Wright Medical Settles, ... But Wait, There is Less

Everyone loves a parade, and so the parade of legal settlements by prominent health care organizations continues.  The latest to march into view is Wright Medical Group, as reported by Bloomberg:

Wright Medical Technology Inc. agreed to pay $7.9 million to resolve U.S. criminal and civil investigations into whether it paid kickbacks to induce doctors to use its hip and knee devices.

Prosecutors in Newark, New Jersey, today charged Wright with conspiring to violate a federal anti-kickback statue through consulting contracts with orthopedic surgeons. The U.S. agreed to drop the case in 12 months if a monitor agrees that Wright has reformed the way it hires consultants.

Wright, based in Arlington, Tennessee, also agreed to a $7.9 million civil settlement with the Justice Department and inspector general of the Health and Human Services Department to resolve fraudulent-marketing claims. The company entered into a five-year corporate integrity agreement.

Here we go again. A company is accused of giving kickbacks, aka bribes, to individual doctors, in this case orthopedic surgeons, to get them to use the company's products. Such payments clearly violate medical ethics (especially doctors' obligations to put the interests of patients ahead of their personal financial interests), leading to decision making not in the best interests of the patients. However, the penalty to the company itself is minuscule, only a fraction of the company's revenue, according to Google Finance, in 2009, just under $500 million. As we have noted endlessly before, financial penalties to corporations are diffused among all shareholders and employees, and possibly customers and patients.

Do we really expect that this penalty will change anything, or deter future bad behavior by this or any other company?

But our government continues to treat the corporate employees who authorize, direct, or implement bad behavior like this as essentially above the law. In this case, like in many others we have discussed previously, no one who authorized, directed or implemented the bad behavior will have to pay any sort of penalty or suffer any sort of negative consequences.  Does anyone in their right mind believe that Wright Medical really is

pleased to announce these agreements and look[ing] forward to working with the independent monitor as we continue our commitment to the highest standards of ethical and legal conduct

That was a quote from Wright Medical CEO Gary D Henley. He may be pleased to announce the agreements, since they really amount to such a tiny pinprick of a penalty. After all, Mr Henley will be able to to continue to use Wright Medical's revenues, virtually unaffected by this penalty, to justify his compensation (per the 2009 proxy statement, $2,036,517 in 2009, and his continuing accumulation of wealth, e.g., 436,601 shares of stock, currently valued at $13.86/ share according to Google Financial.)

I leave an assessment of what the company's previous commitment to "the highest standard of ethical and legal conduct" was to our dear readers.

We will not have true health care reform until we end the unholy alliance between big government and big health care organizations, that is, health care corporatism. Then, maybe, we can make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

When a Key Opinion Leader Questions the Hand That Fed Him: from "Master Teacher to Someone Who Didn't Know What He Was Doing"

We just posted an update on the ongoing cozy relationship with medical device companies, in particular, those that make prosthetic hip and knee joints, and some orthopedic surgeons.  Some surgeons, including many prominent academic leaders and practitioners, have been paid huge amounts, and have often failed to make more than the most minimal disclosure to their patients, or to the audiences of their talks or the readers of their ostensibly scholarly articles.  Deferred prosecution agreements with device companies shed light on these payments, but did not curtail them.  Yet the surgeons and the companies who paid them defended the payments as legitimate consulting agreements, and royalties for worthy innovations. 

Now the New York Times has reported on a dispute between a well-paid consultant and an artificial joint manufacturer that provides new insights into these financial relationships. To summarize,

IT was a long, fruitful medical marriage that is fast becoming an angry public divorce, one that offers a rare look at a clash between a top-shelf consultant and his corporate patron over patient safety.

For years, Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, trained hundreds of doctors to use its products and talked it up wherever he went. In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a master surgeon and paying him more than $8 million over a decade.

Those days are gone. Dr. Berger started complaining to Zimmer a while back that one of its artificial-knee models was failing prematurely, and he went public recently with a study that he says proves it. Zimmer told him that the problem was not the artificial knee, but his technique, and pointed to data overseas indicating that the knee was safe.

Last year, Zimmer did not give Dr. Berger a new contract. The company says it routinely rotates consultants.

'I trained hundreds of doctors for them and made them tens of millions,' Dr. Berger said in interview here, in which he also lambasted Zimmer executives as dissembling, out-of-touch bureaucrats. 'So was this just a coincidence? Maybe it was. Maybe it wasn’t.'

In more detail, here is how Dr Berger's relationship with Zimmer began:

The surgeon, a tall, balding man with a boyish manner, was finishing his fellowship at the Rush University Medical Center in Chicago at the time, one of the country’s top centers for joint replacement. The center has had long ties to Zimmer, whose headquarters is about two hours away, in Warsaw, Ind., and the young surgeon quickly came to the company’s attention.

