A U.S. Dept. of Justice probe into Medtronic Inc.’s (NYSE:MDT) marketing practices for its Infuse bone growth product line is growing, according to a report in the New York Times.
The Old Grey Lady reports that federal prosecutors are grilling physicians in connection with the investigation and have sought records from the U.S. Army, which participated in a later-retracted study investigating the use of Infuse in wounded combat veterans.
Larry Biegelsen of Wells Fargo Securities told the newspaper that Infuse sales will reach nearly $900 million in for the Fridely, Minn.-based medical device goliath this year, with off-label use by doctors accounting for 70 percent to 80 percent of total Infuse sales.
Recently, the FDA put the kibosh on MDT’s Amplify spine device — essentially a turbo-charged version of the Infuse product — saying it’s concerned about links between cancer and the bone morphogenetic protein. The Amplify device was designed to address concerns about off-label use of the Infuse device.
In July, an FDA advisory panel recommended that the federal watchdog agency approve the Amplify rhBMP-2 Matrix, which uses recombinant bone morphogenetic protein-2 to promote bone growth at the site of the implant. It’s designed to treat vertebral compression in the lower back in patients with degenerative disc disease. But the panel was split over the cancer risk posed by the device, voting six to five with three abstentions that the device’s benefits outweigh any risks.
Of the patients implanted with the device in clinical studies, nine developed cancer over a two-year span (3.8 percent of that group), compared with two, or 0.9 percent, in the control group, according to the FDA (PDF). Over a five-year span, there were 13 cancer events in 12 patients in the Amplify group (5 percent), compared with four cases in four patients (1.8 percent) in the control group. Two more Amplify cancer events were reported in Medtronic’s 2010 annual report for its investigational device exemption, with one more in the control group, bringing the total number of cancer events to 15 for 12 Amplify patients and five events for five of the control group patients.
The investigation is also likely to bring up an ugly chapter from the company’s past, particularly the sorted history of Dr. Timothy Kuklo, a Medtronic consultant and former military doctor at Walter Reed Army Medical Center, who was accused of fabricating research on the Infuse device, which was being used on soldiers who had been injured in combat in Iraq and Afghanistan. The Journal of Bone and Joint Surgery later retracted an article Kuklo had written on the benefits of Infuse.
Medtronic admitted in 2009 that it had paid Kuklo nearly $800,000 from 2001-2009 in consulting fees to speak on the company’s behalf.