March 29, 2024

Senators Seek Information on Side Effects of Medtronic Bone-Growth Product

Two senators on Tuesday expanded an investigation of the medical device maker Medtronic, demanding that the company turn over records involving millions of dollars in payments to researchers and internal correspondence with doctors who had published its research on a controversial bone-growth product.

Senator Max Baucus, Democrat of Montana and chairman of the Senate Finance Committee, and Senator Charles E. Grassley, Republican of Iowa, wrote to Omar Ishrak, Medtronic’s recently named chairman and chief executive, seeking extensive documents related to its bone-growth product, Infuse.

“Reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” Senator Baucus said in a statement. “We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits,” he added.

Medtronic, in a statement late Tuesday, said it would respond to the senators’ request. The company did not comment specifically on the accusations of unreported complications and financial bias in research, but said it routinely reported all adverse events to the Food and Drug Administration “irrespective of any financial relationship between the company and the clinical investigator or study author.”

Marybeth Thorsgaard, a spokeswoman for Medtronic, said three specific complications listed in the letter — abnormal bone growth, swelling in the neck and throat, and a form of sterility — were all listed as side-effect warnings on the Infuse product label.

The senators’ query was prompted in part by a forthcoming spinal journal article saying some of the 13 Medtronic-sponsored studies of Infuse had failed to properly disclose complications.

The Justice Department has been investigating the marketing of Infuse, according to Securities and Exchange Commission filings by Medtronic since late 2008, and to people who have been contacted more recently by federal investigators.

And in May, Senator Baucus wrote to the company to ask why it had canceled contracts with Novation, a group-purchasing organization. The senator said he was concerned that patients or hospitals could end up paying more for Medtronic products. Senate staff is reviewing Medtronic’s confidential reply.

The senators set a July 11 deadline for Medtronic to respond, saying that they wanted the company to furnish “all documents and communications” with researchers, medical journals, the F.D.A., advisory board members and other Medtronic consultants, concerning adverse events or complications from the product.

Infuse is a bioengineered protein used instead of real bone in many graft operations. The F.D.A. has warned of serious problems for some spinal surgery patients. Infuse, approved by the F.D.A. for limited purposes in 2002, is widely used for broader purposes, as doctors are allowed to do.

Medtronic had $15.9 billion in sales and $3.1 billion in profit last year. The company does not break out sales by products, but Infuse has been one of its best sellers.

Article source: http://feeds.nytimes.com/click.phdo?i=dc37b49644321b80f3264fe9e9c2db06

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