Susan Chimonas

Professional Medical Associations and Their Relationships With Industry: A Proposal for Controlling Conflict of Interest

Professional medical associations (PMAs) play an essential role in defining and advancing health care standards. Their conferences, continuing medical education courses, practice guidelines, definitions of ethical norms, and public advocacy positions carry great weight with physicians and the public. Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflict of interests. Any threat to the integrity of PMAs must be thoroughly and effectively resolved. Current PMA policies, however, are not uniform and often lack stringency. To address this situation, the authors first identified and analyzed conflicts of interest that may affect the activities, leadership, and members of PMAs. The authors then went on to formulate guidelines, both short-term and long-term, to prevent the appearance or reality of undue industry influence. The recommendations are rigorous and would require many PMAs to transform their mode of operation and perhaps, to forgo valuable activities. To maintain integrity, sacrifice may be required. Nevertheless, these changes are in the best interest of the PMAs, the profession, their members, and the larger society.

Physicians and Drug Representatives: Exploring the Dynamics of the Relationship

BackgroundInteractions between physicians and drug representatives are common, even though research shows that physicians understand the conflict of interest between marketing and patient care. Little is known about how physicians resolve this contradiction.ObjectiveTo determine physicians’ techniques for managing cognitive inconsistencies within their relationships with drug representatives.Design, Setting, and ParticipantsSix focus groups were conducted with 32 academic and community physicians in San Diego, Atlanta, and Chicago.MeasurementsQualitative analysis of focus group transcripts to determine physicians’ attitudes towards conflict of interest and detailing, their beliefs about the quality of information conveyed and the impact on prescribing, and their resolution of the conflict between detailers’ desire to sell product and patient care.ResultsPhysicians understood the concept of conflict of interest and applied it to relationships with detailers. However, they maintained favorable views of physician–detailer exchanges. Holding these mutually contradictory attitudes, physicians were in a position of cognitive dissonance. To resolve the dissonance, they used a variety of denials and rationalizations: They avoided thinking about the conflict of interest, they disagreed that industry relationships affected physician behavior, they denied responsibility for the problem, they enumerated techniques for remaining impartial, and they reasoned that meetings with detailers were educational and benefited patients.ConclusionsAlthough physicians understood the concept of conflict of interest, relationships with detailers set up psychological dynamics that influenced their reasoning. Our findings suggest that voluntary guidelines, like those proposed by most major medical societies, are inadequate. It may be that only the prohibition of physician–detailer interactions will be effective.

New Developments in Managing Physician-Industry Relationships

OVER THE PAST2YEARS,POLICIES GOVERNING THE RElationship between physicians and pharmaceuticalanddevicecompanieshaveundergoneremarkable changes. A 2004 task force appointed by the AmericanBoardof InternalMedicineFoundation(ABIM)and the Institute on Medicine as a Profession (IMAP) found existing guidelines to be lax. At that time, the industry’s PharmaceuticalResearchandManufacturersofAmerica(PhRMA)Code ignored many salient issues, such as disclosure, speaker’s bureaus,andghostwritingandsetonlymodestboundariesaround dispensing food,gifts, andtravel reimbursements. TheAmericanMedicalAssociation’s ethicalguidelines largelyduplicated PhRMA’s;however,onsuchpracticesasgift taking, itwaseven morepermissive.TheAmericanCollegeofPhysiciansacknowledged the influence of gifts on physician practices but did not prohibit them. Governmentbodies, includingtheOfficeof the Inspector General of Health and Human Services, essentially endorsedthePhRMACode. Academicmedicalcentersdidnot set a better example. Few of them had rigorous policies, and the exceptions received little notice. At that same time, pressure to strengthen the governance of physician-industry relationships was mounting. First, a substantialbodyof research indicated thatgifts, stipends, andhonoraria from drug companies influenced physicians’ treatment decisions. Second, the media were relentless in exposing drug company–physicianmisconduct,whichranged fromfalse statements and billing to off-label promotion of products to outright bribery. Third, whistleblowers were alerting federal and state prosecutors to drug and device company illegalities, leading to successful prosecutions that resulted in millions of dollars in settlements and fines. From 2000 to 2004, 12 major health care fraud settlements led to pharmaceutical companies paying almost

