A disagreement over a 10-patient study conducted at the University of Saskatchewan four years ago hit the pages of The New York Times on September 5, 2012.
At issue was whether or not, Vertos Medical Inc., a small California device company and developer of the “mild” procedure, tried to squelch research and intimidate Daryl Fourney, M.D., the investigator conducting the study by filing a formal complaint against him with his university.
Royal University Hospital, University of Saskatchewan/Wikimedia Commons and Drm310This story begins in November 2007, when the University of Saskatchewan Investigational Review Board (IRB) approved a 10-patient pilot study of patients who were on a waiting list for laminectomy with fusion surgery. The study would be conducted by Dr. Fourney after he received a grant to fund the work (not from Vertos). The IRB reviewed the proposed study protocols, including a six-month end point, and approved the study plan. Dr. Fourney agreed to abide by those protocols.
“mild” Procedure
Vertos’ “mild” procedure treats lumbar spinal stenosis by removing portions of the lamina and ligametum flavum to restore space in the spine. According to published studies, the procedure provides an early option after failed injection, but before more invasive surgery.
“mild” Tool Kit/Vertos Medical Inc.The first University of Saskatchewan patient was treated in September 2008 and the final and tenth patient was treated by July 2009. In May 2011, according to the company, Dr. Fourney submitted a draft of his results from the study to Vertos and it included 18-month follow-up data. A month later, the company sent Dr. Fourney a letter taking issue with his decision to include 18-month data. They copied the University.
Dr. Fourney did not want to limit his study report to a six-month follow-up, which was the study protocol, and which was Vertos’s request. Negotiations between the company and Dr. Fourney ensued. But no compromise was reached. Eventually, Dr. Fourney’s study result report was published in the journal Neurosurgery but not, according to the company, as a clinical study. Instead, it was published as a ‘case series’ report which is Level 4 evidence.
So why did this little study on the prairies of Saskatchewan end up in The New York Times?
New York Times reporter Barry Meier wrote that that the disagreement over the study, “provides a glimpse into the sometimes contentious world of medical testing and the federal rules that allow device makers to market new products with little or no data about their long-term effectiveness or safety.”
The “mild” procedure has been cleared by the FDA through the 501(k) clearance process.
Carragee
Meier backed up this narrative by bringing in Eugene Carragee, M.D., the editor of The Spine Journal, the official journal of the North American Spine Society.
Dr. Carragee reportedly said it was, “not surprising to see device producers like Vertos laud studies that supported their product and denounce ones that did not.” But the intensity of the complaints by Vertos about Dr. Fourney reminded him, stated the article, “of a time not that long ago when a manufacturer could prevent a study with negative results from being published.”
Dr. Carragee, according to Meier, said that what he found most striking about the episode was how Vertos and its allies were attacking Dr. Fourney about the quality of his research when the research being used to promote the company’s procedure was also limited and of questionable value.
Meier reports that Dr. Carragee said: “The thing that gets me about this is the double standard. The positive findings are pushed far beyond their scientific merit and the limitations of it are being ignored…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.”
Jim Corbett, the CEO of Vertos said regarding Dr. Carragee: “I don’t know what he knows. I can only say what I think is that it’s neither of those. It was a very basic disagreement over the conduct of the scientific elements of a pilot study. It was our first step to understand how to design a better study.
“I have no idea how Dr. Carragee could have any direct knowledge of the scope or intensity of our concerns. He could have learned something from the Times reporter and he could have learned something from Dr. Forney.”
Corbett said inclusion of information after the end point of the protocol would have meant reaching a conclusion without adequate data. “Dr. Fourney simply said that the patients needed surgery, but never explained why or provided data to demonstrate why. It would not be a good study.”
