There have safety concerns surrounding Infuse for several years, but this product truly became a subject of controversy after a group of spine experts publicly denounced Infuse in the June 2011 edition of The Spine Journal. The authors of the study contended that Medtronic-paid researchers failed to mention a number of serious side effects related to Infuse, including:
- Retrograde ejaculation (leading to male infertility)
- Radiating back and leg painr
According to the review, the rate of Infuse complications is 10 to 50 times higher than what is estimated in the 13 Medtronic-funded studies. The journal also reported that the doctors listed as co-authors were paid a median of at least $12 million to $16 million per study by Medtronic. The Spine Journal review was published shortly after other studies found that Infuse was related to retrograde ejaculation.
Concerns escalated after the Spine Journal publication, and in an effort to prove that their product was safe and effective Medtronic asked Yale to conduct independent reviews based on the study data. The two independent studies, which were published on June 18, 2013 in the Annals of Internal Medicine, both suggest that Infuse does not work and may cause serious health problems, including cancer.
Dr. Harlan M. Krumholz, a Yale Professor who oversaw the review, said that while the two research teams had slight variations in their results, both studies found little reason to use Infuse. “The general, overall picture is that they failed to find a big benefit” said Dr. Krumholz to the New York Times. “And they found there might be some harms.” Overall, the reviews found that the early Medtronic studies underreported side effects while placing emphasis on favorable results. One team, led by scientists at Oregon Health and Science University, found a small, increased risk of cancer with Infuse. The other team, led by researchers from the University of York in England, found little evidence for using Infuse over a traditional bone graft, which takes bone from the patient’s own body.
Medtronic Manipulated Research Studies
The allegations made by the Spine Journal authors have led to numerous investigations and suspicions about Medtronic’s conduct with regards to Infuse. In October 2012, the U.S. Senate Finance Committee issued a report following their 16-month investigation. The report showed that doctors listed as authors were paid approximately $210 million over 15 years in royalties and consulting fees. The investigation’s findings state that Medtronic never disclosed these close financial ties to the public. Furthermore, the published medical studies never mentioned the serious risks associated with Infuse.
The Senate report charged Medtronic with manipulating the content of Infuse studies. For example, investigators found internal company documents showing that a Medtronic employee advising against a table showing Infuse complications in a clinical trial. Medtronic employees were found to be involved in every part of the Infuse studies, in some cases they even inserted their own language to portray Infuse in a more positive light.