Medtronic Manipulated Studies?

Medtronic Manipulated Studies?

October 30th, 2012 // 5:01 pm @ jmpickett

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There is nothing like a stack of internal documents to tell a story. And so, the US Senate Finance Committee has released a wad showing Medtronic employees were secretly involved in drafting and editing favorable journal articles about its spinal fusion product while the device maker paid millions to influential doctors whose names were on the studies.

Over a 15-year period, Medtronic paid $210 million to 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, according to the documents, which were first reported by The Milwaukee Journal-Sentinel and Medpage Today.

Meanwhile, Medtronic (MDT) execs inserted language into studies that promoted InFuse as a better technique than an alternative by emphasizing the pain associated with the alternative, according to the Senate investigation. And there is an e-mail exchange showing a Medtronic employee recommended against publishing a complete list of adverse events that were possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.

“These publications are prestigious and influential, and their standing rests on rigorous science and objectivity,” says US Senator Chuck Grassley in a statement. “It’s in the interest of these journals to take action, and the public will benefit from more transparency and accountability on their part.” Grassley spearheaded investigations into conflicts of interest among physicians and academics with ties to drug and device makers.

The investigation extends long-running scrutiny of the controversial device maker and Infuse, which was approved by the FDA in 2002 and contains a genetically engineered version of a naturally occurring protein. Since then, Infuse has been implanted in more than 500,000 patients by more than 2,300 surgeons and racked up hundreds of millions of dollars in annual sales.

Last year, meanwhile, a medical journal devoted an entire issue to dissecting the controversy over Infuse. The Spine Journal reviewed 13 studies previously published elsewhere and discovered that side effects were downplayed or omitted. These included cancer, sterility, infections and dissolving bones. There was also leg and back pain (back story).

And these occurred between 10 to 50 times the original estimates calculated in the studies. Moreover, all 13 studies were funded by Medtronic. However, none of these side effects were reported in the papers, even though the studies were peer reviewed (see here). The journal is the official publication of the North American Spine Society.

“While the report confirms what was reported in the June 2011 issue of The Spine Journal, the committee’s access to Medtronic’s internal documents presents a more detailed and disturbing picture of what can go wrong when ethics and patient safety are compromised for profit,” the organization says in a statement.

For its part, disputed the report. “Medtronic does not agree with many of the findings in the staff report. In particular, Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events. In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product’s FDA-approved label.

In addition, the staff report’s characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments. In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry,” the device maker says in a statement.

After the Spine Journal released its issue, Medtronic hired Yale University to oversee an independent review of the safety and effectiveness of Infuse. “This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Harlan Krumholz, a Yale professor of medicine who is overseeing the review, tells the paper.

“It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit,” he adds. “It’s no wonder the public has lost confidence in the drug and device industries.”

The Senate report is quite lengthy – there are more than 2,300 pages – and make take some time to load, but here you can find the link right here.

As for the interesting e-mail, the 2004 note was written by Julie Bearcroft, who was director of technology management in the Medtronic biologics marketing department, and she was involved in editing a 2005 article in the Journal of Bone and Joint Surgery. She recommended against publishing a full list of adverse events.

The complications had been seen in a clinical trial and formatted in a detailed table, according to an internal Medtronic email. But on her suggestion, the table was not included in the published paper. “I personally think it is appropriate to simply report the adverse events were equivalent in the two groups without the detail,” Bearcroft wrote in a note on a draft of the article.

After the editing change was made, the lead author of the paper, a surgeon named Ken Burkus sent a draft to his co-authors with the note, “this manuscript documents the superiority in clinical and radiographic outcomes with (Infuse)…” He received $6.4 million from Medtronic from 1998 through 2010, according to the Senate documents. [The first reference to the e-mail can be found on page 9 of the report].