Senator Al Franken (D-Minn.) is pushing for more details on Medtronic‘s (NYSE:MDT) study of its Infuse Bone Graft, saying that the product may have “potentially skewed the risk profile” for patients and exposed “insufficient vigilance” by the FDA, according to the Minneapolis Star Tribune.
The senator raised these concerns in a letter to both Medtronic CEO Omar Ishrak and newly appointed FDA Commissioner Robert Califf.
Franken’s worries were raised when the Star Tribune published an article Sunday covering the review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, the senator wrote.
The Minneapolis Star Tribune reported that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– including about 1,000 adverse event reports and 4 deaths – within 30 days, as the federal safety watchdog requires. The Fridley, Minn.-based company instead shut down the review in 2008; company executives said the adverse events database compiled from the review was misfiled but eventually reported to the FDA in 2013, according to the newspaper.
The 5-year delay failed to draw any flags at the FDA, which redacted the number of adverse events from a public, 3-sentence summary. The data was only released after the Star Tribune filed a Freedom of Information Act request was granted in September 2015.
Doctors who reported the 4 deaths said they were not related to the use of Infuse (including 2 patients with heart conditions, 1 who died from cancer and another from abdominal inflammation). Although Medtronic revealed “a small slice” of the data in a 2008 bid to expand the indication for Infuse, but the FDA would not accept it as evidence, according to the Star Tribune.
“To this day, neither the company nor the FDA has publicly disclosed full details of the study,” the newspaper reported.
Shortly after the article was published, Medtronic responded, disputing the paper’s report, saying the piece made false insinuations and omitted key facts.
Medtronic said it acknowledged that results from its review were not properly archived nor fully assessed for reportability to the FDA, but that once the data was located in 2013 it was promptly reported “to all appropriate regulatory bodies.” The data does not change the safety and efficacy for Infuse, the company said.
“Despite these facts the article suggests Medtronic attempted to conceal information about the [retrospective chart review], including information about adverse events reported in the data. This suggestion is false, and we want to set the record straight by sharing details that were provided to the Star Tribune but omitted from the article,” Medtronic said in a prepared release. “We have fully lived up to our principles of transparency and disclosure.”
