Money talk has rarely been an easy conversation between doctors and their patients. But the Association of American Medical Colleges is placing bets that a good deal of financial transparency will go a long way toward improving trust between doctors and their patients.
Tipping their hand
AAMC wants physicians to disclose conflicts of interest to patients
The group last week released its third and final report in a series on financial conflicts of interest. This one, In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making, focuses on how academic medical institutions and their physicians should address and disclose to patients financial conflicts of interest that have the potential to negatively affect the delivery of patient care.
“This report focuses explicitly on the physician's interaction with the patient,” Joanne Conroy, the AAMC's chief healthcare officer, said during a June 30 news briefing.
Conroy noted that previous AAMC reports on financial conflicts of interest have dealt with more internal types of disclosures: the need, for example, for a physician to disclose a financial tie to a company when he is presenting related continuing medical education material or for a principal investigator to disclose an ownership interest in a company for which she is conducting clinical research.
But the new report, Conroy said, tackles how academic medical institutions and their doctors should disclose to patients any industry relationships that could hold sway over what treatments they recommend. Those relationships include, but aren't limited to, medical-product company ownership, royalty deals and research and design involvement. “Less than 1% of medical schools have adopted policies on conflict of interest in clinical care,” said Conroy, who called such disclosures a “new concept.”
The AAMC report isn't the first to address clinical-care conflicts of interest, however. In April 2009, the Institute of Medicine published Conflict of Interest in Medical Research, Education and Practice. The report, in part, addressed clinical-care conflicts of interest, but it largely focused on relationships that aren't integral to the practice of medicine and could be easily avoided. They included accepting gifts and meals paid for by industry, ghostwriting papers and acting as a promotional speaker for products.
Patrick Brennan, chair of the task force that compiled the AAMC report and chief medical officer of the University of Pennsylvania Health System, said the report differs because it considers how to manage industry relationships that are key to developing therapeutic advances.
“We know that those relationships with industry are important, and we don't want to interrupt them,” Brennan said. “I think physicians are concerned that such disclosures will be off-putting to patients—that they will be perceived as negative and will cast aspersions on the physician. But our experience has been that it actually raises the physician's stature in the patient's eyes. They're pleased to know that their doctors are involved in the development of medicine and devices.”
Estimates of how much money is paid by drugmakers and devicemakers to physicians in consulting fees were not available from the IOM report, the AAMC or other sources.
Among the task force's recommendations are that academic medical centers set thresholds for reporting, evaluating and disclosing physicians' relationships with industry; involve their patient communities in determining how doctors and the institution should convey financial conflicts to patients; and consider how different reimbursement models may also influence doctors' clinical decisions.
The report pushes the premise that doctors should disclose their conflicts to patients in the clinical setting when those conflicts are directly relevant to prescribed care. The big question for many clinicians and administrators, however, is how best to make those disclosures. Should it be in writing, or through a direct conversation?
A growing number of healthcare-related institutions and companies have begun listing physician payments online, but Conroy said research suggests that less than 5% of those sites' hits come from patients. What's more, simply listing payments does not provide patients with perspective for understanding the nature of a physician's work, Conroy said. “In the report, we say it's really the physician who should be having a conversation with the patient when a conflict reaches a certain level.”
Steven Findlay, senior health policy analyst for Consumers Union, applauded that proposed approach, but acknowledged that providers have a challenge to meet in determining how best to have such conversations with patients.
“Obviously, this is an evolving area and there are no best practices,” Findlay said. “Frankly, some patients don't know what a conflict of interest is. They'll feel disoriented having that conversation. But if doctors adopt very simple and clear language, then disclosure will be very helpful.”
Implementing such disclosure policies will, no doubt, be challenging, particularly without a thorough understanding of what patients deem relevant when it comes to conflicts of interest.
To begin with, Conroy said, the medical community does not have a lot of evidence about how patients use disclosures. There is a dearth of studies not only about the effect of conflict-of-interest disclosures on patients' care decisions, but also a lack of information about what kinds of conflicts and at what dollar level patients believe it is important for doctors to disclose.
Guy Chisolm, vice chair of the Lerner Research Institute at the Cleveland Clinic and a member of the AAMC task force, said his organization is one of the few medical institutions to have implemented a clinical-care conflict-of-interest disclosure policy.
In 2008, the clinic began listing in physicians' online biographies any equity ownership in medical-product companies, royalty payments, financial compensation from drug and medical-device companies exceeding $5,000 and any industry-related board memberships.
Last year, the provider began talking with patients about how best to have doctors disclose relevant conflicts of interest during appointments or care episodes. The clinic sent questionnaires to 3,000 members of a patient panel. Officials were surprised by what they learned.
“If you ask them what they wanted to know about their doctors' conflicts, the majority want to know a lot,” Chisolm said. “They want to know the dollar amount, the company.” But the panel was less clear, Chisolm said, on how it wanted to learn about that information. “We talked about putting out a brochure that talks about the industry partnerships or including a line item about it in appointment reminders, but when we ran that by our patient group, they didn't like it. They weren't quite clear whether it was the wording or information overload, but I had a difficult time coming away with a take-home message.”
Josephine Johnston, a research scholar with the Hastings Center, a healthcare ethics think tank, believes pilot studies could help uncover the types of disclosure that would be most effective. “Studies that say what happens when we make these different forms of disclosure would be helpful,” she said. “And, if the disclosure doesn't change a patient's treatment decision, did they feel like the information was still helpful?”
While disclosure was at the center of the AAMC task force's recommendations for managing clinical-care conflicts of interest, the group also stressed that simply revealing conflicts to patients isn't enough to ensure undue influence of industry relationships on treatment decisions. The task force said academic medical centers need to take a leadership role and put in place mechanisms for minimizing the effects of the conflicts.
James Crane, associate vice chancellor for Clinical Affairs at St. Louis-based Washington University and CEO of the medical school's physician faculty group practice, concurred with the group. His organization put in place a clinical-care conflicts of interest policy roughly 4½ years ago. Among other measures, the policy requires that doctors and the institution at large not accept royalty payments for any products that are purchased or prescribed at the university medical center. The medical center also reviews all of physicians' consulting and royalty agreements to ensure they meet certain fair-market-value standards.
“I do think academic medical centers need to be leaders in this area,” Crane said. “I think these kind of consulting relationships also occur in community hospitals, but we have a special duty because we train the next generation of physicians.”
The AAMC task force's suggested actions for managing clinical-care conflicts of interest included making a record of verbal disclosures in patients' medical records so organizations can begin tracking how patients respond with regards to their treatment decisions; having a colleague provide documented corroboration when a physician prescribes or uses a device in which the doctor has a financial interest; appointing an oversight committee to monitor practice patterns; or transferring a patient to the care of another physician.
“It's an important point to make that there are other steps aside from disclosure that academic medical centers should take, because by the time you're sitting in the doctor's office, it's very unlikely that you'll turn around and leave because of a conflict of interest,” said the Hastings Center's Johnston.
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