'Rich has a very clever set of hands, and because of that he is enabled with the ability to innovate surgical techniques,' said Roy Crowninshield, who was Zimmer’s chief scientific officer.

Dr. Berger’s skills matched Zimmer’s marketing strategy. To distinguish itself from competitors, the device maker had started promoting minimally invasive surgery, a technique that uses smaller incisions than traditional surgery. Zimmer trained doctors in the procedure, using its device.

Soon, Dr. Berger, who was then pioneering a type of small-incision surgery that allowed patients to leave the hospital on the day of surgery, became a linchpin of Zimmer’s efforts. In 2002, he was prominently featured in a press release about Zimmer’s plans to build a training facility for minimally invasive surgery.

'We are clearly excited about Dr. Berger’s data,' J. Raymond Elliott, the company’s chairman and chief executive at the time, stated in the release.

Over the next few years, the physician estimates, he helped train hundreds of surgeons on Zimmer’s behalf.

And in more detail, here is how things went wrong: 

As he tells it, his relationship with Zimmer frayed over a version of a widely used Zimmer knee, known as the NexGen. The model at issue, called the NexGen CR-Flex, is designed to provide a greater range of motion than the standard NexGen.

Most surgeons implant an artificial knee using a cement-like adhesive to bond the thigh bone to the portion of the device that bends. But some specialists, like Dr. Berger, try to avoid adhesives because the cement can break down and cause device failure. So Zimmer also sells an uncemented version of the CR-Flex that relies instead on the bone naturally fusing with the implant.

Dr. Berger says that he gave the device, which is supposed to last about 15 years, to about 125 patients in 2005, the first full year he used it. But by early 2006, some X-rays showed lines where the implant met the thigh bone, an indication that the device was loose and had not fused completely. Patients could walk, but they were reporting pain, apparently a result of the loose joint.

He says he soon brought the problem to the attention of Zimmer officials, including the company’s new top scientist, Cheryl R. Blanchard. Zimmer executives pointed to the success of the NexGen, but the company did not have separate test data on the uncemented flexible model because the F.D.A. had not required the company to study it in patients before selling it.

Later, as more patients complained about the device and Dr. Berger had to replace some of them, he spoke to Ms. Blanchard again, he said. This time, he said, she and other Zimmer officials suggested that his technique was the problem because no other surgeon had complained.

'Suddenly, I went from someone who was their master teacher to someone who didn’t know what he was doing,' he said.

BY 2007, Dr. Berger, although still a Zimmer consultant, had stopped using the device and had learned, he said, that several other surgeons had also experienced problems with it. But unlike Dr. Dorr, the physician who sent out the alert about Zimmer, Dr. Berger said he initially had hoped to avoid a public showdown with the company. So he followed a more traditional route by performing a study with another Rush surgeon, Dr. Craig J. Della Valle, who was also having to replace the Zimmer knee.

Dr. Berger and Dr. Della Valle first presented their study at a medical meeting last fall and again this year at a national meeting of the American Association of Orthopedic Surgeons. They found that the uncemented Zimmer knee failed early in about 9 percent of some 100 patients studied. Also, the knee exhibited signs of looseness in about half of all patients and has since been replaced in some of them, Dr. Berger said.

But Zimmer was unswayed. In a filing with the Securities and Exchange Commission, Zimmer made note of the study but also pointed to the knee’s very positive results in a large database of orthopedic patients in Australia. Officials there confirmed the low failure rate. The company also said that the cement-free CR Flex accounted for only a small fraction — about 2 percent — of its overall knee sales.

The most striking lesson of this case is that Dr Berger was only valued as a consultant as long as his work completely followed the marketing party line.  As soon as he questioned the company's product, or the executives who were promoting it, he became "someone who didn't know what he was doing."  Of course, a truly valued consultant should be respected, if not sought for honest advice, whether or not it fit  preconceived notions or marketing strategies.  Thus, how Dr Berger was finally treated suggested he really was hired to market product.  "Consultant" was just a pretty title.. 

We  (and many others) have discussed (e.g., here) how pharmaceutical, biotechnology, and device companies cultivate "key opinion leaders" who really are nothing more than salespeople with fancy academic titles or well-known practices.  The case of Dr Berger suggests that apparently distinguished academics and practitioners hired as "consultants" by such companies ought to be regarded as salespeople until proven otherwise.  Physicians who are wooed by company marketers to take on such consulting roles, often with praise for their ability to "innovate," "excite," or become a "master teacher," may want to consider whether those flattering them merely want to hire another high-profile part-time salesperson.  They may further may want to think about how they would look should this relationship be revealed for what it really is.  If something goes wrong, they should think about what it would be like to deal with "dissembling, out-of-touch bureaucrats."  Sometimes there is a price to pay for taking all that money.

