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Dispatch from the Pharmasphere: An Industry’s Fault Lines on Display

2008; Elsevier BV; Volume: 51; Issue: 2 Linguagem: Inglês

10.1016/j.annemergmed.2007.12.009

1097-6760

William B. Millard,

Healthcare cost, quality, practices

Global pharmaceutical companies—and not just their marketing divisions—know about individual physicians in immense detail. What do physicians know about them?Coloring Inside the Shifting LinesThe term compliance in these circles carries a specialized meaning. It refers not to a patient’s observance of a physician’s directives but to a company’s obedience to federal anti-kickback and False Claim Act (FCA) laws, assorted state laws, and Food and Drug Administration (FDA) regulations.Other sets of rules, including the Compliance Program for Pharmaceutical Manufacturers of the Department of Health and Human Services’ Office of the Inspector General (OIG), the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, and the Accreditation Council for Continuing Medical Education (ACCME) standards, do not have the force of law but are increasingly interpreted as setting minimum standards of conduct.For example, California and Nevada state laws, said Novartis Vaccines and Diagnostics’ vice president for ethics and compliance Ann Beasley Bacon, Esq., mandate the adoption of a compliance plan and incorporate the OIG’s Compliance Program. California has instituted an annual company-wide spending cap per health care provider, forcing companies to better understand the often siloed relations among their own different divisions and KOLs. Certain states add reporting laws and gift prohibitions to their own anti-kickback and false claim statutes; Minnesota, among the more stringent, bans giving any health care provider, from KOLs to veterinarians, items with a value over $50 per calendar year (meals included).Conference participants grumbled about how onerous documenting compliance has become with the patchwork of slightly different state laws, and particularly the incentives created by the FCA (the 1863 “Lincoln law” against knowingly defrauding the federal government, defanged in 1943 but reinvigorated in 1986 during a spate of particularly egregious defense contractor fraud).The FCA measures fines per claim—in the case of misleadingly submitted payment claims for off-label uses in government-insured patients, one claim per prescription—and thus creates a large enforcement incentive. Qui tam provisions also offer up to a 30% monetary incentive for whistleblowers. Dennis J. LaCroix, JD, senior counsel for compliance at Genzyme, called the FCA “the government as bully” and noted that each dollar the OIG invests in such proceedings returns an average of $10, but the detailed and vigorous discussion of precautions implies that he, Bacon, and their listeners regard legal risks to both firms and KOLs as matters of gravity. Along with fines and imprisonment, the “corporate death sentence”—exclusion from government programs—hovered around these discussions as a worst-case scenario.Distinctions between legal and illegal promotion are imprecise, often involving assessments of intent, and out-of-court resolutions like the Parke-Davis Neurontin case (settled in 2004 for $430 million and a guilty plea) keep the fine points from being tested and legally defined in court. The general principle that companies can be held liable for what KOLs do and say, however, is well established. Participating in a corporate speakers’ bureau can thus include extensive training about operating definitions of how FDA regulations might be applied.Presenters repeatedly emphasized advance documentation (“it’s not bureaucracy; it’s risk management,” said LaCroix) and orderly company-wide procedures, including objective, research-based determination of “fair market value” for compensation of speakers and consultants, a key variable in prosecutors’ assessment of the tricky borderline where the payment for KOLs’ services shades off into bribery. The government could conceivably set quantitative benchmarks for fair market value in KOL compensation, LaCroix commented—and noted that one obscure judicial footnote (citation not specified) actually does suggest a benchmark of $500 per hour, an item that he prays no one reads.Pharma officials at this conference appeared to be exerting enormous effort to understand the letter of the law, not to lobby for looser regulation. Conceivably, aggressive prosecution of illegal promotion and COI has left at least some corporate officials chastened and aware that Big Pharma needs to clean up its act, or at least burnish its reputation. Another implication of this discussion is that questionable promotional tactics are a subject of increasing conflict within firms, with medical affairs departments struggling to steer their marketing colleagues toward the high road. KOL contact is a high priority and an intracorporate political football.