Bloomberg News

Medtronic Studies Failed to Reveal Infuse Risks to Patients

June 29, 2011

(Adds closing share prices in sixth paragraph.)

June 29 (Bloomberg) -- Studies funded by Medtronic Inc. failed to disclose serious side effects associated with the company’s Infuse bone-growth treatment, misleading doctors about its safety and causing unnecessary use of the product, a series of articles reported.

No side effects were reported in 13 clinical trials funded by Minneapolis-based Medtronic, while data provided to U.S. regulators showed as many as half of patients had complications including infections, pain, cyst formation and cancer, a review in The Spine Journal found. The report said financial ties between Medtronic and researchers weren’t clearly disclosed.

Doctors began raising questions about Infuse shortly after its approval in 2002 for spinal fusion when patients started experiencing unanticipated side effects, said Eugene Carragee, chief of spinal surgery at Stanford School of Medicine near Palo Alto, California, who led the review. Carragee published a report last month showing the device can lead to infertility in men. The U.S. Senate Finance Committee last week asked Medtronic to detail payments to doctors who conducted research on Infuse.

“We don’t think it should be pulled from the market, but people need to have a realistic idea of what the risks are,” Carragee said in a telephone interview. “Patients and families should have a discussion with their doctors that’s not based on the idea that there are no complications.”

Two reviews, two studies and an editorial appeared in The Spine Journal yesterday devoted to Infuse, a genetically engineered protein used to spur the growth of new bone after spinal surgery. Medtronic’s 13 clinical trials involved 780 patients, according to the review.

Medtronic declined 92 cents, or 2.4 percent, to $38.09 at 4:05 p.m. in New York Stock Exchange composite trading. The shares have gained 2.7 percent this year.

Medtronic CEO Response

The articles raise questions about the researchers’ conclusions, not the data Medtronic submitted to the U.S. Food and Drug Administration to gain approval of Infuse or the information that is available today on how to use the product, said Omar Ishrak, Medtronic’s chairman and chief executive officer, in a statement. The company “strongly believes” in the safety of the product for its approved uses, he said.

The company plans to convene an independent panel of spinal surgeons and outside researchers to examine the concerns raised by the journal, said Richard Kuntz, chief scientific, clinical and regulatory officer for Medtronic, in a telephone interview. The company tracks the side effects from its products closely, and has been watching for any problems from Infuse, especially cancer and infection, he said.

No ‘Smoking Gun’

“I am not aware that there is any smoking gun out there that is a real issue,” Kuntz said. “I have to respect the issues raised by this journal and look into it.”

One of the studies disputes the severity of pain stemming from removal of bone from the hip to use during a spinal fusion, one of the main reasons patients and surgeons turn to Infuse. Two other articles examine Infuse’s potential impact on the nervous system and the reabsorption of bone.

Medtronic, the world’s largest maker of heart devices, generated $3.4 billion in sales from its spinal unit in the 2011 fiscal year ended April 29, according to Bloomberg data. Medtronic doesn’t specify Infuse revenue in its earnings reports.

The report also found that the financial ties between the company and the researchers weren’t clearly disclosed and the trials may have been designed in a way to make standard alternatives for spinal fusion look bad. Authors of the 13 studies reviewed had significant ties to Medtronic, with a median financial support of $12 million to $16 million, according to the article.

“It is hoped that lessons can be learned from this era in spinal research and publication,” the researchers wrote in one of the reviews in the Spine Journal. “Such lessons might prove valuable in the future, allowing us to better serve not only our community of researchers and clinicians but especially our patients who rely on the expeditious but safe introduction of new technologies.”

--Editors: Angela Zimm, Andrew Pollack

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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