Posted on May 27, 2011
Dr. Eugene Carragee of Stanford University has suggested that Medtronic's "Infuse," a popular protein that grows the bone for spinal fusion procedures, is linked to sterility. This challenges a study the FDA relied on to approve Infuse in 2002.

Dr. Carragee culled the data from his own patients. Of the 69 who received Infuse, five developed temporary or ongoing sterility. Conversely, only one of 174 men became sterile after bone graft -- the other major spinal fusion. Of 80,000 patients who receive the same procedure annually, half are administered Infuse. Only men were affected in Carragee's study.

Dr. Carragee study was prompted by a Croatian doctor who had questioned inconsistencies in the original Infuse experiments since 2006. That study was conducted by Drs. Kenneth Burkus and Thomas Zdeblick and helped pass Infuse through the FDA's regulatory barrier. Both doctors now believe their original study found a statistically insignificant connection between Infuse and sterility.

However, questions remain. The original study did not test Infuse against a test group. Instead, they created test groups based on surgical techniques, indicating that their results were somewhat irrelevant to the heart of the issue. The single strongest criticism of Drs. Burkus and Zdeblick are their financial ties to Medtronic, the company that makes Infuse. Both doctors denied any financial influence.

Amazingly, Dr. Zdeblick also defended his study by questioning Dr. Carragee's retrospective study, which is normally more "misleading" than clinical trials. It may be true that more study has to be done on Dr. Carragee's findings, but this defense by Dr. Zdeblick sounds like a foolhardy attack on the adage that hindsight is 20-20.

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