“I don’t want sales and marketing people around choosing KOLs,” said LaCroix. “If a salesman gives money to a KOL, it looks like a bribe, and it basically is. I want [KOL responsibility] in Medical Affairs.” The term compliance in these circles carries a specialized meaning. It refers not to a patient’s observance of a physician’s directives but to a company’s obedience to federal anti-kickback and False Claim Act (FCA) laws, assorted state laws, and Food and Drug Administration (FDA) regulations. Other sets of rules, including the Compliance Program for Pharmaceutical Manufacturers of the Department of Health and Human Services’ Office of the Inspector General (OIG), the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, and the Accreditation Council for Continuing Medical Education (ACCME) standards, do not have the force of law but are increasingly interpreted as setting minimum standards of conduct. For example, California and Nevada state laws, said Novartis Vaccines and Diagnostics’ vice president for ethics and compliance Ann Beasley Bacon, Esq., mandate the adoption of a compliance plan and incorporate the OIG’s Compliance Program. California has instituted an annual company-wide spending cap per health care provider, forcing companies to better understand the often siloed relations among their own different divisions and KOLs. Certain states add reporting laws and gift prohibitions to their own anti-kickback and false claim statutes; Minnesota, among the more stringent, bans giving any health care provider, from KOLs to veterinarians, items with a value over $50 per calendar year (meals included). Conference participants grumbled about how onerous documenting compliance has become with the patchwork of slightly different state laws, and particularly the incentives created by the FCA (the 1863 “Lincoln law” against knowingly defrauding the federal government, defanged in 1943 but reinvigorated in 1986 during a spate of particularly egregious defense contractor fraud). The FCA measures fines per claim—in the case of misleadingly submitted payment claims for off-label uses in government-insured patients, one claim per prescription—and thus creates a large enforcement incentive. Qui tam provisions also offer up to a 30% monetary incentive for whistleblowers. Dennis J. LaCroix, JD, senior counsel for compliance at Genzyme, called the FCA “the government as bully” and noted that each dollar the OIG invests in such proceedings returns an average of $10, but the detailed and vigorous discussion of precautions implies that he, Bacon, and their listeners regard legal risks to both firms and KOLs as matters of gravity. Along with fines and imprisonment, the “corporate death sentence”—exclusion from government programs—hovered around these discussions as a worst-case scenario. Distinctions between legal and illegal promotion are imprecise, often involving assessments of intent, and out-of-court resolutions like the Parke-Davis Neurontin case (settled in 2004 for $430 million and a guilty plea) keep the fine points from being tested and legally defined in court. The general principle that companies can be held liable for what KOLs do and say, however, is well established. Participating in a corporate speakers’ bureau can thus include extensive training about operating definitions of how FDA regulations might be applied. Presenters repeatedly emphasized advance documentation (“it’s not bureaucracy; it’s risk management,” said LaCroix) and orderly company-wide procedures, including objective, research-based determination of “fair market value” for compensation of speakers and consultants, a key variable in prosecutors’ assessment of the tricky borderline where the payment for KOLs’ services shades off into bribery. The government could conceivably set quantitative benchmarks for fair market value in KOL compensation, LaCroix commented—and noted that one obscure judicial footnote (citation not specified) actually does suggest a benchmark of $500 per hour, an item that he prays no one reads. Pharma officials at this conference appeared to be exerting enormous effort to understand the letter of the law, not to lobby for looser regulation. Conceivably, aggressive prosecution of illegal promotion and COI has left at least some corporate officials chastened and aware that Big Pharma needs to clean up its act, or at least burnish its reputation. Another implication of this discussion is that questionable promotional tactics are a subject of increasing conflict within firms, with medical affairs departments struggling to steer their marketing colleagues toward the high road. KOL contact is a high priority and an intracorporate political football. “I don’t want sales and marketing people around choosing KOLs,” said LaCroix. “If a salesman gives money to a KOL, it looks like a bribe, and it basically is. I want [KOL responsibility] in Medical Affairs.” Most practitioners are aware that drug firms monitor prescribing patterns and identify MDs with what they call a “heavy pen.” It is less widely known that the firms keep elaborate databases on the careers of established thought leaders, sorting out the “Big Kahunas” and impressive young “up-and-comers” with promising research publications from the information “hoarders,” who are ranked high in scientific knowledge but low in “industry affinity” and “intention to communicate” and are thus not primary targets for commercial communiqués. A distinct subsidiary industry has arisen in the past decade to help pharma companies’ medical science liaisons (MSLs, in industry parlance) improve their communications with key opinion leaders (KOLs), applying social network theory, influence-mapping software, and quantitative metrics for the many variables involved in “cross-functional KOL relationship management.” The acronyms, euphemisms, and corporate buzzwords flew thick and fast at the recent two-day conference “Defining Appropriate and Effective Interactions with Thought Leaders and Key Opinion Leaders (KOLs)” in Tyson’s Corner, VA, sponsored by the Center for Business Intelligence, an organization specializing in such corporate retreats. But the event’s final presentation, by Anton Ehrhardt, Ph.D., senior medical director for the global medical affairs division of Millennium Pharmaceuticals, cut directly to the chase. In refreshingly frank terms, Ehrhardt acknowledged the reasons KOLs are of such interest to the corporate world. The “dirty little secret” in this field, he said, is that people working in pharma view the KOLs as sales agents, and pharma-friendly KOLs in turn view these companies as “The Bank.” As Ehrhardt described this reductionist (and, in his opinion, regrettable) quid pro quo, one of his slides simply showed the acronym “KOL” in large-font type atop stacks of cash. Ehrhardt’s message to his colleagues indicates a philosophical gap between the marketing and medical branches of pharma companies, an institutional schizophrenia that affects the increasingly complex balance between business and medical decisionmaking. Marketing personnel want a KOL to promote their product to peers—particularly for lucrative off-label uses that the detailers cannot legally discuss—but a physician or researcher attains KOL status through expertise and credibility, not advocacy. A firm’s MSLs take pains to distinguish themselves from the sales force and frequently find themselves at odds with it. (In a later informal conversation, Ehrhardt recalled an incident where marketing department personnel tried to edit one of his reports to weed out findings not favorable to a product, along with his emphatic response: “Bite me. It’s the data.”) The entire American medical industrial complex has been publicly pummeled by recent reflections on paradoxes, inequities, and conflicts of interest (COI) in medical economics. Examples ranging from the research literature to the lay media include publications by Henry Stelfox, MD, and colleagues,1Stelfox H.T. Chua G. O’Rourke K. et al.Conflict of interest in the debate over calcium-channel antagonists.N Engl J Med. 1998; 338: 101-106Crossref PubMed Scopus (512) Google Scholar Jerome Kassirer, MD,2Kassirer J.P. On the Take: How America’s Complicity with Big Business Can Endanger Your Health. Oxford University Press, NY2004Google Scholar Jerome Groopman, MD,3Groopman J.E. How Doctors Think. Houghton Mifflin, Boston and NY2007Google Scholar Atul Gawande, MD,4Gawande A. Piece work: medicine’s money problem.in: New Yorker. 2005: 1-5Google Scholar Bernard Lo, MD,5Lo B. Wolf L.E. Berkeley A. Conflict-of-interest policies for investigators in clinical trials.N Engl J Med. 2000; 343: 1616-1620Crossref PubMed Scopus (185) Google Scholar Marcia Angell, MD,6Angell M. The Truth about the Drug Companies: How They Deceive Us and What to Do about It. Random House, NY2004Google Scholar Jerry Avorn, MD,7Avorn J. Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. Knopf, NY2004Google Scholar and Carl Elliott.8Elliott C. The drug pushers.in: Atlantic Monthly. 2006: 82-93Google Scholar Of all components of that complex, the pharma industry has arguably sustained (or, critics hold, self-inflicted) the worst damage to its ethical reputation. Conventional “detailing,” the process by which drug salespeople promote their newest, most expensive drugs to doctors in one-on-one meetings, and high-pressure sales techniques have elicited resistance from many physicians (and a growing number of institutions9Millard W.B. Docking the tail that wags the dog: banning drug reps from academic medical facilities.Ann Emerg Med. 2007; 49: 785-791Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar). It has made the MSL-KOL connection an increasingly important component of pharma’s external relations strategy. According to R. Michael Broad, PhD, medical director of KOL-profiling software vendor OpenQ, Inc., opinion leader programs now involve roughly one-third of the “total marketing spend” on a drug. Viewed with maximum skepticism, these communications are simply sales pitches on a higher level of scientific discourse, insidiously placing physicians on a slippery slope where they find their professional integrity difficult to defend.10For a firsthand account of this process from one psychiatrist’s perspective, fortuitously published one week after the Center for Business Intelligence’s KOL conference, see Carlat D. Dr. Drug Rep.New York Times Magazine. 2007Google Scholar Others might see information exchanges between MSLs and KOLs as a categorically different phenomenon, clearly distinguishable from practices such as all-expenses-paid skiing junkets for high prescribers. Different firms and reps may practice their trade ethically, unethically, or somewhere in between, but physicians cannot simply eschew contact with commerce as if it were a contaminant. The firms make indispensable products; their contrasting motivations at least intersect with medicine’s professional mission, and at best act symbiotically with it. Conflict of interest in this area is often more a matter of forms and degrees than a binary on/off condition. Popular books like Groopman’s How Doctors Think make patients increasingly aware of their doctors’ cognitive processes and the inherent weaknesses. A comparable glimpse inside pharma’s language, assumptions, and operating procedures may likewise help