Conflict Resolution: New Stanford Medical Center Policy Limits Drug Company Access and Gifts.

STANFORD, Calif. -- Stanford University Medical Center has joined a small cadre of other major academic medical centers in enacting a policy aimed at limiting the potential influence of pharmaceutical and other biomedical companies in its day-to-day clinical and educational activities.

The new policy prohibits physicians from accepting industry gifts of any size, including drug samples, anywhere on the medical center campus or at off-site clinical facilities where they may practice. Among its other provisions, it bans pharmaceutical, bio-device and related industry representatives from patient care areas and medical school facilities except for in-service training on devices and equipment and by appointment only, as well as allowing industry support of educational activities only under well-regulated conditions.

The policy takes effect Oct. 1.

While the policy recognizes the value of industry collaborations, which help speed the availability of vitally needed drug treatments, it aims to ensure that doctors' and scientists' interactions with industry are ethical and avoid conflicts of interest that could affect patients and the integrity of the school's training programs.

"We do not want industry dollars to have the potential to influence how we train people or give clinical care, and I think this document sets out ways of minimizing this potential," said Harry Greenberg, MD, professor of medicine and chair of the 23-member School of Medicine task force that developed the policy. He noted that the medical school already has a strong, long-standing policy that governs conflicts of interest in research activities and that the new policy will complement it by minimizing potential conflicts in the clinical and educational arenas.

The new policy was unanimously approved June 16 by the medical school's executive committee and was adopted in August by the medical boards at Stanford Hospital & Clinics and Lucile Packard Children's Hospital. It applies to all physicians who practice at the two hospitals, including community physicians and the research faculty in the School of Medicine.

The policy puts Stanford in the forefront of a small but growing movement among academic medical centers to manage potential conflicts of interest created by the widespread marketing practices of the pharmaceutical industry. Of the $21 billion the pharmaceutical industry spends every year on marketing, as much as 90 percent is directed at physicians through various mechanisms, such as free meals, gifts and drug samples and sponsorship of continuing medical education programs and other events, according to an article published Jan. 25, 2006, in the Journal of the American Medical Association.

These marketing practices have the potential to influence physician practice patterns, including the drugs doctors prescribe. Although the majority of physicians queried in national surveys say they don't believe they personally are swayed by industry tactics, they believe a majority of their peers are.

Philip Pizzo, MD, dean of the School of Medicine, said he has been concerned for some time about the pervasive presence of the pharmaceutical industry in the medical profession, an issue that's been highlighted in recent years in news articles, books and the medical literature. He began a discussion in the Stanford medical school community on the issue through his "Dean's Newsletter" in the summer of 2005; last fall, he asked Greenberg, who is senior associate dean for research, to convene a task force to draft a policy.

"In recent years we have witnessed an erosion of the public trust in the profession of medicine and even in the value of science," Pizzo said. "Part of that is related to the market forces that have increasingly converted medicine from a profession to a business, but a significant factor has also been the perception that physicians and scientists may be accepting gifts and gratuities from industry at the very time that the cost of drugs is skyrocketing.

"It is essential that medical professionals and scientists reclaim the moral high ground and avoid the appearances of conflict of interest that can otherwise cloud or alter the trust of the American public. It is my hope that the stance being taken by Stanford will serve as beacon of responsibility for the medical and scientific professions."

The policy is modeled in part after one approved in 2005 by the Yale Medical Group. The Hospital of the University of Pennsylvania also approved guidelines for interactions with pharmaceutical industry earlier this year, and a few other academic medical centers have said they're considering similar policies, which are being encouraged by the Association of American Medical Colleges.

Stanford's policy is broader than those of its counterparts in that it regulates devices, the biotech, hospital and research equipment and supply industries, as well the pharmaceutical industry throughout the medical center including laboratory research facilities.

The policy declares that it is "unacceptable for patient care decisions to be influenced by the possibility of personal financial gain" and exhorts physicians to divorce all clinical care decisions from any benefits they may receive from a company.

