In 2002, Medtronic gained approval for a product called Infuse. The artificial bone graft uses a genetically engineered protein called rhBMP-2 to help regrow bone in the spine. Although the idea sounded promising, within only several years of being on the market Infuse was called into question over its potential side effects.
Medtronic has been accused of promoting Infuse for off-label (unapproved) uses such as in the cervical spine. In 2008, the U.S. Food and Drug Administration (FDA) warned that using Infuse off-label in the cervical spine could lead to a life-threatening injury.
In 2011, an entire issue of the Spine Journal was dedicated to highlighting the complications of Infuse. The authors of the review, led by Editor-in-Chief Dr. Eugene Carragee, criticized Medtronic-funded researchers for failing to mention a number of side effects, including the risk of cancer, increased back and leg pain, infections and male sterility. The spine experts also pointed out the fact that surgeons were paid millions by Medtronic.
The Spine Journal publication was a rare and unusual move scientists, dealing a serious blow to Infuse’s reputation. In response to the growing criticism over the product, Medtronic funded $2.5 million to have two groups independently review all the data from its studies. The review, which involved studies from one British group and one Oregon group, was led by Dr. Harlan Krumholz of Yale University. Both teams were given detailed data from 17 spinal studies involving over 2,000 Infuse patients, safety reports given to regulators and other publications.
The Oregon group, from the Oregon Health & Science University in Portland, found that Infuse did not work better than a traditional bone graft and came with a low but increase risk of cancer; a traditional bone graft uses bone from a patient’s own body. The studies were published on June 17th in the Annals of Internal Medicine.
Late last year, a report from the US Senate found that Medtronic employees had helped write and edit studies promoting Infuse. The so-called ghostwriting is considered a serious breach of integrity in the scientific community because the bias can affect a decision about a patient’s health.
In commenting on the review, D. Krumholz told Bloomberg that “I remain concerned that products like these are approved with too little study before they reach the market and too little afterward…There is a tremendous amount of uncertainty about the benefit it provides and how safe it is.”