The New York Times published a story in early September about a disagreement between Daryl Fourney, M.D. and Vertos Medical, Inc. over the publication of a case study of patients undergoing Vertos’ “mild” procedure. On September 18, Vertos’ CEO Jim Corbett told us his side of the story.
Corbett cited errors on the Times story and left us wondering why this ten person case study was worthy of coverage in America’s “Newspaper of Record.”
This week Dr. Fourney tells his side. He had a lot to say.
The “Mild” Study
A quick review.
In November 2007, the University of Saskatchewan approved a pilot study of ten patients who were on a waiting list for laminectomy with fusion surgery. The University reviewed the proposed study protocols, including a six-month endpoint, and approved the study plan.
Vertos’ “mild” procedure treats lumbar spinal stenosis by removing portions of the lamina and ligametum flavum to restore space in the spine.
Publishing Disagreement
After the endpoint of the study was hit, Dr. Fourney wanted to include information obtained after the study that six out of the ten patients needed surgery. The company objected to including post-study data. Dr. Fourney disagreed and the company filed a complaint with Dr. Fourney’s University. His study was eventually published in the journal Neurosurgery as a case study and included his information about the needed follow up surgery.
NY Times: Intimidation, Cover-Ups and Product Safety
The Times reported, the situation was, “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 NY Times Source: Wikimedia commons and HaxorjoeThe Times further reported that the company tried to intimidate Dr. Fourney by filing a formal complaint with the University of Saskatchewan. “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, ” wrote Barry Meier, the Times reporter.
The Times also quoted The Spine Journal Editor Eugene Carragee, M.D. saying, that the intensity of the complaints by Vertos about Dr. Fourney reminded him “of a time not that long ago when a manufacturer could prevent a study with negative results from being published.”
Charges of intimidation, cover-up of clinical evidence and federal rules allowing products with no data about safety and effectiveness got our attention and we dug in.
Intimidation
Was this, as Dr. Carragee asserts, an example of corporate misconduct? Or is it a case of a misunderstanding?
Vertos’ Corbett told us that the company did not file a formal complaint against Dr. Fourney and only sent a letter to him and the University about his plan to include data in his report past the study endpoint.
Dr. Fourney says that isn’t true and the company did indeed file a formal complaint against him with his employer.
“The Times characterized this correctly. Mr. Corbett does not, ” said Dr. Fourney. He said the letter referenced by Corbett was not where the company lodged the complaint against him to the University.
“The formal registration of complaint of scientific misconduct from Mr. Corbett and Vertos is in a separate letter…It was addressed to the President of the University of Saskatchewan with a copy to the Chair of the Research Ethics Board. It states, ‘Dear Peter [MacKinnon]: I am writing to register a formal complaint of scientific misconduct against your faculty, Dr. Daryl Fourney.’”
“Either Mr. Corbett has forgotten about his own letter or he is attempting to mislead readers of Orthopedics This Week, ” said Dr. Fourney.
“I Forgot”
Corbett went with the memory excuse.
“For clarification, I did forget that I sent this additional letter, ” Corbett said. “That was my mistake. At the end of the day, none of this changes the fact that my concerns were based on a sincere disagreement over the science, or lack thereof, behind Dr. Fourney’s study.”
Did Dr. Fourney think the company was trying to intimidate him? Was he intimidated?
“Yes and yes. Any professor would feel intimidated by an allegation of scientific misconduct. This was not a mere disagreement regarding ‘the science’ as Mr. Corbett attempts to portray. Rather, Vertos has questioned my credibility, ” said Dr. Fourney.
Unsafe Devices Without Data
Did Dr. Fourney agree with the Times’ characterization of this being an example of implanting new products into patients with no data about safety?
“I generally agree with this statement from The New York Times, said Dr. Fourney. “However, the published data on “mild” shows that it is safe in large numbers of patients. There is only one anecdotal note from BNI in a letter to the editor of Pain Physician that really questions safety. However, BNI has not done a clinical study as of yet. I have never disputed that “mild” appears to be relatively safe in the published studies—the main question is how effective it is. If the effectiveness long term is low, then it is questionable how much risk, if any, is acceptable.”