No more free drug samples

4 billion in criminal and civil fines. The largest was the 2001 TAP/Lupron case, with an

Academic Medical Centers' Conflict of Interest Policies

875 million settlement. Taken together, these developments were making the status quo unacceptable. In January 2006, the ABIM-IMAP task force published its policy recommendations on conflict of interest. The proposals captured significant media and academic attention and stimulated many academic medical centers (AMCs) to reconsider their guidelines. In April 2008, a task force appointed by the Association of American Medical Colleges (AAMC) issued recommendations on conflict of interest, and in June2008, the association’s executive council approved them. With only a few exceptions, the positions in the 2 documents are similar, providing them with presumptive standing in the field. Both proposals are much more exacting than earlier guidelines on physician-industry relationships. The proposed guidelines prohibit all gifts (zero-dollar limit), whether onor off-site, and prohibit food provided by industry: “Industrysupplied food and meals are considered personal gifts and will not be permitted or accepted.” Both proposals recommend that product samples are centrally managed to “distance the company and its products from the physician.” The AAMC would also restrict industry representatives’ access to physicians, requiring credentialing mechanisms and formal appointments and invitations. Both propose that industry funds for continuing medical education and travel to bona fide medical meetings should be distributed not by academic departments but from a central medical center office. Both prohibit ghostwriting and differ only on speaker’s bureaus. The ABIM-IMAP task force prohibits these activities; the AAMC proposals “strongly discourage” them. The AAMC report does not make reference to the many positive changes that some of its members have already made. At least 25 medical centers from both the public and the private sectors and from all regions of the country, including Boston University, University of Massachusetts–Worcester, and Yale University; University of Pennsylvania and Pittsburgh University; the universities of Michigan, Wisconsin, and Chicago; and the entire University of California system, now have in place strong conflict-of-interest policies. These AMCs have been joined by such health care delivery organizations as the Henry Ford Health Systems (Detroit), Kaiser Permanente (northern California), and the US Veterans Administration network. How did these changes come about? Immediately after the publication of the ABIM-IMAP recommendations, the Pew Charitable Trusts contacted IMAP to explore strategies to promote their enactment. The discussions, joined by Commu-

Managing conflicts of interest in clinical care: the "race to the middle" at U.S. medical schools.

Susan Chimonas and Jerome Kassirer argue that giving out “free” drug samples is not effective in improving drug access for the indigent, does not promote rational drug use, and raises the cost of care.

