Wednesday, July 29, 2009

Polly Want a Million (Plus)

We have frequently posted about attempts to justify financial relationships among physicians and medical academics on one hand, and pharmaceutical, biotechnology, device and other health care corporations, on the other. Some defenders of such relationships now have gone so far as to start their own society, whose meeting was covered and commented on by fellow "pharmascolds," including Dr Daniel Carlat and Dr Howard Brody. The usual justification of these relationships is that they are necessary for "innovation" and the onward progress of medical science, education, and care. I have yet to see any logic or evidence to back up these assertions, nor have I seen anyone defend these relationships who does not also have personal financial relationships of their own with health care corporations. (See examples here, here, and here.)

Meanwhile, cases of individual physicians and academics whose lucrative relationships with industry seem to generate huge conflicts of interest continue to surface. The latest example ferreted out by investigators working for US Senator Charles Grassley (R - Iowa) is that of Dr David Polly. (Recall that Dr Polly was one of the strongest defenders of Dr Thomas Kuklo, who was accused of falsifying clinical research results in a way that seemed to favor the product of his own corporate benefactor [see post here].)

The main points were reported by David Armstrong and Thomas M Burton in the Wall Street Journal,

In May 2006, University of Minnesota spine surgeon David Polly urged a Senate committee to fund research into the severe arm, leg and spine injuries suffered by soldiers in Iraq and elsewhere.

Dr. Polly told the committee he was testifying on behalf of the American Academy of Orthopaedic Surgeons and referenced his prior work caring for soldiers as a surgeon at the Walter Reed Army Medical Center.

What Dr. Polly didn't disclose during his testimony was that his trip to Washington was paid for by Medtronic Inc., the big medical-device maker whose bone growth product, called Infuse, has been used to treat soldiers, according to company records.

Dr. Polly and colleagues in Minnesota subsequently received a $466,644 Department of Defense grant for a two-year study beginning in February 2007 to evaluate Infuse in cases where an injury is also infected, according to the university.

Dr. Polly was paid $1.14 million by Medtronic for consulting services from 2004 to 2007.

Details of Dr. Polly's consultant billing were provided by Medtronic to Sen. Charles Grassley, an Iowa Republican who has been scrutinizing the relationship between academics and industry.

Although there have now been many reported cases of medical academics who collected large payments from health care corporations, the services they provided in exchange for the money have not always been very clear. Defenders of financial relationships among physicians and medical academics and industry have argued that most payments were for valuable research, education, or health care activities. However, Senator Grassley's office provided the details of Dr Polly's invoices, and several of the news articles so far described what he did for the money. Per the Wall Street Journal article,

In total, Dr. Polly billed Medtronic for more than $50,000 in lobbying-related costs. He made trips to Washington in 2005 and 2006 and called on several members of Congress, according to the records.

According to billing records, Dr. Polly's billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter -- or 216 hours over three months. In some months, he conducted at least some Medtronic business on nearly every day.

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.

An accompanying post on the Wall Street Journal Health Blog provided more information:

Did you ever wonder what doctors do to earn big consulting contracts from medical device companies and pharmaceutical concerns?

Records released by Medtronic to Sen. Charles Grassley, a longtime critic of the ties between academics and and health-care companies, provide a rare and detailed glimpse into the daily billings of a consultant — in this case, spine surgeon David Polly of the University of Minnesota.

Polly collected more than $1 million in four years of work for Medtronic, according to the records, which you can take a look at here.

The services he provided were many, but among them, Polly was paid to write articles for medical journals; write a chapter in a book and a book outline; recruit patients for publicity efforts; attend Medtronic national sales meetings; travel to conferences in Japan, Paris and elsewhere; lead training and educational sessions for physicians; and lobby Congress.

Polly also billed for at least two phone calls with Medtronic CEO William Hawkins as well as charging the company $2,000 when Mr. Hawkins visited an operating room. In October, 2003, he billed the company $12,000 for attending a medical meeting of the North American Spine Society, at $4,000 a day.

There are also scores of entries for work billed in five-minute increments, usually to send email or return phone calls. The bill for each five-minute charge? $49.48 a pop.

So did the $1.2 million Medtronic spent on Dr Polly's services inspire any "innovation?" Did it lead to any scientific progress or improved health care? I am not sure.

