Surgeon in the Crosshairs – Part 1

The headlines jumped out from the pages of one of Medtronic's hometown papers, the St. Paul Pioneer Press, at the end of July.

"U surgeon's fees face new scrutiny – from payer"
"Medtronic critical of billing; conflicts of interest probed"

The surgeon in the crosshairs of those headlines is David W. Polly Jr., M.D.  He is the chief of spine surgery at the University of Minnesota, secretary of the Board of Specialty Societies of the American Academy of Orthopaedic Surgeons, and sits on the Academy’s Board of Directors.

David  W. Polly Jr., M.D.Polly was on active duty in the United States Army for 25 years and finished his service as chair of the Department of Orthopaedic Surgery and Rehabilitation at Walter Reed Army Medical Center.

He’s also a consultant to Medtronic, which has reportedly paid him nearly $1.2 million in consulting fees over the last five years. 

In this two-part article about managing the complex relationships between physicians, universities and device companies, we talk to Dr. Polly. He speaks candidly about his experience under the public microscope and what lessons fellow physicians can take away from his experience when political scrutiny is turned on their university and company partners.

In part two, we seek out the counsel of Mark DuVal, a Twin City attorney experienced in these relationships, to offer up a checklist of important items that physicians need to consider as they partners with their university and a device company. 

Disclosures and Complex Relationships

The local headlines in the Twin Cities were spawned by a July 24 letter from Senator Chuck Grassley to the President of the University of Minnesota. The letter criticized the University for its conflict-of-interest policy, which only required professors to disclose receiving more than $10, 000 annually from a consulting contract with industry.

Grassley wanted to know how the University could adequately manage conflicts of interest without knowing the size of the financial interest. The University quickly replied that it was reviewing that disclosure policy.

The records show that Polly received $500 per hour for many hours of work performed on behalf of Medtronic. It turns out Polly was a meticulous record keeper. The public disclosure of those records included such small items as Polly billing Medtronic $125 to download CDs from meetings.

Competing Interests

The relationship between a physician, a university and a company is necessary if the university physician or university want to commercialize something. It has also become highly complex with competing interests. 

The relationship is measured, in large part, by money. Universities need money, surgeons are valuable commodities, and companies have the money. Universities and companies have a fiduciary responsibility to act in their own best interest. Only the physician has promised to act in someone else's best interest―the patient.

Navigating that complex financial relationship is a challenge for physicians. Just ask Jeff Wang, M.D., at UCLA. When the temperature is turned up by a U.S. senator, the surgeon can find him or herself alone.

Dr. Polly, in response to a question about advice to younger colleagues in navigating this relationship, said the physician/university relationship is a revenue-sharing one in which the university itself is also conflicted because it wants IP (intellectual property). “They want a revenue stream. They want to be able to support the University of Minnesota. Our state budget does not cover the cost of running the university.”

In most institutions, the academic health center is a cash cow. So, they [universities] are trying to get all they can to try to allow the rest of the university to do its job. – Dr. Polly

Attorney DuVal said, “Remember, these institutions benefit significantly when their faculty have strong, productive relationships with industry. If you stifle talented people too much they will go elsewhere where the fruits of their labor are respected and rewarded.” 

[We] may in fact drive companies away from collaborating with universities and toward collaborating with people in private practice who may not have any of those oversight requirements. – Dr. Polly

Grassley and Medtronic

Polly thinks Senator Grassley is trying to do the right thing and has no problem with Medtronic’s public statement about reviewing items he had submitted to them for reimbursement. But he does believe that the senator is applying a 2009 perspective to 2005 activities, and the times have changed.

“Senator Grassley is trying to do what he thinks is the right thing, and I don’t have a problem with the concept of what he is going after, ” said Polly.

In response to our question of Medtronic’s public comments about reviewing his billings, Polly said, “I think that anytime a senior U.S. senator asks you a question, you say, ‘We’re gonna go back and do our homework.’

“And so I don’t have a problem with, ‘go back and do the homework’…No payment was ever made to me for consulting activities without them having been reviewed by an approving authority within the company. As Senator Grassley’s website has shown with the sheets―that I did not necessarily have copies of―there were significant numbers of items that were disallowed. 

“When they were disallowed, I didn’t get paid for them so there was oversight on the part of the company contemporaneously to the submission of the documents. I think that they [Medtronic] are faced with the problem again, of current 2009 best practices being applied to 2005–2006 activities.”

