A 16-month U.S. Senate investigation inflicts a black eye on Medtronic ($MDT), concluding that the medical device company manipulated data about its controversial bone growth product Infuse to help boost sales.
Senate Finance Committee investigators determined in a 2,315 page report that Medtronic forked over hundreds of millions of dollars to physician authors, dubbed "consulting fees," to promote the product, and never disclosed the connection or the company's role in influencing at least 11 medical journal articles concerning Infuse, Bloomberg reports. The report asserts that Medtronic officials helped write, edit or shape those articles, and also knew Infuse had product risks and didn't disclose them.
Committee members examined more than 5,000 Medtronic documents for their investigation, according to the story. Their work began not too long after a series of articles published in the Spine Journal alleged that researchers with financial ties to Medtronic downplayed Infuse's side effects or omitted them from various scientific articles. Bloomberg notes that Infuse sales plunged when the Spine Journal articles hit. Not surprisingly, Medtronic disputed "many" of the Finance Committee's findings.
"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 company said in a statement. "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."
Medtronic also said the report's description of physician payments was both "misleading and unfair," because "the vast majority of such payments" were royalty payments rather than consulting fees. That said, the company added that both types of payments "are commonplace and appropriate practice in the medical device industry."
The North American Spine Society, which publishes the Spine Journal, said in a statement that the Finance Committee report "presents a more detailed and disturbing picture of what can go wrong when ethics and patient safety are compromised for profit."
- read the Bloomberg story
- here's Medtronic's full statement
- check out The North American Spine Society's comments
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