It is clear, however, that a good chunk of this money went to support marketing, advocacy, and lobbying. The items in bold italics above were clearly in support of marketing, advocacy and lobbying, not science, medical education, or patient care. (To give Dr Polly the benefit of a doubt, some other items listed above could have been related to research, education, or patient care, although this is not indisputable.)

So the case of Dr Polly corroborates my deep skepticism of the financial relationships among physicians and medical academics on one hand, and corporations that sell health care goods and services on the other. We "pharmascolds," - a preferable term might be health care skeptics - suspect that many of these relationships are really about stealth marketing and advocacy. The companies often pay to market their products and services, or advocate positions to the companies' advantage, but prefer that their salespeople and advocates are cloaked in academic guises, and wreathed in the rarefied aura of respected academic institutions. (Note that some of us are just as skeptical about relationships among academic institutions and other health care not-for-profit organizations on one hand, and such corporations on the other, for analogous reasons.)

While the leadership of our formerly distinguished medical academic institutions remains infiltrated, if not dominated by people earning many thousands of dollars from health care corporations, I must remain skeptical about how much of these institutions supposedly academic output is actually stealth marketing and stealth health policy advocacy.

At the very least, medical academics, medical academic institutions, and other health care not-for-profits or NGOs should reveal in detail what payments they get from companies selling health care products or services, and how these payments could relate to the companies' marketing or lobbying efforts. In the US, some such disclosure would be mandated by the proposed "Sunshine" legislation now being considered by the US Congress. (By the way, note that this problem is hardly confined to the US, and needs global, not just American attention.)

However, physicians (at least physicians in full-time private practice, academic positions, and employed by mission-oriented not for profit organizations) should go further, and consider whether receiving industry money is worth the ongoing damage it does to our professionalism and our professional reputations. Medical schools, universities, health care foundations, disease advocacy groups, and other health care not-for-profits and NGOs should also go further, and consider whether receiving industry money is worth the ongoing damage it does to their missions, and their institutional reputations.

See also comments by Prof Margaret Soltan on the University Diaries blog.


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Anonymous said...

just imagine if doctors decided not to collaborate with medical device companies at all. i do not know of any sick patient who would be willing to undergo spine surgery with a device designed only by an engineer. imagine how the surgeon will explain this to the patient: Ms. patient, you need spine surgery, i need to insert a medical device designed by an engineer but i am not sure it is going to work.

there has been no evidence presented that proves any illegal or wrong doing. i have not seen any disclosures from the reporters or the senator and his staff.

Roy M. Poses MD said...

Anonymous, congratulations on deploying two logical fallacies in a four-sentence post!

The fallacies employed in combination were the red herring fallacy, and the slippery slope fallacy.

The red herring was responding to an argument that I did not make: that no doctor should ever collaborate with a medical device company.

This was also a slippery slope, the slope running steeply from the implication that academic physicians, physicians in private practice, and physicians employed by a mission-oriented health care not-for-profit organizations should reconsider whether getting outside payments from health care corporations is worth the dmanage to their professionalism to no physician should ever work with a medical device company.

I do admit that in my next to last paragraph, the physicians I meant were those who had an ostensible full-time academic, practice, or not-for-profit position. I will revise that paragraph.

However, nothing I said would prevent medical device companies from taking advantage of physicians' expertise to design products.

I certainly have no objection to physicians working full-time for pharmaceutical, medical device, biotechnology and other health care corporations. I also have no objection to physicians collaborating with such corporations.

I do have a big objection to physicians being paid as "consultants," but really for marketing who then help corporations market their products without revealing these financial relationships.

Finally, anonymous, you see nothing wrong with being paid to lobby the government on behalf of a company, but doing that lobbying in the guise of an academic providing disinterested advice?

Anonymous said...

Dr. Poses, congratulations on your non objective response. it is biased.
first, there is nothing in my statements that says you said "no doctor should ever collaborate with a medical device company."
second, not everyone considers receiving payments from health care corporations damaging to their professionalism. thats your opinion and yet it seems you are stating it as a fact. I think doctors should be paid for their feedback by medical device company, in addition, the feedback should be documented and relayed to the FDA (or other gov agency). third, i do not see anything wrong in being paid to lobby for a product that you really believe works as long as you disclose it. the statement "that lobbying in the guise of an academic" - seems like a judgement without proof.

with regards to the accusations of the senator...

