Since 2002, Medtronic and a group of doctors with financial ties to the medical device company were aware that a new biological agent used in back surgery was linked to sterility in men.
But that crucial information was not revealed in medical journal articles written by those doctors, including surgeons who would receive millions of dollars in various royalties from Medtronic.
Prompted in part by Journal Sentinel stories, independent researchers at Stanford University looking at their own patients have found strong evidence connecting the lucrative product to retrograde ejaculation, a condition that causes sterility in men.
Though original data linking the product to the complication was included in information sent by the company to the Food and Drug Administration as part of the approval process in 2002, those doctors were still claiming there was "no relationship" between the product and the complication as recently as last year.
Medtronic and the doctors contend that the sterility complication was caused by surgical technique, not the product. But professional guidelines and independent doctors contacted by the newspaper say serious complications should be listed in published papers, regardless of what they assume to be the cause.
A new Journal Sentinel analysis found that last year alone Medtronic paid more than $6 million in royalties to a handful of doctors who over the last nine years co-authored papers about the product, known as Infuse, without cautioning that it was linked to male sterility. None of the royalty payments was for Infuse.
One of the authors, Thomas A. Zdeblick, is a University of Wisconsin School of Medicine and Public Health orthopedic surgeon. Zdeblick and Taz Consulting have received more than $23 million in various royalty payments from Medtronic since 2002. Zdeblick also is the editor of the journal where two of the Infuse papers that failed to mention the link were published.
Last year, a Journal Sentinel investigation found that doctors who had financial relationships with Medtronic produced substantially better results with Infuse in the clinical trial leading to its FDA approval than doctors who did not have financial ties to the company.
The newspaper articles documented growing concerns about Infuse side effects and how associated surgeons authored research that has been criticized as little more than marketing.
Meanwhile, Medtronic is under investigation by the U.S. Department of Justice on allegations of off-label marketing of Infuse, a case that could be settled in the near future with civil and criminal penalties, according to a Wells Fargo analyst's report issued last month. Companies are not allowed to promote their products for unapproved, or so-called "off-label," uses.
Thursday, May 26, 2011
Researchers get royalties, papers omit sterility link - JSOnline