I hope that Dr Berger will consider donating the $8 million he made to the cause of more honest teaching and research about orthopedic devices. 

Meanwhile, patients and physicians should be extremely skeptical about the pronouncements of paid consultants and key opinion leaders who work for corporations marketing health care goods and services.  We all should demand at least that those paid by such vested interests reveal such financial arrangements in detail if they expect us to listen to their spiels, take their advice, and particularly be subject to their decisions.  

Deferred Prosecution Agreements End, So Let the Payments Grow

Starting in 2007, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. These revelations were the results of deferred prosecution agreements made in 2007 between four of the companies and the US Department of Justice after the latter charged Biomet, DePuy, Zimmer, and Smith and Nephew with giving surgeons kickbacks, disguised as consulting fees, to promote their products.  Stryker entered into a voluntary compliance agreement (see post here). 

We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves. A 2008 post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.

Now in 2010, Bloomberg News reported on the results, such as they were, of these ballyhooed agreements:

The government declared last year that it had overhauled the financial relationships between surgeons and the biggest makers of knees and hips, saying the threat of criminal prosecution for 'kickbacks' had forced them to slash payments to physicians. Results of the crackdown were 'truly extraordinary,' said Christopher Christie, a former U.S. attorney for New Jersey who is now governor, in testimony to Congress in June 2009.

It was too good to be true. Compensation ended up being higher after the September 2007 deferred prosecution agreement because payments were postponed, according to data compiled by Bloomberg and interviews with seven surgeons.

'It’s back to business as usual' says Charles D. Rosen, president of the Association for Medical Ethics, who is a spine surgeon in Irvine, California. 'Nothing will change until someone goes to jail. It’s a big game.'

Apparently, while during the course of the agreements the companies decreased payments to surgeons, they made up for it later:

Prosecutors in the New Jersey U.S. Attorney’s Office, which headed the case, reported a 'satisfactory completion' in March 2009 of the probe of Biomet Corp., Johnson & Johnson’s DePuy unit, Smith & Nephew PLC, Zimmer Holdings Inc. and Stryker Corp. Payments in 2008 fell to $105 million from $272 million the year before, the Justice Department lawyers said.

The companies increased doctor compensation for 2008 to about $300 million, according to the data compiled by Bloomberg from reports posted on the device makers’ websites. Fees for 2008 were delivered in 2009, the surgeons say.

Payment delays were 'a common happenstance,' says Teresa Ford, a Seattle attorney who represents 150 doctors who have consulting or royalty agreements with orthopedic device makers. “None of them had significant changes in their relationships.”

Also,

A month after the government closed its case, Zimmer CEO David Dvorak told analysts on a conference call that the action didn’t result in a 'material change' to what it pays surgeons.

Attempts by Bloomberg reporters to find out more did not reveal much:

Since the agreement, payments to surgeons have been appropriate and for legitimate purposes, according to spokespeople for the five companies. Wright says on its website that it adheres to industry ethical standards in its dealings with consultants.

As for 2008 fees that weren’t delivered until 2009, three of the companies say they froze payments while monitors were reviewing contracts with surgeons to ensure they were proper. Spokesmen for Stryker and Smith & Nephew declined to comment. Three of the court-appointed monitors say they’re barred from talking about the details of their work. The two others, including former U.S. Attorney General John Ashcroft, didn’t return telephone calls. The department declined to release reports the monitors filed.

We have repeated often (e.g., here) the argument that limiting punishments of health care organizations for wrong-doing to corporate fines and deferred prosecution agreements has not deterred further wrong-doing.  Most of the cases which we have discussed involved pharmaceutical and biotechnology companies, and sometimes health insurers.  It seems that the argument also applies to device manufacturers. 

To underline the lack of a deterrence effect, others payments by other device companies to other surgeons have also recently come to light. In 2008, we discussed payments made by Medtronic revealed in various court filings. Medtronic just started voluntarily revealing more information. For example, as reported by the St. Louis Business Journal, Dr Larry Lenke helped Medtronic develop a spinal surgery system, so

In the first three months of 2010, Lenke earned $832,000 in royalties from Medtronic, putting him on track to top $3 million in royalties this year.

Lenke received between .5 percent and 1 percent of sales of the system in royalties.

'The royalties are very small, but the sales are large,' he said. Lenke is cho-chief of adult and pediatric spinal, scoliosis and reconstructive surgery and the Jerome J. Gliden professor of orthopedic surgery at the Washington University School of Medicine, the director of spinal surgery at Shriners Hospital for Children, and a spine consultant to the St. Louis Rams and Blues.

Like the surgeons we discussed in 2008, neither Dr Lenke nor Washington University seemed to make an effort to reveal his multi-million dollar relationship with Medtronic.

