At ASCO Annual Meeting, a Candid Look at Conflict of Interest

Cynthia J. Gordon, PhD

Disclosures

July 08, 2015

In This Article

The Forecast for Sunshine

Symposium panelist Mark Ratain, MD, the Leon O. Jacobson Professor of Medicine at the University of Chicago, published a paper in the Journal of Clinical Oncology last year detailing his concerns about the Sunshine Act.[14]

"Like the weather forecast for Chicago"—where the ASCO annual meeting is held, and which had been experiencing intermittent rain for the past several days—"it's worse than we thought," Dr Ratain said, eliciting a guffaw from the audience.

The goal of the Sunshine Act was to create transparency. Ideally, it would scrutinize industry relationships with physicians, thereby discouraging unethical behavior and inappropriate prescribing of expensive drugs, Dr Ratain said. And, it potentially would affect patients' choices about physicians.

Can it really achieve all of this? "I say [that] the Sunshine Act is unlikely to have significant benefit," Dr Ratain stated.

First of all, he noted, patients are unlikely to access the data. And even if they do, most of the data represent noise rather than signal.

"Let's suppose a patient looks at the data and says, 'Gee, maybe I want to change my physician,'" Dr Ratain said. "I think a patient is only likely to consider doing that if they have a problem with their physician anyway—in which case they probably should go find a different physician regardless of what's in the database."

"There's plenty of bias out there," he added. "And there are plenty of financial incentives out there that are not going to be illuminated or significantly impacted by financial transparency reporting," Dr Ratain said.

Take, for instance, this British cartoon about dentists, Dr Ratain said, showing the audience a depiction of a patient, mouth agape, with "£" symbols inscribed on each tooth. How many jokes are there along the lines of "My dentist needs a new boat?" he asked. Patients are aware that healthcare providers—physicians and dentists—have financial interests.

The irony is, he continued, that Congress approved the Sunshine Act, knowing that financial transparency reports have little impact.

"It turns out that some of the most popular stocks in Congress are companies that spend the heaviest on lobbying," Dr Ratain said.[15] "As opposed to Open Payments, I would refer everybody in this room to MapLight.[16] And then I'd like you to write your congressman and tell him, 'I'd like to change congressmen, because I don't like your financial transparency reports,'" he said, drawing even more laughter from the audience.

Dr Jagsi agreed that the limited transparency offered by the Sunshine Act is probably not a panacea.

"Let's assume that they could actually fix all of the problems that happened in that system, and that we could have a wonderful, clear system of disclosure that was accurate," she suggested. "Would that be enough?

"It's unclear whether patients can truly make appropriate sense of this very complex information on physicians' financial incentives or detailed disclosure statements and determine the weight to give their advice in various scenarios," she said. "It may be that we're asking too much of patients by saying, 'We'll gather all this information and present it to you, and then you can decide how to interpret this information.'"

If disclosures don't matter, why bother?

"Let's be candid," Dr Moy said. "One of the reasons we care about COIs so much is that we care about the public perception of our profession."

By definition, "financial COIs occur when physicians are tempted to deviate or do deviate from their professional obligations for economic or other personal gain," Dr Moy said. "So you can see why COI is an essential medical ethics issue—because it interferes with the fiduciary nature of the patient/physician relationship, where it's expected that we avoid COIs that may undermine patient care.

"Traditionally, these policies have relied on disclosure," she continued, where we trust physicians and researchers to transparently disclose all relevant financial relationships. "But is mere disclosure enough?" she asked. "The answer may be no."

There has been growing concern that management of COIs requires stronger measures than just disclosure. Dr Moy cited a 2014 New York Times piece, "Doctors' Magical Thinking About COIs."[17] In it, Dr Aaron E. Carroll called out radiation oncologists specifically:

Our thinking about COIs isn't always rational. A study of radiation oncologists found that only 5% thought they might be affected by gifts.... This "magical thinking" that somehow we, ourselves, are immune to what we are sure will influence others is why COI regulations exist in the first place. We simply cannot be accurate judges of what's affecting us.

To be fair, Dr Moy noted that the study cited by Dr Carroll was more than a decade old and surveyed only 241 radiation oncologists. "But, these are very provocative data," she said.

So besides disclosure, what else is there?

In recent years, COI policies have moved from merely requiring disclosure toward prohibiting specific relationships. In 2013, ASCO revised its COI policy to "prohibit abstracts and papers in ASCO journals if the first, last, or corresponding author is a company employee or paid speaker."[18] This led to outcry from some ASCO members, who said that prohibiting these studies from the ASCO forum could be detrimental to oncology, Dr Moy said. As a result, ASCO suspended the policy in the following year for 3 years in order to collect data.

In an examination of ASCO's initial, disclosure-only policy, A. Craig Lockhart, MD, MHS, of Washington University in St Louis, Missouri, surveyed 1967 ASCO members (about 80% "producers" [researchers and physicians] and about 20% "consumers" [patient advocates]).[19] They found that more than 30% of consumers were not familiar with the policy, and that about 25% rarely or never bothered to read disclosures. Despite that, approximately 55% thought that the policy should be more rigorous than disclosure alone, compared with about 35% of producers.

When asked to indicate the types of relationships that were most "concerning," a majority of ASCO members cited "speakers' bureau (slides provided)" presentations and "stock ownership" (72% and 81%, respectively). Regarding what strategies for management of COIs might be most effective, most respondents thought that "public disclosure," "peer review," "auditing of content," and "alternative views presented" would be effective.

Dr Jagsi suggested adding more distance between industry and physicians as an alternative strategy to minimizing COIs: "Rather than providing samples for low-income patients, how about providing vouchers? How about indirect, rather than direct, funding of CME [continuing medical education]? How about limiting grants for research to institutions rather than individual physician-investigators?"

With oncology research evolving to include more private funding and industry ties, it's critical to develop effective strategies for COIs, Dr Moy said.

"And it's crucial for us in the oncology community to inform the development of these policies, so that they truly foster public interest and are not just reactionary," she said.

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