A U.S. Senate report blasts Medtronic (NYSE:MDT) over its handling of the controversial bone morphogenetic protein sold under MDT’s Infuse label, saying the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies.
The Minneapolis-area medical device company denied the charges, according to a statement emailed to the Milwaukee Journal Sentinel and MedPage Today.
"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," according to the statement, which cited its adverse event reports to the FDA’s MAUDE database and its listing of the risks on the Infuse label.
Medtronic also said the portrayal of its financial dealings with physicians in the Senate report is 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," the company said, according to the Journal Sentinel and MedPage Today.
Medtronic produced more than 5,000 documents for the Senate finance panel, which is led by Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa), according to the committee’s report. A review by Senate staffers found that Medtronic paid out about $210 million in royalties, consulting fees "and other miscellaneous arrangements" to "physician authors of Medtronic-sponsored studies."
The report also found that the company "was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants," but did not publicly disclose its ties to those doctors.
A Medtronic employee, a director of technology management in its biologics marketing department named Dr. Julie Bearcroft, steered the drafting of a 2005 Journal of Bone and Joint Surgery article to exclude details of adverse events, according to the report. Emails from Bearcroft to other Medtronic employees show that her suggestions to limit the description of the adverse events extended to deleting a table listing specifics of the events.
"The e-mail exchange indicates that, in addition to Medtronic editing the manuscript without attribution, the company was recommending that the article omit a complete accounting of adverse event data, including serious adverse event data that were already considered a documented concern by FDA in similar application," according to the 2,315-page report.
"I have made some significant changes to this document (some at the request of [lead author] Dr. [Ken] Burkus) both in format and content," Bearcroft wrote in 1 email, asking "How much information should we provide relative to adverse events?" and noting "I don’t believe we want to report in the same manner as we do in IDE studies. I personally think it is appropriate to simply report the adverse events were equivalent in the two groups without the detail."
Medtronic also sought to manipulate the perception of Infuse as a less painful alternative for spine surgery, the report alleged, and prepared glowing remarks by Dr. Hal Mathew to the FDA advisory panel on InFuse in 2002. Medtronic hired Mathew as vice president of medical & clinical affairs in 2007.
And the documents show that Medtronic lobbied for weaker safety rules for a clinical trial examining Infuse for cervical spine procedures "that would have allowed the company to continue the trial in the event that patients experienced severe swelling in the neck," according to the report.