A prominent U.S. senator has raised questions about the appointment of a former Medtronic Inc. consultant to a top position at the U.S. Department of Veterans Affairs, according to documents obtained by the Star Tribune.
In a Sept. 28 letter to Veterans Affairs Secretary Eric Shinseki, Sen. Charles Grassley asks whether Dr. Stephen Ondra's "policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest" given his prior relationship with the Fridley-based medical technology giant.
Ondra and Medtronic mutually severed their financial relationship in July 2008. But just prior to that, Medtronic paid him $3.6 million in royalties related to spine-surgery instruments, according to financial disclosure forms he submitted to the VA.
Grassley's letter asks a series of questions about Ondra's work at the department, including whether he has any contact with Medtronic. A Grassley spokeswoman said Wednesday the letter was a "continuation of his work to establish greater transparency when it comes to drug and device-maker payments to physicians."
Shinseki replied on Sept. 30 that Ondra has fully complied with the VA's ethics policies and that no conflict exists. Ondra's previous relationship with Medtronic was revealed as part of the vetting process for the VA position, and he is not involved in procuring medical devices, Shinseki wrote.
On assuming his new post, Ondra was required by government ethics rules to restrict his contact with private industry.
Medical technology companies frequently employ doctors to advise them on how their products work, and occasionally doctors invent new devices. But critics like Grassley, R-Iowa, have questioned whether these often-lucrative relationships taint patient care.
Grassley co-sponsored legislation, since passed into law, that will require medical device companies to publicly disclose consulting relationships with physicians.
Since 2005, the VA has purchased about $83.4 million of Medtronic products, according to the Federal Procurement Data System's website. A VA spokeswoman said Ondra "makes no financial decisions or has any influence on what medical devices are purchased by the VA."
While noting that Ondra is not a Medtronic employee, Grassley characterized the surgeon's relationship with the company as "unambiguous and substantial." Further, Grassley notes that Ondra "was able to penetrate the political establishment at its highest level to obtain a senior position at the VA" because of his previous ties to the company.
Medtronic spokesman Brian Henry said Ondra received fair market value payments for his intellectual property. "To our knowledge, in conjunction with his new position, Dr. Ondra has not worked on anything on behalf of Medtronic, nor have we asked him to do so," he said.
A decorated war veteran who served in Iraq, Ondra was also a supporter of President Obama, serving on the president's transition team. Some colleagues and Medtronic officials characterize Ondra as a brilliant neurosurgeon and prolific researcher who is well-known in the field of back care.
Ondra's candidacy for his current post was supported by Medtronic Chief Executive William Hawkins III, who wrote a letter of recommendation to Secretary of Defense Robert Gates on his behalf. This was at the suggestion of Dr. S. Ward Casscells III, who was then assistant secretary of defense for health affairs, according to a series of internal e-mails obtained by the Star Tribune.
"I have known Dr. Casscells for many years and was comfortable in approaching him on this topic," Hawkins wrote in a Jan. 16, 2009 e-mail to the then-head of Medtronic's $3.5 billion spine device business, Steve La Neve. (La Neve left that position earlier this year in a corporate reorganization.)
La Neve replied a day later that Ondra wanted to meet with him or with Hawkins before a reference letter was sent, "so that it can capture his work on appropriate industry-physician relationships and transparency."
In addition to Hawkins, La Neve's reply was sent to Dr. David Polly, head of the spine unit in the Department of Orthopaedics at the University of Minnesota. Polly's own consulting relationship has elicited a Grassley investigation.
Between 2003 and 2007, Polly received about $1.2 million in consulting fees from Medtronic, according to billing records released last year as part of a Grassley probe. At the time, Medtronic said it would investigate Polly's billing practices.
Polly and Ondra both served at Walter Reed Army Medical Center -- one of the nation's top military hospitals -- and Polly was an enthusiastic supporter of Ondra's appointment at the VA.
Through his lawyer, Polly said Ondra "has the highest qualifications imaginable for his position," and called him a "brilliant and successful surgeon and researcher, and an excellent teacher. ... The country is fortunate to have him."
Ondra's past relationship with Medtronic surfaced as an potential issue late last year, six months after he assumed his new job at the VA. David Miller, a Medtronic vice president, e-mailed Ondra to see if he could meet with Medtronic officials at a meeting of the North American Spine Society in San Francisco. Ondra was the keynote speaker at the meeting of spine surgeons.
The purpose, according to an internal e-mail, was to discuss Ondra's "thoughts on what industry's role should be in the Healthcare Reform initiative, how we can maintain the highest level of quality in our products and services while controlling costs and what our role should be in the appropriate development of comparative-effectiveness research and data."
A VA attorney advised Ondra not to meet with the Medtronic group. "Your meeting with Medtronic under these circumstances would create an appearance that we are giving preferential treatment to one of our vendors," wrote staff attorney Walter Hall in an e-mail.
Ondra declined the meeting. In a reponse to Medtronic's Miller, he wrote, "Due to my position in government, such a meeting is not advised due to a variety of issues and appearances."
This is not the first time Grassley, who is seeking reelection, has targeted Ondra and other doctors who are paid Medtronic consultants. In a letter sent last April to Hawkins, Grassley requested information about 32 spine surgeons, including financial disclosure for consulting agreements and their participation in company-funded clinical trials. Ondra was among those on the list.
Ondra did not respond to an e-mail seeking comment.
Staff writers David Shaffer and Patrick Kennedy contributed to this report.
Janet Moore • 612-673-7752