October 25, 2012 — According to a U.S. Senate investigation published today, Medtronic Inc., manufacturer of the Medtronic Infuse Bone Graft, hid evidence of adverse effects, edited health journal articles, paid physicians tens of millions of dollars in undisclosed “consulting fees” or royalty payments, and promoted their products for off-label use.
The investigation found that Medtronic manipulated at least 11 medical journal articles. In many cases, the physicians and researchers never disclosed their financial ties to Medtronic in the publications.
The Senate Committee on Finance found that Medtronic paid about $210 million in royalties, consulting fees, and other fees to a group of 13 physicians who authored Medtronic-sponsored studies over the course of 15 years. The investigation also found that Medtronic “was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by the physician consultants.”
However, the link between Medtronic and the authors was not fully disclosed. According to the Committee,
“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.”
One researcher was Dr. Thomas Zdeblick, who was paid $34 million between 1996 and 2010 in royalties and consulting fees from Medtronic. Dr. Zdeblick, who has been the editor of the Journal of Spinal Disorders & Techniques since 2002, published two studies co-authored by Medtronic. Although the journal published many studies favorable to the Infuse, the financial ties between Dr. Zdeblick and Medtronic were never disclosed.
Medtronic also attempted, unsuccessfully, to gain weaker patient safety rules for a clinical trial to test the Infuse in the cervical spine. This use has never been approved by the FDA because it has been linked to angioedema, a life-threatening swelling in the neck. Medtronic sought weaker safety rules that would have allowed them to continue the study, even if patients suffered severe swelling in their neck.
Serous side effects of the Medtronic Infuse Bone Graft include:
- Excess bone growth
- Swelling in the neck
- Nerve injury
- Male sterility
- And more