Powered by Sunshine: Next Steps for Making Transparency Matter

DURING THE PAST 4 YEARS, A NUMBER OF ACADEMIC medical centers (AMCs) have taken the lead in implementing new policies that more strictly manage the relationships between physicians and industry. Transforming once-entrenched practices, the new measures prohibit accepting gifts, food, and drug samples and restrict faculty consulting and speaking arrangements. Although many faculty members believe these changes are long overdue, others complain that the policies sully their reputations and reduce their income. Because the measures break new ground, uncertainties about their shortand long-term consequences are widespread. In this Commentary, we discuss accomplishments at the leading institutions and evaluate prospects for future change. Implementing conflict of interest policies demands substantial time and resources, as well as a deep commitment to effective oversight. Issuing a policy is merely the first step; next come the appointment and staffing of a faculty/ administration committee that, together with an expanded compliance office, answers faculty queries, investigates violations, reviews disclosure forms, and develops and implements individual management plans that must become embedded in the institutions’ governance and culture. The commitment is typically initiated and sustained by a deep sense of professional values and by the conviction that, left unregulated, industry marketing practices undermine patient well-being and scientific integrity. At the same time, new practices mandating financial transparency, particularly industry Web sites that report payments to physicians, have the potential to make an AMC the subject of unflattering media coverage. Moreover, no institution wants to receive an inquiry from a senator’s office about a faculty physician’s ties to industry, which almost inevitably produces reputation-damaging media coverage. Such an inquiry may also adversely affect funding from the National Institutes of Health and even spur investigations by state attorneys general. The easiest policy prohibitions to enact and enforce are those involving gifts and food provided by industry. The extensive literature on the effect of gifts on physician decision making makes it easier to persuade faculty to forgo contributions such as pens, notepads, and meals. So, too, managing vendors’ presence on campus is not difficult. Rather than ban them altogether, exemplary AMCs regulate their access. Salespersons can be required to attend orientation seminars, demonstrate knowledge of institutional policies, wear identifying badges, be prohibited from entering patient care areas, and be allowed entrance to practice settings by appointment only. Violations can be managed by suspending the individual or, in the case of repeated violations, all company representatives. The overall effect can be to substantially reduce sales representatives’ presence. Innovative AMCs prohibit faculty participation in speakers’ bureaus, which train physicians to market products and usually require them to use company slides. Because joining speakers’ bureaus is lucrative, some faculty are likely to protest the ban, but leaders are unlikely to reverse the policy, finding it unacceptable for physicians to serve as salespeople. There is no uniformity among leading institutions’ policies for drug samples, CME funding, speakers’ bureaus, and disclosure. To control drug samples, exemplary institutions follow different paths. For instance, one institution adopted an “eSample” dispensing system whereby physicians log on and order a specific medication, some AMCs have experimented with voucher systems, and others allow samples in the pharmacy if those products are on formulary. Whatever system is in place, the aim is that samples be better monitored, less frequently used, and detached from interactions between the drug representative and the physician. Innovative AMCs allow faculty to consult with industry and receive honoraria for lectures. Rather than demonization of the companies and severance of all ties, the goal is careful oversight. AMCs can regulate the percentage of time faculty may devote to outside activities (eg, limiting it to 1 day in 7 or 5) or limit outside income to a percentage of base salary. Only a few institutions require faculty to obtain advance permission to consult or lecture for a company. These allowances notwithstanding, a few entrepreneurial-minded physicians will probably resign their faculty

Health Industry Practices That Create Conflicts of Interest

Purpose National recommendations specify how medical schools should manage clinical conflicts of interest (CCOIs), including gifts and payments to physicians from pharmaceutical companies. A 2008 study showed that few schools had policies in keeping with the recommendations. The authors conducted a follow-up study in 2011 to assess possible improvements. Method To obtain policies in 12 areas of CCOI, the authors searched the Web sites of all 133 medical schools existing in July 2011 and contacted schools that had no online policies. Policies were scored as no policy, permissive, moderate, or stringent, based on published recommendations; each school’s scores were averaged to assess overall policy strength. Changes since 2008 were evaluated. The authors also collected information on schools’ public/private status, hospital ownership/affiliation, and National Institutes of Health (NIH) funding to determine whether these characteristics were associated with differences in policy strength. Results Policies were obtained for a representative sample of 127 (95%) medical schools. The frequency of stringent policies increased from 2008 to 2011 in all CCOI areas, and medical schools’ overall policy strength more than doubled. However, less than stringent policies remained the norm for all areas except ghostwriting. Greater NIH funding was associated with stronger policies in five areas and with higher overall policy strength. Conclusions Schools have made great progress toward national standards, yet room for improvement remains: The data reveal not a race to the top but a shift from the bottom to the middle. Follow-up research should explore whether stronger policies emerge in the future.

From Disclosure to Transparency The Use of Company Payment Data

Powered by Sunshine: Next Steps for Making Transparency Matter Susan Chimonas , Nicholas J. DeVito & David J. Rothman To cite this article: Susan Chimonas , Nicholas J. DeVito & David J. Rothman (2017) Powered by Sunshine: Next Steps for Making Transparency Matter, The American Journal of Bioethics, 17:6, W1-W2, DOI: 10.1080/15265161.2017.1324584 To link to this article: http://dx.doi.org/10.1080/15265161.2017.1324584