physicians make their industry contacts more constructive than parasitic. What pharma personnel say to each other in the relatively protected environment of an insiders’ conference11At the Tyson’s Corner event, the media presence was minimal, and audio/video recordings were prohibited, increasing the likelihood of candor among the participants.Google Scholar inevitably reflects what Groopman, applying Daniel Kahneman and Amos Tversky’s observations about common errors and heuristics, might term an anchoring bias. From the marketing perspective, use and advocacy of a firm’s products are presumed appropriate and desirable unless demonstrated otherwise. A physician (particularly an influential one) does not begin any conversation with this presumption; he or she needs evidence for or against it. That fundamental gap exists in every medical-pharmaceutical interaction, and the MSLs are developing increasingly sophisticated tactics for bridging it. The specific KOL focus as a distinct activity within pharma is less than a decade old, but some of the principles applied in the field draw on studies of American electoral behavior performed over 60 years ago by mathematician/sociologist Paul Lazarsfeld, founder of Columbia University’s Bureau for Applied Social Research, and his student Elihu Katz.12Lazarsfeld P et al. The People’s Choice. NY: Duell, Sloan and Pearce, 1944; Katz E, Lazarsfeld P. Personal Influence. NY: Free Press, 1955. A preliminary presentation by Aafia Chaudhry, MD, of the information consulting firm 81qd (a branch of Medical Knowledge Group) provided much of the intellectual foundation for the conference’s strategic sessionsGoogle Scholar They noted that voters who were relatively certain of their preference tended to read more news, while more uncertain voters followed personally known opinion leaders. Lazarsfeld and Katz posited that information moved in a “2-step flow,” with influential individuals acting as critical social nodes in the distribution. Later elaborations by Everett M. Rogers extended these analyses to farmers, physicians, and other groups, codifying them as “diffusion of innovations” theory.13Rogers E. Diffusion of Innovations.5th ed. Free Press, NY1995Google Scholar In the spread of any new technology or idea, Rogers identified a bell curve comprising innovators, early adopters, the early majority, the late majority, and laggards. When Pfizer marketed the new antibiotic tetracycline in the 1960s, it enlisted Katz and 2 other Columbia sociologists to study how the new agent found acceptance among physicians and what effect the company’s journal advertising had on the process.14Coleman J.S. Katz E. Menzel H. Medical Innovation: A Diffusion Study. Bobbs-Merrill, Indianapolis, IN1966Google Scholar These studies were among the case materials that Rogers used in developing his diffusion paradigm. Pfizer’s marketing efforts were relatively restrained by today’s standards, operating in the era before direct-to-patient advertising, but the knowledge gained about communication channels, the effects of time, and the social configurations that affect perceptions of information utility has been invaluable to the pharma industry. In particular, the studies have underscored the value of “micro channels” of interpersonal communication relative to the “macro channels” of the mass media. Opinion leaders combine high levels of knowledge in a technical domain with a strong willingness to communicate that knowledge to peers. The KOL subset within the wider group of opinion leaders adds 2 other qualities, innovation and industry affinity. (Interestingly, number of prescriptions is not considered a defining variable for KOLs. Doris Makari, MD, medical sciences director of Medimmune, Inc., added that skeptics are at least as valuable as brand advocates when pharma officials are recruiting members of advisory boards, assuming that a board’s mission is to generate actual scientific advice.) Vendors of information services now aid pharma firms in their goal of focusing their resources on KOLs—not information hoarders, “noisemakers” who combine low technical knowledge with high propensity for communication, “false positives” with low ratings on both scales, or physicians who are simply averse to industry. Firms can use extensive proprietary databases to track and graph physicians’ publications, clinical trials, grants, academic credentials, editorial board positions, journal impact factors, guideline committee involvement, peer recommendations, disclosure statements, metrics for drug brand affinity such as consultant and speaker positions, and myriad other variables, all searchable by specialty and geography. Some of the systems use natural language processing to mine vast numbers of publications for pertinent data. An MSL looking for a writer of multiple review articles on a given clinical topic (indicative of a high intent to communicate) or a frequent first or last author on PhaseII trials (a likely innovator) can find one through these systems. He can also find the top-tier specialists in Indianapolis or Idaho City who are active in the relevant specialty societies, have or have not advocated a particular product or aligned too closely with a competing firm, have not attained a high “physician exhaustion factor” by being chased by too many MSLs and reps, and have circulated scientific messages that map closely onto the firm’s concerns. The ability of