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  #1  
Old 06-05-2006, 07:35 AM
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What is Medtronic’s influence in the world of arthroplasty information?

We’ve had myriad discussions and inquiries regarding negative reports (mostly from one reporter from The Street) who relies primarily on information obtained from consultant doctors paid by Medtronic.

Some of these topics are below:

Medtronic does spinal tap
http://adrsupport.org/eve/forums/a/tpc/f/7701036081/m/9...821027081#1821027081

Re: Article Library, Hope Slips for Disc Implants...
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/7...681038081#7681038081

Medtronic may have a great device, but...
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/4...911046081#4911046081

Should we be concerned with this?
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/4...471086081#5471086081

Research for Hard Core Plastics Geeks
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/1...131027081#1131027081

You can thank Medtronic for your continued pains
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/8...871028081#5871028081

Failed ADR and Biased Studies?
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/2...301046081#4301046081

ADR Charite critique
http://adrsupport.org/eve/forums/a/tpc/f/7501036081/m/7...241027081#6241027081
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"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
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  #2  
Old 09-19-2006, 03:02 PM
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A member reminded me of this article from January; here it is below. Courtesy of The New York Times.
________________________________________

January 24, 2006
Whistle-Blower Suit Says Device Maker Generously Rewards Doctors
By REED ABELSON

A prominent surgeon in Wisconsin was paid $400,000 a year by Medtronic for a consulting contract requiring him to work just eight days. Another doctor in Virginia received nearly $700,000 in consulting fees from Medtronic for the first nine months of 2005.

These doctors work in a growing field, complex back surgery, and this makes them particularly valuable to the spinal-implant division of Medtronic. In recent years, the company has spent tens of millions of dollars on consulting contracts and other types of payments to them and numerous other prominent surgeons, according to papers filed as part of a whistle-blower lawsuit. The suit contends that some of these payments were made to attract or retain the doctors' business.

Medtronic, based in Minneapolis, is one of the country's largest medical device makers, with $10 billion in annual sales.

The documents shed new light on a matter that has troubled the medical device industry for years: the assertion that companies employ a variety of financial ruses to pay doctors who use their devices, a practice that medical and legal experts say is unethical and possibly illegal. But despite industry efforts to clean up such practices, the documents and accusations made by former Medtronic employees suggest that the problem persists and may have gotten worse.

The lawsuit, filed in United States District Court in Memphis two years ago and since amended, was brought by the whistle-blower, a former Medtronic employee. The Justice Department, which has the right to intervene in the case but has not yet done so, is seeking to recover Medicare funds. According to legal filings, it proposes that Medtronic settle the matter by paying $40 million.

The suit, which was sealed until Jan. 13, accuses Medtronic of giving spine surgeons "excessive remuneration, unlawful perquisites and bribes in other forms for purchasing goods and medical devices."

The plaintiff, Jacqueline Kay Poteet, a senior manager of travel services for Medtronic until 2003, has also accused the company in a supplemental complaint of continuing these improper payments in 2004 and 2005. Her lawyer, Andrew R. Carr Jr. of the firm of Bateman Gibson in Memphis, has objected to the proposed settlement offer as too low. Whistle-blowers typically receive a share of any settlement. A Justice Department spokesman declined to comment.

All the doctors involved in the lawsuit who were reached for comment said that the payments to them were appropriate and fair compensation for work done for Medtronic.

The company, which said it continues to cooperate fully with the government to resolve the case, declined to comment directly on the accusations, saying they remained the subject of litigation.

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."

Medical device makers, with billions in sales at stake, have for years actively courted physicians who prescribe their products and recommend them to other doctors. Companies frequently compensate doctors through generous consulting fees and speaking honorariums, or by underwriting their trips to attend medical conferences, former employees and industry consultants say.

The internal Medtronic documents filed as part of the suit offer an unusually detailed glimpse of the intense campaign that device makers wage to win doctors' loyalty. They show that Medtronic spent at least $50 million on payments to doctors over some four years, through June or later in 2005.

Both doctors and device companies defend the financial relationships they have as essential for the development of what are often life-saving products. But critics contend that these financial ties exert too much influence on medical decisions, and that the payments are rarely, if ever, disclosed to patients.

The payments become illegal when they are linked to a doctor's use of a particular device and violate the federal law against kickbacks, which says that payments and other benefits cannot be provided to doctors if the payments are intended to induce them to use the company's products.

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."

In addition to consulting fees and other payments, the lawsuit said, 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 the Medtronic documents, the company closely tracked the use of its devices by the doctors who attended the conferences, choosing some for "special attention."

Ms. Poteet, the whistle-blower, worked for Medtronic until an injury forced her to leave in 2003. She was also involved in a legal dispute with Medtronic over her disability benefits; it has since been resolved. At Medtronic, she arranged trips for doctors to the company's conferences and became familiar with attempts to win the doctors' favor.