Is it really true the good doctor did not disclose his ties with medtronic? Didnt the committee receive some sort of a CV or information on the doctor? that would certainly reveal his relationship with medtronic?

is the research with the doctor as PI approved by the University really just about INFUSE? i heard it was about bone infection? was it a clinical trial? or was it an animal study? did it involve patients? did he actually influence any of the results?

it seems to me all these reports are one sided, i have not read any response from the doctor to tell his side of the story.

lets say he forgot to disclose his financial relationships, okay, so now it is known.... then what? does it change anything? What does that got to do with asking for funds for research for injured soldiers from the wars?

Bytheway, did anyone in the committee ask the doctor about his relationship with medtronic? was it required? especially when the topic of Infuse was discussed? i find it hard to believe that no one bothered to ask?

Lastly, isnt the senator up for re-election in 2010?

Anonymous said...

Dr. Poses and the rest of you naysayers etc.,

Do these words ring true in any of your ears...from someone far greater than you.

Let the first one among uou who are without sin cast the first are obviously suffering from delusions of grandeur, because you are playing, the media, and the senator are all hurling boulders...WHY???

Have you a personal grudge or something???

Roy M. Poses MD said...

Dr Polly's anonymous supporters seem unable to provide any logic or evidence to justify his behavior, so they have resorted to various ad hominem attacks on me, and on Senator Grassley.

Then again, I have not seen anyone base their defense of the sorts of behavior Dr Polly and many other "key opinion leaders" exhibited on logic and evidence.

Anonymous said...

I trained at Walter Reed and dealt with Polly from the late '80s to early 00's. His arrogance and belligerance were legendary. He was rude and condescending to his medical peers. He is an extreme narcissist. Yes, patients would benefit from his skills - but I always felt that it was really all about feeding his pathologic needs, and the illusion of putting the patient first was a perfect cover. I did not expect him, however, to pursue a greedy, possibly unethical course. I thought that invoking feelings if fear and power over those around him was enough to stroke his ego. Amazing how narcissism lead to such poor judgement.

Anonymous said...

Sounds like Anonymous -posting 8/2/09 got his/her feelings hurt when orders were being given...possibly passed over for a promotion..Dr. Polly (all doctors/especially surgeons) need to have big egos-they couldn't do those 8-12 hour complicated surgeries without one....sounds like bitter herbs-
Dr. Poses: who died and left you judge and YOU have any evidence that Dr. Polly did something wrong? I am Not attacking you - I simply am stating what appears to be the truth since you defend yourself so vigorously...Why are you so interested in this-you seem to be a nice IM doc in a small eastern community...why don't you speak with Dr. Polly, come see what he does on a daily many of people he helps on a daily basis...again...judge not lest ye be judged....

Roy M. Poses MD said...

To the anonymous commentator who posted on 3 August - if you read my post carefully, you will see that I was not acting as "judge and jury" for Dr Polly. My main point was that the data that came out in his case suggest that the "key opinion leaders" are well-paid as consultants by the drug, device, and biotech industry for consulting that supports marketing and advocacy, not just and probably more than consulting about scientific, technical and clinical questions. This is further evidence that the financial relationships among academic physicians and other "key opinion leaders" and health care corporations may distort education, research and health care advocacy in favor of the corporations' interests.

Dr Polly hasn't called me, and certainly hasn't invited me to visit him and observe his day to day activities. I did listen to the interview with him on Minnesota Public Radio:

I am sure he is a dedicated physician, and works hard to help his patients. However, nothing he said refuted the idea that his consulting for Medtronic had the effect of advancing the company's marketing and policy interests.

J said...

All I know is that this man is an amazing doctor who has performed surgeries on my uncle over the past 3 years that I don't believe anyone else could have done (it's a long story). I and my family trust him implicitly and I have to say that I don't really care how much money he is making. Did you see how much money professional athletes are making now days? And for what?

Go ahead and blast me, I don't have any rationale to back this up, but my uncle is alive and walking because of this man.