by Brendon Nafziger
, DOTmed News Associate Editor | August 04, 2011
Medtronic Inc. will give $2.5 million to Yale University researchers to undertake two safety reviews of its embattled Infuse bone growth product.
In what is thought to be an industry first, the Fridley, Minn.-based company said it would provide an independent team of researchers with full patient data sets in order to examine the company's blockbuster back-treatment product.
Infuse, brought to market in 2002, has come under fire after newspaper reports suggested studies conducted by doctors with financial ties to Medtronic downplayed or didn't report complications and side effects which turned up in later, independent research. Infuse is also called recombinant bone morphogenetic protein-2, or rhBMP-2.
The criticisms prompted a Senate investigation, launched in June
. That month, The Spine Journal, in an unprecedented move, also dedicated an entire issue
to Infuse. One study in that issue found a higher incidence of male sterility linked with the product than described by past industry-sponsored research.
For the new studies, Medtronic will provide unpublished clinical trial information and all adverse event reports filed with the FDA since the product was approved. Outstanding clinical trial results will also be made available on the ClinicalTrials.gov website.
The project will be led by Dr. Harlan Krumholz, a cardiologist and professor of epidemiology and public health at the Yale School of Medicine, who will assemble a committee of 12-15 expert advisors. Then, two unnamed "leading organizations" with "significant expertise" will be tasked with conducting the reviews. Medtronic expects Yale to complete the studies within six months, and make the data available over the next year and a half.
"We understand questions have been recently raised about rhBMP-2 and look forward to sharing our conclusions publicly on the safety and effectiveness of this product at the end of our reviews of a full set of patient-level product data," Krumholz said in a statement.