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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
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