Tag Archives: medtronic

Independent reviews find less benefit, more harm than first reported for bone protein product

Efforts to correct biased and dangerous medical studies are making more headlines.

Shortly after I posted about a new idea to correct missing and misreported research, I got an email from AHCJ member John Fauber, an investigative reporter at the Milwaukee Journal Sentinel.

His latest story for the Journal Sentinel and MedPage Today involves an extensive undertaking coordinated by Yale University to correct the record on a product made by Medtronic called Infuse. The project is called YODA, for Yale Open Data Access. (Read more..)

Infuse — officially a device — consists of a metal cage fitted around a sponge that is soaked in a genetically engineered protein. The protein is supposed to promote bone growth and healing. It works, but perhaps too well. Side effects linked to its use include bone overgrowth that can trap and irritate nerve roots causing chronic pain. It has also been tied to a complication called retrograde ejaculation, which leads to sterility in men.  Patients who receive infuse also experienced more problems with wound healing and more cancer.

All in all, pretty devastating outcomes for patients who were hoping to feel better after their back surgeries. Continue reading

Investigation: Medtronic paid millions to surgeons; ghostwrote papers

Over at the Milwaukee Journal Sentinel and MedPage Today, John Fauber updates Side Effects, his long-running investigation into conflicts of interest, with coverage of a Senate inquiry which Fauber’s work helped inspire.

The Senate investigation, led by the familiar bipartisan duo of Max Baucus and Chuck Grassley (2,315-page PDF | press release), involved the review of about 5,000 pages of documents from medical device maker Medtronic (a frequent subject of Fauber’s reporting) over the course of 16 months.

Fauber, who is uniquely qualified to do so, summarized the report’s key findings:

Medtronic marketing employees were secretly involved in drafting and editing favorable medical journal articles about the company’s lucrative back surgery product while the company paid millions to the surgeons whose names lent weight to the studies, documents from a U.S. Senate investigation reveal.

The company’s undisclosed manipulation of information about its genetically engineered spine surgery product, Infuse, included overstating its benefits and downplaying concerns about serious complications.

Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product.

Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse

John Fauber follows up his previous investigations into the myriad problems and conflicts of interest surrounding Medtronic’s Infuse product with a story on the emerging national epidemic of what pain specialists are calling “failed back surgery syndrome.” One local pain specialist Fauber contacted said that a full 10 percent to 15 percent of his patients suffered from the condition.

To bring the whole thing full circle, Fauber spends much of the body of this latest installment explaining how conflicts of interest and other questionable ethical situations, including off-label use, propelled the early and sustained success of Medtronic’s spine-fusion blockbuster and set the stage for the emerging pain epidemic.

Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.

Medtronic hires Yale researchers to review Infuse data

Medtronic, the manufacturer of spine fusion product Infuse, has hired Yale University researchers to review patient data and adverse event reports for the product.


Photo by planetc1 via Flickr

The review follows months of reporting by John Fauber for the Milwaukee Journal Sentinel and Medpage Today that have raised questions about the independence of doctors involved in clinical trials for the product.

The Wall Street Journal’s John Carreyou and Tom McGinty also used their paper’s Medicare data stockpile to look at the conflicts of interest and royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed.

Serious complications involving Infuse have gone unreported in medical journal articles that were written by doctors who have financial ties to Medtronic.

The June issue of The Spine Journal was devoted to unreported complications related to Infuse, revealing that “complication rates … were 10 to 50 times greater than the estimated complication rates revealed” papers co-authored by doctors with financial ties to the company.

In a statement about the review by Yale researchers, Eugene J. Carragee, M.D., editor in chief of The Spine Journal, says “this appears to be a big first step in the right direction” but points out three challenges that lay ahead for the reviewers.

Top docs spar over Medtronic research, Iraq service

Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel‘s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal‘s recent Infuse issue devoted to the many complications and conflicts of Infuse.

The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.

The showdown began with Zdeblick’s defiant response to the Spine Journal‘s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.

The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.

In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.

“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.

Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.

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