Dr Lenke's official web-page at Washington University does not reveal financial ties to, much less multi-million dollar royalties from Medtronic. A quick review of a few of Dr Lenke's published articles reveal such vague disclosures as:

One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

[Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, et al. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lubmar scoliosis: a prospective multicenter evidence-based study. Spine 2009; 34: 2171-78.]

The most specific disclosure I could find was:

Dr Lenke was a consultant for Medtronic until January, 2009, and is a patent holder with Medtronic.

[Silva FE, Lenke LG. Adult degenerative scoliosis: evaluation and management. Neurosurg Focus 2010; 28: 1-10.]

So the more things change, the more they stay the same. Device companies are still paying royalties, sometimes enormous sums, to the surgeons who helped them develop lucrative devices. Many of these surgeons are in practice, and some are prominent academics. The surgeons, and their academic institutions when applicable, do not seem to be going out of their way to reveal these sometimes massive financial relationships to patients, many of whom end up implanted with the very devices that generate these enormous payments. While some of the surgeons and influential academicians and prolific authors, they do not seem to go out of their way to reveal these sometimes massive financial relationships to their audiences and readers, even while touting aggressive, procedure-oriented, device-centric approaches to manage orthopedic problems.

So although the "Sunshine Act" was made part of the US health reform legislation, there is not yet much sunshine out there.  In my humble opinion, at a minimum, physicians should reveal, in detail, all financial relationships that might appear to have a probability of influencing their clinical decision making to the patients for whom such decisions are made.  Physicians should also reveal, in detail, all financial relationships that might appear to have a probability of influencing any related teaching or research. 

Furthermore, as an Institute of Medicine's report on conflicts of interest, which as received strikingly little attention, recommended:

researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial.

Also, the report said we need

to develop a new system for funding high-quality accredited continuing medical education that is free of industry influence.

These idealistic recommendations seem a long way from the reality of our currently money-focused system of medical education and research.

The $20 Million Dollar Journal Editor

Last week, the Milwaukee Journal-Sentinel reported on a royally paid journal editor:

In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders.

It would be the beginning of a beautiful friendship.

In the years to come, Zdeblick would receive more than $20 million in patent royalties from Medtronic for spinal implants sold by the company. And the medical journal he edited would become a conduit for positive research articles involving Medtronic spinal products, a Journal Sentinel analysis found.

Zdeblick took over editorship of the Journal of Spinal Disorders & Techniques seven years ago. Since then, studies involving Medtronic spinal products or that were funded by Medtronic appeared in the journal at least once per issue, on average.

Dozens of studies that mentioned Medtronic products have been published while Zdeblick has been editor. But in issue after issue, readers of the journal were not told that he was receiving millions of dollars in royalty payments from Medtronic at the same time.

Most of the time the articles, including some co-authored by Zdeblick himself about devices for which he gets royalties, had good things to say about the Medtronic products. Only on a small number of occasions did the articles find major problems with Medtronic devices.

And often the articles did not disclose financial ties the authors had to Medtronic.

Here are some specifics:

From 2003 through 2007, Zdeblick got more than $19 million in royalty payments for spinal devices from Medtronic, according to a January 2009 letter by U.S. Sen. Charles Grassley (R-Iowa), who has been investigating payments to orthopedic surgeons by Medtronic. In 2008, Zdeblick got another $2 million from Medtronic from royalties and working as a consultant, according to UW records.

To assess the relationship, the Journal Sentinel reviewed every article published in the journal since Zdeblick became editor.

The journal is published seven or eight times a year and typically has a dozen or so articles. The articles were searched to see if Medtronic products were used as a part of the study or if the study was funded by Medtronic.

At least 70 such articles were found in 56 issues of the journal from 2002 through October 2009.

• A 2005 study by researchers in France found favorable preliminary results with Medtronic's Maverick artificial disc.

In 2007, Medtronic paid Zdeblick $144,000 in royalties for the Maverick disc, according to Grassley's letter.

•  In August 2009, Zdeblick co-authored a study that involved Medtronic's Premier Anterior Cervical Plate as well as the plate of another company, Synthes. The study involved using two different kinds of bone grafts with the plates. Zdeblick got $654,000 in Premier royalties from Medtronic in 2007.

•  Zdeblick also co-authored three articles, in 2002, 2003 and 2005, involving Medtronic's BMP-2 and the LT-Cage, a device that paid him $1.4 million in royalties in 2007. None of those studies disclosed that he received millions of dollars in royalties from Medtronic.

Often articles in the journal had good things to say about Medtronic products:

•  In the 2002 study, Zdeblick and the co-authors concluded that BMP-2 and the LT-Cage led to a solid union and high fusion rates. In the 2003 study they found that BMP-2 may become 'the new gold standard.'

