NASS 2011: Controversies in Chicago

"Who are we to believe?" asked the surgeon from the audience during a well attended session called "Controversies In Spine" at the 26th Annual Meeting of the North American Spine Society (NASS) held in Chicago the first week of November.

The question was put to Eugene Carragee, M.D., the editor-in-chief (EIC) of The Spine Journal (TSJ) whose controversial June 2011 issue about BMP researchers hovered over the meeting like an elephant in the room. The controversy centered on allegations that some researchers were biased because of payments from industry.

"I'm 10 years into my practice. Who do we believe? When the literature comes out, what's real and what's not?”

Carragee said there are process changes in place so that the disclosures are clearer, the associations are clearer. “I think 15 years ago in publishing it would be impossible to connect the primary data to an article. Now you can.... There are plenty of reasons to think that there can be a better review.”

"On the other hand, if someone says I have a really really powerful growth factor and I gave it to 800 people and I didn't have a single or adverse reaction that is ascribed to this powerful growth factor—then, I think your mother would tell you what to believe there."

Research, Corruption and Bias

Jerry Knirk, M.D., from the Boston area told Carragee from the audience, "Your paper regarding BMP really brings up the fact that we need a better way to fund research. And it's an interesting thing to note that not only politicians are corruptible by large amounts of money. We need a way to fund research that's not depended on industry and massive amounts of payments to individuals for data."

Carragee told Knirk that there was a whole literature on incentives and the acknowledged biases and apparent biases.

"But certainly if you line all these things up where you have the sponsor and the investigator who has products with the same sponsor also writing the paper on the products, they have a financial relationship with the same sponsor, you're compounding the risk of intentional or unintentional bias all the way along the way."

"In the [June] editorial we've said this is a problem that is as old as the Scriptures and as clear as the U.S. Constitution. This is not new business. I don't think that we should have an exceptional idea of ourselves that in the early 21st Century these motivations that are found in the Old Testament have suddenly disappeared, " added Carragee.

With that exchange and the ensuing reports in The New York Times, Reuters and other media about the controversies surrounding BMP research, it was tempting to see the NASS meeting as being about Carragee and TSJ.

Przybylski Tackles Controversy

The outgoing NASS President, Greg Przybylski, M.D., fed into that narrative by devoting a portion of his annual presidential address to the controversies surrounding TSJ. The annual addresses are touchstones about the state of spine care and providers.

Przybylski told attendees that there had been "a lot of controversy raised lately despite the fantastic accomplishments of TSJ, including becoming the leading spine journal in the U.S. Many focused on the June issue on BMPs with lots of questions and concerns being raised."

Elsevier Primary Decision Maker

"TSJ is in fact, the journal of NASS. It is owned by Elsevier who is the publisher. While we work collaboratively, Elsevier is the primary decision maker in terms of choosing the editor-in-chief. There is a separation between TSJ and the TSJ Editorial Board and the NASS Board and association in order to maintain scientific integrity.

"This is no different than other professional medical associations in which the journal has an arms-length relationship. The Association does not, and should not have any activities that could be politically motivated that influence the editorial process."

Przybylski said the editorial process is guided by rules of its own and Elsevier ensures that those rules are followed.

Five Trends in Spine

Przybylski's speech however, focused primarily on the socio-economic issues confronting the spine care community. He noted numerous problems with the Affordable Care Act and spoke about five trends that he believes will impact providers.

1. Limitation. In the past there were few limitations as choices made by physicians and patients were approved routinely. But with more spine procedures being performed, Przybylski said insurers began to look at coverage and "misplaced financial incentives."

2. Innovation. Most clinical studies used to be done in the U.S. and venture capital was readily available. But now, he said trials are moving to Europe with less than half of all trials done in the U.S. in 2009 and venture capital availability has declined. He also noted a 2.3% excise tax on device manufacturers that will result in job losses and reduced investments by industry.

3. Regulation. Documentation to get paid used to be less complicated, said Przybylski. But continuing medical education and recertification requirements, quality reporting, electronic mandates, more data collection and lessened industry financial support for continuing education is making it harder on physicians to comply with regulations.

4. Compensation. Przybylski said providers will be challenged as the fee-for-service system is phased out. He also pointed to a 30% cut in physician payments scheduled for 2012, the IPAB, primary care flexing its muscles at the RUC (Relative Value Scale Update Committee ) and bundled payments will all make it hard for physicians to get paid.

5. Incarceration. “But, what I’m most fearful of is incarceration, ” said Przybylski. He noted that in the past, government investigations have focused on institutional audits with settlements over fraud involving billing practices and fraudulent billing by durable medical equipment services. |

   But that’s changing, according Przybylski, as congressional investigations and recovery audits are now focusing on physicians. “The DOJ will look at individual practitioners for criminal investigations.” He cited the possible kickback problems with physician-owned distributorships and Medicaid criminal indictments by state Attorneys General.

"The future seems sobering, " said Przybylski.

The Face of NASS?

Given these external pressures on NASS members and recent efforts to convince payers and regulators that the association is the professional society "to believe" when it comes to providing unbiased scientific evidence for quality spine care, we wondered if the high profile of Carragee and TSJ was pitting members against one another and making Carragee the face of the society?

We asked Dr. Carragee and some former presidents and a former editor-in chief of the journal that question.

