When Commerce and Medicine Collide

University of Pittsburgh tackles conflicts of interest

Barbara Barnes, M.D., has been concerned about the impact of commercial interests on the practice of medicine for some time. And although that interest did not begin with the supply chain, it has found its way there.

Barnes, who is board-certified in internal medicine, is associate vice chancellor, continuing education and industry relationships, for the University of Pittsburgh Schools of the Health Sciences. As such, she coordinates the continuing education program for the six health-sciences schools and oversees the CME program for the School of Medicine. She is also vice president, sponsored programs, research support and continuing medical education for the University of Pittsburgh Medical Center. As such, she directs CME across the health system, and manages the clinical trials office and the IDN’s portfolio of extramurally funded projects. UPMC comprises 20 hospitals, an extensive network of physician practices and hundreds of service locations in western Pennsylvania.

In October 2006, Barnes was appointed co-chair of the Industry Relationships Task Force for the University of Pittsburgh Schools of the Health Sciences and UPMC. The task force was created at a time of national debate about potential conflicts of interest between medicine and industry, she says. An article about the topic (“Health Industry Practices That Create Conflicts of Interest,” Journal of the American Medical Association, Jan. 25, 2006) had been published earlier in the year. In it, Troyen A. Brennan, M.D., Harvard Medical School, and his co-authors, had concluded that “conflicts of interest between physicians’ commitment to patient care and the desire of pharmaceutical companies and their representatives to sell their products pose challenges to the principles of medical professionalism.”

Despite self-imposed codes of conduct by physician groups, manufacturers and the federal government, more stringent regulation was necessary, according to the authors, including the elimination of gifts, pharmaceutical samples, funds for physician travel, speakers bureaus, ghostwriting, and consulting and research contracts.

As a result of that article, a number of institutions across the country developed industry relationship policies, and the leadership of UPMC and the Schools of Health Sciences (SOHS) believed they should follow suit.

Interest began with CME
Barnes was well-suited to the task. For a decade or more prior to the formation of the task force, she had been involved in issues surrounding continuing medical education. For example, she became active in the Society for Academic Continuing Medical Education, and today is the organization’s representative to the Council of Academic Societies, which represents the faculty leadership of U.S. medical schools and teaching hospitals. She is the 2009 chair of the board of directors of the Accreditation Council for Continuing Medical Education.

It was her involvement in CME that drew her attention to some disturbing trends. Somewhere between 50 and 60 percent of the expenses of CME are provided through industry support, she says. “There has been considerable national debate about the potential influence this funding can have on the … objectivity of CME.”

She has been a vocal part of that debate. For example, in 2004, she editorialized about a report in the Journal of the American College of Cardiology whose authors concluded that “state-mandated continuing education has little impact on physician practice or patient outcomes, except perhaps as related to new therapies being promoted by the pharmaceutical industry.” In her published comments, Barnes concluded, “It is critical that our profession’s social contract be af?rmed by the rededication of practitioners to continuously improving their competence, the commitment of CME providers to deliver educational activities that effectively convey the best available evidence without in?uence by commercial interests, the development by regulators of oversight mechanisms focused on improving health care quality, and funding of research agendas to gain further knowledge about how physicians learn and change.”

Three years later, she published, with co-authors, a “risk stratification tool” to assess commercial influence on continuing medical education.

“Initially, as a CME provider, and subsequently as someone who has been very involved in the accreditation system at the national and state level and in professional organizations, I have become very interested [in this topic] and have a certain level of responsibility in understanding what additional safeguards need to be in place to prevent conflicts of interest,” she says today.

To be sure, Barnes is not alone in her concerns. The Accreditation Council for Continuing Medical Education has toughened its standards to ensure the independence of CME activities from commercial involvement. (The ACCME Standards for Commercial Support may be viewed at the organization’s Web site, www.accme.org.) In addition, the American Medical Association’s Council on Ethical and Judicial Affairs is currently working on a white paper on industry support for professional medical education.

Conflicts in the hospital
It was only natural that Barnes’ interest in the influence of commercial interests in continuing medical education would spill over into potential conflicts of interest in the hospital system. A 20-year veteran of hospital administration, Barnes says that her interest in continuing medical education has broadened into other areas, such as quality improvement and “trying to understand how we can work collaboratively with industry to fulfill our public and charitable mission with appropriate safeguards in place, so there is no adverse impact on quality, cost and patient access.”

