Doctors with financial ties to Medtronic Inc. (NYSE:MDT) are on the hot-seat for failing to disclose infertility risks associated with the company’s Infuse bone growth product.
The Fridley, Minn.-based medical device giant’s clinical trials found a risk of retrograde ejaculation, a condition that occurs when sperm and semen back into the bladder rather exit via the urethra, according to a Stanford University School of Medicine study. The condition can lead to permanent sterility.
The company included the findings in information sent to the FDA, but attributed the complication to the surgical technique used with Infuse — which has been widely used to fuse spinal vertebrae during surgeries since 2002 — rather than to the product itself.
Critics argue that such serious complications should be listed in published papers, regardless of the assumed cause, and accuse several doctors who published previous studies of Infuse of omitting vital information while receiving royalties from Medtronic.
The connection was omitted from at least four papers published by a group of doctors with financial ties to Medtronic, who continued to claim there was no connection between the product and retrograde ejaculation, the Milwaukee Journal Sentinel reported.
One of the authors, Dr. Thomas Adeblick of the University of Wisconsin School of Medicine and Public Health, and his Taz Consulting group received $24 million in unrelated royalties from MDT since 2002, according the Sentinel, which launched an investigation last year of doctors with financial ties to the company. The newspaper’s investigation found that docs on the Medtronic payroll produced substantially better clinical trial results for Infuse than doctors without MDT affiliations.
Last year alone, the firm paid out more than $6 million in non-Infuse royalties to doctors who co-authored papers on the bone growth protein over the last nine years. None of the papers mentioned the infertility risk.
Among 69 patients treated with the Infuse product 7.2 percent developed retrograde ejaculation compared to 0.6 percent of those who didn’t receive Infuse, according to the Stanford study.
“To have such strong evidence that a life-changing complication of sterility exists, and then cover it up, in my opinion is obscene,” Dr. Charles Rosen, an orthopedic surgeon and president of the Assn. for Medical Ethics, told the Sentinel.
Medtronic officials argue that the Stanford study lacks the scientific rigor of the company’s research.
"It is important to look at data from randomized, FDA-regulated trials in which there are multiple surgeons participating, instead of looking at data from a non-randomized data set, such as a single surgeon’s own patients, as was the case at the Stanford study," Medtronic spokesman Brian Henry said in an email.
The company’s Infuse trials disclosed all relevant findings, but the rates of complication were not high enough to statistically link retrograde ejaculation to Infuse, Henry said.
The Infuse product, already mired in a U.S. Dept. of Justice’s probe of alleged off-label marketing, brought in $900 million for MDT in its most recent fiscal year.
