Medtronic's Disclosure Bumbling
Medtronic's awkward efforts to shake loose from Senator Chuck Grassley's investigative grip just don't seem to end.
Bill HawkinsMedtronic Chairman and CEO Bill Hawkins was asked on June 8 by CNBC about the company's financial relationship with former Army surgeon, Dr. Tim Kuklo. Kuklo has been accused by the Army of falsifying results of studies conducted on soldiers using Infuse.
CNBC's Mike Huckman asked Hawkins about the extent of Medtronic's financial relationship with Kuklo and whether the company would fully cooperate with an investigation of that relationship by Senator Grassley.
This OTW writer was watching the live interview and was shocked to hear Hawkins respond that, "Our relationship began after he [Kuklo] left the Walter Reed Medical Center and went to Wash U [Washington University in St. Louis]."
Oopsy.
Medtronic send out a "clarification" a couple of days later.
"Bill (Hawkins) indicated that our relationship began with Dr. Kuklo when he joined Washington University. The correct answer is that while we began a consulting relationship with Dr. Kuklo in August 2006, Dr. Kuklo did perform a number of reimbursable functions, including training and education, for the company while he was a practicing physician at Walter Reed...."
At best, the chairman received a bad staff briefing since he probably doesn't personally monitor all physician consulting agreements.
However, the issue here isn't that Hawkins got an important detail wrong, but that the issue of Medtronic's consulting agreements with surgeons keeps getting in the way of company business. Senator Grassley has Medtronic by the ankles like a pit-bull and he's not going to let go until he's satisfied that Medtronic has disclosed all of their consulting contracts and has a system in place to disclose and monitor all such contracts in the future.
Grassley initially got into the Kuklo controversy because Medtronic didn't include Kuklo's name on a list of consultants that the senator had previously requested from Medtronic of surgeons involved with InFuse.
A Medtronic spokesperson told us that Medtronic had submitted the names of all surgeons who had specific consulting contracts that only involved work on InFuse. The company also has other general consulting agreements, some of which include InFuse work. They did not disclose those contracts.
We're convinced that Grassley's investigative staff doesn't believe that Medtronic has complied with the letter and spirit of their requests. Medtronic's "technical" compliance with Grassley's requests is only inviting additional scrutiny and more requests for information.
Surgeon Fears
Medtronic is not going to win a battle with a U.S. Senator over the meaning of what "is" is.
We're starting to hear from surgeons that they are very concerned about working with companies that are inviting such scrutiny. We're convinced that companies biting the bullet with enhanced compliance programs are going to benefit in the long run by attracting top surgeons who want to do research in the lab, not in their lawyer's libraries. Zimmer’s Dave Dvorak and other companies that have taken such steps look more prescient every day.
Senator Grassley is clearly building a case for passage of his "Sunshine Act".
We urge Medtronic to pull the curtains wide open and let the sun blind the senator into loosening his grip on their ankles and surgeon's fears.