Prior to the creation of the task force in October 2006, UPMC and the Schools of Health Sciences had a variety of policies and procedures in place to safeguard against conflicts of interest, says Barnes. But the task force set about to centralize and codify them, and to make them more explicit. “I think more important than the policy was the process we put into place to educate our [internal] communities [about conflicts of interest] and to monitor compliance,” she says.

No gifts
In November 2007, the new policy was published, and it went into effect February 2008. Among its key provisions are the following:

  • Schools of Health Sciences and UPMC personnel may not accept personal gifts, including food, from industry representatives, regardless of the dollar value of the gifts.
  • Consulting arrangements between industry and university or UPMC personnel must be reviewed and approved in advance. Consulting contracts without any substantial job duties are considered gifts and, therefore, are prohibited.
  • Industry representatives must register with UPMC supply chain management and be specifically invited to meet with healthcare providers for a specific purpose to be allowed into Schools of Health Sciences or UPMC facilities.
  • Attendance of faculty and physicians at industry-sponsored meetings is subject to restrictions designed to ensure that such events promote evidence-based clinical care or advance scientific research.

Vendors who want to call on UPMC must register with ProTech Compliance, a Pittsburgh-based vendor credentialing firm.

UPMC set up a 24-hour, toll-free Compliance Helpline, to which employees and vendors who do business with the IDN can report potentially criminal activities or violations of the industry relationship policy. Calls to the Helpline are handled in confidence and are not recorded.

What’s more, UPMC weighed the pros and cons of the practice of pharmaceutical sales reps dropping off samples of medications to physicians’ offices. On the one hand, the task force concluded that samples can lead to overprescribing or otherwise influence physicians’ decisions. On the other hand, it realized that samples fill a valuable role, particularly in helping patients who can’t afford the cost of some medications. In the end, UPMC implemented a Web-based system called the eSample Center, developed by MedManage Systems Inc., Bothell, Wash., in which physicians order the samples they want online. The medications are then shipped to their offices.

Getting the word out
Key to implementing the new policy was communicating it to employees and others who work and train at the IDN, as well as the faculty, staff and students at the Schools of the Health Sciences. The policy was posted on a special Web site (www.coi.pitt.edu/IndustryRelationships). Included on the site are Frequently Asked Questions, key contacts, and a variety of educational tools for vendors, clinicians and others. Working groups and committees supplement the efforts of the departments and administration to keep the principles of the policy in front of UPMC staff.

And vendors? “Overall, there has been a high level of interest by industry in understanding our policy and wanting to comply with it,” says Barnes. “When issues did arise, we had processes in place to communicate with the employers of the [sales] representatives, and we worked with them to achieve resolution. Everyone is recognizing that we have a responsibility for transparency and professionalism.”

Almost 3,600 industry representatives have taken an online training course that synopsizes the industry-relationships policy.

Impact on acquisition of new technology
“We do a lot of supplier education, seemingly on a daily basis,” adds Jim Szilagy, chief supply chain officer for UPMC. He has found the industry relations policy to be most helpful in the evaluation and acquisition of new technology. “We try to control new technology that enters into the system,” he says. “We have processes in place that help us do that. And as we get better at this …we’re able to do the evaluations, bring in the products we want and prevent those we don’t want from coming in.” In the last fiscal year, the supply chain staff fielded 137 new-product requests. Seventy-nine trials were conducted and 37 new products and technologies were brought in. “We were able to vet them through the right process and only include those that would actually be beneficial to our patients and clinicians,” he says.

“This points to a very interesting challenge for academic medical centers,” adds Barnes. “We need to bring the latest and greatest of healthcare to our patients, and that involves new drugs and services.” On the other hand, providers have to deal with fiscal constraints. “This creates some competing priorities.”

Such issues aren’t resolved quickly or easily. That said, with its industry relations policy in place, UPMC is working on it. “A real benefit of the policy – and maybe an unintended consequence on the positive side – has been the improved communication among the departments, particularly supply chain management,” says Barnes “This was an area I never had much formal interaction with.

“By delineating processes for communication, we’ve been able to better understand some of our common interests and concerns, and collaboratively address them. It has allowed us to take a more broad-based approach to work out some of these challenges.”