The Senate Finance Committee released on Thursday the findings of a 16-month investigation into the actions of Medtronic regarding a bone-graft product, InFuse, which the Minnesota-based company has marketed since 2002 for use in spinal-fusion surgery.
The report (which contains more than 2,000 pages of supporting documents, many of which were subpoenaed from Medtronic) concludes that Medtronic played a major role in “drafting, editing and shaping” medical journal articles about InFuse and that the company did so without revealing that it had given the physician-authors of those studies about $210 million in consulting and other fees over a 14-year period.
The Medtronic-influenced medical journal articles about Infuse not only overstated the benefits of the product, but downplayed or failed to mention its serious side effects, which include infection, sterility, pain and an increased risk of cancer, according to the Senate report.
(One of the physician-authors who failed to disclose his financial ties with Medtronic was University of Minnesota spinal surgeon Dr. David Polly, who received a ‘cautionary letter’ last December from the university for violating several of that institution’s conflict-of-interest disclosure requirements.)
Findings aren’t new
These findings are not a surprise. The Senate Finance Committee’s investigation was launched in 2011 as the result of a Milwaukee Journal-Sentinel and MedPage Today investigative report. In addition, as I reported here more than a year ago, one medical journal — the Spine Journal — took the remarkable step of devoting an entire issue to a scathing series of articles on how 13 Medtronic-funded studies had misled the medical community and the public about Infuse’s safety problems.
Still, the details in this report, are startling. The report describes, for example, how in 2004 Dr. Julie Bearcroft, Medtronic’s director of technology management in its biologics marketing department, suggested to Dr. Ken Burkus, a Georgia surgeon who was the lead author of a major paper on InFuse, that he remove a detailed table from the paper that showed complications related to the product that had occurred in his study.
“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 paper.
The table did not appear in the final paper.
On Thursday, the editors of the Spine Journal released a statement in response to the Senate Finance Committee’s report.
“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 statement reads. “… Physician and industry collaborations can benefit patients, but these relationships must conform to the highest standards of ethics and disclosure. If surgeons had known that the lead authors of the 13 original studies on InFuse had received payments ranging from $1.7 to $64 million from Medtronic and that its marketing employees were co-authors and co-editors, would they have been as eager to use InFuse on their patients?”
Medtronic issued a statement as well on Thursday, in which the company expressed strong disagreement with the report’s findings.
“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,” the statement says. “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 report’s key findings
Here is the Senate Finance Committee’s summary of its key findings:
- Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic. The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fully disclosed.
- Medtronic paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty, and other miscellaneous arrangements.
- An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
- Medtronic officials inserted language into studies that promoted InFuse as a better technique than taking a bone graft from the pelvic bone (autograft technique) by emphasizing the pain of the autograft technique.
- Documents indicate that Medtronic prepared Dr. Hal Mathew’s remarks to the U.S. Food and Drug Administration (FDA) advisory panel meeting prior to InFuse being approved. At the time, Dr. Mathews was a private physician but was hired as a vice president at Medtronic in 2007.
- Medtronic documents show the company unsuccessfully attempted to adopt weaker safety rules for a clinical trial studying InFuse in the cervical spine that would have allowed the company to continue the trial in the event that patients experienced severe swelling in the neck.
In August 2011, Medtronic announced it had given Yale University a $2.5 million grant to conduct a study to determine the effectiveness and safety of InFuse. The results of that study will be published next year.
You can download the Senate Finance Committee’s report from the committee’s website.