•  In a 2006 study, a different group of authors concluded that BMP-2 when used with a hip bone graft significantly improved the success of the fusion surgery with minimal risk to the patient. The 2005 French study of Medtronic's Maverick artificial disc that did not involve Zdeblick concluded it was a 'promising therapeutic technique.'

Dr Zdelblick declined to comment for the Journal-Sentinel, but:

In a statement, a spokesman for the spinal journal said Zdeblick has disclosed his financial relationship with Medtronic to the company that publishes the journal, Wolters Kluwer Health/Lippincott Williams & Wilkins.

All manuscripts submitted to the journal go through a rigorous review process using reviewers who have an objective viewpoint, Robert Dekker, director of communications with Philadelphia-based Wolters Kluwer Health & Pharma Solutions, said in a statement. 'Thanks to our strict peer review policies and processes, we have no concerns about the existence of this relationship,' Dekker said in an e-mail.

Dekker declined to provide a list of the reviewers used by the journal or information about their financial relationships with device companies. He also declined to comment on how Zdeblick made decisions about manuscripts and reviewers.

Of course, as the Journal-Sentinel pointed out, editors can make publication decisions independent of the recommendations of peer-reviewers. They also are free to select peer-reviewers who might have a particular viewpoint about a manuscript, its topic or authors, and to make and enforce editorial suggestions for changes in manuscripts.  It is beyond me what good that disclosure of conflicts of interest to a for-profit publishing corporation does in the absence of further disclosure.  Keep in mind also that the division of Wolters Kluwer that publishes the journals, Wolters Kluwer Health & Pharma Solutions, not only publishes journals and textbooks, but "provides marketing and publications services, business intelligence products, and advanced analytical tools and services" to pharmaceutical corporations.

Furthermore,

'It's absolutely a conflict,' said Richard Smith, the former editor of the British Medical Journal.

At a minimum, Zdeblick's conflict should be fully disclosed by his journal whenever a study involving a Medtronic product is published, said Smith, the author of 'The Trouble with Medical Journals.'

However, because he makes so much money from Medtronic royalties, he really should not be editing the journal at all, Smith said.

Just to add icing to the cake, Prof Margaret Soltan pointed out on her University Diaries blog that Dr Zdeblick is not only a journal editor, but a Professor and Chairman of Orthopedics and Rehabilitation at the University of Wisconsin.  In addition, his web-page at the University notes that he is on the editorial board of another orthopedics journal, Spine, also published by Wolters Kluwer Health. 

So here we go again.  How should we assess the objectivity of an ostensibly scholarly medical journal whose editor was made rich by royalties from a company whose devices were often evaluated in the articles published in the journal?  How should we assess the honesty of a journal editor who received millions in royalties from Medtronic, but who only deigned to disclose as an author in his own journal, "One or more of the author(s) has/have received or will receive benefits, (e.g., royalties, stocks, stock options, decision making position) for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript." (as in Zdelblick TA, Phillips FM. Interbody cage devices.  Spine 2003; 28: S2-S7.)  (Note that this sort of disclosure seems to be standard operating procedure for orthopedic surgeons who make millions from royalties and consulting fees, e.g. see this post.)

Prof Zdelblick had numerous opportunities to influence his colleagues, trainees, and students in his roles as journal editor, journal editorial board member, author of scholarly articles, and professor and chair of orthopedics.  At the very least, the people who read his journal or his articles, listened to his lectures, or participated in his clinical teaching should have at least had the opportunity to judge for themselves whether being paid over $20 million might have just biased what he wrote and said a tiny bit.  But can anyone doubt that $20 million dollars would profoundly influence one's thinking?  Can anyone doubt that an inventor who got rich from royalties might not be more enthused about the use of the devicesthat generated the royalties than would an academic whose salary is unrelated to the use of any device?   It seems to be an abuse of entrusted power for a journal editor, professor, and department chairman not to clearly disclose such huge conflicts of interests to readers, learners and colleagues.

This is just the latest vivid example of the conflicts of interest that permeate health care.  When multi-million dollar men pretend to be unbiased editors and professors, is it any wonder that we regularly overuse and overvalue the devices and drugs that they are selling?

ADDENDUM (6 January, 2010) - See also comments on the Spine Blogger, and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

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.

More Lucrative Payments to Orthopedic Surgeons: This Time Consulting Fees By Medtronic to Spine Surgeons

Starting last year, we posted (here, here, here, here and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves. Our last post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.

This month, the Minneapolis Star-Tribune published a series of reports on its investigation of payments made to orthopedic surgeons by medical device maker Medtronic. Unsealed documents from an ongoing lawsuit suggested that this company also made some strikingly large payments to orthopedic surgeons who perform spine surgery. The Star-Tribune's first article focused on a single surgeon:

Dr. David Polly's reputation precedes him and it's worth a lot. Among spine surgeons, this rather unremarkable-looking 51-year-old is a rock star.

