The feud between spine surgeons who were involved in the research and development of Medtronic's Infuse and the surgeons who feel the product was inappropriately marketed continues to escalate, according to two letters set for publication in the July 12 issue of The Spine Journal.
Tom Zdeblick, MD, has disputed the claims made by Eugene Carragee, MD, that Medtronic failed to reveal complications with its bone morphogenic protein product Infuse. Dr. Carragee published a report in The Spine Journal, the journal of the North American Spine Society for which he serves as editor-in-chief, finding that while the company disclosed complications to the FDA during the approval process, it did not disclose them in the studies published in professional journals about its effectiveness.
An additional study found that the instance of retrograde ejaculation among male patients treated with Infuse was significantly higher than company-sponsored studies reported.
Dr. Zdeblick was one of the surgeons who received compensation from Medtronic, although his compensation came from developing a different product, the LT-cage. In a letter to The Spine Journal, Dr. Zdeblick questioned the time Dr. Carragee spent treating injured members of the military and accused Dr. Carragee of using Infuse for off-label purposes during the study, indicating a higher level of RE among Infuse patients.
"[Dr. Carragee] admits that he uses the same dose regardless of the patient or implant size," Dr. Zdeblick wrote in the letter. "We know BMP-2 to be very dose dependent. This certainly makes the utility of his results suspect. In addition, the implant he used is cortical allograft bone. There are reports of increased inflammatory reaction and bone lucencies when allograft is combined with BMP-2…How patients are approached about RE has change through the years, and its incidences may have been under reported in the past."
In a response letter, The Spine Journal stood behind its choice to publish both articles about rhBMP-2 and disputed Dr. Zdeblick's claims of flaws within the studies' designs. While the surgeons did use the same dose for all patients, only the smallest dose was ever used, according to the letter. All patients were also given the same follow-up assessment to track RE. The letter also addressed Dr. Zdeblick's concerns that the time Dr. Carragee took away from the study to treat patients in the army skewed his study on RE occurrences, saying these claims "have no basis in reality."
Finally, Dr. Zdeblick claims to have no financial interest in Infuse. However, he received $23 million in various compensations from Medtronic, which led The Spine Journal to question this claim. "There is nothing wrong with making money or even lots and lots of money," says the letter. "But surely it is a very reasonable concern that Dr. Zdeblick's arrangement gives him a simple, obvious and compelling financial interest in the fortunes of Medtronic and their Infuse product."
Read the two letters set for publication in The Spine Journal about Infuse.
Related Articles on Infuse:
Dr. Thomas Zdeblick Defends Relationship With Medtronic, Disputes Inappropriate Reporting Claims
NASS to Companies, Surgeons: Stop Inaccurately Promoting Bone Growth Factors
Dr. Eugene Carragee: Industry-Sponsored Reports Lack Serious Complications of BMP Use
Tom Zdeblick, MD, has disputed the claims made by Eugene Carragee, MD, that Medtronic failed to reveal complications with its bone morphogenic protein product Infuse. Dr. Carragee published a report in The Spine Journal, the journal of the North American Spine Society for which he serves as editor-in-chief, finding that while the company disclosed complications to the FDA during the approval process, it did not disclose them in the studies published in professional journals about its effectiveness.
An additional study found that the instance of retrograde ejaculation among male patients treated with Infuse was significantly higher than company-sponsored studies reported.
Dr. Zdeblick was one of the surgeons who received compensation from Medtronic, although his compensation came from developing a different product, the LT-cage. In a letter to The Spine Journal, Dr. Zdeblick questioned the time Dr. Carragee spent treating injured members of the military and accused Dr. Carragee of using Infuse for off-label purposes during the study, indicating a higher level of RE among Infuse patients.
"[Dr. Carragee] admits that he uses the same dose regardless of the patient or implant size," Dr. Zdeblick wrote in the letter. "We know BMP-2 to be very dose dependent. This certainly makes the utility of his results suspect. In addition, the implant he used is cortical allograft bone. There are reports of increased inflammatory reaction and bone lucencies when allograft is combined with BMP-2…How patients are approached about RE has change through the years, and its incidences may have been under reported in the past."
In a response letter, The Spine Journal stood behind its choice to publish both articles about rhBMP-2 and disputed Dr. Zdeblick's claims of flaws within the studies' designs. While the surgeons did use the same dose for all patients, only the smallest dose was ever used, according to the letter. All patients were also given the same follow-up assessment to track RE. The letter also addressed Dr. Zdeblick's concerns that the time Dr. Carragee took away from the study to treat patients in the army skewed his study on RE occurrences, saying these claims "have no basis in reality."
Finally, Dr. Zdeblick claims to have no financial interest in Infuse. However, he received $23 million in various compensations from Medtronic, which led The Spine Journal to question this claim. "There is nothing wrong with making money or even lots and lots of money," says the letter. "But surely it is a very reasonable concern that Dr. Zdeblick's arrangement gives him a simple, obvious and compelling financial interest in the fortunes of Medtronic and their Infuse product."
Read the two letters set for publication in The Spine Journal about Infuse.
Related Articles on Infuse:
Dr. Thomas Zdeblick Defends Relationship With Medtronic, Disputes Inappropriate Reporting Claims
NASS to Companies, Surgeons: Stop Inaccurately Promoting Bone Growth Factors
Dr. Eugene Carragee: Industry-Sponsored Reports Lack Serious Complications of BMP Use