June 29th, 2011
“It harms patients to have biased and corrupted research published…It harms patients to have unaccountable special interests permeate medical research,” read an excerpt from an article concerning the Medtronic bone growth product called Infuse published in a special issue of The Spine Journal entirely dedicated to the matter. In the journal, a series of doctors criticize the research done on the Medtronic product claiming that researchers concealed complications, and minimized risks they encountered during clinical trials.
The New York Times wrote that “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”
Infuse is a product developed by Medtronic for the purpose of facilitating bone growth. It is composed of a bioengineered material, and the product is used in an estimated 108,000 spinal fusions in the United States each year.
“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” said the editor of the special edition of The Spine Journal, Dr. Christopher M. Bono. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”
In 2002, Medtronic reported studies done on Infuse to the FDA as required for approval. The FDA responded by stating that the risk of complications were severe enough to warrant printing them on the label. During the last decade, however, many studies were done on the product, and the ones that were funded by Medtronic concluded that there were no significant risks associated with using Infuse.
No word yet as to how this uncharacteristic outcry by the medical community will affect Medtronic or other medical professionals considering prescribing Infusion