"I feel it's very important for physicians to avoid situations where there is a conflict or an appearance of a conflict with respect to pharmaceutical and device companies," said Harvey Cohen, MD, PhD, the Adalyn Jay Chief of Staff at Packard Children's Hospital. "This policy, by intent and content, goes a long way in helping ensure that this happens."

The policy specifically prohibits Stanford physicians and scientists from accepting gifts from companies, however small. Doctors are already prohibited from accepting "substantial" gifts -- i.e. those valued at more than $100 -- under guidelines developed by physician groups such as the American Medical Association and the Accreditation Council for Continuing Medical Education. But small gifts, such as logo pens, pads, tote bags and drug samples, are still common accoutrements in doctors' offices, both at Stanford and elsewhere.

David Magnus, PhD, director of the Stanford Center for Biomedical Ethics and a member of the task force, said studies suggest that small gifts can have as much of an influence on physician thinking, prescribing and purchasing habits as large gifts.

"Gift giving creates a reciprocal obligation that is a powerful force, and pharmaceutical companies know this very well," he said. "So we're discouraging it from happening anywhere at the medical center."

Larry Shuer, MD, chief of staff at Stanford Hospital and a professor of neurosurgery, said he's "certain that most medical staff would feel that they are not influenced in their medical decision-making by free pens or doughnuts from an industry representative. However, we all agree that the appearance of possible conflict is what we must try to avoid, as the public perception may be different from that of the physicians."

The policy also bans pharmaceutical sales and marketing representatives from entering patient care areas and only allows them access in non-patient care areas, such as research laboratories, by explicit invitation. The presence of pharmaceutical representatives on patient wards is considered inappropriate and unnecessary, Greenberg noted, particularly in this era of digital technology, in which physicians no longer need pharmaceutical representatives to supply them with up-to-date medical literature that's now readily available on the Web.

Vendors selling medical equipment also would not have access to the hospitals or medical school without an appointment. Faculty members involved in purchasing equipment would have to disclose any financial relationships they or their family may have with the company in question and could be excluded from the decision-making process.

In addition, the policy states that companies cannot pay for meals for faculty members or trainees for Stanford activities on or off campus except under the strict guidelines set by the ACCME, and it provides guidelines for participation in industry-sponsored events off campus. For instance, even if a company provides funding for food for a given program, it cannot control the speakers or the content of the program, which would have to present a balanced view of therapeutic options. Those involved in planning the program would have to disclose any relevant financial relationships. What's more, no industry sales and marketing representatives could be present during an educational activity, and no promotional materials could be handed out.

The policy also contains provisions that prohibit faculty from publishing articles in medical journals that have been ghostwritten by industry representatives, and reinforces existing practice that faculty disclose related financial interests in any papers they publish or presentations they make. Greenberg said he doesn't know how common it is for Stanford faculty to submit ghostwritten papers, but that it's a common industry practice that he believes is inappropriate.

In addition, the policy mandates that all residents, trainees and staff be educated about potential conflicts of interest in interactions with industry.

Richard Popp, MD, emeritus professor of cardiology and a former senior associate dean of faculty affairs at the medical school, said he believes the policy is important in terms of protecting patients. "The idea is that a lot of marketing activities of the pharmaceutical industry are aimed at inducing doctors to use certain drugs and the question is, are they using a particular drug because they were seduced by the pharmaceutical industry or because it's best for the patient? The fact is you always have to do what's best for the patient."

But, he added, balancing that imperative with the need to maintain ethical working relationships with industry can be a challenge.

"I think it's worthwhile to call attention to the subtle influence of industry, especially when it comes to the marketing of drugs, and gifts and taking people to dinner and so on. That has to stop," Popp said. "But saying industry is bad and we should not have anything to do with industry is not a good idea. There are a lot of things we could not do without the help of industry. So we have to work ethically together for the benefit of patients."

A copy of the new policy is available online at: http://med.stanford.ed/coi/. Video about the policy is available online at: http://mednews.stanford.edu/releases/2006/september/coi.html.

Stanford University Medical Center integrates research, medical education and patient care at its three institutions -- Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu.