BLOGSCAN - On Device Company's Obfuscation of the Reasons for Payments to Surgeons

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody analyzed further the case of the huge royalties paid to spine surgeons by Medtronic (see our most recent post here).  He wondered why surgeons would get such sizable payments for "intellectual property" related to devices that they neither seemed to use or to research?  I would note that the lack of clarity about the reason for Medtronic's payments to these surgeons is just part of a larger lack of clarity about most of the payments made to physicians and medical and health care academics for "consulting" or serving on advisory boards.  If such professional-industrial collaboration is so important for "innovation," one wonders why the people engaged in it are almost never willing to disclose the topics of these wonderful interchanges?

Post Title → BLOGSCAN - On Device Company's Obfuscation of the Reasons for Payments to Surgeons

Spine Surgeons Reticent About Disclosing Huge Medtronic Payments

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. 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.

In 2008, our post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.  In 2009, an article in the New England Journal of Medicine showed that almost 30% of surgeons who got such payments in 2007 failed to disclose them when they presented at the 2008 American Academy of Orthopedic Surgeons meeting.(1)

Medtronic's Payments to Spine Surgeons

This month, the media reported that Medtronic also made payments, sometimes huge, to orthopedic and spine surgeons (see this post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and our summary post here.) 

Now further investigation by John Fauber of the Milwaukee Journal-Sentinel suggests that surgeons receiving often huge payments from Medtronic may not have been good at disclosing them either.

The article examined payments made to surgeons who authored two major studies about bone morphogenetic protein-2, a biologic drug manufactured by Medtronic used to promote bone growth at surgical sites:

Over the last decade, a small group of prominent surgeons from around the country has been enlisted by medical device-maker Medtronic to do clinical research or write articles about the company's new spine surgery product.

This year alone, many of those doctors received payments of hundreds of thousands to millions of dollars each in royalties for a variety of other Medtronic spinal devices, according to a Journal Sentinel analysis of newly released company payments. Medtronic began disclosing the payments this year, in advance of a federal requirement set to take effect in 2013.

Since it won approval for narrow uses in 2002, the product - bone morphogenetic protein-2, known as BMP-2 - has been an increasingly dominant force in spinal fusion surgery, with sales of about $800 million a year, often for use in other procedures.

Independent doctors say the product's success is due largely to positive findings made by the surgeons affiliated with the company.

Doctors involved with two of the many research articles on BMP-2 published since it was approved - one in 2002, the other in 2004 - received a combined $6 million in royalties this year for other Medtronic spinal products, the newspaper found. The payments went directly to the doctors or business entities they are associated with.

No Disclosure in a 2002 Article

The Journal-Sentinel article referred to two scholarly articles written about BMP-2. Regarding the first,

At the time BMP-2 was approved in 2002, little was known about the financial connections between Medtronic and doctors associated with the clinical trial. Likewise, little was known that year when the Journal of Spinal Disorders & Techniques published the article on the trial.

The paper made no mention of doctors getting royalties or having any financial connection to the company.

[Note: I am unable to find this article using standard search techniques, so I cannot give a citation for it.]
Regarding the lack of disclosures made in the first article,

The four co-authors of a 2002 paper about that trial received a total of $2.8 million this year from Medtronic in royalties for products not including BMP-2.

The paper made no mention of any financial relationship between the authors and Medtronic.

Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September.

Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties.

Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments.

Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year.

He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2.

The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products.

Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002.

In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.

Little Disclosure in the 2004 Article

Regarding the second article,(2)

Three of the four authors of a 2004 article on the study of the productare listed as receiving nearly $4 million this year in royalties from Medtronic for a variety of spinal products, not BMP-2.

That paper was important because it involved a clinical trial that had to be stopped because the product was causing troubling bone formation in the spinal canal of patients. In the paper, that finding was downplayed, with the authors describing the results as 'encouraging.'

[Professor Dan] Spengler, the Vanderbilt orthopedic surgeon and former medical journal editor, said he doubted the paper would have been written in such positive terms by authors without financial ties to Medtronic.

He described the article as egregious, saying it 'just blew off the complications. It's a horrible article.'

Orthopedic surgeon [University of California - Irvine Clinical Professor Charles] Rosen said the paper was biased, calling it 'more of a marketing paper than an objective scientific study.'

Regarding the disclosures made in the second article,

The article described three of the authors as consultants to Medtronic, though it did not disclose that any of them were receiving royalties at the time.

Regis Haid, lead author of the article and an Atlanta neurosurgeon, told the Journal Sentinel he was getting royalties for other Medtronic products. Haid noted disclosure rules for medical journals have become more stringent in recent years.

