On September 30 of this year, the federal government made public any financial transactions between for-profit companies and physicians that took place during the prior year. As stipulated by the Physician Payments Sunshine Act, the Center for Medicaid and Medicare Services (CMS) has created the Open Payments program database, in which pharmaceutical and device manufacturers report on “transfers of value” to individuals, and the data goes up on the program’s website.
The database is huge and has too many columns to be easily viewed across even two computer screens. You can customize your view and run a search, but it’s sometimes glitchy. Still, the main goal has been accomplished: Patients—or anyone—can type in their physician’s name and find out if they have received monies (or gifts or lunches) from industry.
The motivation behind the Open Payments database is, of course, transparency. And most people agree that transparency is a good thing. What often gets lost in this discussion—and is a major cause of concern—is that, at present, the data is presented without much context. The CMS website says it plainly: “Open Payments does not identify which financial relationships are beneficial or which may cause conflicts of interest.”
And that is where the controversy and concern come in.
The Importance of Context
“Information without context isn’t transparency,” said Heather Pierce, JD, MPH, senior director of science policy and regulatory counsel for the Association of American Medical Colleges (AAMC).”If you don’t understand the data, you’re not better informed.”
Further, some of the transactions listed in the database are questionable, said David Nielsen, MD, executive vice president and CEO of the American Academy of Otolaryngology-Head and Neck Surgery. “It’s not unlikely that a physician who would say they’ve never taken money will still find themselves listed on the Open Payments website.”
This discrepancy is due to the fact that the rules for reporting make it safer for companies to overreport than to underreport. So a company might provide a buffet lunch at a meeting and then take the list of attendees and divide out the cost. “Physicians can challenge data like that,” said Dr. Nielsen. “I know it’s an extra effort, but we [at AAO-HNS] think it’s important to do—dispute it and get it fixed.”
It’s tough to know what patients might make of seeing industry funding to their physicians. Patients should remember that physicians are integral to research and development efforts for new drugs and devices, said Barbara Barnes, MD, associate vice chancellor for continuing education and industry relationships at the University of Pittsburgh Schools of the Health Sciences. “We want our physicians to do research—industry-sponsored research,” she said, noting that the summary data includes royalties. “The only ones who can develop useful new tools are the ones who use them every day in practice.”
Conversations
So what makes a good payment and what makes a bad one? These are the questions physicians are grappling with. “The Sunshine Act has started a lot of conversations that weren’t there before,” said Pierce. “It’s an important conversation to have in our community.”
Academic medical centers have been tooling up their conflict of interest policies for at least the last decade. In 2008, the University of Pittsburgh Medical Center enacted a new unified policy, which covers the medical center and other health science programs such as dentistry and nursing. “We consolidated a lot of separate pieces into one policy,” Dr. Barnes said, and they studied what other organizations and universities had done.
There were certainly tricky areas, and the university task force created working groups to address such things as industry-sponsored education and consulting agreements.
Dr. Barnes considers the policy a living document. As new challenges arise, whether from external forces (changes in regulations) or internal situations (a faculty member who may fall into a gray area), clarifications are issued in formats such as frequently asked questions. “We refine interpretations as needed,” Dr. Barnes said, though she noted that “the principles have been extremely durable.”
“It’s a culture change and a behavior change,” Dr. Barnes added. “We’re all trying to move things in the right direction.”
Determining a Conflict
Medical students are exposed to conflicts of interest and industry relationships much earlier in their careers than their mentors were. At the University of Pittsburgh, for example, students attend a seminar in their first year. “It’s a new world,” Pierce said, “and patient access to communication is part and parcel of becoming a physician in the 21st century.”
Pierce said that students should understand that the database is not a list of wrongdoing but simply a list of transfers of value. A pizza lunch can appear alongside a textbook purchase or research funding. That means physicians have to decide for themselves what constitutes a conflict and what is justifiable.
How should physicians go about doing that? They can start by perusing established conflict-of-interest policies, such as those provided at academic medical centers or by associations such as AAMC.
Information without context isn’t transparency. If you don’t understand the data, you’re not better informed.—Heather Pierce, JD, MPH
If you work for an academic medical center, you must comply with their institution’s policy. Indeed, you may have to justify data that appears in the Open Payments database to your institution. “For us, it’s another data source,” Dr. Barnes said. “We do query the database.”
Moreover, physicians should also think through what different financial transactions or relationships might entail. “Industry has a different goal than physicians—they’re beholden to shareholders,” said Dr. Nielsen. “whereas physicians’ primary goal is patient health. That must be put ahead of one’s own financial or professional interests.”
There is certainly evidence that physicians can be biased by transfers of value. Indeed, these biases can be subconscious unless doctors take the time to think through them. Awareness offers some protection against undue influence. So one question to ask yourself is who benefits from the relationship. Is it you or your patients?
We want our physicians to do research—industry-sponsored research. The only ones who can develop useful new tools are the ones who use them every day in practice.—Barbara Barnes, MD
“You should know what your data look like, why they’re there, and how to explain them,” Pierce said. Most importantly, she added, you should decide whether you want that kind of payment or not. “Are you enthusiastic about the choices you’ve made? Are you willing to talk about those choices, those interactions?” Another litmus test, said Dr. Nielsen, is to “avoid relationships or transfers of value that you’re not willing to read about in a front page news story.”
Associations such as AAO-HNS and AAMC provide their members with resources and fact sheets to help address these issues. They can also act as “firewalls” between industry and physicians, serving as middlemen in a sense, by contracting for unrestricted funds for educational and research activities, said Dr. Nielsen.
Academic medical centers have supports in place for their faculty, such as staff members who review consulting agreements and make sure they are consistent with the institution’s policy. Dr. Barnes recommends that physicians in private practice have someone else review their agreements: “What are the terms? What are you obligating yourself to?”
“This is an opportunity for physicians to acknowledge and talk about the payments they receive and [think about] why they’re important,” Pierce said.
Jill Adams is a freelance medical writer based in New York.