Complication from spinal product omitted from studies, reasearches have financial ties to product's producer

Sunday, June 12, 2011 by: Neev M. Arnell
Tags: Medtronic, male sterility, health news

(NaturalNews) In a study released Wednesday, a Stanford University surgeon said that one of Medtronic's best-selling spinal products can cause a condition which results in male sterility. The finding contradicts earlier research by doctors with financial ties to Medtronic, who did not find a connection between Infuse, the spinal product, and sterility. (http://www.nytimes.com/2011/05/25/business/2...)

According to a study, men treated with Medtronic's Infuse product during spine surgery were more likely to develop a particular infertility problem than those who did not get the product. Editorials questioned why the issue was not examined more in the Medtronic-funded studies.

The Stanford surgeon, Dr. Eugene J. Carragee, said he decided to study Infuse based on a complaint he received from an orthopedic surgeon. Dr. Tomislav Smoljanovic of Croatia, stated some problems with the product in an article related to the product.

Smoljanovic noted that, while identifying that six men in the Meditronic-sponsored study had developed the sterility-related condition, the researchers had not identified how many of those men had received Infuse as opposed to the bone graft used in a standard procedure.

Carragee's deeper look at the original study led him to question why the researchers had not broken out the patients in their study into those who received Infuse and those who did not, which, he said, is the standard way to present clinical trial results.

Thomas Zdeblick, a participant in the key Medtronic-funded study and director of the University of Wisconsin Spine Center, said there was no attempt to hide data on this issue from the original trial, but rather, there weren't enough numbers to reach statistical significance, "and the issue was left without a conclusion." (http://www.foxnews.com/health/2011/05/27/stu...)

Carragee said that among the 69 men he treated with Infuse, 7.2 percent suffered from retrograde ejaculation compared to less than 1% of the 174 patients who did not get the product. Carragee said that he and his colleagues posted their study online, ahead of the print version, because of these public health implications.

"In my opinion, it is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures so that they can make their best-informed decision," Carragee said in a press release from the North American Spine Society, which is the association for spinal surgeons that publishes the medical journal.

The new study will likely further inflame the debate over whether industry-financed researchers present their findings in ways that benefit their corporate sponsors.

Six of the Medtronic study co-authors received a total of more than $6 million in various royalties from Medtronic, although none of the royalties were for Infuse. (http://www.jsonline.com/features/health/1225...)

The Milwaukee Journal Sentinel released the following records from a public registry of physician payments maintained by Medtronic:

Ken Burkus, a Columbus, Ga., surgeon, and his RBCK Research & Consulting received $782,000 in various royalty payments from Medtronic in 2010. He is a co-author of all four of the papers on Infuse.

Thomas A. Zdeblick, a University of Wisconsin School of Medicine and Public Health orthopedic surgeon who, along with Taz Consulting, has received more than $23million in various royalty payments from Medtronic since 2002, was co-author of three of the papers. He is also the editor-in-chief of the journal where two of the papers were published.

Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $755,000 in royalty payments last year.

Rick Sasso, an orthopedic surgeon with the Indiana Spine Group and co-author of one of the papers, got $2.7 million in various royalties from Medtronic last year.

Thomas Kleeman, a New Hampshire surgeon, co-authored one of the papers. He received between $106,000 and $111,000 in royalties and other payments last year.

Curtis Dickman, a Phoenix surgeon, co-authored one of the papers. Dickman and his Vantage Investments LLC got $389,000 in royalties last year.

Sources for this story include:
http://www.foxnews.com/health/2011/05/27/stu...
http://www.nytimes.com/2011/05/25/business/2...
http://www.jsonline.com/features/health/1225...