He said BMP-2 provides excellent benefit to patients, adding he had it implanted in his own neck in an off-label procedure. ;I have BMP in me, and I would put it in you . . . ,' he told a reporter.

Through September, Haid and Spinal Engineering LLC received about $2 million in royalties this year from Medtronic.

Meanwhile, co-author Ken Burkus, a Columbus, Ga., surgeon, and RBCK Research & Consulting, received $573,000.

'Very importantly, you cannot assume that such royalty payments were made prior to 2010,' he said in an e-mail, declining to say whether he got royalties at the time the paper was written. 'I follow the rules to my fullest ability as put forward by the specific journal.'

He took issue with criticism that the paper put a positive spin on a troubling clinical trial.

'I believe the words used were appropriate . . . ,' he said. 'I believe the words used were neither 'positive nor negative' but rather were representative of the data presented.'

He said if other doctors have problems with the paper, they should take it up with the editor of the journal: 'They can write a letter to the editor.'

Co-author Charles Branch Jr., chairman of neurosurgery at Wake Forest University, and the university itself have received $1.2 million in royalties this year.

A spokeswoman for the university said it owns the intellectual property rights to Branch's patents and that royalties generally are split with 35% to the individual and 65% to the university. None of those royalties involved BMP-2, university media relations manager Bonnie Davis said in an e-mail.

She said Branch and Wake Forest were getting royalties at the time the paper was published, but not when the trial was going on.

In a separate e-mail, Branch said use of the term 'encouraging' in the paper 'was not a strong endorsement,' but, rather, recognition that patients getting BMP-2 had superior results to those receiving a traditional bone graft.

Summary

So here we go again.  Once again we see an example of a single medical device company paying heroic amounts, hundreds of thousands to over a million dollars a year, to surgeons ostensibly as royalties for their intellectual property.  The company and the surgeons were all rather cagey about the nature of the intellectual property for which the money was paid, and about the justification for the size of the payments.

While it is likely that the payments have been going on for a while, previous influential articles written by some of the surgeons receiving the payments contained at best minimal disclosure of their financial relationships with Medtronic, and gave no hint about the magnitude of these relationships.  These previous influential articles seemed more enthusiastic about a Medtronic product than was justified by their results.  Of course, maybe getting hundreds of thousands or millions of dollars a year from a commercial health care firm could lead to some excess enthusiasm about its products.

It seems that every drug, biotechnology, and device company has its stable of highly paid physicians and surgeons who can be counted on for their enthusiasm about the companies' products, and their reticence about their financial relationships with the companies.  We have often discussed the pervasiveness of the web of conflicts of interest that seems to link most commercial health care firms with most influential medical academics and practitioners.  The web seems even more pervasive than we once imagined, and the conflicts seem even more intense. 

Those who laud ties between academic medicine and industry may perseverate about how collaboration leads to innovation, while denying that mere money can influence professional judgement.  However, it is difficult to imagine how even the most well-intentioned professional would not be influenced by hundreds of thousands or millions of dollars a year.  When professionals hide the magnitude of such relationships, it only raises more suspicions that they know they have something to hide because they realize they have been bought.

The ever increasing revelations about conflicts of interest pervading academic medicine should inspire extreme skepticism about clinical research or clinical teaching supported in any way by commercial interests.  At the very least, these revelations justify the need for detailed and complete disclosure of all financial relationships among commercial health care firms and academic and practicing physicians, and others who make or influence health care decisions. 

I suspect that if such full disclosure took place, physicians, other health care professionals and the public, at least those who had not been paid themselves, would be so aghast that such relationships would not remain legal for long. 


References
1.  Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M.  Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009; 361:1466-1474.
2. Haid RW, Branch CL, Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cates. The Spine Journal 2004; 4: 527-539.

Post Title → Spine Surgeons Reticent About Disclosing Huge Medtronic Payments

BLOGSCAN - Medtronic's Multi-Million Dollar Payments to Spine Surgeons

Starting in 2007, we discussed the huge payments made by four medical device companies to orthopedic surgeons and medical organizations related to the use of hip and knee prostheses.  (See post here with links backward.)  Payments, in the millions of dollars per year range, went to surgeons including noted academics, and leaders of the main orthopedic physicians' society.  Payments went to medical schools, teaching hospitals, and professional societies.  Many of these financial relationships were not disclosed, and the disclosures that were made rarely indicated the amounts involved.

Now the Wall Street Journal reports millions being paid to spine surgeons by Medtronic in connection with devices used in spinal fusion.  See Dr Howard Brody's discussion here on the Hooked: Ethics, Medicine, and Pharma blog, and also Felix Salmon's discussion here on the Felix Salmon blog.

