Financial ties that bind: Studies often fall short on conflict-of-interest disclosures

Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published on Wednesday in JAMA Surgery.

The omission can have a real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest.

“The issue is anytime there’s a new technology, people get really excited about it,” said lead researcher Mehraneh Jafari, M.D. “Whoever is reading the data on it needs to have the most information.”

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The study sought to “assess the credibility and accuracy” of conflict-of-interest statements—also known as COIs—in such journal articles, wrote the researchers. They did this by sampling 10 large surgical and medical device manufacturers. This list includes Medtronic, Stryker Corp., Intuitive Surgical, Covidien, Edwards Lifesciences Corp., Ethicon, Olympus Corp., W.L. Gore & Associates, LifeCell Corp. and Baxter Healthcare.

The researchers also pinpointed the 10 physicians who received the highest compensation from each company. They then searched for articles published by these physicians between Jan. 1 and Dec. 31, 2016, and reviewed the full text of each article for COI disclosure.

According to their findings, those 10 companies paid more than $12 million in 2015 to the 100 doctors included in the study. The median payment to these physicians was $95,993.

Jafari, a surgeon at the University of California-Irvine, said the disclosures aren’t necessarily omitted in bad faith, but standards for disclosure vary from one conference or publication to another.

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“It’s not necessarily because surgeons are trying to hide conflicts of interest, but because the system is broken,” she added. “People don’t understand what the rules are and there’s no one clearing it up.”

It’s a problem because even the appearance of conflict can cast doubt on research, she said.

“We work very hard on our research, it’s difficult to conduct, we’re proud of what we do, and the papers we write might change patient outcomes for the better,” Jafari said. “We don’t want there to be the appearance of bias.”

The researchers concluded that the only way to make sure doctors are upfront about all potential conflicts is to have a universal process for full disclosure for every financial relationship in every paper.

A separate commentary letter by Greg Sacks, M.D., M.P.H., Ph.D., and Joe Hines, M.D., in the same issue of JAMA Surgery suggested, though, that the study might have used too high a standard to determine conflicts of interest. For instance, it cited the case of one doctor who disclosed the relationship he had with one device maker he was writing about but not another one because he didn’t think it was a conflict.

Still, it reiterated the need to revise current disclosure procedures: “Given the enormous sums of money invested by industry into physician relationships, enforcing accurate disclosure … is a critical step to ensuring the integrity and reputation of our fields.”

The financial ties between medical device manufacturers and providers go well beyond academic research and ivory towers.

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As many as 94% of doctors, according to research published in the New England Journal of Medicine, report getting some kind of benefit from the industry. These benefits can range from a fancy dinner or cocktail party with a sales representative to new equipment for students to use in the classroom to payments for being consultants.

With the passage of the Physician Payments Sunshine Act, which became law as part of the Affordable Care Act, medical product manufacturers are required to report to the Centers for Medicare & Medicaid Services payments made to physicians and teaching hospitals, among other things. These payments are tracked in a federal database, which researchers used for this study. The database also offers patients a way to see their physicians’ financial relationships with these companies.

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“I think the better and more information that patients and the public have, the better information they can have for their own care and what providers they turn to,” said Matt Wetzel, vice president and assistant general counsel for AdvaMed, the trade association of medical device manufacturers.

And the financial support is often a good thing, Jafari said. The industry money that goes into the academic end of medicine comes out in the form of better training, better product development and better-prepared surgeons, she added.

Wetzel agreed. “The partnership is really a benefit to patients at the end of the day, but having that context around that relationship is important.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.