Medical journals have long had to wrestle with the possibility that financial bias influences the work they publish, but if the growing controversy over Medtronic's Infuse spinal product is any indication, they may not be doing enough.
That's according to the Spine Journal, which this week published an entire issue focusing on the clinical research and literature around Infuse, a blockbuster bone-growth protein sold by Medtronic. According to the journal, the doctors engaged in industry-funded studies of Infuse downplayed its risks and some had staggering financial ties to Medtronic that weren't adequately disclosed in their published research.
"Can the reader tell if the authors have a trivial relationship with the industry or do the authors receive millions of dollars each quarter from the sponsor?" asked an editorial in the Spine Journal. "Although you may wonder, you would not likely be enlightened."
In our series Dollars for Docs, we've been tracking how money from the drug and device industry has pervaded the medical field and influenced the decisions that doctors make both in the clinical setting and in research.
According to Eugene Carragee, a professor of orthopedic surgery at Stanford and editor of the Spine Journal, readers "absolutely" need to be informed of the dollar amounts that doctors are receiving from industry. These days, all medical journals require their authors to make some type of disclosure about potential conflicts of interest, but some require more detail than others. They also vary in how much of the information they then disclose to the public. Carragee's journal, for instance, requires dollar amounts to be reported within ranges and makes the information available to readers.
But his is the exception. Leading U.S. medical journals such as the New England Journal of Medicine [PDF], Annals of Internal Medicine, and Journal of the American Medical Association don't require their authors to disclose ranges or specific amounts that they're receiving from sponsors. The three journals use the same standard disclosure form [PDF] first developed in 2009 by the International Committee of Medical Journal Editors.
The form does require authors to disclose what kind of ties they have to sponsors of the article and other drug and device companies. Authors are asked to check off whether they've received grants, royalties, consulting fees, writing fees, speaking fees, money for travel, or have stocks or other potential conflicts of interest. The form asks them to specify the companies that are paying them—but it doesn't require that specific drugs or devices related to the payments be named.
Several current and former editors at these journals say the dollar amounts involved aren't what matters—all readers need to know is that a financial tie exists.
Jeffrey Drazen, NEJM's current editor, said it's hard to judge how much money would be enough to bias a doctor: "No matter where I draw the line, there will be some who say it's too much and some who say it's too little."
"The value of disclosure is overblown," added Jerome Kassirer, a former NEJM editor and a distinguished professor at Tufts University School of Medicine.
He said readers often don't know how to interpret disclosures and that journals often don't make them easy to find. NEJM, for instance, posts disclosures on its website but doesn't always include them in the journal's print version.
Major medical journals also rely on an honor system. There's little—if any—checking to see if disclosures are accurate and complete.
"They can lie to us, and we don't do lie detector tests," said outgoing JAMA editor Catherine DeAngelis, who said her publication gets thousands of submissions a year and doesn't have the time or money to hire another staff member to check up on conflict-of-interest disclosures. And if she had the money for one more staffer?
"Believe me," she said, "it wouldn't be for that."
It's not unheard of for significant conflicts to be either undeclared by researchers or omitted by journals. Reuters recently examined reports in the British Journal of Dermatology and found several instances in which researchers failed to report their financial conflicts.
And last year, a study led by Columbia University professor David Rothman found that fewer than half of journal articles authored by researchers with financial ties to orthopedic device-makers actually disclosed them. Rothman co-authored this week's editorial in the Spine Journal.
Sometimes financial ties exist within the journals themselves, not just with their contributors.
As the Milwaukee Journal Sentinel has reported, Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin, conducted several positive studies on Infuse and other Medtronic products while he was editor of the Journal of Spinal Disorders & Techniques, which published some of his work. He also received more than $20 million in royalty payments for several Medtronic medical devices, including one that is used with Infuse. (Zdeblick told the New York Times that he did not have a "direct financial interest in the success of Infuse or Medtronic.")
As we've noted, Medtronic last year adopted a new policy restricting the role of royalty-earning physicians in clinical trials, but it doesn't appear that the policy would apply to studies like those flagged by the Spine Journal.
While the policy bars physicians from serving as clinical investigators for products on which they receive royalty payments, they may still serve as paid consultants or trainers for those products, write about them and participate in clinical studies involving other Medtronic products.
We've asked Medtronic to comment on the policy, but the company instead provided a prepared statement asserting that Infuse is safe, and pledging to "refine our policies as warranted."
Charles Ornstein of ProPublica contributed reporting.