What seems lacking is a clear rationale for any payments, much less for payments of the sizes listed.  The WSJ article cited a Medtronic spokesperson, "surgeons' device-development work goes beyond mere consulting when the company deems that they are contributing valuable intellectual property to a product. But that intellectual property doesn't necessarily have to be patented."  The reporters found, "search of spine-device patents awarded to the Norton surgeons turned up about a dozen total for Drs. Puno, Johnson, Campbell and Dimar, most owned by companies other than Medtronic. The search turned up no patents for Dr. Glassman."  So what intellectual property that was not or could not be patented could be worth millions a year?

Post Title → BLOGSCAN - Medtronic's Multi-Million Dollar Payments to Spine Surgeons

Physicians As Significant Investors in the Manufacturers of the Devices They Implant

OK, the holidays are over, so it's time to catch up.

Just before the New Year, the New York Times reported on some questionable financial entanglements among spine surgeons and the companies that make the devices they use. The main points are below, somewhat edited and re-ordered as necessary for clarity.

Spinal-fusion surgery is one of the most lucrative areas of medicine. An estimated half-million Americans had the operation this year, generating billions of dollars for hospitals and doctors.

Spinal screws are relatively simple to develop and cost only $65 to $100 to make ... often by a supplier that handles the production of screws for a variety of companies.
A single screw ... sells for about $1000....
Doctors’ taking significant ownership stakes in spinal parts makers, critics say, provides an extra financial incentive for a doctor to recommend a surgery. It may be one of the most distinct examples yet of the way monetary considerations can play a role in the way doctors practice medicine.

Such doctors face 'an awfully pernicious conflict of interest,' said Dr. Richard A. Deyo, a physician and health services professor at the University of Washington in Seattle.

About 30 start-up companies have begun selling spinal devices, including screws, in the last couple of years. And industry experts say about a dozen companies have doctors among their investors. Because most of the companies are private and the relationships are not publicly disclosed, there is no way to know how many spine surgeons around the country are partial owners of device makers.

One of the fastest growing companies is Allez Spine, of Irvine, Calif. It was founded on a business model that called for the 120 doctors who invested in Allez to serve as “its customer base,” according to a lawsuit filed by a former chief executive last April. Those doctors, who pay $50,000 or more to become investors, own two-thirds of the company, according to legal filings.

Selling the company’s screws to its “investor-doctors” was a way to “generate more profits for the company” according to a related lawsuit involving the former executive.

At one midsize Nevada hospital, a surgeon who performs many spinal fusions is an Allez investor who uses the company’s screws, said an administrator.
The identities of most of the surgeons who invest in Allez are not publicly disclosed. And the doctors who could be identified and were called for comment did not return repeated telephone calls.

Some of the new [spinal screw] companies aim to recruit surgeons who perform a high volume of back operations, according to doctors who have been approached. The exact nature of the investment opportunity is left vague in the discussions, the doctors say, with details made available only to those who agree to become investors.

One surgeon described being contacted by Globus Medical, a start-up company in Audobon, Pa. The surgeon said he was not persuaded to use Globus screws and other hardware, despite the sales representative’s mention of the 'good opportunities' available if he were to become a large user.

The policies of Globus forbid its representatives from offering stock to reward surgeons who use their products, said Dave Demski, chief financial officer of Globus.
At Alphatec Holdings, a company in Carlsbad, Calif., doctors are shareholders because they have either invested directly or are paid in stock for consulting, according to filings by Alphatec, which is one of the few publicly held companies among the small start-ups.

The chairman of Alphatec’s scientific advisory board is Dr. Stephen J. Hochschuler, a prominent surgeon who helped start the Texas Back Institute, one of the largest spine clinics in the country.

For his work as an adviser, Dr. Hochschuler received a restricted stock grant that was worth about $640,000 when Alphatec went public in June, according to the company’s public filings. Because the share price has fallen, the grant — which vests over five years — is currently now worth only about $270,000.

Dr. Hochschuler, in a written response to an interview request, said doctors should work closely with device companies like Alphatec.

Some surgeons who have bought Alphatec stock argue that their holdings are no different than their investments in any other company.

Dr. E. Claiborne Irby Jr., a surgeon in Richmond, Va., who invested in Alphatec before it went public, says he uses its devices, but not exclusively. 'I don’t change anything I do because of any kind of investment,' he said.

But federal regulators and law-enforcement officials are on the lookout for surgeons who step over the line.

Doctors 'are supposed to make the decision based on the best interest of the patient,' said Peter Winn, a lawyer in the United States attorney’s office in Seattle, who has aired his concerns in a speech to spine surgeons.