pharma firms to profile physicians in such exhaustive, scalable, recombinable detail creates qualms on both sides of the professional borderline. Some participants in discussions of diffusion analytic methods shy away from the very terms influence and influence mapping (which presenter Aafia Chaudhry, MD, called “an archaic and almost noncompliant term”). They prefer engagement—at least in communications that might travel outside the company, and information security is such a concern in this field that participants spoke in guarded terms of using read-only, nonprintable documents with critical material confined to dropdown boxes rather than open (copyable) text. A whiff of paranoia accompanied these conversations, along with a sense that an arms race among companies could produce redundancies and leave target physicians numbed and resistant. Perhaps influence mapping is ultimately most useful internally, when MSLs need to justify marketing expenses to inquisitive senior management. Still, one marvels at the sheer mass of information the method can generate while noting that few other fields would muster the material resources or incentives to apply it. What pharma firms might do with this information, and with the medical experts thus selected for speakers’ bureaus, advisory boards, clinical study design and execution, and paper authorship or review, constituted the conference’s core problems. Legal worries also surround the companies’ stewardship of the information they have amassed about KOLs. Data privacy laws differ broadly between the US and Europe, and officials of firms doing business in both areas are not always aware of the contrasting requirements. European Union directive 95/46/EC protects individuals’ rights to know and control personally identifiable information far more strictly than American federal privacy laws, which largely leave businesses self-regulated, said Neil A. Jones, Ph.D., director of branded solutions for Medical Marketing Research International and Medical Marketing Studies US, Inc. American businesses can legally collect information without notice and distribute it without restriction, reports Jones, but those doing business in Europe must observe higher standards of transparency. Personal information is only collectable in Europe with a subject’s unambiguous consent, health care information can only be processed by health care organizations, sensitive data categories (ethnic, political, sexual, etc) carry further restrictions, and a collecting entity must notify the subject before processing data or transferring them to a third party. Subjects have the right to examine and correct information on them; data transfer to countries with inadequate safeguards is banned. To keep the US out of that category, the Department of Commerce developed a parallel set of principles in 2000 known as the Safe Harbor Arrangement, a voluntary mechanism whereby companies annually self-certify that they are compliant.15http://www.export.gov/safeharbor/Google Scholar The implications for firms working with KOLs under these rules include maintenance of a Data Protection Officer, and procedures for access, appeal, and responses to inquiries within 40 days. Individual consent in the US is on an opt-out basis, in contrast to the opt-in European standard. The physician who objects to inclusion in corporate databases may find that formal mechanisms do not equate with practical safeguards; Safe Harbor is a relatively untested system, and a European Commission report released in 2002 found irregularities in both transparency and enforcement mechanisms.16Commission Staff Working Paper: The application of Commission Decision 520/2000/EC of 26 July 2000 pursuant to Directive 95/46 of the European Parliament and of the Council on the adequate protection of personal data provided by the Safe Harbour Privacy Principles and related Frequently Asked Questions issued by the US Department of Commerce. [http://ec.europa.eu/justice_home/fsj/privacy/docs/adequacy/sec-2002-196/sec-2002-196_en.pdf]Google Scholar Current American political preferences for corporate self-regulation do not automatically rule out future adoption of tight European-style privacy standards. With or without test cases or legal changes, the internal precautions that Jones advises companies to establish are likely to add further administrative friction to pharma-KOL interactions that could previously be relatively informal. Pharma detailers frequently appear in the media as insidious, sinister, or overbearing. Some flash appealing smiles and dangle posh perks that warp physicians’ judgment; others pursue busy, independent MDs with a zeal bordering on a stalker’s obsession. Their colleagues in the MSL population, however, cast a different profile at this conference: more cautious about legalities, quick to distance themselves from the excesses of marketing and sales personnel, and in some cases acutely aware of the reasons behind their industry’s poor ethical reputation. Roughly a quarter to a third of this audience were field representatives, and some MSLs and executives have previously “carried the bag,” but the distinct non-sales functions of MSLs appear to be a point of pride, often a touchy one. Some were bracingly frank about why they approach KOLs: OpenQ’s Broad, for example, said during his presentation, “That’s their job, really, to discuss off-label products.” Others express at least an ostensible