In part one of “Surgeon in the Crosshairs, ” David Polly, M.D., Chief of Spine Surgery at the University of Minnesota, talked to OTW readers about his experience as an industry consultant and the role of surgeons in an increasingly complicated relationship with industry and universities.
It was one of the most refreshing conversations we’ve had with a leading spine surgeon on the topic. The discussion shed light on an issue that goes to the heart of collaboration and innovation in orthopedics. Dr. Polly’s experience of media and political scrutiny offered lessons for his colleagues and led us to seek out guidelines for physicians looking to enter into collaborations with industry and academia.
In this week’s part two of “Surgeon in the Crosshairs, ” Dr. Polly continues his discussion with OTW and describes the pitfalls of disclosure in light of his congressional testimony on behalf of the American Academy of Orthopaedic Surgeons (AAOS). Finally, industry attorney Mark DuVal offers his “Polly-Approved” checklist for physicians to use in taking charge of their own compliance management.
Public Disclosures
Last week we outlined how Senator Chuck Grassley’s release of detailed billing records of Dr. Polly’s work as a Medtronic consultant thrust Polly into the public spotlight. There were no allegations of improper payments, no charges of undue industry influence on clinical studies, or any accusations that patients did not receive the best care.
There was, however, one criticism of Dr. Polly’s actions as an industry consultant that he admits was valid.
U.S. CapitolIn May 2006, Dr. Polly testified on behalf of AAOS in front of a congressional committee. He was urging Congress to fund orthopedic research for soldiers. He didn’t tell the committee that Medtronic had paid his expenses for the trip.
We asked him about the disclosure oversight.
“Yeah…if I had that to do over again, I would do it differently, ” said Polly.
“I can’t tell you the specifics behind it. What I can tell you is that anytime I’ve had a disclosure form on which I had the opportunity to disclose that I have a consulting relationship with Medtronic, I’ve done that. In the testimony before Congress, people were typically saying I’m representing, you know, breast cancer, prostate cancer, etc. So that’s how that played through. There was no intent to mislead or deceive, but there is a perception that full transparency wasn’t achieved.”
“So I accept that criticism and that’s appropriate. The fix, I think, is to provide disclosure sheets to people testifying before Congress and allow them to, beforehand, provide appropriate disclosures.
“I am delighted to comply with that anytime or anyplace. Anytime I am given a disclosure statement, my tendency is to over disclose. I’m still disclosing that I received Department of Defense research support that finished about a year ago.”
“I think that the best way for people to get what they want is to ask for it.”
“It never occurred to me in the limited testimony time to [disclose the Medtronic connection]. Perhaps I should have, I don’t know. But if I am asked in any format to disclose who I get paid by, it’s easy: the University of Minnesota, consultant for Medtronic, U.S. Army retiree, Department of Defense research support, and whatever else is appropriate.”
The fact that an experienced professor like Dr. Polly was caught off-guard about disclosure speaks volumes for the need for clear and widely accepted guidelines for physicians to follow when they enter into a relationship with industry and universities.
Times Have Changed
Mark DuVal“Times have changed. Get over it, ” said Mark DuVal in interviews with OTW. DuVal is President of DuVal & Associates, a Twin Cities law firm specializing in FDA and regulatory issues.
We asked DuVal: What can physicians do to protect themselves before they get into industry/university relationships?
Most importantly, DuVal said, always ask yourself: Have your financial relationships compromised or biased your [medical] decisions and the care of your patient?
And then, look out for yourself and take charge of your own compliance management.
Make your own personal compliance your objective. Don’t rely on your institution or the company with whom you’ve worked to protect you if times get tough—they may be loyal, they may not be. It depends on how bad the publicity is and the pressure gets. – Mark DuVal.
He offered up the following guidelines. After reviewing the list, Dr. Polly called them “spot-on.” (Bolded headings are ours).
- Consider Adverse Publicity – Begin your consulting relationship with potential adverse publicity in mind. Ask yourself, how would my relationship look if it were on the front page of the newspaper or on the nightly news? Are you viewed as a product evangelist or prostitute for one company or product? It’s acceptable to be an enthusiastic user/prescriber, but try to maintain some sense of balance.
- Documentation and “Fair Market Value” – Document your relationship with the Company—the agreement must be in writing to qualify for protection from government prosecution under the Personal Services Safe Harbor to the Anti-kickback Statute. Also document all that you bill a company with detail—the matter, time spent, work performed, and mention names of people with whom you’ve dealt and/or products on which you’ve worked. Would the rate you are being paid meet an outsider’s view of “fair market value” or is it a reflection of your ego?
- Go Beyond Disclosure Requirements – Be scrupulous about meeting your institution’s guidelines—go above and beyond disclosure requirements if necessary. The more you can demonstrate transparency and openness, the better off and less subject to criticism you’ll be. Consider disclosing all the money and other remuneration (stock, stock options) you receive and making your time sheets available to your institution even if it does not require them to be disclosed. Remember to disclose on other occasions as well, such as in a journal article or speaking in front of a professional audience. Many organizations have disclosure guidelines and, if they don’t, disclose anyway.
- Independent Perspective – Use a third party (friend, mentor, colleague, institutional ethics officer) as a sounding board for your financial relationships. They don’t need to have veto power, but they should be able to provide an independent perspective. It will make you think of things you might do along the way to protect your reputation.
- Don’t Get Greedy – Don’t be greedy or too attached to one company. Be wary of doing business with companies that seem overly desperate for your assistance and sales of their product to you, your practice and/or any affiliated institutions. You are entitled to be paid for your time, but make sure that the time you bill does not appear to deprive your employer of your services during a work day. Also, be careful when the cumulative hours billed in a day seem to be more than a normal human can bill in a day. Ensure that you do not appear to bill for every conceivable second and/or overbill for time spent on tasks that could be done in far less time than you’ve billed.
- Know Existing Standards – Know the AdvaMed Code of Ethics, PhRMA Code, and the company’s guidelines on interactions with healthcare professionals so you know the rules. Also abide by the AMA Code and your medical specialty society’s rules if you are a member.
- Take Charge of Compliance – Don’t rely on your institution or the company with whom you’ve worked to protect you if times get tough—they may be loyal, they may not be. It depends on how bad the publicity is and the pressure gets. Make your own personal compliance your objective.
- Times Have Changed – Remember that the world has changed—it’s no longer how it used to be. Get over it.
- Know the Risks – You are entitled to be paid for all the time you legitimately work. Don’t be an apologist for it, but view the public’s perspective independently of your freedom to work and to be paid at fair market value. You may decide to take the risk of criticism, but do it knowingly and protecting yourself the best you can.
- Know Your Biases – Most importantly, ask yourself always: Have my financial relationships compromised or biased my [medical] decisions and the care of my patient?
Finally, we asked DuVal how physicians can protect themselves if their industry client gets in the crosshairs of the media or government.
DuVal suggested that in addition to following the guidelines above, physicians should ensure that they’ve had an open and honest dialog with the company about the boundaries of their relationship and how that relationship might be perceived by the public. He also suggests that physicians keep a written record, like emails, of those conversations.
We wondered what Medtronic thought of these recommendations.
Marybeth Thorsgaard, a Medtronic spokesperson, told us: “Our intent in the coming weeks is to announce a new standard for clarity and transparency in these relationships that will build on our previous work in crafting the AdvaMed Code of Ethics and our strong support for the Physician Payments Sunshine Act, currently pending in Congress.”
Getting into the crosshairs of public scrutiny is a price physicians now have to pay if they want to collaborate with industry and universities to develop innovative new devices for patients. As Dr. Polly pointed out in part one of this two-part story, the price of compliance may not be worth it for a university physician, and industry may find itself dealing with more physicians in private practice in the future.
Hopefully Dr. Polly’s experience and candid discussion about the future of these collaborative relationships, along with Mark DuVal’s guidelines, will offer physicians a framework to take charge of their own compliance management.