Guyer: “A Sign of the Times”

Rick Guyer, M.D.Rick Guyer, M.D., 2008 NASS president, told us he believes the controversy is important to a small proportion of the society’s membership and it would be mistake to say that the issue was the focus of the NASS meeting or the organization. He told us what was happening is a sign of the times, not just in medicine, but in all areas. He reminded us that NASS continues to grow; now having 6, 800 members. He believes the changes to strengthen transparency and disclosures are a good thing.

He told us that the way Dr. Carragee and TSJ went about the BMP articles can be debated, but the principles are sound.

Baker: “Controversy Detracts From Urgent Problem”

Ray Baker, M.D., NASS president before Przybylski told us that to say the face of NASS in 2012 looks like Gene Carragee is more “conspiratorial than the reality.”

He told us the controversy is unrelated to NASS in the larger sense. He said Carragee was not asked to be EIC of TSJ as a part of the new “ethical NASS.” He was nominated by Charlie Branch, M.D., received the approval of the board, and was then formally accepted by Elsevier as EIC because of his qualifications. Period.

Ray Baker, M.D.Baker said NASS honestly seeks diversity, including seeking out some board members with a strong track record of industry relations. “You only have to look as far as Charlie [Branch] and my choices for program chairs (who sat as board observers): Steve Glassman, M.D. and Alex Vaccaro, M.D. Thus, mixing the two topics is really a stretch and, I believe, incorrectly portrays the inner workings of NASS and the relationship between NASS and TSJ.”

In retrospect however, Baker says NASS could have done some things better, including accurately portraying TSJ as separate from NASS. Nevertheless, he said the association had upheld the sacred firewall between a professional medical association and journal/editorial content. “We did not use TSJ as a bully pulpit for NASS' views.”

Baker believes that all detracts from a far more urgent problem: how to maintain the U.S. as #1 in medical device innovation over the next decade?

“We need to spend less time 'circling the wagons and shooting inward'; we need to work together to improve the FDA; work on coding, coverage, and reimbursement to facilitate adoption of appropriate new technologies; and work with industry to produce revolutionary innovations that improve quality at a low cost. To accomplish this, we all need to work together. This includes associations and industry, as well as physicians and industry. These relationships are not only appropriate, they are vital to the future of spine care.”

“That is why the NASS AM in Chicago was really more about our new registry and our value awards, and less about TSJ/BMP.

Branch: “Accused and Accusers Lining Up For Battle”

Charlie Branch, M.D., the previous editor of TSJ who nominated Carragee for the post told us the 2011 NASS meeting was by many metrics a great success.

Charlie Branch, M.D.“Yet, the focus on Gene Carragee’s analysis and commentary on the BMP studies generated a great sense of disappointment. Given that much of his presentation had already been published, this wasn’t really new information but should have been a very meaningful platform for honest, scientific debate of the merits and flaws of the original studies and Carragee’s retrospective analysis.” 

But, says Branch, given the highly charged presentation of the June issue of TSJ and the NASS press releases “fanning the fire, this scientific meeting became more of a media or professional society circus. If this entire subject had been presented in the journal and by the NASS Media team with a humility or lack of hubris that Gene Carragee appeared to embrace with his platform presentations, then a true scientific debate and credible search for meaning and truth might have ensued.”

“Instead, the potential for this has been lost forever in the polarity of the accused and the accusers lining up to do battle.”

Finally, we asked Dr. Carragee about the controversy.

Carragee: “Problem of Systematic Bias”

Carragee said he is only an "ex officio" NASS board member.

“I serve as the editor in chief of TSJ. NASS, like most organizations with ‘sister’ publications, adheres to a policy of independence for the journal’s editorial board. The editorial board in turn follows the guidelines of the International Committee of Medical Journal Editors, the Committee on Publication Ethics and other editorial best practices. In my opinion, The Spine Journal and NASS enjoy a mutually beneficial relationship, largely in part because of that very independence.”

Carragee says that the journal shares with NASS the mission of improving quality clinical care. The journal's mandate is to do so through the scientific presentation of evidence, with the debate and dialog of a scientific journal; NASS has a much broader platform to effect that end. “I would disagree that we are moving away from that point of reference.” 

“For medicine as a whole, the last decade or more has brought into focus the problem of systematic biases associated with large economic forces and potential conflict of interests. From Nature, to Lancet, to NEJM and JAMA, these have become important and high-priority issues to address in the field of scientific publication—it's not a matter of "outing" researchers with conflicts, as you put it, but giving the reader the context to judge potential research bias. Addressing potential research bias, be it in study design, data collection, analysis or presentation, is the primary operational function of an editorial board. It should not, in my opinion, be controversial when an editor works to that end.”

Luther, Hemingway, Kennedy and Euripides

We asked him about his biblical references and whether or not he sees NASS undergoing a Reformation where he is the Martin Luther.

Regarding biblical references, Carragee wasn’t so sure. “In the June BMP-2 editorial we cited Hemingway and John Kennedy; in the vertebroplasty editorial it was Arthur Conan Doyle and Shakespeare; in my BMP-2/cancer symposium presentation it was Euripides. Although afflicted at a young age with a classical Jesuit education, I haven't found it an adult disability. Martin Luther was a radical, innovative theologian—none of our proposals regarding editorial process reforms are particularly new. If people are shocked, it's more along the lines of Claude Raines in ‘Casablanca’—who was ‘shocked, shocked’ to discover gambling going on at Rick's American Cafe.”

Where NASS stands today in its relationship with TSJ and whether the BMP controversy is symptomatic of a deeper schism between various member groups within the organization itself will play out over the term on the new NASS president elected in Chicago, Michael Heggeness, M.D., Ph.D. of Baylor University.