It's Complicated: Taking Conflict of Interest Beyond Pharma Payments to Researchers

I wrote a piece recently for Health News Review about conflicts of interest. The original post is below, followed by more great examples of writers describing unexpected conflicts in detail.

When writers mention conflict of interest in a story it typically is in one context: researchers taking money from Big Pharma. But conflicts abound in medical research, so much so that documenting all the conflicts can seem daunting, especially in a breaking story.

Matthew Perrone at the Associated Press made it look easy last week with the story "New device uses light to screen for melanoma," which Dr. Steve Atlas and I reviewed for Health News Review. Under deadline pressure, Perrone did a terrific job on the story and, as far as conflicts go, went well beyond what most reporters do. Here are some of the conflicts he found that other health writers should look for:

Physician groups. Every other story about a disease or device quotes a past or present official with the relevant professional association. The first quote in Perrone's story is from a well-known dermatologist, Dr. David Pariser, who says, "Every day patients come in with 20 moles on their back and the dilemma is, which ones are suspicious and need to be biopsied?"

Pariser, as Perrone notes, is the past president of the American Academy of Dermatology, but he also has a stake in the device's success. He "consulted for the device's maker, Mela Sciences Inc. of Irvington, N.Y., on its presentation to FDA."

Expert sources. Perrone contacted Dr. Leonard Goldberg for some outside expertise on the device. Goldberg seems like a good choice. The former Chief of Dermatologic Surgery at Baylor College of Medicine has published numerous papers on skin cancer. In describing Goldberg, though, Perrone made sure to point out that Goldberg has at least one significant corporate tie that might play into how he views skin cancer. He called Goldberg "a dermatologist at the Texas Medical Center and vice president of the Skin Cancer Foundation, a disease awareness group that accepts donations from makers of sunscreen."

Decision-makers. When Perrone researched Dr. George Elias, a Maryland oncologist, and found that he "had no ties to the company or the device," he might have decided just to quote him without any caveats. But he made it clear to readers that Elias, too, had placed his faith in the device's success. "Elias voted with the majority of an FDA panel that narrowly endorsed the device last year."

This is important context because, as Perrone explains, the decision to approve the device was not easy. "At a meeting last fall, FDA scientists said Mela Sciences had not shown how its device would influence day-to-day decisions by doctors. The agency also worried about its use by general doctors not accustomed to identifying suspicious skin moles. Despite these concerns, the panel of advisers narrowly backed the overall safety and efficacy of the device in a 8-7 vote."

Regulatory agencies. The debate over whether to approve a new device or drug is not uncommon, but you would not get that impression from most news stories on approvals. Time-pressed reporters often just take the press release from the company involved and interview a few people for quotes. The regulatory history is deemed just that. Perrone, though, set the stage for what may be a troubled future for this device. He did this, in part, by holding the U.S. Food & Drug Administration accountable the same way he held everyone else in the story accountable.

"Regulators worried that the device could give physicians a false sense of certainty, leading to fewer biopsies," Perrone wrote. "Another concern was that doctors could misinterpret the device's feedback, particularly error messages when a mole cannot be scanned. Regulators said this week that they ultimately approved the device after Mela Sciences agreed to limit its use to board-certified dermatologists who undergo a specialized training course."

Perrone pressed Christy Foreman, the director of FDA's Office of Device Evaluation, for an answer on why the agency did an about-face. "This device represents new technology. At the end of the day I don't know that this will be the best technology out there, but it is a step forward to allow continued innovation in this area," Foreman said in Perrone's story. That's far from a ringing endorsement and a nod to the agency's dual role as both a safety watchdog and an "innovation" booster.

Perrone's piece is a nice reminder of the importance of pointing out conflicts, even with just a phrase or two. There's no need to belabor them in a quick story or to make it seem like something nefarious is going on. Readers deserve to know, though, where your sources stand, how they are connected to the issue at hand and whether they have a stake in the outcome.

And here are a few other strong examples of conflict-of-interest reporting:

Ghostwriters: Often it takes several years before news leaks out or a Congressional inquiry turns up evidence of pharmaceutical company ghostwriting in the medical literature. Laura Newman at Medscape put concerns about ghostwriting right into the lead of her story on a psoriasis drug. "Briakinumab (Abbott) has been proven to be a far more effective drug than methotrexate for improving moderate to severe psoriasis, according to a 52-week, head-to-head-trial published in the October 27 issue of the New England Journal of Medicine.

But an outside expert criticized the trial for including too few patients and criticized Abbott for hiring a ghost writer to prepare the first draft of the article." Later, Newman writes, "Abbott Laboratories provided support for the study, and the first draft of the manuscript was written by a medical writer employed by Abbott, with input from the authors."

Competing researchers: In covering a new study, it often makes sense to quote someone who has worked in the same field, but you also need to be mindful of how their own research might be affected by the new study's findings. The Wall Street Journal's Ron Winslow noted recently that a researcher he was quoting had more than one reason to say good things about a study on preventive mastectomy that confirmed his earlier findings. "Several other published studies have subsequently contradicted the 2007 findings.

Monday's study, though, is special because it is population-based, not based on patients going to a clinic. Therefore it has a broader representation of mutation-carrying families, said Mark Robson, clinic director of the clinical genetics service at Memorial Sloan-Kettering Cancer Center in New York. Dr. Robson, who wasn't involved in the study but whose team did a study that also contradicted the 2007 research, wrote an editorial accompanying it."

Everything else: Antidote especially likes the growing trend in disclosure boxes at the end of the stories. WebMD does it regularly, as does MedPage Today, which gives them a bright baby blue color that can't be missed. Peggy Peck, MedPage's executive editor, wrote about a new "good cholesterol" boosting drug, saying:

The evacetrapib trial was funded by Eli Lilly, which is developing the drug. Nicholls reported receiving significant research grants from Eli Lilly, AstraZeneca, Novartis, Resverlogix, Roche, Anthera, and LipoScience. He also disclosed receiving payment for serving on speakers' bureaus or as a consultant to Merck, Takeda, Roche, CSL Behrin, Sanofi-Aventis, Omthera, Eli Lilly, Boehringer Ingelheim, and Abbott. Nissen said the Cleveland Clinic has received funding to perform clinical trials from AstraZeneca, Pfizer, Novartis, Karo Bio, Takeda, Resverlogix, and Eli Lilly.

Cannon reported receiving grants from Merck, GlaxoSmithKline, Accuetrics, AstraZeneca, and Takeda. He has received consulting fees and honoraria from Pfizer, and support for travel and meeting expenses from Merck, GlaxoSmithKline, AstraZeneca, BMS Sanofi, Alnylam, and Novartis. He also said he received payment for independent symposia from AstraZeneca and for serving on data safety monitoring boards at Merck as well as consultancies for BMS Sanofic, Alnylam, and Novartis (funds donated to charity). He said he owns stock in Automedics.

When disclosure boxes can be nearly as long as the story (or the study that prompted the story), you have to wonder what's going on with all the stories out there that provide not even a shred of information on potential conflicts of interest.