Wednesday, October 20, 2010

"Toxic and Dangerous?" - The Watchdog vs Medtronic's Man at the VA

An odd story that appeared earlier this month linked several people we have discussed on Health Care Renewal.

On one hand, we posted about how Dr David Polly, a spine surgeon at the University of Minnesota, testified before the US Congress in support of research on treatments of bone injuries afflicting US soldiers.  He did not then reveal that he had been paid more than one million dollars for consulting by Medtronic, the manufacturer of a bone growth product used to treat such injuries, also the source of payments of his expenses for the trip to Washington.  At the time, we suggested this case was a reminder to be skeptical about academics who are really stealth health policy advocates for industry.

On the other hand, in a post about renewed payments by makers of artificial joints to orthopedic surgeons after the US government advocated a series of deferred prosecution agreements as a cure for such apparent conflicts of interest, we quoted Dr Charles Rosen, "Nothing will change until someone goes to jail. It’s a big game."

The link between them appeared in two related articles.  First, the Minneapolis Star-Tribune reported on the appointment of another Medtronic consultant to a top leadership post in the US Department of Veterans Affairs:
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.
It appears that Medtronic lobbied hard for the appointment of its former consultant:
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.
The details are:
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.'
(It is not clear whether the last sentence above is meant to be an ironic pun about regulatory capture.)

A post on Pharmalot explains what Dr Ondra's first priority was once he got his government job:
Within a few days, however, Ondra objected to the proposed nomination of another spine surgeon, Charles Rosen, as US Surgeon General. Why? As founder of the Association of Medical Ethics, Rosen publicly questioned consulting ties between doctors and device makers and, for his trouble, allegedly suffered retaliation by members of the American Academy of Orthopaedic Surgeons (see this). In a January 21, 2009 email exchange with Davd Polly, a University of Minnesota professor who was another Medtronic consultant, Ondra acknowledged never having heard of Rosen, but reacts viscerally to a recent story in The Orange County Register that details Rosen’s self-appointed role as a watchdog.

'Since this individual is toxic and dangerous I would leave nothing to chance,' he responds to Polly, who had forwarded the newspaper story to Ondra. Polly, by the way, is a nationally known spine surgeon who came under congressional scrutiny for his work several years ago for the device maker, something that Rosen had criticized (look here). 'This moment in history is too important to our country to let such a disreputable and dangerous person continue his self-promotion crusade,' Ondra continues. 'I would encourage you and any other physicians and citizens to weigh in on this to HHS and public health.'
Got that?  Medtronic pays Dr Ondra millions.  Medtronic pushes for Dr Ondra's appointment to a top VA leadership position.  Once in that position, Dr Ondra confers with another million dollar Medtronic consultant, and then works to block the appointment as Surgeon General of a known foe of the cozy web of conflicts of interest that afflicts medicine.  Thus do conflicts of interest work to promote the capture of government by special interests. 

The Pharmalot post concluded with this opinion:
'It’s obvious that Dr. Ondra benefited from his relationship with Medtronic. And since he worked to kill off the nomination of Chuck Rosen, Medtronic’s main critic, I can see how Medtronic benefited from Dr. Ondra,' says Paul Thacker, a former Grassley staff investigator and US Army specialist. 'What I don’t understand is how I and other veterans have benefited from all this back-door dealing. What’s in it for us?'
That is a good question. It appears that nothing was in it for veterans, or the US public. But everything was in it for Medtronic and the doctors it pays so well.  I would submit that it is the readiness of big health care corporations to create conflicts of interest that seduce physicians to put their loyalties to their corporate sponsors ahead of the public interest that is toxic and dangerous.

This convoluted story suggests the urgent need for full disclosure of all relationships between physicians and others who make decisions and wield influence in health care on one hand, and health care organizations on the other hand.  If physicians want their health policy efforts to be met with anything other than guffaws and cynical eye rolls, they need to seriously consider swearing off the sorts of cushy corporate relationships that Dr Ondra and Dr Polly embraced.


Anonymous said...

This moment in history is too important to our country to let such a disreputable and dangerous person continue his self-promotion crusade

This is horrendous.

I believe Lenin and Stalin made similar comments about adversaries.

Anonymous said...

This type of manipulation occurs at all levels of medicine. In the ongoing Mercy Medical v. Aultman saga we have the latest update courtesy of The Akron Beacon Journal’s Cheryl Powell’s - Aultman ordered to pay rival.

In the latest revelation we learn that when Mercy brought suit Aultman offered to settle by having Mercy and themselves placing $5M each in a community health foundation. The results would be:

Aultman would be able to keep its illegal kick back scheme quiet.

Aultman would be able to take credit for forming the community health foundation.

Aultman would deplete the cash reserves of a competitor.


“Aultman Health Foundation must pay rival Mercy Medical Center $4 million in attorneys’ fees and reimburse taxpayers $266,400 for secret payments it made to insurance brokers.”

It appears that with everything else Aultman hide the tax liability involved with the kick backs There will now be a CPA hired to review Aultman’s tax returns for the next three years.

Aultman’s ultimate response, they plan to appeal.

Steve Lucas

Anonymous said...

Nothing in it for Veteran's or the U.S. public? Are you kidding me? You got an extremely bright and talented neurosurgeon to give up his practice and all the royalty money he was earning to work for a government salary. The better question is how did they talk him into that? I think the U.S. public is extremely fortunate to have talented individuals make personal sacrifices for the benefit of the country.

Roy M. Poses MD said...

Anonymous of 22 October,

There are lots and lots of "bright and talented" physicians out there. What particular talent did Dr Ondra have which made him especially qualified to be a Senior Policy Advisor, ( a quite high management position (, at the VA? It is not obvious from his biography that he has particular policy expertise.

Given the amount of money he got from a device company, are we sure he wasn't one of those "best and brightest," who were so dubbed mainly by the marketers who paid them? (See this post: Although he supposedly got royalties for his "intellectual property," I was unable to find any patents in his name in a Patent Office search.