Some powerful U.S. Senators are leveling serious charges against Medtronic, releasing today a sharply critical report on the company's spine product, InFuse.
The report, from Finance Committee Chairman Max Baucus, D-Mont., and senior member Chuck Grassley, R-Iowa, accuses Medtronic of failing to disclose the company's role in editing and writing medical journal articles to downplay the risks of the bone growth product.
The allegations against Medtronic are not altogether new.
Last year, an influential, peer-reviewed publication called The Spine Journal took a hard look at research on InFuse. The product is a protein that stimulates bone growth and is used in spinal fusion surgery.
Eugene Carragee, editor-in-chief of The Spine Journal, said the clinical research on InFuse, a total of 13 articles published in medical journals, was perplexing in its lack of warning about adverse effects.
"Our conundrum last year was that we had 13 trials and not a single complication that any of the authors associated with the drug, which is astounding," Carragee said.
He says even a simple drug like aspirin would have some ill effects.
As The Spine Journal took stock, the Senate Finance Committee raised questions about the financial relationships between Medtronic and the doctors writing about InFuse.
The committee got Medtronic to hand over more than 5,000 documents relating to the InFuse product. A 15-month investigation ensued. The committee is now concluding that Medtronic manipulated studies to underplay serious side effects of InFuse. They include male sterility and increased risk of cancer.
The report also says Medtronic paid fees to the authors of the studies on InFuse.
Medtronic denies any improper influence over the research as well as any financial inducements made to doctors. The company said it has taken steps to be more transparent about research on InFuse. In August 2011, Medtronic hired Yale University to independently review all the research data for the InFuse product. The results will come out in January.
"The way to go forward is for a commitment by the companies and by academics to have data upon which inferences are being made about the safety and effectiveness of drugs to be widely available," said Harlan Krumholz, a Yale University professor of medicine leading the review.
Krumholz said Medtronic did not have any say over who Yale commissioned to conduct the independent reviews. And Medtronic won't control how Yale shares the findings.
"And that should instill a lot of trust that they've decided to say, 'Fine, here are all the data. Let's hear what people say about it,' "Krumholz said.
Krumholz believes this kind of transparency is the way forward for Medtronic and other companies.
But Debbie Wang, an equity analyst with Morningstar, doubts changes are imminent given the close financial ties that companies commonly have with doctors researching their products.
"I think that this kind of activity is widespread and I don't think it's just Medtronic that's doing it," Wang said.
In the meantime, she says Medtronic probably won't suffer much from the Senate Finance Committee report on InFuse. Wang notes that sales of InFuse had already been flagging due to longstanding concerns.
And investors didn't seem too concerned by the report's findings: Medtronic's stock finished the day slightly up.
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