commitment to scientific independence and a recognition of prevalent pitfalls. In a presentation guiding MSLs in selecting KOLs for company-sponsored clinical trials, Arthur Lazarus, MD, MBA, senior director of clinical research for AstraZeneca, presented alarming data on scientific integrity: allegations of research misconduct (conflict of interest, billing problems, human subject protection irregularities, or data falsification) rose 30% from 2005 to 2006, some 40% of primary investigators are aware of misconduct but have not reported it, and the FDA inspects only 1% of trial sites. Lazarus’s message was not to take advantage of the limits of enforcement and cut corners but to regularize and professionalize corporate procedures in setting up studies, and above all to seek investigators with high professional standards. The critical topic of conflict of interest, treated at length by Larry Staubach, MD, former vice president for global medical affairs and pharmacovigilance at Stiefel Laboratories, is largely a common sense matter of transparent disclosure of interests (at least annually), protection of patient well-being and academic integrity, and open recognition of the relations between loyalties and judgment. Staubach stressed how apparent as well as real conflict of interest can wreak havoc, urging colleagues to adhere to written procedures that pass the “red face test.” These include the option of recusing a KOL from a trial or consultancy, not just telling the expert informally to “take care of this” when impartiality problems arise. Failure to disclose and manage potentially compromising commitments or interests, in Staubach’s view, does more damage than the conflicts themselves. Tellingly, a perspective that one might expect to counter in a pharmaceutical company atmosphere was essentially unvoiced at these talks. In reaction to the wave of bad press, exposés of malfeasance, and institutional efforts to curb conflict of interest, some commentators who unabashedly embrace corporate aims and laissez-faire economic philosophy have denied that medical-industrial conflict of interest is a problem at all. What conference speakers Ehrhardt, Staubach, and Lazarus take for granted about conflict of interest—the normative view recently recounted from personal experience by Daniel Carlat, MD (“When you are treated like the anointed, wined and dined in Manhattan and placed among the leaders of the field, you inevitably put some of your critical faculties on hold”17Carlat D, op. cit.Google Scholar)—strikes commentators like Harvard hematologist Thomas Stossel, MD, and Reason magazine’s Ronald Bailey18Bailey R. Is industry-funded science killing you? The overrated risks and underrated benefits of pharmaceutical research ”conflicts of interest.”.http://www.reason.com/news/show/122020.htmlGoogle Scholar as insupportable. Using a definition of research misconduct limited to fabrication, falsification, or plagiarism of results, Stossel has argued that evidence for detrimental effects from conflict of interest is lacking, even in the face of reported scandals and soaring promotional expenses: “Negative anecdotes are disproportionately influential, because unpleasant experiences tend to be indelible, whereas positive outcomes, such as from the academic–industrial relationships that have resulted in useful products, receive little attention and leave a less lasting impression.”19Stossel T.P. Regulating academic–industrial research relationships—solving problems or stifling progress?.N Engl J Med. 2005; 353: 1060-1065Crossref PubMed Scopus (125) Google Scholar If one group of ethicists has memorably dubbed the difficult relations between academic medical centers and industry “dancing with the porcupine,”20Lewis S. Baird P. Evans R.G. et al.Dancing with the porcupine: rules for governing the university-industry relationship.CMAJ. 2001; 165: 783-785PubMed Google Scholar the Stossel-Bailey school of thought would have us believe the porcupine is Ginger Rogers. The social boons from pharmaceutical profit-seeking efforts are such a substantial and unmixed blessing, Stossel claims throughout numerous writings, that nearly any conflict of interest regulation at all creates adverse risk-benefit balances—even threatening, he has claimed, to drive drug manufacturers to cease their primary activity and manufacture dog food instead.21Stossel T.P. Regulation of financial conflicts of interest in medical practice and medical research: a damaging solution in search of a problem.Perspectives in Biology and Medicine. 2007; 50: 54-71Crossref PubMed Scopus (45) Google Scholar The KOL conference, however, presented little evidence that residents of the Pharmasphere (at least this cross-section of it) adhere to an ideology that considers Gordon Gekko’s “greed is good” speech from the film Wall Street a serious and even admirable manifesto rather than an instance of dramatic irony. Instead of mounting combative opposition to ethics regulations or offering hyperbolic worst-case scenarios about strangled golden geese, the MSLs and other officials appear to be making efforts (some energetic, some merely dutiful) to perform more responsibly toward KOLs, legal entities, and public opinion. Whether this constitutes lip service or serious housecleaning is a determination that influential physicians will need to make every time the people operating the influence-mapping machinery select their names.