Arrayed before him as he spoke at the annual Design of Medical Devices Conference at the University of Minnesota were two dozen doctors, engineers, students and medical device company representatives, some furiously scribbling notes. In this reverential group, Polly's mention of a particular surgical technique or medical device would be golden.

They already knew much about this man with a 29-page résumé. The head of orthopedic spine surgery at the university, Polly has led close to 80 research studies and co-written at least 90 scientific papers on repairing aging, injured and contorted spines. In an era of active baby boomers, many with ailing backs, Polly's specialty is a growth industry.

Polly's paid consulting relationship with Medtronic Inc., the global leader in medical devices, was not a focus of discussion that muggy April day. The Fridley-based firm makes the plates, screws, cages, neurostimulators and bone grafts that largely comprise the toolbox of spine repair.

A recently unsealed whistleblower lawsuit, and Congressional and Justice Department investigations, are finally bringing into public view the practice of handsomely reimbursing top doctors to consult for medical device companies.

The $344,375 in consulting fees Polly allegedly received from Medtronic in 2006, and similar amounts in 2004 and 2005, are only emerging because of a complaint filed in a whistleblower lawsuit by two former Medtronic employees in U.S. District Court in Massachusetts.

Another article focused on another surgeon:

Dr. Kenneth Burkus is quite confident his eight-year relationship as a paid consultant for Fridley-based medical device maker Medtronic Inc. hasn't compromised his patients' care.

The Columbus, Ga., surgeon said he receives royalties for helping to develop the company's artificial neck disc and other products. A whistle-blower lawsuit filed in Massachusetts federal court alleges that he was paid $416,775 for consulting work in 2006.

I thought it might be useful to examine the extent that these two surgeons have disclosed their relationships with Medtronic in their published work.

Dr Polly is by far the more prolific writer. Most of his recent work is in Spine. So I looked at a 2008 review article on treatment of scoliosis for which he was senior author.(1) This is what was disclosed in the article:

Although one or more of the author(s)has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of the manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other non-profit organization which the author(s) has/have been associated. One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That was really specific, wasn't it. The disclosure does not identify which author received payments, what company made the payments, how much they were, or what their purpose was.

I found two recent articles authored by Dr Burkus, both again in Spine. The most informative disclosure statement was from an article by Dimar et al(2)

One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That wording seems familiar, and presumably is the boilerplate favored by Spine. Of course, it is no more specific here than it was before.

The new investigations by the Star-Tribune suggest that huge payments to orthopedic surgeons by medical device companies are hardly confined to those related to hip and knee prostheses, and that spine surgeons seem no more eager to disclose these payments in any detail to the readers of their research articles than were surgeons who specialized in hip and knee replacement.

So I get to repeat myself. In my humble opinion, a disclosure that a journal article's author received some sort of "benefits" from a company does not quite have the impact of a disclosure that the author received hundreds of thousands of dollars in consulting fees. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for spine surgery, especially involving the use of specific products, might just have been a bit influenced by making hundreds of thousands of dollars a year in consulting payments from the manufacturers of those products.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from consulting fees almost enough to make a doctor rich? Inquiring minds want to know.

This is another argument for requiring full and detailed disclosure of all payments made to physicians, and to health care academics, and health care decision makers, beyond their usual salaries or fees, and that could have any bearing on their clinical or health care decision making.



References

1. Lenke LG, Kuklo TR, Ondra S, Polly DW. Rationale behind the current state-of-the-art treatment of scoliosis (in the pedicle screw era). Spine 2008; 33: 1051-1054.

2. Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistance matrix versus iliac crest bone graft. Spine 2006; 31: 2534-2539.

More Multi-Million Dollar Orthopods

Starting last year, we posted (here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

I was surprised how little attention this issue received in the media, given the size of the payments involved, and the extensiveness of the lists of those who received them. Demonstrating the anechoic effect, the issue received almost no attention in any medical or health care publications. Yet every now and then, the story resurfaces.

This week, it resurfaced courtesy the Philadelphia Inquirer, which published two related articles. The most vivid was about a lawsuit filed by a patient who received artificial hip implants that failed. MedInformaticsMD quoted relevant parts of the article and commented on some issues related to the above story here.

The Inquirer also published a companion story with background information on payments made by hip and knee implant manufacturers. Reporter Josh Goldstein took the opportunity to look into payments made to other Philadelphia area surgeons.

Locally, 29 doctors and others received a total of $7.9 million last year. Most of that money went to two of the region's busiest and most prominent orthopedic surgeons.

