Attack on Researcher by Maker of “Mild” Spinal Device Raises Troubling Questions

A medical researcher who has raised questions about the effectiveness of the Mild spinal device has come under fire from Vertos Medical, the maker of the product.  According to a report from The New York Times, Vertos filed a complaint with the University of Saskatchewan accusing Dr. Daryl F. Fourney of scientific misconduct and ethics violations, after he reported some troubling findings from a small clinical trial for Mild.

Dr. Fourney insists he had an ethical duty to report his findings on the Mild procedures.  And at least one of his supporters has compared the Vertos attack on Dr. Fourney’s to a “time not that long ago when a manufacturer could prevent a study with negative results from being published,” according to the Times.

Vertos’ Mild product is used in a procedure to treat lumbar spinal stenosis, a common back condition of aging that can make walking and standing difficult, accord to the Times.  During the procedure, a small opening is made in the back and a special device is used to scrape away spinal tissue that has thickened.  The Mild procedure is used in people who are not yet candidates for traditional back surgery, and is intended to be an alternative to the cortisone shots that are used to control pain in such patients.  Mild procedures, which cost around $5,000 per patient, have been performed on some 10,000 people, according to Vertos.

Under his agreement with Vertos, Dr. Fourney was supposed to report on the progress made by Mild patients six months after they had undergone the procedure.  According to the Times, the trial started out well enough, with most patients reporting improvement at the six-month mark.  But later, Dr. Fourney said he began hearing from some patients who were in pain again. Overall, six out of 10 patients Dr. Fourney had treated with Mild developed pain so severe that they had to undergo the very back surgery the procedure was meant to avoid.  Dr. Fourney told the Times that this number represented an “unacceptably high” failure rate that raised “red flags”.  His findings were recently published in the journal Neurosurgery.

It was when he sent a draft copy of his report to Vertos that the company turned on Dr. Fourney.  In a letter to the researcher, Vertos called his findings a “gross misrepresentation of the facts.”  Vertos also filed the misconduct charge with the University of Saskatchewan, claiming Dr. Fourney had violated the terms of the study by following patients beyond its six-month term without getting clearance from Vertos first.  The company also claims that the patients Dr. Fourney chose for the trial were inappropriate because they were already back surgery candidates.  For his part, Dr. Fourney said the study protocol did not bar such patients, and pointed out that Vertos had originally marketed Mild as an alternative to back surgery, the Times said.

Vertos has also called Dr. Fourney’s finding an outlier, pointing to other studies that show positive outcomes with Mild.  But Dr. Eugene Carragee, a researcher with Stanford University and editor of The Spine Journal, noted that the research Vertos used to defend Mild suffers from their own shortcomings.

“The thing that gets me about this is the double standard,” said Dr. Carragee, has been a frequent critic of the medical device industry. “The positive findings are pushed far beyond their scientific merit and the limitations of it are being ignored.

Dr. Carragee also criticized Vertos’ for the intensity of its campaign against Dr. Fourney.

“Either this company has a poor or odd understanding of what the ethical responsibilities of a researcher are or this was a naked attempt at intimidation,” he told the Times.

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