“If the pain and disability scores had gotten worse and he presented that data saying look the pain scores improved at six months, but got worse in a year, I had to do surgery, that would be a wholly rational conclusion, ” added Corbett
Meier writes that the company filed a “complaint” with the University of Saskatchewan. “In that complaint, Vertos accused Dr. Fourney of scientific misconduct and violating ‘research ethics’ by failing, among other things, to follow the study’s original protocol and by independently deciding to follow his patients for added time without seeking agreement from Vertos.”
“We did not file a complaint against Dr. Fourney, ” said Corbett. “We sent the letter [noted earlier]. That’s it. Filing a complaint is a very different thing.”
The company said the letter stated the following:
Dr. Fourney, we have had this discussion on this population of patients three times in the past year. The various elements described in your manuscript provide, at a bare minimum, ‘perceived’ scientific misconduct. This is evidenced by the multiple issues we have raised previously to you, and in this letter.
Corbett said Dr. Fourney never responded directly to him about the letter. “I did hear from the University. They said they appreciate my communication. They later wrote that they looked into it and have resolved it.”
Corbett also told OTW that the Times “distorted and omitted” important facts about the “proven” “mild” back-pain relief procedure.
“The article highlighted an extremely limited and scientifically flawed study (only 10 patients), while failing to even mention that its conclusions are contradicted by a vast body of FDA-registered research (on clinicaltrials.gov)—including more than 400 patients tracked in eight published studies. The long-term research performed by Dr. Fourney was not registered with the FDA as is the proper scientific protocol. His study also didn’t provide any data that would lead to his long-term conclusions. This boils down to a sincere disagreement on the science.”
We ask again, why was this such a big deal worth coverage in The New York Times?
We have reported in the past on stories in the Times and The Wall Street Journal which weave a narrative of industry misbehavior and greed at the expense of patients. Clearly, the relationship between industry and surgeons has undergone a significant change since the deferred prosecution agreements with major hip and knee makers and the passage of the Sunshine law contained in the healthcare law, also known as “Obamacare.”
Accusations against the company for trying to intimidate Dr. Fourney through an official complaint and associating the company and Dr. Fourney’s disagreement to the larger issue of surgeon industry relationships and a controversial FDA clearance process, did not serve to inform surgeons, industry and the public about science.
Daryl Forney, M.D.
University of SaskatchewanIt’s hard to imagine that Dr. Fourney would be easily intimidated. He’s a well-known clinician and researcher.
Spine recently named him and Scott Boden, M.D., reviewers of the year for completing the best reviews for the journal in 2011.
Dr. Fourney has served as president of the Canadian Spine Society and is a member of Spine’s associate editorial board. This past year, he served as the annual meeting chair for the American Association of Neurological Surgeons and Congress of Neurological Surgeons Joint Section on Disorders of the Spine and Peripheral Nerves. He is currently the director of the neurosurgery residency program at the University of Saskatchewan and authored more than 60 published peer-reviewed articles during his career.
If a journalist wants to weave a narrative which rests on the premise that industry is behaving badly, he must offer evidence with the same rigor and accuracy that is expected in medical technology reporting.
The Times story offered no evidence that the “mild” procedure was improperly cleared by the FDA, nor did the story offer credible evidence that this company filed a “complaint” against Dr. Fourney or tried to squash evidence.
Are there lessons here for industry? We asked Corbett.
“I’ve been a CEO for 26 years and have been involved in all levels of trials, studies and device development. This was a very unique case and I can’t draw any lesson yet, ” said Corbett. He also told OTW that he did not expect this situation to have any impact on the company’s regulatory or coverage status. He said the majority of the U.S. is now covered, with more decisions to come.
He added, “Thankfully, Medicare contractors are required to use peer-reviewed literature to make their decisions. The New York Times is not one of them.”
Are there lessons for researchers?
We wanted to ask Dr. Fourney. Unfortunately, he was unavailable in time for this story’s deadline, but a University of Saskatechewan official told us that Dr. Fourney will be available to discuss the details of this study in the near future and respond to this story. We’ll report back on his side of the story and what lessons may be learned by researchers as the surgeon/industry relationship continues to evolve.
