The long dark night of the Ethics Inquisition at the North American Spine Society (NASS) may be coming to an end.
In a remarkable admission by Chris Bono, M.D., the incoming president of the society, Bono says that “polarizing” events, like the “BMP issue” created a “noticeable rift” between NASS and other societies and some of its members.
Bono made the comment in an article written in the July/August edition of SpineLine.
Internecine Warfare
The reference to the BMP issue relates to the June 2011 Spine Journal Infuse article written by its Editor-in-Chief Eugene Carragee, M.D. Carragee alleged that some researchers were biased because of payments from Medtronic, plc, maker of the product.
An independent Yale study funded by the company eventually determined that we were back where we were before The Spine Journal’s assault on Infuse. Infuse works in certain patients and certain indications and not in others. And it is comparable to iliac crest bone graft (ICBG)—(the gold standard)—in its ability to stimulate bone growth.
A review of payments to surgeons by the company showed that many of the payments were for unrelated patents and many took place after the research was conducted.
But the damage was done. Support from industry waned and a purge of surgeons with strong industry ties left the NASS board isolated and captive to a Groupthink mentality that sent the pendulum swinging hard to assuming collaborations between surgeons and industry were inherently suspect. The society added an “ethicist” to its board of directors.
Collaboration Damage
Medtronic received the message and sent back one of their own. At the 2013 annual society meeting there was no Medtronic sales booth. The company only had an open space with chairs, tables and sofas. There was no sales staff, but only personnel from the company’s Office of Medical Affairs.
The ethics Inquisition didn’t just stop with an article in The Spine Journal and an internal membership rift. With the assistance of NASS public relations staff, the information found its way into the national press and ultimately a U.S. Senate hearing led by Iowa Senator Chuck Grassley.
Grassley used The Spine Journal’s words to paint a picture of unethical companies hiding evidence from regulators and paying surgeons to cook research evidence.
Gone Too Far
Slowly society leaders began to get the message. At an annual spine technology meeting held in Cabo, Mexico, in June 2015, NASS Executive Director Eric Muehlbauer told attendees that perhaps the society had gone too far in establishing and enforcing ethical standards. “Our ethics rules are constantly evolving, so we take great care to assess whether or not the rules go too far in establishing and enforcing ethics standards.”
Now the incoming president goes further.
In his SpineLine article, Bono says, “Let’s get everything out in the open. NASS, as a society has some real work to do.”
“Whether justified or not, past events have created a noticeable rift between NASS and other societies and some of its members. There has been a perception of uninhibited and full endorsement of polarizing events, like the ‘BMP issue.’ There have been allegations that NASS has actively blocked the approval or coding of new technologies. There has been a general sense that NASS is no longer a ‘spine surgeon’s society.’ I have lived through all of these events. In fact, I can take some responsibility via involvement in some of these events. Taking the next (and most difficult) step, I can tell you that I can understand the reasoning behind each of these complaints.”
Acknowledgment is the first step to recovery. Bono was Carragee’s deputy at The Spine Journal when the charges were made.
“In the past, we have perhaps gone too far in keeping distance between our industry partners and society leadership. This has sent the wrong message.” He said that by nature of NASS’s pioneering disclosure and divestment policy, “an apparent wall had been placed between those ‘with industry ties’ and the inner workings of the society for fear of biased decisions.”
That “apparent wall, ” was built by NASS leaders who publicly praised Carraggee’s courage and work. In his outgoing presidential address in 2012, NASS President Greg Przybylski, M.D. devoted a significant portion of his speech to address the controversies surrounding The Spine Journal.
Przybylski told attendees that there had been “a lot of controversy raised lately despite the fantastic accomplishments of The Spine Journal.”
While acknowledging that the pendulum had swung too far, Bono stuck firm to the notion that the importance on Level 1 compliance (i.e., divestment) for board members and certain committee chairs is critical. This will not go away.
Time to Change
“As the first Coverage Committee Chair, what legs do I have to stand on when I am asking for reimbursement (or not) of a new technology on behalf of members? They are quite simple: evidence and unbiased impartiality. At the same time, should I not speak to industry representatives or surgeon innovators? Should I close my ears and eyes to the information they have to provide? Am I so insecure in my ability to discern information, whatever the source, that I should be exclusionary? My answer is, succinctly, no.”
Bono wrote that he hears comments from, “NASS no longer supports surgeons, ” to “NASS is just a surgical society.” That NASS is “so pro-industry it’s disgusting, ” to “NASS has turned its back on industry.”
Each of the, statements, according to Bono, “represents an extreme opinion founded in at least some reality. While here is not the place to discuss events in detail, I acknowledge this.”
It’s not only about surgeons, said Bono. “As much as our ‘multidisciplinary’ society boasts equal treatment of nonsurgical and surgical issues, there is a tendency (I hope unintentional) to address nonsurgical issues with less fervor. As the membership growth has been more from nonoperative practitioners, greater attention must be paid to making sure things are as equitable as possible.”
Bono’s Promise
But the society can move beyond the tumult by believing in NASS. He promises there will be no hidden agenda on his watch. He said the society won’t support everything that “comes down the pike, ” but will also not be “wishy-washy, noncommittal” and only support something that has five high-quality randomized controlled trials.
Bono says the society has not “cowered away” from difficult issues (e.g. percutaneous sacroiliac joint fusion.) “Instead we have confronted them, albeit not with a unilateral rubber stamp of approval but rather with a balanced approach to enable reasonable access to treatments.”
He said a few years ago someone close to him and unhappy with NASS asked him why he stayed involved in NASS. “If you’re not involved, you have NO influence. It means you’re giving up.” Bono didn’t want to give up.
“It’s easy for NASS to be perceived as all for the ‘surgeons’ or all for the ‘nonoperative’ guys. Or as ‘anti-industry’ or an impedance to innovations. I am committed to listening to voices that have been inadvertently muted in years past.”
“NASS, ” continued Bono, has become a “machine in many ways—for health policy, guideline development and advocacy. Our roots, however, have grown from the development of the science of health care. We need researchers within our leadership ranks, both physician and nonphysician, to help guide us along the road of true advancement of spine care.”
Bono concluded that NASS can be considered guilty of making some decisions in a vacuum. “It’s time to equalize to atmospheric pressure to make the best possible choices.”
Chris Bono is a very smart guy. He was accepted into medical school in his senior year in high school and currently serves as chief of the Orthopedic Spine Service at Brigham and Women’s Hospital in Boston.
He’s got a lot of bridges to senior surgeons, industry and others to rebuild, and he’s taken the first step.
