, a reviewer, and a proofreader throughout the develop-
`ment of this article. The research presented in this article is that of
`the author and does not reflect the official position or policy of his
`employer.
`
`Declaration of Conflicting Interests
`The author(s) declared no potential conflicts of interest with respect
`to the research, authorship, and/or publication of this article.
`
`Funding
`The author(s) received no financial support for the research, author-
`ship, and/or publication of this article.
`
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