Monday, August 31, 2009

Thoughts on Orthogate

I haven't had much to say about orthogate, the ongoing scandal involving Medtronic, Dr. Tim (the forger) Kuklo, and Dr. David (the consultant) Polly.

It's pretty clear that Dr. Kuklo is a bad apple, assuming that it's true that he made up data regarding the Medtronic bone growth product Infuse, including forging the names of colleagues who later said they had no involvement in the study. (See Doug Bremner's particularly colorful review of these events here). Outright fraud can happen in any system, no matter how well regulated, so the Kuklo disaster is not necessarily grounds for calling for systemic reform.

The David Polly case is a tougher call. Obviously, Polly, a professor at the University of Minnesota and the former head of orthopedics at Walter Reed, made a barrel-full of money consulting for Medtronic on Infuse. In fact, between 2003 and 2007, Polly received more than $1.14 million in fees and expenses from Medtronic. According to the Wall St Journal, the main "bad" thing that Polly did was failing to disclose at a May 2006 senate hearing that Medtronic had funded his trip. Polly was at the hearing to drum up more government funds for research on treating wounded soldiers, and he and his colleagues in Minnesota evenutally won a $466,644 Department of Defense grant for a study on Infuse. Obviously, Polly should have told the Senate that he was speaking on behalf of Medtronic; instead, he claimed to be speaking on behalf of the American Academy of Orthopaedic Surgeons.

To his credit, Polly didn't run and hide behind a veil of "no comment." In fact, he went on the radio program All Things Considered and
said that he was a "rookie" that day. He said it didn't appear there was a forum or venue to make such disclosures at the hearing. "If there had been, certainly I would have been delighted to disclose," he said. "And if I was asked to testify before Congress tomorrow or currently, I would probably do things differently to be a little more clear about who I have financial ties with."

Is this believable? Who knows? In my experience, people who rise to the rarified ranks of academia like Polly are extremely shrewd about regulations and paperwork. I'd be surprised if it didn't occur to Polly that the Senate would have wanted to know that Medtronic was paying him $6000 to testify, according to the New York Times

Subsequently, the WSJ and others had a field day going over Polly's detailed consulting and billing records:

His consulting log indicates that on one occasion he spent one minute to wake up a Medtronic executive, although he listed "no charge" for that service. He did bill Medtronic for the 30 minutes he spent in the car with that executive after waking him up.

The amounts of money seemed excessive, and while there's nothing wrong with a company paying an expert lots of money to help them develop products for patients care, even Medtronic shareholders were rattled by the scope of the payments. At the Medtronic annual meeting, shareholder John Burbidge was quoted in the
Twin Cities Pioneer Press as saying that while he understood the need for input from physician consultants, he was "taken aback" by the sums of money involved.

"Is it really necessary to pay that kind of money to doctors in order to get good information?" he asked. "Can you rely on information that you pay that much money for?" added Burbidge, who said he is a longtime Medtronic shareholder. "Obviously, nobody is going to want to tell you anything you don't want to hear and jeopardize his relationship with the company."

Eventually, although Polly denied any malfeasance, the heat was too much for him and he
resigned his post as a board member of the American Academy of Orthopedic Surgeons, saying that the issue had become a "distraction" for the organization.

What to make of orthogate? Kuklo, apparently, is just a unethical doctor/researcher who allowed his greed to influence his professional decisions. Polly, on the other hand, seems like a good guy who made a mistake in disclosure. In some ways, it's surprising to me that he even quit the orthopedics organization. I'm willing to bet that many of his colleagues on the board do the same kinds of lucrative consulting gigs. Are they all supposed to resign now?

Perhaps the lesson here is that when physicians decide to work with industry, and when the amounts of money become astronomical, they will inevitably teeter on the brink of greed. Once greed takes over, they may start to do bad things. That's why transparency of such payments will be helpful, so that we can closely monitor doctors who seem to be making just a teensy bit too much money from industry.


Roy M. Poses MD said...

Dr Carlat, I thought Dr Polly's and Dr Kuklo's payments were related to spine surgery, not hip replacement. If so, you may need to change your graphic.

Doug Bremner said...

His crimes were more than a failure to disclose. Charging a company to write up research results? I have never heard of that. And doing paid lobbying for a company? No one who calls himself a prof. Should be allowed to do that.