To do otherwise, he said in an interview, 'is a violation of the ethical rules, and it has been since the time of Hippocrates.'

It seems that there are an endless variety of schemes out there to financially entangle physicians with the companies that make the products they may use or prescribe for patients. It raises the question of whether physicians who own a significant proportion of a particular company can make decisions for patients about whether to use that company's products without being influenced by the consequences of such decisions on the physicians' own pocket-books?

This is just more evidence of the pervasive web of conflicts of interest that has seemingly caught up many physicians and other influential people in health care. The physicians involved ought to remember that their duties are to the patients first. They ought to select implantable devices first according to their ratios of benefits/harms for patients, and maybe second, according to price. The manufacturers of spinal devices, and other health care corporations should not put physicians in positions in which the decisions they make for patients could be influenced by the effect of these decisions on their investments.

Finally, I can't help wondering if conflicts of interest could also somehow be affecting what appears to be ridiculously high prices charged for simple pieces of hardware whose manufacture is out-sourced, and which seemingly could not have entailed much in the way of research and development costs?

Post Title → Physicians As Significant Investors in the Manufacturers of the Devices They Implant

Medtronic's Payments to Doctors: "Too Damn Lucrative to Believe Anyone Can Resist"

The New York Times reported allegations about the payments device manufacturers have made to physicians.

Documents came from a whistle-blower lawsuit which charged that Medtronic Inc., the medical device manufacturer, gave sugeons "excessive remuneration, unlawful perqueisites and bribes in other forms for purchasing goods and medical devices."

The Times reported that the documents show that:

Medtronic spent at least $50 million on payments to doctors over some four years, through June or later in 2005.
Medtronic played host at medical conferences where the 'principal objective' was to 'induce the physician, through any financial means necessary' to use its devices.
According to Medtronic documents, the company closely tracked the use of its devices by the doctors who attended the conferenences, choosing some for 'special attention.'
While payments to some doctors slowed during 2004, when the company was first under investigation, they rebounded last year.... A doctor in Virginia, Hallett Matthews, for example, made $300,000 in consulting fees in 2003, but only $75,000 in 2004. Last year, the company paid him nearly $700,000 for his consulting work through September.
Dr Matthews ... said the spike in payments was a result of a change in how he was paid, requiring him to document his work before he received any money and therefore increasing the amount he received last year. The consulting fees he got from Medtronic, he said, are compensation for his time spent away from his family and practice.
Medtronic's overtures to doctors often began when the surgeons were still in training, Ms. Poteet said. The company commonly paid for doctors to attend any of 200 professional meetings a year. If the doctors wanted to go snorkeling or play golf, the sales representatives or Medtronic employees almost invariably paid for the expense, she said.
When the doctors visited Memphis, she said, Medtronic employees would take them to a local strip club, PlatinumPlus, disguising the expenses as an evening at the ballet.
A spreadsheet compiled by Medtronic for a June 2003 meeting in Dana Point, Calif., indicated what Medtronic hoped to accomplish with each doctor attending an event....
This list of 230 or so doctors included an estimate of the dollar value of the devices each doctor used in surgery, including the value of the devices made by Medtronic. One doctor is described as 'a 100 percent compliant M.S.D. customer,' while others were cited for 'special attention.' M.S.D. referred to Medtronic Sofamor Danek, the largest competitor in the spinal device market.
Many doctors were paid consulting fees far higher than the $3,000 a day a surgeon might typically expect, documents from the legal filing suggested. Dr. Thomas A. Zdeblick, the Wisconsin surgeon, signed a 10-year contract in 1998 that required him to consult with the company for two days every three months, a total of eight days, for which he would be paid $400,000 a year, according to a copy of his contract. Those payments stopped in 2004.

The New York Times article contained some reaction to the allegations about Medtronic's interactions with physicians.

In a written response, a spokesman, Rob Clark, said, 'We take these allegations very seriously and we do not tolerate conduct that is illegal or unethical.' Consulting arrangements with doctors to improve devices, he said, 'are critical, in our view, to the delivery of state-of-the-art health care and are perfectly legal.'

On the other hand,

But even if the payments are within the law - and Medtronic has not been found guilty of any illegal activity - the increasing amounts being given to doctors distort their judgment, said Arthur Caplan, a medical ethicist at the University of Pennsylvania, who said such industry payments were 'too damn lucrative to believe anyone can resist.'

Amen to Dr Caplan.

We surely need better mechanisms to prevent both parties, physicians and health care organizations (device makers in this case, but not limited to device makers) from partaking of such relationships, and when prevention fails, for penalizing them.

Post Title → Medtronic's Payments to Doctors: "Too Damn Lucrative to Believe Anyone Can Resist"