Monday, October 24, 2011

Doctors didn't disclose spine product cancer risk in journal -

Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company's spine surgery product in a 2009 paper about results of a large clinical trial.

The surgeons left out important data and claimed there was no significant link between the product and cancer.

The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.

The breach is the latest conflict-of-interest controversy facing Medtronic, which is under investigation by a U.S. Senate committee and the U.S. Justice Department for its marketing of the spine surgery product known as bone morphogenetic protein-2, or BMP-2.

The product is the bone growth stimulating biological agent used in the company's Infuse, which has been approved by the U.S. Food and Drug Administration, and Amplify, the unapproved product that was the subject of the 2009 paper.

In June, independent researchers found a systematic failure to report serious complications with BMP-2 in 13 papers published over nearly a decade. The papers were written by doctors who received millions of dollars from Medtronic. The unprecedented rebuke, which was published in the Spine Journal, was prompted in part by stories in the Journal Sentinel.

Medtronic and the lead author of the Amplify paper say there was no "statistically significant" cancer connection to the product at the time the paper was accepted for publication in the Journal of Bone & Joint Surgery . Medtronic also said results from the Amplify clinical trial can't be applied to BMP-2 in general.

The researchers had information showing that at two and three years after being implanted with the genetically engineered protein, significantly higher numbers of Amplify patients were being diagnosed with cancer, but they did not report it on their paper.

The authors mentioned the cancer link only in a table accompanying the paper. The text itself never addressed the concern of whether BMP-2 might fuel cancer.

"As a physician, you go by what your colleagues publish," said Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics. "It's an abuse of trust."

Posted via email from Jack's posterous

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