Richard H. Rothman, founder of the Rothman Institute at Thomas Jefferson University Hospital, received nearly $3 million last year from Stryker. A Rothman spokesman said most of that money came in royalty payments for a hip Rothman helped design.

The other surgeon, Robert E. Booth Jr., who practices at Pennsylvania Hospital, received nearly $2 million from Zimmer Corp., the company that makes the so-called gender knee for women. Booth is one of eight patent holders on it.

Both doctors declined to be interviewed. Through spokeswomen, they said they disclose their company ties to patients. There is no indication that either have engaged in any wrongdoing.

Indeed, many patients seek out surgeons like Booth and Rothman, who help design implants, precisely because they are known as pioneers in the field.

At 72, Rothman, the former chairman of orthopedic surgery at Jefferson, remains busy, replacing more than 600 hips and knees a year. Implants cost as much as $7,500 each.

According to Stryker's disclosures, the company paid Rothman $2.9 million in 2007. In addition, Rothman received $316,885 in "corporate assistance" for research, $52,906 in air travel, $4,705 for ground transportation, and $1,757 in meals.

'The vast majority of payments Dr. Rothman receives from Stryker are royalties for the Accolade hip implant,' said a statement provided by the practice he founded, the Rothman Institute.

At Pennsylvania Hospital, Booth, one of the nation's busiest knee surgeons, routinely replaces a knee in under a half hour - 12 to 14 a day, or about 1,200 a year.

Last year, Zimmer paid Booth $1.9 million, plus $35,729 in air travel, $3,135 for lodging, $1,214 for meals, and a $6 gift.

Susan E. Phillips, a senior executive at the University of Pennsylvania Health System, said Booth's contract with Zimmer prevents him from discussing royalties.

The articles focused on the question of whether these sorts of humongous payments were disclosed to patients, or whether they affected direct patient care by the surgeons who received them.

Since some breathtakingly huge payments were made to apparently very influential surgeons, I wondered if the surgeons disclosed such large payments to other doctors who might be influenced by their words.

In the articles I was able to quickly access published by Rothman during 2007, I found some disclosures of his relationship to Stryker, but none that revealed their magnitude. (These do not constitute a complete sample of his publications, just what I could easily obtain on the web.)

Lettich T, Tierney MG, Parvizi J, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: two- to seven-year results. J Arthoplasty 2007; 22 (Suppl 3): 43-46.

Richard H. Rothman MD, PhD and ... are consultants for Stryker orthopedics.

Pour AE, Parvizi J, Sharkey PF, Hozack WJ, Rothman RH. Minimlly invasive hip arthoplasty: what role does patient preconditioning play? J Bone Joint Surg 2007; 89: 1920-1927.

In support of their research for or preparation of this manuscript, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Stryker.

I was able to access one article written by Booth in 2006, and one in 2004. Again, neither revealed the magnitude of his relationship to Zimmer.

Lonner JH, Jasko JG, Booth RE. Revision of a failed patellofemoral arthroplasty to a total knee arthroplasty. J Bone Joint Surg 2006; 88: 2337-2342.

In support of their research for or preparation of this manuscript, one or more of the authors received grants or outside funding from Zimmer, Inc. In addition, one or more of the authors received payments or other benefits or commitment or agreement to provide such benefits from a commercial entity (Zimmer, Inc.) Also, a commercial entity (Zimmer, Inc.) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution, or other charitable or non-profit organization with which the authors are affiliated or associated.

Bezwada HP, Nazarian DG, Booth RE. Acetabular wear in total hip arthroplasty. http://www.emedicine.com/orthoped/TOPIC371.HTM.

Nothing to disclose.

In my humble opinion, a disclosure that a journal article's author received some sort of "grants" or "payments" from a company does not quite have the impact of a disclosure that the author received millions of dollars in royalties. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for joint replacement, or for replacement in specific circumstances or with specific products, might just have been a bit influenced by making millions of dollars a year in royalties from specific joint implants.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from royalty payments enough to make a doctor quite rich? Inquiring minds want to know.

Now You See Them, Now You Don't: 2007 Lists of Payments Made by Orthopedic Device Companies Vanish Into Cyberspace

Starting last year, we posted (here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

The information we used in those posts about the payments came from lists posted on the internet by the five companies. The lists were posted under deferred prosecution agreements a US Attorney made with four companies (Biomet, DePuy Orthopedics, Smith & Nephew, and Zimmer Holdings) and an agreement allowing federal supervision of Stryker Orthopedics. The companies were charged with violating anti-kickback laws by paying orthopedic surgeons as "consultants" to use their products. The lists on which I based the above posts contained data from nearly all of 2007.

