Medtronic Infuse Studies Investigation. A just-released U.S. Senate Finance Committee report accuses medical device maker, Medtronic Inc., of editing self-funded journal articles and paying physicians massive sums for Medtronic-sponsored studies of its Infuse® bone-grafting product.
The Committee issued its 2,315-page report following a 16-month investigation of over 5,000 documents and 13 separate Infuse® studies. The findings reveal that ties between Medtronic and its physician consultants were, at best, questionable.
Medtronic Inc. is accused of ghost writing sections of 11 medical papers in collaboration with physician authors who received so-called “consulting fees” in the hundreds of millions of dollars to promote Infuse®, the U.S. Senate investigation found, said Bloomberg Businessweek.
Medtronic is also accused of wrongly promoting Infuse® as better than other procedures. “Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic,” Senator Max Baucus (Democrat-Montana), the Committee chair, and Senator Charles Grassley (Republican-Iowa), said in a statement.
The Committee inquiry, which began in June 2011, looked into surgeons paid by Medtronic
The Committee inquiry, which began in June 2011, looked into surgeons paid by Medtronic who did not report Infuse®-related complications. The government report states that Medtronic paid some $210 million in royalties and consulting fees to the physician authors of its self-sponsored studies from November 1996 through December 2010, said Reuters.
Some of the hundreds of millions of dollars paid to the implicated physicians who co-wrote the papers included two corporate entities linked to some of the involved physicians, said the Milwaukee Journal Sentinel and MedPage Today.
Meanwhile, none of the studies mentioned complications related to Infuse® and “The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles.
Medical journals should ensure industry role contributions be fully disclosed,” said the Senate Committee on Finance report, according to Reuters.
Analysis was published in the renowned Spine Journal one week after the inquiry. The North American Spine Society, publisher of the Spine Journal, said in a statement that the Committee report “presents a more detailed and disturbing picture of what can go wrong when ethics and patient safety are compromised for profit,” the Milwaukee Journal Sentinel and MedPage Today said in their joint report.
While studies were presented in a positive light, touting Medtronic’s Infuse® as a landmark treatment in back surgery, they were, in fact, created and edited with direct input by internal Medtronic staff, the Milwaukee Journal Sentinel and MedPage Today jointly reported.
The report states that Medtronic employees—some even in the firm’s marketing department—secretly worked
For example, the report states that Medtronic employees—some even in the firm’s marketing department—secretly worked with physician authors to create the 11 papers from 2002 to 2009.
The practice, although not illegal, is criticized as being a breach of integrity and transparency, said the Milwaukee Journal Sentinel and MedPage Today. Doctors and patients use these articles to come to medical decisions and expect these documents to be unbiased and accurate.
And, while none of the Medtronic-funded clinical trials reported Infuse® side effects, FDA data revealed that nearly half of all patients treated with Infuse® suffered significant complications such as infections, pain, cysts, and cancer, said Businessweek.
The device maker is accused of not only minimizing negative information about Infuse®, it also removed information concerning significant complications and overstated its benefits.
“The findings also should prompt medical journals to take a very proactive approach to accounting for the content of the articles, along with the authorship of the articles and studies they feature,” said Chuck Grassley (Republican-Iowa), senior Committee member, said Reuters. The Committee maintains sole jurisdiction over Medicare and Medicaid.
In recent years, Medtronic has been at the center of controversies that have questioned the safety of Infuse® and how Medtronic marketed its bone growth product.
Medtronic Infuse® was approved by the U.S. Food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients who suffer from lower spinal degenerative disease.
The spinal growth product is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in one type of spinal surgery and some dental procedures; however, the product is used, for the most part, in off-label procedures.
Impact to Medtronic Infuse Bone Graft Patients
“Medtronic’s actions violate the trust patients have in their medical care,” said Senator Baucus. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” the Senator added, according to the Businessweek piece.
“I am just sad this happened,” said Ray Baker, MD, a Kirkland, Washington, pain specialist who also was part of an advisory panel to Medicare and Medicaid on Infuse®. The Committee’s problems reveal issues that should have been addressed at least ten years ago, Baker noted.
“At every level when we thought, ‘that wouldn’t happen,’ it happened. The integrity of our scientific literature is our foundation. It’s what predicates our treatments,” he said, according to the Milwaukee Journal Sentinel and MedPage Today.
Meanwhile, patients continued and continue to suffer from serious, long-lasting injuries related to the highly marketed Infuse®, such as such as male sterility, increased cancer risks, infections, bone dissolution, and increased and worsening back and leg pain.