You know, I understand how they [Medtronic] could say what they could say, – Dr. Polly

Documentation

In a world of transparency where documents are posted on a website, Polly says that those documents, intended as time cards and never intended as stand-alone documents, essentially become stand-alone documents.

Given that, says Polly, physicians are either going to have to become even more detailed and create a huge stand-alone document that becomes a time card, or risk becoming less clear. 

“And then in the future, contracts may say, ‘Item I, Subparagraph A, subsection 3’ or ‘the physician reported 10 minutes’ or 20 minutes or 30 minutes on that particular topic area without ever saying what it actually was, ” said Polly.

Public Time Sheets

“The other part about this is that if all these kinds of time sheets become public domain, the company is now providing essentially competitive, strategic intelligence to their competition.

“So that having the kind of detail that some may ask for becomes more problematic and it becomes such a challenging hassle factor or paperwork requirement that it probably isn’t worth the time, energy, or effort of the consulting surgeon even at DOJ-determined fair market values.” 

Polly said he did most of his work in a way that he thought could be time-stamped so that if someone came back and asked him if he really spent time at 5:30 in the morning responding to emails, the email would be a time-stamped event that could be looked at. 

“Generally, I intentionally did a lot of work off of my cell phone because if someone were to subpoena or obtain the cell phone company records, you can look at the time stamp on the phone call and see that yeah, in fact, that did happen and it was the duration of time as stated. So, I intentionally tried to do it in a way that it was traceable, trackable, and verifiable in order to try to be transparent.” 

Polly’s extraordinary level of disclosure brought additional scrutiny.

“Apparently, I have stepped on the toes of some people in the way that I did things, and perhaps, some things may have been aggressive by 2009 standards [even] when they were done in 2005 or 2006.

And so, I recognize that times change, rules change, and you deal with those changing rules.” 

Universities and Companies

The issue of universities and companies working with physicians does become a significant ongoing challenge, according to Polly.

“Universities want their faculty’s IP. Companies want physicians’ IP, and how you navigate that becomes particularly problematic. I['ve] got ongoing discussions with my university about that and there will inevitably―in these complex arenas―be different interpretations capable given these complex fact sets.” 

Conflicting Interests

On a larger scale, Polly believes it is becoming clear that physicians are going to have limits on the work they can do if they have a vested interest in a topic.

You will probably not be able or allowed to do clinical research on that topic material. The definition of clinical research becomes challenging so if it is a randomized controlled trial and you are a significant financial stakeholder in it, you will probably be precluded. – Dr. Polly

“Then, the challenge becomes, what if you are the smartest user or developer of something, shouldn’t you be able to report your ongoing results of your use of that product? …So we’re going to get into a series of unintended consequences with these attempts to remove all conflicts, and removing all conflicts in my mind becomes an impossible task.” 

Polly says everyone is conflicted in a number of different ways. While oversight committees have the laudable goal of trying to remove systemic bias from reporting of research information, he fears that not allowing any conflicts will impair progress and “has the unintended consequence of the person with the best idea―who may be best suited to use the new device, product, procedure, whatever―not being allowed to do it and that seems counterintuitive.

“So, you know, I feel strongly that it’s important to struggle through with this. I think the avoidance of systemic bias is important.”

As physicians calculate the value of industry interaction, the concept of direct compensation for consulting time is going to lose more and more of its luster because of the consequences that go along with that. – Dr. Polly

The Michelson Lesson

What’s the main thing Polly would tell a young colleague with a good idea who wants to work with both a company and a university?

“That’s a little bit complex. It depends on what resources they have.

“What [Gary] Michelson and others have taught us is it’s really not about who has the good idea or who has the good idea first. It’s about who is able to patent the idea first.

“And so, if you have access to a good patent attorney, step one is to do the patent search and establish your rights to the intellectual property.

“And then you have choices about where you go from there. 

“Some universities have good technology transfer offices that will do that and work through it. I have something that I worked [on] with some grad students. The university has done the patent search and is now in the process of trying to market the IP to industry and that is a reasonably protected process. 

“In exchange for that, universities usually take a substantial portion of any revenue that comes back and that’s sort of the way it goes. So that becomes the challenge about university versus non-university settings.”

Part 2

In Part 2 of this look at the relationships between physicians, universities and industry, attorney Mark Duval offers our readers a checklist of things to do to make sure they don’t get burned by a school’s inadequate disclosure policy and are protecting a physician’s financial interest versus the school’s interest. Polly says DuVal’s checklist is “spot on.”

Read Part 2 in the next edition of Orthopedics This Week.