The United States Senate's Finance Committee released a report today, which stated that Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees.
Medtronic is a leading company in the medical device industry, and is the world's largest maker of heart-rhythm products. The report mostly concerns Medtronic's care of the InFuse device, which uses a genetically engineered protein to create bone growth for spinal fusion surgery along with a fusion device. For a time, the InFuse device, which was approved for use in 2002, was a huge moneymaker for Medtronic, garnering the company $800 million a year. Its sales have since plunged since a series of articles written in The Spine Journal showed that InFuse elevated risk for infertility, infections, and cancer. Since then, sales of the device are a fraction of what they once were, at $141 million during the second quarter of 2011.
The Senate's report, written after the committee reviewed 5,000 of Medtronic's documents over 16 months, found that the company was heavily involved in "drafting, editing, and shaping the content of medical journal articles". While 13 articles about the device stated that InFuse had no side effects, the documents released by the Food and Drug Administration found that as many as half of the patients enrolled in trials experienced pain, infection, cysts, and other complications. The report also states that "[an] e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse effects possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article" and that Medtronic officials inserted language into articles that would make InFuse seem better than the alternative, a bone graft procedure, by emphasizing the pain of the surgery.
The report also stated that Medtronic paid $210 million to physician authors from November 1996 to December 2010. But Drs. Glassman and Dinar, who co-authored a 2007 Amplify study with Dr. Boden, stated that they wrote and edited the articles themselves, and that they mentioned InFuse's adverse effects in numerous peer-reviewed publications. They say that the $9.7 million that they received from the company were for royalties. But their Amplify article did not disclose the contributions that they received from Medtronic. According to The Wall Street Journal, the disclosure read in part, "No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript."
Medtronic said in a statement about the matter, "Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events. In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product's FDA-approved label. In addition, the staff report's characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments. In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry."