Medtronic queried about surgeon

A prominent U.S. senator has sent a letter to Medtronic Inc. asking why a previous request for the names of the company's paid medical consultants did not include an orthopedic surgeon who is now being investigated for allegedly overstating the benefits of a Medtronic product used to repair spine and bone injuries.

In a May 18 letter to Medtronic CEO Bill Hawkins, Sen. Charles Grassley, R-Iowa, said he was "concerned" that Dr. Timothy Kuklo's name was not on the list of consultants Medtronic provided. The letter was made public in Wednesday's Congressional Record.

Grassley, ranking Republican on the Senate Finance Committee, is investigating what he calls "substantial" financial ties between the medical device industry and physicians. Kuklo, a former surgeon at Walter Reed Army Medical Center, is accused of making false claims about the use of Medtronic's Infuse bone-growth product in soldiers injured in Iraq.

In October, Grassley sent a letter to Hawkins requesting the names of doctors who have consulting agreements with the company, specifically those involved with its Infuse product.

Approved for use in the lower back and for some dental applications, Infuse is often used by doctors "off-label" -- in ways not approved by the Food and Drug Administration (FDA). Last July, the FDA warned doctors that using Infuse in the neck could lead to serious complications.

Medtronic provided Grassley with financial information for 22 doctors and dentists who practice nationwide. They earned between $100 and $67,600 a year; but Kuklo was not on the list, nor were any doctors from Minnesota.

Officials at Walter Reed said an investigation found that a study conducted by Kuklo and others probing the use of Infuse to heal bones shattered in warfare overstated the product's benefits. The study was published in a British medical journal, which later retracted it. The Walter Reed investigation was reported in the New York Times last week.

Kuklo remained a consultant with Medtronic until earlier this month, but is "no longer active as a consultant," spokeswoman Marybeth Thorsgaard said in an e-mail.

Medtronic said it is cooperating with Grassley's investigation, and will make Kuklo's payments public once it provides a response to the senator. An investigation of Department of Defense records by the Center for Public Integrity and Northwestern University's Medill School of Journalism found that Medtronic paid for at least 15 trips by Kuklo, worth more than $13,000, between 2001 and 2006.

It is common for medical device companies to hire doctors as consultants. Doctors often provide insight into how well the devices work and how they might be improved. However, those relationships, some of which involve thousands of dollars, have not only drawn the attention of Grassley, but of the U.S. Department of Justice, as well.

Kuklo is now an associate professor in the medical school at Washington University in St. Louis.

Earlier this week, Grassley sent a letter to officials at Walter Reed, the editors of two medical journals that handled Kuklo's Infuse study, and the head of Washington University, requesting information about Kuklo.