Device maker Medtronic Inc. saw sales of its Infuse Bone Graft product fall again in the first quarter of this fiscal year. According to to Medtronic’s quarterly earnings report, Infuse sales shrank to $141 million in the first quarter of 2013, down from $174 million from the same time last year, a slide of 19%. The Infuse decline weighed on Medtronic’s core spinal business, which saw sales fall to $645 million in the first quarter, down from $651 million last year.
Medtronic Infuse is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in a certain type of spinal surgery. Over the last several years, Medtronic has been embroiled in controversies that have shed doubt on the safety of Infuse, and the company’s marketing of the product.
Medtronic’s Infuse problems began in 2008, when the U.S. Food & Drug Administration (FDA) issued a safety alert warning that Infuse Bone Graft had been associated with serious complications when used in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage. While Infuse hasn’t been approved for cervical spine procedures, it’s been estimated that 85% percent of the procedures that employ Infuse constitute off-label uses of the product.
Last summer, the Spine Journal raised serious questions about the validity of the research that was used to gain FDA approval of Infuse. The journal’s critical analysis of 13 Medtronic sponsored Infuse trials found that the studies failed to report serious complications, including:
- Ectopic or uncontrolled bone growth
- Ongoing or chronic radiating pain in the legs or arms
- Male sterility
- Retrograde ejaculation
- Nerve injuries causing severe and chronic pain
The same study also raised concerns about the financial ties between Medtronic and the researchers who conducted the 13 studies. Some apparently had associations with the device maker valued at more than $10 million.
The publication of the Spine Journal expose prompted Medtronic to take the unusual step of commissioning researchers at Yale University to review Infuse clinical trials. Results from that review are expected later this year
In 2011, another analysis found that the high doses of Infuse that are often needed in off-label procedures could be associated with an increased risk of cancer. The study was conducted by Dr. Eugene Carragee, a prominent spine researcher at Stanford University and frequent critic of Infuse. Carragee was also the author of the Spine Journal critique that questioned the Infuse clinical trials.
Infuse was also the targeted by a Senate investigation last year, sparked by the concerns raised by the Spine Journal study. The U.S. Justice Department recently closed an investigation of Medtronic’s marketing of Infuse without bringing any charges. In March, however, Medtronic agreed to pay $85 million to resolve a federal lawsuit brought by shareholders that alleged the company’s officers and executives made false and misleading public statements about Infuse, which then artificially inflated the company’s stock price.