Readers of Covering Health are likely familiar with medical device manufacturer Medtronic and John Fauber’s coverage of conflicts of interest surrounding the company’s Infuse product.
It seems that U.S. Senators Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) also are aware of the coverage.
The two, leaders of the Senate Finance Committee, have demanded “an extensive trail of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments.” [See the letter.]
Over the past year, Fauber, of the Milwaukee Journal Sentinel (see update), has reported that the company made payments to surgeons “involved in the clinical testing of Infuse or who wrote positive medical journal articles that failed to link the product to serious complications.” Those complications include unwanted bone growth outside the fusion site and sterility in men.
Infuse is a biological agent used in spinal fusion surgery that stimulates bone growth.
A professor of orthopedics at Dartmouth Medical School is pleased the Finance Committee is investigating, saying it is doing public health work because his profession and the FDA failed to prevent this circumstance.
It appears there is more news to come about Infuse:
Next week, independent researchers are expected to publish more papers revealing additional serious complications with Infuse that were not reported in numerous articles published over the last decade and co-authored by doctors with financial ties to Medtronic. The independent researchers said their research also was prompted in part by Journal Sentinel reports.
This post should have mentioned that the Medtronic coverage is a joint project between the Milwaukee Journal-Sentinel and MedPage Today.