Because the devices are so profitable, the money being spent by Medtronic "is peanuts," said a former employee who still works in the industry and insisted on not being identified for fear of retaliation. Sales representatives earn generous commissions, so they will work hard to satisfy the doctors' demands, the employee said, adding, "You're going to make sure you do whatever he wants, whatever it is."

In recent years, the device makers have become a big source of additional income for surgeons, many of whom are increasingly reliant on their generosity. "The amount of money is astronomical," said Dr. James Herndon, a former president of the American Academy of Orthopedic Surgeons. The device makers, he said, "know the volumes these surgeons have."

"They seek them out, and they seek relationships with them."

Such financial relationships have attracted government attention, and United States attorneys in Boston and Newark issued subpoenas last year to eight major manufacturers, including Medtronic, as part of a wide-ranging investigation into the relationships between doctors and device makers. Medtronic is also the target of another whistle-blower lawsuit in Memphis, where its spine division is based; that suit also accuses it of making improper payments to doctors.

This heightened scrutiny has caused some companies to scale back their efforts, industry consultants, lawyers and former employees say. In addition, the industry trade group AdvaMed has issued voluntary ethical guidelines for companies; the guidelines, for example, disapprove of serving as hosts to conferences at luxury resorts.

"Over the last couple of years, companies are saying no" more often to doctors, the former Medtronic employee said.

But the lawsuit asserted that any changes by Medtronic might have been only temporary. Its "bribery program," as it was described in the suit, "has not only failed to cease, but continues unabated with increased payments made to many physicians," the suit said.

While payments to some doctors slowed during 2004, when the company was first under investigation, they rebounded last year, it said. A doctor in Virginia, Hallett Mathews, 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. Mathews, who was not named as a defendant in the suit, 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 gets from Medtronic, he said, are compensation for his time spent away from his family and his practice.

Spinal implants are used in complex back surgery, known as spinal fusion, to help make a patient's spine more stable. The cost of the components involved in typical fusion surgery for the lower back is around $13,000, according to Orthopedic Network News, an industry newsletter in Ann Arbor, Mich., and the overall United States market has grown to about $4 billion a year.

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 Medtronic lawyer, Todd N. Sheldon, raised concerns in 2003 about whether the company should pay to take doctors sailing or fishing, or ask for contributions, according to a company e-mail message that is part of the legal filings. "When we are sending scores of doctors to a nice resort like this under the guise of training and education on our products," he said, "I think we need to be more careful and stick to the limits of our rules as best we can."

Medtronic said it had been a leader in pursuing industry ethical guidelines that suggest that device companies provide only "modest meals and receptions" and not pay for costly leisure activities.

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, Ms. Poteet said. 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.

A surgeon in Phoenix, who used an estimated $400,000 in devices, favored a rival maker, Spinal Concepts, the spreadsheet said. Company representatives were urged to make overtures to him. "M.S.D. corporate involvement at this program," it said, "would help us earn a bigger share of his business on a grand scale."

In the case of an orthopedic surgeon, Jesse Butler, Medtronic was competing with a spine company, Acromed, now part of a Johnson & Johnson unit. Acromed had previously asked Dr. Butler to take part in a research study of one of its devices "to buy his business," the spreadsheet notes said. The sales representative wanted Dr. Butler to use more Medtronic implants. "He has a consulting agreement for this, yet has not done much in the way of it," the notes said.

Johnson & Johnson declined to comment on the matter.

Dr. Butler, who was not named as a defendant in the lawsuit, said his participation in the study had nothing to do with a preference for Johnson & Johnson devices. "We don't make any money off these studies," he said.

Companies are eager for his business because he is a busy surgeon, but Medtronic "never did anything inappropriate," he said. The consulting arrangement "didn't really go anywhere," he added.

The notes for one doctor suggested an expectation that those offered an arrangement where they helped design a device would become loyal users. For example, K. Daniel Riew, an orthopedic surgeon in St. Louis, who is named as a defendant in the lawsuit, was described in the spreadsheet as using a substantial dollar amount of competing devices in his surgery. "He will be designing a new plate with M.S.D.," the notes say, "so all of his business will gravitate our way in the near future." Dr. Riew could not be reached for comment.

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.

Dr. Zdeblick, who is a defendant in the lawsuit but who said he was unaware of the accusations against him, said he worked much more than what was required, as many as three or four days a month.

"I was working like crazy in those years," he said, and was being paid at market value for his work. He now does a minimum amount of consulting for Medtronic and is being paid per diem, he said.
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
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  #3  
Old 12-24-2009, 11:13 AM
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Question Side Effects | Are Doctors' Loyalties Divided?

Journal editor gets royalties as articles favor devices

By John Fauber of the Journal Sentinel
Posted: Dec. 24, 2009

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.

Zdeblick declined to comment for this story.

While journal editors wield tremendous influence in medicine, they rarely are put under the spotlight.

"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.

Journal editors elude fray

The situation with Zdeblick and the journal is yet another twist in the ongoing controversy over conflicts of interest in the field of medicine.
In the last two years, there have been several high-profile cases involving influential doctors, including some at UW, who were getting large sums from drug or device companies without fully informing their patients or the universities they worked for.

