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Senate probe targets ex-Army surgeon

WASHINGTON — An influential Republican senator is investigating a former Army surgeon who the Army says forged signatures and falsified data in a study touting the benefits of an implant from Medtronic.

Sen. Charles Grassley of Iowa has long been a critic of the drug industry’s influence over physicians, but increasingly he has turned his scrutiny on ties between surgeons and companies like Medtronic, the largest medical device maker in the world.

In a letter to Walter Reed Army Medical Center, Grassley asks the Army to hand over all materials from its investigation of Dr. Timothy Kuklo, who authored a paper on Medtronic’s Infuse spinal implant that later had to be retracted after publication.

The Army’s report, completed in October, found that Kuklo forged the signatures of four colleagues on the paper before submitting it to a British medical journal, where it was published last summer. The Army also said Kuklo’s claim that he reviewed 138 veterans treated for leg wounds for the study did not match Walter Reed’s own records.

Minneapolis-based Medtronic confirmed Tuesday that Kuklo is a consultant for the company but said the research discussed in the article was conducted before he started working for Medtronic.

Spokeswoman Mary Thorsgaard tried to distance Medtronic from the study, saying the company “did not participate in the collection or analysis of the data, the preparation of the manuscript for the journal article, or the submission.”

In his May 15 letter to Walter Reed, Grassley presses Army officials on whether Kuklo properly disclosed any and all financial conflicts of interest.

Kuklo retired from the Army in 2007 and is now a professor of orthopedic surgery at Washington University in St. Louis. The Army is not pursuing disciplinary action against Kuklo, although it notified Medtronic and Washington University of its findings.

A spokeswoman for the university Tuesday could not confirm whether the university is investigating Kuklo.

“To protect the people involved, and the integrity of an investigation, Washington University does not confirm whether any particular case is under review,” spokeswoman Joni Westerhouse said in a statement.

Kuklo was working for the university when he submitted the Infuse study, though he did not perform the research there. He remains on staff at the university’s medical school with full privileges, Westerhouse said.

Calls placed to Kuklo’s office were not answered.

In a letter to Washington University’s chancellor, Grassley requests a complete list of all research grants awarded to Kuklo and asks whether he properly disclosed any financial conflicts of interest.

Grassley has spent the past year probing ties between medical researchers at the nation’s top medical schools and drug and medical device companies. The investigations come alongside a bill from Grassley and Sen. Herb Kohl, D-Wis., that would require companies to disclose all payments to physicians over $100.

The investigation of Kuklo is not the first involving Medtronic’s Infuse. In November, the Department of Justice subpoenaed Medtronic as part of a probe into whether the company encouraged unapproved uses of the spinal graft. Grassley is conducting a similar inquiry.

Infuse uses a man-made version of a human protein to spur bone growth. The Food and Drug Administration approved the system to fuse parts of the spine together during lower-back surgery as well as for oral and dental procedures.

However, serious complications have been reported when doctors use the graft for alternate uses. In July the FDA warned doctors that use of Infuse for neck surgeries led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.