Study Disagreements
Daryl Fourney, M.D.What about including data after the endpoint of the study was hit?
Dr. Fourney says whoever tipped off the Times must have read his response to Dr. Chopko’s letter to Neurosurgery. (See Fourney DR. In reply Neurosurgery 2012; 71:E526-8.)
“Dr. Chopko asked why the article included data after the study closure at six months. I explained that after the study closed, I kept seeing patients with refractory neurogenic claudication. I felt this was important for patients and physicians to know about this, and my Research Ethics Board (REB) agreed. Although Vertos did not want to extend the study protocol, the REB determined that it was my ethical obligation to include the reoperation results as ‘post-study’ outcomes.”
Cover Up?
Corbett said that he didn’t try to keep Dr. Fourney from publishing his results in a report. He just didn’t want it part of the study because revising the protocol retrospectively would have been difficult.
“[That’s] not entirely true, said Fourney. “They did not want me to report on the need for reoperation after six months, despite the Research Ethic’s Boards’ confirmation that it was my ethical obligation to report it.
Did he speak with Dr. Carragee about this?
“I spoke to several academic colleagues, in confidence, about my problems with Vertos trying to prevent my results from being published through several means including the misuse of allegations of academic misconduct.” He agrees with Dr. Carragee’s description on the Times that Vertos has a “poor or odd understandings of what the ethical responsibilities of a researcher are or this was a naked attempt at intimidation.”
Dr. Fourney said he believed the Times story was fair because both side were able to weigh in. “Your method of interviewing me with these questions after publishing Vertos’ side is clearly biased.”
Fourney’s Rebuttals
Dr. Fourney added that he went to his Research Ethics Board to get their opinion on what to do about the post-study need for reoperation, and received their memorandum agreeing that it was his ethical obligation to report this data. “We never breached the protocol of the original study. The findings after six months were described in the article as ‘post-study outcomes.’” He disputes the suggestion that his study was not FDA-registered, but it was only post-study events that were not part of the FDA-registered protocol.”
Study Size
He takes issue with the description of the study as having methodological limitations because it only involved ten patients, while the limitations of the Vertos-funded research, which he described in detail in his response to Dr. Chopko’s letter, including serious conflict of interest oversights, have not been mentioned. (See Fourney DR. In reply Neurosurgery 2012;71:E526-8.).
He points out that enrollment was ceased after he realized that MRIs showed no decompression and many patients had refractory neurogenic claudication.”
Case Series Versus Clinical Study
He also takes issue with Vertos’ description of the study as a “case series” rather than a clinical study. “All studies lacking a control group are essentially case series. This includes all of the “mild” studies with the exception of one small randomized trial that compared “mild” to epidural steroid injection. Despite the positive ‘conclusions’ of that study, after analysis of variance with repeated measures, there were no significant between group differences (PRLL vs. ESI) for average VAS improvement (P = 0.54) or ODI (P = 0.86). The mean ZCQ patient satisfaction score also showed no statistically significant between group differences at week six (P > 0.05). (See Brown LL. A Double-blind, Randomized, Prospective Study of Epidural Steroid Injection vs. The mild® Procedure in Patients with Symptomatic Lumbar Spinal Stenosis. Pain Pract 2012.)”
Dr. Fourney says a key finding of his study, which he says has not been challenged, is that the “mild” procedure did not produce any measurable decompression on post-op MRI.
Corporate Sponsorship
Vertos said Dr. Fourney received a grant to fund his work, but that the grant did not come from them.
Dr. Fourney said this is “another key factual flaw.” He said this suggests that some other competitor may have funded this work. “The contract with the University of Saskatchewan clearly names Vertos as the sponsor.”
After hearing directly from the company and Dr. Fourney, we are still left scratching our heads wondering who wanted this in The New York Times and why the paper saw this case in Canada as an example of U.S. rules that “allow device makers to market new products with little or no data about their long-term effectiveness or safety.”