Then the universities themselves, including UW, came under fire for accepting millions of dollars from drug companies to sponsor continuing education courses for doctors. Often those courses were little more than drug company marketing that downplayed the risks of drugs and promoted benefits. Sometimes articles used in those courses were ghostwritten by agents working for the drug companies even though the names of prominent physicians were put on the articles.

Medical journals also have been criticized for not always requiring authors to fully disclose financial conflicts.

Largely escaping the fray, however, have been journal editors such as Zdeblick.

Journal editors, who often are physicians, may have their own financial relationships with drug or device companies, although seldom are those conflicts disclosed, doctors say.

"It's a black box," said Jerome Cassirer, the former editor of the New England Journal of Medicine. "Nobody has any idea what goes on in the editorial offices of journals."

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.

He said Medtronic is the market leader with three times the revenue of the second-leading company and that it generates a higher volume of news and announcements that warrant a high volume of coverage. "Our coverage of Medtronic products is in no way tied to or impacted by any separate relationship between the company and Dr. Thomas Zdeblick," he said.

In an e-mail, Marybeth Thorsgaard, a spokeswoman for Medtronic, said the journal is independent and peer-reviewed."Medical publications have safeguards against selection bias along with disclosure requirements," she said.

'They are like a king'

The editors of medical journals can be some of the most powerful people in medicine. They can accept or reject manuscripts of studies involving drugs or devices.

They can send a study out to peer reviewers who may be sympathetic to a particular drug or device by virtue of their own financial relationships with the companies that make those products. They can give authors more leeway to say positive things about a drug. They can turn down studies that say bad things about the product of a company they get money from.

"Once an editor makes a decision, there is no recourse; they are like a king," said Kassirer, author of "On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health."

Medtronic is the world leader in the fast-growing, multibillion-dollar field of spinal devices. It markets a variety of implant hardware used in spinal surgery, as well as the biologic, bone-forming substance known as recombinant human bone morphogenetic protein-2, or BMP-2.
The last decade has been a dynamic period for research and the introduction of new spinal implant devices.

However, the growing number of surgeries with such devices, just like the increased use of brand-name drugs, has contributed to the spiraling cost of health care in the U.S.

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."

Questioning influence

Charles Burton, vice president of the Association for Ethics in Spine Surgery, questioned the propriety of Zdeblick's articles being published in his own journal.

"Should you put the fox in charge of the chicken house?" said Burton, a St. Paul, Minn., neurosurgical spine specialist. "I don't think you could say it is anything but an assault on the integrity of medical practice."
A related group, the Association for Medical Ethics, says no one who serves on the editorial board of a journal should receive more than $50,000 from a device or drug company.

"How can he not be influenced...if an article slams a product of the company paying him?" said Charles Rosen, president of the group and a clinical professor of orthopedic surgery at the University of California, Irvine, School of Medicine. "He's only human."

BMP-2, also known as Infuse, is an expensive genetically engineered compound used in spinal fusion surgery. It was mentioned in several articles by a variety of researchers, including Zdeblick.

A big advantage to the product is that it can eliminate the need to harvest bone from the patient's hip that is used in the surgery.

However, it costs as much as $4,500 per vial, doctors say, and it has been associated with complications when it is used off-label, meaning it is being used in applications for which it has not been approved by the Food and Drug Administration.

Its annual sales are nearly $800 million, and most of that is the result so-called off-label use, according to 2009 commentary in the Journal of Bone and Joint Surgery. Its use grew from less than 1% of all spinal fusions in 2002 to 25% in 2006, according to a 2009 study in JAMA.

In 2008, the FDA alerted doctors to life-threatening complications that were occurring in patients who got BMP in cervical fusions, an off-label, unapproved use of the product. The cases involved problems with breathing, swallowing and speaking.

BMP-2 was approved by the FDA for lumbar fusions in 2002.

The Journal of Spinal Disorders was co-founded by Dan Spengler in 1987. He remained co-editor until 2000.

After Zdeblick took over as editor, the journal had much more of a focus on spinal implant devices, said Spengler, a professor of orthopedics and rehabilitation at Vanderbilt University Medical Center.

Spengler said it is fair to question whether someone like Zdeblick should be editor of a spinal journal.

Whenever Medtronic devices are mentioned in its articles, it is going to pose a conflict, especially when Zdeblick is an author of the studies, he said.

"There is no getting around it," said Spengler, who now serves on the editorial board of another orthopedic surgery journal.

One solution would be for the journal to point out that Zdeblick receives royalties from Medtronic whenever a study involving Medtronic is published. Another solution is simply to have an editor who does not have a conflict of interest, he said.

"You sure would like to be squeaky clean on the conflict-of-interest side," he said. "I don't know how he does it."

Find this article at:

http://www.jsonline.com/watchdog/wat.../80036277.html
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
Reply With Quote
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