Medical Journals Fare Poorly in Latest Medtronic Infuse Scandal

The most recent scandal involving Medtronic Inc.’s <"http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft">Infuse bone growth product is raising new questions about some prestigious medical journals. In light of the latest Infuse revelations, one must wonder if publications like the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA) do enough to screen for financial bias in the studies they publish.

Last week, we reported that The Spine Journal had taken the unprecedented step of devoting an entire issue to Infuse (aka recombinant human Bone Morphogenetic Protein or rhBMP-2). The issue revealed that many Medtronic-funded studies of Infuse downplayed its association with serious side effects, including male sterility, infection, bone loss and unwanted bone growth.

According to The Spine Journal, in 13 Medtronic-funded studies conducted between 2000 and 2010, such problems occurred in 10% to 50% of patients who were administered Infuse or a sister product. However, the complications weren’t reported in the final published articles, even though they were peer-reviewed. According to Eugene Carragee, the Spine Journal’s editor, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

While most medical journals do require some sort of financial disclosure, how detailed it must be varies among publications. According to ProPublica, The Spine Journal requires dollar amounts to be reported within ranges and makes the information available to readers. However, this is not common, as most journals don’t require authors to list ranges or specific amounts. For instance, NEJM, JAMA, and the Annals of Internal Medicine use the same disclosure form that requires authors disclose if they’ve received grants, royalties, or other types of payments from medical companies, but they don’t need to reveal how much they’ve been paid, ProPublica said. And while they must name the companies paying them, authors do not have to identify the drugs or devices that relate to the payments.

There’s also little checking to see if disclosures are accurate and complete, ProPublica said, with most medical journals relying on the “honors system.”

“They can lie to us, and we don’t do lie detector tests,” outgoing JAMA editor Catherine DeAngelis, told ProPublica. DeAngelis pointed out that 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.

Sadly, ensuring against financial conflicts-of-interest doesn’t seem to be a big priority for some medical journals. When asked by ProPublica what she would do if she had more money or staffers, DeAngelis replied, “Believe me, it wouldn’t be for that.”

This entry was posted in Defective Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.