Medtronic has claimed that a recent article published by the Minneapolis Star Tribune (Minneapolis, USA)—criticising the company’s handling of data related to its Infuse bone graft (rhBMP-2)—makes false claims and excludes key facts regarding the retrospective chart review (RCR) of the product between 2006 and 2008.
Medtronic claims in a press release that it provided the newspaper with an “extensive account” of circumstances and events around the RCR, which was “largely omitted” from the article.
Acknowledging the failure to adequately archive the RCR upon its discontinuation in 2008, Medtronic states that the RCR information was not fully assessed for “reportability” to the US Food and Drug Administration (FDA). The company states that it has updated its clinical policies and training to enhance its reporting practices.
Medtronic argues that upon discovery of the RCR data in 2013, the company took fast and rigorous action to assess and report the information to all appropriate regulatory bodies. Adverse events reported do not affect the safety and efficacy profile of rhBMP-2, Medtronic contends.
According to the Medtronic release, the Star Tribune article suggests that the company attempted to conceal information about the RCR, including information about adverse events reported in the data. Medtronic asserts that this suggestion is false.
Medtronic’s rhBMP-2 has faced criticism in the past from The Spine Journal, who in 2011 dedicated a whole issue to early studies of the product. Claiming that the product was in fact safe, Medtronic commissioned an independent review of the product by Yale University following the publication of the issue. Medtronic has not exhibited its products at NASS—publishers of The Spine Journal—since the publication of the Yale article. After receiving a number of complaints about the product, Medtronic resolved the claims of around 950 plaintiffs for an estimate US$22 million. In 2012, US Senate Finance Committee members also released the results of a 16-month investigation into claims that Medtronic “manipulated” studies surrounding the bone graft. The report questioned ties between Medtronic and its physician consultants. Following all of the controversy surrounding the product, the FDA went on to approve rhBMP-2 for three new spinal surgery indications in December 2015.
Medtronic’s recent press release takes a detailed look at that information it alleges that the Star Tribune failed to report. According to Medtronic, the newspaper ignored the following facts:
- Information from the RCR had not been assessed for reportability during the 2006-2008 period. Since the company did not complete an analysis of adverse events in the accumulated records, Medtronic claims that there is no basis for the paper’s implication that Medtronic intentionally failed to report information in 2008.
- When the RCR was discovered and assessed by Medtronic in 2013, personnel from the company’s regulatory and clinical safety groups concluded that the adverse event data identified in the RCR were consistent with those already known across a wide body of literature and clinical study. According to the press release, this conclusion was validated by an independent physician. The information apparently contained no new types or unusual numbers of adverse events that had not been previously reported in clinical trials, MDR reports, or medical literature.
- More than two years ago, Medtronic submitted the adverse event data to FDA, which was submitted after consultation with, and guidance from, the FDA by means of a summary report. Apprently, the Star Tribune article insinuates that this was not a detailed accounting. Medtronic denies this claim, stating that the submission included a line-by-line description of 1,039 reported events, including specific codes associated with the conditions reported. The report reflected a wide range of conditions, including events such as diarrhoea and hypertension. According to the press release, the FDA did not require the company to submit individual MDR’s for all these conditions, it did require a detailed summary of the reported events. The submitted summary report provided the required adverse event information in a 76-page table accompanying the report. This level of detail allowed the FDA to conclude that the adverse events in the RCR were consistent with the known history of INFUSE, claims Medtronic. The FDA has not required any labelling changes to the product since Medtronic provided RCR information to the agency.
- The Star Tribune mischaracterises the use of adverse event data by Yale in their systematic review, claims Medtronic. In their meta-analysis, the Yale team only included adverse event data collected during clinical trials, which is why the RCR data was not included in the study. The RCR data was reported after the trial data included.
- The Star Tribune report also attributes certain statements to a former Medtronic, James Kirwin, who the company claims only have limited involvement in the RCR process.
Medtronic ends the release by stating that patient safety is its main concern with all of its products, and that it continues to stand by the safety of rhBMP-2.