New Developments in Managing Physician-Industry Relationships

Over the past 2 years, policies governing the relationship between physicians and pharmaceutical and device companies have undergone remarkable changes. A 2004 task force appointed by the American Board of Internal Medicine Foundation (ABIM) and the Institute on Medicine as a Profession (IMAP) found existing guidelines to be lax.¹ At that time, the industry's Pharmaceutical Research and Manufacturers of America (PhRMA) Code ignored many salient issues, such as disclosure, speaker's bureaus, and ghostwriting and set only modest boundaries around dispensing food, gifts, and travel reimbursements.² The American Medical Association's ethical guidelines largely duplicated PhRMA’s; however, on such practices as gift taking, it was even more permissive.³ The American College of Physicians acknowledged the influence of gifts on physician practices but did not prohibit them.⁴ Government bodies, including the Office of the Inspector General of Health and Human Services, essentially endorsed the PhRMA Code.⁵ Academic medical centers did not 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 substantial body of research indicated that gifts, stipends, and honoraria from drug companies influenced physicians' treatment decisions.^{6 - 8} Second, the media were relentless in exposing drug company–physician misconduct, which ranged from false statements and billing to off-label promotion of products to outright bribery.¹ 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 $4 billion in criminal and civil fines. The largest was the 2001 TAP/Lupron case, with an $875 million settlement.⁹ 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.¹ 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 June 2008, the association's executive council approved them.^{1 ,10} 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 on- or off-site, and prohibit food provided by industry: “Industry-supplied 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.”^{1 ,10} 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,¹ the Pew Charitable Trusts contacted IMAP to explore strategies to promote their enactment. The discussions, joined by Community Catalyst, a national consumer advocacy organization, led to the establishment of the Pew-funded Prescription Project. Under its auspice, and with additional funding to IMAP from the Attorney General Consumer and Prescriber Grant Program, IMAP has been investigating the origins and consequences of the policy innovations and providing technical assistance to AMCs. Presuming that the AAMC recommendations will further stimulate change, in this Commentary we report on findings to date to help facilitate the process.

Change has come from the top down. The dean's office has typically taken the lead in inspiring, formulating, and enacting new policies. Almost everywhere, the dean has had ready allies on the faculty. In particular, chairs of pharmacy and therapeutics committees, seasoned in industry strategies to influence purchasing and prescribing decisions, have often been supporters. Many deans have also been assisted by faculty, such as a professor of medicine who carried a supply of inexpensive pens in her white coat and, whenever she saw a colleague holding a pen with a drug company logo, took it away and substituted one of her own unmarked pens. So too, deans have been prodded to tighten their conflict-of-interest policies by medical students and house staff. But in the end, medical centers are hierarchical places, and at universities like Yale, Stanford, Pennsylvania, and Pittsburgh, it was the deans who appointed and charged the task force to draft new policies, and together they presented and defended the documents before the governing committees (the faculty practice group, the department chairs, the faculty council). With approvals forthcoming, the new policies were announced. In no case that we know of was a dean's support for a rigorous policy derailed, voted down, or even substantially weakened.

What motivated the leadership? Deans and faculty leaders had read journal articles on the power of gifts to physicians. They had scanned the media stories and were eager to preempt the issue rather than be publicly embarrassed. Beyond that, many of them expressed a vigorous and unqualified commitment to the principles of professionalism. They insisted that scientific knowledge and patient need, not marketing, had to drive medical decision making. Athletes might display company brands on their clothing, but physicians should follow a higher standard to protect their own and their profession's integrity.

What kept other deans from acting? First, there was a fear that pharmaceutical companies would retaliate by withholding research funds, a fear exacerbated by a shrinking National Institutes of Health budget and an increasing dependence on industry support. Second was a fear that faculty members who were unhappy about the policy would leave for another institution that would not restrict their activities. Third, deans hesitated to tackle the issue in light of the complicated structures of their institutions. Could one policy cover not only the medical school faculty but also community physicians, nurses, dentists, physical therapists, and public health practitioners? Although no dean we spoke to minimized the importance of conflict of interest, some among them preferred to live with the problems they were familiar with rather than face those they could not predict.

It is too early in the process to evaluate fully the effects of the new policies. Some first impressions, however, may be offered. Thus far, there has been no significant movement of faculty from AMCs with strong policies to those with weak policies. Undoubtedly a few “silent departures” have occurred, but they remain the exceptions. Also, no one has reported a decrease in pharmaceutical company research funding. This ought not to be surprising because pharmaceutical company innovation, and profits, require the knowledge that resides in academic basic science and clinical departments. Deans have also proven adept at initiating change that first affects faculty in the major allied hospitals, leaving for a later stage the community physicians in more distant facilities.

When new policies are introduced, discussions are often heated. Some deans have been accused by faculty members of depriving their children of a college education by taking away drug company payments. But once the policies are in place, passion dissipates. Advantages outweigh disadvantages. Faculty members welcome the time saved by not meeting with pharmaceutical representatives or having to fend them off. They discover that product samples are not as necessary as they had thought; in some places, physicians are able to dispense vouchers for samples or have the samples stored in and distributed from a central commissary.

No one seems to care much about pens, notepads, or even the disappearance of free lunches, certainly for themselves, with only occasional regrets for their staff. Some departments are subsidizing food at grand rounds or setting aside a reserved line in the cafeteria for residents so they will not be late for a meeting. There is also an increasing number of accounts of physicians taking personal pride in turning down speaker's bureau invitations. “My school does not allow it” is an efficient and sometimes welcome way out.

The AMCs are just beginning to devise monitoring and enforcement procedures, locating oversight (usually in the deans' offices), and setting up hotlines for questions or complaints or Web sites for disclosure reports. A number of universities (such as Pennsylvania, Pittsburgh, Wisconsin, and Michigan) have focused their enforcement efforts on the vendors. If a pharmaceutical company representative violates the rules on gifts, meals, registration, or formal appointments, they are first warned; if they persist in their violations, they are suspended and eventually banned. Under such circumstances, as would be expected, vendors are compliant.

Although some faculty members have asked whether they might be fired for accepting a drug company pen, they have learned that the goal is less on implementing a schedule of penalties or appointing a gift police than on changing the culture of the institution. The objective is to promote a shift away from a sense of entitlement among physicians and, even more important, among residents and medical students. Are there gaps in adherence? Of course there are, and they particularly occur off-site. But more noteworthy is the prevailing compliance and good will. The new policies lose their controversial character rather quickly. The faculty moves on—and this should encourage other AMCs to appoint their own task forces to design and implement change.

As change becomes embedded in medical centers, it will be vital to analyze outcomes both qualitatively and quantitatively. There are many important questions to be answered: Do attitudes and practices change over time? Do house staff and medical students experience the change in terms of an intensified commitment to professionalism? Do disclosure requirements affect appointments to formulary committees or teaching assignments? As visits from pharmaceutical representatives decline, do physicians' prescriptions for generics increase? What effect on research funding might occur? Does the pharmaceutical industry devise new strategies that undercut the policies, and if so, how do the AMCs respond?

Last, but certainly not least, will AMCs make sufficient progress to obviate the need for government intervention?