Overview: Medtronic has been faced with a number of issues over Infuse, an artificial bone graft product that utilizes a bone morphogenetic protein (BMP). The device has become controversial following reports that Medtronic allegedly paid doctors to hide serious side effects such as male sterility and cancer. Things only got worse for Medtronic when a Senate report issued late last year found that a number of studies promoting Infuse were likely biased, as they were edited and written by Medtronic employees. The safety issues have apparently not failed to take a toll on Medtronic’s revenue. The Memphis business journal reports a decline in the company’s spine division; the company said this is at least partially due to a drop in BMP sales.
- Medtronic’s Spinal Division suffered a third quarter decline of 3 percent; this can be partially attributed to lower sales of BMP, from which Infuse is derived
- Medtronic Infuse is a controversial product due to reports that doctors were paid to omit side effects
- A Senate report issued last year found that positive Infuse studies were manipulated by Medtronic employees; Dr. Harlan Krumholz has offered expert commentary on the matter
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Drop in Infuse Sales
The Memphis Business Journal reports that overall sales for Medtronic increased 4 percent in the fiscal third quarter. However, the company’s spinal division suffered a decline of three percent in third-quarter revenue to $753 million. This compared to $784 million for the third quarter a year ago. According to Memphis Business Journal, Medtronic said that lower sales of the company’s bone morphogenetic protein, from which Infuse is derived, along with balloon kyphoplasty are the reason for the drop in revenue. Infuse has been a growing issue for the company over the past two years, particularly after the expert reports speculated that doctors were bribed to hide side effects in their Infuse studies.
Medtronic Infuse Safety Issues
In June 2011, the Spine Journal dedicated an entire issue Infuse; a group of spine explored the side effects of Infuse, such as male sterility, cancer, infection, leg and back pain and other complications. The authors of the review noted that Medtronic-sponsored studies failed to mention these obvious side effects and questioned the integrity of the industry-funded research. This report at least in part influenced the United States Senate Finance Committee to further investigate the matter. In a report issued late last year, the Senate Finance Committee found that several studies promoting Infuse had been edited, or “ghostwritten” by Medtronic employees. This type of manipulation is not illegal, but is considered a breach of integrity.
Yale has been recruited to conduct independent research on Infuse and its potential side effects. The review is being led by Dr. Harlan Krumholz, a professor of medicine at Yale. In commenting on the events, Krumholz told Bloomberg that “Sometimes what you are reading about in a study may not be everything…We have to change the way this kind of science has been conducted.” He stated to Star Tribune that “Time and time again, I have seen instances where the process is not fully independent and, at the end, the science is being commingled with other interests”.