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Sterility Seen in Men Treated with Medtronic Infuse Product

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A recent study suggests the Medtronic spinal product, Infuse, may increase the risk of male sterility. A Stanford University surgeon released a study that found men treated with Infuse developed a condition that causes temporary or permanent sterility. Infuse is a bioengineered bone growth protein widely used in spinal fusion procedures. The protein is Medtronic’s best selling spinal product, says The New York Times, with estimated sales of about $900 million in the most recent fiscal year. Dr. Eugene J. Carragee, a professor and Division Chief of Spinal Surgery at the Stanford School of Medicine, posted the study on The Spine Journal website this Wednesday. The findings differ from Medtronic-sponsored researchers who found no connection between Infuse and a condition causing sterility. Dr. Carragee’s study revealed men who received treatment with Infuse rather than a bone graft developed a condition causing sterility at a far higher rate, reported the Times. His study included 240 patients previously treated by him with Infuse or a bone graft. Among the sample, 69 men received Infuse and five developed a complication related to sterility, compared to only one patient among 174 men who received a bone graft. Infuse is often used in the spinal fusion procedure anterior lumbar fusion, says the Times, which is performed on about 80,000 patients a year in the U.S., with half the patients receiving Infuse. The original study sponsored by Medtronic involved surgeons, Dr. J. Kenneth Burkus and Dr. Thomas A. Zdeblick. The study was released in 2002, shortly after the U.S. Food and Drug Administration (FDA) approved Infuse. Dr. Carragee questions their method of dividing patients by the surgical technique used rather than by men who received Infuse. He points out in his Web article the standard way to present a clinical trial is to divide those who received Infuse from those who had not. Both Dr. Burkus and Dr. Zdeblick defended their findings saying, “Not enough men had experienced in their study to statistically link the problem to Infuse,” reported the Times. They also reported conclusions from a major clinical study on Infuse revealed the drug had no adverse effects, including sterility-related complications. In an e-mail, Dr. Zdeblick shared his opinion of Dr. Carragee’s study saying it “was of limited value because it reflected the results of a retrospective look at patients rather than a clinical trial. Such reports ‘are notorious for being misleading.’” Dr. Carragee’s study does more than spark a debate over the issue of Infuse being linked to male sterility. According to the Times, it will also heighten examination of industry-financed researchers and whether their study findings favor the interest of corporate sponsors. Medtronic paid Dr. Burkus and Dr. Zdeblick millions of dollars in consulting fees or royalty payments. Dr. James D. Kang of the University of Pittsburgh provided commentary for Dr. Carragee’s study and noted that industry support could explain the differences between both Infuse studies. However, Dr. Burkus and Dr. Zdeblick insist the compensations did not affect their scientific judgment. The new study findings startled Dr. Dan M. Spengler, reported the Times. A professor and former chairman of orthopedic surgery at Vanderbilt University, Dr. Spengler said the study provides additional evidence about the risk of using Infuse. Marybeth Thorsgaard, a spokeswoman for Medtronic, said the company believes it provided the FDA and

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doctors with all available medical information about Infuse, reported the Times. She also said, “You have to consider the totality of the data that has been presented, not how one study was reported.” Nonetheless, other doctors have questioned the 2002 report of Dr. Burkus and Dr. Zdeblick. Dr. Tomislav Smoljanovic, an orthopedic surgeon in Croatia, has challenged the 2002 study by writing over 35 letters to various medical journals. The letters mentioned that while the study identified six men who developed the sterility-related complication, it did not identify how many men received Infuse rather than a bone graft. Dr. Burkus and his colleagues responded by disclosing that five of the six men affected received Insure. The doctors insisted the figure was not statistically significant to link Infuse and male sterility, reported the Times.

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