I recently had occasion to revisit this question, and decided to take another look at these lists. But lo and behold, when I used the links from my earlier posts (Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer), I found that two of them now went to lists of data pertaining only to the early part of 2008. No 2007 data was available from the Biomet and Smith & Nephew lists. Furthermore, perusal of those companies' web-sites did not reveal any obvious way to access the 2007 data. [See addendum below. By 12 May, 2008, three days after this was posted, the Smith & Nephew list included all 2007 data, and the Biomet list included all 2007 data, but appears to have truncated its 2008 data alphabetically after "Wo...."]

When I reviewed the 2007 lists, I was struck by how many doctors, academic institutions, and other not-for-profit organizations were on the lists, and how much money some of them received. The potential for payments of hundreds of thousands or millions of dollars to influence the thinking and actions of these people and organizations was obvious. Many of the orthopedic surgeons involved were prominent practitioners or academics. The likelihood that their practice, teaching or research might have been influenced by financial entanglements of this magnitude was obvious. Similarly, the likelihood that large payments to academic institutions or professional societies might influence their actions and policies was also obvious.

But, two of these lists are now lost in cyberspace. So those wishing to use them to inform their thinking about the people and organizations involved are out of luck. Whether by the end of the year the 2008 lists will essentially provide the same information as the 2007 lists is unknown. Even if they do, the loss of the 2007 lists will make it difficult to determine whether the financial relationships revealed in 2008 were new or not. Furthermore, erasing the 2007 data would obviously reduce the perceived overall magnitude of some of the financial relationships. In summary, erasing the 2007 data off the internet suggests that the companies want to provide as little transparency about their payments to orthopedic surgeons, academic institutions, and professional societies as possible, and that the companies want to minimize perceptions of the magnitude and duration about these financial relationships.

We are only making slow progress in making the web of financial entanglements that pervades health care more transparent.

ADDENDUM (12 May, 2008) - As noted in the comments, the 2007 information from Biomet was apparently recently added to the list available on the web. It now begins after item 168, thus apparently truncating the 2008 data for recipients starting with names beginning with alphabetically after "Wo...." Also, Smith & Nephew has also loaded its 2007 information, apparently completely.

BLOGSCAN - Continuing Investigation of Orthopods' Financial Relationships with Prosthetic Joint Manufacturers

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody expanded his focus a bit to include medical device companies. He posted about the ongoing investigations of orthopedic surgeons' financial relationships to the manufacturers of prosthetic joints. He cited an unnamed senior general surgeon who "did not think that anywhere near as much real 'consulting' ever got done as cash flowed into docs' pockets." This story keeps bubbling just below the surface. Stay tuned, as I suspect there will be more developments.

Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface

Late last year, we posted (here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

Despite the obvious potential for these payments to influence practice, teaching, and research, the issue received almost no attention after the initial media reports. Last week, however, it created a few more ripples. As reported by Bloomberg News, via the Washington Post,

Four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants, a U.S. investigator told Congress.

The unidentified companies control about three-quarters of the $9.4 billion worldwide market for hips and knees, said Gregory E. Demske, an assistant inspector general at the Health and Human Services Department, at a hearing yesterday of the Senate Special Committee on Aging.

'Illegitimate' payments, the extent of which is unknown, influence orthopedic surgeons' medical judgment and are so common that it will be difficult to eliminate the practice, Demske and other witnesses said. The fees have enriched doctors and distorted the market by bolstering sales of lower-quality devices, they said.

'Industry and physicians are equally culpable,' said Sen. Herb Kohl (D-Wis.), chairman of the panel. 'Some physicians make it known to the companies that they will be loyal to the highest bidder. Where does the patient's well-being fit into the equation?'

Even an executive at one of the device companies admitted problems with the payments.

It's clear the device companies went too far, said Chad Phipps, Zimmer's general counsel.

'In hindsight it now appears that as the industry expanded to meet patient needs, the use of consultants may have been excessive at times,' Phipps told the committee.

In addition, a Minneapolis Star-Tribune story referred to

Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to 'adult entertainment' clubs. Fat checks for what some see as questionable work.

And a Wall Street Journal story gave this example

In some cases, a company sales representative would spend one or two hours in an operating room watching a surgeon implant his company's device. The company would then pay the doctor for eight to 10 hours of 'training' services, according to findings that government investigators shared with the committee.

Maybe I shouldn't be amazed that this story has provoked so little response, much less outrage. Even though some academic orthopedists were getting literally millions of dollars a year (see this post), very few seem worried that such fabulous payments might have had some influence on their clinical decisions, on what they taught their students or colleagues, or on their research.

As noted before, some people are concerned by how physicians may be influenced by gifts of pens, coffee mugs, and pizza lunches. If we should be concerned about coffee mugs, how much more should we be concerned by multi-million dollar royalties or consulting payments?

But of course, it's easier to forbid coffee mugs and pizzas for medical students and house-staff than making the chair of orthopedics choose between his job and his multi-million dollar royalties.